VERNON COLEMAN tm


   

 

men in dresses Betrayal of Trust - out of print (was £9.95 paperback and may be available from your library)

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PREFACE

The public trust doctors. But the public has been betrayed. Doctors trust drug companies. But that trust has been betrayed. And animals trust us all. And we have betrayed them.

In the past, protests about animal experiments have usually been either ethical or moral or have been based on the argument that they are scientifically invalid. In this book Iintend to take the argument one step further and to show that animal experiments are not merely unscientific and useless but are also a major factor in the incidence of iatrogenesis (doctor-induced disease) which is now the commonest cause of serious illness in the developed world. Animal experiments are killing people.

Those who perform or support animal experiments often argue that the work they do cannot be stopped until acceptable replacements have been developed (since it is they who will decide which replacements are 'acceptable', it is easy to see that this is simply a way of organising an indefinite delay). The fact is, however, that we would be better off with nothing rather than the present system. The existence and availability of alternatives is irrelevant because animal experiments are not just pointless and inaccurate; they are also misleading and a major danger to public health. They must be stopped. Animal experiments are far, far worse than useless and we would all (with the exception of the drug industry and its employees) be much better off without them.

Animal experiments are at the heart of a major deceit; a massive confidence trick which drug companies use to help them trick doctors into prescribing drugs which are neither safe nor effective. It is no accident that iatrogenesis is one of the commonest causes of ill health today-it is, indeed, a result of a deliberate policy

The greed of the pharmaceutical industry and the greed of an unquestioning and easily bought medical profession have allowed those who test new drugs to pass off animal experiments as a valuable aid. The truth is that even after doing animal experiments we still have to do tests on people but the animal experiments enable the drug companies to get away with fewer tests and in consequence the use of animal experiments is directly responsible for the size of the iatrogenesis problem. International, computerised monitoring of drug side effects (which 1 have been suggesting for decades) would cost very little to organise and would save thousands of lives but would badly damage drug industry profits.

Animal experimenters kill around a thousand animals-cats, dogs, monkeys, rats, mice, sheep, guinea pigs-every thirty seconds. Those animals all die in vain. As this book clearly shows, animal experimentation is a betrayal of many different types of trust.

Vernon Coleman Devon, December 1993

 

CHAPTER ONE

THE HARM DOCTORS DO

The incidence of doctor induced illness is now epidemic throughout the western world, and although the medical profession accepts that doctor induced illness is commonplace, many doctors still seem unwilling to accept that the problem is a serious one. In 1988, in my book The Health Scandal, I reported that Dr Gareth Beevers, a physician at the Dudley Road Hospital in Birmingham and a lecturer in medicine at Birmingham University, had estimated that 10- 15% of patients were in hospital with drug related problems. Two years later, in 1990, DR Patrick Pietroni, Senior Lecturer in General Practice at St Mary's Hospital Medical School, claimed that at any given time one in six patients were in hospital because of some side effect of their medication. No one disputed this figure. One medical commentator seemed quite proud of the fact that if only one in six patients in hospital are there because they have been injured by doctors, then it must also be true that five out of six patients in hospital haven't been injured by doctors.

Iatrogenic illness-doctor induced disease-is now a massive problem, though I suspect that the 'one in six' figure is an underestimate. It is impossible to quantify the overall size of the problem precisely-particularly in general practice-for the very simple reason that nine out of ten doctors fail to record or report drug side effects (even though the evidence shows that 40% of patients suffer side effects while taking drugs). The threat of legal action means that doctors are constantly wary of admitting any sort of liability.

But, using the official figures, I have made an attempt to produce a serious estimate of the number of patients who suffer from iatrogenesis in England (where the population is around 46,000,000).

According to the British Department of Health there were 255,000 hospital beds in England in 1990/91 (the figure has been falling steadily since 1980). Of these 255,000 beds, 46,000 were for geriatric patients and 78,000 were for psychiatric patients both groups tend to be long-stay patients-and this means that there were 131,000 beds for acute, short-stay, medical, surgical and obstetric patients whose length of hospital stay is (again, according to government figures) usually around six days. Applying the 'one in six' figure, it is clear that if all the 131,000 available beds were occupied all of the time, then 21,833 patients on acute wards would be there because they had been made ill by doctors.

Since there are approximately sixty periods of six days in a year it is clear that if all hospital beds were full all the time then there would be 1,309,980 patients a year in hospital because they had been made ill by a doctor.

However, on average only around three quarters of the beds available are full at any one time. So this figure needs to be reduced to 982,485.

To this, of course, we need to add the psychiatric and geriatric patients who are in hospital because they have been made ill by doctors. As I have already pointed out there were 124,000 hospital beds available for psychiatric and geriatric patients in 1990/91. If we assume that each patient stayed in his or her bed for a month (long-stay hospitalisation is discouraged these days) this would mean a total of 1,488,000 patients going through longstay hospitals. But, again, we can assume from government figures that only three quarters of the available beds were occupied at any one time and so this gives us a figure of 1,116,000 patients. If we then divide this by six we find that an additional 186,000 patients in geriatric and psychiatric hospitals were in hospital because they had been made ill by doctors.

Added together the figures suggest that in 1990/91 a total of 1,168,485 patients were in hospital in England because they had been made ill by doctors.

I found this figure so staggering (it suggests that doctor induced illness is now the greatest causes of illness in England) that I decided to tackle the figures another way.

The Department of Health figures show that in 1990/91 (the last year for which figures were available in the autumn of 1993) English hospitals treated 7,524,000 patients. If one in six of these patients were there because they had been made ill by doctors then the total number of patients needing to go into hospital in 1990/91 because of problems caused by a doctor would be 1,254,000.

So, either way, the figures produce similar results: suggesting that well over a million patients a year are admitted to English hospitals because they have been made ill by doctors. The conclusion has to be that iatrogenesis is undeniably a major cause of illness in modern society. Even if we (generously) accept the older 'one in eight' figure for the number of patients suffering from iatrogenic illnesses in hospitals, it is clear that the size of the problem is now enormous.

THERE IS NOTHING new in the fact that doctors kill people. Doctors have always made mistakes and there have always been patients who have died as a result of medical ignorance or incompetence.

But, since we now spend more on health care than ever before, and since the medical profession is apparently more scientific and better equipped than ever before, there is a savage irony in the fact that we have now reached the point where, on balance, well-meaning doctors in general practice and highly trained, well-equipped specialists working in hospitals do more harm than good. The epidemic of iatrogenic disease which has always scarred medical practice has been steadily getting worse and today most of us would, most of the time, be better off without a medical profession.

Most developed countries now spend around 8% of their gross national products on health care (the Americans spend considerably more-around 12-14%) but through a mixture of ignorance, incompetence, prejudice, dishonesty, laziness, paternalism and misplaced trust doctors are killing more people than they are saving and they are causing more illness and more discomfort than they are alleviating.

Most developed countries now spend around 1% of their annual income on prescription drugs and doctors have more knowledge and greater access to powerful treatments than ever before, but there has probably never been another time in history when doctors have done more harm than they do today.

It is true, of course, that doctors save thousands of lives by, for example, prescribing life saving drugs or by performing essential life saving surgery on accident victims.

But when the medical profession, together with the pharmaceutical industry, claim that it is the advances in medicine which are responsible for the fact that life expectancy figures have risen in the last one hundred years or so, they are wrong. It is, for example, commonly claimed that modern scientific medicine has led to improvements in life expectation in most developed countries from around 55 years at the start of the century to over 70 today.

The evidence does not support this claim.

The improvement in life expectancy which has occurred in the last hundred years is not related to developments in the medical profession or to the growth of the international drug industry; but the increase in iatrogenesis is related to both these factors.

Whichever facts you look at, they seem to support my contention that although doctors may do a limited amount of good, they do a great deal more harm.

IF DOCTORS REALLY did help people stay alive then you might expect to find that the countries which had most doctors would have the best life expectation figures. But that isn't the case at all.

In America there is one doctor for every 500 people and life expectancy for black males is around 65. In Jamaica there is one doctor for every 7,000 people and life expectancy for men is around 69. In North Korea there is one doctor for every 400 patients and life expectancy for males is 63 years. In South Korea there is one doctor for every 1,500 people and life expectancy is 64 years. America spends more per head on health care than any other nation in the world and yet its citizens have one of the lowest life expectancy rates in the western world. (It is, of course, possible to argue that there are many other differences, other than the number of doctors, between South Korea and North Korea; but it is reasonable to expect doctors to influence those factors. Moreover, if doctors as a group are going to claim responsibility for health care successes-which they do-then it is surely also fair that they should take overall responsibility for mortality and morbidity rates.)

The Americans spend around $2,000 per person per year on health care and yet out of every 1,000 live births twelve children will die before they reach their fifth birthday. In Japan, where the expenditure on health care is considerably less than half that in America, the number of children who will fail to reach their fifth birthday will be eight out of every one thousand born. The Americans spend around 12-14% of their gross national product on high technology medicine but, on average, they are sicker and die younger than individuals in most other developed countries.

Infant mortality rates in Asia are lower than those in Western Europe while estimated life expectancy at birth is higher in the Far East than it is in the over-doctored West.

Only when severely underdeveloped countries are compared to developed countries are there clear differences in infant mortality rates and life expectation figures and in these instances it is the differences in the infrastructure of the countries which explain the difference. My view may sound startling and controversial but it is a view shared by a growing number of independent experts around the world. These figures hardly support the image of doctors as an effective healing profession.

Even more startling, perhaps, is the evidence of what happens when doctors go on strike and leave patients to cope without professional medical help.

You might imagine that without doctors people would be dying like flies in autumn. Not a bit of it. When doctors in Israel went on strike for a month admissions to hospital dropped by 85% with only the most urgent cases being admitted, but despite this the death rate in Israel dropped by 50%-the largest drop since the previous doctors' strike twenty years earlier-to its lowest ever recorded level. Much the same thing has happened wherever doctors have gone on strike. In Bogota, Colombia, doctors went on strike for 52 days and there was a 35% fall in the mortality rate. In Los Angeles a doctors' strike resulted in an 18% reduction in the death rate. During the strike there were 60% fewer operations in 17 major hospitals. At the end of the strike the death rate went back up to normal.

Whatever statistics are consulted, whatever evidence is examined, the conclusion has to be the same. Doctors are a hazard rather than an asset to any community In Britain the death rate of working men over 50 was higher in the 1970s than it was in the 1930s. The British were never healthier than they were during the Second World War.

Figures published by the United States Bureau of Census show that 33% of people born in 1907 could expect to live to the age of 75 whereas 33% of the people born in 1977 could expect to live to the age of 80. Remove the improvements produced by better living conditions, cleaner water supplies, and the reduction in deaths during or just after childbirth and it becomes clear that doctors, drug companies and hospitals cannot possibly have had any useful effect on life expectancy Indeed, the figures show that there has been an increase in mortality rates among the middle aged and an increase in the incidence of disabling disorders such as diabetes and arthritis. The incidence of diabetes, for example, is now reported to be doubling every ten years and the incidence of serious heart disease among young men is increasing rapidly. Today death rates from heart disease among adults are 50 times higher than they were at the start of the century. In countries such as America where there has been a slight fall in the incidence of heart disease, it is clear that the improvement has been a result of better eating habits (by and large this simply means consuming less fatty food) rather than any improvement in medical care. The explosion of drugs and surgical treatments for heart disease has had no positive effect on death rates. On the contrary, there is a considerable amount of evidence to show that the increase in the use of such procedures as angiography, drug therapy and heart surgery has resulted in more deaths. People in the West are being doctored and drugged to death. Four out of five people in the world live in underdeveloped countries but four out of five drugs are taken by people in developed countries. Despite the expenditure of enormous amounts of money on screening programmes, deaths of young women from cancer continue to go up and every time one infectious disease is conquered another seems to take its place. Bacteria are becoming increasingly resistant to antibiotics and the number of disabled and incapable citizens in developed countries is increasing so rapidly that it is now clear that by the year 2020 the disabled and incapable will outnumber the healthy and able bodied.

In Britain, where free access to doctors and hospitals is available to everyone, life expectancy for 40 year olds is lower than almost anywhere else in the developed world. In America 6% of hospital patients get a drug resistant, hospital induced infection and an estimated 80,000 patients a year die in this way. This puts hospital infections high among the top ten causes of death in America.

When doctors and drug companies produce figures which show that there has been a (usually slight) increase in life expectation during the last one hundred years or so, they invariably overlook the massive contribution made by improved living conditions, cleaner drinking water, better sewage disposal facilities, more widespread education, better (and more abundant) food and better and safer methods of transport. All these factors have had a far more dramatic influence on mortality and morbidity rates than the provision of health care services.

Relief organisations working in underdeveloped parts of the world are well aware that they can make an impact on mortality rates far more speedily by providing tools, wells and shelter than by building hospitals or clinics or importing doctors and nurses. Sadly, the governments receiving help are often loath to accept this and are frequently much more enthusiastic about building state of the art hospitals complete with scanners, heart transplant teams and intensive care units than they are about building homes, installing irrigation systems or planting crops.

This obsession with high technology leads to problems in all areas of health care. For example, the control of malaria was going well for as long as stagnant pools of water were removed, but when it was discovered that the mosquitoes could be killed by spraying DDT and that the disease could be controlled by using drugs such as chloroquine, the authorities stopped bothering to remove stagnant pools. Today mosquitoes are resistant to DDT and the parasites which cause malaria are becoming resistant to the drugs: malaria now kills around 1.5 million people a year.

THOSE WHO ARGUE that doctors are responsible for any improvement in life expectancy which we may enjoy overlook the fact that from the dark ages, through the Renaissance and up to the first few decades of the twentieth century, infant mortality rates were absolutely terrible and it was these massive death rates among the young which brought down the average life expectation.

The Foundling Hospital in Dublin admitted 10,272 infants in the years from 1775 to 1796 and of these only 45 survived. In Britain deaths among babies under one year old have fallen by more than 85% in the last century. Even among older children the improvement has been dramatic. In 1890 one in four children in Britain died before their tenth birthday. Today 84 out of every 85 children survive to celebrate their tenth birthday. These improvements have virtually nothing to do with doctors or drug companies but are almost entirely a result of better living conditions. In 1904 one third of all British schoolchildren were undernourished. Poor diets meant that babies and small children were weak and succumbed easily to diseases. Older children from poor families were expected to survive on a diet of bread and dripping and many women who had to spend long hours working in terrible conditions were unable to breast feed their babies, many of which then died from drinking infected milk or water.

When the improvements in child mortality figures are taken out of the equation, it is clear that for adults living in developed countries life expectation has certainly not risen in the way that both doctors and drug companies usually suggest.

It isn't even possible to credit vaccination programmes with the improvement in life expectation since the figures show quite clearly that mortality rates for diseases as varied as tuberculosis, whooping cough and cholera had, as a result of better living conditions, all fallen to a fraction of their former levels long before any of the relevant vaccines were introduced.

IF DRUGS WERE only ever prescribed sensibly and when they were likely to interfere with a potentially life threatening disease, the risks associated with their use would be acceptable. But all the evidence shows that doctors do not understand the hazards associated with the drugs they use and frequently prescribe inappropriately and excessively. Many of the deaths associated with drug use are caused by drugs which did not need to be taken.

The best example of the modem tendency to over-prescribe probably lies in the way that antibiotics are used. One in six prescriptions is for an antibiotic and there are at least 100 preparations available for doctors to choose from. When antibiotics-drugs such as penicillin-were first introduced in the 1930s they gave doctors a chance to kill the bacteria causing infections.

The impact made by antibiotics has been exaggerated because most of the diseases which are caused by organisms, which are susceptible to antibiotics, were on the decline before the antibiotics were introduced.

Nevertheless, these drugs are undoubtedly of considerable value. The problem is that although doctors are aware of the advantages of these drugs (if they are in any doubt, the drug companies will frequently remind them) they seem unaware of the hazards associated with their unnecessary use and there is no doubt that most of the prescriptions which are written for antibiotics are unnecessary Many patients are suffering from viral infections which are not susceptible to antibiotics and others would get better by themselves without any drug being prescribed.

Various independent experts who have studied the use of antibiotics claim that between 50% and 90% of the prescriptions written for antibiotics are unnecessary. To a certain extent doctors over-prescribe because they like to do something when faced with a patient-and prescribing a drug is virtually the only thing most of them can do. And to some extent prescribing a drug is a defence against any possible future charge of negligence (on the basis that if the patient dies it is better to have done something than to have done nothing). But the main reason for the overprescribing of antibiotics is, without doubt, the fact that doctors are under the influence of the drug companies. The makers of the antibiotics want their drugs prescribed in vast quantities. It makes no difference to them whether or not the prescriptions are necessary.

The over-prescribing of antibiotics would not matter too much if these drugs were harmless and if there were no other hazards associated with their use. But antibiotics are certainly not harmless. Penicillin alone is said to kill over 1,000 people a year, and if nine out of ten prescriptions are unnecessary then it is not unreasonable to assume that nine out of ten deaths are unnecessary too. The unnecessary and excessive use of antibiotics causes allergy reactions, side effects and a huge variety of serious complications. There is also the very real hazard that by overusing antibiotics doctors are enabling bacteria to develop immunity to these potentially life saving drugs. There is now no doubt that many of our most useful drugs have been devalued by overuse and are no longer effective.

IT IS NOW widely accepted that at least 40% of all the people who are given prescription medicines to take will suffer uncomfortable, hazardous or potentially lethal side effects.

I say 'at least' because, for a variety of reasons, the vast majority of doctors never admit that their patients ever suffer any side effects. In Britain, for example, nine out of ten doctors have never reported any drug side effects to the authorities-authorities who admit that they receive information on no more than 10-15% of even the most serious adverse drug reactions occurring in patients. In other words they admit that they never hear about at least 85-90% of all dangerous drug reactions! Astonishingly, it is even accepted that some doctors will withhold reports of serious adverse reactions and keep their suspicions to themselves in the hope that they may later be able to win fame by publishing their findings in a journal or revealing their discovery to a newspaper or magazine.

Because the real figures about drug hazards are hidden, patients assume that drugs are safe to take, will act in a predictable, effective way and are of recognised quality and standard. None of these assumptions is correct and none of the thousands of the drugs which are available satisfies these criteria. Patients who take drugs are taking a risk; they are often taking part in a massive experiment, and by taking a medicine may become worse off than if they had done nothing. To make things worse no one knows exactly how big the risks are when a particular drug is taken. All drugs are potential poisons that may heal or may kill.

The medical profession, the drug industry and the regulatory bodies all accept that the hazards of using any drug will only be known when the drug has been given to large numbers of patients for a considerable period of time.

ASTONISHINGLY, DESPITE the hazards associated with their use, drugs are controlled less in their development, manufacture, promotion, sale and supply than virtually any other substance imaginable.

In an average sort of year in a developed country, at least 1 in 250 people will be admitted to hospital because of a drug overdose. One in 50 of them will die. Even more worrying is the fact that every day thousands of people are admitted to hospital not because of an overdose but because a drug taken at prescribed levels has caused serious and possibly life-threatening symptoms. Since doctors rarely admit to it when adverse effects occur, the chances are that the true figures are much higher than this.

One of the major reasons for the disastrously high incidence of problems associated with drug use is the fact that the initial clinical trials, performed before a drug is made available for all general practitioners to prescribe for their patients, rarely involve more than a few thousand patients at most. Some initial trials may involve no more than half a dozen patients.

However, it is now well known that severe problems often do not appear either until at least 50,000 patients have taken a drug or until patients have used a drug for many months or even years. Because of this a huge death toll can build up over the years. Drug control authorities admit that when a new drug is launched no one really knows what will happen or what side effects will be identified.

Doctors and drug companies are, it seems, using the public in a constant, ongoing, mass testing programme. And the frightening truth is that far more people are killed as a result of prescription drugs than are killed as a result of using illegal drugs such as heroin or cocaine.

The treatments for many common diseases such as arthritis, backache and allergies such as hay fever and eczema frequently provide inadequate relief and often cause adverse effects which are far worse than the original complaint.

THE MOST CONVINCING evidence for the failure of our current drug testing systems to protect patients properly lies in the number of drugs which have to be withdrawn after they have been tested on animals and issued with licences. Withdrawing drugs from the market is not something which either the manufacturers or the authorities approach lightly. Apart from the obvious commercial losses that follow when a drug is taken off the market, withdrawing a drug means a certain amount of embarrassment for everyone concerned. Drug companies, licensing authorities and scientists who have written glowing reports about the drugs which are removed all try to avoid this obvious humiliation.

The following list, which is taken from evidence supplied to me by various sources including the British government, details some of the principal drugs which were completely or partly taken off the market, or which were made available only with restrictions, because they weren't considered to be safe enough. The list relates to drugs which were dealt with between 1961 and 1993. Not all these drugs were marketed in every country. And, bizarrely, some drugs which have been withdrawn in some countries are still on sale in other countries. Some of these drugs were withdrawn from the market after being on sale for just a few months. Others were taken off the market after being available for over half a century. And some were banned for use by general practitioners but still retained for use in hospitals. There are even drugs which have been withdrawn but which are now being used again for other disorders. For example, thalidomide (which was originally introduced in 1956 as a sedative and hypnotic and which was withdrawn from the market in 1961 because of teratogenic effects) is now being used in the treatment of leprosy.

The main trade names for the withdrawn drugs are included in brackets.

As I HAVE already pointed out some drugs which have been withdrawn in one or more countries are still available, and still widely prescribed in other countries. And just as bizarrely, even when a drug is withdrawn from sale in one or more countries there is frequently little cooperation between the authorities around the world. It would seem logical to expect that when a drug is withdrawn in one country information would be passed to other countries so that similar action could immediately be taken elsewhere. My information shows that this does not happen. For example, the drug phenformin was officially withdrawn from the market in the USA and France in 1977, but was only officially withdrawn in the United Kingdom five years later in 1982.

THE NUMBER OF patients being injured by drugs would undoubtedly be considerably higher if it were not for the fact that many patients either never start taking tablets which have been prescribed for them, or else stop taking their tablets early. Stopping a drug because it produces unpleasant side effects is very common and many patients never start taking pills because they are frightened of what might happen to them. In most developed countries up to 70% of all the drugs prescribed are thrown away! The drug companies do not mind, of course. They have still sold the drug and made their profits. It is one of the great ironies of modern life that not taking the drugs you are prescribed can sometimes save your life.

IT IS NOT only by prescribing drugs or vaccines that doctors do harm. There is plenty of evidence to show that patients are at risk merely by going into hospital.

At least 1 in 20 of all hospital patients will pick up an infection in hospital-mostly urinary tract, chest or wound infections and mostly caused by doctors and nurses failing to wash their hands often enough.

Since Ignaz Philipp Semmelweiss first demonstrated (in the mid-nineteenth century) that deaths in the delivery room were caused by dirty hands, every child has been taught the importance of basic personal hygiene. Sadly, the message does not seem to have got through to the medical and nursing professions. One recent study showed that nurses washed their hands only once every three times after cleaning around a patient's catheter. Another study at a major hospital showed that hand washing by staff was well below recommended levels. A study of doctors' habits showed that two out of three anaesthetists failed to wash their hands before treating a new patient (even though anaesthetists frequently perform venepuncture surgery) while one in three surgeons did not wash their arms properly before an operation.

At least one third of all hospital infections are caused by dirty hands and the cost in simple financial terms is colossal (though not, of course, as horrendous or as unforgivable as the cost in human terms). And it is hardly surprising that people who stay at home to be treated-or who go home quickly after day-case or short-stay surgery-usually get better much quicker than people who need long-stay treatment.

DRUG-RELATED TRAGEDIES are often the ultimate responsibility of the drug industry rather than the medical profession, but there is ample evidence to show that incompetent or careless doctors do cause a horrifying amount of death or injury.

In America, the Public Citizen Health Research Group has shown that 'more than 100,000 people are killed or injured a year by negligent medical care'. The real figure is probably considerably higher than this and there can be little doubt that many of the injuries and deaths are caused by simple, straightforward incompetence rather than bad luck or unforeseen complications.

When doctors from the Harvard School of Public Health studied what happened to more than 30,000 patients admitted to acute care hospitals in New York, they found that nearly 4% of them suffered unintended injuries in the course of their treatment and that 14% of these patients died of their injuries. This survey concluded that nearly 200,000 people die each year in America as a result of medical accidents. This means that more than four times as many people die from injuries caused by doctors as die in road accidents.

Carotid endarterectomies - in which deposits are removed from the arteries in the neck-are currently fashionable in America where doctors earn $1.5 billion a year performing them. But when a study of carotid endarterectomies was recently completed it was found that 64% of these operations were either unjustified or of debatable value because the symptoms were not severe enough to justify the risks of the operation. For pacemaker implants the equivalent figure is 56%. Coronary bypass operations are immensely popular among heart surgeons (and extremely profitable) but a major study conducted in Europe showed that many patients who don't have surgery live longer than those who do. In 1990 American surgeons performed 350,000 coronary bypass operations and charged $14 billion for them. When one researcher studied 300 patients who had had bypass operations at several hospitals in California, he discovered that 14% of the patients would have thrived as well without surgery as with it, while another 30% were borderline. Around 50% of lower back disc operations and up to 70% of hysterectomies are probably unnecessary. In America death toll from unnecessary surgery alone has been estimated to be as high as 80,000 patients per year.

Two Irish doctors recently reported in the British Medical Journal that 20% of British patients who have slightly raised blood pressure are treated unnecessarily with drugs. Two pathologists who carried out 400 post mortem examinations found that in more than 50% of the patients the wrong diagnosis had been made. A British Royal College of Radiologists Working Party reported that at least a fifth of radiological examinations carried out in National Health Service hospitals were clinically unhelpful. In Britain the Institute of Economic Affairs claimed that inexperienced doctors in casualty units kill at least one thousand patients a year.

Today's doctors may laugh at the surgeons who chopped out lengths of bowel to treat constipation or who cut out pieces of brain to treat hysteria, but modern practices may to future generations seem no easier to understand. Around the world there are still hundreds of doctors chopping out lengths of bowel, putting staples in stomachs or wiring up jaws to treat patients who eat too much. There are still hundreds of doctors giving patients electric shocks because they are depressed or chopping out bits and pieces of brain to treat problems as varied as schizophrenia, anxiety and drug addiction. Most alarming of all, perhaps, is the fact that as hospitals are filled with increasingly sophisticated equipment (which doctors and technicians often do not entirely understand) so the opportunities for error are constantly being upgraded. For example, there have been several reports showing that patients receiving radiation treatment have been given the wrong dosage.

It was recently estimated in one medical publication that three quarters of Britain’s surgeons were still using hernia repair techniques which were regarded internationally as obsolete. Surveys of junior hospital doctors regularly show an alarming ignorance about drugs, prescription writing and the performance of simple, practical procedures.

The overuse of medical facilities-particularly surgery-is a common cause of unnecessary injury and death. When a patient is likely to die if an operation is not performed, the risks associated with the operation may be acceptable. But when procedures are performed unnecessarily the risks become unacceptable.

According to Fortune magazine, American hospitals now try to attract doctors who will bring in patients likely to run up substantial bills. Centres offering investigative facilities often offer lucrative partnerships to doctors who are prepared to promise to make lots of referrals. Research in British hospitals has shown that pregnant women who are in private beds in NHS hospitals are twice as likely to have their babies by Caesarian section as women in NHS beds. Could this be due to the fact that surgeons looking after private patients can charge a hefty extra fee for delivering a baby by Caesarian section?

TODAY, WE HAVE sophisticated diagnostic aids, monitoring systems, drugs, microscopic surgery, lasers and a thousand and one other miracles and yet we are, by and large, over-cautious, hypochondriacal, drug abusing, overweight, neurotic, constipated, nervous, neurasthenic, hysterical and unhealthy. We are a tribute to and a product of our times.

When, to this appalling roll call of doctor induced disease, you add the steadily increasing dissatisfaction with extended waiting lists, arrogant doctors, indifference and a lack of civility or caring it is hardly surprising that millions of people are today abandoning the traditional suppliers of medical help and seeking help from alternative practitioners.

In 1984 a survey of British family doctors revealed that 16% of GPs spent less than 12 hours a week with their patients, including the time spent on home visits, while only 10% spent more than 28 hours with their patients. Another survey showed that the average British doctor spends slightly less than 23 hours a week talking and listening to patients.

When GPs can't make a diagnosis or need help with providing their patients with treatment, they usually refer them to hospital. But the evidence shows that hospital specialists are no more reliable than GPs and many patients referred to hospital are likely to see a doctor with less experience.

The National Audit Office in Britain said in 1990 that it suspected hospital consultants of neglecting health service duties for private commitments in many of the hospitals it had visited. In general surgery fewer than half of all new patients and only one third of all patients attending a hospital clinic are seen by a consultant. In medical clinics just over a quarter of patients are seen by doctors who have worked for less than six months in their present speciality after registration. Much of the work performed in hospitals is done by tired, incompletely trained doctors.

The rise in the number of people seeking help from alternative and complementary medical practitioners-often untrained and offering unproven forms of treatment-is a sign that a growing number of people are dissatisfied with the service provided by the orthodox medical profession and are prepared to try almost anything rather than to entrust themselves to allopathic medicine.

Orthodox medical practitioners like to give the impression that they have conquered sickness with science but there are, at a conservative estimate, something in the region of 18,000 known diseases for which there are still no effective treatments-let alone cures. Even when treatments do exist their efficacy is often in question. A recent report concluded that 85% of medical and surgical treatments have never been properly tested.

As drug companies become increasingly aware that curing serious disease is beyond their capability (and, indeed, their desire-for why should drug companies, which make their money out of people being sick, want to make people well?), they spend more and more effort on finding drugs to improve life or performance in some vague way.

There can be little doubt that a former Director General of the World Health Organization got it absolutely right when he startled the medical establishment by stating that 'the major and most expensive part of medical knowledge as applied today appears to be more for the satisfaction of the health professions than for the benefit of the consumers of health care'. The evidence certainly supports that astonishing and apparently heretical view. Profits, not patients, are now the driving force which rule the medical profession's motives, ambitions and actions. Doctors don't seem to care any more. The passion has gone out of medicine.

In my view the biggest single reason why the medical profession is killing so many people is its alliance with the pharmaceutical industry.

The myth that we live long and healthy lives thanks to the drug industry and the medical profession has increased our expectations. We no longer expect to fall ill. We expect a magic solution when we fall ill. We don't want to be bothered making any effort to stay healthy because we have been taught to have faith that if we fall ill then the medical men will be able to cure us.

The drug industry likes to pretend that it has made us healthier, but it is the drug industry that is in particularly good health!

Twenty years ago the world drugs market was worth a miserly $12 billion. By the end of the 1980s it was worth $140 billion. By 1990 it was worth well over $170 billion and the industry estimates that it will be soon be worth well over $300 billion a year. And today the drug industry has almost total control over the medical profession.

Over 40% of the information doctors receive about the drugs they prescribe comes directly from drug company representatives and drug company leaflets. Well over 50% of the rest of the information they receive comes from medical journals and meetings which are sponsored by drug companies. In the mid 1970s, in my book The Medicine Men, I warned that the medical profession was being controlled by the drug industry and had no real right to call itself a profession. Today, there is no longer any doubt. Today, the drug industry owns the medical establishment and much of the medical profession.

It is widely accepted that the majority of illnesses do not need drug treatment. Most patients who visit a doctor neither want nor expect drug treatment. But at least eight out of ten patients who visit a general practitioner will be given a prescription (though growing numbers of patients do not take the drugs that are prescribed for them).

Sadly, the myth about our improving health is just that-a myth. We do not live longer or healthier lives than our predecessors. On the contrary, although we consume greater and greater quantities of medicine than ever before, more of us are ill today than at any time in history. On any day you care to choose in just about any developed country you care to mention, over half the population will be taking a drug of some kind. A recent survey of 9,000 Britons concluded that one in three people are suffering from a long standing illness or disability~ Other surveys have shown that in any one fourteen-day period 95% of the population consider themselves to be unwell for at least a few of those days. At no time in history has illness been so commonplace. We spend more than ever on health care but no one could argue that there is any less suffering in our society

The number of people attempting suicide is increasing every year and as more and more powerful drugs are produced and handed out the number who succeed is also increasing-despite the expenditure of vast amounts of money on equipment and drugs designed to bring people back to life again. Patients do not treat doctors in the same critical way that they treat other providers of a service because they have been taught to trust the medical profession. But that trust now appears to be misplaced.

What on earth can be the explanation for all this?

Is it simply that doctors are in the pay of the drug industry? Or are doctors more dishonest, more stupid and more incompetent than ever before?

In the chapters that follow I will provide some alarming answers to these straightforward questions.

 

 

CHAPTER TWO

DOCTORS: INCOMPETENT,IGNORANT AND FRAUDULENT

In order to understand exactly why doctors are doing so much harm, it is first of all necessary to demolish a very basic medical myth: that medicine is a science.

The truth is that it is not. That may seem a startling claim. But it is not difficult to prove.

Doctors, medical researchers and drug companies do, of course, like to persuade all present and potential consumers of health care that medicine is a science which has advanced beyond the mystical incantations and witch doctor remedies of the past.

But modern medicine is not a science and modern clinicians and medical researchers are not scientists.

Modern clinicians may use scientific techniques but in the way that they treat their patients they are still quacks and charlatans, loyal to existing and unproven ideas which are profitable and resistant to new techniques and technologies which may be proven and effective.

The fact that a doctor may use a scientific instrument in his work does not make him a scientist-any more than a typist who uses a word processor is a computer scientist. The scientific technology available to doctors may be magnificent but the problem is that the application of the scientific technology is crude, untested and unscientific.

It isn’t difficult to find examples showing the ineffectiveness of modern medical science.

Cancer is the killer that frightens people most. The very word is so emotive that most doctors try not to use it when talking to patients. Instead of talking of cancer they talk of 'tumours' and 'growths'. But large charities trying to raise money aren't so shy; they know that this fear can easily be translated into cash. Around the world some of the biggest, best established and most successful charities are those collecting money for 'cancer'. Between them they attract hundreds of millions of pounds worth of donations and legacies every year.

Many of those who give money to one of the high profile cancer charities do so in the same spirit that they would buy insurance; by making a donation to a cancer charity they are, they hope, helping to ensure that if they or one of their loved ones ever contract cancer then their donation will have helped to pay for a cure. People whose relatives have died of cancer make donations partly in memory of their loss and partly in the hope that by giving money they will help to ensure that the same thing doesn't happen again.

The huge army of cancer researchers and administrators who are kept in business by the money they raise through this potent stimulus-fear-are certainly not shy about using the word ‘cancer'. They know that many people who see the word 'cancer' on the side of a collecting tin will find it impossible to resist making a donation. Many people subconsciously feel that by making a donation to a cancer charity they are buying themselves some instant protection. It is, after all, much easier to slip a few coins into a stranger's tin than it is to stop smoking or avoid eating cancer inducing fatty foods. The big cancer charities employ thousands of scientists, and their publicity specialists make sure that every new piece of research is passed on to newspapers and television. All around the world patients (especially children) who are alleged to have been cured by new anti-cancer remedies are ruthlessly paraded in front of potential supporters. Journalists are rarely as sceptical as they should be and the man and woman in the street can hardly be blamed for believing that researchers are managing to conquer cancer.

In order to ensure that money continues to pour in, the big cancer charities must, of course, persuade potential contributors and supporters that they are making progress in the fight against cancer. The man or woman who puts a coin into a collecting tin for a cancer charity is almost certainly convinced that the researchers he or she is supporting have already made great progress and have helped to tame this much feared killer.

But are the thousands of highly paid, much lauded cancer researchers really making noticeable progress in the fight against cancer? I don't think so. And my scepticism is shared by a growing number of other medical observers. There has been some success in the treatment of cancers of the blood (diseases such as leukaemia) but the mortality figures show that as many people (if not more) are dying from commoner forms of cancer now as were a generation ago. One in three people already have, or will develop, cancer. Figures from around the world show that the picture is much the same everywhere. More than ten per cent of America's entire health care bill is spent on cancer research and treatment. But in America, during the last fifteen years or so the incidence of cancer has steadily risen as has the number of people dying of cancer. Writing in the European Medical Journal DR Jack Tropp - Director of the International Health Information Institute in Los Angeles, a Member of the Board of Directors of the International Association of Cancer Victors and Friends (the oldest holistic cancer information centre in the United States) and author of Cancer.. A Healing Crisis - has pointed out that 'despite the billions of dollars spent each year for cancer research and treatment, using the traditional methods of choice: surgery, chemotherapy and radiation therapy, in the overall picture nothing has changed in the mortality rates in the last thirty-five years.' Independent scientists who have assessed the value of the war against cancer agree that we are losing the war, and that there is no evidence to suggest that decades of expensive research have made much, if any, effect on the most fundamental measure of success-death.

I don’t think there is much doubt that (if their aim was to save human lives) the regiments of enthusiastic volunteers who spend their free hours working in fund raising shops or raising money by organising stunts and events could have spent their time and energy in other far more effective ways. To describe cancer research as of doubtful financial validity is to be generous to a fault. To be blunt, the charities those fund raisers have so enthusiastically supported have failed miserably to conquer cancer.

In areas where cancer has become more amenable to treatment, or now takes fewer lives, it is changes in lifestyle that are responsible. Chimney sweeps' boys who used to scramble up chimneys to loosen the soot were prone to develop cancer of the scrotum because of all the soot. After the Chimney Sweeper's Act of 1788 this particular practice was gradually outlawed (though it was still common enough at the end of the nineteenth century). Now that young boys are no longer pushed up chimneys the incidence of this particular type of cancer has fallen. In the last few decades the incidence of stomach cancer has fallen but this has been a result of a change in dietary habits rather than the result of laboratory experiments.

Despite all the sponsored jogging and other fund raising, the incidence of some cancers-cancer of the skin and cancer of the colon, for example-is going up, not down. All the effort, all the money, all the misguided hope and faith that have been poured into cancer research hasn't worked.

Consider breast cancer - one of the most constantly publicised and most greatly feared forms of cancer. Because of its very nature it is a type of cancer which arouses much emotion. Newspapers, magazines and medical journals have for decades been full of articles describing new forms of treatment. At the beginning of 1993 the medical journal The Lancet, in an editorial, commented that: 'If one were to believe all the media hype, the triumphalism of the profession in published research, and the almost weekly miracle breakthroughs trumpeted by the cancer charities, one might be surprised that women are dying at all from this cancer.'

But women are still dying from breast cancer. Indeed, the overall death rate from breast cancer hasn't changed and isn't changing. Despite all the talk and all the promises the number of women dying from breast cancer hasn't altered. The disease is still as great a killer as it was decades ago. Approximately 25,000 cases of breast cancer are diagnosed every year in Britain and 180,000 a year are diagnosed in the United States of America.

(Incidentally, when an animal researcher attempts to test the safety of a potential breast cancer treatment on a laboratory mouse the chances are that the mouse will be male. The reasons are simple: male mice are easier to catch and cheaper to buy.)

Raising money for cancer research is now big business. But it is a business that has, if you assess its effectiveness critically, been a dismal failure. And the cancer industry has faded because it has concentrated its efforts on the wrong targets. Millions of pounds have, for example, been spent on giving cancer to animals and thousands of highly paid researchers have spent much of the money raised by enthusiastic volunteers on watching cancers spread throughout millions of animals. The cancers which affect animals are, of course, quite different to the cancers which affect human beings.

We know what causes most forms of cancer.

Cancer is created by chemical pollutants, by unhealthy food and by tobacco. Poisoned water supplies, dangerous prescription drugs and the over use of X rays have also contributed to the incidence of cancer. With immune systems constantly battered by polluted air, adulterated, chemically impregnated food and a constant onslaught from the drugs we buy for ourselves or allow our doctors to prescribe for us, it is not surprising that increasing numbers of people succumb to one of the many different types of cancer.

But tackling these causes does not seem to be a priority. Governments subsidise tobacco farmers and bend over backwards and sideways to accommodate the wishes of the pharmaceutical industry.

Most ironic of all is the fact that the evidence now suggests that many of the treatments used for patients with cancer (and regarded by those who support the 'cancer industry' as evidence of the effectiveness of their war) may themselves cause cancer and that instead of offering hope to parents, the medical profession itself may now be the major cause of childhood cancer! In October 1993 the British Medical Journal published a research paper which, it concluded, showed that 'modern chemotherapy for childhood cancers may be an independent aetiological factor for second tumours'. The authors of the paper, a team of medical scientists from the Nordic Society of Paediatric Haematology and the Oncology Association of the Nordic Cancer Registries, representing the five Nordic countries of Denmark, Finland, Iceland, Norway and Sweden, pointed out that: 'The risk for a second malignant neoplasm after cancer in childhood or adolescence seems to be high relative to that in the general population and also in comparison to the relative risk for second tumours observed after a first tumour diagnosed late in life.' Another report, published in the same issue of the British Medical Journal, noted that: 'Most childhood leukaemia is now thought to be due to mutations initiated by environmental agents.' The British Medical Journal noted that the only confirmed culprit is X rays, though the drug chloramphenicol is a probable culprit.

The ultimate explanation for the failure of the cancer industry to conquer cancer is probably the simplest and yet the most cynical. The cancer industry has, like the pharmaceutical industry, become large and powerful and dependent for its existence upon the terrors it is supposed to be trying to banish from our world. The pharmaceutical industry has no interest in curing illness. Cures for heart disease or arthritis would lose it billions of pounds. The industry prefers to sell long-term treatments which never cure but which do provide it with enormous profits. The cancer industry is now in the same position. If cancer were conquered by teaching people how to adapt their lifestyles so that they avoided the provocative factors which are known to cause it then a massive, international, multi-billion dollar industry would be out of business. Thousands of highly paid researchers, animal breeders and handlers and administrators would have to seek useful work in the real world.

The future of the cancer industry depends upon the continuing threat from cancer. If cancer were conquered or controlled, thousands of well paid people would be out of work.

THE OTHER MAJOR concern of recent years has been AIDS. From the way that journalists and politicians have dealt with the AIDS story you might imagine that the virus causing this disease was a completely mystery; that it had arrived from nowhere and that doctors and scientists were now struggling, shoulder to shoulder, to find a cure. That isn't quite true. AIDS, like so many other modern diseases, was created by man. And to medical researchers AIDS has been more of a financial bonanza than a deadly target to be eliminated.

No one is sure exactly where the virus causing AIDS came from (if, indeed, AIDS is caused by this single virus-there is, at the time of writing, considerable controversy over this, though the scientific community, which has an enormous vested interest in the now traditional HIV-AIDS theory, is reluctant even to accept that AIDS may have some other cause). There are, however, several theories about the origin of AIDS and these theories all have one thing in common: they all suggest that the disease originated as a result of laboratory experiments.

Under normal, healthy, natural circumstances there are barriers which prevent the spread of viruses from one species to another. Human beings are not normally vulnerable to viruses which afflict dogs or cats, for example. But scientific researchers, deliberately transferring viruses between species, have overcome this natural safety mechanism and opened up a Pandora's box of horror that can be never be sealed again. Back in 1989, writing in the Journal of the Royal Society of Medicine, DR J Seattle pointed out that: 'Viral species tend to be restricted to the host animal species which they infect', but warned that: 'It would appear that the AIDS epidemic may be just one of the latest of several mammalian cross species viral transfers triggered by the techniques of virology developed in the twentieth century, which subsequently spread out of control in the new host species'.

Just when, and how, the HIV virus which causes AIDS was first installed in human beings is a mystery

One British researcher has claimed that AIDS was introduced into the human blood pool in 1922 when at least 34 people were injected with blood from chimpanzees to see if the animals' malarial parasites would have any effect on humans. Another 33 people received blood from this initial group and it is claimed that it was these individuals who were the first AIDS carriers.

A second possibility, reported at length in Rolling Stone magazine by writer Tom Curtis, is that the AIDS virus was injected into human patients along with the poliomyelitis vaccine. The medium that scientists used to produce the vaccine-the kidneys of monkeys caught in the wild-was found sometimes to be contaminated by monkey viruses which were then passed on to unsuspecting, innocent and usually healthy human patients. Between the mid 1950s and the early 1960s many tens of millions of people around the world were injected with a polio vaccine that contained a monkey virus. (The virus was later claimed to make human cells prone to cancer. We'll probably never know now whether mothers who dutifully took along their children to be vaccinated against polio were unwittingly having their children injected with cancer inducing viruses.)

What we do know is that vaccines were administered to many people in Africa in the late 1950s. If, as has been alleged, one of the vaccines used was contaminated with an unknown monkey virus, then it is, I suspect, possible that the AIDS virus may have come from that mass inoculation programme.

Sadly, I doubt if we are ever likely to know for sure whether or not the AIDS virus did originally come from a vaccination programme. Leaders of the medical establishment seem reluctant even to discuss the possibility and orthodox medical journals have dedicated little space to the study of this question. One wonders if their reluctance to investigate could be inspired by an awareness that if a link is discovered the cost to their beloved pharmaceutical industry could be unbearable; both from expensive lawsuits and through the fact that if a link is proven it might permanently frighten members of the public into refusing to accept vaccinations.

Those are by no means the only theories about how the HIV virus first came to affect human beings. But all the theories I've been able to find involve laboratory animals and research scientists.

WHICHEVER ANIMAL RESEARCH laboratory the AIDS virus came from there is little doubt that once AIDS had arrived on the scene the world's pharmaceutical companies were quick to leap upon the idea of making a profit out of the disease.

It was the pharmaceutical industry, largely through its more or less total control of the medical establishment, which helped to manufacture and maintain the AIDS myth. The myth-the inaccurate assertion that AIDS was the greatest threat to humankind since the Black Death plague-began by accident, was built up for crude commercial reasons and was eventually exaggerated by pressure groups who had their own very special reasons for turning a nasty disease into a global threat. AIDS brought together several groups of people who had nothing at all in common and united them in a unique way

In the beginning it was just a good news story: another potentially lethal disease for which there seemed to be no obvious cure available. A few well known victims-particularly film stars-gave the disease a rare glamour that enabled the feature writers to put a little spin on what was basically a rather low key story. The drug companies quickly recognised that AIDS offered unprecedented opportunities to make money; within a short space of time they were making millions of dollars out of selling AIDS tests and new drugs.

At the peak of the AIDS scare-in the mid 1980s-shares of companies offering AIDS related products were rocketing skywards. In April 1987 Fortune, the American business magazine, ran a special feature entitled 'Aids stocks worth the gamble' in which it reported that shares in several individual companies had gone up by as much as three hundred and sixty per cent in twelve months. In the first three months of 1987 a portfolio of shares offering AIDS solutions rose by a staggering forty-one per cent.

The medical establishment stoutly supported the plague theory. In the 1980s a spokesman for the British Medical Association warned that by 1991 every family in Britain would be touched by AIDS and attacked me viciously when 1 quoted evidence supporting a less 'scary' point of view. Other medical establishment groups jumped on the 'AIDS is going to kill us all' bandwagon and the official line was defended with unprecedented ferocity. (1 have fought many campaigns against the establishment but the AIDS campaign seemed to arouse particularly self-righteous, sanctimonious venom and I was mocked and vilified by many 'AIDS is the modern plague' theorists.) The World Health Organization forecast that 100 million people might be infected by the year 1990 and the Royal College of Nursing forecast that one in fifty people in Britain would have the disease by the early 1990s.

Then, with the drug industry behind the promotion of AIDS, at least four separate groups of people realised that there were advantages to be gained out of turning the story into a major international threat.

The first to realise the significance of AIDS were probably the religious activists who had for years hated the 'free sex' attitudes at had survived the sixties. They quickly realised that in AIDS they had a heaven-sent opportunity to frighten people into abandoning their promiscuous ways. In the early days much of the most terrifying AIDS propaganda came from religious pressure groups who wanted to spread their own sanctimonious message and were perfectly prepared to exaggerate the facts a little in order to scare the electorate into their arms.

Second, there were many other business groups who recognised the profit making opportunities associated with AIDS. Insurance companies used the threat of AIDS as an excuse to push their premiums up at a far faster rate than they would have ever dared do without AIDS. Hospital and clinic managers started making money out of offering AIDS tests and AIDS counselling.

Even companies which were not directly involved greeted the AIDS scare with delight. The tobacco industry, for example, must have been extremely grateful to see pundits on television warning of a coming plague which, they predicted (using figures that were plucked out of the night), might eventually kill as many as a hundred thousand Britons a year. The tobacco companies knew that cigarettes were already killing one hundred thousand Britons a year.

Naturally, politicians were not slow to take advantage of the disease. They realised that AIDS was a heaven-sent opportunity to scare the living daylights out of their electorates. Politicians love scaring people-it gives them a good excuse for introducing tough legislation that would otherwise never get passed. And conservative administrations-particularly those in power know very well that people always vote for right wing politicians (and for the status quo) when they feel threatened. Once they saw just how rapidly the AIDS scare campaign was growing the politicians leapt onto the bandwagon and did what they could to exaggerate the threat. Some of the advertising campaigns launched to warn the public about the threat of AIDS would have been laughed at if people hadn't already been frightened out of their wits.

There was one final group who had a vital part to play in helping to create the AIDS myth. Right from the beginning it seemed clear AIDS was primarily a threat to homosexuals and this worried the gay pressure groups enormously. They quickly realised that if AIDS remained a predominantly 'gay' disease there would be a real risk that politicians, doctors, researchers and the public would quickly tire of the disease and funds would not be made available to continue the research work that had been started. They realised that in order to keep public interest in the disease high they had to change the public perception of the disease; AIDS had to become a predominantly heterosexual disease. So, all around the world gay pressure groups worked hard at changing public perceptions. Since there are many homosexuals working in television and radio, in publishing, in journalism and in the world of entertainment, the campaign was difficult to build up and within a very short time the message had been distorted so successfully that many people really began to believe what was being broadcast.

DESPITE THE INTERNATIONAL media blitz provided by a willing army of drug company controlled medical journalists it had been clear from the earliest days that AIDS was not going to be a major threat to society in general.

Way back in 1987 the medical magazine Pulse reported that the ~only sexual practice' likely to lead to AIDS virus infection was receptive anal intercourse. The magazine was quoting data from the San Francisco Men's Health Study, published in the Journal of the American Medical Association. The study of more than one thousand heterosexual, homosexual and bisexual men reported that-and I quote-'receptive anal genital contact is the major mode of transmission of HIV infection'. The report went on to say that 'there was no evidence of epidemic spread due to any other sexual mode of transmission'.

This report made sense. After all, the evidence showed that AIDS was primarily a blood borne disease and whereas ordinary vaginal sex does not usually lead to damaged tissues (and therefore bleeding), anal sex does.

In 1988 the British Medical Journal published a paper entitled 'Heterosexual transmission of HIV by haemophiliacs'. It was written by three doctors from the University Hospital in Rotterdam, in the Netherlands, who had for three years followed thirteen haemophiliacs and their partners. Their conclusion was-and I quote: 'In the absence of other risk factors transmission of HIV from men to women by vaginal intercourse is infrequent'.

In a paper entitled 'Human immunodeficiency virus infection, hepatitis B virus infection and sexual behaviour of women attending a genito-urinary medicine clinic, authors from the West London Hospital, Charing Cross Hospital and Central Public Health Laboratory in London studied 1,115 women who attended a genito-urinary clinic in west London. The authors reported that more than half of 424 women who said that they had non regular sexual partners never used a condom. They also said that the two women who were seropositive for HIV who completed a questionnaire on their sexual behaviour reported that they had had anal sex. The authors of this paper concluded that-and I quote: 'Heterosexual women in London are at a low risk of becoming infected with HIV.’

In another scientific paper, also published in the British Medical Journal, researchers from the London School of Economics and Political Science and St Mary's Hospital studied prostitutes. They came to the conclusion that-and I quote from their paper -'the most important risk factor for prostitutes in the West is sharing needles and syringes for drugs'. In 1992 researchers found that fewer than 30 of 1,000 prostitutes in Glasgow were infected with the AIDS virus-all of them were injecting drug users. The researchers in Glasgow pointed out that the virus was more likely to be spread by prostitutes through the use of dirty injecting equipment than by unprotected sexual intercourse.

One of the most important papers published on the subject of AIDS was probably the one produced by the European Study Group in 1989. This was published in the British Medical Journal under the heading 'Risk factors for male to female transmission of HIV. The coordinating centre for this report was the World Health Organization Collaborating Centre on AIDS in Paris and there were participating centres in Italy, Greece, the Netherlands, Germany and Spain. The authors of this report concluded - and I quote - 'The only sexual practice that clearly increases the risk of male to female transmission was anal intercourse'. The authors went on to say that-and again I quote-'no other sexual practices have been associated with the risk of transmission'.

As it became clear that AIDS was not going to become the feared plague, there were many attempts to justify the original forecasts. In some areas it was suggested that patients suffering from cancer should be listed as AIDS victims. In others areas it was suggested that patients suffering from tuberculosis should be included in the AIDS statistics.

Eventually, in an editorial in the British Medical Journal in the early 1990s the International AIDS Coordinator at the National Cancer Institute in the United States of America, announced that 'the HIV epidemic in North America and Europe probably peaked ... in the mid 1980s' while the Institute of Actuaries in Britain eventually admitted there was 'no evidence to support the hypothesis of a 'heterosexual explosion' of AIDS or HIV infection in this country'. But by then it was too late, for the AIDS myth had created a new industry of researchers, advisers and self-styled experts and newspapers were regularly carrying stories of areas where the number of AIDS counsellors exceeded the number of AIDS sufferers. By 1992 in many areas there were found to be two or three times as many AIDS counsellors as victims. Many of the under-employed AIDS experts seemed to keep themselves busy doing their very best to maintain the AIDS myth-the myth which paid their quite unjustified salaries.

DESPITE THE EVIDENCE AIDS was constantly promoted as a 'plague'. By devoting an extraordinary amount of time to the problem of AIDS and by refusing to put forward any point of view which did not support the idea of AIDS as a major plague television caused more fear and more hysteria than anything else I can remember. It is worth remembering that by September 1987 - probably the peak year for AIDS, when it was difficult to turn on a television set without finding a programme outlining the horrors of AIDS-the official government estimate in Britain was that eight heterosexuals had contracted AIDS through sex since 1981. Just to put things in perspective it is worth pointing out that in just two years four times as many people had died while horse riding. Instead of spending millions trying to encourage heterosexuals to wear condoms the government would, perhaps, have been better occupied spending its money trying to encourage horse riders to wear hard hats.

The effectiveness of the industry lobby to promote AIDS as a fearful (and therefore profitable) disease came home to me on numerous occasions in the 1980s when I was vilified for telling the truth about the disease. Guests at a dinner where I was speaking as the guest of honour walked out when 1 dared to suggest that AIDS was not a major threat to heterosexuals. Editors who published my articles about AIDS received indignant telephone calls from self-styled experts insisting that I should not be allowed any sort of public platform for my views. I was repeatedly threatened and attacked for daring to quote the research papers which proved that AIDS was not the new plague.

By the second half of the decade it had become professionally dangerous to dare to suggest that AIDS was not a killer plague. Few people in television or in publishing would even listen to a rational scientific argument.

In early 1987 1 had a telephone call from a researcher for a TV company who told me that he was planning a documentary about AIDS.

'What do you think about AIDS?' he asked me.

I told him that I thought that AIDS was a serious problem, but it was just one of many serious medical problems and that the threat it posed had been exaggerated by some doctors, a lot of politicians and most journalists. The researcher was silent for a moment or two. I could tell by the silence that he was disappointed. It wasn't quite what he hoped to hear.

'We're planning a major documentary,' he said. 'We want to cover all the angles. Haven't you got anything new to say about AIDS?'

'I don't think AIDS is a plague that threatens humankind,' I insisted. 'I think it is a dangerous, infectious disease that currently affects a small number of people and that may, in the next few years, affect thousands more.' I then pointed out that I believed that the evidence about AIDS had been distorted and the facts exaggerated.

'We really want you to come on to the programme and talk about some of the problems likely to be produced by the disease,' persisted the researcher.

'I'm happy to come on to the programme and say that I think that the dangers posed by the disease have been exaggerated,' 1 said.

The researcher sighed. 'Quite a few doctors have said that to me. But it really isn't the sort of angle we're looking for.'

I didn't expect to hear from the researcher again and I didn't. His company produced a networked television programme about AIDS that appeared on our screens a short time after that conversation and most of those who viewed it will have gone to bed thinking that AIDS was the greatest threat to humankind since the Black Death.

During the last few years I've lost count of the number of times I have had that same conversation with TV researchers and producers. During the late 1980s I received an average of three or four requests a week to appear on television. But during that same period (when countless programmes about AIDS were being made) 1 received no invitations to speak about AIDS on television.

Time and time again the facts about AIDS have been carefully selected to satisfy the public image of the disease (and to provide a good story) rather than to relate the truth.

When it became quite plain that the talk of plagues had been wildly exaggerated, an attempt was made to maintain the myth by claiming that the disease was about to devastate Africa.

Once again the claim was fraudulent.

THE CRUELLEST OF cruel ironies must surely be that AIDS, which was almost certainly created as a result of experiments on animals, has led to the creation of a massive sub-industry devoted to using laboratory animals to try to find a cure for the disease. The research industry which has been created has consumed vast amounts of money, has inspired accusations of professional double dealing and jealousy and has never got anywhere near to finding a cure.

Throughout the 1980s research institutes around the world who needed extra funds simply had to add AIDS onto their project titles and then sit back to wait for the cash to roll in. The AIDS industry has become vast. In 1991 the total amount of money spent on AIDS research around the world was $1,500,000,000. In 1992 it was estimated that the expenditure on AIDS research would reach $1,625,000,000. Most of that money was allocated for animal experiments. (This sum doesn't include the vast amount collected by voluntary workers, large numbers of whom seem constantly eager to help raise money for AIDS. I wonder if they would be as keen to raise money for unfashionable but nevertheless lethal disorders such as cancer of the colon).

The AIDS story, which had begun in an animal experimenter's laboratory, has gone full circle. In the end the industry which had created the disease has made the greatest profit from it. Hardly a 'triumph' for medical science.

THERE WERE TIMES before and during the Renaissance when doctors were scientists and medicine was a science.

In the thirteenth century there was Roger Bacon, the Franciscan monk who is credited with the invention of the telescope, the microscope, the diving bell, gunpowder, locomotives, flying machines and spectacles and who is said to have moaned that 'medical men don't know the drugs they use, nor their prices'. In the sixteenth century there were Galileo, the Italian scientist who also studied medicine and who got into terrible trouble with the Church for supporting Copernicus' view that the planets revolved around the sun, and Andreas Vesalius, the Belgian physician whose descriptions of human anatomy made a vital contribution to the renaissance in medicine. There was Franciscus Sylvius, also known as Francois de Bois and Franz de le Boe, a German physician, physiologist, anatomist and chemist who believed that disorders were caused by chemical actions and could therefore be diagnosed and treated logically; Santorio Santorio, an Italian physician, physicist and physiologist who devised the first watch, thermometer and weighing machine and was the first person to introduce scientific instruments to medical practice; and Michael Servetus, a Spanish physician who was eventually executed by the Calvinists and whose major contribution to medical thinking was his discovery of the circulation of the blood to and from the lungs.

And there was Paracelsus, christened Aureolus Philippus Theophrastus Bombastus von Hohenheim, who travelled throughout Europe battling against what he saw as primitive, unproven and out of date medical theories. Paracelsus, who was born in 1493 and who died in 1541, rejected the old idea that illness is a result of a failure of balance within the body (oddly enough this old fashioned idea, rejected by scientists for 500 years is now fashionable again among some practitioners of alternative medicine). Paracelsus claimed that illnesses needed to be treated within specific organs, using specific chemical compounds to treat the organ and the disease. He believed in experimenting on patients who needed treatment and he burnt all the old textbooks which he regarded as unscientific. Paracelsus wanted the alchemists to stop their constant search for ways to turn lead into gold and to spend their days trying to make medicines.

Since he was threatening the status quo Paracelsus was banned and condemned and attacked and driven out of his home. Many attempts were made to silence him. Paracelsus, who was oddly enough born in Basle, the home of many of today's leading drug companies, was in many ways the founder of the pharmaceutical industry. But these days the industry does not recognise its mentor, possibly because those industry chiefs who have heard of him are only too aware that if Paracelsus was alive today he would be appalled by the industry he helped to create.

All these men lived and worked in the sixteenth century. Many of them risked their lives to do their work and they were proud, fearless and desperate for knowledge. These were true scientists: they tried to prove or to disprove their theories and were prepared to be proved wrong, and they were prepared to experiment and to put their ideas to the test.

But modern doctors and medical researchers are more like Descartes, the seventeenth-century French philosopher who used experiments not to find the truth but merely to illustrate his theories.

The foundation of modern, twentieth-century medical thinking is the Cartesian principle that although the mind and the body are linked they are essentially separate entities. Descartes did not believe in experimental science or the objective assessment of ideas. He was a philosopher who dabbled in science but his ideas were to dominate many aspects of medical thinking and teaching for some time. He believed in intuition and he believed that man could be regarded as a simple mechanical creation. It is for this reason that many doctors treat the lesion or the organ that they believe to be failing to function properly rather than the patient, his fears, and his symptoms. Doctors organise laboratory

tests and then believe that by treating abnormalities they are acting scientifically.

When a patient complains of pain the doctor does tests to find the cause of the pain but doesn't bother to treat the pain because that would interfere with the results of the tests. Meanwhile, the patient suffers so much from the pain that he becomes even more severely ill. With that sort of background it is hardly surprising that the reputation of modern allopathic medicine as a healing branch of science is crumbling rapidly. Too many modern doctors neither cure nor care.

The modern clinician and the modern medical researcher base their opinions and their conclusions almost exclusively on subjective observations and wishful expectations-observations and expectations which are likely to be based on inaccurate historical perspectives and experimental experiences with members of another species.

Superstition and suspicion are the principal foundations of twentieth-century medical science. Error is built upon error and unproven theories are used as building blocks for new ideas. Assumptions, prejudices and hearsay compete with subjective observations and personal interpretations of symptoms and signs for the doctor's attention and allegiance. To be truly scientific the doctor would have to subordinate his personal opinions to impartial knowledge gained by analysis and experimentation, but if he did this the doctor would lose the mystique and authority which is traditionally a part of the medicine man's armoury. By becoming a scientist he would become a technician and lose his god-like powers.

Modern physicians and surgeons do not see the human mind and the human body as a single entity (which is why the medical profession has been slow to embrace the principles of holistic medicine and doubly incompetent in its attempts to deal with stress related disorders) and they rely more on hopes and assumptions than on evidence and objective clinical experience. The modern clinician is as narrow minded and as influenced by his personal experiences and interpretations as was his predecessor two thousand years ago.

In true science an idea is born and then tested before conclusions are drawn. Without testing there can be no science and an idea can never be more than an opinion or a hypothesis. The true scientist will do everything he can to disprove his hypothesis, excluding probability, chance, coincidence and the placebo effect, and ignoring pride, vanity and all commercial pressures in his search for the truth. Sadly, such devotion is rare indeed within the world of medicine. All too frequently doctors use case reports as testimonials. They will admit that all patients are different and then they will draw conclusions about the treatment of thousands of patients from single case reports published in a medical journal. Statistics are essential for determining probabilities, for making predictions and for choosing the best possible remedy but doctors frequently use their own interpretations of statistics. A doctor will say: 'I have seen 300 patients with this disease over the last five years and this treatment or that remedy is best'. He will forget that there are many possible remedies which he has probably never considered and he will ignore the fact that some of his patients may have died and many of them may have got no better. When case histories are viewed subjectively the mind of the viewer can and often will lie and distort in order to protect the viewer's pride and vanity.

MOST PATIENTS PROBABLY assume that when a doctor proposes to use an established treatment to conquer a disease he will be using a treatment which has been tested, examined and proven. But this is not the case.

The British Medical Journal in October 1991 carried an editorial reporting that there are 'perhaps 30,000 biomedical journals in the world, and they have grown steadily by 7% a year since the seventeenth century'. The editorial also reported that: 'only about 15 % of medical interventions are supported by solid scientific evidence' and 'only 1 % of the articles in medical journals are scientifically sound'.

What sort of science is that? How can doctors possibly regard themselves as practising a science when six out of seven treatment regimes are unsupported by scientific evidence and when 99% of the articles upon which clinical decisions are based are scientifically unsound?

The savage truth is that most medical research is organised, paid for, commissioned or subsidised by the drug industry. This type of research is designed, quite simply, to find evidence showing a new product is of commercial value. The companies which commission such research are not terribly bothered about evidence; what they are looking for are conclusions which will enable them to sell their product. Drug company sponsored research is done more to get good reviews than to find out the truth.

The other type of research is done by doctors or scientists wishing to advance their careers. All young doctors and medical scientists who wish to progress within the medical establishment must publish as many scientific papers as possible.

The real, unstated reason for many medical theses and papers is that they give appointments committees something to measure. But is this a criterion which commends itself to the general public who pay for our services? Would you prefer your treatment to be supervised by a physician who had published fifteen papers rather than fourteen? A general practitioner claims that she was told by a fellow doctor: 'Find something to measure, and then keep on measuring it until you can put six points on a graph. Then start submitting abstracts, because you'll soon be applying for senior registrar jobs and you'll need at least ten publications to get on the short list.' The GP claims that the registrar who told her this also said: 'Look, I'll help you out a bit. I'll put your name on everything I publish from this lab if you put my name on everything you publish.'

Those scientists who still do original and unsponsored research might claim that their work is of potential value but the evidence contradicts that view.

The first genetically engineered crop to be released into the wild was a tobacco plant which was resistant to herbicides and therefore able to be more heavily sprayed against weeds. In both Britain and America freak giant calves and lambs were born on experimental farms after attempts to produce herds of identical animals went disastrously wrong. Instead of weighing 80 lbs several of the calves developed to 150 Ibs or more and had to be delivered by Caesarian section. In other experiments scientists have 'created' a creature that was half sheep and half goat, have kept monkeys heads alive without their bodies and have made a female monkey pregnant with human sperm.

Even more worrying is the fact that there is now a considerable amount of evidence to show that many modern so-called scientists are prepared to 'alter' their results if their experiments do not turn out as planned. (This cavalier attitude towards scientific experiments may well have been acquired from the world's drug companies-which have a well-deserved reputation for amending or suppressing unsatisfactory results).

It is now reliably estimated that at least 12% of scientific research is fraudulent.

THE FAILURE OF the modern medical 'scientist' to conduct his research in the traditional logical and analytical scientific way is perhaps best illustrated by the dependence of so many researchers (both those subsidised by the drug industry and those working for their own personal or professional satisfaction) on animal experiments-despite the fact that animal experiments are now known to be of no practical value.

Time and time again medical experts who have looked critically at animal experiments have concluded that such experiments are far worse than useless.

A leading toxicologist has shown that a standard cancer test used on rats gives results which can be applied accurately to human beings just 38% of the time. Put another way that means that 62% of the time the results animal experiments obtain are wrong. Tossing a coin would at least give a 50% chance of success-and that would, therefore, be a considerable improvement on the majority of medical experiments performed these days.

THE SAD TRUTH is that the modern clinician does not put his treatments to the test and does not want to put his treatments to the test. Indeed, if it is suggested that he expose his treatment methods to a true, scientific analysis he will throw up his hands in horror, arguing that it would be unethical to test his treatments for that might deprive his patients of help. He will argue that his treatments do not need to be tested because he knows that they work. Today's medical training is based upon pronouncement and opinion rather than on investigation and scientific experience. In medical schools students are bombarded, with information but denied the time or the opportunity to question the ex cathedra statements which are made from an archaic medical culture. The drugs and tools which are used may be devised with the aid of scientific techniques but the way in which they are used is certainly not scientific.

If medicine was a science, then when a patient visited a doctor complaining of a symptom he would be given the best, proven treatment, a treatment that was quite specific for the disease. Treatments for specific symptoms would be predictable and diagnostic skills would, because they would be based on scientific techniques, be reliable within certain acknowledged limits. But that is not what happens at all. In some areas of medicine specialists operate in a way that would be considered a variety of pseudoscience if the practitioners did not happen to have qualifications recognised by the medical establishment. Consider, for example, the practices of psychiatry, psychosurgery and psychoanalysis, widely accepted medical specialities where doctors clearly still make decisions about treatments according to their personal beliefs, instincts and hunches rather than according to any scientific principles.

Psychiatrists cannot even agree on which collections of symptoms constitute mental disorders. It was only in 1980 in the third edition of its Diagnostic and Statistical Manual of Mental Disorders that the American Psychiatric Association deleted homosexuality from its list of mental disorders. In 1985 at a meeting of 7,000 psychiatrists in Phoenix, USA, three out of four main speakers said that schizophrenia did not exist. Kleptomania, pyromania, gambling and transvestism are not recognised mental disorders but there is a condition called hypoactive sexual desire disorder (defined as persistently or recurrently deficient or absent sexual fantasies and desire for sexual activity-the judgement of deficiency or absence is made by the clinician). Where is the logic in any of this? Psychiatrists can offer no scientific evidence to support their decisions to accept some categories of mental illness while rejecting others.

We are led to believe that psychiatry is a modern-day science but in reality it is still a black art, based on rumour, suspicion and gossip rather than anything remotely resembling science.

Two-thirds of the people who commit suicide will have visited their GP within a month of killing themselves and half of these will have consulted their GP within a week of their death. Surely there must be something wrong with mental care when most of the people who kill themselves do so shortly after seeking professional help?

The cruellest irony is undoubtedly the fact that many of those who kill themselves do so with pills their doctors have prescribed.

Both general practitioners and psychiatrists have wildly and irresponsibly prescribed tranquillisers and sleeping tablets for millions of patients and have produced an army of addicts around the world. The way in which untold millions of people worldwide became hooked on the benzodiazepine tranquillisers is an excellent example of the way that the medical profession and the regulatory authorities allow themselves to be dictated to by the powerful international drug companies. Time and time again warnings were ignored or suppressed as the drug companies, which were making vast profits from these drugs, managed to persuade doctors that the hazards associated with the products had been exaggerated.

The first benzodiazepine was launched on the American market in early 1960 and the problems associated with the drugs first started to appear shortly afterwards. In 1961 a paper was published in the journal Psychophannacologia which described how patients who had been taking a benzodiazepine suffered from withdrawal symptoms when the drug was stopped. By 1967 there were enough worries about the drugs in America for a recommendation to be made that the drugs be scheduled under drug abuse laws. At a symposium I helped organise for the British Clinical Journal in 1973 the hazards associated with the benzodiazepines were described with quiet precision. By the mid 1970s the problems associated with the benzodiazepines were being widely discussed in public but doctors were still prescribing the drugs in massive quantities and the companies making them were as enthusiastic as ever. The drugs were given to students going to college for the first time and for people who found their work or home life worrying or demanding. Ironically, thousands of doctors started taking the drugs too to help them cope with the rush of patients wanting new prescriptions. The benzodiazepines became an essential part of life for millions of people, a universal panacea.

The benzodiazepines should have been controlled in the early 1970s at the latest. There was plenty of evidence available then to persuade the authorities to warn doctors of the hazards of prescribing these drugs in large quantities and for long periods. But the authorities did nothing for over 15 years and what should have been a small drug addiction problem became the biggest drug addiction problem the world had ever known.

In Britain it was 1988 when the government finally acted and issued a warning telling doctors that they should not prescribe the benzodiazepines for long periods of time. But the government did not act because it had access to new clinical information (indeed it admitted that it was acting as a result of information that had been accumulating over the years) but because the pressure on the politicians had become so great that they had no choice: despite the eagerness of the drug industry to continue selling the benzodiazepines in vast quantities, and the eagerness of the medical profession to help by continuing to prescribe the drugs, politicians were getting worried by the size of the public anxiety about the benzodiazepine problem. In an official statement the junior health minister admitted that the government had acted because of articles which 1 had written-and my articles had been based on information that had been published in the 1960s and early 1970s.

Maybe all this should not come as too much of a surprise. After all doctors suffer more from mental illness than any other group in our society and have a higher suicide rate too. Moreover, within the medical profession psychiatrists suffer more from mental illness than any other speciality and they have the highest suicide rate of all.

Consulting a psychiatrist about a mental disorder is about as logical as entrusting your financial affairs to a bankrupt accountant or giving your faulty motor car to a mechanic whose own car is constantly breaking down.

Psychosurgery is, if anything, even more alarmingly poorly based. The great days for psychosurgery were in the 1960s and by 1963 over 15,000 leucotomies had been performed in Britain alone. The first leucotomies had been performed in the 1930s when it was thought that the frontal lobes were the source of delusions in mental patients. American workers removed the frontal lobes from chimpanzees in 1935 and thought that the animals were more contented afterwards. In the following year a neurosurgeon working in Portugal tested the theory and injected alcohol into the frontal lobes of 20 schizophrenics. Since then thousands of patients have had surgical operations to cut off their frontal lobes. The operation is still being done today and has been recommended for a wide range of conditions including schizophrenia, depression, obsessional neurosis, anxiety, hysteria, eczema, asthma, chronic rheumatism, anorexia nervosa, ulcerative colitis, tuberculosis, hypertension, asthma and pain due to cancer. Leucotomies have even been performed on patients suffering from anxiety caused by barbiturate toxicity Since those who have had the operation performed are rather quiet and contented, few of them have complained.

In 1974 the World Health Organization published a book called Protection of Human Rights in the Light of Scientific and Technological Progress in Biology and Medicine. It included the comment that 'the procedures in contemporary psychosurgery are based on inadequate or limited research and they entail many hazards. Psychosurgery has unpredictable effects on a precious organ which, even when a locus of society's discontent, should rarely need a lesion instead of special care'.

But surgeons still perform leucotomies and some even write about their experiences. One review of 150 articles on the subject concluded that 90% were of a standard below that normally required by the editors of scientific journals (which must be pretty low if you remember that according to a report in the British Medical Journal only 1% of journal articles are scientifically sound).

Psychoanalysis, the third branch of specialist 'brain care' is just as innocent of scientific support as psychiatry and psychosurgery but, for those who practise it, probably the most profitable since patients are usually advised to continue treatment for years rather than months.

I do not believe there is any scientific evidence to show that psychoanalysis is of any value at all. I am convinced that talking to a psychoanalyst is unlikely to be any more useful than talking to a hairdresser, a priest or a barman. One major study showed that patients treated with psychotherapy are likely to become mentally ill, develop signs of alcoholism or commit a major crime. An American psychiatrist recently concluded that 'the average consumer of therapy is likely to be influenced and perhaps overwhelmed by the emotional problems of therapists' and that most patients had been 'overtly manipulated or even abused by at least one therapist'.

TIME AND TIME again new treatments and new techniques are introduced on a massive scale without any scientific support and without doctors knowing what the long-term consequences are likely to be. Instead of experimenting and then practising tried and trusted techniques, modern medical practitioners use their patients as guinea pigs and practice their black art as a massive international experiment.

High dose contraceptive pills were prescribed for years for millions of patients without anyone knowing exactly what was likely to happen. When it became clear that high dose contraceptive pills were killing hundreds of women, lower dose contraceptive pills were introduced. As 1 pointed out in the 1960s, when I was still a medical student, we still don't know what effect the contraceptive pill is likely to have on the children of women who took it. Medicine doesn't anticipate disasters-it simply reacts to them. This sort of approach can hardly be described as scientific'.

Two specific examples illustrate perfectly how medical techniques are adopted on a mass scale without doctors having any idea what is likely to happen to the patients who are involved. I have deliberately chosen one 'experiment' which involves male patients-vasectomy- and one which involves female patients breast enlargement. Both experiments are surgical procedures which are performed on healthy, young adults.

Vasectomies, or male sterilisation operations, have been popular for several decades and around the world many millions of men have already had the operation. It is a fairly quick and simple surgical procedure and the number of men having the operation is steadily increasing. The tubes which lead from the testes (where the sperm are produced) to the penis are simply cut or sealed so sperm cannot get through. By the end of 1991 approximately 50 million young and healthy men around the world were believed to have had the operation.

In recent years, however, some doctors have started to have fears about its safety. There have been some independent studies which have indicated that the operation may be linked to cancer of the testes or prostate, to heart disease, to immunological disorders, to a lack of interest in sex or to premature ageing. The possible links to cancer are particularly worrying. For example, a study of 3,000 men who had undergone vasectomy showed that eight developed testicular cancer within four years of the operation.

Considering the number of men involved, the fact that the operation is performed on healthy young men and the fact that it is still being performed, one would imagine that a scientifically based profession might have halted the operation until the risks had been defined with more precision. Not a bit of it. Vasectomies are still being performed with as much enthusiasm as ever and as far as I am aware there are still no plans to bring together experiences from around the world to try to find out exactly what risks are involved.

The fact that there might be real dangers associated with breast enlargement operations using silicone gel implants exploded into public view in early 1992 although the operation to increase breast size had, like vasectomy for men, been popular for several decades-and worries about the operation had been voiced many years before.

Right from the start surgeons had realised that the popular female yearning for large breasts could become big business and they struggled hard to justify what some cynics saw as little more than an opportunity to make money.

In the early 1980s the American Society of Plastic and Reconstructive Surgeons argued that 'there is a substantial and enlarging body of medical information and opinion to the effect that these deformities (small breasts) are really a disease'. Plastic surgeons gave the disease a name-micromastia-and did their best to stamp it out. It is estimated that in the last thirty years over two million victims of micromastia have been identified and 'cured' by plastic surgeons in America alone.

To start with surgeons injected silicone directly into the breasts but when it became clear that this might cause problems as the silicone wandered around the recipient's body and started to trigger all sorts of reactions and possible problems (not least the fact that the enhanced breast quickly started to shrink as its silicone boost disappeared), surgeons started to install their silicone breast enlargers in small plastic bags which were thought to be safer.

At the end of 1991 and the beginning of 1992, however, a huge controversy blew up in America over the safety of these implants. Consumer advocates, the Citizen Health Research Group, estimated that 155,500 women had had problems with ruptured implants or infections, 123,300 women had hardened breasts and over 250,000 simply found their implants uncomfortable. Representatives of the medical profession insisted that there was no evidence that the implants caused health problems but a spokesman for the Food and Drug Administration (FDA) confessed that he was 'struck by the lack of data', adding that 'in 1991, after 30 years of use, we really still don't have the data ... we need to get to the bottom of this'.

It was estimated that 15,000 American surgeons relied on cosmetic surgery for a fair chunk of their income.

Early in January 1992, the FDA asked doctors to stop using silicone gel implants while they reviewed new evidence suggesting that the gel might cause autoimmune reactions or connective tissue disorders. On 27 January 1992 the British government's Chief Medical Officer wrote to doctors saying 'there is no reason for advising a general change in this form of surgical practice in the United Kingdom. The decision to have this form of surgery remains one for the patient to take after consultation with her medical advisors'. The Chief Medical Officer said that the Department of Health had requested information from the FDA-the same FDA which had asked surgeons in America to stop using silicone breast implants.

The problem was that even after 30 years of use no one really seemed to know how silicone that leaked out of the sac might affect the body, though there was talk of weakness, immune system damage, poor memory, fatigue, chronic flu-like illnesses and so on.

By the end of February 1992 the FDA had been advised that there should be controlled clinical trials to assess the hazards associated with silicone implants. It seems not unreasonable to wonder why clinical trials had not been initiated by the surgeons who had first started using the implants 30 years earlier and it certainly seems reasonable to assert that a scientific approach to breast enlargement would have involved such studies.

THE ABSENCE OF scientific evidence supporting medical practices is apparent in all areas of medicine.

With a very few exceptions there are no certainties in medicine. The treatment a patient gets will depend more on chance and the doctor's personal prejudices than on science.

This problem isn't a new one, of course.

In the preface to The Doctor’s Dilemma, playwright George Bernard Shaw points out that during the first great epidemic of influenza which developed towards the end of the nineteenth century, a London evening newspaper sent a journalist posing as a patient to all the great consultants of the day. The newspaper then published details of the advice and prescriptions offered by the consultants.

The whole proceeding was, almost inevitably, passionately denounced by the medical journals as an unforgivable breach of confidence, but the result was nevertheless fascinating. Despite the fact that the journalist had complained of exactly the same symptoms to the many different physicians, the advice and the prescriptions that were offered were all different.

Little has changed.

Even in these days of apparently high technology medicine there are almost endless variations in the treatments preferred by differing doctors.

Doctors offer different prescriptions for exactly the same symptoms; they keep patients in hospital for vastly different lengths of time, and they perform different operations on patients with apparently identical problems.

There are, it seems, no certainties in medicine.

The unexpected seems to happen so often that it really ought to be expected and the likelihood of a doctor accurately predicting the outcome of a disease is often no more than 50:50.

There is, indeed, ample evidence now available to show that the type of treatment a patient gets when he visits a doctor will depend not so much on the symptoms he describes but on the doctor he consults.

So, for example, consider what happened when 430 Scottish family doctors were asked to explain how they would treat a 35 year old accountant complaining of backache brought on by digging in his garden.

The 'case history' was deliberately made fairly precise.

However, despite this precision the recommended treatments varied enormously.

Less than a quarter of the doctors said that they would definitely prescribe a painkiller. Nearly 10% said that they hardly ever prescribed a painkiller in such circumstances. Eight per cent of the doctors said they might refer the patient to hospital but 52% said that they never referred such patients to hospital. Forty-eight per cent said that they usually advised bed rest for up to one week while 8% said that they usually advised bed rest for between one and four weeks.

Around 10% of the doctors said that there was a good chance that they would refer the patient to an osteopath but the other 90% said that they hardly ever, or never, referred patients to osteopaths. Such enormous differences are surprisingly commonplace these days.

Going to a GP really is something of a lottery and it is important to remember that treatments vary not because patients are different but because doctors are different!

Another survey involving 700 family doctors showed that 12% might be willing to prescribe a sleeping tablet without even seeing the patient involved. Over half the GPs confessed that they would prescribe a cough medicine without seeing a patient and nearly two-thirds of the doctors said that they might prescribe an antacid without a patient needing to come into the surgery. How can a scientist prescribe for a patient he hasn't even seen?

Medical practice varies enormously from country to country too. In America, each year, 61 in every 100,000 people have a coronary by pass operation. In Britain only about 6 in every 100, 000 have the same operation. In Japan 1 in

100, 000 patients will have a coronary by pass operation. In America and Denmark seven out of every ten women will have a hysterectomy at some stage in their lives but in Britain only one woman in five will have the same operation. Why? Are women in America having too many hysterectomies or are women in Britain having too few? In

America 20% of babies are born by Caesarian delivery. In England and Wales the figure is 9%. In Japan 8% of confinements end in a Caesarian delivery.

Even within individual hospitals there are likely to be enormous variations between the beliefs of different consultants. Some ear, nose and throat consultants still believe that tonsils and adenoids should be removed at the earliest possible opportunity while others believe that the operation is useless or harmful and should hardly ever be done. Some surgeons remove gall bladders through tiny incisions, others prefer massive incisions. Some doctors still recommend that ulcer patients follow a milky diet while others claim that such dietary advice should have been abandoned as outdated.

Despite all these variations in the type of treatment offered most doctors in practice seem to be convinced that their treatment methods are beyond question. Many GPs and hospital doctors announce their decisions as though they are carved on stone.

But on the basis of this evidence it seems that most decisions about how patients should be treated are based on nothing more scientific than guesswork, personal experience, intuition and prejudice.

THE SADDEST AND most worrying aspect is that modern treatments are potentially dangerous and the abuse and misuse of science often leads to personal tragedy.

For example, a few years ago most surgeons believed that the best treatment for breast cancer was a radical mastectomy in which the whole of the breast would be removed, together with surrounding tissue and underlying muscle. A radical mastectomy is a brutal and disfiguring operation. I now doubt that this operation was ever of any proven benefit. Indeed, I suspect it was often less successful than far less destructive surgery. Sadly, however, there are still thousands of doctors removing breasts for no good reason other than the fact that it is what they have always done. How can the brutal and pointless removal of women's breasts be scientific?

Such worthless and dangerous treatments are by no means unusual. Indeed, they are often administered for many, many years and when pressed for an explanation or for supporting evidence surgeons will usually defend their activities by claiming that they are using 'clinical judgement'. This sounds as if it is a professional decision but what it really means is that the surgeon has strong opinions and is not prepared to listen to anyone else. By and large doctors do not like to have their methods assessed scientifically and even when techniques are assessed doctors will frequently ignore the results if the scientific evidence does not fit in with their own personal prejudiced beliefs. New treatments are tried until they kill too many people and have to be abandoned or until something more exciting comes along. Drug companies which describe themselves as 'ethical' but which are, in reality, part of the most unethical industry ever created-encourage this unscientific attitude because they know that if medicine ever became a science their profits would crash.

But, you may say, even if treatments are not selected with scientific precision, surely diagnoses are made in a scientific fashion?

Again, the evidence does not support that contention.

When scientific methods are used it becomes clear that the likelihood of a doctor accurately predicting the outcome of a disease is often no more than 50:50. For example, consider the survey I have already quoted in which two pathologists reported that after carrying out 400 post-mortem examinations they found that in more than half the patients the wrong diagnosis had been made. This presumably also means that in more than half the patients the wrong treatment had been given. And since modern treatments are undeniably powerful it also presumably means that a large proportion of those patients may have died not because of their disease but because of their treatment. The two pathologists reported that potentially treatable disease was missed in one in seven patients. They found that 65 out of 134 cases of pneumonia had gone unrecognised while out of 51 patients who had suffered heart attacks doctors had failed to diagnose the problem in 18 cases.

Ignorance has become commonplace in medical practice.

A study of GPs reported in a medical newspaper a few years ago showed that a quarter of general practitioners did not know about the connection between smoking and heart disease while, amazingly, 20% of GPs were unaware that cigarettes could cause lung cancer. (One magazine editor refused to publish an article I wrote quoting this survey, on the grounds that he couldn't believe that doctors were so ignorant.) From France comes evidence that in the final examinations for medical students in Paris one-tenth of the candidates made no mention of tobacco when asked to list factors responsible for causing cancer. By contrast well over a third of the students mentioned the type of cancer produced in horses' mouths by the rubbing of the bit.

When seventy GPs were questioned it was found that 50% knew little about the ingredients of popular non steroidal anti-inflammatory drugs-probably the most commonly used drugs in medicine today, and taken regularly by millions of arthritis sufferers.

A recent survey showed that many experienced family doctors had inadequate knowledge about the diagnosis and treatment of common disorders. Questionnaires which were posted to 1,400 general practitioners included questions about common conditions such as anaemia, middle ear infection, glandular fever and jaundice but many of the doctors who responded failed to mention answers that were important. Some gave unusual answers and some gave answers that were clearly wrong. Only half the doctors in the survey mentioned the three most common symptoms in middle ear infection. More than half left out important questions to ask a patient with jaundice. The average general practitioner spends only four hours a year at postgraduate courses.

Doctors go to great lengths to disguise the fact that they are practising a black art rather than a science. The medical profession has created a 'pseudoscience' of mammoth proportions and today's doctors rely on a vast variety of instruments and tests and pieces of equipment with which to explain and dignify their interventions. This, of course, is nothing new. The alchemists of the middle ages and the witch doctors of Africa realised that words and spells reeked of gods and sorcery and so they created a secret and impenetrable structure of herbs, songs, dances, rattling of special bones, chants and ceremonial incantations. They even used such techniques as trephining. Today's clinicians have much more sophisticated mumbo jumbo to offer. They have laser surgery and psychotherapy, CAT scanners and serum manganese assessments to substantiate their claims to be scientists. But however good the impenetrable pseudoscience may sound or seem to be, and however well based on scientific principles the equipment may be, the practice, the use of the equipment and the techniques is still little more than mumbo jumbo.

Now, if doctors were aware that medicine was not a science and that they were pulling what is undoubtedly the largest and most successful confidence trick ever tried, the damage would be fairly minimal. But the problem is compounded by the fact that the vast majority of doctors believe the lie that they are taught; they believe that they are scientists practising an applied science. As medical students, would-be doctors are taught that they will be practising a scientific discipline and there is little doubt that most, however much they may bumble and fumble with the principles of science, believe that they are scientists.

One result of this false faith is that doctors use the available technology with little or no thought for their patients. The result is therapeutic chaos. Patients are wildly and dangerously over- investigated and treatment programmes are planned and defined by guesswork rather than by a scientific analysis of possibilities and consequences. In order to protect themselves from the anxieties which would otherwise accompany their ignorance and their lack of knowledge, doctors seek assurance and comfort by immersing themselves in technology. Doctors are trained to seek certainties and taught that investigation is an end in itself rather than merely a signpost towards a therapeutic end.

The needs of the patient are forgotten as doctors glory in their knowledge. Too many doctors obtain satisfaction not by making patients better or relieving their discomfort but by playing a series of intellectual games in which the collection and analysis of test results is regarded as far more important than the support and comfort of a patient. Too often patients are over-investigated, over-diagnosed, over-treated and undercared for. 'Curing' not 'caring' has become the sole criterion and too often, success is measured in the laboratory rather than the sickroom.

What has happened?

Why has this powerful legacy of scientific thought been allowed to crumble away?

Why has twentieth-century medicine drifted back towards witchcraft and black arts?

The answer is simple.

In the last century the practice of medicine has become no more than an adjunct to the pharmaceutical industry and the other aspects of the huge, powerful and immensely profitable health care industry.

Medicine is no longer an independent profession.

Doctors are no more dedicated to the saving of lives and the improvement of patients welfare than are the thousands of drug company salesmen and marketing men. Doctors have become nothing more than a link connecting the pharmaceutical industry to the consumer.

 

 

CHAPTER THREE

THE DRUG INDUSTRY: DECEITFUL, CORRUPT AND RUTHLESS

How and why did doctors lose touch with science? How did a young, forceful, imaginative, thrusting, healing profession become little more than a pill pushing trade, influenced by the marketing whims of a corrupt and ruthless industry and content to hand out the latest pills without investigations and without criticism?

To understand how and why this has happened it is necessary to go back several hundred years to the days of the apothecaries. For what happened then explains both how the medical profession was to develop and how it was to be influenced during the latter part of the nineteenth century and the twentieth century.

Before the modern medical establishment was founded, practising clinicians fell into several categories.

First, there were the university trained physicians who had acquired qualifications on the basis of their bookwork and academic skills rather than on any practical knowledge of medicine or patients. They dressed immaculately and fashionably and they wrote and spoke in 'dog Latin'. They knew virtually nothing about the practical side of clinical medicine. The physicians, who were very few in number, provided most of the medical care for the establishment but were not, at that time, considered to be specialists or consultants. In many countries the physicians were the only people who were officially entitled to charge for giving medical advice.

Although they were not considered to be in any way professionally superior to the apothecaries who provided a similar service for the great majority of the public, the academically qualified doctors were regarded as socially superior to all other practitioners and they were the only members of the medical profession who could expect to enter a large house through the front door. Other health professionals had to enter through the servants' or tradesmen's entrance.

The second group of medical professionals were the surgeons. They were allowed to do virtually anything with a knife but they were not allowed to give their patients pills or potions. The surgeons had acquired power after a terrific and long lasting battle with the 'midwives'-untrained, often illiterate women who usually learned their trade from their mothers and who had provided practical medical care for millions of people living in villages and country areas for centuries. (The midwives did not, incidentally, confine themselves to looking after women who were pregnant or in labour. In the seventeenth century some midwives, whose knowledge was essentially practical, had acquired wonderful reputations and had been paid more than physicians or surgeons by the rich who wanted the best available medical care and didn't care about qualifications. There were midwives who could charge a thousand times as much as a physician for a consultation.)

It was the third, and most important group of medical professionals, the apothecaries, who treated the majority of those citizens who could afford to buy professional medical care. Although traditionally they had been trained to dispense medicines, and by law they were, in some countries, still not permitted to offer any advice, the apothecaries were the first general practitioners.

The law which prevented the apothecaries from charging for advice in some ways still influences the medical profession. When the apothecaries could only earn their money by dispensing a drug and their advice had to be free, it was inevitable that every consultation would end with the patient being handed a bottle of something. It is not hard to see the effects of this in the way that medicine is practised today.

Although the brighter, more ambitious and more literate apothecaries undoubtedly read some of the available medical texts, and almost certainly knew far more about people, illnesses and medicines than many physicians, they were strictly forbidden to charge fees for advice or information about how best the medicines they sold could be used. Academically qualified practitioners obviously felt that medicines were an insignificant part of the medical profession for they happily allowed the apothecaries to take total control of the preparation and dispensing of drugs.

But by taking control of all herbal medicines the apothecaries established a power base. The academics soon realised the mistake they had made and struggled hard to regain power. In Britain the conflict came to a head in 1703 when the physicians accused an apothecary called Rose of prescribing medicines without first referring the patient to a physician. Although the physicians won the case, the House of Lords reversed the decision after an appeal and ruled that apothecaries could see, examine and prescribe for patients who had not consulted physicians. The Lords still ruled that apothecaries could not charge for an examination but only for the medicine that was dispensed.

The various branches of the medical profession split up slightly differently in different countries. In Italy, France and Germany the apothecaries were the forerunners of the pharmacists. In Britain the apothecaries were the predecessors of today's family doctors and provided the main driving force behind the development of the modern medical profession.

The tradition linking apothecaries and medicines had now been established and most patients expected to be given a drug of some kind at the end of a consultation-and most apothecaries were keen to oblige them. In this way the tradition of patient-illness-doctor-prescription was established.

Apothecaries soon began to take over the general control of medical care in Britain and, indeed, in many other countries. By the mid-nineteenth century the apothecaries were granting licences to hundreds of ambitious young men.

The rise to power of the apothecaries was, not surprisingly perhaps, quickly followed by a rapid rise in the number and size of companies making medicines for the apothecaries to dispense.

There was one development which, above all others, made it possible for the young pharmaceutical industry to expand rapidly and to become truly international: that development was the birth of the pill-making machine.

When the apothecary's profession had been young, most practitioners had handed out herbal remedies which they had prepared themselves. As their practices grew they realised that they needed medicines at a far faster rate than they could make them. There was, quite clearly, a burning need for medicines to be prepared commercially The apothecaries had succeeded in outlawing the midwives and the other unqualified individuals who had for centuries provided medical help, and had established themselves as the leading members of the medical profession. The public wanted and needed them. Everyone, rich or poor, who fell ill expected to be treated by an apothecary. The apothecaries found that business was booming. They didn't have the time to waste in their back rooms hand rolling pills and making up mixtures. They needed to be busy in their consulting rooms or making home visits. They needed suppliers to make and prepare their medicines for them. They needed more-and more efficient-drug companies.

But first there was a problem: those would-be drug company moguls who wanted to manufacture and sell their products around the world needed to find a way to prepare predictably sized doses of their drugs which could be easily transported and stored. Weighing scales devised by Sanctorius (also known as Santorio Santorio) had made the process of preparing medicines slightly more scientific, but the apothecary in practice in the early part of the nineteenth century still used a pestle and mortar to mix his compounds. Finished medicaments were sold as mixtures, powders or pills and the rate at which an apothecary could stock his shelves (and therefore make money) depended upon his own dexterity and that of any assistants he had. Every pill had to be made by hand: the active ingredients being first ground together with a pestle and mortar, then rolled like a piece of pastry before being divided into short sections and rolled into spheres. Without machinery to standardise the preparation of pills it was difficult to ensure that each dose was identical and pill rolling by hand inevitably meant that some pills contained more active constituent than others. Making pills was a very unscientific business and it was difficult for any one manufacturer to gain an advantage by increasing his output. An apothecary who wanted to double his output of hand rolled pills would have to hire twice as many apprentices.

The problem was overcome by a man who, although now largely forgotten, was destined to become the most important single influence on the foundation of the enormously powerful pharmaceutical industry.

Born in Devon, England in 1787, William Brockeden trained as a watchmaker but also earned money as an author and artist. It was in his capacity as an artist that he made the discovery that was to revolutionise the preparation of medicines and enable apothecaries to replace pill-rolling apprentices with efficient and reliable tablet making machines.

Brockeden was infuriated by the fact that he could not obtain drawing pencils which were free from grit and he had the idea of compressing pure, powdered graphite in a die between two punches. Realising that his invention could have other uses, he then took out a patent for a device for 'Shaping of pills, lozenges and black lead by pressure in a die'.

In 1844, just a few months after Brockeden's patent was granted, the Pharmaceutical Journal in Britain announced: 'We have received a specimen of bicarbonate of potash compressed into the form of a pill by a process invented by Mr Brockeden and for which he has taken out a patent. We understand the process is applicable to the compression of a variety of other substances into a solid mass, without the intervention of gum or other adhesive material'.

The invention was immediately successful all around the world and, even though some experts dismissed machine-made tablets as nothing more than a passing fancy (one disgruntled apprentice wrote to the Pharmaceutical Journal asking whether he had trained for three years only to spend his future writing out labels and wrapping up bottles of factory made tablets), the apothecaries and their patients found machine-made tablets irresistible. They were easier to take and carry around than powders or mixtures and they looked modern and scientific. Machines soon started turning out tablets by the thousand and within a few years of Brockeden's patent being registered small companies making compressed tablets were springing up all over the world. Apothecaries had discovered that it was easier and cheaper to buy finished tablets from a specialist supplier than it was to make them.

Throughout Europe ambitious young businessmen started making tablets and in Switzerland, Germany and Britain chemical companies which had previously specialised in the production of dyes turned their attention to medicines-with the clear intention of selling them to doctors around the world.

Thus it was that the Industrial Revolution had its first direct effect on the medical profession and the international pharmaceutical industry was born. The pharmaceutical industry was formed as an inevitable consequence of the growth of the medical profession. The efficacy of the tablets being made may not always have been particularly high but the companies were, after all, merely satisfying a demand.

To begin with the newly born industry was created to supply the growing market for medicines. Within a century the new industry would be creating its own markets and influencing and controlling the medical profession around the world.

At the end of the nineteenth century the scientific element of medical practice was largely tied up with therapeutics. It had been that way since Paracelsus. Trying new products and experimenting with new techniques when patients could not be saved with existing techniques were the most powerful scientific elements of medical practice.

But by handing over the preparation of their drugs doctors were handing over control of the scientific element of medicine and were about to put themselves in the control of a small industry which started by serving the profession but which would end up by controlling it.

THE MEDICAL PROFESSION began its intense love affair with the drug industry through necessity. The love affair grew as both partners realised that there were huge profits to be made out of the partnership. The industry could sell vast quantities of its pills at very high prices. And the doctors had a ready supply of pills to hand over to their patients.

But how has the industry grown so rapidly and so dramatically?

And, even more important, how have doctors become so dependent upon and so closely linked to the pharmaceutical industry? How has an apparently independent and prosperous profession been taken over so completely by an industry with no motive for its existence other than simple profit?

When doctors handed over the preparation and development of medicines to the blossoming drug industry they had an opportunity to hand over all the business aspects of the profession and to retain control of the scientific aspect of drug production. They didn't do this. Instead they abandoned science and became businessmen in their own right. They stopped experimentation, and original thinking quickly became of secondary importance to practice management. Medicine, once the most respected of professions, became a business just like boot mending or hairdressing. Doctors abandoned their loyalty and their responsibility to their patients and handed over control of their profession to a powerful, ruthless, international industry. I don't think that the profession did this knowingly or deliberately it happened slowly and gradually. But it happened. And the drug industry was, not surprisingly, very happy about the way the new relationship developed.

Today, doctors are not scientists. They do not think like scientists, nor do they behave like scientists. But the big problem is that they still think of themselves as scientists and they still want to act like scientists.

And by providing doctors with high technology drugs the pharmaceutical industry enables doctors to maintain the myth.

Doctors have put their total trust in the pharmaceutical industry and the industry, keen to make sure that doctors prescribe what it wants them to prescribe (for only in this way can profits be maximised), does not now simply provide the drugs for doctors to prescribe, it also controls a huge chunk of medical education. Over 40% of the information which influences doctors' decisions as to what to prescribe comes directly from drug companies. The drug industry spends billions of thousands of dollars a year buying advertisements and hiring salesmen to tell doctors what to prescribe. On top of this they pay out much more by giving doctors money for bogus clinical trials and 'travel expenses'. There are very few medical societies in the world which have never received drug company support.

The drug industry (which now usually describes itself as the 'ethical' pharmaceutical industry) also pays for most of the medical journals which exist. The majority of the world's 30,000 medical journals accept huge fees for drug company advertising and many have very little other income. Some journals produce special supplements for drug companies which want to promote particular products. Some journals will publish drug company produced articles which look like independent scientific papers but which are written by or for drug companies wanting to sell their products. A century ago drug companies produced their own scientific journals to publish information about their products. Today drug companies do not need to publish their own journals in order to make their products look scientific. The companies hire technical writers to produce scientific papers and then get apparently 'independent' doctors to put their names on them. The doctors aren't much bothered about the contents of the papers but they enjoy seeing their names in the journals and they like the fact that the drug companies will then fly them around the world in great luxury in order to attend meetings and to read 'their' scientific papers. Many 'authors' even receive vast consultancy fees for their 'work'. Doctors are also sometimes expected to write letters of defence to medical journals if a product is threatened.

It is impossible to say just how much the pharmaceutical industry influences today's medical journals, but I for one certainly suspect that the influence is too great.

THE GENERAL RELUCTANCE of medical journals to publish articles and letters questioning the value of vivisection is, it seems to me, a worrying example of the power of the drug companies.

Vivisection is, without a doubt, essential to the success of the world's drug companies. By testing new substances on animals they are able to market new drugs without doing too many tests on human beings. If drug companies performed massive human trials many of their new products would never get onto the market. Properly conducted, exhaustive trials on human patients would show that many drugs either didn't work or weren't safe (or, as in many cases, didn't work and weren't safe). Drug regulatory authorities admit that many side effects will only become apparent when drugs have been on the market for some time. In Britain, for example, in February 1993, the Committee on Safety of Medicines and Medicines Control Agency admitted that 'despite extensive premarketing trials some drug safety hazards will emerge only after widespread use in general practice'.

Animal experiments are an essential part of the premarketing trials procedure for drug companies, but if a test done on animals shows that a product is dangerous to animals, a drug company will usually ignore the test-arguing that animal tests are of unknown clinical significance.

There are many drugs on the market which are known to cause potentially serious problems in animals. For example, tamoxifen, a drug which is widely prescribed for the treatment of breast cancer and infertility, is known to cause liver tumours in rats. The manufacturers of omeprazole, a top selling drug for the treatment of duodenal and gastric ulcers, point out that gastric cell hyperplasia and carcinoids have been observed in life long studies in rats. The makers of Zoladex, used in the treatment of prostate cancer, breast cancer and endometriosis, say that in mice long-term repeated dosing with the drug produced 'histological changes in some regions of the digestive system manifested by pancreatic islet cell hyperplasia and a benign proliferative condition in the pyloric region of the stomach'. They add that 'the clinical relevance of these findings is unknown. The makers of tretinoin, used in the treatment of acne, point out that recent studies in mice treated with tretinoin and exposed to artificial sunlight suggest that tretinoin may speed up the appearance of sunlight-induced skin tumours. They say: 'The significance of these studies as related to human beings is unknown. There is a more comprehensive list in Chapter 4, detailing the names of many other products which are also known to cause serious problems when given to animals.

When animal tests have helped a drug company obtain a licence, the company will put its new drug on the market and quickly make it available for thousands of doctors to prescribe to millions of patients.

The reasoning behind launching drugs to lots of doctors is simple: the unscrupulous and cruel aim is to maximise profits before side effects become apparent. Drug companies aim at getting their new products prescribed very quickly before doctors notice that patients are being killed or made ill by the drug. Regulatory authorities which allow drug companies to submit animal tests as part of the screening process are encouraging this cynical attitude towards patient safety.

When problems become apparent after a drug has been taken by patients, drug companies may use the fact that they performed animal experiments as evidence that they tested the product. But if a patient discovers that the drug that has caused him problems was previously known to cause problems in animals, the company may argue that the original animal experiments could not be used to predict what would happen when the drug was given to humans because of the anatomical and physiological differences between animals and humans.

CLINICAL PHARMACOLOGY is the medical speciality which is responsible for evaluating drugs and providing doctors with allegedly independent advice on which drugs to prescribe. It ought to be independent. In the 1920s in America doctors, pharmacologists and experimental scientists were not allowed to work with or for drug companies. But today there are very few clinical pharmacologists around who have not received drug company money and who are not now on drug company pay rolls. The vast majority of academic prizes in clinical pharmacology departments are funded by drug companies and well over half the medical research done in universities and teaching hospitals is paid for directly by the drug industry. Governments can no longer put together independent groups of clinical pharmacologists to assess new drugs because there aren't enough specialists around who haven't received drug company money.

The inevitable result is that many of the people who decide whether new drugs are suitable for widespread use have received drug company money. The drug industry has managed to obtain such total control of the profession that it can now decide more or less at will which drugs get licensed. And, of course, another result of this power is that other, non drug types of treatment are ignored or even suppressed.

Consider the story of the TENS machine-a simple device which can be used to control pain.

Everyone suffers from pain some of the time. Some people suffer from pain most of the time. And thousands of very unlucky people suffer from pain all of the time.

Pain is the one symptom just about all patients hate, fear and complain about. But it is one symptom that doctors are terrible at treating. Most doctors know very little about pain control. Many medical textbooks dismiss pain as though it were an irrelevance. And medical schools do not bother much with teaching students about pain relief.

Worst of all there is a conspiracy between doctors and drug companies which ensures that millions of patients in pain are denied easy, cheap, reliable pain relief so that profits can remain high.

The story began when what is called 'the gate control' theory of pain was accepted.

This theory, put forward by MeIzack and Wall, suggested that when body tissues are damaged, messages carrying information about the injury travel towards the brain along two quite separate sets of nerve fibres. The larger fibres carry messages about sensations other than pain and the smaller fibres carry the pain messages. The messages which travel along the larger fibres tend to arrive at the spinal cord before the messages travelling along the smaller fibres and, if there are enough non painful sensations travelling, the pain messages won't be able to get through.

Once this theory had been accepted it was possible to explain all sorts of natural phenomena which had, up until then, been a mystery. So, for example, it became clear that when we rub a sore spot what we are doing is increasing the number of non-pain messages travelling towards the spinal cord (and thence the brain). If you knock your elbow you will automatically reach to rub the spot because subconsciously you know that by rubbing the area you will be able to cut down the amount of pain that you feel.

Having realised just how rubbing a sore or painful place can relieve pain, the next step was to come up with a way of stimulating the passage of non painful sensations even more efficiently. When the idea of using electricity to produce the necessary stimuli was first put into practice in the late 1960s, it was suggested that electricity should be introduced into the body through electrodes surgically implanted in the spine. Although that did work the fact that it involved an operation limited the usefulness and availability of the procedure.

Then, it was discovered that all nerves within an inch or so of the surface of the skin can be stimulated by electrodes which are simply stuck onto the skin. And that encouraged medical researchers to start giving patients pocket sized battery operated stimulators which sent out a continuous series of electrical pulses. The pulses got into the large nerves of the body via silicon electrodes stuck onto the skin with a special conducting paste.

It worked!

More exciting still it was found that Transcutaneous Electrical Nerve Stimulation (it quickly became known as TENS) did not just stimulate the passage of sensory impulses designed to inhibit the passage of pain impulses; it also stimulated the body to start producing its own pain-relieving hormones, the endorphins.

During the last ten years an enormous number of research projects have shown that TENS machines are convenient, safe and effective. They are also cheap to buy and extremely cheap to run.

In a study conducted with patients suffering from rheumatoid arthritis it was found that TENS equipment produced pain relief in up to 95% of patients with up to 50% of patients getting long-term relief.

But it isn't just arthritis patients who benefit from using TENS machines. Up to 90% of patients get short-term relief from pain and 35% of patients are still benefiting after two years of use. Moreover TENS machines have been shown to be effective in the treatment of all kinds of pain. For example, a Swedish study has shown that TENS machines are the only pain killers required by 70% of women in labour.

With this sort of success available from a small, cheap, portable, long lasting machine that can be used at home without any training and that does not seem to produce any side effects at all, you might imagine that doctors would be recommending TENS machines to millions of patients-and that shops would have different models stocked high on their shelves.

But if you try to buy a TENS machine you'll have difficulty,

Why?

Because drug companies don't want patients in pain to be able to deal with their symptom so easily and quickly and cheaply. Drug companies make huge amounts of money out of selling drugs to pain sufferers, and TENS machines would cost them a fortune in lost sales.

So, doctors and drug companies have conspired to keep TENS machines away from the public. Even governments are doing their best to stop people buying TENS machines. For example, the British government recently put a tax of 17.5% on these devices.

You ought to be able to buy one in your chemist's shop. But I doubt if you'll be able to. If you want to try one you will have to ask your doctor to refer you to the nearest pain clinic where with luck-you should be able to obtain one on loan.

It makes one wonder what would happen if a scientist found a cure for cancer or heart disease. Would the drug industry suppress that too?

THE DRUG INDUSTRY'S ownership of the medical profession would not be so much of a problem if the pharmaceutical industry was honest. But it is without a doubt the most ruthless, most blatantly dishonest and most manipulative industry anywhere in the world. It makes the arms industry look positively angelic by comparison. Its opponents are destroyed or vilified and its executives abuse their power whenever their companies are threatened. Millions of patients are deliberately put at risk to boost drug company profits and doctors help in this pharmaceutical carnage by uncritically prescribing new and untried products when existing products or alternative therapies would do the same job much more safely and much more effectively. The drug companies do not set out to help humankind. They are, quite simply, in business and if the profits to be made out of selling baked beans or lawn mowers were greater then these companies would almost certainly be making baked beans or lawn mowers.

In the 1970s, when the American Securities and Exchange Commission investigated the amount of bribery in American companies, it found that there were three industries which were dirty and greedy: oil, aircraft and drugs. Many companies admitted paying bribes to governments so that they could get approval to sell their drugs.

One threatened investigation alone led to more than 100 medicinal products being 'withdrawn` or 'recalled' and numerous leading drug firms were implicated in corruption, fraud or making false statements.

Time and time again drug companies have misleadingly understated side effects associated with new drugs, given inadequate warnings about dosages and the risk of addiction and made misleading claims for their products.

Around the world, drug companies have changed the manufacture and specification of drugs without giving adequate warnings, they have produced misleading data sheets for doctors and they have given unsuitably and inappropriately broad indications for the uses of new drugs so as to maximise sales.

Time and time again drug companies have painted an unduly rosy picture when launching new products. Drug companies are routinely selective when they make clinical data available to doctors and they omit certain types of patient from trials. For example, although the elderly take far more drugs than any other group, drug companies usually exclude the elderly from their trials since old people are far more likely to suffer from side effects and uncomfortable or potentially dangerous adverse reactions.

It is drug companies which benefit most from the fact that only a tiny proportion of the clinical papers published in the world's medical journals are statistically valid. Drug companies have a vested interest in ensuring that the quality of published research remains low. If the world's medical journals started to publish incisive, accurate studies, thousands of drugs would have to be removed from the shelves overnight.

The present system of chaos and confusion does at least allow drug companies to continue to sell their products and doctors to continue to prescribe them in apparent ignorance of their uselessness and dangers.

The vast majority of journal editors help to maintain the situation. Their salaries are usually paid or subsidised (directly or indirectly) with drug company money and they are far more interested in publishing new and exciting papers which promise cures galore than in publishing papers which show how much damage is being done by useless and potentially lethal products. One popular method is to compare a new drug with the worst available products so that the new product comes out well (for example, when launching a new anti-arthritis drug one ploy is to compare it not with soluble aspirin-which is relatively safe-but with non soluble aspirin which most sensible physicians and patients avoid because they know it causes stomach upsets).

Companies also play down side effects, they suppress worrying trials and they launch drugs quickly before side effects can be discovered. Doctors who discover unpleasant or dangerous side effects while conducting initial trials are likely to have their trial stopped.

Drugs which are of no clinical value whatsoever are introduced onto the market and drug companies sell vast quantities of drugs which anyone can see must do more harm than good. Instead of introducing new drugs for diseases, drug companies spend most of their money in trying to copy existing drugs and then finding new marketing niches for their products. The industry which was originally led by scientists is now led by marketing men. Instead of looking for new drugs with which to conquer disease, drug company executives spend their time looking for new marketing angles for existing and otherwise useless products or looking for ways to get round the patent laws and introduce a drug to compete with a product which is already successful.

When doctors organise clinical trials for new drugs, they are likely to be told that the drug company whose product they are testing will decide whether or not the report they are writing will ever be published. Drug companies retain the right to censor unflattering comments or to withhold publication of trials which will not help sell their product. Doctors put up with this because if they don't they won't get paid. The profession has become as dishonest as the industry. Tragically, this attitude frequently spills over into the way doctors treat the patients they use as guinea pigs. In most countries it is virtually normal practice these days for doctors not to tell patients that they are being used in a clinical trial. Thousands of patients have suffered serious side effects after being 'abused' in this unethical way. Some have died.

The dishonesty certainly spills over into the way doctors regard the trials they are asked to take part in. Numerous doctors have been charged with faking results and inventing patients when allegedly testing drugs for big companies.

Despite the drug industry's awesome reputation for dishonesty (and the medical profession's rising reputation in this area) the licensing bodies around the world do not do their own assessments of new drugs. Amazingly, they still trust the drug companies who apply for licences.

ADVERTISING INTENDED To educate doctors is frequently blatantly dishonest too.

Early on the drug companies realised that their most important task was to create and sustain a scientific image. They have always known that their success is built upon this perceived image. From the start they have expressed a stern distaste for the makers and sellers of traditional 'quack' remedies. Most of all, however, they have concentrated on making their products sound scientific. All big drug companies know that what a drug promises is far more important than what it delivers. Time and time again drug companies have introduced new products and sold them for a range of disorders when there was only the vaguest evidence to show that the product did any good at all. The pharmaceutical industry is unique in that its products are sold not to the people who consume them but to doctors.

Two or three decades ago drug companies realised that in order to make huge amounts of money they needed to find common, long-term, ill defined illnesses, find drugs that produced some sort of measurable effect, perform experiments on animals, patent their drugs and then put an enormous amount of effort into marketing their new remedies for modern ills.

From the 1960s onwards drug companies realised that they had to really market their drugs if they were going to make big money. They had to make patients want their drugs and they had to spend huge amounts of money on doctors-wining and dining them, paying them consultancy fees and convincing them that their new drugs would satisfy patients' needs.

One government minister has admitted that the drug companies have broken the rules with their advertising dozens of times. False claims and inadequate warnings are so common in drug company advertisements that the whole industry would collapse if drug company directors were forced to resign every time a breach was uncovered.

Misleading advertising is deliberately designed to encourage doctors to prescribe products inappropriately or excessively; it is as honest and as reliable as the average political manifesto; it is unscientific, crude, biased, inaccurate, misleading, deliberately mendacious in tone and content and if it is believed it is because the doctors who read it trust the pharmaceutical industry and do not understand that they are being used.

Drug company advertising material can be divided into two types.

First, there is the selling material designed to catch the doctor's eye before he prescribes. Much of this material looks as if it has been designed to attract five year olds. There are lots of pretty pictures, cartoons, pull-outs and gimmicks. Second, there is the scientific information which gives some basic details about what the drug is alleged to do. Most of this small print is incomprehensible to anyone who isn't an expert in that particular field. The drug companies want prescribing doctors to think that they are co-operating in a scientific adventure but they don't want them cooperating too much.

If drugs were truly life saving there would be no need for salesmen, faked trials and advertising hype. But the truth is that for each new drug a need has to be created and the risk ratio between the drug's advantages and disadvantages has to be manipulated in the drug company's favour.

HEALTH MINISTERS INVARIABLY have the power to discipline and fine drug companies which ignore the rules but they hardly ever do, for their allegiance is quite clearly not to patients but to the drug industry.

After one drug company was prosecuted and found guilty of producing misleading advertising for one of its products, the company and its medical director were both fined relatively modest amounts but the company was allowed to continue to sell the product concerned.

Three thousand random analyses on medicines a few years ago showed that a third of the drugs tested had failed to reach specification. For example, tests conducted on one drug showed that some tablets dissolved within five minutes while others took more than an hour.

There is also some absurdity in the fact that whereas the makers of sweets must declare what ingredients their products contain, so that parents can avoid additives which may cause allergy problems, the makers of drugs are under no such obligation and, indeed, some drug companies use colorants which are believed to be responsible for allergy reactions.

There is no doubt in my mind that the regulatory authorities are far too gentle on the drug industry, showing a sense of trust that is, to say the very least, misplaced. (More cynical observers might claim that it is hardly surprising that the world's regulatory authorities are gentle when one remembers that many of those employed by the regulatory authorities are also receiving drug company money.)

There are very few individuals in the world's drug regulatory systems who are not in some way beholden to the drug industry.

When the British government was asked about the fact that many members of the committees given the task of investigating drugs were beholden to the industry a government spokesman replied: 'Members are appointed for the expert advice they are able to give. Any involvements they may have in research sponsored by the pharmaceutical industry helps them keep in touch with important aspects of drug development. By following the ethical standards set by the code of practice on declaration of interests members are able to avoid conflicts of interest which might otherwise impair the objectivity of the advice they give'.

THERE CAN NO longer be any doubt that drug companies simply cannot be trusted. And yet that is exactly what governments and the medical profession do: they rely entirely upon drug company sponsored research before deciding whether a drug is safe to prescribe.

Everyone ignores the acknowledged fact that the best selling products are not necessarily the most effective ones, but often the drugs that are promoted the hardest and backed with the most imaginative marketing programmes.

While ignoring the law and breaking all existing rules in the pursuit or profit, drug companies can comfort themselves with the knowledge that even if things go wrong and they are sued, they will be extremely unlikely to lose. If all else fails drug companies will argue that since the drug was given a licence by the relevant authorities the drug company concerned must have done everything it could have been expected to do to test its product. The company can hardly be blamed, goes the argument, for unpleasant or serious side effects which only become available after the drug has been licensed and launched. The drug companies behave in this outrageously aggressive and ruthless way because they are in the world's most profitable industry. The industry attracts greedy people who simply want to make money rather than well intentioned individuals who want to save the world. If the cocaine barons of Colombia knew how easy it was to make money legally by selling prescription drugs, they would give up their smuggling rackets overnight and move in to the 'ethical' drug industry. At least, they would if they were tough enough. There is, however, a chance that they would retreat licking their wounds, for this is a tough industry where only the most ruthless stand a real chance of surviving.

A few decades ago there were thousands of drug companies. During the American depression in the 1930s over 3,500 drug companies collapsed and went bust. Today the sale of drugs around the world is controlled by a relatively small number of companies.

It is not difficult to see why the drug industry behaves in such a ruthless manner. The profits to be made out of selling drugs are phenomenal. It is not at all uncommon for a drug company to sell several hundred million dollars worth of one product in a year. Companies can make 90 cents pure profit for every one dollar's worth of a drug that they sell. The raw materials for a drug may cost less than $100 a kilo. Turning the raw materials into 100,000 pills and packing them may take the total cost to $ 1000. The retail price for 100,000 pills may be over $100,000. The only other internationally sold product that can compare for profitability is cocaine.

Drug companies frequently make minimum annual profits of between 30% and 50% on their capital employed. These profits, incidentally, come after the massive above and below the line payments to doctors.

Nor are profits likely to drop, because the number of drugs doctors prescribe does not seem to be slowing down. A recent survey of over 2,000 patients admitted to hospital showed that within a ten year period the number of drugs prescribed per patient had shown an increase of almost 50%.

Perhaps this is not too surprising, for doctors all around the world can often make extra money by prescribing more drugs. In Japan, for example, the opportunities for making money by prescribing more drugs are uniquely absurd. The Japanese government gives a fee to each doctor every time he prescribes a drug. The doctor buys his drugs at a much lower price from a wholesaler and keeps the profit. Japanese doctors have a powerful financial incentive to prescribe lots of medicines. The more expensive the medicine the higher their profit. The twentieth century doctor still has much in common with the apothecary who earned his living by handing out drugs.

Ten years ago companies that made drugs accounted for 5% of the London stock market's capitalisation. They now represent more than twice that percentage of the market. In 1982 drug companies accounted for 7.4% of the American market. Today their share is twice that. Drug companies are now the biggest sector on the stockmarket-bigger even than oil companies.

It is impossible for any outsider to know what the end of the year real profits are for the big drug companies, but I doubt if any other industry in the world comes close to the drug companies when it comes to profitability. While most other industries were suffering badly during the worldwide recession of the late 1980s and early 1990s, shares in international drug companies continued to rocket.

The drug companies do not always admit to such huge profits, of course. There are many techniques for cutting profits and therefore cutting taxes and limiting the danger of controls being introduced.

The simplest trick for international companies (and the biggest drug companies have been international ever since the chemical companies realised the benefits of selling the same drugs all over the world at the end of the nineteenth century) is to move profits from countries where the taxes are high to countries where the taxes are low by manufacturing basic chemicals in the low tax Country and then charging subsidiaries in the high tax country a high price for them. This quickly, easily and legally ensures that profits end up in the right place. There is no other legal industry anywhere in the world which makes profits to match those of the drug industry.

Occasionally politicians mutter about the obscene levels of drug company profits but the industry is efficient and ruthless and politicians are usually dealt with easily. The truth is that most politicians are, for a variety of reasons, reluctant to interfere with the drug industry .Drug companies which make money provide jobs and pay taxes; in most developed countries they bring in revenue from abroad. Even the least effective drug company should be able to sell its product to developing countries.

But the key factor in the failure of the politicians to control the drug industry is surely that neither politicians nor industrialists are particularly keen to see illness conquered. The drug industry wants to see as many people as possible suffering from long-term, incurable illnesses. The politicians want to see people die before they become old and dependent. If more money was spent on preventing cancer (around 80% of cancers are preventable) then the average life expectancy would go up dramatically and the incidence of disease and disability would fall. But the drug industry doesn't want a healthy nation (it would sell fewer drugs) and the politicians don't want any more people living to an old age because they know that they would not be able to cope with the pension bills they would have to pay. The astonishing truth is that the drug industry needs to keep the voters ill in order to maintain its profits and the politicians want to help them achieve that aim.

The medical establishment, which has sold its soul for pots of gold and which is now controlled by an industry whose primary aim is to maximise the number of sick people in society, rarely criticises the drug industry.

Most academic research departments, medical journals and medical associations rely heavily if not exclusively on the drug industry. The drug industry effectively owns the medical establishment.

THE DRUG INDUSTRY does, of course, deny that it is driven by exclusively mercenary motives. Its representatives and spokesmen will argue that the industry spends huge amounts of money on research looking for new drugs and that it is an honourable and public spirited industry

It isn't difficult to prove that this argument is absurdly dishonest. The truth is that much of the money allegedly spent on 'research' is, in reality, spent on marketing. There are many ways in which drug companies can confuse this issue and many techniques are used by those who are skilled in financial legerdemain.

The simplest trick is to organise 'postmarketing clinical research trials' in the period immediately after a drug has been launched and to pay family doctors to prescribe the new drug and to assess its value.

Sometimes doctors are given cash for this arduous work (up to $150 per patient seems to be the going rate in the early 1990s), sometimes they are 'paid' with air tickets, and sometimes they are rewarded with colour television sets or computers. Patients are usually unaware that they are being used as guinea pigs and that their repeated visits to the surgery for check-ups are designed to earn their doctor extra money It is presumably up to the GP to decide whether or not to declare his free TV set to the tax authorities.

These widely organised GP trials are usually of no clinical relevance at all (indeed, the completed forms which the GPs send in are sometimes just thrown away) but the idea is simply to get the doctor to prescribe the new drug. After three new drugs were launched and 'helped' along with trials of this type it was discovered that 5% of all doctors were responsible for over 50% of the prescriptions for these products.

A recent survey showed that several thousand general practitioners were willing to try a new drug before it was released for general use, while thousands more were keen to try new drugs as soon as they were released and without waiting to see what side effects or problems might develop. Altogether around a third of general practitioners say that they are happy to try new drugs before they are in common use-and before the advantages or disadvantages of the new drug have been properly assessed.

Apart from the cash payments and free TV sets the only explanation for this recklessness with their patients' lives has to be that in some way GPs feel that if they are prescribing brand new, untried drugs they are practising 'scientific' medicine.

Technically, the expenditure of money on clinical trials in general practice can be classified as 'research' but in practice it ought to be included under 'marketing' costs. The trials are of very little scientific value and often fail to spot side effects. There are often special financial benefits to be obtained by classifying 'marketing' costs as 'research' since in some countries a drug company's allowed profits are linked to its research costs.

The cruellest irony in all this is that drug companies really ought to be putting some genuine effort into organising real postmarketing clinical trials, for we still have very little idea about the effectiveness or safety of any of the thousands of drugs currently available.

Antibiotics have been around for forty years and the drug companies making them must have made billions of dollars in profits, but no one yet knows for how long antibiotic tablets should really be taken when treating any specific condition. Should you take an antibiotic course for 5, 7, 10 or 14 days? The bizarre truth is that your guess is probably as good as your doctor's, and his is probably as good as the drug company's.

Apart from failing to test its products properly, there are several ways in which the drug industry shows that it is more concerned with profit than with healing the sick and conquering disease.

First, the vast majority of the 'new' drugs which the industry produces are not really offering anything new at all but are merely variations on existing themes.

According to the World Health Organization only about 200 drugs are essential. At any one time there will, however, be anything up to 30,000 drugs on the market (the precise figure varies from day to day and from country to country). Only 16% of the drugs sold by European pharmaceutical companies meet the World Health Organization definition of essential drugs. (The 16% comes to far more than 200 because, of course, there are numerous versions of each of the 'essential' drugs on the market). Most of the non essential drugs will be duplicates produced by profit-hungry drug companies which want to share the world's most profitable markets. None of this will stop a drug company claiming that its new product is a life saving miracle drug that must be allowed onto the market without delay if lives are to be saved. In the United Kingdom there were 28% more drugs on the market in 1990 than there were in 1980.

Once any drug becomes a success manufacturers will rush to produce their own variations on the theme. Bestselling product categories attract a huge amount of competition and at any one time doctors will be faced with scores of different antibiotics, painkillers, high blood pressure treatments, tranquillisers, sleeping tablets, oral contraceptives, vitamin preparations and non steroidal anti-inflammatory drugs suitable for the treatment of arthritis. The available choices will not, however, all be different substances. The brand names may vary but the ingredients will often be identical.

There are many advantages to companies making what are called 'me too' drugs, but the main one is that by the time a company comes second onto the market a variety of unpleasant side effects are bound to have been associated with the original drug. Because new drugs are never thoroughly tested before they are launched, new drugs can always be promoted as virtually free of side effects. Only after the drug has been taken by thousands of patients will the problems and disadvantages be obvious. Thus drug companies producing 'me too' alternatives have an enormous advantage.

New drugs also have one big advantage over existing products: because they will have been given to relatively few patients, the list of side effects associated with their use will be small.

With a little bit of luck such drugs will also be able to offer some very minor advantage or other. It isn't difficult to turn doctors away from a well tried original by telling them that you have produced a new and improved version.

In an attempt to persuade drug companies to produce genuinely new drugs for conditions where there is no existing treatment, the American government passed a law offering a seven year monopoly and special tax breaks for drugs designed for a potential market of less than 200,000 patients. Drug companies producing treatments for relatively uncommon diseases such as AIDS qualify for this special deal.

But companies are already finding ways to use the tax breaks in ways that were never intended and are now using what is called a 'salami technique' to use the system to get extended sales and low taxes for drugs that would be commercially viable anyway.

By specifying different groups of symptoms for groups of 200,000 patients or less a drug company can get all the advantages of producing a drug with a small market without having to limit the potential upside of its profits.

ALTHOUGH IT IS firmly based in the developed part of the world, the international drug industry will happily make whatever profits it can in the developing countries, marketing its products as unscrupulously as the tobacco giants.

Although drug companies spend virtually no money on studying the sort of diseases which afflict human beings in the developing countries, they do nevertheless sell around 20% of the value of their combined drugs to the governments of those countries. The drug companies will admit that diseases which afflict the people of Africa and Asia aren't profitable enough to merit any research investment but they will happily sell their expensive brand name versions of tranquillisers, sleeping tablets, pain killers, and the other pharmacological garbage of the developed world into those countries.

Moreover, when they sell into developing countries the drug companies, like the tobacco companies, can use advertising and marketing techniques which not even the lax governments of the West would allow.

Indeed, they don't just sell off products which are too dangerous for sale in the developed countries: they also use drugs in ways that would never be allowed in developed countries. For example, doctors in developing countries may be encouraged to prescribe drugs to help improve the growth of malnourished children who really just need better food.

There is a ruthlessness about the drug companies which makes the arms business look positively philanthropic. Drug companies have even been known to push up prices of drugs in small developing countries which have been hit by epidemics. To the drug industry profit is everything.

OCCASIONALLY, OF COURSE, the medical profession decides that it is time to do something and to make an attempt to break free from the pharmaceutical industry.

The Canadian Medical Association has just published new guidelines for physicians which state that: 'Conflicts of interest between the personal benefit of the physician and the well-being of patients should always be resolved in favour of the latter. Physicians should not accept a personal benefit from industry when this would have the effect of influencing their practice in ways that would not be for the good of their patients.'

It would be nice to think that at least a few doctors might follow these guidelines. But I am sceptical. I first exposed the medical profession's reliance upon the pharmaceutical industry back in 1975 in my book The Medicine Men. That book was criticised viciously by the medical establishment. I have no doubt that the medical establishment will greet this book with the same howls of anguished protest.

THE DRUG INDUSTRY has emasculated the medical profession; taking away its power, strength and self-respect. Drug companies have, quite simply, bought control of the medical establishment with their money

When it took over the development and production of drugs at the end of the nineteenth century, the drug industry took over the most obviously scientific element of medical practice. When the apothecaries handed over pill making to the chemical companies their only real link with science disappeared.

Despite the attempts by people like Paracelsus to establish a scientific attitude towards diagnosis, practical medicine had for centuries depended almost totally upon therapeutics for its advances. When doctors started to rely on drug companies for the creation of new drugs, they abandoned an activity which had led to most of the post-Renaissance developments in medicine. Apothecaries mixing medicines had not merely made up their compounds according to existing recipes; they had experimented and tested new compounds, discarding the useless or the dangerous and retaining the useful, the effective and the safe. They may not have understood how to organise a properly structured double blind clinical trial and they may not have been able to report their findings to huge audiences at sponsored conferences, but they were inspired by an unquenchable thirst for knowledge. Doctors who wanted to build successful practices had to rely heavily on their own basic scientific skills.

The rapid building of a commercial relationship with a developing pharmaceutical industry has done more than simply separate medical practitioners from fundamental scientific principles; it has also made the profession sloppy, careless, lazy and introspective.

Today all doctors have access to the same range of scientifically prepared drugs, but the whole business of preparing drugs has become so complex and so sophisticated that no one doctor can understand all the scientific principles involved. Doctors have been effectively separated from the science upon which they are traditionally dependent, and in consequence they have become obsessed with their own self-interest.

Medicine has become a 'business' rather than a profession and, like all businessmen, modern doctors are influenced by profit rather than any other motive when considering what to do. A continuing association with a ruthless industry which constantly favours profit at the expense of everything else has rubbed off on the profession.

Doctors have become so used to doing what they are told by the industry that they have become accustomed to prescribing pills for every problem. They have lost the breadth of vision to enable them to see opportunities for cure outside the traditional range of pharmacological opportunities.

It is often said that patients are hooked on taking pills-but this really isn't true. The fact is that it is doctors who are hooked on prescribing pills. Many patients go into a doctor's consulting room merely wanting advice or help. They don't expect to be given pills. But most doctors end most consultations by handing over a prescription. In one recent survey it was shown that a quarter of all the women in one city area were being treated for psychiatric disease. Another study showed that more than half the elderly patients admitted to the medical wards of a hospital had been prescribed tranquillisers by their family doctors.

Doctors are reluctant to tell a patient that there is nothing wrong with him or her, because they feel that if a patient walks into the consulting room there ought to be something wrong. They think that if they can't find something wrong-something that can be treated with a modern, powerful drug-then they have failed. Drugs are the only things that link them to science.

Drugs are all they have. Without drugs they are nothing. And so every time a patient walks into the surgery they must find something for which they can prescribe.

Once they have a suitable drug in mind they can hand over responsibility to the all powerful drug company. They have faith in the drug company because for them the drug company is the only connection they have with science.

If they cannot find anything wrong with a patient then, too often, doctors will simply prescribe a vague, rag-bag drug such as a tonic or a tranquilliser.

The drug industry has convinced doctors that everyone they see must need a drug and that there is a pill for every ill. The majority of doctors might as well be employed directly by the drug companies as pretend to be independent, authoritative scientists. They prescribe what they are told to prescribe in exactly the same way that the drug company representatives promote what they are told to promote.

Brockeden's pill making patent turned the ordinary pharmacist into a pill counting, bottle labelling automaton, an overpaid pharmacy clerk. And now Brockeden has turned the ordinary general practitioner and hospital consultant into pill prescribing automatons.

Aware of this, and embarrassed and humiliated by the disappointment they feel as they limp through their professional lives, doctors struggle to retain some sense of vocational pride by exaggerating their self importance, swaggering through the hospital wards and treating their patients with ill disguised contempt.

The modern doctor would like to be regarded as a mystical healer: that, indeed, is how he probably sees himself in his dreams.

But in reality the modern doctor is little more than a drug company employee, pushing the latest line in wonder drugs with evangelical enthusiasm, never daring to criticise or to question the promotional material he is shown, grasping his free pen, golf ball or umbrella and wearily handing out the latest wonder drug until it is superseded by another wonder drug-and imagining that by prescribing the latest new drug he is remaining on the frontiers of science and helping to push back the barriers of ignorance.

Today's doctors are no longer capable of thinking for themselves.

They are easy prey for any commercial pressure group and yet they are, at the same time, narrow-minded and prejudiced. Worst of all, they have, as a profession, become so much part of the establishment that they ignore or suppress all new ideas that do not come from the drug industry: they are, as a profession, incapable of having or even accepting original thoughts. The power the drug industry exerts over the medical profession has encouraged incompetence, laziness and greed and has destroyed the professional final few links with science. Doctors have no critical or imaginative faculties left.

As they have acquired a dependence upon drugs, doctors have also lost the ability to see other possible ways of treating illness. It is, I believe, their unspoken allegiance to their paymasters which explains why most doctors refuse to have anything to do with TENS machines for combating pain or with relaxation techniques as a remedy for stress. The majority of clinicians prefer to keep on prescribing pills: painkillers for discomfort and tranquillisers for nervousness. It is this same allegiance and misplaced loyalty (sustained by a certain amount of professional jealousy and a fear of the financial cost of allowing competitors to challenge the professional traditional superiority) which leads doctors to reject alternative or complementary forms of medicine.

Too often people don't die because of a lack of knowledge: they die because the medical profession and the drug industry have no interest in making people healthy but every interest in keeping people ill. Doctors may not realise that this is what is happening. And some drug company executives probably do not realise it either. But the system has sucked them in and the system is now calling the shots.

THE FACT THAT the medical profession is dominated and controlled by the pharmaceutical industry would not matter so much if the drug industry was honest, responsible and ethical. But it isn't. There is no other industry in the world which is as profitable or as ruthless as the drugs industry.

The pharmaceutical industry is (and has for many years been) the most consistently and astonishingly profitable industry in the world. Although drug company turnover is usually slight when compared to huge international companies, the profits in this industry invariably put drug companies high up amongst the top companies in the world. The industry pays retainers and fat fees to a vast number of politicians, journalists and professional lobbyists and uses its consequential power to keep profits rising at a healthy rate.

In America since 1980, drug prices have risen at nearly six times the rate of other goods. The cost for a standard set of childhood vaccines rose from $7 in 1982 to $129 in 1992. When one drug is sold to treat sheep the cost is $ 15 (possibly because sheep aren't worth much, so the price can't be allowed to rise too high or else no one will buy the drug), but when the same drug is sold for the treatment of human patients the price rises neatly to $1,500.

For a long time now drug companies have enjoyed massive profits and their earnings have grown at the rate of 15-20% a year. It is hardly surprising that the industry has for years been the brokers' favourite and also hardly surprising that when the word was out that the American government was thinking of introducing controls to limit drug company profits, the shares of many leading companies fell considerably.

In September 1992 The Economist newspaper pointed out that drug firms also include in their Research and Development budgets all sorts of expenses, such as providing free pills to doctors, which look more like promotional spending. The newspaper commented that equally flexible arithmetic is used in the drug industry's attempt to employ its own genre of economics, dubbed 'pharmoeconomics', to defend its most expensive drugs from unwelcome criticism on the grounds of cost.

When Imigran, a new £8-a-pill drug treatment for migraine, was launched, it was estimated that if all Britain's migraine sufferers were treated with the drug it would cost the taxpayer £1.34 billion-increasing Britain's £3 billion a year drug bill by almost 50% in one stroke! In most developed countries the increase in the drugs bill has dramatically outstripped growth in retail prices for nearly a decade and new products can cost as much as $200,000 a year per treatment. In April 1992 the chief operating officer of Hoffman-La Roche said he feared ever higher drug bills could bankrupt most health services. He suggested that patients should pay a contribution towards the cost of all Hoffman expensive new drugs, with exemptions for the poor.

The obscene level of profit-taking within the pharmaceutical industry has spilled over into other areas of health care. In 1991 American hospital profits increased 23% to more than $10 billion-more than the combined profits of every publicly traded movie studio, record label, broadcasting, cable, advertising and publishing company in the whole United States of America. In 1992 profits in the medical equipment industry (which is worth a colossal $23 billion a year) rose by around a quarter. Health care is a bonanza; a virtually unregulated and unlimited source of cash for unscrupulous companies of all kinds. Drug company employees, unconscionably greedy vultures living off the sick and needy, are paid fat salaries for their loyalty.

The drug industry's success is now truly global. In 1993 it was reported that the Japanese were spending $228 each on drugs per year. The average general practitioner in Japan earns $327,000 a year and most of that is made by selling drugs (Japanese doctors don't just prescribe drugs-they also dispense them). In Germany the average citizen spends $169 on prescription drugs. In Switzerland, home for much of the world's pharmaceutical industry, there was much anger when it was disclosed that dozens of pharmaceutical products cost 38% more in Switzerland than in the United Kingdom, Germany, France, Italy, Belgium and the Netherlands.

Whatever dishonest and over-profitable practices are commonplace in the developed world, we can be sure that these pale beside the way the drug industry does business in the developing world. Between 1981 and 1992 the International Federation of Pharmaceutical Manufacturers Association dealt with a modest 72 complaints, citing 926 alleged breaches of its code of pharmaceutical marketing practices. Just over half these complaints were confirmed, but the interesting thing is that 92% of the complaints dealt with breaches alleged to have taken place in developing countries. (Looked at another way this means that in a decade the International Federation of Pharmaceutical Manufacturers Association had to deal with just 5 or 6 complaints of breaches said to have taken place in developed countries).

The drug industry claims that it needs to keep its prices high to pay for the research it does. Within the industry this is something of an ongoing joke, for anyone who has ever studied the way that drug companies work knows that far more money is spent on promoting drugs than on researching or developing new drugs. In order to make things easier for its political allies the industry massages the books by including marketing costs as 'research'. In America, President Bill Clinton recently commented that: 'The pharmaceutical industry is spending $1 billion more each year on advertising and lobbying than it does on developing new and better drugs.'

The one area where the drug companies should be doing plenty of research-the surveillance of new and existing drugs in an attempt to spot signs of worrying, troublesome or potential lethal side effect trends-is the one area where very little money or effort is spent. I have for decades been advocating the setting up of a simple, international system for observing new drugs. It would be easy and cheap to operate and would simply involve some co-operation between doctors around the world. Drug companies sell their products internationally, so it would seem to make good sense that they should watch out for side effects on an international basis too. But I know of no drug company sponsored international system for spotting side effects. If a doctor in, say, Australia notices side effects with a drug and writes to a company in his country, it might be months before doctors in, say, Germany are aware of this observation. This lack of international cooperation works to the drug companies' advantage because it means that there are lengthy delays before drugs are withdrawn. It is this lack of international cooperation which explains why there are often months or years between a drug being withdrawn in one country and the same drug being withdrawn in another country.

By the time a drug receives a licence to be prescribed for human patients, very little will be known about its possible side effects. Many of the pre-launch trials will have been conducted not on human patients but on members of other species. These tests allow drug companies to get away with murder-literally because although the industry and the authorities accept these tests as valid both recognise them as unreliable. If a drug is shown not to cause cancer in the animals on which it is tested, it is considered safe for use on humans. On the other hand, if a drug does cause cancer in animals then (as I will prove later) the results will be ignored-on the grounds that the relevance of animal experiments to human patients is not known or cannot be reliably estimated. By using animal experiments the drug companies have things entirely their own way. They can't lose.

Using animal experiments enables the pharmaceutical companies to put drugs onto the market without doing very many tests on human beings. The number of patients studied in clinical trials before a drug is marketed is, on average, only 1,480. It is sometimes much less than this. This is quite insufficient to detect the majority of adverse effects (and it does, therefore, enable drug companies to promote new products as being safe and free of side effects).

In 1993 the Committee on Safety of Medicines and the Medicines Control Agency admitted that '...some drug safety hazards will emerge only after widespread use in medical practice.' In the same year Ralph Edwards, of the World Health Organization Collaborating Centre for International Drug Monitoring in Sweden, writing in The Lancet, pointed out that: 'At the stage when a new drug is released onto the market there is only limited evidence about its safety in human beings.'

In 1985 in Britain a working party on adverse reactions recommended to the Committee on Safety of Medicines that drug companies should conduct surveillance studies on most newly marketed drugs intended for widespread long-term use. It suggested that these studies be controlled under voluntary arrangements to be agreed between the Committee on Safety of Medicines and the industry. However, this proposal doesn't seem to have done much good.

In 1992 the British Medical Journal published a paper by doctors working for the Medicines Control Agency and the Committee on Safety of Medicines. The paper, which was entitled 'Review of company postmarketing surveillance studies', concluded that: 'Company postmarketing surveillance studies have made only a limited contribution to the assessment of drug safety, principally because of weak study designs and difficulties in recruitment.' The authors of the paper admitted that: 'Individual studies cannot be identified as information provided to the Medicines Control Agency by companies is commercially confidential under the Medicines Act 1968' and commented that 'companies have generally been slow to provide information about their postmarketing surveillance studies'. The authors of the paper also complained that 'almost all the studies reviewed were slow to recruit patients and some had to be abandoned as a result. Delay in completing these studies increases the likelihood that any hazard will be identified by other methods and therefore reduces the value of the study.'

Amazingly the review also disclosed that postmarketing tests for new drugs involved, on average, only 1.6 times as many patients as had been involved in the premarketing tests. Since newly launched drugs are often taken by hundreds of thousands or even millions of patients within weeks and months, these extremely modest surveillance attempts were clearly grossly inadequate and an indication both of the unwillingness of the industry to help protect patients from serious side effects and of the weakness of the controlling statutory bodies whose job it is to protect patients.

Drug company sponsored postmarketing surveillance studies are voluntary and informal. One former chairman of the Committee on Safety of Medicines has described the studies as, in the main, 'inadequate and badly done' and 'often just a marketing exercise'. Drug company reports are not examined by any independent experts and there is no requirement for a manufacturer to publish its findings. If a drug company discovers a serious side effect with a best selling product it can merely suppress its report and so enhance its profits until other, independent sources have discovered the problem. Even if the company has sent a report in to the authorities it need not worry: the authorities are prevented by law from making public any information they may have obtained from the company. The public, the consumers, the patients-the people who are paying for all this-have no rights. One government spokesman admitted in 1992 that most postmarketing surveillance trials are valueless as their design is so poor. These trials are however of enormous financial advantage to the drug companies, not only because they help to get drugs prescribed more widely, but because these trials can be described as research intended to ensure that a drug is safe, and the money spent can be used to push up the company's tax allowable profits.

Rather than organise exhaustive, independent and properly questioning surveillance studies, drug companies much prefer to pay general practitioners or hospital consultants to perform what can most generously be described as 'informal' postmarketing trials. GPs are frequently encouraged to take part in these trials by the fairly generous payments they receive. It isn't difficult for GPs to add several thousand pounds a year to their income by doing a few trials. Patients are switched from their usual medication (on which they might well be happily controlled) and given a new drug. They are often not even told that they are being used as guinea pigs for the benefit of the drug company and their doctor.

When the trial is over, the doctor fills in a card and sends it off the drug company. (The company may not even bother to process the information). The advantage to the company is that at the end of the 'trial' the GP will have become accustomed to the name of the new drug, and will have acquired a modest loyalty to the pharmaceutical company concerned. If all goes according to plan (which it usually does) the GP will then prescribe the new drug to new and existing patients whose symptoms seem to suggest that they might be suitable.

There are no controls on GPs' prescribing habits and, although most doctors only have a very sketchy knowledge of the drugs they prescribe, they are usually extremely defensive about their rights to prescribe whatever takes their fancy

Even more worrying is the fact that the attraction of making money out of testing new drugs on patients is clearly far too much for many general practitioners. Faking and fiddling, endemic practices in scientific research these days, are both commonplace among doctors doing marketing trials for drug companies.

In November 1993 the British Medical Journal reported that 26 doctors had been referred to the General Medical Council for allegedly falsifying data for drug trials. One GP sent in completed test forms to a drug company before it had even supplied the drug. Other doctors have claimed cash when the drug involved was not available in their area. The chairman of a drug monitoring group at a hospital in the north of England commented: 'Doctors can easily earn £50,000 yearly from clinical trials. Probably millions are being fraudulently earned. It's a bad system. .A company might not investigate too closely if the GP's information looks funny but shows their drug in a good light.'

No one knows how many companies are marketing dangerous drugs about which the available evidence has been faked. The US Food and Drug Administration is reported to be increasingly reluctant to accept the results of UK trials when companies apply for licences to sell their drugs in America.

Keeping a check on new drugs is left almost entirely to the drug companies themselves. The industry, governments and the international medical establishment defend this bizarre and insupportable practice by claiming that general practitioners are encouraged to fill in report cards when they notice side effects. This quite informal system is given great credence by the authorities but it is, sadly, inadequate and totally ineffective. Only about one in ten doctors ever fills in a report card (it may or may not be relevant that there is no payment for doing so) and the system's only value is to the authorities who want to pretend that something is being done to limit the incidence of drug-related morbidity and mortality.

If the British authorities have reservations about a drug, they may give the product a licence but ask doctors to report specific problems. In one month-long study 100 doctors were told of 638 adverse effects by their patients, but those 100 doctors only officially reported 35 side effects to the authorities. Ten of the adverse effects were classified as severe but only two of the ten were reported on yellow cards. The reporting system does not work.

Whenever I mention the fact that the medical profession is controlled by the pharmaceutical industry, doctors leap up and protest that they are not in the slightest bit swayed by the exhortations and persuasions of the industry. They indignantly tell me, with dignity clearly bruised, that they never attend free drug company luncheons, that they never accept free gifts from drug company representatives, that they, indeed, never even agree to see drug company representatives, that they never read the bundles of drug company sponsored literature which falls through their letter box every week, that they never look at the colourful and often slightly childish advertisements which litter (and help pay for) medical magazines (even such apparently august publications as The Lancet and the British Medical Journal

rely heavily on drug company advertising-the BMJ, for example, receives around 40% of its advertising income from the drug industry) and that they are far too well informed and too sceptical ever to be swayed by the industry's massive marketing budget.

I always believe these protesting doctors, of course. It would be rude not to.

But there must be some doctors who listen to and are susceptible to the drug industry's wiles. For one thing the industry would have long ago reduced its marketing budgets if the free pens, free golf balls, free meals and free foreign trips didn't work. For another, the evidence shows that despite their protests nearly all general practitioners in Britain do meet representatives of drug companies.

Back in the mid 1980s the drug industry was estimated to be spending £5,000 per general practitioner promoting its products in the United Kingdom. The figure is undoubtedly higher now and rising annually-but the amount of money spent by the government on educating doctors about new drugs is paltry At a conservative estimate the industry spends 40 times as much money on persuading doctors to prescribe its products as the government spends on trying to inform doctors about which products to use.

In June 1993 Dr Brian O'Mahony, a general practitioner in Ireland, wrote a paper for the British Medical Journal entitled 'Interactions between a general practitioner and representatives of drug companies'. In the paper O'Mahony reported that in a 50 week period he received a total of 109 visits from drug company representatives and received a gift on 64 visits. The gifts 'consisted of stationery, pens, diaries, calendars or trinkets (mugs, tapes, towels, clothes brush, desk tidy, air freshener, ice scraper and flower seeds)'. O'Mahony said that he was given samples of drugs on 103 of the visits and received a total of 174 samples altogether. 'The total value of the samples recorded in this study was £1,485 which constitutes a substantial gift to a general practitioner,' said O'Mahony, who also reported that: 'Advertising has been shown to influence physicians' prescribing habits so that they tend to prescribe analgesics according to advertised guidelines rather than published scientific literature.'

When A.J. Cronin wrote his bestseller The Citadel he described medical meetings at the beginning of the century as being splendid affairs, with drug companies offering doctors cheap hotel accommodation, free trips, souvenir gifts and free theatre tickets.

'Since those days,' wrote DR George Dunea, attending physician at Cook County Hospital in Chicago, 'the pharmaceutical companies have become even more generous, especially in North America. Each year they spend some $33 billion on promotion and advertising-successfully, it would seem, judging by the price of their shares. From mugs and diaries they have moved on to education, sponsoring speakers and guest lecturers for whom nobody else seems disposed to pay; and their advertisements fatten prestigious medical journals and keep alive others that might easily have died in utero.'

Some doctors regard drug company money as a rightful perk; others, naively, seem to think that they are taking advantage of the industry by accepting its money!

It is hardly surprising that the drug industry has no difficulty in finding doctors prepared to support it publicly whenever it feels threatened. 1 have been an opponent of the power of the pharmaceutical industry since the early 1970s (my first book, The Medicine Men, dealt with my fears about the growing influence of the drug companies) and since then I have noticed that whenever I appear on TV to debate the issue of drug companies or new drug products and ask my opponent: 'Have you ever received drug company money?' the answer, is usually: 'Yes. But so what? All doctors do.'

O'Mahony is not alone in his views and the efficacy of drug company representatives is as potent in hospitals as it is in general practitioners' surgeries. Writing in the magazine Hospital Doctor DR Tony Gardner said: 'Drug reps really believe that cheap promotional gimmicks ... will persuade doctors with years of clinical experience and pharmacological acumen to prescribe their company's products-and they're dead right. Consider this scenario. It's 4 am and you're on the ward wondering what antibiotic you can give to a chesty crumbly in bay two... "Oh sod it," you think to yourself. "I'll give him what's written on the side of my pen".

In an editorial published in the summer of 1993 The Lancet reported that: 'No one doubts the importance of pharmaceutical marketing and promotion to the drug industry. Promotion and marketing expenditure averages 20-30% of sales turnover, or about two to three times the average expenditure on research and development. Industry executives themselves freely admit that success depends more on creative marketing than on innovative research.'

In November 1993 The Sunday Times reported that one of the UK's biggest drug companies had been accused of paying out tens of thousands of pounds in cash payments, free foreign trips and champagne receptions to doctors who prescribed its drugs. The use of gifts to doctors has been described by Health Action International as encouraging 'a sense of obligation among prescribers which has an insidious impact on choice'.

I am by no means the only doctor to be concerned about the way that the medical profession seems to accept drug company money without question. Writing in the Journal of the Royal College of Physicians in July 1993, DR A.B. S. Mitchell, Clinical Tutor of St Ann's Hospital in London, pointed out that 'the pharmaceutical companies are being regarded as milch cows by doctors: if not for themselves, then for their departments and health centres'.

Mitchell went on to consider the influence of pharmaceutical companies on prescribing habits over the last five decades and discovered what he described as a pattern of decadence. 'In the past two decades drug prescription and costs have soared exponentially,' he wrote, going on to observe that:

'Clinical meetings at lunch time used to be provisioned by cheddar cheese and cream crackers washed down with hospital coffee, often in a smoke filled room with coughing patients.' Things have changed however. 'Postgraduate and continuing medical education,' writes Mitchell, 'has come to rely increasingly on support from the pharmaceutical industry. The doctor decides disbursement among the competing companies and receives benefit from them. The NHS pays for the drugs.'

Mitchell calls for a divorce between drug houses and medical education and asks: 'Are we prostituting our medical registration and prescribing privileges? Should not the enthusiasm be for the meeting, its content and collegiability, and not for the company's lunch, which is not really free?'

It is, I fear, likely to be some time before any such divorce takes place, for the industry has closely penetrated all layers of the medical establishment. The drug industry even has close links with the regulatory authorities. For example, consider the British Committee on Safety of Medicines, established in 1970 under section 4 of the Medicines Act 1968 to give advice about the safety, quality and usefulness of drugs.

According to the latest annual report of the Medicines Commission, there were 21 members of the Committee on Safety of Medicines in 1992. Members of the CSM have an enormous responsibility and a great deal of power over the drugs British doctors prescribe. Many (though not all) of the 21 members of the CSM were, according to the annual report, listed as having personal interests of one sort or another with drug companies.

The CSM has a subcommittee which exists to deal with safety~ efficacy and adverse reactions. There are 20 members of this sub committee and once again many of them have links of one sort or another with big drug companies.

I realise that these people do declare their interests and 1 do not suggest for a moment, of course, that any of these individuals have acted improperly or have deliberately allowed their drug company interests to influence their attitude towards new drugs. But I don't think that is enough. The very existence of a relationship (however loose it may be) between the industry and the regulatory authorities seems to me to show an unacceptable level of contact with the industry which must be controlled. We would, I suspect, all be concerned if we found that many of our judges were receiving consultancy payments from large gangs of criminals.

I feel that the Committee on Safety of Medicines would have a better image and more public respect if its members were all seen to be as independent as they would undoubtedly tell us they are. The international drugs industry has a well deserved 'dirty' image. Is it really impossible to find doctors to sit on the CSM who don't have links with drug companies?

ANY REMAINING DOUBTS about the effectiveness of the drug industry in controlling doctors' prescribing habits can be removed when one studies what happens to new drugs which are put onto the market. If drug company promotional efforts were of little significance it would be reasonable to suspect that new drugs would only acquire a noticeable market share after a fairly lengthy time period. After all, new drugs are competing with existing products which are, by definition, well tried. Theoretically, it should be quite difficult for a new product to break into the market place and acquire prescriber loyalty.

In practice, however, new products become 'fashionable' very quickly-far more speedily than one would imagine they might. In a report entitled 'Market penetration of new drugs in one United Kingdom region: implications for general practitioners and administrators', authors from the Drug Utilization Research Unit at the Department of Therapeutics and Pharmacology of Queens University, Belfast, the Department of Bacteriology at the Royal Victoria Hospital in Belfast and the Department of Therapeutics and Pharmacology at Queen's University, Belfast concluded that: 'The increase in prescribing of these (new) drugs seems to be greater than can be accounted for by an increase in patients with specific indications for these drugs. This suggests that the profession has not instituted effective checks to ensure that the legitimate promotion of new products does not lead to inappropriate and wasteful use.'

If there are any final doubts let them be removed by this comment from a study commissioned by a group of five pharmaceutical companies. The study concluded that: 'pharmaceutical manufacturers can have confidence that ... when sales messages are communicated through journal advertising market shares of new prescriptions will increase.'

Now, this would be of only limited significance if the drug companies-whose exhortations must have been responsible for this over enthusiastic prescribing-were honest and honourable when it came to promoting their new products. After all, if the drug industry was scrupulously accurate in its advertising and promotion it wouldn't really matter whether doctors got their prescribing information from an official body or the industry.

But the industry's advertising isn't honest.

According to a survey recently published in the Annals of Internal Medicine, 62% of the pharmaceutical advertisements in medical journals were either grossly misleading or downright inaccurate. A total of 109 advertisements from 10 leading medical journals were each reviewed by two doctors and an academic clinical pharmacist. The reviewers used guidelines from the Food and Drug Administration to assess the advertisements. In 30% of cases the independent reviewers disagreed with the advertiser's claim that the drug was the drug of choice. In 44% of cases the reviewers thought that the advertisement would lead to improper prescribing if a doctor had no information about the drug other than that provided in the advertisement.

In Britain, the Association of the British Pharmaceutical Industry tries to regulate itself through a voluntary code of practice, but a study published in 1990 by Andrew Herxhieirner and Joe Collier, past and present editors of the Drug and Therapeutics Bulletin, concluded that 'the code has failed to deter promotional excesses'. The authors of the study estimated that between 1983 and 1988 no fewer than 100 breaches of the code were detected a year. (You will remember, however, that in a decade the International Federation of Pharmaceutical Manufacturers Association had received just 72 complaints).

The secretary of the Association of the British Pharmaceutical Industry was reported in the British Medical Journal as commenting: 'We are currently updating the code, but we think it's already working adequately.'

The power of the drug industry to control its working environment and, to a large extent, its own destiny was vividly illustrated in 1993 when an attempt was made in the British Parliament to introduce a new piece of legislation (the UK Medicines Information Bill) which was, modestly and apparently sensibly, intended to overcome the secrecy behind the decisions about drug licensing applications.

Astonishingly, the law in Britain prevents the government from releasing any information about drug companies and their products. Neither the medical profession nor the public have any right of access to information about prescription drugs. Even victims of side effects of licensed medicines are unable to find out anything about the drugs they have taken (inevitably, this helps to make it difficult for a patient who has been injured by a drug to sue the manufacturing company).

The proposed bill failed to pass onto the statute book because 77 amendments were tabled, which meant that the time available for the bill ran out. Most of the amendments were tabled by a number of Conservative Members of Parliament who receive payments to represent the pharmaceutical industry. The government explained their apprehension about the proposed change in the law by warning that disclosing formerly confidential information about drugs (including details of how they had been tested prior to being put on the market) would 'cause unjustified alarm' and 'would increase the danger to the public'.

Some critics have claimed that the government's reluctance to allow information about premarketing drug tests to be made public (despite its clear promise under the Patient's Charter to make available to patients a clear explanation of any proposed treatment) was not so much a sign of their determination to keep information secret as a sign of their embarrassment at the possibility of the public finding out just how little information they have when licensing new drugs. The government frequently claims that the Committee on Safety of Medicines is an effective way of monitoring drug problems, but only a tiny minority of doctors ever bother to report side effects to the CSM which is, as 1 have often complained, more of a toothless poodle than an effective watch-dog.

Just as frightening is the way that the pharmaceutical industry manages to influence and even control so many of the world's apparently independent medical journals. In my early book Paper Doctors (published by Temple Smith in 1977) 1 reported how some journals were charging drug companies a fee-said to be around £500-to publish an article of average length. The Journal of International Medical Research, for example, was in September 1975 charging £85 per printed page for scientific papers published in it. According to the publishers, 'In addition to publishing medical and scientific papers the Journal of International Medical Research also undertakes the recording, transcription and publication of symposia, under its imprint; with, where necessary, the translation of the proceedings into languages other than English'.

Volume 3, Supplement 3 of the Journal included the proceedings of an international Vivalan Symposium held at the Cunard International Hotel, London. This symposium was attended by 28 foreign employees of Imperial Chemical Industries Ltd., the manufacturers of Vivalan (an anti-depressant drug), 78 doctors from Argentina, Australia, Belgium, Brazil, Denmark, Eire, Finland, France, Germany, Holland, Italy, Japan, Mexico, Norway, Poland, Portugal, Sweden, Switzerland and Yugoslavia, and 110 doctors from different parts of the United Kingdom. There were 125 pages in the Journal Supplement referring to Vivalan.

When I wrote to ICI for prescribing information about Vivalan I was sent a colourful and well produced brochure describing in the usual glowing terms the work done, proving how effective and unique Vivalan is. The prose was based largely on twelve references listed in the back of the brochure in proper scientific fashion. The majority of these references dealt with information published in the Journal of International Medical Research. Did ICI pay for the publication?

I commented in Paper Doctors that few GPs would see the Journal regularly and even fewer would know that companies could buy space in it to publish their papers. Many doctors probably see nothing wrong in companies paying for the publication of articles. But it worries me.

During the decade and a half since the publication of Paper Doctors, drug companies have become even cleverer and these days many of them 'use' apparently independent doctors to get their papers published in medical journals. One drug company employee I spoke to complained bitterly that his research work was regularly being published under the names of doctors who had done little or none of the work. The doctors are, of course, happy to have their names on these papers (publishing scientific papers is essential for the doctor who wishes to make his way up the career ladder in academic medicine).

In 1992 The Lancet reported on a new publication entitled Medical Publishing, the third in a series of practical guides published by Pharmaceutical Marketing. This publication, giving advice to company employees trying to get articles published, explained: 'The editor should be unaware that you are behind (the offer of a review article) so don't offer it free of charge if the journal normally expects to pay contributors, nor use your company address'.

Around the world even apparently reputable journals now frequently publish supplements dealing with specific drugs which are supported wholly or partly by the companies making those drugs. The company concerned can then quote the references from the journal supplement in its advertisements and its sales representatives can quote the supplement when talking to potential prescribers. There is no doubt in my mind that many otherwise sceptical doctors are influenced by the apparently independent nature of these supplements and similar publications.

DR George Dunea, attending physician at Cook County Hospital in Chicago, put it straightforwardly enough when he wrote in 1992: 'Considering the pharmaceutical industry's enormous influence on doctors' prescribing habits, there remains the point of view that neither doctors nor institutions should have to depend on the money of drug companies, nor for that matter the medical journals that carry their advertisements-surely a different prescription to follow in the real world.'

The simple truth is that the drug industry has 'bought' the medical profession and that it now controls the education of graduate doctors and the way in which patients receiving drug therapy are treated.

DESPITE THE FACT that the restrictions governing the sale of prescription drugs can hardly be described as onerous, the drug industry has, in recent years, begun to put an increasing amount of effort into attempting to have its products accepted for sale 'over the counter' without a doctor's prescription. In Britain sales of over-the-counter drugs have increased by nearly 8% a year over the past five years-extremely strong growth compared to most other consumer goods. Denmark, traditionally a fussy country about drugs, has given drug companies the green light to sell dozens of drugs previously available only on prescription. Italy has done the same thing and America is moving that way too.

In countries such as Britain where governments pay some or all of the cost of prescription drugs, it is not surprising that drug companies have found very few obstacles being placed in their path by governments. Selling drugs without prescription ensures that governments save money and drug companies can make even bigger profits.

The over-the-counter drug industry is still relatively small. In Britain in 1991, consumers spent £440 million on over-the counter medicines (excluding vitamins, contraceptives and dietary supplements) but the rate of growth and the potential excite drug company bosses. In America the OTC market is worth around $13 billion a year. Pharmacists, not surprisingly, welcome these changes. They see their profits and their role improving. Doctors tend to be rather gloomy-forecasting enormous problems as patients are given access to powerful drugs (as though patients could prove to be more irresponsible than doctors when dealing with prescription drugs).

There is another reason why drug companies are keen to have more of their prescription drugs sold over the counter. Although doctors are slow to report side effects for prescription drugs, there is at least some degree of monitoring when drugs are available only on prescription. But as more and more drugs become available over the counter, without any monitoring or any controls, it becomes increasingly impossible to keep track of any developing or suspected problems.

And how effective are drug companies going to be at warning patients about possible side effects? Consider the drug terfenadine, for example. During recent years the drug terfenadine (better known as Triludan) has become one of the most popular treatments for hay fever and other allergy problems. Doctors have prescribed it in huge quantities, regarding it as both safe and effective and impressed by the fact that it produces less drowsiness than other antihistamines. It has also become popular for the treatment of skin rashes and allergic rhinitis.

For some time now Triludan has been regarded as so safe that it has even been available over the counter in Britain without a prescription. A pack I bought without a prescription claimed that 'Triludan Forte is for the fast effective treatment of hayfever, rhinitis, insect bites and nettle rashes'.

It was the fact that the drug did not seem to cause drowsiness that helped to make it so popular and enabled the company which makes it, Marion Merrell. Dow, to claim that 'reports of drowsiness are extremely rare' and to boast that 'patients usually may drive or perform tasks requiring concentration` while taking the drug (though the company did warn that 'in order to identify sensitive people who have unusual reaction to drugs it is advisable: to check the individual response before driving or performing complicated tasks').

But look what happened in the summer of 1992 when Marion Merrell Dow issued a warning about Triludan (also available under the brand name Seldane) to doctors. DR H. C. Masheter, the Medical Director of Marion Merrell Dow, warned doctors that the company was aware of reports associating Triludan with serious heart trouble and with the deaths of some patients (although he didn't call them deaths-he referred to them in his letter as 'cases ... with a fatal outcome'). In his letter to doctors, Masheter didn't say how many people may have died after taking his company's top selling product. He stated that worldwide 'serious cardiovascular adverse events (including cardiac arrest ... ) have been reported at a rate of less than one per million patient months of treatment'.

How much less?

And this, remember, is a drug which is recommended for the treatment of hay fever, allergic rhinitis, stings, insect bites, nettle rashes and itchy skin rashes-none of which is a condition usually regarded as anything other than irritating but trivial. A drug, moreover, which can be bought over the chemist's counter by anyone.

In his letter to doctors, Masheter warned that patients who had liver damage should not take Triludan and he gave a list of drugs which might increase the chances of a serious problem developing.

But nowhere on the box of Triludan tablets I bought over the counter was there any warning that the tablets might be lethal if taken with other drugs. Nor was there any information leaflet in the box I bought. The box in which the tablets was sold didn't even warn patients to talk to their doctors.

Masheter told me that Marion Merrell Dow was making plans to include a warning leaflet in its over-the-counter boxes.

Patients who took Triludan for hay fever or an insect bite did not simply risk dying of a heart attack, even though the manufacturers knew that some avoidable factors increased the chances of patients dying. The list of side effects known to be associated with Triludan was at the time said to include: abdominal pain, dyspepsia, hair loss or thinning, heart arrhythmias, bronchospasm, confusion, convulsions, depression, dizziness, headache, insomnia, jaundice, liver problems, menstrual disorders, musculo skeletal pain, nightmares, palpitations, skin rash, sweating, tremor and visual disturbances.

That horrifying list of side effects was not something that had been put together by angry or disillusioned doctors or patients. It was the official list of side effects which was printed by the manufacturing company Marion Merrell Dow and which was available to doctors.

But this list of possible side effects did not appear on the box 1 bought over the counter at my local friendly chemist's shop.

I asked Masheter how many Triludan tablets his company had sold. He couldn't tell me. But he estimated that they had sold enough of the product for at least 135 million patients to have taken the tablets for a month each.

In my view the authorities have failed to protect the public, and the increase in the number of prescription drugs sold 'over the counter' will, in the long run, add to the danger to patients-not because patients will be less wary than doctors, but because the number of pills taken is likely to increase dramatically.

 

 

CHAPTER FOUR

ANIMAL EXPERIMENTS: ILLOGICAL,UNSCIENTIFIC AND POINTLESS

As I have already pointed out, one of the key techniques used by pharmaceutical companies to get new products onto the market is to perform initial trials on animals other than human beings. Animal experiments offer drug companies an enormous advantage: if an experiment shows that a drug does not harm a particular animal, then that experiment can be used to help the drug onto the market. The company will suggest that the absence of any serious problems when the drug was given to an animal shows that the drug will probably be safe when given to human patients.

But, on the other hand, if an experiment shows that a drug causes serious problems when given to an animal, the results will be dismissed on the grounds that animal experiments cannot be regarded as relevant to human beings because of the enormous anatomical and physiological differences between, on the one hand, human beings and, on the other hand, cats, dogs, monkeys, rabbits, rats, mice and other creatures.

Many outside observers who do not fully comprehend the depths of dishonesty to which the drug industry will stoop find it difficult to believe that anyone could get away with such blatant double-edged trickery. In this chapter 1 will prove that this is exactly how drug companies operate.

IT IS DIFFICULT to understand how any medical scientist can possible defend the use of animal experiments as part of a drug testing programme. The usefulness and reliability of animal experiments has been so devalued in recent years that 1 do not believe that any reputable, independent scientist could possibly attempt to defend the use of animal experiments on logical, scientific grounds. Those who perform and support animal experiments are so embarrassed and ashamed of what they do that they frequently use euphemisms to disguise their activities. It is quite common, for example, for experimenters to talk of animals 'taking part' in experiments and 'helping us with our research'. The word 'experiment' has been replaced by the word 'procedure', which is less evocative. Experimenters have their own language. Here are just a few choice phrases they use (and their meanings):

In unguarded moments even the medical establishment acknowledges that animal experiments are absurdly unreliable. The British Medical Association is, as one would expect it to be, a staunch supporter of animal experimentation. But this stance becomes difficult to understand when one studies the British Medical Association's book, The BMA Guide to Living With Risk (first published in 1987), in which readers are told that 'if salt and sugar were being tested as potential food additives today, and if judgement of acceptability was to be based purely on the laboratory and animal testing, it is unlikely that either would be permitted for use in food'. It is difficult to imagine a simpler or more damning indictment of animal experimentation than to admit that animal experiments are so unreliable that neither salt nor sugar just two of many other commonly consumed substances which are known to cause serious problems when given to other members of the animal kingdom) would pass safety tests if animal tests were relied upon!

Incidentally, many other powerful and important substances such as the heart drug digoxin and the pain killer morphine would have failed animal experiment tests and would not therefore be available to us now if the vivisectors had been listened to. Heaven only knows how many other valuable drugs have been lost to medicine because animal experiments falsely suggested that they were highly toxic to human patients. In recent years an increasing number of medical journals have published sceptical or revealing comments. I am grateful to Jill Russell DCR for helping to compile this list of examples.

'Despite the claims of the animal modellers, their studies have largely been irrelevant to psychiatric problems or have lent token support to human studies ... The enormous field of mother-infant separation and deprivation research in animals does not contain a single study that had a discernible clinical impact ... The research did reveal marked variation within and between species that casts considerable doubt on extrapolations to humans, and that vitiates any results that seemingly 'confirm' human studies.' The Veterinary Record, 1986.

'The predictive value for man of toxicological testing in animals is open to question.' Prescribers' Journal, 199 1.

'...we currently are unable to assess clinical pain objectively and reliably in animals.' Laboratory Animals, 1992.

LAWYERS WHO HAVE studied the evidence for and against the use of animal experiments have been convinced by the argument that animal experiments are so unreliable as to be useless. Consider this quote from the Idaho Law Review:

Animal studies have no place in the courtroom. They suffer from inherent and incurable defects that make them entirely unreliable as proof of human response to toxic substances. They fail to account for astonishing differences between animal species and humans; indeed they fail to account for large differences in test results that occur within individual animal species. They rest on unproven assumptions that humans and animals will respond similarly to the same substances and that large doses administered under experimental conditions can be reliably translated into lower doses more commonly encountered in the real world.

MOST CONVINCING OF all, however, is the evidence from the drug companies themselves. A vast number of drugs sold for doctors to prescribe for human patients are known to cause cancer or other serious problems when given to animals. In my view, if anyone believed that animal experiments were of value then none of these drugs would be on the market.

The Imperial Cancer Research Fund, one of the largest and richest charities in Britain, is also one of the most fervent supporters of animal experiments. During 1989, 1990 and 1991 several scientific papers written about experiments involving dogs were published by scientists working for the ICRF. For one experiment 60 male beagle puppies were anaesthetised and then bled to death.

The Fund claimed that the dog experiments were done because there were fears that a drug might cause problems in people. They told me that 'the FDA requested investigations of the mechanisms of hyperplasia associated with high doses of misoprostol'.

One of the papers published by the ICRF scientists ended: 'In conclusion, misoprostol effectively elicits a hyperplastic response in the gastric mucosa...'. The drug company making misoprostol told doctors: 'Cytotec (misoprostol) in multiples of the recommended therapeutic dose in animals has produced gastric mucosal hyperplasia... In patients, histological examination of the gastric biopsies taken before and after treatment with misoprostol after up to one year's duration have shown no adverse tissue response attributable to misoprostol.' In other words the scientists from the ICRF showed that the drug produced hyperplasia in dogs but the drug company still sold the drug for human use and stated that human patients did not respond in the same way. The authorities are clearly happy that the drug is safe for human use.

This was not, however, an isolated example of a drug causing a problem in animals but then still being held to be safe for use by human patients.

The information which follows was taken from the individual data sheets produced by the relevant drug companies. I have included this huge number of drugs because it is the very quantity of drugs on the market-despite the fact that these products are known to cause serious or potentially serious problems in animals-which is of significance (though I do stress that this list is by no means comprehensive). Many of these drugs are extremely popular and are prescribed for millions of patients around the world. It is impossible to obtain precise figures for the number of patients involved because of the secrecy laws.

It would seem to me logical to argue that if animal experiments are worth doing, then (unless the benefit of using a drug can be shown clearly to outweigh the potential hazard) all these drugs should be taken off the market immediately-whereas if these drugs are considered safe for human patients then there is no point in continuing with animal experiments.

These short sections are intended only to illustrate the point I want to make, and are not intended to provide useful information about the drugs concerned.

 

 

ABBOTT LABORATORIES LTD

HYTRIN

Containing terazosin as terazosin hydrochloride.

Use: Hytrin is indicated in the treatment of mild to moderate hypertension.

Contra-indications, warnings etc. Carcinogenicity: Hytrin has been shown to produce tumours in male rats when administered at a high dose over a long period of time. No such occurrences were seen in a similar study in mice. The relevance of these findings with respect to the clinical use of the drug in man is unknown.

 

 

ASTRA PHARMACEUTICALS LTD

LOSEC

Contains omeprazole as enteric-coated granules.

Use: treatment of reflux oesophagitis. Treatment of duodenal and benign gastric ulcers including those complicating NSAID therapy.

Contra-indications, warnings etc. Animal toxicology: gastric ECL-cell hyperplasia and carcinoids, localised to the oxyntic mucosa, have been observed in life-long studies in rats. These changes have been related to sustained hypergastrinaemia secondary to acid inhibition, and not to a direct effect of any individual drug. No treatment related mucosal changes have been observed in patients treated continuously for periods up to 5 years.

 

 

BAYER plc

DTIC-DOME

Active ingredient: 5-(3,3-dimethyl- 1 -triazeno) imidazole-4-carboxamide prepared as the citrate salt (dacarbazine).

Use: metastatic malignant melanoma, sarcoma, Hodgkin's disease.

Contra-indications, warnings, etc. Studies have demonstrated this agent to have a carcinogenic and teratogenic effect when used on animals.

 

 

BENCARD

RIDAURA TILTAB TABLETS

Containing 3 mg auranofin.

Use:.. in the management of adults with active progressive rheumatoid arthritis only when non-steroidal anti-inflammatory drugs have been found to be inadequate alone to control the disease, i.e. when secondline therapy is required.

Contra-indications, warnings, etc. Gold has been shown to be carcinogenic in rodents although there was no evidence of carcinogenicity in 7 year dog studies.

 

 

BOEBRINGER MANNIFIEIM UK (PHARMACEUTICALS) LTD

BEZALIP

Contains bezafibrate.

Use: in hyperlipidaemias of Type 11 a, 1 lb, 111, 1 V and V.

Contra-indications, warnings, etc. Warnings: the chronic administration of a high dose of bezafibrate to rats was associated with hepatic tumour formation in females. This dosage was in the order of 30 to 40 times the human dosage. No such effect was apparent at reduced intake levels approximating more closely to the lipid-lowering dosage in humans.

(Author's note: Drug companies often excuse animal results by claiming that the dosage used in animal tests was far higher than that used in human beings. If such studies are irrelevant because of the high dosage, then why do them?)

SPIROCTAN

Contains spironolactone

Use: Spiroctan is recommended for the treatment of congestive cardiac failure, cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome and also for diagnosis and treatment of primary hyperaldosteronism.

Contra-indications, warnings, etc. Carcinogenicity: spironolactone has been shown to produce tumours in rats when administered at high doses over a long period of time. The significance of these findings with respect to clinical use is not certain.

 

 

BRISTOL-MYERS PHARMACEUTICALS

BiCNU

Contains a 30 mI vial containing 100 mg carmustine and a 5 MI vial containing 3 mi sterile ethanol diluent.

Use: BiCNU is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:

  1. Brain tumours-glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumours.
  2. Multiple myeloma-in combination with prednisone.
  3. Hodgkin's disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
  4. Non-Hodgkin's lymphomas - as secondary therapy as above.

Contraindications, warnings etc. BiCNU is carcinogenic in rats and mice, producing a marked increase in tumour incidence in doses approximating those employed clinically.

 

 

CIBA LABORATORIES

APRESOLINE

Contains hydralazine hydrochloride.

Use: hypertension.

Contra-indications, warnings etc. Warnings: hydralazine, in lifetime carcinogenicity studies, caused, towards the end of the experiments, small but statistically significant increases in lung tumours in mice and in hepatic and testicular tumours in rats. These tumours also occur spontaneously with fairly high frequency in aged rodents.

With due consideration of these animal and in-vitro toxicological findings, hydralazine in therapeutic doses does not appear to bear a risk that would necessitate a limitation of its administration. Many years of clinical experience have not suggested that human cancer is associated with hydralazine use.

 

 

CILAG LTD

TOLECTIN 200/400 MG CAPSULES

Contains tolmetin sodium dihydrate.

Use: rheumatoid arthritis; osteoarthritis; ankylosing spondylitis; periarticular disorders such as fibrositis and bursitis.

Contra-indications, warnings etc. Renal papillary necrosis has occurred in animals after long-term administration although there has been no evidence of renal toxicity in clinical trials.

 

CP PHARMACEUTICALS LTD

CHENDOL 125 and CHENDOL 250

Contains chenodeoxycholic acid.

Use: for dissolution of radiolucent cholesterol-rich gallstones in functioning gall bladders. It has a particular place where surgery is contra-indicated or those patients anxious to avoid surgery.

Contra-indications, warnings, etc. Precautions: chenodeoxycholic acid, given in long- term studies at doses of 600 mg/kg/day to rats and 1000 mg/kg/day to mice, induced malignant liver cell tumours in female rats and male mice. The clinical significance of these findings is not known.

 

EVANS MEDICAL LTD

NORMAX

Contains danthron docusate sodium.

Use: constipation in geriatric practice. Analgesic-induced constipation in terminally ill patients of all ages. Constipation in cardiac failure and coronary thrombosis (conditions in which defaecation must be free of strain).

Contra-indications, warnings etc. Precautions: in experimental animals, danthron has been associated with adenocarcinomas in the bowel and tumours in the liver.

 

 

FARMITALIA CARLO ERBA LTD

FARLUTAL

Contains medroxyprogesterone acetate.

Use: palliative treatment of hormone-sensitive malignancies. Farlutal has been successfully used to produce regressions in breast, endometrial, prostatic and renal cell carcinoma.

Contra-indications, warnings etc. Precautions: it should be noted that long-term administration of medroxyprogesterone acetate to beagle dogs has resulted in the development of mammary nodules which were occasionally found to be malignant. The relevance of these findings to humans has, however, not been established.

PHARMORUBICIN RAPID DISSOLUTION

Contains epirubicin hydrochloride with lactose and hydroxybenzoate.

Use: antimitotic and cytotoxic.

Contra-indications, warnings, etc. Like most other anticancer agents, epirubicin has shown mutagenic and carcinogenic properties in animals.

ZAVEDOS

Contains idarubicin hydrochloride with lactose.

Use: antimitotic and cytotoxic agent.

Contraindications, warnings, etc. Warnings: like most other cytotoxic agents, idarubicin has mutagenic properties and it is carcinogenic in rats.

 

 

GEIGY PHARMACEUTICALS

TEGRETOL

Active ingredient: carbamazepine.

Use: epilepsy generalised tonic-clonic and partial seizures.

Contra-indications, warnings etc. Precautions: in rats treated with carbamazepine for two years, the incidence of tumours of the liver was found to be increased. There is, however, no evidence to indicate that this observation has any significant bearing on the therapeutic use of the drug.

 

 

GLAXO LABORATORIES LTD

GRISOVIN TABLETS

Contain griseofulvin.

Use: the treatment of fungal infections of the skin, scalp, hair or nails where topical therapy is considered inappropriate or has failed.

Contra-indications, warnings etc. Precautions: long-term administration of high doses of griseofulvin with food has been reported to induce hepatomas in mice and thyroid tumours in rats but not hamsters. The clinical significance of these findings is not known.

 

 

HOECHST

LASILACTONE CAPSULES

Contain frusemide and spironolactone.

Use: in the treatment of resistant oedema where this is associated with secondary hyperaldosteronism; conditions include chronic congestive cardiac failure and hepatic cirrhosis.

Contra-indications, warnings, etc. Carcinogenicity: spironolactone has been shown to produce tumours in rats when administered at high doses over a long period of time. The significance of these findings with respect to clinical use is not certain.

 

 

ICI PHARMACEUTICALS

ATROMID -S

Contains clofibrate.

Use: in the treatment of severe hyperlipoproteinaemia where full investigation has been performed to define the abnormality.

Contra-indications, warnings etc. Clofibrate has been shown to produce liver tumours in rats and mice. The liver changes found in rodents have not been seen in other species, including sub-human primates and man. The relevance of this finding to man has not been established.

NOLVADEX, NOLVADEX -D AND NOLVADEX -FORTE TABLETS

Containing tamoxifen citrate.

Use: treatment of breast cancer and anovulatory infertility.

Contra-indications, warnings etc. Gonadal tumours in mice and liver tumours in rats receiving tamoxifen have been reported in long-term studies. The clinical relevance of these findings has not been established.

ZOLADEX

Containing goserelin acetate.

Use: (1) Prostate cancer. (2) Advanced breast cancer in pre- and perimenopausal women suitable for hormonal manipulation. (3) Endometriosis.

Contra-indications, warnings etc. General: following long-term repeated dosing with Zoladex, an increased incidence of benign pituitary tumours has been observed in male rats. Whilst this finding is similar to that previously noted in this species following surgical castration, any relevance to man has not been established.

In mice, long-term repeated dosing with multiples of the human dose produced histological changes in some regions of the digestive system manifested by pancreatic islet cell hyperplasia and a benign proliferative condition in the pyloric region of the stomach, also reported as a spontaneous lesion in this species. The clinical relevance of these findings is unknown.

 

 

LEDERLE LABORATORIES

NOVANTRONE INJECTION

Contains mitozantrone hydrochloride.

Use: for the treatment of advanced breast cancer, non-Hodgkin's lymphoma and adult acute non-lymphocytic leukaemia. Novantrone has also been used in the palliation of non-resectable primary hepatocellular carcinoma.

Contra-indications, warnings etc. Warnings: Novantrone is mutagenic in vitro and in vivo in the rat. In the same species there was a possible association between administration of the drug and development of malignant neoplasia. The carcinogenic potential in man is unknown.

PROSTAP SR

Contains leuprorelin acetate.

Use: in the treatment of advanced prostatic cancer and the management of endometriosis, including pain relief and reduction of endometriotic lesions.

Contraindications, warnings etc. Warnings: Men: whilst the development of pituitary adenomas has been noted in chronic toxicity studies at high doses in some animal species, this has not been observed in long-term clinical studies with Prostap.

THIOTEPA

Contains Thiotepa (N,N',N''' triethylenethiophosphoramide)

Use: A polyfunctional alkylating agent used alone or in combination with other cytotoxic drugs, hormones, radiotherapy or surgery in the treatment of neoplastic diseases.

Contra-indications, warnings etc. Thiotepa has been reported to possess mutagenic activity on the basis of bacterial, plant and mammalian mutagenicity tests. It has also been reported to be carcinogenic in mice and rats. These effects are consistent with its activity as an alkylating agent. The carcinogenic potential in humans has not been clearly established.

 

 

ELI LILLY & COMPANY LTD

CELANCE

Contains pergolide base.

Use. adjunctive treatment to levodopa in the management of the signs and symptoms of Parkinson's disease.

Contra-indications, warnings etc. Carcinogenesis, mutagenesis and impairment of fertility: two-year carcinogenicity studies in mice and rats used doses up to 340 and 12 times the maximum human oral dose (6 mg or 6000 micrograms/day equivalent to 120 micrograms/kg/day). A low incidence of uterine neoplasms occurred in both rats and mice. Endometrial adenomas and carcinomas were observed in rats. Endometrial sarcomas were observed in mice. These occurrences are probably attributable to the high oestrogen/progesterone ratio, which would occur in rodents as a result of the prolactin-inhibiting action of pergolide mesylate. These endocrine mechanisms are not present in humans. However, there are no human data with pergolide to substantiate this conclusion concerning the lack of potential for human risk.

Mutagenic potential was evaluated in a battery of tests. A weak response was noted in one test but the other 3 tests were negative. The relevance to humans is unknown.

SECONAL SODIUM

Contains secobarbitone sodium.

Use: For the short-term treatment of severe, intractable insomnia.

Contra-indications warnings etc. Carcinogenesis: animal data show that phenobarbitone can be carcinogenic after lifetime administration.

SODIUM AMYTAL INJECTION

Contains arnylobarbitone sodium.

Use: may be used parenterally to control status epilepticus, but it is not the barbiturate of choice in the routine treatment of grand mal epilepsy.

Contra-indications, warnings etc. Carcinogenesis: animal data show that phenobarbitone can be carcinogenic after lifetime administration.

 

 

MARION MERRELL DOW LTD

DESTOLIT

Contains ursodeoxycholic acid.

Use: the dissolution of radiolucent (i.e. non-radio opaque) cholesterol gallstones in patients with a functioning gallbladder.

Contra-indications, warnings etc. A product of this class has been found to be carcinogenic in animals. The relevance of these findings to the clinical use of ursodeoxycholic acid has not been established.

SABRIL TABLETS

Contains vigabatrin.

Use: treatment of epilepsy which is not satisfactorily controlled by other antiepileptic drugs.

Contraindications, warnings etc. Warning: animal safety studies indicate that vigabatrin causes intramyelinic oedema in the brain white matter tracts. Currently there is no evidence to suggest that this effect occurs in man.

 

 

THOMAS MORSON PAHARMACEUTICALS

DOLOBID

Contains diflunisal.

Use: relief of pain and also inflammation associated with osteoarthritis and rheumatoid arthritis.

Contra-indications, warnings etc. Precautions: in rats and dogs, high oral doses of diflunisal (50-200 mg/kg/day), as with aspirin, produced similar pathological changes (gastro-intestinal ulceration and renal papillary oedema). These dosages are approximately 3 to 12 times the maximum dosages recommended in man.

 

 

ORTHO

ORTHO DIENOESTROL CREAM

Contains dienoestrol.

Use: atrophic vaginitis and kraurosis vulvae in post menopausal women, and for the treatment of pruritus vulvae and dyspareunia when associated with the atrophic vaginal epithelium.

Contra-indications, warnings etc. ...long-term continuous administration of natural and synthetic oestrogens in certain animal species increases the frequency of carcinomas of the breast, cervix, vagina and liver. There is now evidence that oestrogens increase the risk of carcinoma of the endometrium in humans. At the present time there is no satisfactory evidence that oestrogens given to post-menopausal women increase the risk of cancer of the breast, although a recent long-term follow up of a single physician has raised this possibility. However, because of animal data there is a need for caution in prescribing oestrogens for women with a strong family history of breast cancer or who have breast nodules, fibrocystic disease, or abnormal mammograms.

(Author's note. Do oestrogens only increase the risk of cancer in female animals who have a strong family history of breast cancer, or who have breast nodules, fibrocystic disease or abnormal mammograms?)

RETIN-A LOTION, GEL, CREAM

Contains tretinoin.

Use: topical application in the treatment of acne vulgaris in which comedones, papules and pustules predominate.

Contra-indications, warnings etc. Recent studies in mice treated with the active ingredient (tretinoin) of Retin-A and exposed to artificial sunlight suggest that tretinoin may speed up the appearance of sunlight-induced skin tumours. Laboratory mice treated with tretinoin but not exposed to sunlight did not develop skin tumours. The significance of these studies as related to human beings is unknown.

High oral doses of tretinoin (retinoic acid), like Vitamin A, are teratogenic in animals.

 

 

PARKE-DAVIS RESEARCH LABORATORIES

LOPID

Contains gernfibrozil and polysorbate 80 PhEur.

Use: primary prevention of coronary heart disease in men between 40-55 years of age and with hyperlipidaemias who have not responded to diet and other appropriate measures.

Contra-indications, warnings etc. Precautions: long-term toxicity studies in rats and mice were carried out at one and ten times the human dose on a weight for weight basis. In male rats receiving ten times the human dose, there was a significant increase in incidence of benign liver nodules and liver carcinomas. Male rats receiving a dose equivalent to the human dose had no statistically significant increase in the incidence of liver carcinomas. At all dose levels, there were no statistically significant differences from controls in the incidence of liver tumours in female rats, or in mice of either sex.

Electron microscopy demonstrated a marked hepatic peroxisome proliferation following Lopid administration to the male rat. Similar changes have been sought but not found in the human liver at up to 27 months' continuous gernfibrozil therapy.

Male rats had a dose-related increase of benign Leydig cell tumours. Subcapsular bilateral cataracts occurred in 10%, and unilateral cataracts in 6.3% of the high dose males.

 

 

PFIZER LTD

MITHRACIN

Contains plicamycin, mannitol and disodium phosphate.

Use: treatment of refractory hypercalcaemia associated with a variety of neoplasms.

Contra-indications, warnings etc. Warnings: antineoplastic and cytotoxic agents have been shown to be mutagenic and carcinogenic in animals and possibly man. Only limited animal and in vitro mutagenicity studies have been carried out with plicamycin; the possibility that plicamycin has similar effects to other antineoplastic cytotoxic agents should be borne in mind.

 

 

RHONE-POULENC RORER LTD

CALCITARE

Contains calcitonin (pork).

Use: short-term treatment in (a) Paget's disease of bone, (b) hypercalcaemia.

Contra-indications, warnings etc. A species and strain-specific dose-related increase of pituitary adenomas has been observed in long term toxicity studies in the rat. As the significance of these findings to man is uncertain, long term use is not recommended.

CALSYNAR

Contains synthetic salmon chloride. The solution also contains sodium chloride, sodium acetate, acetic acid and phenol.

Use: short-term treatment of.. (a) Paget's disease of bone; (b) Advancing osteolytic hypercalcaemia of malignancy; (c) Pain associated with advanced metastatic bone cancer. (d) Postmenopausal osteoporosis.

Contra-indications, warnings etc. Precautions: rat carcinogenicity studies have shown a dose related excess of pituitary tumours. As the significance of this finding is uncertain, long-term use is not recommended.

 

 

ROCHE PRODUCTS LTD

ROACCUTANE

Contains isotretinoin.

Use: the treatment of cystic and conglobate acne and severe acne which has failed to respond to an adequate course of a systemic antimicrobial agent.

Contra-indications, warnings etc. Precautions: at the completion of a lifespan study in rats there was an increased incidence of phaeochromocytoma in animals given isotretinoin at dosages of 32 and 8 mg/kg/day, but not 2 mg/kg/day. Since rats are particularly prone to develop this tumour type, the significance of this finding for use of Roaccutane in man is uncertain; nevertheless, repeated courses of treatment are not normally recommended.

 

 

SANOFI WINTHROP

NEGRAM

Contains nalidixic acid.

Use: treatment of acute or chronic infections.

Contraindications, warnings etc. Nalidixic acid has been shown to induce lesions in weight-bearing joints of young animals. The relevance of this to man is unknown.

 

 

SCHERING HEALTH CARE

ANDROCUR

Contains cyproterone acetate.

Use: Control of libido in severe hypersexuality and/or sexual deviation the adult male.

Contra-indications, warnings etc. Warnings/side-effects: cyproterone acetate has been found to cause liver abnormalities in animals, including the development of tumours.

CYPROSTAT

Contains cyproterone acetate.

Use: Palliative treatment of prostatic carcinoma.

Contra-indications, warnings etc. Cyproterone acetate has been found to cause liver abnormalities in animals, including the development of tumours.

DIANETTE

Contains anti-androgen cyproterone acetate and oestrogen ethirryloestradiol.

Use: in women only: (a) severe acne, refractory to prolonged oral antibiotic therapy, and (b) idiopathic hirsutism of mild to moderate degree.

Contra-indications, warnings etc. Warnings: like many other steroids, cyproterone acetate, when given in very high doses and for the majority of the animal's life-span, has been found to cause an increase in the incidence of tumours, including carcinoma, in the liver of rats. The relevance of this finding to humans is unknown. Dianette has been shown to have good liver tolerance in women given prolonged treatment.

 

 

SEARILE

ALDACTIDE Contains spironolactone and hydroflumethiazide.

Use: Congestive cardiac failure.

Contra-indications, warnings etc. Warnings: carcinogenicity: Spironolactone has been shown to produce tumours in rats when administered at high doses over a long period of time. The significance of these findings with respect to clinical use is not certain.

CYTOTEC Contains misoprostol.

Use: for the healing of duodenal ulcer and gastric ulcer including those induced by non-steroidal anti-inflammatory drugs (NSAID) in arthritic patients at risk, whilst continuing their NSAID therapy.

Further information: Cytotec in multiples of the recommended therapeutic dose in animals has produced gastric mucosal hyperplasia. This characteristic response of E prostaglandins reverts to normal on discontinuation of the compound. In patients, histological examination of gastric biopsies taken before and after treatment with misoprostol after up to one year's duration have shown no adverse tissue response attributable to misoprostol.

NAPRATEC

Contains Naproxen and Cytotec (containing misoprostol).

Uses: Naproxen is indicated for the treatment of rheumatoid arthritis, osteoarthritis (degenerative arthritis) and ankylosing spondylitis. Cytotec is indicated for the prophylaxis of non-steroidal anti-inflammatory drug induced gastroduodenal ulceration.

Further information: Cytotec in multiples of the recommended therapeutic dose in animals has produced gastric mucosal hyperplasia. This characteristic response of E prostaglandins reverts to normal on discontinuation of the compound. In patients, histological examination of gastric biopsies taken before and after treatment with misoprostol after up to one year's duration have shown no adverse tissue response attributable to misoprostol.

 

 

E.R.SQUIBB & SONS LTD

DOLMATIL TABLETS

Contains sulpiride (and hydrated silica, lactose, magnesium stearate, methyl cellulose, potato starch, talc).

Use: acute and chronic schizophrenia.

Contra-indications, warnings etc. Warnings: in long-term animal studies with neuroleptic drugs, including sulpiride, an increased incidence of various endocrine tumours (some of which have occasionally been malignant) has been seen in some but not all strains of rats and mice studied. The significance of these findings to man is not known; there is no evidence of an association between Dolmatil use and tumour risk in man.

 

 

THAMES LABORATORIES LTD

CHENOFALK

Contains chenodeoxycholic acid (CDCA). (And gluten).

Use: Dissolution of radiolucent gallstones measuring up to 15 mm diameter.

Contra-indications, warnings etc. Warnings: chenodeoxycholic acid, given in long-term studies at doses of 600 mg/kg/day to rats and 1000 mg/kg/day to mice, induced malignant liver cell tumours in female rats and benign liver cell tumours in female rats and male mice. The clinical significance of these findings is not known.

URSOFALK

Contains ursodeoxycholic acid (UDCA) and gluten.

Use: Dissolution of radiolucent gallstones measuring up to 15 mm diameter.

Contra-indications, warnings etc. A product of this class has been found to be carcinogenic in animals. The relevance of these findings to the clinical use of UDCA has not been established.

 

 

TILLOTTS LABORATORIES

SULPITIL

Contains sulpiride.

Use: For the treatment of acute and chronic schizophrenia.

Contra-indications, warnings etc. Warnings and precautions: in long-term animal studies with neuroleptic drugs, including sulpiride, an increased incidence of various endocrine tumours, some of which have occasionally been malignant, has been seen in some, but not all, strains of rats and mice studied. The significance of these findings to man is not known. There is no current evidence of an association between neuroleptic use and tumour risk in man.

 

 

UPJOHN LTD

DEPO-PROVERA

Contains medroxyprogesterone acetate.

Use: Progestogen: for the treatment of endometriosis.

Contra-indications, warnings etc. Warnings, precautions, side-effects: endometrial tumours have developed in monkeys given fifty times the human contraceptive dose but the relevance of this to man has not been established.

HEMABATE STERILE SOLUTION

Contains carboprost as the tromethamine salt.

Use: treatment of post-partum haemorrhage due to uterine atony and refractory to conventional methods of treatment with oxytocic agents and ergometrine used either alone or in combination.

Contra-indications, warnings etc. Precautions: animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone.

PROSTIN E2

Contains dinoprostone.

Use: oxytocic agent. For the induction of labour when there are no foetal or maternal contraindications

Contraindications, warnings etc. Precautions: animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone.

 

 

WELLCOME MEDICAL DIVISION

MYLERAN TABLETS

Contains busulphan.

Use: For the palliative treatment of the chronic phase of chronic granulocytic leukaemia.

Contra-indications, warnings etc. Precautions: busulphan has been shown to be mutagenic in various systems, including bacteria, fungi, Drosophila and cultured mouse lymphoma cells.

In vivo cytogenetic studies in rodents have shown an increased incidence of chromosome aberrations in both germ cells and somatic cells after busulphan treatment.

Busulphan interferes with spermatogenesis in experimental animals.

RETROVIR CAPSULES AND SYRUP

Contains zidovudine.

Use: For the management of patients with advanced HIV disease.

Contraindications, warnings etc. Mutagenicity: zidovudine was weakly mutagenic in a mouse lymphoma cell assay and was positive in an in vitro cell transformation assay. Clastogenic effects (chromosome damage) were observed in an in vitro study in human lymphocytes and in in vivo oral repeat dose micronucleus studies in rats and mice. An in vivo cytogenetic study in rats did not show chromosomal damage. The clinical significance of these findings is unclear.

Carcinogenicity: zidovudine was administered orally at three dosage levels to separate groups of mice and rats (60 females and 60 males in each group). Initial single daily doses were 30, 60 and 120 mg/kg/day and 80, 220 and 600 mg/kg/day in mice and rats respectively. The doses in mice were reduced to 20, 30 and 40 mg/kg/day after day 90 because of treatment-related anaemia, whereas in rats only the high dose was reduced (to 450 and then 300 mg/kg/day on days 91 and 279 respectively).

In mice, seven late-appearing (after 19 months) vaginal neoplasms (5 squamous cell carcinomas, one squamous cell papilloma and one squamous cell polyp) occurred at the highest dose. One late-appearing squamous cell papillorna occurred in the vagina of a middle-dose animal. No vaginal tumours were found at the lowest dose.

In rats, two late-appearing (after 20 months) vaginal squamous cell carcinomas occurred in animals given the highest dose. No vaginal tumours occurred at the middle or low doses in rats.

The predictive value of rodent carcinogenicity studies for humans is uncertain and thus the clinical significance of these findings is unclear.

IN ADDITION TO the general warnings I have recorded above there are many drug companies which warn doctors not to give specific products to patients who are pregnant. These companies invariably report having performed experiments on pregnant animals but then often go on to admit (something like): 'the relevance of these studies to human beings is not known'. (It is difficult to avoid asking the question: 'Why do the studies if the relevance is not known?' A huge number of drug companies seem to be doing animal tests without knowing their relevance to human patients.) On other occasions drug companies report that animal experiments have shown that their drugs cause problems-but that human experience suggests that the drug is entirely safe so the animal experiments can be safely ignored! Animal experiments provide answers for all seasons. It is not surprising that drug companies love them.

In some of the examples which follow, drug companies seem uncertain about the significance of the animal experiments which have been done. If the relevance of the animal experiments is not known or the experiments cannot be relied upon, then why on earth does anyone do them? (Just as puzzling are the many instances where drug companies state that animal experiments have not indicated that there will be any problems if their drugs are given to pregnant women-but still advise doctors against giving those drugs to pregnant women!) These short sections are intended only to illustrate the point 1 want to make and are not intended to provide useful information about the drugs concerned.

 

 

 

ABBOTT LABORATORIES LTD

ENFLURANE

Use: an inhalation anaesthetic.

Use in pregnancy: reproduction studies have been performed in rats and rabbits. Following single and multiple maternal administrations, no evidence of teratogenicity due to enflurane was found in the developing foetuses in these species. The relevance of these studies to the human is not known.

ISOFLURANE

Use: an inhalation anaesthetic.

Use in pregnancy: reproduction studies have been carried out on animals after repeated exposure to anaesthetic concentrations of Isoflurane. Studies with the rat demonstrated no effect on fertility, pregnancy, or delivery or on the viability of the offspring. No evidence of teratogenicity was revealed. Comparable experiments in rabbits produced similar negative results. The relevance of these studies to the human is not known.

 

 

ALCON LABORATORIES (U.K.) LTD

BETOPTIC

Contains betaxolol hydrochloride.

Use: reduction of elevated intra-ocular pressure in patients with ocular hypertension and chronic open-angle glaucoma.

Use in pregnancy: although animal studies have not demonstrated any specific hazard there are no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response this drug should be used during pregnancy only if clearly indicated.

TOBRALEX

Contains tobramycin.

Use: in the treatment of external bacterial conditions of the eye and its appendages.

Use in pregnancy: reproduction studies in animals at doses up to thirty three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the foetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

 

 

ALPHA THERAPEUTIC UK LTD

FLUOSOL

Contains perfluorodecalin (Perfluamine INN), and perfluorotri-n-npropylaminepropylamine (Perfluamine INN).

Use: during percutaneous transluminal coronary angioplasty to reduce or prevent intraprocedural myocardial ischaemia.

Use in pregnancy: reproduction studies have been performed in rats at approximately three times the human dose and have revealed no evidence of impaired fertility or harm to the foetus due to Fluosol. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

 

 

ASTRA PHARMACEUTICALS LTD

PULMICORT

Contains budesonide and sorbitan trioleate and chlorofluorocarbons.

Use: for bronchial asthma.

Use in pregnancy: in pregnant animals, administration of budesonide causes abnormalities of foetal development. The relevance of this finding to man has not been established.

RHINOCORT

Contains budesonide, sorbitan trioleate and chlorofluorocarbons.

Use: seasonal and perennial, allergic rhinitis and vasomotor rhinitis. Use in pregnancy: in pregnant animals, administration of budesonide causes abnormalities of foetal developments. The relevance of this to man has not been established.

 

 

BAYER UK LTD

CANESTEN TOPICAL PRODUCTS

Contains clotrimazole BP.

Use: a broad spectrum antifungal.

Use in pregnancy: in animal studies clotrimazole has not been associated with teratogenic effects but following oral administration of high doses to rats there was evidence of foetotoxicity. The relevance of this effect to topical application in humans is not known. However, clotrimazole has been used in pregnant patients for over a decade without attributable adverse effects.

CANESTEN HC

Contains clotrimazole and hydrocortisone.

Use: a broad spectrum antifungal.

Use in pregnancy: topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this to humans has not been established.

In animal studies clotrimazole has not been associated with teratogenic effects but following oral administration of high doses to rats there was evidence of foetotoxicity. The relevance of this effect to topical application in humans is not known. However, clotrimazole has been used in pregnant patients for over a decade without attributable adverse effects.

NYSTAFORM - HC OINTMENT/CREAM

Contains nystatin, chlorhexidine acetate, hydrocortisone.

Use: in infected dermatoses where fungal (particularly monilial) and/or bacterial infection is present.

Use in pregnancy: topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established.

 

 

BERK PHARMACEUTICALS LTD

BERKAPRINE

Contains azathioprine.

Use: facilitates the survival and function of organ transplants.

Use in pregnancy: although it has been shown to be teratogenic in laboratory animals, clinical evidence suggests that the risk is not appreciable in man.

 

 

BRISTOL-MYERS PHARMACEUTICALS

SOTAZIDE

Contains sotalol hydrochloride and hydrochlorothiazide.

Use: in the management of mild or moderate hypertension.

Use in pregnancy: in animal studies Sotazide has been shown to have no adverse teratogenic effects in doses up to 25 times the recommended human dose. However, its safe use in human pregnancy has not been fully established.

TOLERZIDE

Contains sotalol hydrochloride and hydrochlorothiazide.

Use: in the management of mild or moderate hypertension particularly where a gradual fall in blood pressure is indicated such as in the elderly.

Use in pregnancy: in animal studies Tolerzide has been shown to have no adverse teratogenic effects in doses up to 50 times the recommended human dose. However its safe use in human pregnancy has not been fully established.

 

 

BROCADES

LOCOID C CREAM and OINTMENT

Contains hydrocortisone 17-butyrate and chlorquinaldol.

Use: the products are recommended for clinical use in the treatment of conditions responsive to topical corticosteroids, e.g. eczema, dermatitis and psoriasis, where secondary bacterial or fungal infection by a microorganism susceptible to chlorquinaldol is present or is to be prevented.

Use in pregnancy: in pregnant animals, administration of corticosteroids can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established.

 

 

CHARWELL PHARMACEUTICALS LTD

MIGRALEVE

Contains buclizine hydrochloride, paracetamol and codeine phosphate.

Use: the treatment of migraine attacks which can include the symptoms of migraine headache, nausea and vomiting.

Use in pregnancy: Migraleve has been in wide use for many years without apparent ill consequence. Although experiments in some species gave rise to adverse effects following the administration of buclizine to pregnant animals, e.g. foetal abnormalities and maternal deaths, these occurred at doses in excess of 120 times the human daily dose. Whilst there are no specific reasons for contra-indicating Migraleve during pregnancy, as with all drugs it is recommended that Migraleve be used in pregnancy only when the physician has considered the need in respect of the patient's welfare.

 

 

CILAG LTD

GYNO-PEVARYL CREAM

Contains econazole nitrate.

Use: the treatment of vulvitis associated with candidal vaginitis. Balanitis.

Use in pregnancy: in animals econazole nitrate has shown no teratogenic effects, but is foetotoxic at high doses. The significance of this to man is unknown as there is no evidence of increased risk when taken in human pregnancy.

PEVARYL TC CREAM

Contains econazole nitrate and triamcinolone acetonide.

Use: For the topical treatment of inflammatory dermatomycoses and inflammatory skin conditions complicated by or threatened by bacterial or fungal skin infection.

Use in pregnancy: Topical administration of corticosteroids to pregnant animals can cause foetal abnormalities. The relevance of this finding to human beings has not been established.

 

 

CP PHARMACEUTICALS LTD

ARTHROXEN

Contains naproxen.

Use: the treatment of rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, and acute musculoskeletal disorders.

Use in pregnancy: there is inadequate evidence of safety of the drug in human pregnancy. As with other drugs of this type naproxen delays parturition in animals but the relevance of this finding to human patients is not known.

 

 

DISTA PRODUCTS LTD

ILOSONE

Contains erythromycin estolate.

Use: antibiotic.

Use in pregnancy: reproduction studies in rats, mice and rabbits, with doses several times the usual human dose, have revealed no evidence of impaired fertility or foetal harm related to erythromycin. There are no adequate studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

KEFADOL

Contains cefamandole nafate.

Use: in the treatment of infections of the lower respiratory tract, genito-urinary tract, bones and joints, bloodstream (septicaemia), skin and soft tissue, gall bladder and peritoneum, and pelvic inflammatory disease in women, when due to susceptible micro-organisms.

Use in pregnancy: reproduction studies in rats given doses of 500 or 1000 mg/kg/day (approximately 5 times the maximum clinical dose) revealed no evidence of impaired fertility or harm to the foetus due to cefamandole nafate. There are, however, no adequate and well controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

 

 

DUPHAR LABORATORIES LTD

YUTOPAR.

Contains ritodrine hydrochloride.

Use: management of uncomplicated pre-term labour and/or foetal asphyxia in labour where it is desired to obtain uterine relaxation.

Use in pregnancy: experiments in animals have shown that even in high dosage Yutopar has no teratogenic properties. Nevertheless, in view of the limited available information from human studies, the administration of Yutopar is not recommended during the first 16 weeks of pregnancy.

 

 

ICI PHARMACEUTICALS

FLUOTHANE

Contains 2-bromo-2-chloro-1,1,1-trifluoroethane stabilised with thymol.

Use: Fluothane is a volatile anaesthetic which is suitable for the induction and maintenance of anaesthesia for all types of surgery and in patients of all ages.

Use in pregnancy: although the data from experimental investigations in animals cannot be directly related to man, it would be prudent to avoid general anaesthesia with inhalation agents during early pregnancy, except where such use is essential.

 

 

INVICTA PHARMACEUTICALS

CARDURA

Contains doxazosin mesylate.

Use: for the first-line treatment of hypertension and may be used as the sole agent to control blood pressure in the majority of patients.

Use in pregnancy: although animal tests have shown no evidence of teratogenic effects, the clinical safety of Cardura during pregnancy has not yet been established.

LUSTRAL

Contains sertraline hydrochloride.

Use: the treatment of symptoms of depressive illness.

Use in pregnancy: fertility studies conducted in rats, at doses approximately 20 times the maximum human dose, indicated that sertraline had no adverse effects on fertility. There was, however, decreased neonatal survival following maternal administration of sertraline at doses approximately 5-6 times the maximum human dose. Similar effects on neonatal survival have been described for other antidepressant drugs.

Reproduction studies have been performed in rats and rabbits at doses up to 20 times the maximum daily human dose. There was no evidence of teratogenicity or embryotoxicity at any dose level. At the dose level corresponding to 5-6 times the maximum daily human dose, however, sertraline caused maternal toxicity which in turn delayed ossification processes in foetuses.

There are no adequate and well-controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Lustral should be used during pregnancy only if clearly needed.

 

 

JANSSEN PHARMACEUTICAL LTD

DAKTARIN ORAL GEL and DAKTARIN ORAL TABLETS

Contains miconazole base.

Use: miconazole is a synthetic imidazole antifungal agent with a broad spectrum of activity against pathogenic fungi (including yeasts and dermatophytes) and Gram-positive bacteria (Staphylococcus and Streptococcus spp.).

Use in pregnancy: in animals, miconazole has shown no teratogenic effects but is foetotoxic at high oral doses. The significance of this to man is unknown.

NIZORAL

Contains ketoconazole.

Use: Nizoral is an imidazole-dioxolane antimycotic which is effective after oral administration and has a broad spectrum of activity against dermatophytes, yeasts and other pathogenic fungi.

Use in pregnancy: when administered in high doses (over 80 mg/kg) to pregnant rats, Nizoral has been shown to cause abnormalities of foetal development. The relevance of this finding to humans has not been established, although Nizoral is contraindicated in pregnancy.

 

 

KABI PHARMACIA

CALMURID HC

Contains carb.amide (urea), hydrocortisone and lactic acid.

Use: atopic eczema; Besnier's prurigo; acute and chronic allergic eczema; neurodermatitis and other hyperkeratotic skin conditions with accompanying inflammation.

Use in pregnancy: in pregnant animals, administration of corticosteroids can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established.

 

LEDERLE LABORATORIES

LEDERCORT CREAM and OINTMENT

Contains triamcinolone acetonide.

Use: the treatment of inflammatory skin conditions such as atopic dermatitis; contact dermatitis; eczematous dermatitis; generalised erythrodermia; neurodermatitis; nummular eczema; otitis externa and seborrhoeic dermatitis.

Use in pregnancy: topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in early pregnancy, i.e. in large amounts or for prolonged periods.

SUPRAX

Contains cefixime.

Use: the treatment of the following acute infections when caused by susceptible micro-organisms: upper respiratory tract infections, lower respiratory tract infections, urinary tract infections.

Use in pregnancy: reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of impaired fertility or harm to the foetus due to cefixime. In the rabbit, at doses up to 4 times the human dose, there was no evidence of a teratogenic effect; there was a high incidence of abortion and maternal death which is an expected consequence of the known sensitivity of rabbits to antibiotic-induced changes in the population of the microflora of the intestine. There are no adequate and well-controlled studies in pregnant women. Suprax should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

 

 

LEO LABORATORIES LTD

DICAPEN INJECTION

Contains sulbactarn and ampicillin.

Use: the treatment of infections caused by susceptible organisms.

Use in pregnancy: animal reproduction studies have revealed no evidence of impaired fertility or harm to the foetus due to sulbactarn and ampicillin. However, safety for use in human pregnancy and lactation has not been established.

FUCIBET CREAM

Contains betamethasone and fusidic acid.

Use. the treatment of eczematous dermatoses including atopic eczema, infantile eczema, discoid eczema, contact eczema and seborrhoeic eczema when secondary bacterial infection is confirmed or suspected.

Use in pregnancy: topical administration of any corticosteroid to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.

 

 

ELI LILLY & CO LTD

DOBUTREX

Contains dobutarnine and sodium bisulphite.

Use: Dobutrex is indicated for adults who require inotropic support in the treatment of low output cardiac failure associated with myocardial infarction, open heart surgery, cardiomyopathies, septic shock and cardiogenic shock. Dobutrex can also increase or maintain cardiac output during positive end expiratory pressure (PEEP) ventilation.

Use in pregnancy: Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility, harm to the foetus, or teratogenic effects due to dobutamine. As there are no adequate and well-controlled studies in pregnant women, and as animal reproduction studies are not always predictive of human response, dobutamine should not be used during pregnancy unless the potential benefits outweigh the potential risks to the foetus.

 

 

RHONE-POULENC RORER LTD

VALLERGAN

Contains trimeprazine tartrate.

Use: in urticaria and pruritus. Premedication for anaesthesia.

Use in pregnancy: there is inadequate evidence of the safety of Vallergan in human pregnancy, but it has been widely used for many years without apparent ill consequence. Some phenothiazines have shown evidence of harmful effects in animals.

 

 

ROCHE PRODUCTS LTD

FANSIDAR

Contains sulfadoxine and pyrimethamine.

Use: treatment and prophylaxis of Plasmodium falciparum malaria.

Use in pregnancy: foetal damage has been observed in the rat when any drug containing a folate inhibitor, including Fansidar, is administered in early gestation. The damage is caused by the folic acidantagonist, pyrimethamine, a component of Fansidar; the damage can be prevented by the concomitant administration of folinic acid.

However, no such adverse effects attributed to Fansidar have been reported during human clinical use, and the preparation is, therefore, not contraindicated during pregnancy. The usual medical practice of avoiding the use of Fansidar during early pregnancy should be followed unless considered essential by a medical practitioner.

 

 

ROUSSEL LABORATORIES LTD

ACTINAC

Contains chloramphenicol, hydrocortisone acetate, butoxyethyl nicotinate, allantoin and precipitated sulphur.

Use: in the topical treatment of acne vulgaris and other acneiforin conditions.

Use in pregnancy: in pregnant animals, administration of corticosteroids can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established.

PROCTOSEDYL

Contains cinchocaine hydrochloride and hydrocortisone.

Use: for the short-term relief (not more than 7 days) of pain, irritation and pruritus associated with haemorrhoids, pruritus ani.

Use in pregnancy: in pregnant animals, administration of corticosteroids can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established.

SURGAM

Contains tiaprofenic acid.

Use: rheumatoid arthritis, osteoarthritis; ankylosing spondylitis; low back pain; musculo-skeletal disorders such as fibrositis, capsulitis, epicondylitis and other soft-tissue inflammatory conditions; sprains and strains, postoperative inflammation and pain, and other soft-tissue injuries.

Use in pregnancy: although animal studies have not revealed evidence of teratogenicity, safety in human pregnancy and lactation cannot be assumed and, in common with other non-steroidal anti-inflammatory agents, administration during the first trimester should be avoided.

 

 

SANOFI WINTHROP LTD

BIOGASTRONE

Contains carbenoxolone sodium and lactose.

Use: the treatment of benign gastric ulcers in young and middle-aged patients, hie those within the age range of 16 to 65 years.

Use in pregnancy: although animal studies have shown no hazard, there is inadequate evidence of the safety of carbenoxolone in human pregnancy. Biogastrone should be avoided in patients who are pregnant.

 

 

SERVIER LABORATORIES LTD

NATRILIX

Contains indapamide hernihydrate.

Use. the treatment of essential hypertension.

Use in pregnancy: no teratological effects have been seen in animals but because animal reproduction studies are not always predictive of human response, Natrilix should be used during pregnancy only if clearly needed.

 

 

SMITH KLINE & FRENCH LABORATORIES

STELAZINE

Contains trifluoperazine.

Use: a piperazine phenothiazine tranquilliser with potent antipsychotic, anxiolytic, and anti-emetic activity, and a pharmacological profile of moderate sedative and hypotensive properties, and fairly pronounced tendency to cause extrapyramidal reactions.

Use in pregnancy: Stelazine has been available since 1958. There are some animal studies that indicate a teratogenic effect, but results are conflicting. There is no clinical evidence (including follow-up surveys in over 800 women who had taken low-dosage Stelazine during pregnancy) to indicate that trifluoperazine has a teratogenic effect in man.

VERTIGON SPANSULE CAPSULES

Contains prochlorperazine.

Use: the short-term symptomatic treatment of vertigo due to Meniere's disease, labyrinthitis or other causes; nausea and vomiting associated with vertigo or other causes; and as an adjunct in the short term management of anxiety states.

Use in pregnancy: prochlorperazine has been widely used for many years without apparent deleterious effects in pregnancy. There is however evidence of harmful effects in animals.

 

 

E. R. SQUIBB & SONS LTD

ECONACORT CREAM

Contains econazole nitrate and hydrocortisone.

Use: the topical treatment of inflammatory dermatoses where infection by susceptible organisms co-exists.

Use in pregnancy: topical administration of corticosteroids to pregnant animals can cause foetal abnormalities. The relevance of this finding to humans has not been established.

HALCIDERM TOPICAL

Contains halcinonide.

Use: in acute and chronic corticosteroid-responsive conditions including psoriasis and eczema.

Use in pregnancy: topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established.

TRI-ADCORTYL CREAM/OINTMENT and OTIC OINTMENT

Contains triamcinolone acetonide, neomycin, gramicidin and nystatin.

Use: the topical treatment of superficial bacterial infections, cutaneous candidosis and dermatological conditions known to respond to topical steroid therapy when threatened or complicated by bacterial or candidal superinfections. These include eczema and psoriasis.

Use in pregnancy: topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established.

 

 

STAFFORD-MILLER LTD

COLIFOAM

Contains hydrocortisone acetate.

Use: topical treatment of ulcerative colitis, proctosigmoiditis and granular proctitis.

Use in pregnancy: systemic and topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established, but at present steroids should not be used extensively in pregnancy, that is in large amounts or for prolonged periods.

QUELLADA LOTION

Contains gamma benzene hexachloride.

Use: treatment of scabies and body lice infestation.

Use in pregnancy: at very high doses foetal toxicity has been demonstrated in animals (rats and dogs). Quellada Lotion has been in wide use for many years without apparent ill consequence.

 

 

UPJOHN LTD

DALACIN T TOPICAL SOLUTION/LOTION

Contains clindamycin phosphate.

Use: treatment of acne vulgaris.

Use in pregnancy: safety for use in pregnancy has not been established. Reproduction studies have been performed in rats and mice using subcutaneous and oral doses ranging from 100 to 600 mg/kg/day and have revealed no evidence of impaired fertility or harm to the foetus due to clindamycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

 

 

WELLCOME MEDICAL DIVISION

LYCLEAR CREME RINSE

Contains permethrin and isopropanol.

Use: the treatment of infections with the head louse Pediculus humanus capitis.

Use in pregnancy: although animal reproductive studies have not revealed any evidence of impaired fertility or harm to the foetus from the administration of permethrin during pregnancy, they have shown that this compound crosses the placental barrier and is excreted in milk. Animal reproductive studies are not always predictive of the human response.

TRI-CICATRIN OINTMENT

Contains neomycin sulphate, bacitracin zinc, nystatin and hydrocortisone. Use: topical treatment of eczema and dermatitis and intertriginous conditions in which bacterial or candidal infection is present or likely to occur.

Use in pregnancy: no specific studies have been conducted in pregnant patients although the active ingredients have been used topically for many years without evidence of adverse effects. The expected clinical benefit of treatment to the patient must be balanced against any possible, but unknown, hazard to the developing foetus.

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. Although the relevance of this finding to human beings has not been established, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods of time.

ZOVIRAX CREAM

Contains acyclovir.

Use: treatment of herpes simplex virus infections of the skin including initial and recurrent genital herpes and herpes labialis.

Use in pregnancy: systemic administration of acyclovir in intemationally accepted standard tests did not produce embryotoxic or teratogenic effects in rats, rabbits or mice. Experience in humans is limited, so the clinical benefit to the patient must be balanced against any possible but unknown hazards to the developing foetus.

In a non-standard test in rats, foetal abnormalities were observed, but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain.

 

 

WYETH LABORATORIES

ANTEPSIN TABLETS

Contains sucralfate.

Use: tablets: for the treatment of duodenal ulcer, gastric ulcer and chronic gastritis.

Use in pregnancy: teratogenicity studies in mice, rats and rabbits at doses up to 50 times the human dose have revealed no evidence of harm to the foetus. Safety in pregnant women has not been established and Antepsin should be used during pregnancy only if clearly needed.

ROBINUL INJECTION

Contains glycopyrrolate.

Uses: (1) to protect against the peripheral muscarinic actions of anticholinesterases such as neostigmine and pyridostigmine, used to reverse residual neuromuscular blockade produced by nondepolarising muscle relaxants.

(2) as a preoperative antimuscarinic agent to reduce salivary, tracheobronchial and pharyngeal secretions, and to reduce the acidity of the gastric contents.

(3) as a preoperative or intra-operative antimuscarinic to attenuate or prevent intraoperative bradycardia associated with the use of suxamethonium or due to cardiac vagal reflexes.

Use in pregnancy: although reproduction studies in rats and rabbits revealed no teratogenic effects from glycopyrrolate, safety in human pregnancy and lactation has not been established. Diminished rates of conception and of survival at weaning were observed in rats, in a dose-related manner. Studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate. The significance of this for man is not clear.

ROBINUL-NEOSTIGMINE INJECTION

Contains glycopyrrolate and neostigmine methylsulphate.

Use: reversal of residual non-depolarising (competitive) neuromuscular block.

Use in pregnancy: reproduction studies in rats and rabbits revealed no teratogenic effects from glycopyrrolate. Safety in human pregnancy and lactation has not been established. However, diminished rates of conception and of survival at weaning were observed in rats, in a dose-related manner. Studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate. The significance of this for man is not clear.

WITH ALL THIS evidence available it is difficult to avoid the sad but inevitable conclusion that animal experiments are used because they are financially expedient. Animals are not just relatively cheap to use but there are also clear commercial advantages for the world's most successful and ruthless industry The bizarre but unavoidable conclusion is that drug companies depend on the fact that animal experiments are unreliable in order to get their new products onto the market without testing them properly The very unreliability and unpredictably of animal experiments makes them valuable. Drug companies test on animals so that they can say that they have tested their drugs before marketing them. If the tests show that the drugs do not cause serious disorders when given to animals, the companies say: 'There you are! We have tested our drug-and have proved it to be safe!' If, on the other hand, tests show that a drug does cause serious problems when given to animals, the companies say: 'The animal experiments are, of course, unreliable and cannot be used to predict what will happen when the drug is given to humans. We have, however, tested our drug.' This double-edged absurdity, which only works because of the enormous influence which the pharmaceutical industry holds over governments and regulatory authorities, and which would sound like a nightmare conjured up by a paranoid lunatic if it were not so easily proved, means that the industry never loses and patients never win.

There is even evidence to show that drug companies will sometimes perform animal experiments on products made by other companies. The only reason I can think of for a company to do animal experiments on another company's products is to obtain results which might add to the confusion and suggest that a product may not be safe. It is always possible to obtain disturbing results if you give animals a high enough dose of a drug.

In order to disguise the real (commercial) reasons for performing animal experiments, drug companies will sometimes claim that they don't like doing animal experiments but do them because they are required to do so by the law. This is not true. There are, for example, no laws in Britain requiring animal experiments to be performed during drug testing. Drug companies say that they are required to perform animal experiments by law. Government spokesmen say that it is drug companies who choose to do animal experiments in order to test the safety of their drugs.

When the drug company Roussel, one of the biggest in Europe, was taken to court by the British government because of advertisement claims for an anti arthritis drug called Surgam, the company, which had claimed in advertisements published in the British Medical Journal that the drug was gentle on the stomach, was asked to produce the evidence for this claim. The only evidence Roussel produced was from experimental studies on two animal tissues (neither of which was stomach tissue) which they had combined in order to support their claim. Even the expert witnesses called by Roussel in its defence testified that data from animals could not be extrapolated safely to patients.

You might imagine that after this fiasco drug companies would be wary about making claims (whether for efficacy or safety) based on animal experiments. You would be wrong. Nothing has changed. And medical journals still allow drug companies to publish advertisements for drugs which have been tested on animals. I know of no medical journal editor who has refused to accept advertisements for products which have been tested on animals. (For the record the European Medical Journal, which I edit, carries no drug company advertising at all-and, indeed, accepts no paid advertising of any kind).

SCIENTISTS OUTSIDE THE pharmaceutical industry support this sham for several reasons. First, of course, animal experiments have now been used for so long and by so many scientists that thousands of reputations would be irrevocably shattered if it were accepted by the research industry that the work they have been doing for so many years was fatally flawed. Second, it is remarkably quick and simple to plan, research and write and publish scientific papers if you are using animals. Decent and useful research, involving human patients, is much harder to organise and since most of the medical scientists using animals in experiments are not medically qualified, most of them would not, in any case, be allowed to perform any sort of clinical research. Prolific publishing (usually accompanied by optimistic conclusions about the value of the research) is the best way to ensure a steady income from grants. It is the quantity not the quality of research which governs the financial results. The charities which pay for much of the animal research want to be able to fill their annual reports with impressive and optimistic accounts of research in progress.

The second-rate scientists who perform animal experiments

outside the pharmaceutical industry are undoubtedly grateful to the industry for creating and maintaining the myths which support the milieu in which they work. And the industry in turn, recognising that the fact that universities still perform animal experiments supports the validity of their work, is also grateful, often commissioning highly paid research work from 'independent' scientists in universities and colleges. In some universities whole departments are financed exclusively by the drug industry.

The myth that animal experiments are of value to doctors and patients is sustained because the vast majority of doctors-the only people who could expose the absurd rigmarole for the sham that it is-are either uninterested in how drugs are tested (and apathetic about the dishonesty involved) or are so beholden to the industry that they are unwilling or unable to criticise it.

The vast majority of the thousands of medical journals in existence rely to a greater or lesser extent on drug industry advertising to stay alive and so the editors of these journals are reluctant to publish anything critical of any aspect of the system as it operates.

Articles criticising the drug industry, the way drugs are tested or the use of animal experiments are rare. The existence of so many medical journals, largely sustained by drug company advertising, means that there is a steady and constant demand for new scientific papers. And so the whole system is self-supporting. The industry needs to publish research papers in order to satisfy the regulatory authorities and to convince possibly sceptical doctors that their products have been well tested and proven to be both efficacious and safe. Independent researchers need to publish papers in order to provide the charities which fund their work with evidence with which to impress their subscribers and donors. And the journals need articles to publish.

Those who perform and defend animal experiments sometimes try to explain away the differences which exist between the results obtained when drugs are given to animals and when drugs are given to human beings, by claiming that the dosages used when giving drugs to animals are too high. Strangely, they never bother to explain why they deliberately make the dosages they give so high as to be of no value. The truth is that no one does know how much of a drug to give to an animal in the hope of obtaining results which might be relevant to another animal (a human being) weighing a hundred or a thousand times as much and having entirely different physiological and anatomical systems.

The differences between results obtained when giving drugs to children on the one hand and to adults on the other is so vast that paediatricians frequently complain when drug companies fail to perform special trials on children. Similarly, all good physicians know that adult human beings of different sizes and different ages may respond in different ways to the same drug. (There is something quite absurd about giving a 7-stone woman and a 20-stone man exactly the same dose of an antibiotic, for example). Many drug companies now warn prescribers that special dosage rules must be followed when giving drugs to elderly patients.

It should, therefore, be clear to anyone with any knowledge of physiology that the only possible argument for trying out drugs on animals is in the hope that the tests will show signs of toxicity. However, even this hope is dashed because there is a huge amount of evidence available to show that when given drugs animals frequently react quite differently from human beings. A cat can't be expected to react in the same way as a dog or a sheep or a cow or a mouse or a guinea pig or a rat or a human being when given a drug. Of course, the simple law of averages means that occasionally there will be results which seem of value-but how is anyone supposed to know which results to take notice of and which to ignore? Most doctors, even many who support vivisection, will confirm that animal experiments can be misleading. After the European Medical Journal published a survey showing that 88% of doctors agreed that animal experiments can be misleading because of anatomical and physiological differences between animals and humans, the editor of the British Medical Journal wrote to say that he felt that most doctors would agree with the phrase that 'laboratory experiments performed on animals can be misleading because of anatomical and physiological differences between animals and humans'. The Dean of Medicine at the University of Southampton expressed his surprise that the survey did not find that 100% of the doctors who took part in the survey believed that animal experiments could be misleading. The problem, of course, is that no doctor can tell you which animal experiments are going to be most misleading.

If you test a drug on eight species of animal and the drug turns out to cause cancer in two of those animals, to cause liver problems in another two, to cause blindness in two more and to be quite safe in a final pair, should you accept the results from the two that develop cancer, the two who develop liver problems, the two who become blind or the two who remain well?

In practice, of course, no one knows which results to accept and which to ignore, so all the results are ignored (as shown by the number of drugs currently freely available for doctors to prescribe which are known to cause serious problems in animals).

The absurdity of the whole business of giving drugs to animals, and expecting to obtain useful results, is taken even further away from logic and practicality by the knowledge that animals in cages behave quite differently from animals in the wild, and by our understanding that since diet, exercise patterns and genetics all have significant effects on the way human beings respond to disease and drug therapy, it is likely that these or other influences may also affect animals when they are given drugs.

I have concentrated in this chapter (and, indeed, in the whole of this book) on the uselessness of animal experiments designed to help doctors judge or evaluate new drugs. But animals are often used to 'help' surgeons decide on the value of new surgical procedures and those who support and defend animal experimentation often claim that without animal experiments no progress would be made in surgery

This is, of course, absolute nonsense, for as practising surgeons will readily confirm, the differences between animal and human anatomy and physiology is so great that trying out new techniques on animals is worse than useless-and quite likely to lead to dangerous consequences.

Moreover, attempts to perform controversial or questionable operative procedures in animals (in an attempt to identify or quantify the risks involved with those procedures) have clearly been regarded by the medical establishment with contempt.

For example, even though experiments have shown that vasectomy operations accelerated arteriosclerosis in monkeys, no one seems to have taken any notice of this discovery and several million vasectomy operations are still performed annually on humans.

No one knows which experiments, if any, can be regarded as providing useful information and so no experiments can possibly provide information which can be useful (except retrospectively!).

If we don't know which animal experiments are relevant, then there is no point in doing any of them.

Finally, in recent years some surgeons, scientists and entrepreneurs have claimed that in the future it will be possible to save human lives by breeding and then implanting organs from animals which have been genetically altered so that they are not rejected by the human tissues. The theory is that by implanting human genes in animals such as pigs the scientists will be able to breed creatures which will be part animal and part human being. The scientists believe that when the hearts, livers and other organs are chopped out of these hybrid animals and stuck into human patients, they won't be rejected.

I have several reasons for objecting to these experiments.

First, 1 have strong moral and ethical objections to the idea of mixing human and animal genes to create new animals.

I know that it is unfashionable to have moral or ethical objections to anything scientific these days, but just where is this sort of research going to end? If scientists mixed postman genes with whippet genes we could get our letters delivered more quickly. But at what point does the creature the scientists are creating stop being an animal and start acquiring human rights? Can you legally tear the organs out of a creature which is part human? How many human genes do you need to get a credit card? If one of these new hybrid creatures starts getting mail from the Readers' Digest, will the scientists still be able to tear its liver out without having their collars felt?

Second, who gave scientists permission to start messing around with animals this way? Has anyone faxed God and asked for his views? Scientists are claiming patents on some of the animals they're creating. What will happen if God hears about this? Will he (or she) be happy?

Third, no one else seems to have thought about this (or dared to mention it), but where is the money going to come from to pay for all the extra transplant operations? We'll need regiments of extra surgeons and thousands of new hospitals. At the moment it is the shortage of transplant organs which is saving nations from bankruptcy, but when surgeons can pop into their nearest supermarket and pick out a hybrid heart 'Ready for Use: From the Freezer to the Chest Cavity' we're going to have big problems.

Animal organ transplants could be used to save several hundred thousand lives a year. The total bill could easily mean that in Britain the rest of the NHS will have to close down. Or taxes will have to go up to £1.78 in the £1 to pay for it all.

Has anyone else stopped to think all this through?

Fourth, when are things going to go seriously, horrifyingly, frighteningly, blood chillingly wrong? When men in white coats say that everything is foolproof and nothing can go wrong, I get this funny tingling feeling down my spine. Things will go wrong. Believe me. Things will go wrong. Remember: one in six patients in hospital are already there because doctors and medical scientists have screwed up.

Fifth, what about the enormous religious and cultural problems all this is going to create? If you try flying into the Middle East with a pigskin belt holding your trousers up you're likely to be deported and have your belt confiscated. What happens if you've got a pig's heart pumping away in your chest? ('I'm sorry, sir, we'll have to confiscate the heart but you'll be free to leave the country afterwards.')

It makes me go cold inside. Are we all really this desperate to live for ever?

 

 

 

CHAPTER FIVE

ANIMAL EXPERIMENTS MUST STOP

 

Although the evidence showing that animal experiments are worse than worthless is overwhelming, animal experimentation retains a considerable amount of powerful support. The establishment tends to support vivisection. Politicians, civil servants and journalists who have not studied the subject in any depth assume that animal experiments must be necessary because that is what they are told by the medical establishment.

The establishment is wary of the anti-vivisection argument because it has been encouraged to believe that those who favour it are simply cranks-fired by an over zealous enthusiasm for the welfare of animals and a failure to understand the requirements of science. The image of the antivivisection movement has been deliberately clouded by lies, deceit and propaganda. 1 have been repeatedly accused of not being a qualified doctor. I have been accused of having links with terrorists. I have received threats to my life. My files have been burgled. My telephone has been tapped (and simply switched off during attempts to broadcast).

The doctors who make up the medical establishment support the use of animal experiments because they, in turn, have been told that they are essential for the development of new drugs. They are told this by the big international drug companies.

The truth is that those who support animal experimentation are quite clearly wrong. When individuals who support animal experimentation are given the facts, they cannot defend their position. Animal experiments are so unreliable that it is possible to prove anything by doing them-one just has to select the results carefully It is no more possible to support animal experimentation in logical argument than it would be to support slavery or to oppose the emancipation of women. If vivisection were stopped tomorrow it would never be introduced again because no one would ever be able to find an argument supporting its introduction.

Animal experiments are so barbaric and so unsupportable on moral, ethical, scientific or medical grounds that once they are stopped no one will ever dream of letting them start again.

However, the battle against vivisection (which should be fought by those who care for the safety of human patients as well as animals) must be fought not just against waves of prejudice but also against apparently endless seas of ignorance and indifference. Confused and frightened by the pro-vivisection campaigns (which I regard as the crudest and most vicious form of intellectual terrorism ever seen-usually being dependent on the 'if we stop animal experiments then children will die' argument) ordinary members of the public do nothing. It is their money which is used for most animal experiments. The experiments are done in their name but they remain silent.

Most experiments are done or paid for by pharmaceutical companies. It is the drug industry (which, as I have shown, depends on animal experiments for its healthy profits) which persuades politicians and journalists that animal experiments are essential. It is the drug industry which gives animal experimentation a veneer of credibility and respectability. And it is, therefore, the drug industry that we should be aiming at as we battle to stop animal experiments.

Some politicians who support the antivivisection campaign insist that we should aim for a pan-European ban on the grounds that a single country ban would be impractical. It would only be impractical for the drug industry. Can you imagine the chaos that would exist if the industry had to produce drugs that had not been tested on animals, just for one country? A single country ban would quite quickly lead to a universal ban. If, for example, Britain or Germany announced that it was no longer going to allow the sale of drugs which had been tested on animals, then animal testing would stop very quickly. The drug companies wouldn't move their testing procedures to Russia or Africa (as the politicians now claim they will if we force them out of our countries) because there wouldn't be any point in doing any animal experiments if by so doing they adversely affect their own sales.

Animal experiments will never be stopped by waiting for the legislators to take action, because the drug companies control the legislators. Animal experiments will be stopped by public opinion forcing politicians to take action (in just the same way that public opinion has led the way to all other great social changes). Modern politicians do not lead-they simply follow public opinion.

The drug companies will continue to argue that animal experiments help doctors save lives. This book has, I believe, shown that that claim is a lie. The money spent on animal experimentation is money wasted. The number of patients now being injured by badly tested drugs is so great that iatrogenesis is one of the commonest causes of serious ill health in the western world. If the money spent on animal testing were spent on proper clinical trials (not to mention preventive medicine programmes) then far more lives would be saved. The pharmaceutical industry, which is marketing led rather than being led by patients' requirements, has no interest in patient welfare. The principles upon which the industry is based mean that patients inevitably suffer.

Animal experimentation is done with a false mantle of science by men and women who claim to be educated and civilised. It is based on lies and ruthlessly used to make money. A side effect is that millions of patients are made ill. Those who perform and support animal experimentation have betrayed us all.

Animals can help doctors save human patients.

But not through experiments.

MANY VERTEBRATES - INCLUDING monkeys, pigs and elephants plants as medicines as well as food. Sick animals seek out and cat plants which they know will help them; they eat some plants, they hold others in their mouths (we call it buccal absorption) and they rub yet others onto their skin (we call that topical application).

Ethiopian baboons who are at risk of developing schistosomiasis eat balanites fruits, which are rich in a potent antischistosome drug. Chimpanzees in Tanzania use a herb which has a powerful antifungal, antibacterial and antinematode activity. If they just ate the herb it wouldn't work because the valuable compound would be destroyed by stomach acidity. So they hold the leaf in their mouths in the same way that angina patients are encouraged to hold glyceryl trinitrate in their mouths to expedite absorption. Kodiak bears apply a drug topically which helps to kill parasites. They scratch the root into their fur. European starlings combat parasitisation to their nests by fumigating incubating eggs. Lethargic chimps with diarrhoea treat themselves with vernonia. Howler monkeys use herbal medicines to control birth spacing and to determine the sex of their offspring. Koala bears use different types of eucalyptus to vary their body temperature. Sloth bears get drunk through eating fermenting madhuca flowers.

We can learn an enormous amount by watching other animals.

But instead of watching these animals the men in white coats cage them, stick electrodes into their heads, sit them in metal boxes for weeks at a time to make them depressed, separate them from their families, sew up their eyes, and inject chemicals into their brains while they are awake.

In a generation or so our descendants will look back at the vivisectors and wonder not just at the sort of people they were, but at the sort of people we were to let them do what they did.

Animal experiments must stop. And they must stop now. For your sake; for your children's sake; and for the sake of the animals the vivisectors kill.

 

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