An inquiry into the influence of the pharmaceutical industry on the NHS by the Commons Health select committee on will begin this autumn.
It will examine any conflicts between the commercial drive of the large and wealthy drug companies and the need of the NHS for well-researched medicines.
All Health committee members have receievd a copy of Charles Medawar's book 'Medicines out of Control.' They have also seen the debate below.
I intend to give evidence concentrating on the use the Pharmas have made of patients' group as Trojan Horses to get access to MPs and to influence decsions.
The inquiry follows concern over the alleged suppression of data from clinical trials involving children given anti-depressant drugs.
When a government working group saw the data from trials of Seroxat in children, they recommended the drug, and all others in its class except Prozac should be banned from use in children because they did not work and side-effects included inducing suicidal thinking.
The committee will look at drug innovation; the conduct of medical research; the way companies promote their drugs; and the evaluation of the efficacy, safety and value for money of drugs. Submissions are invited to the Secretary of the Committee at the House of Commons.
Westminster Hall Adjournment Debate
25th May 2004
Paul Flynn (Newport, West) (Lab): The discovery of medicines and the work of scientists in pharmacy over the past 150 years have been and continue to be a triumph. My purpose today is not to attack the work of those scientists, but to concentrate on how it has been used, subverted and perverted by the pharmaceutical industry in pursuit of greed.
Often, the only purpose of the pharmaceutical giants seems to be maximising their profits. They do so in an age when we in the western world have conquered most of the major diseases that assailed us in the past. The pharmaceutical industry pursues its goals by disease-mongering—trying to invent new diseases and exaggerating existing ones. Its activities have a huge impact on human health, public consciousness, medical practice and the ballooning burden of health service finances.
Those in the industry engage in such practices by inventing new illnesses, and billions of pounds have been spent on attempts to convince healthy people that they are sick. Such new illnesses include social phobia, attention deficit and hyperactivity syndrome and compulsive shopping disorder—it is hard to believe that the latter is not a joke, but it appears to be genuine. Social phobia is a new invention by the drug firm Roche. In order to promote and create a market for its anti-depressant, the company decided that people who occasionally feel shy or intimidated by society actually suffer from a psychiatric disorder.
Firms do such things by exaggeration and claiming that diseases that affect a small minority actually affect many millions. We know that depression or chronic obesity are life-threatening, but when a definition of obesity includes Russell Crowe, Brad Pitt and George Clooney, one may presume that it is almost certainly drawn so widely in the self-interests of the company that hopes to extend that view. GlaxoSmithKline tells me that it believes that 25 million people in Britain should be on anti-depressants. That is a vast exaggeration to promote the use of substances that are of little utility and can lead to dependence.
The companies define inevitable features of normal lives—sadness, grief, ageing and even baldness—as illnesses. The British Medical Journal had a competition to put together a list of 20 non-diseases in descending order of non-diseaseness, and came up with: ageing, work, boredom, bags under the eyes, ignorance, baldness, freckles, big ears, grey or white hair, ugliness, childbirth, allergy to the 21st century, jet lag, unhappiness, cellulite, hangovers, anxiety about penis size or penis envy, pregnancy, road rage and loneliness. The drug companies have attempted to reclassify each of those things as illnesses that require medical intervention. Baldness is an interesting one. When the firm Merck produced a new hair growth drug, it planted stories in newspapers suggesting that bald people suffered from emotional trauma and that hair loss led to panic and emotional difficulties. There are similar stories in dozens of other cases.
The tactics are not deeply serious, in that they only involve emptying the pockets of gullible people. However, there is a terrible side to such practices, because the drive for profits has led to something that I, with my scientific background, find deeply shocking. I have always respected the integrity of trials, and particularly double-blind trials. All scientific evidence is based on them. We now know that there is severe criticism of the veracity of the trials that are carried out.
One such case involved an antiarrhythmic drug called Lorcarnaid. Ninety-five people with heart problems were involved in a trial in Nottingham in 1980, and the tests went on for many months. During the test, one of the people on the placebo died, but nine of the people taking Lorcarnaid died. The report was not published through the whole of the 1980s, but it was eventually published 13 years later. In the intervening period, the drug directly caused the death of between 20,000 and 70,000 Americans per year. More American males died from the use of Lorcarnaid than died in Vietnam.
We now know from the recent evidence—from an article in The Lancet and another in the British Medical Journal—that the trials of the drug Seroxat on children were misreported, that the data collected did not match the published conclusions and that the advantages of the drug were exaggerated and the disadvantages downplayed. The result of that trial was fixed. There were two other trials whose results were not published for 12 years. That is a shocking indictment of a drug. According to the Department of Health, that group of anti-depressants—selective serotonin reuptake inhibitors or SSRIs—are at present prescribed to 100,000 children in Britain. They have never been recommended or approved for children, but that is the situation today—a slightly happier situation than that in America, where 10 million children are prescribed those drugs.
We have been conditioned to believe that there is a pill for every ill. Let us again take the example of what has happened with anti-depressants in this country. In 1994, there were 2.6 million prescriptions; in 2003, there were 14 million. If those drugs worked and were successful, we would have seen a corresponding reduction in the icidence of self-harm or suicide. We have seen no such thing.
A typical example of how such drugs are marketed—it applies to dozens of examples, although we will take just one, in which the marketing strategy was leaked—again involves GlaxoSmithKline. The publicity firm involved was In Vivo Communications. The firms decided to raise the awareness, in their words, of the condition known as irritable bowel syndrome. It is rarely a disabling condition, so they gave it a makeover and it was remarketed as a serious mass scourge. For many people, it is a mild functional disorder, but a three-year medical education campaign was launched as the strategy for the drug Lotronex. The aim was to establish irritable bowel syndrome in the minds of doctors as a significant and discrete disease state and to convince patients that IBS is a common and recognised medical disorder. That was not the case before that campaign. In such cases, the idea of the disease is established and built up, so that fear-mongering about the latest illness is accompanied by news of the latest wonder drug.
Articles were planted in the medical journals; the health correspondents were recruited to write about Lotronex. Medical opinion had to be shaped so that there would be a reception for the drug, and groups were formed to maximise its sale. There were plans to establish patient groups. In the event, the drug was withdrawn after serious and fatal adverse side effects. The food and drug administration in the United States said that using the drug to treat patients in whom the condition was not serious—95 per cent. of them—could do more harm than good. That is one example of the irresponsible way in which those companies behave.
Part of that irresponsible behaviour was the creation of patient groups. As our stricter regulations make it difficult for companies to advertise new medicines, some of which are useless or damaging, a favourite way of getting their message across is to infiltrate existing patient groups or to set up new groups. Again, that is in their literature. We all know how many patient groups we are in contact with in our daily lives. There are hundreds in this country, many of which do splendid work, but we must look at patient groups that are formed alongside campaigns for new drugs. We want more openness with patient groups.
The splendid Mind organisation has played a valuable role in exposing the dangers of anti-depressants. Its chief executive made a principled resignation from the Medicines and Healthcare products Regulatory Agency because he thought that reports on the dangers of anti-depressants were being suppressed. Mind takes not one single penny in funding from drug companies.
The Depression Alliance, however, which admits to taking 80 per cent. of its funding from drug companies, has not uttered a word of criticism about anti-depressants. I have had much correspondence with the Depression Alliance. I have met its representative and accused it of acting as a stooge to pharmaceutical companies. That accusation could be made about many patients' associations. They are put in a position in which they have to ask whether they should attack the people who fund them and put the jobs of a quarter of their staff at risk—in the case of the Depression Alliance, it would be three quarters of the staff—or continue to say nothing.
There is a serious danger that we politicians listen to patient groups in our all-party groups whether they support patients or have a secret agenda as Trojan horses acting in the interests of drug companies. There are few cases of shameless promotion of drugs and drug companies, but in every case in which organisations receive substantial donations from drug companies, their mouths are bandaged when they should be criticising. I ask the Minister to support genuinely independent sources of information.
One of the Government's greatest triumphs is their establishment of the National Institute for Clinical Excellence, but it comes under attack when it releases reports, as with yesterday's preliminary report. NICE has an objective view, and it is a small voice against the might of the pharmaceutical companies.
We need a campaign of demedicalisation. We have deregulation, but more is necessary with the onslaught of companies finding new diseases and inventing new treatments. There is also the problem of "Me too" drugs. When the patent on a drug is running out, companies tend to rework part of the drug, rename it and establish it so that they can get a new patent. That process is cynical, expensive and counter-productive. I want to see greater transparency with drug company donations to tackle the problem of Trojan horses.
We live in an incredible world. In the United States, 10 million children are on anti-depressants, and the third greatest cause of death after cancer and heart disease is medical intervention. The Americans are the greatest buyers of medical health—they spend almost three times what we in the UK spend on some areas of health—yet their life expectancy is lower than in the UK and most European countries.
We in the western world waste billions on drugs and medicines for trivial and non-existent complaints or complaints of doubtful value, while people in the under-developed world are dying from lack of simple medicine, sanitation, immunisation and clean water. Meanwhile, the scandal of the over-prescription of neuroleptic drugs to those in homes for the elderly and to women in prison continues. We are pushing people into a dependency culture. The disease-mongers gnaw away at our self-confidence by playing down the strategies of self-coping.
There is a good side, however, with a growing realisation of the harm that is being done by over-medicalisation. "Breaking the Bonds", the splendid book by Dorothy Rowe, is probably the best book on escaping from depression by the techniques of self-awareness, meditation and exercise. A new book entitled "Healing without Freud or Prozac" by Dr. David Servan Schreiber is causing a great stir. Like Dorothy Rowe's book, it supports using exercise, throwing endorphins around our bodies and serotonin around our brains, and using other non-drug remedies.
The splendid new book by Charles Medawer, "Medicines out of Control", which was published a month ago, gives a clear view of what has happened over the past few years. Instead of dishing out anti-depressants and reaching for the prescription pad—a great temptation to clear a waiting room—a GP in Cardiff prescribed self-help, self-coping books to those who suffer from such problems. Such policies will certainly not do anyone any harm. They are non-addictive and non-dangerous.
The medically celebrated writer on such matters, Ivan Illich, said: "The medical establishment has become a major threat to health."
He said that people are conditioned to get things, not to do things. They want to be taught, moved, treated or guided rather than to learn to heal or to find their own way. The more money we spend on coping with death and pain, the further away we drift from reality. The choice is for us to continue to become more passive and dependent on ourselves or to stand on our own feet and cope in an active way with our problems.
I have the chance now only to go rapidly over an enormous subject, but it is clear that many lives have been destroyed in order to fuel the profits of the pharmaceutical companies. Many people's lives have been thrown into confusion and dependency because of their reliance on addictive drugs that have little value. I wish to finish with a quote from The Lancet. A month ago, it concentrated on the fiddling of the research results for Seroxat, and said:
"People around the world understand the desire to achieve success and to work in a profitable environment. They will not, however, tolerate the notion that in biomedical research this could be at the expense of their children's lives."
The Minister of State, Department of Health (Ms Rosie Winterton) : I congratulate my hon. Friend the Member for Newport, West (Paul Flynn) on his success in securing this debate, which is on an extremely important issue. As ever, his contribution was thoughtful and thought provoking. I am well aware that he has raised several worries, but I hope that he agrees that this debate provides an opportunity to consider the major contribution that medicines have made to health care delivery and how they have eased the burden of chronic disease on a vast number of people.
Many diseases have been eradicated by vaccination programmes, and fatalities from some diseases have been reduced. Polio disappeared from the United Kingdom, and the meningitis C vaccine, which this Government introduced, dramatically cut the rate of that terrible disease. Spending on statins is now about £230 million a year more than three years ago—an investment that has already achieved a 23 per cent. fall over five years in death rates from heart disease and strokes in people aged under 75. Vast advances and many benefits have come from medicines, but our challenge is to ensure that all developments serve the best interests of patients. If we are to achieve a society that is fully engaged in health, every aspect of health care design and delivery must focus on patients' best interests—on people, not clinicians, managers or the pharmaceutical industry.
My hon. Friend mentioned several concerns about that industry, which plays an extremely important role. We all want the development of new and potentially life-saving treatments, and we want them to be available for patients as soon as that is safely possible. For any medicines to be licensed, however, the pharmaceutical industry must demonstrate that it can provide evidence of the safety, quality and effectiveness of any medicine. That includes evidence from clinical trails. We need fully to evaluate the risks and benefits of a medicine in the circumstances in which it will be used. The Medicines and Healthcare products Regulatory Agency monitors the safety and use of all the medicines that are on the UK market.
My hon. Friend referred to patients' groups. It is true that many patients' organisations not only in the mental health sector, but across the board, are given support by the pharmaceutical industry. I hope that he also accepts that charity law ensures that, as with all charitable donations, support can be accepted only on a no-strings-attached basis. He also referred to the medicalisation of normal everyday problems, such as grief, and their classification as diseases that seem to require drug treatment. I share his concern that we must not encourage the belief that there is a pill for every ill.
At the same time, we must recognise the burden that depressive illness places on people. It is felt at all levels of society and affects young and old, and rich and poor. We must ensure that we achieve a balance between recognising and supporting those who need some form of intervention and medicalising the emotions that we all feel from time to time.
Even when we get that balance right, we need to decide what sort of therapy will have the right outcome for the patient, whether it is talking therapy or drug therapy. I believe that all health interventions should be made against that background. That is one of the reasons why we tried to increase the number of bereavement services that are available. My hon. Friend was right to highlight that issue and to say that people may have been steered too readily towards drug therapy when alternatives might have been examined.
I join my hon. Friend in praising the National Institute for Clinical Excellence. It is in the sort of sector that we are discussing that NICE can come into its own. It is producing guidance on the effective management of depression and anxiety to tackle head-on the question of prescription and over-prescription in that area. It has delivered guidelines and appraisals to help clinicians and managers deliver more effective mental health services, including talking therapies. It is now examining further work, including how we deal with anxiety and related common mental disorders, the management of disturbed behaviour in acute settings and the management of self-harm.
We need to use that process to ensure that we get right the balance of treatment that is available, so that we provide talking therapies where that is most appropriate and avoid the pitfalls of over-prescribing that are associated with benzodiazepines—an issue on which I have met with representatives of various groups. At the same time, we need to recognise the testimony of those who tell of the benefits that appropriate drug therapy affords. Lives have been turned around by modern anti-depressants, which are much less dangerous in terms of overdosing than older anti-depressants and have a better safety profile.
My hon. Friend also referred to the safety of selective serotonin reuptake inhibitors—SSRIs. As he knows, an expert working group of the Committee on Safety of Medicines is undertaking a comprehensive scientific assessment of the available data on the safety of SSRIs, particularly in relation to withdrawal reactions and suicide behaviour.
Paul Flynn : That study was interrupted for reasons that the Minister may know. One of the people who gave evidence was Dr. David Healy, who claimed that there was a six times increased likelihood of suicide for people on SSRIs in comparison with a group in the same condition who were on placebos. Another trial involved groups of children, and one group was healthy, while the other had problems. One of the healthy children, who was on Seroxat, committed suicide. Does the Minister not accept that the research on Seroxat has been fiddled? It has been corrupted; that is what The Lancet and the British Medical Journal say. Is that not a reason why the Government should act or at least give some acknowledgement that the CSM and the MHRA, which are full of people with long experience as employees with contracts for the pharmaceutical companies, could come to some objective conclusions that are rather different from what she is saying now?
Ms Winterton : I hope that my hon. Friend will allow the expert group, which is taking evidence from a wide range of sources, to come to its conclusions. Those conclusions will be placed in the Library, and there will be an opportunity for us to debate them.
On my hon. Friend's point about clinical trials in paediatrics for SSRIs, I hope that he understands that I cannot comment on the specific case that he raised, because it is the subject of an investigation. However, he knows that the MHRA has published summaries of the relevant clinical trials and that the European law governing both the industry and clinical trials has been strengthened.
I turn now to our overall approach to medicines. We are putting increasing emphasis on medication reviews, which is helping in the appropriate management of drug therapies. That has been recognised in the general medical services contract for GPs. We are also funding a taskforce, which has published a medication review guide for patients providing information about what medication reviews are and what patients can expect. We want people to understand their medicines, to be able to manage them and to have access to the maximum amount of information about them.
It has not been possible to address every issue that my hon. Friend raised, but I hope that he recognises in the light of a range of actions—the regulation of medicines, the work of the expert group, the work being taken forward by NICE, the delivery of the medicines management collaborative and the development of clinical practice through the national service frameworks—that the Government will not shrink from taking the necessary action to protect and promote public health, and to put the patient at the centre of health care delivery and design.
Motion An early day
This House applauds MIND for refusing financial aid from outside bodies: is concerned that several patients associations rely on funding from the pharmaceutical industry which may be used to promote their commercial interests: notes that the Depression Alliance admits to receiving more than 80% of their money from unnamed drugs companies: contrasts Mind’s vigorous recent campaign exposing the dangers of anti-depressant drugs with the silence of the Depression Alliance: calls for all organisations involved with All Party Parliamentary Groups to publicly declare the identity of their donors to assist judgements on possible conflicts of interest and to avoid the abuse of these groups as Trojan Horses to smuggle pro-drug propagandists into parliament.