Just before Christmas, the House of Commons was given the opportunity to debate the excellent report on the influence of the pharmaceutical industry produced by the Health Select Committee earlier in 2005 and the Government’s response to it. The debate ran for several hours. Below are some edited extracts. The full debate can be found on the Parliament website, www.parliament.uk.

Licensing

Paul Flynn MP: A serious situation has just been revealed in a report by the university of Sussex, which shows that we have been much too ready to license drugs in this country, compared with the United States. Between 1971 and 1992, nine drugs were withdrawn in the United States because they had serious adverse effects, whereas the figure in this country was 24. In our rush to put drugs on to the market for the benefit of the pharmaceutical companies, we are conducting experiments with those drugs and using the public as guinea pigs, and those guinea pigs often do not survive the experiments.

I want to give the House a clear example of the disastrous failure of our regulatory system. The Food and Drug Administration in America has claimed that there were 144,000 cases of heart attacks and strokes due to the use of Vioxx. However, in answer to a parliamentary question asking how many bad reactions had been discovered here under the yellow card system, I was told that there were never more than half a dozen a year. There is evidence of 4 million prescriptions for medicines of this type being prescribed, and if America had not discovered the terrible, fatal side-effects of Vioxx, we would still be using it, and British patients would still be being killed by it.

Ghost-writing

Kevin Barron MP: The report also raised the issue of ghost-writing, which relates to cases in which well-known doctors or academics put their names to research articles that they did not write. They may not even have seen the data referred to. The practice was criticised in the report, and has recently received media coverage as well. The evidence taken by the Committee was led in part by the Royal College of Psychiatrists, which submitted written evidence of its concern. Last week I received a letter from its president, Professor Sheila Hollins, who wrote:

"I know that the Health Select Committee, in its report on the influence of the pharmaceutical industry, was very concerned about the failure of drug companies to publish all their findings regarding the efficacy and safety of drugs. This was also the most important issue raised in our submission to the Committee. I am aware that this situation is unlikely to have significantly changed; and many members of this college have grave concerns about the impact of selective publishing upon the trust placed in the pharmaceutical industry by patients and professionals alike."

Julia Goldsworthy MP: Despite recognising the important and revolutionary contribution of the pharmaceutical industry, the report highlighted a series of concerns that ultimately stem from the fact that certain issues have been ignored for nearly 100 years and from the imbalanced approach that the Government have adopted to the pharmaceutical industry.

Allegations were made about badly designed and biased clinical trials—trials biased towards showing drugs in the best possible light. There is evidence of selective publication of evidence relating to those trials, in which the negative evidence was not made public or full data sets were not published. Allegations were also made about ghost-writing, with the names of third-party so-called "independent" academics being added to papers not authored by them. Sometimes their names were added, but they did not have full access to the full data sets on which the reports were based. The Committee felt that there needs to be much greater balance between promoting the interests of the pharmaceutical industry, and promoting the health of the public and the effectiveness of the NHS. Unfortunately, in many respects the Government's response, published in September this year, reflects the perpetuation of this imbalance. Many of the recommendations were not acted on, and in many cases the justification given was that the Government did not recognise or acknowledge the problem identified by the Health Committee report.

Paul Flynn MP: My greatest shock in the last couple of years was when the BMJ published an article two years ago, giving examples of reports presented in the medical journals—reports that had got past the very suspicious editors—in which the conclusions did not match the data. The data said something and the conclusions said something else. There were examples of how this was done; the pharmaceutical companies write most of the reports and hawk them round for others to sign and approve. They get some figures and they provide some fat fees.

Dr. Blumsohn spent a year requesting to see the full data on which the work that was published under his name was based. He was one of two lead authors. Two years after raising his concern, he was suspended from his university post. In The Observer last Sunday, Proctor and Gamble is reported as saying that it is "standard industry practice" not to hand over all data to professionals. That seems extraordinary, and it is regrettable that the Government have failed to respond in any way to that crucial issue in their response to the report. That is the key issue turned up by the Health Committee.

New Code of Practice

Paul Flynn MP : The new code of practice (ABPI) is entirely cosmetic and has been described by the British Medical Association as lacking teeth. The Drug and Therapeutics Bulletin describes it as fundamentally weak in all respects. It is purely window-dressing to hide the drugs industry's continuing close collaboration with the MHRA, which has been so detrimental to patients.

I believe that this report is among the three best that I have seen in my 20 years in Parliament. I believe that it required a response from the Government that reflected the courage and thoroughness of David Hinchliffe and the other members of the Committee. Sadly, the Government's response is lamentable. Not only did they not respond to the Committee's clear and important calls, but they ignored many of them altogether.

Wonder Drugs

Paul Flynn MP: A few weeks ago, I received a letter that interested me greatly, as I had a constituent suffering from pancreatic cancer. The letter was about a new wonder drug called Tarceva, of which I had never heard. On investigation, however, it turns out that the cost of prescribing this drug will be £16,000 a year. Its effect was to increase the life expectancy of pancreatic cancer patients by 12 days, and it had adverse side effects including death in 10 per cent. of the patients involved. Increasingly, MPs are being approached to use our office here to put forward a case for the drug industry. That is a thorough abuse of our position.

I sent a book to all the members of the Committee before it started its work. The book is called "Medicines Out of Control?", by Charles Medawar. It asks what would have happened if we had gone to see Sigmund Freud when he practised as a doctor. He gave all his patients and friends, and took himself, a medicine he knew that was believed to improve people's mental health and stability. That medicine was cocaine: it was the popular drug of the time. A later popular drug was bromide, which creates its own form of psychosis, called bromism, which was a scourge of society at the time of the first world war.

For an awful period in the 1960s and 1970s, diazepam—or valium—and other similar drugs were prescribed like smarties. That caused great distress and did very little good. There was also the experimental period of the mental health industry in the 1950s, with the inducement of deep psychosis, lobotomies, leucotomies insulin coma therapy and electroconvulsive therapy. People were used as guinea pigs and suffered greatly.

More recently, we have had the tricyclics, which were regarded as wonder drugs, but they are now seen as old-fashioned and have been replaced by selective serotonin reuptake inhibitors—SSRIs—of which Seroxat is one. When the campaign against Seroxat was mounted by a few courageous people outside the drug industry, the drug companies mounted a ferocious campaign to ensure that the voices who were protesting about the dangers of Seroxat were muffled.

Tentacles of influence

The key, and most dramatic, moment in the Health Committee inquiry was the unbelievable evidence about the inducements given to clinicians and others to use particular drugs. One of the questioners asked whether the free trips, the holidays and the chance to take one's wife, husband or girlfriend to the Bahamas or the Alps had any effect. The witness replied that they did not, but that articles in the British Medical Journal and The Lancet did. The point, made with great force, was that the way to influence public and medical opinion was to get articles written by authoritative figures in those journals.

Poor response

David Amess MP: It can be argued that the industry has been left to its own devices for too long. That was the thrust of the Health Committee report. The industry can target not only general practitioners, hospitals, treatment groups, medical journals and professional bodies in distribution campaigns but individuals as well. The Health Committee thought that that practice put genuinely ill and vulnerable people at risk to some extent. Everyone, including patients and consumers, should be protected from pharmaceutical companies' persuasive product pushing.

I am not suggesting that the Department is naive enough to assume that the interests of the health sector and of the pharmaceuticals industry are synonymous. Clearly, although there is an overlap, the former is driven primarily by patient care and the public interest, whereas the latter must also weigh medical need against the returns that it will get from its investment. This is why, quite wisely, the Committee concluded that a key recommendation of its report would be that the sponsorship of the industry be passed from the Department of Health to the Department of Trade and Industry, so as to avoid that conflict of interest. I very much regret that this recommendation was rejected by the Government in their response to our report. It was disappointing that in their response, the Government committed only to a suitably planned review of the MHRA "perhaps on a four-yearly cycle", without giving a start date for the review cycle, which leaves us unclear as to whether the process will go ahead. A four-year cycle is too loose and not realistic enough.

Diease promotion

Mr. Charles Walker MP: I am grateful for the opportunity to speak in this important debate. I thought that I would need to have my boxing gloves on, metaphorically speaking, to take on the hon. Member for Newport, West (Paul Flynn), but as I listened to his excellent speech, I found that I agreed with much of it. I must first declare an interest in that Merck Sharp and Dohme is based in my constituency. I am pleased to have that company there, it is a good employer and I hope that it continues to operate out of the UK as well as other countries. The pharmaceutical industry plays an important role in the UK.

Before I became a Member of Parliament, I worked in health care as a PR person. That is why I listened with great interest to the hon. Gentleman. At the tender age of 27, I was responsible for promoting certain diseases, one of which was osteoporosis, and 11 years ago, it probably needed promoting. The system works as follows. Some motivated and passionate charities are connected with certain diseases, and they have very little or no money. In such cases, generous pharmaceutical companies with a treatment for one of those diseases come along and sponsor some of the charities' activities. I have to say that I now regret my involvement in promoting some diseases, especially depression. While some people do suffer from serious depression and SSRIs are useful drugs for treating it, I am concerned that too many doctors, for whatever reason, prescribe SSRIs without taking the time to understand the causes of their patients' problems.

Minister replies

Liam Byrne MP (Parliamentary Under-Secretary of State for Health): As part of the ongoing reform process, the MHRA recently revised its medicines advisory committee structure. The Commission on Human Medicines came into being on 1 November. It is not a direct result of the Select Committee report, but it does deal with some of the issues raised in that report. For example, each advisory committee now contains two lay members, to ensure that wider judgments are made about risk benefit as well as about medical and scientific matters. Importantly, the new structure allows the patient voice to be heard in the regulatory process, and the rules on the interests of committee members have also been strengthened. As a result, the new committee's chairman and members will not be allowed to hold financial interests in the pharmaceutical industry.

The sixth area, which many hon. Members on both sides of the House will welcome, is the registration of clinical trials. The Health Committee argued in favour of the registration of all clinical trials and the publication of the results of trials. The Government largely accept that argument. We fully support the case for transparency and accountability, and we are working nationally and internationally to get the principles applied in practice. A number of important developments have taken place in the past year, and it is now clear that the movement towards registering trials and providing much better public access to research evidence about safety and effectiveness is unstoppable. Much of the momentum comes from a shared aim of the Government and the industry to build public confidence.

Several Members, such as the hon. Member for Falmouth and Camborne and my right hon. Friend the Member for Rother Valley, mentioned the report in The Observer a week or two ago about the alleged case of research misconduct involving a comparative study of two drugs for the treatment of osteoporosis. The MHRA is investigating that at the request of the chief medical officer. The aim of the investigation is to establish whether there has been an abuse of the regulations governing clinical trials, but it will also seek to establish whether legislation requiring companies to submit immediately to the MHRA any new information that might affect the risk-benefit balance of the product has been breached. The Government view that as a very serious matter—false research can lead to the wrong treatment being given.