Select Committee on Health Minutes of Evidence


Examination of Witnesses (Questions 100 - 119)

THURSDAY 14 OCTOBER 2004

DR DES SPENCE, MR GRAHAM VIDLER, DR IKE IHEANACHO DR PETER WILMSHURST

  Q100  Dr Naysmith: So how do we achieve the switch? Do patients like the talk therapies better than being given pills and shoved out the door?

  Dr Spence: I do not know how you do that, but it goes back to what this general argument and discussion is about, which is looking at the current relationship between the industry, health care professionals and government as a whole. It is that close relationship that gives them an undue sway over the health agenda.

  Q101  John Austin: This is a question for Dr Iheanacho and Mr Vidler. In your evidence you have actually said "a weak and unco-ordinated regulatory system is enabling the pharmaceutical industry to further its own interests without sufficient regard to public health." That is a fairly damning indictment. What do you mean by "a weak and unco-ordinated regulatory system"?

  Mr Vidler: We noted in our evidence two specific examples, one of which was around the reclassification process, where our concern is that the process is being driven by targets imposed by government, so that the assumption is that a reclassification is a good thing in its own right because the government believes that more people should have access to medicines over the counter and more people should take control of their own treatment. What this leads to is a situation where drugs are being reclassified without due consideration given to whether or not they are actually bringing public health benefits. We have a situation where drugs are reclassified and there are clear benefits for the company whose drug it is in terms of profits, but the benefits to the public are much less clear. The most recent high-profile example is the statin Zocor, where we know that the drug works at a particular dose for high-risk patients. To speed up the reclassification process, it is being allowed to be sold over the counter at a lower dose and to patients at lower risk. We simply do not know if it will be effective for that group, but what that group is being asked to do is spend £13 a month to participate in a clinical trial, to see if the product works in those conditions. That was the first key area we flagged up: reclassifications. It might be better if Ike spoke about advertising and promotion.

  Dr Iheanacho: From the experience of Drug and Therapeutics Bulletin, the clearest example of weak regulation comes in the promotion of prescription-only medicines. A large part of our workload is assessing new medicines, and in the course of that we occasionally look at the advertising that accompanies those medicines. Our experience, which echoes that of others, is that often those products are promoted misleadingly. There is something in the regulatory system that allows that to happen, and it is worrying.

  Q102  John Austin: Can I ask you as well about the monitoring of side effects and adverse reactions, and whether the regulatory control there is sufficient? In some of the evidence we received which referred to the early detection of safety hazards, there is the use of the black triangle labelling that doctors; nurses and other medical staff are then asked to record adverse reactions to those medicines. My understanding is that that is a voluntary system, not mandatory. Does it work as a voluntary system?

  Dr Iheanacho: If you mean does it identify every adverse reaction it should do, the answer to that is no. The system is voluntary from two aspects really. It is voluntary in the sense that it relies on companies to put the triangles on all of their products. In the past, from our own work, we know that two or three years ago that was a problem, because we identified several cases where companies, for whatever reason, had not been doing that. I think that has been tightened up now, so you can expect a new product which should have a black triangle on it to have it.

  Q103  Dr Naysmith: Is it mandatory on the drug companies to notify the MHRA if there is a potential . . .

  Dr Iheanacho: Absolutely. It is mandatory for drug companies but it is not mandatory for health care professionals. If you are a doctor and you are told about an adverse reaction by your patient, it relies on you to fill in a yellow card and submit that to the Committee on the Safety of Medicines. That is voluntary.

  Q104  Chairman: Can you explain to us why it is voluntary? It does seem rather odd.

  Dr Iheanacho: That is a good question. It is not voluntary everywhere. It is not voluntary throughout the world. I cannot answer for it. It is not my policy. I think at the time it came about there must have been a genuine feeling that doctors would report adverse reactions, would be keen to submit to a system which would collect all these data and make them available for future prescribers and eventually patients. Do not forget that a lot of this grew up in the wake of the thalidomide scandal in the Sixties, and at that time I guess there was a genuine feeling that if this kind of thing could happen again, people would be very keen to report adverse reactions but the reality is that often it does not happen, I suspect for a number of reasons: there are other things to do, doctors are busy.

  Q105  John Austin: Has it worked, for example, with Seroxat? There has been a lot of concern about side effects.

  Dr Iheanacho: I think witnesses after us will give you a lot more background to what has happened in terms of that, but the short answer is there has been a problem with yellow cards in relation to Seroxat in terms of how that information was collected and dealt with by the regulator and made available to people who might be in a position to prescribe the drug. So yes, there has been a problem with that particular drug, but others can say a lot more about that.

  Q106  John Austin: Do you or the CA have a view as to how the public interest may be better served by a different regulatory system?

  Dr Iheanacho: I think ultimately it is difficult to get away from the idea that, difficult though it may be, the best person to tell you about an adverse reaction is the person who is suffering it. That raises a lot of problems for regulators because they say "It is very difficult; patients will not be able to understand what a serious effect is, or what a minor effect is; it is going to produce a lot of data; there will be a lot of noise in the system"; but ultimately, if you want a pure account of what happened and you want to be able to tie that to the taking of a particular medication, the best person to tell you that is the patient. If you rely on a third party to tell you that, diligent though he or she may be, you start to erode some of the experience. In fact, you may not get the experience if you rely totally on the yellow card system.

  Q107  John Austin: Dr Iheanacho has just told us that it is mandatory on the part of the drug companies to report all adverse drug-related events to the MHRA. You have just indicated in a fairly stark statement that there were inducements to you to not publish certain information, but in your evidence you have actually suggested that drug companies knowingly submit fraudulent material when negotiating with the regulatory authorities. Would you like to comment further on that.

  Dr Wilmshurst: I have documented in publications the fact that, for example, in the case that I was involved in, the drug amrinone, when I published a paper on the side effects of the drug in the British Medical Journal, I was contacted by a regulator in the Netherlands, the Netherlands Committee for the Evaluation of Medicines, who pointed out that he did not understand our paper because on our clinical record cards the side effects were not reported. I had a copy of my clinical record cards, and the documents he had were a forgery from the company. The company had altered our clinical record cards, omitting side effects. I have also published an example where the same company got at the New England Journal of Medicine to try to suppress a publication from Stanley Rubin and colleagues in Los Angeles about the side effects of amrinone. So there are lots of examples where that occurs.

  Q108  John Austin: How commonplace would you think it is now?

  Dr Wilmshurst: I suspect it as common now as it ever was, and I think it was very common. In my experience, there were a number of people influenced by the company to withhold data in one way or another. Sometimes they withheld data because they were influenced by opinion leaders within the profession, who were paid consultants to the company who went along and spoke to them and persuaded them not to publish. They told them their data was aberrant and we were told by a very eminent professor of cardiology that our results were aberrant, it would be very embarrassing for us when we published. We went ahead and published and I presented data at the American Heart Association, and when I did, three professors of cardiology contacted me, came up to me and said, "We got data like yours but the company persuaded us not to publish." They got opinion leaders in, who were well paid to persuade them not to publish.

  Q109  Dr Naysmith: I wonder if we could return for a moment to Mr Vidler and Dr Iheanacho and the reclassification of drugs from prescription-only medicines to other categories. You were suggesting that this might lead to safety problems, and we have probably dealt with this a bit, but is it possible, do you think, that this can mean that not very effective medicines or even ineffective medicines get much wider circulation and promotion? Really, what I am saying is, in the reclassification process, should there be an attempt to look at whether the medicines are effective or not?

  Dr Iheanacho: Yes. As things stand at the moment, that is specifically excluded by law from the process of reclassification if you are seeking reclassification of a product for a use which is identical to the use that it previously had as a prescription-only product. If you want your drug to be reclassified for disease X as an over-the-counter drug—exactly the same disease, exactly the same patient categories—the evaluation process does not ask the question "Is it effective?" because the assumption is that, if the drug has a licence and has been relicensed repeatedly, one can take it as read that it is effective in the indication which is being proposed. The only way to refuse a reclassification is if you think that use of the drug in the way that is proposed in the new use raises safety concerns. That might be a reason for refusing reclassification but you cannot refuse reclassification on the basis of efficacy at that stage. The only way you would be able to stop a drug being reclassified is if somebody during the relicensing process, which should happen every five years, says for example,"Hold on a minute. We have had this drug for 10 years now. Look at all the data. Actually, on the whole, it doesn't look that effective. Why has it got a licence?" That does not happen all that often.

  Q110  Dr Naysmith: Presumably, you would expect it to be less effective than other drugs on the market being sold on prescription because one assumes that there will be better products coming along and they will be the ones which have their patents still in existence, and almost by definition these drugs should be less effective.

  Dr Iheanacho: Possibly. One has to be careful about tarring the whole of the OTC market as being ineffective. That is clearly not true. There are many drugs which are available over the counter which do bring great benefits to patients, but to go back to your specific question, could the reclassification process as it stands lead to ineffective or less effective medicines being promoted to patients without their knowing, yes is the answer.

  Q111  Dr Naysmith: Do you agree, Mr Vidler?

  Mr Vidler: Entirely, yes.

  Q112  Dr Naysmith: What can we do about it? What should we do about it? At that stage it would not be sensible, would it, to ask for efficacy tests on these medicines all over again medicines?

  Dr Iheanacho: As the system stands at the moment, that could not happen. It would need a fundamental change in the way that we think about reclassification, or the way the regulator thinks about reclassification. The only mechanism at the moment is greater critical analysis of in the relicensing process, so that when a drug comes up for relicensing, to ask the question again "Does it still deserve its licence?" which should happen; that is part of the system.

  Q113  Dr Naysmith: It is meant to happen now, but it does not?

  Dr Iheanacho: It does happen, in inverted commas, but you see very few drugs actually having their licences revoked on the grounds of efficacy, I suppose partly because if the regulator has taken a decision that something is effective, there must be an in-built inertia about saying, "Actually, having looked at all the data again and new data that have come along, it doesn't deserve it." The other thing to bear in mind is that when a new drug is licensed, there is a lot of evidence saying how effective it is and that it deserves a licence, and so on. The minute it gets its licence, that research work often dries up completely, because there is maybe no benefit for the industry, the particular company involved, in publishing new research once it has its licence. It may actually be the case that there are no new efficacy data, so for the regulator to say, "Actually, in the round we think that wasn't a good decision the first time and we will revoke the licence" is unlikely to happen very often.

  Q114  Dr Taylor: I suspect I am being rather naïve really, but I thought that gradually, over the years, we were getting rid of the ineffective drugs. Looking back, we got rid of expectorants long ago, we largely got rid of the appetite suppressants that do not work, we got rid of excess vitamins. What are the ineffective drugs that you are talking about that are still marketed extensively?

  Dr Iheanacho: Perhaps it would help to give a specific example. I suppose the most prominent example of a drug which has undergone reclassification which I do not think has yet come to the market but soon will, is a drug called Hyoscine or Buscopan, which is a treatment for a condition known as irritable bowel syndrome, and in particular, relief of spasm in irritable bowel syndrome. If you want an example of a drug which is ineffective, or at least appears to be ineffective for the reason its reclassification is being proposed, that is a very good example.

  Q115  Dr Naysmith: I want to talk about the Pharmaceutical Industry Competitiveness Task Force, PICTF. Both of you have submitted evidence to do with the industry, government, the Prime Minister's involvement, and there is a big 70-page document where the Task Force set out lots of proposals to try and improve the competitiveness of the drug industry in this country. I do not want to go into all the details of it, but since lots of you have mentioned it in your evidence, (a) do you think it is working and (b) is it working to the benefit of patients and health care in this country, or is the benefit totally to pharmaceutical firms?

  Dr Iheanacho: I think it is working in the terms that it is meant to work, which essentially is to promote the business interests of industry, which is a perfectly legitimate thing for government to be interested in. If you look at the reports produced annually and you see the targets which are set and measure up whether they are being met, in those terms it is a very successful collaborative. With most of the targets that PICTF sets itself, it is much clearer to see what the benefits are for industry than they necessarily are for patients. I am not saying that it is a wholly useless collaborative that cannot possibly do any good, but when you read the documents, when you see how the collaborative works, you sometimes have the feeling, "Well, OK, I can see why they are doing this. It is a big industry, it pays a lot of tax, it is very important, it does a lot of research. These things are all very important, but actually, what is the spin-off going to be for patients in the long term?"

  Q116  Dr Naysmith: Do you think the Department of Health and the Government should play a stronger part in trying to decide what the industry does in terms of benefits to patients and the population in general?

  Mr Vidler: Certainly, yes. We quite understand the Government's desire to have a competitive pharmaceutical industry contributing to the economy and contributing to employment, but that needs to be in second place to public health benefits. As Ike was saying, PICTF does a good job in its own terms. Where is the public health balance to that, and is it strong enough? Those are the questions we are asking.

  Q117  Mr Amess: I am going to ask you a couple of straightforward questions. Gentlemen, do you welcome the influence of the industry in the promotion of newer drugs? The other point that I wanted to raise with you: how corrupted are doctors by the pharmaceutical industry in the promotion of these new products? Here we have a witness telling us all about free lunches. If these free lunches are as rife as perhaps you are going to share with us, it is not going to do this Committee's campaign on obesity much good, is it?

  Dr Spence: I can only give you a personal perspective of 10 years' experience. I can tell you that I know hundreds of doctors and I know what the industry is like on the ground. The industry on the ground is unbelievably vociferous and active in promoting its own message, and there is a widespread hospitality culture in medicine. Whether the profession want to accept that or not is open to debate. The amount of hospitality received by the medical profession compared to other public services is, in my view, a complete disgrace. If you had other public servants, like civil servants or teachers or policemen, receiving that level of hospitality, there would be a public outcry. There is this idea that doctors are somehow different from other people, that we are anointed by God and made of a different moral fibre. That simply is not true. Doctors share the same failings as the rest of humanity. They are just representative of society as a whole. You cannot blame doctors, because this is what they have been used to. I always say talking about these things is rather like playing Father Christmas. "Oh, Father Christmas, you gave me too many presents this year!" It is that sort of relationship. That is what we are going to move away from. That is why it is difficult for doctors to hear this. It is so ingrained in them that they do not see it as being a problem, but it is a problem because it affects directly the medicines and health care that is delivered to patients in this country, and we have a professional and moral obligation to protect them.

  Dr Wilmshurst: I think there are the issues around the influence on doctors, but there is also a more important influence, and that is the influence on government. When I did work with amrinone years ago, the fact is that we discovered we had been lied to about the clinical trial certificate. There was no clinical trial certificate for the oral drug, and we had conducted trials at St Thomas's and others at the National Heart Hospital, Hillingdon Hospital, the Freeman in Newcastle and in Birmingham.

  Q118  Mr Amess: Who lied to you?

  Dr Wilmshurst: The pharmaceutical company. They told us they had a clinical trial certificate for the drug, and we conducted trials, and when we discovered that there was no clinical trial certificate, we went back to the Medicine Control Agency, or CSM, as I think it was called then, and they conceded that there was no clinical trial certificate, but the senior vice president of the company, Dr Trout, came over from America and said that the company would not be prosecuted for the breach of the Medicines Act—a serious breach—because he was going to tell the Health Minister that if they were prosecuted, they would shut down all manufacturing of drugs in this country, which would include their large manufacturing plant near Newcastle Upon Tyne. The company was not prosecuted although there was a clear breach of the Medicines Act.

  Q119  Mr Amess: When was this?

  Dr Wilmshurst: This was in the mid-Eighties.

  Mr Amess: I will not question you any further on this point. You had me mildly interested if it was since 1997.


 
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