THURSDAY 14 OCTOBER 2004

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

  Q120  Dr Naysmith: Who would have authorised the certificate and how could it be possible that you thought there should be a certificate and there was not one?

  Dr Wilmshurst: Because the company sent us a letter saying they had got it.

  Q121  Dr Naysmith: Who should they have applied to to get it?

  Dr Wilmshurst: The Committee on the Safety of Medicines.

  Q122  Dr Naysmith: Had they not been asked at all or had they refused to give one?

  Dr Wilmshurst: They had not been asked. However, if I had suspected initially that they had not got one and asked them, they would not have told me anyway. It did not occur to me that they would not have one when they said they had, but if I had asked the Committee on the Safety of Medicines, they would not have told me anyway because it was confidential between them and the company.

  Q123  Chairman: You have got to be of a certain age to remember a Conservative government. Some might say that your evidence here is a little bit out of date. How would you say the current practices are similar? Have you evidence that is more up to date than 20 yeas ago?

  Dr Wilmshurst: I had a meeting with the Chief Medical Officer two years ago and gave him other examples of serious research misconduct. I have written to him repeatedly since then asking what he has done about it, and I get a postcard acknowledging my letter.

  Mr Amess: This is much more interesting!

  Q124  Dr Taylor: Can I go back to Dr Spence. We are led to believe that generic prescribing is being used more and more. We are led to believe that general practices have their own drug formularies more and more. Are these not lessening the effect that the drug companies can have?

  Dr Spence: I reflect the question back to you: has that had an impact upon the drug costs to the NHS, which still stand at £9 billion per year, rising at an annual rate of 8-10%? Evidently not. The greatest cost to the NHS are not the generics but the branded drugs. You are probably aware of the issues about accusations of manipulation in the generic industry a few years ago anyway, and I think a number of companies were fined over that. As for the use of formularies, these are not compulsory formularies and there is a huge variation from practice to practice. Within a certain area there may be even a twofold difference in what GPs prescribe, and there is no way of controlling that.

  Q125  John Austin: You mentioned the prescribing habits of doctors. If I could pick out an example, there has been an enormous explosion in the cost of prescribed drugs for indigestion and the use of proton pump inhibitors. There is some concern that they are being prescribed indiscriminately when there are more traditional and cheaper methods which might be effective. To what extent do you think that the alleged over-prescription of PPIs is as a result of pressure from the pharmaceutical industry?

  Dr Spence: It is all about pressure. In fact, I wrote the complaint to the ABPI about the promotion of a PPI known as Zoton Fas Tab. What was happening there was the industry were using a third party to come into general practice to switch patients from Zoton to Zoton Fas Tab because Zoton was coming off patent. The PPI market is huge and the representatives were very effective at persuading practices to allow the switch to happen.

  Q126  Dr Taylor: Going back to drug formularies, would it be feasible to have PCTs producing standard drug formularies for their particular area and in some ways getting them enforced? Hospital formularies seem to be much more widely used and accepted.

  Dr Spence: It is certainly my experience that that is not the case. In our area we have something called the Glasgow Formulary, which is produced jointly between the hospitals and the PCT, and there are great variations between which hospitals use which medications and which medicines consultants use. The problem is that the authorities are very reluctant to take on the medical professions because the medical professions tend to hide behind this idea that we are professionals and we know best, so it is very difficult to enforce a formulary upon hospitals and doctors and general practitioners.

  Q127  Dr Taylor: Should that be one of our recommendations?

  Dr Spence: Absolutely. If you assume that the drug costs in the UK over the next year or two will go up by £1 billion, which is a likely projection, you have an enormous financial responsibility to contain this. I do not want to quote the Leader of the Opposition, but apparently £1 billion would put an extra 40,000 police officers on the street. That might be something worth considering. You might be better off putting 40,000 regulators into the drugs industry and find out what doctors are actually doing.

  Q128  Dr Taylor: Is it fair to ask you whether there is any move among doctors to be less receptive to the freebies?

  Dr Spence: Yes, I think there is. I can quote a survey, an online survey in the BMJ of 1,500 respondents. I think they were largely doctors. Ninety-six per cent of them said there should be transparency in the relationship between the industry and doctors, and what we are calling for is a compulsory register, in the same way as Members of Parliament have, of contacts and hospitality received from the industry. If there is not a problem with the industry, let your peers and let the patients decide. It will be important for the NHS to take that lead, because no other country has done that, and the onus of responsibility should rest with the industry because they know who they are seeing and they know how many contacts there are.

  Q129  Dr Taylor: So another of our recommendations should be that doctors should report in detail their contacts?

  Dr Spence: Yes, but the problem with self-reporting goes back to the problems with the yellow cards. Rest it with the industry. They have the infrastructure and they know who they are seeing at the moment. If the industry has nothing to hide, let them publish this information.

  Dr Taylor: Certainly when we get them before us we will want to ask them about their expenditure on advertising and drug reps.

  Q130  Mr Jones: I just want to intrude in this discussion between the two doctors and say there might be another way of looking at the problem. The problem that you are describing is a problem of undue influence of the industry over GPs in their prescription practice.

  Dr Spence: Not just GPs but hospital doctors as well.

  Q131  Mr Jones: Largely GPs in terms of the prescription of pharmaceuticals, I think. Instead of looking at it from one end of the spyglass, looking at how we regulate the industry in order to reduce the undue influence, you might look at it the other way round and say that perhaps we should look at the gate keepers. If we remove a great deal of the control the gate keepers, i.e. the GPs, have over which drugs they prescribe, that might be a more effective way of dealing with the problem.

  Dr Spence: Yes. There is a problem. You have to seek to resolve it. Our perspective is that we want to use resources like the Drug and Therapeutics Bulletin to deliver effective and cost-effective treatments to patients. How do you deliver that? There are lots of different models, but you need to tackle this problem.

  Q132  Chairman: That thought was behind my question some time ago, when I asked you about any changes to these practices through PCTs, where there has been a more collective discussion about prescribing practice at a local level. You said that might be happening, but the practice of inducement through the lunches side is still there.

  Dr Spence: I suppose if the PCT were more proscriptive to the doctors who work for them—notionally they are independent contractors but in fact they actually work for the PCT—the industry's influence would be much less, but they would exert that influence at the PCT level rather than the medical level. There are lots of different threads to this, but certainly a more prescriptive formulary would be one end, but I do believe very strongly that there has to be some register.

  Mr Vidler: Can I just add that it is important that we do not lose sight of the fact that the industry also has a direct influence on consumers, and in those circumstances it is not feasible to imagine that we can quickly build up consumers' knowledge and understanding to a level where they can cope with it, and in those circumstances we do very much need to focus on regulation of the industry.

  Q133  Mrs Calton: Dr Spence, could you say whether you think that doctors who actually resist contact with the pharmaceutical industry and reps actually prescribe more appropriately?

  Dr Spence: That is a difficult thing. I suppose the reverse is true; there is some evidence that if you see more pharmaceutical represents, you prescribe more of the new drugs, so conversely I guess that is true. Again, it is slightly anecdotal, but in my experience, those people who distance themselves from the industry do practise in a more effective and cost-effective way.

  Q134  Mrs Calton: If promotional activity is severely curbed, it seems highly unlikely for economic reasons that any major pharmaceutical company could operate with acceptable levels of profit. Do you believe that that is so?

  Dr Spence: What does "acceptable levels of profit" actually mean, seeing as the pharmaceutical industry has been the most profitable industry throughout the 1990s, and despite the downturn in the market has still maintained enormous profits throughout? Reasonable profits? They are unbelievably profitable already.

  Dr Wilmshurst: I just wanted to mention the point that there is a lot of discussion about the interaction between pharmaceutical reps and GPs, but in fact, the companies influence GPs I think rather more because GPs are sceptical about what reps tell them. They are influenced more by opinion leaders, which is why the pharmaceutical industry pays opinion leaders so much. The senior people can get £5,000 plus for one hour's talk to their colleagues in cardiology, and that is obviously because that is how much the pharmaceutical industry rates those people.

  Dr Spence: That happens at a local level, with local specialists coming in and giving messages to local GPs, and these guys are being paid very handsomely for delivering their message—an independent message but . . .

  Q135  Mrs Calton: I accept absolutely and from the evidence that you have been giving that an enormous amount is going on. The question is, what would happen if you withdrew all of that, or if you regulated it so heavily that it did not happen?

  Dr Spence: My view is you would have a much more appropriate and better health care system.

  Q136  Mrs Calton: Can we move on to consumers, the public. What is your view on the part the pharmaceutical industry has to play in informing the public about the medicines they make and how they might be used? We touched on this earlier.

  Mr Vidler: We believe it potentially has an important role to play, and clearly, the industry has widespread experience of marketing and great skills to bring to bear in translating that into education. The problem with what is happening at the moment through disease awareness campaigns is that people are not being given a holistic view of the situation. They are being given a view which leads down a fairly narrow track to a drug-based solution, where that may not be appropriate. That sort of information and that sort of awareness-raising has its place but it needs to be part and parcel of a holistic approach.

  Dr Iheanacho: I obviously echo a lot of that.

  Q137  Mrs Calton: In a sense what you are saying is that it is more of the nature of propaganda than it is of true information in the round?

  Mr Vidler: We would need to distinguish. There is obviously a spectrum of disease awareness campaigns and promotional activity. At one extreme of that spectrum, you are fairly close to propaganda. There are some less bad examples as well.

  Q138  Mrs Calton: Could you give us a broad view of the effectiveness of self-regulation in drug promotion? I think from what you have said already you feel it is not particularly effective.

  Dr Iheanacho: No. I suppose it is being generous to say it is not effective. I would say that the self-regulatory bits that we come across in terms of promotion of particular medicines to doctors, for example, are very weak indeed. In some sense, their activities are so questionable in terms of actual regulation that you have to ask why they are there at all. The conclusion that I think I have reached is that they are there because they need to be there, so that if somebody asks "What is the regulation?" people can point to them and say "There is the regulatory system." But if you were looking for evidence that this is a system which acts in a way that I think most reasonable people would want a regulatory system to act in terms of advertising, that is, it can spot misleading advertising quickly or react when misleading advertising is brought to its attention; can investigate it quickly and stop it happening if necessary; effectively punish whichever company is doing it and be seen to have done that; and crucially, inform the people who have been misled quickly and as widely as possible that they have been misled, and act as a deterrent to that company or someone else doing it again; if those were the standards that you wanted to see in a regulatory system, they are, in my view, largely absent from the present regulatory arrangement.

  Mr Vidler: We have suggested for that reason that the current web of regulation and self-regulation over advertising and promotion needs to be replaced by one single independent advertising unit.

  Q139  Chairman: Can I conclude by picking up a couple of points that have come out in the session so far. Dr Wilmshurst, you mentioned a few moments ago the way drug companies will pay eminent cardiologists £5,000 for an hour's session to talk about their products. How widespread is this practice, and do people not see through what is going on? Surely, people can make up their own mind as to the merits of this practice.

  Dr Wilmshurst: People do not always know, because people do not always declare their conflicts of interest.