Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 400 - 406)



  Q400  Dr Naysmith: How can you achieve the balance that we were just talking about between informing sick people of, say, a new medicine and making sure that people know about it and get its benefits and inadvertently increasing the number of the worried well who are not depressed? I know people can feel unhappy and miserable periodically and not necessarily be clinically depressed. That was the basis of the conversation we were having in the House of Commons a few weeks back. How do you get the balance right?

  Mr Thomson: I am not sure I understand the question.

  Q401  Dr Naysmith: You have new products and people recognise that they are useful and functional and have a benefit to confer for people who suffer from a disease but at the same time you could convince quite a lot of people that they would be happier if they were on this product as well if you were not careful. Is it not a problem?

  Mr Thomson: I suppose it could be. I fail to see how, in what we do, it would be an issue because what we are predominantly doing is raising awareness of a condition which I hope we all accept exists. I can see how raising awareness of that issue by definition is likely to convince people that they have it, but that is for the doctor's diagnosis to confirm.

  Q402  Dr Naysmith: None of these people are rushing along to see GPs with bits of paper off the web or what they have read in The Guardian or The Telegraph saying, "I think this applies to me. Can I have some of it?"?

  Mr Thomson: I hope they do because it is a vastly under-diagnosed condition. On average, it takes nine visits to the GP in this country to get a diagnosis of depression. There is a legitimate job there to raise awareness of the symptoms. There are 2.9 million people with a diagnosis of depression in this country. There are several million more who probably have that condition and have it undiagnosed, largely because of the stigma still surrounding the condition. In terms of what we produce, the link between new treatments is way further down the line and any new treatment, once it had been approved by regulators, would come into our literature and stand or fall alongside all the other treatments. We do not recommend any treatment at all.

  Dr Wallace: One thing that would help would be to involve a wider constituency of people in decisions that are made. For example, NICE is starting to do that with its consultative panel. Then you would involve not only the people who are at risk and get ill but also the people who have been told they are at risk and do not get ill, often a much larger number of people. You would change the interests, if you like, of the people informing the decisions.

  Q403  John Austin: I want to come back to the regulatory process. Clearly it is in the interests of the pharmaceutical industry to get its new products on the market as quickly as possible. In that they may be aided and abetted by pressure from patient organisations and patient groups. Over the last decade, do you feel there is any evidence that patients have been put unnecessarily at risk by an acceleration of the process?

  Ms Hirst: Yes. I do not think there is sufficient evidence to warrant the speedy acceptance of some of the drugs. I accept that with certain conditions getting a drug on the market as quickly as possible is essential but if we take the insulin issue there is no urgency about getting a new insulin onto the market, so why does it go through the regulatory process quite so fast without, in my view, the evidence being strong or being looked at sufficiently?

  Mr McDonald: In terms of the disease-modification and finding therapies for multiple sclerosis, the issue is not so much the idea of risk with things being brought to the market quickly but of the possible long term benefits. This is why we have the 10 year monitoring scheme which is agreed with the Department of Health. There is an issue around drugs which are licensed on the basis of relatively short term evidence, if they are going to be used in some cases for decades. That 10 year monitoring study which is underway at the moment is intended to look at the longer term benefits in addition to the shorter term benefits which have been demonstrated for those drugs, but obviously it also has the benefit that, if there are risks attached to taking the drugs over a longer period than is usual in clinical trials, that will tend to emerge from that study as well.

  Mr Thomson: There are two parts to the question. It is not something I have considered before but, off the cuff, the condition I represent is one which, if left untreated, will lead people to kill themselves. I would be in favour, as long as due diligence is observed, if there is a new treatment which is effective, and I would want to see it on the shelves as soon as possible and being in a GP's armoury. Where Mr Flynn and I agree—those are not words I have ever said before—is that, once a drug is in use, I would like to see regular monitoring of it and we leave ourselves open to criticism as a society if we do not implement that, certainly in the first few years of its introduction. I agree with him also that the yellow card scheme in the vernacular is a bit of a pup. I would certainly support any moves to strengthen that, which would incur more cost for the industry, but I do not think it falls to industry to do that. I think it falls to us as a society to implement those things.

  Ms Hirst: I support that. If there was proper monitoring over the long term, a lot of concerns would go away. It is the fact that a drug comes onto the market and then what happens? We often talk about long term benefits, forgetting that all drugs have long term risks as well and I think that is key to having proper monitoring.

  Q404  John Austin: Some drugs and therapies will react differently with different people. A drug which is very beneficial to one group of patients may cause severe harm to others. Does a patient organisation have to be particularly wary of the influence of the pharmaceutical industry in those circumstances and perhaps need to bring pressure on the pharmaceutical company to present that remedy as a therapy of last resort?

  Mr Thomson: We are almost coming back to the issue of patient information leaflets. I would support a crystal mark or a far simpler method of producing patient information leaflets that a patient with that condition can read and understand. The litigious nature of the business is such that these patient information leaflets run to several pages. Companies are forced to produce them in that way. I have some Neurofen here which I had to take earlier on, having over indulged after the Arsenal match last night. The patient information leaflet in that would dissuade me from ever taking it and yet I take it routinely because I digest the information and take it with a pinch of salt. Antidepressants are powerful medicines and I would like to see sensible patient information on there that people understand and can use to exercise choice. It is simply not there at the moment.

  Q405  Dr Taylor: I was so interested that you said you thought it was society's responsibility to monitor for side effects after the explosive sales when drugs are released, because so far everybody has told us that they thought it was industry's responsibility in that phase immediately after the preliminary release, when it is released to the wider population. How should society do this?

  Mr Thomson: Society is probably wrong. I think it is your responsibility. Once a drug is approved for use and licensed, you may well want to involve industry because they are likely to have the data but, as we have heard, that data is often called into question so I think it is the regulatory body's responsibility to ensure that that ongoing monitoring carries on. The regulatory body is woefully under-resourced. How many people work in the MHRA to police this activity? 60 odd? It is preposterous.

  Q406  Dr Taylor: Do you think there should be a limited release to begin with, limited prescribing? If it is a really major advance like the anti-TNF drugs, they are only allowed to be prescribed by NICE guidelines and by limited people, whereas something like Vioxx was released to everybody.

  Ms Hirst: We did have at one time—I do not know whether it still exists—a post-marketing surveillance body which was independent. It seems to me that it would be unrealistic to expect drug companies to be open, above board and totally transparent in monitoring their own products. I am sorry if I sound cynical but I really do think that is unrealistic. An independent body like that could monitor.

  Chairman: Can I thank our witnesses for a very helpful session? We appreciate your cooperation with our inquiry. Thank you very much.

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Prepared 26 April 2005