Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 360 - 362)



  Q360  Dr Naysmith: This will probably be the last question. There have been questions about the reliability of summaries of product characteristics. I know you have strong views on these, Paul.

  Paul Flynn: From listening to what has been said, it is revealing—and I think we are all used to this—that the person who actually writes the documents is the one who has the power and it is the pharmaceutical industry that writes these documents now. Then there is approval by the CSM. What is significant is that neither the CMS nor the MHRA nor the industry has exposed the scandals that we have had and the dangers of the terrible side-effects. Recently drugs have been exposed by programmes like Panorama. One patient organisation, not one in the pay of the pharmaceutical industry but MIND, did the heroic job on the MHRA by resignation on this, together with groups elsewhere in the world. We have to look at the position we are in where the might of the pharmaceutical industry is enormous, where their tentacles of power go through the whole of the medical establishment, including the regulatory bodies and into the patient organisations. We need a stronger voice and transparency to defend the patients' interests.

  Q361  Dr Naysmith: In a way, that is the nub of this whole question. There have been suggestions that the drug manufacturers use the summaries of product characteristics to mislead readers about their products. This might be a question for Melinda Letts. How can this happen when SPCs are jointly produced by the company and the regulator and in law have to be consistent with the licence?

  Paul Flynn: I think they are very resourceful in ensuring that their case gets across. We would all share what I think is behind your questions, the view that the advice given is not adequate and masks the potential side-effects in many cases. They are often written in a way that is not readily understandable to most of the patients who receive them, and certainly they have a long history, which is part of their nature, it is endemic to pharmaceutical companies, to deny the danger, the "addictivity", of their products. Over the 150 years that I mentioned all these drugs were all sold as harmless drugs that were non-dependent. Every one of them proved to have little utility, be damaging and addictive or encourage dependence in some way. We cannot ignore where we are now with a history of pharmaceutical companies behaving in this way for 150 years. There has not been some change. With new drugs we are still conducting experiments on a massive scale on the public. They might have been tried on animals and trials might have taken place but the whole confidence we have in trials has been undermined by what has happened with GlaxoSmithKline and Seroxat. The duty of all of us I believe, and I am sure it will come out in your report, is to make a stand for organisations to be strengthened to defend themselves against the insatiable greed of the pharmaceutical industry.

  Q362  Dr Naysmith: You have made your case very strong.

  Mr Prior: Leaving aside the specific cases where evidence has been concealed or distorted or whatever, I think it is also true to say that no amount of pre-marketing studies on medications will reveal what the large-scale use, once they are on the market, will reveal. We need to be much more ready to go out proactively to check for side-effects in the first couple of years of marketing and be prepared to hear those messages and proactively ask people, "What are you experiencing?" There is a deeper malaise here. There is a myth, particularly in the British public that I do not find elsewhere in the world, that there is one set of nice, clean, effective drugs with no side-effects and there is a nasty set of toxic stuff that evil pharmaceutical companies adopt and peddle to us. This is a complete myth. There is nothing that you take by way of a drug which does not have risks attached to it. All drugs carry some benefits and some adverse effects. We can know some of that before things are marketed; we can know a bit more afterwards, but everybody has their own body and their own mind and will have different experiences. We need to enter into this with a much greater degree of scepticism.

  Ms Letts: I simply wanted to add, in response to your question, that one of the things the working group is looking at is improving the readability guideline and introducing much better ways of communicating about risk, as well as introducing some supplementary information about side-effects., for precisely the reason that Cliff Prior has referred to, that people often do not understand that there are likely to be side-effects with anything that you take. With my 13 years background of working for people with long-term conditions of one kind or another, what I have to bear in mind all the time is that for many of those people it is a matter of having to weigh up the benefit of the drug against the side-effects that they may have to put up with. The public find it very difficult to understand how to weigh up risk and benefit. We have been looking at that on the working group. I do think it is relevant here to say, and it is one of my recommendations to this Committee, that patients should have the absolute right to inspect the evidence that led the regulators to license the drugs in the first place. It is wrong that that is not the case.

  Chairman: May I thank you, Ms Letts and gentlemen, for a very interesting session. We are most grateful for your co-operation.

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