Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 340 - 359)



  Q340  Dr Taylor: I do want to focus a little more on the fault of the medical profession. I remember that when the first worries about the addictive properties of these came out, I hoped many of us actually stopped prescribing them, but they were prescribed for a long time after the first worries were made known. Should we not be investigating the conduct of the medical profession in going on prescribing after the first hints of trouble were known?

  Mr Woolas: Yes, very much so.

  Q341  Dr Taylor: I will move on to regulation. Many of you have already said that the charities need strict regulation. Just one point to Mr Flynn: in the table of the charities that are in receipt of funding, in your paper, I think it is fairly significant that those that do not receive funding, apart from MIND, are probably the ones that the pharmaceutical industry would not be able to make any money out of in any case?

  Paul Flynn: I think that is probably true.

  Q342  Dr Taylor: So it is not that they are declining it because they are very well-minded and good-hearted charities; it is probably because they cannot get it?

  Paul Flynn: No, that is not true of MIND, for instance, and YoungMinds as well, another splendid organisation. I believe there are some charities that look like a public relations group for a drug, and I think we are very suspicious of them. I am not inclined to go into too much detail on this but there are so many of the charities that appear whose only purpose seems to be pushing drugs and emphasising the advantages of drugs. There was an example with a group called In Vivo Communications where they had, as part of disease mongering, a whole group set up to popularise or to identify irritable bowel syndrome as a specific concrete disease. There was a drug available, which has now been withdrawn because it had fatal side-effects, but there was a whole campaign by a pharmaceutical company that was exposed the public. There were various stages of the campaign. The first was to persuade the medical press and the medical establishment that this was indeed a problem that affected many millions of people. Then part of their campaign was to set up patient organisations in order to push the need for the use of this drug. I believe we have evidence that the pharmaceutical industry, knowing that they cannot in this country advertise directly to the public, used the patient organisations, set them up or used existing ones deliberately to put their case. We know ourselves from the letters we have from individual constituents. Handwritten letters are far more convincing than something from a drug company.

  Q343  Dr Taylor: Can I just go back to regulation and pull together all your ideas on regulation because this has to be one of our huge recommendations? I think Mr Flynn mentioned that the Charity Commission, so that is one organisation that should be strengthening its act. Is that right?

  Paul Flynn: I made a list of suggestions at the last part of my report, which I will not read to you now, on pages 6 and 7. Many of those are to strengthen organisations like the one represented by the witness here, the LMCA, and other organisations that are certainly benign and have no axe to grind as far as maximising the sale and use of drugs.

  Q344  Dr Taylor: It is primarily the Charity Commissioners and the MHRA?

  Paul Flynn: Yes. Action has been taken on the LMCA.

  Ms Letts: Mention has been made of patient organisations set up by pharmaceutical companies. Such organisations certainly do exist and I think that is one of the reasons why I think we need to have a clearer way through something like the LMCA of being able to establish the bona fides of patient organisation. That would be a great help to the existing ones.

  Mr Prior: If I may comment specifically on that, I think the MHRA and the medicines regulatory bodies are probably a better channel than the Charity Commission, which of course has the whole panoply of all sorts of different charities to regulate and is unlikely to have the specific focus on this area that would be needed. I would like the medicines regulatory agencies to have a strategic relationship with patient organisations, not only co-operating with them on regulation, transparency, accountability and so on of patient organisations but also working with them on early indications when problems are starting to emerge with treatments. I do say "treatments" because it is not just pharmaceuticals that have caused problems. Herbal medicines have caused problems, non-medical therapies, technologies and so on, all sorts of things have caused problems. Patient organisations are often aware of the early anecdotal evidence, the buzz that "well they told us this was not addictive but we did not half have problems coming off it". It can take years, 10 and sometimes 20 years, for that early patient information to be taken seriously by the regulatory bodes. We have to move towards the yellow card system being opened up to direct reporting by patients. Evidence from other countries suggests that that is not a very strong method unless you are proactive about it. I would like the MHRA to have a channel that hears about what we are observing with antipsychotics, whatever it might be—cardiac risks, weight gain risk—and, in view of that, say, "All right, we hear enough news from you on this to fund you to conduct an informal patient survey". If that comes back saying, "This seems to be a more common problem", then they go to a full-scale clinical trial to try and lift the lid on that and to shorten this terrible period, this very long period, between the early news and so on. Whilst the other witnesses are saying things that are absolutely true, there is a real problem here. There is even more of a problem on the European front for patient organisations where the sources of alternative funding are almost nil and the European front, of course, is becoming increasingly important in medicine regulation. This is only one of the influences on patient organisations. Certainly, if I were to list the undue and improper influences brought to bear by different funders, government and NDPBs would be at the top of the list, followed closely by non-pharmaceutical corporate interests. Almost all corporate fundraising, apart from the pharmaceutical industry, which is regulated, is direct cause related marketing; it is directly to sell their product. In the course of looking at undue influences, we have to recognise that removing one undue influence from the scene may simply serve to influence the undue influence of other parties. Balance, transparency, accountability and regulation are needed on this across the board. I am astonished by the fact that in joining the Medicines Commission I was required to declare interests in the pharmaceutical industry and nothing else. Personally, I am much more influenced by the fact that I would not be alive without advanced antibiotics than I am by any financial grant to the organisation.

  Q345  Dr Taylor: I am extremely worried about writing this report because we have already heard from many witnesses previously that the vast amount of research is funded by drug firms; the vast amount of postgraduate education is funded by drug firms; these patient groups are funded by drug firms. Some of you have actually implied that some of this money is absolutely essential and cannot come from other places. How do we make the compromise? Is there possibly an argument, as has been put to us, that if drug firms reduced their prices because they were not spending all the money on these other things, then the drugs would cost less, they would have more money and then things could be government funded. Is that cloud cuckoo land?

  Ms Letts: I do not think we would want to be entirely government funded in any case.

  Q346  Dr Taylor: I do not mean entirely, but more?

  Ms Letts: Sometimes there are just as many pressures, as we have already alluded to, for patient organisations in resisting the pressures that government or NDPBs or other people want to put on them. Therefore, I think it is, as we have said, it is a matter of establishing the bona fides of the organisations and perhaps, through such a process, being able to offer training and support to some of the less well-resourced organisations in how to deal with these influences. I have always believed it does not have to be the case that taking money from somebody means that you have to do what they say. That has not been the case in my experience. You take the money; if they do not like what you did, then you may not get it again but at least you have had it for the time being and you did something that you thought was good with it. If you have the courage of your convictions and say what you believe to be right and do what you believe to be right with the money that you have, then very often you will find that the funders will not go away because in some way you have all moved on and their understanding of your agenda has developed, just as your understanding of their agenda has developed.

  Q347  Dr Taylor: You can take the money without being influenced?

  Ms Letts: I have actually explicitly resisted pressure from companies and I have not failed to have a grant renewed.

  Q348  Dr Taylor: Many of the research doctors who have spoken to us have said that they have not been influenced by the money they have had to do the research, but they admit that other people are influenced.

  Ms Letts: That may be the case. I cannot speak for other people. I said earlier on that you have to know absolutely what your objectives are, what your strategy is, what your non-negotiables are, what are the things on which you will not compromise.

  Paul Flynn: The main problem is that we look at the problems of the planet and find that the third largest cause of death and illness is medical intervention. There is a deliberate campaign by the pharmaceutical industry to medicalise all society and convince us all that we cannot get through life without their support. It is extraordinary that this has been so successful. The great problem is that it has made us a dependency culture. Giving us the idea that there is no answer to our problems except a pill that gnaws away at our self-confidence and our ability to cope in the way we have for thousands of years.

  Ms Letts: That is exactly why every organisation that I have been involved in and am involved in puts out the message that drugs are only one part of treatment; they are only one aspect of treatment. In fact, "Ask about Medicines Week", of which I am a director, has, as a fundamental message of the week, that patients must have the right to participate in the prescription decision and to choose whether to have that drug or whether to have any drug at all or to have some different form of treatment.

  Mr Woolas: In our support group I would say that we do receive funding from the state in the form of legal aid, which we have on occasion received. I think I would want to distinguish between state funding and government funding. I think state funding can be independent. The Opposition parties receive state funding. I would say that I would want to distinguish the funding for treatment from the funding for advocacy and support. I think there are ways that we can guarantee independence on that front by a combination of funding that in our case would not involve the pharmaceutical companies.

  Q349  Dr Taylor: This is a question for Mr Woolas. For the record, could you tell us the source of your statement that 1,800 patients have died from benzodiazepine use.

  Mr Woolas: It is contained in the memo from Mr Behan. The figures are based on Home Office figures. Part of our campaign is to ensure that coroners' and pathologists' reports actually test for benzodiazepines. The media phrase is "a cocktail of other drugs". That normally refers to benzodiazepines. The figures are contained in the written evidence that I have given quoting the Home Office that resulted from a series of parliamentary questions.

  Q350  Chairman: It is sourced in that evidence to us?

  Mr Woolas: Yes.

  Q351  Dr Naysmith: Given what Richard Taylor and John Austin have said, I had better admit to the fact that I am an officer of the All Party Stroke Group. I have no idea whether that is funded by the pharmaceutical industry or not. Maybe they are, so I had better admit it. I am active on lots of other backbench health groups as well. I want to ask Mr Prior about something he has really referred to quite a lot already, but I would like to clarify it. In your written evidence, you recommend that the drug regulatory process should be opened up to include all stakeholders and you expanded on that a bit. Is it just in terms of side-effects of drugs or do you want them involved much more than that? Is it just patients you are talking about or does "all stakeholders" mean other people as well?

  Mr Prior: I am particularly thinking of people who take the medications and, where people are too ill to speak for themselves, the carers of the people who take the medications. I think it is on the positive side as well as the negative side. I work in a field where for many years people were really trying to treat the wrong problem. They treated the problem that doctors thought was the problem rather than asking the people taking the medications, living with the condition, what they saw as the major problem. It is about the positives as well as the adverse effects. We do need more patient/user/carer representation throughout the medicines regulatory system. Of course, once you do that, patient organisations become yet more important. It is additionally important to follow up on the concerns, and there are real problems out there, which can deflect patient organisations. We stand on our track record for transparency and openness on this, but, for every one of us, there is always some other organisation that perhaps is prepared to cut a corner. Regulation defends good patient organisations. It is to the benefit of good patient organisations. We need that additional level of regulation, that transparency and that openness and the balance. When we survey our members about what they see as most important in this field, they do not want the pharmaceutical industry hobbled. They want the development of better medicines with fewer side effects. They also want the development of alternatives to medicines as well. They want a balanced range, but they do not want the pharmaceutical industry hobbled. They do want the patient voice to come through loud and clear throughout the regulatory system.

  Paul Flynn: They want the patient voice uninfluenced by donations from the pharmaceutical industry. It is not true to defend the yellow card system, which has vastly under-reported the effect of adverse reactions. It was alarming to hear a government minister recently in a debate defending the idea that the only people who should be on the MHRA and taking on this very important body are people with years of experience in the pharmaceutical industry as they are the only people who could make these decisions when many lay people and others with a scientific background can make the decisions there. I think we have suffered from a preponderance of people on the MHRA over the years with 20 or 30 years in the pharmaceutical industry; their mindset is very different from that of other people who examine these things.

  Q352  Dr Naysmith: We have seen quite a lot of evidence that people are pleased with the extension of the yellow card system and it can go further?

  Paul Flynn: Yes.

  Q353  Dr Naysmith: To pick up on one or two other things that we need to clear up before we finish this morning, over the last three weeks, we have heard a lot about patient information leaflets and their shortcomings. Why has it taken so long for there to be any serious attempt to improve these leaflets? Perhaps Melinda Letts could start?

  Ms Letts: I do not know why it has taken so long. I am very glad that there is a serious attempt because I think many of us know the shortcomings of patient information leaflets. I have heard a lot about that over the years, which is why I was very glad to be asked to chair the working group.

  Q354  Chairman: Mr Woolas has to leave as he has government duties to perform. We appreciate his attending today.

  Ms Letts: They have been compulsory since 1 January 1999. Among the shortcomings are not only the layout and the contents, which as you probably know are heavily regulated, but also the fact that not everybody does get them, even though it has been compulsory, supposedly, since 1 January 1999. There are various problems leading to this, including splitting packs. I find it almost impossible to believe, but apparently it is true, that the reason why pharmacists cannot photocopy them when splitting packs is to do with copyright. I cannot understand why that has not been able to be sorted out by now. In any case, my working group is charged with looking at improving their quality. We have been working for a year and we are focusing on that.

  Q355  Dr Naysmith: Are you finding co-operation from the pharmaceutical industry? Do they really want this information to be much more widely available in a readable form?

  Ms Letts: It is a little difficult. There are two pharmaceutical industry representatives on my working group. I certainly have not detected any resistance to improving the readability and quality of the leaflets from those members. I am aware that for the industry generally there is a certain amount of apprehension on a procedural and logistical basis, particularly as there are changes that we are suggesting should be introduced now in advance of some legislative changes coming into practice. There is a concern that if we have to change what we are doing at one time, is there going to be another new guideline issued a short time later that is going to make us change everything all over again? The working group is quite clear that the interests of the patient must come first.

  Q356  Dr Naysmith: Do you produce drafts of these leaflets to improve them?

  Ms Letts: We do not produce drafts. If we did, we would be very busy indeed I think. The drafts are written by the companies. They do not have to be approved by us either. They have to be approved by the CSM, the Committee on Safety of Medicines, as part of the licence application. Some leaflets have come to us for comment where there are thought to be special cases. For example, in a recent statin that was going over the counter, the leaflet was brought to us for comment, but we are not the body that actually approves them or drafts them or writes them.

  Q357  Dr Naysmith: Do you think there has been improvement?

  Ms Letts: No, I do not think there has so far. It is far too early to say there has been any improvement. The changes in European legislation are only coming on stream early next year. For example, one thing that is going to happen is that the order of information is going to change.

  Q358  Dr Naysmith: You are saying that in some special cases you have seen some examples. Do you think they are going in the right direction or do you think it is too early to say?

  Ms Letts: I could not say I was hugely impressed by any of them. What we need is a wholesale improvement. We need these new guidelines that we are working on. One of the important things that is going to come in is a requirement for user testing to take place. That has been mentioned in guidance since 1999 but it has had a minuscule take-up and it now going to become compulsory.

  Q359  Dr Naysmith: Why is that? Is there any reluctance to involve users in the testing?

  Ms Letts: I really cannot speak for the industry. I am not involved on their side, but I imagine that if it is not made compulsory, then it is simply another stage that they have to go through in this long and complicated procedure of getting an approval. It does not rise to the top of the priority list. I am simply speculating. I really cannot say. It is not something I am responsible for, but I am glad that it is becoming compulsory because it seems an obvious thing to do, if you are writing leaflets for people about something as important as their medication, to test them out on potential users.

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