Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 320 - 339)



  Q320  Chairman: Mr Prior, a lot of the pharmaceutical companies make donations to charities. Would it not be a more appropriate way of patient organisations receiving income to get it from those charities rather than directly from the companies?

  Mr Prior: I think a balanced range of funding would be highly desirable. At Rethink we are in a much stronger position in that we have over £40 million a year in alternative sources of income, which makes us very robust against any influence from pharmaceutical companies who provide less than 1% of our income. Many patient organisations struggle to survive. They do not have alternative sources of income.

  Q321  Chairman: If it is less than 1%, in view of the suggestions from Mr Flynn that you are possibly compromised as a consequence of receiving that money, why, with it being only such a small amount, do you continue to receive it?

  Mr Prior: I think all sources of funding bring strengths. I know it has been suggested in previous sessions before this committee that government funding, for example, should replace pharmaceutical funding of patient organisations, but I am afraid that anybody who thinks that government funding comes without strings or without influence is being exceedingly naïve. All sources of funding bring their biases. Even raising funds direct from the public brings a bias. It is much easier to raise funds for attractive conditions, if you like, cuddly conditions, rather than for difficult and edgy causes, like severe mental illness, our own area, and in addition, to raise funds from the public you have to stay in the public eye. If you stay in the public eye you are more tempted to make controversial statements. All sources of funding bring bias. What is important here is to know that patient organisations are, as in our own case, genuinely controlled by the people they are there to represent. We have a shareholding membership made up of people living with the conditions we are about and their passion and energy would not allow us to tell anything other than their experience in our campaigns. Secondly, patient organisations should have a balanced range of funding which is fully declared, not just a declaration of money that comes from the pharmaceutical industry; that is important, but also a declaration of what other sources of funding they have, government funding and so on. It would be wonderful if charitable trusts were prepared to put more funds specifically into allowing patient organisations to survey the experiences of the people they represent and campaign on that basis. However, even then most charitable trusts have their own agenda. They set their own criteria. Again, that can distort the message that is heard from patient organisations. Balance and transparency and accountability are what are important here.

  Q322  Chairman: Ms Letts, do you have any comments on Mr Flynn's opening remarks?

  Ms Letts: I would not disagree with anything that Cliff Prior has just said. What I would like to add is that I think that all patient organisations should have guidelines for all the funding that they accept and particularly guidelines that they have with pharmaceutical companies. These should include an absolute insistence on independent governance, on editorial control, on independent decision-making and so on, and an absolute ban on promoting any company's products, whatever those products are. I have written these policies myself for a National Asthma Campaign in the past and LMCA and most recently for Ask About Medicines Week. I would like to supplement what Cliff Prior said about patient organisations struggling to survive. It is one thing if you are running an organisation such as I did with asthma where you are running a national charity dealing with an emotive issue where it is easy to make your case and get your funding, even though public fundraising, as Cliff has suggested, does drive you sometimes into doing things or emphasising things that perhaps you would not want to emphasise. However, if you run a small support group for a rare condition affecting a small number of people, none of whom is particularly cute or cuddly then it is difficult, or, as in my most recent experience, if you are leading an umbrella body whose interaction is at policy level, not directly at patient level, it is very difficult, and finding core funding for organisations like these is a constant and exhausting struggle. Government does stubbornly refuse to understand this. Government funding tends to come either with explicit or implicit strings attached, or it tends to be in the form of project funding which is no use at all if you have not got an infrastructure to support the projects. I think that what we need to see is much clearer standards to establish the bona fides of a patient organisation. The patient organisation that I chaired until recently, the Long-Term Medical Conditions Alliance, discussed this quite frequently but, ironically, we never had the core funding available to get the infrastructure that we needed built up in order to introduce such a system. We need to introduce these standards to establish the bona fides of patient organisations. What I would add to what Cliff has said about the need for balance in funding is that indeed you are influenced from all sides when you accept funding and what is absolutely essential—and this is very difficult again for a lot of small organisations who have not got the staff or the infrastructure—is to be very clear about your objectives, your policies, your strategies and the things on which you will not compromise. One of the things on which you have to be absolutely clear is that you will declare all sources of funding. I have been on the receiving end on one occasion of an attempt by a company to persuade me not to declare in an annual report some funding that we had received. I think you have to have the courage to stand up to that kind of pressure.

  Q323  Chairman: The company did not want you to declare money that they had given?

  Ms Letts: They had not given it. They had paid for something that we had carried out so, because they had not given it directly to us, it had not gone through our books, the suggestion was that it should not be declared and I insisted that it must be declared.

  Q324  Chairman: Do you want to mention the company?

  Ms Letts: Yes. It was Glaxo Wellcome.

  Q325  John Austin: If I could stay with Ms Letts, nothing in my questioning should be taken as implying any criticism of your integrity. We know that you have always argued for a relationship with the pharmaceutical industry and that it should be restrained by a code of practice. During your period with the Long-Term Medical Conditions Alliance and, as you say, you have always been open in your declarations, you were working for or did undertake some consultancy work for a number of organisations, including one of the companies which was involved in the drug launches of Viagra and Celebrex. We now understand that Celebrex is one of those—

  Ms Letts: Sorry—which company was that?

  Q326  John Austin: With the Chandler Chicco agency.

  Ms Letts: Ah, Chandler Chicco, yes.

  Q327  Chairman: Who were working for the pharmaceutical industry and involved in the drug launch of Celebrex, about which I think there are considerable safety concerns and questions at the moment. In that capacity did possible conflicts of interest ever occur and, if so, how did you handle them?

  Ms Letts: I had no idea that Chandler Chicco was even involved with that drug. In fact, I have ever heard of that drug, Celebrex, that you mentioned. They commissioned me to write a report on something which I was happy to write a report on for them. They are a communications consultancy and I had absolutely no involvement in any of their direct work with any of those drugs that you mentioned. I simply wrote a report for them. It was a research report that I put together for them on the current European situation and current European campaigning about direct-to-consumer communications, and I put both sides of the story very clearly in that report. No, I do not think there is any possible conflict of interest that I can think of there.

  Q328  John Austin: You mentioned the GSK incident to the chair. Have there been other occasions when pharmaceutical companies have tried to influence you in some way?

  Ms Letts: When you are running a patient organisation this word "influence" bears a little bit of examination. Of course, another word for "campaigning" is "influencing", and we are all involved in influencing. That is what you do when you meet with people, so of course any company that one is dealing with wants one to understand their point of view. I have been sometimes what could be called a bit bloody-minded in resisting it. Anyone who tries to influence me will probably get a counter-productive reaction from me. I am not very susceptible to that kind of approach. The important thing is that what you have to have in your mind is who it is you are there for, who it is you are working for. What I always ask myself is, what is going to be in the best interests of the patients whom I am ultimately here to speak or work for? I believe, as I think you have alluded to already, that the best interests of the patients who I have always worked for, those people with long term conditions, are served by maintaining a dialogue with pharmaceutical companies because those companies make products on which in many cases people depend, sometimes on a day-to-day basis and sometimes periodically but they make those products and it is important to remain in contact with them. That is what I believe. I do not believe that it means you have to adopt lock, stock and barrel the agenda of the pharmaceutical company. You have to go into such relationships knowing full well that they have a commercial imperative, and that is what one would expect in the world that we live in. If you are clear about who you are there for and, as I said, what your non-negotiables are, then I think you can conduct a fairly robust dialogue. I am certainly aware, in the time I have been doing this, because I have both seen and been given explicit feedback, of having influenced companies themselves and persuaded them that it is not a very good idea to try to capture a patient organisation, for example.

  Q329  John Austin: The difficulties for some organisations have been explained. Some organisations are more cuddly than others and more easy to raise funds for. Some conditions it is more difficult to raise funds for. If there were no funding from the pharmaceutical industry what sort of impact do you think that might have on the patient's voice generally?

  Mr Prior: Some would really struggle. Some patient organisations would close altogether and then support would not be available to people living with those conditions. For some, like us, there would be a bit of a hit but it would not be anything tremendously significant, so there would be a range of different effects. Then organisations would be more open to influence from other directions. If I can give you an example of this, our main interest is with people affected by psychoses and over the last five or 10 years there has been a major debate about two different classes of anti-psychotic medication—an old class which was cheaper and a new class which was more expensive—and obviously the pharmaceutical companies wanted to sell the new class and there was very clear direct evidence from surveys that we conducted of NHS agencies that government agencies wanted to control the prescribing of these because they were more expensive and cost was a major factor restricting prescription. The way we tackled that was by going out to people who were taking medications on a very large scale and surveying them about their experiences and the benefits and disbenefits that they found. We produced a report which was presented to NICE and actually was the line that NICE very much followed, which was not to say, "New drugs good, old drugs bad". It was to say, "They have both got benefits and side effects. The range of side effects is different. People need an informed choice in order to arrive at the best treatment for them". That was possible only through the most intense job of trying to raise absolutely neutral funds. We could not touch government funds because they were biased against spending more money. We could not touch pharmaceutical funds because obviously they would be biased in favour of selling more of the new drugs. We found there were almost no sources of funding to support that sort of neutral inquiry into the experiences of patients. We were very fortunate to find two trusts, King's Fund and the Gulbenkian Foundation, which were prepared to support it, but even then it came with strings. I think the strings were right. The King's Fund's condition was that a full data set of the survey must be published on our website, and good on them for insisting on that. That is the sort of influence I like, but it is incredibly difficult and simply removing pharmaceutical funding would damage patient organisations and the work that they do. Replacing it with government funding would create disproportionate influence from one party. We need a more balanced approach. We need to see more charitable trusts contributing to this field, but we also, as patient organisations become more influential, need to defend their position—and I think this is in our own interests—by introducing standards. Governments or regulatory agencies should fund these developments under umbrella bodies for patient organisations Patient organisations would then be expected to adhere to publication of interests, accountability, showing how they are controlled, how they get the views of their beneficiaries, before their evidence is taken seriously by bodies like NICE or the CSM, or indeed by the media who are all too prone to report the controversial comment rather than the one that is well-founded in evidence from large numbers of people with that condition.

  Paul Flynn: We already have the umbrella body, of course. The problem with it is that it cannot enforce its recommendations. There is no way of monitoring what is going on and it is described as being a distant dream, the possibility that it can impose any sanctions. The evidence is that only 26% of the UK groups that were surveyed recently had any kind of conflict of interest statement on this. There is no disagreement with the Long-Term Medical Conditions Alliance's guidelines and aims. There is also a problem with the Charity Commission because the suggestion that they have absolute control is another fallacy. In a letter to me they said that under the Charity Accounting Regulations there is no general requirement for charities to disclose the sources of their donations and the kind of control they have is very weak, as I mentioned in my written statement. We do need some kind of tightening up on this. They said that the requirements to provide information on the source of donations are less stringent than those relating to the expenditure of a charity. There is a great dispute about those charities and patient organisations saying they have no choice but to accept money that is given to them and those who very successfully resisted money that they thought was tainted because it was intended to influence their policies.

  Ms Letts: As we are talking about the umbrella organisation I assume that Mr Flynn was referring to LMCA. As I said, our wish when I was in the Chair to introduce such a system was hampered by the fact that we did not have the money to fund the infrastructure to make it work. I think, and in fact one of my recommendations to this committee would be, that there should be core funding provided without any strings attached by government to the LMCA or some other such umbrella body to set up such a system so that it becomes a matter for anybody who wants to join in the Alliance. I am sure a lot of people would still want to join it, in fact probably more. There would be some kind of standard attached to it to recognise the bona fides of member organisations. One of those standards I absolutely agree should be that all interests should be very clearly declared in annual reports and so forth and not simply pharmaceutical industry funding. In answer to the question what would happen if there were no pharmaceutical industry funding, I think that unless there was a lot of work done to counterbalance this potential outcome, there would probably be undue influence exerted by other funders, including government. Both Cliff Prior and I have referred to the notion that government funding comes without bias as being really untenable.

  Paul Flynn: It is biased by government but I think all that is in the government's interests is the wellbeing of the patients and the pharmaceutical industry's interest is to maximise their profits. I believe that if we did see withdrawal of all the funding, it would liberate the patients' organisations, give them a new respectability and credibility, and would certainly help those who have properly resisted all funding from pharmaceutical companies over the years and have led the campaigns to expose the dangers of pharmaceutical drugs and the benefits of pharmaceutical drugs.

  Q330  Chairman: Mr Woolas, could you say a bit about how you became involved? Obviously you are here as a constituency MP and not as a minister. Can you say a little about what has happened in your constituency that made you become involved in this whole area?

  Mr Woolas: Thank you for the opportunity to do so. It might be helpful to you and your Committee if I referred you to the Westminster Hall debate of 7 December 1999, column 186, in which I outlined the case of the benzodiazepine campaign. Essentially, my constituency has an estimated 5,000 involuntary addicts to benzodiazepine drugs; that is an estimate from our primary care trust.

  Q331  Chairman: Is there some specific reason why that is such a high figure, or would you say that is not uncommon elsewhere?

  Mr Woolas: It is not uncommon elsewhere. There are particular reasons to do with the area of Greater Manchester in which my constituency falls, but it is not an uncommon figure. What is perhaps special about my area is that there is a very well-developed support group for the involuntary addicts of benzodiazepine drugs, and that support group has indeed grown up, over the last five years, into what is now a nationwide support group. We have the first primary care trust funded treatment service for withdrawal from benzodiazepine addiction, but we are dependent, as a national organisation, on voluntary funding from individuals. In particular, our efforts to bring legal cases have been hampered by the lack of legal aid, the lack of funding for advocacy, and of course the enormous resources of the particular companies that have provided benzodiazepines over the last 30 years.

  Q332  Chairman: Can I ask you specifically: to what extent do you believe that the drug manufacturers were responsible for the current levels of use and the dependence on benzos?

  Mr Woolas: That goes to the nub of the problem. I have referred the Committee to two submissions of written evidence to this inquiry: first, from my constituent, Mr Barry Haslam, who has submitted his evidence to you; and, secondly, from a constituent of Clive Soley, Mr Michael Behan. In addition, those two documents provide the historical record of how Wyeth Brothers and Roche in particular we believe in our campaign withheld information showing that the addictive levels of these drugs were much higher than the prescription guidelines stated. Indeed, as you will know, Mr Chairman, I wrote to you on 13 October of this year suggesting that a number of documents that we have become aware of in our research for legal action in this country and in other countries would show, in my view beyond doubt, that that deliberate withholding of the information was intentional.

  Q333  Chairman: You feel the Committee could help you in this respect?

  Mr Woolas: I think the Committee could be an enormous help if the documents referred to in the memorandum from Mr Behan were requested by this Committee because I believe that would show evidence existed that the addictive effects of these drugs were much greater than was known to the regulatory authorities in this country, and therefore of course to patients. In particular, I believe the statements issued by ex-medical directors of Wyeth—Dr Dipak Malhutra and Thomas Harry who were responsible for the development of Ativan—show that what I am saying is the case.

  Q334  Chairman: Can you say a bit more about the initiative by the PCT in terms of helping people with this problem in your area? Has this been funded entirely by the local PCT or has there been some help from national government?

  Mr Woolas: The situation is that our campaign does not advocate immediate withdrawal from benzodiazepines. We believe that would be very dangerous. Our campaign is to have the prescription guidelines enforced. Unfortunately, they are not being enforced. There are some 20 million repeat prescriptions in this country. Therefore, availability of facilities for withdrawal treatment from these drugs is extremely important. I would point out that in the evidence that has been presented, the Home Office statistics, the number of deaths by poisoning from benzodiazepine involuntary addiction in this country is 1,800. This is some nine times greater than the number of deaths from heroin misuse. The funding for the withdrawal treatment is exclusively from our primary care trust. The difficultly we have is, of course, that the withdrawal treatment is not a central part of the national drug withdrawal strategy, and nor therefore is it one of the five priorities given to primary care trusts by national policy. In other words, it is a local decision by the board of our PCT to commission a service in conjunction with the North-West.

  Q335  Chairman: It is locally funded, basically?

  Mr Woolas: It is therefore locally funded but it is government funded, of course.

  Q336  Chairman: Barry Haslam, in his evidence on page 6, makes a number of recommendations for action. Mr Haslam has fought hard on this over many years. He writes to me at least once every week and, to his credit, he has worked very hard. I will not go into one of his recommendations, and you will not want that either, which is to sack the Health Minister Rosie Winterton and her special advisers forthwith and appoint Phil Woolas MP in her place. You probably do not want to comment on that and I will not ask you to do so. His first recommendation is that there should be an independent and full public inquiry to be ordered by the Government as a matter of urgency into benzodiazepine, SSRIs and "Z" drugs. Is that something that you personally would support and, if so, how do you feel that might address some of the issues you have raised with the Committee?

  Mr Woolas: I support that and it is something that the Government of the Republic of Ireland has undertaken with significant success. There are two reasons for this. One is that to address this issue requires cross-departmental policy co-ordination. Our campaign in particular has lobbied the Home Office on the scheduling of the drugs, that is the rules that pertain to the storage of drugs, because there is a street trade in temazepam in particular. Obviously, that involves the Health Department, the ODPM and a number of government departments in having that policy, which is needed to enforce the prescription guidelines, to give confidence to doctors and patients in the independence of the regulatory authorities, and to provide the treatment that the addicts require. Incidentally, for example, the prison service in its guidelines does recommend this for prisoners, but not for the general public.

  Q337  Dr Naysmith: I have been asking questions about the use of benzodiazepine and SSRIs for the last few years. It looks, quite clearly, as if benzodiazepine use is dropping and being replaced by SSRI use. Is that something on which you have any views?

  Mr Woolas: I do not believe that to be true. The number of benzodiazepine prescriptions has dropped slightly, but it runs into tens of millions. There is a fallacy in the Western world that the benzodiazepine problem was addressed in the 1980s, particularly by the high profile campaigns, the That's Life programme and other legal actions. In fact, the prescription guidelines have not been enforced for the past 20 or 30 years. What has happened is that the media, understandably, have paid attention to SSRIs, and Seroxat in particular. Personally, I am supportive of the campaign of Paul Flynn and others but that has not replaced the problem of benzodiazepines; it has supplemented it and, in my view, made it worse.

  Paul Flynn: It is alarming that the level of prescriptions of SSRIs has now reached 25 million, which is approaching the peak levels for benzodiazepines. It is so depressing to look at the answers for treating depression, including mild depression, over the past 150 years. The miracle drug for Sigmund Freud, of course, was cocaine, which he used himself and recommended for his patients. Heroin was then introduced as an answer to opium addiction. Then the bromides were introduced; again, those did enormous damage at the time of the First World War. We have gone through a succession of drugs and now the benzodiazepines, the tricyclics and the SSRIs have all been introduced as non-addictive drugs with great utility that will be very successful in treating depression and in treating addiction. In fact, all of them have been used as the answers, the cures, to problems that they themselves have created. This is an uncanny repetition of the same mistake being made by the medical establishment over a period of 150 years of introducing cures that turn out to be curses and problems. We now know the difficulties with the SSRIs, which were introduced because they did not have the effects of the tricyclics. Those are now being exposed. The awful part of this, and this comes from someone who like most of us has had scientific training, is that we always believed in the integrity of scientific trials but we realise, to our horror, that the scientific trials have been fixed; they have been suppressed; data has been found, as in the Lancet report of April of this year, that the conclusions of the trials were different from the data. We know that organisations as eminent as the MHRA rely not on the data of the trials but only on the conclusions. I believe that a great confidence trick has been perpetrated on the world by the pharmaceutical industry which has behaved in a disgraceful way. I hope the case that is going on in America now about the trials of SSRIs will bring the pharmaceutical industry back to a position where they behave with honour and integrity. There is certainly a wealth of evidence that they are not doing that now.

  Q338  Dr Taylor: I do apologise. Mr Austin's declaration of interest means that I have to make one as well. I am one of the Vice Chairs of the Associate Parliamentary Health Group, which is funded by a wide range of industries. This is still dealing with benzodiazepines. I am horrified to hear from Mr Woolas that they are still prescribed in millions. Short-term injections of benzodiazepines are still used for surgical procedures and to enhance local anaesthetics. Are they still prescribed in millions as tablets to patients?

  Mr Woolas: Yes, they are. The estimate of the mental health charity MIND is that 1.2 million people in the United Kingdom are affected by addiction to benzodiazepines, including Valium, Ativan and lorazepam.

  Q339  Dr Taylor: So these millions of prescriptions are all for the people who are already addicted?

  Mr Woolas: That is exactly the point. The difficulty is that because the drugs are so addictive, particularly Ativan, and because the prescription guidelines were not toughened until 1988, some 25 years after the introduction of the drugs, and because even today the prescription guidelines, which essentially limit a prescription to three weeks, are not enforced and because the difficulties of withdrawal from the drug make the problem worse in many cases, the easy solution is for the doctors to carry on prescribing and for the patients to keep taking them. That results in over 20 million repeat prescriptions and over 1.2 million addicts in the country, many of whom are elderly people living in residential and nursing care, but by no means exclusively.

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