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UNCORRECTED TRANSCRIPT OF ORAL EVIDENCE To be published as HC 42-i House of COMMONS MINUTES OF EVIDENCE TAKEN BEFORE HEALTH COMMITTEE
THE INFLUENCE OF ThE PHARMACEUTICAL INDUSTRY
Thursday 25 November 2004 MS MELINDA LETTS, PAUL FLYNN MP, MR PHIL WOOLAS MP and MR CLIFF PRIOR MR JIM THOMSON, MR GLYNN MCDONALD, MS HELEN WALLACE and MS JENNY HIRST Evidence heard in Public Questions 316 - 406
USE OF THE TRANSCRIPT
Oral Evidence Taken before the Health Committee on Thursday 25 November 2004 Members present Mr David Hinchliffe, in the Chair John Austin Siobhain McDonagh Dr Doug Naysmith Dr Richard Taylor ________________ Memorandum submitted by Paul Flynn MP, Beat the Benzos Campaign and Rethink Severe Mental Illness
Examination of Witnesses
Witnesses: Ms Melinda Letts, Chair, Committee on Safety of Medicines Working Group on Patient Information and Past Chair, Long-Term Medical Conditions Alliance, Paul Flynn a Member of the House, Chair, Commons All-Party Group on Rheumatoid Arthritis, Mr Phil Woolas a Member of the House, Trustee, Beat the Benzos Campaign, and Mr Cliff Prior, Rethink Severe Mental Illness, examined. Q316 Chairman: Can I welcome our witnesses to this morning's first session and thank you all for your helpful written evidence; we are most grateful to you. Could I ask each of the witnesses briefly to introduce themselves to the committee, starting with Ms Letts? Ms Letts: My name is Melinda Letts. I am an independent consultant working with charities and other health organisations. Until May of this year I chaired the Long-Term Medical Conditions Alliance and among a number of other things I am now a Director of Ask About Medicines Week and Chair of the Committee on Safety of Medicines Patient Information Working Group. Mr Woolas: I am Mr Phil Woolas. I am Member of Parliament for the Oldham East and Saddleworth constituency and a representative as a trustee of the Beat the Benzos Campaign, which is a support group for involuntary addicts on benzodiazepine drugs. Paul Flynn: I am Paul Flynn, Member of Parliament for Newport West, a long term critic of the pharmaceutical industry, especially their disease-mongering and over-prescription and the medicalisation of society. Mr Prior: I am Cliff Prior. I am Chief Executive of Rethink, which is a charity for people affected by severe mental illness. I am also Vice Chair of the Long-Term Medical Conditions Alliance and a member of the Medicines Commission. Chairman: Thank you. We have one declaration of interest from Mr Austin. John Austin: I just wish to declare that I chair the All-Party Parliamentary Osteoporosis Group which receives administrative and secretarial support from the National Osteoporosis Society, which is mentioned in Mr Flynn's evidence as receiving some financial assistance from the pharmaceutical industry. Q317 Chairman: We are splitting this morning's session into two, as you well know, and it will be roughly an hour for each group, so could I ask for the questions and answers to be brief and sharp. Mr Flynn, could I start with you? How did you get into this whole area? Am I right in thinking that it was through constituency concerns? Paul Flynn: Yes, it was; it was entirely through constituency concerns. The first one was when a constituent committed suicide using the drug Roaccutane and I was shocked to discover that there was no organisation for the defence of people in this circumstance and the patient organisation that one would have thought would have represented people was one that had a very large donation from the manufacturers of Roaccutane because there was a widespread belief that those on this drug were more prone to commit suicide. Over the years I have come across in my constituency work a whole range of instances where those that one would have thought would have been the first line of defence in the interests of patients, the charities and the patient organisations, were being influenced and certainly being financed by the pharmaceutical industry. I have learned over the years that it is impossible to over-estimate the greed, the guile and the resourcefulness of the pharmaceutical industry. While the science is wonderful the marketing of their products, I am afraid, is very much out of self-interest in order to maximise their profits and I believe that these organisations that we look towards to defend the patients are ones that have been influenced - not corrupted; many of them are magnificent organisations - and we do notice that those that have the largest donations are often the ones that have the quietest voices when it comes to exposing the side effects of pharmaceutical drugs. Q318 Chairman: You specifically say in your submission that some patient organisations may refrain from criticism of pharmaceutical companies because those companies fund the organisations. You give an example of a concern on page 4 of your evidence where you talk about a particular product, where you suggest that information from clinical trials is being suppressed and, "A courageous leading campaign has been pursued by MIND who receives no contributions from any pharmaceutical company. There has been silence from SANE and Depression Alliance who accept donations". This is fairly strong criticism. Can you expand on this? Paul Flynn: I was present at the formation of an All-Party Group on Depression of which the Depression Alliance were the main sponsors. Again, they are an organisation that certainly do very good work but it has been significant during the past year, and I have had two debates on Seroxat in that period, where this international scandal on the damage that is done by Seroxat, involving the suppression of files, an immense scandal involving millions of people, was not exposed by the Depression Alliance or the other patient organisations. Depression Alliance did confess to taking, in meetings we had with them, 80 per cent of their funding from the pharmaceutical industry. They were silent when this matter was being exposed by organisations like MIND who take not a penny and a very courageous stand was made by Richard Brook of MIND. The heroes of the exposure of this scandal were not the MHRA or those bodies that should be defending the patients. It was very much the campaigning patient organisations and I think very recently, when Viox was exposed as being a very dangerous drug, I went on to the Arthritis Care website, again, an organisation that is doing a magnificent job, and it was significant that they were advising people to continue taking Viox even though it has been exposed as a drug that has probably killed by a minimum estimate 7,000 people and caused 25,000 heart attacks. Arthritis Care was suggesting that people continue to take the drug and then see their doctors and probably go on to another drug. It is not insignificant that the website is financed by Merck Sharp and Dohme, manufacturers of Viox itself. The charities and the patient organisations will say they are not influenced unduly by this but why on earth then are they taking the drawings because we certainly know that the ABPI have said that they regard the patients' associations as the ground troops. They had a battle plan in which they wanted to employ ground troops in the form of patient support groups in order to weaken the political, ideological and professional defences. That is a declared policy of the pharmaceutical industry, to use patient organisations to subvert us. I will make one final point. In Paris last week the WHO were challenged on their view that depression will become the third greatest cause of illness in the world by 2020 and they were challenged on whether they were being unusually influenced by the pharmaceutical industry. The defence of the World Health Organisation was, "Yes, we are suspicious of the pharmaceutical industry but we do listen to charities and patient organisations". I believe that for all of us, politicians, the public, our defences go up when we have advertisements and persuasion from the drug companies but we are open to persuasion by organisations like the patient organisations we trust. I believe we see it within this House when some of our All-Party Groups have been used as Trojan horses to bring the voice of the pharmaceutical industry into this House and to use it generally throughout the whole of the medical establishment. Q319 Chairman: One of the questions I asked at the start of this inquiry internal to our committee was to look at the number of All-Party Groups that do have a connection with the industry. Do you have any specific examples of policies being influenced by All-Party Groups in the interests of the industry? Paul Flynn: I sit on many of these All-Party Groups in order to watch the activities that go on. I was rather alarmed to receive a document from an organisation called Phase IV recently which tried to recruit me in order to subvert, in my view, the All-Party Group on Rheumatoid Arthritis in order to find what they described as success stories and tragedy stories in order to promote the use of the anti-TNF drugs. These are drugs that have been approved by NICE but have certain side effects that NICE warned of. This was an attempt by a body, which is a PR agency, to use the group in that way. I believe that every time we have invitations to All-Party Groups the invitations are littered, rather like the clothes that are worn by racing drivers, with advertisements for the companies. They are not doing this out of some charitable reason or for the benefit of the patients. They are doing it to advance their position in this way. The damaging effect is not that we can say in this case or that case that they have actually worked in a way that was obviously promoting the drug, but their main effect is to silence the organisations when they should be critical. I believe the evidence is that the regulatory authorities are ones of self-regulation that are not working, that are weak and we are seeing, in the case of many of these organisations that exist, a lack of the alertness and the desire to defend the patient interest against a whole host of examples we have had of drugs over the years from Thalidomide, Destobel(?), Araldine(?), now to Viox and a whole stream of others. My lifetime experience of the pharmaceutical industry is that about 50 per cent of all medicinal drugs have harmful side effects and the other 50 per cent have side effects that we have yet to discover. It has been a history of experimentation on a large scale between patients and drugs and, sadly, the results on the harm of the drugs were only revealed in many cases when they had been used by millions of people. We do not have bodies that defend patients' interests in the way that they should. 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 one per cent of our income. Many patient organisations struggle to survive. They do not have alternative sources of income. Q321 Chairman: If it is less than one per cent, 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 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 LNCA 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. My 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 make 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 do not think 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 on the European position. They were research reports 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-effective 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 ten 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 that governments or regulatory agencies should fund under umbrella bodies for patient organisations to create, which patient organisations would then be expected to adhere to on 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 per cent 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 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 1800. 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 addition 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 dugs, 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. 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 form 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 or 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 1800 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 defend 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, on 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. 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. Memorandum submitted by MS Society and GeneWatch
Examination of Witnesses
Witnesses: Mr Jim Thomson, Chief Executive, Depression Alliance, Mr Glynn McDonald, Head of Policy and Campaigns, MS Society, Ms Helen Wallace, Deputy Director, GeneWatch UK, and Ms Jenny Hirst, Co-Chairman, Insulin-Dependent Diabetes Trust, examined. Q363 Chairman: We express our thanks to the second group of witnesses for your co‑operation with our inquiry. Could you each briefly introduce yourselves to the Committee? Mr Thomson: I am Jim Thomson and I am Chief Executive of Depression Alliance. In the interests of declarations of interest, I should start by making one and that is that although I have been with Depression Alliance for three years, in my immediate previous incarnation I also came into contact with the pharmaceutical industry. I was Director of Fundraising and Marketing for the largest anti-vivisection organisation in this country. Part of my role there was to play an active part in undercover investigations into that industry and its suppliers. Ms Hirst: I am Jenny Hirst. I am Co-Chairman of the Insulin-Dependent Diabetes Trust and as such I am a volunteer with no conflicts of interest. Mr McDonald: I am Glynn McDonald, Head of Policy and Campaigns at the Multiple Sclerosis Society. I am also a trustee of the Disability Alliance. The Multiple Sclerosis Society provides the secretariat for the All-Party Parliamentary Group on this. Ms Wallace: I am Helen Wallace, Deputy Director of GeneWatch UK, which is a not-for-profit organisation whose aim is to ensure genetic technologies are used in the public interest. Our funding at the moment is from charitable foundations. Q364 Chairman: I think several of you were here for the earlier session. You will probably be aware oaf some of the written evidence we have received and you will have had a chance to look at that written evidence. You will be aware of something mentioned in the previous session, the suggestion that patient organisations are the ground troops of the pharmaceutical industry. I do not know whether any of you feel that that description applies to your organisation? Mr McDonald: No. Mr Thomson: My organisation has spoken to you several times in this and previous sessions. I do not recognise the organisation from anything I have heard, so, no. Q365 Chairman: To be fair to you, may I give you the opportunity to respond to Paul Flynn's comment. As you are aware, he was talking about the specific SSRI issue and suggesting that there had been a courageous campaign pursued by MIND, who receive no contribution from any company, but silence from SANE and Depression Alliance who accept donations. Would you all respond to that? Is that an unfair criticism? Mr Thomson: I would love to respond to that. He says in his memorandum that there is worldwide alarm because of the effects of SSRIs. There is not worldwide alarm but there is an investigation ongoing in this country, which I believe is going to report back soon. There was alarm caused by the so-called heroic (I think that was the word he used) coverage by Panorama. May I say for the record that I do not find it particularly heroic when a programme goes to air and the principal resource offered to people that it is going to alarm is a help-line that has been shut for a month. I spent all day the previous day before that programme on Panorama went out trying to get Panorama to put another resource up there and not to broadcast an number that had shut, but there we are. He further says that there has been silence from SANE and Depression Alliance who accept donations. As he well knows, there has not been silence from Depression Alliance. In fact I have written to Paul Flynn on four occasions and he has written back to me on a number of occasions. I gave up the correspondence when it became clear that the points I was making about the role of a charity as opposed to the role of the regulator were falling on deaf ears. It is not Depression Alliance's role to campaign in that way. In fact, a political campaign of that type is strictly prohibited under charity law. We have not been silent. Q366 Chairman: You would strongly refute his argument that your organisation has in some way been compromised on this issue? Mr Thomson: On five separate occasions, one in person and four in writing, I have asked Mr Flynn to provide one piece of evidence of where my organisation has been in any way influenced by the pharmaceutical industry and he has been unable or unwilling to do so. In fact, for the purposes of the Committee, I have brought a copy of everything that we produce here and I repeat that offer. If anybody can show me one example of pharmaceutical industry bias, and given what I told you about my previous incarnation I suggest I am the last person to not recognise bias, then I am quite happy to offer my resignation. Q367 Chairman: We discussed in the previous session the difficulties that some organisations have in functioning without support from the industry. Mr McDonald, what impact would it have on your organisation if the resourcing you receive from the industry was no longer available? Mr McDonald: The effect would not be so much upon our organisation as upon people with MS. May I explain the way in which we receive money from the pharmaceutical industry? Our turnover is about £28 million a year. We are involved with a scheme which receives donations from three manufacturers of disease-modifying drugs for people with MS where those companies each put in £350,000 over three years, which is matched by £350,000 from the MS Society. We act as an independent administrator for that money. It goes direct to the NHS to fund MS nurses. That arose out of the risk-sharing scheme for provision of disease‑modifying drugs. The Department of Health wanted the industry to contribute towards development of infrastructure for delivering those drugs. At the request of the Association of British Neurologists and the UK MS Nurses Association, the Society stepped in and offered to act as an independent broker for that money to put a step between individual companies and individual nurses. If that money was withdrawn, the effect would not be on our organisation because we do not actually benefit from that money directly; it would be on people with MS who would have less access to MS nurses. Q368 Chairman: Do you think that more could be done to develop that kind of principle whereby there is not the direct connection between the patients' organisation and the company? Have you other ideas on how that might evolve? Mr McDonald: I think what causes some discomfort, and there are numbers of specialist nurses around, is the idea that there might be direct link between those individual practitioners and individual companies. We were quite happy to act in the role which was requested of us, to act as an independent intermediary. If I can give you an example of how that works, we receive the money from the companies; there is then an advisory panel which decides where the money should go. There is a bidding process and a panel decides in which areas that money should be allocated. There is no drug company representation on that group, and so there is no suggestion that nurses are being put in areas where the drug companies see an opening for their market. They are going to places purely decided on the basis of need. Q369 Dr Naysmith: This question is to Helen Wallace. The issues that GeneWatch is concerned with tend to be technical and have a different kind of applicability to what we have been talking about this morning, the side-effects and so on, and very laudable they are. Do you think they are of concern to any other patient organisations? Have any other organisations come in behind you on that? Ms Wallace: Yes. We have done some work with the Consumers' Association, for example, on the direct marketing of genetic tests to members of the public. Our particular concern and the issue I have raised in my submission is about healthy people; it is not so much about patients but about disease mongering, if you like, to people who are told they are at risk of becoming ill in the future. One of our concerns is that there is not an organisation really that will represent the views of those people in government policy or in regulation and that we therefore need to consider new mechanisms to get the broader public involved in this debate. Q370 Dr Naysmith: have you ever come across any opposition from patient organisations or consumer organisations to the kinds of thing that you are doing with the idea that you might be blocking progress for them or their supporters? Ms Wallace: We have been criticised by one of the patient organisations, the Genetic Interest Group, yes, for work that we have done. Q371 Dr Naysmith: What sort of group is that? Ms Wallace: They represent groups of people with genetic disorders mainly, a collection of different charities. They do play a role in a lot of consultative meetings and they do take pharmaceutical industry funding. Q372 Dr Naysmith: Do you think the pharmaceutical industry has any role to play in this kind of negative criticism? Ms Wallace: I can certainly say that the industry is not happy with the kinds of things that we are advocating in terms of regulation of genetic tests. They have told me, of course, that they are opposed to those tests. I am not aware of any action that they have specifically taken to try to prevent us from raising these issues. Q373 Dr Naysmith: Could I turn to Mr McDonald and mention something from your submission? The Society states: "Where the Society is in partnership with the industry, publication of results is always expected." Why do you think that is so important? Mr McDonald: That is purely for reasons of transparency. With any research which we as an organisation finance, and at the moment we have about £12 million or research commitments, it is an absolute that all the results of those trials or research projects are published. We would expect that to apply if we did any joint work with the pharmaceutical company. Equally, we would expect it if it was something being done entirely independently by a pharmaceutical company. We want publication of all results of research. Q374 Dr Naysmith: Would you take that as far as terminating your partnership with a pharmaceutical company if it refused to publish something, and publish something in a timely way as well? Mr McDonald: In practical terms, that would happen before any joint work took off if it became apparent that there were any kinds of restrictions on publication. Once we had set out an agreement, if it then appeared that there was a reluctance to publish, we would not continue with that arrangement. Q375 Dr Naysmith: Turning to Jenny Hirst now, you have been quite critical in your submission and you suggest that the commercial influence of the industry and the culture of secrecy in UK drug regulation leads to "largely poor quality research". What do you mean by that? Can you justify that statement? Why is the research of poor quality? Ms Hirst: Relying on the evidence of the Cochrane reviews, which we certainly class as independent and good quality reviews, for insulin, for instance, the genetically-produced insulin, at least 80 per cent of the research was funded by the drug industry and both Cochrane reviews have shown that it was methodologically poor. It has not it looked into the long-term effects of the insulin and obviously for people with diabetes that is key. It concerns us that this sort of research has been relied upon for the approval of drugs and for people to make decisions upon. Q376 Dr Naysmith: Yet there have been some amazing advances in using different forms of insulin in diabetes compared with even 10 or 15 years ago. Ms Hirst: Have they, in fact? There is really not the evidence to show that. What we have actually got now are genetically-produced insulins where there is no evidence to show that they are better or more reliable, but they are far more expensive. The cheaper animal insulins, which have a long history of safety, are not even advertised and doctors and diabetes specialist nurses tend to think that animal insulins are not available any more because they are not advertised, again an influence that the drug companies are having. Q377 Dr Naysmith: Would you tend to say that these influences are such that drug regulation is failing to protect and promote patients' health? Is that a statement you would agree with? If things were better regulated, it would be better for your patients? Ms Hirst: Yes, and I am unhappy about the relationship between the drug companies, the MHRA, and the role that patients cannot play in all of that. Q378 Dr Naysmith: How would you rectify the situation? What would you expect your organisation and other patients' organisations to do to improve this? What would you be able to do? Ms Hirst: What would we like to be able to do? We would like to be better represented within the regulatory authorities; to ensure that there is greater transparency; be allowed, as it were, to look at the research properly; to have access to the yellow card scheme and the adverse reaction reports and be able to report. I realise that that is supposed to happen, that patients are going to be able to report, but I think patients need all of that information. They need to be able to access it if that is what they want. Q379 Dr Taylor: May I go on along that tack just for a moment? You are content that there is no advantage of the genetically-produced insulin over the others and the only rationale for them is that they make more money for the drug firms? Am I over-stating you? Ms Hirst: You are over-stating me. A wide variety of insulins need to be available to suit all needs, but what we have now got is increasing pressure from the industry to make us believe that the genetically-produced ones are better for everybody, which I do not believe. Q380 Dr Taylor: You would agree they are better for some people? Ms Hirst: They are for some people, but not for everybody. Q381 Dr Taylor: What is the incidence of the inability to take the genetically-produced insulins? Ms Hirst: What we know is that 30,000 people, which is about ten per cent of people requiring insulin, are still using animal insulins but I come back to the evidence. The research has not been done so we do not know. There have never been long term comparative trials, for instance, to show the difference in people. Q382 Dr Taylor: Has any work been done on why these 30,000 cannot take it? Ms Hirst: No, and that is even worse, is it not? Dr Taylor: Yes, it is. Q383 Dr Naysmith: There is also the question that, if you are using pig insulin, you run the risk of organisms which might be there in the animal insulin which will not be there in the genetically produced stuff. Ms Hirst: There is no evidence of that at all. Animal insulins are as highly purified as the so-called human insulins. Q384 Dr Taylor: "Disease mongering" is a very good phrase because we seem to be in a position where patient awareness groups, illness awareness groups, are fostering the climate where one could get into a state where you are worried about your blood pressure, your weight, your cholesterol. Would you comment on this? Ms Wallace: Our particular concern is that that is likely to expand in future. There is a definite shift towards treating risk factors rather than diseases and clearly that can be beneficial in some circumstances, but what we are seeing with proposals to use genetic tests in particular to expand those risk groups is a system in which the tests themselves are not properly assessed. There is no mechanism to assess whether or not the test is useful to decide who should take a particular medicine. There is no mechanism to assess whether the test is valid, whether it is linked with the risk of disease that is claimed. There is no regulation to prevent direct sales to consumers or direct advertising to consumers. It is therefore certainly possible that this becomes a route by which large numbers of people - potentially the whole population - become convinced that they are at genetic risk for common diseases and need to take medication. There is clearly an interest from the pharmaceutical industry in using these types of tests to expand the market for medication. Q385 Dr Taylor: Your submission is a great help. You have told us the questions to ask potential witnesses. You have made a whole string of recommendations which I think we will certainly follow up. Does anyone else want to come in on the disease mongering? Mr Thomson: This is something that is often mentioned in the context of depression. I would like to establish that context because, without harping back to Mr Flynn's evidence, I had a conversation earlier on - Dr Naysmith was in the room at the time - about the incidence of depression and its status. Mr Flynn mentioned then that in his view there was a handful of people in this country suffering from serious depression and the rest were the worried well, created either by the pharmaceutical industry or by me and my evil organisation. I would like to correct that and to establish the context for the illness. Mr Flynn also mentioned that the WHO predicts that by 2020 depression will be the third biggest burden on health services worldwide. He misquoted because it is the second biggest by 2020. It is a serious, enduring mental illness and my organisation certainly does not need to disease monger to realise the job that we have on combating depression. I wanted to establish that, in the view of the Committee, there is a reason for me being here and that reason is that the condition exists. Dr Naysmith: Mr Thomson referred to a meeting that took place in the House of Commons. I was indeed in the room but I think I had a position somewhere in between him and Mr Flynn, which is occasionally the case. Q386 John Austin: On the depression issue and the role of your organisation and its relationship with the pharmaceutical industry, can I ask whether your Alliance accepts that there is some risk of dependence on SSRI anti-depressants and whether you have alerted your membership to that risk or are you more fearful of dissuading people from taking medication? Mr Thomson: Absolutely not. We support all therapies being available. We publicise information about all therapies fairly equally. Our most recent publication was on cognitive behavioural therapy which is a non-pharmaceutical intervention. Q387 John Austin: Have you specifically issued warnings about the possible risk of dependency on SSRIs? Mr Thomson: I have brought all our publications with us and one of them is called Depression and Antidepressants. That issue is specifically covered in that publication so it is quite wrong to say that we have not alerted people to that risk. Q388 Dr Taylor: Certainly diabetes is one thing that you do need to be aware of and promote. Have you any comment? Ms Hirst: Yes. People with diabetes are prime targets for drugs for cholesterol, obesity and blood pressure. I do have concerns that the easy way out is to take a pill, whereas to eat sensibly and exercise, the standard line, is vital. I do worry that pills will be pushed as an easy option. I think we all worry about that. Mr McDonald: There are tightened, specific, diagnostic processes around MS. It is not something which is susceptible to disease mongering. Q389 Dr Taylor: Can I go back to Helen Wallace? Obviously the genetic approach is going to be good for some patients. Could you tell us the sorts of groups that it is going to help? Ms Wallace: There are examples already of genetic tests obviously in use in diagnosing genetic disorders, which is clearly beneficial, but there are familial forms of some common disorders, familial cancers, and the most obvious example is the Braco test associated with risk of breast cancer, which can be useful to some women from high risk families who want to know their risk. That is why we are arguing for regulation. I am not saying that these tests are bad in general. There will be some circumstances where they are useful to some people but they are going to much more questionable for use in the general population across the board. Q390 Dr Naysmith: Because of misuse of inadequate information now, things are being marketed too soon. As someone who has studied genetics in the past, it seems to me it will be possible one day, I suspect, to identify individuals who will benefit from specific treatments and drugs. It may be multifactorial in lots of ways and polygenic as well but we will get there one day. Would you agree that it is possible that we will get there one day? Ms Wallace: I would agree that the number of useful tests will expand. The jury is still out and in some ways it is not totally relevant to the decision about assessment but, as to what extent it will be useful, say, to scan the genomes of everybody in the population, I would argue that there is enough data already on some diseases to show that that is not going to be useful, for example, for trying to find out who is genetically susceptible to lung cancer. We know there is not a significant genetic component to that disease and I think the potential has been generally exaggerated. In terms of regulation, it is irrelevant what side of that debate you come down upon because you can still agree that the tests should be assessed. Q391 John Austin: You suggest in your evidence that this focus on drug based and diagnostic approaches may lead to reduced funding for other health issues. Do you think there is a role for patient organisations to help the government and other agencies in putting the genuine contribution of the pharmaceutical industry into perspective in relation to other interventions like leading healthy lifestyles and other public health measures? Is there a danger that there may be a switch of resources away from public health measures? Ms Wallace: Yes. If we look at the situation at the moment as analysed to some extent in the Wandless reports and in work by the Health Development Agency, a very tiny proportion of medical research is spent on public health interventions so the Health Development Agency found something like 0.4 per cent of research output in terms of publications was looking at those very important public health interventions which, as your Committee knows from its reports on obesity and tobacco, are the things that are going to make most difference. The reason for that is that funding tends to follow the priorities of the pharmaceutical industry and of patients that need treatment and not look at these other priorities in terms of prevention. I would argue it is not so much patient groups but perhaps new mechanisms to involve the broader public in decisions about research that would help to counter that. There has been a step towards that in the new science strategy that has been published, which does advocate public involvement, but it advocates public involvement very much at the end of the pipe to look at how new technologies might be applied and what the risks are. Many organisations, including ours, are arguing we should shift that involvement upstream to make decisions about research funding and what the priorities should be that involve the public as well as scientists. Q392 Dr Taylor: You all represent a number of patient organisations. Have you ever felt that financial dependence on the pharmaceutical industry has produced adverse effects? Mr Thomson: The interesting thing there is financial dependence. It implies a passivity in the relationship and we are in no way passive in our relations with - I hesitate to use the words "the pharmaceutical industry" because I have no encounters with the pharmaceutical industry. I have encounters with a number of companies who are in competition with one another. This idea that it is an industry that is seeking to influence me I do not recognise. The reality is that in an ideal world we would probably like to rely, which we do, on far less funding from companies within that industry but unfortunately my organisation exists in the real world, not the ideal one. Government's core funding of our organisation does not pay the rent on the building, let alone any staff, the lights etc., and it is not a grand building. In fact, one year it was voted the ugliest building in London. The fact is that we do rely on that but we are very careful in those relationships and we do not accept money from the pharmaceutical industry; we aggressively seek it. There is a fundamental difference because that gives us an equality within the relationship. Q393 Dr Taylor: Would you agree with the witness in the last session who said she was quite confident she was not influenced? Mr Thomson: We have two separate policies on fund raising, one generally, which I will not bore you with because the core of it is repeated in the second one, which is regarding funding from the pharmaceutical industry. Q394 Chairman: If you could leave that with us, that would be excellent. Mr Thomson: What it points out is that as a charity we are bound by what we can and cannot accept. If there are no strings donations, there are only two very tight conditions under which we can turn down a donation. That pertains to other organisations as well in the charity sector. I do wonder why that question has never been asked of people who overtly broadcast the fact that they do not accept any industry funding because that leaves their trustees quite liable. Q395 Dr Taylor: As a charity, you have to accept donations? Mr Thomson: There are two conditions under which we can turn them down. Those conditions are if there are strings attached or if, by accepting it, we would prejudice other funding areas so if it would blacken the name of the organisation. Were we to only be accepting money from one company I would feel quite happy about turning it down on that basis because we would be seen to be favouring one over another. We do not do that and I am quite happy that we do not risk the charity's name by accepting those moneys. Ms Hirst: I would totally agree that a charity can grow, develop and reach more people if it accepts pharmaceutical industry money, but we are set up with a deliberate policy of not accepting pharmaceutical industry money. That is because we have problems with industry and its influence. We also felt that in order to represent the people we do represent we could only do that if we remained independent. You cannot criticise the pharmaceutical industry and specific drug companies and take their money at the same time, or I do not feel you can, and we as an organisation do not feel you can. The other point that we feel quite strongly about is that it is how the public see you which is that you can be as independent as you like and make judgments you like if you accept pharmaceutical industry money, but if you see adverts that are for a charity alongside a major drug company the general public on the whole think there is an link and you are giving approval to a product, not something any charity should do. Q396 Dr Taylor: Where does the bulk of your funding come from? Ms Hirst: People and legacies, the general public. I fully accept that that limits us and we never did set out to be Diabetes UK as employing 164 people. I still think that charities like us can do a worthwhile job without accepting pharmaceutical industry money. Mr Thomson: By accepting or seeking, as we do, pharmaceutical industry funding we are then gagged and not able to launch campaigns that would adversely affect the income of those companies. Our most recent campaign does exactly that. We had a conference last week looking at the issues around parallel trade, counterfeiting and online pharmacies, all serious topics. One of the outcomes from that conference which was covered in The Telegraph on Monday this week is that we will be lobbying industry to look at tamper proof packaging of their products and that will cost the pharmaceutical industry a great deal of money, running into several billion dollars no doubt because they will have to retool all their productive facilities to produce their medicines in tamper proof packaging. That is an issue of patient safety and that is where we are coming from. The fact that it adversely affects companies that fund us is neither here nor there in terms of patient safety. That is what we need to do, so we do it. If we compromise our funding, so be it. Q397 Dr Taylor: The MS Society is obviously a very large society that needs a lot of money. Do you think you have been influenced? Tell us about the beta interferon episode. Mr McDonald: I would agree with Jenny that as a voluntary and membership organisation one of our most prized assets is our reputation for independence. In terms of the relationship with the pharmaceutical industry that rests on three things. The first is transparency. Our accounts set out where money has come from, from individual pharmaceutical companies. The second is our code of practice which is appended to our evidence and freely available. The third is in terms of accountability. We have 45,000 members, 30,000 of whom have MS which means that over a third of all people with MS in the UK are members of our society and we are accountable through an elected board to them. On the access to beta interferon campaign, that has to be set in the context of our overall activities: millions of pounds' worth of our own reason commitments, 350 branches across the UK, a helpline, £1 million of individual support grants every year. That is the context for our activities on beta interferon. It is probably worth me going back over some more figures which were not included in the evidence. In the two years to the decision on providing the disease modifying drugs the MS Society received a total of £18,000 from manufacturers of those drugs, set against an income in those two years of £53 million. Q398 Dr Taylor: It is a very small amount. Mr McDonald: It is a very small amount. There was a reference earlier to voluntary organisations being described as the ground troops of the pharmaceutical industry. We are not that but we would unashamedly be regarded as the ground troops for people with MS. It is on that basis that we undertook the campaign for access to beta interferon, to put those people on an equal footing with people with MS who lived in France or Germany, where those drugs are readily available. Ms Wallace: The industry operates at a bigger level than the level that came up in the earlier questions in terms of selecting who gets money in the first place. We have talked about whether individuals are affected in terms of how they respond to industry pressure, but those organisations and those individuals are selected as part of an industry strategy to promote its own aims. For example, it is perfectly legitimate for patient charities to campaign for earlier access to new medicines and that is something which coincides with the pharmaceutical industry's interests but that kind of work will inevitably get more funding from the industry than work that is against the pharmaceutical industry's interests. I think that is really where the system gets distorted and where the priorities get distorted, rather than in individual caving into pressure or that kind of development. Q399 Dr Taylor: You would agree tighter regulation is needed? Ms Wallace: Yes. 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. Ms 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 modelling 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 ten 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 ten 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. |