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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Did you read the report Joe?
- Richard Horton (4 February 2009)
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Now we need to act
- Des Spence (6 February 2009)
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The National Health Service must take a stand.
- Alan Rodger (8 February 2009)
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Doctors and the Industry : two to tango
- David Gillen, David Roblin, Mark Edwards, Ruth, Hargreaves (10 February 2009)
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Re: Doctors and the Industry: two to tango
- Hugh Mann (12 February 2009)
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Horton’s bluster unconvincing
- Joe G Collier (14 February 2009)
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Setting an example
- Sudhakar S George (15 February 2009)
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Transparency of self regulation under the ABPI Code
- Heather J Simmonds (27 February 2009)
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Richard Horton, Editor The Lancet
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Joe Collier's editorial about the RCP working party report - Innovating for Health - is a satirical fairytale of wonder and mystery. (Please note my severe competing interest: I chaired the working party, wrote its final report, and had several spirited and friendly discussions with Joe during its preparation.) Joe says that "the interests of patients seem to have been a secondary consideration". Joe: have you actually read our report?! It seems not. Derek Calam was our patient representative and spoke on behalf of the RCP's Patient and Carer Network, a group of patients - not doctors - who advise the College on patient-related matters. Derek completed a survey of his members for us, and their views informed not only the chapter entited "Patient Care" (the longest chapter in our report), but also the entire document. All 10 recommendations we made in that chapter came directly from our consultation with patients. We also took evidence from consumer organisations - eg, the principal policy advisor of Which?, patient charities (eg, Diabetes UK and SANE), and we received written evidence from many individuals and groups from the non-professional, non-industry sector. The mystery to me is that Joe took part in a consultation at the College in which I explained all this in great detail. But for whatever reasons he now chooses to ignore the very patient-focused methods we adopted. Joe says that our real agenda was to rehabilitate the image of industry. That will be a surprise (and possibly an insult) to Derek and to 7 other members of the working party who are neither pharmaceutical physicians nor work directly for industry. I doubt that industry sees me as much of a friend either. The closest I have ever got to being fired was over an editorial The Lancet ran criticising AstraZeneca. What all members of the working party wanted to do was end the slanging match between critics of pharma, doctors, and industry - a slanging match that does no-one much credit, and certainly doesn't help patients get the medicines they need. Joe also says there is little direct criticism of industry in our report. Again, please read what we have said Joe. We: - review masses of past evidence about industry spin, manipulation, adverse influence, and substandard research; - stress acute patient anxiety about the infiltration of industry into the lives of doctors; - raise serious concerns about the industry funding of patient organisations; - emphasise and strongly criticise the endemic gift culture that industry and medicine collude in; - point out the steep loss of trust in industry because of these shortfalls in its behaviour; - and underline the lack of industry leadership to clean up its act. I'm not sure what more we could have said. The report is studded with quotes criticising industry. But we wanted to go beyond that kind of stand-off and see if we could find a point of appropriate collabotration between the NHS, academic medicine, and industry. Surely, we asked, appropriate collaboration with the interests of patients as the governing principle was better than simply shouting at one another, as we have largely done for decades. To be fair, Joe does say there are "positive recommendations" and that "we would do well to adopt several of the recommendations". Thanks for that, at least. But his editorial wants us to fight the old battles and that is not what we wanted to do. Far more importantly, it is not what patients told us they wanted us to do. We listened to these patients, and our report is the outcome. Richard Horton Competing interests: I chaired the RCP working party and wrote its final report |
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Des Spence, GP Glasgow G20 9DR
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There is a sea change. Patient are increasingly weary of medicine and suspicious of large corporations. Many of the public no longer believe in the long list of new illnesses that once marched from the Industry research factories. At the same time the Pharma Industry patents are running out . The industry is skint, needs to cut costs and to try develop a new approach - just like every other major business sector. Also many individuals within the industry are embarrassed and deeply upset by their public persona. The Industry , need, want and acknowledge they need to change – morally and above all financially. See a slashing of the saturated sales forces and a drive towards real innovation. The real issue for the colleges to consider is us – Doctors not the Industry. What have we been doing? We are supposed to be intelligent and the patient advocate but have engaged in medicalisation , exposing patients to the risks of a succession of highly questionable medical treatment. Only to enjoy the largesse , flattery, freebies and trips of Pharma – unquestioning the content of education and inappropriately defending these gifts in kind. We have let ourselves , the profession, but worse of all the patients down. The Colleges and GMC need to give specific and direct advice to doctors in this relationship. The core theme must be full disclosure of all payments, an end to all sponsored education and to severely limit the access of sales reps – that simple. This would generate a level playing field for the Pharma Industry, allowing them to move forward with lower costs and once again to take pride in quality research not bankrupt quality marketing. Competing interests: nofreelunch |
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Alan Rodger, Recently retired 8 Clairmont Gardens, Glasgow G3 7LW
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It seems to me that there is one critical group missing from this debate - the employers of nearly all medical practitioners in this country. It has been said to me by a good friend who is a pharmaceutical representative that he would be sacked if he accepted so much as a paper clip let alone a cup of coffee from the company supplying his employer with stationery supplies. Yet doctors expect gifts and hospitality from the very industry that is the major supplier to their employers. The four NHS national authorities should take a lead in saying what is acceptable for its employees in their relationship with suppliers. And perhaps the best remunerated group in the NHS, the doctors both junior and senior, could consider paying for some of their own postgraduate education, as happens in many professions and for all self-employed, utilising the tax system for some reimbursement, rather than depending on the capriciousness of industry handouts and bribes. Competing interests: I have shares in a pharmaceutical company in an ISA. In the past I accepted financial support for educational travel from the pharmaceutical industry but not in recent years. The dept I directed till recently accepts educational and research funding from several drug companies. |
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David Gillen, Medical Director Pfizer Ltd Pfizer Ltd Walton Oaks Tadworth KT20 7DG, David Roblin, Mark Edwards, Ruth, Hargreaves
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Dear Dr Godlee The current edition of the BMJ is interesting and the message - "It takes Two to Tango" is in our view, highly appropriate with regard to the relationship between medicine and the pharmaceutical industry. We are pharmaceutical physicians who made a positive choice to join the Industry. We are members of royal colleges and faculties and collectively have over 60 years of experience in Industry across Research & Development, Medicines Regulation, Medicines Policy, Academic Pharmaceutical Medicine as well as Medical and Scientific Affairs. In our view our company, as well as the Industry as a whole, is making real strides to create an improved relationship between the NHS, Academia and Industry. This is a relationship that we believe must be led by science and medicine and is essential to ensure that the UK continues to be at the forefront of Drug Research, Development and Innovation. The risks to this, as reported in the RCP report (1) are clear, significant and cannot be understated. Transparency is an area that we recognise is important we focus on. At Pfizer we have been committed to Clinical Trial registration and disclosure of Clinical Studies for several years (please see http://www.pfizer.com/research/clinical_trials/clinical_trials.jsp) and recently posted our 1000th Clinical study result. We also regularly post updates to the Pfizer Pipeline (http://www.pfizer.com/research/pipeline/pipeline.jsp). In addition Pfizer has led in its policy of transparency in our relationships with Patient Organisations (2), and now have announced the next important area of transparency called for in a "new more mature relationship"- that of Payments to Doctors (3) Continuing on the theme of transparency in Industry, we firmly do believe that we, as well as other Pharmaceutical Physicians, can play an important and appropriate role in educating Health Care Professionals in training about aspects of Clinical Pharmacology and Therapeutics such as the Principles of pharmacokinetics and pharmacodynamics, the Development of Medicines, Medicines regulation & manufacturing and the importance of Pharmacovigilance. For example, is it not deeply worrying for patients everywhere that so many medical students surveyed lacked confidence in prescribing warfarin (1)? We are all therefore delighted to be involved in one of the first pilots of this with an "innovative" medical school - Brighton and Sussex (BSMS). In our experience, an absence of grown up discussion between Industry and Medical Students may lead to the inappropriate "entitled" attitude of some sections of Medicine in the past and even today. It is therefore disappointing to read some of the "mis-informed" correspondence on the recent BMJ news item (4) reporting the course we teach on. We would invite those with negative views of the "Student Selected Course in Drug Development" that we run with BSMS to come and see it for themselves rather than criticise from afar! They would find no free lunches, pens or mouse mats on this course. The course opens an educational dialogue and is an important step to ensure that future doctors understand how drugs are researched and developed such that they can make their own minds up concerning the merits or otherwise of therapeutic interventions. In this light it is surprising to find that this initiative is criticised. A silo like approach to clinical research will further distance industry professionals and practising clinicians. Both parties need to work together to ensure that potential new medicines are advanced effectively to those who need them – the patients. Transparency in that relationship is key and the future. In summary, we welcome the debate that we hope will be triggered by the recently published RCP report "Innovating for Health: Patients, Physicians, the Pharmaceutical Industry and the NHS " (1) and look forward to arguing our case, and with a new cadre of researchers and clinicians leading the search for new medicines for patients in the UK and the world. Yours truly, Dr David Gillen Medical Director Pfizer Ltd, BSc MBBS MRCGP MFPM Dr David Roblin, Vice President, Head of Research, PGRD Sandwich, BSc MBBS FRCP MFPM Dr Mark Edwards Director of R&D Public Affairs BSc MBBS FRCA Dr Ruth Hargreaves, Medical Director CNS Pfizer Europe , MD, MRCP, MRCGP, FRCPath, FFPM References: 1-Royal College of Physicians. Innovating for health: patients, physicians, the pharmaceutical industry and the NHS. Report of a working party. London: RCP, 2009. 2- http://www.pfizer.co.uk/Inhealthcare/PatientGroups/Pages/Patientgroups.aspx 3- http://www.reuters.com/article/marketsNews/idINN0953964720090209?rpc=44 4- Rebecca Coombes- BMJ 2009;338:a3179 Competing interests: All those listed above are employees of Pfizer Ltd DG was a member of the RCP working party that authored “Innovating for health: patients, physicians, the pharmaceutical industry and the NHS” |
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Hugh Mann, Physician Eagle Rock, MO 65641 USA
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In every tango, one dancer is leading, and the other is following. Since the
designated doctors work for the pharmaceutical industry, who is leading,
and
who is following? Moreover, as employees of the pharmaceutical industry, do
the designated doctors receive straight salaries, or do they also receive
bonuses and commissions? If they receive bonuses and commissions, how
are
these payments determined? Competing interests: None declared |
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Joe G Collier, emeritus professor of medicines policy St George's, University of London, SW17 0RE
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Richard Horton’s commentary on my editorial1 raises important questions but ultimately its content and style served only to strengthen my view that there are flaws in the working party and its processes and that these are sufficient to diminish its value. In my editorial I outline what I believe are the features of an ideal working party and use them to argue how the Royal College of Physicians (RCP) working party has failed. Horton does not quibble with most of my observations so I assume these are acceptable. His two material concerns are that I say ‘that the interests of patients seem to have been a secondary consideration’, and that ‘there is little direct criticism of industry’. On the first point, Ian Gilmore (President of the RCP) in his Foreword to the report, describing the origins of the working party, and having said that ‘the partnership established between physicians, industry, academia and the NHS needs to be improved’, added that the RCP and pharmaceutical industry representatives had ‘identified several factors critical to the future of the pharmaceutical industry and to pharmaceutical research in the UK. Among other things these included the need to create new partnerships between industry, academia, clinicians and the public.’ Other issues were mentioned, but the idea of partnerships is listed first and seems to me the most fundamental. Assuming that ‘the public’ and ‘patients’ are interchangeable in this context, and that ‘partnership’ means a relationship amongst equals, it might follow that the report would make recommendations on how, for example, patients, industry, the NHS, government and doctors should work together as ‘equals’ on key issues of policy and decision-making in order to resolve the current dilemma. However, of the dozen or so firm (‘must-’, ‘should-’) recommendations relating to patients, the notion of a real partnership features in only one, and even then patients are the last ‘interested group’ to be mentioned! In the other patient-orientated recommendations, the wording makes patients a group to be helped. As to the second point and so my observation that there is little direct criticism of industry, Horton defends the working party’s stance by arguing that the report was indeed critical because much of the received/gathered evidence published in the report was critical. However, in the context of a working party, such material can only offer ‘indirect’ criticism. For ‘direct’ criticism one needs to look at the recommendations of the working party and in this respect its members remain essentially silent. In passing, Horton argues that a bias towards industry would have been unlikely since 8 of the working party’s members ‘are neither pharmaceutical physicians nor work directly for the industry’. That, of course leaves 9 members who did have links. It seems an oversight that no such conflicts of interest were included in the text of report itself. The significance generally of ‘recommendations’ seems to have escaped the group. Recommendations are key markers of the group’s findings, and so give the strongest indication of the way members were thinking. The section of the report on ‘Gathering the evidence’, states ‘The findings of the Working Party were reported and tested against the views of over 50 experts in September 2008’. I was amongst those experts and in reality, while there was some discussion about the evidence, the actual findings (recommendations) were never divulged and so any notion of ‘testing’ is unreal. Working parties can play a very important role in changing how we think and act. It was enterprising of the RCP to undertake an enquiry into the pharmaceutical industry and ultimately it has served to stimulate valuable debate. Sadly, on this occasion, the working party itself wasted an opportunity. The RCP should now establish guidelines for Working Parties that will avoid such miscarriages in the future. Reference 1 Collier J. Doctors, patients, and the pharmaceutical industry. New report reflects a working party that has lost its way. BMJ 2009;338:443 Competing interests: Author of original editorial |
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Sudhakar S George, ST3 in nephrology Salford Royal Foundation Trust, M6 8HD
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I agree wholeheartedly that the drug industry has far too much influence on the medical profession. I attended two recent BMJ "Masterclasses" on Cardiology and Respiratory Medicine held at BMJ House. I was disappointed to see that on both days, there was a drug company sponsored talk promoting the prescription of two drugs (procoralan by a cardiologist and spiriva by a respiratory physician). Surely the BMJ should be setting the correct example to the rest of us? Competing interests: None declared |
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Heather J Simmonds, Director, Prescription Medicines Code of Practice Authority 12 Whitehall, London, SW1A 2DY
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Health professionals reporting violations of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry to the Prescription Medicines Code of Practice Authority (PMCPA) can be reassured that matters are not ‘swept under the industry carpet’ (Editorial, Professor Joe Collier, BMJ 6 February). Full details of completed cases are published on the PMCPA website (www.pmcpa.org.uk). Complainants are fully involved in the process and can appeal rulings and comment on appeals from respondent companies. The only cases that are not published in detail are those ruled not to be within the scope of the Code – and in these cases complainants have similar rights of appeal. Professor Collier is correct to state that the Medicines and Healthcare products Regulatory Agency (MHRA) could prosecute companies but this is a very rare event. Its activities are also published on its website but the detail is very much less than that published by the self regulatory system. The transparency of the UK self regulatory process is a key feature in maintaining confidence of all involved. The Code includes requirements about declaration of sponsorship, employing health professionals as consultants (including encouraging those heath professionals to declare that interest) meetings and hospitality. As illustrated on the front cover of the BMJ it takes two to tango (a theme the industry has been using since 2006 to publicise the Code). Anyone who is concerned about the activities of a pharmaceutical company can submit a complaint and judge the system for themselves. The PMCPA like many others will be studying the Royal College of Physicians report carefully to see what recommendations can be made for changes to the Code. Those with comments on the Code are welcome to submit them to the PMCPA for consideration. Competing interests: Director of the Prescription Medicines Code of Practice Authority which administers the ABPI Code of Practice for the Pharmaceutical Industry |
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