Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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The Romans maybe getting it right
- Krisantha Weerasuriya (5 April 2009)
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Competing interests of Tremblay Consulting
- Paolo Tomasi (6 April 2009)
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conflict and other matters
- Michael Tremblay (6 April 2009)
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Reply to "conflict and other matters"
- Krisantha Weerasuriya (8 April 2009)
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what? more on conflict?
- Michael Tremblay (9 April 2009)
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Who pays for what
- Joan McClusky (10 April 2009)
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Further thoughts
- Michael Tremblay (26 August 2009)
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Krisantha Weerasuriya, Regional Adviser, Essential Medicines World Health Organisation, New Delhi, India
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The article by Garattini and Chalmers brings together cogent arguments for making the patient the main beneficiary of medicines and all others involved in medicines working within that framework1. This is not utopian and would probably have been achieved if there had not been distortion by sectors that were profiting hugely and therefore able to impose undue influence. Perhaps there is a similarity to the financial crisis. Banks were supposed to provide finance to activities for consumers and society which would provide a reasonable return to them, but with “light” regulation banks redefined their purpose. Pharmaceutical companies were supposed to develop and produce useful medicines for patients but with compliant regulation redefined their purpose too. The commentary on the article seems a one-agenda rebuttal, mired exactly in what Garratini & Chalmers criticised2. While agreeing that their four suggestions would benefit patients, he specifically states that “ … the Italian approach to funding independent clinical trials is unlikely to be a good idea.” though it is not specified to whom it would not be a good idea. It quotes a survey of 20 Venture Capital Fund managers as the basis for pharmaceutical companies aligning their research and investment more closely with public priorities, if proper incentives are given3. Hardly a study for decisions on investing billions in research. It then states that funding more independent clinical trials would not make problem of bias, poor design, conflict of interest and research misconduct “go way”. Nothing absolutely will, but independent public scrutiny will certainly make these factors very much less when compared to clinical trials done by pharmaceutical companies. The commentary then criticises the basis of Italian Regulatory Authority’s fund but does not evaluate how it has worked and what has been achieved (or not). The conclusion is based on what industry will do if the suggested changes are brought about; the current abysmal record of industry and their concerns is hardly the basis to make such decisions. The Roman (with the one from Oxford) maybe getting it right. Finally no competing interests have been declared by the author of the commentary; would not “Advised a Fortune 100 pharmaceutical company on its global e-business strategy, Regulatory and policy study of the structure of the European biotechnology industry for a Fortune 100 health sector company” (among many others)4 influence opinions that are produced? Perhaps it is also the time for journal editors to have some minimum scrutiny on self-declared competing interests (or select better writers for commentaries?). (Affiliation given for information only; the views are entirely personal) 1. Silvio Garattini, Iain Chalmers. Patients and the public deserve big changes in evaluation of drugs BMJ 2009;338:b1025 2. Michael Tremblay. Commentary: Risks of doing as the Romans do. BMJ 2009;338:b1107 3. Ackerly DC, Valverde AM, Diener LW, Dossary KL, 4 Schulman KA. Fuelling innovation in medical devices (and beyond): venture capital in health care. Health Aff 2009;28(1):w68-75. 4. http://www.tremblay-consulting.biz/experience.html (Accessed 5th April 2009) Competing interests: An interest in ensuring medicine are primarily for health |
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Paolo Tomasi, Scientific Administrator, EMEA London E14 4HB
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Michael Tremblay, the author of this critical response to the article
by Garattini and Chalmers, has declared no competing interest. However, a
quick look at his business' website shows that he has:
Presuming that these activities were not done for free, I would consider them to be a significant conflict of interest, particularly as the author criticises a tax imposed on pharmaceutical companies' marketing and advertising expenses. Of course, the merits and problems of such an approach are open to discussion, but in my opinion a constructive approach is not fostered by failing to mention possible significant conflicts of interest. Competing interests: None declared |
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Michael Tremblay, partner UK, TN25 6RJ
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Krisantha Weerasuriy believes I have not disclosed a potential conflict of interest. I actually have none in respect of the commentary that I wrote as I am not currently retained by any pharmaceutical company and the work referenced in the letter was done as far back as the dotcom era and before. I'm sure we all have done work at some time in our lives which would put us into some sort of conflict with someone somewhere sometime and I doubt employees of the WHO are immune! My work on the international trade in counterfeit prescription medicines was conveniently ignored, an area in which the letter writer has familiarity and in which I designed an approach that aligns government and industry interests; I take some pride in shifting discussion from a focus on theft of copyright, to one of patient safety -- a view not held widely by anyone at the time the work was done. I also advise governments, a point conveniently left out in the review of my CV, as it shows I don't play favourites. I think the BMJ's process of reviewing authors is more than adequate and I did not misrepresent my views, neither with this letter, too. Though I am certainly miffed. The writer uses employment affiliation but then said it was a personal view: people should not be allowed to use such affiliations as it may give their personal views credibility where none is deserved. I would appreciate an apology from the letter writer as it suggests dishonesty on my part. In respect of the substantive points raised by the letter writer: I fear the shortness of space in my commentary left many issues hanging in the air or inadequately covered (the limit is something around 400 words). The venture capital paper was published in Health Affairs -- perhaps the author is not familiar with the publication -- and adds to what we already know about how to use policy to align industry interests and since I am all in favour of aligning industry to public policy goals that is why I cited the paper. What in fact is 'not a good idea' is establishing policies based on weak or flawed foundations, and my analysis suggests that Italy has done that. I was concerned to determine what I think are the consequences of the policy and its potential to undermine research going forward; my view that it will be unlikely to align industry interests toward public policy goals still stands. I am not convinced that no good will come from the pharmaceutical industry, any more that I assume that all governments are benign and only good will come from them. It is a balance of give and take, and that is why it is important to understand how the different actors behave or not under different policy scenarios -- something Italy appears not have done. I have no problem with more independent clinical trials either. I am concerned, though, about the ability of academic communities to influence research priorities independently of public scrutiny, a sort of bias, too. The Italian agency may in fact become 'captured' by the academic community as it develops its goals as academics often uncomfortable with public scrutiny of their research priorities. I would trust the Italian agency to establish priorities as long as it sought guidance from the public, too. My greater fear as a policy advisor is that the policy will actually undermine the ability of Italy to do good medicines research, not enhance it. As improving the quality and status of Italian research is an overarching goal of the Italian government, this policy may have unanticipated and perverse consequences. In the end, we will all be losers. Competing interests: I wrote the commentary to which the letter writer refers. |
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Krisantha Weerasuriya, Regional Adviser, World Health Organisation New Delhi, India 110 002
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I have given my affiliation as part of the full and total (and not selective or partial) disclosure, which is the only method I know of declaring potential conflicts of interest. I am also familiar with and have read the publications that I discuss in my communication, including those that are open access on the internet1. There is no need to respond to any other comments in the reply by Tremblay as nothing else of substance has been said. (Affiliation given again for information, as part of full and total disclosure; the views still remains personal) 1. Ackerly DC, Valverde AM, Diener LW, Dossary KL, 4 Schulman KA. Fuelling innovation in medical devices (and beyond): venture capital in health care. Health Aff 2009;28(1):w68-75. Competing interests: None declared |
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Michael Tremblay, policy advisor United Kingdom TN25 6RJ
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I regret that my earlier commentary appeared not to have added any additional matters of substance, but the substance of my analysis that Italy has pursued a poor policy still remains unchallenged. Indeed, in the responses to the main paper, there is the apparent suggestion to prohibit the pharmaceutical industry from doing any research on the basis of conflict of interest, but obviously all researchers are in conflict, why pick on medicines research alone -- what about medical devices, nanotechnology, electric cars, and so on. The point is that from what we know about how research yields results, we have struck a deal, uncomfortable for some, that the pharmaceutical industry (along with all the universities that do biomedical research) take on the risk of discovery. The problem we have with that is that the public (through paying for the medicines) reimburses the industry for this private risk, which might not be undertaken otherwise and some people don't like that. Certainly the pharmaceutical industry could do more to engage the wider public in their research work (but I suspect that were they to do that more formally, there would be criticism of that, too). However, the reality is that there is a sort of 'iron triangle' (as we policy folk call it) linking government, the industry and the academic research community, or what I call the medico-industrial complex of interlocking interests, which may not always be aligned in the public interest. Ooops, I'm criticising the pharmaceutical industry! Perhaps I have a conflict of interest, oh dear. If correspondent Tomasi feels disclosure of conflicts of interest would enhance the nature of debate, then he is surely misled, for he is confusing debate about issues and debate about authors (it is called ad hominem in the jargon and rightly enjoins people from attacking individuals, rather than what they say.) Oh yes, by the way, no one paid me to write the short few words for the BMJ; as a self-employed policy advisor, I took the time at no income benefit to write the commentary with all the good will in the world and using my not inconsiderable understanding of health policy to reflect on the paper I was responding to. They stand or fall on that basis alone. May I suggest through this response a solution to anxiety some folk feel about how to express personal views while in paid employment. When writing in a personal capacity, you should write under your own name, but put your employment status in the conflict of interest box. There is no necessary formal conflict of interest by being in paid employment (the correspondent is in error in this respect). A conflict of interest arises with employment disclosure when in virtue of that employment the individual's views may differ from their employer's (e.g. an ethical issue for instance), so therefore, personal beliefs and issues are not a conflict of interest except with the employer for whom that person works (this is one reason we protect whistle blowers). If an author is paid to hold certain views on issues then they would be writing in an official capacity and that is of course quite a different matter. In my experience, people don't really understand this. This is one reason why it is common to remove the names of authors from papers to be reviewed to avoid giving the authors more credit than they may deserve. This rarely happens with letters. Wittgenstein wrote: "Wovon man nicht sprechen kann, darüber muss man schweigen", which means "Whereof one cannot speak, thereof one must be silent", from his Tractatus Logico-Philosophicus, written in 1922. The scientific literature would be a much saner place if people paid more attention to this. Competing interests: I wrote the commentary that is subject to this exchange of responses |
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Joan McClusky, Medical writer New York, NY 10003
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Regarding Tremblay's critical review of a suggestion to emulate Italy's approach to funding certain types of clinical trials: He describes the transfer of funds as one from the "haves (industry) to the have nots (research)." The goals are listed as achieving a better return on public investment in medicines research and improving research productivity. The key negative aspect of this approach--at least to Italy--is the potential loss of research to more congenial places with "more receptive commercial environments." This is a somewhat dry analysis with a rather heavy handed conclusion -"do this and you'll lose industry and jobs." But Italy's approach has a certain charm that should not be overlooked. The implied message seems to be, "if you will pay 95% of this amount to market your drugs, you can contribute 5% to fund studies of orphan drugs, direct treatment comparisons, observational outcome studies, and pharmacovigilance." It is, in fact, a kind of tithe on advertising to support worthy research. Competing interests: None declared |
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Michael Tremblay, health policy advisor Tremblay Consulting, TN25 6RJ
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The original issue under discussion was whether Italy's tax on pharmaceutical companies was a sensible way to fund independent clinical trials. The need for such trials is not in dispute, only how they are paid for. This note is to update the original commentary. A Jayadev and J Stiglitz writing in Health Affairs in December 2008, suggest that publicly funded clinical trials would reduce pharmaceutical industry costs, along with value-based pricing of drugs. ["Two ideas to increase innovation and reduce pharmaceutical costs and prices", Health Affairs, 28, no 1 (2009):w165-w168]. The idea is not new but the mechanisms of funding are at issue. These authors, focusing on the US, see the clinical trials being funded by the National Institutes of Health, a more arm's length and research oriented body than Italy's. This addresses my concern that AIFA is possibily conflicted within the system, in the manner it raises money and how it establishes its trial priorities. D Light, also writing in Health Affairs, has recently reanalysed pharmaceutical research productivity data, showing that European productivity, measured in terms of 'importance', exceeds US productivity. In short, European pharmaceutical research is more value-adding than US. Adopting value-based pricing as well would signal to industry that what they are doing in Europe is probably better value, than what they are doing in the US, where reimbursement practices appear to favour me-too drugs. Light makes the important point "...lower European prices seem to be no deterrent to strong research productivity." ["Global drug discovery: Europe is ahead", Health Affairs, 28 no 5 (2009)w969-w977] The issue at hand is to learn exactly what is driving this and why. My fear is that some folk may seek to tax the goose that may be laying the golden eggs. From Light, we now may have a clue that European research practices may be more productive than US. Regretfully, Light does not disaggregate European data by country so we cannot see which jurisdictions and practices may be more effective. This would help assess my contention that Italy's approach may undermine its pharmaceutical research productivity. Competing interests: I wrote the commentary on the original BMJ article |
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