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EDUCATION AND DEBATE: Ray Moynihan Cochrane at crossroads over drug company sponsorship BMJ 2003; 327: 924-926 [Full text]

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Drug company sponsorship would endanger health care improvement

Peter R Mansfield   (17 October 2003)

The future of systematic reviews

Paolo Bruzzi   (18 October 2003)

Payors should pay

Chris Hogness   (18 October 2003)

Drug companies could help improve access to reviews

Ben Toth   (19 October 2003)

Grab All The Cash . . . And Run . . .

Joseph . C . Obi   (19 October 2003)

Cochrane in the hands of industry even if not sponsored

JOÃO M. OLIVEIRA   (20 October 2003)

Only indirect funding to the Collaboration is acceptable

Giuseppe Biondi-Zoccai   (20 October 2003)

Cochrane Colloquium in Barcelona. A view from the debate in Spain

David Bussé (MD, PhD, MScPsych)   (24 October 2003)

Drug company sponsorship would endanger health care improvement 17 October 2003
Peter R Mansfield, Director Healthy Skepticism Inc, 34 Methodist St, Willunga SA 5172, Australia Send response to journal: Re: Drug company sponsorship would endanger health care improvement	The Cochrane Collaboration is the foundation for many efforts to improve health care. Drug company sponsorship would tilt the foundation making the whole house of health care reform unsafe. Healthy Skepticism's work to improve health by reducing harm from misleading drug promotion depends on the Collaboration for a gold standard comparator for promotional claims. ( www.healthyskepticism.org ) If we could not rely on the Collaboration, where could we go? The Collaboration's most priceless asset is a reputation for reliability. Companies spend billions trying to achieve such a reputation without success because a small scratch can ruin the whole record. If the Collaboration accepts drug company sponsorship then we will not know which reviews we can trust. If we can't trust the Collaboration why should anyone support it? If we can't trust it why should taxpayers fund it? Andrew Moore "strongly defends" tarnishing the gold standard by taking money from Pfizer. He asserts that: "We had explicit rules to ensure independence." Clearly he was not financially independent. The only way to ensure independence of judgement is to refuse funding from vested interests because any gift can lead to unintended unaware bias.<1,2,3> The best defence is to sign the NoFreeLunch pledge ( www.nofree.lunch.org ) There are three main ways that drug companies can increase the funds available for Cochrane reviews: pay their taxes, lower their prices and quit their misleading promotion. Consequently we need to change our systems for paying drug companies to enable them to have good returns on investment without tax avoidance, high prices and misleading promotion. The key to that is to reduce wasteful competition that increases their costs. Having companies compete to tilt the Collaboration their way would just make everyone's problems worse. 1. Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift giving. Am J Bioethics 2003;3(3):39-46. 2. Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA 2003;290:252-255 3. Mansfield PR. Bribes for doctors: a gift for bioethicists? Am J Bioethics 2003;3(3):47-8. Competing interests: I have recieved gifts from drug companies in the past but signed the NoFreeLunch pledge in 2001.
The future of systematic reviews 18 October 2003
Paolo Bruzzi, Head, Unit of Clinical Epidemiology National Cancer Research Institute, L.go R. Benzi, 16132 Genova, Italy Send response to journal: Re: The future of systematic reviews	Sir, the scenario depicted by Moynihan (1) resembles the discussions within the Catholic Church on permitted contraceptive methods: both are out of touch with what is going on in the real world. In few years, the concepts put forward by the EBM movement revolutionized the philosophy and practice of medicine. A key factor in this dramatic change was the development and refinement of the methodology that enables to systematically evaluate and summarise all the available information, usually fragmented in many trials of varying size, quality, reliability and accessibility. However, in the near future, there may be little left to meta-analyse. Big Pharma, where the majority of new treatments come from, is increasingly adopting the one-shot-trial strategy, aimed at bringing new drugs into the market as soon as possible. A large -sometimes oversized- randomised trial, resulting from international, even worldwide, prestigious though often occasional co-operation, faultless from a methodological and documental viewpoint, and initiated soon after (and sometimes before) the completion of phase I-II trials, is worth its costs (few millions) if it warrants the licensing of a (marginally?) effective drug just a couple of years earlier. Replication of these trials is seldom possible, both in the case of positive results, for ethical reasons, and in the case of negative results, because nobody is interested in replicating a large, good quality, negative trial. Furthermore, skyrocketing trial costs make it increasingly difficult to run trials not sponsored by pharmaceutical companies. As a consequence, medical practice and guidelines will be increasingly relying on the results of just one trial, valid as it may be (see, as an example, ref. 2 and the accompanying editorials). As new treatments progressively replace the old ones, the role of standard systematic reviews in the building of medical knowledge will become more and more marginal, and nobody (including the industry) will care who pays for them. The discussion within the EBM community should focus instead on the development of methodologies to help clinical decisions in a world where these are to be more explicitly based on extrapolations or indirect evidence. More important, the medical community as a whole should decide whether its present role in the setting of clinical research priorities is satisfactory. When discussing these issues, my suggestion is to leave the industry out of the door. 1) Moynihan R. Cochrane at crossroads over drug company sponsorship BMJ 2003; 327: 924-926 2) Goss PE, M.D., Ingle JM, Martino S. A Randomized Trial of Letrozole in Postmenopausal Women after Five Years of Tamoxifen Therapy for Early-Stage Breast Cancer. Published as an early release of the N.E.J.Med. at www.nejm.org October 9, 2003 Competing interests: Paolo Bruzzi, in the past 20 years, accepted in several instances from no less than 12 pharmaceutical companies one and/or another of the following: Reimbursement for attending a symposium - Fee for organising education - Funds for research - Funds for a member of staff - Fees for consulting. Unfortunately, he was never offered a fee for speaking, nor does he hold any stocks or shares in any pharmaceutical company.
Payors should pay 18 October 2003
Chris Hogness, Associate Director of Curriculum, Faculty Family Medicine of Southwest Washington Southwest Washington Medical Center, Vancouver, WA 98668 USA Send response to journal: Re: Payors should pay	Governments who pay for health care for their populations, and health insurers who pay for health care for their clients--"Payors"--and the patients they cover--have the greatest interest in determining the truth about cost-effective health care. I would have no problem with, in addition to public funding sources, Cochrane receiving significant funding from the health insurance industry. I completely agree with those who maintain that all of the available evidence suggests that pharmaceutical industry funding would bias the results of reviews in favor of the sponsor's drug. The bias of payors in favor of spending less has not been as clearly shown to influence study results, and is in any case a healthier bias in an era of exponentially rising health care costs. --Chris Hogness, M.D. Competing interests: None declared
Drug companies could help improve access to reviews 19 October 2003
Ben Toth, Head of Knowledge Management NHS Information Authority Send response to journal: Re: Drug companies could help improve access to reviews	As a first step, and perhaps as an alternative to funding the production of reviews, pharmaceutical companies could help improve access to reviews. The Web is a vital source of information, and search engines are a popular means of finding information on the Web - a recent survey of British students found that 45% used Google as their first port of call when looking for information. Until Cochrane Reviews are visible in search engines such as Google the impact of Cochrane Reviews will always be less than the funding agencies and review authors would wish. The easiest way to do this would be for pharmaceutical companies to work with the Cochrane Collaboration and Wiley Interscience to remove the barriers to Cochrane Reviews. Competing interests: None declared
Grab All The Cash . . . And Run . . . 19 October 2003
Joseph . C . Obi, Chief Consultant WellnessClinics.co.uk Send response to journal: Re: Grab All The Cash . . . And Run . . .	Sua Cuique Voluptas (Everyone Has His Own Pleasures) Competing interests: Dr Joseph Chikelue Obi MBBS MD MPH DSc FRIPH FACAM is also the Chairman of the General Wellness Assembly (GWA); an International Professional Body for Independent Wellness Consultants.
Cochrane in the hands of industry even if not sponsored 20 October 2003
JOÃO M. OLIVEIRA, Medical Director - INSTITUTO PORTUGUÊS DE ONCOLOGIA FRANCISCO GENTIL 1099-023 LISBOA - PORTUGAL Send response to journal: Re: Cochrane in the hands of industry even if not sponsored	We should be afraid that the Cochrane Collaboration becomes a tool of pharmaceutical industry but not only because of direct sponsoring. With all the main clinical trials decided, performed and analysed by the industry, what else is left to review? Even if strictly independent, reviews can only review the issues that drug-sellers decide to investigate. Evidence Based Medicine is increasingly "working for" the pharmaceutical industry as the mainly (and soon the one and only) "evidence maker". In fact, it must be acknowledged that the highly-paid, industry-driven trials almost monopolize the capacity of the clinical researchers community all over the world, with research issues decided in accordance with commercial interests that are seldom coincident with the public-health real questions. Therefore, a strictly independent, non-industry-sponsored, Cochrane Colaboration, forced to review the only evidence available, should be much more useful to the pharmaceutical companies than a "suspect" one funded by them. To counteract this, other players (governments, regulatory bodies, academic institutions, insurance companies, social security, etc.) should commit themselves much more deeply to fund and/or perform research on health questions that are "orphan" in the eyes of the pharmaceutical industry but of utmost relevance to obtain health gains and to preserve the economic survival of health systems even in developed countries. Competing interests: Direct participation in industry-sponsored trials from 1988 to 2001. Since 2001, participation in decisions concerning research contracts between my Institute and pharmaceutical companies.
Only indirect funding to the Collaboration is acceptable 20 October 2003
Giuseppe Biondi-Zoccai, Cardiovascular Medicine Fellow Institute of Cardiology, Catholic University, 00168 Rome, Italy Send response to journal: Re: Only indirect funding to the Collaboration is acceptable	Only indirect funding to the Collaboration (eg central offices, website, publishing efforts) would be acceptable and uncompromising. Any means of individual funding to reviewers would instead undermine reviewers' independency and credibility in an irreversible way. Competing interests: None declared
Cochrane Colloquium in Barcelona. A view from the debate in Spain 24 October 2003
David Bussé (MD, PhD, MScPsych), Medico Adjunto, profesor asociado (SpR in Psychiatry and Lecturer) CSMA MJ- Diputació de Barcelona Send response to journal: Re: Cochrane Colloquium in Barcelona. A view from the debate in Spain	Congratulations for your interesting paper. It's being sent to our evidence based mental health's list for Spanish Psychiatrist to open a debate. In Spain the drugs industry sales and puts its nose in "everything". But in Spain there's not enough funds to carry on research from the Goverment, compared with the well-setled Northern European areas. I think that some unsolidarity, selfish or chauvinist views appear. Maybe they do not understand what is the meaning of the saying: "to be on other's shoes". The drug industry implies a way to help us with our CME, which it is going to be a benefit for our best practice, in the best profit for our patients. Since Hippocrates there have been ways to learn and improve Medicine, and our Jury clearly explains what are the ethics which each of us, -from North to South- West and East we must keep our ethics and morals in mind, applying it in order to improve our learning ever. Competing interests: None declared