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LETTERS: Phil B Fontanarosa and Catherine D DeAngelis JAMA's policy on industry sponsored studies BMJ 2006; 332: 177 [Full text]

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Constant Gardener Syndrome

Stephen J Senn   (20 January 2006)

JAMA Policy & The Brave New World

Stephen JW Evans, Kenneth Rothman   (31 January 2006)

Constant Gardener Syndrome 20 January 2006
Stephen J Senn, Professor of Statistics Department of Statistics, University of Glasgow, UK, G12 8QQ Send response to journal: Re: Constant Gardener Syndrome	The main objection I have to the JAMA policy is not that it requires independent validation of analysis but that it only appears to require it for pharmaceutical industry sponsored studies. There have been a whole host of examples ranging from McBride's 'studies' of debendox to the recent case of stem cell research in South Korea, where 'academic' researchers appear to have falsified data. Academics (and I am one) are subject to many pressures ranging from desire for fame to need to get tenure to ambition for promotion. These 'interests' are extremely important but go largely unrecognised. Hardly any contributers to medical journals ever declare them. As a statistician and a sceptic I am not against distrust but I am against selective distrust. If distrust is our currency we need to make it universal and apply it to academics and journal editors as well. To make an apposite analogy, the 'Constant Gardener Syndrome' from which our society suffers is to take it as axiomatic that the pharmaceutical industry is uniquely corruptible by motive whilst forgetting that authors of thrillers as well as film producers, directors and actors also make a living. Post stem-cell meltdown, what justification does JAMA have for giving academics a free ride? Competing interests: The author consults regularly for the pharmaceutical industry His academic career has been considerably furthered by publication.
JAMA Policy & The Brave New World 31 January 2006
Stephen JW Evans, Professor of Pharmacoepidemiology The London School of Hygiene & Tropical Medicine, London, WC1E 7HT, Kenneth Rothman Send response to journal: Re: JAMA Policy & The Brave New World	To the editor: Fontanarosa and DeAngelis (1) claimed that our editorial about JAMA's new rules for industry-sponsored studies contained "numerous errors and misconceptions." In their elaboration, however, they mention only two specific problems: 1) the title of our editorial suggested that the JAMA policy applies only to clinical trials, but in fact the policy applies to all studies; 2) our editorial states that under the new policy, authors from industry must hire an academic statistician before submitting a paper to JAMA, whereas the JAMA editors suggest that their new policy allows submissions from industry without an academic statistician. JAMA will simply refuse to accept these submissions until after an academic statistical review is purchased by the authors. Regarding their first claim, we agree that the title of our editorial, which referred to trials, was misleading, but this mistake was not ours. Our editorial's title was "The Brave New World of Journal Submission." An editor of the BMJ changed the title after we reviewed final proofs and without consulting us, thus confusing the issue and making it seem that we misunderstood how broad JAMA's new policy is. We reported this error to the BMJ on the morning it appeared in print, and it appeared in the BMJ online rapid response on December 13 (2). The BMJ have published a correction acknowledging this on 21 January (3). Fontanarosa and DeAngelis must have overlooked the rapid response, and the BMJ editors did not mention that the error was theirs when they reviewed the letter from Fontanarosa and DeAngelis. Their second claim surprises us. We would not have guessed that JAMA is encouraging authors from industry to submit papers without academic statistical approval. The editors will be bound to reject these submissions under their new policy, though they may make a distinction between those they might reconsider and those that they will not reconsider. If a paper must have a statistical author from an academic institution to be acceptable, we assumed that investigators who work in the private sector would not consider submitting a paper to JAMA without such an author. Why would JAMA want to review such submissions if they are unacceptable a priori? Does this stance imply that the academic review is merely cursory, and that the academic statistician who must be consulted would not join the original investigators as an author of the paper? Or is JAMA suggesting that investigators from industry should submit papers with an incomplete list of authors, and then add another author during the review process? Fontanarosa and DeAngelis describe our criticism of their policies as "blatant and unbalanced" and they take umbrage "that a journal like the BMJ would criticise another journal's policy on such a pressing issue without properly vetting the material for accuracy." We would have thought that journal editors would welcome criticism of their work as warmly as they encourage critical appraisal of the papers they publish, even if the criticism appears in a forum outside of their control. Interestingly, previous editors at JAMA chose to publish criticism of editorial policies at Science and the New England Journal of Medicine (4). As for vetting for accuracy, we sent JAMA a copy of our essay before it was published in the BMJ, and they did not respond. Furthermore, we presume that the editors of JAMA believe that all journals should have such a policy. Finally, citing examples of industry malfeasance, of which we agree there are many, does little to justify an inequitable policy, and one that we believe will be difficult to implement. We are not aware of instances where the malfeasance can be regarded as the responsibility of the industry-funded statistician who authored the paper. The examples cited by Fontanarosa and DeAngelis would probably not have been prevented by having the analysis reviewed by a statistician from an academic institution. At the least, some specific evidence on this point should be cited by JAMA to justify their policy. As we stated earlier, the problems are much wider. To suggest, as Fontanarosa and DeAngelis do, that we "do not fully acknowledge the magnitude and implications of these problems" is unwarranted. Statisticians who are members of major professional societies, such as the Royal Statistical Society or American Statistical Association, are subject to an ethical code of conduct. JAMA suggests by their policy that such statisticians are less ethical than their academic colleagues. As Senn noted (5), "independent" academic authors have their own biases, and unlike authors from industry, they do not usually have to undergo the intense scrutiny of regulatory authorities. Kenneth J. Rothman, vice president, epidemiology research RTI Health Solutions, RTI International, 200 Park Offices Drive, Research Triangle Park, NC 27709, USA Stephen Evans, professor of pharmacoepidemiology (stephen.evans@lshtm.ac.uk) Medical Statistics Unit, London School of Hygiene and Tropical Medicine, London WC1 7HT References 1. Fontanarosa PB, DeAngelis CD: JAMA's policy on industry sponsored studies. BMJ 2006;332:177. 2. Rothman KJ, Evans S: Corrections and a rebuttal to Vandenbroucke. BMJ Rapid response Dec 13, 2005. http://bmj.bmjjournals.com/cgi/eletters/331/7529/1350#123723 3. Correction: Extra scrutiny for industry funded trials. BMJ 2006;332:151 4. Rothman KJ: Conflict of interest--The new McCarthyism in science. JAMA 1993; 269:2782-2784. 5. Senn S: Constant gardner syndrome. BMJ Rapid Response Jan. 20, 2006 http://bmj.bmjjournals.com/cgi/eletters/332/7534/177 Competing interests: KJR is an employee of RTI Health Solutions, an independent non-profit research organisation that does work for government agencies and pharmaceutical companies. SE has no conflicts of interest to declare.