BMJ  2006;332:177 (21 January), doi:10.1136/bmj.332.7534.177

Letter

JAMA's policy on industry sponsored studies

Editor—The editorial by Rothman and Evans, that accused the JAMA editorial policy governing industry sponsored studies of being "unfair and absurd," contains numerous errors and misconceptions.^{1 2}

The title of the editorial incorrectly implies that the JAMA policy applies only to clinical trials. An independent statistical analysis is required for any type of industry sponsored study in which the data analysis is conducted only by statisticians employed by the research sponsor. Rothman and Evans also incorrectly say that the policy requires authors to hire an academic statistician before their submission will be considered by JAMA. The policy clearly states that studies in which the data analysis has been conducted only by statisticians employed by the company sponsoring the research will not be accepted for publication in JAMA. Failure to have the independent analysis completed at the time the paper is submitted does not preclude initial evaluation and review of the paper. The authors also contend the policy may require arbitrary distinctions, such as defining academic statistician. We clearly indicated that the independent analysis must be conducted by statisticians at an academic institution, such as a medical school, academic medical centre, or government research institute. This analysis, which is conducted using the entire raw dataset, serves to corroborate independently the analysis performed by statisticians employed by the sponsor, and by virtue of involvement of an academic centre, provides an additional layer of institutional oversight.

Ironically, this blatant and unbalanced criticism of the JAMA policy was published just two days after the New England Journal of Medicine issued its expression of concern about the VIGOR study, which directly resulted from concerns about data integrity, analysis, and reporting in a major industry sponsored study.³ This example, as well as numerous other serious scientific and ethical lapses involving industry and industry sponsored studies, such as incomplete reporting of data on celecoxib,⁴ suppression of studies of paroxetine,⁵ and delayed reporting of design defects in implantable cardioverter defibrillators,⁶ have resulted in doctors and the public now having an unprecedented lack of trust and confidence in manufacturers of drugs and devices.

We believe our policy is necessary and sound. What we find unfair and absurd is that some companies and research sponsors will resort to tactics that manipulate clinical research data and misrepresent scientific information; that some commentators, such as Rothman and Evans, apparently do not fully acknowledge the magnitude and implications of these problems; and, surprisingly, that a journal like the BMJ would criticise another journal's policy on such a pressing issue without properly vetting the material for accuracy.

To help ensure confidence in industry sponsored studies, JAMA will continue to require an author who is independent of the sponsor to take responsibility for the completeness and integrity of all the data in the study and will continue to require an independent statistical analysis for studies in which the data analysis was conducted only by statisticians employed by the sponsor.

JAMA, 515 N State Street, Chicago, IL 60610, USA Phil.Fontanarosa{at}jama-archives.org

JAMA, 515 N State Street, Chicago, IL 60610, USA

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Competing interests: None declared.

References

1. Rothman KJ, Evans S. Extra scrutiny for industry funded trials. BMJ 2005;331: 1350-1. (10 December.)[Free Full Text]
2. Fontanarosa PB, Flanagin A, DeAngelis CD. Reporting conflicts of interest, financial aspects of research, and role of sponsors in funded titles. JAMA 2005;294: 110-1.[Free Full Text]
3. Curfman GD, Morrisey S, Drazen JM. Expression of concern: Bombardier et al. "Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis," N Engl J Med 2000;343: 1520-8. N Engl J Med 2005;2813-4.[Abstract/Free Full Text]
4. Hrachovec JB, Wright JM. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001;286: 2398.[Free Full Text]
5. Gibson L. GlaxoSmithKline to publish clinical trials after US lawsuit. BMJ 2004;328: 1513.[Free Full Text]
6. Maisel WH. Safety issues involving medical devices: implications of recent implantable cardioverter-defibrillator malfunctions. JAMA 2005;294: 955-8.[Free Full Text]

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