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Androgen Study Group Urges Investigation Into Ethical Violations By JAMA Regarding Controversial Testosterone Study


8/11/2014 8:10:36 AM

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BOSTON, Aug. 8, 2014 /PRNewswire/ -- The Androgen Study Group (ASG) this week submitted a request to the Journal Oversight Committee to investigate violations of "accepted standards of medical journal ethics and editorial integrity" by the Journal of the American Medical Association (JAMA). The 13-page complaint alleging multiple ethical violations was addressed to Dr. Edward Shortliffe, Chairman of the Oversight Committee. The complaint was in regard to the publication by JAMA of a study by Vigen et al in November, 2013 that reported increased cardiovascular risks in men receiving testosterone prescriptions compared with untreated men.

The article has been controversial since its publication, as it contradicted decades of research. It raised national concerns regarding cardiovascular risks in men treated with testosterone, causing many men to discontinue treatment. It prompted the FDA to launch a safety review of testosterone products, and created a new area of medical malpractice, with plaintiff attorneys advertising nationwide for men who had suffered heart attacks and strokes after using testosterone.

The study has already undergone two formal corrections, one for misreporting data, and another that revealed large data errors. More than 160 leading testosterone researchers and 29 medical societies from around the world joined ASG in calling for retraction of the study following revelation of the data errors, asserting that the magnitude and quality of the errors rendered the study "no longer credible." JAMA and the study authors have stood by their findings.

The ASG complaint notes that JAMA's editor-in-chief was personally apprised 2 days after publication that the study's central results were misreported. One week after its initial publication JAMA replaced online the original study with a revised version. Yet JAMA failed to disclose for two months that this highly read article had already undergone a major correction. The ASG alleges this failure by JAMA to alert the public of this correction was an "active form of deception" that had real-world ramifications, as numerous media stories and scientific reports repeated the erroneous results. This lack of transparency represented a "major breach of editorial ethics," according the complaint.

In March, 2014, JAMA published a second correction revealing a series of major data errors: 1) the number of men in one group was changed from 1132 to 128, representing an error rate of 89% involving >1000 individuals, 2) the number of men in a second group was changed from 397 to 1301, a difference of >900 individuals, representing an error rate of 69%, and 3) 100 of the 1132 "men," or 9% of the group, were discovered to be women.

A few months earlier, editor-in-chief Howard Bauchner published an editorial asserting that JAMA had the right to independently review study data because "the first priority in decisions about publication will always be the integrity of the research." Given the multiple, egregious errors discovered in this study, JAMA's obligation was either to retract the article or to review the data itself to assure its accuracy. Failure to do so violated JAMA's own critical objectives of publishing "valid" research and "maintaining the highest standards of editorial integrity."

The ASG notes the FDA's recent denial of a petition to add cardiovascular warnings to testosterone products closely followed its own submitted analysis. With regard to this study, the FDA commented that methodology decisions were "not appropriate" and concluded, "Given the described limitations of the study by Vigen et al. it is difficult to attribute the reported findings to testosterone treatment."

The ASG complaint concludes: "This article is a mess, and JAMA has behaved badly. Something is terribly amiss when a premier medical journal publishes such an obviously weak study that contradicts well-established literature, and in so doing, fosters fear among the public. The concern is heightened when the journal's response to inescapable evidence that the study is meritless is to deceive, distort, stonewall, and dig in."

The full text of the ASG complaint can be found here.

About The Androgen Study Group (ASG)

The Androgen Study Group is a multidisciplinary group of clinicians and researchers dedicated to education and accurate reporting on testosterone deficiency in men and its treatment.

For more information, go to www.androgenstudygroup.org.

For media inquiries please contact Lisa Fiyod at contact@androgenstudygroup.org, or 617-939-1148.

SOURCE The Androgen Study Group

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