The following letter was signed by three medical societies and more than 125 scientists and physicians from 24 countries, including 59 full professors (8 emeritus), 6 journal editors, and 12 medical society presidents. Signers include U.S. faculty from Harvard, Johns Hopkins, Brown, Cornell, Cleveland Clinic, Mayo Clinic, Baylor Medical College, Tufts, and Boston University, among others. The professional societies are The International Society for Sexual Medicine (ISSM), The Sexual Medicine Society of North America (SMSNA), and The International Society for the Study of the Aging Male.
The full letter can be read below or on their website.
March 25, 2014
Howard Bauchner, MD
Editor-in Chief, JAMA
330 N. Wabash Ave
Chicago, IL 60611-5885
Re: Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels by Vigen et al
Dear Dr. Bauchner,
In the best interests of medical science, we write to recommend retraction of the article by Vigen et al published in JAMA Nov 13, 2013 (1).
As physicians and scientists interested in the testosterone field, we welcome any new addition to the scientific literature that furthers knowledge in this important area. However, there must be a reasonable minimum standard for the quality of publications such that the reported science is credible. The publication of results that are unlikely to be accurate is a disservice to the scientific community and the literature. Due to new revelations, we believe the article by Vigen et al no longer meets the acceptable minimum standard.
The credibility of this article was initially compromised by its original mis-reporting of data, requiring a post- publication revision on January 15, 2014 (2). Now it has been revealed via a new published correction that there were major errors in values presented in the text and figure. The quality and magnitude of these errors indicate gross data mismanagement and contamination, to a degree that the reported results are no longer reliable. Our recommendation for retraction follows guidelines published by The Committee On Publication Ethics (COPE) (3), which has stated that journal editors should consider retracting a publication if “they have clear evidence the results are unreliable, either as a result of misconduct (eg, data fabrication), or honest error (eg, miscalculation or experimental error).”
On March 4, 2014 JAMA published several letters regarding this article (4), the authors’ reply (5), and also a new correction (6). In response to the criticism that the authors had improperly excluded 1132 men from analysis who had received a testosterone prescription after experiencing an event (MI or stroke), the authors indicated they had revisited this value presented in the text and Figure 1, and had made “an incorrect notation” regarding this value.
They now assert the numbers of men excluded for this reason was 128, not 1132. This is an 89% error rate, involving >1000 individuals. The number of men now excluded due to missing coronary anatomy increased from 397 to 1301, a 69% error rate, involving 904 individuals. Astonishingly, 100 women were now identified among the original group of 1132 individuals, meaning that one out of eleven “men” in the study were actually women.
It is impossible for the scientific community to have any confidence in the results of a study when there have been unrecognized errors involving more than a thousand individuals, and nearly 10% of a dataset is populated by the wrong gender. The study by Vigen et al is no longer credible. In the interests of science and the medical literature, we urge you to retract this article immediately.
Abraham Morgentaler, MD, for the Androgen Study Group and the following:
1. Vigen R, O’Donnell CI, Baron AE, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA.2013 ;310(17):1829-1836
2. Correction: Incorrect language. JAMA 2014;311(3):306
3. Wager E, Barbour V, Yentis S, Kleinert S; COPE Council. Retractions: guidance from the Committee on Publication Ethics (COPE). Obes Rev. 2010 Jan;11(1):64-6.
4. Morgentaler A, Traish A, Kacker R. Re: Deaths and Cardiovascular Events in Men Receiving Testosterone. JAMA 2014; 311(9): 961-2.
5. Ho PM, Barón AE, Wierman ME. JAMA 2014; 311(9): 964-5.
6. Correction: Incorrect Number of Excluded Patients Reported in the Text and Figure. JAMA 2014; 311 (9):967.
Hormone Therapeutics April 29th, 2014
Tags: cardiovascular risk, data mismanagement, errors, health risk, JAMA, journal of american medical association, low t, low testosterone, medical literature, medical mistake, myocardial infarction, public health, quality of life, retract article, risks associated with testosterone therapy, safety, stroke, testosterone therapy, well-being