“Gross data mismanagement” led to unreliable results that contradicted 30+ years of medical literature, producing a media frenzy that misled consumers and compromised public health.
BOSTON, March, 25, 2014 /PRNewswire/ — Three professional medical societies and a highly distinguished international group of over 130 scientists and concerned physicians have petitioned the Journal of the American Medical Association to retract the article that precipitated recent concerns regarding cardiovascular risks with testosterone therapy. In a letter addressed to the editor-in-chief of JAMA, Dr. Howard Bauchner, the group cites “gross data mismanagement,” rendering the article “no longer credible.” The article by Rebecca Vigen and colleagues was published in the November 13, 2013 issue of JAMA, entitled “Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels.” The results of this article were widely reported as new evidence that testosterone therapy is associated with cardiovascular risks, resulting in a Food and Drug Administration safety bulletin issued January 31, 2014. The retraction letter was written by the Androgen Study Group.
This article has already undergone two published corrections. The first was published January 15, 2014, due to misreporting of primary results. A second correction published just a few weeks ago, on March 4, 2014, now reveals major errors presented in the article’s text and figure. Specifically, in response to a letter questioning a group of 1,132 men, the authors re-examined their data and discovered the correct number should have been only 128, an 89% error rate, involving more than 1,000 individuals. The value for a second group has now been increased by more than 900 individuals. Finally, the authors discovered this dataset included 100 women, meaning nearly 10% were the wrong gender for the study.
The protest 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.
“This is an extraordinary event,” stated Dr. Abraham Morgentaler, Associate Clinical Professor of Urology, Harvard Medical School, and Chairman of the Androgen Study Group, noting the only continent without a co-signer is Antarctica. “In my 25 years in academic medicine I have never witnessed anything like this response to a journal article. To call for retraction of an article is exceedingly rare. To have several professional societies and so many of the most accomplished experts in the field unite in this action indicates the seriousness of the article’s errors, and the magnitude of damage this article has caused to the public’s perception of testosterone therapy. Lost in the media frenzy that followed this article’s publication is the fact that substantial evidence accumulated over 30 years has shown repeatedly that higher testosterone levels are associated with bettercardiovascular outcomes. In the interests of medical science and the public good, JAMA should do the right thing and retract the article.”
Failure to do so continues to harm public health, the experts believe. Martin Miner, MD, Associate Clinical Professor of Family Practice and Urology at Brown University states, “Many of my patients stopped taking testosterone because of the JAMA article, even those who had experienced substantial benefits. And now we find out it was all based on nothing but sloppy science. We are talking about real consequences on individuals’ health and quality of life.”
“There is nothing more fundamental to science than honest and accurate reporting of results,” said Abdul Traish, PhD, Professor of Biochemistry and Urology at Boston University. “The scientific community has spoken: the publication of this article is a violation of the trust between a premier medical journal and the public. It is now up to JAMA to repair that trust.”
To read the full letter, click here.
Hormone Therapeutics April 29th, 2014
Tags: cardiovascular risk, data mismanagement, errors, health risk, journal of american medical association, low t, low testosterone, medical article error, medical literature, mistakes, myocardial infarction, public health, quality of life, retract article, risks associated with testosterone therapy, safety, stroke, testosterone therapy, well-being