In a startling new development about the low-t therapy controversy, more than 130 physicians and scientists and 7 professional societies from around the world have determined that the original Journal of the American Medical Association (JAMA) paper about increased cardiovascular risks for men taking testosterone replacement therapy contains major errors and should be retracted from the journal.
In addition to the issues detailed in my first post, the March 14, 2014 petition cites newly disclosed, glaring errors, and states that “the quality and magnitude of these errors in values indicate gross data mismanagement and contamination to a degree that the reported results are no longer reliable.”
Here’s a synopsis of the background. The original JAMA paper was published on November 13, 2013. On March 5, 2014, the journal published several letters of criticism from leading testosterone experts including a first response by Dr. Abraham Morgentaler, Associate Clinical Professor of Urology at Harvard Medical School, Beth Israel Deaconess Medical Center and Director of Men’s Health Boston.
The journal also published the study authors’ correction, where they clarify that the “30% increase in the risk of stroke, heart attack and death” for men who had been prescribed testosterone therapy was not a raw figure, but based on Kaplan-Meierestimates, a statistical manipulation of the data as detailed in my earlier post, The Low T Story: Hunting for the Truth.
In the authors’ response to further criticism though, there were startling new revelations that prompted testosterone experts around the world to call for retraction of the entire paper.
The study authors say that they made an “incorrect notation” about the numbers for two groups of men who were excluded from the study. According to the petition signatories, this “incorrect notation” translates to an 89% error rate in the number of men excluded from the study who received a testosterone prescription after experiencing a heart attack or stroke, and a 44% error rate in the group who were excluded due to coronary anatomy irregularities.
Beyond those errors though, for me, this one takes the cake:
“Astonishingly, 100 women were now identified among the original group of 1,132 individuals, meaning that one out of eleven “men” in the study were actually women.” Dr. Morgentaler says to MedPage Today, “They found that almost 10% were women in an all-male study, so why should we believe any of the other data?”
Can you imagine Jon Stewart right now, saying “Whaaaaaaaat? No wonder their T was low!”
“It’s dismaying since this paper came into field where people have looked at cardiovascular risks with testosterone in over 200 studies over more than 20 years. The caliber of scholars and clinicians who have signed on this petition for retraction is like nothing I’ve ever seen. It speaks to how strongly these experts each believe the article represents false information and has hurt the cause of medical science,” Dr. Morgentaler told me via email.
It will be interesting to see if and how swiftly this paper is retracted. For a complete discussion about separating the facts from the frenzy, an informative discussion of symptoms, side effects and correct testing for testosterone deficiency in men, check out our feature story: Low T: Separating Facts From Frenzy.