The latest conflagration is a debate over the veracity of a widely cited study, which was published last November and found that treatments used to boost testosterone levels increased the risk of heart attack, stroke and other cardiovascular events in men who had a history of heart disease.
The study, which appeared in the Journal of the American Medical Association, examined records of more than 8,700 men with low testosterone in the Veterans Administration health system between 2005 and 2011. It was one of two studies that prompted the FDA this past January to begin an investigation into concerns over cardiovascular risks of several widely touted testosterone therapies.
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.
In response, one of the JAMA co-authors, Michael Ho, a cardiologist at the VA Eastern Colorado Health Care System, says that he and his colleagues stand firmly by the study results, which ‘remain unchanged even if we include the patients that were questioned with regard to exclusion criteria.
For an appointment or consultation with Dr. Gary Bellman, please contact the office or call 818-912-1899