A study the FDA has cited as a reason to investigate the cardiovascular safety of testosterone drugs has come under heavy fire from critics. Physicians and researchers are calling for the November paper's retraction, citing at least two corrections that they say compromise its credibility.
As MedPage Today reports, the Androgen Study Group, comprising more than 125 doctors, has sent a letter to Howard Bauchner, editor-in-chief of the Journal of the American Medical Association (JAMA), asking that a study that linked testosterone therapy to a greater risk of death, heart attack and stroke in some patients be pulled from the publication.
With the market for testosterone therapies rapidly expanding, so-called "Low-T" drugs have landed at the heart of a safety controversy, with activists going so far as to urge the FDA to label the treatments with black-box warnings. Last year, the JAMA study raised red flags on the big-selling drugs. AbbVie ($ABBV), Eli Lilly ($LLY) and Endo ($ENDP), among others, are selling into a market expected to reach $5 billion by 2017, which critics say has been expanding as drugmakers have steered men toward using them as lifestyle treatments.
But the journal has since published two corrections to the paper, one clarifying that results were based on estimates rather than raw data, and the other--on which the Androgen Study Group's letter centers--involving a reclassification of more than 1,000 patients excluded from the study, including 100 who were women.
"They found that almost 10% were women in an all-male study, so why should we believe any of the other data?" Harvard Medical School's Abraham Morgentaler told MedPage Today. "These data were so off that it's hard to believe the data for the entire study are accurate."
Study author Michael Ho of the Eastern Colorado VA, on the other hand, says he and his colleagues "stand firmly by the results" of their study, claiming they were not altered by the changed reasons for exclusion. "Misperception about that could suppress research that raises important questions about patient safety," he told the news source.
In the meantime, the FDA is looking into testosterone drugs itself, announcing a decision in January to reassess the safety issue. So far, the agency hasn't reached a conclusion, a stance that has sparked the ire of those convinced the drugs are dangerous.
"In the face of this accumulating evidence, this statement is reckless and is a betrayal of the FDA's role as an agency in the U.S. Public Health Service," Sidney Wolfe, founder of the advocacy group Public Citizen, said in a petition last month.
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