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Controversy Over the Latest Testosterone Therapy Studies

Published on Apr 7, 2014 at 6:15 pm in Dangerous Drugs.

In January of this year, the U.S. Food and Drug Administration (FDA) announced an investigation into cardiovascular risks posed by several popular testosterone therapies. According to its alert, the FDA is investigating “the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.”

One of the studies that lead the FDA to its decision looked at the records of 8,000 men with low testosterone treated at VA hospitals. That study was published last fall in the Journal of the American Medical Association (JAMA). On average, the men were about 60 years old, and many had underlying heart disease; some of the men received testosterone treatment while others did not. The results showed a 30% increased risk of stroke, heart attack, and death in the group taking testosterone treatments.

The JAMA study is now being challenged by some who say the study design and interpretation contained flaws. In an interesting twist, The Wall Street Journal reports that one of the leading challengers is a Harvard urologist who is on the take from AbbVie. AbbVie is the Abbott Labs spin-off that now markets Androgel, which is a billion dollar product used by millions of men.

The urologist, Dr. Morgentaler, was quoted as saying, “The article that set the stage for this concern and prompted the FDA to issue a safety alert [that is] based on data that is no longer reliable.”

The Wall Street Journal writes, “Morgentaler, by the way, has received payments from AbbVie, which markets AndroGel, the most widely used testosterone treatment. Similarly, several of the other academics and physicians who have signed his letter also have relationships with drug makers, including those that sell these therapies.”

In response, the Journal reports that Morgentaler “dismisses suggestions that the group is a stalking horse for drug makers. ‘A great number of the people who do research in testosterone do have some financial relationships or have received grants with some of those companies,’ he says.”

Part of the controversy involved the decision criteria for exclusion of some patients in the data. JAMA is standing by its article. One of the study co-authors, Michael Ho, a cardiologist at the VA Eastern Colorado Health Care System, says they “stand firmly” by the findings, which “remain unchanged even if we include the patients that were questioned with regard to exclusion criteria.”

The medical journal sent a statement saying, “Numerous letters to the editor regarding this paper were published in March, including one from Dr. Morgentaler. JAMA has no plans to retract the paper and was, indeed, pleased to allow critics to voice their concerns and have the authors respond. Dialogue between authors and readers is always encouraged.”