Testosterone Heart Study Attacked By Doctors with Drug Maker Ties

A group of scientists calling themselves the “Androgen Study Group” has called for a prominent medical journal to retract a paper, which first raised concerns about potential heart risks from testosterone therapy side effects.  

In a letter to Howard Bauchner, editor-in-chief of the Journal of the American Medical Association (JAMA), the group calls for the retraction of a study published in November 2013, involving a review of data on 8,700 veterans with low testosterone following a coronary angiography.

The JAMA study found that an increased rate of heart attack, stroke and death among men receiving testosterone replacement therapy (TRT), including gels, patches, injections and other forms.

The letter calling for the retraction is signed by Abraham Morgentaler, MD, for the Androgen Study Group, and lists a number of co-signers, including several professional medical societies and dozens of scientists worldwide. However, the group does not appear to disclose it’s close connections Auxilium Pharmaceuticals, the manufacturer of the popular Testim gel and other testosterone treatments.

The group points out that there have been two corrections published regarding the initial article, indicating that the errors are “gross data mismanagement” that call into question the findings of the study and have led to confusion over the health risks of testosterone. At one point the letter notes that one of the corrections involved 100 women who took testosterone and seems to imply that they were part of the study.

What the letter does not say is that the 100 women were actually excluded from the study before the data was tallied and calculated, and that the correction simply acknowledged that the researchers threw out their data before tallying the results of the study.

Ties to Pharmaceutical Companies

While the Androgen Study Group appears to be an independent, concerned group of professions, it actually consists of at least five doctors and scientists, four of which have close ties with Auxilium Pharmaceuticals, the makers of several testosterone replacement therapy (TRT) medications

In addition to Dr. Morgentaler, the group includes Drs. Martin Miner, Andre Guay, Mohit Khera and Abdulmaged Traish. With the exception of Traish, all are appear to be consultants for Auxilium which sells Testim, Testopel and Striant. Conflict of interest declarations made in a study published earlier this month on erectile dysfunction in the American Journal of Medicine state that Drs. Miner and Guay are Auxilium consultants. In an October 6 issue of Clinical Endocrinology News (PDF), Guay called for off-label use of testosterone products and revealed that he was on Auxilium’s scientific advisory board.

Morgentaler is currently listed as a member of the Auxilium scientific advisory board in an executive profile on Bloomberg Businessweek, and Khera was mentioned as a consultant for Auxilium in a release by Paradigm Medical Communications on controversies in the treatment of male hypogonadism, which came out about the same time as the JAMA study. In a number of papers in recent years, Traish has maintained that he has no ties to any pharmaceutical company.

The Androgen Study Group’s web page also makes no obvious mention that four of its five members work for the makers of some of the more popular testosterone treatments. The letter attacking the JAMA study, which has raised serious questions about the $2 billion per year testosterone replacement therapy market, appears to be the group’s only initiative to date.

Testosterone Heart Concerns

In response to the criticism, researchers who published the JAMA study in November 2013 have indicated that they stand by their research and that the two minor retractions had no effect on the findings of the research.

JAMA officials have said they have started a “dialogue” between the Androgen Study Group and the researchers who conducted the study, who are from the VA Eastern Colorado Health Care System. The publication calls for more research into the side effects of testosterone to clarify the health risks, and has not said it will retract the article. The researchers behind the original study have also called for more research into testosterone health risks.

A follow up study published earlier this year in the medical journal PLoSOne further increased concerns in the medical community, indicating that testosterone treatments may double the risk of heart attacks for young men with a prior diagnosis of heart disease and for older men regardless of any prior heart problems.

In January 2014, the FDA launched an investigation into the safety of testosterone therapy, which could result in new warnings for the medications or restrictions on use of the popular gels, patches, injections and other treatments.

Testosterone replacement therapy has increased in popularity in recent years, as direct-to-consumer marketing has encouraged men to seek prescription treatment for low testosterone levels, or “low T”, if they are experiencing fatigue, decreased sexual virility or other symptoms that are often common with aging. Other popular brand name medications include AndroGel, AndroDerm and Axiron.

In recent years, the use of testosterone drugs has increased more than a factor of five, with recent reports suggesting that many men are now receiving the prescriptions without testing or even if they have normal testosterone levels. More than five million testosterone product prescriptions were filled last year in the U.S. alone.

Amid the mounting concerns, a growing number of men throughout the United States are pursuing potential Testim lawsuits, AndroGel lawsuits and other testosterone treatment lawsuits, claiming that the drug makers withheld information about the risk of heart attacks, strokes and blood clots associated with use of the medications.