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Physician’s Group Disputes Demand for Testosterone Drug FDA Warning

Testosterone Drug FDA Warning - Physicians Challenge Watchdog GroupA group of physicians has come together to dispute requests for warning labels on products to treat low testosterone levels or “low-T.” The Androgen Study Group was created by doctors to fight a move by consumer advocate group Public Citizen, which has petitioned the FDA to add warning labels to testosterone products. However, members of the Androgen Study Group appear to have some conflict of interest in their fight, since there are apparent ties between members and the pharmaceutical industry.

On February 25, 2014, Public Citizen sent its petition to the FDA, urging the agency to add a black box warning concerning cardiovascular risks for men taking testosterone therapy.

According to the organization’s press release, the request was based on “growing evidence of the risks of heart attacks and other cardiovascular dangers.” The organization cites studies dating from 2010 and a meta-analysis of studies dating back two decades that show a link between testosterone use and a higher risk for serious cardiovascular events.

Study group responds to Public Citizen

This month, the Androgen Study Group sent their own response to Public Citizen’s petition, urging the FDA to reject restrictions on testosterone therapy due to cardiovascular risk. The group cites literature spanning 30 years that shows benefits of testosterone therapy in regards to cardiovascular risk. The group also discarded evidence submitted by Public Citizen, stating the organization had provided evidence from only four studies to support a higher risk factor and two were without scientific merit.

Despite the seemingly compelling evidence presented by the Androgen Study Group in its response to the Public Citizen petition, concerns have been raised about the authenticity of the group’s objectivity in the matter. Although the website for the Androgen Study Group specifically calls itself an “independent professional organization” that does not receive funding from pharmaceutical organizations, the member list paints a different picture. All of the members on the list except one are physicians that have worked as consultants for  Auxilium, a pharmaceutical company. Auxilium sells testosterone drugs, including Testim, Testopel and Striant.

Evidence of the link between group members Drs. Martin Miner and Andre Guay was noted in a study published in the American Journal of Medicine in January 2014. Bloomberg Business Week listed Dr. Abraham Morgentaler, another member of the Androgen Study Group, as a member of the Auxilium scientific advisory board. Paradigm Medical Communications has noted Dr. Mohit Khera, another Androgen Study Group member, as an Auxilium consultant. A fifth member, Dr. Abdulmaged Traish appears to be the only one on the list to maintain his autonomy from the pharmaceutical industry.

Concerns about testosterone drugs

Although the Androgen Study Group continues to defend the safety of testosterone drugs, other medical professionals believe otherwise. Concerns have been specifically voiced about the method in which testosterone drugs are dispensed today – often without a full medical history of the patient.

According to Public Citizen, more than five million prescriptions for testosterone drugs were filled in 2013, indicating a significant increase in the number of prescriptions given out. Unfortunately, reports of testosterone therapy side effects have also increased during that time.

Some men who have suffered those side effects are now taking their complaints to court. Despite a delay in a testosterone drug FDA warning, these men are alleging that injuries like heart attacks and strokes are a direct result of testosterone therapy. They also claim that the manufacturers of these drugs are not providing sufficient warning about the potential dangers associated with their products.

Some of those testosterone drug lawsuits may be coordinated into multidistrict litigation in the federal court system, if a motion for centralization is passed. Multidistrict litigation is a way to simplify early trial proceedings for a growing number of similar lawsuits against the same defendant.

  1. FDA, FDA Evaluating Risk of Stroke, Heart Attack and Death with FDA-Approved Testosterone Products,

  2. CBS Chicago, 2 Investigators: Low-T Drugs could have Dangerous Side Effects,

  3. CBS Denver, Low-T Patients Poised to Sue Drug Makers,

  4. PR NewsWire, Androgen Study Group Urges FDA to Deny Public Citizen’s Petition to Add Black Box Warning to Testosterone Products,

  5. Public Citizen, Public Citizen Petitions FDA for a Black Box Warning on Testosterone Products,

  6. The American Journal of Medicine, All Men with Vasculogenic Erectile Dysfunction Require a Cardiovascular Workup,

  7. Clinical Endocrinology News, Consider Off-Label Androgen Therapy,

  8. The Androgen Study Group, Members,