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Doctors’ Group Launches Offensive Against Stronger FDA Warnings on Testosterone Drugs

testosterone drug FDA warningIn the face of compelling evidence that “Low T therapy,” testosterone producing drugs increase chances of strokes and heart attacks, doctors with apparent vested ties to the industry are now claiming the opposite: that such drugs actually help prevent heart attacks.

After it recently formed to take on “unnecessary” concerns about the safety of Low T therapy gels, creams, patches and injections, a group of doctors calling itself the “Androgen Study Group” is now urging the U.S. Food and Drug Administration (FDA) to reject a petition by the trusted consumer watchdog group Public Citizen, one that calls for the strongest FDA warning on testosterone drugs about the increased potential for heart attacks and strokes.

Controversy brews around stronger FDA warnings

Declaring its opposition to stronger FDA testosterone warnings in a May 7 letter to FDA Commissioner Margaret Hamburg, M.D., the Androgen Study Group rejected the scientific merit of the latest studies showing significantly heightened cardiovascular risks for patients on testosterone therapy drugs.  The same studies these doctors poo-poo and are seeking to discredit had prompted the well-respected consumer advocacy organization Public Citizen to file a petition with the FDA in February calling for the strongest testosterone warnings possible on medications such as AndroGel, AndroDerm, Testim, Axiron and others.

The studies, whose credibility is now a source of contention, had only confirmed upon their publication longstanding suspicions about the dangers of testosterone therapy. One study published in the November 2013 issue of the Journal of the American Medical Association (JAMA) found older users of testosterone drugs more vulnerable to heart attacks, strokes and death—findings that in March 2014 the Androgen Study Group unsuccessfully asked the editor-in-chief of JAMA to retract; additional findings published in the medical journal PLoSOne in January 2014 suggested Low T drugs may double the risk of heart attack for young men with a prior history of heart disease and for men above the age of 65 with no prior heart troubles.

These findings preceded an announcement by the FDA that the regulatory agency would review the safety of these drugs.

Questionable industry ties?

The Androgen Study Group prefers to be known as an independent cluster of medical professionals and members of the scientific community committed to the objective representation of testosterone drugs.  In its letter to the FDA, for example, the group claims its independence, and that its members own no stock in testosterone pharmaceuticals; and, the group’s web page makes no clear mention that at least four of its five members enjoy close ties to Auxilium Pharmaceuticals, a leading manufacturer of testosterone.

In fact, group members Abraham Morgentaler, Martin Miner, Andre Guay, and Mohit Khera, all doctors, appear to be consultants for Auxilium, which sells Testim, Testopel and Striant testosterone drugs. Conflict of interest declarations made in a study published in March 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, where he called for off-label use of testosterone products, Dr. Guay revealed that he was on Auxilium’s scientific advisory board.  Similarly, Morgentaler currently appears on a list of Auxilium scientific advisory board members in an executive profile in Bloomberg Businessweek, and Khera, as a consultant for Auxilium in a release by Paradigm Medical Communications on controversies in the treatment of male hypogonadism.  Traish in recent years has maintained his neutrality.

Testosterone therapy lawsuits

These latest appeals by the Androgen Study Group come on the heels of numerous prominent physicians, medical organizations and journals raising concerns about the risks associated with testosterone drugs in recent months—especially in cases when such therapies lack medical necessity.

The testosterone replacement industry has reaped enormous profits— more than $2 billion per year— from a five-fold jump in the use of its drugs to treat not just the clinical condition of “hypogonadism” but other more less medically compelling symptoms related to aging, such as lower sex drive and weight gain.

Recently a growing number of testosterone therapy lawsuits have begun to dribble into courts across America, alleging that inadequate warnings about potential heart risks led to cardiovascular complications.

  1. Wall Street Journal, “FDA Requires Strong Warnings on Two Testosterone Gels,”
  2. PR Newswire, “World Experts and Androgen Study Group Petition JAMA To Retract Misleading Article on Testosterone Therapy,”
  3. The Androgen Study Group, Letter to FDA,