US District Judge Matthew F. Kennelly in the Northern District of Illinois ordered a notorious doctor who promoted testosterone replacement therapy for 30 years to turn over his tax records showing how much he was paid by the drug’s manufacturers.
The plaintiffs charge that the drug makers misrepresented that AndroGel is a safe and effective treatment for hypogonadism and a condition they referred to as “low testosterone,” when in fact the drug causes serious medical problems, including life-threatening cardiac events, strokes, and thrombolytic events.
AndroGel, a testosterone drug manufactured by AbbVie, causes the hematocrit level to increase, thereby thickening the blood. This effect, if not monitored and controlled properly, can lead to life-threatening cardiac events, strokes and thrombolytic events. Defendants failed to adequately warn physicians about the risks associated with the AndroGel and the monitoring required to ensure their patients’ safety.
The hormone has been used off-label to treat a range of symptoms such as loss of energy, decreased muscle mass and reduced libido.
Must reveal payoffs
Morgentaler must now reveal:
- Written agreements and 1099 tax statements about money received from defendants AbbVie Inc., Abbott Laboratories Inc., Eli Lilly and Co., Actavis, Inc., Auxilium Pharmaceuticals, Inc., and Pfizer, Inc.
- Powerpoint slides and presentation notes referring to testosterone replacement therapy (TRT) going back 7 years.
- All documents and communications relating to the risks and benefits of TRT with the defendants going back 3 years.
Judge Kennelly’s ruling ends Morgantaler’s battle against a subpoena from the plaintiffs’ steering committee, which has portrayed the doctor as actively shaping “the science, marketing, and use of TRT products involved in these MDL proceedings.”
Abbvie alone spent $20 million from August 2013 to December 2015 in payments to doctors to promote TRT, according to ProPublica’s Dollars for Docs database. During the same time period, Morgentaler took $73,056 in payments from various drug companies.
Morgentaler founded the Androgen Study Group, which reviews studies about TRT. He must now produce all documents regarding the Group as well as a March 29, 2014 letter to Howard Bauchner, MD, Editor-in-Chief of JAMA recommending retraction of an article “Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels.” The article by Rebecca Vigen, MD was published anyway in JAMA’s Nov. 13, 2013 issue.