What do Howard Stern and a “crappy” patient questionnaire written on toilet paper have to do with treatment for low testosterone? More than you may think.

Sunday’s New York Times piece on AndroGel titled Selling That New-Man Feeling detailed the great lengths AbbVie has gone through in recent years to tout and grow the market for so-called “Low T” (or low testosterone).

Promoted by, among many others, Dr. Harry Fisch of the eponymous radio show broadcast on the Howard Stern channel on Sirius-XM, Androgel is a medication originally approved for hypoganadism, but has been broadly promoted as a treatment for Low T - an unapproved use with limited proven medical basis. The methodology for identifying Low T is through a patient questionnaire on a website owned and promoted by AbbVie called IsItLowT.com. At that site, a the questionnaire asks a series of general and guiding questions to determine if the patient is a candidate for AndroGel.

According to the NY Times, however, the patient questionnaire is a farce. It was designed by a Dr. Morley who was paid by AbbVie to come up with a “short and sexy” questionnaire. He recalls that he designed the questionnaire “in 20 minutes, in the bathroom, scribbling the questions on toilet paper.” His thoughts on it? “I have no trouble calling it a crappy questionnaire.”

The whole thing would be something out of a Seinfeld episode if it weren’t actually quite serious.

We see two major issues here:

  1. The wide off-label use of a medication for treatment of a dubious malady. As we detailed in an extensive white paper on this issue, pharmaceutical marketing often leads to these situations and should be better monitored not only by the FDA, but by pharma’s customers – payers, health systems, and providers.
  2. The safety risks of broad off-label use. When medications like AndroGel are used in a broad population for indications not tested in clinical trials, significant rates of unexpected adverse events are certain to arise. As we detailed in our report at the Drug Safety Monitor, we see a number of adverse event trends for AndroGel that are not covered in the current label.

There needs to be better post-marketed observation and action resulting from real world adverse events. During clinical trials, medications are tested for limited safety and efficacy among a small homogeneous population. When they gain approval, the medications find themselves in use for many more indications and by a much broader population.

 

Related Read: Post Approval Adverse Events... What's the Real World Impact? [INFOGRAPHIC]

 

And that’s where the problems start.

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Brian Overstreet

Brian Overstreet

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Topics: FDA, Drug Safety, Clinical Evidence

Brian Overstreet

Written by Brian Overstreet