Friday, March 07, 2014

FDA's "Crimean Referendum" Putsched Aveed Through the Approval Process

The FDA recently approved Endo Pharmaceuticals' testosterone replacement therapy drug Aveed (testosterone undecanoate), "ignoring a petition submitted last week by a consumer group that claimed the agency should first conclude a safety review of alternative products," reports Alexander Gaffney ("Endo's Aveed Approved by FDA, Drawing Anger from Consumer Group").

The approval "will likely greatly expand the use of testosterone, now found to increase the risk of heart attacks and other cardiovascular diseases," wrote Sidney Wolfe, founder of Public Citizen's Health Research Group (see "Letter to the FDA Protesting Aveed").

"Public Citizen also raised the prospect that FDA's approval of the drug, based in part on the findings of its advisory committee, might have reached a different conclusion had the advisory committee known about the potential cardiovascular risks associated with the drug."

"It is likely, if not certain, that the vote against safety would have been even greater had there been a presentation and discussion of the cardiovascular risks known at that time," Wolfe wrote.

You know what this reminds me of?

It's like Putin stacking the deck in the upcoming Crimean "referendum." Here's how a Soviet-era propagandist might depict the FDA Aveed advisory committee vote:


  1. Anonymous8:34 AM

    An unbelievably stupid comment. Do you actually think Sidney Wolf does not have an axe to grind, and that the FDA just does whatever the industry wants? Because you are sadly mis-informed if you think that...

    1. What's his "axe," other than promoting patient safety?

  2. Anonymous10:16 AM

    "should first conclude a safety review of alternative products," reports Alexander Gaffney" Where in the FDCA does it indicate that the approval of a drug for safety and efficacy is based on a safety review of alternative products?

    1. FDA has the option to ask for more safety studies, I believe.


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