After years of my exposing the FDA for their “pay to play” tactics with the pharmaceutical industry at the cost of loss of lives, it appears some momentum is growing. Public Citizen, a nonprofit consumer advocacy organization since 1971 who works to ensure that government works for the people – not for big corporations — is also calling for Woodcock’s firing.
Public Citizen is asking Health and Human Services Secretary Xavier Becerra to fire Janet Woodcock as well as fire Patrizia Cavazzoni and Billy Dunn over the FDA’s approval of Biogen’s Alzheimer treatment, Aduhelm. The controversial approval of Aduhelm led to three experts on the FDA Advisory Committee to resign.
Billy Dunn, the acting director of the Office of Neuroscience in FDA’s Office of New Drugs, worked with Biogen on the November 2020 document assessing the drug. Usually, the regulator and pharmaceutical companies write separate briefings in preparation for FDA advisory committee meetings — not together.
Three advisory committee members had problems with the approval of the controversial Alzheimer drug and resigned. One of the members is Dr. Aaron Kesselheim, a professor at Harvard Medical School who also a director of the Program On Regulation, Therapeutics, and Law at Brigham and Women’s Hospital. He publicaly stated that the FDA is giving the “go ahead” for Aduhelm despite not having enough proof that the drug will help Alzheimer’s patients. His resignation letter to the FDA stated “Accelerated approval is not supposed to be the backup that you use when your clinical trial data is not good enough for regular approval.”
Kesselheim called the approval of Aduheim “probably the worst drug approval decision in recent U.S. history” in a scathing resignation letter he sent to Interim FDA Commissioner Janet Woodcock this past week.
The FDA advisory committee voted unanimously not to approve Aduhelm, but unexplainably, the FDA approved the drug and three advisory committee members have resigned from the committee over the decision.
In 1995, the FDA approved OxyContin, of Purdue Pharma and the Sackler family fame, for the treatment of chronic pain absent substantial evidence of efficacy, resulting in the CDC’s statement, “We know of no other medication routinely used for nonfatal conditions that kills patients so frequently.” As is the case with the FDA’s approval of OxyContin for the treatment of chronic pain, it is the ultimate violation for the FDA to approve drugs that have not proven substantial evidence of efficacy.
In Woodcock’s tenure with the FDA beginning in 1986, and leading up to her appointment as Interim FDA Commissioner, this country has been immersed in an opioid epidemic with over 500,000 deaths and countless addictions. Woodcock has become the “lapdog” for the pharmaceutical industry and there is not an opioid she has not approved — as families are destroyed and the death toll mounts.
It’s time for Woodcock to be fired — past time!
Investigative Reporter exposing the manufactured opioid epidemic, FDA, Purdue Pharma (Sacklers) and recently COVID-19 (facts or fears)
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