by Sharyl Attkisson at Sharyl Attkisson
The FDA has just approved a new treatment for early Alzheimer’s that’s being billed as the first potential “cure” that addresses the root cause rather than just treats symptoms.
The drug, aducanumab, could provide hope to millions of patients and families impacted by the terrible disorder.
However, there are numerous controversies surrounding the medicine and its approval.
First and foremost, not one of the FDA’s advisers recommended approving it.
The FDA’s decision shows a stunning disregard for science and eviscerates the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
The Health Research Group from the watchdog group Public Citizen
The full statement from the watchdog group Public Citizen, which fought against aducanumab’s approval, appears below.
The U.S. Food and Drug Administration (FDA) today announced its approval of aducanumab for treatment of Alzheimer’s disease despite the nearly unanimous conclusion of an independent panel of expertsconvened by the agency in November that there was not sufficient evidence that the drug was effective. In December Public Citizen called for an investigation of the unprecedented and inappropriately close collaboration between the Biogen and the FDA during the analysis of data from the key clinical trials of the drug. Dr. Michael Carome, director of Public Citizen’s Health Research Group, released the following statement:…
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