FDA's accelerated approval for a controversial Alzheimer's drug called "Aducanumab" has sparked outrage and prompted calls for resignation of top officials.
The Food and Drug Administration (FDA) said in a statement last June 7 that it was giving an accelerated approval for Aducanumab, otherwise known as Aduhelm, a drug said to treat Alzheimer's.
The journey towards a cure for the brain disease, which is said to be nearly as deadly as cancer and heart disease, still continues despite many previous studies having already been conducted. The approval of Aducanumab has initially raised hopes that a solution to Alzheimer's has already been found.
However, the drug, which is produced by pharmaceutical company Biogen, is said to be very expensive and, more importantly, unproven. The drug's efficacy has yet to be proven by available studies.
FDA's Accelerated Approval
FDA usually undergoes a strict process when approving a drug.
The process includes the assessment of benefits and risks of the drug based on clinical data, as well as the proposed strategies for managing risks.
Accelerated approval can be given to drugs that "treat a serious or life-threatening condition and provide therapeutic benefit over available therapies."
Last November, an FDA advisory committee voted against the approval of Aducanumab, stating that there was no strong evidence that proved that the drug is effective against Alzheimer's.
The full document explaining the committee vote can be accessed here.
A quick search in ClinicalTrails.org, the database of privately and publicly funded clinical studies around the world, also shows that Biogen conducted two clinical trials that were both halted "based on futility analysis done."
The Fallout of the FDA Approval
Three expert advisers to the FDA, who are members of the advisory panel, have resigned since the announcement of the accelerated approval of Aducanumab was announced, according to a report by Ars Technica.
Furthermore, the FDA has been on the receiving end of harsh criticisms from industry experts as well as researchers for their decision. Calls have also been made for top officials of the FDA to resign from their positions, including a letter that advocacy group Public Citizen sent to the Department of Health and Human Services.
Per Ars Technica, the letter calls for the resignation of the following officials: acting FDA Commissioner Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni, and CDER Office of Neuroscience (ON) Director Billy Dunn.
The letter lists the group's criticisms against the FDA approval, including the "unprecedented, inappropriate close collaboration" between FDA and Biogen, which the group felt compromised the review.
Public Citizen also questions the approval for use of the drug for all types of Alzheimer's patients when it has only been tested on patients with the mild form of the disease.
Lastly, the advocacy group also laments the disregard for the advisory committee who voted against the approval of Aducanumab.
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Written by Isabella James