Saturday, May 25, 2024

FDA Broke Own Rules Collaborating w/ Big Pharma for Alzheimer’s Drug

Even Biogen had halted the drug's development in 2019 due to significant evidence that the drug would be ineffective...

(Joshua Paladino, Headline USA) Two House committees investigated the Food and Drug Administration’s fast-tracked approval of Aduhelm, a controversial and unproven drug that biotechnology corporation Biogen created.

The Oversight and Reform and the Energy and Commerce committees issued a report that found the approval process “rife with irregularities,” UncoverDC reported.

The horrible results from the clinical trials of Aduhelm, combined with its high price tag, made the approval seem suspicious. And the report confirmed that suspicion by asserting a “collaboration” between Biogen and the FDA to get Aduhelm’s approval.

The 11-member Peripheral and Central Nervous System Advisory Committee, which gives outside opinions on drug approval, could not muster a single “yes” vote for Aduhelm, also known by its generic name Aducanumab.

Ten members voted “no” and one voted “uncertain.”

Yet, the FDA authorized Aduhelm on an accelerated pathway that requires another randomized controlled trial on people with Alzheimer’s disease.

In one trial, Aduhelm showed promising results, but researchers could not replicate them, and further trials showed insignificant improvements in Alzheimer’s disease despite deadly side effects.

The advisory committee members disagreed with the decision to fast-track Aduhelm’s approval because they “did not agree that it was reasonable to consider the clinical benefit of the one successful trial as the primary evidence supporting approval.”

Even Biogen had halted the drug’s development in 2019 due to significant evidence that the drug would be ineffective.

But Aduhelm promised too much profit for Big Pharma and its captured regulators at the FDA to turn down. Leaders at Biogen and the FDA reportedly met and emailed more than 100 times in the months leading up to the approval of Aduhelm.

At the cost of $56,000 per year for each patient, Aduhelm would cost the Medicare system $29 billion per year, assuming that about 500,000 Medicare recipients with Alzheimer’s disease would take the drug.

The current cost of the entire Medicare drug program is about $37 billion per year.

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