A project eighteen months in the making, the report, entitled "The High Price of Aduhelm's Approval: An Investigation into FDA's Atypical Review Process and Biogen's Aggressive Launch Plans," reveals that the FDA's standard drug approval process is "rife with irregularities."
The way the FDA reviews and approves drugs, as well as the way drug companies price and market them, is nothing short of disturbing. Fraud and corruption demarcate every step of the process, the report shows.
Of particular concern in the case of Aduhelm is how the FDA's Peripheral and Central Nervous Systems Drug Advisory Committee (PCNS Advisory Committee) overwhelmingly agreed that the data presented by Biogen failed to show that Aduhelm provides any benefits to patients.
Biogen provided one questionable study in favor of the drug, which is what led the committee to make this conclusion. This was followed by not a single member of the FDA's advisory committee voting in favor of the drug's approval.
Even so, the FDA fast-tracked Aduhelm's approval in 2021, which prompted several of the committee members who voted against this resigning in protest. This is what prompted the lawmakers' probe into what transpired. (Related: In 2007, Consumer Reports published the results of a survey revealing that more than 80 percent of Americans believed, even at that time, that Big Pharma has too much control over the FDA.)
"While we all support the search for new cures and treatments to address devastating diseases like Alzheimer's, we must ensure that expediency does not take precedence over protocols that ensure the independence and scientific rigor of FDA," said Energy and Commerce Committee chair Frank Palline Jr. (D-NJ).
The incestuous relationship between Big Pharma and the FDA must end if public confidence in regulation is ever to be restored
Prior to the FDA's fast-tracked approval of Aduhelm, legislators found, representatives from the FDA and Biogen met together no fewer than 115 times. There were also "substantive" email exchanges that go far beyond what is considered to be normal for sponsor and regulator.
"Meanwhile – reminiscent of the FDA's negligence surrounding the mRNA COVID jabs and contradicting the agency's internal recording policies – additional informal meetings, emails, and telephone calls were undocumented," wrote Michelle Edwards for Undercover DC about the probe.
"Moreover, the report finds that the joint briefing document provided to the PCNS Advisory Committee failed to adequately represent differing views within the FDA on Aduhelm."
The PCNS Advisory Committee was never even given the option to oppose the FDA's fast-tracked approval for Aduhelm, the probe further found. The agency never put the issue up for discussion or a vote, and instead jumped to approve the drug after just a three-week period of what turned out to be negative feedback about the drug.
Had the FDA simply followed its own guidance and internal practices, there never would have been a need for any investigation, the legislators' report states. Since proper protocols were not followed, many are now wondering: how many other drugs were approved under similarly illicit circumstances?
"The report raises questions about the agency's approval of other drugs," tweeted the Association of American Physicians & Surgeons (AAPS), quoting statements that were made in conjunction with the release of the new report.
"I hope this inspires a full re-examination of the nature of the communications between FDA and industry."
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