Office of Inspector General Investigating FDA’s Accelerated Approvals

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  • Source: UncoverDC
  • 09/19/2023

The unprecedented accelerated approval of Pfizer's COVID-19 "vaccine" Comirnaty has left many experts asking questions. On June 7, 2021, before the fast-track approval of Pfizer's jab, the U.S. Food and Drug Administration (FDA), also through its accelerated approval pathway, approved Aduhelm (aducanumab) for the treatment of Alzheimer's—"a debilitating disease affecting 6.2 million Americans." The drug's sudden approval brought hope for the nation's aging population grappling with the tragic disease. Still, the harsh truth about Biogen's $56,000 per year treatment is the therapy isn't entirely proven and can potentially cause brain swelling in many patients.

Aduhelm was approved despite the fact ten of the eleven members of the FDA advisory panel voted against approval, stating not enough data existed to prove the drug slowed cognitive decline. The 11th voted "uncertain." Following the approval, frustrated lawmakers and physicians demanded an investigation into the drug's controversial endorsement. On July 9, 2021, FDA interim commissioner Janet Woodcock, M.D., requested the Office of the Inspector General (OIG) conduct an independent investigation into the communications between Biogen and the FDA that led to the approval of Aduhelm. The investigation is currently underway.

Advisory Committee Members Resign Following Approval

Aduhelm's accelerated FDA approval came after intense skepticism and debate by the advisory committee over whether the drug—a monthly infusion that's not curative—actually helped patients at all. Three key advisory committee members have resigned in protest immediately following the drug's approval. 

One of those members is Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School who has served on the advisory committee for nervous system therapies since 2015. Upon his resignation, he wrote the agency's decision on Biogen's drug "was probably the worst drug approval decision in recent U.S. history," adding: 

"At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug's effect on brain amyloid was likely to help patients with Alzheimer's disease. 

It is clear to me that FDA is not presently capable of adequately integrating the Committee's scientific recommendations into its approval decisions."

Kesselheim's exodus follows neurologist Joel Perlmutter of Washington University in St. Louis and David Knopman of the Mayo Clinic. Perlmutter noted that he had quit the committee "due to this ruling by the FDA without further discussion with our advisory committee." 

First Time Ever FDA Approval Follows Zero Recommendation From Advisory Panel

Several experts have raised questions about the role of the FDA's advisory committees. Particularly the realization that the agency, in its final decision, went against the overwhelming recommendation of the same panel it assembled to study the drug. Biostatistician Scott Emerson, a professor emeritus at the University of Washington, who has served on many advisory committees in different disease areas, commented about the approval of Aduhelm:

"This isn't the first time when I was on a committee where the committee voted one way and the FDA decided another. This was the first time that nobody voted for approval of this drug—nobody—and they went against that."

While the FDA doesn't have to follow the recommendations of its advisory committee (one study found that from 2008 to 2015, the agency went against the committee 21% of the time), decisions to override their guidance occurred when the votes were much closer. However, the situation with Aduhelm is much more complex than the FDA going against the advice of its panel. Instead of being based on firm evidence that the drug reduced cognitive decline, which the FDA confirmed was unclear, Biogen therapy's accelerated approval was based on a "surrogate endpoint" that the drug removed toxic protein plaques (beta-amyloid) in patients' brains. 

But last November, during the advisory committee meeting, Billy Dunn, the director of the FDA's Office of Neuroscience, stated emphatically"We're not using the amyloid as a surrogate for efficacy." Because of his statement, the panelists were not asked to explore that possibility. Panel experts were perplexed when Aduhelm's approval was explicitly based on using amyloid levels as a surrogate endpoint. In a letter to the chair of the panel, Dunn explained that after the panel hearing, additional dialogue took place that "raised further consideration of the accelerated approval pathway." Dunn wrote:

“We recognize that there has been tremendous public interest in aducanumab and differing viewpoints on the extensive and complicated data supporting the application for aducanumab. Our discussions leading up to the decision to grant an accelerated approval for aducanumab considered a wide range of views, both external and internal to FDA. We appreciate the comments from the advisory committee members and can assure you that we listened carefully and viewed the meeting proceedings as an important source of input as we discussed the appropriate action.”

The NIH Announced Federal Spending of $3.1 Billion Annually on Alzheimer's Research

Interestingly, in November 2017, Bill Gates announced investments totaling $100 million to advance research on Alzheimer's disease. Several leading pharmaceutical companies, including Biogen, GSK, Pfizer, J&J, and Eli Lilly, benefitted from the donation. Additionally, partners including Wellcome, Gates Ventures, Bezos Expeditions, Biogen, AARP, and others have joined together to form Alzheimer's Disease Data Initiative (ADDI). On December 28, 2020, the National Institutes of Health (NIH) announced Federal Alzheimer's and dementia research funding had reached $3.1 billion annually. Yet, there is not a cure in sight.

The Hypocrisy of Aduhelm's Approval and Ivermectin's Censorship

As pointed out by TrialSite News, the risk-based approach to approve Aduhelm may end up being "one of the worst decisions in modern history. With a high price point, this will also cause turmoil with payers seeking to determine if the drug is worth covering." Yet if we change subjects from Aduhelm's fast track approval and look, for example, at what the FDA has done with Ivermectin, "then the hypocrisy of this charade becomes more clear." It also puts into perspective the unparalleled accelerated approval of Pfizer's COVID-19 jab, Comirnaty. 

With nearly 58 studies "overwhelmingly demonstrating safety and efficacy of Ivermectin, the FDA, as well as the NIH, opted to only look at a subset of studies and even then focus on ones with less compelling results." In the context of a pandemic where "hundreds of thousands of people are dying and where a small but growing chorus of doctors have argued that early treatment with Ivermectin is critical for reducing hospitalization and therefore more serious problems, it is difficult to observe. Summarizing Ivermectin's censorship, TrialSite explains:

"But the generic, repurposed drug is cheap, and the system isn't set up to support those types of therapies. That's why Merck, with a more exotic competitive product, just received a commitment for a $1.2 billion purchase from the U.S. government if the company makes it to the EUA or approval milestone."

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