False Hope and Deadly Consequences

Blog#90- 11/24/21

By Richard Davis

Just when it seemed that the validity of science was gaining credibility among the masses the story of Aducanumab (Aduhelm) shows that profit still rules. Aducanumab is a drug that claims to slow the progression of Alzheimer’s Disease.

The Federal Drug Administration (FDA) approved the drug in June despite the fact that an advisory committee of experts outside of the FDA, as well as many Alzheimer’s specialists, said that that it was not clear if the drug provided benefit to patients. They noted that the drug presented a high level of risk because of serious side effects.

The FDA and other regulatory bodies are supposed to protect us from harm when it comes to approving new drugs. In the case of Aducanumab, the manufacturer Biogen stands to reap a harvest of millions, if not billions, of dollars if the drug is approved for the Medicare population.

It is estimated that the intravenous infusions of Aducanumab could cost $56,000 a year. That does not include the cost of administering the drug as well as expensive scans and lab work that would need to be done on a regular basis. Medicare has not determined if it will approve this drug, but you can bet that Biogen is putting a lot of pressure on lawmakers and policymakers to push the approval process along.

According to the Centers for Medicare and Medicaid Services (CMS) approval of Aducanumab could be a major contributor to an increase in Medicare premiums in 2022. CMS estimates that Medicare Part B premiums could increase by $259.20 a year and Part B deductibles could increase from $203 to $233.

In addition to the financial burden posed by Aducanumab, it is clear that this drug is not safe.

During clinical trials there were different levels of dosing. No matter the dose, any improvement in disease status, either by scan or by functionality was equivocal at best. There certainly was no justification to approve a drug that caused brain swelling or bleeding in 41% (425 of 1029) of patients receiving a high dose.

Biogen tried to minimize the drug’s side effects by saying that swelling and bleeding was mild or moderate in most patients. If I knew that a drug was causing any kind of new brain pathology to be superimposed on a pre-existing brain disease I would not want to take the risk of making things worse or of causing death, as has happened in at least two cases.

In a recent WEB MD article it was noted that, “Two large studies looked into Aduhelm’s effectiveness. Both lowered the number of beta-amyloid plaques. One found that high doses of the drug slightly slowed — but didn’t stop or reverse — troubles with thinking, memory, and the ability to function. The other study didn’t show a benefit and was stopped early.

That one successful study wasn’t enough to win over the FDA advisory panel, but the agency decided to move forward. It gave Biogen, the company that makes Aduhelm, 9 years to confirm the drug’s possible benefit in a “post-approval” study. The FDA has launched an investigation into its decision-making process because of concerns about the drug’s fast approval. And some hospital systems have decided they won’t give Aduhelm to patients until there’s more research to show it’s safe and effective.”

Alzheimer’s is deadly disease affecting millions of people and their families. Medical research has yet to develop drugs and treatments that can significantly slow or stop progression of the disease. A company such as Biogen is providing false hope and counting on the vulnerability of people who would accept false hope at any cost. It should be clear to non-scientists and anyone who possesses a shred of common sense that the hope that Aducanumab provides is for Biogen to reap immoral profits while vulnerable lives are put at risk.

Comments | 2

  • Wider Implcations

    Does not this warning about compromised integrity of FDA approval practices undercut our confidence in the official “evidence-based” FDA and CDC recommendation regarding Covid-19?

  • Possible

    The official agencies have always been compromised by the marketplace. COVID is no exception. That means we have to remain skeptical and try to gather as much information as possible and make our own decisions when possible.

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