What You Should Know About Aduhelm, the New Alzheimer’s Drug

The Food and Drug Administration (FDA) made one of its most controversial decisions in the middle of the summer about Aduhelm, a new drug that is supposed to treat Alzheimer’s disease. The drug supposedly removes buildup of beta-amyloid proteins, which scientists believe are the root cause of brain cell death in patients with Alzheimer’s.

Per the New York Times, a report reviewed by the FDA contained little to no clinical data that would determine Aduhelm’s effectiveness against the disease. However, the agency rejected the advice of its advisory board and approved the drug. Now, prominent healthcare providers are refusing to administer it.

How did the FDA reach its decision to approve Aduhelm?

Journalists for the Times revealed evidence of a back-channel campaign between the FDA and the drug’s manufacturing company, Biogen. The campaign – known as Project Onyx – held secret multiple meetings between Biogen executives and an agency ally by the name of Billy Dunn. In 2019, Dunn met with a top Biogen executive to ensure his support for the approval of Aduhelm. This backdoor meeting violated several FDA protocols. A month later, FDA officials recommended a regulatory shortcut that can guarantee the approval of Aduhelm.

The agency was divided on the decision to approve Aduhelm. The advisory committee rejected drug approval based on the lack of clinical data. To date, the drug contains two clinical studies that generated mixed results concerning the effectiveness of the drug. FDA officials ignored the criticisms of the advisory committee and approved the drug anyway.

However, officials decided against granting the drug full approval. Instead, officials granted the drug “accelerated approval,” where a drug’s effect can be deemed “reasonably likely” to predict a clinical benefit to patients. The agency based its decision on the potential role that the drug can play in removing amyloid-beta plaques.

The backlash was swift

The agency encountered backlash immediately. Of the 11-member advisory committee, ten of its members voted against the approval of Aduhelm. Three members of the FDA’s advisory board resigned over the decision to approve the drug. The agency encountered an internal investigation that explored the relationship between the FDA and Biogen. Janet Woodcock, the Acting Commissioner of the FDA, requested an independent review of the process by an inspector general. Although the agency has conducted its own investigation into the controversial decision, Congress launched its own investigation a month later. The investigation is still in full effect.

Some of the largest healthcare and insurance providers in the country refuse to administer or cover Aduhelm. The Cleveland Clinic, Mount Sinai, UnitedHealth Group, and Blue Cross Blue Shield are all refusing to support the use of the drug. The Cleveland Clinic, in particular, declared that a federal investigation that affirms the integrity of the drug’s approval must be conducted before the organization administers the drug.

Meanwhile, doctors have remained conflicted. Some doctors choose to refer their patients to other doctors who feel comfortable prescribing the drug. Patient advocacy groups support the use of the drug, claiming that it is a much-needed remedy after decades of no treatments.

But does Aduhlem do what it says?

This is the crux of the issue. Aduhlem was in Phase 3 clinical trials, and one trial showed that the drug does actually reduce the plaques created by beta-amyloid proteins. However, those trials ended “in 2019 because an independent monitoring committee concluded that the drug did not appear to be helping patients. A later analysis by Biogen found that participants receiving the highest dose of aducanumab in one trial experienced a very slight slowing of cognitive decline, but participants in the other trial did not benefit at all,” according to the New York Times. The paper also reports that brain swelling or bleeding can occur when patients take Adulhelm.

It is worth noting that while the science says beta-amyloid proteins are linked to Alzheimer’s disease, there is no proof that they cause the disease.

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