Opinion: The FDA Was Right to Approve Aducanumab for Alzheimer’s


Someone in the United States is diagnosed with Alzheimer’s disease every 65 seconds. Slowly robbing its victims of their memory and independence, Alzheimer’s is as debilitating as it is deadly. Nearly 121,000 Americans died from Alzheimer’s in 2019, making it the sixth leading cause of death.

Sadly, treating the disease has been a losing battle. Medical scientists have not developed a new treatment since 2003, and all existing treatments only slow Alzheimer’s progress at best.

But a new drug gives hope of reversing this concerning trend.

Recently the Food and Drug Administration (FDA) approved aducanumab for the treatment of Alzheimer’s disease. Aducanumab introduces a desperately needed new treatment because it could reverse the symptoms of the disease when taken in high doses.

But the drug has been receiving more attention for its controversial approval than its pathbreaking medicinal properties.

Drug producers Biogen and Eisai had abandoned trying to have aducanumab approved by the FDA after failing a futility test in 2019. However, after developing an expanded dataset, the producers found evidence for the drug’s revolutionary properties. So, they asked the FDA to allow aducanumab to reenter the approval process, and the agency broke protocol and agreed. Aducanumab eventually received priority review on its way to approval.

Unfortunately, the FDA’s decision has been called “dangerous,” “horrifying,” and a “disaster” for introducing new standards of evidence into its approval process. As an article in The Washington Post put it, “Greenlighting the drug could set a dangerous precedent, opening the door to treatments of questionable benefit.”

Such criticisms are well intended, but they are also misguided. The far greater threat to those with Alzheimer’s and other serious illnesses is that the agency will be overly stringent in approving new treatments.

Historically the agency’s demanding approval process delayed the arrival of beta-blockers, antidepressants, and birth control pills in the United States. Over 25,000 cancer patients have died every year while waiting for treatments the FDA eventually approved.

Most recently the FDA nearly abandoned its approval process by granting emergency use authorizations to many products in the battle against the COVID-19 pandemic. Those decisions have been overwhelmingly successful.

Facing a crippling shortage of COVID-19 testing supplies, the FDA granted test producers the authority to create tests and diagnose patients in March 2020. Rather than going through the standard approval process, producers submitted evidence that their products worked after testing enough patients.

Two weeks after the FDA announcement, U.S. testing capacity expanded from 7,800 to 38,000. As of August 2020, only two of 140 COVID-19 tests were recalled.

Like aducanumab, the drug remdesivir faced little prospects for FDA approval after failing to meet efficacy standards, even though it showed success in treating Ebola, SARS, and MERS in clinical trials.

Remdesivir’s promising results prompted many physicians to strongly request that the FDA allow patients access to the drug, although it was only experimental at the time. After becoming “the standard of treatment” for COVID-19, the FDA approved remdesivir in November 2020, despite its never having gone through the formal approval process.

The FDA also substantially reduced the length and size of clinical trials in order to develop a COVID-19 vaccine as quickly as possible. Far from criticizing the FDA for making a hasty decision, many medical professionals have hailed COVID-19 vaccines as Nobel Prize-worthy and have praised the FDA for granting emergency use authorizations for them.

Before COVID-19 many medical researchers believed Alzheimer’s disease would become the next pandemic. Without breakthroughs in how to treat the disease, it still might be. The FDA’s decision to forgo its standard procedures when approving aducanumab follows a strong recent success pattern.

Improvement often requires change. The FDA has recognized this, and its decision deserves praise.

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Raymond J. March, Ph.D., is a research fellow and director of FDAReview.org at the Independent Institute, in Oakland, Calif. and an assistant professor of agribusiness and applied economics and faculty fellow at North Dakota State University. He wrote this for InsideSources.com.

Raymond J. March, Ph.D., is a research fellow and director of FDAReview.org at the Independent Institute, in Oakland, Calif. and an assistant professor of agribusiness and applied economics and faculty fellow at North Dakota State University. He wrote this for InsideSources.com.

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