Categorized | Health, Pushback

Aduhelm, New Alzheimer’s Drug, Tangled in Controversy

FDA, Aduhelm

Biogen estimates a target population of between 1 million to 1.2 million individuals could use Aduhelm. One Wall Street firm estimates that Biogen could reach Aduhelm sales of $5 billion by 2025.

By Al Norman

On June 7, Biogen, a drug manufacturer based in Cambridge, Massachusetts, and its Japanese partner, Eisai, issued a press release announcing that the U.S. Food and Drug Administration (FDA) had granted “accelerated approval” for a brand name drug called Aduhelm (aducanumab-avwa) as the “first and only Alzheimer’s disease treatment” that works by reducing amyloid beta plaques in the brain — one of the defining pathologies of Alzheimer’s.

Haruo Naito, the CEO of Eisai said: “This approval has the potential to bring hope to the future of global health, society and, most importantly, the patients and their families, and represents a great step toward the advancement of holistic ecosystem solutions for this devastating disease.” In clinical trials, more than 3,000 people received at least one dose of Aduhelm.

Biogen noted that “continued approval” of Aduhelm as a treatment for Alzheimer’s disease “may be contingent upon verification of clinical benefit in confirmatory trials.” Despite this disclaimer, Biogen called the approval a “historic moment” that would transform the treatment of people living with Alzheimer’s disease, and spark continuous innovation in the years to come.”

But what this “historic moment” sparked instead was a major controversy as complicated as the drug itself. Biogen cautioned that their new drug could cause “serious side effects, including: Amyloid Related Imaging Abnormalities or ARIA … a common side effect that does not usually cause any symptoms, but can be serious. It is most commonly seen as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain with the swelling…some people may have symptoms such as: headache, confusion, dizziness, vision changes, and nausea.”

Some micro-hemorrhaging was reported, and confusion/delirium and altered mental status/disorientation.

patient-centered, Social Security, ageist, nursing, COVID, Trump, vaccineReaction was swift. The advocacy group Public Citizen sent an “emergency response” to the FDA about what they called “the unproven medication.”  “We demanded that the FDA revoke its approval because there is nowhere near enough evidence that Aducanumab is effective.”

The group claimed that ”intense pressure” from a number of groups pushed the FDA to “narrow” its prescribing recommendations. But Public Citizen wants the FDA to revoke its approval altogether, because “geriatric experts and the FDA’s own independent advisory committee strongly urged the agency not to approve the medication.”

Public Citizen also called for an investigation of “inappropriately close collaboration” between the FDA and Biogen. The group said 40 percent of people who took Aduhelm in clinical trials had swelling and bleeding in their brains, and charged that Biogen was planning to charge an average of $56,000 per patient per year for treatment.

“That price tag is so exorbitant that it might single-handedly jack up insurance premiums across the board and drain tens of billions a year from Medicare,” Public Citizen said. Biogen defended the high price tag for Aduhelm treatment. “This is a disease that is already costing $355 billion per year to U.S. society,” a company spokesman said.

On July 15 the Cleveland Clinic and Mount Sinai health systems refused to administer Aduhelm. “Based on the current data regarding its safety and (effectiveness), we have decided not to carry aducanumab at this time,” the clinic said, calling for “continued research in this area.”

The clinic wrote in a statement, “The FDA’s approval of Aduhelm has raised serious concerns and questions by clinicians, patients and caregivers and a cautious approach is required. Mount Sinai Health System will not administer Aduhelm until the outcome of the FDA Inspector General’s Investigation of Biogen is complete,”  it wrote.

Following these actions, the Institute of Clinical and Economic Review (ICER) voted 15-0 that there is no evidence that Aduhelm provides a net health benefit to patients. ICER has also said the drug is cost effective at no more than $8,400 per year. The FDA now has called for an independent federal probe into its representatives’ interactions with Biogen. United Health Care, Humana, and several Blue Cross Blue Shield plans have not decided to wait for further information before covering Aduhelm.

Biogen estimates a target population of between 1 million to 1.2 million individuals could use this new drug. One Wall Street firm estimates that Biogen could reach Aduhelm sales of $5 billion by 2025. But for now, the medication is as tangled in controversy as the disease it targets. Patients and their families who continue to hope for an effective and affordable way to treat Alzheimer’s are no doubt frustrated by the delay and uncertainty swirling around this drug rollout. Accelerated approval is clearly not going to happen.

Al Norman worked in the elderly care field for 38 years, lobbying for programs and funding to help elders and the disabled live independently at home.

 

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