As soon as the FDA approved Biogen’s Alzheimer’s drug Aduhelm in June 2021 against the advice of their advisory committee, experts have wondered whether Medicare would cover it. The Centers for Medicare and Medicaid Services (CMS) determines Medicare coverage for drugs based on whether the drug is “reasonable and necessary for diagnosis or treatment.” While CMS rarely puts restrictions on drugs approved by the FDA, the questionable effectiveness of the drug made the agency reconsider. In clinical trials, Aduhelm did not significantly reduce Alzheimer’s symptoms and caused brain swelling and bleeding in 40% of participants.
Earlier this month, CMS proposed to restrict coverage for Aduhelm to only Medicare beneficiaries taking part in clinical trials approved by CMS. Some scientists and advocates applauded CMS’ decision to demand more evidence before putting millions of seniors at risk from this drug. But not everyone was happy.
Biogen, the makers of Aduhelm, claimed the CMS decision would “exacerbate health inequity in dementia care.” And the Alzheimer’s Association, a patient organization that receives funding from Biogen, called the decision “shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics.”
It’s true that Black and Hispanic/Latinx people are more likely than whites to develop Alzheimer’s Disease and are less likely to be enrolled in clinical trials. But is that a sufficient justification to cover Aduhelm for all Medicare beneficiaries? Or is their concern for health equity a tactic to advance the interests of pharma? Here’s why their argument doesn’t hold water…
First, we don’t know if Aduhelm actually works to reduce Alzheimer’s symptoms or progression. The approval was based on Aduhelm’s removal of amyloid plaques in the brain, which is a surrogate marker, not a clinically meaningful outcome. Restricting access to an unproven and potentially harmful drug is not discrimination, it’s good policy.
Also, experts have pointed out that Biogen did not recruit enough people of color in their Aduhelm trials to match the levels of Alzheimer’s seen these racial/ethnic groups. Biogen’s EMERGE trial only had 11 Black patients and 67 Hispanic/Latinx patients — about 5% of the trial participants. If Biogen and the Alzheimer’s Association are so concerned with making Aduhelm accessible to people of color, why did they include so few of these participants in their Phase 3 trials?
“If this trial didn’t even have communities of color, then the findings aren’t even generalizable to us,” said Dr. Joyce Balls-Berry, associate professor of neurology at Washington University School of Medicine, in STAT News.
Dr. Jonathan Jackson, executive director of Mass General Hospital’s Community Access Recruitment and Engagement Research Center, concurred. “Where was concern when I and others asked for enriched and diverse sampling during years of clinical trials so we’d know if Aduhelm worked in ‘women, Blacks, and Hispanics?'” he wrote on Twitter.
While it’s important to point out racial disparities in the incidence of Alzheimer’s Disease, putting so much emphasis on access to Aduhelm ignores the root causes of these disparities, such as access to primary care, clinical trials, and disparities in underlying health issues linked to Alzheimer’s.
“It sounds a little performative and I don’t hear any action behind the real issues of inequity in Alzheimer’s management,” said Dr. Sharon Brangman, distinguished service professor of geriatrics medicine at SUNY Upstate Medical University, in STAT News.
Performative activism refers to actions that are taken to increase one’s social capital rather than because they actually believe in the cause. In this case, Biogen and the Alzheimer’s Association appear to be invoking the concept of discrimination to achieve their financial goals and make themselves appear conscientious at the same time. This is a blatant example of pharma and pharma-funded organizations co-opting the language of health equity to argue for their own interests.
Jackson put it best in his on-point Twitter thread: “This is performative allyship, plain and simple. This is the type of language that belies racism and discrimination in 2022: a tempting misdirect, commodified language, a passionate plea on behalf of ‘the voiceless,’ despite the routine silencing of those very individuals.”
As Biogen and other pharma-funded organizations push back against CMS’ Aduhelm decision, it’s essential to take a critical look at their arguments and motivations. The CMS comment period is going to be a battle; with billions of dollars on the line, Biogen will not give up without a fight. But neither will the advocates who are demanding more evidence on this drug before Medicare covers it.