Clouded Judgment on Aducanumab

Source: Daniel R. George

Last week, the Centers for Medicare and Medicaid Service (CMS) upheld its decision to limit payment for aducanumab, the monoclonal antibody controversially approved by the FDA for treating Mild Cognitive Impairment, to patients in eligible clinical trials.

We have previously written here about the “disaster” that was the FDA’s decision-making process on aducanumab—a drug with major questions about efficacy, safety, and cost—as well as the challenges in curing Alzheimer’s due to its heterogeneity and age-related syndromal nature. We also have written critically about the “psychopolitics” techniques that advocates have used to try to lobby for the drug's broad coverage in the U.S. healthcare system, despite the aforementioned concerns.

Indeed, the decision was a repudiation not only of Biogen—the company that developed the biologic and had marketed it for $58,000 annually after receiving the shocking FDA approval last June—but also organizations like the Alzheimer’s Association and USAgainstAlzheimer’s, which have come under intense scrutiny for their role in banging the drum for a treatment nearly all (unfunded) experts opposed. We believe these organizations, which ostensibly exist to advocate for patients and carers but have tended to, at times, use their moral capital to act as lobbying groups for industry, should use this somewhat embarrassing turn of events to reflect on their social contract with those living with dementia and their loved ones.

A Troubled History

The Alzheimer’s Association was founded in 1980 by a group of family caregivers to provide support to those facing dementia and advance research. As we write in our book American Dementia, the original medical advisors included people who somewhat problematically helped reinvent Alzheimer’s as a single disease of epidemic proportions that was not normal aging and that could eventually be cured.

For the past decade, the Association has been pushing “ending Alzheimer’s” while, relatively, devoting less attention to public health, prevention, and care. They have repeatedly claimed that a cure may be just another donation or funding cycle away and that medical interventions could save money. In the process, they have sometimes contributed to the stigmatization of people living with dementia—a phenomenon they have also decried—by evoking insulting images (e.g., zombies) in their own promotional materials.

Organizational blind spots

The AA’s false promises have distracted many from addressing remediable challenges to brain health like reducing pollution and toxins like lead in water and air, increasing years of education throughout the population, making hearing aids accessible, and bringing arts-based quality of life enhancements to those living with dementia. Moreover, contrary to the Association’s shibboleths about a fast-approaching cure for a singular disease, research has shown that Alzheimer’s is a heterogenous syndrome or set of conditions, perhaps not curable at all, that can be better addressed through prevention. As we have written here, studies suggest that multiple Western countries that have invested during the 20th century in addressing social inequity and improving public and environmental health are now experiencing falling rates of age-specific dementia.

Hence, we conclude that the Association’s persistent false claims of imminent research breakthroughs, support for overdiagnosis and overmedicalization, faith in an impending panacea (e.g., the aducanumab debacle), and relative neglect of interventions that might actually help people affected and their carers have led the organization to stray from its founding ethos and fail to serve public health.

A way forward

We hope there will be proper soul-searching within the leadership ranks, as organizations like the AA are the first line of support families often turn to when faced with the challenges of dementia care. Local chapters do fantastic work to help families, and its national leadership would do well to reconnect with core values of prevention, care, intergenerationality, purpose, and inclusion that are at the core of what people care about and wish for in a healthy society.