OPINION:
In July 2020, almost a year before Biogen’s dementia medication Aduhelm was approved, the biotechnology company convened a meeting of advocates and experts to discuss “strategies to help communities of color address dementia.” In the meeting brief, Biogen describes its plan to engage with minorities, including encouraging stakeholders to build trust and relationships with communities of color “to ensure equitable access when disease-modifying treatments could become available.”
However, when it came to Aduhelm, the drug’s efficacy for patients of color was of little priority. Patients of color were barely represented in the clinical trials; less than 1% of the participants were Black, and 3.2% were Latinx. Biogen is now conducting a “real-world” study that aims to enroll 16% Black or Latinx patients, but they are marketing the drug to people for whom they haven’t tested it.
Black patients are more likely to carry the apoE4 gene, which raises the risk for Alzheimer’s and increases the risk of bleeding and brain swelling from Aduhelm. Although Biogen claims a commitment to lessening racial disparities, promoting a drug to an unstudied population at higher risk of harm from the drug is hardly racial equity.
Despite these issues, Biogen is using consumer advocacy organizations to promote Aduhelm. The Alzheimer’s Association website provides information on Aduhelm, and CEO Harry Johns stated, “we believe the FDA did the right thing, which is [to approve Aduhelm based on] one positive trial and other scientific evidence.” Similarly, UsAgainstAlzheimer’s Chairman George Vradenburg stated, “we strongly supported the FDA’s approval of Aduhelm” at the organization’s 2021 National Summit.
Biogen has given hundreds of thousands of dollars to The Alzheimer’s Association, and UsAgainstAlzheimer’s in a single fiscal year. Communities of color need to consider whether these organizations support patients’ interests or those of drug manufacturers. The Alzheimer’s Association and UsAgainstAlzheimer’s tout valid points about the mistreatment and discrimination of people of color in health care, such as not “feeling listened to” or being “treated differently because of [your] race” to make people of color trust these groups. Yet, their support of Aduhelm contributes to Biogen’s profits.
Since Aduhelm has been in the pipeline, consumer organizations funded by Biogen have amped up “disease awareness” campaigns among Black and Latinx patients. UsAgainstAlzheimer’s, for instance, reports, “Blacks are two times as likely to get Alzheimer’s as Whites.” Likewise, the Alzheimer’s Association calls Alzheimer’s the “Silent Epidemic” among Black Americans, states that the disease is underreported and undertreated in Black and Latinx patients and that 7 million Black patients will have Alzheimer’s by 2030. These are disease-mongering efforts to increase sales of Aduhelm among these communities.
Biogen claims Alzheimer’s is diagnosed at later stages in minorities, and — not coincidentally — Aduhelm is approved only for early stages of Alzheimer’s, including mild cognitive impairment (MCI). Therefore, Biogen has advocated for increased early cognitive screening, especially among patients of color. For example, a Black woman and a Black man pose on the It’s Time We Know website, one of Biogen’s disease awareness sites encouraging cognitive screenings.
Likewise, in June 2021, Biogen announced a partnership with CVS to conduct cognitive screenings “particularly in racially and ethnically diverse communities.” We identified no evidence that the September launch happened — and that’s a good thing. These cognitive screenings would most likely have overdiagnosed people of color with MCI and Alzheimer’s: Hardly, as Biogen puts it, “an equitable response to Alzheimer’s disease and dementia.”
The validity of current screenings is questionable because frequently used cognitive screening tests, including the Montreal Cognitive Assessment (MoCA) and the Modified Mini-Mental State Examination (3MSE), have been shown to be biased against people of color. Test results depend on educational level and socioeconomic status, and Black Americans performed poorly on certain parts compared to Whites with the presently defined cutoffs. In a clinical setting, biased tests will increase the number of people eligible for Aduhelm prescriptions and patients Biogen can profit from.
Even if one accepts that dementia rates in Black and Latinx patients are high and projected to increase, why wouldn’t the focus be on prevention rather than biased cognitive screenings?
Racial disparities in Alzheimer’s are likely due to multiple factors, including racial disparities in health care access, educational status, and chronic disease prevalence. About one-third of Alzheimer’s cases can be attributed to modifiable risk factors, including hypertension, depression, and diabetes. Cognitive screening will neither address any of these factors nor prevent the progression of Alzheimer’s, and MCI screenings are not recommended by the US Preventive Task Force.
Elders should refuse cognitive screening, Aduhelm, and future drugs for MCI. Patients and their providers should instead focus on exercise, smoking cessation, and education, all of which reduce cognitive decline. Treating hypertension and other chronic diseases and using hearing aids lower the risk of dementia.
Biogen’s targeted “education,” amplified by industry-supported consumer advocacy groups, will only lead to more patients of color getting MCI diagnoses and Aduhelm infusions. Corporate preying on underserved communities under the guise of equity isn’t the sort of inclusion communities of color need.
• Naisa Rahman is a research assistant with PharmedOut, a Georgetown University Medical Center research and education project promoting rational prescribing. Caroline Renko is the project manager of PharmedOut.
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