Clinical Trials and the Exclusion of People with Disabilities

By Stephanie Meredith

A recent federal proposal regarding research for a new class of treatment for Alzheimer’s disease has drawn sharp rebuke from an unlikely critic: a coalition of Down syndrome and intellectual disability advocacy organizations. The reason?  The Centers for Medicare & Medicaid (CMS) proposal, which is open for public comment until February 9, specifically excludes people with Down syndrome and other intellectual disabilities from participating in the clinical trials. This decision would subsequently prevent them from accessing the treatment (https://www.ndss.org/cms-comment/).

Image is of a yellow square box with a partial purple circle in the lower left hand corner. A picture of hands in a white lab coat holding a bottle of medicine and an iPad. Text reads: A recent proposal federal proposal regarding a new class of treatment for Alzheimers disease,,, specifically excludes people with Down syndrome and other Intellectual Disabilities from participating in the clinical trials

As the mother of a 22-year-old son with Down syndrome, this is particularly concerning to me because, by age 40, most people with Down syndrome have the plaques in their brain that increase their risk of developing Alzheimer’s symptoms. Ultimately, the National Institute on Ageing estimates that about 50% of people with Down syndrome will develop Alzheimer’s as they age (https://www.nia.nih.gov/health/alzheimers-disease-people-down-syndrome).

Right now, my son lives a full life. He works at the local grocery store, has launched a photography career, volunteers at food pantries, and coaches lacrosse. He is active and engaged in his community, and he deserves to enjoy a full, rich life as much as anyone else. Moreover, the boys he coaches in lacrosse, his coworkers, his friends, and his family also want him in their lives as long as possible. But this proposal would leave people like Andy behind when they are actually most at risk.

This discrimination is particularly egregious because the research community has been more than willing to perform research on people with intellectual disabilities in the past when it benefited everyone else. Between 1955-1970, children with intellectual disabilities at the infamous Willowbrook State Institution in New York were injected with hepatitis and made to drink chocolate milk mixed with feces from other infected children to study their immunity after being given a preliminary vaccine for the disease. The defense used was that these children would have been infected anyway in the institutional setting; that they were an easily accessible population to use; and that the benefits to the rest of the population were worth it.

The profoundly unethical behavior of those researchers and the horrific Tuskegee Study of Untreated Syphilis prompted the development of the Belmont Report by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines ethical principles and guidelines for the protection of human subjects of research focused on beneficence, respect for persons, and justice. Under the principle of justice, marginalized populations are not supposed to be excluded from research if the treatment could substantially benefit them, and the principle of “respect for persons” outlines that researchers must get informed consent from research participants. 

Perhaps those who outlined this discriminatory CMS proposal were concerned that they could not obtain informed consent from individuals with developmental disabilities. However, the Belmont Report explicitly says, “The extent of protection afforded should depend upon the risk of harm and the likelihood of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in different situations.” Therefore, the determination should be made individually and based on the capacity of the person and their caregivers for consent and also take into consideration the potential for benefit in a population at such high risk for Alzheimer’s.

CMS must consider that their exclusion of people with intellectual disabilities, as a historically stigmatized population, from this Alzheimer’s research and future treatment sends a strong message that says: “When you were the easiest research population, we were willing to sacrifice your dignity and autonomy to benefit everyone else. But when the research stands to substantially benefit you, we’re willing to cast you aside.” 

Part of the problem here is that people with disabilities, and particularly intellectual disabilities, are routinely left out of public health equity initiatives because they are not properly recognized as a minority population that faces discrimination and significant health inequities. We need CMS to change course on this proposal. And we also need the CDC Office of Minority Health and Health Equity, the NIH National Institute on Minority Health and Health Disparities, and the Agency for Healthcare Research and Quality to more explicitly include people with disabilities as health disparity populations they serve so that when Andy and his peers face discrimination like this Alzheimer’s research proposal, they have somewhere to turn for support.

 The National Council on Disability (NCD) called on these agencies to convene a meeting about the importance of including people with disabilities as a health disparity population on December 7, 2021, and we need to make sure this movement continues to gain traction.

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