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/).

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Multi Colored Trim on a square box. Black text on white background reads: To Promote More Informed Healthcare and Greater Equity Towards People with Disabilities: 1. Insurance Coverage of independent genetic counseling. 2. FDA Regulation of Advertising claims made by testing labs. 3. better educational infrastructure for patients to understand testing and disabilities. 4. Insurance coverage of testing contingent on the provision of better patient education and access to independent pre-test and post-test counseling

In Response to the NY Times: Prenatal Screening and the Social Bias Against Disability

By Stephanie Meredith

A recent New York Times article, “When They Warn of Rare Disorders, These Prenatal Tests Are Usually Wrong” by Sarah Kliff, indicates that when cell-free DNA prenatal screening results show that a baby has high chances for some rare genetic conditions, the baby actually does not have the condition 70-90% of the time (a false positive) (2022). Many parents at the other end of the screening results describe the experience as stressful and scary because they weren’t given sufficient information about the accuracy of the tests and the possibility of false positives. Kliff shares that one reason why expectant parents misunderstand the screening tests is because testing labs describe their screening tests as “reliable,” “highly accurate,” etc. in their advertising materials. Moreover, the author asserts that the companies are highly motivated to expand testing so that they can increase profits in a highly lucrative market. Yet, this widening pool of expectant parents who are undergoing testing can leave some parents in the lurch when they don’t receive the counseling and information they need to properly understand the screening tests. Kliff effectively highlights these important issues and presents a strong case for FDA regulation of advertising claims made by testing labs and insurance coverage of independent genetic counseling.

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