Alzheimer’s Disease: Diversity Makes a Difference (Part II of II)
How is thalidomide—the drug that resulted in over 10,000 children with birth defects—related to Alzheimer’s? Once a scandal that rocked the health care world, thalidomide can now be viewed as a vital lesson on the importance of inclusivity in clinical trials—something lacking in the Alzheimer’s disease space.
What happened? In the 1960s, the drug thalidomide was introduced into the market as a miraculous modern day sleeping pill, with the added benefit that it could also be used to prevent morning sickness in pregnant women. Within months, severe deformities in children were on the rise, which traced back to thalidomide use during pregnancy—a horrifying tragedy that left over 10,000 children with disabilities for the rest of their lives. This catastrophe could have been prevented during the clinical trial phase if women had been included in the studies. This cautionary tale underscores how crucial it is for clinical trials to include diverse subjects. This is especially true with Alzheimer's disease.
Last week, we discussed the rising epidemic of Alzheimer’s disease (AD)—affecting an estimated 16 million Americans by mid-century—and highlighted the impending financial burden on our national health care system ($1.1 trillion by 2050). Through that lens, the future looks bleak. But we are confident that, if we take the right steps now, we will be able to avert this impending crisis and make real progress in our search for a cure and treatments for Alzheimer’s disease.
To that end, federal and philanthropic funding is on the rise, and there are over 100 clinical trials currently underway. Nevertheless, the only way that we can find breakthrough cures for AD is to heed the cautionary tale of thalidomide and recruit a wider variety of patients. To find a cure, we need more shots on goal—and to operationalize that, we need to increase the number of patients and intentionally work to diversify characteristics like race, gender, and socioeconomic status.
Recruiting patients for clinical trials is always hard, but it is especially hard with Alzheimer’s disease. One issue inherent to AD is cognitive impairment, which creates obvious complications. Also, these patients likely cannot drive themselves—a significant, but often overlooked, barrier to participation that ultimately leads to the exclusion of specific patient populations, especially those from more remote or lower income areas.
- Remote Location Disparity. Most studies are held in or near large metropolitan cities, given that it is usually universities and hospitals that are equipped to perform the trials. But what happens if you live several hours away from the nearest city? The answer currently is that you likely cannot participate. Why? Because to reach these sites, rural-dwelling individuals and their caregivers must potentially travel hundreds of miles to receive treatment, often for multiple sessions that continue over several years of time. Unfortunately, this may not be a viable option, leaving behind a huge part of the population—a group suffering from higher levels of poverty and disabilities, and containing the largest proportion of military veterans, who have a 60 percent higher likelihood of Alzheimer’s disease.
- Socioeconomic Disparity. Individuals from lower socioeconomic brackets are also frequently absent from Alzheimer’s clinical trials. As a further blow to inclusion, this group often includes minorities who have a higher likelihood of acquiring Alzheimer’s due to certain risk factors, including cardiovascular disease and diabetes. Patients in this group typically receive care from a family member, rather than a professional, due to prohibitive costs and less amenable insurance coverage. Thus, these family members who act as caregivers must provide transportation to and from clinical trials, which requires time off work. This hurdle may be impossible to overcome when a family is living paycheck-to-paycheck, especially when trials need regular engagements. Finally, there is usually a lack of reimbursement for transportation and other expenses incurred while traveling to a clinical trial.
Encouragingly, a new wave of ideas has emerged that challenges the conventional construct of clinical trials. One of the most promising ideas is to bring the trial to the patient instead of the patient to the trial using mobile labs and devices. While new technology like telemedicine and remote monitoring has made mobile trials more viable than ever, there are still not enough resources and infrastructure to make a material difference to the status quo.
It is in cases like this where philanthropic capital has a comparative advantage and can make a real difference. Being more nimble and risk-tolerant than government or commercial funds, it is often able to step in to create a proof-of-concept that can unleash activation energy and ultimately crowd in other funds. Philanthropists can also forge partnerships with academia, industry, and government that ensure the whole is greater than the sum of its parts.
For the last two years, the Milken Institute Center for Strategic Philanthropy has been working to identify high impact philanthropic opportunities in Alzheimer’s disease for the individual and family foundations with which we work. November, being Alzheimer’s disease awareness month, is a useful reminder that we can only get where we need to be through coordinated action and symbiotic partnerships. We are always eager to dialogue with interested organizations that are also working in Alzheimer’s disease, and we welcome feedback and input to our efforts.
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