This article was written by Lucy Tournas, LSI Scholar and 3L at the Sandra Day O’Connor College of Law, who attended LSI’s Third Annual Workshop on Healthspan Extension Policy and Regulation.
What if there were currently drugs with the potential to treat aging? Specifically, these proposed treatments may delay heart disease, osteoporosis, diabetes, and overall frailty. While this sounds amazing and could help combat the astronomical costs of healthcare and pain and suffering in this country, there is currently no mechanism by which the FDA can approve such interventions.
I have had the opportunity to work on this evolving issue for the past three healthspan conferences, and each year the science and debate becomes more astonishing. This year we began with an interesting talk by journalist and author David Ewing Duncan. He has run hundreds of tests on himself, including whole genome sequencing, targeted bloodwork based on rapid dietary changes, and brain scans. He noted that the data is great, but we are at a phase in which we need a push for analysis in order to create meaningful data.
There were a number of fascinating talks on the science of aging, specifically James Kirkland (Mayo Clinic), Lewis Gruber (SIWA Therapeutics), and Felipe Sierra (National Institute on Aging) all explored the role of senescence cells (cells that have stopped dividing) in the aging process. These academics and health industry professionals have conducted animal trials showing a drastic decrease in diseases associated with aging when senescent cells have been removed. SIWA Therapeutics is even developing an antibody used to clear senescent cells which they hope to get approved for human trials.
Learn more about cellular senescence and aging from Dr. Kirkland.
While potential breakthroughs are extremely exciting, both Randolph Nesse from ASU’s Center for Evolution and Medicine and Attorney Robert Milligan addressed practical concerns. Nesse focused on evolutionary constraints. Where there has been talk that aging is perhaps unnecessary and an offshoot of evolutionary neglect, Nesse mentioned that natural selection left us with many traits to cause injury. We have unavoidable vulnerabilities, caused by core tradeoffs that must be understood before we contemplate finding a cure for aging. For example, tissue repair increases cancer, cancer prevention damages cells, increase metabolism generates free radicals, and so on His take away was that if we slow aging, we will likely increase cancer. Similarly, ASU Professor of Civil and Environmental Engineering, and of Law Brad Allenby challenged the group to think of the possible ecological concern cause by humans living longer.
Robert Milligan addressed insurance coverage. He noted that Medicare does not provide coverage for lifestyle drugs, the category likely to include medication related to aging. Using obesity as a case study, he noted that for Medicare to cover bariatric surgery, a patient needs to present with obesity and one other indicator. It may be unlikely that insurance companies will cover treatments for asymptomatic persons. This would make healthspan medications available only to the wealthy. He said that reimbursement must be at the forefront of the discussion, as insurance companies exist to conserve funds, not promote public health.
Faculty Director Gary Marchant and I discussed the regulatory hurdles this drug classification has when getting approval from the FDA. Specifically, the FDA only approved drugs for disease. We argued that the FDA can treat aging as a disease, and there are ways to develop multi-indicator biomarkers to create trials going forward. Our proposal will be expanded in a subsequent paper with more details.
Materials from workshop presentations are now available here.