When asked when we might expect to see FDA approved “age-reversal” drugs, Dr. Sinclair’s response was that drug development “is hard…super hard.”
It often takes billions of dollars to complete clinical trials, often after many failed attempts.
But, Dr. Sinclair adds, health-span extending drugs may already be here. They just haven’t yet gone through the painstaking process of FDA trials yet.
“In my view*,” Dr. Sinclair notes, “we’ve got some drugs already–Metformin, Rapamycin–that I strongly believe can slow down aspects of aging, so we already have some technologies. They’re not evenly distributed. It’s not available to everybody because most doctors are unaware or unwilling to prescribe these medicines to people who are healthy…but the data looks good.”*
Metformin is usually used on diabetic patients, while Rapamycin is often used to prevent organ transplant rejection.
But studies have shown that Metformin’s effect on cellular metabolism and many other diseases that come with aging (diabetes, cardiovascular disease, cognitive decline) can substantially delay mortality.
So much so, that patients with diabetes and on metformin often live longer than patients without diabetes, not on Metformin.
Rapamycin similarly shows a delay in age-related pathology.
Yet, Dr. Sinclair explains, a number of safety and efficacy measures need to be cleared so that drugs can be approved for “healthy” patients.
What we’re talking about is a radical departure from traditional medicine.
We’ve all come to expect that we go to the doctor for our once-a-year physical (if we’re lucky); the doctor listens to our lungs and our hearts; and notes that our test results are not ideal, but natural “for our age.”
We don’t fight against aging. We try and do a gentle landing, if you will.
The FDA, too, is an organization built around safety, and as such is risk-averse.
If the FDA approves a drug that inadvertently kills even one person, that one life is perceived as more valuable than all the lives lost by not approving a drug.
