I wanted to share an interesting perspective by statistician Gary Liberson, PhD. He recently published some valid points on the present system of FDA licensing and the difficulty that companies face in finding an economic justification for longevity research without seeking a specific disease.
According to Liberson, the problem lies with the FDA approval system that requires a pharmaceutical company show three things: (1) a mechanism of action (i.e., identify why a drug works), (2) safety and (3) efficacy in managing a measurable biologic end point associated with a disease. This last condition, according to Liberson is a problem.
In his post, Liberson provides an example of a researcher who has discovered a medicine that could add 4 years to the average lifespan. The FDA approval process would ask: “What disease will it cure?” The researcher says: “It won’t cure disease, it will postpone or mitigate the lethality of some diseases.” FDA then says: “While we do not now nor have we ever thought about aging as a disease metric, we accept the concept. All we need to do is test your drug on a sufficiently large population and for a long enough period of time to prove to us it works.” That procedural nonsense is the problem.
According to Liberson: “We have all seen the biotech industry produce many startup companies that have discovered mechanisms of action that academics, investors, and Industry thought might mitigate aging. Yet, these companies’ candidates ultimately did not control or cure a specific disease in any clinical trials. Longevity research is aimed at postponing, not curing disease. How do we now go back and test drugs to see if they postpone the onset of a disease?”
The FDA clearly needs to refocus their thinking with regards to aging and modifying their current strategies on how drugs are brought to market. Unfortunately this seems to be a dead end street at the moment. The FDA doesn’t recognize aging as a treatable condition and only approves treatments for “Diseases.”
Even their definition of disease seems completely arbitrary – example: Why is Type II Diabetes considered to be a disease while Sarcopenia, the loss of muscle mass and function that accompanies aging, is not?
We can’t afford to wait years to see if a particular drug has any positive results on aging and life span nor does it make sense to simply reform the existing protocols for drug approval – What is needed is a suitable measurement system, namely the biomarkers of aging that would provide us with valuable insights into the biological age and health condition of trial participants.