Regulators Will Likely Continue to Make Development Difficult, Even After Aging is Recognized as a Medical Condition

It is the nature of regulators at the FDA to aim for zero risk at any cost, and this is particularly apparent in the case of preventative therapies intended to be deployed widely in comparatively healthy people. Absent unusual political pressure, any number of ongoing deaths while therapies are assessed is treated as an acceptable cost to avoid even small numbers of deaths that may occur due to use of a new therapy. Thus even after aging is recognized as a medical condition by regulators, it is likely that they will make it too expensive to assess potential therapies. Instead, companies will gain clinical approval for treatment of specific age-related conditions, and widespread off-label use will become a political battle, clinics and physicians versus regulators. The result of this will be the usual consequence of heavy regulation: a dramatic slowing of progress, and increased cost to patients. There is a major challenge for discovering and developing anti-aging drugs. How does one design a clinical trial to convince patients, physicians, payers and, especially, the FDA that a drug actually works? To do this, a company would have to prove that its drug extends lives. You can't test such a drug in young or even middle-aged people, as these groups still have considerable life left - assuming a life expectancy of 80 years. Thus, you would probably need to study the drug in healthy 70-year-olds (with a placebo control group as comparator) and then follow these subjects ...
Source: Fight Aging! - Category: Research Authors: Tags: Daily News Source Type: blogs