Legal problems of registering substances and therapies to cure aging - Daria Khaltourina
A number of compounds are known to have some anti-aging effects, reducing the rate of aging or extending the lifespan in animals and probably in humans. At the same time, these drugs are not widely marketed to the general public as cures against aging, which probably causes unnecessary losses of healthy life years for many people.
Health experts blame the international legal framework, which only allows registering drugs against certain diseases. This refers to Food and Drug Administration in the United States, and other national agencies which all follow the World Health Organization's guidelines for drug registration. As a result, some geroprotective substances are registered as either drugs against certain diseases (for example, diabetes) or food supplements.
One of the reasons named for this situation is that aging is not in the official list of diseases in the International Classification of Diseases. At the same time, there is a number of conditions which are not considered as diseases, like pregnancy, but there are medicines which are prescribed for these conditions.
Another problem is that most anti-aging drugs and therapies are supposed to have preventive rather than treating effects for a broad spectrum of diseases, and it would take long and expensive clinical trials to justify their beneficial effects. Registering geroprotective substances as medicines for more than one disease seems to be a workable solution. However, geroprotective effects can be more pronounced for some conditions, and much smaller for others, which would make it difficult for them to compete with drugs targeting specific diseases.
Another option is to promote the inclusion of aging into the official disease classifications which would require coordinated advocacy efforts at the global level. Alternatively, conditional registration of new drugs and therapies to cure and prevent aging should be developed and promoted. In any case, a system for testing drugs and therapies to cure aging effectiveness should be established.
In sum, the most promising strategies to ensure registration of new drugs and therapies to cure aging are:
- advocacy for acknowledging age related conditions like sarcopenia as treatable diseases;
- international lobbying to acknowledge aging as a treatable and partly preventable condition;
- promoting legal framework for conditional registration for the drugs and therapies to cure aging.