#fda #drugs #elderly
One of the most important jobs our various Federal agencies provide is public safety. For example, the EPA is charged with making sure we have clean air and drinking water. The FAA with providing safe air travel. And the FDA is charged with providing Americans with safe food and drugs.
When a new drug is created (not a generic), it goes through a lengthy approval process at the FDA. There are many phases to bring a new drug to market, from the initial viability of the drug, to research, to approval, to post-approval monitoring. During the research phase, the new drug will be tested in both; in vitro (in a test tube) and in vivo (in a live organism). While you cannot have the latter without the former, it is the latter that matters most to us. And according to Geriatrician Dr. Louise Aronson, companies do not perform the level of drug testing we should expect on older citizens.
While promoting her new book, Elderhood: Redefining Aging, Transforming Medicine, Reimagining Life, Dr. Aronson, who is also a professor at UC San Francisco, noted how consumers are grouped into various age groups when under 65 years old, and into a single age group once above. For example, children are grouped into 17 different stages, where each stage will have different needs. This makes sense, as we all know that young children grow and change very quickly as they mature into adulthood. For adults, those stages are reduced to only 5. This also makes sense as the rate of change for adults is lower than in children. However, after adults reach 65, they are all grouped into a single stage.
To make matters worse, drug companies do not even test their drugs in adults older than 65. The logic being these adults may have other illnesses which can muddy the results of the test. While this is a logical explanation if your goal is clean results, it is illogical when these same companies are allowed, by the FDA, to market and sell the very drugs which were not tested on the elderly, to the elderly.
Just as it makes sense to have various stages for young, growing, children, it makes no sense to me, that we do not have at least more than one stage for the elderly. Just as the bodies of children change quickly when young, so do the bodies of the elderly.
The FDA is failing our older citizens by not imposing stricter testing protocols on drug companies. It is for this reason that Dr. Aronson explains “any medication can do anything” to older adults. Hence a medication which may advertise abc side-effects, may in turn have xyz side effects in the elderly and vice versa.
