Clinical trials can sometimes remind us of the leisure making of an expensive bottle of Bourgogne that can take 20 years. But potentially life-saving therapeutic novel drugs should not be compared to fancy red libations. Indeed, there are mixed opinions about clinical trials and how long it can take to get a new drug approved in our country.
Before we condemn the current mechanism of approving new drugs in the USA, we should stroll through the history of human experimentation.
Medical research, like many things, has a dark past. Humans were experimented on involuntarily or unknowingly by famous and not so famous scientists and physicians. Some of these experiments led to discoveries that we still benefit from. However, some forms of human experimentation were outright heinous, like those done by the occupying Nazis and Japanese. Even our own Department of Health physicians have carried out unethical experiments on our own vulnerable prisoners and institutionalized.
Today there exists a whole set of rules that governs and protects humans in research (Revised Common Rule 2017, Belmont Report 1979). The appropriately high value of protecting human subjects has made the drug development process the opposite of “quick and dirty,” which most would agree is a good thing. As with many things in life, there are pros and cons. The Food and Drug Administration (FDA) has been contrarily viewed as being obstructionist, harming patients by making the approval process so lengthy and expensive. Personally, I think that in trying to understand why the journey from laboratory bench to a new prescription drug is so lengthy, it is difficult to tease apart administrative quicksand from the delicate duty of protecting humans.