The Politics of Drug Development

While I was training in psychiatry 30 years ago, the field was changing around me.  The older psychoanalysts were forced — reluctantly — to add prescription of psychotropics to their practices or else patients would never make it to their door. Of course, they had little to no training in pharmacology and less interest so they didn’t usually know what they were doing. While I was ascending in the ranks of psychiatric trainees, the best and the brightest of us were ushered into special training in pharmacology research.  I was (and probably still am) about as idealist and apolitical an up-and-coming psychiatrist that anyone could have invented.

The next resident psychiatrist after me to take that “psychopharmacology fellowship” found out how much money the university made from doing pre-FDA approval clinical trials of the most popular kind of clinical trial; psychotropics, he fought for — and got– a big raise over what I had received as salary for the same position. I was told it costs over a billion dollars to bring a new prescription drug from idea to prescription. I don’t know if that was correct.  I never checked. Most current estimate available, and controversial, is $2.6 billion. Me — still trying to be apolitical — let’s just say that Mr. President appears to have an interest in industries that have dollar signs with large amounts of zeroes after them. But to evaluate the drug development process, we need to discuss factors other than speed and quantity.

Those Yalies came out this very month to proclaim that one in three drugs “passed by the FDA turns out, in a few years, to have safety concerns.  The specific charge of the FDA when it passes drugs is to prove “safety and efficacy.” Most of these don’t result in recall of the drug, so they aren’t necessarily totally “unsafe” —  and I am glad the FDA folks are doing a good a good job of monitoring drugs after they have been passed. The drugs involved have mostly been on an “accelerated” path for approval. The problem of the material rewards from pharmaceutical production as opposed to proofs of safety and efficacy is not a new one. If you are interested there is a fairly good summary of what is said about financial alliances of the past that many believe to have set up the current political climate of pharmaceutical companies. Not that I ever directly observed alleged goings-on at such level.