Sunday, October 4, 2020

Remembering Thalidomide

Does anyone out there remember hearing about Thalidomide? It was a pharmaceutical agent that was introduced into West Germany in 1951. It's original availability was as an over the counter medication. It was indicated for insomnia, morning sickness and anxiety amongst other cavalier options striking the user's fancy.

It was the usage in pregnancy that caught all the press all over the world. The drug caused roughly 10,000 malformations in newborns. Thalidomide was being introduced into the United States by Smith Kline French. SKF sought and obtained a license to market the product in the US amidst the development of the evidence of first trimester malformations. The product was not ever marketed in the US subsequent to this evidence.

The Thalidomide babies are prominently imbedded in the memories of those who read any sort of news in the 60's. As a result, the Food and Drug Administration implemented more rigorous requirements for all new drug development from that point onward. Today there are countless checks and cross-checks in the development of any new pharmacologic agent introduced to the US armamentarium. It costs a ton of money and plenty of time to get a new medication past the FDA guidelines. And that is as it should be.

I mention this here in the fall of 2020 in light of all the press you see and hear about the development of a Coronavirus vaccine. I come from 30 years of service working in the  pharmaceutical industry. It is daunting the amount of bureaucracy that is entailed in the development of a new entry into the market. Every company in the industry spends loads of money maintaining a research and development division who are pressing every day for new medications and modalities that can cure cancer, alzheimers, MS, spinal cord injuries, etc. 

It is in the face of that reality that we look forward to a vaccine and antivirals that will stop the spread of the coronavirus and pull us out of the nightmare in which we all are integrally intertwined.  However, we all want it done right. There are just no shortcuts to that end point.

A short study up on the thalidomide tragedy should shift our focus to that fact.