Dr. Frances Oldham Kelsey is 100

Happy 100th birthday to Dr. Frances Oldham Kelsey, the pharmacologist whose bold stance against inadequate drug testing saved countless newborns from the perils of thalidomide, a drug which caused severe birth defects in over 10,000 infants. On her first month on the job at the U.S. Food and Drug Administration in 1960, the Canadian-born scientist resisted pressure from thalidomide's manufacturer to quickly approve the drug, which was already being widely prescribed in Europe as a painkiller for pregnant women. As a result of Dr. Kelsey's insistence on further safety testing, the drug was never approved in the US, saving an untold number of children from its devastating effects.When Dr. Kelsey started working at the FDA, she was part of a new generation of scientists who wanted to ensure that drugs were proven safe and effective before being marketed to the public. At the time, the FDA did not have the authority to enforce these requirements and pharmaceutical companies often engaged in minimal safety testing. It was even a common practice for companies to send new or experimental drugs to doctors for them to try out on their patients.When Dr. Kelsey received the application from the Richardson-Merrell Company for approval of thalidomide, the company expected a fast approval since the drug was already in use in numerous countries including Germany, the UK, and Australia. Distrustful of the information provided by the company and, as she later explained, feeling that its repre...
Source: PharmaGossip - Category: Pharma Commentators Authors: Source Type: blogs