Scientists with scruples make for some of my favorite heroes. Here is one of them: Frances Oldham Kelsey.
In 1960, in her first assignment on the first month at her new job at the United States Food and Drug Administration, Kelsey stood up to powerful corporate interests and demanded scientific studies to demonstrate the safety of a drug already in use in Europe to ease symptoms of morning sickness for pregnant women. Her fearless stance and attention to solid evidence prevented thalidomide from being distributed in America. In Europe where the drug, sold as Kevadon by the William S. Merrell Company, had been legal, about 8,000 infants were born with missing limbs.
Kelsey’s scientific career was amazing from the outset: she earned both a Ph.D. and an M.D, and taught at the University of Chicago for years before moving to her position at the FDA. She had prior history in serving as a watchdog for drug safety, having worked to identify the toxic portion of a medicine known elixir sulfanilamide, which was advertised to help colds but eventually was found culpable for 107 deaths. Kelsey’s group figured it out – the poison was diethylene glycol, the stuff that makes antifreeze work.
At any rate, Merrell launched a hard push to get thalidomide approved — making phone calls, sending representatives on multiple visits, and sending letters to Kelsey. But the scientist refused to budge, saying that no studies had shown it to be safe, and no studies had been conducted to demonstrate its safety on foetuses. Merrell insinuated that Kelsey was being libellous. Kelsey stood her ground, noting that Merrell’s promotion of the drug relied on anecdotal evidence and not scientific rigor.
After five different applications to the FDA, Merrell gave up its fight. Very soon after, the tragic reports surfaced of the babies born with missing limbs who had been exposed to thalidomide.
Because of Kelsey’s work, the US government passed legislation in 1962 that required the FDA’s approval for all medicines, and that drugs needed “adequate and well-controlled studies” that proved both safety and efficacy. Human subjects that signed up for trials had to be given informed consent.
Source(s): @uchicagomedicine.org, “How a courageous physician-scientist saved the U.S. from a birth-defects catastrophe,” March 9, 2020, by Stephen Phillips. @cfmedicine.nlh.nuh.giv, _Changing the Face of Medicine_, “Dr. Frances Kathleen Oldham Kelsey”.
