Dr. Frances O. Kelsey, a Canadian pharmacologist, was hired as a reviewer for the US Food and Drug Administrationin 1960 and one of her first jobs was to review the drug Thalidomide, then being pushed as Kevadon, a drug already in use in Europe and parts of Africa to prevent morning sickness in pregnant women. At that time, samples of the drug had already been freely distributed to physicians’ offices by the drug’s manufacturer, Marion Merrell Dow. At that time, there were no policies or legislation in place to prevent drugs from being distributed in this manner prior to thorough testing. The drug company was lobbying the FDA to quickly approve the drug for marketing, but Kelsey was steadfast in her refusal to do so. She felt that the drug required further testing and was concerned over one British study that demonstrated serious neurological side effects from the drug.
In refusing to allow the drug to be marketed, Kelsey caused quite a stir. Audio newsreels of interviews with representatives from the manufacturer are almost chilling to hear. In one interview, a representative states that they “feel that they have done everything possible” to ensure that the drug was completely safe to go to market. In another, the representative reminded the interviewer that this wasn’t something to be too overly concerned with, as the only persons who had experienced any kinds of negative side effects, after all, were women who were 2 months into their pregnancy.
Once children began being born with severe birth defects, Kelsey was hailed as a hero. Her actions clearly prevented many deaths and birth defects both in the USA and world-wide. As the negative effects of Thalidomide became more widely publicized, marketing and sales of the drug were quickly stopped. Canada was the last country to stop sales of the drug, in 1962. However, the result of the distribution of samples of the drug to US physicians still resulted in 17 children being born with severe defects in the US. In Canada, approximately 125 children survived with birth defects. Worldwide, there are estimates of anywhere between 10,000 and 20,000 victims. Many of the victims today are around the age of 50 and have suffered tremendous hardships as a result of what was a serious lack of drug testing oversight and accountability.
Kelsey’s actions have a tremendous legacy. Significant drug testing reforms were passed by Congress just months after the public outcry over Thalidomide use. The US FDA continues to have strict standards for drug testing, distribution and marketing — many which were initiated as a result of Kelsey’s insistence on thorough testing prior to distribution and use. The oversight that Kelsey insisted upon has, over the years, saved lives and, yes, helped to further science, now much more safely. So while it might be ever-tempting to join in complaining over research ethics guidelines, standards, requirements and processes, it’s helpful to remind ourselves why they are here to stay.