Do You Know Who Frances Kelsey Is?
6 CommentsBy Ed Silverman // September 16th, 2010 // 12:35 pm
The odds are that you don’t, but her actions a half-century ago helped transform the way prescription drugs are tested and approved. Kelsey, you see, was a new FDA employee in 1960, when she was assigned to review Kevadon, which was the brand name for thalidomide. The drug caused severe birth defects in thousands of babies born overseas after being prescribed to help women sleep or manage morning sickness. But babies often had limbless arms, malformed legs or extra appendages.
A physician and pharmacologist, Kelsey questioned its safety. “It just came with so many extravagant claims that I didn’t believe,” Kelsey, now 96, tells The Washington Post. Her decision set in motion a lot of intrigue as the manufacturer, Merrell, pushed back by complaining about her to the FDA. But kelsey held her ground and after the scandal became known, President John Kennedy gave her the Federal Civilian Service award.
Congress, meanwhile, amended the Food, Drug & Cosmetic Act to require safety and effectiveness testing and informed consent in clinical trials. What did informed consent have to do with it? As the paper notes, Merrell gave the drug to more than 1,000 US docs to distribute to 20,000 patients as part of a so-called investigational trial, but some patients were not informed they were participating in a trial. The upshot - about 40 babies in US were born with deformities.
To honor Kelsey on the 50th anniversary of her groundbreaking effort, FDA commish Margaret Hamburg yesterday gave her the agency’s first Kelsey Award which, in the future, will be given to an FDA employee to “celebrate courage and scientific decision-making.” Want to know more? Read this and this.
industry insider
The law was named for the late great senator from Tennessee, and champion of Civil Rights, the Hon. C. Estes Kefauver.
http://en.wikipedia.org/wiki/Kefauver_Harris_Amendment
Mike Wokasch
I suspect there have been many worthy candidates for the Kelsey Award over time but unfortunately we’ll never know who they are. Some I’m sure have been asked to leave the agency, others passed over for promotions, or even moved aside before to much public attention was brought to their concerns about the safety of products.
We need the agency and its management to establish a culture that allows those with expertise and personal integrity to do their jobs and not be in fear of negative career consequences that might result from applying their expertise. Perhaps this Kelsey Award is a step in the right direction.
http://www.PharmaReform.com
R. Boyce
It takes guts to speak up, especially when so many others are against you! Integrity must win in the end or we may as well all be dead. I applaud Margaret Hamburg for her work at the FDA. IMO, they are doing remarkable things … lots of recalls of dangerous drugs. Maybe she should be given the Kelsey Award. If she can get something approved to eliminate genetic discrimination in pharmaceutical companies, I will personally send her a few dozen roses.
Anti-Labour
I agree. A logical candidate for the award would be Dr. David Graham. However, this would have about as much chance of happening as Pete Rose getting in the Baseball Hall of Fame.
Justice in MI
Could not agree more with Mike’s comment:
“I suspect there have been many worthy candidates for the Kelsey Award over time but unfortunately we’ll never know who they are.”
In any event, the Kelsey award may not be around more than a couple of years. If the “small government” cabal has its way, the FDA, EPA, Dept. of Education, Oil and construction regulation, etc. will be old history.
They have as much use for France Kelsey as for Stalin.
industry insider
Several other proposed awards:
The Lester Crawford Trophy: to the FDA official who has failed to disclose the most conflicts of interest in a given year;
The Janet Woodcock Prize for delay, obfuscation and misdirection;
The Thomas Laughren Award for failure to disclose the most significant safety issues in a given year; and finally
The Marvin Seife Memorial Trophy for the FDA official who has taken the most bribes in a given year (Seife was head of Office of Generic Drugs during the Generic Drug scandal, and went to prison for his misdeeds).