In 2010, the New York Times dubbed her our “Quiet Savior from Harmful Medicines.” That same year, FDA commissioner Margaret Hamburg presented her with the eponymous Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health. In 2000, she was inducted into the National Women’s Hall of Fame.
Frances Oldham Kelsey died last August at the age of 101. Her life was reexamined and celebrated in much the same way as it has been for decades, but the New York Times said it best. Kelsey—likely unwittingly—became an FDA mascot, and her perceived heroism as a “savior from medicine” says everything about the agency today.
Kelsey’s stint as an FDA reviewer began in 1960, around one year before the world discovered the tragic effects of Thalidomide. Initially touted as a treatment for morning sickness and a painkiller, Thalidomide was approved in Canada and over 20 European and African countries before it became apparent that its use by pregnant women resulted in extreme birth defects for infants. Despite demand for its approval in the United States, Kelsey had repeatedly declined or delayed approving Thalidomide prior to this revelation, for reasons that remain unclear.
Once it became obvious that Thalidomide was dangerous, though, the FDA took full credit for protecting American babies. Kelsey, who had lived with “insinuations that she was a bureaucratic nitpicker, unreasonable—even, she said, stupid”, according to a Washington Post report from 1962, became an instant celebrity. Nine months after Thalidomide’s removal from foreign markets, President Kennedy awarded Kelsey the President’s Award for Distinguished Federal Civilian Service for displaying “exceptional judgment in evaluating a new drug.”
So who was Kelsey—plodding reviewer or prudent guardian? The FDA desperately wants the public to believe it is the latter. Protecting the public from medicine, rather than from disease, became an integral part of the FDA’s modus operandi in the post-Thalidomide era. The lives saved by delay are always celebrated; the lives that it costs are never accounted for.
The true story of Thalidomide is that the episode changed the medical approach toward treating pregnant women for nearly any minor illness: Virtually nothing is prescribed for pregnant women except Tylenol, Robitussin and Amoxicillin. The reason is simple: It is difficult to predict the effects of medicine on developing fetuses. Unfortunately, this useful—albeit tragic—lesson has not had as great an impact on medicine as the idea that medical treatment is inherently threatening and that approval should be delayed whenever possible.
In 1989, European regulators approved kidney cancer drug Interleukin-2. The FDA approved the same drug three years later, during which time 3,500 Americans lost their lives to kidney cancer when they might have been saved. The Nobel Prize-winning drug researcher Dr. George Hitchings estimated the FDA “killed 80,000 people” by approving the anti-bacterial medication Septra (effective in treating deadly bacterial infections such as meningitis) five years after it was approved in England.
Walter E. Williams explained in his book American Contempt for Liberty that the “message is to always err on the side of overcaution where FDA’s victims are invisible and the agency is held blameless.” The phantom victims of FDA sluggishness, however, are all too real.
The Wall Street Journal ran a series of op-eds in 2016 highlighting the stories of young boys suffering from Duchenne muscular dystrophy (DMD), a fatal and extremely painful genetic disorder. The FDA is sitting on an extraordinarily promising treatment for DMD but, for unknown reasons, has yet to approve it. As the Journal noted in July, “the agency may have days to wait, but the boys don’t.” More recently, amid the upset over the EpiPen price-hiking scandal, the U.S. House committee on energy and commerce demanded an explanation for the lack of available generic EpiPen products in the United States (several have been available in Europe for years).
The reason is fairly simple. The FDA has successfully made the case that the government, not drugs, are the true saviors from illness. This public perception coup should never be underestimated. Kelsey’s non-action in the case of Thalidomide led to the adoption of the Kefauver-Harris Drug Amendments in October 1962, which dramatically expanded FDA power. The amendments charged the FDA with ensuring that all drugs entering the U.S. marketplace have to be both safe and effective, with no time limit for approving new medicine. Greater safety also means greater delays, and a loss of life that can never be measured. Kelsey, described as a heroine by the Washington Post both in 1962 and in 2016, singlehandedly changed the relationship between the government and the health-care market by changing the public mindset about that relationship.
Accepting the premise that you need the FDA may be Kelsey’s true legacy—whether or not she intended it. She did not find any cure, discover any danger, or knowingly save any lives. But in large part because of her, life-saving medicines are too often viewed as an enemy. It can take 12 years and billions of dollars for a drug to get to market. Of course, no lives are saved by a drug that isn’t available soon enough. Kelsey likely believed she was helping people, but her primary contribution was to the FDA.
Devorah Goldman is senior health care analyst at Capital Policy Analytics, a consulting firm in Washington, D.C.
