Earlier this month Dr. Frances Oldham Kelsey passed away. Although not a household name today, she became that rare thing: a civil servant who was not anonymous. To the contrary, for a time, Dr. Kelsey was recognized by the public at large as a hero.
Despite enormous pressure from lobbyists and the same sort of pressure reviewers face today that, if approved elsewhere, a drug should also be approved here, Dr. Kelsey held her ground, insisting that more proof of safety was needed before the drug thalidomide could be approved for treatment of “morning sickness” and insomnia in pregnant women. Ultimately, the drug was not approved here, and Dr. Kelsey was heralded by President Kennedy and others for saving unknown thousands of American children from serious birth defects. Perhaps equally important, her experience with thalidomide led to stricter clinical testing standards and conflict of interest rules not only in the U.S. but elsewhere around the world.
I wanted to use this blog both to recognize Dr. Kelsey and to appreciate the thousands of others we will never know by name who have worked at the FDA to keep us safe. It is easy to point to large, bureaucratic agencies as a source of delay, but it is essential that, even when questioning those agencies as we have some obligation as citizens to do, we step back and recognize their fundamental importance. The very fact that trained experts are willing to toil day in and day out to safeguard the public at large, typically for less than they could make in other lines of work (and sometimes while subject to outspoken critiques from those they are working hardest to protect), gives me great comfort and fills me with gratitude.
As a society, with respect to pharmaceuticals, we must constantly decide how to balance safety and access. It is inevitable that our tolerance for risk, combined with the particular medical issues we face, will cause us to reevaluate that balance from time to time, as the 21st Century Cures bill moving through Congress now does. Like many others, I have found myself on both sides of this debate – wanting the strongest consumer protections but also wanting flexibility for those individuals facing extraordinary health challenges who want to take on additional risk. Where does the answer lie? We should not be overly cautious as that inevitably impedes access, but we must take great care in safeguarding the public, as only these dedicated public servants can do. For that, I offer them my thanks.