… and the unexpected hero who saved American babies
Pregnancy is one of those magical times when we, as a society, tell women how much they should just relax and enjoy growing a new human being and then do everything in our power to turn them into anxiety incarnate. Nothing strikes fear into the heart of a new mother like the prospect of some choice she makes, even the seemingly inconsequential, harming her unborn child irrevocably. It was no surprise, therefore, that The Business of Being Born (more on that some other day) used the example of thalidomide to invoke skepticism, even suspicion, of obstetric interventions based in the precautionary principle.
The precautionary principle states, in essence, that when actual risk is uncertain but at least plausible, actions should be taken to avoid or minimize the theoretical harm. For example, while there is no evidence that live-virus vaccines (not the ones currently recommended during pregnancy) would cause harm to an unborn child, they are still contraindicated during pregnancy because risk “cannot be excluded for theoretical reasons.” Obviously, this principle is not cut-and-dried as sometimes the expected benefit is outweighed by any theoretical risks. No medical body would recommend you forego an ultrasound when you need to know if you have a dangerous condition like placenta previa because of “theoretical” risks; the actual risks to mother and baby are far too great. Still, given all the unknowns in fetal development, the medical community generally accepts the precautionary principle as a good thing. And nothing points out the grave consequences of ignoring that principle like the story of thalidomide.
In the 1957, a German pharmaceutical company began marketing the recently developed thalidomide. Originally marketed as a sedative, the indications soon expanded and it became widely recommended as a treatment for morning sickness. The company marketed it as “nontoxic” and safe for pregnant women. Based on 1950s scientific scrutiny and understanding, such a designation was not entirely unfounded. The animal experiments had shown that even extremely high doses of thalidomide were unable to kill the test animals and there were no side or teratogenic effects (malformations) noted. Yet, within a few years, an observed increase in devastating birth defects was correlated to thalidomide exposure during pregnancy, and it was taken off the market. Thalidomide was responsible for the deaths and deformations of thousands of children, many of whom were rejected and institutionalized, worldwide.
But, there is a hero in this tragic history. In the popular narrative of thalidomide, she may be considered the unlikeliest of heroes. In most countries where pharmaceutical companies sought approval for thalidomide, it was approved and then aggressively marketed. But not in the United States.
In 1960, the application for approval of thalidomide hit the desk of a recently hired pharmacologist, Dr. Frances Oldham Kelsey. At the time, because of the lack of regulation, the distributor expected the swift approval that thalidomide had seen in the rest of the developed world. However, Dr. Kelsey refused to approve what she deemed a “peculiar drug.” She noted that the drug did not produce the desired effect, sedation, in the animal subjects. This result, along with the meager scientific backing in the application that left her “very unimpressed”, particularly troubled her. What other aspects of the drug (reactions, side effects) might also be different in humans than in animals? Since the drug was for non-fatal conditions with medication already on the market, Dr. Kelsey refused to be rushed. She insisted on more data and tests results despite enormous pressure from the companies seeking to profit from thalidomide.
Thanks to Dr. Kelsey’s perseverance in demanding quality science, thalidomide was never approved for use in the United States prior to its worldwide withdrawal in 1962. While there were some injuries sustained due to quantities of the thalidomide distributed for testing purposes, she is credited with saving thousands of American babies from preventable birth defects. As the terrible story of thalidomide broke, public outcry demanded stricter regulation of pharmaceuticals. The Kefauver-Harris Drug Amendments, which passed new regulations requiring proof of safety and efficacy, informed consent of clinical trial participants, reporting of adverse drug reactions to the FDA, and disclosing side effects and efficacy in advertising, were signed into law in 1962, the same year Dr. Kelsey received the President’s Award for Distinguished Federal Service. President John F. Kennedy noted:
“Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States. Through high ability and steadfast confidence in her professional decision she has made an outstanding contribution to the protection of the health of the American people.”
That is Dr. Frances Oldham Kelsey: scientist and former employee of the Food and Drug Administration (FDA).
It really grinds my gears when I hear people use thalidomide as an excuse for why they “don’t trust science.” If anything, thalidomide is a warning of what happens when we don’t trust and value science. It is the tale of what happens when anecdote and marketing are given more weight than scientific study. And when the same people who purposely use thalidomide to poison the well against modern medicine turn around to sell you treatments and supplements based in that very same paradigm of marketing over scientific evidence that caused the very same thalidomide tragedy they’re exploiting… it’s maddening.
Just as celibacy wasn’t the “problem” that caused the tragic sex abuse crisis in the Church, science wasn’t the “problem” that caused the thalidomide tragedy. In both cases, children were devastated and credibility seriously jeopardized (maybe in perpetuity for some). But, we must remember that it was a failure to value those principles— the principles of celibacy, the principles of scientific inquiry— not the principles themselves, that caused these tragedies.
Science is the means by which we come to understand the mind-boggling grandeur of creation. Reasonable skepticism of the results of scientific inquiry is one thing; it’s what experts and peer-reviewers are expected to have. However, to reject “science” is to reject knowledge and understanding of the natural world in favor of emotion and superstition. If we learn anything from thalidomide, we learn that there is a real, potentially devastating human cost to rejecting the value of science.