The thalidomide tragedy, refracted through the classic NCFCA LD negative case, unfolds as follows:
“Thalidomide, a sedative sold by a German drugmaker, was said to relieve everything from anxiety to morning sickness, but it led to perhaps the greatest pharmaceutical scandal of all time. About 10,000 babies, many in Germany, Britain and Australia, were born with severe defects in the 1950s and 1960s after their mothers took it. Some babies had no arms or legs. Others had no ears or malformed kidneys” (NYT). This was because Europe valued the PROACTIONARY PRINCIPLE—the drug was both minimally tested and aggressively marketed. Fortunately, the United States valued the PRECAUTIONARY PRINCIPLE, recognized the insufficient safety data, and refrained from approving the drug, thereby saving countless lives.
You’ve undoubtedly confronted this argumentation already this year (heck, statistically speaking, you’re RUNNING it), so how do you best combat the Holy Grail of LD applications? Here are a few ideas.
[1] Thalidomide wasn’t stopped in the US by the precautionary principle
Sam Kazman writes in the Journal of American Physicians and Surgeons:
“[Thalidomide’s] U.S. licensee filed for FDA approval in 1960. The application was handled by Dr. Frances Kelsey, who withheld approval while she investigated possible peripheral nerve damage from the drug. But during the course of her investigation, the drug became linked to severe fetal deformities, which soon resulted in its worldwide withdrawal. Dr. Kelsey was hailed as a hero for preventing thalidomide’s widespread use in the U.S. and received the Presidential Gold Medal for Distinguished Service. In September 2010, she became the first recipient of a new FDA award named in her honor. In retrospect, it’s unclear whether it was investigative skill or luck that led Dr. Kelsey to hold up the thalidomide application. For one thing, she was investigating peripheral neuritis, not fetal deformities; her subsequent claim that the two were related is dubious.”
James Kim and Anthony Scialli corroborate this claim in their article for the journal Toxicological Sciences. The obvious NEG rejoinder is that by exercising caution regardless of the justification, the FDA did prevent thalidomide from ravaging the US through the precautionary principle; however, indiscriminate, indefinite caution creates massive disadvantages just screaming for AFF to spotlight. (Imagine if we delayed approval of all medicine to eliminate concerns about every conceivable side effect…)
In fact, Conor Friedersdorf notes in The Atlantic that the FDA’s notoriously stringent drug review standards were implemented after thalidomide, so don’t let NEG get away with applying contemporary FDA standards to the thalidomide incident to justify the precautionary principle:
“The FDA’s current approach to drug approval was shaped by a tragedy in Europe, where the drug thalidomide, meant to treat morning sickness, caused birth defects and deaths in perhaps tens of thousands of babies in the 1950s. Largely in response, Congress passed legislation in 1962 that raised barriers to bringing new drugs to market. Thereafter, the FDA was charged with ensuring not only that a new drug was safe, but also that it was effective. And Congress eliminated the time constraint that had forced the FDA to move expeditiously on new drugs. By about 1980, new drugs needed an average of 10 years to gain approval.”
[2] Thalidomide wasn’t approved in Europe due to the proactionary principle
[A] Standards of the Time
Regulators in Europe arguably accorded with the scientific parameters of their era, per the UK’s Science Museum:
“During early testing, researchers at the company found that it was virtually impossible to give test animals a lethal dose of the drug (based on the LD50 test). Largely based on this, the drug was deemed to be harmless to humans… [later in article] In the 1950s, scientists did not know that the effects of a drug could be passed through the placental barrier and harm a fetus in the womb, so the use of medications during pregnancy was not strictly controlled.”
Arthur Daemmrich, Director at the Smithsonian Institution’s Lemelson Center for the Study of Invention and Innovation, attests to this as well. The point? Negatives typically characterize the proactionary principle as flouting commonsensical guardrails, but caution is relative to knowledge; you can’t disregard restrictions you don’t know exist. Even if researchers should have known—they should have engaged in further research to minimize their ignorance—at what point does this process stop? Eradicating so-called “unknown unknowns” is a Sisyphean task.
[B] Misinformation
Moreover, thalidomide’s negative repercussions were potentially shrouded by coordinated misinformation. According to Michelle Martin’s Reuters piece:
“The firm that invented thalidomide, a drug that caused birth defects in thousands of babies, carried out a deliberate misinformation campaign when experts first spotted possible severe side effects, a report commissioned by the German state of North-Rhine Westphalia (NRW) said on Friday… [later in the article] The report, produced by the University of Muenster, said that once experts started drawing links between thalidomide and nerve damage, the manufacturer gave out intentionally false information and hushed up knowledge it had about the drug’s side effects. The study said the firm had also used delaying tactics and threats of potential claims for damages against the state to keep the drug, which achieved high sales, on the market for as long as possible.”
Martin does mention that Reuters was unable to independently validate the University of Muenster’s conclusions. Even considering that qualifier, the report undermines the notion that the proactionary principle constituted the sole cause of thalidomide’s popularity.
[3] Thalidomide’s legacy fostered undue caution
I’d recommend you explore the following resources:
- Maggie Mertens, an NPR correspondent, discusses how thalidomide precipitated the FDA’s near-exclusion of women of “childbearing potential” from clinical research, creating a dearth of data on women’s health issues such as heart attacks and strokes, which manifest differently in women than men.
- Friesendorf’s Atlantic piece above and Ezra Klein’s NYT op-ed talk about the FDA delay with self-administered COVID-19 testing.
- Kazman’s article above and his op-ed for the Competitive Enterprise Institute provide several examples of the “invisible victims” of FDA delays and analysis of the regulatory and journalistic incentives in the wake of thalidomide.
Thalidomide is an admittedly compelling example—these responses aren’t unassailable arguments, but merely conversation starters to facilitate more informed debate about a formidable application.
Joel Erickson coaches Lincoln-Douglas debate for Ethos and British parliamentary debate at Wheaton College, where he studied philosophy.