Most people have heard of the thalidomide tragedy. Few people have heard that this tragedy prompted lawmakers to create an even greater tragedy. In short, there were two thalidomide tragedies.
In the first case, babies were born with severe deformities after their mothers took the drug. The second tragedy was more serious and damaging. Lawmakers used thalidomide as an excuse to pass legislation that would have done little or nothing to prevent the first tragedy, but resulted in six decades of lost lives. Those lives were lost because the legislation resulted in fewer useful drugs being developed and sold.
Here are the two opening paragraphs by Charles L. Hooper and David R. Henderson: “Two Thalidomide disasters,” RegulationWinter 2024-2025. It’s the main article.
Another excerpt:
The FDA’s rules were changed with the Kefauver-Harris Amendments of 1962. These amendments required pharmaceutical companies to prove both safety and efficacy before a new drug could be marketed.
Note the irony. What kind of problem did thalidomide have? An effectiveness problem? No; it did what it was supposed to do: treat anxiety and morning sickness. A safety problem? Yes. The FDA already had rules in place to prevent unsafe drugs. The FDA could have rejected thalidomide based on rules that had been in place since 1938.
Anticipating Rahm Emanuel’s maxim by nearly half a century that “You never want a serious crisis to go to waste,” Congress and President Kennedy did not waste it and the Kefauver-Harris Amendments were passed. The opportunist Kefauver got his bill because of the thalidomide tragedy, even though his bill had virtually nothing to do with the thalidomide tragedy. (italics in original)
And:
Part of the reason for this delay is the much higher drug development costs after Kefauver-Harris. In subsequent decades, capitalized drug development and approval costs per drug approved have increased by 7.5 percent per year in real terms: $179 million in the 1970s, $413 million in the 1980s, $1.04 billion in the 1990s to early 2000s, and $2.56 billion in the 1970s. the 2000s to early 2010s (all in 2013 dollars).
If this 7.5 percent annual growth rate were to continue, costs would more than double every ten years. But the cost increase appears to be the case speed up: The annual growth rate over the past ten years was 8.5 percent. The cost is likely to be at least $8 billion today (in 2024 dollars).
In short, we have fewer medicines and the costs per medicine have exploded. Is this only due to the bad drugs eradicated by the new rules? Several researchers have concluded that the answer is no. Peltzman came to the same conclusion, viewing the cull as if “an arbitrary marketing quota… had been placed on new drugs after 1962.” The adjective “random” is not something a supposedly scientific organization strives for.
Read the entire article.
The photo is by Estes Kefauver.