Most individuals have heard of the thalidomide tragedy. Few individuals have heard that that tragedy led lawmakers to trigger a fair greater tragedy. Briefly, there have been two thalidomide tragedies.
Within the first one, infants had been born with extreme deformities after their moms took the drug. The second tragedy was extra severe and damaging. Lawmakers used thalidomide as an excuse to cross laws that might have achieved little or nothing to forestall the primary tragedy however has led to 6 many years of misplaced lives. These lives had been misplaced as a result of the laws led to fewer helpful medicine being developed and bought.
These are the 2 opening paragraphs of Charles L. Hooper and David R. Henderson, “Two Thalidomide Disasters,” Regulation, Winter 2024-2025. It’s the lead article.
One other excerpt:
The FDA’s guidelines had been altered with the Kefauver–Harris Amendments of 1962. These amendments required drug firms to show each security and efficacy earlier than a brand new drug could possibly be marketed.
Notice the irony. What sort of drawback did thalidomide have? An efficacy drawback? No; it did what it was speculated to do: deal with anxiousness and morning illness. A security drawback? Sure. The FDA already had guidelines in place to forestall unsafe medicine. The FDA may have rejected thalidomide primarily based on guidelines that had been on the books since 1938.
Anticipating by almost half a century Rahm Emanuel’s maxim that “You by no means desire a severe disaster to go to waste,” Congress and President Kennedy didn’t waste this one and the Kefauver–Harris Amendments had been handed. The opportunist Kefauver acquired his invoice due to the thalidomide tragedy though his invoice had virtually nothing to do with the thalidomide tragedy. (italics in unique)
And:
A part of the explanation for this slowdown is the a lot greater value of drug growth after Kefauver–Harris. Within the subsequent many years, capitalized drug growth and approval prices per accredited drug have elevated at 7.5 % per yr in actual phrases: $179 million within the Nineteen Seventies, $413 million within the Nineteen Eighties, $1.04 billion within the Nineteen Nineties by early 2000s, and $2.56 billion within the 2000s by early 2010s (all in 2013 {dollars}).
If this 7.5 % annual progress charge had been to persist, prices would greater than double each 10 years. However the price enhance appears to be accelerating: The annual progress charge during the last decade has been 8.5 %. The price as we speak might be already at the least $8 billion (in 2024 {dollars}).
Briefly, we have now fewer medicine and the price per drug has exploded. Is that this attributable solely to the dangerous medicine that had been weeded out by the brand new guidelines? A number of researchers have concluded that the reply is not any. Peltzman got here to this similar conclusion, seeing the culling as if “an arbitrary advertising quota … had been positioned on new medicine after 1962.” The adjective “arbitrary” isn’t one thing a supposedly scientific group strives for.
Learn the entire article.
The image is of Estes Kefauver.
