Most individuals have heard of the thalidomide tragedy. Few folks 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 critical and damaging. Lawmakers used thalidomide as an excuse to cross laws that will have completed little or nothing to stop the primary tragedy however has led to 6 a long time of misplaced lives. These lives had been misplaced as a result of the laws led to fewer useful 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 might be marketed.
Observe the irony. What sort of downside did thalidomide have? An efficacy downside? No; it did what it was imagined to do: deal with nervousness and morning illness. A security downside? Sure. The FDA already had guidelines in place to stop unsafe medicine. The FDA may have rejected thalidomide based mostly 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 need a critical 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 received his invoice due to the thalidomide tragedy regardless that his invoice had nearly nothing to do with the thalidomide tragedy. (italics in authentic)
And:
A part of the rationale for this slowdown is the a lot greater value of drug growth after Kefauver–Harris. Within the subsequent a long time, capitalized drug growth and approval prices per permitted drug have elevated at 7.5 p.c per 12 months in actual phrases: $179 million within the Nineteen Seventies, $413 million within the Nineteen Eighties, $1.04 billion within the Nineties by means of early 2000s, and $2.56 billion within the 2000s by means of early 2010s (all in 2013 {dollars}).
If this 7.5 p.c annual progress fee had been to persist, prices would greater than double each 10 years. However the fee improve appears to be accelerating: The annual progress fee over the past decade has been 8.5 p.c. The price right this moment might be already at the very least $8 billion (in 2024 {dollars}).
Briefly, now we have fewer medicine and the fee per drug has exploded. Is that this attributable solely to the unhealthy medicine that had been weeded out by the brand new guidelines? A number of researchers have concluded that the reply isn’t 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.
