Most individuals have heard of the thalidomide tragedy. Few folks have heard that that tragedy led lawmakers to trigger a fair larger tragedy. Briefly, there have been two thalidomide tragedies.
Within the first one, infants have 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 move laws that will have completed little or nothing to forestall the primary tragedy however has led to 6 many years of misplaced lives. These lives have been misplaced as a result of the laws led to fewer helpful medication being developed and offered.
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 have been altered with the Kefauver–Harris Amendments of 1962. These amendments required drug corporations to show each security and efficacy earlier than a brand new drug could possibly be marketed.
Observe 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 medication. The FDA might have rejected thalidomide primarily based on guidelines that had been on the books since 1938.
Anticipating by practically half a century Rahm Emanuel’s maxim that “You by no means desire a critical disaster to go to waste,” Congress and President Kennedy didn’t waste this one and the Kefauver–Harris Amendments have been handed. The opportunist Kefauver acquired 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 explanation for this slowdown is the a lot larger price of drug growth after Kefauver–Harris. Within the subsequent many years, capitalized drug growth and approval prices per authorized drug have elevated at 7.5 p.c per 12 months in actual phrases: $179 million within the Seventies, $413 million within the Nineteen Eighties, $1.04 billion within the Nineteen Nineties via early 2000s, and $2.56 billion within the 2000s via early 2010s (all in 2013 {dollars}).
If this 7.5 p.c annual development price have been to persist, prices would greater than double each 10 years. However the associated fee enhance appears to be accelerating: The annual development price over the past decade has been 8.5 p.c. The associated fee right now might be already not less than $8 billion (in 2024 {dollars}).
Briefly, we’ve got fewer medication and the associated fee per drug has exploded. Is that this attributable solely to the unhealthy medication that have 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 medication 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.
