Most people have heard of the thalidomide tragedy. Few people have heard that that tragedy led to an even greater tragedy. In other words, there were two tragedies with thalidomide.
In the first case, a baby was born with severe deformities after the mother took the drug. The second tragedy was more serious and damaging. Lawmakers used thalidomide as an excuse to pass legislation that did little or nothing to prevent the original tragedy, yet resulted in 60 years of lives lost. These lives were lost because this law reduced the development and sale of useful medicines.
These are the two opening paragraphs of Charles L. Hooper and David R. Henderson, “Two Thalidomide Disasters” Regulations, Winter 2024-2025. This is the lead article.
Another excerpt:
FDA regulations were changed in 1962 by the Kefauver-Harris Amendments. These amendments required drug companies to provide both safety and efficacy for new drugs before they are marketed.
Note the irony. What problems did thalidomide have? A question of efficacy? No; it did what it was supposed to do: treat anxiety and morning sickness. Is it a safety issue? fork. The FDA already had rules in place to prevent unsafe drugs. The FDA could have rejected thalidomide based on rules dating back to 1938.
Anticipating Rahm Emanuel’s maxim nearly half a century ago: “You never want a serious crisis to go to waste,” Congress and President Kennedy decided not to let this crisis go to waste.Kefauver-Harris The amendment was passed. Mr. Kefauver, an opportunist, got his bill because of the thalidomide tragedy, even though his bill had little to do with the thalidomide tragedy. (italics in original)
and:
One reason for this slowdown is that drug development costs have increased significantly since the Kefauver and Harris study. In subsequent decades, capitalized drug development and approval costs per approved drug increased by 7.5% per year in real terms. In the 1970s, it was $179 million, in the 1980s it was $413 million, in the 1990s and early 2000s it was $1.04 billion, and in the early 2000s it was $2.56 billion. Ta. 2000s to early 2010s (all 2013 dollars).
If this annual growth rate of 7.5% continues, costs will more than double every 10 years. However, cost growth appears to be accelerating. The annual growth rate over the past 10 years has been 8.5 percent. Current costs are probably already at least $8 billion (in 2024 dollars).
In other words, the number of drugs has decreased and the cost per drug has exploded. Is this just due to bad drugs being eliminated by the new rules? Several researchers have concluded that the answer is no. Peltzman came to the same conclusion, viewing the cull as if “arbitrary marketing quotas were imposed on new drugs after 1962.” The adjective “arbitrary” is not what the so-called scientific organization is aiming for.
Please read the entire article.
Photo by Estes Kefauver.
