Posted: 7/10/2018
Vicious Cycle Of Government Intervention Since 1906
If you need an example of an almost ideal/stylized, but unfortunately, all too real vicious cycle of excessive government intervention just take the official history of drug approval by the U.S. Food And Drug Administration.
The only positive entry I could find perusing this history was: “1905 The American Medical Association (AMA) begins a voluntary program of drug approval that would last until 1955. In order to advertise in the AMA and related journals, drug companies must show proof that the drug will treat what they claim”. Without the vicious cycle of government interventions, we would probably have a much better system of private, voluntary drug testing and approval.
Thalidomide 1962
First, I am not a doctor nor am I medically trained etc.
The Thalidomide scandal of 1962 and its aftermath is a great example of a highly irrational, overreaction by our elected representatives that was never corrected. Thalidomide apparently has been an important drug. It is still used today.
In the U.S., the Thalidomide disaster was prevented thanks to “FDA inspector Frances Kelsey, who prevented the drug’s approval within the United States despite pressure from the pharmaceutical company and FDA supervisors. Kelsey felt the application for thalidomide contained incomplete and insufficient data on its safety and effectiveness. Among her concerns was the lack of data indicating whether the drug could cross the placenta, which provides nourishment to a developing fetus.” (emphasis added)
So what actually caused the breakdown of safety tests and approval for this drug? The sources below do not really tell.
It was approved as an over the counter drug in 1957 in Germany on the safety claims of the maker (what?). Did any German health authorities then approve this drug? Why was this drug so quickly promoted and sold as a morning sickness treatment for pregnant women (on the claims of the maker that it was safe for pregnant women as well)?
“Between 1958 and 1960 it was introduced in 46 different countries worldwide”. How was that possible that this drug was so fast approved and marketed worldwide?
“Around this time [1960?], Australian obstetrician Dr. William McBride discovered that the drug also alleviated morning sickness. He started recommending this off-label use of the drug to his pregnant patients, setting a worldwide trend. ” Did nobody verify this claim?
Apparently, highly advanced countries like the UK had inadequate government drug approval procedures in place up to 1962. How come?
“Until Thalidomide tragedy, the drugs were being sold by notification to health authority and NO safety, efficacy or quality data were required to be submitted prior marketing.” This was the sorry, troubling state of affairs in Western Europe.
Since The Thalidomide Scandal Drug Efficacy Needs Approval
Before Thalidomide (1962), the FDA drug approval process was only concerned with drug safety. Then, U.S. legislators rushed to pass the so called the Kefauver Harris Amendment (a.k.a. Drug Efficacy Amendment), which required drug efficacy as well. We still suffer from this incredibly misguided and short-sighted decision! This was certainly not the “finest achievement in consumer protection”, rather the opposite or everything else!
How Many Lives Were Shorted!
We will perhaps never find out how many lives were shortened since the the drug efficacy requirement came into effect in the U.S. However, I bet many more people were prematurely killed or harmed then by Thalidomide, because new and safe drugs were not speedily approved based on safety alone.
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