The FDA, forged in misery and sustained in suffering

When the first effective antibiotics were discovered, it was soon realized they were actually inexpensive industrial compounds. Easily available in a solid or powder, the liquid forms however were rare and only the company that discovered the compounds had an effective water soluble version.

Hopeful competitors tried many kinds of solvents, and some sold harmful ones. In the most infamous case a deadly solvent was used, killing dozens of people in the US and forging the political demand for a regulatory agency with real power.

The predecessor to the FDA was formed, celebrating the animal testing model and rigorous scientific trials that were popularized by the German company which discovered the compounds. New drugs would take 1 – 2 years. Yet within weeks of this regulatory bodies inception, a powerful new antibiotic that was effective against the majority of Flu strains was discovered, and that Flu season was predicted to be a very bad one.

As the season approached and testing dragged on and on, the bodies started piling up. Instead of simply not using solvents known to be deadly, the regulatory body insisted on it’s rigorous testing model. The same politicians and doctors who cheered the new regulatory body now changed their minds and demanded an early release of the drug. The government never wavered from the scare and irrational over-reaction of dozens of people dying, and tens of thousands would die from a vicious flu season that otherwise would not have.

The fascinating story of the formation of the FDA type regulatory body was told in Thomas Hager’s superb “The Demon Under the Microscope

That was the circumstance the FDA was forged in, and it has pretty much repeated this story over and over again. New drugs now take many more years and anywhere from half a billion dollars to more than a billion to get to market. Patients lying on their death beds are not allowed to try experimental medicine for fear it may ‘hurt’ them – even though we can drink ourselves to death perfectly legally and consume numerous products we certainly know cause cancers and other illnesses.

If we ‘own’ our bodies, it is certainly not only in the context of unwanted pregnancies that is so. We should all have the choice to try any medication or food we want, without some overbearing parental figure treating us all like ignorant children. If we have a right to life, then we have a right to pursue the material means to further and enrich our lives – without having to get some bureaucrats approval.

How would the FDA respond if we had a drug to cure aging?

The FDA… You can drink yourself to death, but you can’t try life saving experimental medicine even if you are dying and exhausted all treatment options…because it may hurt you. This fundamental premise violates our basic civil liberties and treats us all like infantile morons. And in a practical sense, the overly precautionary principle embraced does more harm than good, even from the very first case that caused the creation of the predecessor to the FDA, FDA’s massive regulatory hurdles and irrational standards do far more harm than good, as Kira Beilis‘s excellent article conveys superlatively.

http://kolber.typepad.com/ethics_law_blog/2014/09/how-would-the-fda-respond-if-we-had-a-drug-to-cure-aging-guest-post-by-kira-peikoff.html