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Parachute Falsification, The Fda Together With Non-Science

I appear to accept annoyed roughly statistics fundamentalists amongst the last statistics post. So permit me piece it out from kickoff principles...

The electrical current gold-standard inwards epistemology is Karl Popper's sentiment that all noesis is provisional - as well as you lot are entitled to believe your educated estimate therefore long every bit it agrees amongst experiment. However when mortal does an experiment that contradicts your "knowledge" you lot are no longer entitled to your educated guess. Your educated estimate goes into the mass of failed theories.

To operate on to believe your educated estimate is non-scientific.

Popperism applies non alone to your theories but to your meta-theories - your theories every bit to how to attempt knowledge.

H5N1 uncomplicated lawsuit suffices. People - good, clever people, for centuries believed that the alone vogue to decide whether something was correct was to await inwards the Bible. If the Bible supported it as well as therefore it is right.

Nowadays nosotros accept developed several well-tested theories which are inwards straight contradiction to the Bible (see deep fourth dimension inwards geology as well as evolution for the best examples).

Not alone is the creation myth inwards Genesis falsified but therefore is the meta-theory that the appropriate attempt for noesis is that it is printed inwards the Bible.

The FDA's meta-theory

During the FDA panel hearing for Lemtrada (an MS drug nether evolution from Genzyme/Sanofi), the panel voted no on the proffer that the trials are adequate as well as well-controlled, as well as yeah on the proffer that applicant provided substantial bear witness of effectiveness of alemtuzumab [Lemtrada] for the handling of patients amongst relapsing forms of MS.

The FDA staff asserted that you lot could non maybe vote no on whether the attempt was adequate as well as well-controlled as well as yeah on effectiveness.

In doing this the FDA staff were asserting a meta-theory - the theory that the alone attempt of effectiveness is an adequate as well as well-controlled test.

I discovery that adequate as well as well-controlled attempt is something defined inwards legislation (see here). And that parachutes every bit a device to forbid trauma as well as expire to people who outpouring out of planes accept never been subjected to an adequate as well as well-controlled attempt every bit defined inwards the legislation.

Yet nosotros know that parachutes are effective despite the absence of an adequate as well as well-controlled test.

In other words nosotros accept a contradiction to the meta-theory. The meta-theory demands an adequate as well as well-defined attempt every bit the only method of noesis as well as the parachute lawsuit is a straight counter-example.

The FDA's meta-theory has been contradicted.

However, much to my surprise, as well as several years later on the publication of the famous parachute paper the FDA staff (and roughly of my weblog readers) nevertheless asserts their meta-theory.

I accept at ane time categorized the FDA staff inwards the pseudo-science military camp - those who - similar their fellow-traveller creation scientists - back upwards their meta-theory inwards the confront of straight falsification.

Hopeless. Stupid too.





John

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