vol1 - Page 312

 FDA's fundamental purpose in determining the efficacy
 of a new drug prior to authorizing its marketing is to protect
 the public from_mislabeied drugs that do not perform as
 advertised by their pharmaceutical sponsor° Whether a drugis
 #most effective # or _least effective _ for a particular purpose,
 however,_ is left to the marketplace to determine -- the doctor
 and_ hispa_tiente the parties most intimately involved in the
 treatment process. _/ Obviously the drug that is nmost
 effective # for a particular patient may not be as effective for
 another patient suffering the same condition_ This determination
 is_ in essences the practice of medicine _- a function into which
 the federal government may not intrude)
 Obviously a drug that is nmost effective w for one
 individual may not be the #most effective # drug for another
 individual° Aspirin may be the #most effective _ medicine for a
 patient suffering from a headache° That patients however, may
 find Tylenol #more effectiveo _ However_ this is not to say that
 aspirin is not _effective _ and does not frays a Ucurrently
 accepted medical use in treatment in the United States n as the
 DEA standard would mandate. Indeed, to .adopt DEA's standard,
 would, in effect, allow the Agency to dictate specifically how
 medicine will be practiced throughout the United States_ That
 is, in the end only one drug per disease would be #most
 _/ Affidavit of Dro Dennis Petro_ _ 97. Dr. Petro
 distinguishes FDA Wapproval_ for mefficacyX from nacceptance# in
 the marketplace: _The market for drugs is not the FDA or
 scientific investigators or clinical researchers .... The
 market is the patient .... If patients . . . reject a drug it
 does not matter that the drug is FDA approved as 'safe' and
 'effective,' the drug is a failure. It is not _accepted. 'H /_<_