The necessity for double-blind controlled studies did not originate with
Medicine or Science but instead originated with government through the
Kefauver-Harris act from 1961 or so. Kefauver-Harris was a reaction to the
thalidomide (sp?) tragedy from the 1950's, the drug prescribed for morning
sickness that resulted in children born without arms, hands, fingers, toes,
feet, legs, etc. I assume that given the graphic nature of the tragedy it
was not difficult to create the Kefauver-Harris act--and get it passed.

When the FDA was created in the 1930's, it was charged with only allowing
drugs/OTC medications/medical devices on the market that were safe.

The purpose of Kefauver-Harris was to insure that drugs/OTC
medications/medical devices were proven to be both *safe* and *effective*.
The government came up with the idea of the double-blind controlled study
as the only method to judge effectiveness by eliminating placebo.

The irony to me is that given the advancements in communication that have
occurred since the early 1960's (the internet in particular), if a
drug/treatment/device were attempted to be marketed that was not effective,
then it would quickly die. I know this from personal experience as I am an
advertising copywriter by profession and have produced numerous campaigns
for new product introductions [and have begged clients to not make claims
that aren't true] and have witnessed what happens when a product cannot
live up to the promise of its advertising.

It dies.

Quickly.

Mr. Kefauver was a liberal democrat from Tennessee. Historically, the
democrats have always exhibited more faith in government control than in
the free market economy. The government demand of effectiveness created by
Kefauver-Harris is just more evidence of that lack of faith in the free
market economy.

Of course, they don't do double-blind controlled studies on medications for
pregnant women due to the unethical nature of such a study--so the
thalidomide tragedy could easily be repeated.

If one of the intentions of Kefauver-Harris was the elimination of birth
defects, it is quite possible that children born with brain-injury will
continue to have that birth defect throughout their lives due to Medicine's
insistence of double-blind controlled studies--as imposed by government,
not science--despite the incredible promise of Hyperbaric Oxygen Therapy
which cannot be proven effective through a double-blind controlled study,
i.e., witness the recent Canadian debacle.

What's the answer? I don't know, but I certainly don't want anyone heading
up the government who advocates Big Government.

Let us pray that algore concedes.

By the way. Mr. Kefauver died from cardiac arrest in 1963. An uncle of mine
worked for a company named Baxter at the time, and he told me that Baxter
manufactured a drug that could have saved his life. The drug was scheduled
to go on the market but was postponed when Kefauver-Harris became law and
instead it first had to go through a very lengthy, time-consuming
double-blind controlled study, which prevented Mr. Kefauver's recovery.




~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"I have sworn upon the altar of God, eternal hostility against every form
of tyranny over the mind of man." --Thomas Jefferson, an early advocate of
Hyperbaric Oxygen Therapy.
----------------------------
David Freels
2948 Windfield Circle
Tucker, GA 30084-6714
USA
770/491-6776 (phone and fax)
509/275-1618 (efax, sends fax as email attachment)
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