Uninformed Consent, part 2

[Guest guest]

" WC Douglass " <realhealth

Daily Dose - FDA: The house that Big Pharma built

Mon, 11 Dec 2006 08:05:00 -0500

 

 

Uninformed Consent, part 2

 

In the last Daily Dose, I wrote to you about the sticky wicket of

" informed consent " with regard to medical experimentations.

Ninety-nine percent of the time, these " experiments " involve the use

of untested or unproven drugs. My focus in the last essay was a blood

substitute called Polyheme...

 

According to online sources, the FDA held a public hearing on the

informed consent issue - specifically as it relates to the

administration of Polyheme - at a satellite campus of the University

of Maryland on October 11th. I have not yet heard or read anything

about the minutes of that meeting.

 

Beyond this, the FDA has said that it'll more closely examine how the

blood substitute is used. They've also stated that they'd soon release

guidelines on " non-consent " trials. This is the part that interests me...

 

I didn't realize the FDA had an official policy on medical experiments

on Americans without their informed consent. But apparently, there is.

A 1996 regulation, 21CFR50.24, is the loophole under which Polyheme is

being administered without informed consent. Well, I looked up that

statute and found some pretty scary wording.

 

Apparently, as long as it's approved by a body called an Institutional

Review Board (IRB) and a licensed physician who IS a member or

consultant of this board, but supposedly NOT affiliated with the

experiment in question, it's perfectly legal to execute medical

experiments under a vague " emergency research " component of 21CFR50.24

under the following conditions, as reprinted from the exact text of

the statute:

 

" The human subjects are in a life-threatening situation, available

treatments are unproven or unsatisfactory, and the collection of valid

scientific evidence, which may include randomized, placebo-controlled

investigations, is necessary to determine the safety and effectiveness

of particular interventions. "

 

Now I'm no lawyer, but let me see if I can translate this properly:

 

It seems to me that under this law, it's OK to conduct experimental

research without informed consent on anyone who risks death from

disease on ANY time frame. This is a highly subjective measure -

prostate cancer patients are in a " life-threatening situation, " yet

may not die of their disease for 20 years or more. More below...

 

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Also, the law reads to me as though such undisclosed experiments are

fair game for anyone with a life-threatening disease for which a

single " hired gun " doctor and some nebulous review board deem that

existing treatments (read: competing manufacturers' drugs) aren't up

to par.

 

Again, this is open to the interpretation of the Institutional Review

Boards - which are hired and paid for by Big Pharma (more on this in

the next Daily Dose).

 

Ironically, these Boards are right, in a way. The vast majority of

FDA-approved drugs are the farthest thing from satisfactory, if judged

from an efficacy and safety standpoint. And of course, these IRBs

aren't evaluating any of the natural disease treatments that really

ARE safe and effective, but I digress...

 

Further, 21CFR50.24 piggybacks this ridiculous " satisfactory

treatment " rationale with an ends-justify-the-means validation for the

necessity of scientific evidence (read: drug trials) of newer, safer,

more effective and satisfactory treatments.

 

Lastly, the law is clearly aimed at providing a loophole for drug

research. Why else would there be that mention of " randomized,

placebo-controlled investigations. " This nomenclature refers

specifically to drug trials, as anyone with half a brain knows!

 

I can't believe - no, check that - I wish I couldn't believe that the

FDA would sign into law something as blatantly aimed at clearing the

way for Big Pharma to make unwitting guinea pigs out of every one of

us, no matter the cost. The integrity of the entire statute rests upon

the integrity of these Institutional Review Boards...

 

And as you'll find out in part three of this essay series, this may be

far too much to hope for.

 

Exposing hidden dosing,

 

William Campbell Douglass II, M.D.

 

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