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.

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.