Daily Dose - Flashback to the future of drug trial oversight

[Guest guest]

" WC Douglass " <realhealth

Daily Dose - Flashback to the future of drug trial oversight

Tue, 12 Dec 2006 08:45:59 -0500

 

 

 

Uninformed Consent, part 3

 

In the last Daily Dose (part 2 of a 3-part essay series), I concluded

my thoughts on the FDA's legislative facilitation of Big Pharma's drug

testing on the unsuspecting public under the heading of " emergency

medicine " by pointing out that the ONLY checks and balances in place

on this system are official-sounding, yet poorly defined entities

called Institutional Review Boards...

 

Now, just so you don't think that one obscure piece of legislation can

turn me into some sort of conspiracy nut who imagines that our noble,

selfless FDA doesn't have our best interests in mind when they sell

our right to informed consent down the river - and entrust our safety

to a bunch of puppets for the drug biz - I want to refresh you with

something I wrote about these IRBs back in April (Daily Dose, 4/4/06).

 

As you know, I'm not usually in the habit of re-running stuff I've

already written to you, but this was almost spookily prophetic - not

to mention way ahead of the story. Besides, I can say it no better now

than I did back then. So here goes:

 

" According to the New England Journal of Medicine, 80% of

pharmaceuticals trials in the early 90s were conducted by faculty at

medical universities. These are credible, ethical-minded folks with

little to gain from any particular outcome or expediency. Today,

however, 75% of these trials are contracted out to private, for-profit

test centers...

 

These testing entities are paid directly by Big Pharma, and NOT

directly supervised or managed in any meaningful way by the FDA... In

fact, the whole drug testing process is almost entirely monitored by

other private firms called Institutional Review Boards (IRBs),

appointed by the FDA but paid by Big Pharma.

 

In other words, both the testing entities AND the review entities are

nothing more than hired guns for the pharmaceuticals industry!

 

According to the extraordinary November 6th [2005] expose` from

Bloomberg News, the following abuses, conflicts of interest, and

examples of outright negligence have been documented against private,

for-profit drug testing entities in the U.S.:

 

* A Houston research clinic tested drugs on human subjects for 20

years using unlicensed employees. The FDA's own records show they KNEW

about this abuse, yet did nothing. At least one person died in one of

this clinic's trials, a fact later linked by the blame-averse FDA to

criminal wrongdoing at the clinic.

 

* At least one instance in which the review board (IRB) in charge of

overseeing a drug's testing was owned by the SAME PEOPLE as the

testing center that was evaluating the medication.

 

* The Chairman and Director of the largest private drug-testing center

in North America is repeatedly listed as a " doctor " in official SEC

filings, yet has never practiced medicine anywhere, and holds a degree

not from a major accredited U.S. medical school, but from a " medical

college " in the Caribbean.

 

There's more, too. The Bloomberg piece cites incomplete record

keeping, the use of clinic staff and their family members as test

subjects, inadequate training of drug study administrators, and an

appalling lack of involvement by physicians in the testing process.

Remember, these are the folks the FDA has wisely entrusted with the

oversight of the very studies " proving " drugs like Vioxx are safe... "

 

That's it for my rehashing - just wanted to reiterate a point. Keep

reading...

 

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That point is this: With every passing year, the " regulators " the Feds

have overlooking the testing of the drugs we consume are increasingly

affiliated with and beholden to the drug industry and NOT to anything

even resembling principled, unbiased medicine.

 

And that nobody in the mainstream is reporting this to us.

 

Bottom line: Unless it really is a bona-fide life-and-death emergency,

if you go to the hospital, Emergency Department, or even the doctor's

office for anything that involves taking a pill, wearing a

trans-dermal patch, or enduring an injection of ANY type, make sure

you know exactly what's going into your body...

 

And that you're not being made a guinea pig for some untested chemical

that could actually PUT you in a life-and-death struggle.

 

Never repeatin' without good reason,

 

William Campbell Douglass II, M.D.