Drug testing on auto-pilot-with Big Pharma as air traffic control!

[Guest guest]

" WC Douglass " <realhealth

Daily Dose - Drug testing on auto-pilot-with Big Pharma as

air traffic control!

Tue, 04 Apr 2006 12:05:00 -0500

 

 

 

 

 

 

 

Daily Dose

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April 04, 2006

 

 

 

Trials and Terrors, part 2

 

The Ides of March British drug trial fiasco I wrote about in the last

Daily Dose forms the perfect " opener " for a story I've been sitting on

for a few months. It involves corruption and abuses in all levels of

the American patent pharmaceuticals testing system - from Big Pharma

and the FDA on down to the testing centers, and even to the individual

test subjects themselves.

 

This is a sordid tale, one I've known about (or suspected) for years.

But to give credit where it's due, the extraordinary expose` I'm about

to summarize for you here was originally broken by the Bloomberg News

in November of 2005...

 

Let's start with some context. You probably already know that Big

Pharma's financial lifeblood is patents. Only when the drugs they make

are protected by a patent (generally the first 7 or 8 years after

they're released) can they remain premium-priced - in other words,

overpriced. Once the patents expire, generic versions of drugs

undercut these profitable meds, to the tune of an average 85%

reduction in sales in the first year after a patent expires, according

to the Bloomberg piece.

 

In order to keep raking in the billions, the world's most profitable

industry (prescription drugs are this, you can look it up) has to

either keep inventing new, patentable drugs or changing existing

formulas enough to be re-patented. This means lots of testing and

human trials - an increasing amount every year...

 

But how safe and accurate is this testing?

 

A little more context points to the answer. 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 or firms that farm

out the tests to hospitals or doctors' offices. This is what American

company Paraxel did for Tegenero AG in the recent drug test that

maimed 6 at a UK hospital.

 

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

directly supervised or managed in any meaningful way by the FDA,

according to the Bloomberg piece. 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!

 

The Bloomberg article outlines an incredible catalog of documented

abuses in this mad scramble for Big Pharma's filthy lucre. Keep reading...

 

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According to the extraordinary November 6th 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...

 

Beyond this, the article points to a disturbing shift in the

demographic breakdown of drug trial participants. Whereas once they

were a mix of college kids, minorities, or young working folks who

needed a little extra cash, now most are poor immigrants from Latin

America, many of them unable to read or comprehend the informed

consent paperwork or liability waivers before farming out their bodies

to Big Pharma.

 

Several such Latino sources for the Bloomberg piece admitted blatantly

breaking study rules against participation in multiple trials

simultaneously, or enrolling in new trials immediately after finishing

other trials - before the old drugs can clear from their systems. Such

things confound and render invalid drug testing results.

 

Bottom line: The system we use for testing the drugs we're putting

into our bodies is corrupt, beholden to Big Pharma, unaccountable,

slipshod, virtually un-monitored by the FDA, and all but invalid...

 

In other words, status quo for the drug business.

 

Always chicken about being a guinea pig,

 

William Campbell Douglass II, MD

 

P.S. Kudos again to Bloomberg News for giving my skeleton flesh -

providing numbers and facts for a saga I already knew was true, but

had little hard data on.