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Deadly Medicine- The Outsourcing of Clinical Trials of Big Pharma's New Drugs

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posted on Dec, 13 2010 @ 08:10 PM
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In the new Vanity Fair, I read this very chilling article, and I see it is available online at their site:

www.vanityfair.com...

It is a four page read, but I urge all to read it.

From the article:
Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves?

They admittantly are postulating the 200,000 Americans killed- (see below quote).
Is this a conspiracy to keep Big Pharma raking in the bucks and offering freebies to the
clinics and offices that push their drugs?


In 2009, according to the Institute for Safe Medication Practices, 19,551 people died in the United States as a direct result of the prescription drugs they took. That’s just the reported number. It’s decidedly low, because it is estimated that only about 10 percent of such deaths are reported.

Conservatively, then, the annual American death toll from prescription drugs considered “safe” can be put at around 200,000.
That is three times the number of people who die every year from diabetes, four times the number who die from kidney disease.
Overall, deaths from F.D.A.-approved prescription drugs dwarf the number of people who die from street drugs such as coc aine and heroin.
They dwarf the number who die every year in automobile accidents.
(My emphasis added.)

The lax protocol and regulation overseas, along with the "promise of care for the duration of the trial" to the people participating makes these trials attractive...
These people seem not to realize that as soon as the trial is over, their care is ended. Period.

Many U.S. medical investigators who manage drug trials abroad say they prefer to work overseas, where regulations are lax and “conflict of interest” is a synonym for “business as usual.” Inside the United States, doctors who oversee trials are required to fill out forms showing any income they have received from drug companies so as to guard against financial biases in trials.
This explains in part why the number of clinical-trial investigators registered with the F.D.A. fell 5.2 percent in the U.S. between 2004 and 2007 while increasing 16 percent in Eastern Europe, 12 percent in Asia, and 10 percent in Latin America. In a recent survey, 70 percent of the eligible U.S. and Western European clinical investigators interviewed said they were discouraged by the current regulatory environment, partly because they are compelled to disclose financial ties to the pharmaceutical industry.
In trials conducted outside the United States, few people care.


This makes me even more disgusted with the pharmeceutical companies here...
They decide what to tell patients about the trials overseas, because they are not held accountable.

In 2007, residents of a homeless shelter in Grudziadz, Poland, received as little as $2 to take part in a flu-vaccine experiment. The subjects thought they were getting a regular flu shot. They were not. At least 20 of them died.

They decide the people of value, apparently.

Chilling disclosure about the popular drug Seroquel:

Up to 70 percent of the prescriptions for Seroquel were written for a purpose other than the one for which it had been approved, and sales rose to more than $4 billion a year.

It was prescribed for children with autism-spectrum disorders and retardation as well as for elderly Alzheimer’s patients in nursing homes. The company touted the drug for treatment of aggression, anxiety, anger-management issues, attention-deficit hyperactivity disorder, dementia, and sleeplessness.

It turned out, however, that AstraZeneca had been less than candid about the drug’s side effects. One of the most troubling: patients often gained weight and developed diabetes. This meant a new round of drugs to treat conditions caused by Seroquel.

In an internal e-mail from 1997 discussing a study comparing Seroquel with an older anti-psychotic drug, Haldol, a company executive praised the work of the project physician, saying she had done a great “smoke-and-mirrors job,” which “should minimize (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study.”



Smoke and Mirrors?

Gee... I thought that only happened when it came to all other aspects of the GOV.

The article aims at the slacker, utopian way that Big Pharm seems to operate above the law.

Most people trust their doctors when it comes to prescription meds... especially the elderly.

Physicians, often on retainer from pharmaceutical companies, are free to prescribe a drug for any reason if they entertain a belief that it will work. This practice turns the population at large into unwitting guinea pigs whose adverse reactions may go unreported or even unrecognized.


What a sad situation.
Concluded: never believe the "new wonder drug out" is really what it is touted by your physician. Ask him to see his drug sample closet... that will give you a clear idea of whose team he is batting for.



www.vanityfair.com...




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