Human Testing Masks Death, Injury, Compliant FDA (Vns Message Board)

Title: Human Testing Masks Death, Injury, Compliant FDA

Birdbomb - November 9, 2005 04:22 PM (GMT)

LINK TO ARTICLE

Drug Industry Human Testing Masks Death, Injury, Compliant FDA

Nov. 2 (Bloomberg) -- Oscar Cabanerio has been waiting in an experimental drug testing center in Miami since 7:30 a.m. The 41- year-old undocumented immigrant says he's desperate for cash to send his wife and four children in Venezuela.

More than 70 people have crowded into reception rooms furnished with rows of attached blue plastic seats. Cabanerio is one of many regulars who gather at SFBC International Inc.'s test center, which, with 675 beds, is the largest for-profit drug trial site in North America.

Across the U.S., 3.7 million people have enrolled in drug tests sponsored by the world's largest pharmaceutical companies. The companies have outsourced 75 percent of experimental drug trials to centers like SFBC, a leader in a $14 billion industry.

At the same time, the U.S. Food and Drug Administration has farmed out much of the responsibility for overseeing safety in these tests to private companies known as institutional review boards. These boards are also financed by pharmaceutical companies.

So, the drug industry is paying the people who do the tests -- and most of the people who regulate those tests. And that combination can be dangerous, and sometimes deadly.

``The fundamental problem is a system in which investor- owned businesses have control over the evaluation of their own products,'' says Marcia Angell, editor in chief of the New England Journal of Medicine from 1999 to 2000. ``Oversight of clinical trials is too important to leave in the hands of drug companies and their agents.''

`I'm in a Bind'

Most of the people lining up at SFBC to rent their bodies to medical researchers are poor immigrants from Latin America, drawn to this five-story test center in a converted Holiday Inn motel.

Inside, the brown paint and linoleum are gouged and scuffed. A bathroom with chipped white tiles reeks of urine; its floor is covered with muddy footprints and used paper towels. The volunteers, who are supposed to be healthy, wait for the chance to get paid for ingesting chemicals that may make them sick.

They are testing the compounds Big Pharma, the name for the world's largest pharmaceutical companies, hopes to develop into best-selling medicines.

Cabanerio, who has a mechanical drafting degree from a technical school, says he left Venezuela because he lost his job as a union administrator. For him, the visit to SFBC is a last resort. ``I'm in a bind,'' Cabanerio says in Spanish. ``I need the money.''

Conflicts of Interest

Few doctors dispute that testing drugs on people is necessary. No amount of experimentation on laboratory rats will reliably show how a chemical will affect people. Helped by human testing, drugmakers have developed antibiotics capable of curing life-threatening infections as well as revolutionary treatments for diseases like cancer and AIDS.

These medical success stories mask a clinical drug trial industry that is poorly regulated and riddled with conflicts of interest. Every year, trial participants are injured or killed.

Rules requiring subjects to avoid alcohol and narcotics and to take part in only one study at a time are sometimes ignored by participants, putting them at risk and tainting the test data.

The consent forms that people in tests sign -- some of which say participants may die during the trial -- are written in complicated and obscure language. Many drug test participants interviewed say they barely read them.

Ken Goodman, director of the Bioethics Program at the University of Miami, says pharmaceutical companies are shirking their responsibility to safely develop medicines by using poor, desperate people to test experimental drugs. .......

ellgee - November 11, 2005 02:42 PM (GMT)

quotes cuts - copied and pasted from the above link

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Joanne Rhoads, the physician who directs the FDA's Division of Scientific Investigations, says that view isn't realistic. ``What the FDA regulations require is not any gold standard for trials,'' Rhoads, 55, says.

The agency doesn't have enough staff to aggressively monitor trials, she says, adding that FDA regulations are a bare minimum and much more oversight is needed. ``You cannot rely on the inspection process to get quality into the system,'' Rhoads says. ``I know many people find this not OK, but that's just the truth.''

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Polsgrove, 55, died during a trial for generic schizophrenia drug clozapine that was sponsored by Miami-based Ivax Corp., the largest U.S. maker of generic drugs.

Fabre left Polsgrove in the care of John Rodriguez, who had no medical credentials, according to the FDA. Just six days before Polsgrove enrolled in the experiment, an FDA inspector visited Fabre's clinic and found that Rodriguez had screened subjects, performed physicals and conducted electrocardiograms.

The inspector believed Fabre's false claim that Rodriguez was a licensed physician's assistant, Rhoads says. A call to the Texas Board of Medical Examiners would have revealed that Rodriguez was unlicensed.

Rhoads says FDA inspectors don't normally verify medical licenses. ``On a routine inspection, it's not likely that they're going to dig because it takes a lot of work to do that,'' Rhoads says.

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The FDA can investigate a trial site at any time. Rhoads says when inspectors review a test center, they follow a checklist.

``The bottom line is, the inspections by the FDA field investigators are done by people who are trained in investigation, but they don't always have a tremendous scientific or medical background,'' Rhoads says. ``They're basically doing an audit process.''

This is downright frightening!!! Click on the link and read the entire article - it's a MUST READ!

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