Vanity Fair: Most clinical trials conducted on sick Russians, homeless Poles, slum-dwelling Chinese

[Amerigo Vespucci]

Politics

Deadly Medicine

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? The authors investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in a lethal profit machine.

By Donald L. Barlett and James B. Steele•

Photo illustration by Chris Mueller

January 2011



http://www.vanityfair.com/politics/features/2011/01/deadly-medicine-201101

You wouldn’t think the cities had much in common. Iaşi, with a population of 320,000, lies in the Moldavian region of Romania. Mégrine is a town of 24,000 in northern Tunisia, on the Mediterranean Sea. Tartu, Estonia, with a population of 100,000, is the oldest city in the Baltic States; it is sometimes called “the Athens on the Emajõgi.” Shenyang, in northeastern China, is a major industrial center and transportation hub with a population of 7.2 million.

These places are not on anyone’s Top 10 list of travel destinations. But the advance scouts of the pharmaceutical industry have visited all of them, and scores of similar cities and towns, large and small, in far-flung corners of the planet. They have gone there to find people willing to undergo clinical trials for new drugs, and thereby help persuade the U.S. Food and Drug Administration to declare the drugs safe and effective for Americans. It’s the next big step in globalization, and there’s good reason to wish that it weren’t.

Once upon a time, the drugs Americans took to treat chronic diseases, clear up infections, improve their state of mind, and enhance their sexual vitality were tested primarily either in the United States (the vast majority of cases) or in Europe. No longer. As recently as 1990, according to the inspector general of the Department of Health and Human Services, a mere 271 trials were being conducted in foreign countries of drugs intended for American use. By 2008, the number had risen to 6,485—an increase of more than 2,000 percent. A database being compiled by the National Institutes of Health has identified 58,788 such trials in 173 countries outside the United States since 2000. In 2008 alone, according to the inspector general’s report, 80 percent of the applications submitted to the F.D.A. for new drugs contained data from foreign clinical trials. Increasingly, companies are doing 100 percent of their testing offshore. The inspector general found that the 20 largest U.S.-based pharmaceutical companies now conducted “one-third of their clinical trials exclusively at foreign sites.” All of this is taking place when more drugs than ever—some 2,900 different drugs for some 4,600 different conditions—are undergoing clinical testing and vying to come to market.

Some medical researchers question whether the results of clinical trials conducted in certain other countries are relevant to Americans in the first place. They point out that people in impoverished parts of the world, for a variety of reasons, may metabolize drugs differently from the way Americans do. They note that the prevailing diseases in other countries, such as malaria and tuberculosis, can skew the outcome of clinical trials. But from the point of view of the drug companies, it’s easy to see why moving clinical trials overseas is so appealing. For one thing, it’s cheaper to run trials in places where the local population survives on only a few dollars a day. It’s also easier to recruit patients, who often believe they are being treated for a disease rather than, as may be the case, just getting a placebo as part of an experiment. And it’s easier to find what the industry calls “drug-naïve” patients: people who are not being treated for any disease and are not currently taking any drugs, and indeed may never have taken any—the sort of people who will almost certainly yield better test results. (For some subjects overseas, participation in a clinical trial may be their first significant exposure to a doctor.) Regulations in many foreign countries are also less stringent, if there are any regulations at all. The risk of litigation is negligible, in some places nonexistent. Ethical concerns are a figure of speech. Finally—a significant plus for the drug companies—the F.D.A. does so little monitoring that the companies can pretty much do and say what they want.

[snagglepuss]

1. Just when I thought I heard it all. What utter scum. nt

[somone]

2. The drug industry is more dangerous than ever

And they have the government by the balls

[sabrina 1]

3. Pure evil.

But it can be fixed easily. Congress needs to pass a law forbidding clinical trials from being done anywhere but in the U.S. Or, the FDA needs to state that such trials will not be accepted by them.

And we talk about Hitler. To think so little of human life, to prey on the poor and uneducated, to risk their lives, and all for profit, not even a single principle involved. And of course, if as the article states, these trials are not suitable to judge how Americans will react to the drugs, Americans will die also. Scum is too good a word for them.

[Celebration]

4. this is SO recommended n/t

[Divernan]

5. Explosive, 4 page article in Vanity Fair - read it all to know SOME of the drugs to avoid.

Vanity Fair should get a Pulitzer, if not a Nobel prize for this expose. I'm printing a copy to give to my family doctor.
There's a particularly damning section re "Celebrex". Also this:
"Rescue Countries"

"One big factor in the shift of clinical trials to foreign countries is a loophole in F.D.A. regulations: if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval. There’s even a term for countries that have shown themselves to be especially amenable when drug companies need positive data fast: they’re called “rescue countries.” Rescue countries came to the aid of Ketek, the first of a new generation of widely heralded antibiotics to treat respiratory-tract infections. Ketek was developed in the 1990s by Aventis Pharmaceuticals, now Sanofi-Aventis. In 2004—on April Fools’ Day, as it happens—the F.D.A. certified Ketek as safe and effective. The F.D.A.’s decision was based heavily on the results of studies in Hungary, Morocco, Tunisia, and Turkey.

"The approval came less than one month after a researcher in the United States was sentenced to 57 months in prison for falsifying her own Ketek data. Dr. Anne Kirkman-Campbell, of Gadsden, Alabama, seemingly never met a person she couldn’t sign up to participate in a drug trial. She enrolled more than 400 volunteers, about 1 percent of the town’s adult population, including her entire office staff. In return, she collected $400 a head from Sanofi-Aventis. It later came to light that the data from at least 91 percent of her patients was falsified. (Kirkman-Campbell was not the only troublesome Aventis researcher. Another physician, in charge of the third-largest Ketek trial site, was addicted to cocaine. The same month his data was submitted to the F.D.A. he was arrested while holding his wife hostage at gunpoint.) Nonetheless, on the basis of overseas trials, Ketek won approval.

[arikara]

10. Since what they are doing is common practice now

its probably safer to avoid all new drugs.

[arikara]

6. I wonder if Vanity Fair has any pharmaceutical ads in their next issue

good for them. I heard ages ago to avoid the brightest newest drug on the market like the plague, and this is why. If you really need to take a pill for something, be sure the doctor gives you a prescription for something that has been around for at least 8 years, that way its efficacy and side effects are well known.

[Divernan]

13. I've been doing this for the last 15 years.

That was when I had my first brush with lobbyists for Big Pharma and researched what was going on in that industry. Told my doctor I didn't want any of the new, "improved" treatments. Let someone else be the guinea pig.

The really big elephant in the room about which no one talks is this. Big Pharma wants to test these drugs on people who are not now and probably never have taken any other drugs. Why? Because Big Pharma never spent the bucks to test the interaction of the most commonly used drugs, let alone the less commonly used ones. People are simultaneously on drugs for cholesterol, blood pressure, allergies, PMS, a host of psychiatric drugs, etc. Throw in some Viagra, antibiotics, and alcohol, etc. and you have a veritable witch's brew.

And cripes, have you listened to the caveats on the tv ads for the latest offerings from Big Pharma?

Side effects may include short term memory loss(Lipitor/statins), breast enlargement in men and/or loss of libido(propecia/Finasteride).

Discontinue use if you experience stomach and intestinal problems, such as bleeding and ulcers or a heart attack or stroke leading to death (Celebrex); suicidal thoughts, visual or auditory hallucinations and or criminally violent nightmares.

Immediately consult your physician if you experience cancer, stroke, heart attack, blood clots or dementia, start coughing up blood, lose your sense of taste, experience blurred vision.

And on and on.

[arikara]

14. OMG don't I know it

I'm amazed that after watching any of those ads anyone would take a pill. Yet so many aren't happy unless they walk out of the doctors office with a prescription or 2 in hand.

[Divernan]

7. Keep kicking this - it's extremely important to the health of you and your family.

[formercia]

8. K&R n/t

[enough]

9. k&r (nt)

[XanaDUer]

11. One more reason they hate US

and it's not for our freedoms.

[Tutankhamun]

12. So, let's get this straight. We are not allowed to import drugs from foreign

countries such as Canada. Our government claims it is too dangerous to allow importation of FDA approved drugs that have been used safely, in many cases, for decades. Yet, we are to believe that human trials are perfectly safe when conducted without any real oversight in impoverished corners of the world. These are places where sewers are rudimentary if they exist at all, drinking water is routinely polluted, and access to physicians is nonexistent.

We don't really need to ask why our leaders forbid drug importation by private citizens, yet allow testing on foreign soil in the worst of conditions. The obvious inconsistency in safety regulations (and the absence thereof) means big money for corporations. Corporate money trumps the health and finances of the masses.

[jmowreader]

15. Try "reimport" drugs from Canada

In a lot of cases, the "drug reimportation" from Canada really means the drugs came out of the manufacturer's US plant, were trucked to Canada where they were put in smaller bottles and trucked back to the US.