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Body Hunting: The Outsourcing of Drug Trials

Who will hold the pharmaceutical industry accountable for the outsourcing of drug trials?

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Takeaways


Multinational drug companies like Pfizer, Eli Lilly and Merck have a business problem. Industry labs are bursting with spanking new compounds and insight into which human tissues to aim them at, courtesy of new techniques first pioneered by genetic engineers and biotechnologists in the 1970s.

"There are more investigational new drugs, more experimental treatments today than ever before," former Food and Drug Administration commissioner Mark McClellan exulted before a meeting of industry researchers in 2003.

But just as the biotech revolution took off, the pipeline turning those new compounds into sellable products had started to clog.

Proving new drugs worked in humans, as required by the FDA, had become a spectacularly complex, expensive and time-consuming endeavor, a constant cause for complaints from industry analysts and investigators.

Clinical trials were a "vast canyon" that eviscerated new drugs — a veritable "valley of death," they said. "Large trials have become the norm," bemoaned another. "All professionals taking part are now reconciled to the idea that such trials will take forever and will cost the earth."

According to CenterWatch, a publisher specializing in the clinical research industry, in order to launch a single drug a company has to convince more than 4,000 patients to undergo 141 medical procedures each in more than 65 separate trials.

First come the small Phase one studies that test a new drug's safety, then the slightly larger Phase 2 studies that look for hints of effectiveness — and finally the extensive Phase 3 studies that aim to prove a drug's effectiveness with statistical certainty.

More than 100,000 people have to be enticed to call in for initial screenings for such trials, as only a fraction show up for their appointments — and of these only a fraction would be medically eligible.

With the expense of finding and retaining a single test subject for a clinical trial running to at least $1,500, and with some 90% of the drugs entering clinical trials failing to garner FDA approval anyway, minimizing the cost and length of clinical trials had become crucial to corporate salubrity.

And yet, in the United States at least, enlisting sufficient numbers of trial volunteers is difficult, to say the least. Back in 1954, Americans offered their children as human guinea pigs by the millions for Jonas Salk's experimental polio vaccine.

When the results of that massive trial were released, radio announcers blasted the news. Church bells clanged. Traffic snarled as drivers jumped out of their cars to shout with joy. But not long after, the hastily approved vaccine infected 220 children with polio, and public trust in clinical experimentation started to deflate.

Revelations of unethical trials followed — exposés of the U.S. government-sponsored Tuskegee Syphilis Study in the early 1970s proved a historical nadir — and disillusionment hardened into dislike.

Today, although Americans buy on average more than ten prescriptions every year, less than one in 20 are willing to take part in the clinical trials that separate the dangerous drugs from the life-saving ones.

New outfits like Quintiles Transnational and Covance call themselves "contract research organizations" (CRO). For a fee, they take a drug company's blueprints for a clinical trial and promptly deliver patients, investigators and results in return.

"At Quintiles," the company's Web site says, "we know it's all about results. That's what you want. And that's what you'll get, on schedule or maybe even a little ahead of it.” Some CRO’s even insert trial results into FDA applications and splice them into prestigious journal articles on behalf of their industry clients.

At first, CROs performed this trick by capitalizing on a previously unexploited pool of potential subjects: the millions of patients treated at local clinics and private practices by community physicians. Then they slowly started to look beyond U.S. borders.

After all, the FDA had long allowed drug companies to submit data from clinical trials conducted outside the United States, in 1987 even going so far as to accept a new drug application with data solely from overseas trials.

Back then there had been no big stampede abroad, as academic investigators considered data from developing countries unreliable. Not so the new CROs.

Just as automakers and apparel manufacturers had fled the stringent labor and environmental laws of the West to set up shop in the developing world, drug companies and CROs streamed across the border. Although companies aren't required to alert the FDA before testing their drugs on non-U.S. patients, nor does the FDA track research by location after approving new drugs. It is clear that the tectonic plates have shifted.

Between 1990 and 1999, the number of foreign investigators seeking FDA approvals increased 16-fold, the U.S. Department of Health and Human Services' Office of the Inspector General found. By 2004, the FDA estimated, drug companies angling for FDA approval of their new products were launching over 1,600 new trials overseas every year.

The most popular destinations are not Western Europe and Japan, but rather the broken, impoverished countries of Eastern Europe and Latin America. Russia, India, South Africa and other Asian and African countries have proven equally fruitful.

Between 2001 and 2003, the number of trials conducted in the United States — and the number of investigators hired to oversee them — plummeted. While U.S.-based investigators dropped by 11%, the number of investigators abroad fattened by 8%.

By 2006, GlaxoSmithKline, Wyeth and other drug giants predicted, half or more of their trials would be conducted overseas. Fleeing the empty test clinics of the West, drug makers who have set up shop abroad wallow in an embarrassment of riches. The sick are abundant — and costs are low.

In India, "apart from the low cost of field trials," enthused a Pfizer press release, "a billion people means there is never a shortage of potential subjects." In South Africa, a leading CRO noted on its Web site, patients suffered "an extremely high prevalence of HIV/AIDS and other major diseases including diabetes, hypertension, mental illness and cancer."

Their lack of access to medicines made them particularly appreciative of the free drugs offered in trials, no matter how experimental. "The vast majority of people have only the most basic healthcare," the Quintiles Web site noted, allowing "clinical trials [to] provide study participants with access to more sophisticated medicine."

And so, in contrast to the agonizingly slow pace of enrollment in trials at home, recruitment abroad is rapid.

In South Africa, Quintiles herded 3,000 patients for an experimental vaccine study in just nine days. They inducted 1,388 children for another trial in just 12 days.

And unlike U.S. patients, who hemmed and hawed and often simply dropped out of studies, in India, boasted Vijai Kumar, head of a New Delhi-based industry trial center, "we have retained 99.5% of the subjects enrolled."

Editor’s Note: © 2006 by Sonia Shah. This piece originally appears in Sonia Shah's The Body Hunters: Testing New Drugs on the World’s Poorest Patients (The New Press, September 25, 2006). Published with the permission of The New Press.

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