Big Pharma's Deadly Experiments

By Kelly Hearn, AlterNet. Posted June 9, 2006.

A newly surfaced report alleges that in 1996, drug monolith Pfizer gave an unproven drug to Nigerian children and infants suffering from meningitis -- without the authorization of the Nigerian government. Completed five years ago and coming to light in a May 7 Washington Post investigation, the confidential report, written by a panel of Nigerian health experts, concluded that administering the drug Trovan to 100 patients suffering a deadly strain of meningitis was "an illegal trial of an unregistered drug." The drug was ultimately shown to be ineffective. A lawsuit against Pfizer claims some of the children in the trial died and others suffered brain damage.

The report surfaces as more and more clinical research relocates to the Global South in order to escape burdensome regulation schemes in the United States and Western Europe. AlterNet has obtained an early look at a book to be published later this year -- The Body Hunters: How the Drug Industry Tests Its Products On the World's Poorest Patients (New Press), by investigative journalist Sonia Shah -- that raises the curtain on a trend that's harming patients and health care systems while eroding the developing world's trust in conventional medicine.

Researchers needing patients and freer working conditions have for years found a honey pot in the world's slums and shantytowns. The fact that poor, desperate patients are willing to try anything, means companies like GlaxoSmithKline, Merck and Wyeth currently conduct 30 percent to 50 percent of their experiments outside Western Europe and the United States, and plan to boost foreign trials by 67 percent this year, according to USA Today. Their urgency is understandable; Shah's book notes that to get a single drug to market, drug companies are forced "to convince more than 4,000 patients to undergo 141 medical procedures each in more than 65 separate trials."

Clinical investigators and the companies backing them argue that overseas trials get drugs to a lucky few and lead to faster cures for us all. But Shah, the author of Crude: The Story of Oil, deftly takes that Big Pharma myth to task, tracing how drug trial exports ruin third-world health care systems, steer attention away from public health needs like clean water and sanitation, and ignore the health safety of subjects.

From the history of placebo controls to a modern map of how loophole-prone laws in the 1980s paved Big Pharma's easy way, Shah shows that "the main business of clinical research is not enhancing or saving lives but acquiring stuff: data" -- making it an industry instead of a social service, as it would have the world believe. As an industry, she argues, they should be denied the regulatory winks and nods reserved for a public health entity.

Hearn: What struck you as the worst case of excess or neglect you found while researching this book?

Shah: It was probably the trial I covered in Zambia [involving a drug to combat cryptosporidium, a diarrhea-causing infection]. It was stark, children dying, little kids dying. But from what I can tell if these kids had received antiretroviral therapy they could have survived. But they were put into a trial for a drug that never benefited them or their families or siblings because the drug was so completely targeted for other populations, almost a luxury drug for fighting an infection that in Western children means a day of diarrhea. It is so mild in kids who are healthy that lots of people don't even notice it.

So for such a minor condition they tested the drug on people who were so, so sick. And in the end, 12 kids died.

Kelly Hearn: You write that by the late 1990s, pharmaceutical companies had grown frustrated with the pace of academic hospitals and research centers, and changed the contracting focus to "contract research organizations," private companies that promise to get drug trials done quickly. What role do these companies play in the scheme of drug trials, and to what degree are they responsible for the growth in overseas trials?

Sonia Shah: There are two things, a push and a pull, that force trials overseas. The push is a patient recruitment bottleneck. Most trials don't meet recruitment deadlines, whether it's because Americans aren't interested or their profiles are wrong. Often the right kind of patients don't exist in enough quantity in the U.S., or if they do they drop out of trials.

The big pull is the contract research organizations (CROs). If anyone is a body hunter, it's the CRO industry, an industry that has largely escaped public notice, perhaps because of the weird, vague sounding moniker, CRO. Public Citizen called them, more accurately, "human experiment corporations." They are, though, just a business, and are not any more venal than other actors involved.

Hearn: Like you, many journalists and health experts I have interviewed almost invariably say the FDA should require new drugs to outperform existing ones rather than simply work better than a placebo. Given your sense of the FDA's ruling culture, the growing public frustration with drug companies, Washington's current political climate, and so on, is there real hope of this happening in the next few years?

Kelly Hearn is a former UPI staff writer who divides his time between the United States and South America. A correspondent for the Christian Science Monitor, his work has appeared in The Nation, The American Prospect and other publications. He is a regular contributor to AlterNet.

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