Excerpts on Drug Trials: Another Life and The New York Times

Another Life Malaria Excerpt

Excerpted from Another Life, pp. 40-41, published December 2008

By Andrew Vachss

“What did you think all this ‘cure for malaria’ press-release slop was really about? Unless there’s a way to vaccinate against it, we can’t get personnel to remain there for the length of time we’d need. No amount of firepower will take out those damn mosquitoes. Malaria kills millions of Africans every year, but not half as many as it would if the indigenous people hadn’t developed some genetic resistance over the centuries.

“That’s why blacks get sickle-cell and other races don’t. You want non-native experts to live there, you have to guarantee them more than protection from the warlords. Human-borne disease isn’t a problem: we can fly in whores every week, certified clean. But those miserable little bugs . . .”

“So the people who are putting up all that money are just . . . ?”

“Businessmen,” Pryce finished my sentence. “This is about money. Period, end of sentence. And they get a triple-return on their investment, too.”

I looked a question at him.

He held up a hand. Went back to his trick of ticking off points on his webbed fingers. “One, there’s all that recognition as saviors of humanity: prizes, great press, tax breaks . . . maybe even a goodwill barrier against hackers. Two, there’s the oil. Three, the drug companies get to experiment on humans.”

I remembered that one—it was the Mole’s theory of where HIV had actually been developed: in Haitian prisons, when Papa Doc was in charge. “No lab rats, no FDA, no . . .”

“Exactly. You could test anything on those sorry bastards. Africans don’t trust us. Why should they? Nigeria may be the richest country on the whole continent, but it has the highest rate of polio in the world. In South Africa, they think they can prevent AIDS with a good hot shower and lots of soap. Once we get deep enough into the Congo, all we have to do is pay off the warlords, and they’ll round up the cattle for us to brand.”

Outsourcing of Drug Trials Is Faulted

Excerpted from The New York Times, February 18, 2009

By Natasha Singer
Published February 18, 2009

As many American companies in the last decade have sent tasks like customer service and computer support to other countries, drug makers have followed suit by outsourcing clinical trials — the human studies that determine the safety and efficacy of medicines.

Now, an article about the globalization of clinical trials, published Thursday in The New England Journal of Medicine raises questions about the ethics and the science of increasingly conducting studies outside the United States — when the studies are meant to gather evidence for new drugs to gain approval in this country.

The article, by several Duke University researchers, suggests an ethical quagmire when drugs intended for wealthy nations are tested on people in developing countries. The authors suggest that human volunteers in foreign countries may be unduly influenced with the promise of financial compensation or free medical care to participate in clinical trials.

The report, “Ethical and Scientific Implications of the Globalization of Clinical Research,” also asks whether drug research conducted in developing countries is relevant to the treatment of American patients.

“We don’t want to imagine that lower-income countries are the clinical trial mill for higher-income countries,” Dr. Kevin A. Schulman, the lead author of the article, said in a phone interview last week. Dr. Schulman is a professor of medicine at the Fuqua School of Business at Duke, in Durham, N.C.

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