Testing Tidal Wave Hits Overseas

By Mary Pat Flaherty; Deborah Nelson; Joe Stephens
Washington Post Staff Writers
Monday, December 18, 2000

Second of six articles

A global boom in overseas drug experiments is changing the way new drugs are tested on humans and approved for U.S. consumers as pharmaceutical companies shift to countries where regulations are looser, costs lower and trusting patients plentiful.

Companies searching for lucrative drugs are turning abroad to hold faster human experiments, offering poorly paid foreign doctors handsome fees for every subject they recruit into tests that help speed drugs to market. In some cases, the companies test drugs deemed too risky to try out in the United States, a Washington Post investigation has found.

The globalization of drug testing has resulted in a system increasingly dominated by profit incentives, where no single regulator can see the whole picture or inspect experiments effectively, according to interviews on five continents with doctors, health officials and patients. For Americans, it means some of the newest drugs on U.S. shelves are tested at sites far removed from U.S. regulators--sometimes in countries with few inspectors and little history of examining drugs for safety and effectiveness.

"I'm scared. I'm real scared," said Stan Woollen, deputy director of the Food and Drug Administration division that monitors human drug testing, at a conference last June in San Diego. "With these huge trials that are being conducted on a faster and faster basis, maybe the system is becoming overwhelmed."

The FDA inspects only a sliver of foreign test sites and rarely does so while the tests are underway. It gets involved when a pharmaceutical company submits foreign test results to back up a request to sell its drug to American consumers--which is often years after the overseas tests are concluded.

The FDA's paper review of foreign trials is "very late in the pipeline to worry about the consumer or the patients in those trials," said Marcia Angell, former editor of the New England Journal of Medicine. And when the FDA reviews a drug this way, "it's essentially saying 'caveat emptor' ['buyer beware'] when the drug is approved for sale."

When the FDA refused to let California-based Maxim Pharmaceuticals Inc. test a new drug on Americans with liver disease --the FDA wanted more safety tests on animals first--the company went to Russia. In three weeks last year, Russian doctors screened 149 patients, but the doctors were not told about the FDA's concerns.

By going to the former Soviet Bloc, Maxim avoided a delay that could have cost millions. The firm was about to raise $20 million in a private stock sale touting its leading drug's potential. It needed to try the drug on humans quickly to speed its development.

The company said it did not evade any FDA rules and followed Russia's.

"We abided by all of their local rules," said Maxim's chairman, Larry G. Stambaugh. "Why would they care what FDA wanted?"

The Offshore Boom

Overseas drug experiments have grown at a staggering rate during the last decade.

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