Uninformed consent for experimentation

The Washington Post ran a series of articles on some of the problems with the drug industry. Here is just a bit of it:

Two years ago, for example, the American pharmaceutical giant Pfizer Inc. had high hopes for its schizophrenia drug Zeldox, which was predicted to earn Pfizer $600 million in profits within four years. But the Food and Drug Administration was concerned about indications that the drug affected heart rhythms and issued a "not approvable"letter, meaning Zeldox required more tests on human subjectsbefore it could be approved for sale in the United States....The Post visited one of those trial sites at a Bulgarian mental institution last spring.

A drug information sheet given to patients at the State University Hospital of Neurology and Psychiatry, a crumbling asylum outside Sofia, the capital, made no mention of the FDA's concerns. Luchezar Hranov, who ran the study for Pfizer, also said he did not inform volunteers of the FDA's action.

"I don't believe anyone would care," Hranov said. "The FDA is out of someone's reach. I would have to do an educational course."

The three-page information sheet told patients Zeldox had "been tested in studies involving more than 3,000 patients, and the results of these studies are currently being reviewed by government regulatory authorities in Europe and the United States." The sheet noted that Zeldox appeared "to slightly affect the electrical activity of the heart in some people."

Pfizer neglected to tell Hungarian regulators about the FDA action, as well, said both Janos Borvendeg, medical director at Hungary's National Institute of Pharmacy, and Tamas L. Paal, head of the institute, which is his country's equivalent of the FDA for drugs. Hungary had been one of the test sites for Zeldox in Pfizer's original round of research before the FDA intervention. Under Hungarian regulations, Pfizer was obliged to report the FDA action to Hungarian officials because Zeldox was part of another ongoing trial last year, Paal said.

The Dilemma: Submit or Suffer
'Uninformed Consent' Is Rising Ethic of the Drug Test Boom

By Sharon LaFraniere, Mary Pat Flaherty and Joe Stephens
Washington Post Staff Writers
Tuesday, December 19, 2000