Halt in drug study draws medical journal's ire

By Thomas H. Maugh II
Los Angeles Times

In a highly unusual action, the prestigious Journal of the American Medical Association (JAMA) today is publishing incomplete results from a prematurely aborted drug trial, along with a scathing editorial blasting the drug's manufacturer for halting the trial.

The massive trial enrolled 16,602 patients in 15 countries in a five-year effort to determine if the anti-hypertension drug verapamil is better than cheaper diuretics and other drugs. But Pharmacia, which manufactures verapamil under the trade name Covera, ended the study two years early before researchers could determine whether the drug provided any possible benefit.

The company broke a covenant with volunteers in the trial, who "were not only deprived of personal benefit ... but also the social benefit of genuine scientific contributions," wrote the co-authors of the editorial, Dr. Bruce Psaty of the University of Washington and Dr. Drummond Rennie, a JAMA deputy editor.

"What the company apparently treated as a simple commercial matter rendered the original promise to participate in research that contributes substantively to medical knowledge impotent, useless, and fraudulent," they said.

Dr. Henry Black of Rush-Presbyterian-St. Luke's Medical Center in Chicago, who led the study, said the company told him the trial was stopped for "commercial reasons," with no elaboration. A spokeswoman for Pfizer, which purchased Pharmacia last week, said she did not have enough information about the study to comment on it. The company had spent $50 million on the study when it was halted.

The study began enrolling patients with high blood pressure in 1996 and was to continue through 2002, but the study was halted in 2000. About half the patients received verapamil — a long-lasting member of the family of drugs called beta-blockers. The rest received either a diuretic or a short-acting beta-blocker, atenolol.

Because the study was halted early, the team was unable to determine whether verapamil was less effective than the other drugs, as good as them, or perhaps even better, Black said.

The patients in the study received their medications free, as well as medical care for their hypertension, but those benefits were halted along with the trial.

"If (the trial) had been continued to the originally planned completion, the improved blood pressure control associated with trial participation might have produced substantial health benefits," Psaty and Rennie wrote.

Dr. Catherine DeAngelis, editor of JAMA, said that she could understand the company's action from an economic viewpoint, but that it was wrong ethically. She said this was the first time in her four-year tenure that the journal had published incomplete results.

The journal does publish results from studies that are terminated early because either benefits or risks are found to be so great as to render completion of the study unethical. In this case, however, neither the researchers nor the company knew any results before the study was ended.

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