Medical Journal Assails Company for Halting Drug Trial
In a highly unusual action, the Journal of the American Medical Assn. is publishing incomplete results today from an 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 whether the anti-hypertension drug verapamil is better than less expensive diuretics and other drugs. But Pharmacia Corp., which manufactures verapamil under the trade name Covera, ended the study two years early before researchers could determine whether the drug provided any 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 deputy JAMA 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 R. Black of Rush-Presbyterian-St. Luke’s Medical Center in Chicago, who led the study, said the company told him the trial was being stopped for “commercial reasons,” with no elaboration. A spokeswoman for Pfizer Inc., which purchased Pharmacia last week, said she did not have enough information about the study to comment on it. The company had already spent about $50 million on the study when it was halted.
The study began enrolling patients with high blood pressure in 1996 and was scheduled to continue through 2002, but it was halted in 2000. About half the patients received verapamil -- a long-acting calcium channel blocker. The rest received either a diuretic (which promotes water loss) or a short-acting beta-blocker called atenolol.
Because the study was halted early, the team was unable to determine how verapamil performed relative to the other drugs, 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, the editor of JAMA, said that she could understand the company’s action from an economic viewpoint, but that it was ethically wrong. She said this was the first time in her four-year tenure as JAMA editor that the journal had published results from incomplete research.
The journal does publish results from studies that are cut off because it is found that completion of the study would be unethical. In this case, however, neither the researchers nor the company knew any results from the study before it was terminated, Black said.
