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Early end of study on drug lambasted

©Associated Press

April 23, 2003

CHICAGO -- In a scathing condemnation of the pharmaceutical industry, editors at one of the nation's top medical journals said a company shortchanged science by halting a large study of high blood pressure drugs to save money.

The Journal of the American Medical Association published the incomplete study Wednesday to highlight a practice its editors call highly unethical -- particularly since it involved treatment for a dangerous condition that affects millions of people worldwide.

"How can a sponsor do this when everybody . . . particularly the patients, have given their energy, their blood, their bodies . . . and suddenly they're just blown off?" said Dr. Drummond Rennie, a deputy JAMA editor.

The study was designed to see if a medicine called Covera was as effective as two other hypertension drugs at preventing heart-related complications of high blood pressure. Covera, known generically as verapamil, appears to have been similarly effective but the data are incomplete.

The study began in 1996 and was halted in 2000, two years early.

Covera was originally made by G.D. Searle, which later became part of Pharmacia Corp. Pharmacia was bought this month by Pfizer. Vanessa McGowan, a spokeswoman for Pfizer, said the company had only limited information on the study and could not comment on it.

A data analysis after the study was stopped showed signs that Covera might be slightly better at preventing heart attacks than atenolol and the diuretic hydrochlorothiazide, said the lead researcher, Dr. Henry Black.

Black said the company cited "commercial reasons," with no elaboration, for halting the study.

Aborting the study prevented researchers from making a valid comparison, said Black, who called the company's actions unethical.

Dr. Catherine DeAngelis, the editor of JAMA, agreed.

"While you might understand it from an economic standpoint, from an ethical standpoint" it's wrong, she said.

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