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JAMA assails halting of study Company's ending heart-related work called unethical By Associated Press, 4/23/2003
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The Journal of the American Medical Association published the incomplete study today 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 ended 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Covera was originally made by G.D. Searle, which later became part of Pharmacia Corp.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, lead researcher Dr. Henry Black said.
Neither the company nor researchers knew the results until that analysis, Black said. He said the company cited ''commercial reasons,'' with no elaboration, for halting the study.
The study involved 16,602 patients with high blood pressure and was conducted at 661 centers in 15 countries. It was halted after the company had already spent about $50 million, said Black, dean of research at Chicago's Rush-Presbyterian-St. Luke's Medical Center.
Aborting the study prevented researchers from making a valid comparison, said Black, who called the company's actions unethical.
Dr. Catherine DeAngelis, JAMA's editor, agreed. ''While you might understand it from an economic standpoint, from an ethical standpoint'' it's wrong, she said.
The aborted study and a critical editorial by Rennie and University of Washington heart specialist Dr. Bruce Psaty appear in today's JAMA.
''The responsible conduct of medical research involves a social duty and moral responsibility that transcends quarterly business plans,'' the editorial said.
Black said the Covera study's participants received free blood pressure drugs and medical care, and most were understanding about halting the study.
This story ran on page D4 of the Boston Globe on 4/23/2003.
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HICAGO -- 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.