Halted blood-pressure drug study shortchanged science, critics say
Tuesday, April 22nd 2003, 12:00 am
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CHICAGO (AP) _ 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Covera was originally made by G.D. Searle, which later became part of Pharmacia Corp.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, 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 around $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, the editor of JAMA, 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 Wednesday's JAMA.
``The responsible conduct of medical research involves a social duty and moral responsibility that transcends quarterly business plans,'' the editorial said.
The editorial cites a few other instances of studies stopped for commercial reasons _ actions, Psaty said, that are ``just going to discredit companies and make recruitment to trials more difficult.''
Black said the Covera study's participants received free blood pressure drugs and medical care, and most were understanding about halting the study. He said researchers devised the study and sought company funding after suggestions that older forms of widely used drugs like verapamil, known as calcium channel blockers, might be linked to cancer and heart problems.
Those short-acting calcium channel blockers have largely been replaced by longer-acting versions such as Covera, Psaty said.
DeAngelis said the journal has not published incomplete research in her four-year tenure, and University of Pennsylvania ethicist Arthur Caplan called the move ``hyper-unusual.''
``They're clearly doing it to make a point,'' he said.
``In the business world, cutting your losses and deciding not to pursue something is an everyday decision, but that's not the ethics of human experimentation,'' Caplan said.