|
In a highly unusual move, the Journal of the American Medical
Association (JAMA) published the incomplete results of a drug
trial cut short along with a scornful editorial condemning
the drug manufacturer for calling off the study.
The study’s purpose was to determine whether the high
blood pressure drug Covera, known generically as verapamil,
was as effective as two other hypertension drugs at preventing
heart-related complications of high blood pressure.
The trial, which began in 1996, enrolled 16,602 patients
with high blood pressure in 15 countries and was halted in
2000, two years early. Pharmacia, which manufactures Covera,
called off the study for "commercial reasons" before
researchers could determine whether the drug provided any
benefit. Pharmacia was recently bought by Pfizer.
JAMA editors are calling the trial’s halt unethical,
saying that trial volunteers were deprived of personal benefit
and medical research has a certain moral responsibility and
social duty to uphold.
The company had spent $50 million on the study when it was
called off. Study participants had been receiving their medications
for free, as well as medical care for hypertension, however
the benefits stopped along with the trial.
Studies can be terminated early if it is deemed that its
benefits or risks make completion of the study unethical.
However, in the current study the results were not known before
the study was ended.
Results from the study could have been beneficial to millions
of people worldwide who suffer from hypertension, but the
trial was stopped before researchers could accurately compare
the drugs.
The
Seattle Times April 23, 2003
| 