HEALTH WATCH RESEARCH SAFETY RULES OUTDATED, PANEL SAYS

People in medical studies are inadequately protected from risks, with
hazards often poorly explained and scientists often in conflicts of
interest, a panel of experts reported today in The Journal of the American
Medical Association.

Federal regulations designed to ensure human safety are outdated and
limited in reach, the panel said, and review boards at medical centers
whose job it is to oversee safety in studies are often undertrained,
overburdened and swamped with paperwork.

"The current system is straining and in danger of falling apart," said
Arthur Caplan, a co-author and director of the Center for Bioethics at the
University of Pennsylvania Health System.

"It costs too much, is too bureaucratic and doesn't give the kind of
protection to subjects that people have a right to expect," he said.

Caplan said the first step should be to gather data on what happens to
research subjects and on how review boards do their work of overseeing
patient safety, Caplan said in a telephone interview Tuesday.

Then, steps need to be taken --- including possible federal legislation ---
to streamline the system under which research is conducted and to
strengthen the rules that govern it, Caplan and his colleagues wrote.

Currently, the only regulations are the ones developed 17 years ago by the
Department of Health and Human Services and the Food and Drug
Administration, and they only apply to government-funded research.

"If you're privately funded, you can ignore all those rules, and that's a
major problem," Caplan said.

Medical centers increasingly get funding from drug companies and other
for-profit entities rather than the federal government, the ethicists
wrote. Concerns have mounted that researchers may be paid by the number of
subjects they enroll, which gives them an incentive to put the sponsor's
interest ahead of the subjects' interests, they said.

Also, the forms used to obtain subjects' consent to be studied have "become
vehicles for reducing legal liability for researchers and institutions,
rather than empowering subjects to make good choices about being in
research," Caplan said.

NIH panel backs methadone use: The administration's push to expand the use
of methadone treatment is getting a boost from a panel of scientists who
say the synthetic narcotic helps decrease drug use and criminal activity
among heroin addicts. The 12 scientists convened by the National Institutes
of Health acknowledge that methadone is not a panacea for substance abuse.
But in a report published today in the Journal of the American Medical
Association, the panel finds that heroin addiction is a treatable disease
and urges the government to expand the availability of methadone programs.
Methadone, first used widely some 30 years ago, is a narcotic that blunts
heroin addicts' craving for the street drug and eases the painful symptoms
of heroin withdrawal. It has some of the same physiological effects on the
brain as heroin, but without the "high" that addicts crave.

(Copyright 1998 The Atlanta Journal / The Atlanta Constitution)

Checked-by: Pat Dolan