Less ads, more data urged for drug safety
Susan Heavey, Reuters, June 1, 2006
- When it comes to drug safety, U.S. patients and
doctors need less advertising hype and more data to
help decide whether to use prescription medicines,
health researchers said on Tuesday.
panel of behavior experts, statisticians and other
scientists said the Food and Drug Administration
should consider simpler information on risks and
benefits, such as a chart listing basic facts and
how new drugs compare to older ones.
in particular should be toned down so patients can
make rational choices, several experts said. Often
they make broad claims without proper data, they
unrealistic expectations about what the product is
going to do for them," said Peter Ubel, head of the
University of Michigan's behavioral sciences center.
comments came at the start of a two-day workshop
held by the Institute of Medicine (IOM) to discuss
the risks and benefits of medicines.
scientific organization convened the meeting to help
guide the FDA, which has faced renewed controversy
in recent years following its handling of suicide
risk in youth taking antidepressants and heart risk
with Merck & Co. Inc.'s withdrawn arthritis drug
director of the FDA's drug center, said the agency
would consider the advice. While he acknowledged the
recent controversy, he said current safety issues
are not as serious as historic crises that
established and later overhauled the FDA.
"The questions we're
looking at now ... are much more subtle benefit-risk
issues to detect," he told the audience of
government scientists, industry representatives and
The panel was
unrelated to an upcoming IOM analysis of agency's
drug safety review process expected in July.
At the meeting,
researchers said deciding whether to use a medicine
is complex and both patients and doctors can be
confused by too many numbers. Graphics and charts
Steven Woloshin, a
professor of medicine at Dartmouth Medical School in
New Hampshire, welcomed the FDA's recent effort to
redesign drug labels but said more could be done
Studies show patients
benefit from including a simple table with basic
numbers on side effects and how well a therapy
works, he said.
Last year, the drug
industry adopted voluntary guidelines to make its
ads more balanced. It also spent more than $11
billion on consumer ads and doctor promotions,
according to research from IMS Health.
Still, University of
Pennsylvania epidemiologist Brian Strom said people
cannot rely on the marketplace or regulators to
moderate medicine use.
"When a drug is
released there is immediate pressure to have large
sales," he said. "We need the most data possible."