By
Janice Billingsley
HealthDay Reporter Thu Apr 28,11:48 PM ET
THURSDAY,
April 28 (HealthDay News) -- The U.S. Food and Drug Administration
( FDA) has been faulted by some critics for waiting too long
to take drugs off the market that carry potentially dangerous
side effects.
A recent example: Vioxx and Bextra, part of the controversial
class of cox-2 painkillers. Both have been linked to an increased
risk of cardiovascular problems.
But during a panel discussion this week, the agency was singled
out for just the opposite reason. By banning certain drugs,
the experts claimed, the FDA fails to adequately weigh the
benefits that some medications -- including cox-2s -- provide
for people who are dependent upon them for improved quality
of life.
And, the agency is also denying consumers the right to decide
for themselves -- in tandem with their doctor -- whether to
take a drug or not, speakers said.
"There is informed consent, and if there is adequate educational
information, patients can analyze the risks and benefits of
taking a drug," said Dr. Irvin Modlin, a professor at Yale
University School of Medicine.
He was one of several speakers present for the panel discussion
titled Strong Medicine: What's Next for Drug Development?
It was part of a pharmaceutical conference and exhibition
in New York City that concludes Thursday.
"The FDA, in its balancing benefit versus risk, gives risk
the greatest weight. Benefits get scant attention," claimed
panelist Peter Barton Hutt, a Washington, D.C., lawyer who
specializes in food and drug law. He was chief counsel for
the FDA from 1971 to 1975.
The other panelists were Sarah W. Fuller, president of Decision
Resources, a Massachusetts-based research and advisory firm
that focuses on the drug industry, and John Swen, executive
director of science policy and public affairs for the pharmaceutical
company Pfizer Inc.
Because of its intent to lower risk to consumers, the FDA
has become tougher on companies seeking approval for drugs,
calling for longer clinical trials and more of them. This
scrutiny is one reason behind the rising cost of prescription
medicines, Hutt contended.
"In eight years, the cost of bringing a drug to market has
gone from $804 million to $1.7 billion," he said.
Fuller said the future of drug research is promising. She
cited the work of smaller biotech companies, as well as innovations
in manufacturing and advances in technology and science, that
have improved diagnostics and drug delivery.
"The pipeline of new drugs is robust, with 1,300 drugs in
research and development, and 300 in late-stage development,"
Fuller said. Without going into specifics, she said they include
drugs to treat so-called "pre-disease" conditions, including
vaccines. And there's much research into drug therapies for
people over 65, who will make up 20 percent of the U.S. population
by 2010, she said.
Swen acknowledged that the drug companies need to do a better
job of explaining to consumers how they research and develop
medicines.
"We need to promote greater transparency. People don't understand
the ethics of clinical research," he said.
Swen would not comment on Pfizer's decision earlier this month
-- based on an FDA request -- to remove Bextra from the market.
Cox-2 inhibitors have been embroiled in controversy since
Merck & Co. withdrew Vioxx last September after research showed
users were at increased risk of heart attack and stroke. Only
one cox-2 inhibitor, Celebrex, also manufactured by Pfizer,
remains on the market, and the FDA has asked that the drug
carry a heightened black box warning of possible side effects.
