Filed at 11:11 p.m. ET
WASHINGTON (AP) -- At least five medications now sold to consumers pose
such risks that their sale should be limited or stopped, said a government
drug reviewer who raised safety questions earlier about the arthritis drug
Vioxx.
In testimony Thursday before the Senate Finance Committee, Food and
Drug Administration reviewer David Graham cited Meridia, Crestor,
Accutane, Bextra and Serevent. Drug makers defended the use and safety of
their products.
Graham contended the country is ``virtually defenseless'' against a
repeat of the Vioxx debacle. Dr. Steven Galson of the FDA rejected that
comment as having ``no basis in fact.''
Merck & Co. pulled Vioxx from the market on Sept. 30 after a study
indicated the popular painkiller doubled the risk of heart attacks and
stroke when taken for longer than 18 months.
The committee chairman, Sen. Charles Grassley, suggested an independent
board of drug safety may be needed to ensure the safety of medications
after FDA approval. An ``awful lot of red flags'' were raised before Vioxx
was withdrawn, said Grassley, R-Iowa., and the agency disdained, rather
than listened to, its own reviewers.
Graham contended that FDA has an inherent conflict of interest that
triggers ``denial, rejection and heat'' when safety questions emerge about
products it has approved.
In his view, the five most worrisome drugs that demand speedy
action:
--Meridia, a weight-loss drug. He said the agency should consider
whether its benefits outweigh the risks of higher blood pressure and
stroke among people taking it. ``I don't think Meridia passes that test,''
Graham said.
--Crestor, an anti-cholesterol drug. He said the government should
evaluate the occurrence of renal failure and other serious side effects
among people taking Crestor. Two of three other statin competitors prevent
heart attack and stroke and do not cause renal failure, he said.
--Accutane, an acne drug linked to birth defects. Graham said the drug
represents a 20-year ``regulatory failure'' by the FDA and sales should be
restricted immediately.
--Bextra, a painkiller. Graham said the drug poses the same heart
attack and stroke risk as Vioxx. He recommended designing studies to look
at the drug's cardiovascular risks.
--Serevent, an asthma treatment. He said the drug was shown, with 90
percent certainty in a long-term trial in England, to cause deaths due to
asthma. GlaxoSmithKline, told by the FDA to do a large, clinical trial,
begged off. ``We've got case reports of people dying, clutching their
Serevent inhaler,'' Graham said. ``But Serevent is still on the
market.''
Galson, acting director of the FDA's Center for Drug Evaluation and
Research, said the agency already has taken steps to alert consumers to
those drugs' safety concerns. That includes heightened warnings for
Serevent; a tougher risk-management plan to ensure pregnant women don't
use Accutane; and an upcoming advisory committee hearing regarding
Bextra.
``Each of these do have special safety issues, but they're under
evaluation and we're watching them carefully,'' Galson said.
Tim Lindberg, a spokesman for Abbott Laboratories, said ``science
continues to support the safe use of Meridia to treat obesity.''
AstraZeneca PLC, maker of Crestor, has confidence in the drug,
spokeswoman Emily Denney said. ``To date, the FDA has not given us any
indication of a major concern regarding Crestor,'' she said.
Carolyn Glynn, spokeswoman for Roche Holdings AG, a maker of Accutane,
acknowledged that the drug carries risk and said it is reserved for
serious cases. ``This drug is extremely beneficial as long as it's used
safely and appropriately,'' she said.
Susan Bro, a Pfizer spokeswoman, said Bextra did not increase the risk
of serious cardiovascular events in a recent analysis of nearly 8,000
arthritis patients who took the drug from six weeks to 52 weeks. She said
Bextra has been found to be safe and effective when used as indicated.
GlaxoSmithKline, maker of Serevent, issued a similar statement about
its product.
In his testimony, Graham said the FDA's Office of New Drugs
unrealistically maintains a drug is safe unless reviewers establish with
95 percent certainty that it is not.
That rule does not protect consumers, Graham told the Senate committee.
``What it does is it protects the drug,'' he said.
Grassley accused the FDA of attempting to intimidate Graham. Sen. Jeff
Bingaman, D-N.M., urged President Bush to name a new leader at the FDA,
where Lester Crawford is the acting commissioner.
Graham said he fears continued intimidation.
``I was frightened before,'' he told reporters after the hearing.
``Senior management at the FDA did everything in their power to intimidate
me prior to my testimony,'' he said.
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