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Expert Warns Against 5 FDA-Approved Drugs
Expert Warns Against 5 FDA-Approved Drugs -- Posted by Gumbo on 12-05-04 07:00
Expert Warns Against 5 FDA-Approved Drugs
November 19, 2004
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 painkillers 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withdrawn, said Grassley, R-Iowa., and the agency disdained, rather than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:
a.. 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.
b.. 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.
c.. 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.
d.. Bextra, a pain killer. 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.
e.. 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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