Expert Warns Against
5 FDA-Approved Drugs
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An "awful lot of red flags" were raised before Vioxx was withdrawn,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
_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,"
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
"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,"
Reference Source 89
November 19, 2004