belgareth
11-18-2004, 07:10 PM
In numerous articles the FDA has claimed that they cannot guarantee the safety of
drugs purchased from other countries, even though many of them are manufactured right here on the same assembly line
as the ones we pay 2-5 times as much for. Then we see articles like this one. It makes me wonder who the FDA is
really protecting.
__________________________________________________ ______________________
Expert Warns Against 5 FDA-Approved Drugs
By DIEDTRA HENDERSON, AP Science Writer
WASHINGTON - 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 (news, bio, voting
record), 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 An "awful lot of red flags" were raised before Vioxx was withdrawn, said Grassley, R-Iowa., and the agency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 (news, bio, voting record), 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.
drugs purchased from other countries, even though many of them are manufactured right here on the same assembly line
as the ones we pay 2-5 times as much for. Then we see articles like this one. It makes me wonder who the FDA is
really protecting.
__________________________________________________ ______________________
Expert Warns Against 5 FDA-Approved Drugs
By DIEDTRA HENDERSON, AP Science Writer
WASHINGTON - 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 (news, bio, voting
record), 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 (news, bio, voting record), 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.