Concern with the FDA
Posted: Sat Dec 11, 2004 8:57 pm
Here is a rather long article (no link available for posting, sorry) about some ongoing problems within the FDA. Of course there are always two sides to every story but this is but another reason why I have never been all that comfortable with this organization.
Harry
__________________
F.D.A. Failing in Drug Safety, Official Asserts
By GARDINER HARRIS
New York Times
WASHINGTON, Nov. 18 - Federal drug regulators are "virtually incapable
of protecting America" from unsafe drugs, a federal drug safety reviewer told a Congressional panel on Thursday, and he named five drugs now on the market whose safety needs "to be seriously looked at."
In testimony before the Senate Finance Committee, Dr. David Graham, the reviewer in the Food and Drug Administration's Office of Drug Safety, uused fiery language to denounce his agency as feckless and far too likely to surrender to demands of drug makers.
"We are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world," Dr. Graham concluded.
Dr. Steven Galson, the director of the F.D.A.'s Center for Drug Evaluation and Research and one of the agency's top civil servants, later said that Dr. Graham's new numbers "constitute junk science" and were "irresponsible."
Dr. Graham, with more than 20 years of service at the Food and Drug
Administration, cited the anti-cholesterol drug Crestor, the pain pill Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne
drug Accutane. Makers of each drug defended the medicines as safe.
Dr. Sandra Kweder, deputy director of the F.D.A.'s office of new drugs,
told the panel that Dr. Graham was not describing "the F.D.A. that I know" and that she did not see the five drugs he cited as "more
concerning than any others."
The clash was a rare public airing of tensions that have simmered in the agency for decades. It is a fight between those who focus on the potential of drugs to cure the sick and dying and those who see many medicines as high-priced commercial products with potentially risky side effects, between those who view pharmaceutical makers as beneficial
partners and those who see the drug makers as antagonists needing to be curbed.
"My personal view is that our system works very well," Dr. Kweder said.
The exchange came during a hearing called by Senator Charles E.
Grassley, a Republican of Iowa and the chairman of the Finance Committee.
Using his broad authority over much of the government's budget, Senator
Grassley and his staff have been investigating the F.D.A. for months after several controversies swept the agency this year.
The hearing focused on the last of these controversies: Merck's decision in September to withdraw Vioxx, a pain pill that became a $2.5 billion seller and one of the most widely advertised drugs in the world.
Merck withdrew Vioxx when a study it sponsored found that after 18
months of use the drug doubled the risk of heart attack or stroke.
Critics of the F.D.A. have said that studies from as early as 1999 and
2000 showed that Vioxx was a risk to the heart, and many asked why the
F.D.A. had not forced the drug's withdrawal earlier.
The critics' case has been bolstered by many e-mail messages from Merck and by company documents disclosed in lawsuits by users of Vioxx. In many of the documents, Merck executives and scientists discussed the possible link between Vioxx and heart damage years before the company publicly admitted that the drug could cause harm.
Merck executives have said the documents are being taken out of
context.
Raymond V. Gilmartin, Merck's chief executive, testified Thursday that
his company followed a "rigorous scientific process" as it examined the
risks and benefits of Vioxx.
But Dr. Graham and other witnesses severely criticized Merck, saying
the company should have acted years earlier to confirm the risks of
Vioxx. Dr. Graham raised his estimates of those in the United States who had suffered heart attacks or stroke as result of taking Vioxx to a range
of 88,000 to 139,000, up from 28,000. As many as 40 percent of these
people, or about 55,000, died as a result, he said.
Dr. Gurkirpal Singh, an adjunct clinical professor at Stanford University, said at the hearing that Merck scientists had tried to intimidate him after he publicly raised questions about the effects of Vioxx.
Dr. Singh, a rheumatologist and science officer of the Institute of Clinical Outcomes Research and Education in Woodside, Calif., said: "I was
warned that if I continued in this fashion there would be serious consequences for me. I was told that Dr. Louis Sherwood, a Merck senior vice president and a former chief of medicine at a medical school, had
extensive contacts within academia and could make life very difficult for me at Stanford and outside."
Dr. Graham said that in his years at the F.D.A., he had recommended
that 12 drugs be withdrawn. Only two are still being sold, he said.
His list of the five most worrisome drugs angered pharmaceutical
makers, although objections to most of these drugs have long been known. For instance, Accutane, a drug for severe acne, can cause birth defects. The drug's label has warnings about this risk, and the F.D.A. has long been trying to get physicians to confine prescriptions to those women who cannot become pregnant or who are taking birth control.
Dr. Graham said that the F.D.A. needed to do a better job restricting
the drug's sales.
Carolyn Glynn, a spokeswoman for Roche, which makes Accutane, said that her company had worked with the F.D.A. for years to "address the risk of birth defects."
Dr. Graham mentioned Crestor because, he said, it was the only
cholesterol-lowering drug on the market that caused acute kidney failure. And the drug is more likely to cause a serious muscle-weakening disease than similar drugs, he said.
AstraZeneca introduced Crestor last year, but sales have been
disappointing largely because of worries about the drug's safety. Public
Citizen, a Washington advocacy group, has called for it to be withdrawn.
"We are confident in the safety profile of Crestor," said Rachel Bloom-Baglin, a spokeswoman for AstraZeneca. "To date, the F.D.A. has not
given us any indication of a major concern regarding Crestor."
But Dr. Kweder of the F.D.A. told the panel that Crestor's risks are
"something that we are in the process of and have been evaluating very,
very closely."
Studies of the painkiller Bextra, also mentioned by Dr. Graham, have
shown that it increases the risks of heart attack in patients undergoing
cardiac surgery. In rare cases, the drug can also cause a fatal skin
reaction. Despite these risks, Bextra, which is similar to Vioxx, has
never been proved to be any more effective at reducing pain or protecting the stomach than older medicines like ibuprofen that are a fraction of the price and pose none of these suggested or proven risks.
Susan Bro, a spokeswoman for Pfizer, the maker of Bextra, said that the
drug "has been found to be safe and effective when used as indicated to
treat osteoarthritis, rheumatoid arthritis and menstrual pain." She
said the F.D.A. planned to ask a panel of experts early next year to
examine the safety of Bextra and Celebrex, a Pfizer pain drug.
Meridia is a weight-loss pill, made by Abbott Laboratories, that can
cause substantial increases in blood pressure in some patients. Public
Citizen has called for Meridia's withdrawal because it has been
associated with 124 reports of serious cardiovascular problems, including 49 deaths, said Dr. Sidney Wolfe, director of Public Citizen's health
research group.
Dr. Graham testified that few patients were able to withstand Meridia's
side effects long enough to benefit from its use. "What's the utility
of the drug?" he asked.
Laureen Cassidy, a spokeswoman for Abbott, said, "Science continues to
support the safe use of Meridia as a treatment for obesity."
The fifth drug named by Dr. Graham was Serevent, an asthma medication made by GlaxoSmithKline, which stopped a large trial last year after an interim analysis revealed an increased risk of asthma-related deaths and life-threatening episodes among those given the drug.
"We have case reports of people dying clutching their Serevent
inhaler," Dr. Graham said.
After the study was released, the F.D.A. placed a "black box" warning,
its most severe, on the drug's label. The agency concluded that the
drug's benefits outweighed its risks.
In a statement Thursday, GlaxoSmithKline said that it "stands firmly
behind Serevent, which is safe and effective when used appropriately and
in accordance with labeling and treatment guidelines."
Dr. Galson of the F.D.A. emphasized that the drugs mentioned by Dr.
Graham "are all approved and are safe and effective like other drugs that
are approved, recognizing that safe does not mean risk-free."
Dr. Kweder of the F.D.A. defended the agency's handling of Vioxx and
said that Merck had "acted responsibly" when it sold Vioxx. She said that
Dr. Graham's estimates of Vioxx's toll were simply mathematical guesses
and "not real deaths." And she said that it was not unusual when a drug
went on the market "to have ongoing concerns about particular aspects
of its safety."
In his testimony, Mr. Gilmartin of Merck retraced many of the steps his
company had undertaken and noted that while some early studies
suggested that the drug might be a risk to the heart other studies found no problems. He said he believed so thoroughly in the drug that his wife took it until the day the company withdrew it.
Harry
__________________
F.D.A. Failing in Drug Safety, Official Asserts
By GARDINER HARRIS
New York Times
WASHINGTON, Nov. 18 - Federal drug regulators are "virtually incapable
of protecting America" from unsafe drugs, a federal drug safety reviewer told a Congressional panel on Thursday, and he named five drugs now on the market whose safety needs "to be seriously looked at."
In testimony before the Senate Finance Committee, Dr. David Graham, the reviewer in the Food and Drug Administration's Office of Drug Safety, uused fiery language to denounce his agency as feckless and far too likely to surrender to demands of drug makers.
"We are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world," Dr. Graham concluded.
Dr. Steven Galson, the director of the F.D.A.'s Center for Drug Evaluation and Research and one of the agency's top civil servants, later said that Dr. Graham's new numbers "constitute junk science" and were "irresponsible."
Dr. Graham, with more than 20 years of service at the Food and Drug
Administration, cited the anti-cholesterol drug Crestor, the pain pill Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne
drug Accutane. Makers of each drug defended the medicines as safe.
Dr. Sandra Kweder, deputy director of the F.D.A.'s office of new drugs,
told the panel that Dr. Graham was not describing "the F.D.A. that I know" and that she did not see the five drugs he cited as "more
concerning than any others."
The clash was a rare public airing of tensions that have simmered in the agency for decades. It is a fight between those who focus on the potential of drugs to cure the sick and dying and those who see many medicines as high-priced commercial products with potentially risky side effects, between those who view pharmaceutical makers as beneficial
partners and those who see the drug makers as antagonists needing to be curbed.
"My personal view is that our system works very well," Dr. Kweder said.
The exchange came during a hearing called by Senator Charles E.
Grassley, a Republican of Iowa and the chairman of the Finance Committee.
Using his broad authority over much of the government's budget, Senator
Grassley and his staff have been investigating the F.D.A. for months after several controversies swept the agency this year.
The hearing focused on the last of these controversies: Merck's decision in September to withdraw Vioxx, a pain pill that became a $2.5 billion seller and one of the most widely advertised drugs in the world.
Merck withdrew Vioxx when a study it sponsored found that after 18
months of use the drug doubled the risk of heart attack or stroke.
Critics of the F.D.A. have said that studies from as early as 1999 and
2000 showed that Vioxx was a risk to the heart, and many asked why the
F.D.A. had not forced the drug's withdrawal earlier.
The critics' case has been bolstered by many e-mail messages from Merck and by company documents disclosed in lawsuits by users of Vioxx. In many of the documents, Merck executives and scientists discussed the possible link between Vioxx and heart damage years before the company publicly admitted that the drug could cause harm.
Merck executives have said the documents are being taken out of
context.
Raymond V. Gilmartin, Merck's chief executive, testified Thursday that
his company followed a "rigorous scientific process" as it examined the
risks and benefits of Vioxx.
But Dr. Graham and other witnesses severely criticized Merck, saying
the company should have acted years earlier to confirm the risks of
Vioxx. Dr. Graham raised his estimates of those in the United States who had suffered heart attacks or stroke as result of taking Vioxx to a range
of 88,000 to 139,000, up from 28,000. As many as 40 percent of these
people, or about 55,000, died as a result, he said.
Dr. Gurkirpal Singh, an adjunct clinical professor at Stanford University, said at the hearing that Merck scientists had tried to intimidate him after he publicly raised questions about the effects of Vioxx.
Dr. Singh, a rheumatologist and science officer of the Institute of Clinical Outcomes Research and Education in Woodside, Calif., said: "I was
warned that if I continued in this fashion there would be serious consequences for me. I was told that Dr. Louis Sherwood, a Merck senior vice president and a former chief of medicine at a medical school, had
extensive contacts within academia and could make life very difficult for me at Stanford and outside."
Dr. Graham said that in his years at the F.D.A., he had recommended
that 12 drugs be withdrawn. Only two are still being sold, he said.
His list of the five most worrisome drugs angered pharmaceutical
makers, although objections to most of these drugs have long been known. For instance, Accutane, a drug for severe acne, can cause birth defects. The drug's label has warnings about this risk, and the F.D.A. has long been trying to get physicians to confine prescriptions to those women who cannot become pregnant or who are taking birth control.
Dr. Graham said that the F.D.A. needed to do a better job restricting
the drug's sales.
Carolyn Glynn, a spokeswoman for Roche, which makes Accutane, said that her company had worked with the F.D.A. for years to "address the risk of birth defects."
Dr. Graham mentioned Crestor because, he said, it was the only
cholesterol-lowering drug on the market that caused acute kidney failure. And the drug is more likely to cause a serious muscle-weakening disease than similar drugs, he said.
AstraZeneca introduced Crestor last year, but sales have been
disappointing largely because of worries about the drug's safety. Public
Citizen, a Washington advocacy group, has called for it to be withdrawn.
"We are confident in the safety profile of Crestor," said Rachel Bloom-Baglin, a spokeswoman for AstraZeneca. "To date, the F.D.A. has not
given us any indication of a major concern regarding Crestor."
But Dr. Kweder of the F.D.A. told the panel that Crestor's risks are
"something that we are in the process of and have been evaluating very,
very closely."
Studies of the painkiller Bextra, also mentioned by Dr. Graham, have
shown that it increases the risks of heart attack in patients undergoing
cardiac surgery. In rare cases, the drug can also cause a fatal skin
reaction. Despite these risks, Bextra, which is similar to Vioxx, has
never been proved to be any more effective at reducing pain or protecting the stomach than older medicines like ibuprofen that are a fraction of the price and pose none of these suggested or proven risks.
Susan Bro, a spokeswoman for Pfizer, the maker of Bextra, said that the
drug "has been found to be safe and effective when used as indicated to
treat osteoarthritis, rheumatoid arthritis and menstrual pain." She
said the F.D.A. planned to ask a panel of experts early next year to
examine the safety of Bextra and Celebrex, a Pfizer pain drug.
Meridia is a weight-loss pill, made by Abbott Laboratories, that can
cause substantial increases in blood pressure in some patients. Public
Citizen has called for Meridia's withdrawal because it has been
associated with 124 reports of serious cardiovascular problems, including 49 deaths, said Dr. Sidney Wolfe, director of Public Citizen's health
research group.
Dr. Graham testified that few patients were able to withstand Meridia's
side effects long enough to benefit from its use. "What's the utility
of the drug?" he asked.
Laureen Cassidy, a spokeswoman for Abbott, said, "Science continues to
support the safe use of Meridia as a treatment for obesity."
The fifth drug named by Dr. Graham was Serevent, an asthma medication made by GlaxoSmithKline, which stopped a large trial last year after an interim analysis revealed an increased risk of asthma-related deaths and life-threatening episodes among those given the drug.
"We have case reports of people dying clutching their Serevent
inhaler," Dr. Graham said.
After the study was released, the F.D.A. placed a "black box" warning,
its most severe, on the drug's label. The agency concluded that the
drug's benefits outweighed its risks.
In a statement Thursday, GlaxoSmithKline said that it "stands firmly
behind Serevent, which is safe and effective when used appropriately and
in accordance with labeling and treatment guidelines."
Dr. Galson of the F.D.A. emphasized that the drugs mentioned by Dr.
Graham "are all approved and are safe and effective like other drugs that
are approved, recognizing that safe does not mean risk-free."
Dr. Kweder of the F.D.A. defended the agency's handling of Vioxx and
said that Merck had "acted responsibly" when it sold Vioxx. She said that
Dr. Graham's estimates of Vioxx's toll were simply mathematical guesses
and "not real deaths." And she said that it was not unusual when a drug
went on the market "to have ongoing concerns about particular aspects
of its safety."
In his testimony, Mr. Gilmartin of Merck retraced many of the steps his
company had undertaken and noted that while some early studies
suggested that the drug might be a risk to the heart other studies found no problems. He said he believed so thoroughly in the drug that his wife took it until the day the company withdrew it.