【medical-news】拜尔招回“抑肽酶”
发布于 2007-11-06 · 浏览 958 · IP 广东广东
这个帖子发布于 17 年零 181 天前，其中的信息可能已发生改变或有所发展。
Bayer Withdraws Heart Surgery Drug
By GARDINER HARRIS
Published: November 5, 2007
WASHINGTON, Nov. 5 — Pressured by regulators around the world, the German pharmaceutical giant Bayer A.G. announced Monday that it had agreed to withdraw the controversial heart surgery drug Trasylol after a Canadian study suggested that it increased death rates.
The Food and Drug Administration has asked for a phased withdrawal of the drug, which is given before heart surgery to reduce the risks of excessive bleeding, because of concerns that alternative medicines could run short.
“F.D.A. could not identify a specific patient population where the benefits of using Trasylol could outweigh the risks,” said Dr. John Jenkins, director of the agency’s office of new drugs.
In a written statement, Bayer said it still believed the drug was beneficial when used as directed. The F.D.A. said it would try to accommodate doctors who still wanted to use the drug by allowing Bayer to provide the medicine as part of a study.
About 200,000 patients worldwide received Trasylol last year, 110,000 of them in the United States, Bayer said.
Two weeks ago, researchers from the Ottawa Health Institute stopped a study of Trasylol in 3,000 heart and valve surgery patients because although those given the drug had less bleeding, they were half again as likely to die as those given two older medicines.
The F.D.A. asked the researchers and Canadian health authorities for complete results of the study before making a decision. But when researchers said they needed at least six more weeks to comply, the agency decided to act.
The study was the latest in a series of worrisome signs that Trasylol, also known as aprotinin, could be dangerous. Last year, a study published in The New England Journal of Medicine found that the drug increased the risks of kidney failure, heart attack and stroke. The study concluded that halting the drug’s use would prevent 10,000 to 11,000 cases of kidney failure a year and save more than $1 billion a year in dialysis costs.
The F.D.A. convened a panel of experts in September 2006 to review the safety of the drug, and the panel concluded that Trasylol should remain on the market. But within days of the panel’s meeting, the F.D.A. discovered that Bayer had sponsored yet another study of Trasylol suggesting that the drug increased the risks of death and stroke, but the company had failed to disclose the results to the agency or the advisory panel.
Bayer scientists defended Trasylol at the hearing but did not mention their own study or its worrisome results. A company investigation later concluded that the study results were withheld as a result of a “regrettable human error.”
In September, the drug agency reconvened the expert panel, and it again voted that Trasylol should continue to be sold. The agency determined that the drug should be used only in patients at great risk of excessive bleeding.
Through the first three quarters of this year, Trasylol sales amounted to $135 million, mostly in the United States, Bayer said, adding that it was not one of the company’s 10 top drugs.
Trasylol’s history demonstrates that once a drug is approved, halting its sale is exceedingly difficult. Experts on advisory panels are often loath to take widely used medicines out of doctors’ hands, even when their safety is uncertain.
This history also shows how vulnerable the F.D.A.’s drug approval system can be to unwelcome surprises. In the interest of speed, the agency often approves drugs that have not been shown to extend life but have proved effective in lowering cholesterol, shrinking tumors, moderating blood sugar or other such measures.
But these measures may not result in any lasting benefit. Cancer patients may die just as quickly even if their tumors shrink. In the case of Trasylol, which works by blocking enzymes that dissolve blood clots, the agency assumed that any drug that reduced excessive bleeding during heart surgery would benefit patients.
The first hints that this assumption may have been unwise came from researchers who compared the histories of patients given Trasylol with those given other drugs and found that the Trasylol patients fared poorly.
Such studies, however, are fraught with statistical problems. Patients given Trasylol may have been sicker than those given other medicines, so their greater problems may have been due to their underlying illness, not Trasylol. The only way to solve such statistical riddles is to undertake a study in which patients are randomized to receive one of two or three different medicines and then followed closely.
This is how the Canadian trial was undertaken, and the F.D.A.’s independent experts said its results would be important. In the end, the increased risks found in the Canadian study did not achieve statistical significance, but that may have been because the study was not given enough time.
“The fact that this trial was stopped early weighed heavily in our decision,” Dr. Jenkins said.
The F.D.A. suggested that the drug be withdrawn while drug regulators in Germany, where sales of Trasylol were a fraction of those in the United States, demanded it.
“I would say that the F.D.A. decision to request a suspension was one we reached independent of German authorities or any other regulatory agency,” Dr. Jenkins said.
http://www.nytimes.com/2007/11/05/health/05cnd-bayer.html?_r=1&ref=health&oref=slogin
By GARDINER HARRIS
Published: November 5, 2007
WASHINGTON, Nov. 5 — Pressured by regulators around the world, the German pharmaceutical giant Bayer A.G. announced Monday that it had agreed to withdraw the controversial heart surgery drug Trasylol after a Canadian study suggested that it increased death rates.
The Food and Drug Administration has asked for a phased withdrawal of the drug, which is given before heart surgery to reduce the risks of excessive bleeding, because of concerns that alternative medicines could run short.
“F.D.A. could not identify a specific patient population where the benefits of using Trasylol could outweigh the risks,” said Dr. John Jenkins, director of the agency’s office of new drugs.
In a written statement, Bayer said it still believed the drug was beneficial when used as directed. The F.D.A. said it would try to accommodate doctors who still wanted to use the drug by allowing Bayer to provide the medicine as part of a study.
About 200,000 patients worldwide received Trasylol last year, 110,000 of them in the United States, Bayer said.
Two weeks ago, researchers from the Ottawa Health Institute stopped a study of Trasylol in 3,000 heart and valve surgery patients because although those given the drug had less bleeding, they were half again as likely to die as those given two older medicines.
The F.D.A. asked the researchers and Canadian health authorities for complete results of the study before making a decision. But when researchers said they needed at least six more weeks to comply, the agency decided to act.
The study was the latest in a series of worrisome signs that Trasylol, also known as aprotinin, could be dangerous. Last year, a study published in The New England Journal of Medicine found that the drug increased the risks of kidney failure, heart attack and stroke. The study concluded that halting the drug’s use would prevent 10,000 to 11,000 cases of kidney failure a year and save more than $1 billion a year in dialysis costs.
The F.D.A. convened a panel of experts in September 2006 to review the safety of the drug, and the panel concluded that Trasylol should remain on the market. But within days of the panel’s meeting, the F.D.A. discovered that Bayer had sponsored yet another study of Trasylol suggesting that the drug increased the risks of death and stroke, but the company had failed to disclose the results to the agency or the advisory panel.
Bayer scientists defended Trasylol at the hearing but did not mention their own study or its worrisome results. A company investigation later concluded that the study results were withheld as a result of a “regrettable human error.”
In September, the drug agency reconvened the expert panel, and it again voted that Trasylol should continue to be sold. The agency determined that the drug should be used only in patients at great risk of excessive bleeding.
Through the first three quarters of this year, Trasylol sales amounted to $135 million, mostly in the United States, Bayer said, adding that it was not one of the company’s 10 top drugs.
Trasylol’s history demonstrates that once a drug is approved, halting its sale is exceedingly difficult. Experts on advisory panels are often loath to take widely used medicines out of doctors’ hands, even when their safety is uncertain.
This history also shows how vulnerable the F.D.A.’s drug approval system can be to unwelcome surprises. In the interest of speed, the agency often approves drugs that have not been shown to extend life but have proved effective in lowering cholesterol, shrinking tumors, moderating blood sugar or other such measures.
But these measures may not result in any lasting benefit. Cancer patients may die just as quickly even if their tumors shrink. In the case of Trasylol, which works by blocking enzymes that dissolve blood clots, the agency assumed that any drug that reduced excessive bleeding during heart surgery would benefit patients.
The first hints that this assumption may have been unwise came from researchers who compared the histories of patients given Trasylol with those given other drugs and found that the Trasylol patients fared poorly.
Such studies, however, are fraught with statistical problems. Patients given Trasylol may have been sicker than those given other medicines, so their greater problems may have been due to their underlying illness, not Trasylol. The only way to solve such statistical riddles is to undertake a study in which patients are randomized to receive one of two or three different medicines and then followed closely.
This is how the Canadian trial was undertaken, and the F.D.A.’s independent experts said its results would be important. In the end, the increased risks found in the Canadian study did not achieve statistical significance, but that may have been because the study was not given enough time.
“The fact that this trial was stopped early weighed heavily in our decision,” Dr. Jenkins said.
The F.D.A. suggested that the drug be withdrawn while drug regulators in Germany, where sales of Trasylol were a fraction of those in the United States, demanded it.
“I would say that the F.D.A. decision to request a suspension was one we reached independent of German authorities or any other regulatory agency,” Dr. Jenkins said.
http://www.nytimes.com/2007/11/05/health/05cnd-bayer.html?_r=1&ref=health&oref=slogin
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