US consumer body calls for review of cholesterol guidelines
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《英国医生杂志》
Cholesterol lowering guidelines issued in July by the US National Institutes of Health (NIH) are being challenged by a consumer organisation that is petitioning the NIH to appoint an independent panel to review them.
The petition, organised by the Center for Science in the Public Interest, a consumer advocacy organisation funded by subscribers to its newsletter and by individual donors, has asked the NIH to "create an independent review panel free of conflicts of interest to review all the data in the five studies that led to update... If warranted, should issue revised conclusions."
The request follows the revelation that eight of the nine authors of the guidelines had failed to disclose financial associations with the manufacturers of cholesterol lowering agents ( BMJ 2004;429: 247, 31 Jul). The guidelines, devised by the national cholesterol education programme of the NIH's National Heart, Lung, and Blood Institute, were endorsed by the American Heart Association—which also receives funding from the makers of statins.
"This isn't just based on conflicts of interest," said Merrill Goozner, director of the Integrity in Science project at the Center for Science in the Public Interest. "It's based on anomalies in the science. The update went too far, and we want independent experts to do a systematic reanalysis of the data."
The new guidelines recommend lowering the threshold for treating low density lipoprotein cholesterol levels from 130 mg/dl (3.4 mmol/l) to 100 mg/dl for patients without heart disease and from 100 mg/dl to 70 mg/dl for patients with previously existing heart disease. But primary prevention is unproved even in patients with multiple risk factors—including diabetes, argued the consumer group.
The group's petition claims that the guidelines, which cited the heart protection study as showing that statins were beneficial for primary prevention for diabetics, "ignore the three other studies under review that found that statins did not provide significant benefit to people with diabetes."
The new guidelines will radically increase the number of people taking cholesterol lowering drugs, said Dr John Abramson, clinical instructor at Harvard Medical School, Boston, Massachusetts, author of Overdosed America: The Broken Promise of American Medicine, and one of the signatories to the petition. He told the BMJ: "In the one group that could benefit, men aged under 65 with multiple risk factors, you'd have to treat 238 men for one year to prevent one heart attack, and to prevent one death you'd have to treat 526 patients for one year."
"While statins are clearly beneficial in certain high risk individuals," said Dr Abramson, "exercising, eating a healthy diet, and not smoking each individually appear to give more protection against heart disease, as well as the added benefit of preventing diabetes, osteoporosis, and multiple other diseases. One can't help wondering whether the ties between the authors and the statin makers contribute—consciously or unconsciously—to their focus on drugs."
Dr Barbara Alving, acting director of the National Heart, Lung, and Blood Institute, issued a statement in response to the petition, saying that the institute "stands behind" the guidelines and that "several clinical trials in high risk individuals are currently under way."
Dr Alving added that the National Heart, Lung, and Blood Institute was working on further "refining the process for management of potential conflict of interest."(Jeanne Lenzer)
The petition, organised by the Center for Science in the Public Interest, a consumer advocacy organisation funded by subscribers to its newsletter and by individual donors, has asked the NIH to "create an independent review panel free of conflicts of interest to review all the data in the five studies that led to update... If warranted, should issue revised conclusions."
The request follows the revelation that eight of the nine authors of the guidelines had failed to disclose financial associations with the manufacturers of cholesterol lowering agents ( BMJ 2004;429: 247, 31 Jul). The guidelines, devised by the national cholesterol education programme of the NIH's National Heart, Lung, and Blood Institute, were endorsed by the American Heart Association—which also receives funding from the makers of statins.
"This isn't just based on conflicts of interest," said Merrill Goozner, director of the Integrity in Science project at the Center for Science in the Public Interest. "It's based on anomalies in the science. The update went too far, and we want independent experts to do a systematic reanalysis of the data."
The new guidelines recommend lowering the threshold for treating low density lipoprotein cholesterol levels from 130 mg/dl (3.4 mmol/l) to 100 mg/dl for patients without heart disease and from 100 mg/dl to 70 mg/dl for patients with previously existing heart disease. But primary prevention is unproved even in patients with multiple risk factors—including diabetes, argued the consumer group.
The group's petition claims that the guidelines, which cited the heart protection study as showing that statins were beneficial for primary prevention for diabetics, "ignore the three other studies under review that found that statins did not provide significant benefit to people with diabetes."
The new guidelines will radically increase the number of people taking cholesterol lowering drugs, said Dr John Abramson, clinical instructor at Harvard Medical School, Boston, Massachusetts, author of Overdosed America: The Broken Promise of American Medicine, and one of the signatories to the petition. He told the BMJ: "In the one group that could benefit, men aged under 65 with multiple risk factors, you'd have to treat 238 men for one year to prevent one heart attack, and to prevent one death you'd have to treat 526 patients for one year."
"While statins are clearly beneficial in certain high risk individuals," said Dr Abramson, "exercising, eating a healthy diet, and not smoking each individually appear to give more protection against heart disease, as well as the added benefit of preventing diabetes, osteoporosis, and multiple other diseases. One can't help wondering whether the ties between the authors and the statin makers contribute—consciously or unconsciously—to their focus on drugs."
Dr Barbara Alving, acting director of the National Heart, Lung, and Blood Institute, issued a statement in response to the petition, saying that the institute "stands behind" the guidelines and that "several clinical trials in high risk individuals are currently under way."
Dr Alving added that the National Heart, Lung, and Blood Institute was working on further "refining the process for management of potential conflict of interest."(Jeanne Lenzer)