Move to switch statins to non-prescription in US
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《英国医生杂志》
US medical authorities should follow the lead of Britain and allow the sale of cholesterol lowering agents without a prescription, said a US professor of medicine in an editorial published in the American Journal of Cardiology (2004;94:753-6).
British medical authorities switched simvastatin (Zocor) to over the counter status in July, making it the first statin to be available without prescription. Dr Antonio Gotto, professor of medicine at Weill Cornell Medical College, New York, applauded the move, saying that the "proven effectiveness and good safety record of statin medications argues for a similar move in the US."
Johnson & Johnson-Merck is reapplying to the US Food and Drug Administration for over the counter status for its drug lovastatin (Mevacor). The FDA turned the application down four years ago because of safety concerns. Bristol-Myers Squibb is seeking similar approval for pravastatin (Pravachol).
Dr Gotto cited three studies in his editorial that "support the effectiveness of primary prevention." The adult treatment panel III of the national cholesterol education programme, wrote Dr Gotto, "identified a group of patients who qualify for intervention because of their intermediate risk for near-term CHD ."
The programme’s guidelines have come under fire, however; critics say the benefits of primary prevention are not proved for many patients.
Dr John Abramson, clinical instructor at Harvard Medical School and author of Overdosed America: The Broken Promise of American Medicine, says that two of the three studies of primary prevention cited by Dr Gotto in his editorial show that statin therapy does not significantly reduce all cause mortality or the overall risk of serious illness.
"Even in the west of Scotland coronary prevention study ," said Dr Abramson, "100 men with average LDL cholesterol levels of 192 mg/dl, 44% of whom smoked, had to be treated for about two years to prevent a single heart attack. And there is no significant evidence from randomised controlled studies that statins benefit women of any age or men over 70 who do not already have heart disease."
Dr Abramson thinks the focus on lowering cholesterol levels is distracting us from more effective interventions: "Statin therapy can clearly benefit people at very high risk, like those who already have heart disease. But studies repeatedly show that most people who do not already have heart disease derive greater protection from regular exercise, a healthy diet, and not smoking than from taking a statin—though the two approaches are not necessarily mutually exclusive."
Dr Gotto told the BMJ that he believes direct marketing to patients can be helpful. He said: "I believe there are many people who would benefit from statins, especially with safeguards where the pharmacists are involved in the process as they are in Britain. Patients treated for secondary prevention should be treated directly by doctors, but this is for primary prevention, for patients who would benefit from long term statin therapy and would likely fall through the cracks otherwise."
Dr Gotto is a consultant for a number of drug companies, including makers of statins such as Bristol-Myers Squibb, Merck, and Pfizer.
But Dr Abramson is concerned about selling statins direct to patients: "This is an end-run around the opportunity for doctors to coach their patients toward better health. Without doctors who understand the real scientific evidence, there is nothing standing between drug company marketing and patients’ hopes for better health."(New York Jeanne Lenzer)
British medical authorities switched simvastatin (Zocor) to over the counter status in July, making it the first statin to be available without prescription. Dr Antonio Gotto, professor of medicine at Weill Cornell Medical College, New York, applauded the move, saying that the "proven effectiveness and good safety record of statin medications argues for a similar move in the US."
Johnson & Johnson-Merck is reapplying to the US Food and Drug Administration for over the counter status for its drug lovastatin (Mevacor). The FDA turned the application down four years ago because of safety concerns. Bristol-Myers Squibb is seeking similar approval for pravastatin (Pravachol).
Dr Gotto cited three studies in his editorial that "support the effectiveness of primary prevention." The adult treatment panel III of the national cholesterol education programme, wrote Dr Gotto, "identified a group of patients who qualify for intervention because of their intermediate risk for near-term CHD ."
The programme’s guidelines have come under fire, however; critics say the benefits of primary prevention are not proved for many patients.
Dr John Abramson, clinical instructor at Harvard Medical School and author of Overdosed America: The Broken Promise of American Medicine, says that two of the three studies of primary prevention cited by Dr Gotto in his editorial show that statin therapy does not significantly reduce all cause mortality or the overall risk of serious illness.
"Even in the west of Scotland coronary prevention study ," said Dr Abramson, "100 men with average LDL cholesterol levels of 192 mg/dl, 44% of whom smoked, had to be treated for about two years to prevent a single heart attack. And there is no significant evidence from randomised controlled studies that statins benefit women of any age or men over 70 who do not already have heart disease."
Dr Abramson thinks the focus on lowering cholesterol levels is distracting us from more effective interventions: "Statin therapy can clearly benefit people at very high risk, like those who already have heart disease. But studies repeatedly show that most people who do not already have heart disease derive greater protection from regular exercise, a healthy diet, and not smoking than from taking a statin—though the two approaches are not necessarily mutually exclusive."
Dr Gotto told the BMJ that he believes direct marketing to patients can be helpful. He said: "I believe there are many people who would benefit from statins, especially with safeguards where the pharmacists are involved in the process as they are in Britain. Patients treated for secondary prevention should be treated directly by doctors, but this is for primary prevention, for patients who would benefit from long term statin therapy and would likely fall through the cracks otherwise."
Dr Gotto is a consultant for a number of drug companies, including makers of statins such as Bristol-Myers Squibb, Merck, and Pfizer.
But Dr Abramson is concerned about selling statins direct to patients: "This is an end-run around the opportunity for doctors to coach their patients toward better health. Without doctors who understand the real scientific evidence, there is nothing standing between drug company marketing and patients’ hopes for better health."(New York Jeanne Lenzer)