Companies may face tighter regulation over promoting drugs
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《英国医生杂志》
The drug industry may be facing the same kind of sea change in business practices and regulation that other segments of corporate America faced in the wake of Enron and other corporate scandals, says an article in the New England Journal of Medicine ( 2004;351: 1891-900).
David Studdert and colleagues from the Harvard School of Public Health and Harvard Medical School say that the remarkable increase in regulatory, self regulatory, and prose-cutorial activity that currently focuses on conflicts of interest between doctors and drug companies will intensify.
Financial entanglement between the industry and doctors was explored in a theme issue of the BMJ last year
With the continuing publication of studies showing that even small gifts can influence doctors' behaviour, the government will grow more aggressive in enforcing measures against kickbacks, they say, and as the cost of drugs continues to rise and Medicare becomes an increasingly prominent payer the government will seek any means available to reduce the overuse and cost of drugs.
They cite "an extraordinary regulatory ferment in the area of conflicts of interest involving physicians," particularly in their relations with the drug industry. In 2002 the American Medical Association, the American College of Physicians, and the Accreditation Council for Continuing Medical Education each issued or revamped guidelines for doctors' relations with drug companies.
In July 2002 the drug industry adopted a broad code of conduct for its constituencies, and in 2003 the Office of the Inspector General of the Department of Health and Human Services released guidelines with which manufacturers had to comply to avoid liability risk.
One reason for the change, in addition to the rise in drugs costs, is a growing awareness "of the troubling influence that pharmaceutical marketing can have on patient care," say the authors. And with a new federal law dealing with fraud and abuse "the law has begun to annex terrain previously controlled by professional ethics."
The industry spends about $12bn (￡6.6bn; 9.5bn) a year on gifts and payments to doctors, funds more than 70% of clinical trials, and shoulders more than half the costs of formal continuing education programmes in medicine. Financial entanglement has bred close ties between the industry and doctors. Contacts with trainees come early and continue as they move into practice.
The authors cite the Lupron case, in which government investigators probed relations between TAP Pharmaceuticals and various urologists in the marketing of leuprorelin acetate (marketed as Lupron in the United States and Prostap in the United Kingdom), a potent gonadotropin releasing hormone agonist used to treat prostate cancer. TAP Pharmaceuticals was found to have encouraged urologists to bill Medicare at the average wholesale price for Lupron, which they received free or at discounted prices. A settlement required TAP to pay $290m in criminal fines and $585m in civil penalties ( BMJ 2001;323: 828).
The drug industry and medical associations have responded to greater policing but their new codes need further development, say the authors.(David Spurgeon)
David Studdert and colleagues from the Harvard School of Public Health and Harvard Medical School say that the remarkable increase in regulatory, self regulatory, and prose-cutorial activity that currently focuses on conflicts of interest between doctors and drug companies will intensify.
Financial entanglement between the industry and doctors was explored in a theme issue of the BMJ last year
With the continuing publication of studies showing that even small gifts can influence doctors' behaviour, the government will grow more aggressive in enforcing measures against kickbacks, they say, and as the cost of drugs continues to rise and Medicare becomes an increasingly prominent payer the government will seek any means available to reduce the overuse and cost of drugs.
They cite "an extraordinary regulatory ferment in the area of conflicts of interest involving physicians," particularly in their relations with the drug industry. In 2002 the American Medical Association, the American College of Physicians, and the Accreditation Council for Continuing Medical Education each issued or revamped guidelines for doctors' relations with drug companies.
In July 2002 the drug industry adopted a broad code of conduct for its constituencies, and in 2003 the Office of the Inspector General of the Department of Health and Human Services released guidelines with which manufacturers had to comply to avoid liability risk.
One reason for the change, in addition to the rise in drugs costs, is a growing awareness "of the troubling influence that pharmaceutical marketing can have on patient care," say the authors. And with a new federal law dealing with fraud and abuse "the law has begun to annex terrain previously controlled by professional ethics."
The industry spends about $12bn (￡6.6bn; 9.5bn) a year on gifts and payments to doctors, funds more than 70% of clinical trials, and shoulders more than half the costs of formal continuing education programmes in medicine. Financial entanglement has bred close ties between the industry and doctors. Contacts with trainees come early and continue as they move into practice.
The authors cite the Lupron case, in which government investigators probed relations between TAP Pharmaceuticals and various urologists in the marketing of leuprorelin acetate (marketed as Lupron in the United States and Prostap in the United Kingdom), a potent gonadotropin releasing hormone agonist used to treat prostate cancer. TAP Pharmaceuticals was found to have encouraged urologists to bill Medicare at the average wholesale price for Lupron, which they received free or at discounted prices. A settlement required TAP to pay $290m in criminal fines and $585m in civil penalties ( BMJ 2001;323: 828).
The drug industry and medical associations have responded to greater policing but their new codes need further development, say the authors.(David Spurgeon)