Group seeks limits on drug-financed doctors
Posted: Tue Sep 28, 2004 9:09 pm
http://seattlepi.nwsource.com/national/ ... scriptions
Doctors who receive drug company funding would be limited in what they could teach other physicians under new rules being proposed by accreditors.
The Chicago-based Accreditation Council for Continuing Medical Education, which gives its stamp of approval for such classes, was to announce sweeping changes Tuesday to limit the influence of doctors with financial connections to the pharmaceutical industry.
The nation's 750,000 physicians stay up to date on medical advances through mandatory participation in thousands of continuing education activities per year.
In the past, a doctor teaching such a course would disclose his or her financial relationship with any drug company, say as a paid member of the company's speakers' bureau or a grant recipient. Once that was out in the open, the physician might then talk glowingly about anecdotal experience with that company's drug.
Now, a third party with no ties to the drug company would have to tell the doctor what kind of recommendations he or she could make. Anecdotal observations would be replaced by results of systematic clinical trials. Any review of journal literature would have to include negative, as well as positive, studies.
"So this whole thing about just saying 'I've got a conflict of interest. And I've got a relationship. And I've got a personal opinion. And I'm probably biased. But, I'm going to tell you anyways,' that's not allowed," said Murray Kopelow, chief executive of the accreditation council.
Doctors who balk at the new rules will be barred from presenting or teaching at continuing medical education conferences.
The changes were endorsed by the council's seven members, including the American Medical Association. Kopelow could not say how many doctors would be affected.
Earlier this month federal advisers endorsed highly visible "black-box" warning labels linking antidepressants to heightened suicidal thoughts and actions among children. The vast majority of American children who are prescribed antidepressants are taking drugs that have never been proved to ease depression among youngsters.
Pharmaceutical companies are prohibited by law from promoting such off-label use of the drugs. Doctors, however, have faced few similar restrictions.
Dr. Norm Fost, a member of the Food and Drug Administration's Pediatric Ethics Subcommittee, said many doctors are learning about off-label prescriptions during continuing medical education activities. He had no data, though, to support his hunch.
"In 23 studies, none of them has been shown to have any efficacy in children, other than Prozac. And there's all this increasing noise level about toxicity," Fost said. "Why would physicians make millions of prescriptions a year? Where would they get that idea?
"Usually, where they get it is from one of three sources. One: pharmaceutical companies. Two: pharmaceutical companies. And three: pharmaceutical companies."
A Pharmaceutical Research and Manufacturers of America attorney dismissed the notion of "stealth marketing" by drug companies.
"All of the PhRMA member companies know that if they are, in fact, trying to influence the content of an individual speaker's presentation, they're risking FDA enforcement," said Marjorie Powell, PhRMA senior assistant general counsel. "All the companies have to work with FDA all the time."
One observer called the rule changes "enlightened and refreshing," but late.
"Wherever there is a competing financial interest, there is a potential conflict. And wherever there is a potential conflict, you ought to find somebody else to do the job," said Bernard J. Carroll, a semiretired psychiatrist who has lobbied for transparency. "Money corrupts and lots of money corrupts absolutely."
Doctors who receive drug company funding would be limited in what they could teach other physicians under new rules being proposed by accreditors.
The Chicago-based Accreditation Council for Continuing Medical Education, which gives its stamp of approval for such classes, was to announce sweeping changes Tuesday to limit the influence of doctors with financial connections to the pharmaceutical industry.
The nation's 750,000 physicians stay up to date on medical advances through mandatory participation in thousands of continuing education activities per year.
In the past, a doctor teaching such a course would disclose his or her financial relationship with any drug company, say as a paid member of the company's speakers' bureau or a grant recipient. Once that was out in the open, the physician might then talk glowingly about anecdotal experience with that company's drug.
Now, a third party with no ties to the drug company would have to tell the doctor what kind of recommendations he or she could make. Anecdotal observations would be replaced by results of systematic clinical trials. Any review of journal literature would have to include negative, as well as positive, studies.
"So this whole thing about just saying 'I've got a conflict of interest. And I've got a relationship. And I've got a personal opinion. And I'm probably biased. But, I'm going to tell you anyways,' that's not allowed," said Murray Kopelow, chief executive of the accreditation council.
Doctors who balk at the new rules will be barred from presenting or teaching at continuing medical education conferences.
The changes were endorsed by the council's seven members, including the American Medical Association. Kopelow could not say how many doctors would be affected.
Earlier this month federal advisers endorsed highly visible "black-box" warning labels linking antidepressants to heightened suicidal thoughts and actions among children. The vast majority of American children who are prescribed antidepressants are taking drugs that have never been proved to ease depression among youngsters.
Pharmaceutical companies are prohibited by law from promoting such off-label use of the drugs. Doctors, however, have faced few similar restrictions.
Dr. Norm Fost, a member of the Food and Drug Administration's Pediatric Ethics Subcommittee, said many doctors are learning about off-label prescriptions during continuing medical education activities. He had no data, though, to support his hunch.
"In 23 studies, none of them has been shown to have any efficacy in children, other than Prozac. And there's all this increasing noise level about toxicity," Fost said. "Why would physicians make millions of prescriptions a year? Where would they get that idea?
"Usually, where they get it is from one of three sources. One: pharmaceutical companies. Two: pharmaceutical companies. And three: pharmaceutical companies."
A Pharmaceutical Research and Manufacturers of America attorney dismissed the notion of "stealth marketing" by drug companies.
"All of the PhRMA member companies know that if they are, in fact, trying to influence the content of an individual speaker's presentation, they're risking FDA enforcement," said Marjorie Powell, PhRMA senior assistant general counsel. "All the companies have to work with FDA all the time."
One observer called the rule changes "enlightened and refreshing," but late.
"Wherever there is a competing financial interest, there is a potential conflict. And wherever there is a potential conflict, you ought to find somebody else to do the job," said Bernard J. Carroll, a semiretired psychiatrist who has lobbied for transparency. "Money corrupts and lots of money corrupts absolutely."