Healthy Skepticism Library item: 1006
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Hensley S.
Doctor Continuing-Ed Overseer To Tackle Drug Firm Influence
Staff Reporter of The Wall Street Journal 2003 Jan 14
http://online.wsj.com/article/SB104249837652326024.html?mod=googlewsj
Full text:
The nonprofit overseer of continuing medical-education courses for doctors is expected to propose stiffer rules Tuesday to combat drug-industry influence on the programs.
The requirements, which could take effect this fall, would close several backdoors that have allegedly allowed drug makers to affect the content of courses they fund. The rules are “another step toward the prevention of commercial bias by keeping a separation between commercial interests and the content of continuing medical education,” says Murray Kopelow, chief executive of the Accreditation Council for Continuing Medical Education, Chicago, which regulates the CME system.
Current safeguards are supposed to keep industry funding from turning educational courses into marketing sessions, but repeated instances of overt or subtle bias in favor of sponsors and their products have raised questions about the effectiveness of the system. Industry provided $729 million, or more than 60% of the total funds, for continuing medical education courses in 2001, according to the accreditation council. That gives the drug industry too great a role in setting the agenda for physician medical education, some critics contend.
It is unclear if the proposed changes will be adequate to curb the industry’s rising influence, but they represent the most significant revision by the council to the regulation of commercial funding of continuing medical education since 1992, when the current system was put in place. About 36 states require doctors to take continuing-education courses as a condition for renewal of their licenses.
Under the rules, members of course-organizing committees that determine content and pick speakers would be required to disclose their potential conflicts of interest. This information could be grounds for disqualifying members from the tasks and would eliminate one way that some drug makers have allegedly influenced course material.
The rules would address conflicts of speakers, too, and for the first time would require them to disclose their relationships with drug companies in advance, not just at the podium before lecturing. Those who refuse would be disqualified automatically.
Course organizers would be empowered to disqualify speakers with a relationship that constitutes a conflict of interest. Doctors paid as members of drug-company speakers bureaus, for instance, would be prohibited from making clinical interpretations and recommendations under the rules, a change that could exclude many popular speakers on the education circuit.
The rules would also curtail some drug-company sales practices. Pharmaceuticals makers that sponsor courses would be prohibited from leaving the educational material behind during sales calls. The rule would end the common practice of company representatives dropping off CD-ROMs or passwords to Internet sites featuring continuing-education courses supported by the company.
A handful of drug companies and medical-device makers that have accredited educational subsidiaries would be forbidden from presenting courses in clinical areas for which they also sell products. This rule would close a loophole available to about a half-dozen companies that make products regulated by the Food and Drug Administration. Drug maker Eli Lilly & Co., Indianapolis, and surgical-equipment maker Valleylab, a division of Bermuda-based Tyco International Ltd., are among the companies that could be affected by the change.
Still in draft form, the changes will be circulated to more than 1,000 organizations that either put together courses or are concerned with their content. The draft is open for comment until March 15. Then a task force, which has worked on the rules for more than a year and a half, will consider revisions. The accreditation council’s board, which includes representatives of the American Hospital Association, the American Medical Association, and five other organizations, is expected to vote on the measure as early as July.
