The report was based on responses to questions made by 23 major US pharmaceutical manufacturers, and by the Accreditation Council for Continuing Medical Education (ACCME). Given the lack of coverage of this report so far, I will summarize the major points, using quotes from the report itself.
Pharmaceutical Involvement in CME
Pharmaceutical manufacturers fund educational programs that physicians and other health care workers attend, including programs used to fulfill their licensure requirements. These educational grants have become a well-established tool that all of the major pharmaceutical manufacturers use to disseminate information to the medical community. Drug companies routinely fund educational grants to support programs that favorably discuss the companies’ newer and more lucrative products, thereby encouraging physicians to prescribe those products and, ultimately, driving sales.
All of the 23 pharmaceutical companies surveyed funded educational grants. Most of the companies spent tens of millions of dollars annually to fund thousands of educational grants and educational programs. Educational grant budgets reported by individual companies for 2004 ranged from less than $2 million to $117 million. In 2004, total expenditures by commercial sponsors to support CME exceeded $1 billion.
Pharmaceutical Funded CME is Self- Not Government Regulated
ACCME is the primary accrediting body for CME for physicians. Many of the manufacturers’ responses indicated that the manufacturers rely on grant recipients’ accreditation by ACCME and the recipients’ promise to comply with ACCME’s Standards for Commercial Support as safeguards that the educational grants will be used for legitimate purposes. A primary principle of ACCME’s standards is that CME programs must be independent and the commercial sponsor must not control program content.
The FDC Act imposes limits on how manufacturers may advertise their products and forbids them from marketing or promoting their drugs for uses that have not been approved by the FDA. However, these marketing restrictions and the prohibition on off-label promotion apply only to entities involved in the manufacture or sale of the drugs. The FDA lacks jurisdiction over favorable discussions of a product, including a product’s off-label uses, by individuals or in settings independent from the manufacturer. Thus, the FDA does not claim jurisdiction over academic discussions or exchanges of scientific thought regarding off-label uses, except where attributable to the manufacturer.
In 1997, the FDA released guidelines for companies involved in industry-supported educational activities. The guidelines expressed the FDA’s intention not to regulate CME as long as it is independent from the companies whose products are discussed. The FDA advised that educational providers should maintain control over the content of their programs, disclose company funding of programs and connections to speakers, and discuss all relevant treatments for a condition, rather than focusing entirely on the newest medication or on one particular company’s product(s). Beyond this guidance, the FDA does little to ensure that educational grants are used for bona fide educational purposes. Nor does the FDA have a system in place to monitor educational programs.
CME Is Often Not Independent of Pharmaceutical Sponsors
ACCME reported that it reviewed 76 accredited CME providers for compliance with the ACCME Standards. Eighteen [24%] of these CME providers were found to be in non-compliance with at least one element of the ACCME standards. Examples from ACCME’s written findings of non-compliance include:
• 'The provider does not ensure that decisions regarding the planning and implementation of CME activities are made independent of commercial interests. A commercial interest influenced where and how many presentations were scheduled for three years of a CME activity.'
• 'The provider does not ensure that decisions regarding the planning and implementation of CME activities are made independent of commercial interests. Evidence from one activity reviewed indicates that a commercial interest was involved in the selection of faculty and other activities that interfered with
• 'The provider does not ensure that a mechanism(s) has been implemented to identify and resolve all conflicts of interest prior to education activities being delivered to the learner.'
• 'The provider does not demonstrate appropriate management of commercial support. . . . Written agreements for commercial support were signed after the CME activity. However, the ACCME Standards for Commercial Support require written
agreements to include the terms and conditions to which both provider and supporter agree to abide. Therefore, it is the expectation of ACCME that agreements are signed prior to the activity taking place.'
• 'The provider does not demonstrate appropriate management of commercial promotion associated with educational activities. One commercially supported activity contains recurring use of one company’s product trade name at the exclusion of other products.'
• 'The provider does not demonstrate that the content and format of educational activities is without commercial bias. One activity reviewed promotes the proprietary business interests of a commercial interest.'
Company Procedures Have Improved, But Maybe Not Enough
The pharmaceutical industry is paying increased attention to educational grants and its compliance with fraud and abuse laws. The Committee staff’s review suggests that, in recent years, the major drug companies have limited the direct involvement of field sales representatives and sales and marketing departments in the educational grant-making process. Until a few years ago, it was common industry practice for the drug companies’ marketing departments to be responsible for awarding educational grants and for grant funding to come directly from the marketing budget, often from the specific product budget for a particular sales team. While many companies still allow marketing personnel to offer input, the
grant-making authority has largely been removed from the marketing department and placed with medical affairs departments, medical education departments, or general business units.
The responses to the Committee’s inquiry showed that the companies have undertaken some efforts to train employees in complying with corporate policies.
While the fact that corporate headquarters now espouse a commitment to compliance is certainly promising, it does not guarantee that all the company’s agents, operating in a highly competitive marketplace and an industry in which employees’ compensation is often tied to sales volumes, will put those policies into practice.
Continuing medical education has developed into a multi-billion dollar a year industry, much of which is funded by pharmaceutical manufacturers. It seems unlikely that this sophisticated industry would spend such large sums on an enterprise but for the expectation that the expenditures will be recouped by increased sales.
Corporate policies still allow this industry to walk a fine line between violating rules prohibiting off-label promotion and awarding grant money in a manner likely to increase sales of their products, including sales for off-label uses. The opportunity for abuse remains, particularly in the following four areas: (1) kickbacks; (2) veiled advertising; (3) bias in clinical protocols; and (4) off-label promotion.
It is difficult to quantify the risk of kickbacks related to industry-sponsored education where companies overpay high-prescribing physicians as ‘‘consultants’’ or ‘‘speakers’’ for minimal work to develop educational material or teach at educational programs.
Educational grants are often used to sponsor programs to teach physicians about treatment options for particular diseases. The information presented often encourages physicians to change their prescribing practices to favor certain drugs. When the favorable message is delivered in the context of education—even if corporate sponsorship is disclosed—there is an imprimatur of credibility and independence.
As with educational grants, commercial funding of clinical protocol development raises concerns about the introduction of commercial bias—favoring products marketed by the companies that helped fund the program.
The off-label promotion risk of educational grants appears to pose the greatest threat to the Federal health care programs and beneficiaries, but it is also the most difficult to demonstrate conclusively.
The report suggests that the current voluntary system of regulation has not been sufficient to guarantee that continuing medical education activities are strictly educational, and are not allowed to become instruments of stealth marketing. On Health Care Renewal, we have discussed several instances in which CME activities were turned into marketing. (For example, see this post on the stealth marketing of Neurontin.) The (almost) new Senate Finance Committee report is a reminder that physicians need to be very skeptical about the independence of commercially financed CME, even when the sponsorship is by a supposedly "unrestricted" educational grant.
Finally, the fact that this post on Health Care Renewal seems to be the longest discussion of this report available publicly to date, more than a month after its release, suggests that the anechoic effect continues. Or, as Aubrey Blumsohn recently suggested, criticism of the effects of vested interests in health care is just not done because it is considered incivility.
Hat tip to the Center for Science in the Public Interest's Integrity in Science Watch newsletter.