Psychiatr News April 4, 2008
Volume 43, Number 7, page 4
© 2008 American Psychiatric Association
How Much Influence Does Drug Industry Have on CME?
Jun Yan
Continuing medical education is often criticized for a pro-drug-industry
bias. This is part one of a two-part series on the controversies surrounding
industry influences on medical education.
The public trusts medical professionals to provide health care services
that are in the best interest of the patient and based on unbiased
professional judgment. Voices within and outside of medicine, however,
increasingly question how much influence pharmaceutical industry exerts on the
education of physicians.
In particular, the multibillion-dollar continuing medical education (CME)
industry has been criticized for being biased toward product promotion and
undermining balanced and complete education to practicing physicians.
Every year pharmaceutical companies spend a large amount of money on
educational grants for CME activities. The 23 largest pharmaceutical companies
(based on U.S. sales) funded educational grants with budgets ranging from less
than $2 million to $117 million in 2004, according to an April 2007 report by
the U.S. Senate Finance Committee. Committee members Sens. Max Baucus
(D-Mont.) and Charles Grassley (R-Iowa) launched an investigation in 2005 into
an alleged industry practice of funding for-profit medical-communication
companies that use CME activities to promote unapproved (or
"off-label") use of new and expensive medications.
The Senate report found that from 2003 to 2005, oncology, cardiovascular
disease, and "neurology/psychology" (that terminology is used in
the Senate report) were the top three therapeutic areas to which drug
companies allocated educational grants. In 2004, for example, 18 of the 23
largest manufacturers spent a total of $182 million on neurology/psychology.
Five companies did not report data.
CME activities for physicians throughout the country are organized by a
variety of groups ranging from nonprofit professional organizations (like APA)
and academic medical centers to for-profit publishing or medical education
companies. Providers are evaluated and accredited by the Accreditation Council
for Continuing Medical Education (ACCME), whose mission is to oversee CME
through "a voluntary self-regulated system for accrediting CME
providers."
In 2006, commercial support (a term used by ACCME to classify its funding
data) for CME activities accounted for $1.2 billion, while exhibits and
advertising accounted for $240 million of the $2.4 billion income of all
accredited CME providers, according to the organization's annual report.
For-profit medical education companies receive the most funding from the
category of commercial support, but are not the only recipients of industry
grants. Commercial support was a revenue source for all other types of
providers including government/military providers, nonprofit and professional
organizations, and medical school providers, the ACCME data showed (see
chart). Many nonprofit
membership organizations have a long tradition of acting as a
"firewall" between industry funding and product-specific
information so that unbiased CME is provided to their healthcare professional
members (see APA Enforces Strict Rules to Keep Bias out of CME for APA's
policies and procedures governing industry-funded educational programs).
While pharmaceutical companies are not directly involved in creating the
content and scope of educational materials, the possibility of conflict of
interest in industry-funded CME activities has been criticized by academic and
other advocates who believe that these educational programs, especially those
created by for-profit CME providers, are thinly veiled product promotion. The
Senate report stated its opinion that "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."
Sponsor Bias Criticized
Intensifying criticism from academia, the media, and regulators has been
directed at perceived bias in the large proportion of CME content that often
favors a newly marketed product or off-label use of a product manufactured by
the sponsor. The Senate report is primarily concerned about such influence on
drug expenditures for Medicare and Medicaid.
The Josiah Macy Jr. Foundation recently released a summary of a report on
the state of continuing education in health care professions; the report was
derived from a conference conducted by the organization in November 2007 with
36 experts, mostly academics, from medicine, nursing, and education. The
summary concluded that "bias, either by appearance or reality, has
become woven into the very fabric of continuing education," and that the
financial responsibility of pharmaceutical companies to their shareholders and
the moral responsibility of health professionals to their patients are
"fundamentally incompatible."
Daniel Carlat, M.D., an assistant clinical professor of psychiatry at Tufts
University School of Medicine and a vocal critic of industry-funded CME,
agreed. "Industry-funded medical education is not education, but
promotion masqueraded as education," he told Psychiatric
News.
Carlat co-chairs the Massachusetts Psychiatric Society's CME Committee. He
owns and sells an accredited CME newsletter on psychiatry that indicates it
receives no industry funding.
Medical Education Companies Disagree
Medical education companies, however, disagree with the criticism of
industry bias. In a public response to the Macy report, the North American
Association of Medical Education and Communication Companies (NAAMECC), a
trade organization of medical education and communication companies, and the
Coalition for Healthcare Communication, which represents marketing and
publishing associations, criticized the summary. The organizations said that
"the 36 attendees did not represent the full spectrum of [continuing
education] stakeholders, thus limiting the value of the recommendations and
introducing serious opportunity for bias." The CME groups' response also
said that the report "ignores ongoing and increased efforts to ensure
independence and decrease bias."
"With the current accreditation system in place, FDA's guidance on
industry support, and PhRMA's [Pharmaceutical Research and Manufacturers of
America] code of conduct in place, there is no opportunity for sponsors to
influence CME content," said Karen Overstreet, Ed.D., past president of
NAAMECC in an interview with Psychiatric News. "According to
the updated ACCME accrediting standards, [industry] sponsors can no longer
recommend faculty or review content of CME activities, which can be effective
in eliminating the influence from commercial sponsors."
The ACCME revised its accreditation standards several times in recent years
to prevent bias, including requiring needs assessments to justify CME
activities. Current ACCME rules prohibit drug or device companies to become an
accredited CME provider or partner with an accredited provider to create
educational materials. "The content or format of CME must promote
improvements or quality in health care and not a specific proprietary business
interest of a commercial interest," one of the standards mandates.
"Of course, ultimately the CME providers are responsible for managing
the conflicts of interest," Overstreet added. ACCME reviews all
providers' compliance regularly in the re-accreditation process.
In January, NAAMECC announced plans to fund a project to audit accredited
CME activities randomly to quantify the presence of bias and invited other CME
organizations to collaborate in the project.
Who Guards Against Influence?
The Senate report acknowledged the increased effort by the pharmaceutical
and CME businesses in recent years to separate marketing from education and
minimize pharmaceutical industry influence. Some pharmaceutical companies have
adopted the PhRMA code of conduct for marketing, the FDA's guidance on
industry-supported educational activities, Health and Human Services Office of
Inspector General (HHS) compliance program guidance, and ACCME's accreditation
standards for the way in which they distribute educational grants and in their
involvement in CME activities. Many pharmaceutical companies and medical
education and communication companies have set up "firewalls" to
separate personnel involved in marketing and educational grants. Nevertheless,
the committee was unsure about the extent to which these guidelines are
enforced.
The report noted that because the educational activities are funded but not
directly provided by manufacturers, whether CME containing off-label
information can be considered promotional activity and whether the FDA has the
authority to regulate such content is legally murky. The FDA's Division of
Drug Marketing, Advertising, and Communications (DDMAC) is responsible for
reviewing complaints about off-label promotion and refers violations to the
Department of Justice and the HHS Office of Inspector General for enforcement.
The Senate report concluded, "Beyond [its] 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."
The ACCME enforces its standards, including the prevention of bias, through
accreditation and routine reviews. CME providers that do not comply with the
policies may be put on probation or lose their accreditation. The PhRMA code
and HHS compliance guidance are voluntary guidelines.
One of the recommendations in the Macy report summary called for complete
elimination of commercial support of CME activities from pharmaceutical or
medical-device companies. The NAAMECC opposed this recommendation in its
public response: "The summary recommendations would limit free speech by
both providers and supporters" and "eliminate competition, thereby
limit[ing] innovation." overstreet stressed that industry funding is an
important source for a large proportion of CME activities.
Carlat supports the recommendation to prohibit industry funding for CME. He
acknowledged that some may consider his stance against industry-funded CME
self-serving. "I do make money from selling CME," he commented.
"Subscribers pay me to obtain unbiased clinical information. It gives me
an incentive to please the subscribers rather than my sponsor. For
industry-funded CME, however, the incentive is different."
The second part of this series will focus on the debate over industry
presence in the academic training of medical students and residents.
The Senate Finance Committee's report is posted at
<www.acme-assn.org/home/prb042507a.pdf>.
The Macy Foundation report summary is posted at
<www.acme-assn.org/home/advocacy_info/Macy_ContEd_1_7_08.pdf>.
The NAAMECC's response to the Macy summary is posted at
<www.naamecc.org/downloads/Macy%20Foundation%20Response.pdf>.
Related Article:
-
APA Enforces Strict Rules to Keep Bias out of CME
- Jun Yan
Psychiatr News 2008 43: 5.
[Full Text]
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