CME providers gear up to comply with PhRMA code
Eager to follow new guidelines separating drug promotions from
continuing medical education, CME presenters' questions outpace answers at
a meeting of drug industry and education leaders.
By
Myrle Croasdale, AMNews staff. Oct. 7, 2002.
Additional information
Baltimore -- More money or less for continuing medical education?
That's the question CME providers are asking these days as the
pharmaceutical industry refocuses on keeping continuing medical education
free from marketing campaigns.
CME providers hope the answer will be more money for education as drug
companies cut back spending on physician gifts.
Funding for CME and how new guidelines by the Pharmaceutical Research
and Manufacturers of America will impact physician education were hot
topics at the annual meeting of the AMA's National Task Force on CME here
in mid-September.
While PhRMA's voluntary code isn't that different from existing
guidelines put forth by physician organizations, it does have CME
providers re-examining their responsibilities.
"It's an exciting time" with the potential for producing high-quality
CME, said Elizabeth Paczolt, MD, chair of the Medical Society of New
Jersey's committee on medical education.
PhRMA represents about 80 drug and biotechnology companies. Members
have agreed to end the purchase of expensive gifts and meals for doctors
as a promotional tool and to keep continuing medical education programs
free of advertising.
PhRMA represents about 80 drug and biotechnology companies.
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Existing guidelines by the Accreditation Council for Continuing Medical
Education have attempted to make clear the nature of pharmaceutical
contributions to CME. But ties between drug companies and CME events are
sometimes violated.
According to Murray Kopelow, MD, ACCME executive director, the most
common violation of its guidelines is proper disclosure. Thirty percent of
ACCME-accredited providers fail to disclose all pertinent relationships
between the event, speaker and pharmaceutical sponsors.
"Disclosure requires the speaker or group to reveal relevant
relationships," he said, such as all links between a speaker and a product
or company. "These guidelines are a tool to help manage boundaries, and we
need well-defined boundaries that are difficult to change, along with due
process, to make sure violations are dealt with."
Meeting participants commented that speakers at CME events often omit
such information from their disclosures, leaving providers in the awkward
position of knowing more than the CME audience about the speaker's
connections.
Task force members suggested those conducting CME activities ask any
sponsoring commercial companies for their information on the speaker and
let the speaker know the information is on hand, implying that this may
motivate the speaker to be forthright with the CME audience.
Pharmaceutical rep turnover an issue
CME providers at the conference also commented that the high turnover
rate of sales representatives means they often work with drug reps who
aren't familiar with CME guidelines and pressure the provider to acquiesce
to marketing requests that run counter to keeping medical education free
of promotional material.
Training sales reps on exactly what constitutes CME isn't taking place,
they said. Physicians, too, could use training on the separation of CME
and promotional activities.
30% of accredited CMD providers fail to disclose promotional
relationships.
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Drug reps got taken to task again in an update from Tom Abrams,
director of the Food and Drug Administration's Division of Drug Marketing,
Advertising, and Communications, who spoke at the meeting. Abrams listed
several incidents in which his division issued warning letters in response
to pharmaceutical sales staff giving out wrong information at commercial
exhibit halls.
In one case, reps promoted unapproved uses of their product. In
another, salespeople discounted a drug's serious side effects by saying it
was safe instead of making clear that precautions were needed.
Despite all this self-regulation and discussion of what is appropriate
conduct for CME, the medical community isn't united in its view on what is
appropriate behavior.
In mid-September, the American Academy of Pediatrics drew criticism for
publishing books promoting breastfeeding with the logo of a formula maker
on the cover. Critics said the logo's appearance made it look like the
formula maker provided the content of the book. The authors of the
publication were not consulted regarding the logo and publicly decried the
action and what they saw as its implicit promotion of baby formula.
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ADDITIONAL INFORMATION:
Ethics in check
The Pharmaceutical Research and Manufacturers of America weighs in on
the issue of continuing medical education:
- CME events are about education, not marketing products, and time
spent at the event should reflect this commitment.
- Commercial financial support of CME is permissible, but subsidies
must go directly to the conference sponsor. The conference organizer has
to be the one controlling where the money goes and is responsible for
paying the speaker or using funds to lower registration fees.
- Funds should not be offered to compensate health care professionals
for attending meetings.
- Legitimate consultants providing services may be paid. Simply
calling someone a consultant to pay the individual's expenses is not
appropriate.
- Scholarships for medical students, residents and fellows may be
offered if the training institution is the one selecting the recipients.
Source: "PhRMA Code on Interactions with Healthcare Professionals"
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Weblink
Report, "PhRMA Code on Interactions with Healthcare Professionals," in
pdf (http://www.phrma.org/publications/policy//2002-04-19.391.pdf)
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Copyright 2002 American Medical Association. All
rights reserved.