Healthy Skepticism Library item: 1998

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: media release

Croasdale M.
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.
AMNews 2002 Oct 7

Full text:

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.

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.

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.