What started out as a rather uneventful year ended with a crescendo of activity unlikely to be resolved until well into 2004. We accomplished some great things and our docket continues to grow as we become a central point of contact when communication issues arise. Let’s take a walk through the year…

The Office of Inspector General Initiative (OIG)

The year 2003 was one in which it seemed everyone wanted a piece of the industry. Of particular note were the OIG guidelines, designed to provide companies with compliance parameters to avoid anti-kickback and false claims violations. While this would normally not be a concern of the Coalition, there were provisions that could have impacted CME content, so we became involved. We questioned those provisions along with some other cloudy directives in communications with OIG. We felt there was no place for government in the regulation of scientific exchange.

PHARMA Support Initiative

In what was one of our most ambitious undertakings to date, our all-volunteer army produced a multimillion-dollar ad campaign to educate physicians on the industry’s Patient Assistance programs, in which the needy can obtain the drugs they need free of charge. Some of the people and organizations that selflessly donated their time and expertise includes, Charley Hunt, who oversaw the project; the AMP medical journals, who donated ad space; Dora Shankman and her team from Pharmacia, who prepared the schedules and initiated the campaign; Tracey Sears of Conectics, who supervised the implementation of the campaign throughout the year; and Perq/HCI, who monitored the ad expenditure data. Research is currently being conducted to measure impact.

ACCME’s Standards for Commercial Support

In March, the ACCME distributed a draft revision of the Standards for Commercial Support to various industry organizations for comment. The Coalition, along with many others, submitted items they thought to be essential if CME was to flourish. Our overriding theme was that “we shouldn’t try to fix something that wasn’t broke.” It appeared that we were not alone; there was broad opposition to several of the draft provisions, especially in the two matters that concerned us most: the new provisions on conflict of interest and advertising in journals containing CME.

In terms of conflict of interest, a strict interpretation meant that anyone currently engaged with a FDA-regulated company would be barred from participating in related CME. In addition, the proposal further restricted the placement of all advertising in journals containing CME—even beyond the provisions introduced a few years back.

When word filtered back that only cosmetic changes were made in the second draft, the Coalition acted. It was clear that the full impact of these changes was not understood by many of those making decisions. Worse, those most directly impacted by these changes, the CME planners and faculty, were most likely not a part of the vetting process. We felt they should be appraised of the issues so that their voices could be heard. We prepared a position statement urging our membership to contact CME planners and faculty to make them aware of the issues. The internet campaign is underway as this goes to press.

FDA Review of Direct-to-Consumer Advertising Impact

In September, the FDA invited all parties to comment on Direct-to-Consumer advertising’s impact on the public health. Our role was to get as many pro-DTC experts as possible to testify in order to insure a balanced debate. The testimony provided little evidence that there was anything but public good emanating from DTC advertising.

A major communications issue involved was the pressure to include more risk information in the DTC ads. We retained Professor Lew Pringle, a market research expert with years of experience in advertising, to survey the available research on “information overload”. The research clearly indicated that communications efficiency drops dramatically as the amount of information in an ad increases. This was submitted to the FDA docket.

The Bextra Case–First Amendment

In one of the most blatant assaults on the First Amendment in recent years, a California Coalition sued Pharmacia/Pfizer for an article that ran in the Journal of the American Dental Association, claiming it was actually false and misleading advertising. The Coalition arranged for the Association of Medical Publications to file a “friend of the court” brief supporting the First Amendment rights of publishers. Based on the preliminary court data, the judge dismissed the case.

Public Affairs

The Coalition’s role in the betterment of healthcare communications was advanced with the publication of The Right to Know by John Kallir and Peter Frishauf, a booklet on the importance of marketing pharmaceuticals.

We also have a new look: CommonHealth’s Conectics group completely revamped the Coalition website to provide increased maneuverability and search capabilities. The website has enabled us to increase our reach and efficiency enormously.

Strategic Planning

In an effort to more clearly define the Coalition’s future path, Ron Pantello arranged to have the Healthview planning experts study our mission and, given the dramatically increasing demands on our resources, propose ways we can move forward. We are about halfway through the process now.

All in all, it was an extremely productive year and, as we look forward to 2004, we are confident that we are making a difference. We are grateful for all the support we receive from those of you who make it all possible.

Jack E. Angel
Executive Director
Email: jeangel@cohealthcom.org