THE ENVIRONMENT

The year began with unprecedented anti-drug industry attacks from government officials, consumer groups, and managed care/insurance organizations as part of the larger healthcare financing reform campaign being waged in Washington. Criticism was directed at the pharmaceutical industry in general and at several industry "marketing" practices in particular. And, industry's voice in the media was subdued, at best, and barely heard outside of the Washington Beltway.

The Coalition vigorously responded to attacks on communications issues. Critics targeted sales force activities, gifts to physicians, direct-to-consumer (DTC) advertising, industry involvement in continuing medical education (CME), and several other information, educational, marketing, and research activities. While some criticism may be legitimate, most of these attacks were merely symptoms of the real issue of concern--drug pricing--particularly its impact on the elderly.

At times the noise level was deafening, with a continuing barrage of criticism amplified through newspaper and magazine reporting that frequently lacked balance or perspective, including stories in the New York Times, the Washington Post, the Wall Street Journal, Newsweek, and Forbes, to name a few.

The pharmaceutical industry reacted in an unprecedented way, with some manufacturers offering discount cards to bridge the price gap until some form of Medicare drug coverage is in place. This temporarily quieted, but did not silence, the industry's critics, who smelled blood in the public opinion waters.

The industry adopted a code of behavior regarding its relationships with healthcare professionals, aimed at eliminating certain widely criticized practices. It was in accord with the American Medical Association's recently reissued guidelines for its members. And, for the first time since the early 1990s, the industry fought to protect an important communications activity that is thought to be a Constitutional right--DTC advertising.

The Coalition had an unprecedented year of activity, and we were confident that we were on the right side of the issues and found numerous opportunities to act and be heard.

Probably the most significant event for the Coalition was the FDA's request for comment on its regulatory authority in the context of the First Amendment of the US Constitution. Reacting to a number of relatively recent federal court cases that were decided against the FDA, the agency wisely sought views on how it might regulate speech without infringing on the Constitutional rights of the regulated industry, healthcare professionals, and the public.

The Coalition responded with a comprehensive and thoughtful document that addressed the most critical issues of concern to those of us in the communications business. Initially, we planned to incorporate a scholarly opinion on First Amendment rights in the drug regulatory environment. Upon reflection on the limited resources and time available for the response, however, we decided to restrict our comments to three issues of most critical concern: 1) the dissemination of "off-label" information, 2) the DTC controversy, and 3) health information on the Internet. The Coalition comment can be found on the Coalition website, www.cohealthcom.com.

An analysis of industry criticism early in 2002 by one important member of the Coalition, the Association of Medical Publications (AMP), led the AMP to recommend the creation of an information campaign for professionals to be coordinated by the Coalition. As part of its recommendation, the AMP, through its members representing medical and professional journals, volunteered to provide public service advertising space to reach professional audiences.

To identify the health reform issues most important to those audiences, the Coalition conducted research through the Isis Research organization. Results confirmed that for professionals, just as for their patients, the overriding concern was the impact of drug pricing on out-of-pocket costs, which professionals reported their patients were discussing with them on a daily basis.

After much deliberation, the Coalition decided that an interactive campaign would be a very effective way to communicate two ideas to professionals: 1) industry's concerns about out-of-pocket costs for patients, and 2) the specific efforts being undertaken by industry to ensure that patients would not be denied drug therapy because of their inability to pay.

The idea was presented to PhRMA and, with their cooperation and support, an ad was developed by Dorland Global incorporating the PhRMA Patient Assistance booklet, a toll-free 800#, and website access. The campaign will begin in March 2003. In all, the initiative represents a $1.4 million dollar outreach, and research will be conducted to measure the campaign impact.

It should come as no surprise that the population at large does not understand why pharmaceutical marketing is an essential activity. While marketing and communications may be taken for granted by our industry, we need to explain to the public and those influencing policy just how important industry efforts to disseminate information about the uses and limitations of its products are to delivering high quality healthcare to the American public. The average person simply does not understand that a drug is a potential poison in the absence of appropriate information on its use, or that the dissemination of information would take years without "marketing." In an effort to explain the medical marketing process, Coalition members have written a booklet entitled "The Right to Know." It will be available in early 2003.

In a document that was many months in preparation, the Office of the Inspector General (OIG) of the Department of Health & Human Services issued a draft outlining several activities that could place a company in jeopardy of violating the Medicare and Medicaid anti-kickback laws. While the draft targeted specific marketing and sales activities, the Coalition believed that some CME activities also could be negatively affected.

Our comments on these issues were addressed in a response letter to the OIG and also are available on our website. We noted that, in general, the OIG document failed to recognize the role of numerous academic and professional self-regulatory bodies that monitor the CME process. The Coalition's position is that CME is a scientific endeavor that should be overseen by the scientific community and not restricted in any way by government.

In addition to closely monitoring actions by the government that may impinge on the use of the Internet to communicate industry-related information, the Coalition wants to ensure that our views on topics essential to achieving our mission are conveyed via the Internet. Accordingly, we have invested a great deal of time and effort in improving our website as a primary information source for reporters and others interested in healthcare policy topics. The complete redesign of the website, provided by the CommonHealth agency, is well under way.

The Coalition teamed up with a group of interested parties in Washington this year to oppose additional restrictions on DTC advertising beyond the current Federal Trade Commission and FDA regulations. With influential Congressmen and their staffs announcing plans and actively seeking to limit DTC advertising, vigorous action was needed to prevent misguided and, probably, unconstitutional legislation from going forward. The Coalition has played a critically important role providing data and information to lobbyists and industry representatives to demonstrate the value of DTC advertising to the public health. We know from feedback that we have received that our efforts in 2002 were effective, but the real test will come in 2003 when the new Congress will focus on a Medicare prescription drug benefit, just as the electioneering begins for the 2004 Presidential campaign.

Over a year ago, the Coalition developed a new strategic plan to enable us to more effectively achieve our goals. Our first priority was to review our mission, updating key communication issues of concern to our members and revising our mission statement. Coalition volunteers drafted a new Coalition brochure outlining our conclusions. It was designed by the Healthview agency and printed courtesy of Prevention Magazine.

One of the Coalition's key objectives is to establish a resource center to house research reports and information related to healthcare communications and regulatory policies, a forum to discuss critical issues, and a permanent office and Coalition staff. Two academic institutions have proposed plans for such a project; however, it has languished for lack of funding.

Opportunities for the Coalition to partner with other organizations for the achievement of mutual goals arose during 2002, and we will be exploring them in the year ahead. For example, the Healthcare Institute of New Jersey has proposed that we join them in a grassroots effort to educate various sectors of our own industry on the role that pharmaceuticals and pharmaceutical marketing plays in the overall US healthcare system. A meeting has been held to discuss how we might proceed.

Each year we hope that the threats to our freedom to communicate will abate so that we simply can focus on how to communicate better. Unfortunately, these threats seem to increase. In the fall of 2002, prompted by requests from a group of five congressional representatives, the Government Accounting Office (GAO) published a report focusing on DTC advertising issues and research and marketing expenditures. Despite the fact that the GAO report stated in the first paragraph of its summary that industry research expenditures dramatically exceeded those of marketing and promotion--contrary to the loud and long espoused views of critics--press reports on the study did not take particular notice of this finding. The current anti-industry bias of the news media has never been more apparent.

Nevertheless, we plan to reach out to the media in the year ahead to provide a better understanding of the industry. We also will reach out to other organizations that we believe can help us in our efforts to provide balance and bring perspective to the dialog. We would be remiss if we failed to acknowledge the assistance of the Edelman public relations firm in assisting us in our dealings with the news media.

The Coalition has made enormous progress since our beginnings, but the future holds tremendous challenges for industry and communicators. Our most significant contribution to date has been raising awareness of First Amendment rights in the context of governmental regulatory actions. But there are many more issues to be addressed, and a volunteer organization requires a lot of people willing to sacrifice their time and support for the good of us all. We look forward to your support in the coming year. Please contact me personally if you would like to help.

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