Your medical conference has secured a major sponsor to underwrite the cost of an important networking event. They've paid $65,000 to your association and their logo has been printed on banners, giveaways, and water bottles for the evening event. You've widely advertised the event and expect most attendees to be there. But seven days before the meeting, an executive officer in the sponsoring company learns about the sponsorship agreement made by one of his subordinates and abruptly pulls his company support, citing ethics violations.

Far-fetched? Not according to William Fitzgerald, Esq., vice president of global compliance for Alcon Laboratories Inc., who participated in a panel discussion of medical ethics codes at PCMA's Annual Meeting in January. "I'm aware of instances where this has happened," Fitzgerald said. "They may say, 'We've wasted $65,000 on that meeting but we won't let it go on.' And then it's egg on everybody's face."

For medical meeting planners, the economic and professional risks associated with such an incident - or other code violations - are a real threat. That's why the Annual Meeting session, "Demystifying the PhRMA Codes," drew a standing-room-only crowd. As medical meeting professionals and their exhibitors and sponsors grapple with ethics codes that seem to be in constant flux, there's a widespread desire for understanding and clarification.

"I think anyone who has planned a medical meeting [has struggled to comply with the codes]," said Lauren Kramer-Whelan, CMP, principal of Meeting Priorities, LLC, and organizer of the panel. "The top-of-mind examples are: How does a non-profit organization, in particular, cover costs for meetings without the support and sponsorship revenues that have been generated in the past? And how do I ensure that my sponsorship ideas or offers do indeed comply with the codes?"

While medical meeting planners have been asking these questions for several years, there are still no standard answers. And various planners and their exhibitors answer these questions in different ways. "The codes are not new, but the way exhibiting companies are responding to them may be," said Wanda Johnson, CMP, senior director of meetings and education at the Endocrine Society. "Not all companies have adopted the codes and even for those who have, there are interpretations that may change the way people respond to them. Some companies follow the letter of the law; some identify the spirit of the law and view compliance differently. And planners get to respond to it all."

The Elusive Codes
One reason the "codes" cause so much confusion is because there are multiple codes of ethics to be considered, and various ones govern behavior over various types of exhibiting companies and in various locales. The most well-known is the PhRMA code, or the ethics code of the Pharmaceutical Research and Manufacturers of America (PhRMA), an organization that represents research-based pharmaceutical and biotechnology companies. The preamble of the PhRMA Code on Interactions with Healthcare Professionals describes its purpose like this:

"Ethical relationships with healthcare professionals are critical to our mission of helping patients by developing and marketing new medicines. An important part of achieving this mission is ensuring that healthcare professionals have the latest, most accurate information available regarding prescription medicines, which play an ever-increasing role in patient healthcare. … In interacting with the medical community, we are committed to following the highest ethical standards as well as all legal requirements. We are also concerned that our interactions with healthcare professionals not be perceived as inappropriate by patients or the public at large. This Code is to reinforce our intention that our interactions with healthcare professionals are to benefit patients and to enhance the practice of medicine. The Code is based on the principle that a healthcare professional's care of patients should be based, and should be perceived as being based, solely on each patient's medical needs and the healthcare professional's medical knowledge and experience."

While it's difficult to argue with the intentions of the code, there are plenty of disagreements about how to interpret some of its statutes. For instance, it's okay to offer meals in conjunction with an informational presentation or discussion as long as the meals are "modest" - and one sponsoring company may define "modest" in a completely different way than another.

But in addition to the inconclusiveness of the PhRMA Code, there are other codes to abide by as well. In the United States, the Advanced Medical Technology Association (AdvaMed) is responsible for the codes of ethics for medical device and equipment manufacturers. And for events held in Canada or involving Canadian health care professionals, the Rx&D and MedEc codes, which are the Canadian equivalents of the PhRMA and AdvaMed codes, must also be considered. For meetings held internationally, meeting planners must consult the medical ethics codes in the country of destination. And a number of states have begun developing their own unique codes of ethics, obscuring the situation even further.

For instance, the Minnesota pharmacy board limits companies to gifts of no more than $50 in value per year to each physician - and according to Fitzgerald, this limit applies even to Minnesota physicians who may be attending a conference in Canada. Because every state or country may have its own distinct codes, keeping up is certainly a challenge. "It's a moving target as far as the rules go," Fitzgerald said.

Working Through the Confusion
Although following the ethics codes is, in most cases, voluntary, a medical meeting's success will be affected by whether or not its exhibitors adhere to the codes, Johnson said.

"Many of the companies exhibiting at medical meetings are members of the organizations that established the codes, and the codes are strictly enforced by the company's office of compliance," Kramer-Whelan said. "It is critical, therefore, that medical meeting managers are conversant with at least the basics of the codes in the country or state where their meetings are happening. And while there are subtle nuances between the codes, none are impossible to understand or implement.

"Meeting professionals should apply and help enforce adherence to the codes at their meetings and events," Kramer-Whelan continued. "Further, meeting professionals should seek to help educate and inform attendees, exhibitors, and sponsors alike about the do's and don'ts of the language through the use of pre-show staff training, checklists in their printed materials, on the show Web site, and through on-site seminars before the show begins for exhibitors."

In the panel discussion, speakers recommended partnering with exhibiting or sponsoring companies and working together to ensure compliance. Although the exhibiting companies hold ultimate responsibility for their compliance, meeting professionals can save their organizations embarrassment and protect their reputations by helping companies comply. "As a planner, it's your job to ask questions up front about what your organization expects and what your organizational standards are," Fitzgerald said. "Also, if you're asking for corporate support, ask what their standards are … each company interprets [the codes] in somewhat different fashion, depending on the level of risk associated with their industry sector. So at the start, you need to ask what their standards are."

Another panelist, Christopher White, executive vice president, general counsel and secretary of AdvaMed, recommended that planners talk to compliance officers or higher-ranking officials in exhibiting companies rather than relying on the person who purchases a sponsorship to understand the company's approach to the codes.

By the same token, in the planner's own organization, "make sure that those who are soliciting sponsorships understand [the codes] and include them in this discussion," Johnson said. "There are sponsorship programs we offered four years ago that we're not offering anymore because no one will buy them. Make sure your salespeople know what's going on so they're not promising something you can't deliver."

Looking to the Future
As meeting professionals continue to wrestle with understanding the intent and the jurisdiction of the various codes of ethics, many want to know "if this is going to ease up in a few years," Fitzgerald said. "But the answer is no. Every year it's getting tighter and tighter. Everyone wants to know how industry is interacting with those people who recommend, purchase, or prescribe products. And I think rightly so. I pay taxes just like everyone else, so we want to make sure those interactions are correct."

Fitzgerald believes that within the next five years, the industry will see more legislation requiring companies to comply with the ethics codes, and more judicial settlements that rely on the codes as precedents. Another panelist, Michael Glenn, M.D., medical director and physician-in-chief at the Virginia Mason Medical Center in Seattle, agreed that guidelines will become even stricter in the coming years. "There's going to be more transparency, more disclosure, and less subsidy," he said. "I think you can look at the most strict area right now and kind of plan off of that. "There will be a push for more transparency as far as where the money's being spent; I think you can count on that with certainty."

Although the guidelines are expected to become even more stringent, there is "a ray of hope," White said. "I would hope that within the next five years you'll see a greater harmony among the different codes of ethics. However, the codes as they stand now represent the minimum. This is the lowest threshold and I expect that there will be greater rigor added to these codes within five years as well."

Finding Value in the Codes Like other challenges the meetings industry has faced, such as dealing with procurement departments, navigating the medical ethics codes could be looked on with disdain or "an adversarial approach," said Patrick Delaney, managing director of the Ovation Group, who moderated the panel session. However, Delaney challenged meeting professionals to not only meet the requirements, but to find value in meeting them. If this is the way it is, Delaney asked, how can we best use this situation to improve our meetings?

While many professionals have yet to find value in adhering to the codes, others say the codes do have merit. For one thing, "government is paying for a lot of what goes on in the health care field and as a taxpayer, I want to be careful that the money is spent well," Fitzgerald said. "Underwriting the paragliding adventures for visiting nurses is not a good use of that government money, but underwriting an educational session is."

"Medical meetings are typically one of the primary revenue-generating mechanisms for organizations hosting them, particularly non-profit associations and foundations," Kramer-Whelan said. "The codes of ethics are not intended to penalize associations, sponsors, or exhibitors, but rather to focus the organization on the business at hand: to educate medical professionals in a straightforward, responsible, and ethical way. There is great value placed on the educational aspect of every medical meeting I've been involved with, and along with networking with peers, education is the top reason medical professionals continue to attend face-to-face meetings. However, some meetings also have a comparable focus on the social aspect of an annual event; many attendees only see each other on this one occasion, and they want to socialize with their friends. It is of primary importance to keep the social focus modest and appropriate, as defined by all of the codes, rather than extravagant and laden with giveaways that ultimately do not focus on improving the practice of medicine or patient care.

"The primary value of the codes is the focus on the medical profession and patient care rather than giveaways that will ultimately not benefit anyone," Kramer-Whelan continued. "A secondary value of the codes is that everyone has an opportunity to reexamine their meetings to ensure the focus really is on education for medical professionals. This is a daunting task for some, and introspection is sometimes not welcome. Taking a healthy look at the composition and content of a meeting should be a strategic focus for every organization."

Taking Disclosure to Heart

Here is how the American College of Cardiology (ACC, www.acc.org) handles disclosure issues for its meetings and events:

• Request for disclosure information is sent to all presenters in February for the late March/early April meeting.
• Presenters enter their information into an online system according to ACC established policies, topic form/disclosure categories, and sponsorship level.
• Disclosure information is reported out and reviewed by appropriate program authorities and action is taken, if necessary, according to ACCME guidelines.
• Data is extracted from the system and published in the Author/Presenter Disclosure Digest, which is distributed on site via attendee portfolio bags.
• A slide template for presenter's use regarding how to format slides with disclosure information is sent with the request for disclosure e-mail and is on the AV speaker presentation management system, prompting speakers to be sure to include this info in their first slide.
• ACC also publishes a presenters' bulletin noting information for various types of sessions and participants roles; disclosure slide expectations and procedures are included in this publication.
• On site, session co-chairs are given a "moderator's form" and each speaker in their session is listed. The moderator's role is to check the appropriate box for each speaker to indicate whether the speaker disclosed to the audience. Any noncompliant speakers may be dealt with by the proper authorities after the meeting.
• ACC prints in the final program and projects via slide in every session room a "Learners' Bill of Rights" statement whereby the audience is informed that they have the right to receive disclosure information from a speaker (as well as other educational/learning "rights") and if that "right" is violated, an audience member may feel free to bring it to the ACC's attention.

The ACC's Disclosure Policies
The ACC has strong policies in place, and we are constantly evaluating these policies in order to further minimize any appearance of industry influence. We are already in the process of complying with the new accreditation standards of ACCME, strengthening our firewalls related to grant funding for CME, and seeking additional staff to support our accreditation efforts.

Generating and disseminating unbiased and objective scientific information is the cornerstone of the educational agenda of the American College of Cardiology. Industry support must be absolutely unconditional with regard to objectivity. Therefore, the American College of Cardiology is solely responsible for the development, faculty selection, review, editorial control, and content of all programs, products, and services.

The ACC currently conforms to the statements issued on industry relationships by the American Medical Association, the Pharmaceutical Manufacturers Association, and the Accreditation Council for Continuing Medical Education. The ACC accepts, upholds, and endorses these related guidelines with respect to physician and CME sponsor relationships with industry.

All professional societies need to be meticulous in regard to their relationships with industry and have appropriate policies in place so that the educational standards are never compromised by industry relationships and so that they never have the appearance of being influenced by industry.

For example, the ACC never has a meeting without panelists' and presenters' conflicts being disclosed beforehand as well as having any conflicts of interest managed appropriately. We have an ethics committee that surveys and there is sometimes a need to sanction a member who violates our policy.

Concern regarding industry relationships with medical societies, including specialty societies, has grown. Societies should comply with investigations of course, but we should all have policies already in place so that our ethical and educational standards are never compromised by industry relationships. Societies might consider having a member ethics committee review their current policies and procedures. These inquiries tend to be based on perception rather than reality, but it is our job to make sure we do not even appear to be conflicted with industry.

The ACC and the scientific community would prefer having unbiased trial sponsors than industry sponsors; however, public funding for clinical trials is lacking. Therefore, in order to continue our research and improve patient care, we must depend on industry-funded trials. Currently, we do our best to present the trial data in a scientific meeting or published in a medical journal to ensure a balanced review.

Current ACC policies are available on ACC's Web site:

 www.acc.org/education/disclosure/pdfs/ACCFs_COI_
Resolution%20Mechanisms032435.pdf
www.acc.org/qualityandscience/clinical/ position/72532_pf.htm

Contributing Editor Nancy Mann Jackson is a freelance writer in Birmingham, Ala.