“THE PHARMACEUTICAL industry has been embroiled in an entertainment arms race — and it has not served anyone well.” So declared L. Stephan Vincze, ethics and compliance officer, TAP Pharmaceutical Products Inc., Lake Forest, Ill., during his address at the Center for Business Intelligence's first forum on CME. (CBI holds numerous training programs for pharmaceutical executives.) Held November 21 to 22 at the Crowne Plaza Philadelphia Center City, the conference attracted approximately 80 pharma execs and CME professionals.

Discussing the implications of the new Pharmaceutical Research and Manufacturers of America's ethical guidelines, Vincze and the other presenters from drug firms, the American Medical Association, and academic CME offices, said it was time for the pharma industry to refocus on quality science and patient care, rather than on getting doctors' attention through gifts of flowers, candy, monogrammed golf balls, tickets to baseball games, and other entertainment excesses. While the PhRMA code is voluntary, speakers emphasized the importance of adherence to avoid more government regulation.

And although one pharma speaker found the other presenters “too idealistic,” it did appear that pharma companies are taking the code very seriously. Eli Lilly & Co. and TAP, for example, have both rolled out extensive compliance programs. “I'm living proof that there is a compliance officer at TAP,” joked Vincze. He was referring, of course, to the history-making healthcare fraud case, which resulted in TAP paying $875 million in fines to the government — the largest settlement ever paid in such a case. “This is our coming-out party,” he continued, “the first public presentation that I am making regarding what TAP is doing to implement the PhRMA code.” TAP has conducted face-to-face training sessions across the country for sales personnel, and is developing a CD-ROM with 10 interactive modules covering ethics, compliance, and the PhRMA code.

Vincze acknowledged that it would be a challenge for sales reps to deal with doctors who are outraged at the ethics clampdown. He has heard doctors say, “Why us? Why not politicians?” His advice for reps is to tell doctors: “We're into quality products and quality results, and we want to spend quality time with you, giving you quality information — not wasting your time with trinkets.”

Recognizing that it will be awkward for reps to forbid spouses from attending promotional events, such as dinner meetings, Vincze clarified that if the doctor's spouse is also a healthcare professional, he or she may attend. Another sticky area is whether the PhRMA code eliminates charity events, such as golf tournaments. Vincze explained that the code does not necessarily eliminate them, but that pharma companies should pay contributions directly to charities for the purpose of supporting legitimate charitable causes — not for providing entertainment for healthcare professionals. He added that pharma sales reps should not participate in these events.

Speakers also stressed that pharma firms must comply with federal anti-kickback laws, as outlined in the Office of the Inspector General's draft guidance for the pharmaceutical industry. U.S. attorneys' offices are less concerned about compliance with the PhRMA code and more concerned about compliance with anti-kickback and other laws, Vincze said.

In addition to following government regulations and the PhRMA code, pharmaceutical firms should understand and adhere to CME guidelines, such as the Accreditation Council for CME Essentials and Standards for Commercial Support, speakers said.
Tamar Hosansky

ACCME Releases New Standards

The Accreditation Council for CME in Chicago has issued a draft of its new Standards for Commercial Support, and there are major changes, particularly in the areas of disclosure and the definition of relationships between commercial interests, CME providers, and teachers.

The revised Standards state that the current disclosure rules, which stipulate that faculty and sponsors disclose their significant financial interests and other relationships with pharma firms, may not always be enough to ensure the separation of promotion from education. Under the new rules, if people or organizations disclose that they have a conflict of interest with a commercial interest (such as a drug firm), they should not be allowed to control the content of CME — in other words, they should be excluded from serving as a planning committee member, manager, or teacher. Conflict of interest is defined as a relationship “that may be perceived by the ACCME to create a sense of duty or loyalty” to the commercial interest, and as creating “a conflict between the interest of the individual and the interests of the public or learners.”

The new Standards “accommodate every one of our provider types,” says Murray Kopelow, MD, ACCME Chief Executive, “but it is going to require some providers to change how they do business.”

What does that all mean? Here's a hypothetical example: “An accredited communication company, that is part of a larger marketing firm that is part of a commercial interest, puts on CME in the content area in which they have a commercial interest. That very likely would be perceived as a conflict of interest,” explains Norman Kahn Jr., MD, chair of the ACCME's task force on the Standards. Kahn, who is also vice president, science and education, American Academy of Family Physicians, Leawood, Kan., says that the situation is different in the case of an independent communication company that has numerous clients and funding sources, and where everybody adequately discloses their relationships. In that situation, there would not necessarily be a conflict of interest.

If a provider appears to have a conflict of interest, it will have the opportunity to demonstrate to the ACCME that because of its corporate bylaws, firewalls, and organizational structure, it is adequately separating promotion from education, adds Kopelow.

But what about faculty members who own stock in pharma companies? Who serve on pharma speakers bureaus? It depends, says Kahn. “There's no black and white example. Take an extreme case: Someone is trained by a drug firm as a promotional speaker, is paid a lot quite regularly, and has a reputation as being a promotional speaker — that would possibly be a situation where the speaker would be viewed as an agent of that company. In contrast, if somebody is on the speakers bureaus of many companies and is predominantly a CME speaker, not a promotional speaker — in that case, disclosure could be enough.”

The new Standards also address more subtle conflicts of interest. Kopelow believes that they will, for example, help keep formulary interests separate from CME.

However, decisions should not be made on the basis of relationships alone. The content and context of the presentation is also important, says Kopelow. For instance, the new Standards stipulate that “drug company executives could deliver CME on the mechanism of action of their firms' drugs.” That's because pharmacology is just facts, says Kopelow, and the drug firm executives would have more information than anybody else about their own drugs. However, drug executives would not be allowed to synthesize the evidence and make clinical recommendations for the drug's use.

Another major change is that if people refuse to disclose their relationships with commercial interests, they will not be allowed to serve as faculty or planning committee members. Previously, providers only had to stipulate that the person had not disclosed. One area of disclosure has been dropped: There is no longer a requirement that CME speakers disclose if their presentations include discussion of off-label, unapproved, or investigational uses of drugs. Any requirements regarding CME content are included in the ACCME content validation policy issued in July.

The guidelines are open to interpretation and are “very context-dependent,” says Kopelow. The task force decided not to establish hard and fast rules, by saying, for example, that if someone owns $25,000 or more of stock in a drug company, that would constitute a conflict of interest. Instead, “We wanted to clearly articulate the values, the spirit, and the principles upon which decisions should be made,” says Kopelow. It will be up to CME providers to establish their own guidelines. “The ACCME is empowering providers to make decisions about their teachers and authors on the basis of the disclosed information. That's the key and fundamental difference between the new and the old Standards. You can say to the drug company, ‘I'm sorry, but that person cannot speak at this event even though you are the commercial supporter because of her interest in your firm.’”

Other sections of the draft cover management of funds from commercial supporters, advertising and exhibits.

The goal of the new Standards is to protect CME's safe harbor from regulation by the FDA and the Office of the Inspector General, says Kahn. If the CME community doesn't succeed at continuing to regulate itself, demonstrating that it can separate promotion from education, the result will likely be “terrible media attention and government regulation,” he cautions. Adds Kopelow, “We hope that CME will be seen as a strategic asset to protect an institution if it is under OIG scrutiny.”

The comment period on this draft extends until March 15, 2003. Kopelow says that he expects the final draft will be released no sooner than July 2003.

At press time, the draft was embargoed, so we were precluded from gathering responses from the CME community. In the March/April issue, we will offer more analyses on the draft Standards.
Tamar Hosansky

Legislatures Police Pharma Marketing

The release of the Pharmaceutical Research and Manufacturers of America new ethical code didn't short-circuit other efforts to police pharmaceutical companies' marketing to physicians. This fall, the Office of the Inspector General issued a draft guidance compliance program for pharmaceutical manufacturers. And it didn't stop there: 2002 was riddled with other actions intended to curb pharma influence on physicians. Here are just a few:

  • Nothing cheesy will be allowed in Vermont, which passed a law last summer that requires manufacturers to report to the Board of Pharmacy all “gifts, payments, subsidies, or other economic benefits” of $25 or more given to physicians, hospitals, and others authorized to prescribe, dispense, or purchase drugs in that state. The law exempts drug samples, bona fide payments for clinical trial work, and scholarships for medical students, residents, and fellows to attend certain educational and scientific meetings.

  • Hawaii recently said “Aloha, regs,” when it passed a law requiring pharmaceutical companies to report aggregate spending on marketing to the Department of Health. In addition to salaries for detail reps, the law covers all costs associated with “educational programs, seminars, entertainment, trips, remuneration for participating in informational seminars for prescription drugs, product samples in excess of $10 in value, and promotional gifts in excess of $10 in value.”

  • While Wisconsin's attempt to pass a bill aimed at preventing the exchange of gifts for preferential prescription orders died in committee last spring, Massachusetts State Senator Richard Moore is moving forward with a bill in his state that would put the onus on docs to report gifts worth $50 or more from pharmaceutical companies. According to a spokesperson in Moore's office, the idea is to add the reporting requirement into the paperwork required for licensure in Massachusetts.

  • At the federal level, Rep. Peter DeFazio from Oregon introduced a bill amending the Food, Drug, and Cosmetic Act that would require drug companies to disclose the value, nature, and purpose of any marketing or promotional gift over $50 given to health professionals. Under the Drug Company Gift Disclosure Act, the information would be made available to the public on the FDA Web site. The legislation would exempt free drug samples and medical student scholarships. As of press time, the bill was languishing in the House Committee on Energy and Commerce's Subcommittee on Health.

  • “Mandatory reporting of pharmaceutical advertising is an important step in the right direction,” says Eric Hodgson, MD, national president of the American Medical Student Association in Reston, Va., but it does nothing to directly discourage physicians from accepting promotional gifts. During its 2002 annual convention, AMSA passed a policy prohibiting students from accepting promotional gifts of any size or dollar value from pharma. Hodgson explains, “As the next generation of practicing physicians, we must show our patients that maintaining their good health and the doctor-patient relationship is more important than a free pen.”

Disney Gets Into CME

Disney Hotels and Resorts, Orlando, announced that the Annenberg Center, Rancho Mirage, Calif., would be providing accreditation for CME courses developed by the Disney Institute on topics such as interoffice communication, accountability, leadership, and patient satisfaction. The primary venue will be the Institute, but courses also may be held at other resort properties. “When it comes to customer satisfaction and dealing with people, it was a natural to team up with Disney,” says Kraig Johnson, director, CE, Annenberg Center for Health Services at Eisenhower.

More Money for CME

The new guidelines will have positive results for CME, speakers at the CBI conference said. (See main story beginning on page 13.) The funds that were spent on entertainment are being redirected into accredited education. In an audience poll, conducted by Terri K. Moore, program administrator, professional and continuing education, University of North Texas Health Science Center, Fort Worth, 87 percent of participants said their marketing plans included CME, and 62 percent reported that from 10 to 25 percent of their marketing budgets were allocated to CME. To take advantage of that trend, CME providers need to demonstrate educational events' ROI to pharma funders, by conducting more intensive pre- and post-program surveys, Moore said.