CME providers are applauding the recently updated and reissued ethical code of the Pharmaceutical Research and Manufacturers of America(PhRMA), formerly called the Pharmaceutical Manufacturers of America. Called the Code on Interactions with Healthcare Professionals, it replaces PhRMA's decade-old original ethical code, which was developed in reaction to the then-new American Medical Association's Ethical Opinion on Gifts to Physicians from Industry. The nine-point document, available online at www.phrma.org/publications/2002-04-19.391.pdf, covers many of the same issues as the current AMA and Accreditation Council for CME guidelines, including informational events, gifts to doctors, and the independence of accredited CME.
“I think it's an important and very positive step by the industry,” says Alan R. Nelson, MD, special advisor to the CEO, American College of Physicians — American Society of Internal Medicine, Philadelphia. “In order for a gift to be ethical under the AMA guidelines, it has to meet three tests: 1) entail a benefit to patients; 2) be of nominal value; and 3) come with no strings attached. The PhRMA code encourages compliance with these three tests.”
“It is reassuring to all CME providers, and to the public as well, to have an official endorsement [of the AMA gifts to physicians from industry policy] from the pharmaceutical industry,” says Jacqueline N. Parochka, vice president and director of education with Discovery International, Deerfield, Ill., and president of the North American Association of Medical Education and Communication Companies. The code will make our jobs easier because it reinforces the intent of the ACCME's Standards for Commercial Support as well as the AMA policy, she adds. “When questioned, we can point commercial supporters to their own set of guidelines.”
Robert F. Orsetti, vice president, Medical Education Collaborative, Freehold, N.J., agrees: “If company staffs are properly informed and required to abide by code principles, adherence to ACCME and AMA guidelines will become much easier. Presently, much time is spent explaining educational guidelines to pharmaceutical marketing directors who lack a full understanding of the rules.”
One impetus for issuing the code may have been the AMA's increasing efforts to spread the word about the Gifts to Physicians policy. “Some PhRMA member companies have given support to the AMA's effort,” says Orsetti. “It was both appropriate and timely for PhRMA to lend its support to the larger effort and to seek member compliance.”
Another prod may have been the recent rash of bad publicity and governmental crackdowns, such as the TAP Pharmaceutical Products' bribery case, which resulted in the largest health care fraud settlement in U.S. history. (See MM January/February, page 8.) “Patients want to know their doctor isn't being unduly influenced by the gifts they receive,” says Parochka. “That's pretty strong medicine for change.”
While the original PhRMA code that the new one replaces was “important and supportive of the AMA initiative, it was not properly promulgated and reinforced within companies or with those doing business with pharmaceutical companies,” says Orsetti.
Although adherence to the new PhRMA code is voluntary and no enforcement measures are included, Nelson says that because the code was approved at the highest levels of pharma company management, many of whom are on PhRMA's executive committee, “I'd be most surprised if it weren't observed and followed at all of the levels of marketing.”
Orsetti emphasizes that “it needs CEO and president-level support to be adopted by staff. Companies should hold meetings…on a regular basis to allow staff to ask questions, and to remind employees of code requirements and the need for adherence. Frequent reminders are key.”
The new cooperative environment should help. Nelson says AMA's Working Group for the Communication of Ethical Guidelines on Gifts to Physicians from Industry, of which he is chairman, has concluded that it would be appropriate to include the PhRMA code with the other educational products available through AMA's Web site. “After all, we all have a common goal in this. Some of the abuses that have been reported in the press have distressed us all; [these educational efforts] provide some promise of reducing those abuses in the future,” he says.