GAME Meetings Archive

2005 Meeting Report
Managing Commercial Support: Ethics and Codes of Conduct

NEW YORK -- The latest news regarding federal scrutiny of the pharmaceutical industry is that in June the United States Senate Finance Committee submitted a letter to major drug manufacturers requesting information about their systems for awarding educational grants, said Maureen Doyle-Scharff, GAME Board of Directors; Director, Professional Services, Ross Products Division, Abbott Laboratories, Columbus, Ohio.

Doyle-Scharff, in a presentation here the Tenth Annual Meeting of the Global Alliance for Medical Education, stated that the U.S. Senate is concerned that manufacturers may be using educational grants to fund activities primarily to promote their products.

The U.S. Senate inquiry is the latest in a series of crackdowns and investigations. More than $2 billion in fines have been levied against pharmaceutical companies in the past two years. "I'm not suggesting it's because of continuing medical education, but CME is woven within that and has actually been touched upon in some of those cases," said Doyle-Scharff.

The situation is so serious that some big pharma companies are considering completely eliminating grants because they deem CME too risky, she said. To address the crisis "we need to be doing a better job of self-policing across the board with respect to all stake holders. I also believe that providers need to have a comprehensive ethics and guidance process in place. It goes both ways: providers need to not allow dollars to drive decisions," said Doyle-Scharff.

The relationship between medical education and communication companies and industry also has to change, she said. MECCs need to stop viewing commercial supporters as their clients. "When we're talking about independent education, we're the funder, not the client."

Physician attitudes have contributed to the problem as well. "To be even more provocative: What about the physician? What about the faculty? What about the learner?" she said. "I believe that we're not holding them accountable enough. Faculty ignorance is not bliss, and it certainly is not an excuse for faculty members that they don't understand or appreciate the difference between an independent program and a promotional program."

Emerging Nations Establish Standards

To ascertain the status of commercial support regulations and standards, a CME survey was sent to Pfizer's County Medical Directors in the emerging world in 2004, reported Honorio Silva, MD, GAME Board of Directors, Vice President, Science and Medical Professional Development, Pfizer, Inc., New York.

The survey results showed that:

• In Africa and the Middle East, commercial support is regulated in Egypt, Saudi Arabia, South Africa, Turkey, Israel, and UAE.
• In Latin America, there are no standards or regulations for commercial support, except in Peru.
• In Asia, commercial support is regulated in Australia, Japan, Malaysia, Philippines, Thailand, and Singapore. There are specific standards for commercial support in Australia, Japan, Malaysia, Singapore, and Thailand.

Countries in the process of developing commercial support can learn from the current problems in the U.S. "Medical education is a service for the patient and if you disregard this, you pay the consequences," said Dr. Silva. "What we have seen in the U.S. is a result of a process by which some of the players disregarded the customer."

Other countries should not only strive to avoid the mistakes made in the U.S., they should also avoid copying U.S. solutions. For instance, speaking of the ACCME's updated Standards for Commercial Support, Dr. Silva said: "We would not like to have this kind of document in the rest of the world because we would become a kind of witch hunting society."

Sweden Gets Tough on Pharma

New rules for CPD/industry collaboration in Sweden ban social activities at CME events and restrict travel and selection of venues, said Richard Bergstrom VD.LIF, Swedish Association of the Pharmaceutical Industry, Stockholm, Sweden.

All activities must be reviewed by IPLUS, the Institute for the Professional Development of Physicians in Sweden. Industry can pay doctors' course fees, but can only pay a maximum of 50% of expenses, such as traveling and lodging. "We have now these very tough restrictions on traveling. Foreign travel [is prohibited.] You can't take doctors from the United Kingdom to the Riviera for a training course that could have been held in the U.K.," said Bergstrom.

As for selecting participants, "We are only allowed to send invitations to the employers at the National Health Service, not to individuals, because we're not supposed to hand pick people," he explained. "The rules have been issued because of the whole debate about corruption and bribery. These physicians use government funds when they prescribe medicines."

Companies operating in Sweden and elsewhere in Europe will need to accommodate to these rules, in order to make the relationships between pharmaceutical companies and physicians clear and secure and to make sure that industry experts can continue to contribute at national conferences, he said.

"Unless we tidy this up we may end up with a situation where sales reps may be banned from even attending conferences. This is Europe-anything can happen-governments can decide anything they want," he said. "We need to focus on quality reviews and creating systems that are meeting the needs of the real customers, of the physicians."

Reassign Power to Regions

"They say Italians do it better. Seventy percent of the art in the world is in Italy and Italy also has the most complicated and most artistic system of CME," joked Alfonso Negri, MD, PhD, GAME Board of Directors; Technical-Scientific Secretary, Italian Federation of Scientific Medical Societies, Milan, Italy. He provided two examples of Italian CME's peculiarities: Italy is the only European country where the CME system includes all healthcare professionals, and CME credits are awarded based on both the length and quality of the event.

In 2005, a change in the Italian Constitution has assigned the regulatory power on all health-care matters, including CME, to the regions. As a consequence, National CME Committee recommendations must now be approved regionally. The National CME committee has prepared regulatory documents addressing national and regional accreditation procedures. In 2004, it also introduced a system for distance learning. In the works is a process that will allow Italian doctors who attend conferences in EU countries, Canada, and the U.S., to get 50% of the credits recognized. "This is a strong message that they support reciprocity," he said.

As for industry-CME/CPPD relations, Dr. Negri said that under guidelines issued by the European Union of Medical Specialties, commercial support cannot influence content and must be disclosed to the provider/organizer, the learners, and the accrediting bodies.

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