Benefits and Drawbacks Must be Weighed in Physician-Industry Relationships

Presenters of an RSNA 2008 course on physician-industry relationships agreed that such relationships have proliferated but debated the degree to which such relationships benefit the medical profession and society at large, as well as how potential downsides should be managed.

Radiology has been at the forefront of medical specialties when it comes to disclosing physician/industry relationships, said Leonard Berlin, M.D., chair of the RSNA Professionalism Committee. The committee sponsored the "Physicians' Relationships with Industry" course at RSNA 2008.

The "Physicians' Relationships with Industry" refresher course was sponsored by the RSNA Professionalism Committee. Committee chair Leonard Berlin, M.D., said he is fascinated by this thought-provoking topic and has become his own newspaper clipping service when it comes to articles about physicians getting kickbacks, medical journals being misled by researchers and other evidence of the need for disclosure.

"When a doctor is wined and dined by radiology manufacturers or medicine makers, is he or she obligated or beholden to that company?" asked Dr. Berlin, chair of radiology at Rush North Shore Medical Center in Skokie, Ill. "Will this prejudice subsequent medical research?"

A conflict of interest can be defined, said Dr. Berlin, as objectivity being unduly influenced by some material gain. What may be harder to define, he said, is the difference between "influence" and "undue influence."

"Where is the line?" Dr. Berlin asked. "It's hard to believe you wouldn't feel some sort of obligation when you are influenced.

"If a radiologist says something is medically successful, and that radiologist is getting money from one of the big device makers or the maker of contrast media, could that damage the image of radiology in the eyes of the public?" Dr. Berlin continued.

Fortunately, said Dr. Berlin, radiology has been at the forefront of medical specialties when it comes to disclosing physician/industry relationships.

Relationships Hasten Innovations to Clinic

Speaking for the first time on this topic, Rachel Brem, M.D., characterized collaborative efforts between researchers and industry as "relationships which can be healthy."

Clark Silcox, J.D., of the National Electrical Manufacturers Association, said he predicts public policy change in 2009 that will bring disclosure legislation through Medicare law and include criminal penalties for fraud.

Dr. Brem, who has a longstanding relationship with Dilon Technologies, is the director of breast imaging and intervention and vice-chair of the Department of Radiology at George Washington University Medical Center. She started her research with Dilon on breast-specific gamma imaging (BSGI) in 1996. Dr. Brem worked on the science, clinical research and direction Dilon Technologies should take.

"I was involved from the beginning with the design of the equipment and the initial research studies," said Dr. Brem. "It required two groups, breast imagers and nuclear medicine physicians, who typically don't work together, to do just that. In addition, the company needed to understand the culture of academics."

Dr. Brem became a member of the Dilon board after 10 years of working with the company. While her decision may have raised some eyebrows, Dr. Brem maintained the regulatory climate is becoming so stringent that patients may not get new technologies at the speed they are getting them today. "How will innovation reach patients without the collaboration of researchers and industry?" she asked. "There is an increasing feeling of too many restrictions and that could harm the ability of doctors to get new technologies to patients."

Both physicians and industry must be vigilant, said Dr. Brem. "We maintain extremely stringent operating procedures with many deep levels of institutional review board (IRB) oversight," she said. "Oversight is important, but it must, and it can be, managed. If it becomes overly burdensome, it could harm patients."

Physician-Industry Relationships "Ubiquitous"

Considering that there is not enough money available from the federal government, hospitals and medical schools to pay for research, medicine will naturally turn to industry for some funding, said Eric G. Campbell, Ph.D. "Close relationships can quicken the development and marketing of products and drugs," he said. "Many, if not all, of the new drugs and devices on the market today wouldn't exist without these relationships." There is no need to end the relationships, he said, as long as all parties clearly and fully note their participation.

Rachel Brem, M.D. George Washington University

Eric G. Campbell, Ph.D. Massachusetts General

However, Dr. Campbell, an associate professor of medicine at the Institute for Health Policy at Massachusetts General, takes a hard line view on every other potential conflict of interest. Citing several of his own published studies (see sidebar), he noted, "The research in this area shows the industry-physician relationship is ubiquitous in all aspects of medicine," he said.

"Research shows 90 percent of medical students have had a dinner with drug company representatives," Dr. Campbell continued. "Ninety-seven percent of all practicing doctors have a relationship with industry, including department chairs and IRB chairs. There is not a single aspect of medicine today without these relationships."

Dr. Campbell said he believes the most common conflicts of interest occur when doctors accept free lunches in their offices. "This should never happen," he said. "Doctors should not pass the higher cost of medicine and equipment to their patients by accepting free lunches." There is nothing wrong with a physician calling a drug company to arrange a meeting with a drug representative, he said, but those representatives should not be feeding doctors and nurses.

Pointing to free trips as another potential area of abuse, Dr. Campbell cited The Wall Street Journal coverage of an equipment manufacturer taking a group of doctors to New Orleans during Mardi Gras and paying for a float for the doctors to ride in and $25,000 worth of beads for the doctors to toss. Golf outings are also ripe for manipulation, he added. "They're not educational," he said. "What about CME? You don't need to go to Naples for CME—you can do that at home on your computer."

There have been calls for a ban on all industry support of CME and many medical schools and hospitals are considering such restrictions, said Dr. Campbell. "Half of all CME is supported by drug and device companies," he said. "Those companies make significant returns on their investments."

Dr. Campbell noted the discrepancies that arise when physicians are asked about their efforts to self-monitor for potential conflicts. "Interestingly, many physicians believe there is no negative effect on their own behavior but surely there is a negative effect on their colleagues who participate," he said, adding that medical societies must also check their conflicts when receiving money from drug and device makers.

Vendors Involved in Regulation

On the other side of the physician-industry equation, medical vendors have a keen interest as well. Course presenter Clark Silcox, J.D., is secretary and general counsel for the National Electrical Manufacturers Association (NEMA), made up of companies that make X-ray, CT, MR imaging and ultrasound machines and radiation therapy equipment.

"This issue has been around for decades, but now there is increased interest by the media and lawmakers," said Silcox. Congress and some state legislatures have proposals to require disclosure, he said, and interestingly that disclosure will come from the vendors. Early attempts included mandatory disclosure of all discounts. Silcox said that requirement had to be eliminated because, in his industry, every sale of large equipment such as an MR imaging machine is discounted. Such disclosure would give competitors unfair price knowledge, he said.

Academic institutions and medical schools have their own ethics regulations to police themselves, but sometimes the rules are not observed, said Silcox. He predicted a public policy change next year that will bring disclosure legislation in through the Medicare law and include criminal penalties for fraud.