ORLANDO Physicians can expect to have their relationships with the pharmaceutical industry examined increasingly more closely, as government steps up its efforts to scrutinize their links with Big Pharma.
Pharmaceutical company perks, such as travel subsidies to meetings, lavish dinners, and entertainment, are a thing of the past, and full disclosure is now the order of the day, said representatives of the legal, pharmaceutical, and medical profession at the annual meeting of the American Society for Dermatologic Surgery.
Jonah Shacknai, chairman and CEO of Medicis Pharmaceutical Corp., in Scottsdale, Ariz., said he has seen a substantial shift in the past 20 years in what constitutes an appropriate relationship between industry and physicians.
"Scores of companies have been prosecuted by the federal government, and even more have entered into corporate integrity agreements with the feds, whereby virtually every aspect of the commercial program is open to audit and regulated by the feds," Mr. Shacknai said.
In addition, many physicians have been investigated, and several have been prosecuted for malfeasance, such as including lack of disclosure in articles submitted to peer review journals or in relation to speaking engagements, or for accepting gifts from industry, he said.
"During the Bush administration [there has been] an extraordinary increase in enforcement in this area, by about 700%… and it is reasonable to predict that [it] will continue to be of high interest [in an Obama administration]," Mr. Shacknai said.
However, government is not motivated by a moral conviction that close ties between the pharmaceutical industry and the medical profession are wrong, but by a desire to save money, he cautioned.
"They see that certain types of drugs are going to be more advantageous economically for the federal government reimbursement system at a time when there is great fiscal urgency. The country has not awakened to moral reality. What we have awakened to is a new enforcement reality," he explained.
Jeffrey S. Dover, vice president and president-elect of the American Society of Dermatologic Surgery, said that physicians could protect themselves by being transparent about their dealings with industry.
The relationship between industry and the medical profession is very important, he said, noting that medicine needs industry to support research and development, and industry needs physicians for product development, study data, postmarketing surveillance, and advice. But inherent in this relationship are potential conflicts of interest and bias, so that "even with rigorous guidelines, industry will seek ways to influence physicians, especially thought leaders. Doctors must take personal responsibility for their behavior," said Dr. Dover of Yale University, New Haven, Conn., and Dartmouth Medical School, Hanover, N.H.
Robert P. Brady Esq., of the law firm Hogan & Hartson LLP, Washington, DC, agreed. "You have to apply your own personal medical ethics. It's between you and your patient. You cannot be influenced by a mug or cup [from a drug company]that's absurd. You have to have [a] personal test for whether your financial relationships are appropriate. You have to be providing real services, and you need to be able to look at yourself in the mirror and say, 'Yes, Big Pharma has hired me as a consultant, and I'm providing real services at a reasonable return.'"
He warned of the passage of a law, possibly soon, that would require pharmaceutical and medical device companies to disclose the details of all gifts and payments of over $25 that they make. The disclosures would be posted on company Web sites and on the Department of Health and Human Services site.
"Washington, which tends to look at things simplistically, believes that transparency will cure [much] of what they perceive to be a corrupted relationship between the industry and you," Mr. Brady said. "I think they're dead wrong. Your relationship with industry is vital and their relationship with you is equally vital."