SVS: Could restrictions on physician, industry interactions hurt the patient?
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“Most people operate under the assumption that an educated and informed physician provides patients with the best care, and patients benefit from innovative medications and devices,” said Kimmelstiel, director of the adult cardiac cath lab and interventional cardiology at Tufts Medical Center in Boston.
However, he pointed out that there have been a number of regulations, governing “what physicians do and how they do it,” with regards to the interactions of physicians with industry, including anti-kickback laws, the Stark Law and the Sunshine Act. In addition to federal policies, individual states have begun enacting separate policies, and the National Institutes of Health (NIH) has now abolished corporate consulting and banned healthcare investments for its employees.
Specifically, Massachusetts enacted gift ban legislation, which applies to Massachusetts physicians not only when they are in the state, but also wherever they may travel to, and also placed “strict limits” on continuing medical education (CME) and academically professional presentations, explained Kimmestiel. These regulations, which “made illegal practices that are not illegal elsewhere,” also elucidated a double standard because lawmakers are not adhering to these stipulations, he added.
“The current regulations, especially in Massachusetts and Minnesota, threaten our academic mission in terms of post-graduate medical practice,” stated Kimmelstiel. He exemplified the dissipation of a particular interventional cardiology conference that formerly took place in Boston, due to enactment of the new policies.
Also due to the new regulations, Pfizer pulled back grant funding for a visiting professorship program in Massachusetts. “While the companies would not actually be breaking the law by continuing funding, they just don’t want to worry about compliancy issues,” Kimmelstiel said. “They are just walking away from our state instead of having to worry about liabilities due to compliance.” He also referenced the “huge decline” in CME-funded meetings.
“Are there any data to show that industry support can lead to bias in CME or non-CME presentations?” Kimmelstiel questioned. The Accreditation Council in Continuing Medical Education released a report in June 2008, which found that there is “no empirical evidence to support or refute the hypothesis are biased, and there is limited evidence to suggest that CME activities funded by commercial interests can be effective in changing physicians’ prescribing practices.”
He referenced several other data that speak to this issue. For instance, in a survey of 1.6 million healthcare provider participants in online CME activities, less than 1 percent reported bias. However, there was a slight, but significant trend toward the perception of more bias in commercially supported activities—0.8 versus 0.5. Also, 98 percent of the 9,500 physicians at the Cleveland Clinic reported that CME activities were free from bias this year.
Looking away from education toward innovation, Kimmelstiel pointed out that the clinical benefit that results from innovation is “unpredictable and infrequent, and at a cost of huge investment,” adding that time and financial efforts do not always bring about FDA approval.
“In the year following the gift ban enactment in Massachusetts, the Boston Business Journal clearly showed that jobs were being lost in the state,” he said. Also, fewer pharmaceutical companies and medical device makers are willing to host clinical trials in states with such laws.
Dan Wolf, MS, in his recent Massachusetts Institute of Technology's Master's thesis, sought to assess the effects of the recent gift ban in the year since the law was enacted found that 70 percent of industry respondents reported an “impaired ability to collaborate” with Massachusetts physicians, and 83 percent reported a “decreased interest” with Massachusetts physicians. From the physicians’ perspective, 83 percent reported an “impaired ability” to collaborate with industry to develop new devices and new technologies. Also, 79 percent of physicians reported that their education had been impaired. Over half of the respondents said they perceived a negative long-term impact on patient care through impaired physician education.
“Increasingly tight restrictions on free trade and interaction between manufacturers and prescribers truly reduce innovation, efficiency and productivity,” Kimmelstiel concluded. He encouraged policymakers to question: “What innovation construct delivers cures to patients in a timely manner, and do these policies serve those characteristics?”