May 6, 2013 — With Sunshine Act reporting slated to begin in less than three months, it is sobering to note that many physicians and investigators still are unaware of the regulation, a majority are not in favor of making information about physician-industry financial relationships available to the public, and a small percentage would consider not engaging in clinical trials to avoid a perception that they are too involved with one sponsor.
A recent study conducted by Industry Standard Research (ISR), “Sunshine Act: Pharma Impact – Changes in U.S. Physician Behavior,” found that physicians are worried that the Sunshine Act will have a negative effect on their practice. ISR surveyed physicians and other stakeholders affected by the Sunshine Act. Of 103 physician respondents, 74 percent said they were not in favor of sharing these data; 18 percent of the 100 investigators surveyed said they would stop participating in some clinical trials if they started to do “too many” trials for one sponsor, as reported in a recent article in Policy and Medicine (http://www.policymed.com/2013/05/physician-payment-sunshine-act-principal-investigators-and-primary-care-physicians-largely-unaware-of-regulation-1.html).
“If physicians are concerned that interacting with the pharmaceuticals industry has a negative connotation, there could be a chilling effect on those relationships, which are vital to the public health,” said Coalition for Healthcare Communication Executive Director John Kamp. “The Sunshine Act is supposed to lend transparency to these relationships, not undermine them.”
Although the report states that “few physicians believe the rule will have an impact on how they treat patients,” 38 percent of physicians and surveyed say that they are not at all familiar with the Sunshine Act and 23 percent of principal investigators surveyed state that they have never heard of the Sunshine Act.
As part of the study, ISR researchers evaluated physicians’ frequency of use and the value they place on specific communications channels, as well as which channels might be less likely to be used following Sunshine Act implementation. “While the channel expected to be impacted most significantly is ‘group/practice-level detail sessions’ where doctors and their staff typically receives free lunches, we did see a 12-percent drop in the level of interaction expected across all ‘in-person’ activities,” said Andrew Schafer, ISR president.
Indeed, the report states that the Sunshine Act “will have a dramatic impact on the ability of pharma sales representatives to frequently detail physicians, both one-on-one and in a group setting.” The report adds that although 47 percent of physicians indicated that they participate in a group detail on a weekly basis currently, only 30 percent said they plan to continue this practice after the Sunshine Act requirements kick in.
Interestingly, 71 percent of physician respondents stated that they expect pharmaceutical companies to inform them of the value of a service or benefit prior to it being offered to them. However, even though physicians are worried about the potential negative publicity surrounding their interaction with pharma companies, they “mention that they use pharma sales representatives as a key source of information for new medicines and treatments.” One physician quoted in the report said the Sunshine Act rules “will reduce availability to new information about existing and new products.”
“These findings support the fact that industry needs to do all it can to ensure that context regarding the industry-physician relationship is provided and included in press reports about the data that ultimately will be made public,” Kamp said. “The Coalition raised this issue in comments to the Centers for Medicare & Medicaid Services, and we cannot stress enough that getting this point across will make a huge difference in the public’s perception of this information. We have to make clear that these relationships are crucial to keeping physicians informed and to ensuring that patients receive the most effective treatments for their conditions.”