Doctors: Sunshine Act puts the "trial" in clinical trials

Is the Sunshine Act a source of positive energy when it comes to the development of new therapies? That depends on your perspective.

Some say it’s brought necessary transparency to clinical trial arrangements that might otherwise fall into ethical gray areas. Others say it requires quantitative information that could be misleading, or even damage reputations within the medical industry, if taken out of context.

One analysis showed industry spending on U.S.-based clinical research dropped 32 percent between 2013 and 2014, while another 2014 study pointed to decreased physician participation in such trials nationwide. The top reasons physicians cited were lack of time and resources, overly complicated logistics and poor information regarding how to start. But some industry leaders say the Sunshine Act has also discouraged such participation — thereby slowing progress in pharma innovation — because it can make doctors appear to be profiting overmuch from testing that’s supposed to help their patients and humanity as a whole.  

“I understand it is important to have transparency, and we do need to disclose pharma payments to physicians, especially when it comes to marketing and sales,” comments Dan Sfera, CEO of Global Clinical Trials LLC. “However … (the Sunshine Act can) grossly exaggerate and mislead the public on how much the physician actually profits from his involvement in the trial.” In one example, he said, PIs of clinical trials are reported as recipients of all gross funds paid to a trial site, when in fact they only profit after paying out the often-substantial trial expenses.

Congress started Sunshine Act reporting as part of the Affordable Care Act in 2014, specifically intending to bring to light financial relationships between doctors and manufacturers of drugs and medical devices. The goal was to facilitate better patient decisions and deter any inappropriate financial relationships that might lead to increased healthcare costs. Generally speaking, makers of pharmaceuticals, biologics and medical devices must reveal any payments or transfers of value to physicians and teaching hospitals, with any underlying ownership fully revealed. Failure to comply with the 35-page document (which adds 251 pages of commentary) could result in fines of up to $1.15 million.

Those kinds of safeguards help protect the integrity of physician/vendor relationships. However, an unfortunate side effect seems to be that research physicians are failing to step up to the plate to oversee clinical trials out of concerns that the money they earn might be construed as insufficiently altruistic.

As Editor Ed Miseta puts it on clinicalleader.com, “Paying doctors to favor your medicine over another might be undesirable. Paying them for their efforts to assist with the facilitation of research studies is a different situation altogether.”   

So far there seem to be few answers to the conundrum, though multiple physicians and researchers have stated objections. Sfera, for example, calls for more clarity on exactly how physicians are profiting from trials.

Other sources, like Medical Economic Online, simply advise physicians to be hyper-aware when accepting anything of value from vendors, such as speaking fees, consultation fees, lodging or meals. “Be fully informed about how such acceptance will be disclosed, and how it could be perceived by patients, employers and potential purchasers of your practice,” advises lawyer Julie E. Treumann.

Technology firms are trying to address the problem through tools that closely track such exchanges. A CMS called the Physicians Professional Network allows manufacturers to share their version of financial data with physicians, who confirm or challenge it before it’s reported to the government. The tool advises on reporting requirements and industry updates regarding disclosure, aggregating data from state, federal and industry databases and offering contacts if help is needed rectifying discrepancies. A software called MediSpend offers similar functions and is able to track and confirm payments and gifts across thousands of physicians, while Greenphire’s eClinicalGPS can track exchanges across the course of multiple clinical trials.

As the medical community continually adjusts to Sunshine Act requirements, some predict the conflicts will simply resolve themselves.

"In the first few years there's going to be a lot of pain as changes in behavior begin to take shape," says Michaeline Daboul in Becker’s Hospital Review. “Once the ecosystem starts to take shape, hospitals will better manage conflicts of interest, and (the industry) will operate in good standing with ethics and compliance."