Unfortunately, there were many other egregious examples of undisclosed financial interests being brought to light by the Senate Judiciary Committee staff. Foremost among these has been the relationship between spine surgeons and their use of recombinant human bone morphogenic protein-2 (rhBMP-2) in spinal fusion surgery. Whether surgeons should use autologous bone grafts or rhBMP-2 to fuse the implanted spinal hardware has led to a controversial and costly debate.
A recent review of this topic in The Spine Journal observed that all of the original 13 industry-sponsored studies investigating the role of rhBMP-2 in spine surgery were remarkable for the complete absence of any reported clinical adverse events.4 This astonishing assertion quickly unraveled following the publication of reports by unaffiliated authors who began highlighting some rather serious adverse reactions, including bone osteolysis, neurological injury resulting in retrograde ejaculation, and dural laceration. Perhaps this is the most amazing observation: For all published studies reporting on more than 20 patients receiving rhBMP-2, one or more authors were found to have financial associations with the sponsor valued at more than $1,000,000. For all studies reporting on more than 100 patients, one or more authors were found to have financial associations with the sponsor valued at more than $10,000,000. Yes, you counted correctly. There are seven zeros in that number! Again, none of this information was disclosed at the time of publication of any of these studies. My colleague Aaron Kesselheim, MD, JD, MPH, assistant professor of medicine at Harvard Medical School in Boston, found that only one in seven authors identified in whistleblower complaints as being involved in off-label marketing activities adequately disclosed their conflict of interest in subsequent journal publications.5
Bias Bias
According to some behavioral economists, when people have a stake in an issue, they tend to process information in a selective fashion that supports their personal interests, a phenomenon known as motivated reasoning. While most people are ready to accept the possibility of bias in others, few are ready to acknowledge that they themselves might be biased, a phenomenon that has been coined as the “bias bias.” Zach Sharek and colleagues at the Carnegie Mellon University in Pittsburgh, devised a clever experiment to ascertain the level of bias pertaining to COI in physicians and financial planners.6 Half of each group read a set of proposed rules to minimize conflicts for doctors; the other half were asked to review synonymously worded rules to reduce conflicts for financial planners. The authors observed that doctors were concerned that financial advisers might accept free meals or educational junkets from investment companies, yet they rejected the notion that accepting similar gifts from drug companies could ever compromise their own integrity. Similarly, the financial planners wanted doctors to be barred from accepting gifts from pharmaceutical companies, lest their objectivity be compromised—but thought the same restrictions in their own profession would be unnecessary and onerous. In fact, financial planners were more hostile than doctors to the admission of any potential conflicts of interest on their part.
Show Me the Data
In 2009, Massachusetts enacted a gift-ban law that closely resembles the soon-to-be-enacted Sunshine Act. The law banned all industry gifts to physicians, such as sponsored meals and social activities that occurred outside of the hospital or office setting. It also created a public, searchable website that listed all payments (such as consulting work) made to any physician holding a Massachusetts license, including those doctors who live and work out of state. Proponents of this law asserted that it would help protect consumers against spiraling healthcare costs; in particular, rising prescription prices. This opinion is widely held, but is it true? The law was based on the premise that transparency in these transactions is of public importance and that disclosure acts as a deterrent against quid-pro-quo exchanges; physicians may be reluctant to accept large payments if these payments are publicly known and perceived as compensation for prescribing certain therapies. Researchers from Harvard University attempted to validate this finding. To predict deterrence effects of the federal Sunshine Act, the authors studied the experience of two states, Maine and West Virginia, that previously implemented sunshine laws. They examined the effect of these laws on the prescribing of statins and selective serotonin reuptake inhibitors (SSRIs), two therapeutic classes in which marketing plays an important role because the therapies within each class are pharmacologically and clinically highly substitutable.7 They hypothesized that, to the degree that physicians were influenced by industry payments to overprescribe branded therapies—and disclosure deterred physicians from accepting these payments—disclosure laws would lead physicians to decrease prescribing of branded statins and SSRIs. Whereas the percentage of branded statins declined by 45.3% in the nondisclosure state of Rhode Island during this period, the decline in branded prescriptions in the disclosure state of Maine was 50.6%. Overall, there were negligible to small effects of the disclosure laws in Maine and West Virginia for both statins and SSRIs. The authors conclude that the Sunshine Act may have a limited effect on prescribing and on expenditures. The authors may have been naive in their initial assumptions. Since branded prescription products usually require prior authorization, and generic drugs often have lower copayment costs, they underestimated the impact that these restrictions already impose on the sale of branded drugs. The Massachusetts legislators acknowledged this reality in July 2012 when they voted to partially lift the state gift-ban law.8
With all this anticipated sunshine, you might want to pack sunglasses and suntan lotion. But I would throw in an umbrella. And a raincoat. Just to be sure.
The Weather Forecast
The Sunshine Act becomes law on January 1, 2013. It will likely provide a windfall for accountants and healthcare attorneys. An aggregate yearly total of $100 worth of payments or gifts will trigger the inclusion of a doctor’s name onto the public website. Thus, all gifts, no matter how small (such as bagels with cream cheese) will have to be tallied by each healthcare company so that, by year’s end, a determination could be made as to whether the $100 threshold was met. Speaking of bagels, I have not found an answer to the vexing question of how to allocate the cost of one dozen bagels to a group of n doctors, where n=a number that is not a factor of 12. Seriously, these are some of the issues that have kept healthcare attorneys awake at night!
