Are Sunshine Laws Making Any Difference?

Are Sunshine Laws Making Any Difference?

June 7th, 2012 // 1:11 pm @

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Two years ago, the Physician Payments Sunshine Provision was incorporated into health care reform in response to ongoing concerns that undisclosed financial relationships between drugmakers and some physicians was unduly influencing medical practice and patient care. And so, unless the US Supreme Court dismantles or guts the Affordable Care Act, drugmakers next year will be required to post payments exceeding $10 to physicians on their web sites, among other things.

Such disclosure was seen as providing some transparency into the prescribing process. But to what extent might some sunshine change things? In an attempt to gain insight, if not a definitive answer, a group of researchers examined a large database for prescription drug claims for statins and antidepressants that were written between July 2003 to March 2009 in a half dozen states, including Maine and West Virginia, which have their own sunshine laws.

In both Maine and West Virginia, brand-name and generic prescriptions were compared with two other states that do not have sunshine laws in order to determine the extent to which prescribing may reflect disclosure requirements. The analysis examined the change in prescribing, before and after their disclosure laws, and compared those results with the change in prescribing in comparison states over the same period.

The researchers postulated that a difference in prescribing in the disclosure state relative to comparison states would potentially reflect the impact of the disclosure law. What did they find? In some instances, there were statistically significant differences between brand-name and generic prescribing for one or both types of drugs, but overall, there were “small to negligible effects.”

In Maine, for instance, the effect of the disclosure law was small when compared with two other states used as controls. The drop in brand-name statin prescriptions compared with a decline in New Hampshire was 0.8 percent and it was 5.3 percent compared with a decline in Rhode Island. Both findings were statistically significant. In West Virginia, brand-name antidepressant prescribing increased 1.09 percent compared with Kentucky, which was not statisticcally significant, but there was a statistically significant 0.53 percent drop compared with a decline in Delaware (here is the study with a table showing more data).

In other words, there was minimal switching from brand-names to generics among two wildly popular therapeutic categories that were often heavily promoted during the time period examined. Why? The authors speculate that disclosure requirements did not capture all promotional efforts by drugmakers and, while industry payments to physicians may have been disclosed to state agencies, the data may not have been disseminated sufficiently to the public to have an impact.

“These results suggest we’re dealing mainly with noise, statistically speaking,” Genevieve Pham-Kanter, an assistant professor at the Colorado School of Public Health and Department of Economics at the University of Colorado in Denver, tells us. “But I think there’s something to be said for transparency itself. I think policy makers and the public, in general, don’t have any idea of the scope of the payments. Making that known is important itself and is quite separate from any deterrent. The law could be justified on transparency alone.”

Whether these results can or should be used as a proxy for speculating on the utility of the Physician Payments Sunshine Provision remains to be seen. The comparisons, after all, only involve a few states acting as a control for each example analyzed. A wider and deeper analysis would likely yield more meaningful data, assuming the Affordable Care Act is allowed to proceed. In any event, some may use this as ammunition to criticize the argument for disclosure.

[UPDATE: We should note that the study examined prescribing through 2009, which is before some drugmakers had voluntarily established websites as a result of settlements with the federal government over allegations of improper marketing. Meanwhile, Maine did not fully compile or analyze data or provide public education, according to Sharon Treat, a Maine legislator, who also heads the National Legislative Association on Prescription Drug Prices. Last summer, by the way, the law was repealed (read here and here).

And West Virginia had thresholds for publicizing industry payments to all physicians. This contrasts with more complete details that the Sunshine Act will require. Consequently, consumers may not have had easy access to full disclosure data during the study period, which the authors noted. “It’s unlikely that consumers in either state would have had much, if any access to physician payment data,” says Danny Carlat of the Pew Prescription Project.]


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