Thursday, June 6, 2013

Finally, the Sunshine Act: Commentary in NEJM

Last week's New England Journal of Medicine (you can see I'm a bit behind in my journal reading) featured three "perspectives" on the Sunshine Act that became law as part of the Affordable Care Act of 2010:

The third piece, coming from the Center for Medicare and Medicaid Services (CMS) that's responsible for administering the law, is just an overview of what the law requires, and the timeline for implementation. The second article, by Meredith Rosenthal and Michelle Mello, notes that the reason for the sudden interest is that after a delay of about 15 months occasioned (they said) by public comment:
--CMS finally issued its final regulations for implementing the Sunshine Act in February. Data collection (says CMS) is to begin in August and the first public release of data is scheduled for September 2014.

The first piece, by Dr. Aaron S. Kesselheim of the pharmacoepidemiology-pharmacoeconomics program at Harvard, is a summary of what they have learned by studying an earlier example of a state-level Sunshine law, in Massachusetts. Of the various tidbits of information they provide, perhaps the most fascinating is the breakdown of how much money physicians in various specialties rake in in different categories of industry payment. Go to their link and then click on the Figure (B). You'll see that all categories including food, CME conference support, research grants, and education or training are shown as extremely thin slices at the top of the bars in the graph for all specialties, and the vast majority of funds, usually in excess of 90 percent, consists of one category: consulting fees.

Now, according to the official designation, consulting fees mean that these physicians provided a "bona fide service" for the company and the company paid them a reasonable and justified fee for those services. As we have had numerous occasions to note in this blog, it is really hard to swallow that all these physicians provided all these incredibly valuable services for these companies and according earned these fees legitimately. Pharmascolds like me will persist in suspecting that these are thinly disguised bribes to win the loyalties of these docs to the brand in question.

Anyway, Dr. Kesselheim's piece is a reminder of one important value of sunshine legislation. Maybe no patient will ever log onto the website and decide which doc to go to based on which have their hands in the Pharma till. But the few, smart investigators who have the wherewithal to analyze these data can tell the rest of us things about trends in the industry-medicine interface that we'd otherwise never find out. In previous posts we've seen how shrewd investigative reporters have mined these sunshine reports for significant insights--see for example:

This is basically the point made by Meredith and Mello in their commentary. It's unlikely that directly releasing these data to the public at large will change anything. But what our lawyer friends like to call "learned intermediaries" can process these data and take significant actions to limit undue industry influence. They note that insurers in particular may look askance on docs who seem too eager to feed at the industry trough.

One point about the Kesselheim study-- for a while, Massachusetts had a ban on significant gifts from industry, including most meals. The Pharma lobby and the restaurant lobby combined to get this ban repealed:

Since some of the data was gathered while this ban was in effect, it could be that the mammoth consulting fees paid were due to the industry reinvesting what they would have spent on food in other forms of influence; and that if we went back to check today we'd see a lot more spent on food instead. At least the Massachusetts restaurant lobby hopes so.


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