Study Finds ‘Sunshine’ Laws Have Little Effect On Prescribing

The Massachusetts ‘gift ban,’ barring drug- and device-makers from showering doctors with money and meals, was passed way back in 2008, but it remains a live controversy. The House, by my count, has now twice passed repeals of the ban, according to the State House News Service; and it sounds like last week, the Senate once again said no, no repeal, according to Health Care For All.

So I figure this new study just out from the Colorado School of Public Health and Harvard will serve as fodder in the ever-swirling debate. The headline: “New federal disclosure law will have little impact on drugs prescribed.”

And my provincially slanted summary: Maine passed a law in 2004 that required that gifts to doctors be publicly disclosed (which the Massachusetts gift ban also does). Nearby New Hampshire and Rhode Island have not. The researchers compared prescribing of two types of drugs — statins and antidepressants — in which gifts seemed likely to influence doctors to prescribe more expensive brands. And they found extremely little difference made by the public disclosure laws.

Conclusion, from lead author Genevieve Pham-Kanter, Ph.D., an assistant professor at the Colorado School of Public Health and a research fellow at Harvard University and Massachusetts General Hospital: “”If the policymakers who passed these measures were hoping for a deterrent effect they may be disappointed.”

(Of course, if you’re a gift-ban backer, your conclusion may be: It’s not enough to disclose; you have to ban…And the finding makes intuitive sense to me: Have you ever looked up your doctors’ gifts? No? Me neither. So why should your doctor care if they’re listed somewhere?)

More from the press release:

AURORA, Colo. (May 29, 2012) – A Colorado School of Public Health researcher has found that laws designed to illuminate financial links between doctors and pharmaceutical companies have little or no effect on what drugs physicians prescribe…

The report, published Monday in the Archives of Internal Medicine, was prompted by passage of the Physician Payments Sunshine Provision of the Affordable Care Act.

The new federal law requires drug manufacturers to disclose certain payments made to physicians including money for consulting, honoraria, gifts and travel.

“This law is based on the premise that transparency in these transactions is of public importance and that disclosure requirements can act as a deterrent against quid pro quo exchanges – physicians may be reluctant to accept large payments from pharmaceutical firms if payments are publicly known and perceived as financial compensation for prescribing certain therapies,” said Pham-Kanter who is also an assistant professor of economics at the University of Colorado Denver.

Working with Kavita Nair, Ph.D., associate clinical professor at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences and G. Caleb Alexander, MD, MS, Johns Hopkins Bloomberg School of Public Health, Pham-Kanter examined West Virginia and Maine, two states with disclosure laws already on the books.

She specifically investigated the effect of the laws on the prescribing of HMG-CoA reductase inhibitors (statins) and selective serotonin reuptake inhibitors (SSRIs). Marketing plays a heavy role in a physician’s choice of therapy since members of each class of drug are similar and highly substitutable, Pham-Kanter said.

The researchers theorized that if disclosure laws were effective and doctors were deterred from taking payments from pharmaceutical companies, they in turn would be less likely to prescribe branded statins and SSRIs over similar generic drugs.

Using a wide variety of public data, they compared Maine, which enacted a disclosure law in 2004, with New Hampshire and Rhode Island, two demographically similar states without such laws. Then they compared West Virginia, which also passed its disclosure law in 2004, with Kentucky and Delaware which had none.

In Maine, the law was associated with a 0.8 percentage point reduction in the use of branded statins compared to New Hampshire, and a 5.3 percentage point reduction compared to Rhode Island. The researchers found little to no effect in West Virginia.

“Our results show that the disclosure laws in the two states we examined had a negligible to small effect on physicians switching from branded therapies to generics and no effect on reducing prescription costs,” said Pham-Kanter.

She noted that despite the laws, accessing information about how much money a physician received from a pharmaceutical company is still difficult and opaque. Much of the information is not on-line yet.

“Transparency is important in its own right, but if deterring unnecessary, costly prescribing is a concern for policymakers, more direct action may be required,” Pham-Kanter said.

The research was funded by the Edmond J. Safra Center for Ethics at Harvard University.

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  • Wells Wilkinson

    It is good that researchers have started to look closely at the factors that influence prescribing habits of doctors, psychiatrists, or other providers. Upon first impression of the press release but not the actual study, it seems that a 5% decrease in prescribing of brand-name statin drugs is not insignificant from a cost point of view, when this adds up to more than $100 in savings for each monthly prescription.
     
    But the real question is not whether state transparency laws deter prescribing. These laws have been undermined by industry lobbying for loopholes, like Vermont’s ‘recently closed trade secret loophole, and they have been implemented, as the study author points out, so that the data remains ‘opaque’ to consumers.
     
    The more interesting question is whether these payments to physicians influence prescribing – a question answered over five years ago, when New York Times reporter Gardiner Harris looked at the relationship between prescribing, and industry payments to psychiatrists in Minnesota. He found that from 2000 to 2005, payments rose six-fold, to $1.6 million, while prescribing of anti-psychotics rose by nine-fold. He also found that psychiatrists receiving more than $5,000 from industry wrote three times as many prescriptions for atypical antipsychotics than those receiving less or no money.  More recently, researcher Eric Campbell, found “an increased propensity to prescribing more expensive brand-name drugs when less expensive generic drugs are available among physicians with Physician Industry Relationships (PIRs) compared with those without” based on surveys of 3500 primary care and 4 non-primary care specialty doctors in 2010.
     
    The reality is that the drugmakers have far more data about the effect of these policies than do advocates or the general public. A New York Times article back in 2007 pointed out that “Few studies have shown that patients are harmed when their doctors accept gifts or money from drug makers, in part because data comparing the prescribing trends of doctors who accept money and gifts with those who do not have for years been available only to drug makers, not to the public.”

     
    But the federal Physician Payments Sunshine Act differs from the state transparency laws in that the data must be publicly accessible, as well as easily searchable and downloadable. We have heard anecdotal reports that the coming transparency under the federal law is making some doctors not only less willing to accept meals or other gifts, they are actually closing their doors to the frequent visits by drug salespeople.
     
    And consumers may have seen the revelations earlier this month about Abbott Labs paying doctors thousands of dollars to conduct research on unapproved uses of the drug Depakote upon their patients. These practices, revealed along with a $1.5 billion settlement, highlight why consumers need full transparency concerning any payment that could be related to any drug product currently prescribed. Once we have full and meaningful transparency, then we will see what impacts could be.    

    Wells Wilkinson, Staff Attorney, Community Catalyst