January 11, 2015

In his 2005 book, On the Take, former New England Journal of Medicine editor Jerome Kassirer inveighed against the influence that drug and device companies exerted over physicians. Through a variety of strategies, ranging from subsidizing elaborate meals at medical conferences to lucrative consulting arrangements to all-expenses-paid travel to exotic resorts in exchange for product endorsement, corporate America affected and sometimes determined physician behavior. In response, many academic medical centers have banned pharmaceutical sales reps, the “detail men” of yesteryear and put sometimes stringent conflict of interest policies into effect. The Sunshine provision of the Affordable Care Act requires drug companies and device manufacturers to reveal how much money they gave to doctors and to hospitals and to whom they gave it. As of September, 2014 this information is publicly available on a special website maintained by the Centers for Medicare and Medicaid Services. Is this provision having an effect? Will it?

An article written by a health economist and a health lawyer predicted the law would be unlikely to have a direct effect on either patients (by dissuading them from seeing particular physicians) or on physicians (by shaming them into severing their relationship with drug or device manufacturers). It suggested there might nonetheless be a beneficial effect if what the authors called “learned intermediaries,” such as health insurance companies, begin discriminating against people or institutions that are the recipients of what they regard as excessive largesse.

Six states had already introduced legislation requiring disclosure of payments in the form of gifts, food, travel and fees long before the Sunshine Act was passed, and the results in those states give us a preview of what is to come. One study of the Massachusetts law, which went into effect in 2009, concluded that the disclosure requirements were associated with a fall in the total volume of prescriptions, a decrease in the use of brand name drugs, and a rise in the use of generic drugs. But it’s hard to tease out how much of the change was due to the law and how much due to other simultaneous changes in the culture of medicine.

It’s too soon to draw conclusions about the federal law, but some preliminary observations are raising red flags. According to an investigative journalism piece just published in the New York Times, the information available on OpenPayments, the CMS database, is incomplete and replete with errors. Some companies, whether intentionally or accidentally, misspell the names of their drugs and devices or use different names for the same drug in different sections of the database. All told, 40% of the records in the database are missing the names of the doctor or the hospital that received the payment. And indeed, when I checked this out by looking up a local academic hospital, I found that if I entered "Beth Israel Deaconess Hospital," the report said there were no conflicts entered for this facility, but when I entered "Beth Israel Deaconess Medical Center," I found dozens of them.

Even if the reporting were accurate, the real question is whether transparency alone will have a significant effect. I’m doubtful. For some time, medical journals have had disclosure requirements for articles. The result is that the reader knows about consulting relationships, advisory board memberships, and other financial ties authors have with their sponsors. Perhaps the reader will take more seriously those papers in which the authors have no disclosures to make than those where they have a litany of them. But in either case, the article has passed muster: it has made it past the gauntlet of peer review, it has the journal’s stamp of approval. Does anyone seriously discredit a paper because of the author’s pedigree?

Does any of this matter? In particular, what does it have to do with medical care for older people? A great deal. Older patients comprise a huge part of the market for most drugs and most devices.  The average 65-year-old takes 4 prescription medications a day. The average nursing home resident takes closer to 9. In 2015, Medicare spending on Part D, the prescription drug benefit, is expected to account for 14% of total Medicare expenditures in 2015, or $76 billion.
And while the top ten prescription drugs dispensed to older people include such inexpensive generics as hydrochlorothiazine and atorvastatin, many ultra-expensive specialty drugs are used principally in older people. Some of these drugs are one-of-a-kind; many are life-saving. This is where the concern about undue influence of the manufacturer comes in. Precisely because older people take so many medications (and use so many devices) and precisely because they amount to such a big chunk of health care resources, we need to be concerned with what drugs doctors prescribe. Public disclosure of gifts from PhRMA is unlikely to make much of a difference in the all important power of the pen. 

If we want to assure the integrity of the prescribing process--and this is critical because of the number and cost of the medicines taken by older people--we need to prohibit certain kinds of corporate/physician interactions, and to give such bans teeth.

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