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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