The Problem
The pharmaceutical industry spends more than $25 billion each year in direct marketing to physicians, including more than $7 billion for detailing and journal advertising and $18 billion for samples. (1) Ninety thousand sales representatives are deployed.(2) Many promote new and expensive products that lack clear therapeutic advantage and may have unknown adverse effects. (3) Industry representatives often gain access to doctors by offering meals, drug samples and other gifts. This intense marketing is widely believed to undermine quality of care and increase costs to patients, public programs, health care institutions, health insurers and employers. (4-6)
Gifts generate conflicts of interest. Physicians who accept company gifts may feel a need, subconscious or otherwise, to reciprocate. Even small gifts change behavior; (7) public records show that many clinicians receive tens of thousands of dollars per year from the industry. (8)
Industry sales representatives frequently provide inaccurate information (reviewed in Molloy et al.). (9) Yet contact with sales representatives or acceptance of industry support leads to increased prescribing of the funders’ products, increased requests for formulary inclusion and decreased use of generic medications. (3, 10) Nearly all physicians (more than 90 percent) have some relationship with industry, (11) but many often fail to realize the extent to which these relationships influence their own prescribing decisions.(12-14)
Relationships between medicine and industry also exist at the institutional level. Many AMCs depend heavily on pharmaceutical company support for research, education and other organizational activities. (15) Positive relationships with industry may confer institutional benefits, but the attendant conflicts of interest must be addressed.
"The legislation requiring public disclosure of the financial relationships between healthcare vendors and physicians has been widely discussed in policy circles for years. Critics claimed payments for speaking, consulting, research or even the small trinkets and meals delivered during routine sales calls unduly influenced physician choices and inflated healthcare costs. To combat those effects, Congress required public reporting of those payments in a publicly accessible database. The legislation, labeled the Physician Payment Sunshine Act, was included in the 2010 healthcare reform law."
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Prescription project director Danny Carlat identifies issues with the Physician Payments Sunshine Act requiring further clarification and guidance. Addressing those would ensure that manufacturers can appropriately implement the final rule, and enable consumers to benefit from transparency reports published by the Centers for Medicare & Medicaid Services.
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The Pew Charitable Trusts is working to decrease the influence of pharmaceutical marketing on doctors’ practices. With a three-year grant from the Attorney General Consumer and Prescriber Education Grant Program, Pew is collaborating several partners to improve conflict-of-interest policies within the 158 medical schools and 400 major teaching hospitals in the United States.
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The Pew Charitable Trusts appreciates this opportunity to submit comments to CMS's "Information Collection Activities" draft guidance. We suggest that both the research and non-research payment templates be modified in order to make it easier for consumers to identify which drugs, devices, biologicals, or medical supplies are associated with particular transfers of value.
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On Feb. 1, 2013, the Centers for Medicare & Medicaid Services published the final rule guiding implementation of the Physician Payments Sunshine Act, which Congress passed as part of the Affordable Care Act in March 2010 to increase transparency in the relationships between physicians and drug and medical device makers. Here are some of the highlights.
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