October 25, 2011 — Analysis of data on payments from orthopaedic device manufacturers to orthopaedic surgeons before and after a Department of Justice (DOJ) investigation illuminates a complex situation that requires further analysis, concludes a report published in the October 24 issue of the Archives of Internal Medicine.
Jason M. Hockenberry, PhD, now from the Rollins School of Public Health at Emory University, Atlanta, Georgia, and colleagues examined the information. The DOJ case considered payments for consulting, royalties, and research support, excluding reimbursement of travel costs.
In 2005, the DOJ began investigating payments made to surgeons providing hip and knee implants from the 5 manufacturers that sell 95% of these devices: Biomet Orthopedics, DePuy Orthopaedics Inc, Smith & Nephew plc, Stryker Orthopaedics, and Zimmer Inc. The 2007 settlement required the companies to disclose on their Web sites the name, location, and fees paid to each physician. Only DePuy, Smith & Nephew, and Stryker continued to post data through 2010.
In 2007, 939 orthopaedic surgeons received 1041 payments exceeding $198 million. In 2008, after the settlement, 526 orthopaedic surgeons received 568 payments totaling more than $228 million, but this figure fell to $119 million after subtracting a 1-time royalty buyout payment from Zimmer. Mean payments to orthopaedic surgeons were $212,740 in 2007, $193,943 in 2008, $246,867 in 2009, and $233,108 in 2010, which would make up at least 25% of a surgeon's annual salary. Payments ranged from less than $25,000 to more than $1 million, and the decline in number disproportionately reflected smaller disbursements.
Representation by academia showed a "modest increase" from 39.4% in 2007 to 44.9% in 2008, a percentage maintained in 2009 and 2010. This trend, the authors suggest, could reflect a strategy to target surgeons who train other surgeons. Yet Hockenberry and colleagues also note that more than 25% of the surgeons receiving industry money had fewer than 2 publications, indicating perhaps that industry is also targeting high-volume practices, in which presumably surgeons would have little time to conduct studies or write articles.
The physicians in the DOJ investigation represent only about 4% of the 25,000 orthopaedic surgeons in the United States. Although the settlement required that physicians disclose their relationships with device makers to patients, the authors cite studies suggesting that such payments might "interfere with physician judgment and pose a threat to scientific integrity and patient trust."
Limitations of the study, the authors write, include inconsistencies in categorizing payments and continued disclosure by only 3 firms. In addition, points out Robert Steinbrook, MD, from the Yale School of Medicine, New Haven, Connective, in an invited commentary, "the public data provide no information about how the payments relate to research and device development."
Dr. Hockenberry and colleagues conclude that, "universal and detailed disclosure with standardized reporting formats and data elements would make these data more useful to patients, providers, and policymakers." Because the Patient Protection and Affordable Care Act requires public disclosure of gifts and payments from drug and device industries to physicians, such practices will soon be more transparent.
Dr. Hockenberry and one coauthor received funding from the Department of Veterans Affairs. The coauthor also received support from the National Institutes of Health and the Robert Wood Johnson Physician Faculty Scholars Program, and consulted for Consumers Union and Vanguard Health. None of these sources provided support for this article. Dr. Steinbrook has disclosed no relevant financial relationships.
Arch Intern Med. 2011;171:1759-1766. Abstract
No comments:
Post a Comment