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Research Letters |

Updated Estimates of Pharmaceutical Company Payments to Physicians in Vermont FREE

Joseph S. Ross, MD, MHS; Alexander G. Nazem, BS; Peter Lurie, MD, MPH; Josh E. Lackner, BS; Harlan M. Krumholz, MD, SM
JAMA. 2008;300(17):1998-2000. doi:10.1001/jama.2008.560.
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To the Editor: We previously examined the experiences of Vermont and Minnesota with state laws requiring that pharmaceutical companies disclose payments to health care professionals.1 However, in Vermont, companies were permitted to designate payments as trade secrets, preventing their inclusion in our study. Public Citizen subsequently obtained disclosed trade-secret–designated payments through litigation against the companies. We present updated findings and comparison of trade-secret– and non–trade-secret–designated payments.

Our methods have been described previously.1 Vermont law requires disclosure of payments of $25 or more.2 We categorized each payment by recipient and purpose; recipient names were typically not disclosed as part of the settlement. We conducted a descriptive analysis, summarizing all payments over the study period stratified by whether or not they were initially designated trade secret. We focused on payments of $100 or more because these exceed guidelines by the American Medical Association and Pharmaceutical Research and Manufacturers of America for gifts to physicians.3,4 We used χ2 and Brown-Mood 1-way analyses of variance with medians to compare trade-secret– and non–trade-secret–designated payments. Analyses were performed using SAS 9.1 (SAS Institute Inc, Cary, North Carolina). All statistical tests were 2-tailed, using a type I error rate of .002 to account for multiple comparisons.

From July 1, 2002, to June 30, 2004, there were 21 409 payments of any value to all health care professionals and organizations, totaling $4.90 million (median, $52; range, $0.22-$63 458). This sum is $0.69 million less than the $5.59 million calculated by the Vermont attorney general,5 a discrepancy accounted for by our exclusion of discount and rebate payments (not required to be disclosed by law) reported by a single company. Of these 21 409 payments, 9182 (42.9%) totaling $2.72 million (55.5%) were designated trade secret. There was a nonsignificant difference between the median trade-secret– and non–trade-secret–designated payments ($53 vs $51; P = .06), although a greater proportion of trade-secret–designated payments were for $100 or more (29.6% vs 25.0%; P < .001).

There were 5539 payments that exceeded $100, totaling $4.20 million (median, $250; range, $100-$63 458) (Table). Of these, 2713 (49.0%) totaling $2.44 million (58.1%) were designated trade secret; the median trade-secret–designated payment was significantly greater than the median non–trade-secret–designated payment ($500 vs $184; P < .001).

Table Graphic Jump LocationTable. Disclosed Payments of $100 or More From Pharmaceutical Companies in Vermont, July 2002 Through June 2004

Approximately 86% of trade-secret and non–trade-secret–designated payments exceeding $100 were to physicians, comprising 4743 payments totaling $3.20 million (median, $250; range, $100-$20 000). Among these, the median trade-secret–designated payment was significantly greater than the median non–trade-secret–designated payment ($500 vs $177; P < .001) (Table). Trade-secret–designated payments to physicians were more likely to be for education or speakers, and less likely to be for detailing or unspecified purposes, when compared with non–trade-secret–designated payments (P values < .001) (Table), and were less likely to be in the form of food (25.3% vs 67.5%; P < .001).

Among all payments of any value, 30 companies did not designate any trade secrets, 7 designated all trade secrets, and 14 designated some but not all trade secrets. Among payments to physicians that exceeded $100, 46 companies provided 4743, totaling $3.20 million (median number per company, 21; range, 1-973; median total amount, $13 549; range, $116-$994 567).

Data about nearly half of payments exceeding $100 to physicians from pharmaceutical companies in Vermont, accounting for two-thirds the total value, were obtained through litigation; they were available only to the plaintiff, not the general public. Trade-secret–designated payments were of greater value and many were for food. Currently proposed federal legislation (S.2029 and HR.5605) does not permit trade-secret designation of payments. However, proposed state bills, such as in Washington,6 do include trade-secret provisions, which prevent disclosure of substantial numbers of payments. Variation in designation among companies and among payment purposes raises concerns about the appropriateness of trade-secret designation and its practical usage.

Author Contributions: Dr Ross had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the analysis.

Study concept and design: Ross, Lurie, Lackner, Krumholz.

Acquisition of data: Ross, Nazem, Lurie.

Analysis and interpretation of data: Ross, Lurie, Krumholz.

Drafting of the manuscript: Ross.

Critical revision of the manuscript for important intellectual content: Ross, Nazem, Lurie, Lackner, Krumholz.

Statistical analysis: Ross.

Administrative, technical, or material support: Lurie, Krumholz.

Study supervision: Lurie, Krumholz.

Financial Disclosures: Drs Ross and Krumholz reported having served as consultants at the request of plaintiffs for recent suits against Merck and Co Inc related to Vioxx. Dr Krumholz reported having research contracts with the American College of Cardiology and the Colorado Foundation for Medical Care; being on an advisory board for UnitedHealthcare; serving as a subject matter expert for VHA Inc; and being editor-in-chief of Circulation: Cardiovascular Quality and Outcomes and Journal Watch Cardiology of the Massachusetts Medical Society. Dr Krumholz reported that in the past 5 years he has received a research grant from Boehringer-Ingelheim; served as a consultant to Centegen; and served as an advisory board member for Alere, CV Therapeutics, and Amgen. No other disclosures were reported.

Funding/Support: Dr Ross is currently supported by Department of Veterans Affairs Health Services Research and Development Service project No. TRP-02-149 and by the Hartford Foundation. Mr Nazem was supported by the Yale University School of Medicine Medical Student Research Fellowship and the Richard Alan Hirshfield Memorial Fellowship in New Haven, Connecticut. Dr Lurie and Mr Lackner received support from the Irene Diamond Fund.

Role of the Sponsors: None of these organizations had any role in the design or conduct of the study; in the collection, management, analysis, or interpretation of the data; or in the preparation, review, or approval of the manuscript.

Disclaimer: The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs.

Additional Contributions: Adina Rosenbaum, JD, Public Citizen, assisted in acquiring trade-secret–designated data through her role as staff attorney. Cary P. Gross, MD, Yale University School of Medicine, and Sidney Wolfe, MD, Public Citizen, contributed to the conception and design of the original study for which this is a follow-up. None of these persons were compensated for their roles in the study.

Ross JS, Lackner JE, Lurie P, Gross CP, Wolfe S, Krumholz HM. Pharmaceutical company payments to physicians: early experiences with disclosure laws in Vermont and Minnesota.  JAMA. 2007;297(11):1216-1223
PubMed   |  Link to Article
 Vermont statutes; Title 18: Health; Chapter 91: Prescription drug cost containment; 2007 VSA §4632. Pharmaceutical marketers (March 2007). http://www.leg.state.vt.us/statutes/fullsection.cfm?Title=18&Chapter=091&Section=04632. Accessed August 5, 2008
 American Medical Association ethical opinions and guidelines: Opinion 8.061, gifts to physicians from industry (March 2008). http://www.ama-assn.org/ama/pub/category/4001.html. Accessed August 5, 2008
 PhRMA code on interactions with healthcare professionals (January 2004). Pharmaceutical Research and Manufacturers of America. http://www.phrma.org/files/PhRMA%20Code.pdf. Accessed August 5, 2008
 Pharmaceutical marketing disclosures: report of Vermont Attorney General William H. Sorrell (May 10, 2005). State of Vermont, Office of the Attorney General. http://www.atg.state.vt.us/upload/1119349220_Pharmaceutical_Marketing_Disclosures_-_Report_of_Vermont_Attorney_General_William_H_Sorrell.pdf. Accessed August 5, 2008
 Substitute senate bill 5917: requiring the disclosure of gifts made by pharmaceutical manufacturers to persons who prescribe prescription drugs (February 2007). State of Washington. http://apps.leg.wa.gov/documents/billdocs/2007-08/Pdf/Bills/Senate%20Bills/5917-S.pdf. Accessed October 1, 2008

Figures

Tables

Table Graphic Jump LocationTable. Disclosed Payments of $100 or More From Pharmaceutical Companies in Vermont, July 2002 Through June 2004

References

Ross JS, Lackner JE, Lurie P, Gross CP, Wolfe S, Krumholz HM. Pharmaceutical company payments to physicians: early experiences with disclosure laws in Vermont and Minnesota.  JAMA. 2007;297(11):1216-1223
PubMed   |  Link to Article
 Vermont statutes; Title 18: Health; Chapter 91: Prescription drug cost containment; 2007 VSA §4632. Pharmaceutical marketers (March 2007). http://www.leg.state.vt.us/statutes/fullsection.cfm?Title=18&Chapter=091&Section=04632. Accessed August 5, 2008
 American Medical Association ethical opinions and guidelines: Opinion 8.061, gifts to physicians from industry (March 2008). http://www.ama-assn.org/ama/pub/category/4001.html. Accessed August 5, 2008
 PhRMA code on interactions with healthcare professionals (January 2004). Pharmaceutical Research and Manufacturers of America. http://www.phrma.org/files/PhRMA%20Code.pdf. Accessed August 5, 2008
 Pharmaceutical marketing disclosures: report of Vermont Attorney General William H. Sorrell (May 10, 2005). State of Vermont, Office of the Attorney General. http://www.atg.state.vt.us/upload/1119349220_Pharmaceutical_Marketing_Disclosures_-_Report_of_Vermont_Attorney_General_William_H_Sorrell.pdf. Accessed August 5, 2008
 Substitute senate bill 5917: requiring the disclosure of gifts made by pharmaceutical manufacturers to persons who prescribe prescription drugs (February 2007). State of Washington. http://apps.leg.wa.gov/documents/billdocs/2007-08/Pdf/Bills/Senate%20Bills/5917-S.pdf. Accessed October 1, 2008
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