Will Disclosure Quiet the Industry’s Critics? Peter Lurie, MD, MPH Deputy Director Health Research Group at Public Citizen Presented before The National Disclosure Summit Washington, DC March 5, 2009

Why a Doctor Gifts Registry? Transparency/accountability to patients

Statement by American College of Physicians “What would my patients think about this arrangement? What would the public think? How would I feel if the relationship was disclosed through the media?” Source: Ann Intern Med 2002;136:

Why a Doctor Gifts Registry? Transparency/accountability to patients Restore trust in medical profession Facilitates kickback investigations Transparency/accountability to providers Transparency/accountability to payors Promotes research (esp. if names provided) Facilitates journalistic investigations

Uses by Journalists Investigative pieces by local journalists Comparisons by specialty Links to “thought leaders” Links to state disciplinary actions

Public Disclosure of Pharmaceutical Company Gifts to Physicians, VermontMinnesota Threshold$25$100 Trade secret exemption? YesNo Electronic?YesNo Reporting period2 years3 years Median physician gift >$100 (maximum) $250 ($20,000)$1000 ($922,239) Total physician gifts$3.2 million$22.4 million Sources: JAMA 2007;297: ; JAMA 2008;300:

Purpose of Payments >$100 to Physicians in Vermont,

Public Disclosure of Pharmaceutical Company Gifts to Physicians, High rates of underreporting –Companies report $millions one year, nothing the next Responses non-standardized –Aggregation by physician and by gift Exemptions –Samples –Research studies Limited accessibility –Lack of online submissions or reports –Need to file lawsuit in Vermont Lack of national standardization

Problems with the Physician Payment Sunshine Act, 2009 Exclusions –Samples –Research on unapproved products –Gifts totaling <$100 per year –Gifts to other professionals No payments to organizations –MECCs and PBMs –Patient groups –Hospitals and medical schools –Professional organizations No judicial review Low penalties –Intentional non-reporting: cap of $1 million/year

Framework for Addressing Conflict of Interest Potential Conflict Legal Restrictions Policy Restrictions Disclosure

Research Payments to Physicians Research Payments Legal Restrictions Not Desirable Not Feasible Policy Restrictions Pool of Research Funds Disclosure Some journals Some presentations

Non-research Payments to Physicians Non-research Payments Legal Restrictions Limited Political Feasibility Policy Restrictions Institutional Restrictions Boston University University of Michigan University of Pennsylvania Yale University Stanford University Boston Medical Center Geisinger Health System Affinity Health System Kaiser Permanente HealthPartners Disclosure State or Federal Databases

Pharmaceutical Company Promotional Expenditures, U.S., 2004 Total expenditures –Promotion: $57.5 billion –Research: $31.5 billion As % of retail sales –Promotion: 24.4% –Research: 13.4% $61,000 on promotion per physician Source: PLOS Medicine 2008;5:e1

Q: Will Disclosure Quiet the Industry’s Critics?

Q: Will Disclosure Quiet the Industry’s Critics? A: No