Online Disclosure of Physician-Industry Relationships

1. Online Disclosure of Physician-Industry Relationships Robert Steinbrook, M.D. National Correspondent New England Journal of Medicine May 8, 2009

4. Limitations of Disclosure • Provides information and can make financial relationships widely known but does not eliminate bias or resolve problems created by conflicts of interest. Specific amounts usually not disclosed. • “Disclosure” and “reporting” differ. Disclosure implies public availability of the information. Information that is never reported cannot be disclosed, but some information is merely reported and either remains confidential or is disclosed selectively, for example, to some within an institution. • Disclosure can be used to “cleanse” a problematic situation; industry relationships should be managed and some should not to be allowed. • Substantial commitment of time and resources required to provide accurate, clear, and comprehensive information. • Lack of consensus on definitions for categories of relationships and payments, approaches for calculating amounts, and standards for information to be made public.

5. Institute of Medicine ReportApril 28, 2009 • “The disclosure of individual and institutional financial relationships is a critical but limited first step in the process of identifying and responding to conflicts of interest….Disclosure does not resolve or eliminate conflicts of interest.” • Recommendation 3.3 “National organizations that represent academic medical centers, other health care providers, and physicians and researchers should convene a broad-based consensus development process to establish a standard content, a standard format, and standard procedures for the disclosure of financial relationships with industry.” • For example, a term such as “consulting” needs “further specification” because it may refer to “relationships that range from the provision of promotional or marketing support to a company to the offering of technical advice on scientific advances, products in development or research study design.”

6. Related IOM Recommendations • Recommendation 3.1 “Institutions that carry out medical research, medical education, clinical care, or practice guideline development should adopt, implement and make public conflict of interest policies… [consistent with IOM recommendations]” • Recommendation 3.2 “Institutions should require individuals covered by their policies, including senior institutional officials, to disclose financial relationships with pharmaceutical, medical device and biotechnology companies to the institution on an annual basis and when an individual’s situation changes significantly.” • Policies should require disclosures that are sufficiently specific and comprehensive (with no minimum dollar threshold) to allow others to assess severity, avoid unnecessary administrative burdens, and require further disclosures as appropriate.

7. IOM Candidate List of Financial Relationships to Be Disclosed • Research grants and contracts • Consulting agreements • Participation in company’s speakers bureaus • Honoraria • Intellectual property, including patents, royalties, licensing fees • Stock, options, warrants, and other ownership (excluding general mutual funds) • Position with a company • Company governing boards • Technical advisory committees, scientific advisory boards, marketing panels • Company employee or officer, full or part time • Authorship of publications prepared by others • Expert witness for a plaintiff of a defendant • Other payments or financial relationships .

17. Examples of Forthcoming Online Disclosures • Medical Schools: • Stanford • University of Pennsylvania • Companies: • Eli Lilly • Glaxo • Merck • Pfizer

18. 2008 Massachusetts Law • Regulates conduct of pharmaceutical and medical device manufacturers. • Requires reporting and subsequent online disclosure of payments “with a value of at least $50” related to sales and marketing activities. Research grants and consulting related to research excluded. • First disclosure reports cover July-December 2009. Due July 2010. Public availability on a state Web site probably in 2011. • Some gifts banned, such as entertainment, recreation, pens, mugs. Meals restricted.

19. Physician Payments Sunshine Act of 2009 (S.301) • Would establish a searchable federal government Web site listing disclosures of industry gifts and payments to physicians. • Public availability possible by September 2011. • Reporting responsibility on companies, not physicians and researchers. • Threshold for disclosure, $100 in a calendar year (decreased from $500 in earlier version of bill). • Substantial penalties for failure to report.

20. Sunshine Act--additional considerations • Provisions for review of data for accuracy. • Preempts state reporting requirements. • Endorsed by AAMC, AMA, PhRMA, AdvaMed, individual companies. • Chances for enactment in 2009 better than they were in 2008.

21. Proposals from the IOM and Medicare Payment Advisory Commission • IOM Recommendation 3.4 The U.S Congress should create a national program that requires pharmaceutical, medical device and biotechnology companies and their foundations to publicly report payments to physicians and other non-physicians who prescribe medicines, biomedical researchers, health care institutions, professional societies, patient advocacy and disease-specific groups, providers of continuing medical education, and foundations created by any of these entities. Until the Congress acts, companies should voluntarily adopt such reporting. • The IOM proposal is similar to the March 2009 proposal from the Medicare Payment Advisory Commission. The commission’s proposal also covers payments to pharmacies and pharmacists, health plans and pharmacy benefit managers, payments by medical supply companies, reporting of recipient’s of drug samples, and reporting of physicians’ ownership share in hospitals and other health care entities.

22. Considerations for Online Disclosure • Databases should be searchable by physician, institution or company and should allow the aggregation of all payments. • If the information is not timely, it is less useful. The most useful information is current financial relationships. • Some personal identifying information, such as identification numbers of physicians who received payments, may need to be restricted because of concerns about privacy and identity theft. • Should the actual amounts of payments be disclosed? • Should reporting of payments related to clinical trials be delayed until the trial is registered? Should payments to a new drug be delayed until licensure subject to a maximum delay of perhaps 1-2 years? • Should databases be national or international and how should they related to online registries of clinical trials?