Financial Conflicts of Interest: The Limits of Disclosure and Management Peter Lurie, MD, MPH Public Citizen’s Health Research Group Presented at: Conflicts.

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Presentation transcript:

Financial Conflicts of Interest: The Limits of Disclosure and Management Peter Lurie, MD, MPH Public Citizen’s Health Research Group Presented at: Conflicts of Interest, Privacy/Confidentiality, and Tissue Repositories: Protections, Policies, and Practical Strategies PRIM&R Conference Boston, Massachusetts, May 3, 2004

Conflicts of Interest Affect … Study design Research ethics Publication (or not) Data presentation Scientific debates Regulatory Review

Placebo-controlled Trials of Acyclovir to Suppress Recurrent Herpes Genitalis

A Drug Company-sponsored Unethical Clinical Trial in Developing Countries Discovery Laboratories, Doylestown, PA Synthetic surfactant (Surfaxin) 4 surfactants on the market (1st in 1990) Associated with 34% relative reduction in neonatal mortality (Cochrane meta- analysis) “Without doubt the most thoroughly studied new therapy in neonatal care” (NEJM review)

A Drug Company-sponsored Unethical Clinical Trial in Developing Countries Title of internal FDA meeting: “Use of placebo-controls in life threatening diseases: is the developing world the answer?” Location: Mexico, Peru, Bolivia, Ecuador Design: Surfaxin vs. placebo (vs. approved surfactant)

A Drug Company-sponsored Unethical Clinical Trial in Developing Countries February 2001: Public Citizen writes to HHS Secretary Tommy Thompson March 2001: Bolivian health ministry says the study is “totally prohibited” for legal, ethical and social reasons April 2001: Discovery announces study changed to compare to known effective surfactant

April 15, 1997

Content of Medical School-Industry Multicenter Trial Contracts Source: NEJM 2002;

Depiction of Alosetron (Lotronex) Efficacy in Lancet Source: Lancet 2000;355:

Public Citizen Depiction of Alosetron (Lotronex) Efficacy Source: Lancet 2000;356:2009

The Debate Over the Safety of Calcium Channel Blockers Source: NEJM 1998;338:101-6

FDA AC Member Recusals in Drug Procuct-Specific Meetings 18 recusals (1.5%) in 81 meetings in study period Through January 2002: 7 recusals; 0% reason given After January 2002: 11 recusals; 36% reason given Examples of recusals:  Research and consulting on topic of scientific meeting  Principal investigator of related clinical trial  Research on competing products and consulting on product at issue  Invention of competing product

Disclosed Conflict Rates for AC Members and Consultants* *Includes recusals **Percentage of 81 meetings where at least 1 COI was disclosed ***Percentage of 1220 AC member or consultant person-meetings disclosing a COI Through January 2002 After January 2002 Total Per meeting COI rate** 92%87%89% Per person-meeting COI rate*** 24%20%22%

Value of Particular Conflict Types for AC Members and Consultants, January 1, 2001-June 30, 2003 * Consulting arrangements (n=114) *Excludes 99 conflicts through January 2002 without any conflict-type details Investments (n=78)

Conclusions Conflict of interest permeates the entire research process Financial conflict of interest, in particular, has an adverse impact upon the public face of science Some conflicts are so worrisome that disclosure and “management” will not suffice