FY2008 FACA Training Conference

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FY2008 FACA Training Conference

• THE ETHICS OF ADVICE
• Marilyn L. Glynn
• General Counsel
• U.S. Office of Government Ethics

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Possible Conflicts

• outside employment
• board positions
• consulting relationships
• stocks
• options
• research support
• spouses employment
• gifts from industry
• paid expert testimony

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Politics and Advice
Scientists Say They Were Questioned on
Politics The New York Times July 9, 2004
Panel Debates Politics Role In Scientists
Appointment The Washington Post July 22, 2004
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Why Are Conflicts Issues So Important When the
Government is Involved?

• Government action has widespread impact
• Government action can be prescriptive
• Government action can affect health and safety
• Public funds are used
• Public is disengaged from advisors --problems
  with transparency and accountability
• Public confidence in Government operations

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EPA Advisory Boards
Toxic Chemical Review Process Faulted Scientists
on EPA Advisory Panels Often Have Conflicts of
Interest, GAO Says The Washington Post July 16,
2001
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Advisor to DOJ on the Safety of Tasers
Taser Official Removed as Adviser on Stun Gun
Study USA Today May 12, 2005
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Committee to Revise Dietary Guidelines
Diet Panel Nominees Questioned The Washington
Post August 25, 2003
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Energy Task Force
Study Confirms Stakeholders Gave Advice to
Energy Panel The New York Times August 26, 2003
GAO Cites Corporate Shaping of Energy Plan The
Washington Post August 26, 2003
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Defense Policy Board
Inquiry Is Urged Into Role Played By Adviser to
U.S. The New York Times March 25, 2003
Perles Resignation Not a Cure, Group Says
Ethical Dealings of Advisory Boards
Government-Wide at Issue, Watchdog Says The
Washington Post March 29, 2003
The Conflict in Iraq Advocates of War Now Profit
From Iraqs Reconstruction The Los Angeles
Times July 14, 2004
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Vaccine Advisory Committees
Burton Critical of Vaccine Approval Process Staff
Report Details FDA and CDC Conflicts in Approval
of Controversial Rotavirus Vaccine The Committee
on Government Reform Dan Burton (R IN),
Chairman August 23, 2000
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Why Should We Swallow What These Studies Say?
In a society rife with conflicts of interest,
disclosure of such conflicts Is usually a good
tonic. In finance, we can read the fine print
and decide whether to invest or seek other
advice. We can hedge our bets. But in medicine,
where decisions on treatment can have lasting
effects, mere disclosure isnt enough. Jerome
Kassirer Editor in Chief Emeritus New England
Journal of Medicine
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Why Should We Swallow What These Studies Say?
(contd)
It has become a truism on Wall Street that
conflicts of interest are unavoidable. In fact,
most of them only seem so, because avoiding them
makes it harder to get rich. Thats why full
disclosure is so popular It requires no
substantive change. Disclosure covers up the
question of bias with a patina of honesty. It
tells you little or nothing about whether the
disclosed conflicts of interest actually tainted
a report. Jerome Kassirer Editor in Chief
Emeritus New England Journal of Medicine
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FDA Advisory Committees
FDA Advisers Tied to Industry USA Today September
25, 2000
FDA Drug Panel Rife with Conflicts of
Interest The Associated Press April 26, 2006
FDA Advisers Shouldnt Have Ties to Industry,
Group Says The Washington Post March 11, 2005
Implant Panelist Received Grant From Maker The
Washington Post November 18, 2003
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FDA How to Address Conflicts Issues
Number of Drug Experts Available is Limited USA
Today September 24, 2000
FDA Revamps Committee Conflict-of-Interest
Rules Journal of the National Cancer
Institute October 4, 2006
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FDA Act Amendments

• Public Law 110-85
• 110th Congress
• An Act
• To amend the Federal Food, Drug, and Cosmetic Act
  to revise and extend the user-fee programs for
  prescription drugs and for medical devices, to
  enhance the postmarket authorities of the Food
  and Drug Administration with respect to the
  safety of drugs, and for other purposes.
• Be it enacted by the Senate and House of
  Representatives of the United States of America
  in Congress assembled,
• SECTION 1. SHORT TITLE.
• This Act may be cited as the Food and Drug
  Administration Amendments Act of 2007''.

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The Dirt on Coming Clean Perverse Effects of
Disclosing Conflicts of Interest

• A Study by professors at Carnegie Mellon found
  that
• 1. Advisors who had to disclose their conflicts
  gave more biased advice than those who didnt
  disclose conflicts,
• and
• Recipients of advice discounted some of the
  advice given by the advisors who disclosed the
  conflicts. But . . .
• The discounting was not enough to offset the
  increased bias.

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What Can You Do to Address Conflicts and Reduce
the Likelihood of Criticism?

• Cast a wide net for committee candidates Ask
  the public to nominate candidates
• Screen for conflicts make sure the screening
  process is clearly defined
• Require disclosure
• Require recusal where necessary make use of
  partial recusals

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What Can You Do to Address Conflicts and Reduce
theLikelihood of Criticism (contd)?

• In extreme cases, consider divestiture
• or resignation
• Use waivers where necessary
• Promote transparency let the public
• know how youre addressing conflicts

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FY2008 Federal Advisory Committee Act (FACA)
Training Conference

• December 11-12, 2007
• Renaissance Hotel
• Washington DC

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FY2008 Federal Advisory Committee Act (FACA)
Training Conference

• Breakout Sessions Begin at 130