Title: Some Highlights of Institute of Medicine Report on Conflict of Interest in Medical Research, Education, and Practice As Related to Practice Guidelines
1Some Highlights of Institute of Medicine Report
on Conflict of Interest in Medical Research,
Education, and PracticeAs Related to Practice
Guidelines
- Remarks by
- Robert Krughoff, President
- Consumers CHECKBOOK/Center for the Study of
Services - for
- AHRQ 2009 Annual Conference
2The IOM Committees Charge
- Examine conflicts of interest in medical
research, education, and practice and in the
development of clinical practice guidelines - Develop analyses and recommendations to inform
policies to identify, limit, and manage conflicts
of interest in these contexts without damaging
constructive collaborations with industry - .
3Scope
- Conflicts in academic medical centers, research
institutions, professional societies, journals,
etc. - How conflicts might affect persons and
organizations that rely on good research,
education, care, and guidelinesand how these
organizations might use their leverage to enforce
conflict of interest policies - Licensing boards, insurers, provider
organizations, consumer organizations, patients,
etc. - Only considered financial conflicts related to
drug, device, and biotechnology industries, not
conflicts related to - Payment/reimbursement systems
- Professional training and preferences
- Ownership interests in provider organizations
- Intellectual biases
4Definition of Conflict of Interest
- Circumstances that create a risk that
professional judgments or actions regarding a
primary interest will be unduly influenced by a
secondary interest - Primary interests of medicine are to
- Provide beneficial care to patients
- Conduct valid research
- Offer excellent medical education
- Interests of for-profit medical companies are to
- Produce products that improve health
- Ensure a financial return to shareholders
- A conflict of interest is a risk--not necessarily
the existence of biased judgment or action
5Tensions and Challenges
- There are benefits from interactions between
clinicians/researchers and industry - Translation of discoveries into products for
clinical practice - But how big are these benefits, and what if
the system had not evolved this waynot addressed
by committee - And there are risks of interactions
- Bias in professional judgment
- Loss of public trust
- Committee gave evidence of harm, but could
not quantify harm - New policies on conflicts of interest might have
unintended adverse consequences
6Committees Approach to Conflicts of Interest
- Disclosure an essential but limited first step
- Assess likelihood and seriousness of harm
- Determine whether conflict should be prohibited
or managed, and if managed, how
7Recommendations on Disclosure/Management
- 3.1, 3.2 Institutions/organizations that conduct
medical research, medical education, patient
care, and practice guideline development should
adopt and make public conflict of interest
policies for individuals - Create conflict of interest committee to review
disclosures and determine response to conflicts
(e.g., eliminate, manage) - Make disclosures specific enough to identify and
assess risks of relationships - Avoid unnecessary administrative burdens
8Recommendations on Disclosure/Management(contd)
- 3.3 There should be a broad-based consensus
process to develop standard categories and
formats for disclosure of financial interests to
institutions, with the expectation that this
would lead to common software that individuals
could use to report for multiple purposes-- - Reduce burden on individuals who have to report
- Improve adequacy of information to assess
relationships and risks - 3.4 Congress should require pharmaceutical,
medical device, and biotechnology companies to
publicly report payments to physicians and other
prescribers, researchers, health care
institutions, professional societies, providers
of continuing medical education, etc. - Should be in a database searchable by name of
recipient
9Broader-Disclosure Model
- Minority view
- All institutions that will get disclosures should
require that the individual, using the new
standardized reporting requirements and software,
simply do an extra click of the button to send
to a public database the same information that
he/she is reporting to an institution - Rationale
- Would include information on patent and equity
ownership not included in what industry has to
report - Would allow industry reporting to be
cross-checked against reports of individuals to
institutions - Would reveal how aggressive institutions are in
requiring reporting and managing and limiting
conflicts - Would not impose significant burden on
individuals, since only individuals already
required to report to institutions would be
required to report the same information publicly,
and many individuals will have nothing to report
10Recommendations on Continuing Medical Education
- 5.3 Consensus development process should be
convened to develop a new system of funding
accredited continuing medical education that is
free of industry influence and provides
high-quality education - Quotation marks here and later are mine to
highlight ambiguities that trouble me.
11Recommendations on Medical Practice
- 6.1 Physicians should
- Not accept items of material value, or consulting
arrangements, except when a transaction involves
payment at fair market value for a legitimate
service - Not meet with sales representatives except by
documented appointment and at the physicians
express invitation - Not accept ghostwriting
- Limit acceptance of drug samplesif at all, only
give to patients who lack financial access to
medications and only when generic alternatives
are not available and the medication can be
continued at little or no cost to the patient for
as long as it is needed - Professional societies and health care
providers should amend policies to support these
recommendations - 6.2 Companies should have policies and practices
consistent with these recommendations
12Recommendations on Practice Guidelines
- 7.1 Organizations that develop clinical practice
guidelines should - Exclude as panel members individuals with
conflicts of interest - Not accept direct funding of guidelines from
companies or company foundations - Publicly disclose with each guideline their
conflict of interest policies, procedures, and
sources and amounts of indirect or direct
funding for the guideline -
- Report text Some committee members also wanted
groups that develop guidelines to report publicly
all their sources, amounts, and purposes of
funding because industry contributions to general
revenues (e.g., from journal advertising) could
also create undue influence. There was not
consensus on this point.
13Recommendations on Practice Guidelines(contd)
- 7.1 contd--In the exceptional situation in which
avoidance of participants with conflicts of
interest is impossible because of the critical
need for expertise, then organizations should-- - Publicly document that they made a good faith
effort to find expert panel members without
conflicts of interest by issuing a public call
for members and other recruitment measures - Appoint a chair without a conflict of interest
- Limit members with conflicting interests to a
distinct minority of the panel - Exclude individuals who have a fiduciary or
promotional relationship with a company that
makes a product that may be affected by the
guidelines - Exclude panel members with conflicts from
deliberating, drafting, or voting on
recommendations - Publicly disclose relevant conflicts of interest
for panel members
14Recommendations on Practice Guidelines(contd)
- Note the exclusion of panel members with
conflicts from deliberating, drafting, or voting
on recommendations. - Exclusion is not limited to portions of
guidelines that relate to the members conflicts. - Committees judgment was that if the guideline
panel would be able to reach judgment without the
conflicted members deliberation, drafting, or
voting on a conflict-related issue, then the
panel could do this on all issuesthat the
conflicted members role was merely to be a
convenient source of information and
understanding/education for other panel members,
not one of the judges. -
15Recommendations on Practice Guidelines(contd)
- Report text
- Committee believed that an end to direct funding
for guidelines is necessary to avoid the
conflicts that come from industry financing. - An expanded role for public-sector sponsorship of
guidelines would be desirable, but that issue is
beyond committees scope. - Professional societies could collaborate and
share costs. - Pooling mechanisms might be created to support
guideline development in broad categories. - Committee endorsed a recent IOM report calling
for Congress to require designation of a single
entity with the responsibility to-- - Establish priorities for and manage the
development of systematic reviews of clinical
effectiveness - Develop standards for such reviews and for
clinical guidelines - Address conflicting guidelines.
-
16Recommendations on Practice Guidelines(contd)
- 7.2 Accrediting and certification bodies, health
insurers, public agencies, and other similar
organizations should encourage institutions that
develop practice guidelines to adopt conflict of
interest policies consistent with the
recommendations in this report. Two desirable
steps are for - The National Guidelines Clearinghouse to require
that all guidelines accepted for posting describe
(or provide a link to) the developers conflict
of interest policies, the sources and amounts of
funding for the guideline, and the relevant
financial interests of guideline panel members if
any - Accrediting and certification organizations,
public and private health plans, and similar
groups to avoid using practice guidelines for
performance measures, coverage decisions, and
similar purposes if the guideline developers do
not follow the practices recommended in this
report