Transcript conflict of interest - Tech Transfer Central

Technology Transfer Tactics
Audio Conference
October 14, 2010
Best Practices for Managing
Conflict of Interest in University Research
Bernadette M. Broccolo
McDermott Will & Emery, LLP
312-984-6911
[email protected]
Focus of Today’s Discussion
Over the last decade, we have seen virtually
relentless scrutiny of financial ties between drug
and device manufacturers and universities,
providers and research institutes by federal and
state governments, courts, the public, professional
associations and journals, pundits, watchdogs and
the media.
2
In the media…
 “Patient
advocacy
groups…have long
complained that drug
companies exert undue
influence on doctors…”
 “[W]hen doctors are acting
as researchers, they should
not have money riding on
the outcome…”
3
In the media…
 “But
as the volume of disclosure rises,
some fear the ritual will become a mere
formality…”
 “[T]he cozy relationship between
prominent academics and the drug
industry…”
 “The health institutes could place
restrictions on the hospital’s grants or
even suspend them altogether.”
4
Focus of Today’s Discussion
 Conflicts
of interest in research arising from such
relationships
 Interplay with conflicts of interest in medical education
and clinical care
 Interplay with other compliance risks and challenges
 The Laws and Regulations v. Industry Standards/
Emerging Best Practices
 Provider and Industry Response to Scrutiny and Call for
Reform
5
Provider/Industry Relationship Puzzle
Individual and
Institutional Royalty and
Equity Interests in IP
and Spin-Off Companies
Recruitment bonuses
Business entertainment, gifts,
and travel reimbursement
Research
sponsorship and
grants arrangements
Consulting Agreements
Charitable Donations
Speakers Bureaus
Pricing practices
Credit for
published works
CME funding
Scientific advisory board participation
Other Institutional
Relationships
6
Provider/Industry Relationship Puzzle
Emerging Theme of Ethical, Legal and Safety Concerns
 The
concerns arising from all of these financial relationships are
variations on a common theme: They create undue influence that
can:
– Impair judgment in research resulting in risk to human subjects and
unreliable data underlying new product development;
– Change medical prescribing behavior that can pose harm to patients; or
– Diminish the objectivity and integrity of the content of medical educational
programs and materials.
7
Historical Perspective:
Where We Have Been

Federal policy beginning in 1980 (Bayh-Dole Act)
– Encouraging institutions to seek private investment for research.
– Allowing researchers and institutions to share in the financial return on
successful products/inventions.

Well established bodies of law governing COIs in research are
inadequate to meet today’s needs.
– Federal Common Rule and HHS Guidance on Conflicts, FDA, NIH/PHS
– FDA/NIH/PHS
– Focus only:
• Individual conflicts of PIs only (not other research team members)
• Individual and not institutional conflicts of interest
• Reporting (not assessment and management)
– Use dollar thresholds for disclosures of interests (“significant financial
interest”)
– Relies primarily on the IRB and PIs to address conflicts of interest
8
Historical Perspective:
Where We Have Been
 High
profile cases of harm to clinical research subjects
– Put spotlight on financial interests of researchers and institutions.
– Increased focus on both individual and institutional COIs.
– Focus on injury/harm to human subjects.
– Myriad legal theories
• Misrepresentation and fraud arising from failure to disclose COI.
• Breach of fiduciary duty implied under informed consent.
• Negligence, negligence per se.
• Violation of right to be treated with dignity.
• Assault/Battery (subject did not consent to research as conducted).
9
Catalysts for Change:
Where We Are Now

Widespread scrutiny
– Industry and Professional associations
– Courts and the plaintiffs bar
– Regulators
– Legislators (State and Federal)
– Patient advocates
– The Media (national, regional, local)
10
Catalysts for Change:
Where We Are Now

2004 guidance from HHS

Major Institutional Trade and Professional Associations (AAU, AAMC, AMA, IOM)
Related OIG guidance from OIG
 Major Manufacturer Trade Association Ethical Codes on Financial Interests between
Providers and Industry

– PhRMA and AdvaMed Codes

•
Both codes provide parameters for the full range of Interactions of their Members with
Healthcare Professionals.
•
Both codes were recently updated and contain tighter restrictions on industry interactions
with healthcare professionals.
•
The Codes provide some bright line standards that help guide Anti-Kickback Law
compliance efforts.
•
Compliance with the Codes, along with an active compliance program, may be viewed
favorably by the OIG and other enforcement agencies.
ACCME Certification Standards
11
Conflicts of Interest in Research:
2008 Joint AAMC/AAU Report on COIs in Clinical Trials
 Joint
Committee of AAMC and AAU issued a report on
Conflicts of Interest in Research (the “Report”) on
2/28/08.
 Reinforces and supplements 2001 and 2002 reports
 The Report challenged institutions to take action within
two years (2/28/10) to:
– Accelerate the development of COI policies that cover the financial
interests of faculty, institutions and their officials, including deans,
department chairs and division chiefs
– Implement a reporting, evaluation and management process for both
individual and institutional financial COI, that includes a review system
that involves a standing internal committee or an external review entity
12
January 2008 OIG Report:
NIH Conflicts of Interest in Extramural Research
Findings
 NIH could not provide an accurate count
of grantee financial conflict-of-interest
reports from 2004 through 2006.
 NIH is not aware of the types of
financial conflicts of interest that exist
within grantee institutions because
details are not required to be reported
and most conflict-of-interest reports do
not state the nature of the conflict.

Many Institutes’ primary method of
oversight is reliance on grantee
institutions’ assurances that financial
conflict-of-interest regulations are
followed.
Key Recommendations:
– Increase oversight of grantee
Institutions to ensure
compliance with Federal
financial COI regulations
– Require grantee Institutions to
provide details regarding the
nature of COI and its
management
– Require NIH to maintain all COI
from the grantee Institutions in a
database
13
FDA Oversight of Financial Conflicts of Interest in Research:
Report January 2009 OIG
 Federal
regulations require industry sponsors to collect and
disclose certain financial interests of investigators that could create
bias in the clinical research, such as serving as a consultant for the
study sponsor or participating in the sponsor’s speakers bureau.
 January
2009 OIG report sharply criticizes FDA’s oversight of
financial conflict of interest information submitted by investigators
conducting clinical trials.
14
January 2009 OIG Report:
FDA Oversight of Financial Conflicts of Interest
Findings:
One percent of clinical investigators disclosed a
financial interest
FDA cannot determine whether sponsors have
submitted financial information for all clinical
investigators.
Forty-two percent of FDA-approved marketing
applications were missing financial information.
FDA did not document a review of any financial
information for 31 percent of marketing applications.
Neither FDA nor sponsors took action for 20 percent
of marketing applications with disclosed financial
interests.
15
Industry Influence Over Medical Education:
June 2008 AAMC Report
AAMC Report - Guidelines Addressing Gifts from Industry
June 2008

Offers guiding principles and recommendations for how medical schools and teaching hospitals should govern student
and faculty interactions with industry. The report's objective is to prevent conflicts of interest that can distort therapeutic
judgments and decision making. The AAMC's leadership urged all association members to implement policies and
procedures, consistent with the report's guidelines, by July 1, 2009.
– Establish and implement policies that prohibit the acceptance of any gifts from industry by physicians, faculty,
students and residents on- or off-site
– Eliminate the receipt of drug samples or manage their distribution via a centralized process that ensures timely
patient access throughout the health care system
– Restrict access by pharmaceutical representatives to individual physicians by confining visits to non-patient areas
and holding them by appointment only
– Set up a central continuing medical education (CME) office to receive and coordinate the distribution of industry
support for CME activities
– Strongly discourage participation by faculty in industry-sponsored speakers' bureaus
– Prohibit physicians, residents, and students from allowing presentations of any kind to be ghostwritten by industry
representatives

ACCME – (June 2008) Issued a Call for Comments seeking industry input on revised policy proposals,
including a consideration that commercial support be eliminated from CME.
16
Industry Influence Over Medical Education:
Congressional Focus on Educational Grants
Finance Committee Report Focuses on Drug
Company Grants for Medical Education
Inquiry reveals educational grants as
common business practice, but potential for
abuse remains
The Senate Finance Committee
and Senate Committee on Aging
have launched formal probes of
activities that could undermine the
integrity of CME and research as
well as clinical care.
17
Industry Influence Over Medical Education:
American Medical Student Association COI Policy Scorecard

Scorecard on conflict-of-interest policies at the 151 medical colleges and colleges of
osteopathic medicine in the United States.

Assesses policies related to potential conflicts of interest created by industry marketing at
the level of the individual physician and trainee.

Most recent results: of the 151 US medical schools, 8 received As (5%), 14 Bs (9%), 5
Cs (3%), and 24 Ds (16%). These totals include 11 institutions assessed since the original
Scorecard release on May 30, 2008.

52 schools (34%) receive a grade of F. This includes 16 that either submitted policies
graded as F or indicated they had no relevant policies, as well as 13 schools that declined
to submit policies and 23 that did not respond to repeated attempts at follow-up.

September 2008 JAMA Commentary published in the Journal of the American Medical
Association indicates that stricter conflict-of-interest policies adopted by academic medical
centers has not apparently been detrimental to staff retention.
18
Industry Influence Over Medical Education:
Harvard Medical Students Express Concern
March 3, 2009 New York Times Article
Addresses Harvard medical student concerns
regarding industry relationships with Harvard
faculty.
 Just one day after the NYT article, Senator
Grassley sent a letter to Pfizer requesting
information regarding the nature and amount of
payments made to 149 Harvard faculty
members, such as honorarium or research
support.
“Pfizer
is attempting to intimidate young
scholars from professing their independent
views on issues that they think are critical
to science, medicine, and the health and
welfare of American taxpayers.”
19
Institute of Medicine Report:
COI in Medical Research, Education and Clinical Practice
 Issued
in late April 2009 by the Institute of Medicine of the National
Academies
 Comprehensive coverage of conflicts of interest arising from industry
relationships in all three areas of concern
 Reinforces the standards set forth by AAMC and AAU in earlier reports
(2008, 2002 and 2001)
 Recognizes the need for industry/provider collaboration to advance
science
 Reinforces that “disclosure” of interests is not enough to address the risk
 Calls for all the players to contribute to identifying and managing the
conflict of interest risk arising from these relationships
 Calls for uniform approach to transparency
 Urges a commitment to self-reform as the alternative to government
prescribed reform
20
June 2010 AAMC Report:
COIs in Clinical Care
 Reinforces
and complements recommendations in prior reports on
COIs in research and education
 Uses
IOM Report definition of clinical COI
A clinical COI occurs when a secondary financial interest
creates the risk of undue influence in the exercise of the
primary professional duty to the patient
 Actual
and Perceived Risk of Bias continues to be the standard
 Financial
 Heavier
 Patient
interests only (not associational)
hand with regard to royalties
Disclosure is Not Enough
21
June 2010 AAMC Report
7 Recommendations
 Address
Individual and Institutional Interests
 Disclose
Institutional Interests as a COI management step
 The
AAMC principles and standards should apply to all
providers
 AAMCs’
 Involve
own compensation practices can create COIs
patients in determining how to disclose COIs
 No
discussion of special challenges of disclosure,
assessment and management in clinical care setting – but
promise of future guidance
22
Interplay with Other Laws and Standards
• Anti-Kickback Law (Federal and State)
• False Claims Act (Federal and State)
• FDA law and regulations concerning labeling, promotion
and advertising
• Foreign Corrupt Practices Act
• Prescription Drug Marketing Act (PDMA) (samples)
• Medicare Marketing Guidelines
• State Consumer Protection Laws
23
Enforcement Activity
 Pharmaceutical,
medical device and biotech
manufacturers have been and will continue to be the
focus of the government’s intense and aggressive civil
and criminal health care fraud and abuse enforcement
initiatives.
24
Congress
-Anti-Kickback Statute
-False Claims Act
-MMA
Department of
Justice
-Civil/Criminal
Settlements
Office of
Inspector General
(OIG)
- Civil Monetary Penalties
- Exclusionary Authority
- Corporate Integrity
Agreements
Whistleblowers
Food and Drug
Administration (FDA)
-FDAMA
-Off-Label Promotion
Centers for Medicare
and Medicaid Services (CMS)
-Reimbursement Regulations
25
Qui Tam (Whistleblower) Actions
 False
Claims Act cases brought by private citizens on behalf of
the U.S. government
 The qui tam relator receives 15 to 30 percent of the
government’s recovery (can be reduced if the relator was
culpable for the fraud)
 Almost all fraud and abuse cases involving manufacturers
have been brought as False Claims Act whistleblower cases
26
GOVERNMENT V. PHARMA
Company
1999
2001
$ Millions
50
875
49
2002
2003
2004
Allegations
 Off-label marketing of human growth hormone Protropin
 Illegal marketing and price manipulation of Lupron
 Off-label marketing of Neurontin as a result of a Qui tam
complaint
248
 Misreporting “best price” for Cipro and Adalat CC
355
 Free samples of Zoladex distributed to urologists with the understanding that they
would bill for reimbursement
614
 Misreporting “best price” and kickbacks for enteral products
430
346
 Off-label marketing of Neurontin
2005
704
2006
435
40
2007
425
2009
1400
2300
 Misreporting “best price” off-label promotion, managed care kickbacks for Claritin
 Kickbacks to physicians, off-label promotion, off-label promotion via CME and
educational programs
 Off-label marketing of Temodar and Intron-A
 Off-label promotion of Actimmune and misleading use of clinical trial
results
 Off-label marketing of Actiq, Provigil, Gabitril
 Off-label marketing of Xyprexa
 Off-label marketing of Bextra, Geodon, Lyrica,
Zyvox
27
Government v. Device
2007 Hip and Knee Settlements: Allegations
 “This
industry routinely violated the anti-kickback statute by
paying physicians for the purpose of exclusively using their
products”
– “The financial inducements in the form of consulting
agreements . . . in which physicians did little or no work for the
financial inducements but did agree to exclusively use the
paying company’s products.”
– “The physician consultants also failed to disclose the existence
of these relationships with the companies to the hospitals
where the surgeries were performed and, more importantly, to
the patients that they treated.”
DOJ Press Release, 9/27/07
28
Government v. Device
2007 Hip and Knee Company Settlements
 Deferred
Prosecution Agreements (DPAs)
– Zimmer, Inc. ($169.5 million)
– Depuy Orthopaedics, Inc. ($84.7 million)
– Biomet Inc. ($26.9 million)
– Smith & Nephew, Inc. ($28.9 million)
 Non-Prosecution
Agreement (NPA):
– Stryker Orthopedics, Inc. (voluntarily cooperated first)
 5-Year
Corporate Integrity Agreements
29
Government v. Device
2007 Hip and Knee Settlements: Terms
 Retain
a monitor to review all consulting arrangements
 Disclosure of arrangements and amounts paid on company
web pages
 Disclosure of arrangements by physicians to patients
 Needs assessment to determine and document the reasonable
need for consulting arrangements
 Compensation of no more than $500 per hour for time actually
expended (without FMV opinion and Monitor approval)
 Invoices/documentation submitted prior to any payments
 Project manager must certify in writing that invoices reflect
bona fide services provided by Consultant prior to payment
30
Government v. Device
Orthofix International
 2008:
Guilty plea by physician
– “The federal case against Blackstone Medical of Springfield got a boost
yesterday when an Arkansas neurosurgeon pleaded guilty to soliciting and
accepting kickbacks from a salesman who worked for Blackstone's parent
company, Orthofix International, based in Netherlands Antilles, as well as three
other companies. Additional charges were dismissed in exchange for Dr. Patrick
Chan's agreement to cooperate in the government's investigation into separate
allegations that Blackstone and other companies defrauded the Medicaid and
Medicare programs by paying illegal incentives to other doctors. Those
allegations are contained in a whistle-blower's lawsuit.”
– “Chan also agreed to pay $1.5 million to settle allegations against him in the
whistle-blower suit, which alleges Blackstone and another company provided
kickbacks in the form of bogus consulting contracts, fake research studies, and
gifts to Chan and doctors across the nation who agreed to use the companies'
devices in back surgeries.” (Boston Globe, 1/4/08)
31
Government v. Physicians
HHS “Poster Child” Strategy
March 4, 2009 New York Times Article
 Within a few months, federal officials
“plan to file civil and criminal charges
against a number of surgeons” who
allegedly “demanded profitable
consulting agreements from device
makers in exchange for using their
products.”
“What we need to do is make examples of a
couple of doctors so that their colleagues
see that this isn’t worth it.”
Lewis Morris, Chief Counsel to the Department of
Health and Human Services Office of Inspector
General
32
State Attorneys General v. Pharma
 Use
of consumer protection laws and unfair trade practices laws to
pursue off-label promotion
 For Lilly and Pfizer, state AG settlements preceded the federal
settlements:
– Eli Lilly (October 2008) agreed to pay $62 million to 32 states and the
District of Columbia to settle allegations of alleged off-label marketing
related to its anti-psychotic drug Zyprexa.
– Pfizer (October 2008) agreed to pay $60 million to states as part of an $894
overall agreement to resolve a series of lawsuits involving allegations of an
illegal marketing campaign that encouraged physicians, hospitals, and
health plans to prescribe Bextra in higher doses for “off-label” uses after the
FDA had rejected Pfizer’s applications seeking authorization to use Bextra
at higher doses.
33
Reporting and Disclosure Minefields
34
Congressional Focus on Researchers’ Failures to
Report Payments
 Senate
Finance Committee and Senate Committee on Aging
launched investigations of industry/academia/provider
relationships that can affect quality and integrity of CME, clinical
care and research (Grassley)
 Two Phases: Began in certain cases with industry companies and
led to institutions and prominent clinicians/researchers
– Harvard
– Emory
– CRF
– University of Wisconsin
 Developed support for “Sunshine” legislation and triggered selfinitiated reform
35
Congressional Focus on Researchers’ Failures to
Report Payments
36
Congressional Focus on Researchers’ Failures to
Report Payments


October 2008 Dr. Charles Nemeroff, Chair of the Emory University
psychiatry department stepped down as chair of the department after the
congressional investigation determined that Nemeroff regularly exceed the
$10,000 limit for significant financial interests and failed to fully disclose
payments received from Glaxo while he was simultaneously conducting
research into Glaxo Drugs
Emory Settlement
– PI failure to fully disclose financial relationships with industry entities
– Emory as large recipient of NIH grant funds undertook extensive internal investigation
that resulted in agreed-upon sanctions
– PI permanently removed from Chair of Department
– Tight restrictions on future participation in industry speaker bureaus, CME
presentations, and scientific advisory boards, whether paid or unpaid
– No participation in NIH grant applications for 2 years

January 2009 Senator Charles Grassley wrote a letter requesting OIG of HHS
to investigate Emory University over possible violations of NIH grant rules,
government contract rules and other laws governing federally-funded research.
37
The New Transparency
Public Disclosure of Vendor/Provider Relationships
 Disclosure
of physician relationships
– Disclosure alone implies a level of concern and potential
impropriety
– Legitimate financial relationships vs. kickbacks
38
State Sunshine Laws
 Several
states have enacted a sunshine law
– Generally require pharmaceutical or medical device
manufacturers to report gifts or other economic benefits provided
to prescribers or purchases or prescription drugs or devices (e.g.,
hospital, pharmacist, nursing home) and/or impose certain
compliance or conduct requirements.
 Massachusetts
– First state to enact a law specifically requiring reporting by medical
device manufacturers.
– Recently survived a repeal attempt.
– More stringent than other states.
 Vermont
quickly followed suit.
39
State Reporting and Compliance Requirements
State Sunshine Laws
•California – Comprehensive Compliance Program
 District of Columbia – Reporting
•Louisiana - Sales activities as lobbying activities
Maine – Reporting (Clinical Trial Posting)
•Minnesota – Gift Restriction and Reporting
•Massachusetts – Compliance and Reporting
 Nevada – Information regarding Code of Conduct Compliance
 Vermont – Reporting
 West Virginia – Reporting


Ongoing activity in various other states!
40
The “Grassley” Federal Sunshine Law
 Senator
Grassley’s relentless efforts resulted in adoption of federal
sunshine law as part of “ObamaCare” (PPACA)
 Requires annual reporting by manufacturers of drugs, devices,
biologics and medical supplies on website and to HHS
– Transfers of value to physicians or teaching hospitals greater than $10
(unless $100 in aggregate)
•
Various exclusions (e.g., patient samples, limited period device loans, in-kind
charity care items, warranty replacements)
– MD ownership or investment interest in manufacturer or GPO (except
publicly traded companies and holdings through mutual funds)
 Delayed
reporting for product R&D and clinical trials
41
Federal v. State Sunshine Laws
 Limited
preemption of state law
– State law prevails if it requires:
Reporting of other payments/value transfers
• Reporting by other entities
• Reporting of payments/value transfers to other than physicians or
teaching hospitals
•
 Federal
law does not include code of conduct such as
MA sunshine law, PhRMA Code, AdvaMed Code
 State law does not address “institutional interests”
42
HHS Proposed Rulemaking:
Conflicts of Interest in PHS-Funded Research
 May
2009 HHS Notice of Proposed Rulemaking
– Proposed regulations
– Requests for comments on proposed rules and input on other
issues
 May
2010 HHS Proposed Revised Regulations
– Question Posed: “Is a more rigorous approach to investigator
disclosure, management of financial conflicts and federal
oversight needed?”
– Comment period closed July 20, 2010
43
HHS 2010 Proposed COI Rules:
Definition of Interest
 “Significant
Financial Interest”
– Any equity interest in non-publicly traded entities
– Dollar threshold for other categories reduced from $10,000 to $5,000
•
•
•
•
•
•
Value or potential value
Measured on prior year rather than coming 12 months
Includes payments for authorship and travel reimbursement
Includes royalties and royalty-sharing agreements
Excludes royalties from the institution to current employed/appointed
investigators (policy v. license agreements?)
Narrows exclusion for income from teaching etc. sponsored by
public/nonprofit entities to sponsorship by government agency or institution
of higher educations
44
HHS 2010 Proposed COI Rules:
Reporting and Assessment
 Investigator
must report to Institution any “imputed institutional
interests”
– SFIs that reasonably appear to be related to the investigator’s
institutional responsibilities (e.g., research, teaching, professional
practice, IRB membership)
 Institution
must Assess the Interest
– Whether SFI is related to the research
– Whether the relationship creates a COI
– “Could the SFI directly and significantly affect the design, conduct or
reporting of PHS-funded research?”
45
HHS 2010 Proposed Research COI Rules:
Reporting to HHS
 Now:
Only that institution identified a COI and managed, reduced
or eliminated it
 Proposed:
– Report specifics such as investigator name, nature and value, basis for
determination that COI exists, key elements of management plan
– Report anything internal policy requires even if policy is more stringent
than the regulations
46
HHS 2010 Proposed Research COI Rules:
Public Transparency
 Now:
No public reporting
 Proposed:
– Disclosure of details of the SFI on public website prior to any
expenditure of funds
•
Effectively increases institutions’ tracking and reporting burdens
– Posting of COI policies and procedures
47
HHS 2010 Proposed Research COI Rules:
Other
 Address
only financial interests of investigators
 Do not address direct institutional interests
– Complexity
– Seek public comment
 Action
required for new SFI that arose after research began
 Increased institutional burden regarding sub-recipients of PHSfunding
 More stringent training requirements
48
Today’s “Bottom Line”
 The
media, the public and regulators judge “yesterday’s
practices” using “today’s standards” and based on
appearance of conflict.
 Good
intentions and honesty of purpose are not
enough to deflect scrutiny.
 The
IRB process clearly is not enough!
49
Conflicts of Interest in Research:
The Balancing Act
Balancing the desire to encourage innovation through
research and commercialization with emerging best
practices concerning disclosure, assessment and
management of potential conflicts of interest
50
Conflicts of Interest in Research:
A Review of The Potential Liabilities & Risks
endanger Research Subjects’ safety and result in
private claims for negligence, etc.
 May
reduce the public’s willingness to participate in
research
 May
 May
inhibit future discoveries if less support for
research
 Loss
of federal funding
 Sponsor’s
inability to obtain FDA approval or exposure
to withdrawal of approval
51
Conflicts of Interest in Research:
A Review of The Potential Liabilities & Risks
 Government
 Suspension
investigations of research compliance generally
of research activities by IRB and/or government
agencies
 Individuals
and institutions debarred from conducting federally-funded
and FDA-regulated research
 Perfect
Storm: loss of reputation and public confidence in research,
clinical care and education
 Perfect
Storm: criminal and civil liability (Anti-kickback statute, False
Claims Act, FDA marketing and advertising laws, etc.)
52
Institutional Provider Response
Policies/Code of Conduct on Financial Ties to Industry
 Broad
and general policies on financial relationships with industry vendors
 Vendor access and certification policies
 Policy position vary in degree of conservatism
 A prophylactic approach is becoming more commonplace
– Yale School Of Medicine
•
•
•
•
Ban on gifts
Ban on industry-sponsored meals
Ban on drug samples for faculty/family
All industry-sponsored education must meet ACCME standards; faulty must
disclose and resolve Conflicts of Interest to participate
– Stanford
•
•
•
Ban on gifts
Ban on direct industry-sponsored meals
Educational grants must meet ACCME Standards for Commercial Support
53
Institutional Provider Response
Voluntary Exposure to the Sunshine
Other proactive measures:
 Harvard publishes some of the payments doctors receive from
pharmaceutical and medical-device companies
 The University of Pennsylvania School of Medicine and its health
system launched a Web site of searchable information on all outside
activities of its doctors and scientists
 University of Wisconsin-Madison physician group is beginning a pilot
effort notify interested patients as to how to obtain information about
financial relationships their physician might have with private industry.
 Cleveland Clinic discloses business relationships its 1,800 staff doctors
and scientists have with drug and device makers through a database of
payments of $5,000 on the clinic's website.
54
Institutional Provider Response
Adopt Emerging Industry COI Standards
 Current
legal and regulatory requirements no longer qualify as the
minimum standard.
 Standards
exceeding those requirements have emerged from
industry and government agency guidelines.
– Compliance with the guidelines is not mandatory.
– The guidelines are not complete or entirely consistent.
– Showing best efforts to implement the guidelines as appropriate for the
nature and extent of an organization’s operations, risks and resources
(financial and personnel) is advisable.
– Must develop an approach that will be workable and effective for each
entity.
– Art not science!
55
Use Today’s Industry Standards:
Definition of Conflict of Interest
The following definition of conflict of interest articulated in
such guidelines should be viewed as the current industry
standard, rather than as an industry best practice:
A conflict of interest is an Interest that has the potential
to compromise or bias the professional judgment or
objectivity of the holder of the Interest, or has the
appearance of having the potential to compromise or
bias the professional judgment or the objectivity of the
holder of the Interest.
56
Today’s Industry Standards:
Types of Conflicts of Interest

Individual Conflicts of Interest = An Interest held by an
individual, or that individual’s immediate family, that results in a
Conflict of Interest

Institutional Conflicts of Interest = An Interest held by the
institution directly or indirectly that results in a Conflict of Interest

Imputed Institutional Interest = An Interest held by an individual
but that is imputed to the organization by virtue of that individual’s
authority and decision-making capacity within the organization
(these individuals are known as Key Officials).
57
Today’s Industry Standards:
Essential Components of a Conflicts of Interest Program

Reporting


Assessment

Management

Oversight
Competent Conflicts of Interest Committee oversees management
All Interests must be reported by Covered Persons
All Interests must be assessed to determine if they are Conflicts of Interest.
The assessment must follow pre-set criteria and must take into account
whether the Holder is a key decision-maker or a member of the Research
Team
Identified Conflicts of Interest must be reviewed by the appropriate Conflicts
of Interest Committee to determine an effective management strategy or to
determine that there is no effective management strategy available and the
Conflict of Interest bars the holder from proceeding:
 To whom should the Conflict of Interest be disclosed?
 What information regarding the Conflict of Interest should be
disclosed?
 Are changes in personnel or participation necessary? Chinese Wall?
 Does the make-up or nature of the Financial Interest need to change
The Conflicts of Interest Committee must maintain oversight of the Conflict
of Interest to verify that the management strategy is implemented and
remains sufficient to manage the Conflict of Interest
58
Today’s Standards and Emerging Best Practices
 Adopt
some or all of the IOM-AAMC-AAU Recommendations
– Today’s COI programs must go beyond technical legal requirements.
 Establish
a Committee dedicated to overseeing COI.
– Define the relative role of COI Committee, Legal Counsel, Compliance
Officer, Other Staff
– Sufficient, independent qualified personnel to assist in the assessment
– Limited role of Professional Staff
 Clear
separation of clinical and research administration and financial
administration (e.g., formulary and device approval, technology licensing)
within the institution
59
Today’s Standards and Emerging Best Practices
 Apply
new rules to all research, not just federally funded research
 Integrate
the conflicts policies and disclosure processes for Governing body,
senior officers, employees, professional staff, IRB, purchasing and
formulary/device review process, fundraising, education, and tech
transfer/commercialization function
 Integrate
conflicts policies with related policies such as vendor financial
relationships, conflicts of commitment
60
Today’s Standards and Emerging Best Practices:
Reporting of Interests
 More
detailed reporting and disclosure of individual interests
– Disclosure by all Research Team Members (endorsed in the AAMC
Report)
– Disclosure of all “Interests” regardless of value (no thresholds) to address
clinical and research conflicts of interest (Beware of PHS Approach)
– Eliminate judgment by disclosing party of whether Interest presents a COI
– Consistency among COI Disclosure Forms for various constituencies
– Deadline for completing annual disclosure
– Obligation to update
– Need for cumulative disclosure
– Move to on-line disclosure
– Sanctions for late disclosure, incomplete disclosure, failure to disclose
61
Today’s Standards and Emerging Best Practices:
Assessment of Interests
 All
disclosed Interests must be assessed to determine if they give rise to a
potential Conflict of Interest or appearance of a Conflict of Interest.
 There
are no absolute guidelines for when an Interest becomes a Conflict of
Interest.
 Some
Factors to Consider include:
– Intensity of the Interest
– Control and knowledge of the Interest
– Variability of the Interest
– Fiduciary Duty of the Holder
– Extent of authority or influence of the Holder over the research
– Affect of the study results on the value of the Interest
62
Today’s Standards and Emerging Best Practices

Higher Standard: Rebuttable Presumption against significant financial interests in
human subjects research.
– Do not allow research to proceed where there are financial interests related to the research
except in “compelling circumstances” and with appropriate management plans in place to
assure that benefits of the research outweigh the conflicts of interest risk.

“ Compelling Circumstances” - Factors to Consider (endorsed in the Report):
– The nature of the science (e.g., desperate need patient population).
– The nature of the interest.
– The degree to which the financial interest will be affected by the research results.
– How closely the interest is related to the research.
– The degree of human subject risk the research presents.
– Whether the researcher/institution is uniquely qualified to conduct the research and safeguard
the welfare of the human subjects involved (e.g., unique expertise among faculty/nationally,
special facilities or equipment, unique patient population, and experience and expertise of
investigators (this latter factor should not dominate the assessment of the conflict)).

Overall Risk-Benefit Analysis
– Determine whether the potential benefits of the transaction/study at issue outweigh the risks
presented by the conflict.
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The New Frontier:
Universal Database of Interests
Functional Areas Across an Institutional Provider Need to Report Interests
to Common, Integrated Databank
Board of Directors or Trustees
Vendors
Research Sponsors &
Funders
COI Reporting
Forms
Fundraising
Universal Database of
Interests
Pharmacy and
Therapeutics
Committee
Formulary Drug
Manufacturers
Research Support
Office/Division
All Purchasing Officials
64
The New Frontier
Universal Database of Interests – Industry Entity
Functional Areas Across an Industry Entity Need to Report Interests to Common,
Integrated Databank while Maintaining Firewalls
Grant Applications
Grant Agreements
Sales
Speaker Bureaus
Research
Sponsorship
Agreements
Universal Database of
Interests
Institutional
Relationships
Advisory Boards
65
Institutional-Industry Cooperation
To effectively manage financial relationships, institutional providers and industry must
work together to jointly track and monitor relationships, disclose relationships to one
another to improve interest capture, and to assist one another in maintaining an entitywide information system.
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Technology Transfer Tactics
Audio Conference
October 14, 2010
Best Practices for Managing
Conflict of Interest in University Research
Bernadette M. Broccolo
McDermott Will & Emery, LLP
312-984-6911
[email protected]