Transcript Guidelines for PSD Employees Consulting with Outside Industry

Guidelines for PSD Employees
Consulting with Outside Industry
A Workshop for PSD Clinical Department
Executive Administrators and Staff
May 2, 2012
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Guiding Principles
• Clinical decision-making should be based on the best
interests of the patient
• Public trust in the integrity of research must be maintained
• Guidelines for interactions with industry should be explicit
and generalizable
• Partnerships with industry can be valuable in advancing
patient care, research, and education
• A conflict of interest arises when a secondary interest (e.g.,
financial relationship) has the potential to affect a primary
duty (e.g., patient care)
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BENEFITS
Public Benefits & Risks of
AMC/Industry Relationships
• FUNDING
• CO-DEVELOPMENT
• TECH TRANSFER
• ACADEMIC EXPERTISE
AND INDEPENDENCE
• POST-MARKETING
SURVEILLANCE
RISKS
RESEARCH
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• POTENTIAL FOR BIAS OF
RESULTS (COI) & NONCOMPLIANCE WITH
RESEARCH STANDARDS
• SKEWING OF RESEARCH
AGENDA TOWARD
NEW/COSTLY THERAPIES
•AVAILABILITY OF NEW
DRUGS/DEVICES
•CO-DEVELOPMENT
•OBJECTIVE EVALUATION
•ONGOING DEVELOPMENT
& IMPROVEMENT
PATIENT CARE
• EXCESS USE OF
EXPENSIVE, ? SAFE, NONVALUE-ADDED THERAPIES
& DIAGNOSTICS
•IMPACT OF COI ON
PURCHASING
• FUNDING OF GME/CME
• OBJECTIVE
DISSEMINATION OF
INFORMATION
• PROFESSIONAL
SOCIALIZATION OF
STUDENTS/RESIDENTS
EDUCATION
• SKEWING OF THE
EDUCATONAL AGENDA
•BIAS AND PROMOTION
•NEGATIVE SOCIALIZATION
OF STUDENTS/RESIDENTS
A comprehensive review of 29 empirical articles on the effect of industry interactions with
pharmaceutical studies concluded that those interactions led to increased prescription drug costs, and
also to non-rational prescribing in the sense that the newly prescribed drugs had no therapeutic
advantage over the alternatives. (Wazana A. Physicians and the pharmaceutical industry: Is a gift ever just a gift? JAMA.
2000;283:373-380.)
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Scope of Industry Relationship Policy
 Focuses on activities that relate to clinical decision making
 “Industry” includes pharmaceutical, device, hospital supply and bio-tech
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companies
Relationships with Nutraceutical/Vitamin/Supplement Industry are also
subject to review under IRP
Defers to other existing policies and procedures for other types of activities
Applies to all domestic UPMC locations
Applies to all employees, residents, faculty, and students of UPMC and
SoHS
For physicians not employed by UPMC, policy only applies to activities that
they conduct within UPMC facilities
For drug samples, applies only to products and services that must be
ordered by a physician or other healthcare provider (OTC products are not
affected)
NEW YORK TIMES
Crackdown on Doctors Who Take Kickbacks
By GARDINER HARRIS March 3, 2009
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Federal health officials and prosecutors, frustrated that they have been
unable to stop illegal kickbacks to doctors from drug and device
companies, are investigating doctors who take money for using these
products.
For years, prosecutors rarely pursued doctors because they believed that
juries would sympathize with respected clinicians. But within a few
months, officials plan to file civil and criminal charges against a number
of surgeons who they say demanded profitable consulting agreements
from device makers in exchange for using their products.
Roche Pays $20M in Whistleblower Settlement :
Ad Boards and Speaking Events
December 2011
 The Swiss drugmaker’s Genentech unit has agreed to pay $20 million to settle a
whistleblower lawsuit brought by a former sales manager, who alleged that the
Rituxan immunosupressant was marketed off-label and that the promotional
activities caused the federal healthcare programs, including Medicare and
Medicaid, to inappropriately pay for the medication.
 Between 2000 and 2002, Genentech encouraged oncologists and other
physicians to bill the healthcare programs for various off-label uses. In exchange
for their cooperation, Genentech paid some of the doctors up to tens of
thousands of dollars each to serve as speakers before other physicians about offlabel usage, according to the lawsuit .
 Some doctors were also hand-picked by the sales and marketing team - not
medical or science liaisons - for advisory boards and attend ‘medical education
seminars’ at luxurious locations. The drugmakers also what were called ‘Selling
Skills Workshops’ for sales managers and reps, and actively trained them to
avoid detection by the FDA.
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Medical Academics Could Be Legally Liable for Ghostwritten Articles
January 2012 (Bosch X, Esfandiari B, McHenry L (2012) Challenging Medical Ghostwriting in US Courts. PLoS
Med 9(1): e1001163.)
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Researchers at major universities, including Brown, Emory, Harvard, Stanford, Tufts, and Yale, have been
accused in recent years of signing their names to medical-journal articles that were written by others, articles that
promoted the benefits of various medications and were produced under the auspices of
pharmaceutical companies trying to boost their products. Last year The Chronicle reported that a
University of Pennsylvania psychiatry professor accused five other academics of signing an article that was
ghostwritten for the maker of the antidepressant Paxil and made unsupported claims for it.
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The legal liability of ghostwriting could arise because doctors say they relied on an article in their decision to
prescribe drugs, because they thought it came from a reputable academic author. That author usually hasn't
looked at the data, and the ghostwriter knows the named author didn't really do the work. This potentially
could be viewed as intentional misrepresentation, which can cause harm to others, resulting in
liability in personal-injury lawsuits.
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The article outlines other serious consequences, as yet untried in court. One is that named authors and
ghosts could be charged by the U.S. government under the federal False Claims Act. Because
Medicare uses peer-reviewed journal articles in its decisions to allow reimbursement for a particular medication,
it potentially could be shown that physicians responsible for ghost-written articles have perpetrated a fraud against
the government. Drug companies have been fined millions of dollars because of violations of the act; individuals
could be held liable for $11,000 for each false claim.
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There are also possible violations of the federal anti-kickback statute. That law prohibits pharmaceutical
companies from paying physicians or researchers for endorsements, essentially. And paying academics and
ghostwriters is just such an endorsement, the article argues. Violating that law is a felony, and carries a maximum
fine of $250,000 and a five-year jail term.
Public Disclosure of Physician
Payments
 Physician Payment Sunshine Provision of the Patient Protection and Affordable Care Act
of 2009:
 requires drug, biological, hospital supply and medical device manufacturers to report
gifts and payments made to physicians and teaching hospitals.
 The health care reform law requires disclosure of payments whether cash or inkind
transfers to all covered recipients including: compensation; food, entertainment or
gifts; travel; consulting fees; honoraria; research funding or grants; education or
conference funding; stocks or stock options; ownership or investment interest;
royalties or licenses; charitable contributions; and any other transfer of value as
described by the secretary.
 Beginning in September 2013, the DHHS will post this information on a publicly
available, searchable on-line database.
 Some companies – including Johnson & Johnson, Glaxo SmithKline, AstraZeneca, Eli
Lilly, Pfizer, Stryker and Zimmer – are already posting consulting and speaking fees paid
to physicians on their Web sites.
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Consultant Agreement Review
Process
 Refer to Policy ComplianceTools which are available on Pitt COI
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website:
http://www.coi.pitt.edu/IndustryRelationships/PolicyTools.ht
m
Contains step-by-step flowchart and accompanying explanation
page, policy guidance to facilitate an agreement, and departmental
checklist
Onus is on faculty/clinicians to bring the agreement into
compliance using these materials
Faculty/Clinicians should use materials and/or alert industry of
availability of materials to assist them in facilitating an agreement
meeting the policy requirements
COI Office available to answer any questions that may arise
Conveniently Link to IRP Guidance Documents to Facilitate
Agreements with Industry
http://www.coi.pitt.edu/IndustryRelationships/PolicyTools.htm
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Department Administrator
Responsibilities
 Perform review for conflict of commitment
 Ensure Scope of Services covers appropriate consulting
activities
 Faculty/Clinician should provide you with a completed
departmental checklist (from the policy tools site)to assist
you in your evaluation
 Forward approved materials to UPMC COI Office for
substantive review
 Upon approval, remind faculty/clinician to update COI
disclosure and request mutually executed agreement for
filing in department and COI Office
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Outside Engagements with Industry—What is
Appropriate?
Legitimate consulting, where payment is reasonable
and directly related to the services provided, is
permitted under the Industry Relationship Policy
(IRP).
Consulting may not involve marketing or
promotional activities under the IRP.
Where consulting payments are made without
services being provided, or where payment rates are
out of proportion to the service provided, the
payments may be considered kick-backs.
Any consulting agreement, under University/UPMC
policies, requires the prior approval of the
department chair and/or dean.
Consulting Contract Guidelines
 A written contract detailing the proposed services must be
provided to the department chair/administrator in advance;
 Faculty member should direct company to Policy Compliance
Tools website
 In limited circumstances, use of an Addendum helps ensure that
contract terms will comply with IRP (see the Policy Compliance
Tools tab within the IRP Web pages on the COI Web site).
 University’s/UPMC’s name and address cannot appear in the
contract; consultant’s personal address must be used;
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Consulting Contract Guidelines
(cont’d)
 Any non-compete clause in the contract cannot interfere with
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faculty member’s duties at the University/UPMC;
Use of University/UPMC resources is not permitted;
Contract must include specific, legitimate tasks and deliverables;
There must be a direct correlation between services provided and
payment received;
Payment must be commensurate with the tasks performed;
Hourly payment of more than $500 is deemed excessive and
additional approval is required to accept;
Marketing or promotional activities are not permitted;
Consultant cannot be pre-paid for services.
Does agreement provide legitimate
tasks and deliverables?
 Not Acceptable
 Acceptable
 “We will pay you $4,000 per month for
 “We will pay you $250/hr to give
your availability to be on our advisory
board as needed. The board will meet as
necessary.”
 “Dr. X is expected to perform
consulting services for American
Orthopedics, Inc.”
 “You will be paid $10,000 per episode
to appear in 4 video episodes of our
‘Here is the Doctor” series. The
company retains the right to control
content.”
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advice on prosthetic devices at two four
hour meetings a year.”
 “You will be paid $250/hr up to a cap of
$1,200/year for reviewing 12
samples…..”
 “We would like you to lecture on
advances in osteoarthritis to our field
reps and will pay you $2,000 per lecture
to present your personal research. “
Is payment commensurate with
tasks?
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 Not Acceptable
 Acceptable
 “Each attendee and spouse at our
 “Advisor will speak at meeting on
scientific conference will have all
expenses paid at “World’s Best
Luxury Resort” where new
products will be unveiled.”
 “You will be paid $5,000 to identify
experts in the field and will receive
an additional 2.5% of the gross
profit of project fees if all
recruitment goals are met.”
the topic of treatments for bone
disease for an honoraria of $1,200
and agrees that this payment is at
fair market value.”
 “Physician will be available for up to
12 one hour phone meetings per
year to discuss vaccine advances and
will be paid 15 shares of company
stock valued at $16 per share for
each meeting.”
Is the type of compensation
appropriate? Stock Options
 Not Acceptable
“Consultant will receive 500 stock options upon signing the
consulting agreement with Hexangular Cutting, Inc. and
quarterly thereafter.”
 Acceptable
“500 stock options will be awarded for each hour of service
provided to Pharmaceutical Management Systems by the
scientific advisory board member. Options will be awarded
only upon receipt of periodic invoices detailing the dates,
hours, and types of services provided by the member.”
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Is the type of compensation
appropriate? Royalties
 Not Acceptable
“Tinctures & Tonics, Inc. will provide Consultant with 1% of
royalties on net sales of products each annum.”
Receipt of royalties as compensation is always prohibited.
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Intellectual Property Issues
 UPMC and University policies restrict ability to waive and/or assign rights to
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Intellectual Property created during consulting relationship. This only applies
to Intellectual Property that the University and UPMC claim under their IP
policies.
Every provision that requires the physician to waive and/or assign IP rights to
the company must be deleted or revised to acknowledge that the University or
UPMC must waive any rights they may have in the IP before the physician can
assign rights.
If no IP involved with relationship, Agreement can be silent as to IP rights.
To date, over 35 companies have accepted UPMC’s and Pitt’s IP clause
A process is in place to waive UPMC/University IP policies should the
circumstances allow
Consulting Contract Guidelines
Conveyance of IP
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Not acceptable
“Consultant agrees to assign to E. Lixir & Co. all intellectual
property rights, including, without limitation, patents, trade
marks and copyrights, in the work performed hereunder.”
Acceptable
“Any assignment of intellectual property rights shall be subject to
the superior rights of the University of Pittsburgh and UPMC, if
any, under their respective Patent and Copyright policies, and
shall only be effective after they have waived such rights.”
Consulting Agreements: Example A
 “Health-Design, Inc.” asked Dr. X to serve as consultant to
assist in design, development, evaluation and
promotion/presentation of education and training programs
for “Health-Design, Inc.” products.
 Agreement did not permit Dr. X to consult with anyone
else.
 Payment- $4,000/day up to $80,000 per year
 All IP assigned to “Health-Design, Inc.”
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Consulting Agreements: Example A
How does it conform with UPMC/SoHS Policy?
 Payment rate exceeds $10,000/year – Dean approval required, COI
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management plan required and limits may be imposed.
Dr. X cannot serve as P.I. on any research study of commercial interest
to “Health-Design.”
Dr. X cannot advise the University or UPMC on “Health-Design”
products nor purchase such products as a rep of University or UPMC.
Dr. X cannot prepare marketing materials for the company’s products.
Any educational materials should reflect evidence based science and
discuss alternative treatments.
“Health-Design” must acknowledge superior IP rights of University or
UPMC.
Consulting Agreement: Example B
 Dr. X asked to serve as “Pharmacy Company, Inc.” Chief
Scientific Officer. Duties and projected time required are
clearly defined.
 Payment will exceed $10,000 per year.
 Travel expenses are reimbursed.
 IP is owned by “Pharmacy Company, Inc.”
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Consulting Agreement: Example B
How does it conform with UPMC/SoHS Policy?
 Serving in an officer position (e.g., CSO or Chief Medical
Officer) is not permitted; membership on a company’s SAB
is allowable.
 Compensation will exceed $10,000/year – Dean approval
required, and limits may be imposed.
 Conflict Management Plan (University) required
indicating that Dr. X has no conflict with research or
purchasing, or that such COI has been managed.
 “Pharmacy Company, Inc.” must acknowledge superior IP
rights of University and UPMC.
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Consulting Agreement: Example C
 Dr. X was offered a position on “Technology Co. Inc.”
Scientific Advisory Board to provide “assistance and advice
on “Technology Co. Inc.” products.
 The agreement noted a cap on total hours but no projection
of real hours or actual duties
 Payment offered was in company shares, with a non-specific
value
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Consulting Agreement: Example C
How does it conform with UPMC/SoHS Policy?
 The agreement is too vague as to deliverables.
 The agreement is too vague as to compensation; the true
value of the stock is unknown and may exceed $10,000 per
year.
 Dr. X cannot be PI on any research involving “Technology
Company, Inc.”
 Dr. X cannot buy or purchase any “Technology Company,
Inc.” products on behalf of University or UPMC.
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Consulting Agreement: Example D
 The agreement stated that Dr. Y was to advise on the
monitoring of a clinical trial.
 The agreement also noted that Dr. Y would be
reviewing clinical data from identifiable patient records.
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Consulting Agreement: Example D
How does it conform with UPMC/SoHS Policy?
 Serving on a Data Safety Monitoring Board is an acceptable
task under the Industry Relationship Policy.
 Reviewing identifiable patient data suggests direct
involvement in research. Dr. Y cannot serve as a PI or
researcher on a clinical trial at the same time that he is
monitoring the trial as a consultant. Research on a clinical
trial must be handled through either the University’s Office
of Research or UPMC’s Clinical Trials Office.
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Consulting Agreement: Example E
 Dr. Y, a medical researcher, was invited to join Gerson
Lehrman’s “Council of Advisors” to talk with hedge
funds and mutual funds about his opinion of
experimental drugs to treat macular degeneration
 Payment - $500 per hour
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Consulting Agreement: Example E
How does it conform with UPMC/SoHS Policy?
 Divulging unpublished research results violates confidentiality
agreements, and Dr. Y. could be subject to personal liability and civil or
criminal prosecution if securities are purchased or sold based on
material non-public information he provided.
 Dean Levine’s October 21, 2005 memo - posted in the Resources
section of the COI Office’s Web site at www.coi.pitt.edu - cautions
researchers of some of the perils of this type of consultation.
 Some professional organizations have banned or restricted such
relationships. See American Society of Clinical Oncology; Interactions
with the investment industry: practical and ethical implications. Journal of
Clinical Oncology. 2007;25:338–340 (in which ASCO mandated
disclosure of relationships with investment advisors for all ASCO
members, and “strongly cautioned” its members about entering into
such relationships). See, also,Topol, E., Blumenthal, D. Physicians and
the Investment Industry. JAMA 2005;293:2654-2657
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Industry-Sponsored Meetings or
Support for Off-Campus Meetings
 Participation as attendee or speaker is acceptable if…
 Activity is designed to promote evidence-based clinical care
and/or advance scientific research;
 Financial support of Industry is prominently disclosed;
 Industry does not pay attendees’ travel expenses (Speaker’s
reasonable expenses can be reimbursed by Industry);
 Attendees do not receive gifts or other compensation for
attendance;
 Meals provided are modest (i.e., the value is comparable to
Standard Meal Allowance specified by IRS) and consistent with
educational or scientific purpose of event.
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Speaking Guidelines
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A written contract detailing the proposed services must be provided to the
department chair/administrator in advance;
The Speaker’s Agreement Addendum helps ensure that contract terms will
comply with provisions of the IRP (see the Policy Compliance Tools tab within
the IRP Web pages of the COI Web site);
 If proposed Speaker’s Agreement is really for marketing or promotional
activity, Addendum does not suffice; Agreement must be revised to
eliminate all marketing activities.
Compensation for speaking is limited to a modest honorarium not to exceed
$2,500 per event, and reimbursement of reasonable travel expenses;
Presentation must be designed to promote evidence-based clinical care and/or
to advance scientific research;
Marketing activities and promotional speaking are not permitted;
Speaking Guidelines (cont’d)
Content must reflect a balanced assessment of current science and treatment
options, and cannot focus on a single company’s product;
 Speakers must make clear that views expressed are their own, not those of the
University/UPMC;
 Speaker must control content of presentation, and content cannot be subject to
company’s approval;
 University and UPMC personnel cannot author or present information over
which they do not have full control.
 No ghostwriting (being an author of an article written by someone else).
 No authorship of documents for which industry has ultimate editorial
control.
 No reviewing or drafting a company’s “slide deck” on a product – without
actually being the person who gives the talk.
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Speaking Contract Language
 Acceptable
“Advisor will speak at a half-day meeting of Balm & Gilead, Inc., to
discuss the latest research surrounding the topical treatment of
certain allergic drug reactions for an honorarium of $1,200 and
agrees that this payment is at fair market value.”
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Speaking Contract Language
(cont’d)
 Not acceptable
“You will receive $5,000 for attending a dinner meeting at Buena
Vista Resort where new Tinctures & Tonics, Inc. products will be
unveiled.”
 Not acceptable
“Physician shall serve as a Tinctures & Tonics, Inc. advisor for
ongoing physician education activities; shall conduct
presentations, lectures, and meetings at medical conferences in
coordination with T & T, Inc.; and shall conduct training of any
employees, sales representatives, or distributors of T & T, Inc.
products.”
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Speaking Contract Language
(cont’d)
 Not acceptable
“Pharmacist shall provide presentation materials to Tinctures & Tonics,
Inc. at least five days prior to their intended use in order to provide the
company sufficient time to review and approve the materials.
Presentation must comply with FDA requirements, and speaker agrees
not to discuss off-label use of drugs.”
 Not acceptable
“If the Speaker intends to use any materials (e.g., scripts, notes,
handouts, slides, etc.) in connection with the presentation that will
refer, directly or indirectly, by illustration, text or otherwise, to
Autoclaves-manufactured or like products, the materials must be
consistent with labeling or other literature provided by Autoclaves, Inc.”
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Speaking Contract Language
(cont’d)
 Not acceptable
“The Company may provide you with formal or informal training for
speaking on Luscious Lozenges’ behalf. Upon request, the Company will
provide you with technical assistance in preparing or making available
slides, videos or other audiovisual materials. The Company may from
time to time also provide you with suggestions or input on the Company
approved presentations.”
 Not acceptable
“Formal ‘Pharma Profile’ interview for the Apothecary Sales
Newsletter focused on experience using the Panacea drug
compounding system. This interview will focus on your
experience with the product both in teaching and pharmacy
work.”
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Is the Activity Marketing?
 Not Acceptable Duties
 “Formal ‘Surgeon Profile’ interview for *** Sales Newsletter focused
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on experience using ***** System. This interview will focus on both
your clinical and surgical experience with the product….This
interview will also include photos and commentary on intra-operative
experience including commentary of use in your surgical practice
along with commentary on other **** methods.”
 “Support as needed with review of ****** surgeon and sales training
materials and marketing materials.”
 “In providing the Services, you shall use only slides and other
presentation materials developed and made available by ******** in
accordance with its Speaker Resource Center Presentation Download
Agreement, or otherwise approved by ******.”
Speaker’s Arrangements/Ghostwriting:
Example
 “Z Company” offered Dr. X an Author Agreement
to provide “author services” on specific clinical subjects; Dr.
X would be listed as “an author.”
 Agreement contains a non-compete clause.
 “Z Company” retained IP rights
 “Z Company” retained rights to Dr X’s image and words and
the right to re-use them in other formats
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Speaker’s Arrangements/Ghostwriting:
Example
How does it conform with UPMC/SoHS Policy?
 Dr. X should be sure that he has control over content of materials and
cannot sign away future use of his image.
 Content of presentations must be scientifically based, not market-based.
 “Z Company” must recognize IP rights of University/UPMC.
 Dr. X must be sure that the non-compete clause does not interfere with
his University or UPMC duties.
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Industry Sponsored Meetings:
Example
 Dr. X was invited by “ForeignCorp” to attend a conference
overseas and to chair a session.
 The company offered to pay travel and expenses for Dr. X
and spouse.
 Dr. X was invited to a special event at the conference
showcasing a medical device. The event featured the chance
to drive a Porsche on a race track to mimic the excitement of
the new medical device.
 Dr. X has a grant from the company to test the showcased
medical device.
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Industry Sponsored Meetings: Example
How does it conform with UPMC/SoHS Policy?
 Both the event and the proposed engagement of faculty must meet
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the requirements of policy.
The content of the conference must be scientific. More info is
needed to ensure that conference is not just promotional.
If Dr. X is speaking, compensation must be for reasonable
expenses, meals and honorarium only; no payment for spouse or
test driving a Porsche.
If Dr. X is speaking, it must be clear that he “owns” the speech
content and that it is “balanced”.
If Dr. X is merely an attendee, no payment or gifts beyond modest
meals is allowed.
Dr X’s research grant from the company presents a possible
conflict of interest. He cannot promote the product he is receiving
money to research.
For more information…
Visit the University’s COI Web site:
COI/Industry Relationship Policy pages:
http://www.coi.pitt.edu/IndustryRelationships/index.htm
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