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A Workshop for PSD Clinical Department Executive

Administrators and StaffMay 2, 2012

Guidelines for PSD Employees Consulting with

Outside Industry

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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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Public Benefits & Risks of AMC/Industry Relationships

RESEARCH PATIENT CARE EDUCATION

• FUNDING• CO-DEVELOPMENT• TECH TRANSFER• ACADEMIC EXPERTISE AND INDEPENDENCE• POST-MARKETING SURVEILLANCE

•AVAILABILITY OF NEW DRUGS/DEVICES•CO-DEVELOPMENT•OBJECTIVE EVALUATION•ONGOING DEVELOPMENT & IMPROVEMENT

• FUNDING OF GME/CME• OBJECTIVE DISSEMINATION OF INFORMATION• PROFESSIONAL SOCIALIZATION OF STUDENTS/RESIDENTS

• POTENTIAL FOR BIAS OF RESULTS (COI) & NON-COMPLIANCE WITH RESEARCH STANDARDS• SKEWING OF RESEARCH AGENDA TOWARD NEW/COSTLY THERAPIES

• EXCESS USE OF EXPENSIVE, ? SAFE, NON-VALUE-ADDED THERAPIES & DIAGNOSTICS•IMPACT OF COI ON PURCHASING

• 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 companies Relationships with Nutraceutical/Vitamin/Supplement

Industry are also subject to review under IRPDefers to other existing policies and procedures for other

types of activitiesApplies to all domestic UPMC locationsApplies 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 facilitiesFor drug samples, applies only to products and services

that must be ordered by a physician or other healthcare provider (OTC products are not affected)5

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NEW YORK TIMESCrackdown on Doctors Who Take Kickbacks

By GARDINER HARRIS March 3, 2009

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.6

Roche Pays $20M in Whistleblower Settlement : Ad Boards and Speaking EventsDecember 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 off-label 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 ArticlesJanuary 2012 (Bosch X, Esfandiari B, McHenry L (2012) Challenging Medical Ghostwriting in US Courts. PLoS Med 9(1): e1001163.) 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.

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.

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.

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.

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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.

Consultant Agreement Review ProcessRefer to Policy ComplianceTools which are available on Pitt

COI website: http://www.coi.pitt.edu/IndustryRelationships/PolicyTools.htm

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

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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 ResponsibilitiesPerform review for conflict of commitmentEnsure Scope of Services covers appropriate

consulting activitiesFaculty/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.

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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 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.

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Does agreement provide legitimate tasks and

deliverables?Not Acceptable “We will pay you $4,000 per

month for 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.”

Acceptable “We will pay you $250/hr to

give 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. “

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Is payment commensurate with tasks?Not Acceptable “Each attendee and

spouse at our 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.”

Acceptable “Advisor will speak at

meeting on 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.”

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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 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

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Consulting Contract Guidelines Conveyance of IP 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.”

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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.”22

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Consulting Agreements: Example AHow does it conform with UPMC/SoHS Policy?

Payment rate exceeds $10,000/year – Dean approval required, COI 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.23

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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 DHow 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 EHow 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 orSupport for Off-Campus

MeetingsParticipation 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 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;

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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 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 ******.”

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Speaker’s Arrangements/Ghostwriting: Example“Z Company” offered Dr. X an Author

Agreementto 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 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.

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For more information…

Visit the University’s COI Web site:COI/Industry Relationship Policy pages:http://www.coi.pitt.edu/IndustryRelationships/index.htm