The University of Wisconsin Circulated this past week a draft policy on interactions with Industry that would severely restrict physician industry interaction and does little to prevent the adverse events (real conflict of interest) they claim they are trying to prevent.
Part of the policy sets up a Industrial Interactions Review Committee (IIRC) where the faculty will have to run almost all their activities for approval and is given almost carte blanch power to make recommendations to the dean for changes in the policy .
The Policy if adopted would be one of the more restrictive includes the following:
· Gifts to individuals
o No Gifts for which payments or services are not provided includes, money, property, favor, service, food, travel, entertainment and for gods sake don’t borrow a laser pointer.
· Gifts to UWMF
o Non Branded non promotional patient educational materials can only be made at the division or department level, with simultaneous notification to the Industrial Interaction Review Committee. The document does not
· Attendance at outside activities funded by Industry
o Attendance at Industry funded activities (promotional talks), though you won’t be banned from attending industry funded activities you won’t be permitted to eat a bagel or sip coffee. The proposed ruling bans all “gifts” including food and drink (no ice cream for you).
· Speaking at Non-CME Accredited events Sponsored by Pharmaceutical or Biologic Industry
o Prohibition for participation as speakers in outside activities that are not ACCME accredited without prior approval from IIRC with significant restrictions. (This policy directly takes aim at medical physicians)
o Faculty can ask an exception for this but will be asked a list of questions including Why is the activity not ACCME approved?
o One thing the University should consider is that for REMS programs where the FDA mandates physician education that the University provide an exception for at least that portion
· Speaking at Non-CME Accredited Events Sponsored by Device
o For 18 months after approval of the policy faculty can participate in device sponsored events but limit compensation to $500/hour for time spent teaching.
o Must have contract with clear deliverables
o Must submit to IIRC within one month of completion
· Consultation with Industry
o Faculty may participate in non-promotional activities
o Must submit to IIRC for review within one month of completion
· Ownership and Corporate Board Membership
o May Participate
o Must report to the IIRC along with management plan for interactions with patients
· Royalties
o Cannot benefit from sales at UWMF
o Must disclose royalties to patients in writing
o Disclosure of monetary value of all royalties to the IIRC
· Internal Disclosure
o Faculty will disclose to the IIRC listing of entities that support the faculties activities
o Description of the type of activity and weather the activity was certified for CME Credit
o Dollar and Aggregate Amounts from each company
· Disclosure to Patients
o Posting signs around clinics that some faculty have relationships with industry
o Patients will be invited to contact UWSMPH for specific information about their physicians relationships with industry including the monetary value (The names of those inquiring will be kept confidential)
· Site Access by Industry Representatives
Pharmaceutical and Biotech Reps
o Access for industry representatives will be managed by a vendor liason office
o Meetings will be by invitation only
o Requests must be made through the VLO
Medical Device Manufacturers
o Appropriate Credentialing
o Visit is requested by appointment and invitation
o Patient Care Visits to patient care areas is of direct benefit of patients or no patients are present
· Industry Sponsored Scholarships and Other Educational Funds for Trainees
o Donated to central entity or department
o Recipients selected solely at the discretion of the departments
o Industry donor may direct scholarship or educational funds to a specialty
o Scholarships reported to IIRC
· Pharmaceutical Samples
o Medication samples are prohibited
o Except for products approved by pharmacy and therapeutics committee (only if required for safe initiation)
o Nothing on Device Samples
· “Ghostwriting” and Responsible Communications Practices
o Prohibited
o In Multi Center Trials (co-authors) must ensure accurate reporting of data
Summary
The problems with policies like this one from the University of Wisconsin and others is not so much their specific regulations but the principles upon which the authorities base them.
The rhetoric in the “purpose,” “statement” and “basis” sections that take as self-evident that medical progress and public trust require avoiding or “managing” “conflict-of-interest,” a subjective and in the end meaningless term invites coercion and contradicts the principle that physician-researcher-industry interaction is essential.
Also, unsubstantiated is the assertion that medical “professionalism,” as defined, has been compromised by physician-industry collaboration, thereby justifying “management?”
These proposed regulations promise to add bureaucratic burdens to the life of UW physicians and promise no reward for those efforts.
The outcome of the proposed review processes depend entirely on the reviewers, and, if seems likely, such management will become the purview of a compliance apparatus,
This policy will create a culture where interest equals conflict and potentially constructive activities will be curtailed.
Examining or arbitrarily limiting compensation is inconsistent with the principles of a free market.
Many of these policies are almost unworkable and will seriously hinder the advancement of medicine and hinder patient care at the University of Wisconsin.
We think it is interesting that the University has created a stark contrast between rules for physicians and surgeons, where the surgeons who bring in the majority of the revenues will be subject to far fewer rules than physicians practicing medicine.
The policy was sent out with a note to faculty that they are soliciting feedback from each faculty member which can in turn be consolidated and presented to the councils for their consideration. They are on a short time frame (2 weeks) to receive input.
I am surprised physicians are not more outraged by this. Policies like this are created because those in authority have concluded money corrupts and therefore clinical decisions cannot be made objectively. I would think more physicians would view this to be an attack on their integrity and defend themselves more vigorously.