(Reaffirmed, November 2009)
The following document was signed in May 2008 by the American Association
of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS).
We, the undersigned speak on behalf of organized neurosurgery in the United
States. The Guidelines on Neurosurgeon-Industry Conflict of Interest is
a joint effort that culminated after many months of association leadership
and committee input. The respective Boards of Directors of the AANS and the
CNS approved these guidelines.
The impetus for crafting these guidelines was in part elicited by the heightened
scrutiny initiated over the last year by the Federal government into the relationship
between physicians and industry.
In September 2007, Senator Charles Grassley (R-IA) and Senator Herb Kohl (D-WI),
chairman of the Special Committee on Aging, introduced the "Physician
Payments Sunshine Act," which would require drug and device makers to
disclose the amount of money they give to physicians through payments, gifts,
honoraria, travel and other means.
In 2006, Medtronic reached a $40 million-settlement with the federal government
over accusations that the company had paid illegal kick backs to physicians
for using spinal devices. Subsequently, in late September 2007, the U.S. Department
of Justice announced that settlement had been reached with five major medical
device makers that accounted for nearly 95 percent of the market in hip and
knee surgical implants after a multiyear investigation into violations of the
federal anti-kickback statute.
Consequently, the number and degree of questionable financial relationships
between physicians and industry has gained significant public attention through
a series of articles in high profile media outlets including The New York
Times and The Wall Street Journal.
The practice of device and pharmaceutical companies paying physicians, and
the lack of transparency around this can potentially obscure the most important
question that exists between physician and patient: what is best for the patient?"
As professional medical societies, the AANS and the CNS hold the public trust,
seeking to advance the field of neurosurgery as a whole - through public and
professional education, and through the development and evaluation of new technology.
It is with this goal in mind that the Guidelines on Neurosurgeon-Industry
Conflict of Interest was crafted.
The guidelines encompass the following purpose: "Neurosurgeons are necessary
collaborators with industry for technical innovation by providing ideas and
feedback, conducting research trials, serving on scientific advisory boards,
and serving as faculty to teach the use of new technology related to neurosurgical
practice. Neurosurgeons with innovative ideas to improve patient care rely
on industry to bring their creative ideas to practical application in the healthcare
market. The collaborative relationship between neurosurgeons and industry must
be structured to avoid pitfalls of improper inducements or incentives."
In their daily practice, all neurosurgeons
must be guided by ethical principles upon which to base their decisions for
the care of their patients. The goal of medicine always should be to serve
the best interest of the patient, whereas business must promote profitability
for the success of its investors.
"A potential conflict of interest exists whenever professional judgment concerning
choices in patient care has a reasonable chance of being influenced by self-interest
of the neurosurgeon." Accurate, complete, and understandable disclosure of
any potential conflict of interest is required in communications to patients,
the public and colleagues.
"When faced with a potential conflict of interest that cannot be resolved,
a neurosurgeon should consult with the appropriate committee in an institutional
or professional society to determine whether a conflict of interest exists
and how to address it."
We encourage you to read the guidelines and utilize them as a tool to help
provide ethical care to those that entrust you with their health and lives - your patients.
James R. Bean, MD
Anthony L. Asher, MD
American Association of Neurological Surgeons
5550 Meadowbrook Drive
Rolling Meadows, IL 60008
Contact: Thomas A. Marshall
Congress of Neurological Surgeons
10 North Martingale Road, Suite 190
Schaumburg, IL 60173
Contact: Laurie L. Behncke