Johns Hopkins Medicine has adopted a new policy that
significantly limits interactions with
industry while ensuring effective, principled and
appropriate partnerships with drug and medical
device makers.
Called the Johns Hopkins Medicine Policy on
Interaction With Industry, the policy, to take
effect July 1, strengthens and clarifies several
long-standing policies while adding new restrictions on
how Johns Hopkins physicians, scientists, students and
staff may interact with industry.
"This policy will help us promote a culture in which
Hopkins faculty and other personnel can
exercise independent, unbiased judgment in all their
activities while interacting with industry in
appropriate ways that support our missions of delivering
excellent care to patients, and integrity in
teaching and research," said Edward D. Miller, dean of the
School of Medicine and CEO of Johns
Hopkins Medicine.
Chief among the new rules are those that prohibit the
acceptance of gifts or entertainment,
including food — regardless of value — from
pharmaceutical and medical device companies. Consulting
arrangements that carry personal compensation but no real
duties also are prohibited, and, beginning
in 2010, Johns Hopkins will no longer accept free
pharmaceutical samples, though in some limited cases
de-identified samples (those without the brand or
manufacturer's name) may be used for patient
education.
The new policy restricts access by pharmaceutical
representatives to non-patient care areas
only, and then, only on the invitation of the physician or
other Johns Hopkins staff members. Similar
restrictions are levied on medical device industry
representatives. Unrestricted gifts to the
institution from industry may be accepted under certain
carefully spelled-out circumstances.
"Industry plays a crucial role in advancing medical
research and treatments, and the intent is
not to discourage principled partnerships," said Julie
Gottlieb, assistant dean of the School of
Medicine and director of the JHM Office of Policy
Coordination. "The major reason for developing
this policy is to limit the impact of industry marketing
influence on faculty's and physicians' decision
making and by so doing protect patients."
Other areas covered by the new policy include the
following:
Continuing medical
education: The Johns Hopkins Office of Continuing
Medical Education
will continue to be the sole provider of programs offering
CME credit under the Johns Hopkins name,
and all industry-supported CME courses must be managed by
the OCME. There will be central review
of all noncredit educational events supported by industry
to ensure that the programs are consistent
with standards of the Accreditation Council for Continuing
Medical Education. Other provisions of the
policy require disclosure of the industry sponsor whenever
a company supports noncredit educational
courses, and an outright ban on industry funding for Johns
Hopkins department meetings, retreats or
social events.
Participation in
industry-sponsored programs: Johns Hopkins employees
may not speak at
or on behalf of industry-sponsored programs (for example,
"speakers bureaus") if the arrangement
gives a company the right to dictate the content of a
presentation, gives a company final approval over
the content or has a Johns Hopkins faculty member or other
employee acting as a company
spokesperson. In making presentations for which there is
industry payment or support, full disclosure
must be made of the support. Employees may consult with
industry to provide scientific advice
provided that payment for the service is at fair market
value, the arrangement is detailed in a written
agreement and complies with the Johns Hopkins University
School of Medicine's policy on conflict of
commitment, and the arrangement is reported as required by
the relevant Johns Hopkins
administrative unit.
Acceptable professional
practices: Funds for professional travel, industry
sponsorship of
scholarships and other educational support for trainees
will be required to be made at the
institutional, not individual, level. The policy reiterates
an existing ban on ghostwriting.
Purchasing of products and
services: Strict conflict-of-interest rules and
disclosures will
govern the purchase of equipment, products and services.
"Interactions between academic medical centers and
industry are complex and important,"
Gottlieb said. "We continually review and revise our
policies to address the challenging issues of
industry influence and conflicts of interest. Our goal is
to foster a culture at Johns Hopkins in which
professionals exercise independent judgment when making
clinical decisions."
The Johns Hopkins Medicine Policy on Interaction With
Industry is available on-line at:
www.hopkinsmedicine.org/Research/OPC/
JHMindustryinteractionpolicyFINAL.pdf.
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