The Relationship Between Physicians and Medical Industry

The Relationship Between
Physicians and
Medical Industry Representatives
BOB ALLEMAN
W.L. Gore & Associates, Inc.
Southeastern Interventional Sector Leader
Florida Vascular Society
May 2013
Orlando, FL
FINANCIAL DISCLOSURES
• I am a paid associate of
W.L. Gore & Associates, Inc.
• I was told I’d get a free lunch for
giving this presentation*
• *There is no such thing as a “Free Lunch”.
My History
• Pfizer, Inc. from 1984 – 1988
• W.L. Gore from 1988 – currently
• I’ve sold products for arthritis, hypertension, angina,
heart disease, infection, hernias, AV access, AAA repair,
Thoracic repair, PAD, carotid filters, plastic surgery,
Anterior Cruciate Ligaments, fem-pop’s, ax-bifems,
stent-grafting the SFA, biliary stents, heart patches,
carotid patches, pediatric grafts & stents……..
AND THE LIST GOES ON
My History – Physicians I’ve Worked with:
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Rheumatologists
Pain Management physicians
GP’s, FP’s, IM’s
OBGYN’s
Podiatrists
Vascular Surgeons
Cardiac Surgeons
Cardio-Thoracic Surgeons
Pediatric Cardiac Surgeons
General Surgeons
Nephrologists
Interventional Nephrologists
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Radiologists
Interventional Radiologists
Plastic surgeons
Orthopedic Surgeons
Cardiologists
Interventional Cardiologists
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Medical Students
Residents
Fellows
RN’s, RT’s, PA’s
HOW HOLLYWOOD
PORTRAYS MEDICAL
SALES REPRESENTATIVES
ER
TV Series
NBC
September 19, 1994 to April 2, 2009
Love and Other Drugs
Movie
2010
Romantic Comedy
RX GRRL
Little Fockers
Movie
2010
Comedy
Things doctors dislike about sales reps:
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Too pushy
Feel they are trying to “buy” their loyalty
Professional visitors
Uninformed; don’t add value
Too biased
Too many of them
They’re not doctors
Things doctors dislike about working with
industry:
• Companies only care about profits
• Working with companies creates bias
• Working with companies gives the appearance
of being biased
• Doctors, not companies, should drive
advancement & changes in medicine
• Companies are responsible for driving up the
cost of health care
What Medical Industry Reps Contribute
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Well trained and well informed reps add value
Reps can add a new perspective
Good reps present fair-balance
New ≠ Bad
A great source of information
Reps intersect with multiple physicians – Can
disseminate best practices
• Like anything else, “When used properly…”
What the Medical Industry Contributes
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New products
Clinical trials
Support research
Support education
Support societies
Advancing medical care
An ally to the patient & the physician
Physician
And
Industry
Relations
ADVAMED
MARCH 2013
“The Future of Physician-Industry Collaboration”
Tammy Leitsinger
(Endovascular Today, March 2013, Vol. 12, No. 3)
• “In May 2003, the Office of the Inspector
General (OIG), Department of Health and
Human Services provided industry with
comprehensive parameters for
establishing compliance programs, which
should now exist at the core of every
industry compliance program.”
“The Future of Physician-Industry Collaboration”
Tammy Leitsinger
(Endovascular Today, March 2013, Vol. 12, No. 3)
• “…the AdvaMed Code…became effective
on January 1, 2004, and has more than
1,100 medical device industry members…
The code is voluntary and self-regulating,
and its main objective is to encourage
ethical interactions between AdvaMed
members and health care providers, as
well as recognizing important differences
of the medical technology industry.”
“The Future of Physician-Industry Collaboration”
Tammy Leitsinger
(Endovascular Today, March 2013, Vol. 12, No. 3)
• “By no means are these relationship
challenges between health care providers
and industry insurmountable, as the
common goal for both industry and
health care providers has not changed:
providing the best possible medical
treatment for the patient.”
Managing perceived conflicts of interest while ensuring
the continued innovation of medical technology
Andrew Van Haute, JD, Washington, DC
( J Vasc Surg 2011;54:31S-3S.)
• “…Advanced Medical Technology Association (AdvaMed), the nation’s
largest medical technology association representing medical device and
diagnostics companies, developed a Code of Ethics to guide medical
technology companies in their interactions with health care professionals. First
introduced in 1993, the AdvaMed Code strongly encourages both industry and
physicians to commit to openness and high ethical standards in the conduct of
their business, clinical, and research interactions. The AdvaMed Code has been
revised over the years, most recently in July of 2009, to address new issues and
to provide guidance tailored to the unique collaborations in device
development.”
• “…physicians will also benefit from the enhanced transparency of properly
documented principled relationships described in the AdvaMed Code.”
• “By adhering to the AdvaMed Code, manufacturers are supporting
physicians’ obligations to ensure each patient is provided with the
highest level of care, by receiving the treatment option most beneficial
to their individual needs.”
“Navigating the Modern Physician-Industry Relationship”
Steven J. Cagnetta, Esq, and Steven K. Ladd
(Endovascular Today, March 2013, Vol. 12, No. 3)
• “In what ways has the physician-industry
relationship changed in the past 10 years?
• What has changed is society’s view of these
relationships and the regulations on how they
must be conducted. These relationships are
subject to much greater scrutiny than in the
past, and the stakes are much higher. What has
not changed is that physicians still play a huge
role with innovations in medications and medical
devices that have significantly improved the
lives of patients.”
New paradigms for physician-industry relations:
Overview and application for SVS members
Niten Singh, MD, Ruth Bush, MD, Michael Dalsing, MD, and Cynthia K. Shortell, MD,
Tacoma,Wash; Temple, Tex; Indianapolis, Ind; and Durham, NC
( J Vasc Surg 2011;54:26S-30S.)
• “Like physician organizations, the recent intense scrutiny of
physician/corporate interactions has led industry to establish written codes
of interaction or ethics. These guidelines were developed by AdvaMed,
the trade association representing medical device manufacturers.
Although the standards are currently voluntary, member companies have
adopted the new standards…those involved in formulating the codes
recognize the benefits of a robust physician/corporate
interaction…the guidelines written by industry quite closely resemble
those written by physicians. In essence, the benefits inherent to such
interactions include the ability to provide a proper disclosure of a product’s
risk/benefit ratio to the physician, to develop or improve on innovative
products, to encourage research and education, and to provide charitable
contributions.”
• “They reflect…the belief that there is much to be gained by a
continued collaboration with industry partners, and that those
benefits are best realized by creating an environment free of
commercial influence over research, education, and training.”
Conflict of interest and the Society for Vascular Surgery
Bruce M. Elliott, MD, FACS, Charleston, SC
( J Vasc Surg 2011;54:3S-11S.)
• “While independence from bias has always been necessary, the increasing
focus by governmental agencies, industry organizations, and society has
made it important for the SVS to address this issue in a formal way. In June
2010, the SVS Board of Directors approved a set of guidelines specifically
designed to address management of conflict of interest among its members
and its leaders.”
• “These guidelines…were designed to safeguard against abuse while
maintaining valuable collaboration between vascular surgeons and
their industry partners.”
• “Today, there is a heightened awareness of opportunities for inappropriate
financial relationships between industry, pharma, physicians, universities,
and medical societies. Yet conversely, many extraordinary advances in
medical knowledge and technology have taken place because of
appropriately structured industry/physician collaborations. Many
nationally prominent authorities and physician-leaders have achieved their
reputations because of these successful relationships.”
“Private practice perspective on conflict of interest mandates”
Russell H. Samson, MD, FACS, RVT, Sarasota, Fla
( J Vasc Surg 2011;54:15S-8S.)
• Industry representatives in the surgeon’s office: “The Wazana
review found that interactions with pharmaceutical representatives
affected the prescribing practice in cost, non-rational prescribing,
awareness, preference, and rapid prescribing of new drugs, and
decreased prescribing of generic drugs. Some of these practices
patterns will be detrimental to public health; however, the rapid
introduction of new medications can be beneficial, and in some
instances, under prescribing medications can be more detrimental
than overprescribing. For example, as it applies to vascular surgery,
under prescription of statins and antihypertensives has had a negative
effect on patient care.”
• Industry representatives in the operating room or angiography
suite: “In many instances, however, industry representatives can be
critical to the performance of the procedure. They have often
witnessed a large numbers of the procedure(s) being performed
by the surgeon and, as a result, their experience can prove
invaluable when unusual circumstances arise.”
“Private practice perspective on conflict of interest mandates”
Russell H. Samson, MD, FACS, RVT, Sarasota, Fla
( J Vasc Surg 2011;54:15S-8S.)
• Payment for speaking on behalf of a company’s product: “They
provide an opportunity for private practice vascular surgeons to
increase their visibility in the local community. They bring expert
speakers to rural or underprivileged areas that otherwise would be
underserved by medical education opportunities. Such lectures can
inform physicians in other specialties about advancements in the
field of vascular surgery to which they would not have otherwise
been exposed. It has also never been shown that such presentations
have a negative impact on patient care.”
• Conclusions: “This will occur as a result of industry shifting support
from individual surgeons to those institutions (and thus indirectly to
those institutions’ employed surgeons). Thus, many private practice
surgeons will find less opportunity for educational experiences,
less support in the operating room, decreased ability to bring new
technologies into their practices, increasing distrust by the lay public,
and more competition from hospitals, medical schools, and
institutionalized medicine. In the end, it may be their patients that
suffer the most.”
Restrictions on interactions between doctors and
industry could ultimately hurt patients
Carey Kimmelstiel, MD, Boston, Mass
( J Vasc Surg 2011;54:12S-4S.)
• “Emerging data suggest that restrictions on physician-industry collaboration
have the potential to harm patient care by degrading innovation and stifling
medical education.”
• “Total support for CME has declined in large measure due to a reduction in
industry support for these programs. With no reliable source of funding to fill the
consequent financial void, educational programs will likely continue to
diminish in the near-term.”
• “…states which have legislated “sunshine provisions” have experienced a
number of untoward, unintended consequences. These include reduced
interactions between physicians with industry partners as well as reductions in
opportunities for postgraduate medical education. Together, these effects
threaten the pace of medical innovation and ultimately patient care.”
• “…all interested parties should work together to achieve the goals of
enhancing transparency of working relationships without threatening the
pace of therapeutic progress and the evolution of improvements in patient care.”
Medical Reps as Liaisons
Vascular Societies which Industry has
Helped to Found
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Midwestern Vascular Society
Western Angio
SAVS
SVS
PVSS
And the list goes on…
The Formation of the Florida Vascular Society
• 1987-88: Norm Foldenauer suggests a
concept from Michigan to VS’s in Florida
• W.L. Gore sponsors a dinner at a Tampa
restaurant to allow them to discuss possibilities.
(In attendance: B. Blackshear, M. Cohen, M.
Dahger, S. Martin, S. Schrieber & L.Williams)
• Next meeting was in conjunction with ACS in
Chicago and ideas were organized. Again,
sponsored by Gore. (Same group plus M.
Friedell & D. Nunn also attend)
The Formation of the Florida Vascular Society
• Six months later…
• Gore sponsors the first official FVS meeting in
Ft. Lauderdale in conjunction with the Florida
Medical society
• “In a room off of a basement corridor with a bare
light bulb”
• (In attendance: B. Blackshear, S. Martin, D.
Nunn, S. Schrieber, J. Seeger, R. Samson &
L.Williams)
• First president: Daniel Nunn, MD for 2 years
The Agenda of the First Meeting of the
Florida Vascular Society
• A Saturday morning
• The seven attendees each presented a paper
• Then it was time for lunch!
“That’s the last time I
go swimming after
lunch without waiting
an hour first!”
The Formation of the Florida Vascular Society
• Following the first meeting, a group of South Florida
VS that were doing a similar meeting (Which is now
the SFVS) were asked to join the FVS
• The next meeting took place in Jacksonville, FL at
Dr. Nunn’s house & Yacht Club (Again sponsored by
Gore)
• 10 – 20 VS’s from across the state attended
• The FVS had it’s first guest speaker: Bernie
Thompson, MD from Arkansas
• The following meeting had industry wide
sponsorship
Then versus Now
Florida Vascular Society 2013
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132 Members
A four day meeting
Multiple Guest speakers at every meeting
The Waldorf-Astoria
Industry Support of Physician Education
University of Florida –
Gainesville
Quarterly Angio Club meetings
Tampa Bay / St. Petersburg, FL
Quarterly Angio Club meetings
University of Florida –
Jacksonville
Weekly Vascular Conference
What W.L. Gore does for
VS Residents & Fellows
• “The Vascular Surgery Combat Manual” –
Available to surgical residents
• Journals for VS Fellows (JVS, Journal of
Endovascular Therapy & Annals of Vascular
Surgery)
• The graduating VS Fellows program in
conjunction with the SCVS
• And there are hundreds of other medical
companies that do their own educational
support programs.
The 3 Things Medical Reps would like
to have with their physicians:
• Mutual respect
• Partnership
• Improve patient care
Summary / Conclusion:
•Good Sales Reps are helpful
•Be sure to work within
AdvaMed guidelines
•Don’t do Drugs / Stay in Med
School