Lessons from the Minnesota Experience

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Today’s Program
• Presenter
 J. Michael Gonzalez-Campoy, MD, PhD, FACE
• Moderator
 Kim Pepitone, CMPP
• Q&A follows the presentation−but feel free to
send in questions as you have them
Patient Harm
A consequence of “gift laws”
Lessons from the Minnesota Experience
J. Michael Gonzalez-Campoy, MD, PhD, FACE
Medical Director and CEO
Minnesota Center for Obesity, Metabolism and Endocrinology
(MNCOME)
Member, AACE Board of Directors
[email protected]
slide 5
September 16, 2009
Lessons from
the Minnesota Experience
Take Home Message
The unintended consequences of the
Minnesota “Gift Laws” include harm to:
•patients
•medical education
•medical research
•the physician-patient relationship, and
•the physician-industry working relationship
•the Minnesota economy
slide 6
September 16, 2009
Gonzalez-Campoy JM. Endocr Pract. 2009;15(4):292-7
Lessons from
the Minnesota Experience
Minnesota Gift Law
Statute 151.461
• In 1993, the Minnesota legislature introduced “GIFTS
TO PRACTITIONERS PROHIBITED.”
• This statute limits “gifts” from any pharmaceutical
company to an individual physician to $50.00 a year.
• “Gifts” must be included in the reporting to the Board of
Pharmacy under statute 151.47, discussed below,
along with all other funds that exchange hands.
https://www.revisor.leg.state.mn.us/statutes/?id=151.461
accessed 5/13/2009
slide 7
September 16, 2009
Lessons from
the Minnesota Experience
Minnesota Gift Law
Statute 151.461
"gift" does not include:
• professional samples of a drug provided to a prescriber
for free distribution to patients;
• items with a total combined retail value, in any calendar
year, of not more than $50;
• a payment to the sponsor of a medical conference,
professional meeting, or other educational program,
provided the payment is not made directly to a
practitioner and is used solely for bona fide educational
purposes;
slide 8
September 16, 2009
https://www.revisor.leg.state.mn.us/statutes/?id=151.461
accessed 5/13/2009
Lessons from
the Minnesota Experience
Minnesota Gift Law
Statute 151.461
"gift" does not include:
• reasonable honoraria and payment of the reasonable
expenses of a practitioner who serves on the faculty at
a professional or educational conference or meeting;
• compensation for the substantial professional or
consulting services of a practitioner in connection with
a genuine research project;
• publications and educational materials, or;
• salaries or other benefits paid to employees.
slide 9
September 16, 2009
https://www.revisor.leg.state.mn.us/statutes/?id=151.461
accessed 5/13/2009
Lessons from
the Minnesota Experience
Minnesota Payments Disclosure Law
Statute 151.47
• A wholesale drug distributor shall file with the Board (of
Pharmacy) an annual report, in a form and on the date
prescribed by the Board, identifying all payments,
honoraria, reimbursement or other compensation
authorized under section 151.461, clauses (3) to (5),
paid to practitioners in Minnesota during the preceding
calendar year.
slide 10
September 16, 2009
https://www.revisor.leg.state.mn.us/statutes/?id=151.47
accessed 5/13/2009
Lessons from
the Minnesota Experience
Minnesota Payments Disclosure Law
Statute 151.47
• The report shall identify the nature and value of any
payments totaling $100 or more, to a particular
practitioner during the year, and shall identify the
practitioner.
• Reports filed under this provision are public data.
slide 11
September 16, 2009
https://www.revisor.leg.state.mn.us/statutes/?id=151.47
accessed 5/13/2009
Lessons from
the Minnesota Experience
Transparency
• The idea behind these Minnesota laws
was that “transparency” will prevent
collusion of physicians and industry in drug
prescribing.
• “Transparency” of payments to physicians
by industry in turn should keep the cost of
medications down.
slide 12
September 16, 2009
Gonzalez-Campoy JM. Endocr Pract. 2009;15(4):292-7
Lessons from
the Minnesota Experience
Transparency
None of these laws call into question the
ethical, moral or legal implications of the
physician-industry working relationships, nor
do they challenge that physicians should be
paid for the work they do outside the patientphysician relationship.
slide 13
September 16, 2009
Gonzalez-Campoy JM. Endocr Pract. 2009;15(4):292-7
Lessons from
the Minnesota Experience
Minnesota Board of Pharmacy
• The Minnesota Board of Pharmacy has
collected reports since 1997.
• The reports were filed away and were
never publicized because “nobody ever
requested to view the reports.”
slide 14
September 16, 2009
Wiberg, Cody. Personal Communication
Lessons from
the Minnesota Experience
Minnesota Board of Pharmacy
• 2004: Ralph Nader’s Group “Public
Citizen” obtained copies of the reports.
• 2004: Gardiner Harris of the New York
Times obtained copies of the reports.
• 2006: Tom Sheck of Minnesota Public
Radio, and another researcher
from California also obtained copies.
slide 15
September 16, 2009
Wiberg, Cody. Personal Communication
Lessons from
the Minnesota Experience
Minnesota Board of Pharmacy
• 2007: an article written by the researchers
from Public Citizen appeared in the
Journal of the American Medical
Association (JAMA).
• The MN Board of Pharmacy was
immediately deluged with requests for
copies of the reports.
slide 16
September 16, 2009
Wiberg, Cody. Personal Communication
Lessons from
the Minnesota Experience
Minnesota Board of Pharmacy
2006: Cody Wiberg, Pharm D. posted on the
Board of Pharmacy Website the opinion that:
•Nominal meals and luncheons to doctors
are gifts.
•Meals should be counted towards the
state's limit of no more than $50 in gifts by
a drugmaker to a doctor per year.
•Physicians getting paid to complete
marketing surveys is not allowable income.
slide 17
September 16, 2009
Wiberg, Cody. Personal Communication
Lessons from
the Minnesota Experience
Minnesota Board of Pharmacy
2009: Cody Wiberg, Pharm D. absolved
himself of any blame.
•The Board of Pharmacy posted its opinions
which were verbatim what the Office of the
Attorney General gave as its opinion.
•The Board of Pharmacy is mandated to
collect and make the data available -- posting
it online is not a mandate.
slide 18
September 16, 2009
Wiberg, Cody. Personal Communication
Lessons from
the Minnesota Experience
Media Coverage
“Pharmaceutical companies spending less on
Minnesota doctors…”
Jeremy Olson, St. Paul Pioneer Press
June 11, 2009
slide 19
September 16, 2009
Lessons from
the Minnesota Experience
slide 20
September 16, 2009
Lessons from
the Minnesota Experience
This search engine contains public
information from the Minnesota Board
of Pharmacy on pharmaceutical
company payments to doctors and
other caregivers from 2002 through
2008. The Pioneer Press assembled
the 2005, 2006, 2007 and 2008 data,
and the non-profit organization Public
Citizen assembled and provided the
earlier years.
slide 21
September 16, 2009
Lessons from
the Minnesota Experience
Media Coverage
The Omissions
• The income reported to the Minnesota Board
of Pharmacy represents part of the legal work
product of physicians, and it is entirely for the
good of medicine and our patients.
• This income should not be distinguished from
the income physicians derive from patient
care.
slide 22
September 16, 2009
Gonzalez-Campoy JM. Endocr Pract. 2009;15(4):292-7
Lessons from
the Minnesota Experience
Media Coverage
The Omissions
• Clinical research must involve physicians.
• Without clinical research science will not
advance.
• Physician education must take place to
deploy newer, better, safer treatments (i.e.
newer insulins).
• Physician income from clinical research and
education leads directly to patient benefit.
slide 23
September 16, 2009
Gonzalez-Campoy JM. Endocr Pract. 2009;15(4):292-7
Lessons from
the Minnesota Experience
Media Coverage:
The Omissions
• Diseases kill people.
• Drugs treat (or cure) diseases.
• Physicians have current treatments because
of past research and development.
• There is tremendous benefit from the
physician-industry working relationship.
• It is much cheaper to treat a disease than it is
to treat its complications – always.
slide 24
September 16, 2009
Gonzalez-Campoy JM. Endocr Pract. 2009;15(4):292-7
Lessons from
the Minnesota Experience
Medical Publications Impact
• Minnesota led the way casting a negative
light on the physician-industry working
relationship – Sen. Linda Berglin responsible.
• Subsequent states have imitated Minnesota,
including Vermont and Massachussets.
• The media coverage on reported income to
Minnesota physicians directly contributed to
a national movement against industry.
slide 25
September 16, 2009
Gonzalez-Campoy JM. Endocr Pract. 2009;15(4):292-7
Lessons from
the Minnesota Experience
Medical Publications Impact
• The “conflict of interest” movement has led to
an irrational response from institutions with
oversight for medical education such as the
Accreditation Council for Continued Medical
Education (ACCME) and the Association of
American Medical Colleges (AAMC).
• Many journal editors have biased their
journals by applying a different standard to
pharmaceutical sponsored publications.
slide 26
September 16, 2009
Hirsch, L, Mayo Clin. Proc. 2009;84(9):811-821
Gonzalez-Campoy JM. Endocr Pract. 2009;15(4):292-7
Lessons from
the Minnesota Experience
Medical Publications Impact
• “Ghost writing” is a term introduced to justify a
bias against industry sponsored research by
many prominent journal editors.
• The role of medical writers in legitimate
research is ignored by this term.
• The disclosure rules applied to industrysponsored research are not applied to opinion
pieces directly funded by anti-industry
organizations or by trial lawyers’ expert
witnesses.
slide 27
September 16, 2009
Lanier, W. Mayo Clinic Proc. 2009;84(9):771-775
Hirsch, L, Mayo Clin. Proc. 2009;84(9):811-821
ACRE
Association of Clinical Researchers and Educators
slide 28
September 16, 2009
Lessons from
the Minnesota Experience
Conclusion
The unintended consequences of the
Minnesota “Gift Laws” include harm to:
•patients
•medical education (including publications)
•medical research
•the physician-patient relationship, and
•the physician-industry working relationship
•the Minnesota economy
slide 29
September 16, 2009
Gonzalez-Campoy JM. Endocr Pract. 2009;15(4):292-7
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