Thank you for joining ISMPP U today harm - a... · Thank you for joining ISMPP U today! The program will begin promptly at 12:00 noon EST. ... Mayo Clin. Proc. 2009;84(9):811-821

Thank you for joining ISMPP U today!

The program will begin

promptly at 12:00 noon EST

Michele

Stamp

ISMPP would like to thank…

the following Platinum Sponsors for their ongoing support of the society

ISMPP Reminders

• Annual Meeting

- April 19-21, 2010

- Arlington, Virginia, USA

- Call for abstracts−will open soon!

• CMPP

- Next exam: February or March, 2010: watch for details on schedule

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

September 16, 2009slide 5

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

Gonzalez-Campoy JM. Endocr Pract. 2009;15(4):292-7slide 6

September 16, 2009

Lessons from

the Minnesota ExperienceMinnesota 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 5/13/2009slide 7


September 16, 2009

Lessons from


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;https://www.revisor.leg.state.mn.us/statutes/?id=151.461



September 16, 2009

Lessons from


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.




September 16, 2009

Lessons from

the Minnesota ExperienceMinnesota 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.




September 16, 2009

Lessons from

the Minnesota ExperienceMinnesota 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.




September 16, 2009

Lessons from


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.


September 16, 2009

Lessons from


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 patient-

physician relationship.


September 16, 2009

Lessons from


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.”

Wiberg, Cody. Personal Communicationslide 14

September 16, 2009

Lessons from



• 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.


September 16, 2009

Lessons from



• 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.


September 16, 2009

Lessons from



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.


September 16, 2009

Lessons from



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.


September 16, 2009

Lessons from


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


slide 20

September 16, 2009

Lessons from

the Minnesota ExperienceThis 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


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.


September 16, 2009

Lessons from


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.


September 16, 2009

Lessons from


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.


September 16, 2009

Lessons from


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.


September 16, 2009

Lessons from



• 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.

Hirsch, L, Mayo Clin. Proc. 2009;84(9):811-821


September 16, 2009

Lessons from



Lanier, W. Mayo Clinic Proc. 2009;84(9):771-775

Hirsch, L, Mayo Clin. Proc. 2009;84(9):811-821

• “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 industry-

sponsored research are not applied to opinion

pieces directly funded by anti-industry

organizations or by trial lawyers’ expert

witnesses.

slide 27

September 16, 2009

ACREAssociation of Clinical Researchers and Educators

slide 28

September 16, 2009

Lessons from


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


Questions & Answers

To ask a question, please type your

query into the ‘Q&A’ chat box at the

bottom left of your screen. Every attempt

will be made to answer all questions.

Next ISMPP U

DATE: October 21st—first of a special two-part program focusing on health economics outcomes research

TIME: 11am EST—NOTE NEW TIME

TOPIC: HEOR 101- Comparative Effectiveness Research: Rationing or Rational

Thank you for attending!

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Documents

Thank you for joining ISMPP U today harm - a... · Thank you for joining ISMPP U today! The program will begin promptly at 12:00 noon EST. ... Mayo Clin. Proc. 2009;84(9):811-821