Pharmaceutical Marketing:
Taking ActionPaul Scheffer, Formindep President
Disclosure
• No link of interest with any pharmaceutical
or medical device firm
• Prescrire member https://english.prescrire.org/en/Summary.aspx
Plan
1) Short presentation of the No free Lunch movement and network
2) Actions of Formindep on
• Transparency
• Guidelines
3) Actions in medical education worldwide
4) How to get involved?
Impact of Pharmaceutical
Promotion on clinical practice
• No evidence of net improvements in prescribing
• Negative outcomes associated with the interactions between physicians and the pharmaceutical industry:
o Inability to identify wrong claims about a medication;
o Rapid prescription of a new drug;
o Increased prescription rate;
o Prescribing fewer generics, but more expensive medicines with no added therapeutic value.
(Spurling et al., 2010; Wazana, 2000; Norris et al., 2005)
Slide courtesy of HAI ED Tim Reed
Who is influenced by these
strategies?
A little
38%
A lot
1%
None
61%
How much influence do sales representatives
have on your prescribing?
n=102 internal medicine
residents
Am J Med 2001; 110:551
Slide courtesy of HAI ED Tim Reed
Who is influenced by these
strategies?
A little
33%
A lot
51%
None
16%
How much influence do sales representatives have on
other physicians' prescribing?
n=102 internal medicine
residents
Am J Med 2001; 110:551
Slide courtesy of HAI ED Tim Reed
Recommended HAI materials
• HAI webinars
• Fact or fiction. What healthcare professionals
need to know about pharmaceutical
marketing in the European Union
• Understanding and Responding to
Pharmaceutical Promotion: A Practical Guide
WHO’s stand in 1988
• https://apps.who.int/iris/bitstream/handle/10665/38125/924154239X_eng.pdf?sequence=1&isAllowed=y
US national academy of
medicine’s stand in 2009
1) The No Free Lunch movement
The No Free Lunch network
today
First international meeting in Berlin, 15-17 September 2017
The No free Lunch network
• In Asia-Pacific
All India Drug Action Network (AIDAN)
No Free Lunch India
Healthy Skepticism Australia
No Adverstising Please Australia
• In South America
Medicos sin marca Chile
Medicos sin marca Colombia
The No free Lunch network • In the United states
PharmedOut
No Free Lunch USANational Physicians Alliance USA
• In Europe
Mezis Germany
MEZIS Austria
Læger uden sponsor Denmark
No Gracias Spain
Instituut voor Verantwoord Medicijngebruik The Netherlands
No Grazie Pago Io Italy
No Free Lunch PolskaPharmAware UK (no longer active)
Formindep FranceFor a list, non complete: mezis.de/das-no-free-lunch-netzwerk/
Poll
Are you member of a No Free Lunch group?
2) Formindep actions on
transparency
1) Legal actions:
• Kouchner Law decrees obtained in 2007 through anappeal to the Conseil d’Etat, the French SupremeCourt for administrative jurisdiction
• Action to verify if this law was respected in 2008-2009 with a legal action at the penal court against 9key opinion leaders.
BMJ article 2009:
https://www.bmj.com/content/338/bmj.b2347?etoc=
Formindep actions on guidelines
• Why we can’t trust clinical guidelines
Jeanne Lenzer, BMJ 2013;346:f3830
• Fact or fiction. What health care
professionals need to know about
pharmaceutical marketing in the European
Union, HAI
Formindep actions on guidelines
Formindep actions on guidelines
2) Legal actions:
• In 2011, appeals to the Conseil d’Etat against the guidelinesfor Alzheimer and T2 diabetus from the Haute Autorité deSanté (HAS) the National Health Authority, both cancelled.
• Another 6 guidelines were withdrawn voluntarily by theAuthority
• In 2018, appeal of a new type: criminal justice with Anticor.The HAS cancelled from itself its guidelines on dyslipidemia.
• BMJ articles:
https://www.bmj.com/content/342/bmj.d4007 https://www.bmj.com/content/368/bmj.m206
3) Actions in medical education
• 2002 Launch of the Pharmfree Campaign, now Just Medicine campaign
No Kick Backs. No Speakers Bureaus. No Free Samples.
JUST MEDICINE.
• 2007 First annual AMSA score card
The AMSA score card
• 2007 : first annual score card of the public
conflict of interest policy of the US medical
schools
• 2015 : 2/3 of the US medical schools
graded A or B Carlat, D.J., Fagrelius, T., Ramachandran, R. et al. The updated AMSA scorecard of conflict-of-
interest policies: a survey of U.S. medical schools. BMC Med Educ 16, 202 (2016)
AMSA Score card’s scoring criteria
http://amsascorecard.org/
Gifts, Meals, Speaking relationships, CME, Promotional events, Scholarships and awards, Consulting,
Sales reps, Device reps, Disclosure, COI curriculum, COI policy extension, Enforcement
Gift restriction and Prescribing
Exposure to a gift restriction
policy during medical school
Reduced prescribing of newly
introduced psychotropic medications
• King M. et al., “Medical school gift restriction policies and physician prescribing of newly marketedpsychotropic medications” BMJ 2013;346:f264
• Kesselheim A. S., “Drug company gifts to medical students : the hidden curriculum” BMJ 2013;346:f1113
Score cards in other countries
1/2
• In Australia (2011) and in Canada (2013), but with low transformative effects.
• My guess: one year score card, and no/low medical students implications
Mason PR, Tattersall MHN (2011) Conflicts of interest: a review of institutional policy in Australian medical schools. MJA 194: 121–125Shnier A, Lexchin J, Mintzes B, Jutel A, Holloway K (2013) Too Few, Too Weak: Conflict of Interest Policies at Canadian Medical Schools. PLoS ONE 8(7):e68633.
Score cards in other countries
1/2• Score cards in France (2017) and Germany (2019) with
similar AMSA transformative effects
• In France : Formindep has been doing the score cardswith the active support of medical student associations (ANEMF, ISNAR-IMG...)
• In Germany : medical students associations (UAEM-Germany and BVMD) did their first score card, withsupport of Mezis
Scheffer P, Guy-Coichard C, Outh-Gauer D, Calet-Froissart Z, Boursier M, Mintzes B, et al. (2017) Conflict of Interest Policies at French Medical Schools: Starting from the Bottom. PLoS ONE 12(1): e0168258
Conflict of Interest Policies at German medical schools - A long way to go Peter Grabitz, Zoe Friedmann, Sophie Gepp, Leonard U. Hess, Lisa Specht, Maja Struck, Sophie Tragert, Tobias Walther, David Klemperer bioRxiv 809723 – Preprint
The French Score card :
a new model?• In January 2017 : No med school with any
COI policy. All with very low grades
• National answer from the Deans’ Conferenceof Medicine with a strong Ethical and Deontological (November 2017)
https://formindep.fr/wp-content/uploads/2017/11/dean-charter-english.pdf
• 2nd score card in 2018 reoriented : measuring not the COI policy anymore but the ethical charter implementation
An international dynamic
in progress
• Other score cards are coming (Belgium, Italy…)
• First policy papers on the issue from IFMSA and
EMSA in 2019
https://ifmsa.org/wp-content/uploads/2019/09/AM19-Integrity-and-transparency-in-medical-education.pdf
https://emsa-europe.eu/wp-content/uploads/2019/05/Policy-Statement-Conflicts-of-Interest-in-Medical-
Education-Settings-1.pdf
Poll
Are you member of a local or national
medical student association?
4) How to get involved?
As health students:
• Read and watch more on the issue:
HAI webinars, HAI Fact or Fiction synthesis
document, actions in the US, France, Germany…
• Join your national/local medical association and
ask for change in your medical school
• Contact No Free Lunch groups
• Launch a score card in your country (see Peter
Grabitz’s HAI webinar)
How to get involved?
Get inspired by other medical students’ initiatives:
• The 2009 Harvard medical students action (see
the New-York Times article)
• The AMSA Pharmfree Curriculum
• The leaflet of the French medical student « Why
should we stay independent regarding the
pharmaceutical industry »
How to get involved?
The No Free Lunch
Campaign of the ISNAR-IMG
(French national GP residents
Organization)
How to get involved?
Keep in touch: mailing list of the No Free
Lunch network https://mezis.de/mezis-auf-
englisch/
Thank you
PS: other initiatives
PS: other initiatives
PS: official positions
• European Council :
See the 6.1.1 resolution of the Resolution 2071 (2015) of the EuropeanParliamentary Assembly Public health and the interests of the pharmaceuticalindustry: how to guarantee the primacy of public health interests?
In the light of these considerations, the Assembly calls on the Council ofEurope member States:
6.1. with regard to interaction between the pharmaceutical industry and healthsector players, to:
6.1.1. incorporate, into the curriculum for health care professionals specific,mandatory training to foster awareness of the influence of pharmaceuticalpromotion and how to respond;
https://assembly.coe.int/nw/xml/XRef/Xref-DocDetails-en.asp?FileID=22030&lang=en
For a summary of the recommendations : http://assembly.coe.int/nw/xml/XRef/Xref-XML2HTML-en.asp?fileid=22154&lang=en
PS: official positions
• US National Academy of Medicine
Lo B, Field MJ, Conflict of Interest in Medical Research, Education, and Practice, Institute of Medicine, National Academies Press, 2009
Recommendation 5.2 :
Academic medical centers and teaching hospitalsshould educate faculty, medical students and residentson how to avoid or manage conflicts of interest andrelationships with pharmaceutical and medical deviceindustry representatives. Accrediting organizationsshould develop standards that require formal educationon these topics.
PS: official positions
• American Association of Medical Colleges
Industry Funding of Medical Education: Report of an AAMC TaskForce. 2008 http://www.aamc.org/research/coi
Recommendation:
Medical schools and teaching hospitals should designcurriculum standards and teaching materials for all phases ofmedical education — from medical school to residency tocontinuing medical education — that provide tools to educatestudents, residents, and faculty about the processes anddisciplines of drug discovery, development, clinical testing,safety, therapeutics, and regulation.