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

contact@formindep.fr

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.