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MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 1
MEZIS e.V.- Mein Essen zahl ich selbst
Initiative of uncorruptable doctors
MEZIS- No Free Lunch – a different medicine is possible
www.mezis.de
Dr. med. Christiane Fischer Master of Public Health, Member of the German Ethical Council
Medical Director MEZIS
Bildquelle: privat
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 2
Initiative of uncorruptable doctors We aim to act patient beneficial and against for the influenes of the pharmaceutical industry
No! Free Lunch and promotional gifts Company based or sponsored CMEs Post marketing studies run by companies Pseudoinnovative „me too“ drugs
(Ethikbank, IBAN: DE36 8309 4495 0003 1467 15, BIC: GENODEF1ETK)
Yes! EBM based prescription behaviour Independent CMEs Transparency of conflicts of interests Punishment of corruption
www.mezis.de
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 3
MEZIS - today
Founded in 2007
6 board members, 750 members
1 medical director
Webseite: www.mezis.de MEZIS-Nachrichten 3 x/ year
MEZIS-doctors
Press
Literature
Poster
Regional conferences
Lectures (universities, general audience, conferences)
Bildquelle: privat
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 4
The enjoyment of the highest attainable standard of health is one of the fundamental right of every human being...“ (WHO constitution 1946, Universal declaration of Human Rights 1948)
Access to essential medicines and health services is a human right (§ 12 International Covenant on Economic, Social and Cultural Rights, 1966). This includes: Availability, Accessibility, Acceptability and Quality
Access to research results is a human right (§ 15 International Covenant on Economic, Social and Cultural Rights, 1966)
But… Reality is different
Health is a human right
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 5
The pharmaceutical industry tries to establish itself as part of the health
system
Key role against serious diseases Competence and responsibility Part of the health system Research for people
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 6
Pharmaceutical companies are private sector industries
Their primary interest is profit maximation and not the health of the people.
R&D is market driven and not need driven!
But is more a part of the problem
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 7
3-10% of health costs are wasted by abuse, cheating and corruption ; - in Germany about 15 billion € / year
In countries of the south corruption is more direct: direct money flow, unregistered doctors
Bayer‘s Tonic® in India (increasement of poverty)
Contract Research Organizations (CROs)
Corruption in medicine - a global phenomenon
Bildquellen privat
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 8
Many HIV-positive people are and others Hep C positive, in Germany about 300.000
Sofosbuvir (Sovaldi®): 43.500 € in D
Production costs: 40-200 €
In India no patent, as not innovative enough (marginal innovation)
Price: 500 € in India, as Gilead hindered untill recently access in India through „voluntry licences“ and anti diversion
Start of a buyers club as reaction
Also in Europe there are 10 patent post grant oppostions because of being not innovative enough.
Hepatitis C
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 9
Patents and profits
TRIPS sets a minimum standard
Patents are granted for minimum 20 years (§33)
Patents need be granted on all products which are:
New
Industrially applicable
Innovative
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 10
TRIPS Flexibilities
Compulsory licences
Parallel imports
Criteria of what can be patented (section 3d in India)
Exceptions for LDC
Pre- and post-grant oppositions
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 11
Design Company
Ethical Counciling Ethics commission
Conduction University or CRO (Contract
Research Organisation)
Problem:_ informed consens
Analysis Company
Publication Company
Patent Company
Who decides about R&D?
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 12
Research costs
Industry: 800 mio. $
Tax reduction (39%)
Opportunity costs (50%)
150 mio. US$ Model costs
5303 participants instead 2667 per study (US FDA)
Costs calculated 23.572 US$ / person – 6 times as high as NIH
Time per study increased
Success calculated: 20% instead of 50% phase III
43,4 Mio. US$
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 13
Research for whom?
Between 1975 and 2004 1600 NCE in the global market
Only 10% had a proven therapeutic progress
0
10
20
30
40
50
60
70
80 Therapeuticprogress
Therapeuticprogresspossible
No therapeuticprogress
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 14
Real innovation – New knowledge about pathophysiology – new pharmacological strategy + – Clinical relevant progess for patients
Pseudoinnovation:
– No prove of benefit – Only surrogat variables + – No or irrelevant progess for patients
Pseudoinnovation create the highest costs in the public insurance and not the demographic development!
Real innovation or pseudoinnovation
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 15
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Bravo 0 0 0 1 1 0 0 0 0 0
Real advance 4 0 1 1 2 0 0 1 0 1
Offers an advance 5 6 4 8 14 6 3 3 3 3
Possibly helpful 23 12 20 31 27 25 14 22 13 14
Nothing new 34 41 38 69 79 57 62 49 53 42
Not acceptable 7 7 19 17 15 23 19 19 16 15
Judgement
reserved
6 4 2 8 3 9 6 3 7 7
total 79 70 84 135 141 120 104 97 92 82
Real innovation oder pseudoinnovation
Prescrire International, Vol. 22. Nr. 137, S 105 – 107, April 2013
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 16
No therapeutic progress
– No endpoint studies; no decrease in mortality und morbidity (heard attack und apoplex)
– Less security
– 2004 an 2008: more side effects
– More carcinomas and SEAS source: Kastelein et al; Simvastatin with or without Ezitimibe in Familial Hypercholesterinemia, NEJM (2008) 358 (14): 1431-1443):
price:
100 Tbl. Inegy 224,65 € ↔ 100 Tbl. Simvastatin 20 mg: 16,26 €
14-times!
Inegy® - a pseudoinnovation
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 17
Influencing prescription behaviour
In Germany 15.000 pharma reps visit each year 20 million clinics and hospitals.
Pharma reps do not inform, they advertise for their products
Instruments: Gifts, drug samples, lunch invitations, travel expenses, conferencess, advertisments, pseudo-studies…
Do you think you or your collegues are influenced by the pharmaceutical industry?
themselves: 6% of doctors
colleagues: 21% Lieb, Brandtönies: Eine Befragung 300 niedergelassener Fachärzte zum Umgang mit Vertreterbesuchen der Pharmazeutischen Industrie. DÄ Heft 22, 4.6.10
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 18
The influence of the pharmaceutical
industry on prescription behaviour.
„How would you describe ‚selling“ ? Jane Williams: ” Selling is persuading someone
to agree with you and to buy whatever your product happens to be.” (p 88)
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 19
Influencing prescrition behaviour
80% of CMEs are sponsored by BIG Pharma
Themes are set by BIG Pharma Speakers are hand-picked Speaches are often written by companies Unacceptable honararium Sponsoring of local doctors circles
Therefore we ask for: • No CME points for any sponsorerd pseudo-conferences • Strictly differentiate advertistement and information
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 20 BUKO Pharma-Kampagne, Bielefeld
Disease mongering
„You´re feeling great? – That´s unusual ... We better run some tests...“
Menopause of men (created by Jenapharm - www.cgc-pr.com - Cramer Gesundheits-Consulting)
MEZIS – Mein Essen zahl ich selbst. Initiative unbestechlicher Ärztinnen und Ärzte e.V. 21
A different medicine is possible:
http://nofreelunchindia.blogspot.in/
