Transcript Presentation Title

Doctor’s-Pharma Industry
“Healthy- Relationship “
26 February 2009
Competing Interests
MD
GSK employee
Vice- President Apifarma
Member General Council of UNL
Member of Bioethic Council of UCP
Seven Principles of Public Life applied to Doctor’s
Royal College of Physicians. Innovating for health: patients, physicians,
the pharmaceutical industry and the NHS. Report of a Working Party. London: RCP, 2009.
Ethical Decision-Making Model - GSK
1. Is it legal?
2. Is it consistent with Company policy?
3. Is it consistent with GlaxoSmithKline’s values and the Code of
Conduct?
4. Will it benefit all or most of the people involved?
5. Can I explain it to my family and friends?
6. Would I be comfortable if it were printed in a newspaper?
PHARMA INDUSTRY – “MISSION”
Ability of the Industry pipeline to deliver true
improvements over existing drugs , and to deliver
innovation .
Industry’s Responsibilities
Deliver new medicines and vaccines that meet unmet
need and have demonstrable value
Invest in science (both basic and clinical research), develop
partnerships and focus on excellence
Ethical approach to sales and marketing
Be a source of solutions and new ideas and demonstrate willingness
to engage
“FACTS”
There are still no effective treatments available for
thousands of diseases known today worldwide.
More than 30 million children still miss out on
treatments and vaccination each year, and 2 to 3
million die annually from easily preventable
diseases.
“FACTS”
The average life expectancy in Europe is now
almost 80 years compared to 55 years at the
beginning of the 20th Century.
Disease-related mortality rates in Europe have
declined by almost 40% over the last 30 years,
thanks in part to new medicines (EU Health
Report).
“FACTS”
Over the last 20 years, R&D spending by
pharmaceutical companies in Europe has risen
more than seven-fold.
Every big pharmaceutical company invests from €4
billion to €5 billion yearly in the quest for new
medicines.
In 2003 alone, the pharmaceutical industry
invested over €21 billion, which represents 15% of
the total EU private R&D expenditure and a higher
percentage than any other industrial sector.
“FACTS”
Increased demand on health care (including
pharmaceuticals) provoked by :
1) ageing population
2)increase on chronic diseases due to the
latter and changes in lifestyles
3) better diagnose tools
The opportunity
New medicines and vaccines improve
healthcare for individual citizens
Reduce mortality and morbidity
Prevent disease and/or mitigate the complications of disease
Improve the quality of life by reducing hospitalizations and helping
patients avoid surgery
Reduce overall health care spending
Innovation is “THE” fundamental part of The
Pharma Industry contract with society
Reputation – (US) 2000
Comparative Reputation of Industries
Supermarkets
Packaged food
Airlines
Computer hardware
Banks
Computer software
Hospitals
Automotive
Telecom
Life insurance
Pharmaceutical
Health insurance
Oil companies
Managed care (i.e., HMOs)
Tobacco
Health Care News June 2004. Harris Interactive market research..
#1
#2
#3
#4
#5
#6
#7
#8
#9
#10
#11
#12
#13
#14
#15
“Doctors and drug companies must work
together, but doctors do not need to be
banqueted, transported in luxury, put up in
the best hotels, and educated by drug
companies.
Editorial
British Medical Journal
2003;326:12155-6
Areas of Ethical Risks
Gifts
Sponsored Research
Consultancy
CME - Provider / Recipient
Influences on Physician Prescribing Habits
Gifts
Drug advertisement
Pharmaceutical representatives
Influences on Physician Prescribing Habits
Texts
Journals
Colleagues
Formularies
Samples
Patient requests
Personal experience
Cost
Gifts from Pharmaceutical Companies
Pens, toys and puzzles
Household gadgets
Food
Books
Event tickets
Travel and meeting expenses
Cash
Areas of Ethical Risks
Gifts
Sponsored Research
Consultancy
CME - Provider / Recipient
Research in Healthcare
Improves public health
Refines diagnostic processes
Extends the range and quality of treatments
Raises standards of care
Generates knowledge
May increase value for money
May generate wealth
Research Ethics
Proper ethical review
Informed consent
Data protection
Consumer involvement
Use of animals
Individual Responsibilities
Investigator
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well-being of participants
compliance with RGF
registration of trials
ethical approval of research
qualifications of researchers
supervision of students
confidentiality of data
publication and dissemination of outputs
Ethical Industry-Sponsored Research
Full disclosure of conflicts of interest
No restraints regarding publication
Database of clinical trials
Educational Concerns Regarding Industry-Funded
Research
Diversion of faculty away from teaching,
towards more remunerative consultations
Faculty change research direction
Fellows/post-docs diverted to industryrelated topics
Patent- and profit motive-relatedpublication delays affect trainee and junior
faculty career development
Recommendations for Industry-Sponsored Research
Written agreements with university, not
researcher
Alternative therapies selected based on clinical
relevance
Stepwise project results not provided to sponsor
until study is funded and open publication
guaranteed
Enhancing Cooperation Between Physicians and
the Pharmaceutical Industry
Improve compliance
Decrease adverse events
Promote and fund of open, freely-shared
basic science and clinical research, with
appropriate but not excessive
compensation to the sponsoring
investigator, institution and company
Cooperation between the medical profession
and the pharmaceutical industry is
important and necessary at all stages of the
development and use of medicines to
secure safety of patients and efficacy of
therapy.*
*Standing Committee of European Doctors and the European Federation of
Pharmaceutical Industries Associations. Cooperation between the medical profession
and the pharmaceutical industry. Joint declarationof the CPME and EFPIA, June 2005.
http://212.3.246.100/Objects/2/Files/EFPIACPMEJointdeclaration.pdf
Areas of Ethical Risks
Gifts
Sponsored Research
Consultancy
CME - Provider / Recipient
CME- Industry Role
Royal College of Physicians. Innovating for health: patients, physicians,
the pharmaceutical industry and the NHS. Report of a Working Party. London:
RCP, 2009.
CME- Industry Role
“Decoupling the pharmaceutical industry from continuing professional
development. The industry presently pays for about half of all
postgraduate medical education. In order to address widespread
suspicions that drug promotion is carried out through continuing
professional development, the working party recommends weaning
postgraduate training off individual pharmaceutical company
sponsorship over a time bound period, while alternative sources of
sustainable funding are organised through for example the royal
colleges and the Department of Health”
Royal College of Physicians. Innovating for health: patients, physicians, the
pharmaceutical industry and the NHS. Report of a Working Party. London: RCP, 2009.
CME- Industry Role
“Healthcare companies involved in highly technical interventional and
device based therapies have specific responsibilities for the support of
continuing medical education. A transparent commitment to continuing
medical education of healthcare professionals in industry facilitated
programmes should be welcomed and encouraged. Formalisation of
the educational relationship between physicians and industry should
allow a proper balance to be achieved”.
Educational governance for the regulation of industry sponsored continuing medical education in interventional and device based
therapies
J M Morgan1, J Marco2, L Stockx3, F Zanna
1 Wessex Cardiothoracic Centre, Southampton University Hospitals, UK
2 Unite de Cardiologie Interventional Department, Toulouse, France
3 Ziekenhuis Oost-Limburg Campus, Sint-Jon, Genk, Belgium
4 Department of Cardiovascular Medicine, Hypertension, Heart Failure and Preventive Cardiology Unit and Centre d’Investigation
Cliniques CIC INSERM-CHU, Université Henri Poincaré, Nancy, France
Heart 2005;91:710-712
© 2005 by BMJ Publishing Group & British Cardiac Society
GUIDELINES FOR COMMERCIAL SUPPORT FOR CME
European Board for Accreditation in Cardiology
A CME activity has a scientific and educational purpose only. Undue
promotion of specific industry products during the training sessions is
not permitted. If this principle is not respected, EBAC will refuse further
accreditation to the Provider.
► The Provider has the exclusive right to design and to execute the CME
activity. This includes the definition of the scientific programme, choice of
speakers, and the content of the course.
► The industry partner granting financial support may suggest one or more
speakers for the CME course (activity), but the Provider is not obliged to
accept the proposal.
► In any CME activity a balanced presentation of the topic must be given.
► The supporting company will be acknowledged on CME materials as having
provided the sponsorship.
► The supporting company must not use the EBAC logo or its name in any of its
own promotional activities. The company’s support is acknowledged directly
on the sponsored CME activity materials. The CME course materials are
supposed to serve specific educational purposes andcannot serve for
promotional activities of the supporting company.
I think there needs to be a culture change
right across the board – the NHS,
industry,the professions, particularly
academia – and we need to get across the
idea that collaborating with industry is
actually an honourable thing to do.
Sir Michael Rawlins (9 January 2008)
“The time is always right to do what is right”
Martin Luther King
“BURNING AREAS”
GIFTS – Acceptable Value ?
“Scientific “ Meetings –Venue /entert.
Consultant – Value / Disclosure
“Independent” sponsored research
References
http://www.phsj.org
Public Health and Social Justice Website
Royal College of Physicians. Innovating for health: patients,
physicians,
the pharmaceutical industry and the NHS. Report of a Working Party.
London: RCP, 2009.
Yesterdays Decisions…
…Tomorrow’s Scrutiny
‘You will be judged not by whether you kept to
the rules of 2009…but by whether what you did
then looks right now’
Patrick Dixon – Futurist