Transcript Involving Consumers in the Surveillance of Medicines Use and

Involving consumers in the surveillance of
medicines use and quality
and drug promotion
Margaret Ewen
Coordinator, Global Projects (Pricing)
Health Action International (HAI) Global
Amsterdam
Email: [email protected]
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Why this issue?
• Increased focus on access – needs equal focus on
rational use of medicines
• Those who are directly affected by policy decisions must
be engaged in debates
• Clearly civil society needs to be involved in medicine
policy debates as it directly affects their lives
• Civil society engagement:
- democratic accountability
- lobbying for change (individuals/groups)
- providing independent evidence (surveillance)
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Expectations and accountability
• Expectation that legislators and regulators will put public
health needs before any other priorities
• Expectation that regulators will be competent and
enforce legislation and policies
• Expectation that health professionals will work in the
best interest of patients
• Expectation that medicines are effective, good quality
and of therapeutic value
• Expectation that medicines will do no harm
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Civil society understanding of medicines
CS’s understanding of medicines is weak
- pill for every ill
- new better than old
- injection better than tablets
- low cost = poor quality!
- brands better than generics
- generics = counterfeits!
Why? Because of competing interests
Pharmaceutical promotion, media manipulation, capture
by industry of regulators, MoH, doctors, pharmacists,
patients groups. Governments also have interests.
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I DON’T TAKE CHANCES
I ONLY USE ORIGINALS
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Civil society engagement
• CS organises as an interest group around
specific issues
• But so does the government, industry,
healthcare professionals etc.
• Despite CS’s mandate, it is not enough to
influence the public-health agenda
• Power is unequally distributed and the CS voice
is marginalised
• Governments should ensure that interest
relations are equalised
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How to engage with CS
• CS is not a token partner
• Appropriate selection of expertise
• Facilitate CS engagement so they can actively
participate
• Long term perspective
• Provide an environment that equalises power
Remember, CS and governments actually
often want the same thing!
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CS surveillance of medicine use
Reporting adverse medicine reactions
eg. Netherlands (CSO & govt), UK (govt), Denmark (govt), Sweden
(CSO)
European Commission is now encouraging consumer AMR reporting in
proposed changes to EU pharmacovigilance legislation
Canada:
- consumer reporting mechanism but no public access to database
- PharmaWatch & Canadian Broadcasting Corp lobbied for a copy of
database. Five years latter – on CBC website in searchable format
with appropriate controls
- Health Canada issued ‘nasal’ safety advisory – nose severely out of
joint!
- Within a year Health Canada put the database on their website
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Irrational medicine use
Two examples of research in India by CSO’s:
• Antimicrobial use in Delhi – Anita Kotwani:
interviews consumers & health professionals,
focus group discussions
• Marketing and annual turnover of irrational
medicines in India – Community Development
Medicinal Unit
Many examples of CSOs in North and South
informing consumers &/or health professionals
on rational use issues
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CS surveillance of medicine quality
• Difficult for CS to identify poor
quality product. Easier to
identify poor packaging.
• CS often unaware of
mechanism for reporting
suspect packs/product to the
regulatory authority, and get no
feedback when they do report
• CSO’s can identify poor quality
eg. HAI Bolivia uses minilabs to
test medicines
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Drug Promotion
• Is a global concern
• Contributes to the irrational use of
medicines
• However…
– Less than half of countries report that they
regulate promotion (46%)
– Most countries rely on industry self-regulation
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Advertisement from
Taiwan promotes
unnecessary antibiotic
use. Problematic for
society (resistance)
and individual
patients (unnecessary
exposure to
potentially fatal risks).
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Excellent safety, side effect
profile similar to placebo?

USA 2003: illegal ad (below) no risks,
unsubstantiated 3-day relief claim
 USA 2004: warning of serious risks
 USA 2007: safety withdrawal
Pakistan 2005: 1-2 day relief claim
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Canada 2005
Peru 2006
Same drug, same company, same
unethical promotional campaign
 Unapproved use
 Illegal direct-to-consumer advertising
 Costly and not very effective
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Funding of physician ‘opinion leaders’
Physicians who attended sponsored presentations on Vioxx by
another physician wrote an additional $624 worth of prescriptions in
the next year versus non-attendees. Sales visits only led to
$127/physician/year.
Caplovitz A. NJPIRG Law & Policy Center, 2006
Marketed 1999 – 2004:
- Prescribed to 80 million people
- US spending on advertising $550 million (more than Pepsi-Cola 2000)
- VIGOR trial: 4-5 times risk of heart attack
- No more effective than other anti-inflammatory medicines for arthritis
- Estimated 88,000-140,000 extra heart attacks in US, 40% fatal
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“Gabapentin [Neurontin] was promoted by using education and
research, activities not typically recognized as promotional.
“independent” continuing medical education, “peer-to-peer”
selling by physician speakers, and publications…”
Approved use
Prescriptions for gabapentin by diagnostic category
Steinman, M. A. et. al. Ann Intern Med 2006;145:284-293
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Influence on clinical practice guidelines
Survey of 192 authors of 44 chronic disease clinical practice
guidelines JAMA 2002; 287:612-617
59% of authors had financial relationship with
manufacturers of medicines in guideline
Do financial links matter ?
• Eight of the nine authors of the US cholesterol treatment
guidelines released in 2004 had financial links to statin
manufacturers
• These guidelines extend treatment to patient groups in
which a morbidity and mortality advantage has not been
established
• From a previous 13 million, now 40 million Americans are
defined as needing treatment
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2007 CI Report Drugs, Doctors and Dinners
Pakistan: write 200 prescriptions of a particular new
medicine and company pays the deposit on a new car
Oct 2005, Vancouver:
Bayer invites “15 local pain specialist practitioners with
knowledge and expertise in treating multiple sclerosis” to
participate in the “Sativex Pain Specialist Regional
Advisory Board”, Hyatt Regency
“In appreciation of your participation and feedback, we are
pleased to extend an honorarium of $1250… Dinner will
be provided following the program.”
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Barriers to effective regulation
•
•
weak information standards
no active monitoring
•
non-transparent complaints procedures
•
little correction of misinformation
•
burden of proof on complainant, ads run during adjudication
•
sanctions ineffective, “the price of doing business”
•
no systematic evaluation of what does and does not work to
prevent misleading messages & the promotion of inappropriate
use
•
published evaluations and exposés of promotion that distorts
science (academic, NGO, courts) have had little effect on
regulatory procedure
•
the sheer volume of promotional activity!
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WHA 2007 Resolution
Members governments are urged to enact new, or
enforce existing, legislation to ban inaccurate,
misleading or unethical promotion on medicines, to
monitor drug promotion, and to develop and implement
programmes that will provide independent, nonpromotional information on medicines
The key question is one of political will…..
taking the link between promotion and
public health seriously
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