E-DRUG: Consumer Reports on Medicines Conference
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This is the second newsletter in preparation for the upcoming First
International Conference on Consumer Reports on Medicines (CRM I) in
Sigtuna, Sweden, September 29-October 1, 2000.
Background
Medicinal drugs represent an indispensable contribution to humankind and to
the reduction of morbidity and mortality. In the wake of the recent,
impressive scientific feat represented by the completion of the sequencing
of the human genome, we are witnessing new, promising predictions of
further advances in drug therapy to solve the great killers of our time,
notably predominantly in the Western hemisphere, such as cancer,
cardio-vascular disease, dementia and so on. Amid this optimistic rhetoric,
it is perhaps easy to forget that most people on the planet still lack
access to essential drugs and that many existing drugs are used
sub-optimally and irrationally.
One problem is the significant and underreported problem of adverse drug
reactions, particularly after drugs enter the marketplace. Post-marketing
surveillance schemes are inadequate. Voluntary, physician-based reporting
systems, while vitally necessary and in urgent need of improvement, still
exhibit serious flaws. Thus, current statistics - even for those countries
where reporting systems are in operation (and many still lack such systems)
- are unreliable. Indirect measures of the magnitude of the problem are
often provided by various estimates of hospial admissions atrributable to
side effects in the order of around 5-10%.
One important - and obvious - source of side effect information has
hitherto been seriously neglected. This source is the lay person, the
consumer as end user of medicines. We maintain - and the KILEN ELIN
database and other similar databases support this contention - that lay
reports on medicines represent a unique and valuable complementary source
of side effect data. Unfortunately, this statement is not uncontroversial,
as witnessed by the historial lack of interest or, worse, outright
resistance to the idea of lay reporting on the part of segments of
academia, industry and drug regulatory authorities. We, the organisers and
sponsors of CRM 1, believe that the time has come to give the issue serious
attention, recognizing the scientific problems involved i.a. in
interpreting such "signals", but nevertheless moving towards main-streaming
this perspective.
This is the point of departure for the current movement to develop and
refine lay reporting systems. The First International Conference on
Consumer Reports on Medicines will for the first time high-light the issue
of side effect reporting from a consumer perspective internationally.
Consumer reporting would have several benefits. Apart from demonstrating
new, previously unknown or neglected drug effects (beneficial as well as
undesirable), lay reporting offers the consumer an active role and a voice
in the drug field. Narratives solicited as part of consumer reporting
schemes, such as the ELIN database are rich sources of qualitative
information pertaining to drugs in relation to health and sickness, which
has been hitherto overlooked and which we continue to disregard at our
peril.
Strong global response
News about CRM 1 has promped a strong world-wide response. As of now (July
2000), KILEN has received over 100 letters of interest from over 30
countries. Many affirm the importance, relevance and timeleness of raising
the issue of consumer drug reporting locally in their respective countries
and globally.
"It is an extremely important topic and will certainly raise the awareness
of the topic of drug safety from the consumer's perspective", says Dr Mary
Couper, Head of Drug Safety Programme, WHO, who is an invited speaker to
the meeting.
"If we work together, we can have a lot of power, especially in
pharmacovigilance, which is a secondary item in our countries, where many
drugs are used before they are authorized in developing ones", says Jos�
Teran, Ecuador.
"It is an urgent need for Bangladesh to give priority to all these issues
and thus participation in the conference and lessons learned from it would
be the first step", say Dr. Zaman Ara and Prof Tareak-A-Nasir.
"l feel Consumer ADR Reporting is very appropriate and timely. The idea of
ELIN is excellent and would be good for us to link up to", writes Dzulkifli
Abdul Razak, Head of the National Poison Centre, Malaysia.
Illustrious team of speakers
The speakers at CRM1 represent some of the world leaders in the field of
drug information and consumer involvement. To date the following speakers
are programmed: Mary Couper, WHO; Sten Olsson, the Uppsala Monitoring
Centre; Charles Medawar, Social Audit; Kumariah Balasubramaniam, Health
Action International Network; Andrew Herxheimer; Keith van Grootheest,
Lareb; Graham Dukes, Groningen University; Kris Weerasuriya, University of
Colombo; Wilbert Bannenberg, SADP and others.
Call for patient narratives
As mentioned above, patient stories are the primary source of consumer
reports on drug ADRs. The method of collecting and collating narratives as
a basis of policy and action discussion was pioneered at e.g. the Sundsvall
Conference on Supportive Environments in 1991, organised by i.a.WHO and is
also an integral part of the People's Health Assembly 2000 in Dhaka,
Bangladesh December 4-8, 2000. We urge you to gather and compile any
patient narratives you may have regarding medicine use and send them to us
in advance of the CRM1 or bring them with you, as these will be an
important, reality-based starting point for discussions.
Spread the word!
Please feel free to copy and disseminate the conference program and other
information as widely as possible to people, groups and organizations in
your country and/or network who might be interested. The KILEN website is
http://www.kilen.org, where you can also find the program and an
application form.
Kersti Andersson, KILEN, Kammakargatan 7, 111 40 Stockholm
Tel: 08-696 01 00. Fax: 08- 696 01 10
Email: kersti@kilen-institutet.se
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