Paris 15-16 November 2001
The meeting was held at
la revue Prescrire,
83, boulevard Voltaire
It was funded by the
International Society
of Drug Bulletins and
individual ISDB members.
CONTENTS
Purpose and context
Identifying therapeutic advance
Efficacy
Safety
Convenience
Obstacles to the emergence of therapeutic advance
Policy makers and drug regulators
Health-care organisations
Investigators
The pharmaceutical industry
Obstacles to recognition of therapeutic advances by health professionals
and the public
Proposals
For identifying therapeutic advance
For policy makers and regulators
For governments and international organisations
For health professionals and the public
Annex I
About the word consumer
Annex II
Drug pricing
CONTRIBUTORS
The participants and reviewers mentioned below contributed to the successive
drafts of the Declaration over several months.
PARTICIPANTS IN THE WORKING GROUP
_ Danielle Bardelay, La revue Prescrire, (ISDB) France
_ Wolfgang Becker-Brüser, Arznei-Telegramm, (ISDB) Germany
_ Hirokuni Beppu, The Informed Prescriber, (ISDB) Japan
_ Pierre Chirac, Médecins Sans Frontières, France
_ Joe Collier, Drug and Therapeutics Bulletin, (ISDB) United Kingdom
_ Gita Fernando, Sri Lanka Prescriber, (ISDB) Sri Lanka
_ Maria Font, Dialogo sui Farmaci, (ISDB) Italy
_ Rokuro Hama,Kusuri-no-check, (ISDB) Japan
_ Andrew Herxheimer, DIPEx, United Kingdom
_ Christophe Kopp, ISDB Chairman
_ Ksenija Makar-Ausperger, (ISDB) Pharmaca Drug Bulletin, Croatia
_ Gilles Mignot, La revue Prescrire, (ISDB) France
_ José Recalde, Boletin Terapeutico Andaluz, (ISDB) Spain
_ Keiko Sakaguchi,Kusuri-no-Check, (ISDB) Japan
_ Andrea Tarr, ISDB Committee, Drug and Therapeutics Bulletin, United
Kingdom
_ Gianni Tognoni, Informazioni sui Farmaci and Ricerca & Pratica,
(ISDB) Italy
_ Bruno Toussaint, La revue Prescrire, (ISDB) France
_ Elisabeth Veyriac, La revue Prescrire, (ISDB) France
_ Bozidar Vrhovac, Pharmaca Drug Bulletin, (ISDB) Croatia
THE FOLLOWING ALSO REVIEWED THE ISDB DECLARATION
Gilles Bardelay, La revue Prescrire, France
Paul Blake, Martindale - the Complete Drug Reference, United Kingdom
Marc Bogaert, Folia Pharmacotherapeutica, Belgium
Isabelle Breton, La revue Prescrire, France
Jules Desmeules, Pharma-Flash, Switzerland
Silvio Garattini, Mario Negri Institute, Italy
Ellen ‘t Hoen,Médecins sans Frontières, Netherlands
Mohan Joshi, Drugs and Therapeutics Letter, Nepal
Jacques Juillard, La revue Prescrire, France
Marc Legrelle, La revue Prescrire, France
Joel Lexchin, Health Action International, Canada
Dinesh Mehta, British National Formulary, United Kingdom
Jean Louis Montastruc, Toulouse University, France
Jean Pierre Noiry, La revue Prescrire, France
Jörg Schaaber, Pharma-Brief, Germany
Molly Thomas, Rational Drugs, India
ISDB Declaration on therapeutic advance in the use
of medicines
The International Society of Drug Bulletins (ISDB) promotes the publication
of good quality independent information about drugs and therapeutics
to health professionals and the public in all countries.
ISDB convened a Working Group to deliberate on the issue of what
constitutes a genuine Therapeutic Advance as considered from the viewpoint
of patients and the Society. The Working Group met in Paris, France on
15-16 November 2001, and on behalf of the Society, made public the following
Declaration.
I Purpose and context
The practices of the pharmaceutical industry and regulators that
blur the distinction between genuine therapeutic advance and mere innovation
were the driving force behind this ISDB Declaration. ‘Innovation’ is
a central issue for those concerned with drug therapy: the public, health
professionals and their information providers, health policy makers and
regulatory authorities, organisations paying for medicines, and the pharmaceutical
industry. Of these, health professionals have a key role to play in ascertaining
the value of a new drug therapy and making a decision about prescribing
or dispensing it. Their individual skills must however be supported by
independent information. Patients and the public rely on the professionals
to ensure that their best interests are upheld. The pharmaceutical industry
increasingly creates the impression that there is an imperative for a
faster development and approval of innovative interventions (*) that
patients should rapidly have access to. Yet professionals working in
independent drug bulletins have shown that this impression is misleading.
A number of ISDB bulletins critically appraise the evidence on all newly
marketed drugs, and publish their conclusions on whether, and if so to
what extent, these new interventions extend the available options (drug
and non-drug). Overall, no more than a few percent of newly approved
drug interventions in one year offer a worthwhile
advantage to patients over previously available options. The ISDB Declaration
puts the needs of patients and professionals first, and aims to define ‘therapeutic
advance’ in terms of ‘comparative advantage’. Patients’ needs
include both individual and collective needs of the population.
The term ‘innovation’ covers three concepts:
• The commercial concept: any newly marketed me-too product, new substances,
new indications, new formulations, and new treatment methods.
• The technology concept: any industrial innovation, such as use of biotechnology,
or the introduction of a new substance delivery system (patch, spray, etc.),
selection of an isomer or a metabolite.
• The concept of therapeutic advance: a new treatment that benefits the
patient when compared to previously existing options.
* We refer to medicinal products (including traditional
medicines), their new formulations or indications, and we consider
use for treatment or prophylaxis.
It is in the pharmaceutical industry’s interest to blur the distinction
between the three concepts. And in the name of claimed innovation the
pharmaceutical industry imposes its agenda on regulators, and targets
professionals and the public through advertising. Policy makers, organisations
paying for medicines and regulators should act in the best interest of
the public and not accept industry’s claims that an innovation
is necessarily a therapeutic advance.
II Identifying therapeutic advance
When judging whether a new intervention is a therapeutic advance,
it is crucial to consider efficacy, safety, and convenience (helping
patients to use it well). Efficacy, safety and convenience are interrelated:
they must be assessed concurrently and regularly re-assessed as new evidence
emerges. Indeed, continuous evaluation of old substances is essential
so that drugs which are no longer valuable can be eliminated, and new
or better ways of using already approved drugs can be identified. A therapeutic
advance should not be seen in isolation: cost and quality must also be
considered (see Annex II).
1 – Efficacy
Efficacy describes how far a drug achieves its intended effect
(e.g. pain relief, contraception). When considered as a component of
therapeutic advance, efficacy should be assessed in ordinary clinical
practice: this is often called ‘effectiveness’ to distinguish
this from ‘efficacy’ in clinical trials. Controlled trials
are accepted as the reference method for testing drug efficacy. Their
design and performance however are often inadequate, and lead to unreliable
or irrelevant conclusions. The following points raise the greatest concerns:
- studies with wrong comparators, which on the one hand expose patients
to an inadequate level of care, and on the other are likely to produce
results biased in favour of the new drug. Placebo-controlled trials,
when a treatment with favourable risk/benefit ratio does exist, are
extreme and unacceptable cases in this category;
- studies using outcome measures that are unconvincing, clinically
irrelevant, or methodologically weak, or exposed to the risk of misrepresentation
of statistical significance (e.g. surrogate and not predefined endpoints,
scales and measures that are not clinically validated in the specific
clinical condition or population, combined endpoints of unequal relevance);
- studies conducted in populations and/or contexts that do not represent
those where the new intervention would be applied;
- especially controversial and worrying are non-inferiority or equivalence
trials, which represent a large proportion of industry-sponsored clinical
trials. The performance of such trials, often designed for drug registration,
poses clear ethical problems:
- patients included in the trials are misled to expect better care;
- research is not centred on real needs but is performed as part of
the company's marketing plans.
2 – Safety
New drugs are generally approved on the basis of efficacy studies;
safety outcomes being considered as a secondary issue. Safety concerns
frequent as well as rare and serious adverse effects. At the time of
first approval one must be sceptical of an apparently acceptable safety
profile of a new drug, as rare adverse effects can be recognised only
when a large population has been exposed to the drug.
Preclinical toxicity studies are rarely published or otherwise accessible.
Animal studies may have been determined, but often no one knows. All
these data are needed for independent safety evaluation.
Many regulatory bodies and pharmacovigilance organisations publish little
or no safety information to professionals and the public.
3 - Convenience: helping patients and professionals to use drugs
well
Convenience includes ease of use of medications and related devices,
as well as reliability of packaging. An improvement in convenience, resulting
in greater adherence to a drug regimen, can in itself be an advance.
One should remain sceptical about claims of greater convenience for drug
interventions that are not accompanied by the relevant data. Adherence
depends on the convenience of the administration schedule for patients
and health professionals, treatment duration, storage conditions (especially
in warmer climates), together with the quality and safety of packaging,
including patient information and ease of handling the packaging.
But easier use is clearly bad if it makes harm more likely.
III Obstacles to the emergence of therapeutic advance
All parties in the field of research and development of new drug
interventions share responsibility for shaping therapeutic advances.
1 - Policy makers and drug regulators
Lack of transparency and democratic control of regulatory activities,
and the fact that marketing application fees represent often more than
50% of regulatory agencies’ budgets, can weaken consideration of
public needs. As service providers, national and international regulatory
agencies compete among themselves for capturing application fees. This
may lead some agencies to be less stringent vis-à-vis industry.
Moreover, standards of regulatory work and legal frameworks vary internationally.
Where a mutual-recognition arrangement exists, the pharmaceutical company
may withdraw an application from an agency that detects a problem, and
try again with a more lax agency.
It is common to measure a regulatory agency’s effectiveness in
terms of the number and rapidity of marketing authorisations granted,
instead of the quality of decisions. This quality is clearly inadequate
when regulators fail to request postmarketing studies for a new intervention
supported by too little evidence on efficacy and safety at the time of
approval. Such behaviour is unacceptable, even for drugs that target
life-threatening conditions.
Industry pressure on regulators to speed up drug approvals in response
to harmonisation requirements obstructs the recognition of real therapeutic
advances. The quality and relevance of clinical data required for regulatory
submission are inappropriate.
Policy makers have watered down the definition of ‘innovation’.
In Europe the requirement of ‘significant therapeutic interest’ in
Council directive 87/22/EEC of 1986 has not survived in Council Regulation
2309/93 of 1993.
2 - Health-care organisations
The proportion of drug research and development funded by public
authorities, public organisations, health-care providers and health insurance
systems has decreased over the years.
This means there is inadequate funding of trials unattractive to industry:
non-drug treatments (surgery, physiotherapy, complementary and alternative
medicine); multi-drug comparisons; comparisons with drugs that are no
longer patented; trials of methods of managing chronic or terminal conditions
that are commercially unattractive but impose a significant health burden;
and trials involving orphan drugs and neglected diseases.
3 – Investigators
Because of the lack of substantial public funding, and of the
overwhelming (and economically attractive) pressure of industry-sponsored
projects, the academic world no longer has much influence in defining
research priorities in the investigation of therapeutic advances.
Short-term, publication-oriented studies are preferred to the evaluation
of the therapeutic implications of the many promising new findings of
pilot clinical research.
Clinicians looking after the majority of chronic and complex patients’ needs
(mostly unattractive for the industry) only occasionally have a role
in the production of new knowledge on therapeutic and preventive (not
only drug-based) strategies.
Health agencies do not recognise that funds for investigating the value
of claimed innovations should be considered a productive investment for
the routine delivery of care.
With important but marginal exceptions, patients are still playing a
very limited role in promoting, actively conducting or participating
in, evaluative research on topics where drug intervention competes with
non-drug strategies of care.
4 - The pharmaceutical industry
Since the pharmaceutical industry currently dominates the innovation
process, this is mainly drug-centred and driven by marketing strategies
instead of the needs of patients. In addition, a great part of industry
research is aimed at capturing market shares for conditions already well
treated. The de facto monopoly of research has led pharmaceutical companies
to claim that the financial sponsorship of clinical investigations entitles
them to full control and ownership of the data. The dangers of direct
or indirect manipulation of information to be used in submissions for
drug approval must be emphasised. This situation threatens the relevance
and the independence of evidence-based medicine: the assessment of the
overall efficacy and safety profile of drugs for use in the development
of effectiveness-oriented guidelines is thus forced to rely on biased
information.
IV Obstacles to recognition of therapeutic advances by health professionals
and the public
Honest information on new drug interventions depends
on the balance of power between the parties involved: the public,
health professionals and their information providers, health
policy makers and regulatory authorities, organisations paying
for medicines, and the pharmaceutical industry.
Information on new drug interventions comes mainly from the pharmaceutical
industry that invests heavily in promoting novelties. Industry’s
propaganda aimed at blurring the distinction between commercial introduction
of a new drug intervention, technological innovation and therapeutic
advance leads professionals and the public to succumb to marketing ploys
and exaggerated claims by medical representatives and advertisements.
By playing down or withholding trial data that do not support their marketing
strategy, and by frequently failing to carry out postmarketing studies
requested by regulators, not only IVdoes the pharmaceutical industry
mislead professionals and the public, but it also prevents them from
identifying real advances promptly. Such behaviour does not comply with
the 2000 Declaration of Helsinki that stipulates in its 16th clause:“…The
design of all studies should be publicly available.” And in its
27th clause it says: “Negative as well as positive results should
be published or otherwise publicly available.”
The pharmaceutical industry’s pressure on governments can have
a huge impact. In the UK for instance, when the National Institute for
Clinical Excellence (NICE) gave an unfavourable ruling on the value of
zanamivir (which, unfortunately, it then reversed), the manufacturer
made all sorts of threats, including the threat to re-locate its research
and development facilities. Through their export-earning and tax-paying
potential, the pharmaceutical industry can therefore have a significant
impact on official decisions about new medicines.
Regulators are excessively secretive about their decision processes,
and fail to release relevant information promptly to professionals and
the public; this is partly due to a restrictive interpretation of confidentiality
requirements.
Publication and dissemination of information on new drug interventions
come up against several obstacles. The secrecy clause that prevents investigators
from publishing study results without sponsor approval is a documented
obstacle to honest information and a cause of publication bias. The dependence
of many information providers, as well as continuing-medical- education
bodies, on drug advertising resources obstructs honest communication.
Professional bodies are often unwilling to devote sufficient resources
to producing truly independent information. Opinion leaders who accept
money from industry for launching new products are also to blame. Lay
journalists and press agencies often assist industry’s marketing
strategy because they are given biased information and lack independence.
The de facto relaxation of the ban on direct-to-consumer advertising,
sometimes disguised as disease awareness campaigns, provides biased information
to the public. Patient groups are increasingly a source of information
about drugs and treatments. Their frequent weakness and dependence on
industry funding is worrying.
ISDB Declaration on therapeutic advance in the use of medicines
V Proposals
Preamble
The parties that define and enforce the rules of drug development
and marketing are almost all in the rich countries of the North. The
problems considered so far are much worse in the poor countries of the
South, which must unquestionably put the needs of patients and populations
before drug and market-centred interests.
Real therapeutic advances coincide with widening inequalities because
of economic and logistic inaccessibility; misleading innovations contribute
to the pressure of the market on the fragile public health oriented systems.
The recent focus on the constraints of the patent system should not be
considered in isolation: the concept and the policies of essential drugs
should be expanded and reinforced to cover all therapeutic advances for
old as well as for emerging diseases. The potential implications of the
proposals that follow would therefore have even more important consequences
in the countries of the South.
1 - For identifying therapeutic advance
Efficacy
The efficacy of a new drug intervention should be assessed in terms
of overall mortality where relevant, morbidity, and quality of life as
assessed from the patient’s perspective. Therapies for chronic
conditions require long-term studies. Comparative trials assessing the
superiority of an intervention are required when there is an adequately
tested treatment. These requirements are consistent with the latest version
of the Declaration of Helsinki (October 2000), which requires that "The
benefits, risks, burdens and effectiveness of a new method should be
tested against those of the best current prophylactic, diagnostic, and
therapeutic methods."
(Section C clause 29)
Safety
Improved safety compared with existing options can qualify a new
intervention as a therapeutic advance provided that short-, medium- and
long-term pharmacovigilance data are taken into account. All information
on drug safety (including pharmacovigilance data) should be public from
the date of marketing. For a new drug intervention to be accepted as
a therapeutic advance on grounds of safety, several years of active pharmacovigilance
are necessary. The following are required:
well designed pharmacovigilance studies, such as case-control studies
and large cohort studies, to provide a clear picture of safety profiles,
including interactions and safety in at-risk groups (such as elderly
people, children, pregnant women and patients in renal failure),
long-term, large, randomised controlled trials with overall mortality
as the main endpoint for assessing safety of prophylactic interventions
such as antihypertensives and lipid-lowering drugs.
Substances that require intensive monitoring should be listed internationally,
with the year of local introduction.The list should be made available
to professionals and the public worldwide. In each country, a priority
list of drugs to be monitored should be identified, as is done in several
countries. Substances on the priority list should be identified as such
on the label of the medicine and in the Patient Information Leaflet.
The benefit/harm relationship of a drug intervention should be scientifically
re-evaluated at least every five years.
Convenience
Before marketing, studies should be undertaken to show adequate ease
of use and adherence to the dose regimen together with studies showing
that patients understand and can use the accompanying information. Medicines
legislation should incorporate this requirement as soon as possible.
2 - For policy makers and regulators
Regulators must be reminded that they are accountable primarily
to the public and not to the pharmaceutical industry, and that their
responsibility to public health should take precedence over their responsibility
for the welfare of industry. The European Medicines Evaluation Agency,
for instance, must be made accountable to Health and Consumer Protection
Directorate-General, instead of Enterprise Directorate-General of the
European Commission.
Policy makers should actively improve the legal framework for public
health so that regulatory agencies will facilitate access to relevant
information by health professionals and the public. Regulatory bodies
should make available to professionals and the public a register of clinical
trials submitted with applications for approved drugs. This should include
all trials, completed or not, together with their protocols.
Decisions by regulatory agencies should be strengthened by appointing
independent representatives of the public and health professionals to
key bodies in their organisation.
All regulatory agencies should report annually how they have implemented
their policies on the management of conflicts of interest.
Regulators should publish the data from comparative evaluations so that
health professionals and the public can distinguish useful drug interventions
from gimmicks.
When a pharmaceutical company withdraws an application from an agency
that detects a problem, this should be published internationally, and
explicitly declared by the company in any other application for marketing
approval.
Regulators should not only consider the public health implications of
new drug interventions in the approval process, but should identify them
explicitly in the approved product information.
Regulators should improve the post marketing surveillance of new drugs.
3 - For governments and international organisations
International organisations and governments should allocate parts
of health care and research budgets to large-scale trials meeting public
health needs (drug and non-drug therapies). Health needs for such trials
should be based on proposals coming from professionals and the public.
In particular, adequate public funding is needed for trials unattractive
to industry: unpatentable drugs; non drug treatment; multi-drug comparisons;
research on the management of commercially unattractive chronic or terminal
conditions; and orphan drugs and neglected diseases.
Public funding should be sustained over several years, and on a scale
sufficient to establish a sound balance between industrial and public
health research.
4 - For health professionals and the public
At national or regional level, health professionals and patients
organisations should identify research needs for conditions and diseases
requiring therapeutic advances.
Patients should be involved in the design of clinical trials - specifically
the choice of endpoints, outcomes (e.g. quality of life, burden of care),
and of the information for participants. Communication with participants
about trial progress and results should be specified in trial protocols.
Health professionals should be able to compare new therapies with existing
ones, so that they can reliably identify therapeutic advances. They should
be trained to use the basics of evidence-based medicine (notably systematic
reviews, level of evidence, relevant endpoints and outcomes) as well
as handling benefit/harm and cost/benefit relationships. When offering
a newly marketed treatment, health professionals should have all the
information to explain its advantages and disadvantages in comparison
with established treatments, so that the patient can make an informed
choice, and be aware that any unexpected or unwanted effects should be
reported.
The use of sources of independent comparative drug information should
be widely promoted. Initial and continuing medical education on medicines
should be carried out independently of the pharmaceutical industry.
Ethics committees should not approve a study unless it is stated in writing
that the full results will be made publicly available as soon as the
product is approved for marketing.
Health professionals should accept their responsibility to give official
bodies and the media well-informed and impartial advice, openly disclosing
the limits of their knowledge.
Journalists, editors and publishers should be encouraged to check their
sources with impartial and informed experts, to avoid being unwitting
agents of commercial campaigns related to health. This has become topical
with current pressure for the relaxation of the ban on direct-to-consumer
advertising.
ANNEX 1
About the word consumer
The word consumer, instead of ‘patient’, is used
increasingly in medical publications. In reality a consumer is ‘A
person who purchases goods and services for his own needs’ (Collin’s
dictionary).The word consumer therefore is more than a euphemism and
a soothing word for ‘patient’. Indeed using the term tends
to negate the role of doctors and pharmacists and the patient-professional
relationship. The term consumer assumes the patient is independently
and reliably informed, and can choose from the medicines on offer to
treat any health problems: this is rarely the case. The word consumer
has clear commercial connotations. It puts implicit and sometimes inappropriate
emphasis on the role of drug treatments, and tends to overlook non-drug
options (surgery,watchful waiting, psychotherapy, etc.).Those with vested
interests prefer the term consumer since it is consistent with the concept
of direct-to-consumer advertising, e-commerce of medicines, and the industrial
strategy of bypassing health professionals who are viewed as barriers
to expanding drug markets.
Making the patients and the public informed and committed partners in
health care is a desirable aim.
But the word consumer should be avoided when describing the relation
between patients and medicines.
It should be replaced by ‘the public’ or ‘patients’.
Occasionally the word ‘individuals’ may be more appropriate
since those taking medicines to prevent some events (e.g. pregnancy or
malaria) are not ‘patients’.
ANNEX II
Drug pricing
Access to therapeutic advance in developed as well as in developing
countries depends on the affordability of drug interventions and on the
quality of dispensing systems.
Therapeutic advances that the target population cannot afford are of
little value since they cannot achieve the necessary health benefit.
The supposedly rising cost of research and development of new drugs has
long been industry’s excuse for increasingly high drug prices demanded
by industry. But the price of a drug is less related to the cost of research
and development or to therapeutic advance (witness high prices for me-too
drugs), than to the rising cost of promotion, and the laissez-faire of
policy makers and organisations paying for medicines.
National policy makers and organisations paying for medicines should
ensure transparency of drug pricing and research and development costs.
They should resist pressures from drug companies towards the maximum
international price acceptable by rich countries. Price is a major barrier
in the transfer from efficacy as assessed in clinical trials to therapeutic
advance for the patients and the public.
ANNEX I
ANNEX II
Contacts
ISDB
Christophe KOPP (Chairman)
La revue Prescrire (France) - BP 459
75527 Paris - Cedex 11 - France
Tel. 33 1 47708606 - Fax: 33 1 47705204
E-mail: christophe.kopp@wanadoo.fr
ISDB
Maria FONT (General Secretary)
Dialogo sui Farmaci
Servizio Farmaceutico ULSS 20
Via Poloni, 1- 37122 Verona - Italy
Tel. 39 45 591705 - Fax: 39 45 8075607
Email: mfont@nettuno.it
About the International Society of Drug Bulletins (ISDB)
Background
The International Society of Drug Bulletins (ISDB) is a world
wide network of bulletins and journals on drugs and therapeutics that
are financially and intellectually independent of pharmaceutical industry.
It was founded in 1986,with the support of the WHO Regional Office for
Europe. The rationale for the Society is that drug bulletins independent
of funding from industry experience problems not faced by editors and
publishers of other journals.
Membership
The main requirements for membership are editorial and financial
independence, and the quality of the information published. ISDB has
two categories of members: full members who meet all membership requirements
as set out in the Constitution; and recognised correspondents. Recognised
correspondents are institutions or individuals who do not meet all criteria
for membership, but who are sympathetic to the aims of the Society.
Aims
The overall aim of ISDB is to encourage and assist the development
of independent drug bulletins in all countries and to facilitate co-operation
amongst them. ISDB’s priorities are:
- to help all independent drug bulletins achieve the highest professional
standards,
- to support the development of new drug bulletins,
- to identify independent drug bulletins that are not part of the ISDB
network and develop a relationship with them,
- to encourage members to help health professionals communicate more
effectively with patients and the public,
- to work with producers of formularies and people in drug information
centres,
- to campaign for drug regulatory authorities,
- to serve public health first and foremost.
Work of the Society
ISDB holds a General Assembly every three years, which provides
an excellent forum for members to meet and exchange information. In addition,
this allows ISDB members to meet with other attendees, such as producers
of formularies, people in drug information centres and other publishers
of independent drug and therapeutic information that are not already
part of the ISDB network. To help independent drugs bulletins achieve
high professional standards, ISDB organises regional workshops where
people working on long established bulletins can share their experience
with those starting new ones. Such meetings have been held in Algeria,
Hungary, Italy, Japan, Philippines, Italy, Holland and Spain.
To support the development of new drug bulletins, ISDB members also host
visits from editors starting up new bulletins to help them gain experience.
ISDB publishes newsletters which are distributed free to all members
and recognised corespondents. This newsletter serves:
- to keep members and recognised correspondents informed of current editorial
standards for the development of articles and information,
- to keep members and recognised correspondents informed of current issues
and activities, and
- to facilitate communication between members.
Through its meetings, workshops and newsletters, ISDB also encourages
and facilitates discussion on sources of information, organisational
structure, ways that bulletins can help health professionals communicate
more effectively with patients and the public, financial support for
member bulletins, and any other support for bulletins faced with particular
difficulties.
To address public health and drug information issues, ISDB has developed
links with many relevant organisations with members being involved in
various activities and campaigns. Topics of particular interest are:
access to information about medicines, including access to unpublished
data held by drug regulatory agencies; identification of truly innovative
drugs; the impact of undue promotion by the pharmaceutical industry;
resistance to direct-to-consumer advertising of prescription medicines.
Other ISDB activities include the exchange of information on new drugs,
adverse effects, and drug promotion and regulation.
Contacts
ISDB
Christophe KOPP (Chairman)
La revue Prescrire (France) - BP 459
75527 Paris - Cedex 11 - France
Tel. 33 1 47708606 - Fax: 33 1 47705204
E-mail: christophe.kopp@wanadoo.fr
ISDB
Maria FONT (General Secretary)
Dialogo sui Farmaci
Servizio Farmaceutico ULSS 20
Via Poloni, 1- 37122 Verona - Italy
Tel. 39 45 591705 - Fax: 39 45 8075607
Email: mfont@nettuno.it |
