Information for consumers
(International Society of Drug Bulletins) Please do not quote or publish without the permission of the author. Paper prepared for delivery at the conference on European Integration
and Health Care Systems: A Challenge for Social Policy.
A conference organised during the Belgian Presidency of the European The recent stir over the possible lifting of the ban of direct-to-consumer advertising of prescription drugs in Europe has tended to overshadow what really matters when it comes to ‘information for consumers’. Information for ‘consumers’ or for ‘citizens’? Citizens in good health or potential patients? What sort of information: on health matters and a healthy lifestyle, on health problems, or just on medicines? The best way to deal with many health problems is to promote healthier living, even if some patients will need drugs. And lifestyle measures do not only concern cardiovascular diseases, osteoporosis or lung cancer. The fight against diabetes, asthma and AIDS, for example, which are likely to be first targets of DTC promotion authorised in Europe, also involves prevention, screening and lifestyle measures, even if drugs can be especially beneficial in these diseases. Much remains to be done to improve general health information in Europe. But as the focus of this workshop is medicinal products, the question is "just what type of information does the patient, or the average citizen, really need?” First and foremost, comparative information to make enlightened choices A well-informed citizen, a patient and relatives: – can understand the precise place of drugs in the overall management of a given health – can participate fully, with the health professionals, in the treatment decision and choice of drug therapy. This choice will depend on the balance between the likely benefits and potential adverse effects of available drugs, and also their cost-effectiveness; – will understand the optimal conditions in which the chosen drugs are used; – can contribute to monitoring adverse effects, especially those of prescription-only products, which carry a higher risk than over-the-counter products. If they are to be empowered in this way, European citizens need a basic understanding of how the body works, and what can go wrong. Getting familiar with concepts such as the risk-benefit ratio, epidemiology, pharmacovigilance, the placebo effect, etc. would also be useful. This knowledge can be acquired within the family, at school, and in society. When illness strikes, an individual needs comparative information on available therapeutic options: this means not only drugs, but also surgery, physiotherapy, psychotherapy, dietary measures, etc.; sometimes the best option is not to treat. Reliable comparative information can only be obtained from sources that have no direct financial ties with manufacturers of drugs or other devices or methods. Only full independence can guarantee valid comparisons. When treatment includes drugs, the patient needs specific information on their use. This information can be provided by the dispensing pharmacist or the nurse administering the treatment, or can be obtained from the packaging and patient leaflet. The patient also needs reliable information throughout the treatment period, especially on potential side effects, the patient needs to know how and when a treatment should be stopped. A SPECIFIC ROLE FOR EACH ACTOR

Four actors are involved on the field of information on medications. The quality of the
information depends on the balance between the role of these four actors.
The first actor is the group of patients. These citizens are often considered as consumers
but are not necessarily there to consume. They are in no way passive, as reflected by the
multitude of self-help groups, patient organisations and networks that have sprung up
worldwide in recent decades, with the aim of representing patients' interests and keeping
them informed. As regards DTC promotion, which I shall come to shortly, the recent reports
and position statements from Public Citizen in the United States, the British Consumers’
Association, Health Action International or the European Bureau of Consumers' Associations
are good examples of this vitality (1,2,3,4). Patient organisations also play an important role,
although a growing number are directly dependent on drug companies, or are even created
by them, and are thus no longer in a position to provide independent drug information.
The second group of actors -- health professionals -- are a natural vector for conveying drug
information to patients, provided they are independent and competent. Health professionals,
and especially family doctors, specialists in preventive medicine, pharmacists and nurses,
who are in closest contact with patients, are best-placed to bridge the gap between
specialised technical information and day-to-day practice. After a few decades of over-
reliance of some health professionals on information produced by the pharmaceutical
industry, the trend is starting to reverse. The vitality of independent drug information
networks is growing, with such organisations as the International Society of Drug Bulletins,
and, at the national level, the Therapeutic Initiative in Canada, Arznei-Telegramm Netzwerk
in Germany, or la revue Prescrire in France, etc. (5,6,7,8). This trend is part of the
movement towards evidence-based medicine and also reflects patients' and other citizens'
desire to be active, well-informed partners in their treatment. It is noteworthy that more than
25% of ISDB member bulletins have started to publish articles not only for health
professionals but also directly aimed at patients. For instance the Drug and Therapeutics
and Treatment Notes in the UK, NPOJIP (“check your medicines to save your life”) in
Japan, (9).
The third group of actors involved in drug information is the health authorities. This category
is often assumed to include health care insurers (social security and private insurance), even
though they render different but complementary services to patients. Their nationwide
coverage, together with their presence at the local and regional levels, allows these bodies
to support or even initiate the spread of information on health education, screening,
prevention, and at-risk behaviours. Provided they have the political will, of course.
This is also a major potential source of information on drugs, covering fields as diverse as
the use of vaccines and the prevention of side effects. The health authorities and health
insurers in some countries also support and initiate information campaigns and independent
information sources created by patients or health professionals. After all, it is in their
interests to do everything possible to ensure the rational and coherent functioning of the
health care system.
The fourth group is the pharmaceutical industry, which produces and sells drugs. Directly or
indirectly, the pharmaceutical industry also conducts or sponsors a large proportion of all
research and development of new drug substances. It is unfortunate that European public
research organisations have generally failed to adequately deal with unresolved health
problems and that a tiny minority of the so-called "new" preparations produced by the
pharmaceutical industry really provide an extra benefit for the patient (10,11). But that's
another subject.
The pharmaceutical industry has an obligation to provide the information ensuring optimal
use of their products. This is the role of the patient information leaflet and packaging
information. In principle, this type of information is written with the patient in mind. In
contrast, the summary of product characteristics is aimed at the health care professional.

In practice, drug companies have failed to fulfil their duty to inform via the patient leaflet and
SPC. By completely blurring the dividing line between information and promotion, they have
developed highly effective promotional tools and methods that ignore the very special nature
and utilisation of the "merchandise" they produce.
Information for health professionals has given way to promotional material overstating
benefits and minimising risk through every available medium. The place of the SPC has
become highly restricted, and in some cases has simply evaporated, as witnessed by the
majority of medical sales visits to practitioners. The spread of exaggerated or deceitful
information on the benefits of drugs, and the omission of information on adverse effects, is
regularly decried by regulatory agencies and independent monitoring networks such as
MaLAM in Australia, Prescrire's medical rep monitoring network in France, No Free Lunch in
the United States, or GRAS in Belgium, etc (12,13,14,15).
Regarding information for the general public, the pharmaceutical industry has given up trying
to create informative package labelling and patient leaflets, concentrating rather on
increasingly intensive promotion in the various media. Initially advertising was restricted to
self-treatment medications, but this promotional activity is now spreading to an increasing
number of prescription-only drugs. This is especially the case in the United States,
particularly via companies' websites, which are also accessible in Europe. In addition, drug
companies are already using all the other available media, intensively promoting their
products, including prescription drugs, either directly or through the use of opinion leaders.
The first major campaign of this type to hit Europe was for sumatriptan in the early 1990s.
Since then, the number of such campaigns has exploded, and now concerns not only
products used in obesity or erectile dysfunction, but also in osteoporosis, hypertension or
some cancers.
Is the drug industry nevertheless informing patients, or conducting information campaigns on
serious health problems? No. The industry's sole preoccupation now, in the current context
of cut-throat financial competition and the all-powerful shareholder, is to promote their
products in any way possible, including DTCs.

Some say that DTC promotion would have positive consequences, for example, helping to
inform patients who are unaware of they have a medical condition. They say that the poorly
informed "consumer", who is desperately seeking information on drugs, would appreciate
DTC promotion. Yet the negative consequences of promotional abuses are already visible
In the United States, for example, where DTC promotion is widespread and legal, there has
been a massive increase in prescriptions (and sales) of prescription-only drugs that have
been intensively promoted to the public. Compared to 1998, prescriptions rose by a
staggering 34% in 1999 for the first 25 prescription drugs that had been the subject of DTC
promotion. This compared with only a 5% rise overall in other prescription drugs. In 1999,
drug companies spent 180 million dollars on DTC promotion -- 40% more than in 1998 (16).
DTC promotion campaigns in the US have concerned some medium- and high-risk drugs
such as metformin, palivizumab, tolterodine, troglitazone, bupropion, or cyproterone. Other
campaigns have promoted very costly drugs with no proven advantage over cheaper
alternatives with better-known adverse effect profiles (3); two examples are fluticasone and
latest-generation oral contraceptives (3,16,17,18).
A similar situation has developed in New Zealand, where DTC promotion has also been
authorised; to such a point that the authorities there are thinking of reversing their decision
and again banning DTC promotion (3).
So why should Europe want to create a legal framework for DTC promotion and information
campaigns on specific health problems by the drugs industry? Will the European Medicines
Evaluation Agency (EMEA) be able to keep things under control once this Pandora's box has
been opened?
Regulatory measures and good practice guidelines, including those endorsed by the World
Health Organisation, have long been unable to prevent abusive drug promotion to health
professionals (12,19).
It would hardly be in the interests of public health to risk similar abuses, but this time aimed
at patients and the general public. And how can an industry that has just been caught
promoting a dangerous lipid-lowering agent be entrusted with providing reliable and
unbiased information?
Finally, how can EMEA possibly be expected to keep tight control over promotional
campaigns when it already has such a close relationship with the pharmaceutical industry?
Since the creation of EMEA, companies have virtually been free to decide the contents not
only of their SPCs but also of the agency's public assessment reports (EPARs), while the
public has been hard-pressed to glean the slightest objective information (10,20,21,22,23).

Optimal drug use can be encouraged in Europe by giving citizens assess to information
produced independently of the pharmaceutical industry.
Several measures can be taken, for instance:
– health education in schools must be improved, without interference from drug
– existing reliable sources of drug information for the public must be listed and promoted; – complementary independent sources of information aimed at health professionals and patients must be developed, through the media, information centres, websites, networks, etc., based on existing successful models; – health professionals must be trained to think independently about drugs and be encouraged to inform their patients; this means giving them the necessary time and means; – health professionals must be trained in communicating effectively with their patients (25); – health authorities and health insurers must start to engage in high-quality communication on drugs and their correct use, based on experience in certain countries. IMPROVING THE QUALITY OF PATIENT LEAFLETS
The first thing drug companies should be obliged to do is to produce patient leaflets that are
more than incomprehensible legal umbrellas. Research and discussions are required to
ensure that drug packaging becomes a true vector of clear, pertinent and practical
Regulatory agencies should require that package information is pretested to ensure that it
can be understood by patients and promotes good drug use.
This key measure is almost completely neglected at present, despite calls for improvements
from consumer organisations and patient associations.
Enormous efforts are required to clarify the situation surrounding information on medicinal
products, so that each European citizen receives reliable comparative information adapted to
his or her specific needs. The balance of power between the different protagonists must be
corrected. Strong political will is needed to choose between two very different alternatives,
namely artificial support for this European industrial sector, whatever the cost, or the
development of an effective health care system at the service of the end user, i.e. the
patient. Let's hope the authorities make the right choice, because we are all future patients.
Public Citizen Health Research Group "Testimony of Sidney M. Wolfe - Hearing on Direct-
to-Consumer (DTC) Advertising" Senate Commerce Committee 24 July 2001, available on e-
[email protected].

Consumers' Association "Promotion of prescription drugs : public health or private profit ?"
Briefing paper 2001 : 4 pages, av
Health Action International "HAI Europe criticises EC move towards DTCA ans calls for
evidence of health benfit" 17 July 2001 : 6 pages.
Bureau Européen des Unions de Consommateurs "Les compagnies pharmaceutiques ne
sont pas des docteurs" 10 juillet 2001 : 1 page.
L'International Society of Drug Bulletins regroupe une cinquantaine de bulletins
thérapeutiques indépendants de la publicité pharmaceutique. Ils sont édités par des
groupements de professionnels de santé et/ou des groupements de patients, selon les pays.
Contact : by Email:[email protected].

Therapeutics Initiative. The University of British Columbia. Department of Pharmacology
and Therapeutics. 2176 Health Sciences Mall-Vancouver, DC Canada V6T 1Z3.

NPOJIP - Japan Institute of pharmacovigilance-Room 320 Nishimono - 1-10-2-
Matsubara, Osaka #580-0004 Japan -
La revue Prescrire (version anglaise : Prescrire International) BP 459-75527 Paris Cedex
11 - France.

Font M "A survey of ISDB bulletins targetting patients and consumers" ISDB Newsletter
2001 ; 15 (1) : 6-7.
Garattini S et Bertele V "Adjusting Europe's drug regulation to public health needs. The
2001 ; 358 : 64-67.

"ISDB Declaration on Therapeutic Advance" Embargo: 12 December 2001.

"MALAM : encouraging trust worthy drug promotion" Essential Drugs Monitor 1994 ;
(17) : 6-7.

Prescrire editorial board "Sales representatives - A damning report by Prescrire reps
monitoring network" Prescr Int 1999 ; 8 (41) : 86-89.

No free lunch - Department of Medicine - Columbia University. www.nofreelunch.org.
GRAS Groupe de recherche et d'Action pour la santé. http://www.ulb.ac.be/esp/gras.
"DTC in the United Sates in 1999" Therapeutics Letter 2001 (40)

"Direc-to-Consumers Advertisments" The Medical Letter on drugs and therapeutics
2001. Contact by Email : edicalletter.org.
18- DES Actions Canada-Women "Les publicités directes aux consommateurs des
médicaments d'ordonnance diffusées illégalement au Canada" 2001 : 16 pages.

"Drug promotion" Essentiel Drugs Monitor 1994 (17) : 16-27.

International Society of Drug Bulletins "ISDB assessment of nine European Public
Assessments Reports published by the European Medicines Evaluation Agency (EMEA)."
June 1998 : 12 pages.

International Society of Drug Bulletins "The failings of the European Medicines
Evaluation Agency" May 2001 : 8 pages.

"The politics of scientific expertise - Informality, efficiency and transparency" In :
Abraham J et Lewis G "Regulating Medicines in Europe - Competition, expertise and public
health" Routledge, London - New York 2000 : 123-126.

"Democracy, technocracy and secrecy". In : Abraham J et Lewis G "Regulating
Medicines in Europe - Competition, expertise and public health" Routledge, London - New
York 2000 : 172-201.

Prescrire Rédaction "Le bon usage du médicament à l'école" Rev Prescr 1997 ;
17 (176) : 624-626.

Prescrire Rédaction "Critères de qualité des documents d'information aux patients - À
propos du rapport du King's Fund" Rev Prescr 1999 ; 19 (200) : 788-791.

Source: http://oud.frankvandenbroucke.be/html/soc/pdf-files/confGbardelay.pdf


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