E-DRUG: Ensuring ethical drug promotion--whose responsibility?
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[interesting letter from the WHO/EDM team in the Lancet! Rather unusual for
WHO staff to write public letters on the issue of drug promotion, but they
do have a serious point. Any e-drugger in France who would like to comment
about this campaign? Did the French authorities take action?
http://www.thelancet.com/journal/vol362/iss9385/full/llan.362.9385.correspon
dence.26978.1
Copied as fair use. WB]
Ensuring ethical drug promotion--whose responsibility?
Sir--Cardiovascular diseases are a major cause of death in many parts of the
world.1 Smoking, a sedentary lifestyle, an unbalanced diet, hypertension,
obesity, diabetes, and high blood cholesterol concentrations are some of the
most commonly cited risk factors.1
In France, from February to April, 2003, an extensive media campaign
purportedly sought to increase public awareness of cardiovascular disease
risks. In newspapers and magazines, an advertisement displayed a corpse in a
morgue, along with the caption: "A simple test of blood cholesterol could
have avoided this". A 30 s television commercial was equally shocking; it
depicted a couple celebrating a birthday, followed by the husband's
collapse. His wife then watches while he is taken away in an ambulance.
Finally, a voice declares, "You may think you're healthy, but too much
cholesterol in your blood can cause a heart attack."
The campaign was sponsored by the French Committee for the Coordination of
Research on Atherosclerosis and Cholesterol (ARCOL) and Pfizer. There is no
mention of the campaign on ARCOL's website, but Pfizer's French website
promotes it, and offers briefing documents and the television sequence for
free download. We believe the key message of the campaign is that high
cholesterol concentrations cause cardiovascular mortality. Other
cardiovascular risk factors are mentioned, but are seemingly used primarily
to strengthen this message--ie, the more cardiovascular risk factors you
have, the lower your cholesterol concentrations need to be.2 To us, the
implication is that smokers, obese individuals, or those who live a
sedentary lifestyle can safely continue to smoke, remain overweight, or take
little exercise, provided they take medication to reduce their cholesterol
values.
Of all the major factors accepted as cardiovascular disease risks, only
cholesterol is addressed--the campaign's stated aim is not pursued. No
mention is made of an actual medical product, but the campaign coincided
with publication, in The Lancet, of the Anglo-Scandinavian Cardiac Outcomes
Trial-Lipid Lowering Arm study,3 showing reductions in major cardiovascular
events after use of atorvastatin.
We believe the campaign could have worried patients, encouraging them to
request a prescription for statins. If so, we suggest that the campaign
meets the definition of promotion noted in the WHO Ethical Criteria for
Medicinal Drug Promotion:4 ". . . all informational and persuasive
activities by manufacturers and distributors, the effect of which is to
induce the prescription, supply, purchase and/or use of medicinal drugs".
Moreover, we believe the campaign did not respect several of WHO's ethical
criteria, in that it is neither accurate, informative, or balanced. Finally,
we think the information used contained misleading statements and omissions
likely to induce medically unjustifiable drug use or to give rise to undue
risks.
We conclude that this experience underscores the need for health authorities
and those charged with reimbursing or for paying for medicines to urgently
increase their vigilance with respect to drug promotion. In our opinion,
they must also decide how they can play an active and effective part in
regulation of promotional activities, and ensure that balanced health
information is readily available to the public, so that prescribing is not
unduly affected by drug promotion activities.
Jonathan D Quick*, Hans V Hogerzeil, Lembit R�go, Valerio Reggi, Kees de
Joncheere
*Department of Essential Drugs and Medicines Policy, WHO, Geneva,
Switzerland (JDQ, HVH, LR, VR); Regional Adviser for Pharmaceuticals, WHO
Regional Office for Europe, Copenhagen, Denmark (KdJ)
(e-mail:quickj@who.int)
1 WHO. World Health Report. Geneva: World Health Organization, 2002.
2 Pfizer. Nos dossiers th�matiques: le cholest�rol.
http://www.pfizer.fr/Desktop
Default.aspx?tabindex=1&tabid=62&file=/files/dossierThematique/91f7fbf6-7ad4
-498d-b6a9-ebc64e36105c.xml#7 (accessed June 10, 2003).
3 Server PS, Dahl�f B, Poulter NR, et al. Prevention of coronary and stroke
events with atorvastatin in hypertensive patients who have average or
lower-than-average cholesterol concentrations, in the Anglo-Scandinavian
Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA): a multicentre
randomised controlled trial. Lancet 2003; 361: 1149-58.
4 WHO. Ethical Criteria for Medicinal Drug Promotion. Geneva: World Health
Organization, 1988.
Access Essential Drugs Monitor #32 at http://www.who.int/medicines/mon/mon32.shtml
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