Direct to consumer advertising of drugs in Europe
BMJ 2007; 335 doi: https://doi.org/10.1136/bmj.39310.506308.AD (Published 13 September 2007) Cite this as: BMJ 2007;335:526
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than most of us realize and hard to legislate since stakeholders simply work behind supported organizations, patient's groups or advertising agencies.
Two examples:
1. The 'National Stroke Association' [NSA; stroke.org],
".. enabled
by the generous support of .., an elite group of industry partners .."(1).
These include statin manufacturers as well as G.E. (1), also owner of the
NBC news network
(2) with whom NSA also 'partners' in an 'awareness campaign'. Their advertisement is a cute video clip on YouTube entitled Cholesterol
and Stroke (3). A hot-dog on a psychiatrist's couch worries about high cholesterol being a risk factor for stroke--yet there is zero scientific evidence for a causal link. The clip ends by showing a pill box reading
'Rx statins'. The danger of such message is that while some statins have shown to reduce ischaemic stroke, at least 2 statins increase
haemorrhagic in study populations that, at baseline, virtually excluded the 20 to 25% of patients with strokes that are haemorrhagic [simvastatin, approaching significance in post-hoc HPS, and atorvastatin as a primary
endpoint in SPARCL and where the increase was significant (P=<_0.025 both="both" studies="studies" versus="versus" placebo="placebo" a="a" href="http://www.neurology.org/cgi/eletters/68/10/719#7946"/>4).
2. Pfizer, makers of atorvastatin [Lipitor] and
'partnering' with 5 organizations they help finance, publishes MakingTheConnection.ca
where they frighten people about cholesterol with morgue or shark images while enticing people with a lottery or golf memorabilia. Unsaid
(on all but the home page (5)) is the name of the copyright owner [Pfizer]
and the fact that its statin has never saved anybody from early death in
a clinical trial or meta-analysis thereof, and this in a disease that ranks
number one in mortality world-wide. In Canada, these messages are
legal if not mentioning a drug name being 'information-seeking advertising'.
No balance or medical journal level caveats are required or given.
Supporting the authors of the editorial, 'partnering' with stakeholders will be an eternal struggle to get the non-supporting data published.
Even 'information seeking' and 'ask your doctor' ads are vehicles to mislead
as the examples above show. vos{at}health-heart.org
1. http://www.stroke.org/site/PageServer?pagename=CAB
2. http://www.stroke.org/site/PageNavigator/HOME
3. http://uk.youtube.com/watch?v=mZC6TZNcnJA
4. Vos E, de Groot P. Low
LDL cholesterol, statins, and brain hemorrhage, Should we Worry? Neurology
2007 (in publication)
5. http://www.makingtheconnection.ca/en/home/
Competing interests:
None declared
Competing interests: No competing interests
Magrini and Fonts'(1) suggestions do indeed seem sensible if you
focus on their principle of providing information to meet patients' needs.
Although they discuss direct to consumer advertising the role of drug
promotion at an earlier stage may have already influenced the views of the
public and patients.
The current European legislation on drug promotion does not allow an
easy definition of what promotion by a pharmaceutical company before
market authorisation might entail. This is of particular concern as this
can drive healthcare funding without allowing an adequate assessment of
the evidence. Many pharmaceutical companies appear to routinely employ
major marketing companies to promote their new drugs in a variety of ways.
The recent example of the premature promotion of Herceptin for early
breast cancer is reported as being seen as exemplary by the industry and
will be widely copied (personal communication).
By using major cancer conferences as a place to release the early
results from high profile trials it is possible to gain worldwide
publicity. This can also be supported by website press releases to inform
the stock market, which then means that you have one-sided information
freely available in the market place. Other tactics may be used.
Guerrilla media tactics may not be a phrase in widespread use in the
medical world but it accurately describes the ability of "marketeers" to
subtly influence the media. This can give the public biased and
emotionally charged information as patients appear on television and in
the papers. A Google search on "guerrilla media tactics pharmaceuticals"
gives you the simple definition of "Getting more media attention without
news".
The small patient group in Stoke-on-Trent, "Women Fighting for
Herceptin", was heavily supported by one of the world's top ten marketing
companies(2). The ensuing national media campaign pushed politicians into
supporting the unlicensed use of Herceptin and hence undermined the UK
Medicines Act and the role of NICE (National Institute for Health and
Clinical)(3). Many healthcare commissioners caved in under the subsequent
pressure and agreed early funding.
The drive for pharmaceutical company profits is changing the tactics
of information use but in the long run this is much more likely to
undermine public trust in the industry than it is to help patients.
(1) Magrini N, FontM. Direct to consumer advertising of drugs in
Europe. BMJ 2007; 335:526 (15 September.)
(2)Boseley S. The selling of a wonder drug. The Guardian 2006. (29 March.)
(http://www.guardian.co.uk/science/2006/mar/29/medicineandhealth.health)
(3) Department of Health. Speech by Rt Hon Patricia Hewitt MP, Secretary
of State for Health, 25th October 2005:Breast Cancer Awareness. Especially
paragraphs 18 and
21.(http://www.dh.gov.uk/en/News/Speeches/Speecheslist/DH_4121929)
Competing interests:
JH advised healthcare commissioners about the funding of unlicensed Herceptin. A complaint by him about the promotion of Herceptin was upheld.
Competing interests: No competing interests
I have commented in a previous Rapid Response on the claim made by
some organisations that they represent the European consumer and the
European patient that the evidence for such claims is, to put it kindly,
tenuous (http://www.bmj.com/cgi/eletters/334/7600/935#164885).
This is particularly true for one of the organisations cited in
Magrini and Font's article, Health Action International.
The vast majority of the European branch of Health Action
International's funding appears to come from Governmental sources, at
least as far as can be garnered from their website, the latest disclosure
being 2004:
http://www.haiweb.org/01_about_finances.htm
Membership subscriptions for HAI at just over €5000 are relatively
insignificant. HAI funding from patients seems to be around 0.5% and
funding from Governments, who might be thought by some to have a vested
interest in minimising short term expenditure on medicines, and therefore
limiting the information available to patients and potential patients, is
more than 87%.
The fact that this disclosure of information from HAI is far from
complete and two years out of date is perhaps also worthy of comment.
It is likely that nobody involved in this debate is free from a
potential conflict. The views of Pharmaceutical Industry critics are also
value-laden, as is clearly illustrated by the repeated and erroneous
conflation of advertising emanating from the Pharmaceutical Industry with
the provision of information by the Industry. The two are separate
activites, as is acknowledged by Regulatory Agencies across the world.
Nevertheless this misleading equation of promotion with information
provision is repeated by authors such as Magrini and Font, and
uncritically published in journals such as the BMJ.
There are conflicts and value judgements on both "sides" of the
debate surrounding the question of whether or not patients and consumers
should be entitled to request and receive information fom those companies
who have researched and produced the medicines they are taking, or that
they may wish to consider taking.
To suggest otherwise is misleading and self-serving.
I should add these are my personal views and not those of my
employer, Norgine.
Competing interests:
Employee of a pharmaceutical company, Norgine.
Competing interests: No competing interests
Re: "Unbiased evidence based information"? I think not
Given the competing interests listed by Peter Martin it is not
surprising that he has felt compelled on more than one occasion to snipe
at Health Action International (HAI), an independent network working to
increase access to essential medicines and improve their rational use
(‘Unbiased evidence based information"? I think not’
http://www.bmj.com/cgi/eletters/335/7619/526#176485). However, his letter
contains such inaccuracies that on this occasion it deserves a response.
One glaring inaccuracy in Peter Martin’s piece is that our last
declared funding is from 2004, which he suggests would be some foundation
for suspicion. However, if he cared to look on HAI’s homepage
(www.haiweb.org) he would also find our annual accounts for 2006, being
our most recent financial cycle. Suspicion dispelled, I think.
Peter Martin points out that our membership fees represent a small
part of our funding. HAI is membership based, but our membership fees are
on a scale which means the unemployed, those in developing countries,
students and so on pay minimal fees or their fees are waived, so the
income does not necessarily reflect our membership. But even if it did,
if he cares to again visit our homepage, he would see that member
organisations such as Oxfam and Consumers International are also listed.
I think this probably gives us some legitimacy in claiming a reasonably
representative constituency. So, allegations of poor representation
dispelled.
Let us then deal with the main complaint of Peter Martin’s response.
He seems to believe that HAI is doing the bidding of governments who have
a vested interest in restricting patients’ access to medicines. In other
words there is an inherent conflict of interest in HAI accepting funding
from European governments, to which I have two responses.
Firstly, HAI is a global network and most of its work is conducted in
developing countries through regional offices in Peru, Sri Lanka and
Kenya. In those regions much of the fight is about increasing access to
medicines, not limiting it. But it is about increasing access to
essential drugs. So, he is right if he thinks HAI wants to rationalise
access to medicines in developing countries – but only to those
characterised by the WHO essential medicines list, access to which we want
to promote. No drug rationing on behalf of European governments there,
then.
Secondly, the overwhelming majority of HAI’s funding comes from
European governments’ overseas development agencies, not their ministries
of health. This is a perfectly legitimate use of public funds, much of
which is redistributed to our partners in the South and to date, HAI has
won its funding in open competition from overseas development ministries
in the Netherlands, UK, Finland, Sweden and Norway.
Our interest in Europe stems from the fact that in a global market what
happens in Europe affects what happens in the developing world. Our
absolute opposition to the pharmaceutical manufacturers supplying
information to patients is that it represents an absolute conflict of
interest. Make no mistake - if the pharmaceutical industry are allowed to
supply information to patients it will be advertising and will lead to
irrational prescribing, increased medicine use (and therefore costs) and
potentially increased morbidity and mortality.
At least I can agree with Peter Martin on one point; HAI’s opinions
probably are value-laden – HAI's values are that the interests of patients
and consumers should come above the commercial interests of the
pharmaceutical industry. I think that is defendable.
Competing interests:
Director, Health Action International
Competing interests: No competing interests