Rapid Responses to:

OBSERVATIONS:
Tessa Richards
Purely medicinal?
BMJ 2008; 336: 693 [Full text]
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Rapid Responses published:

[Read Rapid Response] Direct to consumer advertising
Anthony N Glaser   (29 March 2008)
[Read Rapid Response] Misdirection by “truth”?
Mohamed Sakel   (30 March 2008)
[Read Rapid Response] Americanisation
Neal J Russell   (3 April 2008)
[Read Rapid Response] A cynical consultation exercise?
Charles Medawar   (4 April 2008)
[Read Rapid Response] Starving for good quality info - flooded with misleading marketing
Norbert Wilk   (4 April 2008)
[Read Rapid Response] Have we disposed of the need for evidence?
Daniel J Beck, YO12 6QL   (5 April 2008)
[Read Rapid Response] DTC: Impossible to stop, once begun?
James B. Russo   (5 April 2008)
[Read Rapid Response] Make all drugs OTC ! DTC is coming ! The day is not far away for patient guided prescription ?
venkatesan sangareddi, chennai 600003   (11 April 2008)

Direct to consumer advertising 29 March 2008
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Anthony N Glaser,
Assistant Professor of Family Medicine
Medical University of South Carolina, SC 29483

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Re: Direct to consumer advertising

Practising in the USA, I am well acquainted with direct to consumer advertising of prescription drugs.

I would strongly suggest (and have suggested in the past to the FDA) that if such advertising is allowed, it should be mandatory for the manufacturer to state the typical cost of a course of treatment with the drug - as I have seen with experience of the $600 treatment for onychomycosis, this information could save a great deal of time in explaining to the patient why the drug is not covered by their insurance, or it could prevent a whole unnecessary discussion in the first place, as patients quite readily recognise that the cost is out of proportion to their problem.

There is one other problem: the (very reasonable) requirement that side effects and contraindications are mentioned in the advertising fails to put them in proportion. Thanks to TV ads, patients are universally convinced that statins are likely to damage their livers, and many are reluctant to take this class of drugs for that reason.

Competing interests: None declared

Misdirection by “truth”? 30 March 2008
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Mohamed Sakel,
Director R & D
East Kent Univrsity Hospitals Trust, UK. CT17 0HD

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Re: Misdirection by “truth”?

The Industry is campaigning in EU to obtain the power to “inform” the public in addition to the clinicians. Information is power. It is the privilege and duty of the clinicians to advise patients after distilling all available information keeping patients’ best interest in mind. How certain the clinicians themselves are when they face “information” provided by the Industry? In this issue of BMJ (29 march 2008), I noticed an advertisement of Xeomin (botulinum neurotoxin) that looks fabulous! The phrases, “new”, “free from complexing proteins” and “low foreign protein load” would immediately appeal to the subconscious thought process of clinicians. These claims must surely be proven facts. But how relevant are these in real life treatment decisions? I don’t know! If trained and, possibly cynical, doctors become unsure, what chances do the public have in discerning through the maze of emphasised but irrelevant facts? Even the highest level of research evidence or conclusions could be manipulated in favour of Industry.

Amongst all these uncertainties in healthcare, one thing is absolutely certain though, and that is that the Industry’s prime motivation is to make profit. The prospect of that profit seems to be less sanguine now a day. 1 The “direct to consumer advertisement” could potentially muddle judgements of patients and help selling more drugs. The industry will do anything within legal limits to sell more of their products. When it comes to business, it will always be business as usual.

Reference: 1.Cole A.Drug Industry anxious about scrapping price regulation scheme. BMJ 2008;336:686

Competing interests: The author uses various types of botulinum toxin for routine clinical practice.

Americanisation 3 April 2008
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Neal J Russell,
student
london sw115hg

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Re: Americanisation

It seems like health in the UK is becoming progressivley more like the USA, where health costs are the highest in the world, and many people make a great deal of money to the detriment of good quality care. First privatisation of the NHS, then Direct To Consumer advertising (i dont beleive it can be called anything other than advertising), what next? The most important lesson we should be taking from the USA is how not to run a health system. I doubt whether that lesson is being learnt.

Competing interests: None declared

A cynical consultation exercise? 4 April 2008
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Charles Medawar,
Medicines' policy analyst
Social Audit Ltd, PO Box 111, London NW1 8XG

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Re: A cynical consultation exercise?

Tessa Richards identifies ‘the European Commission’ as the source of these dismal proposals to allow pharmaceutical companies to promote prescription drugs directly to consumers. More specifically, this ‘consultation’ has been orchestrated by the Commission’s ‘Directorate General for Enterprise and Industry’

The main objective of DG Enterprise and Industry (DGEI) is to promote European trade and economic development. That is a legitimate interest in its own right, but it presents grotesque conflicts of interest when it comes to shaping health policy – and these proposals exemplify them. DGEI greatly over-estimates the support they deserve, no doubt partly in the expectation of strong backing from the industry-funded patient groups that it has traditionally promoted and preferred.

The consultation document lacks any coherent health impact assessment. Its proposals further blur the distinction between high and low quality information, and take no account of the health impact of the far greater quantities of partial information to which people will now be exposed. That is a crucial omission.

The activities of the leading pharmaceutical companies – all deeply engaged with DGEI - mainly distract from the health problems we face. Medicinal drugs are of course sometimes extremely valuable – but can only ever be a small part of the solution.

DG Enterprise & Industry fails to appreciate that you paralyse the healthy human response, once people come to believe that their genes, body chemistry, and social/cosmetic camouflage are key to developing health and well-being. These proposals take absurdly for granted the benefits of technological and medical intervention Health is basically to do with eating sensibility and sufficiently, taking enough exercise, avoiding toxic exposures, and social security and justice. Disease awareness propaganda distracts from these imperatives and makes the situation worse.

Medicines have their place, but it is folly to promote them as if they were the bedrock of health development and the key to maintaining good enough levels of personal confidence, social equilibrium and mental and physical health. This drive to medicalisation not only makes people feel resourceless and ill; it also threatens the very existence of national health services, by creating unsustainable demand.

What do these proposals have to offer in terms of promoting clear and general understanding of the real benefits, risks and harms that come from pharmaceutical interventions? Possibly one step forward; probably three or more steps back.

Competing interests: None declared

Starving for good quality info - flooded with misleading marketing 4 April 2008
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Norbert Wilk,
Deputy Director, Agency for Health Technology Assessment in Poland
30-698 Krakow, Poland

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Re: Starving for good quality info - flooded with misleading marketing

Dear Editor,

I have read the article with growing anxiety and uneasiness as it may bring very bad outcomes regarding Public Health and the availability of Truth, that I particularly treasure, about the effectiveness of drugs.

Recently European Union Alliance for the Dissemination of Evidence (www.eu-ade.eu) have successfully launched a petition to European Commission urging them to finance EU Provision to Cochrane Library. The petition is still available at the address www.cochrane.epetitions.net. Over 11,6 thousand people have signed the petition. It confirms that Europeans are starving for good quality information while flooded with misleading marketing. It appears to me that the proposal put forward by the DG Enterprise (apparently and surprisingly not in cooperation with DG SANCO) would not ease that hunger, but rather bring another even bigger tidal wave instead.

Yours sincerely, Norbert Wilk

Competing interests: None declared

Have we disposed of the need for evidence? 5 April 2008
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Daniel J Beck,
FY2 Doctor
North Yorkshire,
YO12 6QL

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Re: Have we disposed of the need for evidence?

Over the past two decades, the medical profession has undergone a dramatic sea-change. Gone are the days of sacrosanct expert-opinions; we are now practicing in a world of evidence-based medicine. Few would dispute the benefits that this transition has brought to patients worldwide, through a sharing of knowledge and experience.

The EU public consultation document (http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2008/2008_02/info_to_patients_consult_200802.pdf), devoid of any reference to pre-existing research, studies or evidence, appears to have come from a bygone era.

A public consultation is one thing; a thorough search of the literature, resulting in an informed and evidence-based position is something quite different altogether. One would have hoped that before implementing something that has the scope to so utterly change the landscape of European healthcare, a detailed evaluation of the consequences for all parties would be undertaken.

The sad reality is that even had such a search taken place, the results would have been sparce. Having conducted just such a search, I was surprised by the paucity of original research that has been done in this area. But when the European Union publishes no appraisal of the anticipated health consequences of it's policies, and makes decisions with only a token public consultation, and seems unapologetic in its championing of European industry over European health, it is not hard to see why.

Competing interests: None declared

DTC: Impossible to stop, once begun? 5 April 2008
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James B. Russo,
Retired
Bernville, Pennsylvania, USA 19506

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Re: DTC: Impossible to stop, once begun?

In pondering whether to go down the path of America's DTC promotion scheme, EC policymakers should consider how they'd get the DTC promotion genie back in the bottle if, once tried, it is found wanting. The enormous revenue DTC ads bring to the American broadcast and print industries has addicted them to DTC. Therefore,a move to moderate or banish DTC in the States would bring the commercial media to full political alert --with freedom of speech as their battle cry.

Competing interests: None declared

Make all drugs OTC ! DTC is coming ! The day is not far away for patient guided prescription ? 11 April 2008
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venkatesan sangareddi,
cardiologist
madras medical college, Chennai,
chennai 600003

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Re: Make all drugs OTC ! DTC is coming ! The day is not far away for patient guided prescription ?

It needs to be recognised , the modern day internet enabled patients , flooded with contaminated medical information are already a confused lot. Adding further injury would be the DTC .Bye passing the doctors and providing medical information directly to the patients is a favorite game , played by pharma industry. While doctors themselves are struggling to understand & interpret the conflicting data coming out of research labs one would wonder what is in store if DTC is actively pursued !

Dr.Venkatesan sangareddi Madras medical college Chennai ,India

Competing interests: None declared