Social Audit Ltd
P O Box 111 London NW1 8XG
Telephone/Fax 44 (0)171 586 7771
socialaudit@gn.apc.org   http://www.socialaudit.org.uk

 

M. Philippe Brunet
Head, Pharmaceuticals and Cosmetics Unit
European Commission, Enterprise DG
Rue de La Loi 200
B-1049 Brussels

14 July 2000

Belgium

Dear M. Brunet,

I am responding on behalf of Social Audit Ltd to the questions raised in the EC consultation on advertising and electronic commerce. Our particular interest and concern is Direct To Consumer Advertising

1. Limitations of this consultation

We are dismayed by the quality of the consultation on this issue. The Minutes of the EC Pharmaceutical Committee meeting which followed the Ad Hoc Working Party meeting recorded a decision to send out "a questionnaire asking concrete questions and proposing concrete options on possible ways forward", by way of consultation. The questions that emerged (# 7 - 20) do no such thing; some are barely comprehensible. None mentions Direct To Consumer Advertising. It seems doubtful whether this consultation document will elicit much useful comment. We regret that that the Commission had not prepared a briefing in Plain English, setting out what it believes the main issues to be. We recommend this be done in advance of any further consultation.

2. Control of promotional and other information on the Internet

We see absolutely no prospect of effective enforcement of rules governing information on the Internet. We would not recommend the EC to attempt it, but do not think that inability to enforce should prompt any change in the relevant Community legislation. We recognise that the Internet presents some problems, but suggest the Commission simply adopts a policy of 'wait and see', on these grounds:

[a] the technology is developing rapidly, as are the uses to which it is put. Measures introduced tomorrow may not be sufficient the day after that. There is no compelling reason to act, in the meantime, on grounds of safety and public health.

[b] Whatever problems there may be with information quality, the Internet also offers a rich variety of information at low cost;

[c] Unlike promotional information in traditional media, information on the Internet tends to reach only those who seek it. By contrast, promotions in traditional media reach mainly non-target consumers, exposing them to barrages of information they may not need or want or benefit from.

[d] the Internet operates as a relatively level playing field, allowing anyone to publish information for a minimal investment. Thus the unwanted influence of commercial promotion may be offset, or tempered, by health information from independent sources.

3. Direct To Consumer Advertising (DTCA) is the major concern

We recommend the Commission focuses its attention on promotional activities in print, broadcast and other traditional media. It is quite clear that the central issue in what the Commission recognises as "an intense debate" is whether or not to permit Direct to Consumer Advertising (DTCA) and promotion of prescription-only drugs. That is by far the most important question the Commission needs to address.

This issue concerns us deeply. Our concern relates not only to the possible adverse effects of promoting prescription-only medicines to the public, but also to the way in which decisions that may lead legalisation are being taken. We are concerned about:

We believe that, in most countries, DTCA would bring fewer benefits than risks. We fear it presents a major threat to global public health.

We believe this concern to be shared widely among international health, consumer and public interest advocates, including Health Action International (HAI) and the Medical Lobby for Appropriate Marketing (MaLAM). With them, we play a leading role in promoting "the precautionary principle" in relation to DTCA, by unanimous resolution of the NGO representatives attending the May 2000 Roundtable Seminar with senior representatives of the World Health Organisation. See Appendix Two

4. American medicine is hardly a good advertisement for DTCA

We recognise that most people need and want much better information about medicines and health - and have long campaigned for it. But we do not think that this information vacuum either can, or should, be filled by advertising messages and linked promotional activities.

After five years in operation, there is still considerable controversy about the benefits, costs and risks of DTCA even in the USA (and New Zealand). But there precious little hard evidence of what it does and does not contributes to health.

There are, however, some broader indicators that prompt the question: why would other countries want to adopt an American-style national health system? WHO data from The World Health Report (2000) shows that the cost of US healthcare is unaffordably high, and that the country attains outstandingly poor therapeutic value for money. See Table - Appendix One.

Inevitably DTCA adds to the health cost burden. In the US, annual expenditure on DTCA has rocketed to about $2 billion/year. The US recorded a 15% drug sales growth between May 1999 and April 2000 - over twice the average (7%) for the top five European countries in the same period (IMS Health, Drug Monitor, London, 23 June 2000).

American medicine also carries a lot of baggage with it - excessive clinical intervention and over-dependence on high technology - part of 'defensive medicine', a response to the fear of being sued. American medicine also seems riddled with conflicts of interest, and driven hard by money. Big money already has a huge influence in shaping information about benefit, cost and risk and in defining attitudes to health. How much would it take to drown out evidence-based information from reliable independent sources?

Would this characteristically American phenomenon innovation (DTCA) be appropriate in other cultures? That question is most relevant in countries where people do not enjoy the high degrees of freedom and levels of protection available to their US counterparts - e.g. through rigorous enforcement of promotional activity by the FDA, freedom of information laws and consumer rights.

5. Major unanswered questions

Proponents of DTCA - including some patient/consumer groups that have been conspicuously well funded by commercial interests - have suggested that the advantages of DTCA include the provision of useful and helpful information to patients, greater awareness of health problems and treatment options, and lessening the stigma of illness and disease.

These are indeed potential advantages. But they deserve close scrutiny, not uncritical acceptance - if only to find out who would gain, and who would not. Our provisional view is that there probably is some nourishing information in many individual Direct-To-Consumer promotions. However, our main concern is about what happens when predominantly commercial messages become the dominant feature of the overall information diet.

In support of the guiding principle, "above all do no harm", we propose a general moratorium on the further introduction of DTCA. To legalise DTCA, in the absence of good evidence of both health benefits and lack of harm, would be to undermine the core values of medicine, science and democracy. The precautionary principle should be applied - at least until clear answers have been found to questions such as these:

To what extent would health care systems be able to meet the increased demand likely to result from increased volumes and frequency of product and "disease awareness" advertising on target and non-target audiences?

Would DTCA be likely to promote more rational and effective drug use - any more than drug advertising to health professionals?

To what extent might DTCA promote drug treatments over possibly better alternatives (including non-intervention), and/or less effective and cost-effective medical treatments?

What would be the likely overall effect of DTCA on product prices and national drug budgets? Would it improve access to health?

How would DTCA affect different people's health - taking into account also their perception of health and health needs and their dependence on providers?

Does DTCA tend to give an unfair competitive advantage to major multinationals, over smaller companies and local producers?

Would DTCA provide, in effect, a greatly extended patent life for promoted brands - and what would be the likely impact on production and use of generics?

What would be the indirect effects of DTCA on health - including its influence on the editorial independence of the press and media, and their coverage of health issues?

Would high volumes of DTCA tend to distort public understanding of benefit and risk, and of health policies and issues? How would it affect the supply of drug information from independent sources?

To what extent would recent experience in the USA be relevant to the impact of DTCA elsewhere - especially in developing countries - given the US commitment to private rather than public health?

Until health impact assessments have been done - providing sound evidence of the net benefits of DTCA in different cultures and communities - we are committed to maintain the legal status quo, prohibiting the promotion of prescription-only medicines to the general public.

6. Matters of timing

It will take a lot of time and much careful thought to address such questions - and we seem nowhere near finding the answers we need. Possibly the UK government is lagging behind other EU member countries in relevant enquiries and consultations - though we have no reason to believe it. Whatever the case, our government has apparently barely begun to explore the issues concerned:

"The MCA has not made any detailed assessment of the benefits, risks and costs that might follow should the current law be changed" (Medicines Control Agency, Personal Communication, 20 April 2000)

"The Treasury has not undertaken any analysis of the type you describe" (HM Treasury, Personal Communication, 11 May 2000)

The Medicines Control Agency (which acts also for the UK Medicines Commission) is now the subject of a recent referral by Social Audit, addressed to the Parliamentary Commissioner for Administration (The Ombudsman) on the grounds of inordinate delay and secrecy in explaining its views on DTCA. There has been no consultation with consumer interests.

7. Who's making the running in this debate?

In the vacuum created by the silence of government, the pharmaceutical industry in this country is steamrollering the debate in what appears to be the most manipulative fashion.

Two companies (Schering and Biogen) have reportedly been censured by the Medicines Control Agency for, in effect, setting up "consumer groups" to lobby for access to their products. Other companies have directed large payments to selected patient groups, clearly in an attempt to secure their support.

We consider it of great importance that the Commission requires organisations representing patient interests in this debate to disclose in full information about the extent of their sponsorship by pharmaceutical companies. Apropos of this, we emphasise we would not want to see the emerge of patient alliance groups, US-style:

"The National Alliance for the Mentally Ill (NAMI) bills itself as 'a grassroots organisation of individuals with brain disorders and their family members …18 drug firms gave NAMI a total of $11.72 million between 1996 and mid-1999 … NAMI's leading donor is Eli Lilly and Company, maker of Prozac, which gave £2.87million during that period."

Silverstein K., Prozac.org, MOJOwire Magazine - 18 November 1999 at http://motherjones.com/mother_jones/ND99/nami.html

It would not be fair to give the industry two or more "bites of the cherry" in any consultation process - allowing it to speak for itself, and be spoken for by partly 'bought interests'. There is a real risk of this.

We submit as a formal part of this response, the article "The Mark of Zorro" by Michael Jeffries, published in Pharmaceutical Marketing, May 2000. This reports on a briefing to the Pharmaceutical Marketing Society given by the Association of the British Pharmaceutical Industry (ABPI). It illustrates a style of campaigning that arguably subverts the democratic process. The following extracts illustrate this:

"Direct To Patient communication has become a prime objective for the Association of the British Pharmaceutical Industry (ABPI) … Now the ABPI has announced that it is launching the final stages of a campaign before it tackles the Government and the EU head on ...

"It is the spearhead of a carefully thought-out campaign. The ABPI battle plan is to employ ground troops in the form of patient support groups, sympathetic medical opinion and healthcare professionals - known as 'stakeholders' - which will lead the debate on the informed patient issue. This will have the effect of weakening political, ideological and professional defenses … Then the ABPI will follow through with high-level precision strikes on specific regulatory enclaves in both Whitehall and Brussels …

"The ABPI was now approaching the issue by enlisting patient support groups as part of the Informed Patient Initiative. Patient organisations, with their own clinical advisers, were already starting to fight their case for access to drug information. 'Patient groups offer us a big opportunity to provide them with authoritative information for them to use objectively in a way that benefits their members', he said."

"The first phase of aligning the Industry with the Informed Patient Initiative campaign began in 1998 and was now largely completed said Professor Jones (Director, ABPI) …Phase two of the campaign is now involved in seeking alliances with patient groups, the BMA (British Medical Association), Royal Colleges (of health professionals), media and others. A recent publication by the ABPI, The Expert Patient, is part of a softening-up assault to be mounted through those interested parties and opinion leaders by stimulating public debate."

It is not clear to us in what way(s) the introduction of DTCA would improve on information about medicines already available from commercial sources. The way in which in which ABPI has described the value of its initiatives in providing approved drug information suggests DTCA would do little or nothing "to encourage the rational use of medicines.

"Patient packs are the best, simplest and most convenient method of ensuring that patients get full details about their medicine - including how and when to take it, where to store it, possible side effects and other information." Association of the British Pharmaceutical Industry (ABPI) press release, 27 April 1998

"Patients throughout the country can access for the first time comprehensive and authoritative details about their medicines at the touch of a button, thanks to the launch today of a new service by the pharmaceutical industry … By using the Internet, the new Electronic Medicines Compendium (eMC) will provide an entirely new, free service to patients, doctors and other healthcare professionals seeking information about prescription medicines. Because the information contained on the site has been officially approved by the Department of Health, it is uniquely authoritative - and new search facilities make it easy to find." ABPI press release, 24 January 2000

8. In short

We believe the introduction of DTCA is fraught with risk. This is a development that could change the face of medicine. To judge from experience in the USA, its benefits are dubious. It would confront other countries with pressures that could cripple the provision of good basic national health. To make changes in the law that would permit DTCA, without thoroughly investigating the implications would be folly. The impacts of DTCA on different EU member countries would differ; they need careful examination, prior to any proposal to change the law. We think it would be most helpful if the EC negotiated a moratorium of DTCA - to give all concerned the space needed to think. To plan is to choose.

We hope these comments are of interest and use.

Yours sincerely,
Charles Medawar

 

Appendix One

The table below says something about the cost of health attainment in different countries. The data come from The World Health Report (WHO, 2000) with health attainment is expressed here in Disability Adjusted Life Expectancy (DALE). See note below. 

Country

Total per capita health expenditure in international dollars

Disability-adjusted life-expectancy (overall years)

Greece

964

72.5

United Kingdom

1,193

71.7

Spain

1,211

72.8

Israel

1,402

70.4

Finland

1,539

70.5

Australia

1,601

73.2

Norway

1,708

71.7

Belgium

1,738

71.6

Iceland

1,757

70.8

Japan

1,759

74.5

Italy

1,824

72.7

Canada

1,836

72.0

Netherlands

1,911

72.0

Sweden

1,943

73.0

Austria

1,960

71.6

Luxembourg

1,985

71.1

France

2,125

73.1

Germany

2,365

70.4

Switzerland

2,644

72.5

USA

3,724

70.0

 Source: Statistical Annex, Tables 5, 8, The World Health Report 2000, (Geneva, World Health Organisation, May 2000), pp. 176-182. 192-195. Omitted: Malta (70.5 years - $755/head), Andorra (72.3 - $1,216), San Marino (72.3 - $1,301), Monaco (72.4 - $1,799).

"To calculate DALE, the years of ill-health are weighted according to severity and subtracted from the expected overall life expectancy to give the equivalent years of healthy life". Thus "DALE summarises the expected number of years to be lived (for babies born in 1999) in what might be termed the equivalent of 'full health'."

 

Appendix Two

Commitment to the Precautionary Principle in relation to DTCA was agreed by all NGO participants - acting in their personal capacities - in the third WHO/NGO Roundtable, Geneva, May 2000. They included

Ms Saree Aongsomwang (Foundation for Consumers, Thailand, representing Action for Rational Drugs in Asia - ARDA);
Margaret Ewen (International Society of Drug Bulletins, New Zealand);
Ms Manjit Kaur (Echo International Health Services, UK);
Dr Roberto López Linares (Acción Internacional para la Salud, Peru);
Dr Peter Mansfield (Medical Lobby for Appropriate Marketing, Australia),
Charles Medawar (Social Audit Ltd, UK);
Ms Kirsten Myhr (Health Action International, Norway);
Dr Eva Ombaka (Churches Action for Health/World Council of Churches, Kenya);
Dr Bernard Pecoul (Médicins Sans Frontières, Switzerland);
Mr Eric Ram (World Vision, Switzerland);
Dr Mohga Kamal Smith (OXFAM, UK);
Bas van der Heide (Co-ordinator, Health Action International, The Netherlands);

This NGO group has since been expanded to include invited experts: Barbara Mintzes and Dr Joel Lexchin (Canada) and Lisa Hayes (Netherlands).

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