HAI EUROPE CRITICISES EC MOVE TOWARDS DTCA
AND CALLS FOR EVIDENCE OF HEALTH BENEFIT

17 July 2001

Health Action International Europe deeply regrets the recent decision by the European Commission to recommend that pharmaceutical companies be allowed to mount 'disease awareness' campaigns. This is the thin end of a wedge to open the door to DTCA (Direct to Consumer Advertising) - i.e. allowing the promotion of prescription medicines to the general public.

Experience in the US and New Zealand - the only two developed countries to allow DTCA - suggest that drug promotion to patients has pernicious effects on the conduct of medicine and attainment of public health. DTCA is notably linked to higher drug prices and reduced access to medicines: in European health systems, it seems bound to lead to unsustainable demand. The New Zealand government is presently considering a ban on DTCA and over 50 bills on DTCA issues are working their way through a number of US State Legislatures. (Scott Levin, 2001)

Proposals from Brussels expected to be published today (18 July) are intended to relax the existing prohibitions, allowing companies to promote treatments for AIDS, diabetes and asthma. But why does the European Commission believe that companies will act responsibly in Europe, when their record is so poor overseas?

• Earlier this year, the San Francisco Department of Health warned it was considering banning DTCA for AIDS drugs within the city limits, following a public health survey showing that young gay men were less likely to practice safe sex because the unrealistic images in DTC ads for AIDS drugs made it seem like AIDS could be effectively controlled. Some adverts showed vigorous men climbing mountains - nothing like the reality of life on triple therapy. In Europe the emphasis has been on prevention of HIV infection, and patients already have access to much information from independent sources on treatment options and the pros and cons of different treatment regimes. (Josephson, 2001)
  
  
• A diabetes drug, banned in the UK in 1997 because of severe liver toxicity, was advertised to the US public for over two years, without mention in any advertising campaign of the UK ban. Troglitazone (brand name Rezulin in the US) was named as the probable cause of nearly 400 deaths, 63 from liver failure, before it was removed from the US market. The European Commission is recommending that companies involved in 'disease awareness' campaigns should regulate themselves - but what evidence does the Commission have that companies will behave more responsibly in Europe? (Gale, 2001)
  
  
• In New Zealand, the national drug benefit scheme (Pharmac), saw costs for asthma steroid inhalers increase astronomically after an advertising campaign led to large-scale substitution of one steroid inhaler, fluticasone (Flixotide) for a cheaper alternative steroid inhaler, beclamethasone, despite the lack of any good evidence of any advantage to justify the increased cost. What evidence does the European Commission have that company-sponsored information materials and campaigns leading to increased expenses and a strain on public health services and tax revenues will lead to improved health?

The EU nations presently have laws in place to prohibit DTCA and to protect public health. If the law is to be changed, the burden of proof should be on the European Commission and the pharmaceutical industry to show health benefit and lack of harm. However, after years of experience with DTCA - and expenditure now well over US$2.5 billion/year - not a single study has been published to back industry claims of health benefits from prescription drug advertising campaigns. If the evidence did exist, there is no way the industry would be keeping it quiet.

The European Commission has barely examined the health consequences. This whole initiative seems to be driven by the EC's Directorate for Enterprise, with the DG for Consumer Protection and Health on the sidelines. The operative committee (G10) is a high level affair, which meets in secret, joining health ministers with senior industrialists. (See Notes below.) The G10 Committee is planning to extend the proposals that the European Commission has published today - with its final report not due until April 2002.

Health Action International Europe will ask Members of the European Parliament to reject this proposal, unless and until there is clear evidence that the benefits are real and greater than the considerable risks. Not least because any decision to open the door to DTCA would be irreversible, the precautionary principle should apply.

HAI Europe rejects the pharmaceutical industry's view that "the prohibition on the advertising of prescription medicines to the public is unsustainable … and that changes to legislation with therefore be required." (PICTF 4.3)

For more information, contact:

In Europe:
Charles Medawar, Social Audit, UK tel: (+44-207) 586 7771,
e-mail: charles@socialaudit.org.uk

Andrew Herxheimer, physician and promotion expert in the UK, tel: (+44-208)346 5470, e-mail: Andrew_Herxheimer@compuserve.com

Lisa Hayes, Communications Director, HAI Europe, tel: (+31-20) 683 3684,
e-mail: info@haiweb.org

International contacts:
Joel Lexchin, physician, promotion expert in Toronto, Canada, tel: (+1-416) 964 7186, e-mail: joel.lexchin@utoronto.ca

Peter Mansfield, Editor, Healthy Skepticism, (www.healthyskepticism.org) Adelaide, Australia, tel: (61-8) 8374 2245, e-mail: peter@healthyskepticism.org

Barbara Mintzes, author, Blurring the Boundaries: New Trends in Drug Promotion,
Vancouver, Canada, tel: (+1-604) 254 0470, e-mail: bmintzes@telus.net

References

Consumers Association (UK): Promotion of prescription drugs: public health or private profit? 10 July 2001 (http://www.which.net/whatsnew/pr/jul01/general/drugads.html)

Gale E.A.M, Lessons from the glitazones: a story of drug development, Lancet, 9 June 2001, 357, 1870-1875.

Jeffries M., The Mark of Zorro, Pharmaceutical Marketing, May 2000, 4-5.

Josephson D, FDA warning to manufacturers of AIDS drugs, BMJ, 12 May 2001, 322, 1143

Medawar C., Prescription Drugs: Direct advertising? (Guest Editorial), Int. J. Risk & Safety in Medicine, 2001, 13, 81-86. See also: http://www.socialaudit.org.uk (1998-2001).

Mintzes B: Blurring the Boundaries - new trends in drug promotion, Amsterdam: Health Action International, 1998. See: http://www.haiweb.org/pubs/blurring/blurring.intro.html

National Institute for Health Care Management, September 2000). See: www.nihcm.org
New Zealand Ministry of Health, Summary of Submissions on the Direct-to-Consumer Advertising of Prescription Medicines in New Zealand Discussion Paper, Published online, April 2001.

Pharmaceutical Industry Competitiveness Task Force, Final report, March 2001, available at http://www.doh.gov.uk/pictf/pictf.pdf

Scott Levin Inc, "States Take Aim at Direct-To-Consumer Drug Ads" Press Release, 25 June 2001 (www.quintiles.com/products_and_services/informatics/scott_levin/press_releases/press_release/1,2226,245,00.html)

Wilkes M , Bell RA, Kravitz RL, Direct-To-Consumer Prescription Drug Advertising: Trends, Impact, And Implications, Health Affairs, March/ April 2000.

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Background for Journalists

The existence of the European Commission's G10 committee and much of its agenda is due mainly to initiatives from the UK. The prime mover in the G10 committee is Lord (Phillip) Hunt, the UK Health Minister directly responsible for both medicines' regulation and promotion of the pharmaceutical industry.

G10 is a close replica of the UK's Pharmaceutical Industry Competitiveness Task Force (PICTF), set up following a meeting in November 1999 between the Prime Minister (Mr Tony Blair) and the heads of AstraZeneca, Glaxo Wellcome and SmithKline Beecham (now Glaxo SmithKline). Lord Hunt chairs the PICTF, in support of Mr Blair's personal commitment "to ensure that the future of the UK pharmaceutical industry is even brighter". As in the European Commission, the regulation and sponsorship of the industry are combined: "The UK-based pharmaceutical industry is world class and a jewel in the crown of the UK economy, and the Government is determined to do what it can to help the UK industry maintain and enhance its competitive advantage". The recent 90-page PICTF report gives clear evidence of that determination, and also spells out much of the agenda for G10. Specifically, the PICTF made a commitment to the international pharmaceutical industry to push at the boundaries of existing EU law, which currently prohibits DTCA:

"An action plan is agreed between industry and the Medicines Control Agency (MCA) to look at the scope for moving forward within existing EU law. This will cover guidance on disease awareness programmes, including establishing scope for programmes where there is only one treatment available; will offer clarity on what could be included on pharmaceutical company websites under EU law and the scope for providing patient information already available in packs electronically in a more user-friendly way; and seek a practical definition of the distinction between advertising and information in Europe, with a view to the European Commission publishing guidance in this area. This work-plan represents a helpful package of measures."

The Lancet (7 July 2001, p. 45) has described Tony Blair's New Labour commitment to a widening of private-sector involvement in health as "the political equivalent of Margaret Thatcher calling for the nationalisation of banks". Indeed times have changed. Kenneth Clarke, presently a contender for leadership of the UK Conservative Party, was Secretary for Health at the height of Thatcher rule - and he and the pharmaceutical industry were not great friends. He infuriated companies by introducing the Limited List (purging NHS expenditure on a wide variety of less effective drugs) and was so concerned about the closeness of the Department to the pharmaceutical industry that he tried to get the official responsibility for "sponsorship of the industry" transferred to the Board of Trade. He failed.

 

Health Action International Europe's Campaign on DTCA

Health Action International - a network of health, consumer and public interest advocates, founded in 1981 - believes that, in most countries, DTCA would bring fewer benefits than risks. We fear it presents a major threat to global public health.
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 on legalisation are being taken. We are concerned about:

· the imminence of proposals to legalise DTCA and the effective irreversibility of any decision to do so;
· the operation of a domino effect, whereby legalisation in EU member countries would lead inexorably to the development of DTCA as a global phenomenon;
· the lack of reliable evidence on the benefits, risks and costs of DTCA - notwithstanding the major impacts it might be expected to have; and
· the poor quality of debate and deliberation and the undue influence of the international pharmaceutical industry in health policy making.

We clearly recognise that most people need and want much better information about medicines and health. But we do not think that this information vacuum either can, or should, be filled by advertising messages and linked promotional activities.
Proponents of DTCA - including a number of patient groups 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, including "disease awareness" campaigns. 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:

1. 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?
2. Would DTCA be likely to promote more rational and effective drug use - and how would it compare in this respect with drug advertising to health professionals?
3. To what extent might DTCA promote drug treatments over possibly better alternatives (including non-intervention), and/or less effective and cost-effective medical treatments?
4. What would be the likely overall effect of DTCA on product prices and national drug budgets? Would it improve access to health?
5. How would DTCA affect different people's health - taking into account also their perception of health and health needs and their dependence on providers?
6. Does DTCA tend to give an unfair competitive advantage to major multinationals, over smaller companies and local producers?
7. 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?
8. 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?
9. 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?
10. To what extent would recent experience in the US be relevant to the impact of DTCA elsewhere - especially on national health priorities in developing countries - given the US commitment to private rather than public health?
11. Would other countries be disadvantaged by DTCA, to the extent that they lacked the protections available in the US - e.g. rigorous enforcement by the Food and Drug Administration (FDA), freedom of information laws, and consumer rights?
Until health impact assessments have been done - providing sound evidence of the net benefits of DTCA in different cultures and communities - HAI is committed to maintain the legal status quo, strictly prohibiting the promotion of prescription-only medicines to the general public in the European Union.