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Direct-To-Consumer Advertising

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Direct-to-consumer advertising

Some useful references

  1. Ministry of Health (2006): Direct-to-consumer Advertising of Prescription Medicines in new Zealand. Consultation document.
    http://www.moh.govt.nz/moh.nsf/by+unid/FC3DADD34CE32CE9CC2571250076E9F2?Open
  2. S Gilbody, P Wilson and I Watt: Benefits and harms of direct to consumer advertising: a systematic review
    http://qhc.bmjjournals.com/cgi/content/abstract/14/4/246
    Results: From 2853 citations only four reports were found that met the strict inclusion criteria and provided usable results. Direct to consumer advertising is associated with increased prescription of advertised products and there is substantial impact on patients’ request for specific drugs and physicians’ confidence in prescribing. No additional benefits in terms of health outcomes were demonstrated.
    Discussion: Direct to consumer advertising is banned in most countries, and the research evidence tends to support the negative impact that is feared by those who support a legislative ban. Further research is needed into the clinical and economic impact of direct to consumer advertising in healthcare systems.
  3. Canadian Health Coalition website: Includes links to relevant articles including the Jan 2006 Health Council Canada document on Public health implications of Direct to Consumer Advertising and many brief articles.
    http://www.healthcoalition.ca/dtca.html
  4. The Canadian Women’s Health Network This site contains an extensive list of resources on women and Direct to Consumer Advertising. This is a link to their search page, which generates many documents.
    http://www.cwhn.ca/search/Results.htm?category=Direct-to-consumer%20Advertising
  5. Norsigian, J: Feminists challenge unethical marketing by prescription drug companies. Examines advertising campaigns directed at women and looks at how some women's groups have responded.
    http://www.ourbodiesourselves.org/book/companion.asp?id=32&compID=69&page=2
  6. Ministry of Health, December 2005: Information matters: how do consumers find out about pharmaceuticals? Very recent study from Victoria University on how NZ consumers find out drug Info.
    http://www.moh.govt.nz/moh.nsf/by+unid/F309014FBD71198DCC2570DE0009E6C8?Open
  7. Mintzes, B (2002): Influences of direct to consumer pharmaceutical advertising and patients’ requests on prescribing decisions: Two site cross sectional survey. BMJ:324:278-79.
    Concludes: “Patients' requests for medicines are a powerful driver of prescribing decisions. In most cases physicians prescribed requested medicines but were often ambivalent about the choice of treatment. If physicians prescribe requested drugs despite personal reservations, sales may increase but appropriateness of prescribing may suffer. Concerns about the value of opening up the regulatory environment to permit direct to consumer advertising in the EU and Canada seem well justified.”
    http://bmj.bmjjournals.com/cgi/content/full/324/7332/278%20
  8. Mintzes, B (2002): Direct to Consumer Advertising is Medicalising Normal Human Experience BMJ 324:908-9
    http://bmj.bmjjournals.com/cgi/reprint/324/7342/908.pdf
  9. Mintzes, B (2006): Direct to Consumer Advertising of Prescription Drugs in Canada: What are the public health implications? Includes a useful section on DTCA in New Zealand; outlines studies on the effects of DTCA on Dr-Patient relationship; and has some good analyses of what is needed to ensure effective regulation against DTCA
    http://healthcouncilcanada.ca/docs/papers/2006/hcc_dtc-advertising_200601_e_v6.pdf
  10. Healthy Skepticism: “Healthy Skepticism is an international non-profit organisation for health professionals and everyone with an interest in improving health. Our main aim is to improve health by reducing harm from misleading drug promotion”. This sight has a terrific library and a useful “in the news media section” which outlines the latest articles on DTCA and drug promotion.
    http://healthyskepticism.org/

What Are the Public Health Effects of Direct-to-Consumer Drug Advertising?
Elizabeth A. Almasi, Randall S. Stafford, Richard L. Kravitz, Peter R. Mansfield
Background to the debate: Only two industrialized countries, the United States and New Zealand, allow direct-to-consumer advertising (DTCA) of prescription medicines, although New Zealand is planning a ban [1]. The challenge for these governments is ensuring that DTCA is more beneficial than harmful. Proponents of DTCA argue that it helps to inform the public about available treatments and stimulates appropriate use of drugs for high-priority illnesses (such as statin use in people with ischemic heart disease). Critics argue that the information in the adverts is often biased and misleading, and that DTCA raises prescribing costs without net evidence of health benefits. Availbale onlien at: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0030145

Myth: Direct-to-consumer advertising is educational for patients (2004)
The Canadian Health Services Research Foundation has published a series of essays giving the research evidence behind Canadian healthcare debates. See this and more at: http://www.chsrf.ca/mythbusters/index_e.php

Women and Health Protection opposes direct-to-consumer-advertising of prescription drugs
-- with a new poster campaign! See their posters at: http://www.whp-apsf.ca/en

The Canadian Centres for Excellence in Women's Health Working Group on Women and Health Protection Action have excellent resources on direct-to-consumer advertising. See their resources at:
http://www.cewh-cesf.ca/en/publications/whp/index.shtml

and also posters at Direct-to-Consumer Advertising of Prescription Drugs: Prescription for profit - and scroll down.

Direct to Consumer Advertising of Prescription Drugs in New Zealand: FOR HEALTH OR FOR PROFIT? Report to the Minister of Health supporting the case for a ban on DTCA February 2003 by Professor Les Toop, Dr Dee Richards, Professor Tony Dowell, Professor Murray Tilyard, Tony Fraser, Assoc. Professor Bruce Arroll, New Zealand Departments of General Practice Christchurch, Dunedin, Wellington and Auckland Schools of Medicine.

This .pdf file can be downloaded here. It is 95 pages long and 1008K in size.

Contents are:

  • Executive Summary
  • Introduction
  • Growth and Effectiveness of DTCA
  • The role of DTCA in consumer education
  • Prescription medicines: consumer access to information
  • Economic implications of DTCA of prescription medicines
  • Effects of DTCA on the Clinician Patient relationship
  • Implications for medicine safety
  • Medicalisation of Health and Ageing
  • Regulatory Frameworks for DTCA: the United States and New Zealand 28 International Positions on DTCA
  • Conclusions
  • Support from New Zealand Professional and consumer organisations
  • References
  • Appendix 1: Academic pharmacy perspective
  • Appendix 2: New Zealand Consumer Survey
  • Appendix 3: New Zealand GP Survey
  • Appendix 4: Letters of Support

Report to Congressional Requesters United States General Accounting Office GAO PRESCRIPTION DRUGS FDA Oversight of Direct-to-Consumer Advertising Has Limitations GAO-03-177 - October 2002

This .pdf file can be downloaded here. It is 37 pages in length and 380K in size

Contents are:

  • GAO-03-177 Presciption Drug Advertising Letter
  • Results in Brief
  • Background
  • Pharmaceutical Companies Spend More on Research and Development than on DTC Advertising
  • DTC Advertising Appears to Increase Prescription Drug Spending and Utilization
  • FDAÕs Oversight of DTC Advertising Has Limitations
  • Conclusions
  • Recommendation for Executive Action
  • Agency Comments and Our Evaluation
  • Appendix I Scope and Methodology
  • Appendix II Surveys of ConsumersÕ Behavior after Seeing or Hearing Direct-to-Consumer (DTC) Advertisements
  • Appendix III Comments from the Department of Health and Human Services

Vol. 21 (2) Fall 2002, 213Ð223 Journal of Public Policy & Marketing

Direct-to-Consumer Advertising of Prescription Pharmaceuticals: A Consumer Perspective from New Zealand by Sandra Coney

New Zealand is one of only two countries in the world that allows direct-to-consumer (DTC) advertising. Such advertising has increased dramatically since the mid-1990s, and a wide range of promotional activities currently takes place. Compliance with the legislation occurs through an industry body that hears complaints over alleged breaches. The weakness of the organized consumer sector in the country means there is a paucity of complaints, yet a self-regulating system is reliant on complaints for compliance. The author describes the unsatisfactory experience of taking a complaint and examines the argument that DTC advertising provides consumers with important information. The author measures DTC advertising against criteria for quality health information and finds it wanting.

A .pdf of this paper can be downloaded here.

SANDRA CONEY is Executive Director, WomenÕs Health Action Trust, Auckland, New Zealand

.

Vol. 21 (2) Fall 2002, 194Ð201 194 Journal of Public Policy & Marketing

Direct-to-Consumer Advertising of Prescription Drugs: The Evidence Says No by Joel Lexchin and Barbara Mintzes

There is little rationale for direct-to-consumer advertising of prescription drugs. Most new drugs offer little if any therapeutic advantage over existing products. Direct-to-consumer advertisements frequently downplay safety information. Physicians are highly ambivalent about prescribing advertised drugs requested by patients. There is no evidence that direct-to- consumer advertising results in any improvement in health outcomes.

A .pdf of this paper can be downloaded here.

JOEL LEXCHIN is an associate professor, School of Health Policy and Management, York University, an associate professor, Depart-ment of Family and Community Medicine, University of Toronto, and an emergency physician, Department of Emergency Medicine, University Health Network.

BARBARA MINTZES is a doctoral candi-date, Health Policy Research Unit, Centre for Health Services & Policy Research, University of British Columbia. Barbara Mintzes was funded by Health Canada, as part of a project to assess the potential impacts of direct-to-consumer prescription drug advertis-ing on the Canadian health system.

Direct-To-Consumer Advertising of Prescription Medicines in New Zealand
Submission on Ministry of Health Discussion Paper
From Women's Health Action Trust

1. Background
Women's Health Action Trust (WHAT) is a public interest women's health and consumer advocacy group, formed in 1984. We have a long history of activism around the activities of pharmaceutical companies. We have opposed medicalisation of well populations. We have a strong interest in the safety of products and in evidence-based approaches to health care. We have had a close involvement in the development of the Code of Health Consumers' Rights and its application.

2. The experience we bring to this submission

2.1 Knowledge of what constitutes good quality health information

WHAT is at the forefront in developing consumer health information resources in New Zealand and in putting into practice international trends in resource development.

What we've done
  • Translated guidelines into consumer health information for the New Zealand Guidelines Group.
  • Developed education resources for consumers on a range of health topics such as ultrasound scans during pregnancy, hormone replacement therapy etc
  • Under contract to the Health Funding Authority/Ministry of Health, we have developed resources for BreastScreen Aotearoa, the national breast screening programme , and the National Cervical Screening Programme
  • In 2000 we completed a major report for the HFA on an evidence-based approach to developing cervical screening resources. This reviewed the literature on consumer's health information needs.
  • Run a web site www.womens-health.org.nz which contains a great deal of consumer information.

    2.2 Background in consumer perspectives of direct-to-consumer advertising

WHAT has had a long-term interest in direct-to-consumer advertising (DTCA) and has contacted the Ministry of Health (Therapeutics section, then Medsafe) a number of times regarding concerns about particular advertising, going back to 1994.

We made submissions on the Review of the Medicines Act in which we called for a ban on such advertising and for the Ministry to develop independent sources of information for consumers on drugs. In the mid-1990s we met with Dr Bob Boyd to discuss these concerns.

2.2.1 Complaint on Depo-Provera

In 1999 we lodged a complaint with the Advertising Standards Authority regarding advertisements for Depo-Provera that had appeared in New Idea and other magazines. The basis of this complaint were that:

  • The advertisement referred the reader to consumer information elsewhere in the publication but did not provide a page number to find this. The regulations required advertisements to 'include' requisite information. We argued that placing the information elsewhere did not meet the requirement to include.
  • There was no direction to refer side-effects to a doctor
  • It contained a large number of terms - we itemised 24 - that were not readily understood by lay people.
  • The very small print did not meet the requirement that scientific information be clearly communicated.

    The outcome of this complaint was that it was upheld by the ASA Complaints Board. The Board regarded it as a 'test case' that would provide guidance to other potential advertisers. The determination noted a difficulty with an interface between the law and the requirements of the Code in that the advertiser had made an honest attempt to comply with the legislation in accordance with the self-regulatory process, but had breached the Code. We attach the advertisement and ASA judgement.

    2.2.2 Complaint on Xenical

    We began preparing a complaint on the advertising campaign of Xenical ('I'd like to do all the things that most people just read about…..'), including TV ads, billboards, and buses.

    However, the campaign was completed before we had submitted our complaint.

    We had a number of grounds for this complaint:

  • Exploitation of sexual stereotypes of women's body size and playing on women's fears about social and sexual isolation because of body size.
  • Marketing targeted at weight loss when Xenical was approved for the treatment of 'significant obesity.'
  • Failure to include information about side-effects.
  • Unscientific and exaggerated claims - ''The average New Zealander is increasing in bodyweight by a gram a day.' 'Xenical is now scientifically proven to be twice as effective as diet alone.' 'Because Xenical works', 'Lose weight. Gain life.'

    2.2.3 Experience of ASA process

    We would like to comment on the process required by the Advertising Standards Authority. In our experience this involved a great deal of time and effort. In the case of the Depo adverts, we sent a sample from New Idea in June 1999. We were then asked by the ASA for the date of the issue. As the advert had been ripped out of a magazine in a doctor's surgery, we had to track down another example. New Idea declined to tell us when it had been published and the ASA would not find out that information for us. Once the issue had been found, we were next asked for the page numbers. The whole thing took months to provide the detailed information required by the ASA.

    Knowing this, we began gathering the information for the Xenical complaint. This involved obtaining a clip of the ad, which required videoing a great deal of TV. We then paid to have the clip copied from the video. We had to photograph the billboards and find a bus with the ad to photograph. This took many weeks of work.

    Then the campaign disappeared, leaving us having wasted our time.

    The whole process adopted by the ASA means that large numbers of people will have been exposed to the advertising by the time a complaint is laid and a determination reached. In the case of the Depo-Provera advertisement, the company said it had been running it since 1997 and no one had previously complained. The current process will always be ambulance-chasing after the accident has happened.

3. Reasons for seeking a ban on DTCA

We find the arguments in favour of DTCA self-serving and lacking in substance. We provide the following arguments against DTCA.

3.1 Poor quality of information

Consumers are seeking information to meet their health care needs. However, information provided by drug companies is biased and seeks to increase market share rather than objectively inform. Evidence is selectively used and only studies favourable to the product are cited. Consumers are not offered other options, which good quality consumer information should always provide. DTCA cannot enhance consumer choices because only one choice - the product - is offered.

3.2 Medicalisation

Most of the products advertised are aimed at well populations and people with minor or cosmetic complaints. The purpose is to expand markets by increasing the usage of products among people not now using them. People are directed towards pharmaceutical solutions for problems that are of social or lifestyle origin and could be addressed by non-pharmaceutical means, such as diet or exercise. Rather than enhancing autonomy or self-responsibility as proponents claim, these product create dependency on the medical system and pharmaceutical solutions.

3.3 Cost to consumers and health budget

Proponents argue that as prescription drugs can only be obtained from GPs, inappropriate use will be prevented as doctors will not prescribe without a clinical indication. This will involve a wasted visit to the doctor for the consumer, with direct costs for the consultation, as well as opportunity costs such as time off work.

In the case of people with Community Services Cards, there is a direct cost to the health budget of this visit.

If doctors agree to a consumer's request, so as to maintain a relationship, keep the consultation short or because they believe in consumer 'choice' to anything, then this will channel health dollars away from effective expenditure on real health needs. This is not supportable when health dollars are short.

3.4 Undermine doctor/consumer relationship

We support the movement towards partnership and shared decision-making between health professionals and consumers in medical practice. We do not see DTCA as enhancing such relationships, as the information is promotional and of such poor quality.

On the other hand we appreciate that research shows that doctors consistently under-estimate the amount of information that consumers want and that they have traditionally controlled the information that is given. This has to some extent been addressed in New Zealand with the Code of Health Consumers' Rights which requires consumers to be given information, options and to make informed decisions.

However, there is a great need for good quality information to be made available to consumers. WHAT supports the development of such independent sources of information and their availability through print and electronic media and the internet. We see that Government agencies could play a role in supporting the provision of this information.

We do not accept that the argument outlined in the report that banning advertising is paternalistic and empowers doctors. The only interests empowered by the status quo is the pharmaceutical industry.

3.5 Failure of self-regulation

Despite the attempts by the pharmaceutical companies to self-regulate, the recent Medsafe survey showed that compliance was only 69%.

The current structure relies on compliance by the drug companies and on a system of complaints to point out where the system is not working.

There are problems with this approach.

Advertising could comply with regulations and the ASA Code, but still not be in the public interest. For example, it could reinforce harmful social stereotypes about sexuality or body image. It could lead to over-treatment and costs to the health budget.

It relies on someone making complaints, but there is no 'natural' agency or persons to do this. As we have outlined, complaints are time-consuming and frustrating and seem to achieve little even if successful. Individuals are unlikely to complain, even if an advertisement breaches the Code, and this is evidenced by the fact that the Depo-Provera advertisement had been running for two years before we successfully complained.

However, few consumer groups would have the resources to take a complaint. In New Zealand we do not have the equivalent of Australia's Consumer Health Forum, only a system of quite small, community-based groups with slim resources. Thus there is no one in particular to counterbalance the pharmaceutical industry interest.

4. Conclusion: the need for a ban

For the reasons discussed above, WHAT supports option 2 in the discussion paper, a ban on all DTCA. Further, we believe such a ban should also apply to medical devices and technology that are used on the human body, such as automated cervical smear tests and breast implants. We do not see that there is a logic to banning advertising of pharmaceutical products but not these devices whose use can be distorted by commercial interests.

We also think there is a need to ban promotion of pharmaceuticals through 'infomercials' and heavily sponsored television programmes such as Unichem Medical File. The ban should also extend to billboards and other forms at advertising such as buses. (We attach a photo of the Xenical ad on buses.)

We do not accept the arguments against a ban as outlined on page 21 and believe that the arguments regarding a critique of the status quo (page 20) are weak. We note that no health consumer groups were among the stakeholders consulted in the drafting of this discussion document. The Consumers' Institute does not have a great deal of experience in the health sector, and we wonder why our group, given our long-term efforts to engage with the Ministry on this issue, was excluded from putting forward a community-based consumer point of view.

Among the costs of a ban cited in the paper is the loss of revenue to the television industry. There is no counter-balancing assessment of the costs of the status quo. The same argument about loss of commercial revenue could be made to make a case for reviving tobacco advertising. It would extraordinary to accept that commercial benefits to television outweighed the health costs to the New Zealand public.

We note that there has been no evaluation of the health benefits of DTCA in New Zealand. Without this data is not possible to claim that this has been a positive experience in improving the health of New Zealanders.

For these reasons we support a ban and would ask that the Ministry gives particular weight to our submission. We understand there have been few from health consumer groups. We would also ask that in the analysis of submissions, the status of the submitter is noted. In other words, the analysis should distinguish between pharmaceutical and industry groups, health professional groups and health consumer groups.

Sandra Coney
15 February 2001

Editorial - Taking the hype out of the health 'market'

Over 1994 Women's Health Action has lobbied on the issue of entrepreneurialism in health care. We have been particularly concerned at the growing signs of a health 'market' where commercial interests sell health products - tests and drugs - directly to the public. This has been occurring even where there is dubious or no evidence of benefit from the product.

The results of our work have not been reassuring. The Commerce Commission has rejected one complaint taken under the Fair Trading Act. The reasons given can be summed up as 'clinical freedom' - differences of opinion among doctors - and the criminal standard of proof which is applied by the Commission.

We also approached the Medical Council but as the letter in this issue explains, while the council supported our concerns, it stated that it does not have a particular oversight in this area.

In December the government introduced a new Medical Practitioners Bill with new terms of reference for a revised Medical Council. Disturbingly, there is nothing in the TOR which would provide the Medical Council with powers to control excessive entrepreneurialism in health care.

In response to an approach from us about clinics advertising mammography screening to women under 50, the Medical Council advised us to go to the Advertising Standards Authority. If our experience with the Commerce Commission is anything to go on, such bodies have extreme difficulty coming to grips with the science of medical complaints. Misleading advertising in the health area is primarily an ethical issue rather than an issue of commerce.

Over the last few months Merck Sharp and Dohme has been directly advertising Proscar, a prescription treatment for enlarged prostate, through newspapers and television. Proscar is still not on the drug tariff, so consumers must pay $1,500 annually for its use. The official view from Pharmac, the government's pharmaceutical management agency, is that two already subsidised drugs are at least as effective as Proscar.

Proscar does not work all the time and it can have side effects such as impotence, but the advertisements skated over these details. Information about the drugs was printed in tiny unreadable type, or on television, flashed up so briefly it was impossible to take it in.

Advertising of prescription drugs is not at present illegal in New Zealand although information about adverse effects and effectiveness is supposed to be included. In the current review of the Medicines Act, it is proposed that such advertising be banned, but Dr Bob Boyd, Manager of Therapeutics in the Ministry of Health, says that as a ban has not been supported in submissions or at public meetings, it may not appear in the new act.

Women's Health Action supported a ban in its submission, but we doubt that very many consumer groups have made submissions on this topic. And we doubt that members of the public fully realise what an open door policy could mean. Perhaps they might have reacted differently had the Proscar ads been run before they were asked for their opinions.

It is still not to late for consumers to make their views known. A timely letter to Maurice Williamson, Associate-Minister of Health, supporting a ban on advertising prescription medicines and devices to the public could be influential. And we would urge those making submissions on the Medical Practitioners Bill (the closing date for submissions is 23 February 1995) to call for the Medical Council to have oversight of advertising and the promotional activities of doctors. Disciplinary action and fines should be possible where there is a breach.

If we do not want to end up like America, where consumers are bombarded with advertising for products and services, we must ensure that controls are put in place now to prevent this occurring.

Sandra Coney

Review of the Medicines Act

The government has released a discussion paper as part of a review of the medicines legislation. The review has come about because of the problems highlighted with IUDs breast implants and heart valves. Devices such as these have been outside existing medicines regulation. This meant that faulty and dangerous devices could enter the market without any scrutiny about their safety and effectiveness.

The new legislation would cover devices in much the same way as drugs. but other aspects are also covered:

  • The need for regular reviews of products rather than once-only approval to market
  • The need to curb extravagant and unsubstantiated claims about the efficacy of vitamin, mineral and herbal preparations.
  • The lack of 'harmonisation' between New Zealand and its major trading partners, especially the European Union, USA and Australia.
  • Inadequate consumer information - currently manufacturers do not have to provide consumer information with their products.

Product licensing

The review proposes that all therapeutic products - including drugs, devices and equipment - would need a product license (PL) before they could be imported, exported. manufactured or supplied. The PL would be issued after an assessment of the product's safety, efficacy and quality. and would be issued for a specified term. The amount of control of medicines would be proportional to the risk and benefit associated with the product.

Medicines would be classified as 'high risk', for example new medicines or scheduled medicines, or 'lower risk' as with medicines with a well-established pattern of safe use. This category would include most vitamins, minerals, herbal substances and homoeopathic remedies.

Some medicines would be deemed exempt because they are considered to have minimal risk.

Advertising and promotion

Advertising to the general public and health professionals would come under some control. But it is not clear from the review document nor from subsequent statements made by officers of the Ministry of Health exactly what is intended. Currently, pharmaceutical companies can advertise prescription products directly to the public, subject to certain controls. This has often been abused

The discussion document states that prescription medicines may not be advertised (p30), but Dr Susan Martindale (Team Leader Special Projects. Therapeutics Section) has talked about information' to consumers being allowable. This seems to present a loophole which could be exploited by drug companies.

A weakness of the review is that it proposes that drug companies would be able to offer hospitality at medical events if it remains secondary to themain scientific purpose of the meeting'. In practice. such a judgement would always be difficult and subjective.

Consumer information

The issue of who prepares and controls consumer information also needs to be discussed. Women's Health Action proposes a three-way process involving consumers, drug companies and Ministry of Health. At the recent Pharmaceutical Conference, Sandra Coney suggested a levy on drug companies such as exists for liquor manufacturers) to fund a stand-alone body (similar to the Alcohol Liquor Advisory Council) to prepare consumer information and fund sponsor-free continuing medical education. ~

Consumer representation:

A major issue to emerge is the complete lack of consumer representation proposed for any of the committees approving or controlling the use of products. The Ministry seems to have bowed to the view of the pharmaceutical industry that these issues are purely technical and that consumers would not understand.

Similar arguments were advanced over consumer involvement on ethical and other scientific committees but are not sustainable in the 1990s.

Apart from safety, the approval of, drugs can also involve ethical issues. In this newsletter, two such products are discussed: RU486 and anti-fertility vaccines. Consumers should be involved in all committees which affect the public. Women's Health Action also argues that all meetings and hearings should be open to the public as they are in America and allow members of the public to make submissions.

If you wish to make a submission on the discussion document, copies can be obtained from GP Books and from the Therapeutics Section of the Ministry of Health. PO Box 5013, Wellington. Deadline for submissions 20 August 1994.