Author: Health Action International Europe
url: www.haiweb.org
Information is an essential ingredient of medicines. Information enables people to make rational treatment decisions and to adopt healthier lifestyles. It makes people feel more at ease and in control of their health. People need information that they can trust and which is easy to understand. Health Action International (HAI) Europe believes that many information providers fail to recognise that consumers have different needs and capacities to respond to information. Too often consumers are the target for information distorted by commercial imperatives.
Consumer information is not based on all the facts
The development and authorisation of medicines occurs in an environment of secrecy, which serves to undermine the raw material on which consumer information is based. Full details of clinical trials are not made public ? in some cases they are actively suppressed or arguments of ?commercial confidentiality? are used to prevent proper assessments of benefits and harms. Governments, patients? groups an others providing information will say that a medicine is safe and effective for as long as they are not able to review data which raises questions about a medicine?s value. Regulators sometimes appear too slow to scrutinise and too keen to please companies, with whom their relationship comes close to that of service-provider to client.
Information shows consumers little respect
The intention of most providers of information about medicines is to help consumers make the right treatment decision, by providing up-to-date and objective assessments of benefits and harms. But to do so is to be confronted with the reality that consumers vary enormously in their prior knowledge of health and medicine and the extent to which they can absorb different types of information. The solution is usually a ?one-size-fits-all? approach which dissatisfies most of its audience ? for some it is too much, for others too little to be helpful. Information is rarely delivered in a form that consumers can best understand. Insufficient attention is paid to the language and format used. For example, many feel uncomfortable with benefits and harms presented as percentages ? they understand better an explanation of a ?one in five? as opposed to a ?twenty percent? chance of harm ? and with terms such as ?relative risk? or ?absolute risk?. This same insensitivity is shown in the failure of most providers to acknowledge that information to consumers would benefit from adaptation in the light of information from consumers about the reality of taking a medicine.
Advertising by another name
?The way to sell drugs is to sell psychiatric illness. If you are Paxil and you are the only manufacturer who has the drug for social anxiety disorder, it's in your interest to broaden the category as far as possible and make the borders as fuzzy as possible.? [Carl Elliott, bioethicist at the University of Minnesota, quoted in Drug Ads Hyping Anxiety Make Some Uneasy, Washington Post, 16 July 2001]
Advertising prescription-only medicines directly to consumers within the European Union (EU) is illegal, so it is not a tool that can be used by pharmaceutical companies to increase sales and induce brand loyalty. These are goals that have to be achieved within the rules governing information provision, whereby direct connections cannot be made between information about a particular condition and information about particular drugs. Pharmaceutical companies? strategy seems to be to make as many people as possible believe that they have a particular disorder and to insinuate that medicines are the best, ideally only, solution. Vulnerable patients can be relied upon to make the connection. Companies initiate or sponsor ?disease awareness campaigns?, benefiting from association with patients? groups to have their promotional messages accepted as balanced information. For the UK in 2005, the BBC lists details of six disease awareness months, eleven disease awareness days and forty eight disease awareness weeks. In the eyes of companies, ?disease awareness campaigns? are ?medicines selling campaigns? and the function of helping people identify a condition and its most appropriate treatment is distorted into the function of maximising sales. Companies reinforce the messages of promotional information directly provided to consumers by deploying armies of sales staff to foster relations with doctors and pharmacists, whom most consumers implicitly trust to advise them of the best treatment. The effect is a drip-drip approach to get questionable assertions accepted as fact: medicines are better than non-medical treatments, new (brand) medicines are better than old (generic) medicines and if a medicine isn?t working, take a stronger dose.
Case study: Ask About Your Medicines Week
An initiative trialled in the United Kingdom in 2003 and 2004, Ask About Your Medicines Week aims to ?enable more people to make informed choices about medicine taking, by (inter alia) improving access to further sources of helpful, reliable medicines and information?. In 2004 it was funded by the Association of the British Pharmaceutical Industry, Lilly, Merck Sharpe and Dohme, Novartis, Pfizer and Roche, as well as the Ministry of Health. Endorsed by a number of
Primary Care Trusts and voluntary health organisations, the concept of ?partnership? that underlies Ask About Your Medicines Week works to legitimise its essentially pro-industry content. Readers are pointed in the direction of ?the company that makes your medicine? for information and offered a rose-tinted portrayal of the role of industry in lieu of ?facts and figures about medicine?. With the project come ?Medicine Guides?, produced by Datapharm Communications
Ltd, the ?service provider? of Inpharm.com (strapline: ?life-support for the pharmaceutical industry?). In 2003, the Guides were for epilepsy and influenza, and in 2004 for cholesterol. The guides give information about medicines, not medical conditions. The process of diagnosis and consideration of treatment options is reduced to the simple chain that if you have epilepsy, these are the medicines you should take. For the UK government?s National Pharmacy Adviser for the National Health Service Direct website, having the Guides linked to the site ?is a way of providing information on medicines for patients that is outside the existing regulations and which can be tailored to patients? needs.? [Anne Joshua, quoted in The Pharmaceutical Journal, vol 271, 11 October 2003]
Case Study: Trusting patients? groups as source of information?
The Dutch Diabetes Association (De Diabetesvereniging Nederland, DVN) placed an advert in the Dutch press where a local celebrity advocated taking a medicine, Lipitor, which helps lower cholesterol and which may be of benefit to patients with type 2 diabetes. [Amstelveens Nieuwsblad, 13 October 2004] Lipitor is a drug produced by Pfizer, the article refers to research ?made possible? by Pfizer and directs readers wanting to know more to a website ? www.cholesterol.nl ? run by the ?Cholesterol Information Centre?, which is ?an initiative of Pfizer?.
The myth of industry expertise
The usual argument for the involvement of the pharmaceutical industry in providing information to consumers is that as the manufacturers, they know most about a medicine?s characteristics. But this ?expertise? is simply an ability to know what to publish and what to keep hidden. To believe in companies? ?expertise? is to trust them to act against character and not overplay the benefits and downplay the harms of their products. When a drug turns out to be unsafe and has to be withdrawn from the market, information used to promote its uptake is called into question: did such information reflect a safety profile based on a full and honest assessment of the latest data? If, as in the case of Vioxx, there were ?astonishing failures in [the manufacturer] Merck's internal systems of post-marketing surveillance? and a ?disturbing contradiction [between] Merck's own understanding of Vioxx's true risk profile and its attempt to gloss over these risks in their public statements at the time? , the choice would seem to be that the company was either incompetent or dishonest. Neither trait would seem to fit with the assumption of ?expertise?.
The false solution of public-private partnerships
Swallowing the lie of the benign expertise of the pharmaceutical industry, governments and EU institutions seem increasingly hooked on the idea of ?public-private partnerships? for consumer information. For companies, working with ? getting endorsement from ? governments means that their information is more likely to be trusted by consumers and that it is distributed through state healthcare systems, interfaces with consumers such as doctors? surgeries, hospital waiting rooms and government websites. But just as regulatory failures reflective of undue closeness of regulators and companies in the authorisation of medicines rebound on governments, so too can consumer information striving for an impossible balance of health and commercial interests be expected to generate new health scares damaging to governments. Greater distance should be placed between governments as protectors of the right to health and companies as sales-driven manufacturers of medicines. Consumers need to know who is behind the information they are relying on.
Recommendations
? Regulators should develop a greater sense of scepticism towards pharmaceutical companies and the information they do and do not make available.
? The European Medicines Agency (EMEA), due to come up with a definition of ?commercially confidential information?, should see that this is founded on the premise that it is in the public interest to release data unless and until shown otherwise.
? A range of different levels of information should be provided to meet the needs of the widest possible spectrum of consumers: it should be provided for the ?expert? consumer and the ?health illiterate? consumer, as well as the ?average? consumer.
? Providers should draw on the experience of those taking medicines to refine assessments of benefits and harms and to improve how information is expressed.
? Professional associations and patients?/consumers? groups should not endorse industry-funded disease awareness campaigns or other information initiatives, such as Ask About Your Medicines Week.
? The proposed EU-level public-private partnership on information should be rejected.
? The EMEA should be given the role of approving all information originated by pharmaceutical companies.
This policy paper is one in a series outlining HAI Europe?s position
on key issues affecting European medicines? policy. Together with its
counterparts in Latin America, Africa and Asia-Pacific, HAI Europe
campaigns for access to, and rational use of, medicines.
Health Action International Europe
Jacob van Lennepkade 334-T
1053 NJ Amsterdam,
Netherlands
Tel: +31 (0) 20 683 36 84
Fax: +31 (0) 20 685 50 02
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