Many articles in Health Expectations have highlighted patients’ information needs and the consequences of ignoring them. Insufficient information about their illness, prognosis and treatment options is central to people’s dissatisfaction with health care. It comes top of the list of problems identified in patient surveys and is the underlying cause of the vast majority of formal complaints and legal actions.
Successful management of diseases such as asthma, diabetes and AIDS requires active involvement by patients in self-medication and monitoring. Information is needed to support this involvement, so the recent announcement from the European Commission that they propose to allow pharmaceutical companies to provide information for patients with these conditions is, at first glance, welcome. Or is it?
The Commission’s announcement followed a review of pharmaceutical legislation1 and heavy pressure from industry to relax the advertising ban.2 The Commission’s recommendation to the European Parliament calls for retention of the ban on public advertising of prescription medicines, but for a relaxation of the current rules to allow companies to establish a 5-year pilot system ‘to ensure the availability of better, clear and reliable information on authorised pharmaceuticals’ for patients with diabetes, AIDS and asthma.3 Industry sponsored websites providing this information will be required to follow a code of conduct, compliance with which will be monitored by the European Medicines Evaluation Agency (EMEA).
The announcement was not greeted with universal acclaim by consumer groups. Health Action International Europe issued a press release denouncing the move as ‘the thin end of a wedge to open the door to DTCA (direct-to-consumer advertising)’.4 Their concern is based on experience in the only two developed nations to allow direct-to-consumer advertising of prescription medicines – New Zealand and the USA. In these countries, according to a recent report by the UK Consumers Association, DTCA and disease awareness promotions have led to a huge increase in the drugs bill, distortions in prescribing behaviour, and misinformation for patients.5
So is this the first step on the slippery slope to direct advertising, and how should those of us who believe in patient empowerment react? The Consumers’ Association report provides plenty of evidence that many people in the pharmaceutical industry want much greater liberalisation of the advertising regulations. The drug companies claim that DTCA ‘enhances consumer awareness of the symptoms of disease and available therapies’…. and ‘improves patient compliance with chronic-use medications’.2 Unfortunately, there is very little independent research to verify or refute these claims.
The Consumers’ Association report charts the development of DTCA in the US, from the mid 1980s when the first ‘disease awareness’ advertisements (which didn’t mention specific products) appeared in print and on TV, through the early 1990s when print advertisements for specific drugs began to appear, to 1997 when television advertisements for prescription-only products were allowed, with interactive websites providing back-up information. According to the report, US spending on drugs rose by $42.7 billion in the 5 years from 1993 to 1998 and 22% of this increase was accounted for by the 10 most heavily advertised drugs. They fear the same tactics will be used in Europe to chip away at the restrictions.
We know many patients report considerable difficulties in obtaining relevant information. Is it a problem if industry is willing to fill the gap? Perhaps the European Commission’s 5 year pilot will provide an answer to this question. On the face of it, it seems unlikely that the outcome will be favourable. For most patients, the starting point for their information needs is symptom control and treatment options rather than specific products. They want information about the pros and cons of alternative treatments, including detailed explanations about their condition and the likely outcomes with and without treatment. Companies whose raison d’etre is selling products are unlikely to want to advertise their negative aspects by providing, for example, reliable quantified information about potential harms and side-effects. Neither are they likely to want to broadcast the existence of products produced by rival companies.
A lot will depend on the code of practice and EMEA’s determination to police it. A useful starting point would be the guidelines for good quality patient information which emerged from a study of patients’ information needs published by the King’s Fund in 1998.6 This outlined the following characteristics of good quality information:
• Uses patients’ questions as the starting point.
• Ensures that common concerns and misconceptions are addressed.
• Refers to all relevant treatment and management options.
• Includes honest, evidence-based information about benefits and harms.
• Includes quantification of risk and probabilities where possible.
• Includes checklists and questions to ask the doctor.
• Includes sources of further information.
• Uses nonalarmist, nonpatronising language in active rather than passive voice.
• Is well-designed, structured and concise with good illustrations
• Is explicit about authorship and sponsorships
• Includes reference to sources and strength of evidence
• Includes the publication date.