In stark contrast to these theoretical constructs, epidemiological evidence shows a substantial under-diagnosis of many of the major diseases and known risk factors for which effective treatments exist (hypertension, hyperlipidaemia, diabetes, osteoporosis, depression, and childhood asthma). Even after diagnosis, these diseases are massively undertreated.^4-3,4-4 This failure to treat—together with non-compliance (estimated as some 50% for prescribed medicines across all the major chronic diseases)—leads to a considerable social burden of otherwise avoidable morbidity and mortality.^4-5–4-8

These data make the most powerful case for greater public awareness of the benefits of modern medicine. The pharmaceutical industry in Europe has been limited in contributing to this awareness by regulations that, although intended to safeguard public health, may be acting against the interests of European citizens.

Doctors and others have started to come to terms with informed patients.^4-9 Health related information is freely available on the internet, and its use by consumers is accelerating. Physicians must now often share the facts and uncertainties of medicine with their patients as they prescribe appropriate treatments. And patients are taking greater personal responsibility for the choices they consequently make in consultation with their doctors.

Direct to consumer communication (including advertisements) from pharmaceutical companies about prescription only medicines will not diminish the role of the doctor.^4-10 But it may well shift the balance of control in the consultation. It can alert patients to possible diagnoses, risks, and potential treatments—choices that otherwise might not be apparent.^4-11 The quality of the consultation can only be enhanced by the widening and deepening of the patient's knowledge in this way.

Poor communication and misunderstanding between patient and physician is known to lead to suboptimal health outcomes (for example, through medication errors and non-adherence to long term treatment). If doctors must now defend their advice, so much the better for the integrity and robustness of the doctor-patient relationship and for the possibility of geater health gain. Indeed, well informed patients comply better with long term treatment than those who are not.^4-12–4-14

Proponents of the medicalisation theory would argue that the information offered by a pharmaceutical company must be biased in ways in which information from doctors and public agencies will not be. Certainly, all stakeholders have different agendas. Companies will want to increase the market for their medicines; doctors will want to guard professional territory; and the government will want to minimise the cost to the exchequer. But it seems condescending to assume that consumers have no consciousness of these mixed motives and that their scepticism will be dissolved in their anxieties about health and illness. Moreover, consumer surveys and other studies show that direct to consumer advertising provides valuable information on treatments (including risks and side effects); motivates consumers to seek additional information from doctors, pharmacists, and other sources; and increases adherence to treatment and adoption of behavioural changes that lead to better health.^4-15–4-18 It is mischievous to suggest that reducing levels of diagnosis and treatment will somehow improve both the health and wealth of a society.

When a government controls the flow of medical knowledge for purely budgetary reasons, it is the government—not the patient—that is declaring what condition is or is not a normal vicissitude of life. The same might be said of other potential stakeholders convinced that guidance on healthy living is the only information with which the public should be trusted. Yet the issue about direct to consumer communication is not whether it should exist or not—consumers and patients are already inundated with myriad sources of health information. The real question is how to ensure that people have access to the best quality information they need, when they need it. Direct to consumer advertising is just one channel by which healthcare information reaches consumers.

At the moment the pharmaceutical industry, which has perhaps the best information on the medicines they make (and which is legally accountable for their claims) is constrained in Europe from communicating this directly to consumers, whereas other people and organizations are free to disseminate information of perhaps dubious quality. European citizens deserve access to balanced, accurate, evidence based, and comprehensive information about the healthcare choices they face—when and how they wish.

For this to happen they need broad access to product related information from the industry, whether through the internet, advertorials, advertisements, or other information channels. Patients and their care givers, in consultation with healthcare professionals, can then make the best informed decisions.

Information from the pharmaceutical industry must meet all applicable standards for balance and accuracy—but so should other sources of information. Industry advertising is already controlled through legal or regulatory agency initiatives. Other sources of direct to consumer product information from industry should be evidence based, fairly presented, and easily understood. Some new internet guidelines developed by the European Federation of Pharmaceutical Industries and Associations are designed to ensure that consumers receive properly vetted information from the industry.^4-19 The internet is already a wide open marketplace of information, and European regulators cannot turn back the tide. But guidelines like these, which are consistent with the European Commission's Health Online set of quality criteria for health websites, will help to protect the interests of European citizens.^4-20

Finally, conditions that might seem part of the normal vicissitudes of life to some, can be worrisome to others. And, as indicated above, a strong case can be made for liberalised direct to consumer information on seriously undertreated and undiagnosed diseases. To limit access to product information arbitrarily because of unfounded fears about direct to consumer advertising impinges on the rights of Europeans to have all the information they need to make informed choices about their health.—Silvia N Bonaccorso, Jeffrey L Sturchio

We thank Marshall Marinker, Hildrun Sundseth, and Kate Tillett for commenting on early drafts.