In 1994, the Monitor focused on how medicines were being marketed and the potential impact on prescribing and treatment outcomes. Many of the concerns highlighted in that issue continue to be raised by health professionals, consumer groups, scientific journals, academic researchers and meetings of WHO governing bodies. For this reason the Monitor returns to the subject - to stimulate and to contribute to an important debate. Over the years, as new concerns have arisen, so too has the body of evidence linking drug promotion to the use of newer, more expensive but not necessarily more effective medicines (see page 18). One example is the study by Wazana reported on page 22, which involved a systematic review of evidence of how promotion affects doctors' behaviour. Recent research by the US National Institute for Health Care Management Research and Educational Foundation shows that direct-to-consumer advertising, a subject of great topical debate, may be inducing what it terms "significant, and potentially inappropriate, demand for some prescription drugs". The Foundation reports that sales of the 50 most heavily advertised drugs in the USA rose an aggregate 32% from 1999 to 2000, compared to 13.6% for all other prescription drugs. Currently only two developed countries, the USA and New Zealand, permit such advertising, and a Lancet editorial (18 May 2002) concludes that experiences in these countries show potential disadvantages outweighing any claimed benefits.

Adding to the evidence, Canadian researcher Barbara Mintzes in her thoughtprovoking article on page 19 points out that in 1998 the US FDA found that commercials for 52% of the drugs advertised on television violated US regulations. And between 1997 and mid 2001 the Agency sent out 94 notices of violations (48 broadcast, 46 print). The key reasons included inadequate risk information, exaggerated benefits and unapproved uses. Other studies found that a majority of consumers did not understand what prescription-only status meant, and in a California study 43% of respondents thought that only completely safe medicines could be advertised. It is clear that we have a long way to go with consumer education on medicines. Mr Léon Wever, a Dutch legislator, responding to a European Union proposal to permit direct-to-consumer information on treatment options for AIDS, asthma, chronic bronchitis and diabetes, argued that if the aim is to provide information to the public, a change to advertising regulation is not needed. However, he points out that there will always be a "grey" area between information and promotion, which is hard to address in legislation (see page 14).

New issues that have come to the fore in recent years include the targeting of women in drug marketing and the medicalisation of transient and life stage experiences. The quote from a drug advertisement included in the title of the article on page 12 "the essence of womanhood is now in tablet form" makes chilling reading.

In 1999 drug promotion was identified by the WHO/Public Interest NGO Pharmaceuticals Roundtable as a priority for technical collaboration, partly in recognition of the need for more evidence of the effects it has on public health. One outcome is the first comprehensive global database of studies and other material on drug promotion, which is being launched as part of this joint collaboration (see page 18). The database will be a valuable resource to researchers, policy makers, industry and NGOs.

Drug promotion of course, is only one, albeit important, influence on prescribing practice and sales. The potential for conflict of interest and biased recommendations when researchers and treatment guideline developers have undeclared links with industry is another issue. A study in JAMA (see page 4) found that 59% of treatment guideline authors had relationships with companies whose drugs were being considered. A recent tough joint statement by 13 of the world's leading medical journals (page 2) expresses strong concern about the use of clinical trials for marketing rather than scientific purposes, undeclared conflicts of interest and selective reporting of results. It describes a new climate in which "corporate sponsors are able to dictate trial terms which are not always in the best interests of academic investigators, the study participants or science in general". As WHO/EDM Director Dr Jonathan Quick states "the reliability of clinical trials is currently imperilled by three major flaws: conflicts of interest on the part of the investigators, inappropriate involvement of research sponsors in their design and management, and publication bias in disseminating results" (see page 3). He calls for greater clarity on the rights and obligations of clinical investigators and on the management of the entire clinical trials database, complementing the Helsinki Declaration drawn up to protect trial subjects.

Informed clinical decision-making, good prescribing practice and optimal treatment outcomes critically depend on an evidence base that is free from commercial bias, and access to comprehensive scientifically authenticated information. Many countries are increasingly basing their clinical guidelines and reimbursement decisions on a systematic review of all available evidence. Examples include the Scottish Intercollegiate Guidelines Network and the Pharmaceutical Benefits Scheme in Australia. On the other hand, promotion efforts also put considerable pressure on prescribers, and increasingly the general public. While informed and motivated prescribers can have access to unbiased information, this is much less the case for the public. Governments, regulatory agencies and professional organizations need to ensure that all information on medicines provided to prescribers and consumers, and the research on which it is based, contribute to better science and treatment outcomes rather than sales.