Media

Europe’s patients suffer from sick drugs market
by Anita Hardon

Vol. 11 No. 1 : 13 January 2005

IN November, as part of the Dutch EU presidency, a distinguished panel of ministers, public health officials, the pharmaceutical industry and the World Health Organization (WHO) convened in The Hague to discuss how to target research better towards producing ‘priority medicines’. The aim was and remains to identify ‘pharmaceutical gaps’, diseases for which effective treatments are lacking and towards which research should be prioritised. The Luxembourg presidency will continue the work since at stake is a sizeable pot of money to be assigned to medicines’ research under the EU’s 7th Framework Programme for Research.

Superficially the project is laudable – the ‘public health point of view’ is intended to shape how medicines’ research is organised and directed. But at heart it does not deviate from a failing model of medicines’ research which offers European consumers medicines that are usually too expensive and often damaging to health.

Two recent examples illustrate the problems with how drugs are developed and promoted. With both Vioxx, a painkiller withdrawn on being found to increase the risk of heart attack and stroke and Seroxat, an anti-depressant whose use by children has been restricted on safety grounds, medicines over-consumed on the back of heavy marketing turned out to be unsafe. In both cases there have been allegations that the companies involved suppressed or delayed the publication of data indicating safety risks. These cases illustrate the fundamental tension between health and commercial interests, a tension that policymakers seem unwilling or unable to confront.

Relying on the pharmaceutical industry for our medicines means relying on those whose interests are profits first and health a conditional second. Pharmaceutical companies concentrate their research efforts on ‘lifestyle’ drugs such as Viagra and Prozac – medicines for which large markets exist or can be rapidly created by clever marketing. Expenditure on marketing is usually higher than expenditure on research and development, which indicates that strategies are based more on persuading people that a medicine will help them than on producing medicines of genuine therapeutic value.

Developing medicines only where markets are assured is inherently a low-risk strategy, whatever the risks of individual research investments. Yet it is rewarded by monopolies based on intellectual property rights. The EU project assumes that more incentives need to be offered to companies to help them overcome their unwillingness to invest in medicines for which a good return is otherwise unlikely. This amounts to a recipe for making an already expensive system which is not geared to public health needs ever more expensive.

If the medicines generated by this system were as safe and effective as they are expensive, this might be something that consumers could live with. As it is, the pharmaceutical industry has a corrupting influence on the way research is conducted and market approval granted. Tactics described before an ongoing UK parliamentary health committee inquiry include getting respected scientists to put their names to articles ghost-written by industry staff and paying opinion leaders to talk about drugs about which they have no specific competence. The pharmaceutical industry often funds researchers or establishes research institutions and keeps secret new information discovered by its ‘own’ scientists.

The result, highlighted in a letter signed by the editors of 11 leading medical journals, is “selective reporting of trials [which] distorts the body of evidence available for clinical decision-making”. Regulators are constrained from fulfilling their oversight role by dependence on fees from industry for granting licences for new drugs.
The EU project compounds these problems by recommending that checks on drug safety before marketing approval is granted are slimmed down. This is held to stimulate innovation and get products on to the market more quickly, in theory without compromising safety.

But this amounts to a shift from authorising new medicines only when they have proven to be safe, to authorising them until they can be proven to be unsafe. European consumers need to feel confident that medicines’ research is geared towards medicines which offer genuine therapeutic advantage over existing therapies. Founding EU research programs on the principles of transparency of research, independence of regulators and value for money would be the best way of generating such confidence.

· Anita Hardon is professor of anthropology of care and health at the University of Amsterdam.

© Copyright 2005 The Economist Newspaper Limited. All rights reserved.

New approaches to health research and drug discovery
Health and Social Campaigners’ Network international

A pair of crucial meetings took place during the week beginning Monday November 15th 2004. The two proceedings discussed the strategic changes needed to improve the quality and quantity of health and medicines research. At one of the venues, the World Health Organization (WHO) and the government of Mexico organised a ‘Ministerial Summit on Health Research’, held in Mexico City. Across the Atlantic, at The
Hague in the Netherlands, the WHO and the Dutch presidency of the European Union (EU) jointly convened a conference entitled ‘Priority Medicines for Europe and the World’. Consumer and patient organisations were attendees on both occasions. This Health and Social Campaigners’ News International article reviews the main
outcomes of The Hague symposium (and briefly touches on the Mexico meeting), then concentrates on what health campaigners had to say about it. Included in the latter part of the article is a summary of a parallel satellite seminar organised in The Hague by Health Action International (HAI), a consumer-oriented group which is largely critical of the pharmaceutical industry. The HAI seminar was designed to be a response to the
proposals put forward by the WHO and the EU on the important subject of health and medicines research. Read the article