Depressing researchIt is hard to imagine the anguish experienced by the easily manipulated by those with potentially massive parents, relatives, and friends of a child who has taken his or her own life. That such an event could GlaxoSmithKline SSRI paroxetine, for example, be precipitated by a supposedly beneficial drug is a amounted to US$4·97 billion last year alone.
catastrophe. The idea of that drug’s use being based Moreover, the utility of organisations such as the on the selective reporting of favourable research National Institute for Clinical Excellence (NICE) is should be unimaginable. In this week’s issue of significantly undermined in circumstances where The Lancet (p 1341), however, a meta-analysis by they are only able to access data on health-care Craig Whittington and colleagues suggests that this products that are seen as advantageous to the is what has been happening for research into the use of antidepressants in childhood. Their results How confident is society that similar failings will illustrate an abuse of the trust patients place in their not occur on a larger scale in the future? UK Biobank physicians. They also represent an abuse of the trust intends to recruit and follow a cohort of around placed by trial volunteers in the medical and 500000 volunteers. The data collected will be used in part to develop new pharmaceutical products and The story of research into selective serotonin diagnostic tests. Much time and effort has already reuptake inhibitor (SSRI) use in childhood been invested into ensuring appropriate regulatory depression is one of confusion, manipulation, and ethical principles are in place for all stages of the and institutional failure. Although published project. However, the links of UK Biobank with the evidence was inconsistent at best, use of SSRIs to pharmaceutical industry are already clear. John Bell, treat childhood depression has been encouraged by chair of the UK Biobank science committee is also a pharmaceutical companies and clinicians world- director at Roche. In addition, at least part of the wide. Last month, the Canadian Medical estimated £70–500 million required to complete the Association Journal revealed excerpts from an project is envisaged as coming from industry sources.
internal GlaxoSmithKline memorandum demon- With this level of involvement, will a pharmaceutical strating how the company sought to manipulate company really feel obliged to publish information the results of published research. Concerning a derived from these volunteers that one of its products study of paroxetine use in children, the memo- randum states “It would be unacceptable to Changes are required at every level of the global include a statement that efficacy had not been health-care infrastructure. Governments need to demonstrated, as this would undermine the profile collaborate effectively over issues of patients’ safety of paroxetine”. Last year the UK Committee on rather than duplicating efforts. Governmental Safety of Medicines prohibited the treatment of institutions such as NICE require legal powers to childhood depression with any SSRI except ensure that biomedical research is used to improve fluoxetine. Despite this, the Food and Drug health even if this does not equate with improved Administration in the USA appears last week to profits. On an individual level, doctors and have failed to act appropriately on information pharmaceutical company employees must remember provided to them that these drugs were both that without the trust of trial volunteers and patients medical research and practice will become In a global medical culture where evidence-based impossible. People around the world understand the practice is seen as the gold standard for care, these desire to achieve success and to work in a profitable failings are a disaster. Meta-analysis of published environment. They will not, however, tolerate the data supports an increasing number of clinical notion that in biomedical research this could be at decisions and guidelines, which in turn dictate the the expense of their children’s lives.
use of vast levels of health-care resources. Thisprocess is made entirely redundant if its results are so THE LANCET • Vol 363 • April 24, 2004 • For personal use. Only reproduce with permission from The Lancet.


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