IJFAB Blog

Today the BMJ published a re-analysis of the data in Study 329. The results of this study, funded by GlaxoSmithKline were first published in 2001 in the prestigious Journal of the American Academy of Child and Adolescent Psychiatry. That article claimed that the antidepressant paroxetine is safe and efficacious in the treatment of adolescent depression, leading to its widespread use across the globe. Subsequent investigation, culminating in today’s publication in the BMJ, shows that paroxetine is no more effective than placebo in treating depression in adolescents, but is much more harmful. The authors, led by Australian child psychiatrist Jon Jureidini, have gone to extraordinary lengths to secure access to and then reanalyse the original data, some 77,000 pages of it. Their forensic analysis shows just how the original paper managed to ‘prove’ the safety and efficacy of paroxetine – by using end points not specified in the original protocol and by coding away and ignoring side-effects. The full chronicle of the investigation of Study 329 can be found here. The website and articles are well worth a close examination.

In my view, this publication and expose is a ‘game changer’ for research ethics as it shows the perils of data secrecy and the way that it is well nigh impossible to challenge the results of randomised controlled trials without access to the original protocol and the data. And this raises a fundamental question for research ethics: How can it be ethical to approve research and enroll patients unless there is a guarantee of open access to the protocol and data? Without such a guarantee, we risk patients serving as little more than fodder for the marketing machinery of the pharmaceutical industry as trial results are manipulated and skewed to economic imperatives. Psychological Causes The brain plays an important role in levitra pills online trigging an erection, which releases certain neurotransmitters during sexual excitement. This totally tends to ruin a man s life at the age of 40 and shop levitra 70 are known to experience episodes of poor erections at some point of time. Besides, some lubricants that are formulated with desensitizing ingredients are also considered as natural aphrodisiacs which have been used since ancient days. women viagra For women, they can only tell you that they are going through canada viagra prescription a problem but cannot come in and show you the problem. We often justify enrolling patients in research on the grounds of the potential contribution to future knowledge – the research will help guide treatment for future patients, even if some of the trial patients receive placebo. This justification dissolves in the absence of guaranteed open access to data and protocol.

This research is both heartening and deeply dismaying. Heartening because it shows that it is possible for a small number of extremely motivated people (with an enormous amount of effort) to call to account research misconduct, and provide a clear recipe for avoiding future problems of this nature. It is dismaying because the ground has shifted in terms of losing (more/all) confidence in clinical research; and in the knowledge that there will never be enough motivated people to do all of the necessary reanalyses should investigators (both commercially and publicly funded) open up their data. This expose has cast a long shadow over all research findings.

However, a phoenix might rise from the ashes. The restoration of Study 329 could be a trigger to demand that open access become the new norm. Human research ethics committees (institutional review boards) could demand open access as a requirement for ethics approval. Only such a proposal might restore confidence in the clinical research enterprise, and thereby ensure that when patients enroll in research for the greater good, there is some chance of that good coming to pass.