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Rapid Responses: Rapid Responses published:
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"Comprehensive" headline betrays the truth
- James TR Walters (10 September 2004)
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Damage control
- David Rasnick (11 September 2004)
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"Comprehensive" database, far from it....
- Debby Painter (11 September 2004)
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James TR Walters, locum staff grade Cardiff & Vale NHS Trust
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Editor, Owen Dyer is wrong to employ GSK's description of their online clinical trails register as 'comprehensive'. Our joy at the news of major pharmaceutical companies opening their doors to public scrutiny must be tempered by the fact that they are keeping the keys securely in their pockets. The registers which GSK and Eli Lilly before them, have agreed to publish are limited including only summaries of selected trials. In unreservedly welcoming this development both Owen Dyer and Eliot Spitzer (1) are in danger of letting a vital opportunity slip away. In order to take full advantage of this opportunity to develop a comprehensive register of clinical trials (including those from non-pharmaceutical bodies) the profession and govermental bodies need to be proactive in not allowing the pharmaceutical companies to dictate the terms(2). As recommended by a wide ranging international committee of journal editors (3) such a register should be truely comprehensive and include all trials at their inception. Patients and healthcare professionals have suffered as trial results have been withheld and it is only through the establishment of such a policy that this will be prevented in the future. James Walters (1)Settlement sets new standard for release of drug information [press release]. New York, NY: Office of New York State Attorney General Eliot Spitzer; August 26, 2004. (2)Trial Registration :A Great Idea Switches From Ignored to Irresistible. Rennie,D.JAMA. 2004;292 (3)Clinical Trial Registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292:1363. Competing interests: None declared |
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David Rasnick, Visiting Scholar, Dept. MCB, UC Berkeley Berkeley, CA 94720
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Dear Editor, Owen Dyer’s article “GlaxoSmithKline to set up comprehensive online clinical trials register” contributes to Glaxo’s damage control following recent bad publicity in the New York Times and elsewhere. A lawsuit against Glaxo alleged “repeated and persistent fraud” as the company suppressed data from at least four trials of the antidepressant paroxetine. “Glaxo said that all the promised summaries should be posted by the end of 2005. In addition, the company said it would post summaries of selected trials that finished before 2000, ‘if they are likely to inform medical judgment’”. At least one trial date has been set in the USA for a lawsuit against Glaxo because of the toxic consequences of its anti-HIV drugs that were developed and approved by the FDA prior to 2000. Glaxo will most likely determine that trials of those drugs will fall under the category “[un]likely to inform medical judgment”. David Rasnick Member of the South African Presidential AIDS Advisory Panel Competing interests: None declared |
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Debby Painter, Private Researcher Michigan 49042
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Like many in the medical and research community, I was thrilled to hear about the settlement between Mr. Spitzer and GSK. That is until I read the details of the settlement. Some important facts that we must keep in mind about this agreement. "The drug manufacturer also agreed to publish on its website 'summaries' of all of its trials since 27 December 2000, when Glaxo Wellcome merged with SmithKline Beecham.... GSK said that all the promised summaries should be posted by the end of 2005. In addition, the company said it would post summaries of selected trials that finished before 2000, 'if they are likely to inform medical judgment.'" Keeping in mind that most of the drugs currently in question were initially manufactured long before 2000 and that summaries are usually one person's interpretation of what he or she has read, without access to ALL the data from a clinical trial we may still be lacking much information needed to fully learn about the drug's potential benefits or harm. The above comment "if they are likely to inform medical judgment" says it all - that the manufacturer will be decided what is and is not relevant for the medical community and the public at large to know. And lets not forget that the drugs in question are being reviewed for use in depression and in adolescents and children. It has not been made clear that "summaries" or even a minimal of data will be made available for the clinical trials for these medications when used for purposes other than depression and in other age groups Though this settlement is a step in the right direction, it falls short of the goal of the complete disclosure we, the medical and consumer community, are entitled to. Competing interests: None declared |
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