An election pledge to require drugs companies to publish full details of clinical trials for medicines cannot be fulfilled because it is illegal under EU law, the UK Government has admitted.
Psychiatrists and health campaigners renewed a call yesterday for all data on the effectiveness of medicines to be published after a review of clinical trials concluded that antidepressant drugs were no more effective than a placebo for patients suffering from depression.
The pharmaceutical industry is encouraged to publish findings of all clinical trials online but is still, to a large extent, allowed to regulate itself. Critics argue that this system is not enough to ensure that patients, doctors and watchdogs, such as the the National Institute for Health and Clinical Excellence (NICE), get the information that they need to assess the effectiveness of drugs properly.
The review referred to trials submitted in the 1980s and 1990s when four antidepressant medications were being licensed by the US Food and Drug Administration.
More at The Times
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Is this the new vytorin?
http://www.thestreet.com/story/10405109/1/elan-wyeth-play-by-own-rules-in-alzheimers-trial.html
Elan, Wyeth Play by Own Rules in Alzheimer's Trial
Elan(ELN - Cramer's Take - Stockpickr) and Wyeth(WYE - Cramer's Take - Stockpickr) are using a new and unproven endpoint to measure the memory and mental status of patients in phase III trials of their experimental Alzheimer's drug bapineuzumab, say sources familiar with the studies' protocols.
By creating their own test to measure bapineuzumab's efficacy, Elan and Wyeth are seeking an alternative to the so-called ADAS-cog, despite that test's imprimatur as the gold standard measure of cognitive function. The ADAS-cog has been used as the basis for approval for all Alzheimer's disease drugs to date.
Elan has devised a new clinical endpoint, which it calls the Neuropsychological Test Battery, or NTB. The Irish drugmaker has used the NTB in previous studies of its Alzheimer's drugs to demonstrate improvements in the mental status of patients when similar measurements using ADAS-cog showed no benefit.
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