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Explaining the News: Drug Data

What does this mean?

The committee is concerned that, at the moment, it is completely legal for a drugs manufacturer to only release positive trial results to doctors, pharmacists and the medical community when it is testing new drugs. The committee wishes to put more pressure on the government to act upon this law and ensure that pharmaceutical companies are completely open with their trial results, and it is calling on health ministers, regulators and all professional bodies to ensure that methodologies and results are fully disclosed to doctors, patients and medical researchers.

The call is supported by the AllTrials campaign, which has been advocating for research transparency since its launch. It argues that a clinical trial registry should be available and open for viewing. Co-founder Ben Goldacre commented: "It is quite frankly ridiculous that you would accept that half of clinical trial data can be withheld."

Why is it important?

A lack of information means that professionals are not getting the full picture - which in turn means we cannot be sure which treatment is the most effective when managing a condition with pharmaceuticals. The Association of the British Pharmaceutical Industry (ABPI) has defended itself but has also acknowledged a need for improvement, stating: "In late 2013, an ABPI-commissioned study was published in a peer-reviewed journal. This study highlighted a positive trend of increasing levels of disclosure for industry-sponsored clinical trials, with almost nine out of ten of all industry-sponsored clinical trials disclosed by January 31st 2013. However we recognise that there is still work to be done and we are continuing on a journey to achieving greater clinical trial transparency."

Budget also plays a part in these concerns; while the UK currently has around £500 million worth of Tamiflu stockpiled in the case of an influenza pandemic, it has been widely reported that manufacturer Roche is unwilling to release its full clinical trial results - meaning that the effectiveness of the UK's anti-viral policy is in question.

Another factor worth considering is that many volunteers in trials feel as though their effort has gone to waste, as the results are not being used to aid research. Last year a group of over 50 clinical trial participants wrote an open letter to the European Medicines Agency expressing their concern and frustration that they felt participants were being misled.

The Department of Health told the BBC: "We agree that clinical trials need to be more open and transparent and we're working with health organisations in the UK and EU to make this happen.

"All clinical trials conducted in the UK must now be registered on a public database."

Sources

http://www.bbc.co.uk/news/health-25576520

http://www.bbc.co.uk/news/health-21066261

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