Drug firm Roche pledges greater access to trials data

 
pills Research suggests half of all clinical trials have never been published

The pharmaceutical company Roche has announced that it will make more of the data from its clinical trials available to researchers.

The company says it will appoint a panel of experts to evaluate and approve requests to access anonymised patient data.

Start Quote

We understand and support calls for our industry to be more transparent”

End Quote Daniel O'Day Roche

But the announcement has been dismissed as "pathetic" by campaigners arguing for greater transparency from the pharmaceutical industry - an issue I wrote about last month.

It's estimated that half of all clinical trials have never been published and positive trial results are twice as likely to be published as negative findings. The AllTrials campaign wants the pharmaceutical industry to publish all data, and is supported by the Wellcome Trust, the BMJ and NICE.

"More transparent"

Roche, which makes the anti-viral medicine Tamiflu, has been repeatedly criticised by researchers for failing to grant access to all its data on the drug.

In response Roche has appointed a four man panel headed by flu expert Prof Albert Osterhaus to look at data on Tamiflu which the company says will "identify unanswered questions".

Roche says it will also appoint an "independent body" to assess the validity of requests for unpublished trial data for its other medicines.

Daniel O'Day, Chief Operating Officer of Roche Pharma said: "We understand and support calls for our industry to be more transparent about clinical trial data with the aim of meeting the best interests of patients and medicine."

Start Quote

Does Roche expect applause for announcing that it will continue to keep clinical trial findings hidden?”

End Quote Tracey Brown Sense About Science

Mr O'Day told me that although the company would appoint the experts, the panel would be independent and would "stand up to public scrutiny".

"Pathetic"

But the announcement has been met with derision by the organisation Sense About Science, which helped initiate the AllTrials campaign for all clinical research to be published. Its director Tracey Brown said: "Does Roche expect applause for announcing that it will continue to keep clinical trial findings hidden? They're on another planet. Roche's response is pathetic. Which bit of All and Trials do they not understand?"

Carl Heneghan, Director, Centre of Evidence-Based Medicine, University of Oxford, who is part of the Cochrane team reviewing Tamiflu said, "How can any panel be independent if they appoint it and oversee it? It also means there will be confidentiality clauses within any agreement. Either you provide the data in a transparent manner or you don't."

Earlier this month GSK became the first major pharmaceutical company to pledge its support for the AllTrials campaign. GSK said it would publish all clinical trial data dating back to the formation of the company in 2000 when it merged with SmithKline Beecham.

In the past GSK has been caught withholding safety data and last year it agreed to pay $3bn (£1.9bn) in the largest healthcare fraud settlement in US history after promoting two drugs for unapproved uses and other failures.

Its support for the AllTrials campaign is seen as highly significant.

Dr Heneghan said that GSK had provided him with all 30 clinical study reports (CSR) - regarding its anti-viral flu drug Relenza whereas he had received just one regarding Roche's drug Tamiflu.

Roche says it has published 71 out of 74 Tamiflu trial results but these can be just short summaries and not the raw data of clinical study reports which can run into hundreds of pages.

The doctor and columnist Ben Goldacre, who has spearheaded the campaign for data transparency said GSK had "led the field" by signing up to AllTrials and it was "bizarre to see that Roche expect to be praised today for continuing to withhold data." He predicted that the era of drug companies and researchers "routinely withholding important information about clinical trials is coming to an end."

 
Fergus Walsh, Medical correspondent Article written by Fergus Walsh Fergus Walsh Medical correspondent

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  • rate this
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    Comment number 16.

    If Big Pharma had nothing to hide, then they would have had allowed full scrutiny of the raw data of their clinical study reports decades ago. This just smacks of public appeasement, and the current trend for more transparency, which they have been coerced into, rather than leaving the status quo as it is. Does anyone trust a Pharmaceutical Company when we have had to deal with Vioxx and Avandia?

  • rate this
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    Comment number 15.

    some great scientists on this forum

  • rate this
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    Comment number 14.

    Big Pharma always have and always will put profit before truth -Pandemrix was developed for Bird Flu licensed in 2006 and sold cynically to European governments as a swine flu vaccine in 2009/10 - it caused narcolepsy in some children. Glaxo are testing a H5N1 vaccine knowing that the virus must mutate before it can be dangerous and the stocks bought by gullible governments will be useless!

  • rate this
    0

    Comment number 13.

    Come on Roche - if you want the kudos then make ALL your data available......

  • rate this
    +1

    Comment number 12.

    Roche has been embroiled in a controversial row over trial data. This is an attempt to shut up the critics re Tamiflu data specifically.
    Roche has agreed to allow a board of experts to decide what analyses are useful in assessing Tamiflu's public health efficacy & all requested Tamiflu trial data will be handed over.

 

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