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Open Data

Hidden clinical trial data are systematically undermining doctors’ abilities to prescribe treatment with confidence. A whole range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people’s lives and wasting public money.

As of January 2013, the BMJ will no longer publish any trial of drugs or devices where the authors do not commit to making the relevant anonymised patient level data available, upon reasonable request.

On this page we are documenting some of the BMJ’s coverage of adverse outcomes associated with hidden clinical trial data. We are also highlighting the extent of the problem, as shown in our hidden data special issue, published in 2012.

We are also asking you to help us catalogue drugs, devices, and treatments for which a lack of complete clinical trial data has resulted in a skewed evidence base. Fill in our online form to tell us where and when you have seen this reported.

Latest developments

2013 is fast becoming the year of open data. Trish Groves has blogged with an extensive list of recent developments and upcoming milestones.

One key development is the European Medicines Agency’s plan to proactively share all of the clinical trial data submitted to it by companies seeking regulatory approval for a drug or device.

This seachange in transparency came in 2010, after perennial open data advocate Peter Gøtzsche, director of the Nordic Cochrane Centre, sought a ruling from the European Ombudsman on the right of the public to scrutinize those data. This changed their policy and they are now leading the field in allowing external evaluation.

That plan is now under threat as two companies, AbbVie and InterMune, have obtained an interim ruling from the General Court of the European Union to prevent the agency from data sharing, arguing that the patient level data requested “did not meaningfully contribute to the scientific review or evaluation of our products”.

The BMJ, working with the BMA, has requested leave from the court to intervene in the case.

Examples

Relenza

Relenza, developed by Glaxo Wellcome in 1989, was the first neuraminidase inhibitor. While carrying out its 2009 systematic review and meta-analysis, the Cochrane Acute Respiratory Infections Group requested the full set of clinical trial data from GSK, as it did for Tamiflu and Roche.

This page documents the group’s correspondence with GSK leading up to receipt of a redacted version of those data in February 2013.

Tamiflu

Our first open data campaign initiative relates to a public promise Roche made in 2009 to release full clinical trial reports for Tamiflu, the drug recommended for treatment of influenza.

This page documents correspondence with Roche, and the various bodies around the world which licence or recommend drugs. This open correspondence of letters offers readers the chance to witness attempts to compel greater accountability and responsibility in public health decision making and policy.

Vioxx

Rofecoxib (Vioxx)

Rofecoxib was introduced in 1999 as an effective, safer alternative to NSAIDs for the treatment of pain associated with osteoarthritis. Safety concerns emerged about an increased risk of cardiovascular events in some patients, and the VIGOR study was set up to measure this potential problem. The results reported were negative, but subsequent litigation exposed the data manipulation that took place.

Avandia

Rosiglitazone (Avandia)

Rosiglitazone, a diabetes treatment approved in 2000, was withdrawn by the European Medicines Agency in 2010 in relation to increased rates of myocardial infarctions in some patients receiving the drug. The UK’s Medicines and Healthcare products Regulatory Agency has confirmed that evidence now suggests that the risks associated with rosiglitazone outweigh the benefits and “that it no longer has a place on the UK market.” Yet it has not released the clinical trial data to explain its change of heart.

hidden data

Hidden data special issue

Publication is mandatory for publically funded trials in the United States. However, in this special issue, a series of research papers confirmed that a large proportion of evidence from human trials is unreported, and much of what is reported is done so inadequately.

The authors and researchers who contributed to the special issue discuss their findings and the implications in a round table on the BMJ podcast

We need your help with hidden data

Fill in this form with details of any examples you have seen

Open Data News

Open Data Trials campaign (sense about science)

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