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Pharma groups want limited data release

Published on 24/07/13 at 09:22am
richard bergstrom image

The two main US and European pharma lobby groups have released a joint statement saying they welcome independent reviews of study data, but are still resisting full disclosure.

Both EFPIA and PhRMA have published new commitments this morning which they say will see biopharmaceutical companies “dramatically increase the amount of information available to researchers, patients, and members of the public”.

This comes after the Guardian newspaper obtained a leaked memo from director general of EFPIA, Richard Bergström, which aimed to get patient groups onside in blocking the public release of data.

These new commitments include sharing clinical trial data in patients for medicines approved in the US and EU, but only with qualified scientific and medical researchers upon request, and subject to terms necessary to protect patient privacy and confidential commercial information.

It added that researchers who obtain such clinical trial data will be encouraged to publish their findings, but neither group will sign up to full public release of data.

This will frustrate the likes of UK charity Sense about Science and Dr Ben Goldacre, who founded the AllTrials campaign - an initiative seeking complete disclosure of all trial information for greater scrutiny.

Under the commitments those wanting raw data sets showing will need to be approved by review boards convened by the companies themselves. External members will sit on the boards but they will be appointed by the companies, meaning information will still be filtered and not freely available.

Pharma argues that full data release would be risking patient privacy and is open to misinterpretation from the lay public. But critics argue that pharma routinely hides negative data so as to make its products looks more effective, and say the industry is fighting initiatives like AllTrials because it doesn’t want these data to be found.

In a statement EFPIA and PhRMA said it would also ensure that:

  • Companies work with regulators to provide a factual summary of clinical trial results to patients who participate in clinical trials
  • The synopses of clinical study reports for clinical trials in patients submitted to the FDA, EMA, or national authorities of EU member states will be made publicly available upon the approval of a new medicine or new indication
  • Biopharmaceutical companies have also reaffirmed their commitment to publish clinical trial results regardless of the outcome. At a minimum, results from all Phase III clinical trials and clinical trial results of significant medical importance should be submitted for publication.

Both groups said implementation of these new rules will begin from January next year, when European regulators prepare to enact new rules forcing pharma to publish the documents companies submit to win approval of their drugs.

“Companies routinely publish their clinical research, collaborate with academic researchers, and share clinical trial information on public websites,” said Christopher Viehbacher, president of EFPIA and chief executive of Sanofi.

“By endorsing the principles, biopharmaceutical companies commit to enhance these efforts by making additional information available to the public, patients who participate in clinical trials, and to qualified researchers.”

Bergström said: “The data sharing commitments reflect EFPIA member companies’ strong support for sharing clinical trial data to benefit patients and foster scientific discovery in a way that maintains patient privacy, the integrity of regulatory systems, and incentives to invest in biomedical research."

He added that these commitments “stand as a responsible alternative to other proposals being put forth in the European Union,” i.e., the proposal to make pharma release all of its data.

Ben Adams

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