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Pharma industry moves towards greater openness

The pharmaceutical industry has signalled its willingness to open up the vast reservoirs of research data held by its companies this week. But campaigners and researchers pushing for more access to clinical trial data say the moves are little and late.

In a statement released yesterday, two of the world’s leading trade bodies said they would “dramatically increase the amount of information available to researchers, patients, and members of the public”.

Europe’s trade body, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and its north American equivalent the Pharmaceutical Research and Manufacturers of America (PhRMA) said they would make information on trials down to patient level available to researchers. They also pledged to make available the detailed ‘clinical study reports’ which some scientists have been demanding.

Medical research is in a critical period at the moment, with an increasingly vocal group of doctors and scientists demanding greater access to drug company data. These campaigners say that access to these data is vital to prevent the industry burying results that are unfavourable to their products, as has happened in past scandals. Some want drug companies to put all their data on clinical trials into the public domain, while others think researchers should be able to request information from trials that could be released to them after they have been vetted by an independent panel.

This call has been heeded by some bodies, notably the European Medicines Agency, a regulator that is trying to make more information available (see: Drug-company data vaults to be opened). But some businesses have resisted, with two companies suing the agency to prevent release of some of their data.

In response to the move from PhRMA and EFPIA, campaigners accused the industry of not going far enough. Carl Heneghan, director of the Centre for Evidence Based Medicine at the University of Oxford a founder of the AllTrials campaign group pushing for greater openness in clinical trials, said the industry announcement was “clouded in caveats” which could allow a company to refuse a request for information if they thought it was not in their interest to release it.

“In terms of the principles for responsible clinical trial data sharing, outlined by the EFPIA and PhRMA these are to be broadly welcomed,” said Heneghan in a statement. “Yet, there are many details that need to be fleshed out to ensure this is little more than just window dressing.”

But in his own statement, Christopher Viehbacher, president of EFPIA and the CEO of Sanofi, said “Companies routinely publish their clinical research, collaborate with academic researchers, and share clinical trial information on public websites. “By endorsing the Principles, biopharmaceutical companies commit to enhance these efforts.”

Comments

  1. Report this comment

    Sergio Stagnaro said:

    Pharma Industry will never move towards openness of original data, regarding the therapy of Constitution -Dependent, Inherited Real Risks.I mean that Pharma Industry is not able to recognize the possible business of therapeutic action, aiming to remove the predisposition to the present, most common and deadly pathologies, as CVD, T2DM, and Cancer, today’s growing epidemics.

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    Donald Scott said:

    This is always going to represent an obstacle in Science being true to its ethos. How to reconcile profit with progress?

    The recent past suggests that only legal processes and in the UK the Freedom of Information Act allows the public to gain access to the processes used by Pharma to develop and market their products. Clearly not all drugs research is deliberately skewed as to be worthless, but there is a small percentage that has been. How does an industry self-regulate efficiently i.e. honestly, and how can those within the industry report dishonesty and fudging clinical data without retribution?

    I think that the benefits of modern biotechnology may well be exaggerated. The claims made for future progress in drug research and manufacturing is undermined by the culture of selective burying ‘unwanted’ data. Giving third parties the job of providing study subjects that are unsuitable representatives as controls is another distinct issue.

    Thanks for this topic being opened up for discussion.

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    Usman Paracha said:

    Hopefully, this will speed up the drug discovery process.

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    Suleman Ali said:

    It is important for the pharma industry to understand that it needs to do as much as possible to allay the fears of the general public. Full transparency in regards to their clinical trials is required. Patient level data needs to be released as well as results of all studies, irrespective of outcome.

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