Drug companies in the U.S. and Europe, facing the prospect of EU officials forcing them toward more transparency, have now agreed to share some clinical research data. Does this mean a new era of openness or is this just lip service?
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the U.S.’s Pharmaceutical Research and Manufacturers of America (PhRMA) released a joint set of principles last week outlining a plan to allow greater access to clinical drug trial data so that qualified scientists could, in theory, analyse the results and confirm or refute the drug companies’ claims.
It is believed that less than half of research trial data is currently published, with critics saying the data is withheld so that pharmaceutical companies can overstate the effectiveness of their drugs, downplay side effects and maintain a competitive edge over each other — all at the expense of patients.
So strong are the concerns that the European Medicines Agency (EMA) has begun to formulate regulations that would force the companies to publish such data. Many have resisted such interference, as had PhRMA and EFPIA , with PhRMA on record as late as this January formally opposing any wider changes to data publishing.
However, with the publishing of a new set of transparency principles, both companies appear to be at least offering tacit agreement with the EMA initiative. So what are the principles, and what is going on here?
The New Principles PhRMA and EFPIA Have Agreed On
Due to be implemented in January 2014, the Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers outline that data requests will be allowed under certain conditions.
All such requests will first be referred to review boards established by each company. Those boards may include independent scientists and health care professionals, as well as company officials, to offer a balanced assessment of data requests. However, the individual makeup of each review panel will be set by the companies and there will be no mandate that companies have to include outside reviewers.
Researchers will at the same time have to demonstrate that they have the qualifications to handle the data and that their use of the data will fulfill a legitimate research question, though exactly how that is defined appears quite nebulous at this stage.
Other commitments outlined in the document include an agreement for companies to work more openly with regulators to provide a detailed summary of relevant information for patients who participate in clinical trials. Moreover, companies will also agree to make available to the public summaries of clinical study reports when new medicines are approved by Europe and U.S. regulators.
The principles encourage publication of positive and negative results from what are known as all “phase III” trials, where a prospective treatment is given to large groups of people to confirm its effectiveness and monitor side effects — this even if those results do not provide evidence for the effectiveness of a given drug or show signs of above acceptable side effects.
The principles explicitly state, however, that no data will be shared that could compromise pharmaceutical industry competitiveness. The principles also reserve far reaching powers to protect data that companies deem could compromise patient confidentiality.
Given the wider pharmaceutical industry has resisted attempts to force more transparency in data publishing, why have PhARMA and EFPIA suddenly changed course? And is this really all it seems?
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