I smell a strategy coming from PhRMA about this business of AllTrials and RIAT. Two recent articles address the public version. In do the time…, I looked at GSK’s white paper in the New England Journal of Medicine [available via Medscape's write-up GSK Opens Access to Data From More Than 200 Clinical Trials]. Later, in the spice must flow…, I reviewed the head-to-head article from PhRMA in the British Medical Journal [Are clinical trial data shared sufficiently today? Yes]. The private version comes from the leaked memo reviewed in a closing argument… which includes an article from the Guardian [Big pharma mobilising patients in battle over drugs trials data], a retort in eye·for·pharma [Exclusive: The Devil is in the Details], and the actual memo from EFPIA & PhRMA.
GSK is making 200 Clinical Trials [post-2007] available to qualified research teams pending a review of how they plan to use the data [including publication plans] by a panel in independent experts. Technically, that’s data sharing – using their data for an independent research project, approved by GSK. In the PhRMA piece elaborates on this theme of data sharingg and claims that data transparency is a destructive thing leading to betrayed subject privacy and access to proprietary information. In essence, they are agreeing to tightly controlled data sharing and arguing against data transparency.
The advocacy plan, previously approved by the two Boards is underway, and follows four strands:
- Mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data.
- Engaging with scientific associations to shape the industry commitment for data sharing, and to discuss concerns about re-use of data.
- Work with other business sectors that are also concerned about release of trade secrets and commercially confidential data.
- For the long-term, build a network of academics across Europe that has the capacity to counteract mis-use of data [that is deemed to be happen in any case].
Ben Goldacre, author and co-founder of AllTrials:“The industry commitments suggested here are weak and filled with loopholes. They fall way short of the concrete commitments the European Medicines Agency has already made about sharing trial information, and also fall short of recent commitments from GSK and Roche.
The loopholes are especially concerning. EFPIA and PhRMA seem to be suggesting that transparency should only happen for new trials, and reports submitted to regulators after 2014. This will do nothing to remedy the incomplete evidence that doctors and patients are being forced to use right now, on the medicines we use every day and came to market over the past few decades. Sharing trial information going back for at least two decades is vital.
It is also a retrograde step that they suggest only releasing Clinical Study Reports on demand, after a long review process by the company, where they will decide if the applicant is appropriately qualified. The Cochrane Collaboration faced a four year battle to get Clinical Study Reports from Roche on Tamiflu, during which time the company attempted to argue that the Cochrane Collaboration – 14,000 academics producing more systematic reviews than any other organisation in history – were not competent to conduct a systematic review.
There are also some bizarre peculiarities in the details. For example, the suggestion that trial protocols should only be released voluntarily, and on request, after going through a panel run by the company, is extraordinary. This suggests the EFPIA/PhRMA document may not have been thought through carefully. A trial protocol is simply a detailed description of what will be done in a trial, and how it will be analysed. It should be a routinely available public document and, by best practice, made available before the trial even begins.Overall the proposals here are no meaningful alternative to simple, clear transparency on all trials. Doctors, regulators, and policy makers cannot barter away from the simple full transparency that patients need. All results from all trials for all uses of currently prescribed treatments must be made available, if doctors and patients are to make informed decisions about which treatment is best. Where we have anything short of this, patients are exposed to unnecessary harm.”