Last month, I wrote about the publication of full trial data and specifically, whether selective publication is ever justified. The debate rages on thanks to a "leaked" memo and a UK newspaper…
Good Clinical Practice rules dictate that data must be accurate but there is no requirement for full disclosure. In fact some information, such as source data relating to patients’ medical history may need to remain confidential under the ICH guidelines.
However, the GCP guidelines are also clear that data must not be deleted and when altered, this must be done in a way that the original data remains intact.
Clearly data that does not meet these standards has no place in published trials results, but this is not the same as saying that all data gathered with strict adherence to GCP rules should be made public.
As I wrote before, PhRMA (The Pharmaceutical Research and Manufacturers of America) opposes the EMA’s possible insistence on full disclosure of trials data. Now it seems that PhRMA and EFPIA (the European Federation of Pharmaceutical Industries and Associations) may be trying cajole patient groups to oppose the “non-scientific” re-use of trials data.
This comes from a supposedly leaked memo to senior pharma executives, reported by UK newspaper, The Guardian. The newspaper stopped short of publishing the memo itself so we cannot judge for outselves whether the content is really as inflammatory as it seems.
According to the memo, PhRMA and EFPIA have created a four-part strategy to sow doubts. Not only does it say that they intend to enlist patient groups to raise concerns, they will also attempt to win over scientific and business groups. In addition, they call for a network of academics to correct “false interpretations” of data. The memo was supposedly sent to AstraZeneca, Eli Lilly, GSK, Merck, Novartis, Pfizer, Roche and others.
Unsurprisingly, supporters of full disclosure have been quick to respond, reiterating their belief that full disclosure can only benefit patients.
The US Treatment Action Group (TAG) has issued a statement saying that it has joined with a number of HIV/AIDS advocacy groups to urge patient groups and other stakeholders worldwide to support full data disclosure. In particular, they urge support of the AllTrials Initiative, and its full disclosure petition.
The AllTrials Initiative seems to have some powerful friends. Supporters listed on its website include a bewilderingly long list of European government healthcare bodies and health-related charities but, interestingly, very few big pharma companies – GSK being the notable exception.
GlaxoSmithKline’s support isn’t surprising given its intention to share all post-2000 global clinical trials data. I wonder how the memo was viewed by its other recipients.
Will European research suffer from such enforced openness or does the pharma sector stand to gain from the trust gained from such a “warts and all” approach?
I’d love to know what you think!
Blog Author: Dr. G.C. Practice
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