Novartis takes the transparency 'pledge' as Big Pharma critics pounce
Now that many of the major pharma companies have promised to open up, at least somewhat, on their clinical trial data, Novartis ($NVS) has decided to take the pledge as well. But rather than earn plaudits from longtime critics who have castigated the industry for years of secrecy about their clinical trials, it's only likely to stir a growing backlash among commentators who view these moves as far too limited, spurred primarily by a more ambitious approach from European regulators who want to force open the floodgates.
In its release today Novartis says that it will make data available on newly approved drugs through an online portal. But aside from a litany of information about past commitments and its decision to list trials on clinicaltrials.gov, that's about the extent of what Novartis has to say this morning.
Ironically, the BMJ has just posted its own review of Big Pharma's transparency programs. And aside from noting that GlaxoSmithKline ($GSK) has earned the lion's share of the praise so far after taking an early and aggressive stand in favor of data transparency, there's much it finds at fault among the Big Pharma companies now ostensibly opening up.
In a piece titled "From promises to policies: is big pharma delivering on transparency?," Peter Doshi concludes that what the industry is offering now is "controlled access," not open access. Committees are being given the authority to determine what qualifies as a serious research request. Some companies, like Sanofi ($SNY), are redacting what it deems sensitive commercial information. And several, like Novartis, aren't opening up at all on older studies.
"To borrow physician and Bad Pharma author Ben Goldacre's phrase, the past is riddled with "fake fixes," and there remain reasons to be skeptical of the transparency policies industry is actively putting into practice," writes the BMJ's Doshi. "The reality is that most of these systems are still new and largely untested; the ClinicalStudyDataRequest.com website lists just six requests with signed data sharing agreements."
As Bloomberg points out this morning, the U.K.'s House of Commons Committee of Public Accounts has already made clear that limited access through online portals doesn't go nearly far enough. And the EMA has issued draft guidance on new regulations that would demand that the companies really open up on the data to the public. Novartis's action today, following recent moves from the other giants, will do little to slow the pace of change in Europe. -- John Carroll, editor-in-chief (email | Twitter)