NICE seeks more trial data from pharma
pharmafile | September 10, 2014 | News story | Medical Communications, Research and Development, Sales and Marketing | David Haslam, NICE, Tamiflu, alltrials, transparency
NICE is calling on pharma to release more data so it can better assess the costs of new medicines.
The watchdog is updating its guidance on how much data it wants to see from pharma; if it doesn’t get it wants, NICE says it will by-pass a company altogether and go straight to regulators.
The unprecedented move follows increasingly loud calls for greater transparency from pharma companies from across a number of UK institutions and groups, such as the BMJ, the BMA and several Royal Colleges.
It also comes after Swiss firm Roche was criticised earlier this year for its handling of data for the pandemic flu drug Tamiflu, which many academics argue is not efficacious or cost-effective.
Roche also held back data for the drug, refusing for years to release it to the eminent data group the Cochrane Collaboration. This irked NICE, who says that it is impossible for it to fully assess a medicine like Tamiflu if it doesn’t have all the data to hand.
NICE has previously sent a loud message to pharma after signing the AllTrials register last year.
This register was set up by Bad Pharma author Ben Goldacre and Sense About Science in 2013 on the back of the Tamiflu revelations. It is calling for all past and present clinical trials to be registered and their full methods and summary results reported.
To date, nearly 80,000 people and more than 500 organisations have signed the AllTrials petition including NICE and patients involved in NICE (PIN), as well as GlaxoSmithKline, currently the only pharma firm to do so.
Updated guidance on transparency
NICE has outlined its drive for greater access to trial data in an update to the process guide used for developing technology appraisal recommendations.
This follows a public consultation that received responses from more than 50 external organisations, including a number of pharma companies and the industry’s UK lobby group the ABPI.
In the update, NICE says it has strengthened the chapter in the process guide on declarations to ensure that medical directors must sign a declaration when they make submissions to NICE declaring that they have identified all clinical trial data.
NICE adds that it will only approach the European regulatory authorities for more data if the pharma companies have not provided the necessary clinical data.
Elsewhere, NICE has also outlined plans for earlier decision problem meetings so that companies can get advice early on and address any potential issues with the methodology or presentation of clinical trial data, to help speed up the appraisal process.
Professor Carole Longson, director for the health technology evaluation centre at NICE, says: “We strongly believe that all clinical trial data should be made available so that those with responsibility for developing guidance and making treatment decisions have all the necessary information to hand to help them do so safely and efficiently.
“Our technology appraisals process guide has been strengthened to ensure that NICE gets all the relevant clinical trial data needed to develop our recommendations.”
‘Moral imperative’ to publish
At the House of Commons Health Select Committee on NICE last week, NICE’s chair Professor David Haslam was asked by MPs during the hearing whether pharma companies should be able to keep their data secret.
He told them: “We were early signatories of the AllTrials.net campaign. We ask for a signature from the UK medical director of pharmaceutical companies that we have all the data relevant to the topic – the drug that we’re considering. Again it’s an area we do take extremely seriously.
“My personal view on this is I can see no reason whatsoever not to publish all the data, and I think there’s a moral imperative from the point of view of the patients who’ve been part of the trials that their time, their effort shouldn’t be ignored. I think everything should be in the public domain and I’ve always felt that way very strongly.”
‘Tearing their hair out’
Speaking to Pharmafile in an interview earlier this year, Haslam said: “I’ve met a lot of people from the industry over the last year and had a lot of helpful, mainly off-the-record conversations – and I’ve found that most people from the industry absolutely get this [the need for transparency].
“They understand it from a point of view concerning the future of the industry: in terms of trust, in terms of their relationship with the public. For all these reasons, the issue of transparency is incredibly important. And I must say there are folks in the industry who are tearing their hair out looking at what happens to their reputation around some of these issues. And there is an answer [i.e., to be more transparent].”
He explained that it is equally important for pharma to show how it prices drugs, a process that is currently shrouded in secrecy.
He says: “We [NICE] need greater clarity as to why drugs are priced as they are and establishing why they are as expensive as they are is key.”
Ben Adams
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