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Industry transparency commitments "fall short"

Clinical News | July 29, 2013


Peter Mansell

Industry transparency commitments "fall short"

Consumer and campaign groups have condemned as too little, too late new commitments made by industry in Europe and the US to widen access to clinical-trial data.

Meanwhile, the head of the European Federation of Pharmaceutical Industries and Associations (EFPIA) has expressed bemusement about the vehemence that greeted media reports of the association and its US counterpart trying to enlist patient groups in resisting uncontrolled access to clinical-trial results.  

The joint Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers issued by EFPIA and the Pharmaceutical Research and Manufacturers of America (PhRMA) involve sharing patient- and study-level clinical-trial data, full clinical-study reports, and protocols from trials approved in the US and the EU with “qualified scientific and medical researchers upon request”.

The initiative came amid allegations that the EU and US associations plan to enlist patient groups in voicing concerns about ‘non-scientific’ re-use of disclosed clinical-trial data.

Retroactive data

The AllTrials transparency campaign pointed out that the EFPIA-PhRMA commitments do not include any measures to publish retroactive data from clinical trials of already licensed drugs – “the evidence for medicines we use every day” – nor to register all trials before they start.

While the principles outlined by the industry associations are “to be broadly welcomed”, commented AllTrials co-founder Carl Heneghan, there remain “many details that need to be fleshed out to ensure this is little more than just window dressing”.

For example, Heneghan said, companies would need to ensure that scientists or healthcare professionals sitting on independent boards set up to review requests for access to clinical-trial protocols or patient-level/study-level trial data were free of any conflicts of interest.

Moreover, the commitment to make available synopses of clinical study reports (CSRs) filed with regulators on or after 1 January 2014 appears “to be less than what is already being proposed by the European Medicines Agency”, Heneghan noted.

Releasing “the important elements of a clinical study report, which are often less than a 1000 pages, should present no barrier to independent scrutiny”, he argued.

“Particularly given that redaction of identifiable data elements is a reasonably straightforward process.”

Full of loopholes

AllTRials co-founder Ben Goldacre criticised the EFPIA-PhRMA Principles as “weak and filled with loopholes.

The principles “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”.

Only releasing CSRs on demand “after a long review process by the company” is a “retrograde step”, Goldacre maintained.

He pointed to the Cochrane Collaboration’s “four year battle” for access to CSRs on Tamiflu from Roche, “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”.

Trial protocols

That clinical-trial protocols should be released only on request and through a review process “is extraordinary”, Goldacre added. A trial protocol “should be a routinely available public document and, by best practice, made available before the trial even begins”.

The response from Health Action International (HAI) Europe was no less scathing. The industry commitments “fall woefully short of the data transparency that is needed”, HAI Europe said.

“Ironically industry claims to move towards increased access to clinical trial data, while we now know from [the leaked EFPIA-PhRMA] strategy that at the same time they work to oppose concrete moves towards more transparency in EU regulations,” commented spokesperson Ancel•la Santos

Mandatory disclosure

The campaign group called for mandatory disclosure of all clinical-trial data, including raw data, through a publicly accessible database.

“Disclosing only synopses of clinical study reports will not solve the prevailing dangerous practices of reporting bias and mis-use of data by the pharmaceutical industry,” Santos added.

For The European Consumer Organisation (BEUC), the EFPIA-PhRMA statement “locks the door after the horse has bolted”.

The debate on clinical data transparency “has already moved on and there is no way back to their old secretive ways”, insisted BEUC director general Monique Goyens. “It is no longer up to the industry.”

The commitments “do not cover up Big Pharma’s unethical attempts to mobilise patient groups solely to protect their commercial interests”, Goyens said.

“Let’s not forget that the industry has form here – it also attempted to undermine the European Medicines Agency’s transparency policy by going to the European Court of Justice … But currently, the only existing evidence points to the health risks of secrecy and non-disclosure.” 

Surprised by reaction

In a blog on the European association’s website, however, director general Richard Bergström downplayed media reports on EFPIA and PhRMA’s interactions with patient groups over the transparency issue.

“I was, frankly, surprised by the reaction,” Bergström commented.

“Of course EFPIA would discuss the topic of clinical trials data-sharing and transparency with patient groups. Of course we would share our views and put forth our perspective to these essential stakeholders. You know what? Most of them don’t even agree with us.” 

Data transparency that “protects innovation” is transparency “that benefits patients – and patients, ultimately, are the bottom line”, Bergström argued.

As for EFPIA/PhRMA’s transparency commitments, “I do not know if everyone will feel that we are doing enough”, he said. “And not everyone is going to agree with our upcoming response to the EMA consultation. That’s already clear – and it’s fine.”

 The point, Bergström added, is that “people take the time to read the proposal, examine our arguments, and question as they see fit. We are doing the same, and will continue to do so. We will continue to examine others’ positions and engage with stakeholders of all types”.

Quintiles survey

In a recent survey by Quintiles, the US-based provider of biopharmaceutical development and commercial outsourcing services, more than 70% of healthcare executives questioned believed transparency around data sources and information-sharing across stakeholder groups was “very important” or “critically important” to the success of an interoperable health care system.

At the same time, though, the survey found that a large percentage of respondents were unwilling to embrace transparency.

US payers and providers gave their own segments of the industry the highest marks in this respect, with 54% and 5% respectively saying they were “extremely” or “very willing” to be transparent, compared with 37% of biopharmaceutical respondents and just 18% of EU payers.

For its new Collaborative Mandate report, Quintiles surveyed biopharmaceutical executives, managed care executives and providers in the US, and payer-organisation executives in France, Germany, Italy, Spain and the United Kingdom, between 30 April and 30 May 2013.

 

 

 

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