Thursday, March 28, 2013

"Someone has to go to jail"

Drug-company data vaults to be opened

International calls for the pharmaceutical industry to share the results of clinical trials have grown ever more intense amid revelations that high-profile companies have hidden crucial data on safety and efficacy. Now Europe is moving towards measures that would significantly increase disclosure of such data.

The European Medicines Agency (EMA) in London, which licenses drugs for use in the European Union, is developing a policy to publish some clinical-trial data submitted by companies. And next month, major players in the UK medical community will meet to discuss the practical problems of data openness.

The meeting is likely to take place on 19 April and could feature representatives from biomedical charity the Wellcome Trust, as well as the Academy of Medical Sciences, the Association of the British Pharmaceutical Industry and the Association of Medical Research Charities. It marks a move from discussion to action, says Nicola Perrin, head of policy at the Wellcome Trust in London. “We should all stop discussing whether [the issue is] important or not and start having practical discussions about how we move forward,” she says.

The United States already requires that clinical trials used to secure drug approvals are listed in a public online registry. Other countries have rules that encourage registration. But some researchers and campaigners fear that key details are not getting into the public domain, making it difficult to assess a drug’s safety and depriving researchers of data.

Critics note, for example, that in recent years the London-based drug company AstraZeneca has been mired in legal problems including accusations that it concealed data on the side effects of its antipsychotic drug Seroquel (quetiapine). And GlaxoSmithKline (GSK), also based in London, has paid out billions of dollars after pleading guilty to charges including misrepresenting the safety of its diabetes drug Avandia (rosiglitazone) and the effectiveness of its antidepressant Paxil (paroxetine) in children. The Cochrane Collaboration, an international group of medical experts, has called for Roche in Basel, Switzerland, to open up its data on the influenza drug Tamiflu (oseltamivir) so that the group can assess the drug’s efficacy.

Drug companies are making concessions. GSK and Roche have agreed to share data with scientists whose requests are deemed legitimate. But critics say that Roche has not established a fully independent group to assess requests.

Last year, following pressure from campaigners, the EMA said that it would proactively publish certain data submitted by drug companies. The agency is consulting industry and academic researchers and funders on how this would work; it is likely to have a policy in place by 1 January 2014.

“Europe is now ahead of the United States in this area,” says Lisa Bero, a pharmacologist at the University of California, San Francisco, who studies bias in scientific publication. “We’re all waiting”, she adds, to see what will unfold. “This is all very new.”

Bero says that the move towards more transparency is a victory. But “there’s going to be a lot more battles” over how information should be released, how detailed it should be, who should control its release and who should have access to data that might reveal identities of trial participants.

Campaigners such as All Trials, an international group launched in January to put pressure on governments and regulators, have demanded that public registration not be limited to trials used in drug-approval applications and should include full methods and results of past and current trials.

Many medical researchers would be satisfied if summary results were made public, ideally as peer-reviewed papers. But some want full release of the detailed clinical study reports that drug companies submit to regulatory agencies. Researchers who conduct meta-analyses by pooling data from multiple trials also want access to anonymized data on individual participants.

In 2010, the European Ombudsman ruled that detailed data should not be seen as commercially confidential. That helped to drive development of the EMA’s policy, which will increase access to such information. But patient-level data are unlikely to be placed wholesale into the public domain, and companies, researchers, trial funders and patient groups disagree on who should decide which researchers can access them.

Groups also wrestle over who will enforce the rules. The UK Health Research Authority, which oversees standards and regulations in medical research, is assessing the practicalities of assigning the job to the same ethics committees that approve clinical trials.

Kay Dickersin, director of the Center for Clinical Trials at Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, says that serious legal clout is the only way to enforce transparency. Fines are not enough, she adds: for serious infringements, “someone has to go to jail”.

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