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EMA’s proposal to vet drug research that uses its data is “outdated,” say critics

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5076 (Published 11 August 2014) Cite this as: BMJ 2014;349:g5076
  1. Zosia Kmietowicz
  1. 1The BMJ

Campaigners for research transparency have criticised the European drugs regulator for proposing to censor scientists who wish to carry out studies using the agency’s side effects database. They called the European Medicines Agency’s (EMA) draft policy on using the data it holds on case reports of drug side effects as “outdated” and “a barrier to public scrutiny.”

The EMA oversees the EudraVigilance database, which holds reports on the side effects of drugs approved in Europe. Researchers can request access to the raw data held on the database, to perform their own analysis.

On 4 August the agency published a draft policy1 on extending the information it shares with researchers, to include individual case reports of patients’ experiences of side effects. The policy stated that researchers must agree to clear with the agency what they intend to write before they submit their analyses for publication. The agency said that this was to check for the “possible re-identification of patients.”

The draft policy said, “Any issues raised by the agency concerning incorrect analyses, unsupported inferences, misleading statements or the protection of personal data must be addressed to the satisfaction of the agency before submission for publication.”

But the policy has angered campaigners for transparency. Ben Goldacre is an author and a cofounder of the AllTrials campaign (www.alltrials.net), which calls for all clinical trials to be registered and the results reported. He acknowledged that the EMA must act to protect individual patients’ privacy, but he objected to the agency being able to suppress some analyses.

“This is a profoundly outdated world view. Simply because they are the body collecting this public data from EU patients . . . does not give them the right to control how it is used. This seems to simply represent state censorship of scientific discussion and analysis of public health data,” said Goldacre. “If there are flawed analyses, or over-interpretation of risk signals, then that is a matter for public discussion and debate, not censorship by the medicines regulator.”

He said that over a million articles were published each year and that any work of poorer quality “is managed in the academic ecosystem of evidence synthesis and critical appraisal, before it can impact on practice.” He added, “Any harm that the EMA might suggest could theoretically arise from a fractional increase in the total quantity of weak academic publications must be balanced against the huge benefits of wider access to patient data.”

Virginia Barbour, editorial director of medicine and biology at PLoS and a cofounder of AllTrials, said, “It’s essential for public health that there are no barriers to rapid public release of safety data; we need public scrutiny of these data, not decisions made behind the closed doors of the EMA.”

Carl Heneghan, director of the Centre for Evidence Based Medicine and cofounder of AllTrials, described the EMA’s proposed policy—to retain control over the publication of research using its data—as “worrying” and “unworkable.” The policy would take up considerable resources in terms of statistical reviewers, and the agency could also “find itself embroiled in numerous longwinded disputes,” he said.

Heneghan added, “What is clear is regulators are using these measures to prevent more open scrutiny of [their] databases. This is unacceptable and will lead to delays and inappropriate use of resources. Providing transparent and timely information should be a priority of regulators if the full benefits and harms of treatments are to be realised. I continue to be surprised and perplexed that the European Medicines Agency, as a public body, doesn’t think this is a fundamental priority of its work,” he added.

In response to the criticism the EMA said that the policy was not new and had been in place since 2011. “It is not the intention of the EMA to censor the views or conclusions of researchers which may at times question or criticise the position taken by the agency, but rather to offer an opportunity to review,” said the agency.

It added that adverse reaction data could be difficult to interpret, with many confounding factors, and that the implications could be important for public health. “It is relevant and reasonable, given its role in evaluating and taking action on the benefit-risk of medicines, that the EMA has foreknowledge of information, analyses and conclusions that may result from independent analysis by research groups in advance of these being made public,” it said, adding that the consultation process allowed comments that the agency would consider before the policy was finalised.

The EMA’s consultation closes on 15 September. Comments can be sent to: evaccess@ema.europa.eu.

Notes

Cite this as: BMJ 2014;349:g5076

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