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EMA in firing line as transparency debate widens

Swedish regulator claims EU agency withheld information on drug withdrawn from sale in 2008

European Medicines Agency (EMA) - logoThe European Medicines Agency (EMA) has been accused of withholding pertinent information on a drug that was withdrawn from sale on safety grounds in 2008 and subsequently returned to market last year.

Måns Rosén, director of Sweden's SBU health technology assessment agency, claims in the Lancet that requests for information relating to the decision-making process in the return to the EU market of surgical clotting agent Trasylol (aprotinin) have been denied.

The allegations add another dimension to the ongoing debate about transparency in the drug industry, which to data has centred on the publication of clinical trial data by pharmaceutical developers with the EMA seen as driver towards full disclosure.

Trasylol was originally launched onto the market by Bayer and was a successful product for the pharma group, achieving annual sales of €230m (around $300m) in the year before it was withdrawn.

The product was suspended from sale in Europe on the recommendation of the EMA's Committee for Medicinal Products for Human Use (CHMP), following the preliminary results of the BART study in high-risk heart surgery patients.

The results appeared to show an increased death rate in patients receiving Trasylol after 30 days compared to patients taking other medicines, and led to the early discontinuation of the study by its data safety monitoring board.

The drug's safety had been called into question before that, however, with a number of observational studies indicating an excess risk of mortality, although a review in 2007 found no evidence for this from randomised clinical trials.

An independent review in 2007 cleared Bayer of allegations that it deliberately withheld negative safety data on Trasylol from an FDA advisory committee, although it did conclude certain employees at the company had made a "serious error of judgment" in failing to disclose the results.

Last year, the EMA issued a press release which recommended lifting the suspension on aprotinin saying it was based on "a full review of the benefits and risks" and a re-analysis of the BART study data, wrote Rosén in the Lancet article.

"When I contacted the EMA and asked for the scientific basis of this decision, they replied that they could not share the information since the decision-making process was ongoing," he added.

"The EMA might be correct in their decision, but we do not know because the information is still not available more than a year after the press release. This cannot be considered to be an open and transparent process. Patients' safety is at stake.”

Netherlands-based Nordic Group acquired worldwide rights outside the US for Trasylol from Bayer last July, shortly after the CHMP recommended that the marketing authorisation for the drug should be reinstated.

The EMA had not responded to requests for comment by the time this article was filed.

10th July 2013

From: Research, Regulatory

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