The European Medicines Agency has come under fire in The Lancet for what critics call questionable decisions related to drugs from Roche and AstraZeneca (NYSE: AZN). As Reuters notes, the criticism is similar to past attacks on the FDA, and the journal questions not only the EMA's handling of adverse event reports, but also its licensing decisions.
In an article, the journal cites the EMA's handling of a case involving Roche's acne drug Accutane, which has been linked to inflammatory bowel disease and other serious adverse events. In April 2008, Liam Grant of Dublin, Ireland, whose son had committed suicide in 1997, asked the EMA for reports on suspected serious adverse reactions to the drug. The regulator denied his requests, arguing that EU transparency rules did not apply to serious adverse reaction reports. Their release, the EMA maintained, "would not benefit EU citizens because it could result in circulation of data that might prove to be misleading or unreliable."
However, in September 2008 Grant turned to European Ombudsman Nikiforos Diamandouros, who recently called on the EMA to reconsider its refusal to give access to documents relating to Accutane. The EMA said it would give its response to the ombudsman by July 31, according to Reuters.
The article and a separate commentary raise questions about the EMA's recent extension of the licence for AstraZeneca's cholesterol drug Crestor. Paul Ridker and Robert Glynn of Brigham and Women's Hospital in Boston led the JUPITER study of Crestor and maintain the that new use recommended by the EMA for the drug was based not on the trial's pre-specified main goal but on an analysis of a subgroup of patients done after the event.
"Although we believe this expanded indication for statin therapy to be a move in the right direction, it should be noted that this regulatory recommendation was not made on the basis of the trial's prespecified primary endpoint, did not take into account the [enrollment] criterion in JUPITER that required all participants to have an hsCRP of 2 mg/L or greater, which augmented absolute risk, and does not address most of the patients actually studied," Ridker and Glynn write.
The journal points out that the "EMA's transatlantic cousin," the FDA, has been criticized for licensing of drugs like Vioxx (rofecoxib) and Avandia (rosiglitazone). The agency has since formed a Transparency Task Force to develop recommendations for making useful information about its activities and decision-making available to the public in a user-friendly format.
- check out The Lancet article
- read the letter in The Lancet
- get more from Reuters
- read more about Grant's case from USA Today