The lead Editorial in this week's Lancet focuses on decisions by The European Medicines Agency (EMA) not to release documentation on severe adverse reactions and to license a the drug rosuvastatin in certain circumstances.
A complaint had been submitted by Liam Grant from Dublin, Ireland, whose son had committed suicide in 1997. On April 22, 2008, Grant asked EMA for reports on suspected serious adverse reactions to the drug isotretinoin, used to treat severe acne. He requested information on those severe adverse reactions which might cause death or life-threatening illness, require admission to hospital or prolongation of hospital stay, or result in persistent or substantial disability or incapacity, congenital anomalies, or birth defects. These requests were refused by EMA, which argued that EU transparency rules did not apply to serious adverse reaction reports. Mr Grant then turned to European Ombudsman Nikiforos Diamandouros who called on EMA to reconsider its refusal to give access to the documents. On May 10, 2010, On May 10, 2010, EMA (formerly EMEA) published this draft recommendation from Diamandouros.
The Editorial says: "It seems that, as well as its handling of adverse reaction reports, some of EMA's licensing decisions might be open to question. In a letter published online by The Lancet today, Paul Ridker and Robert Glynn note that EMA has recently approved rosuvastatin for the 'prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event'... Ridker and Glynn note that approval was based not on the trial's pre-specified primary endpoint, but on a post-hoc subgroup analysis."
Also highlighted in the Editorial are the postitive steps towards transparency taken by EMA's transatlantic cousin US Food and Drug Administration (FDA)—steps taken following intense criticism the agency received after licensing of drugs such as rofecoxib and rosiglitazone. The FDA has since formed an internal Transparency Task Force to develop recommendations for making useful information about FDA activities and decision making more readily available to the public. The FDA's Transparency initiative has been separated into three phases—creating a web-based resource called FDA Basics, which provides information about commonly misunderstood agency activities and frequently asked questions; improving the FDA's disclosure of information to the public; and improving the FDA's transparency to the industries it regulates.
The Editorial concludes: "Citizens of EU member states should welcome and support transparency initiatives within EMA, which might bring about more openness on licensing decisions and suspected adverse reactions. Since EMA plays an important part in the supervision and approval of medicines in the EU market for the benefit of public health, it should consider providing the widest possible public access to the requested reports in any form, including web-based resources, and pursue a proactive information policy for the public. EMA will respond to Diamandouros' opinion by July 31, 2010. We hope that EMA and FDA will work together and consult each other."
Lancet Press Office. T) +44 (0) 20 7424 4949 E) pressoffice@lancet.com
Correspondence: Paul Ridker, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. T) +1 617 732 8970 E) pridker@partners.org
For full Editorial see: http://press.thelancet.com/emaeditorial.pdf
For full Online First Correspondence see: http://press.thelancet.com/ofjupiter.pdf
Journal
The Lancet