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European Medicines Agency—more transparency needed
Editorial
On May 10, 2010, the European Medicines Agency (EMA, formerly EMEA) published a draft recommendation from the European Ombudsman Nikiforos Diamandouros who called on EMA to reconsider its refusal to give access to documents relating to isotretinoin, which is used to treat severe acne. EMA protects and promotes Europe’s public health through assessment and supervision of medicines, which is mainly the collation and dissemination of information about adverse reactions to medicines throughout the European Union (EU). EMA receives information on suspected adverse reactions to drugs from competent authorities in EU member states, as well as from drug companies themselves. 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—those 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. EMA emphasised that their release would not benefit EU citizens because it could result in circulation of data that might prove to be misleading or unreliable. In September, 2008, Grant turned to Diamandouros. Following his investigation, the Ombudsman concluded that EU rules on access to information apply to all documents held by EMA. In his view, this rule does not mean that adverse reaction reports must automatically be accessible, since some exceptions contained in the transparency rules might apply. He recommended that EMA review its refusal to grant access to the adverse reaction reports. With respect to EMA’s concerns about circulation of data that could prove to be misleading or unreliable, the Ombudsman suggested that, as part of a proactive information policy, EMA could provide additional context designed to render such data and their significance more readily comprehensible by the public. 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 www.thelancet.com Vol 375 May 22, 2010
estimated to have a high risk for a first cardiovascular event”. Intimately involved in the JUPITER study on which EMA’s decision was founded, Ridker and Glynn note that approval was based not on the trial’s pre-specified primary endpoint, but on a post-hoc subgroup analysis. EMA’s decision does not seem to have taken into account JUPITER’s enrolment criterion, which augmented absolute risk by requiring all participants to have a high sensitivity C-reactive protein concentration of greater than or equal to 2 mg/L. EMA’s transatlantic cousin, the US Food and Drug Administration (FDA), has in the past received intense criticism 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 recommendations will focus on disclosing relevant information in a timely manner and in a user-friendly format, and in a way that is compatible with the agency’s goal of protecting confidential information. As a part of this transparency initiative, the FDA’s Task Force has held two public meetings in 2009, and established a mechanism for seeking the public’s input on these issues. As a result of the contributions the Task Force has received thus far, it has decided to separate the Transparency initiative 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. 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. ■ The Lancet
Corbis
European Medicines Agency—more transparency needed
Nikiforos Diamandouros See Online/Correspondence DOI:10.1016/S01406736(10)60760-X The Ombudsman’s full recommendation is available: http://www.ombudsman. europa.eu/cases/ draftrecommendation.faces/ en/4810/html.bookmark
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On May 10, 2010, the European Medicines Agency (EMA, formerly EMEA) published a draft recommendation from the European Ombudsman Nikiforos Diamandouros who called on EMA to reconsider its refusal to give access to documents relating to isotretinoin, which is used to treat severe acne. EMA protects and promotes Europe’s public health through assessment and supervision of medicines, which is mainly the collation and dissemination of information about adverse reactions to medicines throughout the European Union (EU). EMA receives information on suspected adverse reactions to drugs from competent authorities in EU member states, as well as from drug companies themselves. 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—those 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. EMA emphasised that their release would not benefit EU citizens because it could result in circulation of data that might prove to be misleading or unreliable. In September, 2008, Grant turned to Diamandouros. Following his investigation, the Ombudsman concluded that EU rules on access to information apply to all documents held by EMA. In his view, this rule does not mean that adverse reaction reports must automatically be accessible, since some exceptions contained in the transparency rules might apply. He recommended that EMA review its refusal to grant access to the adverse reaction reports. With respect to EMA’s concerns about circulation of data that could prove to be misleading or unreliable, the Ombudsman suggested that, as part of a proactive information policy, EMA could provide additional context designed to render such data and their significance more readily comprehensible by the public. 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 www.thelancet.com Vol 375 May 22, 2010
estimated to have a high risk for a first cardiovascular event”. Intimately involved in the JUPITER study on which EMA’s decision was founded, Ridker and Glynn note that approval was based not on the trial’s pre-specified primary endpoint, but on a post-hoc subgroup analysis. EMA’s decision does not seem to have taken into account JUPITER’s enrolment criterion, which augmented absolute risk by requiring all participants to have a high sensitivity C-reactive protein concentration of greater than or equal to 2 mg/L. EMA’s transatlantic cousin, the US Food and Drug Administration (FDA), has in the past received intense criticism 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 recommendations will focus on disclosing relevant information in a timely manner and in a user-friendly format, and in a way that is compatible with the agency’s goal of protecting confidential information. As a part of this transparency initiative, the FDA’s Task Force has held two public meetings in 2009, and established a mechanism for seeking the public’s input on these issues. As a result of the contributions the Task Force has received thus far, it has decided to separate the Transparency initiative 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. 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. ■ The Lancet
Corbis
European Medicines Agency—more transparency needed
Nikiforos Diamandouros See Online/Correspondence DOI:10.1016/S01406736(10)60760-X The Ombudsman’s full recommendation is available: http://www.ombudsman. europa.eu/cases/ draftrecommendation.faces/ en/4810/html.bookmark
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