1

Prestigious Cochrane Challenges The European Medicines Agency About HPV Vaccines Harms

The Cochrane Nordic Center’s Director, Peter C Gotzsche, MD, MSc, filed a formal Complaint with the European Medicines Agency (EMA) May 26, 2016 regarding the EMA’s 40-page Assessment Report (Nov. 11, 2015) about the safety of the HPV vaccines, which are “supposed to decrease deaths from cervical cancer.”

The Cochrane complaint cited ten serious concerns about EMA’s handling of information in its report; however, I will discuss only those which I find relatively intriguing:

  • Whether the EMA has been open and accountable to citizens and has respected citizens’ rights to know uncertainties related to the safety of the HPV vaccines.
  • Whether the extreme secrecy, with lifelong confidentiality agreements, which the EMA imposed upon its working group members and scientific experts, is needed; is legitimate; is in the public interest; and guarantees that the administration enjoys legitimacy.
  • Whether the redactions the EMA imposed on documents it delivered to the citizens according to Freedom of Information requests were needed; were legitimate; are in the public interest; and guarantees that the administration enjoys legitimacy.
  • Whether the EMA behaves in a manner that guarantees that the administration enjoys legitimacy when the agency uses experts with financial ties to the manufacturers, in particular considering that it is always possible to find experts without such conflicts.