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.
Personally, I find the above four complaints also could be filed with, and against, the U.S. CDC and FDA, since it seems that the EMA probably is patterning its HPV vaccine information and vaccine safety profiles and protocols after the same practices as the U.S. patent holders of the HPV vaccine, the U.S. Health and Human Services, as explained below:
As if this is not enough, the United States Department of Health and Human Services, via the National Institutes of Health, Office of Technology Transfer receives royalties on each HPV vaccine sold worldwide. This happens because technologies used in the production of HPV vaccines were developed at NIH and subsequently patented by them. For three of the last five years, HPV vaccines based on recombinant papillomavirus capsid proteins have ranked #1 based on royalties from product sales. [….]
The major patent holder (National Cancer Institute/NCI), the regulator (FDA) and the vaccination policy maker (CDC) are all divisions of the Department of Health and Human Services (DHHS). These self-dealings typically benefit some administrators, not the government or tax payers. For example, Dr. Julie Gerberding, as the Director of the CDC, [2002-2009] approved the use of Gardasil for cervical cancer prevention as a public health policy is now the president of Merck’s Vaccine division promoting the sales of Gardasil. [1] [CJF emphasis]
The Nordic Cochrane’s complaint stems from HPV vaccine adverse reactions and serious harms peer reviewed articles published by Louise Brinth, MD, PhD, taken from the Danish Syncope Unit at the Frederiksberg Hospital in Copenhagen, describing serious neurological harms after HPV vaccinations.
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