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EMF Studies

10 July 2016

Europe: Complaint Filed Over EMA's Handling of HPV Vaccine Safety Issues

"The European Medicines Agency asked the companies [(GlaxoSmithKline Biologicals, Merck Sharp & Dohme Limited, and Sanofi Pasteur MSD] to search for side effects of the vaccine in their own databases and did not check the companies' work for accuracy," the [Nordic Cochrane Center] notes. It adds that at this point, there is "a huge amount of money at stake: the global expenditure so far on HPV vaccines can be roughly estimated at €25 billion [US$27.85 billion]."

Complaint Filed Over EMA's Handling of HPV Vaccine Safety Issues
by Zosia Chustecka, medscape.com, 5 July 2016

An official complaint has been filed by the Nordic Cochrane Center against the European Medicines Agency (EMA) over its handling of safety issues concerning human papillomavirus (HPV) vaccines.

The EMA looked at the safety issue last year after a request from Denmark, where physicians had documented in the medical literature case reports of chronic symptoms in girls who had received HPV vaccines.

After conducting a review of HPV vaccine safety, the EMA concluded that "evidence does not support that vaccines cause" the chronic symptoms.

At the time, several European researchers questioned the review process.

Now, the Nordic Cochrane group, headed by Peter Gøtzsche, DrMedSci, from the University of Copenhagen, Denmark, has lodged an official complaint. Dr Gøtzsche and colleagues have recently been vocal about the negative effects of mammography, and they have campaigned for more information about potential harms to be included in patient leaflets.

In the complaint, which runs to 19 pages, the Nordic group says that the official EMA report is flawed. It points out several issues with the way the safety review was conducted, including the fact that the manufacturers were asked to search their own databases and that they compared the vaccine to an aluminimum adjuvant instead of a saline placebo.

The group also highlights the "extreme levels of secrecy" that surround the EMA review process, in which experts who are involved in the process are not named and are bound by lifelong secrecy about what was discussed. This contrasts with the workings of other groups, for example, the advisory committees of the US Food and Drug Adminstration (FDA). Advisory committee meetings are open to the public and streamed live online, and documents relating to the case are posted online ahead of the meetings.

The Nordic group argues that in this case involving HPV vaccination safety, the internal report and all other documents related to the case should be made publicly available. "We did not find any commercially confidential information anywhere in the documents we reviewed," it adds.

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