Open letter to EMA re: HPV vaccine safety

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Note from SaneVax: Apparently medical professionals, scientists, vaccine safety advocates and the general public are not satisified with the recent EMA conclusion regarding HPV vaccine safety. They are not willing to accept the fact that the written statement on HPV vaccine safety issued by the European Medicines Agency spent more time attempting to discredit those who filed medically documented questions than it did dealing with an honest evaluation of the safety concerns being raised around the world after Gardasil and Cervarix administration. Medical consumers are no longer willing to accept the word of purported experts unless it is backed up by sound science.

Therefore, the following letter was just emailed to over 120 European Medicines Agency representatives with 446 signatures representing HPV vaccine survivors from over 30 countries requesting scientifically documented answers to the attached questions and an open public meeting with participants from both sides of the debate invited to discuss HPV vaccine safety.

Open letter to EMA regarding HPV vaccine safety

24 April 2016

Dear EMA representatives:

I am sure you are all aware of the European Medicines Agency’s recent ‘investigation’ into HPV vaccine safety. I am also certain you understand that the investigation was cursory at best and most definitely not designed to uncover any real problem that may exist with HPV vaccines. The arbitrary and most likely pre-ordained conclusion reached must not go unchallenged. Public health and safety is at stake, particularly when many scientists around the world follow your lead.

One prime example is a recent study published in a Canadian medical journal entitled, “Adverse events following HPV vaccination, Alberta 2006-2014.” Despite the fact that this study uncovered information indicating 1 in 10 Gardasil users were either admitted to a hospital or an emergency room within 42 days of injection, the conclusion was “Rates of AEFI after HPV immunization in Alberta are low and consistent with types of events seen elsewhere.”

With all due respect, we believe the EMA would find it extremely difficult to locate any country where 1 in 10 previously healthy teens were admitted to hospitals and/or emergency rooms after any given event, including receipt of a vaccine.

With that in mind, representatives from several countries got together over the last few months to compose a letter asking the questions the recent investigation neglected to address.

Initially, the attached list of questions was meant to be sent directly to those people in charge of the EMA’s HPV vaccine safety investigation. However, because of the near universal response to inquiries about HPV vaccines worldwide, we came to understand that a letter sent directly to EMA representatives would most likely not elicit any meaningful response.

Therefore, this letter with both attachments will be published via the SaneVax website and be free for distribution by anyone who cares to do so. The primary purpose is to make all representatives of the EMA well aware of the fact that every action you make is being closely scrutinized by not only those injured and their families, but also medical and scientific professionals around the globe.

The secondary goal of open publication is to show all who are concerned about the safety profile of HPV vaccines that they are not alone. Medical professionals, scientists and medical consumers will no longer tolerate attempts to discredit independent research based on the fact that their research and experience does not fall in line with theories put forth by general consensus supported only by questionable research.

On April 15, 2016, the EMA published a statement online entitled, “Listening to the public’s views on the safety of medicines” where Deputy Executive Director, Noël Wathion, states:

“Public hearings will enrich the scientific decision-making process on the safety of medicines. Although we have many years of experience in involving patients and healthcare professionals in our work, public hearings are a new concept for EMA as they will open up the process of assessing medicines in the EU to the wider public for the first time.”

Public hearings will be held on a case-by-case basis, where the Committee determines that collecting the views of the public would bring added value to its review.

The EMA’s statements and decisions regarding HPV vaccines impact people around the globe. Society cannot wait decades to determine whether HPV vaccines will actually impact cancer rates if the “1 in 10” figure put forth in the Canadian study is anywhere near accurate for other countries.

Therefore, it is imperative for the EMA to meet with and seriously take into account the views of scientists, medical professionals and citizens who are dealing with the impact of HPV vaccines on a daily basis under real world conditions. An open public hearing is the ideal format for a discussion on the real-world consequences of HPV vaccine utilization.

The undersigned (complete list attached) request scientifically documented answers to the attached questions be provided within the next 30 days and an open public meeting as described above to be held before the end of 2016.

Thank you in advance for your attention to this critical public health issue.

Sincerely,

Steve Hinks, Press Officer of the UK Association of HPV Vaccine Injured Daughters (AHVID) and SaneVax Ambassador

Freda Birrell, Chairman of AHVID, representing 285 families whose lives have been severely impacted by HPV vaccines

Karsten Viborg, Director, Chairman, National HPV side effect group in Denmark on behalf of over 5,000 affected families

Alicia Capilla Lanagrán, President of the AAVP, representing over 50 families impacted in Spain

Kiva Murphy, REGRET member on behalf of over 300 affected families in Ireland

Monica Leon Del Rio, President of Rebuilding Hope Association on behalf of 559 families severely affected in Colombia.

Stephen Tunley, Board of Directors SaneVax Inc., on behalf of 50 severely affected families in Australia

Gayle Dickson, Founder of Gardasil Awareness New Zealand, on behalf of over 600 families affected in NZ

Norma Erickson, President of SaneVax Inc., on behalf of 1679 families who reported disabilities and deaths after HPV vaccines in the United States VAERS system and the 446 signatories from over 30 countries in the attached file.

ATTACHMENTS:

Signatures for EMA letter

Questions to EMA

Read the questions to EMA in Spanish here.

Read the questions sent to EMA in Italian at the end of this article.

Read this letter in Croatian here.

EMA Response

Mr. Steve Hinks received the following response from the European Medicines Agency before noon on the 25th of April 2016:

Dear Mr. Hinks,
We hereby acknowledge receipt of your letter of 24 April 2016 and the questions to EMA contained therein as well as your earlier e-mail correspondence of 18 April to Nathalie Bere. 
I confirm that we will do our utmost to respond to your queries within 30 days as you request.
Yours sincerely
Isabelle Moulon
Head of Patients and Healthcare Professionals Department
Stakeholder and Communication Division
European Medicines Agency
30 Churchill Place | Canary Wharf | London E14 5EU | United Kingdom

Comments

  1. Brian Aylward says:

    Are you going to publish the response you have received from the EMA?

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