For immediate release

9th October 2009

ALLIANCE FOR NATURAL HEALTH CALL FOR AN URGENT SCIENTIFIC INQUIRY INTO THE HPV VACCINE USED IN THE UK

The Alliance for Natural Health today is calling on all Members of Parliament in the UK to help stimulate an independent and transparent scientific inquiry on the safety of the HPV vaccine.

Reports of serious and even lethal adverse reactions to the Human Papilloma Virus (HPV) vaccine, Cervarix, manufactured by GlaxoSmithKline, raises grave concern over the safety of the vaccine.  While its closely related vaccine, Gardasil, manufactured by Merck, is recognised by the US Centers for Disease Control (CDC) to trigger severe reactions, namely hospitalisation, permanent disability, life-threatening illness or death, equivalent data in the UK appears not to be publicly available.

In addition, the tragic case of 14-year-old Natalie Morton’s death just two hours following her vaccination, which was considered by the pathologist in her post mortem as being completely independent of the vaccine, has raised further questions in the minds of many about the accuracy of reporting.

The role of the HPV vaccines in the development of disabling symptoms in the cases of Stacey Jones (18), Rebecca Ramagge (13), Lisa Wickenden (13), Carly Steel (13) and Ashleigh Cave (13), appears to be unresolved and circumstantial evidence would suggest that Cervarix may have been at least a contributing factor in their respective conditions.

Dr Diane Harper of the University of Missouri, who was directly involved in clinical trials on HPV vaccines, is among a growing number of scientists who have publicly expressed their concerns over the vaccines’ safety.

Cervarix was approved for use in the European Union in September 2007 for the prevention of precancerous changes in the cervix in girls and women between the age of 10 and 25.  The vaccination programme started in September 2008 for girls aged 12 to 13, delivered in three injections over 6 months.  There is a new, accelerated catch-up programme for girls aged 15 to 18 years starting in September 2009, due to complete by end of the academic year 2010.

Given the number of girls, the lack of transparency on the frequency and type of adverse reactions, as well as the possibility of long-term effects on the reproductive system, the Alliance for Natural Health is requesting all Members of the UK Parliament to put pressure on the Government to initiate an independent and fully transparent scientific inquiry on the short and long term effect of the vaccine.

The Alliance for Natural Health is an international campaign organisation comprised of scientists, doctors, lawyers, practitioners and consumers, working to promote natural and sustainable approaches to health through the use of ‘good science’ and ‘good law’.

Executive Director of the Alliance for Natural Health, Robert Verkerk, stated: “Young girls in the UK—as well as their parents and guardians—deserve to have the full facts on the risks and benefits of this vaccine to help them make properly informed choices. The NHS position is that the vaccine is safe, but the facts would suggest otherwise.  Presently, there are no adequate data available on the comparative risks of Cervarix and Gardasil. Neither is there adequate information on the factors which may predispose certain individuals to serious adverse reactions, nor about the duration and effectiveness of immunity following single and multiple vaccinations.  It is in the public interest—and of utmost urgency—that these key questions are answered by an independent scientific review panel and are made public.”

FOR FURTHER INFORMATION, PLEASE CONTACT:

Sophie Middleton
Campaign Administrator
The Alliance for Natural Health
The Atrium
Curtis Road
Dorking
Surrey
RH4 1XA

Tel: +44 (0)1306 646 600
info@anhcampaign.org

NOTES FOR THE EDITOR:

For more information about the HPV vaccine (by ANH Medical Director, Dr Damien Downing):
http://anhcampaign.org/news/anh-feature-the-hpv-vaccine-gardasil-in-the-spotlight

For more information about cases which may be linked to the HPV vaccine:
http://anhcampaign.org/news/brain-damage-follows-hpv-vaccination-in-uk

The ANH Vaccine Choice campaign page:
http://anhcampaign.org/campaigns/vaccine-choice

About the Alliance for Natural Health:
http://www.anhcampaign.org

The Alliance for Natural Health (ANH) is an international, non-governmental organisation, based in the UK. It was founded in 2002, and works on behalf of consumers, medical doctors, complementary health practitioners and health-product suppliers worldwide, to promote natural and sustainable health, using the principles of good science and good law.

Robert Verkerk DIC PhD MSc BSc
Executive and Scientific Director
The Alliance for Natural Health
Curtis Road
Dorking
Surrey RH4 1XA
United Kingdom

tel:  +44 (0)1306 646 600
fax: +44 (0)1306 646 552
email: info@anhcampaign.org
www.anhcampaign.org

©2012 An Inconvenient Woman. All Rights Reserved.

LONDON (Reuters) – GlaxoSmithKline Plc’s Cervarix is the first product of its kind to show it protects against the five most common cervical cancer-causing viruses, Europe’s biggest drug company said in a statement on Tuesday.

A study, published in Tuesday’s issue of The Lancet, said that as well as protecting against the two most common virus types, the vaccine also provides protection against the next three most common cancer-causing virus types.

Glaxo said the additional efficacy could translate into approximately 11 to 16 percent extra protection against cervical cancer over and above the protection afforded by efficacy against the two most common types alone.

“This is really good news for primary prevention of cervical cancer as it indicates the vaccine could offer women additional protection … beyond what had at first been anticipated,” said Thomas Breuer, head of global clinical R&D at GSK Biologicals.  Click here for the full article published by Reuters.

©2012 An Inconvenient Woman. All Rights Reserved.

“Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has.”

—Margaret Mead, US Anthropologist  (1901 – 1978)

On May 24th at 10:26 pm Cynthia Janak, Research Journalist, Founder and President of International Coalition of Advocates for the People hit the send button on her email client.

The Subject Line read: “Serious Concerns regarding the safety and efficacy of the HPV Vaccines”

The message was addressed:  To the esteemed members of the Robert Koch Institute and Health Minister of Germany,

And the simple message read:

The attached paper has been prepared by concerned individuals from the United Kingdom, United States of America and Holland in regards to the safety and efficacy of the HPV vaccines.

We intend to prove that the serious health concerns that are becoming evident due to Gardasil and Cervarix around the world are valid.  You will see that the studies themselves will prove the lack of efficacy and the increased risks to the health of our young people.  Also entered into this report are communications with the lead researcher for both Gardasil and Cervarix.  Included are reports of young girls and women who have had serious adverse effects and deaths with unknown etiology from America and Europe.   Attached is a video of Karen Maynor who lost her daughter after receiving the Gardasil vaccination.  This mother is trying to come to terms with the fact that the post mortem determination is unknown.

We also want you to know that an inquiry was done by the researchers in the United States as to the overall health and activity level of the affected young people pre-vaccination.  The results of the inquiry and investigation that ensued are startling.  It has been determined that the young people most likely to be affected are very active, athletic and high achievers or have a serious weight problem.  A subset of the affected received the vaccination when they were at the pre-menstrual time of their cycle.  What these three groups have in common is that estrogen, which we know protects the brain from stroke, is decreased leaving the brain more susceptible to damage of the capillaries and the neurotoxin Aluminum.

We are aware that you are questioning the effectiveness of Cervarix.   Thousands of young girls and women are experiencing severe adverse events and their quality of life is vastly diminished around the world from Gardasil and Cervarix HPV vaccines.  Could you please also look at the bigger picture in regards to the safety of our children and take into account the many comments which have been made.

We do so hope you will read our submission and if you wish to ask any questions of the authors, email addresses have been provided.  We do so hope that you will give serious consideration to our many concerns in regards to the safety and efficacy of both HPV vaccines.

Sincerely,
Cynthia Janak

That email was both a culmination and a beginning.

The submission of the paper culminated years of research, analysis, and educational advocacy by a group of dedicated volunteers lead by Cynthia Janak and ICAP co-founder, Leslie C. Botha.  The work was an international effort.  A  group of women – three from the United States, two from The Netherlands, one from the UK and one from Scotland spent two weeks coalescing years of research, examining FDA, CDC and Merck documents relating to Gardasil, compiling a factual report from their respective countries that documented concerns about the safety and efficacy of the HPV Vaccine.

Reports are titled:

Treatise on Gardasil from the United States;
United States Concern for Europe with regards to Cervarix HPV vaccine;
United Kingdom Concerns Regarding HPV-GM Vaccines;
The Dutch Cervarix Concerns;
and, One Mother’s Plea.

The successful submission of these reports to the thirteen scientists at the Robert Koch Institute (RKI) in Germany and to the German Health Minister was also a beginning. The reports represented the first educational advocacy project undertaken by the International Coalition of Advocates for the People. RKI is re-examining the safety of the HPV vaccine for use in their country. Their decision will be made in the next few weeks.

ICAP Advocates, Freda Birrell and Christina England released the reports to the media in Scotland and the UK – and to their respective parliaments. Ms England, a research journalist, has written several well received articles that have been published by news outlets on both sides of the Atlantic. The women have received acclaim and praise for their due diligence in presenting information that backs up their concerns:

The Scotsman – June 2, 2009

http://news.scotsman.com/world/Call-to-review-cancer-vaccine.5323346.jp

In previous posts I have mentioned Netherlands-based ICAP advocates, Janny Stokvis and Annelies Witlam who have worked tirelessly to support the HPV-vaccine education process in the Netherlands, the UK, EU Canada and Americ

ICAP’s first international effort has been a success. Seven women who became international advocates wrote a paper about HPV vaccines to educate all necessary parties in Europe.   This paper has been distributed throughout Europe and to select individuals in the United States.

Presently, thirteen German scientists from the Robert Koch Institute are questioning the effectiveness of these vaccines.  They are also asking for evidence now from the Standing Committee based on the scientists’ views.

Scotland now is questioning the vaccines over fears about the adverse reactions being reported in Scotland and England.

Also, in the UK leading scientists and doctors have raised fresh concerns about the safety of a cervical cancer vaccine.  They have accused the manufacturers of Cervarix and Gardasil, of making misleading claims.

I am proud to be counted amongst these seven women Advocates and a charter member of the International Coalition of Advocates For The People (ICAP).

©2012 An Inconvenient Woman. All Rights Reserved.

Cervarix won out over Merck’s Gardasil in the Netherlands, but has yet to be approved in the United States. That makes European market penetration vital for Glaxo.

“We are delighted with this decision and the fact that since Cervarix received European approval it has been selected as the cervical cancer vaccine for more than half of eligible tenders across Europe,” said Eddie Gray, president of Pharmaceuticals Europe for GSK. “We look forward to working with the Netherlands Vaccine Institute.” Globally, cervical cancer is the second leading cause of cancer death among women.

- check out GSK’s release

©2012 An Inconvenient Woman. All Rights Reserved.

GlaxoSmithKline’s (GSK) cervical cancer vaccine, Cervarix TM, was today confirmed by the Netherlands Vaccine Institute (NVI) as the cervical cancer vaccine for the Dutch National Immunisation Programme (NIP). GSK will supply Cervarixfor the programme, which aims to vaccinate all 12 year old girls.   A catch-up programme for all girls aged 13 to 16 will also start within the first half of 2009, with the aim of reducing the risk of HPV infection and cervical cancer for a broader group of Dutch girls.  The National programme for girls aged between 12 and 13 will commence in September 2009. It is estimated that more than 350,000 girls in total will be vaccinated with Cervarix in the first year.

“We are delighted with this decision and the fact that since Cervarix received European approval it has been selected as the cervical cancer vaccine for more than half of eligible tenders across Europe,” said Eddie Gray, President of Pharmaceuticals Europe for GSK.  “We look forward to working with the Netherlands Vaccine Institute to support the successful implementation of the Public Health vaccination programme so that girls in the Netherlands will benefit from the effective and sustained protection against cervical cancer which Cervarix offers.”

Cervarix has been designed specifically to protect against cervical cancer and has demonstrated high protection against HPV 16 and 18, which are responsible for approximately 70% of cervical cancers1 worldwide. With clinical data from over 6 years of follow-up, Cervarix has the longest duration of protection reported for any HPV vaccine to date.

In the Netherlands, the cervical cancer NIP has been added to the existing National Screening Programme that recommends women of 30 years and over have a PAP-smear test every five years in order to combat cervical cancer.  It is estimated that nationally, up to 700 women are diagnosed with cervical cancer and more than 200 die from the disease each year, making it the second biggest killer of women after breast cancer.2 Cervical cancer is the second leading cause of cancer death among women globally, killing one woman every two minutes.3,4 As well as the deaths associated with the disease, cervical cancer and pre-cancerous lesions are also a significant cause of emotional and physical distress in women.5Alongside screening and a healthy lifestyle, vaccination is expected to significantly reduce the lifetime risk of cervical cancer.6

Notes to Editors

About the Dutch National Immunisation Programme

From 2009, cervical cancer vaccination will be routinely recommended for all girls between 12 and 13 years of age (first year of secondary education). There will also be a catch-up programme in the first half of the year where girls aged 13 to 16 years will be offered the vaccine. Cervarix TM was selected as the cervical cancer vaccine for the Dutch National Immunisation Programme.

About cervical cancer and its progression

Approximately 100 types of HPV have been identified to date7 and, of these, approximately 15 virus types are known to cause cervical cancer.1 Virus types 16 and 18 are responsible for approximately 70% of cervical cancers.1 Persistent infection with cancer-causing virus types can lead to the formation of abnormal cells in the cervix, which, over time, may become precancerous or cancerous.8 Throughout their sexually active lifetime, women may be exposed to cancer-causing virus types. The majority of women will clear an infection spontaneously.  However, if the infection persists it can lead to precancerous lesions or cervical cancer.9

Experts believe that neutralising antibodies – so-called because they have the ability to neutralise cancer-causing virus types and prevent them from infecting cells in the cervix – are essential for cervical cancer protection, post-vaccination.10-12 The World Health Organization (WHO) states that neutralising antibodies are the likely mediatorof vaccine-induced protection from infection.11,12

Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year.4

About the GSK Cervical Cancer Vaccine

CervarixTM has been specifically designed by GSK to provide women with protection against cervical cancer, targeting the two human HPV types, 16 and 18, that are responsible for over 70% of cervical cancer.1

To-date, GSK’s cervical cancer vaccine has been approved in more than 80 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 30 additional countries including Japan. In September 2007, GSK submitted CervarixTM to the WHO for prequalification, towards distribution across the developing world via the United Nations and the GAVI Alliance. GSK also submitted a Biologics Licence Application (BLA) to the U.S. Food and Drug Administration (FDA) for CervarixTM in March 2007.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

GSK Biologicals (GSK Bio) -  is a global vaccine company which has shown itself to be a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Bio has 14 manufacturing sites strategically positioned around the globe. GSK Bio employs over 9,000 people worldwide including more than 1,600 passionate scientists engaged in research aimed at developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2007, GSK Bio distributed 1.1 billion doses of vaccines to 169 countries in both developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, more than one in every ten doses delivered were combination vaccines intended to prevent up to six diseases in one vaccine.

CervarixTM is a trademark of the GlaxoSmithKline group of companies.

©2012 An Inconvenient Woman. All Rights Reserved.