OPEN LETTER TO MEMBERS OF THE UK GOVERNMENT HEALTH SELECT COMMITTEE

 

Dear Members of the Health Select Committee

On 25th October we held a Lobby of Parliament where we hoped to draw to the attention of MPs our concerns around the type, number and severity of reported reactions to the HPV vaccination and the lack of follow-up by the MHRA.  We attach data obtained through FOI to illustrate that chronic illnesses are reported at a much higher rate for the HPV vaccination than for any other vaccination – and the vaccination is only given to girls.

On 2nd November scientists at the Nordic Cochrane Centre published their response to the rejection by the EU Ombudsman of their complaint into the handling of the 2015 investigation by the EMA into POTS (postural orthostatic tachycardia syndrome) and CRPS (chronic regional pain syndrome) as possible side-effects of the HPV vaccination.  They expressed disappointment that the EU Ombudsman did not look at the scientific aspects of the complaint because they believe the “substandard way that EMA evaluates science” has “huge consequences for public health”. The link to the 32-page document is below.

http://nordic.cochrane.org/sites/nordic.cochrane.org/files/public/uploads/nordic_cochrane_views_on_the_ombudsmans_decision_2_nov_2017.pdf

Significantly on page 13 there are details of three cases of POTS in the trials for Gardasil 9 that appear to have been hidden by the vaccine manufacturer.

Researchers from the WHO Uppsala Monitoring Centre (set up in 1978 to look at adverse events globally and avoid another Thalidomide) have raised a safety signal on gastrointestinal dysmotility and have published peer-reviewed papers about clusters of symptoms causing disabling long-term side effects. These appear to have been dismissed by the EMA and the MHRA without proper investigation.

We are also increasingly aware of many girls being incorrectly given mental health diagnoses prior to testing and diagnosis of POTS (since POTS can initially present as anxiety).

It is apparent that the MHRA follow-up Yellow Card reports on receipt to get more information and ascertain the outcome at that point, but they do not appear to do any long-term follow up as has been done in the Netherlands and Japan. Many girls in the UK have disabling long-term illness, but the symptoms are listed on the Patient Information Leaflet and are thought to be mild and transient.  However, the symptom clusters on the Yellow Card report listings that we have obtained through FOI are exactly those that have been detailed by the Uppsala Monitoring Centre.

In response to questions raised we have been assured that large scale post-licencing studies show no evidence of autoimmune or chronic illness, but our reviews have found that none of these studies would have included POTS (postural orthostatic tachycardia syndrome), autonomic dysfunction, Complex Regional Pain Syndrome or undiagnosed clusters of symptoms that are potentially autoimmune or neurological disorders.

We would be grateful for a Health Select Committee Inquiry to address these concerns. The HPV vaccination has been in use for nearly 10 years – we do not want to wait another 30 or 40 years for these concerns to be investigated nor do we want to see any more susceptible girls become ill.

Please do not hesitate to contact us if you would like any further information. We would be happy to meet with any member of the Health Select Committee if they would like to discuss this with us.

On behalf of parents and families

Time for Action – UK Families Affected by HPV Vaccination

___________________

REFERENCES & LINKS

European Medicines Agency Review initiated by Denmark into POTS/CRPS following HPV vaccination

The following links are to documents associated with the 2015 EMA safety review regarding POTS & CRPS following HPV vaccination.  The links include the initial EMA announcement about the review, the Danish report submitted to the EMA, the EMA’s final report giving conclusions from the review and the Nordic Cochrane Centre scientists’ complaint to both the EMA and EU Ombudsman criticising the review process

EMA to assess association of POTS/CRPS with HPV vaccines with a Review
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002363.jsp&mid=WC0b01ac058004d5c1

Danish report to EMA
http://sundhedsstyrelsen.dk/~/media/0A404AD71555435BB311CD59CB63071A.ashx

EMA Assessment Report from the Review finding no evidence for causal association
http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/HPV_vaccines_20/Opinion_provided_by_Committee_for_Medicinal_Products_for_Human_Use/WC500197129.pdf

Overview of Correspondence from scientists at the Nordic Cochrane Centre to the EMA and Ombudsman re: Complaint filed to the European Medicines Agency over maladministration related to safety of the HPV vaccines
http://nordic.cochrane.org/news/complaint-filed-european-medicines-agency-over-maladministration-related-safety-hpv-vaccines

Reply to the European Ombudsman
http://nordic.cochrane.org/sites/nordic.cochrane.org/files/public/uploads/-_our_letter_to_the_ombudsman_13_july_2017.pdf

What do we know about the safety of the HPV vaccines?
Peter C. Gotzsche, Jan 2017
http://tidsskriftet.no/en/2017/01/commentary-and-debate/what-do-we-know-about-safety-hpv-vaccines

PUBLISHED RESEARCH PAPERS & JOURNAL ARTICLES

Med Check – The Informed Prescriber is a rigorously independent and reliable drug bulletin for healthcare professionals. It provides information for informed decision making on treatment and healthcare and is published by the Non-profit organisation, Japan Institute of Pharmacovigilance (NOPJIP).
MedCheck – Harms of HPV Vaccine
April 2015
http://www.npojip.org/english/MedCheck/Med%20Check-TIP%2001-4-25.pdf

From Medwatcher – Japan
Lessons learnt in Japan from adverse reactions to the HPV vaccine: a medical ethics perspective
Indian Journal of Medial Ethics, April 2017
BEPPU, Hirokuni ; MINAGUCHI, Masumi ; UCHIDE, Kiyoshi ; KUMAMOTO, Kunihiko ; SEKIGUCHI, Masato ; YAJU, Yukar
https://ijme.in/articles/lessons-learnt-in-japan-from-adverse-reactions-to-the-hpv-vaccine-a-medical-ethics-perspective/?galley=html

The first two papers discuss an analysis of reports in the global pharmacovigilance database – Vigibase. The reports were produced by a team from the Uppsala monitoring centre (UMC) in Sweden, which is a WHO collaborating centre for pharmacovigilance and drug safety.
Safety Concerns with HPV Vaccines Continue to Linger: Are Current Vaccine Pharmacovigilance Practices Sufficient?
Drug Safety, Aug 2017
Rebecca E. Chandler
https://link.springer.com/article/10.1007/s40264-017-0593-3

Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase
Drug Safety, Sept 2016
Rebecca E. Chandler et al
http://link.springer.com/article/10.1007/s40264-016-0456-3

The following three papers are authored by the Danish doctors who have gone on to set up one of the special intake centres in Denmark assessing and treating girls with adverse reactions after HPV vaccination
Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papilloma virus
Vaccine – April 2015
Louise Brinth, Ann Cathrine Theibel, Kirsten Pors & Jesper Mehlsen
http://www.sciencedirect.com/science/article/pii/S0264410X15004375

Suspected side effects to the quadrivalent human papilloma vaccine
Danish Medical Journal – April 2015
Louise Brinth, Ann Cathrine Theibel, Kirsten Pors & Jesper Mehlsen
http://www.danmedj.dk/portal/page/portal/danmedj.dk/dmj_forside/PAST_ISSUE/2015/DMJ_2015_04/A5064

Is Chronic Fatigue Syndrome/Myalgic Encephalomyelitis a Relevant Diagnosis in Patients with Suspected Side Effects to Human Papilloma Virus Vaccine?
International Journal of Vaccines and Vaccination – June 2015
Louise Brinth, Kirsten Pors, Anna-Alexandra Grube Hoppe, Iman Badreldin and Jasper Mehlsen
http://medcraveonline.com/IJVV/IJVV-01-00003.pdf

Dr Blitshteyn is a very well respected neurologist in New York, and a medical advisor to one of the main Dysautonomia advocacy groups (Dysautonomia International). Dr Blitshteyn was one of the first to publish her concerns regarding the development of POTS following HPV vaccination.
Postural tachycardia syndrome after vaccination with Gardasil
Letter to Ed – European Journal of Neurology 2010 – Blitshteyn
http://drblitshteyn.com/articles/Gardasil_and_POTS.pdf

Postural tachycardia syndrome following human papillomavirus vaccination
European Journal of Neurology – Sept 2013 – Blitshteyn
6 Case studies
http://www.ncbi.nlm.nih.gov/pubmed/24102827

Other research papers
Autoimmunity, Autonomic Neuropathy, and the HPV Vaccination: A Vulnerable Subpopulation
Clinical Pediatrics, Sept 2017
Jill R Schofield, Jeanne E Hendrickson
http://journals.sagepub.com/doi/abs/10.1177/0009922817728701?journalCode=cpja&

Immunological studies of cerebrospinal fluid from patients with CNS symptoms after human papillomavirus vaccination
Journal of Neuroimmunology, Sept 2016
Yukitoshi Takahashi et al
http://www.jni-journal.com/article/S0165-5728(16)30154-0/abstract

Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series
Clinical Rheumatology, July 2017
Manuel Martinez-Lavin, Luis Amezcua-Guerra
https://link.springer.com/article/10.1007%2Fs10067-017-3768-5

HPV vaccination syndrome. A questionnaire-based study
Clinical Rheumatology, Sept 2015
Manuel Martinez-Lavin, Laura-Aline Martinez-Martinez, Paola Reyes-Loyola
http://link.springer.com/article/10.1007/s10067-015-3070-3

Hypothesis: Human papillomavirus vaccination syndrome – small fiber neuropathy and dysautonomia could be its underlying pathogenesis
Clinical Rheumatology, July 2015, Volume 34, Issue 7, pp 1165-1169
Manuel Martinez-Lavin
http://link.springer.com/article/10.1007/s10067-015-2969-z

Postural Orthostatic Tachycardia with Chronic Fatigue after HPV Vaccination as Part of the Autoimmune/Auto-inflammatory Syndrome Induced by Adjuvants
Case Report and Literature Review
Journal of Investigative Medicine, High Impact Case Reports, March 2014
Tomljenovic, Colafrancesco, Perricone, Shoenfeld
http://hic.sagepub.com/content/2/1/2324709614527812.full

Peripheral Sympathetic Nerve Dysfunction in Adolescent Japanese Girls Following Immunization with the Human Papillomavirus Vaccine
Internal Medicine Vol.53 – 2014 – Kinoshita, Abe, Hineno, Tsunekawa, Nakane, Ikeda
https://www.jstage.jst.go.jp/article/internalmedicine/53/19/53_53.3133/_pdf

10 Year Review of the HPV Vaccines and Comparison of Brands
Diane Harper is a professor and chair of the department of family and geriatric medicine at the University of Louisville. Her area of expertise is human papillomavirus and the diseases associated with it and she was the principal investigator of the clinical trials of the Gardasil and Cervarix HPV vaccines. She has since made statements recommending that patients be more explicitly informed of the risks associated with HPV vaccines. She has also written that vaccination efficacy must last at least 15 years – any less duration of efficacy and cervical cancers are merely postponed, not prevented.
HPV vaccines – A review of the first decade
Gynecologic Oncology, July 2017
Diane M. Harper, Leslie R. DeMars
http://www.sciencedirect.com/science/article/pii/S0090825817307746