Linking CFS with the HPV vaccination

The request was partially successful.

Dear Medicines and Healthcare products Regulatory Agency,

In FOI request 12 037 you informed Mrs C. Ryalls:

- a 2003 review estimated that there are between 7 and 3,000 cases of CFS for every 100,000 adults.

- a recent study in 2855 children aged 11 to 16 years enrolled in three state secondary schools in England. The aim of the study was to identify the number of children with newly diagnosed CFS/ME through absenteeism. The results of the study showed that 1% of enrolled children (28 of 2855 pupils) missed ≥ 20% of school because of CFS/ME.

Please provide copies of these 2 studies and your recent correspondence which identified that these studies exist.

Yours faithfully,

Steve Hinks

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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Our Ref: FOI 14/048

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FOILicensing, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Mr Hinks

 

Please find attached the response to the previous FOI request you refer to
( 12/037). I also attach links to the two references detailed in your
request.

 

Afari N, Buchwald D (2003). Chronic fatigue syndrome: a review. Am J
Psychiatr 160 (2): 221–36

[1]http://www.ncbi.nlm.nih.gov/pubmed/12562...

 

Crawley EM, Emond AM, Sterne JA. Unidentified Chronic Fatigue
Syndrome/myalgic encephalomyelitis (CFS/ME) is a major cause of school
absence: surveillance outcomes from school-based clinics. BMJ Open. 2011
Dec 12;1(2):e000252

[2]http://www.ncbi.nlm.nih.gov/pubmed/22155...

 

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Caron Ryalls left an annotation ()

It's important to appreciate that the schools study undertaken by Esther Crawley was conducted with only 3 schools and the criteria they used to diagnose CFS/ME was according to NICE guidelines, which few researchers use because it is so broad and encompasses illnesses other than CFS/ME. To qualify for a diagnosis of CFS/ME (a neurological illness, as classified by the World Health Organisation)in Crawley's study, the child had to have fatigue lasting more than 3 months, of unknown cause plus just one of the following: difficulty with sleeping eg insomnia; joint or muscle pain with no sign of inflammation; headaches; painful lymph nodes without pathological enlargement; cognitive dysfunction, such as memory problems, inability to concentrate etc; sore throat; worsening of symptoms with physical or mental exertion; general malaise or flu-like symptoms; dizziness and/or nausea; palpitations not otherwise explained.

The criteria used misses so many conditions that could otherwise explain the fatigue + symptoms, for example Postural Orthostatic Tachycardia Syndrome (PoTS) and other dysautonomia conditions, Ehlers Danlos Syndrome, autoimmune illnesses such as Sjogrens Syndrome, Lupus, Behcet's Disease, Multiple Sclerosis and many more conditions. So the 1% of adolescents suffering with CFS/ME as quoted by the Crawley study is basically rubbish and has been questioned by most of the ME charities and patient groups - it's grossly inflated.

Also there was a specific study undertaken - "Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK" in 2013 which concluded that:

"there was no association between vaccination with Cervarix and an increased risk of chronic fatigue syndromes"

However, in the body of the full paper (which is restricted behind a paywall), the authors admit that when analysing the Yellow Card reports for CFS and fatiguing disorders, a safety 'signal' would be generated requiring further investigation, if the reporting level was assumed to be 10% or under. The authors decided that the reporting level of Yellow Card Reports would be higher than 10% due the vaccine being relatively new and because of media attention, despite having no evidence that a reporting level of greater than 10% was the case.

I have personally contacted MHRA and searched for evidence of reporting levels of Yellow Card reports, but have been unable to find anything other than an article that suggests Yellow Card reporting levels to be around 10% for serious ADR's requiring hospitalisation and 2-4% of non serious ADRs. CFS/ME would in this instance be classed as 'non-serious' as it is generally not considered life-threatening and often does not initially involve hospitalisation, although it is life changing and extremely debilitating. If this was the case, and reporting levels for CFS and fatiguing disorders were only 2%-4%, this shows without doubt that a safey signal should have been generated and further investigations undertaken. Tragically, this hasn't happened.

My own experience is that parents and patients are not aware of the Yellow Card system and doctors are reluctant to file reports regarding vaccines.

More evidence is becoming available which is highlighting the development of Postural Orthostatic Tachycardia syndrome following HPV vaccination, which may or may not have underlying autoimmune conditions.