Grace Filby: Corresponds with Health Authorities and Parliament

[Note:  Below is a copy of a letter sent by Grace Filby expressing concerns over HPV vaccination policies in the United Kingdom, followed by the official response. The SaneVax Team would like to thank Grace Filby for continuing to hold those in charge of making health policy decisions responsible for their actions.]

2 March 2011

Dear Ms Walker

Thank you for your reply to my email and hardcopy by Recorded Delivery, including the new evidence about Aluminium Syndrome.

Unfortunately you have not addressed some of the points I was bringing to your attention.

My point 3 was about more serious and long term injuries than had originally been expected. You state in your penultimate paragraph that “the number and nature of suspected adverse reactions … is fully in line with what would be expected.” With all due respect, I must emphasise that this is incorrect. It is definitely  not FULLY in line with what had been expected.

Your MHRA 2 year safety review confirms this (though not in the summary). I have placed the exact MHRA text online in an annotation to a Health Minister’s Written Reply in Parliament: http://www.theyworkforyou.com/wrans/?id=2011-02-28a.42938.h&c=27611#c27611

1. “regulatory action was taken at the end of the first year of the immunisation programme (2009) to ensure that the product information adequately reflected the very rare risk of anaphylaxis.”

2. “regulatory action was taken at the end of the first year of the immunisation programme (2009) to include lymphadenopathy as a possible side effect in the product information for Cervarix.”

3. “The cases of gastrointestinal disorders here may represent a more severe form of a recognised gastrointestinal side effect of Cervarix”

4. “Cases of arthralgia are already a recognised side effect but were included in this analysis due to the severity or persistence of symptoms being greater than would be expected of a vaccine-associated effect. As such, the cases may represent a more severe form of the recognised Cervarix side effect of arthralgia/myalgia or be associated with other reported conditions such as chronic fatigue-like illness”.

As I pointed out to you previously, the College of Optometrists published this statement in 2010:

“A colleague has asked me to highlight the possible visual side effects which may occur after vaccination with Cervarix, a human papillomavirus vaccine to prevent cervical cancer. These are rare but may include photophobia, blurred vision or visual impairment. Symptoms may occur several days after the vaccination”.

How could the parents and young children receiving Cervarix in Surrey be expected to know about these additional risks if you do not acknowledge them publicly or even in a letter to me? Yet you say that you “will continue to communicate publically (sic) and particularly with parents and young children … about the safety profile and new developments … as these emerge.” I have already explained that the national bodies like the NHS are censoring new information. The DH have also delayed posting updates by many months. Since you have a Board meeting coming up it is an opportunity to lead the way in openness and transparency – alternatively to continue to say nothing.

You have not addressed my point 4 about the financial costs to Surrey residents of caring for the seriously injured girls. Surrey PCT staff must acknowledge their responsibility for administering all 3 jabs to a previously very healthy and sporty girl at St Bede’s School, Redhill even when she was struggling into school on CRUTCHES from arthralgia – a recognized side effect. Surely this was a huge mistake, along with others I have referred to about misleading the Surrey public over the risks and benefits.

Finally, my associates and I would still like to know whether you are going to raise the issue at the PCT Board meeting on 11 March.

In my link above, there are some new charts based on all the VAERS data which are easy to understand, accessible to the public and make the information a little difficult to ignore. These are being presented at the conference in London on the same day as your meeting.

Yours sincerely
Elizabeth Grace Filby (Ms)

Ms Elizabeth Grace Filby
1 Howard Road
Reigate
Surrey
RH2 7JE

21 February 2011

Dear Ms Filby

Thank you for your e mail to NHS Surrey outlining your concerns regarding the national HPV vaccination programme.

NHS Surrey along with other Primary Care Trusts delivers immunisation programmes under Department of Health direction and guidance to ensure consistency and equitable access for all identified eligible patients.

As you are aware the Department of Health takes advice from the Joint Committee on vaccination and Immunisation (JCVI). The JCVI is an independent expert advisory committee that advises Ministers on matters relating to the provision of vaccination and immunization services. The JCVI gives advice to Ministers based on the best evidence reflecting current good practice and expert opinion. The process involves a robust, transparent and systematic appraisal of all the available evidence from a wide range of sources. Members of the committee are appointed on merit by the Appointments Commission. Before decisions are made at a national level to introduce a vaccination programme, all vaccines go through a robust approval process in order to be granted a UK licence, taking account of effectiveness, safety and harmful effects.

Vaccination and immunization programmes are under constant review to make certain new evidence is taken into consideration and as the Department of Health have already confirmed to you, they will pass on the Shoenfeld and Agmon-Levin paper to the chair of the JCVI, therefore NHS Surrey will wait to hear if any new action is to be taken in light of this evidence.

With regard to the use of promotional material, NHS Surrey adopts national campaigns and we take our steer from the Department of Health.

In response to your comments regarding the safety of the HPV vaccine, you will be aware that the Medicines and Healthcare products Regulatory Agency (MHRA) continually monitor the safety profile of Cervarix. The MHRA’s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe.

The most recent safety analysis of the MHRA is publically available via the web link below:

http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice%E2%80%93G%E2%80%93L/HumanpapillomavirusHPVvaccine/index.htm

Cervarix contains an aluminium adjuvant and it would normally be expected that any adverse reaction to this adjuvant would be reported via the MHRA Yellow Card Scheme. As you are no doubt aware, the Yellow Card Scheme is the UK system for collecting information on suspected adverse drug reactions (ADRs) to medicines.

The first report published in July 2010 contains details of all yellow card reports which are individual safety concerns about Cervarix that have been notified. The headline summary of the report states that:

‘The vast majority of suspected adverse reactions reported to MHRA in association with Cervarix vaccine continue to be related to either the signs and symptoms of recognized side effects listed in the product information or to the injection process and not the vaccine itself (i.e.’psychogenic’ in nature such as faints). For the isolated cases of other medical conditions reported, the available evidence does not suggest that the vaccine caused the condition and these may have been coincidental events. Following administration of at least 4 million doses across the UK since September 2008, the balance of risks and benefits of Cervarix remains positive.’

The second year safety review of the HPV immunization programme is in the Drug Safety Update from October 2010, also available via the above link. The report has more detail and in summary states that:

‘No new risks have been identified for Cervarix despite significant exposure in the UK, and the balance of risks and benefits remains positive. The human papillomavirus (HPV) immunization programme has now completed its second successful year and is ready to enter its third. With at least 4.5 million doses of Cervarix administered up to the end of July 2010 to girls ages 12-18 years across the UK, the vaccine has been shown to have an excellent safety profile. Most Yellow Card reports have related either to the signs and symptoms of recognised, minor side effects listed in the product information, or to the injection process and not the vaccine itself (ie, psychogenic in nature)’.Likewise the Government’s independent expert advisory Commission on Human Medicines have also concluded that the balance of benefits and risks remains positive and that the number and nature of suspected adverse reactions received since the vaccination programme started in 2008 is fully in line with what would be expected.

I note that you would like this issue to be raised at the PCT Board meeting on 11 March. The Board will continue to act in line with MHRA, JCVI and the Department of Health recommendations. We will continue to communicate publically and particularly with parents and young children receiving Cervarix as part of the national programme about the safety profile and new developments that are likely to change practice as these emerge.

Yours sincerely

Anne Walker
Chief Executive