Government decision on national human papillomavirus vaccine programme is a sad day for sexual health

doi:10.1136/sti.2008.032755

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Government decision on national human papillomavirus vaccine programme is a sad day for sexual health

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HPV Vaccination: Ethical imperatives and clinical indications for Gardasil
Peter Greenhouse
Published on: 13 May 2016
HPV immunization programme
Peter G Watson
Published on: 13 May 2016
HPV vaccine programme- Increasing inequality in adolescent's sexual health?
Karen E Rogstad
Published on: 13 May 2016
Government decision on national human papillomavirus vaccine programme is a sad day for sexual healt
Christopher Sonnex
Published on: 13 May 2016
HPV immunisation decision
Margaret A Stanley
Published on: 13 May 2016
Re: HPV immunization programme: not shocked or appalled
Colm O'Mahony
Published on: 13 May 2016
HPV immunization programme: not shocked or appalled
Peter G Watson
Published on: 13 May 2016

Published on: 13 May 2016
HPV Vaccination: Ethical imperatives and clinical indications for Gardasil
- Peter Greenhouse, Consultant in Sexual Health
Dear Editor,
In supporting Colm O’Mahony’s editorial (1), I would like to amplify Karen Rogstad’s concern (2) about the unwitting creation of a two-tier healthcare system for HPV vaccination and the social discord which will inevitably result from the Government’s decision.
Any well-informed parent of sufficient means would want to protect their children against genital warts, so their daughters will necessa...
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Dear Editor,
In supporting Colm O’Mahony’s editorial (1), I would like to amplify Karen Rogstad’s concern (2) about the unwitting creation of a two-tier healthcare system for HPV vaccination and the social discord which will inevitably result from the Government’s decision.
Any well-informed parent of sufficient means would want to protect their children against genital warts, so their daughters will necessarily be involved in the process of obtaining a private prescription for the quadrivalent vaccine: Yet other girls may feel that they have been short- changed, so this could give rise to a nastier kind of humiliating taunting in the playground, targeted at children of the poor, the ignorant and/or the religiose, thus further exacerbating social class and cultural divisions in schools.
Parents will seek advice, and directly request the vaccine, from their GP. Similar to O’Mahony’s experience, I have yet to meet a GP or other doctor who would chose Cervarix instead of Gardasil for their own children. Thus, on grounds of striving to prevent harm and treating people with equity, it could be construed as unethical if GPs did not advise parents and their children of the additional benefits of the quadrivalent vaccine.
We must also consider the clinical circumstances where there should be a clear indication for recommending Gardasil instead of Cervarix: Certain children are likely to have a much higher than average risk of suffering from intractable genital warts shortly after sexual debut, as they have conditions where immunity is compromised in a predictably known, therapeutic or idiopathic fashion (categories A-C), and there are others in whom overt genital warts would be especially inconvenient as they have dermatological conditions which may affect genital skin (category D) eg:
A. Type 1 Diabetes, HIV, Primary Immunodeficiency Syndromes (3)
B. Childhood Leukaemias, Juvenile Rheumatoid Arthritis etc
C. History of (or currently extensive) verrucae, hand warts, or recurrent respiratory papillomatosis
D. Psoriasis, Eczema, Lichen Sclerosis etc.
I would be interested to hear from colleagues who have any other conditions or categories to add to the above list.
References
1. O'Mahony C. Government decision on national human papillomavirus vaccine programme is a sad day for sexual health. Sex Transm Infect 2008; 84: 251
2. Rogstad KE. HPV vaccine programme- Increasing inequality in adolescent's sexual health? STI online (15 August 2008)
3. http://www.ipopi.org/pid-info/list-of-some-primary- immunodeficiencies.html
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Conflict of Interest:
None declared.
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Published on: 13 May 2016
HPV immunization programme
- Peter G Watson, consultant, genitourinary medicine
Dear Editor,
When Dr O’Mahony gets round to reading my letter properly he will see that I did not express scepticism about deriving benefit from the addition of HPV types 6 and 11 to types 16 and 18 in the immunization programme. I stated that I know of no evidence that the addition would help in preventing carcinoma of the cervix. Dr O’Mahony might believe that the immunization programme is about HPV immunization...
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Dear Editor,
When Dr O’Mahony gets round to reading my letter properly he will see that I did not express scepticism about deriving benefit from the addition of HPV types 6 and 11 to types 16 and 18 in the immunization programme. I stated that I know of no evidence that the addition would help in preventing carcinoma of the cervix. Dr O’Mahony might believe that the immunization programme is about HPV immunization and not cervical cancer but the Green Book states that the objective of the immunization programme addresses a subsequent risk of cervical cancer 1 and the same Public Health Minister, Dawn Primarolo, stated that the “policy to vaccinate girls against cervical cancer is one of the biggest public health campaigns in recent history.” 2 If the programme were about HPV vaccination, then for every person included in the programme there would be another who could complain about his exclusion on the grounds of his sex.
Although I think that Dr O’Mahony’s editorial was poor and had no place in a journal that pretends to be scientific, I do not object to him expressing his opinion. However I do object to him extending his opinion to “all of us working in sexual health”. Dr O’Mahony’s reply to my letter suggests that his survey of those working in sexual health did not permit such an extension.
Perhaps those of us working in sexual health need to bear in mind that the immunization programme is aimed at all females of a certain age and not just those females who attend genito-urinary medicine clinics with a first attack of genital warts. Evidence-based medicine can not divorce itself from cost-effectiveness. 3 Dawn Primarolo is quoted as saying, “By choosing the right vaccine we have been able to make savings which means we can extend the programme to 17 and 18 year olds. This could save an additional 400 lives." 2 Someone had to decide whether it was better to save a potential 400 lives or prevent an unknown number of cases of genital warts.
References
1. www.dh.gov.uk/en/Publichealth/Healthprotection/Immunisation/Greenbook/DH_4097254 (Accessed 18/08/2008)
2. http://nds.coi.gov.uk/environment/fullDetail.asp?ReleaseID=374703&NewsAreaID=2&NavigatedFromDepartment=False (Accessed 18/08/2008)
3. www.blackwellpublishing.com/content/BPL_Images/Content_store/Sample_chapter/9781405152921/9781405152921_4_c01.pdf (Accessed 18/08/2008)
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Conflict of Interest:
None declared.
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Published on: 13 May 2016
HPV vaccine programme- Increasing inequality in adolescent's sexual health?
- Karen E Rogstad, Consultant Physician in Genitourinary Medicine
Dear Editor,
O'Mahony's editorial (1) reflects the concern I and others specialising in STIs in young people have about the decision not to vaccinate girls and young women against genital warts types 6 and 11. Others have commented on the biological, psychosocial and cost issues of external genital warts, and I will not re-iterate these (2,3,4). What has been ignored is that at a time when government is trying to red...
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Dear Editor,
O'Mahony's editorial (1) reflects the concern I and others specialising in STIs in young people have about the decision not to vaccinate girls and young women against genital warts types 6 and 11. Others have commented on the biological, psychosocial and cost issues of external genital warts, and I will not re-iterate these (2,3,4). What has been ignored is that at a time when government is trying to reduce health inequalities according to social class, the decision to use Cervarix rather than Gardasil for the vaccination programme is almost certainly likely to increase them.
Most STIs are known to be more prevalent in areas of social deprivation, and to predominantly affect the young, with 55% of genital warts being in young people aged 16-24 (5). O'Mahony has provided the first published evidence of Medical Practitioners in England choosing to pay for the vaccine that will protect their children against a stigmatising and distressing condition. However the cost of the vaccine for the children of those parents in receipt of benefits or on low incomes is beyond their reach. Health Practitioners are in the impossible position of delivering one vaccine to patients whilst they are recommending another to those who can afford it.
Specialists in Sexually Transmitted Infections care for some of the poorest members of society. We are already aware of the burden of deprivation in these young people with regards to poor housing or homelessness, low educational attainment, drug and alcohol abuse, teenage pregnancies and exploitation. To this will be added the additional burden of no protection against a preventable STI whilst their peers, whose parents can pay, will also be spared the burden of genital warts.
This potential for health inequality should be monitored. Additionally, consideration should be given to offering vaccination with Gardasil in the catch up programme to young attendees at sexual health clinics, as they are known to be a vulnerable group and at high risk for STIs.
Competing interests. Advisory work for Sanofi Pasteur and Glaxo SmithKline.
References
1. Colm O'Mahony Government decision on national human papillomavirus vaccine programme is a sad day for sexual health Sex Transm Infect 2008; 84: 251
2. Christopher Sonnex, Immy Ahmed Government decision on national human papillomavirus vaccine programme is a sad day for sexual health
STI online (13 August 2008)
3. Kim JJ. Human papillomavirus vaccination in the UK. BMJ 2008;337:a842
4. Jit M, Choi YH, Edmunds WJ. Economic evaluation of human papillomavirus vaccination in the United Kingdom. BMJ 2008;337:a769
5. Sexually Transmitted Infections and Young People in the United Kingdom: 2008 Report Health protection Agency July 2008 www.hpa.org.uk
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Conflict of Interest:
None declared.
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Published on: 13 May 2016
Government decision on national human papillomavirus vaccine programme is a sad day for sexual healt
- Christopher Sonnex, Physician
- Other Contributors:
  Immy Ahmed
Dear Editor,
The points made by Dr O’Mahony in response to the government’s decision to support a bivalent HPV 16/18 prophylactic vaccine in preference to a quadrivalent HPV 6/11/16/18 vaccine are well made and will be appreciated by practitioners managing the wide spectrum of ano-genital HPV disease.1 The British Association for Sexual Health and HIV (BASHH) has already expressed concerns with respect to the clinica...
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Dear Editor,
The points made by Dr O’Mahony in response to the government’s decision to support a bivalent HPV 16/18 prophylactic vaccine in preference to a quadrivalent HPV 6/11/16/18 vaccine are well made and will be appreciated by practitioners managing the wide spectrum of ano-genital HPV disease.1 The British Association for Sexual Health and HIV (BASHH) has already expressed concerns with respect to the clinical, psychological and financial implications of HPV 6 and 11 infection. An editorial and article in the British Medical Journal have recently shed light on the financial reasoning behind a decision seemingly at odds with clinical sense.2,3
Parents and adolescents, in particular, should be made aware of the two available vaccines and of the clinical problems associated with HPV 6,11, 16 and 18 infection. Some parents may subsequently want their daughters protected against genital warts and low grade cervical dysplasia associated with HPV 6 and 11 infection, in addition to HPV 16 and 18 associated cervical cancer. One suspects this would require opting out of the national HPV vaccination programme and self-payment for the quadrivalent vaccine. This should lead to interesting discussion.
Competing Interests: CS has received lecture fees from Sanofi Pasteur MSD
References
1. O’Mahony C. Government decision on national human papillomavirus vaccine programme is a sad day for sexual health. Sex Transm Infect 2008;84:251
2. Kim JJ. Human papillomavirus vaccination in the UK. BMJ 2008;337:a842
3. Jit M, Choi YH, Edmunds WJ. Economic evaluation of human papillomavirus vaccination in the United Kingdom. BMJ 2008;337:a769
Chris Sonnex
Chair BASHH HPV Special Interest Group
Department of GU Medicine,
Addenbrooke’s Hospital
Cambridge University Hospitals NHS Foundation Trust
Cambridge CB2 2QQ
Immy Ahmed
President, British Association for Sexual Health and HIV
Dept of GU Medicine
Nottingham University Hospitals
Nottingham City Hospital
Nottingham NG5 1PB
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Conflict of Interest:
None declared.
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Published on: 13 May 2016
HPV immunisation decision
- Margaret A Stanley, Immunobiologist
Dear Editor,
I have read the editorial from Dr O’Mahony and the comment from Dr Watson with interest. It may be helpful in this discussion to note that the criteria for selection of an HPV vaccine were spelt out by the Minister Dawn Primarolo on the 2cd of July 2008 in response to a Parliamentary question and is detailed in Hansard http://www.parliament.the-stationery-office.co.uk/pa/cm200708/cmhansrd/cm080702/text/...
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Dear Editor,
I have read the editorial from Dr O’Mahony and the comment from Dr Watson with interest. It may be helpful in this discussion to note that the criteria for selection of an HPV vaccine were spelt out by the Minister Dawn Primarolo on the 2cd of July 2008 in response to a Parliamentary question and is detailed in Hansard http://www.parliament.the-stationery-office.co.uk/pa/cm200708/cmhansrd/cm080702/text/80702w0013.htm
It is clear from this that the decisions were not based exclusively on potential effects on HPV 16 and HPV 18 associated cervical disease but also considered the contribution of the low risk types HPV 6 and 11 to genital disease in women. An analysis of the published literature shows clearly that in the large Phase III trial HPV6/11 related external genital warts and cervical, vulval, vaginal disease was 100% prevented over a 3 year period by immunization with a vaccine containing HPV6/11 L1 VLPs (1 Garland et al 2007). Furthermore the published literature (2 Paavonen et al 2007 3 Ault 2007) if analysed objectively, indicates that there is that there is no difference between the two commercially available vaccines, in terms of efficacy, against HPV 16 or 18 caused high grade cervical intra-epithelial neoplasia (CIN2/3) the surrogate end point for cervical cancer in the trials.
The quadrivalent vaccine had an advantage from the public health perspective of significantly reducing a common sexually transmitted disease, genital warts, and this was reflected in the cost effectiveness analyses undertaken by the Health Protection Agency and others (4 Jit et al 2008, 5 Kulasingam et al 2008). Cost effectiveness is a critical part of health programmes particularly in the context of vaccine policy (6 Kinman et al 2006). A recent publication in the BMJ (4 Jit et al 2008) described cost effectiveness models that show the price differential, £13-£ 21 less per dose, that would need to exist for the bivalent vaccine to be as cost effective as the quadrivalent and indeed the cost price of the vaccine was, very sensibly, one of the criteria employed by the Government and its advisers. In view of all this it does suggest that the decision to buy Cervarix rather than Gardasil was not, as Dr Watson thinks, based entirely on evidence based medicine but that cost was an important, possibly crucial factor.
References
1. Garland, S et al. N Engl J Med 2007;356:1928-43.
2. Paavonen, J et al. Lancet 2007;369:2161-70
3. Ault, KA. Lancet 2007;369:1861-8.
4. Jit, M et al. BMJ 2008;337:a769
5. Kulasingam S et al. Cost Effectiveness and Resource Allocation 2008;6:4
6. Kinman TG et al. Vaccine 2006;24:4769
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Conflict of Interest:
None declared.
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Published on: 13 May 2016
Re: HPV immunization programme: not shocked or appalled
- Colm O'Mahony, consultant
Dear Editor,
I note Dr Watson wishes to "reserve his judgement" about the Cervarix versus Gardasil decision until he knows the details. Unfortunately he will be reserving his judgment ad infinitum because despite requests from me and others the Department of Health refused to release the details of the decision. They have issued the criteria and it appears to have been a tick boxing exercise where cost was paramoun...
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Dear Editor,
I note Dr Watson wishes to "reserve his judgement" about the Cervarix versus Gardasil decision until he knows the details. Unfortunately he will be reserving his judgment ad infinitum because despite requests from me and others the Department of Health refused to release the details of the decision. They have issued the criteria and it appears to have been a tick boxing exercise where cost was paramount.
Dr Watson is also sceptical about additionally vaccinating with HPV types 6 and 11 giving added benefit. There are many studies, showing that Gardasil is almost 100% effective at preventing genital warts the majority of which are caused by types 6 and 11. Not only that, but many abnormal smears are caused by 6 and 11, although they do not progress to severe dyskaryosis. So there is no question that there would have been an enormous clinical benefit by using Gardasil. It is untrue to say that the programme was always about cervical cancer, it was about HPV vaccination and indeed in the reply I received from Dawn Primrolo and Alan Johnson in February 2008 (before any decision was made) they encouragingly used the sentence “It is expected the vaccination of girls would reduce the transmission of infection to boys, by herd immunity, and reduce the number of genital wart cases in boys as well as girls”.
Finally Dr Watson criticises my use of words like "shocked and appalled", but my editorial was only reflecting the opinion of every single Sexual Health/GUM Doctor who has offered me an opinion on this issue. The editorial was approved by the BASHH media committee in response to the outrage expressed by most of the members and other doctors they had been in touch with. Even in the small hamlet of Aberystwyth in Wales, I am sure Dr Watson spends considerable amount of his clinical time managing genital warts with all their physical and psychological consequences. Sexual Health/GUM Physicians should be advocates for their patient’s misery. Our patients can not do it for themselves. It is interesting that there are many well funded charities for cervical cancer who can attract publicity and lobby successfully, but there is none for genital warts. We owe it to our patients to complain loudly when political considerations override the benefits that would have accrued to our patients had the quadrivalent vaccine been chosen.
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Conflict of Interest:
None declared.
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Published on: 13 May 2016
HPV immunization programme: not shocked or appalled
- Peter G Watson, consultant, genitourinary medicine
Dear Editor,
I wish to distance myself from Colm O'Mahony's rather hysterical editorial on the selection of Cervarix for the human papillomavirus immunization programme (O'Mahony C. Government decision on national human papillomavirus vaccine (HPV) programme is a sad day for sexual health. Sex Transm Infect 2008;84:251). I do not yet know why Cervarix was selected ahead of Gardasil and until I do I wish to reserve my...
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Dear Editor,
I wish to distance myself from Colm O'Mahony's rather hysterical editorial on the selection of Cervarix for the human papillomavirus immunization programme (O'Mahony C. Government decision on national human papillomavirus vaccine (HPV) programme is a sad day for sexual health. Sex Transm Infect 2008;84:251). I do not yet know why Cervarix was selected ahead of Gardasil and until I do I wish to reserve my judgement on the decision. It is tempting to believe that immunizing against HPV types 6 and 11 in addition to types 16 and 18 would produce an added benefit. However the aim of the immunization programme is to prevent carcinoma of the cervix and as far as I know there is no evidence that immunizing against HPV types 6 and 11 will achieve that aim. We might argue that there should have been trials to allow the added benefit of immunizing against HPV types 6 and 11 to be shown but there were not so perhaps in selecting Cervarix the Department of Health has simply practised evidence based medicine.
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Conflict of Interest:
None declared.
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