(Not) warts and all
BMJ 2008; 337 doi: https://doi.org/10.1136/bmj.a2186 (Published 23 October 2008) Cite this as: BMJ 2008;337:a2186
All rapid responses
Vaccination for genital warts to prevent cervical cancer: principles
first, please, before details
There are at least 3 interlinked perspectives from which vaccination
against cervical cancer can be looked at by someone: (a) As a public
health measure (b) As a vaccine manufacturer (c) As a parent of daughters.
Dr Phil Hammond (26 Oct) has done very well to discuss all these to some
degree [1].
VACCINATION AS A PUBLIC HEALTH MATTER
With “100,000 new cases in England each year “ [1] “the current
estimate of treating genital warts in England every year is £23 million …”
[1]. Any responsible government would want to do something about the
problem. But is vaccinating every 12 year old girl the best antidote to
this problem? Especially when Dr Patrick Silvestre says all published
study suggest the cancer preventing efficacy of vaccination is just “20 to
30” [2]?
VACCINATION FROM PERSPECTIVE OF MANUFACTURERS
Manufacturers are in the business of selling drugs and vaccines.
Their products need careful probing to verify claims of efficacy and
safety. One of the 2 vaccines under discussion is effective for only HPV
strains 16 & 18, while the other that covers HPV strains 6 & 11
has been known (perversely) to proliferate warts all over the body [3].
Moreover, the government preferred option does not afford protection
against recurrent respiratory papillomatosis (RRP). These HPV 6 & 11
strains are “the cause not only of genital warts, but of recurrent
respiratory papillomatosis” [4].
VACCINATION FROM PERSPECTIVE OF A PARENT
Phil Hammond quotes “a sexual health consultant” as saying “You would
be mad not to protect your daughter against genital warts if you can
afford to” [1]. The way he would protect his 12 year old daughter would be
by taking the government’s advice and vaccinating her with a vaccine that
is not only NOT fool proof, but also could be hazardous. Some other
parents, including myself “would be mad” to choose that method to protect
our 12 year olds for the future, reminding me of what a chief in my Manya
Krobo tribe in Ghana once articulated.
THE TRIBAL CHIEF’S PRIORITIES
During a trip around sub-Saharan African countries studying AIDS at
the grass roots [5], I mentioned in a Public Lecture that the Europeans
and Americans were in the process of producing a vaccine for HIV/AIDS.
“What?” exclaimed one tribal chief sitting in the front row “You mean they
are going to prick us with needles so we can do what we like?” [6]. I
thoroughly identify with this fellow tribesman. Do I teach my 12 year old
daughter the ethics of sexual discipline, or do I ask her to go with the
crowd to be pricked with needles so she can do what she likes? And that
brings me to government diktats and fiats in areas of parental
responsibility.
GOVERNMENT INVADING PARENTAL TURF WITH SEX EDUCATION
Of course, responsible parents are entitled to choose what they
consider to be best for their daughters: Go with government
recommendation, however inadequate, or take their own parental initiatives
in the interest of their child’s health. I for one shall go along with my
tribal chief. But what does one do when the content of government
education material on sex education for children leaves a lot to be
desired? Take this headline in the Daily Telegraph: “Children aged five to
get sex education” [7], the first paragraph of which article begins:
“Children as young as five will be given sex education under Government
plans to cut teenage pregnancy and sexually transmitted diseases” [7].
Another “Government” initiative headlined “Oral sex lessons to cut rates
of teenage pregnancy” [8], which elaborated: “Encouraging schoolchildren
to experiment with oral sex could prove the most effective way of curbing
teenage pregnancy rates, a government study has found” [8].
CONTENT OF THE SEX EDUCATION PROGRAMME
Would the sex education material include information on gonorrhoea of
the throat? Would the children be told of the risks to which phallic
bruising of the palate exposes them with oral sex? [9] Would they be
informed that HIV/AIDS has been known to be contracted through oral sex?
[10 11 12]. Would the advisers of government, namely Chief Medical Officer
and National Institute of Clinical Excellence (NICE) make sure that this
information was also included in the planned sex education for school
children? Dr Tom Stuttaford, the very experienced Health Expert of The
London Times wrote on Monday 10 November 2008: “As 99.7% of cases of
cervical cancer can be shown to have resulted from HPV infection, and more
than 75 per cent of sexually active women have at some time been infected
by HPV, the search for a vaccine that would spare women this hazard was
intense” [13] He went further: “Vaccination is offered early to girls at
about 12 or 13, as by that age 10% of them are sexually active”. But the
question worrying some parents is this: “Why should, for the sake of 10%
who are sexually active, Government recommend that 100% of girls at 12 be
vaccinated?” If the answer is “we do not know which 10% of these 12 year-
olds are sexually active”, the retort naturally becomes: “Do you therefore
introduce sex education in the kindergarten to increase the proportion of
sexually active children from 10%?” You see, when you teach little
children Geography, they have an intense desire to travel. When you teach
them about sex, what stops them rushing out to do it? Dr Stuttaford’s
article in The Times warning people to take care over the Christmas Season
is accompanied by a picture of a couple passionately locked in kissing,
oblivious of the fact that people who do different things with their mouth
can pass on Chlamydia through a harmless pastime like French kissing.
Passing from the UK scene to what I have seen overseas, there is risk
taking and risk taking. Those who take obvious risks, as described below,
will welcome anything to help them prevent diseases. But those African
parents who teach their children to behave themselves are paranoid about
new vaccines especially when they have read that population control
agencies have sometimes laced vaccines with contraceptives [14].
BY ALL MEANS VACCINATE RISK TAKERS
During my fact finding tour of African countries studying AIDS [5 15
16 17] I interviewed no less than 125 international prostitutes on duty.
The East/Central Africans were more independent than the West Africans
which latter were usually controlled by treacherous pimps and unscrupulous
Madames. Some of these West African prostitutes who travelled to Abidjan
for sex were subjected to on average of 20 coital acts in a day by sailors
and tourists for between 50 to 100 dollars per act. I learnt from some of
the girls that, Tafracher, [18] they allowed both anterior and posterior
(vaginal & anal) intercourse depending on client requests, while the
pimps collected the money [19 20]. When they became ill and were
repatriated home to Ghana to die, I visited and examined some of them at
home [19 20 (page 106) 21 22 23] and treated their infections including
genital warts “that allow AIDS virus to invade the body” [20 page 91]. The
state of the perineum of some of these girls was such that I described it
as “perineal devastation” [21 22]. Indeed, visiting their homes as I did
with a local team [23 24] one could easily identify those girls with
disintegrated perineum by how they sat. They would never sit on a chair,
but always on the open end of a bucket – the so-called “Matekole sign”
[21]. Examining them indoors with a female chaperone, those accompanying
me often could not bear the sight of the grotesque genital warts and asked
permission to get out of the room [24]. Photographs I took can never be
shown in a public lecture. But the point of all this is as follows: These
girls received less than 50 pence per coital act in Ghana in the sex
business, while crossing the national border to Ivory Coast fetches nearly
100 times that amount per act. One lady I treated in the tribe not only
returned in less than a year to go to Abidjan again for foreign exchange,
but when she later died from AIDS, her younger sister who had just come
out of school was lured by pimps to go to Abidjan for foreign exchange, at
the expense of her health. “O Dorkita” her mother said to me in the tribal
language when she saw my sheer astonishment: “O Dorkita, Wa be noko!” (O
Doctor, we have nothing!) [20 page 43]. So even with a 20 to 30 percent
success rate of a vaccine doing any good, I would recommend vaccination
for these risk takers. We had tried to get light industries for them in my
tribe to stop them traveling abroad in the sex trade [17], but the control
of the pimps and Madames proved far too strong. In any case, as Joseph
Matthew has just pointed out [25], in the developing countries the
cervical cancer vaccination drive “is more hype than hope with the
available HPV vaccines”
SEX AND ETHICS FOR OUR SCHOOL CHILDREN
The principle of parental instruction of our 12 year olds about sex
requiring discipline with an ethical dimension is a far more important
priority than assuming that what these girls need for their future good is
pricking them with needles so they can do whatever pleases them.
Felix I D Konotey-Ahulu MD(Lond) FRCP DTMH FGA FGCP FAAS FTWAS FWACP
Kwegyir Aggrey Distinguished Professor of Human Genetics and Consultant
Physician Genetic Counsellor in Haemoglobinopathies, 10 Harley Street,
London, W1G 9PF
felix@konotey-ahulu,com
Conflict of Interest: None declared
1 Hammond P. (Not) warts and all. BMJ 2008; 337:a2186
2 Silvestre P. Over optimistic view. BMJ Rapid Response Oct 26 2008
http://www.bmj.com/cgi/eletters/337/oct23_1/a2186#203716
3 Struthers M.Gardasil: warts and everything else …BMJ Rapid
Response 28 Oct 2008
http://www.bmj.com/cgi/eletters/337/oct23_1/a2186#203842
4 Bull Peter. HPV and the larynx. BMJ Rapid Response 28 Oct 2008.
http://www.bmj.com/cgi/eletters/337/oct23_1/a2186#203800
5 Konotey-Ahulu FID. Clinical epidemiology, not epidemiology, is
the answer to Africa’s AIDS problem BMJ 1987; 294: 1593-1594.
6 Konotey-Ahulu FID. AIDS in Africa. Lancet 2002; 360: 1424 (2
November)
7 Paton Graeme. Children aged five to get sex education. Daily
Telegraph, London Thursday October 23 2008.
8 Townsend Mark. Oral sex lessons to cut rates of teenage pregnancy
http://www.guardian.co.uk/uk/2004/may/09/society.schools - 72k The
Guardian/ The Observer Sunday 9 May 2004
9 Konotey-Ahulu FID. Extensive palatal echymosis from felatio – a
note of caution with AIDS at large. British Journal of Sexual Medicine
1987; 14: 286-287.
10 Goldberg DJ, Green ST, Kennedy DH, Emslie JAN, Black JD. HIV and
orogenital transmission. Lancet 1988; ii; 1368.
11 Rozenbaum W, Gharakahanian S, Cardon B, et al. HIV transmission
by oral sex. Lancet 1988; i: 1395.
12 Spitzer PG, Weiner NJ. Transmission of HIV infection from a
woman to a man by oral sex. New England Journal of Medicine 1989; 320:
251.
13 Stuttaford Tom. HPV: An unwanted gift at Christmas. The Times,
10 Nov 2008
http://www.timesonline.co.uk/tol/life_and_style/health/expert_advice/art...
14 Miller, James A. Are new vaccines laced with birth control
drugs? HLI Reports 1995; Human Life International, Vol 13: Number 2.
15 Konotey-Ahulu FID. Slowing HIV contagion among Africans.
International Journal of STD & AIDS 1991; 2: 139
16 Konotey-Ahulu FID. AIDS in Africa: Another perspective.
International Pharmacy Journal 1992; 6: 92-99 (English & French –
Invited Paper)
17 Konotey-Ahulu FID. An African on AIDS in Africa (Guest
Editorial). The AIDS Letter – Royal Society of Medicine 1989, No 11, Feb-
March 1989, 1-3.
18 Konotey-Ahulu FID. Tafracher – Personal View. An invaluable
Ghanaian devulgarizing word. BMJ 1975; 1: 329.
19 Konotey-Ahulu FID. The AIDS crisis in Africa: a survey. In
Appropriate Technologies for AIDS Management in Africa: Editor Kihumbu
Thairu, 3-7 September 1990 Kenya Medical Research Institute, Nairobi.
Commonwealth Secretariat, London pages 42-44.
20 Konotey-Ahulu FID. What Is AIDS? Tetteh-A’Domeno Company,
Watford, England 1989 [ISBN: 0 9515442 0 9]
21 Konotey-Ahulu FID. Some thirty features of AIDS in Africa.
Annales Universitaires des Sciences de la Sante 1987; 4: 541-544
22 Konotey-Ahulu FID. Origin and transmission of AIDS. Journal of
Royal Society of Medicine 1987; 80: 720.
23 Quartey JKM, Konotey-Ahulu FID. The domiciliary management of
AIDS in a rural community in Africa. In: Appropriate Technologies for AIDS
Management in Africa, 3-7 September 1990, Kenya Medical Research
Institute, Nairobi. Commonwealth Secretariat London pages 42-44.
24 Quartey JKM, Konotey-Ahulu FID, Bentsi Cecilia, Antwi Phyllis,
Gboloo D, Ofori Monica, Ofei Beatrice, Amegayao Gertrude. Domiciliary
management and prognosis of AIDS in the Krobo tribal region of Ghana. In:
The Global Impact of AIDS, First International Conference, London 8-10
March 1988 (Abstract W28)
25 Matthew L J. Cervical cancer vaccine in developing countries:
hype or hope? BMJ Rapid Response
http://www.bmj.com/cgi/eletters/337/oct23_1/a2186#204027 (Nov 1)
Competing interests:
None declared
Competing interests: No competing interests
Dear Sir
I would like to contrast the introduction of an expensive new vaccine
to further reduce cervical cancer mortality with the failure to address
the problem of poor skin lesion recognition skills of British GPs.
Intervention to improve those skills could reduce skin cancer mortality,
which exceeds that from cervical cancer. Melanoma mortality could probably
be significantly reduced by targeted education and the use of new
technology.
In 2006 malignant melanoma skin cancer killed 1,852 UK citizens (1)
versus 949 for cervical cancer (2). Clearly great strides have been made
in protecting women from this important disease, and the introduction of
HPV vaccine should reduce mortality further, but women also die from skin
cancer, as do men, and we are not doing enough about it.
Universal screening and now a very costly new vaccine are deployed
against cervical cancer, but there is no programme to reduce the greater
mortality from skin cancer. Early diagnosis saves lives, but this depends
on patients presenting early, and excellent GPs lesion recognition skills,
which continue to be inadequate, as a Parliamentary enquiry found. (3)
The NICE guidance on skin cancer has encouraged GPs to refer more
patients to hospitals but has done nothing to improve their skills, and by
banning most GPs from doing any skin cancer work may even lead to loss of
skills. Furthermore, QOF payments in the new GP contract inevitably divert
limited resources away from areas which they do not reward, which includes
the whole area of skin disease.
We have too few dermatologists (420 for the UK against 2,300 in
Spain, 3,000 in Italy and 8,000 in France). This is not due to a lack of
bright young doctors who wish to train in the specialty, but to centrally
imposed limits on trainee numbers. One consequence of this is too little
dermatologist time for teaching medical undergraduates, GPs and other
health workers.(3)
The new diagnostic technique of dermoscopy has been shown by numerous
international studies to improve lesion recognition in trained hands (4),
but it is not being rolled out into the community. The private sector
offers anxious patients mole screening using modern dermoscopic
technology. Many GPs are interested in the technique but courses and
mentoring are hard to come by and there are no incentives.
While much new money is being directed to further reduce a falling
annual mortality due to one specific cancer, there are no plans to deploy
evidence based interventions against another specific cancer which kills
twice as many and is on the increase. Is this another example of resources
being determined more through special interest lobbying rather than
equitable and evidence based planning?
(1)
http://info.cancerresearchuk.org/cancerstats/types/skin/mortality/?a=5441
(2)
http://info.cancerresearchuk.org/cancerstats/types/cervix/mortality/?a=5441
(3)
http://www.skincarecampaign.org/docs/APPGS/New%20APPG%20on%20Skin%20call...
(4) http://www.library.nhs.uk/Cancer/ViewResource.aspx?resID=282773
Competing interests:
SH uses and teaches dermoscopy, works in a skin cancer clinic and is a trustee of the Primary Care Dermatology Society
Competing interests: No competing interests
I can't believe the naievity of anyone dismissing genital warts as
annoying. Ask any of the 800 new patients who come through my clinic each
year or indeed any of the 100,000 UK new cases if they consider it
annoying. as Phil Hammond said, take as look at my website
www.chestersexualhealth.co.uk in the wart section and tell me you still
think it's just an annoying nuisance. Both vaccines are so far equally
effective for HPV 16 and 18. It will be many years before we know if one
has longer efficacy then the other. The DoH estimated the cost of wart
treatment at an all time low of £134 per patient. The cost here in my
clinic is aprox £423 per patient. Even first visit PBR at my hospital is
£153 and follow up is £90. Most warts need a few visits - do the maths!
Despite GSK's assertion of winning eligible contracts I am not aware of
ANY country that has chosen Cervarix as the national vaccine? Also what
is the issue with Cervarix and the USA? Why won't the FDA approve it?
Have they concerns that the Briish don't know about? Now that top up
payments are in the clear can parents top up and but Gardasil? The NHS
price of both vaccines is £80 per shot, 3 shots are needed.
Competing interests:
I've recieved lecture fees from GSK and Sanolf Pasteur MSD
Competing interests: No competing interests
Sir,
It was unfortunate that Dr. Hammond wrote his piece without asking us for the basis on which the choice of HPV vaccine was made - we would have been delighted to give him the information. We gave full consideration to all of the issues raised by Dr. Hammond and much more that was scientific, logistic and economic.
We used the cost-effectiveness analysis (Jit et al BMJ 2008) to allocate points for quality of scientific information on protection against cervical cancer, protection against warts, logistic details such as stability out of the cold chain and only after the scoring was completed were the prices revealed. Again using the Jit et al analysis, the prices were scored for cost-effectiveness in balance with the other factors. The scoring system had been shared in advance with the manufacturers. In central contracts, the price offered by manufacturers can differ considerably between products and against the list price.
We took full account of the burden of genital warts and the benefits that might come from vaccinating males. Perhaps Dr. Hammond might have asked himself how much he was prepared to pay to prevent genital warts; I assume that even he must have a figure in mind beyond which it would not be cost-effective to use a quadrivalent vaccine.
Professor David M Salisbury CB FRCP FRCPCH FFPH
Director of Immunisation
Department of Health
Competing interests:
None declared
Competing interests: No competing interests
Blogs abvout the HPV vaccine simply reinforce my view that an awful
lot of nonsense is found on the web. Warts appearing 2 or 3 days after a
vaccine blamed on the vaccine? Give us a break!
Competing interests:
None declared
Competing interests: No competing interests
I am a pulmonologist and therefore I am at the receiving end in this subject.Without studying the original article of Dr. Phil Hammond about vaccination against genital warts I gathered following impressions.
Phil has probably worked and studied this subject in depth and therefore he is biased. As common reader I would like to ask these question
1) What is age criteria for that vaccination?
2)What are the benefits in terms of prevention?
3)If wart can be a general affection then why to restrict only genital warts ?
4) And of course what are the adverse effects ?
If we could consider these questions the picture will be clear. Either this concept is not acceptable or it may applicable to many other conditions
Competing interests:
None declared
Competing interests: No competing interests
Who’s mad not to protect his daughter against genital warts if he can
afford to?
The real parent who should pay an extra £350 instead of accepting the
public funded bivalent vaccine or the government as the symbolic parent
who’s mad not to pay for the more expensive option of the quadrivalent
vaccine.
It may be clear that the main objective is to prevent cervical cancer and
deaths from CC. The prevention of genital warts is not on the prevention
priority list, not because it’s not an annoying problem, but mainly
because it’s not a major health problem and of all the health problems
public health has to deal with (and has to save resources for), genital
warts are probably rather low on the priority list. Although some will
invest a lot of money and energy to make us believe- apparently with great
success– that genital warts are a major health problem.
The symbolic parent has already spent a lot of money for a preventive
intervention that eventually might be effective, but that lacks until now
reassuring evidence that the protection will last without need for
boosters and other vaccines to deal with shifts to other HPV-types.1,2
So, if this parent can offer the same protection against the relevant
health problem cervical cancer with the bivalent vaccine at a lower cost,
it seems not to be a sign of madness but of good sense.
The same applies tot the real life parent. The yearly risk your child gets
a genital wart is 0,3%3. The quadrivalent vaccine lowers the risk, but for
how long? So, are you mad not to spend £350 to lower this low risk of this
not extremely important health problem? Perhaps it might be interesting to
imagine what other preventive things you could offer your child for £350:
a bicycle helmet, a nice box of condoms, a smoke-free-house-sticker, a
good filled fruit basket on the kitchen table, … .
Veerle Piessens, MD, Jan De Maeseneer, PhD, MD. Dpt. of General
Practice and Primary Health Care, Ghent University, Belgium.
Conflicts of interests: none.
1. La Revue Prescrire Février 2007/ TOME 27 N° 280, p89-93.
2. La Revue Prescrire Février 2008/ TOME 28 N° 292, p91.
3. http://www.thehpvtest.com/About-HPV/Genital-Warts-FAQs.html
Competing interests:
None declared
Competing interests: No competing interests
Recently, there has been aggresive marketing and promotion of
cervical cancer vaccines in India. This has taken two forms viz academic
and commercial. The former is done through numerous national, regional and
local sponsored presentations by eminent national and sometimes
international experts, usually for a fee. The latter is through press
conferences, public 'education', setting up an 'information help-line' and
widespread adversting and promotional campaigns. Against this backdrop,
the Indian Academy of Pediatrics (IAP) recently published their
recommendation to include HPV vaccine for routine use in all girls at the
age of 10-12 years (1). The 'scientific basis' for this was stated to be:
(i) cervical cancer is the most common cancer and cancer related cause of
death in Indian women as per India's national cancer registry; (ii) it is
responsible for 132000 cases and 74000 deaths as per the same data source,
(iii) compliance with annual Pap smear screening is low, and (iv) the
currently available vaccines are safe and efficacious. In response to
these statements, I dashed off a letter to the Editor of the journal to
try and set the record straight, but this was rejected for publication.
Some of the relevant issues have been highlighted in the current
correspondence in the BMJ. Some others also merit attention. These are
given below.
A) Data from the Indian National Cancer Registry(2,3) show that (i)
cervical cancer is the second most frequent malignancy in women after
breast cancer, (ii) the total number of cases recorded is 7012, (iii)
mortality is around 20%, unlike 56% suggested, and (iv) incidence is
maximal beyond the fifth decade and not in younger age-groups. Therefore,
HPV vaccination must guarantee protection for at least 3-4 decades after
primary immunization in order to be a useful public health intervention.
Of course, it may be argued that certain extrapolations were made to
arrive at the high estimate of disease burden, but the fact is that the
data quoted does not match the source.
B) The IAP recommended that the vaccine be administered only to those
who can afford to pay for it. This statement appears to be intended
primarily to boost vaccine sales; if HPV vaccine has scientific merit
suggesting benefit for women at high(er) risk of cervical cancer, it must
be recommended for those who need it, rather than only those who can
afford it.
C) The critical issue of effectiveness (does the vaccine do what it
is supposed to?) is confused with efficacy (what is the immune response to
vaccination?). Not surprisingly, the following additional issues have been
missed altogether: (i) the lack of practical experience in prevention
programmes world-wide, (ii) questionable acceptance of a vaccine to
prevent a sexually acquired infection that can sometimes (but not always)
cause cancer, and that too only if vaccination is completed before
exposure, (iii) the vaccine does not protect against all causes of
cervical cancer, hence HPV vaccine is not synonymous with cervical cancer
vaccine, (iv) the fact that it cannot replace annual screening programmes
for cervical intra-epithelial neoplasia and (v) some developed countries
have rejected a vaccination programme on these grounds (4).
These facts suggest that currently, there is more hype than hope with
available HPV vaccines; in the context of developing countries.
References
1. Indian Academy of Pediatrics Committee on Immunization (IAPCOI).
Consensus recommendations on immunization, 2008. Indian Pediatr 2008; 45:
635-648.
2. Indian Council of Medical Research. National Cancer Registry
Programme. Consolidated Report of Population Based Cancer Registries 2001-
2004, December 2006
3. Indian Council of Medical Research. National Cancer Registry
Programme. Consolidated Report of the Hospital Based Cancer Registries:
2001-2003, December 2006.
4. Reduction in the risk of cervical cancer by vaccination against
human papillomavirus (HPV) - a health technology assessment. Copenhagen:
National Board of Health, Danish Centre for Health Technology Assessment,
2007; 9(1): 1-14. Accessed from www.dacehta.dk
Competing interests:
None declared
Competing interests: No competing interests
Judicial Watch is a non-partisan educational foundation based in
Washington, DC. [1] In June this year, the organisation produced a special
report on Gardasil after examining the FDA's HPV vaccine records obtained
under Freedom of Information Act (FOIA). [2]
I do not believe that Phil Hammond can have read this report. Having
read it, I can not believe that he'd have been mad enough to inject his
daughter with Gardasil, warts and all, whatever the cost.
Far from protecting against genital warts, it appears that the
vaccine may actually induce them in some children. In the Vaccine Adverse
Event Reporting System (VAERS) reports obtained by Judicial Watch there
were 78 separate cases where, after receiving the vaccine, patients
experienced outbreaks of warts. Here are two excerpts from the VAERS
reports,
"Two days after receiving the first dose of Gardasil, the patient
developed groin warts. There is no known history of these warts. The
patient came back in about a month later and was given the second dose of
Gardasil. A few days after receiving the second dose, the patient had a
huge outbreak of warts. VAERS ID: 292052-1"
"Information has been received from a consumer concerning her 17-year
-old daughter with no medical history and an allergy to sulfa, who on 28-
SEP-2007 was vaccinated with a first dose of Gardasil . . . Prior to being
vaccinated with Gardasil the patient was tested for HPV and genital warts
and all her test came back negative. On 15-OCT-2007 the patient
experienced a fever, and broke out with white bumps that were diagnosed as
genital warts. VAERS ID: 301339-115"
And outbreaks were not limited to genital warts; some patients
experienced outbreaks of warts on the face, hands, and feet. Go figure!
[1] http://www.judicialwatch.org/about.shtml
[2] A Judicial Watch Special Report. Examining the FDA’s HPV Vaccine
Records.Detailing the Approval Process, Side-Effects, Safety Concerns and
Marketing Practices of a Large-Scale Public Health Experiment. June 30,
2008
http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords...
Competing interests:
None declared
Competing interests: No competing interests
Ethical issues as well
Phil Hammond makes a compelling case for vaccinating daughters with
Gardesil rather than Cervarix although I know that this has been contested
by the latter's manufacturers. Incidentally Gardesil appears to have fewer
side effects as well. But there are other ethical issues at stake here. Of
great concern is that the age groups at particularly high risk of HPV
infection (and subsequent cervical dysplasia) are not being offered
protection until too late i.e 14-16 year olds. Since the figures show that
around 40% of fifteen year old girls are sexually active in the UK,
waiting until 2009/10 for their first vaccine is not much use. The Health
Protection Agency is not forthcoming for advice regarding this age group.
Even more troubling is that the postponement till 25years for the first
smear test means that some young women may be harbouring carcinogenic
strains of HPV for at least ten years at the time of their first test.
These policies represent covert rationing, but since it involves teenage
sexuality, there is little fuss. This is typical of the unhelpful stance
taken towards young people in this country. We seem to be incapable of
helping teenagers from (unplanned) early pregnancies and we now abandon
them to preventable diseases.
Take the case of the sensible well informed fifteen year old in a stable
relationship. She seeks contraceptive advice from her GP. She is duly
given the contraceptive pill. She then asks for the vaccine as she knows
that it will confer protection against a carcinogenic virus. She has an
older sister who had to have unpleasant treatments for cervical dysplasia
and she particularly wants to avoid this risk. Her GP refuses to supply
her with the vaccine or provide a private prescription or even give her
advice as to where she could obtain it. Is this ethical? There is a clear
duty of care here and an ethical responsibility towards vulnerable
patients which is being ignored. Imagine if someone was going to a
malarious area and needed a doctor's prescription for the appropriate anti
-malarial. The GP refuses to supply the patient with a script or provide
advice, even though she will be at significant risk of becoming infected.
Would that be ethically or legally acceptable? Both Gardesil and Cervarix
are licensed as prophylaxis for 15 and 16 year olds. Simply saying 'we
don't do it here' is not good enough.
Competing interests:
None declared
Competing interests: No competing interests