A colleague recently emailed me. Her daughter, just turned
12, had come back from school bearing an information leaflet about HPV vaccination
with the Glaxo Cervarix vaccine, and a consent form for the parent to sign.
The consent form nodded inelegantly to Gillick, asserting that ‘[t]he decision to consent or refuse is
legally [the girl’s], as long as she understands the issues in giving consent.’
There was no indication given, in the consent form or the accompanying
literature, as to whether and if so how that understanding would be tested. The
reality is that it won’t be tested at all.
If parental consent is refused, the parent is instructed to
identify the ‘Reason consent refused’, and is told to turn over the page ‘for
additional space to give us your reason for your decision.’
The request for a reason for refusal is perhaps a
well-meaning attempt to ensure that medically misguided reasons for refusal can
be addressed. If, for instance, a parent
refuses because she thinks that there is
a significant chance of anaphylactic shock, further discussion about the
magnitude of that risk relative to the chance of HPV-related disease is
warranted. Fair enough. But the request won’t be read that way by parents. They
will think that there is a legal obligation to provide a reason, and since the
explanatory leaflet suggests strongly that there is every reason to have the
vaccine, and none not to, the effect will be to force reluctant parents to sign
up because they can’t articulate a reason for not signing.
The case for some sort of HPV vaccination is overwhelming. But
the strength of that case should not allow the normal safeguards for ensuring
appropriate consent to be ignored.
The NHS has decided that it will pay only for Cervarix. But
Cervarix is not the only vaccine. Many other countries have opted instead for
Gardasil, produced by Sanofi-Pasteur and Merck. This is not the place to argue
the relative merits of Cervarix and Gardasil. It is enough to say that there is
a good case for saying that Gardasil is a better vaccine that Cervarix. (See,
for instance, here and here). The
UK seems to have opted for Cervarix because
it is cheap. Shouldn’t any proper process of pre-vaccination counselling for
Cervarix include a mention of its main competitor? Parents or girls themselves,
having the full facts, might opt to pay themselves for Gardasil. There is no
mention in the explanatory leaflet of any alternative to Cervarix. The clear
impression is that if you want to avoid cervical cancer you will have Cervarix.
Is there any justification for failure to tell girls and
their parents about alternatives? Can it be argued, for instance, that full
information might cause confusion, and that confusion might result in some
girls failing to consent to any vaccination at all? Surely that’s a hard
argument to run? Or might it be said that to give information about Gardasil
could create a two-tier population, since all the rich girls will get Gardasil,
while all the poor girls get Cervarix? That might be true, but is it a
sufficient reason for the NHS to ignore the basic principles of the law of
consent? Is it a sufficient reason to deny the rich girls the better protection
that Gardasil might give? Let’s suppose for the sake of argument that Gardasil
is indeed better. Is the egalitarian reasoning justifying the withholding of
relevant information so important that it is worth letting some people get
avoidable disease?
Modern European legal debates about consent tend to be
framed in the language of Article 8 of the European Convention on Human Rights.
Article 8(1) is undoubtedly engaged in
the process of consenting girls for HPV vaccination. The Article 8(1) right,
though, is not absolute. Article 8(2) provides that ‘There shall be no interference by a public
authority with the exercise of [the Article 8(1) right] except such as is in
accordance with the law and is necessary in a democratic society in the
interests of national security, public safety or the economic well-being of the
country, for the prevention of disorder or crime, for the protection of health
or morals, or for the protection of the rights and freedoms of others.’
It is hard to see how any conceivable justification for
failing to give information could be squeezed within the ambit of Article 8(2).
An imaginative barrister might say that the egalitarian justification was
really the ‘protection of morals’, but he would expect a hard time from most
judges. Might ‘the prevention of disorder’ help? Hardly: there’s no real danger
that the rich, Gardasil vaccinated girls are going to be beaten up outside the
school gates by their envious Cervarix-vaccinated peers. The only ‘rights and
freedoms’ compromised are the right to
be properly informed and the freedom to act on the information received. In the absence of evidence that proper
pre-vaccination counselling would reduce the take-up of vaccination, it is
arguable that the present regime is unlawful.
Before discussions take place on whether a choice be made between Cervarix or Gardasil – an independent study on the safety and efficacy of these vaccines needs to take place.
The following adverse reactions and deaths have been posted to the Vaccine Adverse Event Reporting System (VAERS). These numbers reflect only 1 to 10% of the population reporting.
9/2/2010
Adverse Reactions
Gardasil – 18,461
Cervarix – 426
HPV Vaccines – 137
TOTAL – 19,024
Deaths
Gardasil 77
Cervarix 4
TOTAL – 81
In March of this year the number of reactions reported stood at 16,000. That means 3,000 more reports were made over the last 6 months – or approx. 125 reports a week. These numbers demand an independent study.
Once that is completed a debate over the type of vaccine can be made. No one should be dying or have their lives ruined by a vaccine that is supposed to protect them.
Speaking from the perspective of an ethicist and not a lawyer, I would have to say that failure to mention alternatives to treatment (either no treatment or alternative modes of treatment, ie Gardasil) smacks of a failure to ensure a free and informed consent to the procedure. Fear of causing confusion and indecision are nothing but distractions from a strongly paternalistic attitude that seems to be at play here. Now, I am a proponent of paternalism when it is called for but I am skeptical if it is warranted in this case.
Failure to mention Gardasil could, perhaps, be justifiable if it was a fringe or experimental alternative. This is not the case, there is a significant contingent of physicians around the world that do endorse Gardasil as appropriate. The numbers posted above, if they are supported by rigorous studies, suggest that Gardasil might be a significantly worse alternative to Cervarix, but I would wager that it is still preferable to no vaccination at all and this qualifies it for discussion at the very least.
On a personal note, in my province of Ontario, Canada (our health plans are provincial, not federal) public moneys covers consultation for Gardasil but not the vaccine itself.
Ethical problems are often resolved without any reference to value or telos. Here, the problem is one of bureaucratic imagination and allergy to criticism. They didn’t anticipate ordinary kinds of objections, and therefor did not put down answers to them. Compare a “frequently asked questions” list on a help page on the WWW. That would reduce the number of objections, but it might also subject the answers to criticism — something to which bureaucrats in an authoritarian system are often allergic. The consent page should also have a warnings section abut risks and likely side-effects of the vaccine to be used.
Looking at this as an ethical problem, having to do with medical paternalism, see Thaler and Sunstein’s book, Nudge. It presents a kind of paternalism called (by Sunstein) “libertarian paternalism”, an oxymoron which suggests that there are often decisions that rational people would make, so people should make unless they have strong reasons not to. Is this one of those cases? The objection to such vaccination of school girls in the USA has been that it seems to weaken strictures on premarital sex. The state or school district calling for such vaccination seems to assume that girls of that age are ready to go off and have sex, an assumption that many parents object to. I haven’t seen objections based on dangers of vaccination.
What is it exactly that we are trying to get away from when we accuse people of “paternalism”? Presumably what we are seeing is vestiges of the old, feudal/aristrocratic societies. “Free and conformed consent” indeed takes us away from this dark age, ensuring that relevant information is disseminated to all and that the choice is with the citizen, not with some authority figure, no matter how well-meaning the authority figure in question.
Fair enough, but can this be taken too far? I read recently that the CEO of Google had come out and said that people don’t want Google to answer there questions, we want Google to tell us what to do next. That may send shivers down the spine (it did mine), but surely there’s truth in it. I guess some people really do want to be told what to do, and who are we to (paternalistically) deprive them of that opportunity?
There’s part of me that wants to play devil’s advocate here, defend the much-maligned bureaucrats, and point out that the consent form in question is good and simple, not confusing those concerned or frustrating them by pointing out that a better remedy would be there if only there was the money, and gently encouraging them to do “the right thing” by asking for justifications for not doing so.
That being said, in response to Dennis I would question the concept that there can be “decisions that rational people would make”. Decisions depend on values and not only on rationality. But I also think there can be such a thing as too much information.
Anyone who wants to find out about Gardsail can find out about it on the Department of Health and NHS websites. There is plenty of information about it there. Googling will quickly provide even more information. So this is not a case where the NHS or DoH are trying to hide information. Indeed they are making it availiable. The issue is whether it should be mentioned on the information sheet that is handed to parents. I have not seen the sheet but it is impossible on a sheet of this kind to provide all the information people need. It can but provide the essentials and let people know where they go to find more information. If the leaflet refers people to the NHS/DoH website then it would seem to do this. We don’t want parents being given bumper packs of 50 pages of studies to read before consenting.
It isn’t clear to me that the leaflet ought to mention Gardasil if, as Charles says in his first post, the NHS will not be bankrolling it as an option. As such, the only choice that is available to many will be either to consent to the available free option or not to. When other medicines or vaccines are prescribed in GP surgeries or in hospitals they are not generally accompanied by a raft of information on all the other potential medications that the NHS decided not to fund and are, therefore, not available to the patient (at least without payment. Why would HPV vaccines be treated significantly differently? Perhaps there is a case to be made as to why, but it doesn’t immediately reveal itself. Is the reason for disquiet because the HPV vaccine involves issues relating to sex? Why, for example, is the HPV vaccine being treated differently from other childhood vaccines?
It seems to me that there is another more pressing ethical issue relating to HPV vaccination. At present this is a gender specific vaccination programme targeting only girls. As such, there is disproportionate burden of risk that is carried by females in trying to bring about a population benefit. Okay the aim of the game is to reduce the rate of squamous cell carcinoma of the cervix, a pathology that only affects females. Men are not really at risk of any sequelae (occasionally genital warts and penile sqaumous cell carcinoma), but they are significant carriers of the virus. If we want to bring about the biggest population benefit then we need to decrease the probability of two people who have not been vaccinated meeting and transmitting the disease. The way to do this is to vaccinate both boys and girls.
Well the Department of Health may say that Gardasil is licensed in the UK, it even is mentioned in the DoH Green Book where it states it can be used alongside Cervarix as long as three injections only take place. Then when you try to speak with government Ministers and MPs about Gardasil they almost deny its existence – “Gardasil is not part of our programme of vaccination”. Yet some people must have had Gardasil, where are the reports kept of any side effects for this vaccine. To also answer the question about Gardasil supposedly being better than Cervarix – there have been 81 deaths with the former and about 4 with the latter and these figures only representing a small percentage of what is actually going on.
The next point I would like to address is 12 year olds being able to override their parents wishes if the latter do not give consent to the vaccination. So it is considered that a 12 year old is mature enough to understand all the information surrounding Cervarix, the positives as well as the negatives. Does the nurse for example inform the girl of all the side effects which have been accepted by GlaxoSmithKline, eg arthralgia, myalgia, lymphadenopathy which is a swelling of the lymph glands which can be caused by infection, autoimmune or a more serious condition. The nurse I am certain will only inform the girl of the relatively mild side effects which are on the information leaflet. Therefore, when and only when all relevant information is disseminated to all, including the parents, their daughters and the general public will there be a greater fairness and honesty surrounding this vaccination programme. At the moment a lot is hidden from the parents so it is up to articles like this to bring out the truth and ask a simple question “If you have nothing to hide then be honest and detail all that can go wrong with this vaccine, no matter how rare you think it may be”. That is the honest approach and one which is upheld by doctors and surgeons when you go for an operation, the same honesty has to apply with vaccines and “what might go wrong”. Until then young girls will be fooled into believing it is a “miracle vaccine” when sadly it is not. The future years will tell the real story.
Cervical cancer screening via the cytology programmes instituted in all North American and Western European countries have already an incidence level of cervical cancer that is lower than either vaccine alone can provide. The true comparator is not between the two vaccines, but between screening which is necessary, and the option to have additional protection from abnormal Pap tests.
Charles Foster’s views on human rights are fundamentally misconceived. The underlying assumption he makes is a rose tinted spectacular view that Government acts for proper motives in a benevolent Utilitarian manner in general and particularly in matters of public health.
Assumptions like these have been proven false over centuries. If it were not so there would have been no need for a European Convention on Human Rights as an endeavour to protect Europeans from the excesses of their own governments and especially its officials.
Foster assumes “… a reason for [parental] refusal [of HPV vaccination] is …. medically misguided” and that “The case for some sort of HPV vaccination is overwhelming”.
There is copious evidence the latter is not the case. The formal medical evidence base is now so corrupted by pharmaceutical commercial interests that medical journals are no longer reliable sources. Corrupt practices in medical publishing are endemic. The inaptly named “Peer review” in medical publishing is a broken system which provides no guarantees or assurances of the reliability of the information published.
The case for providing HPV vaccines to 13 year old girls is far from “overwhelming”. Cervical cancer mortality in under 25s is non-existent. It is vanishingly rare in 25 year olds. It is something which affects predominantly the over 40s.
The “protection” afforded by HPV vaccines is per se unproven. To the extent any “protection” can be assumed, it is recognised that it is unlikely to persist for more than 14 years.
These matters alone call into question the motivations of the individuals in government responsible for pursuing a policy of mass vaccination of 13 year old girls.
Another problem is that health officials and medical professionals are not providing full information on adverse reactions and the importance of the information there is is understated.
A minimum of 90 in every 100 adverse drug reactions for any drug go unreported. Evidence in the medical literature indicates that 98 to 99 of every 100 serious adverse drug reactions go unreported. There is evidence to indicate that cases of death and serious debilitation consequent on the HPV vaccination are being ignored.
And it is not true that refusals are based on “medically misguided reasons”. Foster provides no evidence to support his assertion. “Refusnik” parents include informed medical professionals.
But if it were true, then that is a symptom of the failure to provide reliable accurate information on risk vs benefit. Regrettably, as the formal medical evidence base is now unreliable, European citizens cannot rely on the information government health officials cite to justify their health policies, whether of mass multiple vaccinations or otherwise.
Charles can of course defend himself, but I see a number of problems with this last comment (from Clifford Miller), and in particular the manifestly incorrect assumption that Charles was “asserting” that refusals are based on medically misguided reasons. What Charles actually did was to suggest that a well-meaning attempt to avoid this was *might* have been (“is perhaps”) a motivation on the part of the health officials.
I’m also uncomfortable with the idea that the European Convention of Human Rights should be seen primarily as “an endeavour to protect Europeans from the excesses of their own governments and especially its officials”. I would rather see it as an expression of core European values. I’m not saying it doesn’t or shouldn’t play the other role as well, but there is something that strikes me as profoundly undemocratic about the idea that an supranational convention is needed to protect the citizens of a supposedly democratic country like the UK from its own government. If this is the case, then there is something seriously wrong with our democracy.
The assertion that “medical journals are no longer reliable sources” needs nuancing, not least since you go on to state that “evidence in the medical literature indicates that 98 to 99 of every 100 serious adverse drug reactions go unreported”. Certainly we should not take every study we read in a journal as the gospel. But there are very sophisticated techniques for assessing the merits of such studies, which, while by no means perfect, I think give us good indication, if we care to look, of what science is really telling us about such matters.
Finally on the motivation of the motives of government. Once again I don’t see any specific evidence in Charles’ post that they are always in every case benevolent. On the contrary, the main message was that government officials are not providing enough information. Indeed we should not assume that governments act “for proper motives in benevolent Utilitarian manner”. Governments are made up of people, after all. But neither should we assume the opposite.
Ultimately, of course, it is an empirical (rather than an ethical) question whether the case for vaccination is overwhelming, and sorting out such questions is not the main aim of this blog (as I understand it). What we should try to do, though, is to understand (and not misrepresent) what each other are saying.
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