Cervical cancer vaccine - Japan no longer recommends because of side effects concern

[Crumbledwalnuts]

there are quite a lot of different places this story is written, this is one of them

It's not being withdrawn but the government isn't recommending it any more. At least for now, while it investigates.

What I am saying, is that people will die as a result of this announcement, through falling confidence in the safety of a vaccine that saves lives. Not just in Japan either, but in other countries too. And they aren't even sure of their data.

Noble
"Why not wait until you know there are problems...."

Goodness. It could be far too late by then. How would people feel if they'd had the vaccine only to hear later that problems were suspected? That would be outrageous.

Why do you think people will die? The vaccine doesn't remove the need for regular smear tests.

People will die because they will not get the vaccine due to falling confidence, will get the HPV virus which is a major cause of cervical cancer, which can kill. See the whooping cough deaths in the 70s for an example of this happening.

The vaccine doesn't remove the need for smear tests because there are strains of HPV which aren't in the vaccine so although the risk of cervical cancer is a lot lower, it is not completely eliminated.

One certainly shouldn't generalise, but it is not that Japan is the poster child for preventing outbreaks of vaccine preventable diseases. They are battling rubella at the moment, with at least 10 cases of devastating rubella embryopathy to date and they have had HUGE mumps outbreak (leading to fine data on hearing loss due to mumps that no developed country should generate in this day and age, what with the vaccines available and all).

But everyone's risk for HPV is different. If you have all the information available then you are in a position to decide where your greatest risk lies with currently available information.

Really surprised that you think a ministry that has concerns (whether or not further evidence may reduce them) should suppress them.

And I'm surprised that you think that people dying as a consequence isn't good enough reason for the government to be cautious when making pronouncements on these matters. I'm not saying they should suppress the information.

It seems to me they are covering their backs. Your daughter dies from preventable cervical cancer? Should've given her the jab, it was free and available after all. Your child experiences a serious side effect to the vaccine? Well yes, that's why we don't recommend it.

As for HPV risks, the only way I can tell of not getting it is to be completely celibate. Condoms don't offer full protection. And smear tests are there to pick up cancer signs, not prevent them like the jab. You'd then still have worry and unpleasant treatment, and of course life may intervene making you miss or delay your smear. We have routine smear tests in the UK and people dying of cervical cancer so clearly that's not good enough.

did I say that? Gosh - how I hate those "when did you stop beating your wife" comments. This is what I said: Japan's record in preventing VPDs is less than stellar. Their reaction to concerns is actually ok. They are quick to react to reports of adverse events and that is how it should be.

This article suggests that the investigations will take 6 months to complete, and that only 3 out of 5 on the committee voted to withdraw the recommendation, a decision which has come under criticism in Japan.

blogs.terrapinn.com/vaccinenation/2013/06/18/japanese-health-ministry-withdraws-recommendation-hpv-vaccine/

Only 6 months to draw firmer conclusions. If they reinstate their recommendation, I think that it will take a lot longer than 6 months to restore confidence.

They are passing the buck for any consequences of vaccinating or not vaccinating onto the public, while not actually giving them enough information to inform their decision.

Actually noble I think people are capable of making their own decisions. They can assess their risk of contracting HPV (which is going to vary massively between individuals) and then make their own individual choice wrt whether the HPV jab is worth the risk of side effects.

I personally feel really quite angry that I wasn't given the whole picture before I vaccinated ds1 - and we live with the consequences of that to this day (and ds1 will live with that for the rest of his life). Had I had the information, he may well still have been vaccinated, just on a different timescale. But our choice was removed.

Suggesting that people are capable of making their own decisions rather does away with the need for doctors and medical experts to interpret sometimes exceptionally complex data.

Most people are not medical experts, otherwise, let's face it, a small scale and very limited study wouldn't have led to a disastrous drop in MMR take-up, would it?

And it's a pity that those experts didn't count how many had singles instead as the only paper I'm aware of looking into this found that 94% of people had a measles vaccination - either in the form of MMR or single vaccinations. The lowest (mumps) appeared to be related to the single mumps being unavailable (at a guess at 98% opting for singles had measles, 90% had rubella and only 56% had mumps - overall mumps vaccination rate still 92%).

So it seems that the MMR scare didn't scare people away from vaccinating - not according to that paper. It made them choose what they perceived to be a safer means of vaccination. If 94% were choosing a measles vaccination despite a bunch of them having to pay for singles imagine how close they could have got to 100% if the single had been free (or even available to be paid for via GP's).

People on the whole want to protect their children against diseases, but they do want to do it in a safe manner, & imo it remains unethical for a govt ministry to bury their own concerns because 'it might affect the vaccination programme'. Not as much as cover ups that are later revealed.

Saintly, the paper shouldn't have scared them away from the MMR at all. Any medical expert could have told you that.

It was Wakefield's pronouncement in the press conference that caused the issues, not the evidence.

Actually 'my' medical experts haven't told me that in relation to my younger children at all, but that's a different matter (and one I'm not allowed to mention on here without getting shouted at - unless I am willing to divulge names).

So, sticking to the general point - I think we can summarise.

Your position is:
(1) Concerns that govt bodies such as health ministries have should never be shared until they have been investigated thoroughly and that investigation has reached its conclusion
(2) Until proven otherwise vaccination is always the better option (even for new vaccination where passive surveillance post introduction is effectively part of the safety trials)
(3) Side effects and adverse reactions never outweigh the benefits of whatever it is the vaccination is designed to prevent (even if, as in the case of HPV, you can actually alter your risk of contracting it by behavioural changes).

My position is:
(1) Govt bodies should share concerns, prior to investigations being concluded to allow people to make decisions based on up to date information.
(2) The risk-benefit ratio of a vaccination against HPV is going to vary greatly between individuals depending on their behaviour
(3) Side effects and adverse reactions can have lifelong life changing consequences and therefore informed consent should be given - and can only be given with access to up to date information. This is particularly important for individuals who aren't hugely at risk from HPV because their risk-benefit ratio will be weighted towards the risks.

Saintly, but if you read the paper, it talks about issues with the measles vaccine too, if parents were really using this paper as evidence to avoid the MMR, then why on earth would they go for the single vaccine, which is also linked, in the paper, to developmental problems? And the paper says 'Measles virus and measles vaccination have both been implicated as risk factors for Crohn's disease and persistent measles vaccine-strain virus infection has been found in children with autoimmune hepatitis'.

It wasn't the paper, was Wakefield banging on about single vaccines that started that whole mess. Like I said, people are usually not medical experts who go and examine the evidence themselves and are clever enough to interpret the data.

In which case I would say it was particularly important that if a government body have concerns they share those. With quite simple information people can work out whether they are at high or low risk for HPV infection, and then decide whether it's worth having a vaccination that the govt body feels has a high number of side effects.

As I already said someone high risk may decide it's worth the risk anyway - it's a harder decision for someone low risk.

This isn't about 'right' or 'wrong' decisions (I don't believe such a thing exists anyway). It's about informed consent, so having a vaccination knowing that you have a risk of particular adverse events and accepting those - usually because you have calculated that the potential benefits outweigh the risk. This is not a given though - it will vary from person to person. It becomes problematic in my mind when you have an adverse reaction that you didn't know was a possibility because you hadn't been told - and particularly problematic if the govt knew it was a possibility but decided to suppress that information.

Oh, and you have misrepresented my position.

1)I didn't say that concerns shouldn't be shared. It would be perfectly proper for the government to say it was investigating reports of possible side effects and firm evidence would be expected in 6 months. People could hold off it they wanted to.
Withdrawing a recommendation is easily seen recommending against it. But they are still offering the vaccine. What on earth are people supposed to conclude, when the evidence doesn't yet show any causal link? It's just chaos, and not for a really good reason, as you might expect when lives are at stake.

2&3) vaccination is clearly not always the better option, but the HPV vaccine has been shown to be effective, saves lives, and has been given to millions of people without side effects. No vaccine is completely safe and it is possible that even if a causal effect is shown, the risk might be so low that the vaccine continues to be recommended. Recommendations don't have to be just to have the jab or not, either, when you look at other vaccines, lots of categories come into the recommendations for different at-risk groups.

The governing body doesn't feel there are high numbers of side effects, it is investigating a possible causal link with some serious side effects, for which the current evidence can't establish a causal link.

How can you decide if you are at a high risk of adverse events if it isn't even yet established that these are side effects of the vaccine?

Like I said, they could have said they were investigating possible side effects, and would withdraw the recommendation if a link was established. Withdrawing the recommendation and saying it might be reinstated is just confusing.

No you can't decide whether you are at high risk of a side effect, but you can establish whether you are at particularly high risk of HPV and make a decision based on that. Whether it's have the decision or delay for further information.

Surely that is what they have said btw? They don't recommend it at the moment, its available if you want it, and they're investigating further. Not sure what the problem is unless you assume at this stage that they shouldn't share that they have fears - even for serious side effects. I would have thought that HPV is exactly the sort of vaccination where it was important to share that information because it is possible to establish whether you are at high risk for HPV and therefore the risk-benefit is going to vary from person to person.

Anyway we'll go round in circles on this. It comes down to I prefer to be given all the information available, for concerns to be taken seriously and to be communicated, and for the process to be transparent.

No, to remove a recommendation and to say that healthcare professionals cannot recommend it is not the same thing as saying that they are investigating possible side effects. It's a much stronger statement than that.

Re establishing that you are a high risk of HPV - well, the vaccine is offered to 13 year old girls, consent given by parents. How on earth do you establish that a 13 year old girl is going to be a low risk of HPV for the rest of her life? A 13 year old cannot say she will never have sex. Sex with a condom isn't good enough, lots of couples have unprotected sex and besides, you need unprotected sex to get pregnant. Maybe you should delay until just before you have sex to get the jab. Shit, I've just had unexpected sex and now it's too late? And at 13 committing yourself to regular smears starting over a decade in the future is just a bit ambitious don't you think?

Well personally I wouldn't give my 13 year old dd the jab but would educate her on when she needs to start thinking about whether she wants it (and tbh I think for is she's old enough to have sex she's old enough to decide for herself whether she wants the vaccination or not). I realise that isn't a popular view, but it just comes back to me seeing vaccination as a decision to be made on an individual risk-benefit analysis, rather than a population one.

I don't have dd's - but if one of my younger sons turns out to be gay I will certainly tell them about the vaccination and HPV, despite it not being offered to boys/men. DS1 won't ever be having sex so it's not something relevant to him - and even if it does start to be offered to all boys he won't be getting it (my decision), because as someone who won't be having sex it is not something he needs. I suspect if it is offered to boys he will be expected by public health bods to have it - even though he will not even be having sex. They're not filtering out where it's needed and where it isn't. Again individual risk factors and individual risks/benefits being different than population ones.

This is all very specific though. The broader question is should health bodies share concerns. You don't think so, I do. We're never going to agree because as I said above I see it as a matter for individual health (therefore you need all the information) you see it as a matter for public health (so don't need all the information).

I never said that they shouldn't share concerns. Please don't put words in my mouth.

Well I'm not sure what you're saying then, because the Japanese ministry of health have concerns and have shared them and you have said they shouldn't have done that.

In withdrawing a recommendation (even if temporarily) they are sharing that they have serious concerns. It would surely be unethical for a public body to have serious concerns but to continue to recommend something?

Sharing concerns would be giving information about the possible side effects that have been noted and that further investigations will be taking place as scientists have as yet been unable to establish a causal link.

Factual and informative. I'm all for it.

Withdrawing the recommendation based on incomplete evidence while still providing the vaccine for free is not simply sharing concerns. It is not factual and informative. In fact it is confusing and possibly scaremongering. They could have waited 6 months.