Cervarix: MMR the Sequel? (Update 3)

Statistically speaking, the story that broke last night was tediously inevitable. 1.4 million doses of the Cervarix vaccine have been administered to teenage girls since the program began, and eventually - whether by chance or adverse reaction - one person was bound to die. Yesterday, for whatever reason, that teenage girl was Natalie Morton, and my sympathies go out to her kith and kin. Her death, and the manner of its reporting, will affect public health in ways she'll never know.

There are two possibilities here, reaction or coincidence. As a species we're fairly poor at dealing with probability, and events like this seems far less likely to us than they actually are. The raw facts of the matter are that: a) most teenage girls around Natalie's age will be vaccinated in 2009, and b) a number of teenage girls die every year of initially unexplained causes. The chances of a one of those girls dying on the same day she got her vaccine could be as high as one in a few dozen.

On the other hand it could be an a adverse reaction to the vaccine. The chances of this are also fairly small, but there seems to be a lot of misunderstanding about these risks, largely coming from a misunderstanding of vaccine reaction incidence reports. For example, The Daily Mail make the mistake of suggesting that the Cervarix vaccine has been linked to thirty deaths. Of course it hasn't; the mistake they've made is to use the database of Vaccine Adverse Event Reporting System with the mistaken belief that the data shows confirmed vaccine reactions.

In fact the VAERS simply records people's self-reported ill health occuring around the time of vaccination on the off-chance it might be related. More accurate estimates of risk by the MRHA estimate the risk of severe reactions at around one in a million. To put that into context, about 2% of the population have reactions to penicillin.

The Mail also report that:

Critics say the tragedy highlights the risks of mass vaccination because no testing regime can detect the rarest and potentially most lethal side effects.

These critics appear to be JABS, who were quoted prominently in earlier editions of the Mail's online article, and in their print edition today. I'll move on to that coverage in a moment, but first it's worth pointing out that since he vaccine is likely to save around 700 lives a year, any theoretical, extremely rare side-effects would be comprehensively outweighed by the benefits. It's a self-defeating argument to make.

The response of mainstream media organs has ranged from reasonable (the BBC) to dire (the Daily Mail print edfition); and Malcolm Cole has done an excellent review of the coverage on his own blog, with scores for the various papers.

The Guardian have done an excellent job allaying fears, bringing in a doctor to explain a number of facts about the vaccine and the risks involved, but compromised that work with this bizarre little piece that looks like it was knocked up in a tea break. But as usual the Mail and Express lead the way in irresponsible scare-mongering. Take for example the following headline, kindly sent to me by the Daily Quail (click to enlarge to read the whole article). Some journalists consult doctors, the Mail speak to JABS:

It'll be interesting to see if they dare print anything similar in their Irish Edition.

The Mail article is horrendously biased towards sensationalism, and the The Daily Quail have covered it well:

"A statement from the Director of public health for NHS Coventry, saying 'No link can be made between the death and the vaccine until all the facts are known' was relegated to the last line of the report, while no mention was made of how many cases of cervical cancer might be prevented by the vaccination or how many womens' lives saved each year, or any research indicating that the vaccination is in fact safe."

"However, it was noted that 'more than 2,000 have suffered side-effects ranging from rashes to paralysis', and that 'some critics argue [the vaccine] will encourage promiscuity'."

The side effects are of course triflingly minor; while the suggestion that the vaccine promotes promiscuity is completely baseless in fact, a moral authoritarian fantasy idea for which no supporting evidence has been advanced. Taken together with the shocking exclusions of any sort of balancing information about the benefits of the vaccine, and the way in which the article leads the reader towards conclusions about tainted vaccines, and what we have is an incredibly irresponsible and potentially dangerous piece of reporting that will affect uptake of all vacccines.

Science Minister Lord Drayson recently took on Ben Goldacre in a debate at the Royal Institute. I was there, and he claimed repeatedly that newspapers and media outlets had learned the lessons of MMR; that in 2009 similar failures in science reporting wouldn't happen.

The fact is, they haven't. And if this sort of sensationalist, unbalanced and misguided reporting of distorted facts and cherry-picked evidence continues, vaccination rates will fall again, and diseases which have no business still existing in the 21st century will continue to plague us.

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

UPDATE 1:
News has just come in via The Guardian, suggesting the vaccine did not cause Morton's death. I may blog more on this later:

"A 14-year-old girl who died shortly after receiving a vaccine against cervical cancer had a 'serious underlying medical condition', a preliminary postmortem examination has revealed.

"Although local health authorities stressed that further tests needed to be carried out to establish how Natalie Morton died, they said the human papillomavirus (HPV) vaccine was 'most unlikely' to have been the cause of her" death.

UPDATE 2:
The Daily Mail have now begrudgingly admitted the above, but only as a single line in the fourth paragraph. There is no reference to it in the headline or leader.

"NHS Coventry revealed tonight that had she had a 'serious underlying medical condition' and said the vaccination was 'most unlikely' to have caused her death.

"But the city's primary care trust has nevertheless halted vaccinations for two days while an investigation into Natalie's death is carried out."

And below that, they still say that:

"It is not yet known whether Natalie had an extreme - and very rare - reaction to a standard vaccine, or whether the particular dose she was given was from a rogue contaminated batch."

UPDATE 3:

If you thought that the Mail's coverage was bad, The Express have taken things to an unbelievable level:

PARENTS’ REVOLT AFTER GIRL DIES IN CANCER JAB HORROR

The sheer stupidity of the journalists involved with that criminally misleading headline is matched only by the reactions in the comments:

THE GOVERNMENT MAKES OUR GIRLS INTO PROSTITUTES

The point of government policy is that all girls in every school should be readily available for sex at any time with anyone - in other words they want to make our daughters into prostitutes. Prostitutes have to have various medical treatments to keep them ready for the men - so our government administers this jab to every girl in the country except for those at independent schools, of course. This jab is against a sexually transmitted disease and shows the total failure of the government's sex policy: anything is all right as long as you use a condom.

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DBH (not verified) on Tue, 09/29/2009 - 23:06

A tragic case indeed, but during these times, one death is enough to cause the anti-vax camp to go up in arms. The comments section of the Daily Mail article makes painful reading.

Even if the cause of death is some serious underlying health condition (which it most probably is), it will be seen as a cover up. And all this is probably thanks to irresponsible reporting by the Daily Mail.

Lord Drayson should sit up and take notice. 2 weeks after his debate with Ben, his arguments are blown right out of the water by this tragedy.

DT (not verified) on Tue, 09/29/2009 - 23:22

The way the Mail are squirming to extricate themselves would be amusing were it not such a serious issue. They have an agenda, and woe betide anything that reveals facts that couner it. One can only hope that the authority's quick response in revealing the underlying cause of death will allay people's fears. But by the sound of the rants on the Mail online responses there are quite a number who will have decided, on the basis of preliminary and incomplete information coupled with the overpowering antivax message from the Mail, to forgo this vaccine. Their children risk a particularly nasty form of cancer that despite screening programmes kills nearly 1000 women each year in the UK.

I think serious questions need to be asked of the Mail's senior editors and their role in this affair. Perhaps you MJ could get some type of campaign going which we could all contribute to?

Martin on Tue, 09/29/2009 - 23:27

I agree, but I'm not sure what form such a campaign would take...

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Dr Aust (not verified) on Wed, 09/30/2009 - 01:05

The Fail may be squirming, but they're not letting a good scare go that easily: with utter predictability, the headline for tomorrow reads:

Chaos over cervical cancer jab for girls: Thousands cancel vaccinations after 14-year-old’s death

The story does contains this paragraph referring to the latest reports:

“Last night initial post mortem results suggested the schoolgirl had a serious underlying health condition which meant it was ‘unlikely’ the vaccine had caused her death. The local health trust in Coventry, which made the announcement, would give no further details to the nature of the problem.”

But it follows that up immediately with a sly “scare reviver”:

“It remains unclear whether Natalie’s condition alone was to blame or whether it was a particular reaction when combined with the vaccine.”

Nice.

PS The Daily Distress has an equally temperate (not) headline:

PARENTS’ REVOLT AFTER GIRL DIES IN CANCER JAB HORROR

Teek (not verified) on Wed, 09/30/2009 - 07:49

Here's how th campaign should go DT: start a petition to make all of the Mail's senior editorial staff write out the following 100 times, or until it enters their skulls:

CORRELATION IS NOT CAUSATION
CORRELATION IS NOT CAUSATION
CORRELATION IS NOT CAUSATION
CORRELATION IS NOT CAUSATION
CORRELATION IS NOT CAUSATION
CORRELATION IS NOT CAUSATION
CORRELATION IS NOT CAUSATION
CORRELATION IS NOT CAUSATION
CORRELATION IS NOT CAUSATION
...

here we go again...

Anonymous (not verified) on Wed, 09/30/2009 - 10:06

If this was a death from Ecstasy there would be posters everywhere warning people of the dangers. Would there be scientists trotting out statistics of how millions have taken it safely? Would we be talking of bad bathches? Would we be encouraging people to carry on regardless?

If this was a school accident in a gym or on an away trip or an allergic reaction to a school dinner there would be lawsuits and sackings.

Would we talk of underlying health reasons?

This is either a case of a severe failure in the production process or a dangerous vaccine - so how about a lawsuit, corporate manslaughter? Of course not you say - but why should anyone die from a healthy proceedure?

Stupid points you may think - but they are regularly applied when required, or as a situation dictates. A girl is dead for absolutely no reason.

One spokesman compared it to the risk of food poisoning. Why stop there? How about a bee sting, a car crash, a fall down the stairs.

The reason why people are always running scared from the scientisic community is because it never accepts responsibility and has alot of money riding on a smooth flow of research, applying patents, years of tests and dismissing public concern. It may be that this vaccine is perfectly safe, however the arrogant dismissal of all concerns makes me feel otherwise.

Martin on Wed, 09/30/2009 - 10:38

Anon "If this was a death from Ecstasy there would be posters everywhere
warning people of the dangers. Would there be scientists trotting out
statistics of how millions have taken it safely?"

Probably not, for the rather obvious reason that Ecstacy isn't used to save hundreds of lives a year.

Anon: "Would we talk of underlying health reasons?"

The verdict of the post-mortem is that the girl died of underlying health reasons, and that the vaccine is 'unlikely' as a cause. Why don't you think we should be talking about underlying health reasons?

Anon: "This is either a case of a severe failure in the production process or a dangerous vaccine."

...or a very rare reaction, or a girl who simply died from an unrelated illness on the same day. The evidence now points to the latter, but even if it were a reaction why should we stop a program saving hundreds of lives because of just one freak death? Millions of people are allergic to penicillin; would you call for a ban on that? Or for lawsuits to be brought against the manufacturers? Of course you wouldn't.

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debi (not verified) on Wed, 09/30/2009 - 10:44

Apply that principle to HPV !!
Same should be said for HPV hoax linked to cervical cancer
read FDA report http://www.naturalnews.com/downloads/FDA-HPV.pdf

FlammableFlower (not verified) on Wed, 09/30/2009 - 11:22

"THE GOVERNMENT MAKES OUR GIRLS INTO PROSTITUTES

The point of government policy is that all girls in every school should be readily available for sex at any time with anyone - in other words they want to make our daughters into prostitutes. Prostitutes have to have various medical treatments to keep them ready for the men - so our government administers this jab to every girl in the country except for those at independent schools, of course. This jab is against a sexually transmitted disease and shows the total failure of the government's sex policy: anything is all right as long as you use a condom."

Just decided to report this comment on the Express' website - it asks you to give a reason why you're reporting it - my reason: It is moronic.

Rogue Medic (not verified) on Wed, 09/30/2009 - 11:50

Excellent article. It is a sad commentary on the lack of understanding of science by the average person, that they cannot tell the difference between coincidence and causation.

We do not yet know if there is anything more than coincidence. The coroner suggests that there is not any other connection, besides coincidence. Some of the people commenting clearly do not understand the meaning of causation.

Zeno (not verified) on Wed, 09/30/2009 - 11:58

Phew, FlammableFlower! I thought it was you who were saying that until I got to the last line!

Unfortunately, being moronic may well be a pre-requisite of being an Express reader!

ChrisSamsDad (not verified) on Wed, 09/30/2009 - 12:07

It's seems it's a 'natural' reaction to some tragedy to look for the causes and find someone or something to blame. People are also relying on what they think of as common sense to see a smoking gun here - she had the jab, she died - it must be the fault of the jab.

However, like many other natural reactions and 'obvious' connections, it's not something you can rely on instinct for. Natural reactions and instictive feelings are very useful in some instances, but let us down when it comes to the big picture. We're particularly bad at risk assessment it seems. We'll happily do the lottery and consider there's a chance we might win, but if we'd consider those odds likely in all situations, we'd wear protective clothing around the house, as we're 20 times more likely to suffer a fatal accident in our home.

Zeno (not verified) on Wed, 09/30/2009 - 12:07

debi: Can you summarise why you think that 68-page petition to the FDA (it is NOT an FDA report) from a commercial company, apparently about some device they manufacture, has anything to do with some HPV hoax?

DBH (not verified) on Wed, 09/30/2009 - 12:39

Exactly my sentiments Zeno. I glossed over when I saw the 68-page monster.

Debi: If you want to criticise something, outline your point properly. No-one would take you seriously if you just link to what can only be described as a book, and especially when the link has nothing to do with what you are talking about.

Anonymous (not verified) on Wed, 09/30/2009 - 12:50

"Probably not, for the rather obvious reason that Ecstacy isn't used to save hundreds of lives a year."

there is no means of a scientific test on the vaccinated "subjects". so it's impossible to say whether the vaccine will have good, bad or indifferent results.

Dr Aust (not verified) on Wed, 09/30/2009 - 14:45

Re. anon 10.06

Scientists have tried to talk sensibly about the statistics on MDMA-related deaths. Remember poor old Professor David Nutt earlier this year?

Ditto for food allergies, BTW.

And it is not science that mandates witch-hunts and calls for heads to roll after school accidents. The general insider view of how to deal with tragic events in medicine, for instance, follows the air accident investigation model and tries to analyse the "systems failure" that led to the accident with a view to improving the system and stopping the same thing happening again. The demand to have the people involved in "critical incidents" publicy flogged comes from the same folk as in the Ecstasy scenario - sales- and "shock horror"-chasing newspapers, and headline- and vote-chasing politicians.

"This is either a case of a severe failure in the production process or a dangerous vaccine - so how about a lawsuit, corporate manslaughter? Of course not you say - but why should anyone die from a healthy proceedure?"

Or how about it's not either of these - it is likely a case of an apparently healthy girl who sadly had a serious, probably undetected and quite possibly lifelong underlying medical condition, like a predisposition to cardiac arrhythmia. There are plenty of such "silent" things, though thankfully they are rare. Some can mean you are at risk every time you get excited or stressed. No doubt we will learn what it was in due course, but in the meantime you are just another ill-informed scare peddler.

Bonzo (not verified) on Wed, 09/30/2009 - 16:31

Martin told us,

"but first it's worth pointing out that since he vaccine is likely to save around 700 lives a year, any theoretical, extremely rare side-effects would be comprehensively outweighed by the benefits."

I think Martin may be crystal ball gazing here - and of course the 700 or so to benefit, who Martin can see in his pseudo-scientifically enhanced crystal ball, are only a hazy hypothesis to the poor girl who actually died - and her parents.

Dr Aust (not verified) on Wed, 09/30/2009 - 17:02

I see the anti-vaccine crew have appeared.

I think Martin may be crystal ball gazing here - and of course the 700 or so to benefit, who Martin can see in his pseudo-scientifically enhanced crystal ball, are only a hazy hypothesis to the poor girl who actually died - and her parents.

Isn't it touching the way anti-vaccine nuts get to shed those crocodile tears?

First off, we don't know that the poor girl's tragic death had anything at all to do with the vaccine. The scanty medical evidence we know thus far suggests it did not.

Second, the general estimate, even with all the current cervical screening, is that cervical cancer kills about 1000 women a year in the UK.

Most of these cases are a result of HPV infection. The vaccine is designed to prevent these infections, and is highly effective. So Martin's "crystal ball gazing" is a logical ball-park numerical estimate from the known facts.

Unfortunately it is statistical fact that, in the kind of hypothetical situation Martin discusses, a very few people may be harmed by a vaccination programme which overall has enormous benefits. Vast amounts of work goes into making the numbers harmed as small as they can possibly be.

The same thing applies to many health screening interventions - see e.g. the discussion here.

Sadly, you cannot have benefits without risks with most healthcare interventions. It may sound cold-hearted stated that bluntly, but it is true. The only people who believe you can have benefits WITHOUT any risks are the blinkered and deluded idiots who flog Alternative Medicine.

The death of a young woman like this is a tragedy. So are the 1000 deaths a year in the UK from cervical cancer.

Finally, what the parents really need at this stage, apart from support from their family and friends, is

(i) less attention from the media vultures; and

(ii) the medical facts about what happened to their daughter, delivered as quickly as possible.

Neuroskeptic (not verified) on Wed, 09/30/2009 - 17:11

"I think Martin may be crystal ball gazing here - and of course the 700 or so to benefit, who Martin can see in his pseudo-scientifically enhanced crystal ball, are only a hazy hypothesis to the poor girl who actually died - and her parents."

Er, yeah. Let's assume the vaccine campaign saves 700 lives and kills 1 person. (The vaccine didn't actually kill this girl, it turns out, but, I'm being kind here).

That vaccine would then have saved 699 lives. Or, to put it another way, not using the vaccine would kill 699 people.

But unfortunately the one person who died would be so much more memorable and vivid than the hazy 700 people who were saved. After all, if someone doesn't get cancer, that's not an event. No-one notices. I didn't die from cancer yesterday. Neither did my cat. Neither did you. That's not news.

So one death becomes news and 700 lives saved don't. Luckily, the government doesn't make vaccination policy on the basis of news or what's "hazy" and what isn't, it calculates what will save the most lives and does that.

Which is exactly what's going on here. Thanks, The Government.

You don't like the government because, well, this is Britain 2009, no one likes the government. Gordon Brown is a one eyed Scottish idiot, NuLabour, whine whine whinge whinge. Fair enough, but can you stick to whingeing about Gordon and not let your political opinions affect your judgements about HPV vaccination, because that's actually quite important.

Shel (not verified) on Wed, 09/30/2009 - 18:00

The real reason people are getting scared of vaccines are ignorant comments such as yours.

First, there's your fallacious dichotomy of either a contaminated vaccine or a dangerous vaccine. No other possibilities can exist in your world.

I'm not a doctor. I have followed the ignorant anti-vaccine debate.

If you actually were concerned with the truth an hour's worth of searches on 'enemy' web sites should have given you at least a few of the other possibilities.

Instead, you're just another living example of confirmation bias gone rampant.

You don't understand what can go wrong with vaccines.

It would have been better if the scientists had talked more about time and side effects.

There's a good lay person understanding that gym accidents, car crashes and falls down stairs can kill within hours. Most of the time, there isn't an underlying medical condition.

Street drugs can kill within hours for a variety of reasons just from taking the drugs. Sometimes it turns out that they aggravated an underlying medical condition.

So the first reports on any of the above usually won't focus on underlying medical problems. There are likely and plausible causation explanations that explain how the event can cause death within a few hours.

Vaccines have been given for a very long time. The big risks from vaccines are allergic reactions, catching the disease the vaccine is supposed to protect you from and attacks by the immune system triggered by the virus.

This was her first shot of the vaccine.

You couldn't miss a death causing allergic reaction.

The Cutter polio vaccine contamination debacle still required the time for the disease to affect the body. A few hours isn't going to both cause cancer and then have her die from cancer.

The worst immune response to a vaccine, GBS, is very, very unlikely to take serious effect in a few hours. Even at its worst, she could have been kept alive much longer with the use of a respirator.

And since only one girl had this type of reaction to the vaccine, it's very, very, very unlikely that something was so wrong in what was in this vaccine batch that it also managed to only effect one person.

So there aren't any likely or even plausible explanations that explain how getting a vaccine can kill in a few hours without it being very obvious.

Scientists also know that the vaccine has been given to millions of people and you would expect rare events to occur purely by chance after getting a vaccine.

That's why scientists are ultimately going to be dismissive of the idea that this vaccine can kill a girm in a few hours.

zpvicoa8xgm4a93a

Anonymous (not verified) on Wed, 09/30/2009 - 18:59

I'm supposed to get this vaccine tomorrow. Correct me if I'm wrong, please, but I may back out because of some very unsettling facts:
You can only get HPV once you're sexually active, and I'm still a good few years too young for all that. Depending where you look, the vaccine lasts between 4 and 7 years. If it's 4 years, that'll be round about the time I'll be needing it that it wears off. Under the circumstances, don't you think it's better for me to wait and see how the program goes before jumping in blind? Dismissing the death as an anomaly, there's still alot of other side effects. Apart from that, dose 3 for me would come just before exams. Why risk passing out and a dead-weight arm for a jag which I don't need for years?

DT (not verified) on Thu, 10/01/2009 - 00:24

Anon, I'll have to look back at the relevant papers, but as I recall the protection is expected to last a minimum of 7 years because that's as long as the vaccine studies have taken place. The likelihood is that protection is for longer, but even if it is shown to wane after this time, a booster dose would be a simple way to boost protection again.
We already see this with vaccines like Hepatitis B. You need 3 doses to start with, and originally we were told this would protect us for life. Turns out immunity declined after about 10 years in most people, so booster doses may be required for these. Vaccines for diseases like yellow fever, polio and tetanus also wane after 10 years. People get boosters. It's not a big deal.

James Cole on Thu, 10/01/2009 - 10:53

I see that the BBC have reported further on the underlying medical condition.

"The pathologist who carried out the post-mortem examination on the girl said the tumour was so severe that death could have arisen at any point."

Neuroskeptic (not verified) on Thu, 10/01/2009 - 11:25

Pretty scary. She had a lethal tumor and never even knew...

DBH (not verified) on Thu, 10/01/2009 - 11:46

It is a great shame that it was a tumour. None of the "up in arms" lot will ever believe that.

Lovely how the Daily Mail manages to pull someone out of nowhere (Dr Diane Harper) to skew this story completely.

All in the interest of "balance" huh?

Quoting Dara O'Braian - Get in the bag!

A.J., Wimble (not verified) on Thu, 10/01/2009 - 15:49

I think there are two key facts here that the Daily Mail and others either fail to grasp or just decide to ignore.

1. Coincidences happen. Given the huge number of people who have been vacinated, it is not surprising that one of them happened to die at the same time, quite possibly for completely unrelated reasons.

2. Nothing can be proven 100% safe. If any drug is given to enough people, there will be adverse reactions. The key question is just the gain justify the risk. In this case even if the death is eventually linked to the vaccine, I think several hundred lives saved every year justifies a minute risk of a serious, even terminal side effect.

malcolm coles (not verified) on Thu, 10/01/2009 - 23:46

Hi, as you're covering this, I thought you'd be interested in my attempt to get the relevant NHS result into the first few results on Google.

If you could add a link to the NHS page that would be great. Ditto if you could publicise how other people can help: http://www.malcolmcoles.co.uk/blog/cervical-cancer-jab-please-hel/


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