Sep 30 2009

The HPV Vaccine

The Daily Mail reports of a 14 year old girl who died within hours of receiving the HPV vaccine (the brand being given in the UK is Cervarix, the better known brand is Gardasil). While this story is sensational and sure to stir up fears of the risks of the vaccine, a more sober look at the data shows that the vaccine has a very high safety record.

The bottom line is that we cannot interpret a single case such as this. As present there is no medical conclusion as to why the girl, Natalie, died. She stopped breathing, arrested, and could not be resuscitated. While tragic, this can unfortunately happen from a number of causes. It is plausible that the vaccine was a trigger, but it’s also plausible that it was not.

Of course, as a physician, a science writer, and a father of two young daughters I want to know what the data shows – what is the safety profile of the vaccine. (It’s somewhat misleading to ask “is it safe” although we often resort to this short hand, because it encourages a false dichotomy. Medical interventions are not all safe or all unsafe – they have a risk-benefit ratio. But it is reasonable to characterize the ends of this safety spectrum as either being basically safe or unsafe.)

Joe Albietz at SBM gives us the recent skinny of Gardasil safety, based upon recently published data. Here are the vital stats from the FDA:

“Every year, about 12,000 women are diagnosed with cervical cancer and almost 4,000 die from this disease in the United States.”

After distributing 23 million doses of Gardasil, there have been 772 serious adverse events reported, included 32 deaths. These are no greater than the background rate of reported events for a population this size.

In other words, safety monitoring of Gardasil has not revealed any pattern of excess deaths or serious outcome associated with the vaccine.

What this means is that all the data we have so far is compatible with the conclusion that Gardasil produces no serious side effects. It is possible that rare reactions are hiding in those numbers, but there has not been enough for a statistical pattern to emerge.

The benefit of the vaccine is that it is 94-100% effective in trials so far at preventing precancerous lesions from occurring (the very lesions that turn into cervical cancer). It is too early to say how many lives this will saved (it will be years before we see the effects of the vaccine on cervical cancer incidence), but it is likely that hundreds or even thousands of women per year will be spared death from cervical cancer by this vaccine.

Even if we assume that all 32 reported deaths were caused by the vaccine (very unlikely as that would mean otherwise there would have been zero deaths in the 23 million girls receiving the vaccine in the time period following the vaccine), that would still mean that the benefit of the vaccine outweighs the risk. And keep in mind the true number of excess deaths from the vaccine is certainly less than 32 and may be very close to zero.

Using a single case to promote fear is easy. Putting that case into statistical context is complex. But it is unfortunately true that people are more compelled by one vivid story than they are by mountains of data.

____________________________

Update: The BBC has now reported that initial medical evaluation of Natalie indicates that she had a major underlying health condition that was likely the cause of her death and that the vaccine was unlikely to be a contributing factor to her death.

This makes sense, and is what I suspected. There are a number of known conditions, such as heart defects, that can lead to exactly what was described as happening to Natalie.

I will add any updates as they become available.

Thanks to “Truckle” for the heads up.

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31 responses so far

31 Responses to “The HPV Vaccine”

  1. Graniaon 30 Sep 2009 at 8:58 am

    Thank you for writing on this, it is hard to get people to get some measure of perspective on a tragic death of a girl; but it is stunning to see the wild and unfounded accusations that are being tossed about at the moment.

    The Daily Express has an even worse take on this case:
    “PARENTS’ REVOLT AFTER GIRL DIES IN CANCER JAB HORROR”
    http://tinyurl.com/y8dggy9

    Fearmongering and ignorance abound in the comments.

  2. zenoon 30 Sep 2009 at 9:25 am

    It was bound to happen: a death shortly after a vaccination. Even if and when there is a categoric denial that her death had anything to do with the vaccine, the anti-vaxers will still have a field day, doing what they are oh so good at: cherry-picking what they choose to believe and ignoring (or plainly just not understanding) facts and the evidence. Conspiracy theories will abound.

    Unfortunately, the take-up rate in the UK – and possibly elsewhere (Gardasil will get blamed as well) – will now fall and women will die in the future as a result.

    It is very sad for that girl and those she has left behind and sad for those who are yet to suffer.

  3. Graniaon 30 Sep 2009 at 9:45 am

    I think it is fair to say that were this a vaccine against, just for example, prostate cancer there would have been far less resistance to it.

    There is still a nasty stigma attached to certain types of cancer – the “guilty” cancers – cervical, anal & lung. Probably skin cancer too – i.e. it is your “fault” if you get one of those cancers. You asked for it.

    There was a very similar stigma attached to AIDS – you had innocent AIDS (from a blood transfusion) or guilty AIDS (from sexual contact).

    Add to this the background of the conservative and puritanical element found in certain parts of the UK who campaigned actively against this vaccine being given to young girls and it is not hard to see why the gutter press is running away with this story.

  4. Truckleon 30 Sep 2009 at 9:58 am

    Steve et al.

    The BBC is now reporting that the vaccine is ‘Unlikely to have been the cause’ for the girls death, she apparently had underlying health issues.

    Link :

    http://news.bbc.co.uk/1/hi/health/8281673.stm

    It is still possible that it might have been a contributory factor, but it might well have been coincidence.

    (waits for BIG PHARMA consipracy and coverup nuts to arrive)

  5. daedalus2uon 30 Sep 2009 at 11:11 am

    Now that the vaccine is approved for teenage males, that is the demographic that should be targeted.

    I think that if one implied that a woman would be more likely to sleep with a man if she knew he cared enough about her health to be vaccinated for HPV, that men and boys would sign up to be vaccinated in a heart beat.

    It wouldn’t take very many women for such a meme to go “viral” (so to speak). If a woman being hit on by a man asks him if he has been vaccinated for HPV and then rejects him “just because” if he hasn’t, there will be a strong incentive to be vaccinated.

  6. Joeon 30 Sep 2009 at 11:55 am

    @daedalus2u,

    I hate to break this to you ;) … when it comes to prerequisites for sex- guys LIE (big time). “I can’t have HIV because I am a virgin” … “I have been vaccinated” … “I’ve had a vasectomy” … “of course I’ll still respect you in the morning” …

    The vasectomy thing doesn’t work for me because everyone knows I got in a fight with the doctor I went to for that. I asked him if the procedure would be painful, and he said “Don’t worry, it’s just a little prick …” I have never been so insulted.

  7. Robinon 30 Sep 2009 at 2:04 pm

    Typical knee-jerk stuff from our tabloids I’m afraid.

    Perhaps you’re not familiar with British newspapers – take everything the Daily Mail, The Sun, The Express and Daily Star say with several metric tonnes of salt.

  8. daedalus2uon 30 Sep 2009 at 2:48 pm

    Joe, I don’t know what you are talking about, I have never lied to a woman to get her to have sex with me. I think that lying to women like that is for losers. Unfortunately many women don’t seem to think so, and so they put up with it.

  9. Joeon 30 Sep 2009 at 2:52 pm

    @ daedalus2u on 30 Sep 2009 at 2:48 pm “Joe, I don’t know what you are talking about, I have never lied to a woman to get her to have sex with me.”

    That’s why I had to ‘splain it to you … ;)

  10. artfulDon 30 Sep 2009 at 3:56 pm

    Women don’t believe most lies, but they acquiesce in direct correlation to their appreciation of the effort and skill involved.

  11. Elisheva Levinon 30 Sep 2009 at 4:49 pm

    I am happy that the vaccination is not a problem for most women. My daughter elected to get it, but then, she has had only one complication from a vaccination and the forumula for that one was different than this one.

    However, due to variation, the risk-benefit calculations will be different for each individual. There is simply not one set of statistics that will suffice for everyone. And these things change over time as well. For example, due to an underlying medical condition, specific vaccinations–especially untried ones–are riskier for me than for a healthy person. I therefore must make decisions on the risk for me, and of course, in certain situations, I must protect myself from infection in ways that people who have a lower risk from vaccination do not. The luck of the genetic draw, so to speak!

    The important thing is that we must recognize the right of individuals to make these decisions for themselves and for their children. What’s good for the goose is not always good for the gander!

  12. superdaveon 30 Sep 2009 at 5:42 pm

    Elisheva, your points are well taken but sadly the enemies of western medicine do not understand nuance. On the AoA blog, the mentality is that if vaccine A can be proven unsafe, then vaccines B and C are guilty by association.

  13. Graniaon 01 Oct 2009 at 4:37 am

    While most of the UK papers are now reporting the updated version of the story, the Daily Mail is still doing the scaremongering thing. Their line now is that even the experts think the benefits of vaccine is overhyped:
    “Dr Diane Harper – one of the world’s leading cervical cancer experts – said health officials and drug firm bosses were exaggerating the jab’s benefits. ”
    http://tinyurl.com/y85hdz2

    It is entirely possible that the doctor’s words are being quoted out of context or twisted rather than this reflecting her genuine opinion.

    True enough the Daily Mail is a rag, but it has enormous readership.

  14. Truckleon 01 Oct 2009 at 6:25 am

    Latest is that the girl died of a malignant tumour in her chest, and the vaccine is thought to have had nothing to do with it, merely a tragic coincidence…

    http://news.bbc.co.uk/1/hi/health/8284517.stm

    Now i agree with my brother on this, his theory being if newspapers make a mistake they should be forced to print the correction or retraction of a story in the exact same spot on the paper that they gave the first story, same size font and column space…

    That would soon make newspapers more responsible about the garbage they print if they had to keep filling up prime spots of paper real-estate if they had to keep wasting it on big retractions or corrections.

  15. SteveAon 01 Oct 2009 at 8:23 am

    Unfortunately some people appear to exhibit a ‘no blood on my hands’ mentality when it comes to making decisions about vaccinating their children. They seem to prefer an outcome where their child dies of some vaccinatable condition rather than take the far, far smaller chance that their child will suffer from the effects of an injection. In the latter case they feel they could be blamed for the death or injury; in the former, they can put it down to bad luck, blind chance, or the ‘will’ of whatever vicious god they happen to worship.

  16. superdaveon 01 Oct 2009 at 9:18 am

    I am glad that the vaccine was vindicated but could the BBC have called her something a little more tasteful than “Cancer Jab Girl”?

  17. cuervoon 01 Oct 2009 at 2:28 pm

    Most of the UK coverage of this story has been reactionary fearmongering. The Mail and the Express have had me fuming, like a cartoon character with steam coming out of his ears. But heard a few BBC radio news items that were also heavily skewed to an anti-vax format, which is more disheartening. On several occasions they have followed this story with the upcoming swine-flu vaccs, giving an implicit negativity.

  18. son 02 Oct 2009 at 11:39 am

    Melbourne sacred hearts girls college may 7th 2007
    720 girls HPV vaccinated
    26 girls sick within 2 hours
    4 transported by ambulance to the ER

    pat 1 2h post vacc
    syncope, leg paralysis, facial nerve palsy, aphasic

    pat 2 30 min post
    bilateral lower limb weakness

    pat 3 20 min post
    face and arm paresthesias, palpitations, shortness of breath

    pat 4 3 min post
    syncope, lateral limb weakness

    Could of course be brushed away as psychogenic. Just a amassive HPV related psychogenic event. Just a 5-20 fold “psychogenic” increase in vaccination related syncope reported to the CDC (VAERS) after the introduction of HPV vaccine.

    Consequences from the vaccine is safe just a few get seriously ill and they are scare mongering argument
    Negative public opinion regarding immunisation
    Failure to return for subsequent doses
    Distrust of medical staff

  19. daedalus2uon 02 Oct 2009 at 1:39 pm

    s, it might actually be psychogenic. The likelihood of psychogenic adverse symptoms following vaccinations increases with the degree of hysteria whipped up by anti-vaxers. It becomes self-fulfilling.

    The comment about witches on the other thread is quite appropriate here. Many people have been killed for being witches because they were believed to have caused adverse symptoms, for example stealing or shrinking a man’s penis.

    http://en.wikipedia.org/wiki/Genital_retraction_syndrome

    Is penis stealing a real or a psychogenic disorder? Or both? Calling it psychogenic doesn’t dismiss the symptoms and experiences of those experiencing those symptoms as non-real. It does shift the idea of what treatments are likely to be effective.

    Testing a person for witchcraft and showing that they are not a witch by having them drown, may be sufficient to “cure” a case of penis theft. Killing the person demonstrated to be a “witch” might “cure” it too. If a successful “cure” follows a successful “treatment”, does that demonstrate that there was a causal connection between them?

    Since penis size and presence can actually be measured, presumably symptoms of penis stealing are less subjective than the nausea, vertigo and queasy feelings that you mention following HPV vaccination.

  20. son 03 Oct 2009 at 4:26 am

    Daedalus,
    why would psychogenic effects increase for one type of vaccination and not others? Kindly explain that instead of peddling some ridiculous penis story in a pathetic ad hominem attempt.

    Most claims about vaccines on this blog are just the mirror image of the anti-vaxers scare mongering. Anti vaxers threaten with death by vaccination, the counter claims made on this site with death by non-vaccination.

    Both claim are based on pretty much a very sectarian discourse based on anything but evidence. Evidence that can be garnered from storical mortality figures and e.g. Tom Jeffersons reviews at Cochrane.

    What this blog, and all the swine H1N1 has managed to convince me of is that we have two sects. The anti-vaccinje sect and the pro-vaccine sect bashing each other on the head and branding (maybe I should say stigmatising) the opposition as ungodly blasphemers. Which both avoid any argument based on science. Both refer to feelings, faulty science and pseudo-science produced by parties that have something to gain from it.

    In my case the Cochrane reviews (and a personal dip into mortality data) clinched it for me. “As they say on Mythbuster: “Busted”.

  21. nebaliaon 03 Oct 2009 at 7:00 am

    S
    ‘why would psychogenic effects increase for one type of vaccination and not others?’

    The current target for the HPV vaccine are teenage girls. This IS a group more likely to produce psychogenic reaction particularly when in large groups, as would have been the case in the example you gave.

  22. lizditzon 03 Oct 2009 at 6:18 pm

    s, a group vaccination of school-aged girls is exactly the kind of setting that would induce mass psychogenic illness, as this case report from the New England Journal of Medicine discusses.

    I can’t think of another vaccination that is given in groups.

  23. Graniaon 03 Oct 2009 at 7:05 pm

    Another paper in the UK is using Dr Diane Harper’s words to cast further doubt on the vaccine, and are trotting out Richard Halvorsen (author of “The Truth about Vaccines”) who apparently has no shame at all – he has the nerve to say that he doesn’t believe that the girl had cancer and insinuates that this is some sort of cover-up.

    I googled Dr Harper, and I still think that she is being quoted out of context, and that what she really said is being deliberately twisted to put an alarmist spin on it.

    Daily Express: Jab ‘as deadly as the cancer’ http://bit.ly/S1tmP

  24. daedalus2uon 03 Oct 2009 at 10:33 pm

    s, the example of penis theft was chosen as an example of something that is obviously (obvious to me anyway) solely a result of psychogenic symptoms. Something that people believe in enough to want to beat people to death over it. Maybe that animosity toward those accused of penis theft is like the animosity toward the vaccine manufacturers but without the potential for a legal lottery payoff. Some people believe in the anti-vax nonsense enough to make death threats to Dr. Offit. If psychogenic symptoms are sufficient to invoke homicidal rage in one case (i.e. penis theft), why can’t it in another?

    There is much more of a pushback on the HPV vaccine because it relates to protection against sexually transmitted diseases. Some individuals feel that sexually transmitted diseases are a punishment by God to those who have sex not in accordance with His rules.

    If vaccination for HPV is seen as trying to thwart God’s punishment by HPV infection, cervical cancer and death, it should produce feelings of guilt and a belief that because God’s will can’t be thwarted, that God will impose some other punishment, i.e. syncope, nausea and such.

  25. son 04 Oct 2009 at 7:41 am

    Daedalus,
    avoid making such an example in a Texan bar… ;-)

    Your second explanation is relevant although speculative.

    Psychogenic / psychological explanations are to me medicines waste basket. Used when no physiological and/or biochemical explanation can be found. They are, in my mind, the lazy unquestioning scientists (or doctors) excuses to avoid the hard labour of trying to understand underlying causes.

    History is full of Freudian ideas blaming either the patient or their parents irrespective of the actual facts. A good example is the refrigerator mother idea for ASDs. Another is the Freudian coupling of bedwetting and masturbation. Says tons about Freud btw.

    To get back on track. This does not mean that there are no bad parents or social environments. This does not mean that our “hardwiring” cannot lead to extrem physical reactions to enviromental distress. The environment being a needle, improper nutrition or confused ideas about God and punishment. But to give proper treatment you need to understand the “real” causes.

    Any a priori decision that all patients receiving HPV vaccinations must have underlying, and thus implicitly unresolved, issues of sexual fear is not science it is more akin to charlatanery. It does not explain the 5-20 fold increase in syncope (hypotonic hyporesponsive episode) frequency.(1-3) It is just a plain lazy argument. It could be seen as “denial, rationalization, and displacement to avoid recognizing the physical nature of their disorders”. If you, Daedalus, are able to explain this extreme overincidence, compared to other vaccines, without resorting to psychology I’ll belive you.

    As you by now understand I am not a fan of psychological explanations. Sure mass hysteria may have both physiological and evolutionary explanations, but as an explanation it is really the last resort. Only to be used when you are sure there can possibly be no other explanation. Which should be never…

    Psychoneuroimmunology (/-endocrinology) is a field of research that tries to find that explanation. (“Psychoneuroimmunology is an interdiscplinary field of resesearch including the behavioral sciences, neuroscience, physiology, pharmacology, and immunology. A major aim of the field is to examine interactions between behavior and the nervous and immune systems and how these interactions affect health.”) A PNI explanation on how such a simple thing as a vaccine shot could cause syncope etc, would be much nore valid than the allegorical psychogenic wastebasket explanation. With a correct explanation of the reactions that could lead to a reaction such as syncope, it would be possible to identify these patients beforehand. It would then also be possible to clearly disentangle HPV vaccine caused adverse affects from essentially not vaccine related.

    And evidence for some vaccines is flimsy. As Tom Jefferson’s Cochrane reviews (and those are really good skeptical work looking at the evidence) have shown essentially no evidence exists for influenza vaccines. (And he is not against vaccines in case you wonder.) The need for other vaccines can also be questioned. The Swedish moratorium for e.g. the “old” (whole cell) pertussis vaccine showed only that morbidity increased. Adverse effects did not increase, nor did mortality. 6 children died (1980-1993) during the moratorium, 11 have died (1997-2006) after vaccinations restarted. The increase can probably be explained by an increase of prematures. (4-6) Yes society and parents probably saved some money as vaccinations are cheaper than prolonged medical care and hospitalizations. But that is about it.

    Acknowledging this would probably do much more for the vaccine debate than acrimonious vituperation between the “die by vaccine” and “die by no vaccine” sects.

    We live in a world in which incentives to produce poor or bad research outstrip those for producing good quality studies.
    Tom Jefferson (http://www.attentiallebufale.it/libro/index_en.html and http://jrsm.rsmjournals.com/cgi/search?sortspec=relevance&fulltext=bufale&x=0&y=0)

    BTW the dead english girl seems to have had a undiagnosed tumour in her chest involving her heart and her lungs. (http://news.bbc.co.uk/2/hi/health/8284517.stm, http://www.dailymail.co.uk/news/article-1217280/Cervical-cancer-jab-Natalie-Morton-died-chest-tumour-vaccine.html.) Hmm, a malpractice suit maybe? (If it is possible in the UK.)

    (1) http://jama.ama-assn.org/cgi/content/abstract/302/7/750
    (2) http://www.bt.cdc.gov/coca/summaries/pdf/Syncope%20following%20Immunization%20082009_Interim.pdf
    (3) http://www.bt.cdc.gov/coca/ppt/COCA-Syncope082009CE.pps
    (4) http://www.smittskyddsinstitutet.se/upload/SMI-rapport%20nr%204-2008.pdf
    (5) http://www.ncbi.nlm.nih.gov/pubmed/3588110
    (6) http://www.smittskyddsinstitutet.se/statistik/kikhosta/?t=com&p=10568#statistics-nav

  26. John2on 05 Oct 2009 at 5:37 am

    Why would the existence of a massive undiagnosed tumour in an outwardly healthy 14 year old girl be the subject of a “malpractice suit”?

    I am not sure how it is in the US ,but here in the UK we don’t routinely screen children for asymptomatic tumours, and so it’s not clear at all how you think that a doctor has done something wrong in this case.

  27. son 05 Oct 2009 at 7:33 am

    To quote from the BBC article:
    “A pathologist said her undiagnosed condition was “so severe that death could have arisen at any point”. ”

    “The deputy coroner, who opened and adjourned the hearing at Coventry Magistrates’ Court, said: “It appears that Natalie died from a tumour in her chest involving her heart and her lungs.” ”

    “The inquest was told that the tumour had “heavily infiltrated” her heart and extended into her left lung. ”

    Not the best situation to be in when getting a shot from a vaccine with a great over-incidence of syncope…

    And if the tumour was as invasive as stated on BBC it is highly unlikely that she was symptomless. But maybe the malaise, shortness of breath and fainting spells etc were fobbed off as psychogenic (yeah that was snide of me). (I just assume she should have had enough symptoms to warrant a medical visits. And as things go in the US a malpractice suite directed at the doctor/nurse performing the vaccination is also very likely indeed)

  28. daedalus2uon 05 Oct 2009 at 7:56 am

    s, There isn’t a physiological or biochemical reason for increased syncope with HPV vaccine compared to other vaccines. A “hot spot” of syncope suggests a common cause. If the vaccine is the same in regions where there is no “hot spot”, then the common cause is likely from something different than the vaccine.

    Here is a whole article on syncope following vaccination published in 1997, 10 years before the HPV vaccine was available.

    http://jama.ama-assn.org/cgi/ijlink?linkType=ABST&journalCode=archpedi&resid=151/3/255

    HPV is injected IM. Most of the cases of syncope are too rapid to have occurred other than via psychogenic mechanisms. In one case the person fainted before they received the vaccine. If it isn’t psychogenic, then it must be pretty powerful to have effects before it is given.

    I looked up the case of the 5 girls going to the hospital. Three were released the same day, and the other two were released the next day.

    You may be right about there being a lawsuit if that poor girl had died in the US. But that isn’t about the “standard of care” or the reasonableness of the claims, it is about money and the jury’s willingness to compensate grieving parents with malpractice insurance company’s money.

  29. John2on 05 Oct 2009 at 12:21 pm

    OK, S, I’ll not respond to the snide comment (which was pretty immature by the way), but will just point out that there is no indication that she had sought any kind of medical treatment for any symptoms at all regarding the tumour.

    Thankfully we still don’t have too many people acting as you over here, screaming for a legal case whenever modern medicine falls short of 100% success in every case. We are going your way, but are still thankfully well behind, with cases being reserved for genuine errors, rather than frivolously being filed by people who just have a general grievance against modern medicine,

  30. son 05 Oct 2009 at 3:55 pm

    1) <Immature
    Yeah I know, my fingers just itched too much…

    2) The reason US medical costs are the highest in the world are mayfold, but "defensive medicine" to avoid malpractice suits is one cause.(1) The system also seems to be a leading cause of personal bankruptcy.(2)

    3) Daedalus,
    You skirt the issue. I have not stated that syncope does not occur at vaccination. I have stated that HPV vaccine has an extremely unlikely higher incidence than any other vaccine. There is no evidence of any psychological mechanism resulting in extreme rates of syncope at HPV vaccination.
    It does not follow any logic that a "hot spot" would exclude cause A but not cause B. Or that both A and B may occur concurrently. We do not know. And psychogenic excuses are bad science. No, they are no science at all! They are more akin to religious belief in demons causing illness.
    _______________
    (1) http://scienceblogs.com/denialism/2009/05/what_is_the_cause_of_excess_co.php
    (2) http://www.scientificamerican.com/blog/60-second-science/post.cfm?id=are-medical-costs-the-leading-cause-2009-06-05

  31. [...] have been two stories in particular about alleged severe reactions following vaccines recently, one dealing with the HPV vaccine and the recent cased of what is being called dystonia following the seasonal flu vaccine. [...]

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