Typhoid Jerome

I’ve ripped on the generally poor quality of health and science journalism in the Indy on several previous occasions, and today’s Indy provides ample reason to have another go at them:

My girls won’t have the cancer jab

The new cervical cancer vaccine offers few benefits, says Jerome Burne, father of two daughters. Which makes the risks even more alarming.

So goes the preamble to the article which then goes to fire this opening salvo.

Much as I love my two gorgeous daughters – aged 13 and 17 – and wish to protect them from all harm, I will not be consenting to them having the HPV vaccine against cervical cancer.

It’s a public health initiative that is unnecessary, reckless and ridiculously expensive. Worse, serious doubts about its wisdom have not been properly presented to the public. Instead, children and parents have been bombarded with publicity – “a totally life-saving, revolutionary vaccine” – while the media have largely parroted official assertions that it is “safe, proven and effective”, all of which are unfounded.

Really?

Okay, lets take a step back and sort out the provenance of these remarks by taking a quick look at the background of the author, Jerome Burne, who is describe by one on-line biography as:

…a leading medical and science journalist. For the past 15 years he has been writing regularly for the Independent, the Guardian, the Financial Times, the Observer, the Sunday Telegraph, the Times and, more recently, the Daily Mail,. For three years he edited the award-winning newsletter Medicine Today, which provided accurate and vivid accounts of cutting-edge science.

All of which sounds quite impressive until you realise that the source of that biographical information is the website of one of Britain’s leading purveyors of woo, Patrick Holford, with whom Burne co-authored a book entitled ‘Food Is Better Medicine Than Drugs’ – and if you don’t get the significance of this connection them please allow me to direct you to the inexhaustible Holford Watch where a short sharp education awaits.

Burne’s an interesting case in as much as he seems to have been a credible science journalist and, indeed, can still turn out some creditable material when he puts his mind to it but somewhere down the line, having come to the realisation that Big Pharma isn’t always as honest about its research as it should be, he seem to crossed the dividing line between genuinely critical science reporting and bug-eyed conspiracism and starting hanging out with quacktitioners like Holford and boy does it show in his pronouncements on HPV vaccines, where he appears to writing on day release from the Daily Mail.

For our purposes here, we’ll skip the preamble in which he explains what a vaccination programme is and get straight to his arguments against the HPV vaccine, starting with:

To begin with, it is a fabulously expensive way to deal with a problem which, although horrible for anyone who develops it, is hardly a major health risk. Figures haven’t been widely publicised, but one quoted cost is £100m a year, which works out at £250,000 per life saved. Would this pass the NICE criteria for expensive cancer drugs? We already have a very effective screening programme that has brought deaths from cervical cancer down from 11 per 100,000 in 1950 to 3.4 in 2004, and the numbers are expected to continue falling.

And we’re barely out of the starting gate before Burne resports to comparing apples and oranges.

Yes, £100 million a year sounds like a lot of money, although if that’s the cost for just for vaccinating 12 and 13 year old then it actually works out at about £150 a shot on the current population for a branded vaccination that’s still under a patent. Give it a few years for a patent to expire and for generics to enter the market and the annual programme costs will fall considerably.

Still, if we’re going to play the cost benefit analysis game here then, in addition to noting the unit cost of the vaccine rather than the total programme cost on the cost side we also have to go somewhat further on the benefit side than a simple estimate of the projected reductions in mortality and look at the full range of incidence data, which indicates that around 24,000 women a year get the ‘we’ve found something thats not quite right’ chat with their doctor after having a cervical smear, with 22,000 of those being caught at the pre-invasive lesion stage (what is commonly referred to as having found ‘pre-cancer’ cells) with around 2,000 finding that the diagnosis has come that bit too late and that the cancer has taken hold. Those women all require medical treatment to varying degrees depending on what stage the cancer is at when its diagnosed and that treatment costs money, money that will be saved if the HPV programme proves tobe as effective as other vaccination programmes.

FFS this is no more than a bit of basic maths, even if you stick only to working out the ‘unit cost’ of the programme against a crude measurement of ‘lives saved’, because you’re dealing with a preventative measure, you still have to deduct the savings in treatment costs associated with having 400 women die each year of a preventable cervical cancer from the total cost of the programme before you work out the cost per lives saved.

What Burne is doing is putting up big number that he thinks will sound off-putting but which have no foundation in any kind of reality that isn’t expressed on the back of fag packet and that can be played in a myriiad of way to ‘prove’ just about anything you like. For example, if perform an equally unilluminating calculation of our own in which the £100 million cost of the programme in offset against the potential reducation in total annual incidence, the HPV strains the vaccine deals with account for 70% of diagnoses and the test data shows 100% effectiveness thus far, then we can project that once the full programme is in place we’ll have 17,000 or so fewer women diagnosed with pre-invasive lesions or full-on cervical cancer each year, which give a unit cost of just under £6,000 for each women who won’t require treatment.

That figure is no more meaningful than Burne’s £250,000 a life but its no less valid in terms of being derived from estimates based on current incidence data and £6,000 to avoid cervical cancer will sound like a pretty good deal to the majority of women.

So, to sum up, Burne’s ‘fuck me it’s expensive’ argument is a load of meaningless bullshit.

Moving swiftly on, Burne continues with…

However, the vaccination could actually reverse that. Women still have to be screened because, even when the whole programme is up and running, the number who develop precancerous cells is expected to drop by, at best, 50 per cent. At the moment, the biggest risk factor for cervical cancer is never having been screened; half of those with the disease haven’t. The fear is that the programme may reduce screening attendance as vaccinated women assume they are safe.

So, we need a public education programme running alongside the roll-out of the vaccine to ensure that women are aware that that this isn’t a magic bullet that will eradicate all forms of cervical cancer but a vaccine that should, hopefully, eliminate the two most common strains leaving a much reduced residual risk that needs to monitored and screen for.

That’s just bread and butter health promotion work of a kind that easily undertaken in schools and by general practitioners and other healthcare professionals. so what’s the problem?

However, the much more interesting and misleading statement here is the assertion that ‘the biggest risk factor for cervical cancer is never having been screened; half of those with the disease haven’t’, which is true only in the sense that screening permits cervical cancer to be identified and treated at the pre-lesion stage in a much less invasive fashion than if its not found until its taken hold.

Screening, however, has no bearing whatsoever on the overall incidence of cervical cancer if you take into account the full spectrum of its development from its non-malignant pre-cancer stage right the way through to its full invasive form. Women may be less likely to be subject to an invasive carcinoma due to screening but that has no impact at all on the risk of developing pre-cancerous lesions and once a women has developed those then, even after treatement, they remain subject to an increased risk of developing further lesions or an invasive carcinoma .

In other words, more bullshit, but this is nothing to what follows, when Burne gets on the subject of vaccination risks and alleged side-effects…

Public discussion of risks in the UK gives little hint of possible dangers. (The figures that follow all relate to a brand called Gardasil being used in America. This was to have been the UK choice until one called Cervarix was chosen because it was cheaper. We are told that otherwise they are equivalent.)

Not quite equivalent. Gardasil covers two additional minor strains of HPV (types 6 & 11) not covered by Cervarix but we’lllet that omission pass as its not that relevant, but what is relevant is…

We plan to vaccinate 600,000 12- and 13-year-olds a year, on the basis of trials involving fewer than 1,200 girls under 16 that lasted less than two years.

Objection, M’lud… misrepresentation.

What Burne gives here is only the number of girls (1,200) involved in the phase three trials of the drug, and phase three trials are primarily concerns with assessing the effectiveness of the drug, following on from phases 1 and 2 where the trials focus on monitoring how the drug works and assessing safety in terms of things liek dosage and potential side effects.

More than 20,000 women aged 16 to 26 were also involved in trials. Side effects included birth defects and juvenile arthritis. Only a few; but what happens when millions get the vaccine? Could certain genotypes be particularly vulnerable? No one knows. In fact, I’m asked to enter my children into a vast experiment.

Now we get to the real scaremongering which, as usual, relies heavily on public ignorance of how clinical trials are carried out.

Look, this is how it works – the new drug is given to the test subjects, or rather some of them if its pahse three trial as these are full randomised double-blind trials in which half the test subject are given a placebo.

Once they taken the drug, or placebo, you then monitor them for any adverse health effects for a period of time, which could range from a few weeks to a couple of years or more depending on the drug being tested. the important thing to note is that these trial record any significant adverse health effect experienced by a trial subject during the test period, irrespective of whether it appears to be related to the drug on not. So some of what emerges in trials is genuinely a side-effect, and most of these tend to be pretty obvious short-term effects which occur immediately after the drug is administered.

So you have an injection to administer the vaccine and you, and a number of other test subjects, get a rash which appears a day or two later and disappears after a week or so – that’s a side effect because its obvious that the two events are related.

When you have a trial where subjects are monitored over several months or even years, what you also get is a certain amount of ‘noise’ because some people will fall ill or have other health problems during the trial period for reasons which are entirely unrelated to their involvement in the trial – which is one reason why trials are conducted on a randomised, double-blind basis, because this helps researchers to sift out any significant effects (and side-effects) from any random, unrelated events.

So the mere fact that during clinical trials, a trial subject develops juvenile arthritis or is unfortunate enough to give birth to child with developmental abnormalities may have no bearing on the trial itself – these things may well have occurred to individuals in question even had they not been involved in the trial, so you have to have something more to go on, e.g. the incidence of a particular adverse effect has to be significantly higher in the trial group than in either the placebo group or the general population before you can say that you’ve found a side effect that related to the drug you’re testing.

Already, patterns of side effects are emerging. A body called Justice Watch has been prising figures for adverse reactions to Gardasil from the US authorities. Last October, the total was around 3,500; by this July, the figure had risen to 8,864, including 18 deaths and 140 “serious” reports.

And as of a couple of minutes ago, the number of reported adverse health events in individuals who’ve been administered with Gardasil stood at 11,699, with 34 deaths and 164 ‘serious’ (i.e. life threatening) reports, and if you’re wondering how I managed to ‘prise’ this information from the US authorities, the answer is that it no prising whatsoever as all the data is freely available from the CDC via its online VAERS database.

so I just looked the figures up myself – no prising required.

Again, Burne is conciously using misleading language to create the entirely false impression that the US authorities are somehow supressing information or making it difficult for people to monitor reports of adverse outcomes in individuals who’ve used a particular drug, i.e. the reference to Justice Watch ‘prising’ information out of the CDC, when, in reality, all the information is freely available online to anyone with the gumption to query their database, although some knowledge of medical terminology is useful when interogating this particular database.

And nowhere is the full extent to which Burne is presenting misleading information more apparent than in his next paragraph…

There’s plenty of disagreement over what the cases show. Authorities say they aren’t necessarily connected to the vaccine. Two of the most worrying reactions have been blood clots – what might that be doing if you are one of the older girls on the pill? – and 38 reports of an autoimmune disorder called Guillain-Barré syndrome that can cause paralysis.

Okay, quick point of clarification. As with the drug trial process I ran through earlier, the CDC’s VAERS (Vaccine Adverse Event Reporting System) records all reported adverse health events in individuals who’ve be administered vaccines in the US, irrespective of whether there’s any evidence to suggest that a particular adverse event may be related to a particular vaccine or not.

So the mere fact that certain events are reported in individuals taking certain vaccines proves nothing at all, on its own, its only if the records show a much higher incidence of a particular condition than would otherwise be expected that you need to start invetigating the possibility of a link.

So, Burne gives us two allegedly ‘worrying reactions’ – remembering that he’s provided no evidence whatsoever to support the view that anything he’s mentioned is actually a ‘reaction’ to the HPV vaccine.

So, to start with, we need to know roughly how many people have been given the HPV vaccine (Gardasil) in the US, and as of the end of June 2008, that figure is 5.3 million people.

So, how many of these people have developed blood clots?

Well, the medical term for a blood clot is a thrombus and there are 14 listed symptoms on the database which include the term ‘thrombo’, so we’ll take them all, and throw in pulmonary and cerebral thrombosis and the same for embolisms all of which gives a grand total of 78 cases and an incidence of 1 case in 68,000.

We can then compare to the general incidence statistics for the US.

* Almost 900,000 Americans suffer from venous thromboembolism (VTE) every year.
* Of these, about 380,000 develop deep vein thrombosis (DVT)
* Nearly 300,000 deaths per year.
* Only 50% of those with DVT have symptoms, yet quick, effective treatment is critical
* 600,000 are affected annually by pulmonary embolism (PE).
* Up to 25% of those patients with PE present with sudden death.
* 1 in 20 Americans are affected by hereditary thrombophilia – an inherited predisposition to blood clots.
* 52% of hospitalized adults are at risk of dangerous blood clots.
* The recurrence rate of venous thromboembolism (VTE) is 30% over 10 years.

Oops… the US has a population of 300 million and with 900,000 VTE cases each year we have an incidence of 1 in 333.

So much for worrying about blood clots, eh?

What about our other candidate for a good scare, Guillain-Barré syndrome, which is an auto immune condition which can be triggered by foreign antigens, including vaccines… without going in to detail what happens in GBS is that the immune system repond to the presence of a foreign antigen as normal, by generating antibodies, but gets its wires crossed and mistargets the individuals own nerve tissues.

And the estimated incidence/prevalence of GBS is..?

1 in 100,000.

So, if we’re looking for a possible like between the HPV vaccine and GBS then what we should see is an incidence rate above 1 in 100,000 which would translate into 53 or more cases of GBS in individuals given the vaccine.

And, from VAERS database, the magic figure is…

…41 cases, so we’re actually around 20% down on what you’d expect in a complete random sample of the population.

So Burne has given us to specific examples, neither of which actually stacks up when you do the numbers – and yet’s he’s supposed to be an award-winning health/science journalist.

And he’s not finished yet…

It’s obvious that we need more information, which is why the US Food and Drug Administration called for studies to investigate these possible risks. But the results won’t be in for a decade in some cases. The quickest trial they asked for was one involving 44,000 vaccinated girls who are being followed for six months to pick up signs of any immediate or medium-term problems such as autoimmune disorders or rheumatism. The results will be out in September next year. Meanwhile, UK experts confidently declare that there are no dangers; if so, why run this and the other studies?

First, there’s absolutely nothing unusual in the FDA calling for additional research on a new drug, even after that drug is licenced and in use. For one thing it simply isn’t possible to evaluate whether there may be any long-term risks associated with a particular drug without carrying out long-term studies which can only take place once the drug is in use, and if we had to wait for those long-term studies to be completed before drugs could be broughr onto the market then there would simply be no new drugs at all.

If we followed this argument we might still be waiting the final results of long term trials of penicillin, which is nothing short of a nonsense. Oh, and as he mentions rheumatism, I should note that VAERS shows 59 cases out of the 16 million who had the vaccine so, again, I suspect that there’s little prospect of the the study he refers to find a problem.

But the uncertainty over side effects isn’t all that’s unknown. A key factor in the success of any vaccine is the length of time it confers protection. If it is too short – say, less than 10 years – too many booster shots will be needed. How long will protection last? No one knows; so far, it’s lasted just over six years.

Let’s make another correction here as while Gardasil has, to date, been assessed up to four years, Cervarix has been assessed up to 5.5 years, at which point those given the vaccine were found to have HPV antibody levels 11 times higher than in cases of natural infection. On that data it seems likely that at least this vaccine will have a 10 year plus effective life span, which is more than adequate. Tetanus requires a booster ever ten years so where’s the problem?

Then there is the reaction of the 15 other HPV strains, which account for 30 per cent of the cancers; will that change as the two most infectious ones are blocked? Could it allow them to become more infectious? A recent paper in the New England Journal of Medicine explored the possibility. Will it happen? No one knows.

To give a simple answer to Burne’s question – no.

Removing the two most infectious strains of HPV would have a statistical impact over time simply because cervical cancers arising from other strains would make up a much larger proportion of a much smaller incidence of HPV information – if you make the pond smaller, you make the fish look bigger – but otherwise these strains will be no more infectious that they are now unless its shown that the incidence of of the more infectious strains actually suppresses ther transmission of the less common HPV type by direct competition (virus either eats virus or denies it a habitat, i.e. basic natural selection). The only other possibility here, that the most infection strains ‘prime’ the immune system in a way that makes it better able to fight off the less infectious strains will not be affected as the vaccine will do the priming, assuming that’s even a factor, which it probably isn’t.

And on top of all that, we don’t actually know that the vaccine will prevent cancer. We know it confers resistance to the virus strains most likely to cause cancer, but since the cancers don’t usually appear until a woman is in her late forties, definitive proof will be some time coming.

Does anyone else get the sense that Burne is getting just a little bit desperate with arguments here, to the extent that he’s trying to sell people the idea that we stiff Big Phara with what would amount to an impossible set of standards before allowing them to release any kind of new drugs onto the market?

Me?

Well when I see someone resorting to the ‘moped argument’  – “But-but-but-but-but-but-but-but” – then I start to wonder what else is going on here and, oddly enough, the answer is to be found by looking no further than Wikipedia and its main article on HPV in which we discover that, under the heading of ‘cervical cancer prevention’, and underneath the information on screening programmes, vaccines and the use of condoms, there’s a whole section on…

…NUTRITION.

And before you can say ‘undisclosed vested interest’ we discover that fruit and veg, vitamins A. C. E. Folic Acid, Carotenoids and, our dear old friend, Fish Oil have all been linked by research to a lowering of the risk of persistent HPV infection even if, in the case of Fish Oil, there is only one published paper on the subject.

You can see where this is all going now, can’t you.

From a quick run through some of the papers on PubMed is does seem that there is a correlation between a healthy diet and a lower risk of HPV persistence which, give or take the fact that researchers are trying to work out the precise biochemisty that underlies this, really only amounts to the common sense observation that a healthy well diet leads to a healthy immune system which is better able to deal with viral infections like HPV.

And that would be that were it not for the estalished link between HPV and cervical cancer which, if you’re in the business of flogging vitamin pills and other nutritional supplements, is quite obviously a rich vein of marketing gold of the ‘buy our woo, it can help prevent cancer’ variety.

And then along comes Big Bad Pharma with a vaccine that doesn’t simply lower the risk of HPV infection, it actually eliminates two of the main cancer-linked strains and blows a gaping hole in what might otherwise be a pretty lucrative market for the vitamin peddlers.

Damn those pharmaceutical companies if they don’t keep shitting on the great gravy train of woo by coming up with vaccines for illnesses that could otherwise have been used to flog snake oil in industrial quantities to the congenitally gullible.

What I find most disreputable here is that what have on our hands is someone who has made his living as a science/health journalist for something like 15 years peddling an article that’s a so full of basic errors, misrepresentations and misleading arguments that simply don’t stand up to scrutiny on the back of even the most cursory background research that its nothing short of an embarassment with or without the added frisson of Burne’s association with a major league woo merchant and quacktitioner like Patrick Holford.

  • You are Ben Goldacre and I claim my

  • Very nicely dissected.

  • chris y

    You are Ben Goldacre and I claim my

  • Brilliant work.

  • Gillick

    Provided his daughters understand the procedure it’s up to them to give their consent, not Big Daddy