AstroNutrition Health & Fitness Blog

Ian Hislop was interviewed by Radio 5 Live’s Simon Mayo on Friday. In a discussion about the Eye’s campaigning journalism Mayo brought up the Eye’s coverage of MMR vaccine. The Eye published a special edition about MMR in May of 2002 subtitled “The story so far: a comprehensive review of the MMR vaccination/autism controversy”. It was an appalling piece of scare-mongering journalism. Here are the views of David Elliman and Helen Bedford on the Private Eye publication at the time:

Perhaps not surprisingly the style is of a journalistic expos rather than a well argued scientific treatise, with Andrew Wakefield held up as a crusader for truth, opposing the mighty drug companies and Department of Health. Private Eye seems to have used the kind of lay, anecdotal information that you might read in What Doctors Don’t Tell You and the Informed Parent rather than what you would find in the BMJ or Lancet. Understandably, much space is given to the harrowing accounts of parents who believe that the triple vaccine caused their child’s autism. However, the overwhelming evidence suggesting no link between the vaccine and autism and bowel problems is either not mentioned or dismissed out of hand, while the suggestion of a link is given uncritical prominence.

For example, in telling the story of the evolution of Wakefield’s hypothesis the report fails to mention that at almost each stage independent researchers as well as the original investigators have been unable to replicate the findings. The scientists/researchers listed in the “Who’s who in the MMR story” is nowhere near complete (but then to publish the names of all those who continue to support the vaccine would leave little space for anything else) and reflects the Eye’s bias with seven of the nine doubting the safety of the vaccine. If one were to quantify the evidence for and against a link, the ratio would be in the other direction.

Having read that, have a listen to Ian Hislop’s admission that MMR vaccine is not related to MMR vaccine, and his utter failure to take responsibility for the actions of his publication over MMR vaccine. Simon Mayo’s quiet interview technique can be quite effective at times.

   Ian Hislop on Radio 5 Live 12/12/2008: Play Now | Play in Popup | Download

The Washington Post reports on an FDA decision on long-acting beta agonists (LABAs) in asthma:

The risks of two widely used asthma drugs outweigh their benefits for both children and adults, a U.S. Food and Drug Administration advisory panel said Thursday.

The health panel targeted GlaxoSmithKline’s Serevent [salmeterol] and Foradil [formoterol], made jointly by Novartis AG and Schering-Plough, for restrictions, but it excluded Advair [salmeterol and fluticasone], Glaxo’s biggest-selling drug in the class of medications known as long-acting beta-agonists. It also left alone a fourth such drug, AstraZeneca’s Symbicort [formoterol and budesonide].

The health experts did not say that the use of Serevent and Foradil should be abandoned altogether. Instead, they said the medications’ labeling should be reworded to urge doctors to use the drugs along with an inhaled corticosteroid — as guidelines already recommend.

There was some talk that FDA staff wanted LABAs removed from the market for under 18 year olds. The briefing documents the FDA advisory panel considered are freely available on the FDA site:

Overall, the meta-analysis showed that LABAs were associated with an increased risk of asthma-related events relative to non-LABA treatment as measured by the asthma composite endpoint consisting of asthma-related death, asthma-related intubation, and asthma-related hospitalization. Non-LABA treatment included ICSs [inhaled corticosteroids], short-acting betaagonists, other non-LABA treatments, placebo, or a combination of treatments. The risk difference estimate for the asthma composite endpoint of the LABA rate minus the non-LABA rate was 2.80 (95% CI: 1.11, 4.49) per 1000 subjects. This overall finding for the asthma composite endpoint was supported by both the asthma-related hospitalization and the asthma-related death components. However, findings for individual drugs and subgroups were driven by the asthma-related hospitalization component.

Three of the four drugs (Foradil, Serevent, Symbicort) had positive risk difference estimates for the asthma composite endpoint; however, only Serevent had a statistically significant estimate. The risk difference estimates for the asthma composite endpoint were positive both when (1) LABA without assigned ICS was compared to non-LABA treatment and (2) LABA with assigned ICS was compared to assigned ICS treatment. However, only comparison (1) was statistically significant [3.63 (95% CI: 1.51 – 5.75) per 1000 subjects], and comparison (2) had a small risk difference estimate [0.25 (95% CI: -1.69 – 2.18) per 1000 subjects].

So, the increased risk of asthma events is related to the use of LABAs when used without inhaled corticosteroids. When concern about LABAs came up a year ago, the NPC posted a useful blog post advising on the evidence and action to take:

Healthcare professionals should follow current CHM advice and national guidance on management of asthma. LABAs should be initiated (at step 3) only if inhaled corticosteroids at moderate doses are failing to control asthma symptoms adequately. Before initiating a new drug therapy practitioners should recheck compliance, inhaler technique and eliminate trigger factors. If LABAs are introduced this should be in context of a therapeutic trial.

Professionals should take particular note that LABAs should not be initiated in patients with rapidly deteriorating asthma: they are for “stable but poorly controlled” asthma. Practitioners should consider stepping down LABA use when good long term asthma control has been achieved.

It will be interesting to see if any of these views are revised in the light of the FDA data and the Advisory Panel descisions, but it is arguable that the above advice still stands and that the focus should be on inappropriate prescribing rather than the drugs themselves.

Wakefield’s original 1998 paper, which led to the health scare over MMR vaccine driven by the UK media, was eventually retracted by ten of his co-authors. Another paper published by Wakefield is expected to be retracted by some important co-authors.

In 2002, Wakefield published a paper which is widely known as the O’Leary paper. The conclusion was that measles virus was present in childrens’ bowels, and associated with gut pathology and development disorders in children. This was taken as evidence that Wakefield’s theory on autism being linked to MMR vaccine had a plausible mechanism.

It has been know for some time that results from this study were fatally flawed because of problems with the laboratories involved in the studies. The measles virus they found was actually a contamination present in the laboratory. Additionally, other studies have failed to find the mythical measles virus (Afzal, D’Souza, and Baird).

Earlier this year the Hornig study was published. Hornig replicated the 2002 O’Leary paper and found no difference between the autistic and non-autistic children in terms of measles virus RNA in the bowel. As the author’s put it:

The work reported here eliminates the remaining support for the hypothesis that ASD with GI complaints is related to MMR exposure. We found no relationship between the timing of MMR and the onset of either GI [gut] complaints or autism. We also could not confirm previous work linking the presence of MV [measles virus] RNA in GI tract to ASD [autism] with GI complaints.

Interestingly, the O’Leary of 2002 (whose laboratories gave false positives due to contamination and the omission of a crucial step in the process to detect measles RNA) is the same O’Leary of 2008 who was involved in Hornig study. This has been seized upon by US anti-vaccinators and Andrew Wakefield who have used the fact that the Hornig study carefully checked the reliability of the laboratories performing their tests, to suggest that the Hornig study actually supports the conclusions of the 2002 paper by supporting the reliability of O’Leary’s laboratory. This is the direct opposite of the reality.

In a BMJ rapid response John Stone, of the UK’s leading anti-vaccine website JABS, puts this uber-bizarre debating point across neatly:

the study [Hornig et al] confirms the consistency of O’Leary’s results with two most higly rated labs in the US

Stone may therefore be surprised to read that O’Leary himself is expected to retract the 2002 paper. A letter from Professor Stephen Bustin in The Guardian notes the irony of the same laboratories being involved in both studies.

What makes this evidence wonderfully ironic is that it has been provided by the same individuals (Professor John O’Leary and Dr Orla Sheils from Trinity College Dublin) who reported the original evidence in favour in a 2002 publication.
[...]
It takes no scientific knowledge at all to realise that the reason for this discrepancy is that O’Leary and Sheils have taken exceptional care over their experimental protocols and improved their expertise so that contamination no longer affects their results. Clearly, O’Leary and Sheils have changed their mind on this subject and the expectation now is that both will publicly retract their 2002 publication.

My expectation, when/if this retraction is issued, is that the anti-vaccine movement will find themselves defending a paper which has been retracted by the authors. Not that this is a new experience for them. On the matter of MMR vaccine, faith surpasses reason.

Next Wednesday significant parts of the NHS will be taking industrial action. I am supposedly working to rule, with a “ban on non-essential paperwork, e-mail exchanges, attendance at meetings and telephone calls.” The industrial action is being organised by my union Unite, which in a recent ballot obtained a mandate from the membership for this action (76% for, 23% against), and a mandate for strike action later (53% for, 45% against). When the ballot was taken the credit crunch was already well established, and in part that probably influenced the membership - angry with a below inflation pay deal. Following the ballot Unite’s position was made clear:

Unite’s National Officer for Health, David Fleming said: ‘The stand that our members have taken against the derisory three-year pay deal imposed by ministers has been vindicated.’

David Fleming said: ‘Our members were appalled and angry at the 7.99% three-year pay deal imposed by the government in the spring. Inflation has now broken through the 5% barrier and their household bills are increasing on an almost daily basis.’

‘They were also upset that the government undermined the independence of the Pay Review Body by imposing its own settlement.’

The latter point is a matter of principle, which has not changed. However, treasury’s forecasts are suggesting an annual inflation rate averaging 0.5 per cent next year.The government may not have thought they were being generous at the time, but 7.99% over three years is looking like a good deal in the current economic circumstances. This is not the 1970s, we are not struggling with 25% inflation rates.

People are losing their jobs. Companies with inherent weaknesses, masked until the hard times, with large amounts of employees are looking very shaky. We have people warning that deflation is impending. There is a concern about the level of government debt (although read this piece for a more sober analysis of those “record” debt levels). So, exactly how much support are NHS employees complaining about a 7.99% pay rise over the next three years going to get? Not much I suspect. Would you honk your horn?

Given the current situation, then rather than asking for solidarity from the public over our pay rise, would the union not be better advised to accept it is now a reasonably good deal (even if it wasn’t offered as such at the time) and act in solidarity with the country as a whole? I’d be interested to see if the result would be the same if the membership was balloted now.

Tactically, the action doesn’t even make political sense given the ties between Labour and the unions. Is it really the best time for a union to be creating disruption? Or have I got the purpose of the unions wrong? Do they actually exist to inflict wounds on left wing governments struggling with economic crises?

You’d think they’d learnt nothing from the last time they ushered in the Conservatives.

The Independent recently published an article in which a father explained why his daughters would not be given the HPV vaccine. David Salisbury has written in to correct the article.

I was sad to see the article, “My girls won’t have the cancer jab” (16 November): to use its own words, the article was unnecessary, reckless and ridiculous. The back-of-the-envelope economic analysis was nave. The UK model shows the NICE criteria were passed at a range of prices, including the list price used. Government contract prices can be significantly lower.

The safety concerns raised come from an anti-vaccine website. Analyses show no significant increased risks of serious adverse events; it is irresponsible to raise such concerns when there are no grounds to do so. Presentations on the safety of Gardasil cover 20 million doses under passive surveillance and more than 375,000 doses under active surveillance. And to refer to “a healthy immune system that hasn’t been challenged by too many vaccinations” to prevent cervical cancer is just nonsense.

The safety concerns the father cites appear to come from Judical Watch, which appears to think it has uncovered horrifying evidence of harm from HPV vaccine by examining reports of suspected adverse reactions filed with the CDC in the US. One of the problems of transparency in drug safety is that people with little understanding of the nature of drug safety data can either innocently, or deliberately because of an idealogical opposition to vaccines, create the impression of a safety problem when none exists. More on this later, but it is worth noting that a British non-tabloid newspaper, which ironically was handing out guides to science earlier this year, is allowing seepage of anti-vaccine material into its pages.