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A stab in the dark

Still practising

Chris Preece

Thursday, 27 September 2018

AdobeStock_128513269_vaccine.jpgIt’s Autumn, the season of falling leaves, golden sunlight, irritatingly early Christmas adverts and, of course, flu vaccines. Flu season brings with it a few inevitable conversations. There’s the discussion in the practice as to how on Earth we’re going to make sure the right people come, and more importantly, how we’re going to handle them all when they do. There’s the usual debate with community staff as to whether they’re prepared to vaccinate housebound patients for us (apparently not this year). 

The trickiest though is the “I know you don’t really trust vaccines, but really, it’s worth it” discussion. The flu vaccine seems second only to MMR for triggering such a debate, and this year it’s been further complicated by the introduction of a different vaccine for the over-65s. Whilst the science behind this is relatively straight forwards (the over 65s get an adjuvant vaccine on the grounds that last year’s non-adjuvanted vaccine showed no significant effectiveness) the questions it triggers are less so.

So far, I’ve already had “why can’t I have the better one?” (to which the answer depends entirely on how you define “better”) and “but nothing magical happens on my 65th birthday does it?” (to which the answer is “No, no it doesn’t.”) Both of which pale in comparison to the debate that arises every year, namely “I’m not having it because last time I did, it gave me flu.”

Again, the cold objective answer to that one is a fairly straightforward “no it didn’t”, followed by a reminder that we give it at a time when viral infections are, by definition, highly prevalent, and an acknowledgement that all vaccines can give a mild post-immunisation reaction, but an assurance that whilst severe reactions are possible, they’re rare. 

That final statement has developed a new kind of urgency in this post-Wakefield world. Many people are scared of vaccines in a way that I certainly don’t remember in my childhood. Such fears present a particular dilemma for doctors – how to reassure whilst simultaneously accurately reflecting what risk there is. It’s a delicate tightrope walk, and it requires, amongst other things, really clear evidence relating to precisely that safety.

All of which makes news of the recent BMJ report suggesting that GlaxoSmithKline had been less than transparent with respect to their Pandemrix vaccine particularly disheartening. Pandemrix was one of a number of vaccines produced during the H1N1 swine flu pandemic.  The first sign that there might have been an issue with Pandemrix came from Germany, when Der Spiegel ran an exclusive revealing that German Government officials would be receiving an alternative vaccine to the 50 million Pandemrix vaccines ordered for its people. 

Subsequently there have been accusations that Pandemrix is linked to cases of narcolepsy, and the resulting legal machinations have led to the release of documents that demonstrate that Pandemrix had five times as many adverse events than Arepanrix – another very similar H1N1 vaccine from the same manufacturer.

Of course, cause and effect is extraordinarily difficult to prove, yet this difference between the two drugs is so marked that it raises questions as to why this discrepancy was seemingly neither investigated, nor brought to public attention.

In fairness, Pandemrix is perhaps not entirely representative of vaccines in general, it was rolled out at speed in an attempt to prevent what appeared at the time to be a potentially devastating pandemic. Certainly, it wouldn’t be right to tar all vaccinations with the same brush, and I have no intention of this blog descending into some sort of Anti-Vaxxer conspiracy party. After all, most vaccines, like most medications, are thoroughly researched with detailed evidence with relation to efficacy and safety published for peer review.

Aren’t they? There remains the thorny question of those trials that companies undertake but elect not to share the results from. In a clumsy attempt to understand this better, I took a look at the excellent “EU Trials Tracker”.  Legally all clinical trials in the EU have to report their results to the EU Trials Registry within a year of completion. The tracker records which of these have actually done so. The results are depressing (as well as a potent call to arms for my colleagues in research) with only 51.1% of trials actually having reported.

Now, there are lots of reasons why this might happen – the worst offenders for instance seem to be Universities and Hospital Trusts, implying that many fail to report purely due to organisational or financial issues. Nonetheless, that means that nearly half of our clinical trials have not formally reported their outcomes, and you can’t help but wonder how many other apparently un-investigated risks lie within them, un-reported and unacknowledged. (I looked at GSK out of interest. 92.1% of their trials had been reported. Of those that hadn’t I found four that appeared to relate directly to vaccines. A cursory glance at their competitors implies similar issues.)

This stuff matters. It matters not just because individuals might be harmed by the side effects of these medications (though that’s more than reason enough). It matters because in order to re-establish our patients’ confidence in vaccination it’s essential that everyone be utterly transparent about the benefits and risks. It matters because when I look someone in the eye and tell them that this jab might give them a bit of a sore arm tomorrow, but it’ll have no long-lasting side effects and will protect them and others against potential serious diseases - I need to know that such a statement is true. 

So please drug companies, if you realise that your latest vaccine’s not quite as safe as you hoped, or your trial results aren’t quite perfect, don’t hope that you can just hide the news away. Announce it, clearly and early, and let people make truly informed decisions. We have enough conspiracy theories and scaremongering without providing more fuel for them.

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Chris Preece

Chris has worked as a GP Partner in North Yorkshire since 2004, and still relishes the peculiar challenge of never quite knowing what the next person through the door is going to present with. He was the chair of his local Practice Based Commissioning Group, and when this evolved into a CCG he joined the Governing Body, ultimately leaving in April 2015. He continues to work with the CCG in an advisory capacity. When not being consumed by all things medical, Chris occupies himself by writing, gaming, and indulging the whims of his children. He has previously written and performed in a number of pantomimes and occupied the fourth plinth in Trafalgar Square. Tragically, his patients no longer tell him he looks too young to be a doctor.
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