There is absolutely nothing good about a teenage girl dying as a result of an allergic reaction. But the massive coverage resulting from the inquest into Natasha’s death has at least brought the issue of severe allergies to the forefront of everyone’s minds – and that is good.
However, what is totally not good is that Natasha only died because Pret was (and is still) stretching the 2014 Food Regulations to a place where they were never intended to go.
For years now, all packaged foods sold through retail outlets have had to carry full ingredients labelling. This includes having any of the 14 major allergens that they contain (of which sesame is one) highlighted in bold or italics.
However, in 2014 the regulations were expanded to cover all foods sold loose, without packaging, foods that are wrapped on site and all foods sold through the food service industry whether in a works canteen, a five star restaurant, a hospital, a school, a café or a stand at a football ground.
While the bigger operators were able to incorporate allergen/ingredient information into their systems relatively easily it was realised from the start that requiring that small operators (who make up the majority of the food service industry) should ingredient label every single item they sold would be so onerous a burden that it would effectively put many of them out of business.
A compromise solution was therefore adopted, exempting small outlets from labelling every item of food and allowing them to use fridge stickers, notices or word of mouth to tell customers about allergens. While viable, this solution was always going to be risky as it depended on those outlets understanding the dangers their food might present for allergic customers and being diligent in communicating that danger.
When most of the food is made in front of the customer as it is in most small cafés, that is probably just about workable. However, extending that exemption to a chain that served thousands of products that were most emphatically not made in front of the customer was ludicrous. Stickers on fridges or notices to ‘ask the staff about allergens’ in a heaving high street Pret outlet were never going to provide the kind of reliable information that allergic customers need.
Pret sandwiches and baguettes are retail products
Pret sandwiches and baguettes are, in effect, retail products and should carry full ingredients labelling as would any other retail product.
Inexcusably, Pret made used of this loophole, presumably to save themselves the cost of labelling their products.
Far worse though.
The ‘artisan baguette’ that killed Natasha included sesame seeds in the dough. Not sesame on the outside the baguette which would at least have been visible to the wary allergic customer but baked into the bread where they would be totally invisible.
Yet not only did the baguette not carry allergen warnings, it did not even carry a full ingredients list. That a business the size of Pret that sells hundreds of thousands of products a day could show such a criminal lack of allergen awareness is truly shocking.
And despite the massive amount of negative publicity that they have received over the last week, according to a report in the Sun those baguettes are still on sale without any appropriate warnings.
One can only hope that it will not just be allergy sufferers who will give Pret outlets a wide berth in future but many of those who have read the reports and have been shocked by Pret’s callous profit before care attitude.
Another tragic loss to food allergy…but it seems no matter what we do, how careful those at risk (or their parents) may be over many years….accidents will happen. Yes, they are accidents (as opposed to “on-purposes”) even when gross negligence or ignorance play a role.
Which is exactly why Natasha and thousands of fellow sufferers, sensibly would carry two Epipens at all times, and both she and her parents were well versed in their use. It’s the same reason we belt up before driving…and why all new cars have airbags, because sometimes….other idiots cause accidents…and then sometimes it’s us, perhaps due to appalling road conditions.
BUT…what would be the reaction if every airbag in one particular manufacturers’ cars were found not to activate in a collision…or the seat belt inertia mechanism didn’t lock? There would be hell to pay for that manufacturer. The fact that the council may not have gritted the icy road would be way down on our list of finger pointing.
And so it is with the Epipen. The MHRA, the EMA, the CMO, the manufacturers and the Allergy Experts…have all known since the death of Poppy Harvey in 2010, that the needles in Epipens (and Jexts) won’t reach the thigh muscle in the majority of females. Natasha had two Epipens injected almost immediately after feeling unwell, and nothing happened. Why?
Did the post mortem pathologist follow the needle tracks in order the check her muscle depth at those points…..as was done with Poppy? Poppy had a skin-to-muscle depth of some 20mm, 4mm beyond the reach of her two Epipens. She could have injected a dozen Epipens, and they wouldn’t have saved her, if all were used at the recommended thigh position.
What about Shahida Shahid who died a year before Natasha, after eating an unlabelled takeaway in Manchester. Again, her Epipen failed to make any difference. And Natalie Giorgi, in the USA, who succumbed to a cereal bar in spite of her father (a doctor) administering 3 Epipens immediately….with no response.
These old auto-injectors were based on a design produced for the US military to protect male combatant in the 1st Gulf war. (The Atropen and the Duodote). Men’s thigh muscles are covered by 5-7mm of fat, so no problem fitting a 16mm needle.
To simply fill them with Epinephrine (adrenaline in English) and market them to women, most of whom would not be protected… and to children, where half would not be protected (as discovered at Lister Hospital in Stevenage) is just as negligent as Pret not labelling their Sesame buns…probably worse since the manufacturer knew their needles were too short. If they didn’t know back in the early 90’s, they sure did after 2010 when Poppy died, as it was published by Dr. Richard Pumphrey.
So, why are Epipens still on the Market? Well that’s the $64 million question…..actually the US market alone is worth £1 Billion…so maybe there’s your answer.
So very right – and that is an equally scandalous situation which I first blogged about five years ago.
And there are other autoinjectors on the market with longer needles – Emerade for example has been around for some years now and have a needle length of 25mm ratehr than teh 13-16mm of teh normal Epipen or Jext injector.
OK, realistically, Epipen are not going to wish to give up their stranglehold on the market – but, given the cases that you quote and what is now known about the adipose tissue on female thighs, why are Epipen not making injectors with longer needles? Not to do so seems to be as criminally irresponsible in allergy terms as Pret including sesame in a bread product and not declaring it.
I was asked to undertake research in 2014 which involved having the AAI target areas of my thighs scanned using ultrasound and measurements collected from different points within these areas. We decided to do this when standing, sitting and lying down in case it makes a difference. (People suffering severe allergic reactions are usually advised to lie down with head and heart level and knees up to prevent cardiovascular collapse.)
JEXT 300mcg needles are reportedly 15mm.
Epipen 300mcg needles are reportedly 16mm.
Emerade 300mcg and 500mcg needles are reportedly 24mm.
The skin to muscle distance on my thighs at different points and in three different positions ranged from 13.1mm to 34.9mm
At that time it cost £60 for a private ultrasound scan. It would probably be recommended to get medical advice about interpreting the scan and choosing the best injection site.
The three suppliers to the UK, as instructed by the European Commission should be presenting their in vivo studies at the end of 2019. See below…
From the BSACI today:
One of the conclusions from the 2014 (MHRA) review was that studies in human volunteers were needed to investigate whether the rate and extent of adrenaline uptake into the bloodstream following adrenaline auto-injector deployment is consistent with an intramuscular site of injection and/or penetration. The response of body tissues to the administered adrenaline should also be evaluated. In addition to needle length, the propulsive force of the device as well as the physical barrier of the fascia lata were considered in the review.
The pharmacokinetic/pharmacodynamic (PK/PD) studies were mandated by the European Commission for all brands of adrenaline auto-injector marketed throughout Europe (marketed brands in the UK are Epipen, Jext and Emerade). Results from the studies of Epipen, Jext and Emerade are pending and it is expected that all data will be available by end 2019. Until these studies are back the MHRA will not commit to a specific position.