How peanut flour became a drug….

This weekend’s newsletter carries a report on the Cambridge Peanut Allergy Clinic that I went to visit last month. The clinic was set up by Dr Andy Clark and his colleagues as a result of their successful 2014 trial showing that the immune systems of peanut allergic children could be ‘taught’ to tolerate peanuts by being fed tiny, but increasing doses of peanut protein  over a period of two years.

(And no, before anyone gets any ideas, this is not something that you should ever contemplate trying at home. Because of the risk of reaction, it must only be done in a controlled medical environment with resuscitation equipment and skills on hand.)

The clinic is based at Addenbrookes Hospital in Cambridge but it is a private clinic and treatment is not cheap. The team would dearly love to be able to roll it out across the NHS but this is not likely to happen soon. This is partly because of the dearth of allergy clinics in the NHS able to handle such a programme, but the far bigger hurdle is the regulatory one.

Before the NHS will accept/advise/recommend a treatment it has, quite properly, to be approved by NICE (National Institute for Health and Care Excellence). This means that NICE will assess ‘the clinical and cost effectiveness of health technologies, such as new pharmaceutical and biopharmaceutical products’ and, ideally, provide guidelines (‘evidence-based recommendations’) as to how they should be used. In the case of peanut immunotherapy, since it is a new treatment and there are relatively few experts in the field, the guidelines would be very important.

OK – so what’s the problem?

Well, the problem is that what is used in peanut immunotherapy to re-educate the children’ immune systems is a small amount of peanut flour in a pot of yogurt – a food.

Obviously, the peanut flour that they use has to be processed under pharmaceutical conditions to ensure that it contains exactly the right amount of peanut protein for each dose – and absolutely nothing else. But it remains a food which, outside the reaction suffered by those who are allergic to peanuts, has no other effects of any kind on the body or the mind. It most certainly is not a drug.

But – there is no slot in the NICE regulations for the therapeutic use of a food. Indeed, the therapeutic use of food does not feature in NICE’s, or all too often, the NHS’s thinking – more’s the pity; seduced by the charms of big pharma, it is drugs or nothing. As a result, the only way that the peanut flour needed for the immunotherapy programme is ever likely to get NICE’s approval is if it is classed as a drug. But to be approved as a drug a substance needs to go through a rigorous three phase testing programme costing many hundreds of thousands of pounds and taking up to five years: phase 1 on healthy volunteers; phase 2 on patients to assess efficacy and side effects; phase 3 on patients to assess efficacy, effectiveness and safety.

In other words, to get their peanut flour approved for their immunotherapy treatment, the Addenbrookes team have to reclassify it as a drug and undertake full trials with all the costs associated. Meanwhile families with peanut allergic children have to wait for five years for a flour to be certified as a ‘safe and effective’ drug by NICE before there is any hope of it being made available on the NHS…..

No, it doesn’t make any sense to me either – but that is how it is.

Of course there is nothing new about this situation. The natural health industry (herbal, homeopathic, Chinese herbal medicine etc) has been fighting this battle for years. They argue that their products, like peanut flour, are not drugs. And while it is of course, essential that that they are assessed and rigorously tested for both safety and efficacy, requiring them to use the protocols used for drugs is completely inappropriate and is deliberately disadvantaging them in the market. While the drug companies can recoup their investments with patents and eye watering high prices, the natural health industry could never (nor would ever want to) charge the kind of prices for natural remedies – or foods – that could even start to recover the costs of the trials.

The result, as regards peanut immunotherapy, is that the few drug companies who have shown an interest in this area (see my blog in July last year) are relying on innovative delivery methods (capsules or patches) for the peanut protein which will be patentable so that they can claim exclusivity and charge accordingly.

Not a lot more to say, is there….