Tuesday, May 6, 2008

Neals Yard get gentle slap from MHRA for peddling life-endangering sugar pills

And so the saga continues..... To recap briefly, BBC SouthWest's program Inside Out questioned whether Neals Yard should be selling homepathic remedies for Malaria. The YouTube video is here and the transcript is here.

Neals Yard then put out a press release saying that as it is a "contentious issue" they were withdrawing the product.

Nothing at all to do with the Medicines and Healthcare Products Regulatory Agency investigating them over the issue. Now the MHRA guidelines on homeopathic medicines are as follows (and can be found here):
In 1992 Directive 92/73/EC introduced a Simplified Scheme for homoeopathic products. It is regarded as simplified because although the safety and quality of products has to be demonstrated, products are not permitted to make medical claims. The Scheme is restricted to products for oral and external use and does not allow indications (the descriptions of diseases or conditions for which the medicine is intended to be used). In order to qualify for registration the products must:

* be for oral or external use - this includes all methods of administration with the exception of injections
* be sufficiently dilute to guarantee their safety
* make no therapeutic claims.

My bold. So, as long as they demonstrate they are safe and don't claim to do anything, then they can be registered.

Compare the following two statements. Firstly, from David Carter at the MHRA:
This product was clearly intended to be viewed as a treatment or preventive for malaria, which is a serious and potentially life-threatening disease. We regard the promotion of an unauthorised, self-medicating product for such a serious condition to be potentially harmful to public health and misleading.

Secondly, from Neals Yard press release:
We do not advertise or sell the remedy as a prevention for Malaria. It is supplied on request by practitioners working in Neals Yard Remedies stores, and in fact, the practitioners have been trained to always explain that the remedy should not be considered as a guarantee of prevention of malaria. The name of the remedy is based on its latin name and not on its claim to cure or prevent an ailment.

Clearly the MHRA are not falling from the laughable nonsense from Neals Yard. The MHRA should also be commended on the fact that they were fairly quick in their response to the situation.

Where the MHRA (in my humble opinion) have failed, is that they
... are pleased that Neal’s Yard Remedies have complied with our [MHRA] request and removed this product from the market.

Again, nothing about this request in the Neals Yard press release but it appears that the MHRA asked Neals Yard to remove the product and they did so. This isn't good enough. Had Inside Out not exposed the situation (and subsequent bloggers like myself and The Quackometer) not taken up the story, then MHRA would have done nothing. Despite a UK company selling a sugar pill as a preventative and cure for a life threatening disease, they did nothing.

And when they were alerted? They did the minimum to ensure no real boat rocking. What I would have liked to have seen is the MHRA take some sort of action in proportion with anyone else selling illegal, life-threatening medicines - fines at the very least.

One could argue that the PR fallout from this sort of story is huge, but in reality, the system is favouring the lawbreaker and profits at the expense of regulation, safety and public health.

The full MHRA story is here. The Quackometer has done (as usual!) an excellent fisking here.

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