Tuesday, March 23, 2010

MHRA powerless to stop unregistered medicines being sold in UK

Artrosilium is an unlicensed, evidence-free, bullshit-claiming arthritis therapy. A recent email exchange with MHRA shows it is powerless to stop Artrosilium being sold in the UK.

Artrosilium has been a regular guest on this blog. It is an 'organic silica' gel which the sellers claim can treat arthritis, eczema, psoriasis, verrucas, various skin irritations, haemorrhoids and even prostate problems.

Of course, in the true nature of dodgy products, there's no need to prove any of the above claims - if you're flogging duff medicines and flouting the UK laws then bullshitting about your product's ability won't cause much moral panic. The product was deemed a medicinal product in 2001 by MHRA but is not licensed for sale in the UK.

This blog has featured 5 blog posts on artrosilium, originally on a tip-off from Ben Goldacre on the Bad Science forums; The UK is Unregulated in 2008 introduced Artrosilium and how the MHRA were able to get the company to amend its baseless claims. However, even though the website was a .co.uk domain, this didn't count as a UK presence, and so they were powerless to go any further. The second post in July 2008 looked at The Business Model of Quackery, showing how to get round the pesky UK legislation that stops rogue traders selling unlicensed medicines to unsuspecting (and often vulnerable) people. The third mention was on the 1 year anniversary of this site in Sept 2008 and detailed the involvement of Members of Parliament to get www.artrosilium.co.uk closed down. It now redirects to www.artrosilium.com, which is safe from the meddling hands of the UK authorities, and has stayed that way since Aug 08, as The Wayback Machine will testify. The last 2 posts (here and here) centred on Intramed's disregard for the Advertising Standards Authority, by continually putting unsubstantiated drivel and bullshit in their adverts for their quack products. (Indeed, they are still at it - there have been 10 ASA rulings against Intramed in the last 3 years, the most recent one in March 2010 - This to me indicates a company which doesn't give a rat's ass about advertising, safety or legislation. But you can buy their 'medicines' of you want to - I can't believe anyone would be crazy enough to.)

As a result of this infatuated blogging, this site now comes up 2nd on a Google search for 'artrosilium', and 40% of the keyword traffic to this site is associated with either artrosilium or IntraMed.

As a result, even though the above blogposts are quite old, new comments are still made, often from people who have among other things tried it, been conned by it and been wary of it.

At the tail end of last year (2009), a chap called GrimsbyLad scanned in and emailed an Artrosilium mailshot to this blog, offering a free sample of the product, as well as 11 pages of the usual nonsense of claims like 'guaranteed arthritis relief'. It seemed like a good time to have another crack at the MHRA and trading standards and so dialogue was opened and the email conversation has been sent to this blog for coverage.

The first reply came in late November 2009, which stated:

The product Artrosilium was classified as a medicinal product by the MHRA, in December 2001. It is manufactured in France and has been sold by both Bodywell SA and IntraMed Ltd operating from outside the EU. In both cases the business set-up has rendered enforcement action under medicines legislation through the courts, impossible. There are several other products involved as well, as you will have seen from the ASA adjudications, and other Agencies have experienced similar difficulties in bringing complaints to justice.
For this reason, the MHRA, alongside certain Trading Standards Services, has referred the matter on to the Office of Fair Trading. Your e-mail and the attachments have been forwarded to them also.
My bold. That's a pretty big admission from the organisation in charge of licensing medicines in the UK to say that due to the way company has set itself up, it is no longer able to come under the MHRA's jurisdiction.

The MHRA were then prodded for an update in March 2010, 4 months later. Surely, having noticed that it is possible, by setting up your business in a certain way, you can circumvent UK legislation, the MHRA had made strides to close the loophole?
Unfortunately, OFT have declined to investigate the activities of Intramed. The MHRA and the Trading Standards Service are making a combined effort to exercise some control over the company's agents in the UK but, you will recognise, Intramed are well aware of the advantage their Hong Kong status confers in terms of the regulations.

No explanation was given as to why the OFT have declined to investigate - one hopes that it is because the public are savvy enough to see the product for what it is and that even a cursory investigation into IntraMed sets alarm bells ringing, and so the number of people suckered by this company are few.

The point however remains - if you set your business up correctly, you can sell unregulated medicines into the UK with impunity. And that's according to the people responsible for licensing the medicines in the UK, the MHRA. That, to me, is a breathtakingly dangerous situation to be in.

I have a feeling this won't be the last blogpost on this site about Artrosilium.


BPSDB

4 comments:

  1. Surely this shouldn't be that difficult?

    All electronic products imported into the EU have to comply with various EU Directives. It does not matter where they are made, but it is the responsibility of the person 'placing them on the market' in the EU to ensure compliance (and add a CE mark if appropriate). The Directives are very clear about who the person is and what their responsibilities are.

    Surely it's not beyond the ability of the MHRA to ensure there is/was some similar system in place for medicines?

    ReplyDelete
  2. Breathtaking. If it is this simple to circumvent the MHRA's jurisdiction, it wouldn't surprise me to learn of many new ventures being formed along this business model, simply for the purpose of pushing quackery to a compliant public.

    Your call on @drevanahrris to investigate the MHRA's impotency is spot on - this should become the next Big Thing the SciTech committee goes after.

    BTW am I alone in feeling rather sorry for the MHRA in this case - they feel their hands are tied by those dastardly quacks, and try as they might they simply can't think of a way around them?

    Zeno, good point about EU Directives [insert obligatory Bloody Eurocrats rant here] - Dr*T, I'd consider contacting your MEP for further details on this...

    ReplyDelete
  3. Dr T excuse me if I appear to be stupid but this is my first time on this site. Firstly are you UK based and are you a qualified medical practitioner?

    You state "Artrosilium is an unlicensed, evidence-free, bullshit-claiming arthritis therapy"

    Is that your opinion or a medical fact? Has Artosilium been trialled by a drug company - why, where and when? Where can I access these trials?

    If it has not been trialled, what do you base your opinion on?

    Thanks

    ReplyDelete
  4. Hello Dr A,

    I am UK based, and as the profile says, am not a medical doctor.

    I asked the MHRA (UK medical licensing agency) about Artrosililium - the consider it a medicine but it has not been licensed and therefore illegal to sell in UK.

    It is evidence-free as there is no robust independent evidence that it works (outwith of anecdotes, which are common for all kinds of quackery and other outlandish things such as faith healing, psychics etc).

    Have a look on pubmed and see what trials exist for artorosilium - I'm sure someone with yu0or qualifications is more than capable of going to the primary literature!

    It's not licensed in UK, has no robust evidence base, has been the subject of many Advertising Standards breaches and of course as a result has no indication on manufacturing quality etc etc.

    T

    ReplyDelete

There was an error in this gadget