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.


Tuesday, March 9, 2010

Righteous Indignation Podcast

Just a quick note to say I can be heard jibber-jabbering in this week's Righteous Indignation Podcast, self-appointedly standing in for Marsh. First 'live' podcast I've done, and in fairness I could have benefited from a whisper less Dutch courage and ounce or two more coherence.

Still, the edit is kind, and you can hear Trystan Swale, Hayley Stevens, Gavin Schofield and myself discuss skeptical news, ghosts and interview Rose Shapiro, author of "Suckers: How Alternative Medicine makes fools of us all" here (download).

It was great fun to do - thanks to the RI team for the opportunity.


Thursday, March 4, 2010

HA! Ha! Nelson's Natural World forced to change website by MHRA

Hot off the heels of the 10:23 campaign and the UK Parliamentary Science & Technology "Evidence Check" on homeopathy, a major UK supplier of homeopathic products has been investigated by the MHRA Enforcement Division, and forced to make website changes.

Nelson's had previously stated that their homeopathic product 30c Sulphur
is known amongst homeopaths for its many skin benefits.

This is, of course, not in keeping with the UK legislation on homeopathic products which says that homeopathic products not licensed under the EU's National Rules Scheme must not provide therapeutic indications but bear the legend:
“This is a homeopathic medicinal product without approved therapeutic indications.”

The website now looks like this.

Of course Nelson's know that therapeutic indications are not allowed when selling or marketing homeopathic products, and yet didn't seem to have an issue with disregarding the legislation. I know they know this, because in the UK, there is only one homeopathic product licensed with the MHRA under the National Rules Scheme which is allowed to state therapeutic indications - guess who it's made by? Indeed - Nelson's. Their Arnicare 30c Arnica was licensed by the MHRA last July, some 18 months after the application by Nelson's.

I would have thought that a homeopathic pill supplier, such as Nelson's, leading the way in the industry by providing the necessary documentation over a period of 18 months to the MHRA, would have known the legislation pretty well and known that selling homeopathic remedies with therapeutic indications is not acceptable in the UK. Seems not - it's very tempting to suggest they knew *exactly* what they were doing, but with the UK's libel laws as they are, I'll not be making that suggestion.

In reality, the new website is an example of silly, pointless legislation. On one hand, Nelson's aren't allowed to describe any symptoms that the sugar pills are supposedly an aid for, but must state:
"If symptoms worsen or persist, consult a doctor"

Symptoms? What symptoms? I can't say, but take these pills until they clear up!

In any case, Nelson's are in good company - a similar event happened in Oct 09, when Boots were similarly forced to amend their website in accordance with UK legislation. Indeed, an email I've seen from the MHRA says that due to the number of 'non-compliant' websites, they will be releasing a guidance document on the advertising of homeopathic products. I wouldn't hold your breath though, it's taken them 4 months to get Nelson's to change their website, imagine how long a document will take....