Polypill update

I wrote a few weeks ago about a website that was promoting an unlicensed medicine, the Polypill, and also about the serious conflict of interest of the doctors paid to prescribe it (yes, doctors who are openly paid to prescribe a specific pharmaceutical company's product: just think about that for a moment). I also recorded a piece about it for the Pod Delusion, along with the the wonderful @sparklewildfire, which you can listen to here if you're so inclined.

I contacted the MHRA at the time, as I was concerned about the legality of a website advertising an unlicensed medicine to the general public, and I have just had a reply. This is what they said:

Dear Dr Jacobs,

Polypill

Thank you for your email of 18 June 2013 about the promotion of an unlicensed medicine on the website www.polypill.co.uk.

We have been in correspondence with the advertiser and have completed our investigations. You may wish to know that the website has now been amended and that references to an unlicensed medicinal product have been removed. Advertising of medical treatment services to the public is subject to general advertising standards regulated by the Advertising Standards Authority.

A summary of the outcome of this complaint is also attached. Summary reports are published on our website each month. Any comments you may wish to provide must be done so in writing by 28 August 2013. However, we reserve the right to publish.

Thank you for bringing this matter to our attention.

Yours sincerely

[redacted]

Assessor, Advertising Standards Unit

Vigilance and Risk Management of Medicines

Well, that all sounded jolly satisfactory, so I thought I'd have another look at the website. Here it is.

It's a bit hard to see how references to an unlicensed product were removed. The Polypill is unlicensed, and the Polypill is mentioned extensively on the website. I emailed the MHRA to ask if they were sure the website had been amended, and got this response:

Dear Adam,

Thank you for your email.

Online clinics or pharmacies may promote the service they provide (e.g. medical consultation for individuals) and they may give information on a certain condition and its management but must not promote specific unlicensed or prescription only medicines.  We have published guidance on this that may help to explain our policy and priorities.  This is available athttp://www.mhra.gov.uk/Howweregulate/Medicines/Advertisingofmedicines/BlueGuide/CON189215?useSecondary=&showpage=28.  

The amendments made to the polypill website have removed specific reference to an unlicensed medicine and it now refers to the Polypill Prevention Programme. Any medication necessary for this programme may be delivered in a number of ways.  

Promotion of a treatment service is subject to the general advertising standards operated by the Advertising Standards Authority and any concerns about this are likely to be a matter for them but please do come back if you have any further specific medicine related concerns that you consider we should address. 

Kind regards,

[redacted]

I must say I find this all very puzzling. As far as I can tell, only a minor change was made to the wording of the website.  The original website contained the following sentence:

The combination of drugs which can be combined in a single pill improves the preventive effect whilst minimising all side effects. 

This has now been changed to:

The combination of drugs improves the preventive effect whilst minimising the risk of side effects.

Perhaps the website owners argued that dropping the text "which can be combined in a single pill" is crucial, as they are no longer mentioning the fact that the Polypill is a single pill. If they were going to prescribe the individual components of the drug separately, then you could argue that they would no longer be promoting an unlicensed medicine, as the individual components are licensed (though they would still be promoting prescription only medicines to the general public, which may also be illegal).

However, it seems pretty clear that that's not what's being planned. They are still quite obviously promoting a single pill, even if they have managed to use some Alice-in-Wonderland-esque sophistry to convince the MHRA that they are not.

I seriously do not understand in what parallel universe the MHRA live if they believe that the Polypill website does not promote the Polypill. If this website is legal, then it beats me why any pharmaceutical company would ever bother to do clinical trials and apply for a license for a medicine.