EU Times article - curious MHRA comment and subsequent deletion

[Oliver]

Something slightly curious took place today in the comments to this article on the Times (£) website: Advisers on e-cigarettes

In case you're unaware, the article in question highlights the lack of declarations of interests by the expert panel the MHRA convened to discuss regulating electronic cigarettes.

In particlar, severeal of these experts have strong links to the pharmaceutical industry, either in consulting positions or as shareholders: All concerning smoking cessation products.

So, the following comment was posted by the username "MHRA" this morning, and signed by Dr. Ian Hudson. By 3.30pm, it no longer appeared on the site. Commenters on the Times website are able to delete comments they've posted, although it could easily have been the Times which removed the comment:

The article by Alex Ralph (“Advisers on e-cigarettes ‘failed to declare their interests’ in Big Pharma’s products”) misrepresents the way the MHRA handled conflicts of interests in the case of the Nicotine Containing Products Working Group. The MHRA has a strict conflicts of interests policy in place, outlined in full on our website, this applies to chairpersons and members of the Commission on Human Medicines and any ad hoc or working groups it establishes.
All members of the Nicotine Containing Products Working Group made full statements of any relevant interests in their annual declarations. Mr Ralph states that no interests were declared at the January 2013 meeting, where in fact interests were clearly declared by two members as recorded in the minutes.
No interests were declared at the beginning of the meeting as initial items were general in nature, where the discussion was product-specific relevant interests were declared and taken into consideration when deciding the extent of those members’ participation in the discussion and recorded in the minutes under that specific item. One of these members was then limited in their participation to the group, the other was permitted to participate as the interest was non-personal (meaning no direct remuneration was received by the member) and non-specific (not related to the item being discussed).
The vast majority of the content considered by the working group at both of the meetings was of a broad nature on topics such as the tobacco Products Directive and not product-specific.
Given the highly technical nature of the MHRA’s work, it is difficult to find experts with the relevant expertise who do not have any form of interaction with the pharmaceutical industry, either direct or indirect. Their interests are, however, considered and assessed when deciding on the appropriate level of participation in discussions.
Yours sincerely,
Dr Ian HudsonDirector of Licensing
Medicines and Healthcare products Regulatory Agency

I wonder what's going on here?

 

[low_tar_neil]

Could be something to do with his post being directly undermined by the publicly available minutes, in section 1.4.

http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286838.pdf

 

[Oliver]

It's an ambiguously phrased section - It refers to a specific product but doesn't clarify what they mean by that. Is it a specific brand, or e-cigarettes generally (as opposed to, say, nicotine lollypops or some such)?

 

[NorthOfAtlanta]

Could be Attorneys, he told the truth and admitted that they cannot find experts that don't have ties to BP. They probably "strongly advised " him to take it down.

 

[low_tar_neil]

Yeah, it could well be that. Seems a bizarre thing to admit, given the 'strict conflicts of interests policy' - which apparently is only strict until they can't get anyone uncompromised, or you can just lie.

 

[NorthOfAtlanta]

It is just to broad a statement, the Director of Licensing admitted that MHRA can't find experts that don't have a BP bias.

ETA: In trying to defend against the article he admitted that overall it was correct and not just in the tobacco end of it.

 

[e-pipeman]

Hmmm. It certainly seems like an admission of inherent bias.

While on the subject of the minutes section 5.3.2 is interesting. Because they feel that an NCP is an NCP irrespective of the level of nicotine and therefore subject to regulation how will, for example, potato crisps survive without regulation?

 

[gayhalo]

Well with all the above in mind maybe the MHRA are just not the people who should be taking any interest in them. I have no idea who decided they were the right people to regulate them, we know that according to the MHRA's definition they are not a medicine, so as they cannot find any experts other than pharma people and the product is a CONSUMER product they will have problems. They could have found experts from the food, drink, cosmetics etc. industries but did not. Having experts in NCP's when the product makes no claims that it helps quit smoking to me is making up the answer before the questions are asked.
Maybe we have ourselves to blame. If we had all kept quiet that we had been smokers and are no longer they may not have jumped to the conclusion. Too late for that.
I personally enjoy vaping so much, I hated smoking, I would love ALL smokers to have the chance to try it and if they like it like I do they will do it instead of smoking and maybe save their lives (for a bit longer).
Rambleings of a 67 year old vaper.

 

[gayhalo]

Hmmm. It certainly seems like an admission of inherent bias.

While on the subject of the minutes section 5.3.2 is interesting. Because they feel that an NCP is an NCP irrespective of the level of nicotine and therefore subject to regulation how will, for example, potato crisps survive without regulation?

And stinkies of course

 

[chips]

@CaeruleanSea on Twitter asked the guy who wrote the times article Alex Ralph (twitter @alexralph ) about the mysterious disappearing reply from MHRA.

He replied that "that the MHRA sent same thing to their Letters desk. We've clarified in paper today that interests were later declared in 2013 meeting."

 

[Berylanna]

Where is it written that nicotine-cessation experts are the only people qualified to figure out how to regulate nicotine? What about toxicologists? Family doctors?

 

[chips]

Where is it written that nicotine-cessation experts are the only people qualified to figure out how to regulate nicotine? What about toxicologists? Family doctors?

I agree, I mean they may see its a hard job to find unbias advisors, however I do not believe that it is that hard a job, as you say there are plenty of relevant experts without vested interests.

But maybe the MHRA have their own vested interests and pick advisors that will support their own agenda?

The guy who wrote the mysterious disappearing letter to the times, Dr Ian Hudson himself worked for SmithKline Beecham (manufacturers of Nicorette) from 1989 until he joined the MHRA in January 2001 as Director of the Licensing Division.

 

[gayhalo]

Well with all the above in mind maybe the MHRA are just not the people who should be taking any interest in them. I have no idea who decided they were the right people to regulate them, we know that according to the MHRA's definition they are not a medicine, so as they cannot find any experts other than pharma people and the product is a CONSUMER product they will have problems. They could have found experts from the food, drink, cosmetics etc. industries but did not. Having experts in NCP's when the product makes no claims that it helps quit smoking to me is making up the answer before the questions are asked.
Maybe we have ourselves to blame. If we had all kept quiet that we had been smokers and are no longer they may not have jumped to the conclusion. Too late for that.
I personally enjoy vaping so much, I hated smoking, I would love ALL smokers to have the chance to try it and if they like it like I do they will do it instead of smoking and maybe save their lives (for a bit longer).
Rambleings of a 67 year old vaper.

Ok so I was right.... See EU legislation for whole text

Totally Wicked has obtained written confirmation from the Medicines and Healthcare Products Regulatory Agency (MHRA) that none of its current product range is a medicine or a medicinal device, and that it does not need to obtain medicines marketing authorisations for its products. Notwithstanding that, the MHRA has stated that if MEPs vote for the EU's draft Tobacco Products Directive (TPD) in its current form on the 10th of September, it will require Totally Wicked from 2016 to market the same products as medicines and obtain such authorisations. In other words, it would have to seek medicines licences