The Scientist: Do e-cigs deserve more evidence?
MHRA has done a disservice by not publishing more data on products it licenses, says The Scientist
E-cigarettes are a bit of a hot topic at the moment, particularly after watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) granted the first marketing authorisation for one product late last year.
My fellow blogger Dr Messenger was not amused, but at least having a licensed product means that there will be a brand of e-cig that's reasonably safe and effective, right? Hmm. I don't think we can be so sure about that.
You see, e-Voke, the product in question, was licensed on the basis that it delivers nicotine with a similar pharmacokinetic profile to the Nicorette 15mg Inhalator.
That's it. No other clinical data was submitted or reviewed; there is no evidence I can find that the e-Voke specifically can actually improve rates of quitting smoking.
So if the e-Voke was licensed based on equivalence to the 15mg Inhalator, what's the evidence base like for that product?
Well. The 15mg Inhalator, it turns out, was licensed based on pharmacokinetic equivalence to the 10mg Inhalator; once again there is no evidence of any additional clinical efficacy data being considered when this licence was granted.
That's where it ends, however. Just when I thought I was going to be sucked down a bottomless rabbit hole to some kind of nicotine-based Wonderland, I hit a brick wall. The 10mg Inhalator is no longer marketed, and despite some fairly lengthy searching, I couldn't find any trace of a public assessment report or other regulatory document.
Another concerning factor is that there is no data I can find on the MHRA’s assessment of the safety of the device itself. There are dozens of anecdotes available about e-cigarettes exploding or catching fire, and while one would hope that a licensed product would be manufactured to a higher standard, at this point we're basically taking that point on faith.
Although the products cited in those anecdotes are rechargeable e-cigarette devices – a radically different design to inhalators such as the e-Voke (which is powered entirely by the user's breath) – I still think the MHRA should have provided more data in this area.
All of that leaves us knowing that e-Voke is similar to a product which is similar to a product which is no longer available, and about which there is no readily available information. We have no evidence that it is effective as a smoking cessation aid, and have been shown no real evidence to prove it's safe.
So the whole thing leaves me conflicted. There's no doubt that smoking is a massive public health problem, and anything that can help address it seems worthwhile. But the evidence in this area is simply not there, and we can't push for evidence-based medicine then simply turn away from those principles when it suits us.
Electronic cigarettes are a minefield, and the MHRA has done users and health professionals alike a great disservice by granting the first marketing authorisation on such flimsy evidence.
The Scientist is a medicines information scientist working in the north of England