Is The E-Party Over?

Source from:  TJI 03/19/2013

Had a pharmaceutical company invented the e-cigarette they might have become Tobacco Control's darling. But when profits and ideology come into play, true health interests run a poor third.

Four years ago, in the April 2009 issue of TJI, we already posed the question "Will pharma get its way and have e-cigarettes subjected to drug legislation". Pharmaceutical companies generate massive profits from NRTs (Nicotine Replacement Therapies), mainly gums and patches, and e-cigarettes as a lower priced and freely available adult consumer product pose a serious threat. Surprise, surprise, the EU's current proposed TPD (Tobacco Products Directive) recommends that e-cigarettes be treated as medical devices with all the trial work this entails, in effect removing most e-cigarettes from the market, knowing full well that the majority of e-cigarette manufacturers lack the financial resources to go for medical marketing authorisation.

Devil in disguise

And now comes the sneaky twist in the TPD: this should only apply to e-cigarettes with 4mg nicotine and over. To Mr. Average and the European members of parliament who decide on whether this becomes EU law this may sound reasonable: e-cigarettes up to 4mg nicotine remain free of restrictions, over 4mg they are medical devices. So, nod, nod, nod and pass the Directive. What they do not seem to know: 4mg nicotine is virtually a homeopathic dose and of no use to someone using e-cigarettes as a serious alternative to smoking cigarettes for health reasons.

Just goes to show what millions of dollars' worth of tobacco control sponsorship and lobbying in Brussels can do - this part of the TPD has Big Pharma written all over it. The message is clear: if a smoker wants to improve his health status by switching to inhaling nicotine, then only on the terms of Big Pharma with the full backing of instrumentalised politicians and the tobacco control lobby. Morally reprehensible maybe, but elbow marketing at its best.

What can Big Pharma offer?

One of the answers to nicotine inhalation therapy is Pfizer's medical device Nicotrol. Two clinical studies have confirmed the effectiveness of this approach - which in terms of logic also applies to e-cigarettes. What the studies show is a high initial quit rate at 44-45 per cent at 6 weeks - far better than gums or patches, oh dear - followed by a continuous drop in quit rates similar to those seen with conventional NRTs. The interesting part of these studies is that once patients go off medication (see end point) the quit rates are really no different than placebo.

What this study confirms in essence: inhaling nicotine is a useful and effective approach, but to be successful, long-term treatment is indicated. The safe use of nicotine at different doses has also been confirmed in a Cochrane study examining hundreds of clinical trials which dispels the rationale of the 4mg limit for e-cigarettes.

What now?

If the TPD goes through unchanged for e-cigarettes we can say goodbye to many small and medium-sized manufacturers and look forward to a battle between Big Pharma and Big Tobacco on the medical device front - and here is the good news: the proposed 75 per cent warning label does NOT apply to medical devices. Enditem