My brother in law chain smoked for 20 years. He tried to quit with cognitive behavior therapy, nicotine replacement therapy, and other therapies but nothing worked. Then he suddenly stopped. Surprised, I asked how. He showed me some pills with ‘Tabex’ written on them. Tabex is the trade name for a compound called cytisine that Eastern European smokers have used to help them quit since the 1960s. It’s made from the laburnum plant that grows easily in much of the world, making it cheap, and you can buy it online pretty much anywhere. It costs about £15 for an entire stop smoking pack in the UK and even less in Eastern Europe. It’s much cheaper than what standard smoking cessation drugs cost in the UK. For example Pfizer makes a copycat patented cousin of cytisine called varenicline, which costs £90 per month. However since you have to take varenicline for 3 months, whereas a course of cytisine only lasts a month, varenicline costs 20 times as much. Cytisine also seems to have similar effects as varenicline: at least three randomised trials published in academic journals have shown it is more effective than placebo.
The funny thing is that cytisine isn’t used much in the UK because doctors here can’t prescribe it. Why not? My brother in law likes conspiracy theories and insists the reason is something to do with capitalism and corruption. I’m not into conspiracy theories so I looked for the truth. This took me into the La La Land of drug regulation that is worse than a conspiracy …
The reason doctors in the UK can’t prescribe this cheap effective drug is that it hasn’t been licensed, and drugs that haven’t been licensed can’t be prescribed. The main reason a drug company won’t apply for a licence is that the licensing process is expensive. Since cytisine can’t be patented (it’s not new), the company would not be able to recover the costs of licensing. But since smokers and taxpayers would benefit, why doesn’t the Department of Health commission the licensing process? The UK the government spends 13.9 billion pounds per year on treating smoking related illnesses. If cytisine could reduce these costs by just 1% it would save UK taxpayers 14 million pounds per year. I contacted the Department of Health the to ask (I got the same answer from the EU), and they passed the buck. They said their role is to review applications, not make them. According to a colleague (who wishes to not be named) this isn’t true because there is a provision buried somewhere for the Department of to commission a licence, but I couldn’t confirm this. What the Department of Health does do is fund private/public collaborations, and such a partnership could help a company absorb the cost of licensing. They haven’t done that either.
What other reasons might the Department of Health use for not finding a way to let doctors prescribe cytisine? I have heard three and they don’t add up to a good excuse.
1. Although trials show cytisine works, some might say we need more trials. With the trials and decades of observations I find this difficult to accept but if someone in the Department of Health really believes this, they could commission a trial. Publicly commissioned trials are common for other (less deadly) problems like prophylactic antibiotics for children with colds.
2. If doctors are suddenly able to prescribe cytisine, patients would not be able to buy it because nobody in the UK currently produces or supplies enough. But his can’t be right. If no company would be willing to produce it although it had been licensed, I’m pretty sure a company already producing it in Eastern Europe would be delighted to scale up their operation. (Refusal of a UK drug company to produce a licensed drug would also show that the patent system is not just a reward for research and development but a warrant to overcharge — that’s another point).
3. It could just be inertia — the Department of Health may not be used to doing these kinds of things. This is no excuse because millions are being wasted and smokers need help quitting. It’s time for someone in the Department of Health to follow my colleague’s advice to transcend the “Alice in Wonderland world of regulation” to find a way let doctors prescribe cytisine. Until that happens I’ll have to suffer through my brother in law’s conspiracy lectures. Cytisine may be cheap way to help people quit quit smoking but it doesn’t stop them from buying into conspiracy theories.
Additional reporting and writing by Robert West and Paul Aveyard