Public health experts challenge ‘myopic’ medicine regulator over nicotine replacement products and smoking

Thursday 13 December 2001


Public health experts challenge ‘myopic’ medicine regulator over nicotine replacement products and smoking


LONDON & PRAGUE: the UK medicine regulator is under fire for creating unwarranted obstacles to wider use of nicotine replacement therapy and thereby promoting increased smoking – and the harm that goes with it.  In a review of evidence published today in the journal Addiction[1] and in a declaration prepared under the auspices of the WHO published at a conference in Prague this week [2], experts in the field mount a challenge to the regulators to think again.  They claim that medicine regulators such as the Medicines Control Agency are failing to adequately take into account that smokers are already using nicotine in a much more harmful form through smoking when they impose restrictions and off-putting warnings on NRT products such as patches and gum.


The paper argues that young people, pregnant smokers and smokers with cardiovascular disease (CVD) be encouraged to use NRT if they want to quit smoking. At present there are restrictions and distracting warnings required by the regulator.  The paper also argues that NRT should be used for smoking reduction, to support temporary abstinence, and for long-term use as an alternative to smoking – and that NRT products should be made as widely available as cigarettes. This paper also recommends that regulators and the government do not erect barriers to development of less harmful forms of nicotine delivery devices to compete with cigarettes.


Dr. Ann McNeill, Honorary Senior Lecturer, Department of Psychology, St. George’s Hospital Medical School (lead author on the paper published in Addiction) said:


It’s simple really – the more the regulators place stringent regulations on the use of NRT, the more likely it is that people will continue to smoke, and then die as a result. 


They don’t properly consider the risk of not using the product when they place restriction and warnings on the packs.  The restrictions and stern warnings just make smokers and their doctors nervous, yet smoking is thousands of times more dangerous.


Dr. Jonathan Foulds, Associate Professor, University of Medicine and Dentistry of New Jersey, School of Public Health (co-author) said:


We really need to liberalise the market for nicotine treatments and remove these absurd restrictions. If we applied the same restrictions and warnings regime to cigarettes, then the pack would need to be the size of large tombstone to fit it all on.


In many countries of the world you need a doctor’s prescription to get the nicotine inhaler but you can buy cigarettes almost anywhere. What kind of crazy system is it that makes it so much easier to get the most dangerous product and so hard to get the treatment?


Clive Bates, Director of Action on Smoking and Health in London, (co-author) argues that issues of medical negligence and liability underpin this problem:


The regulators have a ludicrous approach to NRT – it’s like refusing to throw a life belt to a drowning man because they’re worried that it might hit him on the head or the plastic might be toxic if he accidentally swallows it.


If the regulator or medical professional was liable for the consequences of not treating a smoker with NRT, we’d soon see these restrictions come off.


It’s easy to explain why the regulators adopt the ostrich posture when it comes to NRT products – if as moker has a problem when using the drug, the regulator or medical professional might be blamed.  If the smoker doesn’t use the drug, but continues to smoke and suffers the consequences of smoking,then the smoker is to blame.  The system works to protect regulators and doctors, but does little to protect the poor old smoker.


This is a serious case of regulatory myopia, in which the obvious reality of smoking as the main way of taking nicotine has somehow been overlooked when it comes to deciding how to handle nicotine in its safest form.


The authors called on the government to launch a review of regulation in this area – and to ask its Scientific Committee on Tobacco and Health (SCOTH) to form a joint working group with the medicine regulator, the Medicines Control Agency, to develop a new approach to the regulation of nicotine in all its forms.


Clive Bates said:


“Nicotine is not a normal medicine, and can’t be regulated in the normal way.  We need to have the tobacco experts working with the medicines experts to get an approach that put the health of the smoker first.


Notes – all materials available via this press release on the ash web site:

The full text is available on the ASH web site.

[2] WHO-Europe meeting in Prague 13-14th December to announce ‘Regulation of nicotine replacement therapies: an expert consensus’.  This was developed together with regulators from France, Germany and Poland.




Dr Ann McNeill +44 20 8650 0650 (office) +44 79 6858 5868 (mobile in Prague)


Dr. Jonathan Foulds +1 732-235-8213 (US – 5 hours)


Clive Bates +44 20 7739 5902 (office) +44 77 6879 1237(mobile) ISDN available