Public health experts challenge ‘myopic’ medicine regulator over nicotine replacement products and smoking
Public health experts challenge ‘myopic' medicine regulator over nicotinereplacement products and smoking
LONDON &PRAGUE: the UK medicine regulator is under fire for creating unwarrantedobstacles to wider use of nicotine replacement therapy and thereby promotingincreased smoking - and the harm that goes with it. In a review of evidence published today in the journal Addiction[1] and in adeclaration prepared under the auspices of the WHO published at a conference inPrague this week [2], experts in the field mount a challenge to theregulators to think again. They claimthat medicine regulators such as the Medicines Control Agency are failing toadequately take into account that smokers are already using nicotine in a muchmore harmful form through smoking when they impose restrictions and off-puttingwarnings on NRT products such as patches and gum.
The paper argues that young people, pregnantsmokers and smokers with cardiovascular disease (CVD) be encouraged touse NRT if they want to quit smoking. At present there are restrictions anddistracting warnings required by the regulator. The paper also argues that NRT should be used for smokingreduction, to support temporary abstinence, and for long-term use as analternative to smoking - and that NRT products should be made as widelyavailable as cigarettes. This paper also recommends that regulators and thegovernment do not erect barriers to development of less harmful forms ofnicotine delivery devices to compete with cigarettes.
Dr. Ann McNeill, Honorary Senior Lecturer, Department ofPsychology, St. George's Hospital Medical School (lead author on the paperpublished in Addiction) said:
It's simple really - the more the regulatorsplace stringent regulations on the use of NRT, the more likely it is thatpeople will continue to smoke, and then die as a result.
Theydon't properly consider the risk of not using the product when they placerestriction and warnings on the packs. The restrictions and stern warnings just make smokers and their doctorsnervous, yet smoking is thousands of times more dangerous.
Dr. Jonathan Foulds, Associate Professor, University of Medicineand Dentistry of New Jersey, School of Public Health (co-author) said:
We really need to liberalise the market fornicotine treatments and remove these absurd restrictions. If we applied thesame restrictions and warnings regime to cigarettes, then the pack would needto be the size of large tombstone to fit it all on.
Inmany countries of the world you need a doctor's prescription to get thenicotine inhaler but you can buy cigarettes almostanywhere. What kind of crazy system is it that makes it so mucheasier to get the most dangerous product and so hard to get the treatment?
Clive Bates, Director of Action on Smoking and Health inLondon, (co-author) argues that issues of medical negligence and liabilityunderpin this problem:
Theregulators have a ludicrous approach to NRT - it's like refusing to throw alife belt to a drowning man because they're worried that it might hit him onthe head or the plastic might be toxic if he accidentally swallows it.
If theregulator or medical professional was liable for the consequences of nottreating a smoker with NRT, we'd soon see these restrictions come off.
It's easy to explain why theregulators adopt the ostrich posture when it comes to NRT products - if asmoker has a problem when using the drug, the regulator or medical professionalmight be blamed. If the smoker doesn'tuse the drug, but continues to smoke and suffers the consequences of smoking,then the smoker is to blame. The systemworks to protect regulators and doctors, but does little to protect the poorold smoker.
This is a serious case ofregulatory myopia, in which the obvious reality of smoking as the main way oftaking nicotine has somehow been overlooked when it comes to deciding how tohandle nicotine in its safest form.
The authors called on the government to launch a review ofregulation in this area - and to ask its Scientific Committee on Tobacco andHealth (SCOTH) to form a joint working group with the medicine regulator, theMedicines Control Agency, to develop a new approach to the regulation ofnicotine in all its forms.
Clive Bates said:
“Nicotineis not a normal medicine, and can't be regulated in the normal way. We need to have the tobacco experts workingwith the medicines experts to get an approach that put the health of the smokerfirst.
Notes - all materials available via this pressrelease on the ash web site: http://www.ash.org.uk/?press
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The full text is available on the ASH web site.
[2] WHO-Europe meeting in Prague 13-14thDecember to announce ‘
Contact:
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
