LETTERS
Outcome based schemes are more common than you think Patient access schemes that use outcomes are more widely used than Raftery has reported.1 Apart from the Australian experience with bosentan, which Raftery says is the only experience conducted worldwide to date, other schemes are still under way in other countries with successful results. For example, in Italy outcome based schemes of patient access have so far included sorafenib for hepatocarcinoma, dasatinib and nilotinib for acute myeloid leukaemia, temsirolimus for renal cell carcinoma, and pagaptanib and ranibizumab for age related macular degeneration.2 These schemes, which were implemented in 2007, have allowed many patients to be treated cost effectively with crucial drugs. In addition, the regulatory need to register these treatments on a national website has generated a database of all Italian patients receiving these treatments that could be used for nationwide observational studies. Andrea Messori , Area Vasta Centro, Health Service of Toscana, Firenze and Prato, 59100 Prato, Italy
[email protected] Competing interests: AM is a member of the Drug Reimbursement Committee of the Italian drug agency (AIFA), but these are his personal views. 1
Raftery J. Multiple sclerosis risk sharing scheme: a costly failure. BMJ 2010;340:c1672. (3 June.) 2 Lucioni C, Mazzi SF, Polcaro F. Il risk sharing come applicazione del value based pricing. PharmacoEconomics—Italian Research Articles 2010;12 (2):71-80. Cite this as: BMJ 2010;341:c3588
SECOND GENERATION MEPHEDRONE
The confusing case of NRG-1 Since the recent ban on mephedrone,1 2several alternative products have been introduced on internet websites. One of the most prominently discussed second generation products is Energy 1 (NRG-1), also advertised as naphyrone (naphthylpyrovalerone, O-2482), which originated from a group of compounds previously described in the medicinal chemistry literature.3 These products are offered as legal substitutes for the recently criminalised “legal highs,” the mephedrone derivatives. One of the earlier studies exploring the motivation for using these drugs suggested that consumers think that they are more likely to be of higher purity than street drugs, carry a lower risk of physical harm, and not be liable for the criminal sanctions associated with drugs controlled under the Misuse of Drugs Act.4 To obtain an initial snapshot of the post-ban situation, we purchased 17 products online from 12 UK based websites over the six weeks 62
NRG-1 and NRG-2 products purchased online from UK based websites in the 6 weeks after the ban on mephedrone Website No
Label*
Comment Butylone + MDPV (3,4-methylenedioxypyrovalerone) Flephedrone (4-fluoromethcathinone)
1
NRG-1
2
NRG-1
3
NRG-1
Flephedrone + MDPV
3
NRG-2
Methyl-N-ethylcathinone
4
NRG-1
Flephedrone + MDPV
5
NRG-1
Caffeine + traces of mephedrone
6
NRG-1
Naphyrone
7
NRG-1
Butylone + MDPV
8
MDAI
Inorganic composition
9
NRG-1
Mephedrone
10
NRG-1
Inorganic composition
10
NRG-2
Mephedrone + benzocaine
11
NRG-1
Mephedrone
11
NRG-2
Mephedrone
11
DMC
Caffeine + lidocaine
11
MDAI
Mephedrone
12
NRG-2
4-Methyl-N-ethylcathinone
*DMC=dimethocaine, MDAI=5,6-methylenedioxy-2aminoindane.
after the ban on mephedrone in mid-April 2010. Chemical analysis was carried out by established procedures (table).5 Most of the NRG-type products were recently banned cathinones that just carried a new label; this suggests that both consumers and online sellers are, most likely without knowledge, at risk of criminalisation and potential harm. This has important health and criminal justice consequences that will require carefully thought out responses and further investigation. Simon D Brandt senior lecturer in analytical chemistry, School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool L3 3AF
[email protected] Harry R Sumnall reader in substance use, Centre for Public Health, Liverpool John Moores University, Liverpool L3 2AJ Fiona Measham senior lecturer in criminology, Department of Applied Social Science, Lancaster University, Lancaster LA1 4YT Jon Cole reader in psychology, School of Psychology, University of Liverpool, Liverpool L69 7ZA Competing interests: None declared. 1 2 3
4
5
Morris K. UK places generic ban on mephedrone drug family. Lancet 2010;375:1333-4. Winstock AR, Marsden J, Mitcheson L. What should be done about mephedrone? BMJ 2010;340:c1605. (23 March.) Meltzer PC, Butler D, Deschamps JR, Madras BK. 1-(4-methylphenyl)-2-pyrrolidin-1-yl-pentan-1-one (pyrovalerone) analogues: a promising class of monoamine uptake inhibitors. J Med Chem 2006;49:142032. Measham F, Moore K, Newcombe R, Welch Z. Tweaking, bombing, dabbing and stockpiling: the emergence of mephedrone and the perversity of prohibition. Drugs Alcohol Today 2010;10:14-21. Martins CPB, Freeman S, Alder JF, Passie T, Brandt SD. Profiling psychoactive tryptamine-drug synthesis by focusing on detection using mass spectrometry. Trends Anal Chem 2010;29:285-96.
Cite this as: BMJ 2010;341:c3564
CHRONIC KIDNEY DISEASE
Alternative view of CKD and QOF There is an alternative perspective to Spence’s view that opportunistic screening for chronic kidney disease (CKD) is “bad medicine.”1 Referrals from primary care increased after the introduction of estimated glomerular filtration (eGFR) reporting, with a shift towards more advanced disease—suggesting that those with most to gain from specialist review are now more likely to receive it.2 Furthermore, fewer “crash-landers”—a group with particularly poor outcome—have been starting dialysis unplanned.3 Renal clinics were initially overwhelmed, but this is being reversed by better communication between primary and secondary care.4 Systems facilitating the provision of timely advice on an individual patient basis can inform the need for referral. Guidance to support pragmatic referring exists: guidelines state that patients with CKD 3 without proteinuria do not generally require referral.5 Lower eGFR, and even mildly increased urinary albumin excretion, is strongly and independently associated with cardiovascular mortality,6 which increases with the severity of CKD. Meanwhile, evidence for the use of statins is more convincing in patients with less advanced CKD. Measures to identify CKD early, such as the Quality and Outcomes Framework (QOF), and ameliorate progression will reduce the burden of cardiovascular disease. Finally, the point at which a lower glomerular filtration rate becomes pathological is debatable and must be determined on an individual patient basis. Although use of the word “disease” to describe an asymptomatic condition may cause unnecessary concern, this must be balanced against the benefits that the conceptual model of CKD has had in demystifying the condition and aiding communication between clinicians and patients. Andrew Connor specialist registrar in renal and general medicine, Dorset County Hospital, Dorchester
[email protected] Donal O’Donoghue consultant nephrologist, Salford Royal NHS Foundation Trust, Manchester Competing interests: DO’D is the national clinical director for Kidney Care. 1 2 3
4
Spence D. Bad medicine: chronic kidney disease. BMJ 2010;340:c3188. (16 June.) O’Donoghue D. Going upstream: the implication and opportunities of early detection. J Renal Care 2009;35:3-7. Byrne C, Ford D, Gilg J, Ansell D, Feehally J. UK renal registry 12th annual report (December 2009): Chapter 3 UK ESRD. Incident rates in 2008: national and centrespecific analyses. Nephron Clin Pract 2010;115(suppl 1):c9-40. Phillips LA, Donovan KL, Phillips AO. Renal quality outcomes framework and eGFR: impact on secondary care. QJM 2009;102:415-23. BMJ | 10 JULY 2010 | VOLUME 341
