Editorials

Newly licensed drugs

The Medicines Act 1968 set up a licensing authority that grants a marketing authorisation (product licence) for a medicinal product only if it is effective and safe and of good quality. Once licensed, a drug can usually be prescribed by any doctor under the NHS. But general use of a newly licensed drug may be undesirable.

Firstly, the licensing process cannot define uncommon adverse effects. It is easier to measure common therapeutic benefits than rare, but important, reactions. The numerical problem is daunting. If n patients have been treated, and none has suffered a particular adverse effect, then we can be 95% sure that the true incidence of that adverse effect is between 0/n and 3/n.¹ Licensing decisions are based on trials involving on average around 1500 patients,² so at the time of licensing, a serious reaction that affects as many . . . [Full text of this article]

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    StumbleUpon    Technorati    What's this?

Relevant Articles

How NICE may be outflanked

R E Ferner and Sarah E McDowell
BMJ 2006 332: 1268-1271. [Full Text] [PDF]

The influence of big pharma

R E Ferner
BMJ 2005 330: 855-856. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

• Ferner, R E, McDowell, S. E (2006). How NICE may be outflanked.. BMJ 332: 1268-1271 [Full text]  
• Ferner, R E (2005). The influence of big pharma. BMJ 330: 855-856 [Full text]  
• Figueras, A., Laporte, J.-R. (2003). Failures of the therapeutic chain as a cause of drug ineffectiveness. BMJ 326: 895-896 [Full text]  
• Ferner, R.E. (2002). Medicines management: a sour taste. QJM 95: 181-184 [Full text]  
• Jones, M. I, Greenfield, S. M, Bradley, C. P (2001). Prescribing new drugs: qualitative study of influences on consultants and general practitioners. BMJ 323: 378-378 [Abstract] [Full text]  
• Psaty, B. M., Weiss, N. S., Furberg, C. D., Koepsell, T. D., Siscovick, D. S., Rosendaal, F. R., Smith, N. L., Heckbert, S. R., Kaplan, R. C., Lin, D., Fleming, T. R., Wagner, E. H. (1999). Surrogate End Points, Health Outcomes, and the Drug-Approval Process for the Treatment of Risk Factors for Cardiovascular Disease. JAMA 282: 786-790 [Full text]  
• Senn, S., Clark, W., Fisher, M., Misson, J., Sochart, D. H, Williams, H. C, Wolff, F. (1998). Too soon to market. BMJ 316: 228-228 [Full text]  
• Dent, T. H S, Hawke, S. (1997). Too soon to market. BMJ 315: 1248-1249 [Full text]  
• Greenhalgh, T. (1997). How to read a paper: Papers that report drug trials. BMJ 315: 480-483 [Full text]  
• Brodie, M. J, Elferink, A J A, Zwieten-Boot, B J V., Craig, J. J, Morrow, J. I, Wong, I. C (1997). New antiepileptic drugs. BMJ 314: 602-602 [Full text]  
• Burnfield, A., Price, C, Napier, J. C, Holmes, J., Winyard, G., Cardy, P., Peltola, J., Keranen, T. (1997). Interferon beta in multiple sclerosis. BMJ 314: 600-600 [Full text]  
• Smeeth, L., Hippisley-Cox, J., Paris, J. A G, Tiner, R. (1997). Newly licensed drugs. BMJ 314: 604-604 [Full text]