Newly licensed drugs

BMJ 1997; 314 doi: https://doi.org/10.1136/bmj.314.7080.604a (Published 22 February 1997) Cite this as: BMJ 1997;314:604

A probationary period is a good idea

  1. Liam Smeeth, Academic registrara
  1. a Department of Primary Care and Population Sciences, Royal Free Hospital School of Medicine, University College London Medical School, London NW3 2PF
  2. b Department of General Practice, Faculty of Medicine, Medical School, Queen's Medical Centre, Nottingham NG7 2UH
  3. c Wesham Park Hospital, Wesham, Near Kirkham, Lancashire PR4 3AL
  4. d Department of Medicine, Association of the British Pharmaceutical Industry, London SW1A 2DY

    Editor-R E Ferner calls for newly licensed drugs to be on probation until they have been shown to be at least as effective as existing alternatives in randomised controlled trials.1 The clear need for such a probationary period is supported by examination of the drug treatment for adult essential hypertension.

    Observational data suggest an increased risk of myocardial infarction and death in hypertensive subjects treated with short acting dihydropyridine calcium antagonists compared with hypertensive subjects receiving other treatments.2 Whether one believes that these data are worrying enough to preclude the drugs' use or that the drugs' continued use as first line agents is justified,3 there is clearly an urgent need for randomised controlled trials. Thiazides and β blockers remain the only drug treatments for hypertension proved to be effective in reducing cardiovascular morbidity and mortality. Nifedipine (as Adalat) was licensed for hypertension in 1982, and captopril (as Capoten) was licensed in Britain for the treatment of hypertension in 1981 (dates supplied by manufacturers). The pharmaceutical industry has thus had 15 years in which to undertake randomised trials for these drugs but has failed to do so. Given this, it is surprising that the British Hypertension Society has been unable to obtain support from the industry for a trial comparing the main therapeutic classes of antihypertensive drugs.2

    Several new antihypertensive drugs are now being introduced: losartan (an angiotensin II receptor antagonist), nislodopine (a third generation calcium antagonist), and moxonidine (a selective imidazoline receptor antagonist) are three examples. These drugs are marketed for first line use in hypertension, although none has been shown to be effective in reducing morbidity or mortality in hypertension. We could easily enter into a spiral of new unproved drugs being introduced to succeed older “new” drugs (such as captopril and nifedipine) before the …

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