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Letter to the editor

Editor, In reference to the editorial 'The price of urine' by Dr A. Dawson (Aust Prescr 1995;18:26-7), we agree that patient-relevant outcomes should be used to evaluate the efficacy and safety of all therapy-pharmaceutical and nonpharmaceutical. Improvements in symptoms and quality of life, significant adverse effects and impact on mortality would be appropriate measures.

Applying a comparative approach to surgery and finasteride in benign prostatic hypertrophy, the percentages of patients reporting symptom improvement in the two groups are similar.1-4 With regard to quality of life, compared with placebo, finasteride-treated patients were significantly less likely to report interference with function at work or regular activities, and waking at night due to symptoms; and significantly more likely to report improvement in worry and concern due to urinary problems.1,2 The companion article by Mr P. Stricker (Aust Prescr 1995;18:30-2) gave a review of significant adverse effects and the impact on mortality associated with surgery compared with finasteride.

Regarding alpha blockers, terazosin is available and has a similar cost to finasteride. Further, there are ongoing studies comparing finasteride with prazosin. Importantly, alpha blockers work differently from finasteride and have only been shown to be useful short term.5

Your editorial highlights a challenge for companies and the Pharmaceutical Benefits Advisory Committee, especially when introducing a pharmaceutical into an area with little data outcomes for existing therapy. In such cases, it is important to balance the desire for long term outcomes data which may take many years to collect against the needs of patients today.

Lee Ausburn
Merck Sharp & Dohme Australia Pty Ltd
South Granville, N.S.W.


Author's comments

Dr A. Dawson, the author of the editorial, comments:

In my editorial I tried to emphasise the importance for practitioners of examining outcomes that are relevant to their patient's needs. To assess the relative benefits and risks of surgery versus medical treatment of benign prostatic hypertrophy requires a randomised controlled trial. The references quoted by Merck Sharp & Dohme are separate trials using different patient groups who may not have had comparable disease. While this presentation of data is a common marketing technique, the challenge for researchers is to compare alternative treatments directly.

In regard to the comparison of finasteride with placebo, the question for the practitioner is whether a statistically significant improvement in a symptom score demonstrated in a large trial is likely to be clinically significant to the individual patient and outweigh the known and unknown risks of drug treatment. The assumption that the long term outcome trials will be favourable for any treatment should be measured against previous experience using intermediate outcomes e.g. flecainide reduced ventricular ectopic beats, an intermediate outcome, but overall, increased mortality with long term treatment.6


Lee Ausburn

Director, Merck Sharp & Dohme Australia Pty Ltd, South Granville, N.S.W.

A. Dawson