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ISSUE 1 JANUARY
Letters to the Editor

The price of urine

  • Lee Ausburn, A. Dawson

The Editorial Executive Committee welcomes letters, which should be less than 250 words. Before a decision to publish is made, letters which refer to a published article may be sent to the author for a response. Any letter may be sent to an expert for comment. When letters are published, they are usually accompanied in the same issue by their responses or comments. The Committee screens out discourteous, inaccurate or libellous statements. The letters are sub-edited before publication. Authors are required to declare any conflicts of interest. The Committee's decision on publication is final.

 

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
Director
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

 

References

  1. Gormley GJ, Stoner E, Bruskewitz RC, et al. The effect of finasteride in men with benign prostatic hyperplasia. N Engl J Med 1992;327:1185-91.
  2. The Finasteride Study Group. Finasteride (MK906) in the treatment of benign prostatic hyperplasia. Prostate 1993;22:291-9.
  3. Doll HA, Black NA, McPherson K, et al. Mortality, morbidity and complications following transurethral resection of the prostate for benign prostatic hyperplasia. J Urol 1992;147:1566-73.
  4. Fowler FJ, Wennberg JE, Timothy RP, Barry MJ, Mulley AG, Hanley D. Symptom status and quality of life following prostatectomy. JAMA 1988;259:3018-22.
  5. Hytrin product information. MIMS Annual, 1994.
  6. Echt DS, Liebson PR, Mitch ell LB, Peters RW, Obias-Manno D, Barker AH, et al. Mortality and morbidity in patients receiving encainide, flecainide or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991;324:781-8.

Lee Ausburn

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

A. Dawson