Urologist recommends daily Viagra to prevent impotence
BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7379.9/a (Published 04 January 2003) Cite this as: BMJ 2003;326:9
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At a recent pharmaceutical marketing conference I was reminded of the
intricate balancing act involved in managing 'thought leaders' and how
important it is for companies to retain and support credible proponents of
their products. It is a very tricky business, however, as companies need
their thought leader spokespeople to not only appear unbiased, but to be
able to rein in their enthusiasm when they endorse the drug. Too much
enthusiasm and they risk getting dismissed by the wider medical community.
So seeing such obvious cheerleading from the ‘believers’ in the
prophylactic use of sildenafil I imagine there are some very interesting
discussions happening between the company’s marketing and scientific
departments. This might make an interesting case study in the care and
feeding of thought leaders—what does one do if they start being perceived
as carrying their enthusiasm a bit too far?
Competing interests:
None declared
Competing interests: No competing interests
Taking sildenafil as a prophylactic drug to reduce the future risk of
erectile dysfunction may sound ludicrous, but why not? The small study
referred to suggests that in men with ED nocturnal erections are improved
with sildenafil, weather or not this affects long term erectile function
cannot be concluded from this study. [1] Until the results of a trial
designed to answer the question, does the prophylactic use of sildenafil
reduce future ED? We must remain sceptical, but hopeful.
Who would have
thought that aspirin could reduce cardio-vascular mortality in such a
dramatic way? Studies are now suggesting aspirin reduces the incidence of
Alzheimer’s Disease [2], is there room for more than one ‘miracle drug’?
1. Montorsi, Maga F, Strambi T et al. Sildenafil taken at bedtime
significantly increases nocturnal erections: Results of a placebo-
controlled study. Urololgy 2000 56: (6) 906-911
2. Zandi PP, Anthony JC, Hayden KM, et al. Reduced incidence of AD
with NSAID but not H2 receptor antagonists: the Cache County Study.
Neurology. 2002 Sep 24;59(6):880-6
Competing interests:
None declared
Competing interests: No competing interests
EDITOR -- I disagree with Professor Irwin Goldstein of Boston
University, Massachusetts, said
that he was a "strong believer" in taking sildenafil on a daily basis to
"prevent impotence."
On the contrary, there are evidence that long term usage of sildenafil
will let patients who initially responded to it frequently became
resistant with time.1
Besides, Sildenafil (Viagra) has been linked to 240 deaths (128 verified,
112 unverified) reported to the Food and Drug Administration (FDA) during
7.5 months of availability, and to 522 reported deaths after 13 months of
availability.2
It is very dangerous to take this medication without a very good reason.
References
1. El-Galley R. Rutland H. Talic R. Keane T. Clark H. Long-term efficacy
of sildenafil and tachyphylaxis effect. Journal of Urology. 166(3):927-31,
2001 Sep.
2. Cohen JS. Comparison of FDA reports of patient deaths associated
with sildenafil and with injectable alprostadil. Annals of
Pharmacotherapy. 35(3):285-8, 2001 Mar.
Competing interests:
None declared
Competing interests: No competing interests
Sir,
It is certainly an interesting concept to use sildenafil on a daily basis to prevent future possibility of ED.
Many proponents of the use of sildenafil in the post-radical prostatectomy (RP) group cite the nitrergic drenching of the cavernosal tissue with the use of sildenafil in the early post-operative phase. Hong et al (1) showed that the efficacy of sildenafil was indirectly proportional to the length of time from radical prostatectomy and suggested that those with early failure with sildenafil therapy (after RP) should not be disheartened.
Sairam et al (2) have shown that sildenafil influences lower urinary tract symptoms and hypothesise that the drug might continue to have its effect long after its metabolic levels in the blood/plasma have declined.
If one were to take the hypotheses from these 2 studies together, it is possible to imagine the effect that sildenafil might have in the prophylaxis of ED. Of course, the difficulty will be to define or predict the population at risk. One can only suppose that those taking aspirin may come under the 'curve' (population at risk). If aspirin can reduce the risk of cardiovascular morbidity / mortality....
I await eagerly the publication of Dr Goldstein's data.
References
1. Hong, E. K., H. Lepor, McCullough, A.R. Time dependent patient satisfaction with sildenafil for erectile dysfunction (ED) after nerve-sparing radical retropubic prostatectomy (RRP). International Journal of Impotence Research, 1999; 11 Suppl 1: S15-22.
2. Sairam K, Kulinskaya E, Boustead GB, Hanbury DC, McNicholas TA. Sildenafil influences lower urinary tract symptoms. BJU International, 2002; 90: 836 - 839.
Competing interests:
Was a research fellow in erectile dysfunction supported by an independent grant from Pfizer, 1999 - 2000.
Competing interests: No competing interests
either it is a gimmick to bolster declining sales or it is a recipe
for priapism.
Competing interests:
None declared
Competing interests: No competing interests
It may make some sense to prescribe sildenafil on a daily basis when
there are no contraindications to its use.The diabetic patients and the
other progressively ageing patients may find benifit from it.I have been
waiting for proof of its continuous use being harmless.Already there are
patients using this from 3 to 4 years without problem.And why not? Its a
daily problem and why not daily use on a 1 tablet of 50 mg basis.
Competing interests:
None declared
Competing interests: No competing interests
This "opinion" surely represents commercial speech vs.
rational pharmaco-biology. Understandably for a modern
conventional urologist such clinical opportunities inherent
in this realm might be like the discovery of antibiotics or
sulfa but in the same way that overuse has wrecked and
imbalanced therapeutics with these surely this is likely the
same. Accomplishing functional sexuality is too important to
be left to the mere tools of pharmacy, as potent as the ads
and outcomes appear in the present. What a wonderful gift
for the maker of this product all the same. It's simply a
breath-taking notion. I celebrate it's audacity.
Competing interests:
None declared
Competing interests: No competing interests
ED: the NHS should meet current need before preventing future medical needs.
How effective daily sildenafil may be as prophylaxis against the development of erectile dysfunction (ED) remains to be determined. (1) But its effectiveness in the treatment of established ED is not in doubt. (2-5) With the introduction in the UK of oral treatments (sildenafil in 1998, apomorphine in 2001) the locus of ED NHS treatment shifted from specialists to general practitioners. But coincident with increased access to effective oral medication for a distressing condition which carries considerable stigma, NHS rationing of all medication treatments for impotence was introduced.(6)
Rationing medical care is one of the principal ethical challenges to health services worldwide. The UK Department of Health’s (DH) decision to limit NHS medication for impotence treatment to sufferers with one of 12 specific aetiologies, or to those suffering ‘severe distress’ from impotence, attempted to limit costs by confining NHS prescribing to patients with a medical need rather than with a lifestyle request. This policy has been widely criticised for its reliance on arbitrary distinctions between causes of impotence which do and causes which don't qualify for NHS treatments. (7) Nevertheless, the move to curtail potential growth in the volume of NHS anti-impotence prescribing was greeted by some as a welcome sign of a new transparency, by which politicians would at least admit that rationing was now official NHS policy. (8)
In addition to rationing by selection of the underlying causes of impotence eligible for treatment, the DH used data on the frequency of heterosexual sexual intercourse to recommend an upper level for frequency of treatment.(6) Though very much more frequent usage of sildenafil is believed to be safe, (9) the DH advised that ‘one treatment a week will be appropriate for most patients’.
Daniels argues the ethical value relevant to rationing of scarce health care resources is justice, operationalised by referring the allocation of treatment decisions to clinical need understood as the distance between patients’ current health state and the “normal functioning range” for the human species. (10) For impotence treatments, frequency of NHS prescription recommendation was based upon results of the first survey of self-reported patterns of sexual behaviour in the general UK population over a 4 week period. (11) How robust is the linkage between the DH recommendation and this data?
We obtained the complete UK study dataset and examined data from married or cohabiting men aged 20-59 years (n=4624). Analysis was concentrated particularly on the 40-59 age group to which the guidance relates directly (n=2180). Survey respondents were dichotomised into those whose sexual needs would or would not be met by one treatment per week. The sample also contained a sizeable group reporting no sexual activity during the previous four weeks. As patients presenting for treatment of ED clearly aspire to a frequency distribution which does not contain zero, results were recalculated after removal of this group.
Overall, 38% of men aged 40-59 reported sex more frequently than once a week (see table). The data revealed a strong age frequency relationship, 51% of younger men in this group reported sex more often than once weekly, compared with 20% of those aged 55-59. Three hundred and eight men (14%) reported no sexual activity during the survey period. Removing these men further increased the percentages whose pattern of activity would not be met by the recommendation: in the 40-59 age group as a whole to 44%, among the youngest age sub-groups within 40-59 group, to 55% .
For many sufferers of ED, therefore, a treatment of once a week leaves a distance between the relevant population norm and that offered by the NHS, particularly for younger men in the 40-59 age group. If taken to apply to men aged under 40 the DH recommendation, narrowly interpreted, fails to meet the needs of the vast majority seeking treatment for ED (see figure).
By linking advice on frequency of treatment to data on average frequency of sexual intercourse, the DH seeks to restrict supply of impotence treatments without breaching the founding NHS principle that doctors should prescribe sufficient relevant medication to meet the clinical needs of eligible patients. (12) Despite a recent DH review of this policy, a rationale for selecting the 12 causes of ED deemed eligible for treatment remains lacking.
In the interests of transparency and of justice, and to avoid the additional charge of ‘dilutional rationing’ - whereby patients lucky enough to get treatment are offered less of it than meets their needs - DH guidance to clinicians concerning frequency of impotence treatments to be offered on the NHS should refer clinicians to age related average frequencies of sexual intercourse, rather than recommending one treatment frequency for all.
Acknowledgements
Data from the National Survey of Sexual Attitudes and Lifestyles 1990 were obtained from the Data Archive at the University of Essex, where they were deposited by Social and Community Planning Research. We would like to thank Professor Anne Johnson and Andrew Copas of the Department of Primary Health Care and Population Health Sciences, University College, London, for advice in accessing this dataset and for checking our data extraction.
Sexual frequency greater than once per week.
All subjects
Subjects reporting sex at least once during study
period*
Age group (years)
n
%
95% CI
n
%
95% CI
40-44
742
51
(48,55)
687
55
(52,59)
45-49
545
41
(37,45)
484
46
(42,51)
50-54
448
30
(26,35)
385
35
(31,40)
55-59
445
20
(17,24)
316
28
(24,34)
40-59
2180
38
(36,40)
1872
44
(42,47)
20-39
2444
61
(59,63)
2321
64
(62,66)
References
1. Moynihan R. Urologist recommends daily Viagra to prevent impotence. BMJ 2003;326:9.
2. Burls A, Clark W, Gold L and Simpson S. Sildenafil – an oral drug for the treatment of male erectile dysfunction. Birmingham: Department of Public Health and Epidemiology and West Midlands Development and Evaluation Service with the Midland Therapeutic Review Advisory Committee. Sept 1998 Report No. 2.
3. Morgentaler A. Male impotence. Lancet 1999:354:1713-18.
4. Anonymous. Sildenafil for erectile dysfunction. Drug and Therapeutics Bulletin 1998; 36:81-4.
5. O’Leary M. Erectile dysfunction. In: Clinical evidence 2. London: BMJ Publishing Group1999;317-22.
6. National Health Service Executive. Treatment for impotence. Leeds: Department of Health. HSC 1999/148 and HSC 1999/177.
7. Chisholm J. Viagra: a botched test case for rationing. BMJ 1999;318:273-4.
8. Beecham L. UK issues guidance to doctors on Viagra. BMJ 1999; 318: 279.
9. Daniels N. Just health care. Cambridge: CUP, 1985.
10. British National Formulary (September 2002 Edition). London: British Medical association and Royal Pharmaceutical Society 2002.
11. Field J, Johnson A, Wadsworth J and Wellings K. Sexual attitudes and lifestyles. Oxford: Blackwell Scientific, 1994.
12. Nedwick C. Primary care groups and the right to prescribe. BMJ.1998; 317: 1361-65
Competing interests:
None declared
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