Q J Med 2001; 94: 657-658
© 2001 Association of Physicians
Correspondence |
Drugs for personal fulfilment in the elderly
Clinical Pharmacology Service, University of Edinburgh
National Poisons Information Service, Guy's Hospital, London
Sir,
We were interested to see the article by Charlton in which he makes a case for the use of centrally active drugs in attempts to relieve unpleasant psychological symptoms and increase personal fulfilment in old age.1 We would certainly agree that both physical and psychological problems in the elderly are insufficiently recognized and often managed poorly. However, we seriously question his recommendations for the general use of potentially toxic agents for unlicensed and largely unproven indications such as benzodiazepines for the treatment of ‘lack of intensity in emotions’, selegiline/deprenyl for ‘lack of drive’ and SSRIs for ‘reduced social activity’. The elderly are particularly vulnerable to the toxicity of drugs and are also at increased risk of adverse drug interactions. Any additional therapy such as proposed by Charlton should not be undertaken without clear evidence of a favourable risk-benefit ratio. Polypharmacy (particularly with centrally-active drugs) is already a major problem in such patients.
Some of the arguments put forward by Charlton lack scientific credibility and we wonder, for example, what evidence exists to support his claim that the occasional use of benzodiazepines may allow older people to experience events with greater intensity. The informal ‘n=1 crossover trial’ as advocated cannot prove that there is a beneficial pharmacological effect and apparent efficacy in such circumstances is perhaps more likely to indicate a positive placebo response. This in itself is not a problem provided that there are no adverse effects (including dependence on drugs such as benzodiazepines), and that the cost-benefit ratio is favourable. It was suggested that it would be helpful to document and share the information generated by such experiments through the internet, but the mind boggles at the thought of repositories of uncontrolled studies and anecdotal reports which would presumably be accessible by the patients and their relatives. Claims for benefit in the relief of ‘low grade misery’ and other symptoms in the elderly as proposed are scientifically worthless unless this can be established by properly conducted clinical trials such as would be required for other new therapeutic indications.
We accept that Charlton recognizes many of these problems, but feel that his enthusiasm for the free unlicensed use of drugs for the treatment of unpleasant psychological symptoms to increase personal fulfilment in old age is not supported by adequate evidence of efficacy and safety.
References
1.
Charlton BG. The potential for pharmacological treatment of unpleasant psychological symptoms to increase personal fulfilment in old age. Q J Med2001; 94:333–6.
Department of Psychology, University of Newcastle
Sir,
Prescott and Jones' letter unfortunately adopts an excessively formalized approach towards clinical science, which if adopted would bring therapeutic progress to a standstill.
Their remarks about ‘unlicensed’ drugs neglect the fact that a product license is merely a marketing authorization. Licenses restrict the promotion and advertising of drugs to specific indications; they have never restricted either therapy or research.1 This is fortunate, since there are scores of vital drugs being used off-license: neuroleptics for mania, imipramine for panic attacks, dapsone for dermatitis herpetiformis, most drugs in children ... the list is a large one.
Likewise, the comments regarding evidence seem simplistic. The scientific value of treatments is not ‘established’ by clinical trials.2 Properly conducted clinical trials estimate therapeutic effect size, they do not establish ‘claims for benefit’. Indeed, clinical trials cannot be designed until a great deal of information is already known about a drug—indications, subject inclusion criteria, dosage, interactions, main effects, effect measures, etc. In other words, trials come at the end of a long process of discovery which usually begins with imagination, observation and exploration. And the fabrication of pseudo-scientific statistics such as the ‘risk-benefit ratio’ or ‘cost-benefit ratio’ comes even later. There is no algorithm for therapeutic discovery, not can it be brought under bureaucratic control. With regard to unpleasant psychological symptoms in old age, the first step is to acknowledge the problem. The second step to assume that in principle pharmacology may have a role to play. And the third step is (with all the usual safeguards) to employ human creative faculties in looking for useful agents based on more-or-less plausible theories. If this sounds untidy and unpredictable, it is. But that is how clinical discoveries are made.1,3
To demand immediate ‘evidence of efficacy and safety’ is not scientific rigour but therapeutic nihilism.
References
1. Healy D. The antidepressant era. Cambridge MA, Harvard University Press, 1997.
2. Charlton BG. Fundamental deficiencies in the megatrial methodology. Curr Contr Trials Cardiovasc Med2001; 2:2–7.
3. Le Fanu J. The rise and fall of modern medicine. London, Little Brown, 1999.
CiteULike 
Connotea 
Del.icio.us What's this?
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||