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| Untersuchte Arbeit: Seite: 48, Zeilen: 10-29 |
Quelle: Puhan et al 2008 Seite(n): 2, 4, 5, Zeilen: 2: l.col: 2ff; 4: l.col: 22ff; 5: l.col: 48ff |
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| Many head-to-head trials of antibiotics for mild to moderate COPD exacerbations have been conducted although evidence from randomised placebo-controlled trials never showed that antibiotics were effective at all. So, in this case, the evaluation of antibiotics did not follow the general principle that placebo-controlled trials must have shown that the treatment is better than the placebo, before head-to-head trials are to be conducted (ICH Steering Committee, 2000). Probably, this is due to the pharmaceutical industry pressure. In general, big pharma tends to favour placebo-controlled trials in order to show large effects and to avoid direct comparison with competitors. Once a treatment, such as antibiotics for COPD exacerbations, is established in clinical practice an attractive market is available. If a company wants to enter this market it needs to provide a trial showing clinical non-inferiority of a new antibiotic and some advantages in terms of adverse effects or costs. This will make it relatively easy to get approval from regulatory agencies, as long as the drug is safe. The Helsinki Declaration emphasises the great importance of conducting experimental studies for medical progress. However, it also states that one should be very careful before embarking on randomised trials with placebo controls because research participants have a right to the best available treatment (World Medical Association, 2000). Worries about the 'unethical use of placebo' continue (Fergusson D et al, 2005; Michels KB et al, 2003). However, the present thesis tackles the reverse scenario. Might there be cases where experimental treatment did not show superiority over [placebo but where the placebo controls were abandoned nevertheless, thus exposing patients to adverse effects and society to healthcare expenditures not offset by any beneficial effects.] | The Helsinki Declaration emphasises the great importance of conducting experimental studies for medical progress. However, it also states that one should be very careful before embarking on randomised trials with placebo controls because research participants have a right to the best available treatment [1]. Worries about the 'unethical use of placebo' continue [2,3]. However, what about the reverse scenario? Might there be cases where experimental treatment did not show superiority over placebo but where the placebo controls were abandoned nevertheless, thus exposing patients to adverse effects and society to healthcare expenditures not offset by any beneficial effects?
[page 4] Our historical analysis showed that many head-to-head trials of antibiotics for mild to moderate COPD exacerbations have been conducted although evidence from randomised placebo-controlled trials never showed that antibiotics were effective at all. So, in this case, the evaluation of antibiotics did not follow the general principle that placebo-controlled trials must have shown that the treatment is better than the placebo or a sham procedure, before head-to-head trials are to be conducted [9]. [page 5] In general, the pharmaceutical industry tends to favour placebo-controlled trials in order to show large effects and to avoid direct comparison with competitors. In situations like this, however, where comparisons with placebo do not favour a drug, the pharmaceutical industry might be more interested in head-to-head trials. Once a treatment, such as antibiotics for COPD exacerbations, is established in clinical practice an attractive market is available. If a company wants to enter this market it needs to provide a trial showing clinical non-inferiority of a new antibiotic and some advantages in terms of adverse effects or costs. Hence, chance aside, even a new antibiotic lacking specific activity will not be inferior to any established antibiotic in COPD outpatients. This will make it relatively easy to get approval from regulatory agencies, as long as the drug is safe. 1. World Medical Association: Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2000, 284:3043-3045. 2. Fergusson D, Glass KC, Hutton B, Shapiro S: Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding? Clin Trials 2005, 2:218-229. 3. Michels KB, Rothman KJ: Update on unethical use of placebos in randomised trials. Bioethics 2003, 17:188-204. 9. ICH Steering Committee: Harmonised tripartite guideline: choice of control group and related issues in clinical trials (E10). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Geneva 2000 [1]. |
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