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Extra info for Pharmaczeutishe-Wirkstoffe

Example text

It is clear that the exploration of the costs of drug use requires consideration of more than just the costs of the drugs themselves. The costs of a drug’s adverse effects may be substantially higher than the cost of the drug itself, if these adverse effects result in additional medical care and possibly even hospitalizations. Conversely, a drug’s beneficial effects could reduce the need for medical care, resulting in savings that can be much larger than the cost of the drug itself. As with studies of drug utilization, the economic implications of drug use can be predicted prior to marketing, but can only be rigorously studied after marketing (see Chapter 17).

These effects were not detected prior to marketing, as patients with underlying cardiovascular or respiratory disease were excluded from the premarketing studies. Finally, to obtain approval to market a drug, a manufacturer needs to evaluate its overall safety and efficacy, but does not need to evaluate its safety and efficacy relative to any other drugs available for the same indication. To the contrary, with the exception of illnesses that could not ethically be treated with placebos, such as serious infections and malignancies, it is generally considered preferable, or even mandatory, to have studies with placebo controls.

The quantitative strength of an association refers to the effect size. To evaluate this, one asks whether the magnitude of the observed difference between the two study groups is large. A quantitatively large association can only be created by a causal association or a large error, which should be apparent in evaluating the methods of a study. A quantitatively small association may still be causal, but it could be created by a subtle error, which would not be apparent in evaluating the study. 0 a weak association.

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