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PubMed2004

Tailored medicine: whom will it fit? The ethics of patient and disease stratification.

A key selling point of pharmacogenetics is the genetic stratification of either patients or diseases in order to target the prescribing of medicine. The hope is that genetically 'tailored' medicines will replace the current 'one-size-fits-all' paradigm of drug development and usage. This paper is concerned with the relationship between difference and justice in the use of pharmacogenetics. This new technology, which facilitates the identification and use of difference, has, we shall argue, the potential to lead to injustice either by the inappropriate use of difference or through the inappropriate failure to use difference. We build on empirical data from a detailed study of the range of options for the development of pharmacogenetics to present a consideration of the ethical issues that surround patient and disease stratification. In it we explore the ways in which the use of pharmacogenetics may lead to the creation of new, genetically stratified, forms of difference and new forms of injustice based on these divisions. We also examine the ways in which existing forms of difference and social stratification may interact with the use of pharmacogenetics. In conclusion, we suggest how an understanding of these ethical issues could usefully inform future policy discussions.

Clinical Trials as Topic↗

PubMed1983

[Ethical problems of clinical pharmacology in pediatrics].

There is no rational and safe treatment without knowledge of clinical pharmacology. Clinical pharmacology is based on data found in the human. Since results of animals trials cannot be used directly Absorption, Distribution, Metabolism and Elimination rates of drugs in children differ from those known in adults. Therefore pharmacological data in children have to be studied specifically. There are always some questions for the pediatrician whether he is allowed to administer a drug prescribed in adult medicine to children, whether he is allowed to obtain data for therapeutical control purposes and whether he may or even must publish these results for the sake of ill infants. Due to the facts that it is difficult to receive these informations, we do not find dosage schemes, for example in the Physicians Desk Reference or Rote Liste for more than 70% of all registered drugs. A new drug without governmental licence must not be employed in pediatric medicine. After its official approval we may use this new pharmaceutical agent in some circumstances this might be even a must. Especially in Pediatrics there is no strict borderline between the clinical trial of a new drug in a group of patients or its application to a single ill child. Whenever a pediatrician is convinced of the high value of a new drug he will certainly get the parent's permission to apply it for the sake of their child as well as to perform a close therapy control. This attitude and produce is medically, ethically and legally correct.

Child↗

PubMed1994

Oral iron-chelating therapy: the L1 experience.

L1 is the most widely studied oral iron-chelating drug and at present the only one shown to be effective at causing negative iron balance in long-term clinical trials for thalassemia major and other transfusion-dependent refractory anaemias. Because of side-effects, both in experimental animals and in humans, its development as a widely available pharmaceutical agent has been delayed. However, for the large numbers of transfusion-dependent, iron-overloaded patients who do not use DFX because of poor compliance, adverse effects or unavailability of the drug, L1 may be a suitable alternative for iron chelation. However, its use should be restricted to Ethical Committee approved clinical trials. Patients who are capable of using DFX effectively should be encouraged to continue doing so until an oral iron chelator has been fully established for clinical use. It is hoped that 3-hydroxypyrid-4-one analogues of L1 as well as compounds related to pyridoxal isonicotinyl hydrazone, HBED or hydroxamic acid can be found both orally effective and safe for long-term administration. Current and future trials of L1 could address some of the following issues, beside extending present studies on the efficacy and adverse effects of L1: 1. The effect of administering a reduced dose of L1 (< 75 mg/kg per day) on the incidence of adverse effects and on long-term efficacy. 2. The efficacy and adverse effects of L1 at a low dose in patients with non-transfusional iron overload such as thalassaemia intermedia, primary haemochromatosis and congenital haemolytic anaemias. 3. The effect of combining oral L1 with intravenous or subcutaneous DFX on the incidence of adverse effects and efficacy. 4. Elucidation of the mechanisms involved in agranulocytosis and joint toxicity and finding methods to predict for individual susceptibility to these adverse effects and ways of preventing them.

Administration, Oral↗

PubMed1998