Exclusion from Therapy

Another consideration regarding pharmacogenetic testing is the problem that nearly all results will be a matter of probability. Although some genetic associations will be very strong, in other cases a significant number of patients identified as "at risk" will not in fact suffer an adverse event. They would be inappropriately excluded from treatment. Exclusion from treatment may also result from pharmacogenetic testing that identifies a patient as a "nonresponder." Here again, a number of these patients would actually be benefited from the therapy. In cases where the genetic association is not very strong and there is no therapeutic alternative, the ethical justification for exclusion from treatment, whether on the grounds of beneficence or nonmaleficence, is problematic. As a consequence, the case for denying a patient therapy on the basis of pharmacogenetic tests will often be a matter of professional judgment, involving the balancing of different factors, including the availability of alternative therapeutic options (18).

Others have argued that knowledge of a genetic association is insufficient to form the basis of clinical decision making:

However, genotyping or haplotyping for a drug-metabolizing enzyme alone is not a substitute for a thorough patient history that includes a list of prescription and nonprescription drugs that the individual is taking ... This clinical information must be integrated with the genotypic information to assess risk for ADEs. Furthermore, it will not be sufficient for the physician to merely understand drug-drug and drug-genotype interactions within their own specialty. Rather it will be also be necessary to understand predisposition to risk for ADEs involving other disease/organ systems (26).

It is imperative that exclusion from therapy is a decision based on clear evidence. Patients must be fully informed of the risks they are taking in cases when they still want a therapy despite having a genotype associated with serious adverse reactions to it. Similarly, clinicians will need to know the chances of response when giving a potentially ineffective medicine to patients identified as nonresponders.

Although exclusion from treatment raises a number of important ethical problems, it should be recognized that large numbers of patients are currently put at risk when given drugs that are in reality either harmful or ineffective in them. The introduction of pharma-cogenetics offers the possibility of reducing the risks from these situations. These benefits are likely to significantly outweigh the problems outlined previously.

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