Biomarkers of early clinical effect

Another application of biological markers is to reveal preclinical indicators of biological processes before gross phenotypic manifestations are detected.18 These biological markers are sometimes referred to as biomarkers of response or biomarkers of early clinical effect. In some cases, surrogate markers may allow the detection of early patterns of disease or biological conditions that frequently lead to clinical conditions.

The ability to identify early indicators of biological effect prior to other clinical manifestations of the condition raises difficult issues regarding the protection of individual privacy. For example, insurers may be interested in obtaining access to such information since it could be used to estimate an individual's likelihood of developing a specific disease. Employers may gain access to such information via worker monitoring programs, raising difficult issues regarding the appropriate balance between employer and employee interests. Biomarkers of early clinical effect may also be of much interest to other third parties such as family members. Thus, while discussions about the release of such information to third parties have not taken place, these discussions will be an important element of social conversations regarding the use of new molecular and genetic markers of early clinical effect.

A more basic set of issues surrounding the identification of biomarkers of early clinical effect is how we should think about the health status of persons with these biomarkers. For example, should we view persons with significant numbers of mutations in tumor suppressor genes as: potentially diseased, in the earliest stages of disease, or in a "preclinical" state of disease. How we resolve this conceptual issue may have important social implications for an individual who possesses such biomarkers of early clinical effect. Presence or absence or such markers may, for example, affect attitudes regarding the appropriateness of early clinical interventions.

In addition, like biomarkers of exposure, the ability to identify bio-markers of early clinical effect will have implications for toxic tort litigation and other legal allegations of negligence. For example, biomarkers of early clinical effect may play a role in determining damages in toxic tort cases. In toxic tort cases, damages normally include compensatory damages for disease or injury present as a result of plaintiff's wrongful exposure, including medical expenses arising from the exposure. To the extent that biomarkers of clinical effect are indicative of injury resulting from a toxic exposure, even where plaintiff does not yet have gross phenotypic manifestations of the injury or the disease in question, biomarkers of clinical effect could be used to support a claim for compensatory damages.

In addition to compensatory damages, damages may be sought for medical monitoring for diseases arising from the exposure that are not yet present, but may manifest in the future.19 In deciding whether medical monitoring should be included as part of the damages, courts generally consider four factors: increased risk of contracting disease, the seriousness of the disease, toxicity of the exposure, and the diagnostic value of the medical surveillance.20 Biomarkers of clinical effect could support an award of damages for medical monitoring by demonstrating plaintiff's increased risk for contracting a disease in the future.

Lastly, biomarkers of clinical effect could play an important role in establishing claims for an increased risk of future disease due to the toxic exposure. Traditionally, courts have placed a high standard of proof on damages claims for increased risk of disease due to their speculative nature.21 Courts have adopted a reasonable probability standard as to these claims whereby a plaintiff cannot recover unless the prospective disease is reasonably certain to occur.22 While the predictive value of biomarkers of clinical effect may be unclear, they could be used to support a claim for increased risk by offering evidence that a prospective disease will occur.

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