Healthcare -- Administration and Legal
Many vectors -- science, research funding, social acceptance or rejection -- influence how and whether medical technology is eventually adopted into medical praxis (Hogle, et al., 2012). Undergirding the choices and changes is a shared body of ethical standards and law, the establishment of which is often not consensual or efficacious. Any emerging technology can encounter unanticipated social resistance and ethical concerns that can change the course of how medical science research progresses (Hogle, et al., 2012). Medical technology often poses questions about access to expensive innovations and considerations about race, gender, and social justice that are inseparable from the socio-economic levels of patients (Hogle, et al., 2012). In contemporary society, there are the inevitable considerations about patent issues, clinical practice, and the commercialization of medical innovations (Hogle, et al., 2012). The recent court decision finding in favor of Myriad Genetics, Inc. provides a good platform for discussing the differences in biomedical decision-making from clinical, ethical, and legal perspectives.
The distinction between the clinical, ethical and legal aspects of biomedical decision-making. Legal decisions can have substantive and lasting impacts on clinical practice, as the recent case decision Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al. illustrates (Stempel, et al., 2012). The biotechnology industry did not anticipate this decision -- and though it could well be overturned following appeal -- the decision has the capacity to change the way patents for genes...
Clinical laboratories that are currently engaged in the development of single-gene genetic tests will be directly impacted by the decision (Stempel, et al., 2012). The move toward whole-genome analysis could make the policies regarding patent protection for single genes less relevant, and some experts believe the patents could even pre-empt whole-genome sequencing (Cho, 2011; Stempel, et al., 2012). Moreover, the genomic technology literature suggests that patents more effectively act as incentives in pharmaceuticals than as incentives for innovation in the field of genetic diagnostics (Cho, 2011).
The court upheld Myriad Genetics right to patent the isolated genes (BRCA1 and BRACA2) that account for most of the breast cancers and ovarian cancers that are inherited (Stempel, et al., 2012). However, the court did not uphold Myriad's argument to patent the analytical methods used to compare DNA sequences (Stempel, et al., 2012). Opponents of placing patents on genes assert that it will constraint patients' access to medical tests and treatment, and that it will restrict scientific research (Stempel, et al., 2012).
Indeed, the ACLU argues that the Myriad patents permit the company to have a monopoly on the BRCA testing in the U.S. Moreover, according to the National Comprehensive Cancer Network, the fact that Myriad's tests do not look for large rearrangements of the genes has resulted in revised treatment guidelines for BRCA genetic testing. So, now, in addition to the $3,000 Myriad BRCA genetic test, physicians will order a second test that costs an additional $700 -- a cost that insurance companies may not cover.
The court decision is considered by biomedical research companies to be a win. Patent attorneys explain that the value of DNA-based inventions is derived from the idea that DNA claims can be patented. At issue is the consideration that isolated genes -- those removed from the body -- are sufficiently changed with regard to chemical structure that a…
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