Breast Cancer Awareness Month: New Technologies, Legal Dimensions

October is Breast Cancer Awareness Month, and it’s useful to note that several breast cancer-related advances from molecular biology have become central modalities in the fight against the disease. But it’s also interesting to note that there are accompanying legal/regulatory issues that attend to the intersection of genetics and cancer diagnosis/treatment, not all of which are resolved. For example, the breakthrough treatment of Herceptin, an antibody that targets a protein on the surface of cancer cells, has been around for about 10 years or so, with several collateral dimensions: the cost of a biotech drug (high so far as a singular, uncompeted advance), the possibility of generic alternatives (the pending regulation of biosimilars onto market); the use of accompanying genetic testing to identify the patients who will benefit from the drug (a prototypical pharmacogenomics approach).  A quick look at the use of BRCA1/2 testing to identify high-risk individuals raises the very prominent issue of patent rights in genes (Myriad litigation still in the courts; see here for a paper tracing patent conflicts and breast cancer) and the possible misuse of genetic information, whether workplace or insurance (beginning to be addressed with the Genetic Information Nondiscrimination Act/GINA).  Lastly, the evolving regulatory environment for novel biotech drugs was acutely illustrated this year with the FDA’s decision to withdraw its approval for Avastin as a treatment for late stage breast cancer, with the concomitant loss of insurance coverage for patients seeking use of this high-priced drug.  So this particular field is paradigmatic of many collateral legal and/or regulatory aspects of new cancer-related technologies.