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Who Owns Your Cancer Risk Genes, You or the Company that Tests for them?

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Today CNN.com published an article detailing a lawsuit by the American Civil Liberties Union, in partnership with Yeshiva University law school, arguing that patents for the human genes BRCA1 and BRCA2 are unconstitutional.

Just to give some background, BRCA (BReast CAncer) 1 and 2 are genes that are associated with hereditary breast and ovarian cancer, and dramatically raise the risk of developing breast and/or ovarian cancer if mutations in the gene are present. Detection of these mutations before cancer develops allows women the (admittedly difficult) choice to undergo prophylactic mastectomy and/or have their ovaries removed and markedly decrease their risk of cancer.

Today the test for the gene mutations can only be performed by the company that holds the patent for the BRCA genes (Myriad Genetics in Utah), and right now any patient wanting the test must pay (or have insurance pay) $3000 for it. Obviously many patients at risk for familial breast cancer will be unable to afford this cost. In addition, a scientist wanting to perform research on these genes needs permission from the patent holder (and presumably needs to be able to pay for it).

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Stable Disease: Is the Glass Half-Empty or Half-Full?

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Over the past several years, oncologists have experienced an evolution in the way we think about stable disease, at least in the context of lung cancer. Historically, oncologists have graded our work by looking at response rates, or the percentage of patients with tumor shrinkage of 50% or more of their lesions as measured in two dimensions. We considered a drug or combination to be “active” if it had an “objective response rate” (ORR) of 15% or more, and we generally discarded approaches that had a lower ORR than that.

But largely as a response to the recognition that some targeted therapies may potentially halt tumor growth but not significantly shrink or kill a cancer, we’ve come to acknowledge that achieving stable disease can translate to a valuable clinical benefit for patients (as in, patients are likely to live signfiicantly longer). Of course, we all want to see tumors melt away, but at least in the setting of advanced lung cancer, having the cancer shrink just a little or just stay the same for several months at a time is a real improvement over the natural history of what the cancer would do, which is grow steadily over time. We also often see that patients who have chemo with or without radiation before surgery sometimes show no significant tumor shrinkage, but after surgery we find that the tumor contains mostly or only dead tumor cells. So again, stable disease underestimated clinical benefit of treatment. Continue reading


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