The Recalcitrant Cancer Research Act of 2012 was signed into law by President Obama on January 2, 2013 as part of the National Defense Authorization Act (Public Law No. 112-239)1, giving the Director of the National Cancer Institute (NCI) the ability to identify recalcitrant cancers for which to establish scientific frameworks that will guide research efforts.
For each recalcitrant cancer, NCI is to convene a working group of both Federal and non-Federal individuals to provide expertise and assistance in developing the scientific framework. The frameworks are to be completed within 18 months of enactment, then submitted to Congress and made publicly available on the HHS website within 30 days. The bill requires the progress of each scientific framework be reported in the National Institutes of Health (NIH) Biennial Report, with an assessment of progress made in improving outcomes for recalcitrant cancers. The bill further states that the NCI Director “shall consider” each relevant scientific framework when making recommendations for exception funding for grant applications.2
In this legislation, a recalcitrant cancer is defined as a cancer “for which the five-year relative survival rate is below 50 percent.” Unfortunately, mesothelioma meets this definition, with only a five to ten percent five-year survival rate. The legislation also seeks to target cancers that have “not seen substantial progress in the diagnosis or treatment.” Unfortunately, mesothelioma fits this stipulation as well. With only one FDA-approved treatment, many patients have to resort to off label use of chemotherapies, drastic surgery or with luck participation in clinical trials. There is also no test currently available for early detection of mesothelioma.
Substantial progress in mesothelioma has been made, and a scientific framework would help to further the advancement of mesothelioma research. A gene that is linked to mesothelioma has been identified, and the NCI has recently announced patients responded well to treatment in their SS1P clinical trial. The Meso Foundation has already sent a letter to Dr. Harold Varmus, the Director of the NCI, urging him to designate mesothelioma as a recalcitrant cancer, and we will continue our advocacy efforts. Stay tuned for updates on our progress.
Sign up for the Mesothelioma Ambassador Program to join us in advocating that mesothelioma be designated as a recalcitrant cancer for a scientific framework.
To view the text of the bill, visit Thomas.gov and choose the advanced search option, then search HR 733.
Learn more about the BAP1 gene in our blog post, “Genetics and the BAP1 Gene in Mesothelioma.”