Exclusive Patents on the BRCA Genes: Adding Burden to an Already Overburdened Cancer Community
By Sue Friedman, Executive Director, Facing Our Risk of Cancer Empowered (FORCE)
As part of the ACLU’s Taking Back Our Genes campaign , guest blogger Sue Friedman, the Executive Director of FORCE, describes the adverse impact the exclusive patents on BRCA1 and BRCA2 have on the cancer community.
It is our position that the awarding of exclusive patents for the BRCA1 and BRCA2 genes to Myriad Genetics has adversely affected access to care and research specific to hereditary breast and ovarian cancer, adding additional burden to our already overburdened hereditary cancer community. For that reason, we support the litigation challenging the BRCA gene patents and filed an amicus brief with the U.S. Supreme Court with other patient advocacy groups.
In our 13 years of advocating for and serving the hereditary cancer community, we have seen firsthand the adverse effects of exclusive gene patenting.
Exclusive licensing of BRCA testing stifles research, including:
Research on PARP inhibitors, targeted therapy for BRCA-associated cancer: We believe that the BRCA gene patent has had a profound impact by delaying and slowing the development of targeted cancer therapies for people with BRCA mutations. PARP inhibitors are a class of drugs that were developed based on scientists’ knowledge of how hereditary cancers develop in people with BRCA mutations. The drugs showed activity and early studies were promising in several types of hereditary cancers including breast, ovarian, and prostate. PARP inhibitor research has been ongoing since 2005, and today, seven years later, the drugs have yet to gain FDA approval. After meeting with the FDA, we were told that for targeted therapies that benefit a distinct population (such as people with a BRCA mutation) to receive FDA approval, they require that any companion laboratory test identifying a target population must be FDA approved as well. BRACAnalysis — Myriad’s test for BRCA mutations is not FDA-approved. Myriad is a CLIA-approved laboratory; they were never required to receive FDA approval in order to market their test, and it doesn’t appear that they have plans to seek FDA approval. Because Myriad holds the patent on the gene, no other lab can develop an FDA-approved test to identify BRCA mutation carriers.
Research that helps determine which BRCA genetic changes are deleterious and which are not: BIC (Breast Information Core) is a large international consortium organized by the National Human Genome Research Institute (NHGRI), which is part of the National Institutes of Health. BIC’s goal is to provide critical research to determine gene changes that may be cancer-causing versus those which aren’t. Around 2004, Myriad stopped contributing data to the BIC database. About 7 percent of BRCA tests return with an inconclusive result and data from BIC is used to help better classify these variants to determine if they are cancer-causing. According to a 2010 article in the Genomics Law Report, Myriad quietly stopped contributing data to BIC in favor of building its own database to retain a competitive advantage over other gene testing companies once their patent runs out.
Exclusive licensing negatively impacts BRCA test interpretation: Myriad’s decision to no longer contribute to the BIC database has impeded the interpretation of a type of inconclusive test result known as a Variant of Uncertain Significance (VUS). Once the patent does expire, the fact that Myriad no longer contributes mutation information to the BIC consortium will limit other laboratories’ ability to interpret certain test results. A 2011 article from the New York Times suggested that withholding this data may provide a competitive benefit to Myriad over other laboratories after their patent expires. But it comes at the cost of critical information that could help provide information to families that have inconclusive genetic test results right now.
The excessive cost of testing limits access and negatively affects clinical care: There is now evidence-based information demonstrating that identifying those who have the highest risk for breast and ovarian cancer can lower breast, ovarian, and all-cause mortality through genetic testing and surgical prevention. The cost of prevention, both in dollars and human lives, is less than the cost of treating cancer once it is diagnosed. Yet, people are being denied access to critical health information due to the excessive cost of BRCA testing. Financial assistance for BRCA testing is limited, especially for people who have any type of health insurance. With patent exclusivity and a monopoly on the test, Myriad has increased the cost of their test even as the cost of genetic technology and gene sequencing has gone down. The full-sequencing BRCA testing costs about $3,500, making it cost-prohibitive for many people. Further, Myriad charges an additional $750 for expanded testing known as BART to look for mutations known as large rearrangements in some people who test negative with full BRCA sequencing.
You can learn more about FORCE’s advocacy here.
And if you agree that human genes should not be patented, please join us in Taking Back Our Genes.
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