Testimony given by Kim Irish, BCAction’s program manager on March 9, 2012 in San Diego, CA
Note: Individuals are encouraged to submit written comments to firstname.lastname@example.org by March 26, 2012. In particular, the U.S. Patent & Trademark Office is interested in hearing from women who have had trouble accessing insurance coverage of BRACAnalysis or who had trouble paying for testing. If you’d like Breast Cancer Action to include your story in our written comments, please email email@example.com by March 26.
Thank you for the opportunity to speak today. My name is Kimberly Irish, and I bring a different perspective to this hearing today. I represent Breast Cancer Action (or BCAction). BCAction is a national education and advocacy organization that carries the voices of women affected by breast cancer—living with and at risk of the disease—in order to inspire and compel the changes necessary to end the breast cancer epidemic. We represent over 40,000 members nationwide, some of whom have a known BRCA mutation, some of whom do not know if they have a BRCA mutation, and some of whom have no known mutation. We accomplish our mission through working on our three program priorities – putting patients first, where we advocate for more effective and less toxic breast cancer treatments by shifting the balance of power in the Food and Drug Administration’s drug approval process away from the pharmaceutical industry and toward the public interest, creating healthy environments, where we work to decrease involuntary environmental exposures that put people at risk for breast cancer, and eliminating social inequities, where we work to create awareness that it is not just genes, but social injustices that lead to disparities in breast cancer incidence and outcomes. We are also plaintiffs in the lawsuit against Myriad Genetics.
Breast Cancer Action opposes gene patents because they harm women in five key ways:
1. They harm women who have not been able to get information about whether or not they have a mutation that increases their risk of breast and ovarian cancer.
- Some women can’t get the test because of the monopoly and high cost.
- The test may not look at some women’s particular mutation (because even the second test combined with the first doesn’t look at every possible mutation, just the common ones).
- Women who had the test with an indeterminate result are also harmed, because it is not clear from this whether their risk of breast and ovarian cancer increases.
2. Women who were able to get genetic testing and have a clear result are also harmed because, as Congresswoman Wasserman-Schultz described in the video shown at the start of this hearing:
- They should have access to independent second opinion testing before making decisions about organ-removing surgery.
3. Finally, both groups of women suffer when there are impediments to potentially life saving research.
Not all patients are equally harmed. Sometimes things go dramatically wrong and women are unable to get the information they need. I’ll talk about that. Other times, it seems that things worked as they should have when women are able to get information on their mutation. But even in these seemingly “best case” scenarios, there are important ways that gene patents harm women. Let me explain.
The first reason Breast Cancer Action opposes Myriad Genetics’ patents on the BRCA 1 and BRCA 2 genes is that the monopoly means that too many women can’t access this expensive test. Myriad’s monopoly also means that there is no competition present from other companies whatsoever. There are no other options for patients to choose from, so the cost remains high and out of reach for far too many women.
Because of the patents Myriad Genetics holds on these genes, the company can charge whatever it wants for testing, though other labs say they could charge far less. Make no mistake about it–genetic diagnostic testing is expensive. Myriad Genetics’ BRACAnalysis test costs approximately $3,500, with the supplemental BRACAnalysis Large Rearrangement Test in High Risk Patients test (or BART) costing an additional $700. Though some health insurance companies will cover the cost (or a portion of the cost) of testing, not all companies do so. Each insurance company must negotiate with Myriad individually—and we hear stories of women, including a plaintiff in the lawsuit against Myriad, as noted earlier, whose insurance did not have a contract for services for the test. In addition, the BART test is not always covered by insurance, even if the first test is. For women without health insurance–and according to the U.S. Department of Health and Human Services, that number is more than 17 million women between the ages of 18 and 64 –the test is simply not affordable. Uninsured and under-insured women deserve to have the same opportunity to access testing that women with insurance coverage have.
Second, only some mutations are evaluated in Myriad’s standard “Comprehensive BRACAnalysis.” For some high-risk women, in particular women of Latin American and Hispanic ancestry, about 10% of the mutations (called large rearrangements) are missed by the standard BRACAnalysis test. Testing for large rearrangements requires a separate test that is often not covered by insurance.
A third issue is that current testing has limitations in what it can detect. That is, the two tests combined still only look at some of the possible mutations, and there are others of unknown significance. Myriad test results can be indeterminate–-one study found that as many as 10% of people tested had an indeterminate test result, a disproportionate number of whom are women of color. What are women supposed to do when the results are unclear? Should they have prophylactic surgeries? Will their insurance cover increased screenings?
A fourth critical problem with Myriad’s patents is that independent second-opinion testing is not widely available, if at all. And like Professor Misha Angrist from the Duke Institute for Genomic Sciences & Policy who spoke earlier, today is the first I’ve heard that other labs can conduct testing. So if someone tests negative or positive for BRCA gene mutations, how do they know this finding is accurate? For a time, Myriad reported that its method of testing resulted in a high false negative rate – as much as 12%. Before making life-altering decisions wouldn’t YOU want to have the option of a second opinion confirming the results? Nancy S., a Breast Cancer Action member, who tested positive for the BRCA mutations, was not offered second opinion testing by her doctor because it wasn’t an option. In fact, none of BCAction’s members have reported that they could access second opinion testing, or that they even knew it was an option. Women who are at significant hereditary risk and base important screening and other decisions on negative results, or are considering life-altering prophylactic surgeries (where organs and other body parts are removed) should be able to access second opinion testing on which to base these significant decisions. Just as women want to be able to access second opinions from doctors, it is understandable that they may want access to independent second opinion testing as well.
Women of color (including African-American and Asian-American women) are more likely than white women to receive uncertain tests results, creating many questions about which follow up steps they should take, such as: “Does an indeterminate result warrant prophylactic surgery?” and “Does it justify increased monitoring and if so, will insurance pay for it?” Runi Limary, an Asian-American woman and plaintiff in the lawsuit challenging Myriad’s patents, received ambiguous results when she had genetic testing done. Runi was told that this “variant of uncertain significance” has been seen in Asian women, and that these ambiguous results seem to come up more for women of color.
The fifth issue is the limits on future research that may benefit women. BCAction believes that current and future research, which has the potential to save many lives, should not be limited by Myriad Genetics’ monopoly on BRCA 1 and BRCA 2 genes and testing. Last year over 230,000 women were diagnosed with invasive breast cancer. 40,000 women die of the disease each year. Up to 10% may be associated with hereditary risk, including known and as-yet-unknown BRCA mutations. We, our families, and our friends, cannot wait for better prevention, treatment, and surgery. Limits that inhibit other labs from doing tests and research that could save the lives of our mothers, sisters, friends, daughters, wives, and partners are simply not acceptable.
When women cannot access testing, when the test fails to provide conclusive evidence about a particular mutation, when the test provides an indeterminate result, when second opinion testing is not accessible, and when creativity and innovation in research is limited that could potentially save lives, we all suffer. Breast Cancer Action urges an end to gene patents so that women’s health comes first.