For Florida Congress­woman with a History of Cancer, Genetic Patent Case Is Personal

VBCC - May 2013, Volume 4, No 4 - AVBCC Annual Conference
Caroline Helwick

Hollywood, FL—For the first time, the Annual Conference of the Association for Value-Based Cancer Care (AVBCC) was addressed by a member of Congress. At this year’s conference, Congresswoman Debbie Wasserman Schultz, who represents Florida’s 23rd District (which encompasses Hollywood), shared her personal experience with cancer and took the opportunity to discuss the impact of exclusive licensing of genes and their related laboratory tests on patient outcomes. Ms Schultz is on the side of the consumer patient—because she is one.

Difficult Choices after a Cancer Diagnosis
At the age of 41, Ms Schultz was diagnosed with early breast cancer. Her treatment options were fairly straightforward—lumpectomy and radiotherapy. “That would have been the end of it, had a nurse educator not asked for my health history,” she said.

However, her family history of breast cancer and being an Ashkenazi Jew were red flags for carrying the BRCA mutation (ie, the “breast cancer gene”). “My nurse educator suggested BRCA testing, and this process presented a new set of challenges and questions for which no woman could be prepared,” Ms Schultz told AVBCC conference attendees.

“My test showed that I clearly had the BRCA mutation, which conveys an 85% lifetime risk of breast cancer and a 60% risk of ovarian cancer. But I could do nothing to obtain a confirmatory test,” she said. “I underwent 7 major surgeries: a double mastectomy and oophorectomy from the administration of a single test at age 41. I was fortunate to be at the stage in life when I had married and had children. But change my age to 25, and my decision would have been even more significant.”

Thus began Ms Schultz’s journey from a breast cancer diagnosis and survival to her fight against patent protection for genes and the tests that identify them.

She explained that what she most wanted at that time was simply a second opinion. “When I asked about the reliability of this test, I was told it is 100%. Well, knowing that nothing in life is 100%, I knew I would feel better if I could confirm the results. But that was impossible under the current
situation.”

The Genetic Patent Controversy
Myriad Genetics, Inc, currently holds the patent on the BRCA1 and BRCA2 genes, and an exclusive license for the laboratory assay for these mutations. By patenting the genes, Myriad has exclusive control over diagnostic testing and further research for the BRCA genes.
“Currently, there is no way for a woman questioning her genetic risk to get a second opinion, and for many women, the test results are inconclusive,” she said. These genes “hold the key to survival” and guide women in their decision to undergo body-altering surgery, Ms Schultz emphasized.

On May 12, 2009, the American Civil Liberties Union (ACLU) and the Public Patent Foundation filed a lawsuit charging that patents on the BRCA1 and BRCA2 genes, along with patents for several methods of diagnostic screening for the genes, are unconstitutional and invalid. A federal judge ruled that 7 patents were indeed invalid, but this decision was later overruled by an appeals court. Now, the Supreme Court is re-examining the claim regarding the patentability of human genes.

The ACLU argued the case before the US Supreme Court on April 15, 2013. Myriad argued that once a gene is isolated, and therefore distinguishable from other genes, it can be patented. Petitioners argued that patenting those genes violated the Patent Act, because they were products of nature. They also argued that the patents limit scientific progress. A decision is expected this summer.

The suit, Association for Molecular Pathology v. Myriad, is backed by researchers, genetic counselors, cancer survivors, breast cancer and women’s health groups, and scientific associations representing 150,000 geneticists, pathologists, and laboratory professionals.

“No woman should have to go through this process without the confidence of a second opinion, with so much at stake,” Ms Schultz argued. “It is important to give everyone as much certainty as possible when life hangs in the balance.”

Extending to the wider field of the commercialization of genetics, she noted that assays are available for many disorders; however, in 80% of cases, the test can only be performed by 1 laboratory because of patent
exclusivity.

Commenting on her commitment to this issue, Ms Schultz said, “I knew that, with my personal story, I had to do something about this.”

Praise for AVBCC’s Focus on Value
At the podium, Congresswoman Schultz also took the opportunity to applaud AVBCC for its continuing focus on “bending the cost curve for patients and families, which has also been a focus of Congress in the last few years.”

“You’ve dedicated your organization to providing affordable, quality care. I appreciate your dedication to America’s health and well-being, and I look forward to your results,” she added.

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