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Angelina Jolie BRCA1 Mutation: Why Is the Breast Cancer Test At the Center Of a Supreme Court Battle?

In a timely and important op-ed piece in the New York Times, Angelina Jolie discussed her decision to get a preventative double mastectomy to reduce her risk for breast cancer, a disease that took Jolie's mother's life at age 56. 

What Jolie does not mention is that the very same genes that put Angelina Jolie at risk for aggressive breast and ovarian cancer, and the genetic tests that may well have saved her life, are currently at the center of a Supreme Court intellectual property case.

Jolie wrote:

"I have always told [my kids] not to worry, but the truth is I carry a 'faulty' gene, BRCA1, which sharply increases my risk of developing breast cancer and ovarian cancer."

Myriad Genetics currently claims to own the rights to these critical breast cancer genes. Not just their specific test for the BRCA1 and BRCA2 genes, but the actual isolated DNA sequence itself.

That's right. Though this may sound like a concept from a harrowing dystopian future, this is occurring right now, and it has implications right now for the lives of millions of women and men.

As the American Medical Association notes, patents on human genes interfere with the diagnosis and treatment of patients, increases the costs of genetic testing, and blocks other researchers from continuing related research.

How can a corporation possibly own a patent for a naturally occurring human gene? That's a really good question, and Myriad Genetics and the U.S. Patent and Trademark Office have not provided any compelling answers.

Myraid Genetics claims to be exempt from the "natural products" exception to patent law, because there are some slight differences between the gene as it is exists in the body and the gene sequence that they have patented. For example, they removed the non-coding portions of the DNA sequence.

However, this is standard, commonplace science, and Myriad Genetics did not develop new mechanisms for separating coding from non-coding sections of DNA. Ultimately, our cells themselves know the difference between coding and non-coding regions of the DNA, as this is a key part of the process by which genes are translated into proteins.

Jolie recognizes that the option of genetic testing for breast cancer risk certainly isn't an option for everyone. Angelina wrote:

"It has got to be a priority to ensure that more women can access gene testing and lifesaving preventive treatment, whatever their means and background, wherever they live. The cost of testing for BRCA1 and BRCA2, at more than $3,000 in the United States, remains an obstacle for many women."

This business has been hugely profitable for Myriad Genetics. Karuna Jaggar, the executive director of Breast Cancer Action, the brave non-profit taking the case against Myriad Genetics to the Supreme Court wrote: "Myriad Genetics’ claim on our very DNA creates a profitable corporate monopoly for them, generating approximately half a billion dollars a year in revenue. In the last fiscal quarter alone, Myriad made $126 million off genetic testing for breast cancer — a full 85% of their total revenue."

The test for BRCA1 and BRCA2 was developed by an academic researcher at UC Berkeley, a public university, and was funded by over $5 million of federal tax money. But this did not stop the researcher from entering into a private licensing agreement with Myriad Genetics, which then took the publicly supported research and privatized it for their own huge financial gain.

Prominent economist Joseph Stiglitz, of Columbia University, wrote:

"Myriad Genetics ... claims to own the rights to any test for the presence of the two critical genes associated with breast cancer, and it has ruthlessly enforced that right, though their test is inferior to one that Yale University was willing to provide at much lower cost. The consequences have been tragic: Thorough, affordable testing that identifies high-risk patients saves lives. Blocking such testing costs lives. Myriad is a true example of an American corporation for which profit trumps all other values, including the value of human life itself."

This expensive test is frequently not covered by insurance, though access will improve for women with a family history of breast cancer under the Affordable Care Act. Still, Affordable Care Act money should be used to provide medical care that is expensive for a reason, not to prop up an unfair and anti-competitive monopoly.

Other scientists are not allowed to investigate the patented gene, and other variations of the gene whose effect is still unknown. Asian American, Latino, and African American women are more likely to have alternative variants of the gene for which the expected clinical outcomes are uncertain.

In a time when feel-good "walks for the cure" are the face of many cancer charities, and when blanket awareness of breast cancer is promoted rather than specific knowledge and informed action, we need to support grassroots organizations like Breast Cancer Action for their bravery in taking big pharma to court. 

The cause needs to be better embraced by feminist activists of all genders. If you want the laws off of your body, you sure as hell better want the laws out of your genetic code too.

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