Association of Molecular Pathology v. Myriad Genetics will affect us all.

The following post is by Shannon Davis Litchy, attorney, breast cancer survivor, and mom.  Follow her on twitter @SLLitchy

On April 15, 2013, SCOTUS will hear oral arguments in Association of Molecular Pathology v. Myriad Genetics, Inc As an attorney, I have followed the legal wranglings of this case with great interest.  As a breast cancer survivor and someone intimately affected by the BRCA genes, I am gripped by its potential outcome.  Though it may not seem particularly exciting to the average person, this case impacts the future of medical research.  It impacts each and every one of us at a very fundamental level.

Myriad Genetics, Inc. currently owns a patent on the BRCA1 and BRCA2 genes.  A lawsuit has been initiated by a number of medical professionals, breast cancer survivors, and women who carry the genes.  Their lawsuit questions the ability to patent a gene and asks that the current patent be dissolved.   After mixed findings in the lower courts, this case is now headed to the U.S. Supreme Court.

I first became aware of the BRCA genes three years ago, during a breast cancer scare.  Before I took a single test, doctors explained to me that my family history meant I was bound to get cancer in my lifetime.  Apparently, the alarming number of young people in my family, affected by cancer, was not a coincidence.  My brain filled with questions I didn’t know how to articulate.  So, I began to research.  Text books, blogs, and websites became a source of comfort and knowledge, my armor against the fear.  I learned of the hereditary link in breast and ovarian cancers.  I learned that scientists had isolated two gene mutations, BRCA 1 and BRCA 2, and connected them to these cancers.  I read that people with these mutations had an 89% lifetime risk of breast cancer, along with an elevated risk of ovarian cancer.  Finally, I read about a growing number of women taking control of their destinies by testing early and often, and even, having preventative mastectomies.  I envied these brave women.  They were changing the landscape of cancer.  No longer did anyone have to sit around, waiting to be another victim.

I brought this newfound knowledge to my pathologist.  I felt anxious, but empowered, as he directed me to a genetic counselor to take the blood test.  There, I learned that only one lab in the world was able to do the test and, unfortunately, it was not covered by my insurance.  I was told the cost would be anywhere between $4,000 and $10,000.  I felt my world crumble; there was no way I could afford this.  I left devastated, knowing I would spend the next years of my life looking over my shoulder, waiting for cancer to take me.

Eventually, I moved forward.  I tried to forget about all I had learned.  In the back of my mind, though, the nagging fear remained.

In August of 2012, I found a lump.  The cycle of doctors and tests began again.  October brought the call I had been dreading for years.  I had stage 2 breast cancer.

The Myriad lawsuit asks whether a gene can be patented.  Myriad argues that, by isolating the genes from the body, they are no longer naturally occurring and become markedly different in their chemical structure, making them patent eligible.  Petitioners argue that genes are naturally occurring by their very definition and, as such, are not patent eligible.

Most important to those of us in the HBOC community, though, is the significant impact this patent has on the patient.  Allowing BRCA1 and BRCA2 genes to be patented, has far-reaching consequences.  It limits the medical care available to patients:  Myriad is currently the only company able to test for the existence of the mutations in patients.  This keeps patients from seeking second opinions, though false negatives have been reported.  It affects the price of, and access to, testing.  It has a chilling effect on research.  Labs are dissuaded from using these genes when the who, what, when, and how are controlled by one entity’s interests.

I sit here today, as a survivor.  But I also sit here, not having tested for the BRCA genes. Every professional I have seen believes my family carries a BRCA gene, so I am saving up for the test.  It is my duty.  This knowledge could protect my children, my nieces and nephews.   It could help stop the cycle of this horrible disease.

That’s the problem with Myriad holding a patent on human DNA.  They control the availability of it.  They control the cost of it.  As such, they control me and my ability to protect my family.

I am grateful to the discovery made by Myriad Genetics.  It was groundbreaking and has saved lives.  How many more could be saved, though, if it was more accessible?           

 

Want to join the conversation about human DNA patents?  We need your help sharing, tweeting, blogging, and making a statement that human DNA belongs to us all.  We will be on Facebook, and you can learn more here!

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