Cost Effective Genetic Tests Coming Soon – Thanks to ACLU

[N'Zinga Shani]

OneWorld Progressive Institute (OneWorld), Inc. Presents:

  A  HEALTH LITERACY BLOG – APRIL 22, 2015

www.oneworldpi.org/home.html

The mainstream media has been telling us about the "Angelina Jolie effect" involving BRCA genetic testing. This is because shortly after the actress announced that she carried a genetic mutation that dramatically increased her odds of developing breast and ovarian cancer, referrals for both genetic counseling and testing dramatically increased. We are pleased about that.  One of the major issues for testing for many women have been the prohibitively high costs involved; another has been a lack of consistent and thorough counseling and overall education for average women. The costs have been so high (more than $4,000 for both genes) because since the early to mid 1990s a corporate lab called Myriad Genetics was granted a patent on these two human genes.  Why was Myriad allowed to patent human genes that they did not and could not create?  That is the question; fast forward to 2013.

“Myriad BRCA Patents Ruled Invalid by US Supreme Court - Roxanne Nelson - June 13, 2013 Today's decision puts an end to what has been a long and protracted case. Myriad acquired patents on the 2 genes in the mid-1990s. Since that time, it has become the sole commercial provider of testing services for BRCA1 and BRCA2 in the United States.” Medscape Medical News > Oncology - http://www.medscape.com/viewarticle/805756

Myriad lost because for years the ACLU and thousands of scientists, individuals and groups have been challenging the patent held by Myriad in the courts.  It was unethical and outrageous that this giant corporate machine would have been allowed to patent a human gene that affected the lives of millions. They should never have been allowed a patent.  Maybe if Ms. Jolie and other wealthy celebrities, whose families were affected, had joined with the ACLU, who knows, the matter might have been resolved much sooner.  It was a battle that took decades, while Myriad made billions of dollars and literally held (mostly) women as ransom; if they wanted the BRCA tests they could only get it through Myriad because it had the patent to the gene; the cost of testing was prohibitive.  Among those fighting against Myriad, at great personal costs and at times risk of jobs and career, was Ellen Matloff, the former director of Yale’s Genetic Screening and Counseling Center.  She recorded an informative television program with OneWorld in late 2012:  https://youtu.be/UDNqhvWf0aM PT1 (19 mins segment)

In this program we talked about the battle against Myriad Genetics.  OneWorld wrote in support of the ACLU’s stance against Myriad Genetics.  Read about the fight led by the ACLU here: https://www.aclu.org/cases/association-molecular-pathology-v-myriad...

Costs of BRCA and Other Gene Testing, Screening & Counseling Should Soon Be Affordable We are pleased that Angelina Jolie and Rita Wilson have made their personal battles with cancer public, and that Ms. Jolie’s situation has encouraged more women to learn the importance of genetic testing.  Celebrity certainly has its benefits.  We also think it is critically important that community agencies, case workers and clinics talk to poor and minority women about their family medical history, not only for cancer screening, but also for heart disease and diabetes.  Prevention is more effective than cure. 

We are pleased that the ACLU and other scientists have prevailed over Myriad Genetics, and as a result, the exorbitant fees of more than $4,000 that Myriad Genetics was charging for years will be reduced significantly; there will now be multiple laboratories performing the tests.  This is the reason that the tests will now be more financially accessible to a broad array of women. Myriad kept appealing and parsing various aspects of the case in order to try to maintain certain patents that would still allow them to maintain control; but in the end, they lost the war. It would be wonderful if Ms. Jolie, Ms. Wilson and those with star power would become advocate for women who have less financial means so that these women will have access to more specific education and counseling for their specific situations.

Read the real story about why BRCA testing might soon be affordable for most women.  It was written on Dec. 18, 2014 in Fierce Diagnostics by Emily Wasserman

Diagnostics giant Myriad Genetics ($MYGN) suffered a stinging setback in its ongoing battle to keep rival breast cancer DNA tests off the market, as a U.S. appeals court ruled that its patents for the products are not eligible for legal protection.

A three-judge panel in the U.S. Court of Appeals for the Federal Circuit determined that three patents for Myriad's BRCA1 and BRCA2 breast cancer genetic tests should not have been issued, and affirmed a trial judge's decision to allow competing products to remain on the market--including those made by Ambry Genetics, Bloomberg reports. The Salt Lake City, UT-based company was the only company offering the tests until the U.S. Supreme Court last year exempted human genes from patent protection.

In 2012, Myriad won an appeals court affirmation of its rights to patent isolated genes related to cancer, but the following year the U.S. Supreme Court ruled unanimously that human genes were products of nature and nullified 5 of Myriad's patents. But the court also ruled unanimously that a synthetic version of the BRCA1 and BRCA2 genes, or (c)DNA, can be patented.  However, in 2013 the US Supreme Court invalidated the two key patents.  The ACLU and the Public Patent Foundation on behalf of more than 150,000 geneticists, pathologists, and laboratory professionals kept fighting and in the end, they prevailed. This is the main reason that the costs of testing and screening will be more affordable.  Ms. Jolie’s situation has proved the benefits of testing; however, women first need to be educated as to the reasons for counseling, screening and testing. 

Ms. Jolie is informed; average women who have heard stories about aunts and grandparents who died from some form of cancers NEED to be educated about how to investigate family history so they can become better informed.  Going to a reputable counseling center is important so that appropriate investigation and screening can be done by competent professionals.  Not every facility that puts out a sign has skilled professionals to counsel.  Making money should not be the motive behind counseling and screening.  We encourage readers to listen to what certified counselor, Ellen Matloff, had to say about the importance of proper investigation, screening, counseling and testing:  Cancer Screening and Counseling PT2:  https://youtu.be/NylgSFC6RUM

Below are links to various resources and articles we think readers wll find helpful.  Please share them with others.

http://www.fiercediagnostics.com/story/myriad-loses-battle-brca-patent-war/2014-12-18

https://www.yahoo.com/health/cost-effective-genetic-tests-for-breast-and-117023523882.html

Cancer Genetic Screening PT 1:  https://youtu.be/UDNqhvWf0aM

Cancer Screening and Counseling PT2:  https://youtu.be/NylgSFC6RUM

An ACLU sponsored video – Taking Back Our Genes: https://youtu.be/o_KS3Bcc9I8  5:00

Visit OneWorld’s YouTube channel to see more health literacy programs: http://goo.gl/G7KvPY

Browse OneWorld’s comprehensive web site; learn from our vast resources: www.oneworldpi.org

Understand the important of Family Medical History: https://youtu.be/1MSktvYW7io

https://www.aclu.org/cases/association-molecular-pathology-v-myriad-genetics

Myriad BRCA Patents Ruled Invalid by US Supreme Court - Roxanne Nelson - June 13, 2013 Medscape Medical News > Oncology - http://www.medscape.com/viewarticle/805756

OneWorld Progressive Institute, Inc., is a small group of committed volunteers who produce community information and education television programs on health literacy, education and civic engagement.  We also find good information and post informative blogs about issues we believe shine light and are beneficial to many in our communities.  Learn more about us at our web site: www.oneworldpi.org/  and visit our web health section at: http://www.oneworldpi.org/health/index.html  Please share our information with others.  Watch our informative television programs on your public access channels: Frontier (formerly AT&T), Channel 99, drop down; Charter Communications Chan. 21, and Comcast (Xfinity) Channels 10, 15, 18 & 26.

[N'Zinga Shani]

Ms. Jolie is informed; average women-- who have heard stories about aunts and grandparents who died from some form of cancers -- NEED to be educated about how to investigate family history so they can become better informed.  Going to a reputable counseling center is important so that appropriate investigation and screening can be done by competent professionals.  Not every facility that puts out a sign has skilled professionals to counsel.  We encourage readers to listen to what certified counselor, Ellen Matloff, had to say about the importance of proper investigation, screening, counseling and testing:  Cancer Screening and Counseling PT2:  https://youtu.be/NylgSFC6RUM