What else I wish Angelina had said …

© cienpiesnf - Fotolia.com
© cienpiesnf – Fotolia.com

Actress Angelina Jolie has made very public her personal and medical choice to undergo a preventive double mastectomy. Untold millions now know about her family history of breast cancer that robbed her of her mother, young at 56, and the mutation of the BRCA1 gene that led her to choose preventive mastectomies. Doing so reduced her risk of developing breast cancer from 87% to under 5%. All told, Jolie is happy with her decision and offers a positive account of a major surgical procedure – an amputation – that she describes as relatively simple with normal life resuming after only a few days. Her scars are minimal, the results “beautiful,” and her femininity remains intact. I am not criticizing what was surely an agonizing decision for her, but at the same time, I wished in her statement, given her presence on the global stage, her role as a UN ambassador, for some mention of the associated risks and side effects of the same procedure for other women who may not share her elevated risk. In fairness, Ms Jolie is adamant that, given the number of lives that will be claimed by breast cancer this year,

It must 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.

However, she stopped short of explaining why the BRCA test remains expensive and elusive for so many women. Fortunate to have insurance to pay for it, I had the test following my diagnosis of Stage II invasive breast cancer. But there are millions who don’t and who won’t, unless the Supreme Court will overturn Myriad Genetics patent when the case comes before them this summer. Until such times, I have dear friends who would not be able to access this testing, and therefore have less options for treatment and less information about their risk – not to mention the risk of their daughters – for ovarian and breast cancer. But Myriad Genetic Laboratories, Inc. is the only game in town. With no outside competition to help bring down the price, the test remains unaffordable and inaccessible for the uninsured and the poor. Globally, almost a half million women will die this year, most of them living in low-income countries, according to the World Health Organization. What of them? What options do they have if they are high-risk like Angelina Jolie? They may never know.

I first heard about Myriad Genetics one afternoon last year. I was reading an email from Breast Cancer Action, and, at the same time, and somewhat ironically, half-watching the Anderson Cooper show. In full-blown talk-show host mode, he was fawning over savvy Spanx inventor, Sara Blakely. Fresh off the cover of Forbes magazine, as the youngest ever self-made female billionaire, the affable Ms. Blakely was giving me hope that somewhere inside me, lying dormant, is a billion dollar idea, a simple but powerful invention that will change the world. At the risk of being a snob, I’m hoping when my brilliant idea finally comes to fruition, it will have a touch of gravitas. Something a little less Spanx, a little more Penicillin.

To give Ms. Blakely her due, she did what most of us do not. She didn’t just experience a light bulb moment and then abandon it. She threw both arms around that idea, held it tight, and arduously navigated her way through a complex process of patents and trademarks, prototypes and packaging, manufacturing and marketing, schmoozing and selling, until, naturally, Oprah called. Within the next six years, Spanx became something of an institution in the “shapewear” revolution, its inventor on the cover of Forbes and in the enviable position of being able to empower other women through the Foundation that bears her name.

It was the patenting of Sara Blakely’s invention and those of others that piqued my interest that afternoon. A time-consuming process, the application for a patent involves tedious research and perhaps the assistance of a draftsman and a lawyer or two. When Spanx was but a twinkle in her eye, the inventor did her homework by first researching trademarks and patents. I imagine she started where I did, at the website of the United States Patent and Trademark Office (USPTO). Before filing a patent application, it would be important to know exactly what a patent is, who can have one, what can be patented and for how long, and the law governing it. According to the USPTO, a patent for an invention is “the grant of a property right to the inventor, issued by the United States Patent and Trademark Office.” Already, this is a very boring website. The text is too small and it feels like high school homework. I am sorely tempted to leave it for something less arduous, like a Facebook status update, but then I find the part about patent law that I have to re-read because of the Breast Cancer Action email:

Any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent,” subject to the conditions and requirements of the law. The word “process” is defined by law as a process, act or method, and primarily includes industrial or technical processes. The term “machine” used in the statute needs no explanation. The term “manufacture” refers to articles that are made, and includes all manufactured articles. The term “composition of matter” relates to chemical compositions and may include mixtures of ingredients as well as new chemical compounds. These classes of subject matter taken together include practically everything that is made by man and the processes for making the products.
Read it again, because it is really important.

Within the context of Spanx or Penicillin or the telephone, patents make sense. I struggle more with what I thought was a relatively new idea. In fact, the USTPO has been patenting genes since 1980, when the case of Diamond v Chakrabarty determined that a scientist could patent an invention even if the invention was a living thing. So even though a whole biological organism is not patentable, artificially altered organisms can be patented. Thus, the era of gene patenting began.

According to The Hastings Center, a nonpartisan research institution dedicated to bioethics and the public interest since 1969, there has been a flurry of activity in gene patenting – “about 3,000 to 5,000 patents on human genes have been granted in the United States and 47,000 on inventions involving genetic material.” How does that happen? And what on earth does any of it have to do with my genes?

Other than hoping I will take after my lovely mother who, at 75 could still pass for my sister, I have never really considered genetics beyond what’s required for a high school biology assignment involving Punnett Squares and the probability of inheriting blue eyes. It was only after being diagnosed with breast cancer that genetics came up. My physician had explained that because of the location and size of the tumor in my right breast, close to the nipple, that the “simple” mastectomy was the best option. But, wait! There’s more! As there always is, on the cancer trail. With menopause most likely around the corner and my age at diagnosis, my physician recommended the BRACAnalysis test. If the test indicated a mutation in the BRCA1 or BRCA 2 genes, those genes most often associated with breast and ovarian cancer, then she would recommend a double mastectomy and an oopherectomy to boot. Gobsmacked as I was by the prospect of such butchery, it was actually less frightening than the cancer, the cause of which remains unknown.

At this point, I had to remind myself that if someone had informed me of the density of my breast tissue and recommended an ultrasound, the cancer growing inside that dense tissue all those years may not have evaded three mammograms, thus saving me a lot of time and trouble. So I provided a sample via buccal wash i.e. I spat into a test-tube, and I waited. Again. For two excruciating weeks. When the news came that the test was negative, I was delighted. So delighted, I didn’t ask more questions about the genetic material in my saliva which had been sent to Myriad Genetics and analyzed by the scientists to determine my risk for hereditary breast and ovarian cancer.

What Angelina Jolie didn’t tell you is that she and I have something in common. Each of us is intimately involved with Myriad Genetics. In fact, we belong to Myriad. When the staff of the USPTO approved Myriad’s application for a patent on on the BRCA1 and BRCA2 genes, they essentially allowed Myriad Genetics to claim ownership of, and exclusive rights to, my genetic material – and Angelina Jolie’s.

My genetic material. I suppose for years, I have been of the same mind as that espoused back in 1997 in A Briefing on the Proposed EU Directive on the Legal Protection of Biotechnological Inventions:

Most people assume that their bodies are their own – and no-one else’s. They assume that their blood is theirs, unless they care to donate some of it. They assume that, while they are alive, their kidneys, their eyes, their spleens, their hearts are theirs – and will go with them to their graves unless they chose to gift them to others. They might also assume that their genes – the inherited biological material inside each of their cells – are theirs, rather than anybody else’s.

Sadly, my assumptions about my genes have been all wrong. My genes belong to Myriad Genetics. Sobering to realize that whatever I spat into that testtube was seized by a corporation crafty enough to have filed a patent on it. A mere mortal such as myself, however, cannot file a patent application on her own genes, being unable to identify a sequence in the DNA code which would, as I explained earlier, constitute a “new and useful process.” So I can only continue to hold out hope for a patent on my as-yet-to-be-formed billion dollar idea, some “manufactured article” … like Spanx.

Isn’t it grossly unfair that one company can monopolize the genetic diagnostic testing options available for women? Isn’t it wrong for one corporation to reign supreme over the ability for women to ask for a second opinion when genetic testing results are inconclusive or before they have to make critical life-changing treatment decisions like having both breasts and ovaries removed? Isn’t it wrong that one corporation exerts total control over important scientific research that potentially could save lives. Not quite on the level of Spanx and not yet on the cover of Forbes, but Myriad Genetics, is doing rather well. Just give it time. On its corporate website, it boasts of being

… a leading molecular diagnostic company dedicated to making a difference in patient’s lives through the discovery and commercialization of transformative tests to assess a person’s risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. With fiscal year 2011 revenue of over $400 million and more than 1,100 employees, Myriad is working on strategic directives, including new test introductions, companion diagnostics, and international expansion to take advantage of significant growth opportunities that further the Company’s mission.”

I’ll say Myriad is making a difference in my life and the lives of lots of other people, because Myriad owns our lives. Because Myriad owns the patent on “breast cancer genes,” only Myriad can test for them. Again, the language of cancer is so important. Words matter. Myths matter. Even though BRCA1 and 2 are referred to as the “breast cancer genes,” each and every one of us has these in our bodies even if they don’t have mutations.

So it is hardly surprising that on the heels of Jolie’s news, I turned to my “cancer portfolio” to peruse all those test results and pathology reports. In my case, the “comprehensive” in Comprehensive BRACAnalysis, had initially conveyed such relief, it didn’t occur to me to read beyond “No Mutation Detected.” Had I done so, I would have discovered that there was another test that, for an additional cost, would have detected genetic defects missed by the original BRACAnalysis. This newer test, The BRACAnalysis Rearrangement Test (BART), is also owned by Myriad Genetics. Well, of course it is. CNN reported that back in 2006, Myriad, began selling this new test BART, which as I scan my own test result, “would identify large genomic arrangements undetected” by the $3,000 BRACAnalysis. Apparently, doctors had assumed the original analysis included BART. In reality, however, Myriad offered it separately and charged $700 as one would expect of a monopoly.

“No Mutation Detected” is a bold declaration and cause for celebration, but I would have gladly accepted, in bold print and capital letters, at the top of the report, “Make Sure You Ask For The Supplemental BART Too!”

As an increasingly empowered patient, I know I should have read that report more closely. After all, it was about me. But when the result came in the mail, I went ahead and filed it with all the other cancer papers without reading it. My doctor’s office had already called to tell me it was negative and didn’t mention the BART, so I filed it away.

Until this week, when I read Angelina Jolie’s story and thought again of the unflagging work of Breast Cancer Action, from imploring people who have been tested to share their stories about genetic testing with the staff of the US Trademark and Patent Office, to pursuing a lawsuit against Myriad and its patents on our lives. The case was brought before the U.S. Supreme Court just last month. A ruling is expected this summer.

In the meantime, what can we do? What can Angelina Jolie do? The actress has a real-life opportunity to be as powerful as the super-women she has played in the movies. I hope she will stand up and support BCAction in demanding that human gene patents are outlawed and that every single woman – like Angelina Jolie, like me – can make her own medical choice, after carefully considering if the benefits outweigh the risks.

If the answer to what causes cancer lies in my genes and your genes, then no corporation should hold exclusive rights to them or to all the research performed on them. Anyway, aren’t we all supposed to be in this race for a cure together? Oh that’s right, at least Komen and Myriad Genetics are in it together with the Susan G. Komen Foundation receiving funding from Myriad Genetics.

Of course it does.


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