Gene Testing Irony: Once Restricted, Now a Right?

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Gene patent cartoon

No matter where you stand on the question of patenting genes, the ironies involved in the American Civil Liberties Union's (ACLU) lawsuit against the gene testing company Myriad Genetics are wonderful to contemplate. Arguing that genes shouldn't be patented, the ACLU and others sued Myriad Genetics, the patentholder of the BRCA1 and BRCA2 breast cancer gene tests. Last week, the ACLU prevailed in a federal district court.

Never mind all that, let's get on to the ironies. Back in 2000, I wrote an article "Warning: Bioethics Could Be Hazardous to Your Health" in which my lede featured the story of breast cancer survivor Joy Simha. Simha's physicians, following the consensus of bioethical advice, refused to tell her the results of her BRCA gene test. Why?

By refusing to reveal such test results to their patient, Simha's doctors believed they were practicing medicine at the highest ethical level; keeping patients in the dark in such circumstances has been recommended by such prestigious bioethics authorities as a 53-member panel of ethicists and lawyers chaired by Stanford University law professor Henry Greely. "The test for BRCA1 should be confined to the research setting," declared the panel's report which was presented at a conference at the University of Southern California's Pacific Center for Health Policy in 1996. The ethics panel advised women not to take the commercial test for BRCA1 because "there are no known methods for preventing breast or ovarian cancer that would be particularly important to women with versions of these genes."

Nor is the panel at the USC conference alone in its opinion. In 1998, George Annas, director of the Law, Medicine, and Ethics Program at the Boston University Schools of Medicine and Public Health, conceded that the carrier of the BRCA1 gene has a high risk of contracting breast cancer. Nevertheless, he argued in his book, Some Choice: Law, Medicine, and the Market, "Since there is no way to prevent this disease, what good is knowing you will probably get it in the future?" Francis Collins, the director of the Human Genome Project, agreed in U.S. Senate testimony in 1996 that the BRCA1 test should not be commercially available to women. According to Collins, the information that a woman might get from such a test is "toxic."

Toxic? But that was then, this is now. Among many other reasons the ACLU argued against Myriad's patents is:

Individual patients' rights are violated because gene patents impede access to medical information and care.

 What was once declared "toxic" is now apparently a right.

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  1. Slow down Ron, I think I’m missing something here. Was the ACLU arguing against patient disclosure before or was it the bioethics committee or is the bioethics committee now saying that disclosure is a right?

    From the way the article reads one group argued one thing in the past now a different group is arguing something contradictory, nothing strange about that, really. It seems an apples and oranges comparison, but maybe I missed something and one group has changed their position over time. If I am wrong feel free to thrash me with the facts. But as I read it, it would be like saying “democrats were for hcr in 1996, but now republicans are against it, oh the delicious irony!”

    1. capitol 1: The post is trying to highlight a general shift in the ethical analysis of gene testing — for one thing, when the tests were in researchers’ non-commercial hands patients had no rights to the information; when a commercial test comes along, then it’s unethical to charge for it because patients’ have a right to the information.

      1. I dont see the general shift either. Unless the ACLU is representing the general ethical position now. But Im not sure that is true.

        Also, can I borrow a time machine and go back 14 years and beat some sense into the ethicists of 1996?

        1. Mind if I come along?

      2. I don’t think they’re necessarily arguing it’s unethical to charge for it. Just that a patients options for competition in the testing market to make it more effective and affordable would be impended by these bogus patents on something that was really only a discovery of something that’s existed in nature for millenia rather than a true invention.

        Patent your tests, reagents, etc. Not the gene.

  2. “Since there is no way to prevent this disease, what good is knowing you will probably get it in the future?”

    Well for starters, it would impact estate planning.

    1. “Since there is no way to prevent this disease, what good is knowing you will probably get it in the future?”

      Some women will opt for masectomies.

  3. 10,000 spoons? All I needed was one knife! Oh, irony…

  4. Was Joy Simha informed of the policy before she took the test? I would not take any test that I was not privy to the results. Why would anyone?

    1. If you read the original story this is not clearly stated, but I think that she had an expectation of disclosure. I’d dig in to it to find out more, as this is pretty interesting to me , but I gotta go to work…

    2. rctl: She told me that she was not informed of the no-tell policy beforehand.

      1. If not the patient, then who would benefit from such a test? It could be used for legitimate research or for the insurance company to rescind her policy. Since it was probably paid for by insurance, that would be the obvious objective.

  5. Since there is no way to prevent this disease, what good is knowing you will probably get it in the future?

    This puzzles me. The mastectomy is a surgical procedure pre-dating the 19th century.

    1. Actually, Simha was contemplating a preventive mastectomy which is why she wanted the test to get some idea of her risk that she might get cancer in her remaining breast. Although, it seems commonsensical,whether or not a preventive mastectomy would work had not been clinically validated in the mid-1990s. Now of course it is definitely a option that many women choose when their BRCA tests are positive.

  6. What was once declared “toxic” is now apparently a right

    You miss the real point here. Women trump everything, including patent rights. The reason this suit prevailed and another recent one didn’t is because this one was supposedly about women’s rights.

    1. So?

  7. Here’s the point:

    If you could know what disease or injury will probably kill you, would you want to know?

    If such a prediction could be made, do you have the right to have that prediction revealed to you (including actual reliability of said prediction)?

    1. I wouldn’t but every one needs to make their own choice.

  8. The next time I have a doctor look into my ear for an infection I’m going to tell him it is unethical to charge me for that information and he has to do it free of charge and compulsorily so because it is my fundamental right to know what is going on inside of my head. Come to think of it, that argument works for my psychiatrist, as well. No more charging me for sessions, Freud old boy, I’m going to lay down on your couch and you are going to listen. It is my fundamental right! Have your receptionist come in and give me a foot rub while you are at it.

    1. Sorry, the doctor can’t look into your ear for infection in the first place; it seems TriOptimum Megacorp got a patent on ears, and he hasn’t licensed the right to examine them.

      What? Your ears belong to you? They’re a product of natural evolution, not research and design? TriOptimum shouldn’t be granted a legal monopoly preventing your doctor from examining them? Tough shit, you Communist.

  9. “Since there is no way to prevent this disease, what good is knowing you will probably get it in the future?”

    There is no current way to prevent entropy from winning in the end either. By this logic I could argue there is no good in knowing the laws of physics.

    1. always interesting to read

  10. keeping patients in the dark in such circumstances has been recommended by such prestigious bioethics authorities as a 53-member panel of ethicists and lawyers chaired by Stanford University law professor Henry Greely.

    To repeat my questions from last week, what is it with self identified “ethicists”?!?

    But in this case it is worse than usual: your doctor is simply not entitled to run on test on you and withhold the results from you.

    Ever.

    I would—quite literally—assault a physician who tried that on me and take the file by force. Oh, I’d give him or her a chance: explaining first politely then impolitely that I found that to be unacceptable. But I wouldn’t leave without the answer.

    1. Come to think of it, I would be sorely tempted to track down the jackasses from the panel and explain my annoyance to them, too.

  11. Myriad Genetics, the patentholder of the BRCA1 and BRCA2 breast cancer gene tests. (emphasis added)

    This is a false and misleading statement. The ACLU lawsuit wasn’t about patents on the BRCA1 and BRCA2 gene tests, but rather patents on the genes themselves. So if someone comes up with a different method to test those genes, Myriad could sue them for violating their patent. It would be like the inventor of the X-ray patenting the 10 to 0.01 nanometer portion of the light spectrum.

    I have no problem with Myriad getting a patent for a test to identify certain genes. However, giving Myriad the patent on a naturally occurring gene is ludicrous and decreases innovation because other scientists are prevented from inventing better methods for testing for the gene.

    http://www.aclu.org/free-speech/brca-genes-and-patents#05

    1. I agree.

      Since genes encode the blue print for proteins, would it be acceptable for Myriad to patent the “normal” protein and use that protein to treat people with the defective gene?

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