Wednesday, June 03, 2009

Who owns your DNA?

"There is no question we have a problem," Dr. Bellarmino said, not looking at his notes. He had memorized his testimony so he could deliver it while facing the television cameras, for greater impact. "Gene patents by industry post a significant problem for future research. on the other hand, gene patentintg by academic researchers causes far less concern, since the work is freely shard."

Of course this was nonsense. Dr. Bellarmino did not mention that the distinction between academic and industry workers had long since been blurred. Twenty percent of academic researchers were paid by industry. Ten percent of academics did drug development. More than 10 percent had a product already on the market. More than 40 percent had applied for patents in the course of their careers.

Nor did Bellarmino mention that he, too, pursued gene patents aggressively.

~ Next by Michael Crichton (2006)
Michael Crichton isn't shy about infusing his novels with his personal opinions about science and scientists. His 2006 novel Next, for example, takes aim at the practice of patenting of DNA sequences or gene patents. As Crichton pointed out in an op-ed piece in the New York Times, such gene patents aren't just an annoyance. They can end up preventing patients form getting the genetic tests they need and squelching biomedical research. As he put it:
Gene patents slow the pace of medical advance on deadly diseases. And they raise costs exorbitantly: a test for breast cancer that could be done for $1,000 now costs $3,000. Why? Because the holder of the gene patent can charge whatever he wants, and does. Couldn’t somebody make a cheaper test? Sure, but the patent holder blocks any competitor’s test. He owns the gene. Nobody else can test for it. In fact, you can’t even donate your own breast cancer gene to another scientist without permission. The gene may exist in your body, but it’s now private property.
Crichton mentions proposed legislation that would prohibit the patenting of "human genetic material". That bill, the "Genomic Research and Accessibility Act", apparently never made it out of committee. However, a couple of weeks ago, the ACLU, professional groups representing more than 150,000 scientists and several breast cancer survivors filed suit against Myriad Genetics over their breast cancer gene patents. Their monopoly over mutated versions of the genes BRCA1 and BRCA2 has become a significant hardship for anyone who wants to find out whether they have inherited these DNA sequences that can lead to breast and ovarian cancer.
[Myriad] charges $3,000 per test, which often isn’t covered by insurance. No one else can offer the test, and researchers can’t develop new or cheaper ones (or new therapies for that matter) unless they get permission from Myriad and pay a steep licensing fee. So women have no choice about who performs their tests, and they can’t seek those second opinions. That is no small thing. Tests aren’t 100 percent accurate, and results sometimes come back inconclusive. Women with the BRCA1 and BRCA2 mutations have a 40 to 85 percent chance of developing breast cancer, so a positive result helps them decide whether to have their breasts and ovaries removed to prevent future cancer. But with its lawsuit, the ACLU isn’t just fighting Myriad’s patent—it hopes to end the practice of gene patenting entirely on the grounds that it’s illegal, unconstitutional, and interfering with science.
As Rebecca Skloot discusses in her article about the suit, the ACLU is claiming that gene patents violate the patent law that say no products of nature can be patented*. They are also claiming that such patents inhibit individuals' First Amendment rights "to know about their own genetic makeup, doctors’ rights to provide their patients with crucial medical information, and scientists’ rights to study the human genome and develop new treatments and genetic tests." If the ACLU prevails, it could have significant implications for the biotech industry.

Not surprisingly, science fiction has been grappling (toying?) with the issue of patents for many years. You can even get a patent-related SF fix for free:
And remember to be careful who you share your tissue with!



Gene said...

Crichton should stick with what he knows, and leave patent law to experts. He is simply wrong when he says you cannot donate your genes and the genes in your body are owned by others. That is not true, it is irresponsible for him to make such reckless and incorrect legal statements and his lack of knowledge will improperly influence an important debate. Taking legal advice from writers is dangerous.

Peggy said...

Gene: you should read the whole piece Crichton wrote. It seems clear to me that he is well-aware of where the law currently stands, which is why he pointed out that there had been a bill introduced that would change it. Crichton's op-ed focuses instead on the ethics of the current situation where unmodified DNA sequences can be patented, putting broad control of what is done with those sequences (be it medical tests or basic research) in the hands of a single company.

He also points out that some patients who provide tissues for research haven't been required to give clear informed consent, which I find troubling. If people want to provide samples, that's great. But they should be made aware that their tissue could be used in a for-profit product that they have no control over. Again, current law may require that, but that doesn't make the situation ethical.

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Athena Andreadis said...

I never thought I'd find myself agreeing with Crichton, but in this instance he's entirely correct. Patenting genes has had a strong chilling effect on both basic and applied research. And, as you point out, legality is at odds with universal ethics here.