Accompanied by a provocative press release, “Who Owns Your Genes?”, the ACLU and the Patent Foundation, a Cardoza Law School-affiliated non-profit, have filed a lawsuit against Myriad Genetics, which shockingly holds a patent on two human genes associated with breast and ovarian cancer. In the last two decades, private companies and universities have acquired the patent to 20% of the human genome. Intuitively, there doesn’t seem to be any reason private companies should be able to patent genes commonly found in nature, but we’ll address that topic in full later on.
The consequences of these patents are significant. Patent owners have the exclusive right to test and study these genes, and can potentially sue a doctor who removes your genes to examine them. This lawsuit arises over Myriad Genetic’s patent of BRCA1 and BRCA2, two genes normally responsible for the growth of breast cells. When these genes contain certain mutations, however, a woman’s risk of acquiring ovarian cancer increases 60%, and her risk of acquiring breast cancer increases 40-85% (American Cancer Society). Ideally, women with a family history of these cancers should test for whether they have these genes, so that they can plan their medical future appropriately.
Because they own the patent, Myriad is the gatekeeper for women who want genetic tests for BRCA1 and BRCA2, and an expensive gatekeeper at that, charging over $3,000. Plaintiffs in the case complain about Myriad’s refusal to work with their health insurance providers. Because of Myriad’s stranglehold over the patent, even when women are able to obtain tests, they have no recourse for a second opinion when they receive ambiguous test results. The ACLU is thus representing women’s health group, individuals and associations representing over 150,000 scientists.
The ACLU is not messing around. Their lawsuit challenges the very notion of gene patenting, and would undue decades of commercial and legal practice. Tomorrow I will discuss some of the legal issues. We’ll of course be following the case as it develops- but for the non-lawyers out there, cases like this will move painfully slowly.
This morning I noticed that the progressive website, DailyKos, was sporting this lawsuit as their top banner advertisement. The ad takes you to www.aclu.org/brca, where you can read the press release, the complaint, and sign a statement of support.
The lawsuit is Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., and it was filed this May in United States District Court for the Southern District of New York. .
Friday, July 3, 2009
Thursday, July 2, 2009
The Great Baby DNA Vaults
States have significant discrepancies in their treatment of genetic privacy. In a new case out of Minnesota, parents are challenging a Minnesota state law that allows the state to store blood samples of their newborn children without their permission. These samples, called “bloodspots”, are being stored across the country. Texas has stored over four million samples alone, and Michigan is creating a “neonatal biobank” in Detroit, hoping to turn the city into a hub for biomedical research. Good luck- at $19k per home, Detroit could attract doctors and scientists deep in grad school debt.
Lest anyone doubt the magnitude and government support of such projects, the National Institute of Health itself is funding a project aiming to create a “virtual repository” of samples from around the country. There are, of course, positive medical research benefits to storing these samples. Sharon Terry of the Genetic Alliance claims that the stored samples “offer us the beginnings of a national blood bank to understand disease at an early age and follow people longitudinally over time.” A Twin Cities article notes that other uses include validating the accuracy of newborn screening and deciphering how genes and environmental factors interact.
From a civil liberties, or “creepiness test”, you have to wonder whether good intentions trump the government freely messing around with your DNA in experiments. If identifying information is stripped from the samples (it is currently removed in “most cases”, whatever that means), that clearly reduces the concern that the information can be misused. Stanford professor Hank Greely notes, however, “Just because you don't have a name or Social Security number doesn't mean you can't identify it. Once we start using DNA for more and more things like regular medical records, somebody could do a cross-check and say whose blood it is.”
This leads us back to yesterday’s post about what will happen when this information inevitably falls into the hands of health insurance companies, employers, or law enforcement agencies. After all, law enforcement agencies are already on the prowl for DNA fingerprints, rendering Greely’s cross-checking fears a reality for millions of Americans.
States have reacting with varying levels of sensitivity to concerns from parents and bioethics groups. New York, in case readers are planning to have kids any time soon, is a consent-heavy state. Consent from parents is required to administer DNA testing, and samples are presumptively destroyed unless the parent authorizes their use for medical research. Any parent going through this process should probably read all related paperwork extra carefully. Consent is only an unwitting signature away.
A University of Michigan poll showed that 72% of parents would be “somewhat unwilling” or “very unwilling” to have their baby’s blood used for medical research without their permission (56% were “very unwilling”). Two thirds of those individuals were against storage in general. Sounds like a lot of dissenters.
I do not want to sound opposed to opportunities for major medical research that these samples might provide. I also don’t want to sound overly paranoid about “the government” possessing this information. This site simply roots for bioethical common ground to keep pace with scientific advancement. What I am opposed to, however, is a clandestine process that keeps parents in the dark about what their childrens’ DNA is being used for, how it is being stored, and who can potentially access that information. How about if these measures were followed:
1) All parents must opt in to both genetic testing for diseases and the retention of that information (as the New York statute requires).
2) All samples being used for medical research must be heavily scrutinized by regulatory authorities and ethical boards, and not like SEC regulating either. Like, real regulatin’.
3) Samples have all identifying characteristics removed (whatever that is worth).
4) Transferring any samples to third parties must be prohibited, and the penalties for infractions sufficient to deter.
In researching this issue, I found one organization that is vocally opposing DNA storage- the Citizens’ Council on Health Care. Given their frontpage shout out to Senator Tom Cobourn and their videoclip of the Glenn Beck show, it seems like their concern is first and foremost that Evil Obama will steal your genetic information. That’s obviously not the angle we want to take here, and but there’s no reasons progressives can’t be involved in this debate from the libertarian angle as well. I welcome your thoughts on this topic. It’s a big one, so we’re sure to be following up on it in the future.
Below is a link to each of the 50 states’ privacy and consent laws relating to the genetic testing of newborns:
http://www.ncsl.org/IssuesResearch/Health/NewbornGeneticandMetabolicScreeningLaws/tabid/14416/Default.aspx
As a postscript, one article that was very helpful used to be located at this hyperlink:
http://www.twincities.com/ci_12730489?nclick_check=1
The link no longer loads, however.
Lest anyone doubt the magnitude and government support of such projects, the National Institute of Health itself is funding a project aiming to create a “virtual repository” of samples from around the country. There are, of course, positive medical research benefits to storing these samples. Sharon Terry of the Genetic Alliance claims that the stored samples “offer us the beginnings of a national blood bank to understand disease at an early age and follow people longitudinally over time.” A Twin Cities article notes that other uses include validating the accuracy of newborn screening and deciphering how genes and environmental factors interact.
From a civil liberties, or “creepiness test”, you have to wonder whether good intentions trump the government freely messing around with your DNA in experiments. If identifying information is stripped from the samples (it is currently removed in “most cases”, whatever that means), that clearly reduces the concern that the information can be misused. Stanford professor Hank Greely notes, however, “Just because you don't have a name or Social Security number doesn't mean you can't identify it. Once we start using DNA for more and more things like regular medical records, somebody could do a cross-check and say whose blood it is.”
This leads us back to yesterday’s post about what will happen when this information inevitably falls into the hands of health insurance companies, employers, or law enforcement agencies. After all, law enforcement agencies are already on the prowl for DNA fingerprints, rendering Greely’s cross-checking fears a reality for millions of Americans.
States have reacting with varying levels of sensitivity to concerns from parents and bioethics groups. New York, in case readers are planning to have kids any time soon, is a consent-heavy state. Consent from parents is required to administer DNA testing, and samples are presumptively destroyed unless the parent authorizes their use for medical research. Any parent going through this process should probably read all related paperwork extra carefully. Consent is only an unwitting signature away.
A University of Michigan poll showed that 72% of parents would be “somewhat unwilling” or “very unwilling” to have their baby’s blood used for medical research without their permission (56% were “very unwilling”). Two thirds of those individuals were against storage in general. Sounds like a lot of dissenters.
I do not want to sound opposed to opportunities for major medical research that these samples might provide. I also don’t want to sound overly paranoid about “the government” possessing this information. This site simply roots for bioethical common ground to keep pace with scientific advancement. What I am opposed to, however, is a clandestine process that keeps parents in the dark about what their childrens’ DNA is being used for, how it is being stored, and who can potentially access that information. How about if these measures were followed:
1) All parents must opt in to both genetic testing for diseases and the retention of that information (as the New York statute requires).
2) All samples being used for medical research must be heavily scrutinized by regulatory authorities and ethical boards, and not like SEC regulating either. Like, real regulatin’.
3) Samples have all identifying characteristics removed (whatever that is worth).
4) Transferring any samples to third parties must be prohibited, and the penalties for infractions sufficient to deter.
In researching this issue, I found one organization that is vocally opposing DNA storage- the Citizens’ Council on Health Care. Given their frontpage shout out to Senator Tom Cobourn and their videoclip of the Glenn Beck show, it seems like their concern is first and foremost that Evil Obama will steal your genetic information. That’s obviously not the angle we want to take here, and but there’s no reasons progressives can’t be involved in this debate from the libertarian angle as well. I welcome your thoughts on this topic. It’s a big one, so we’re sure to be following up on it in the future.
Below is a link to each of the 50 states’ privacy and consent laws relating to the genetic testing of newborns:
http://www.ncsl.org/IssuesResearch/Health/NewbornGeneticandMetabolicScreeningLaws/tabid/14416/Default.aspx
As a postscript, one article that was very helpful used to be located at this hyperlink:
http://www.twincities.com/ci_12730489?nclick_check=1
The link no longer loads, however.
Wednesday, July 1, 2009
Getting Down to Basics
As sound a jump-off point as any is the Genetic Information Nondiscrimination Act of 2008, known as GINA. This bill gets to the heart of what will be one of the big showdowns of the 21st century, the battle between health-care providers and citizens over whether their genetic information can be used to increase premiums and deny coverage.
This Act was a step in the right direction, shocking given that it passed the Senate 95-0, the House 414-1 (only Ron Paul voted against it) and signed by President Bush. The Act allegedly prohibits insurance companies from denying coverage or charging higher premiums to individuals solely based on their genetic predispositions to developing diseases in the future. The Act also bars employers from using genetic information in hiring, firing and promotion decisions. Senator Kennedy called it "the first major new civil rights bill of the new century." Though Senator Obama came out for the bill strongly during the presidential campaign (what else is new?), he, Clinton and McCain all abstained, probably because the April vote was too close to the election for them to be in Washington for the vote.
While it is always nice to see a bill signed into law that was actively opposed by Chamber of Commerce, there is reason for optimism to stay cautious. New York Congresswoman Louise Slaughter (D) first introduced the bill with bi-partisan support as early as 1995, and every legislative session thereafter. She lamented at one point that "at every juncture we would get more cosponsors than we needed to pass the legislation." Any bill that passes the Senate 95-0 should be held in suspicion to begin with. Slaughter's comments make me think that the lobbyists opposing this bill green-lighted it only after they weakened it sufficiently to fight another day.
As we will see in future postings, individuals' control over genetic information is far from sorted out. Once a person's information is out there, it's hard to imagine it not making into the hands of people who have an interest in it, and similarly hard to imagine health insurance companies and employers not using that information. After all, anti-discrimination laws have never been flawless in preventing discrimination, and when you can put a price tag on our genetic make up, those with an eye on the bottom line won't need to be bigoted to discriminate.
This Act was a step in the right direction, shocking given that it passed the Senate 95-0, the House 414-1 (only Ron Paul voted against it) and signed by President Bush. The Act allegedly prohibits insurance companies from denying coverage or charging higher premiums to individuals solely based on their genetic predispositions to developing diseases in the future. The Act also bars employers from using genetic information in hiring, firing and promotion decisions. Senator Kennedy called it "the first major new civil rights bill of the new century." Though Senator Obama came out for the bill strongly during the presidential campaign (what else is new?), he, Clinton and McCain all abstained, probably because the April vote was too close to the election for them to be in Washington for the vote.
While it is always nice to see a bill signed into law that was actively opposed by Chamber of Commerce, there is reason for optimism to stay cautious. New York Congresswoman Louise Slaughter (D) first introduced the bill with bi-partisan support as early as 1995, and every legislative session thereafter. She lamented at one point that "at every juncture we would get more cosponsors than we needed to pass the legislation." Any bill that passes the Senate 95-0 should be held in suspicion to begin with. Slaughter's comments make me think that the lobbyists opposing this bill green-lighted it only after they weakened it sufficiently to fight another day.
As we will see in future postings, individuals' control over genetic information is far from sorted out. Once a person's information is out there, it's hard to imagine it not making into the hands of people who have an interest in it, and similarly hard to imagine health insurance companies and employers not using that information. After all, anti-discrimination laws have never been flawless in preventing discrimination, and when you can put a price tag on our genetic make up, those with an eye on the bottom line won't need to be bigoted to discriminate.
Welcome to Genetics and the Law
Inspired by Mark Cuban, I began looking into genetics and the law a couple of weeks ago. While I stumbled across a scientifically dense PDF here and there, I was astonished at the lack of accessible information about the legal establishment's preparation for and response to what will be one of the critical ethical areas of the 21st century.
Because this is an area exploding with updates, I would like to post once a day on topics including the role of genetics in the criminal justice system, the healthcare system, among others. In case you're wondering how I have time for this with the bar coming up, you obviously have never hung out with me during finals. I am at my most productive when I'm at my most stressed out. Of course, that is not a unique characteristic:
"If you want something done, give it to the busiest person you know."
-Everyone
Unlike Roving Storm dispatches, these posts will not be epics, and they won't interest everyone. But if you know folks who might be interested, or people who would be interested in posting, pass them on. Let's get the discussion going. Because we all have genes, and we all live under the law.
Because this is an area exploding with updates, I would like to post once a day on topics including the role of genetics in the criminal justice system, the healthcare system, among others. In case you're wondering how I have time for this with the bar coming up, you obviously have never hung out with me during finals. I am at my most productive when I'm at my most stressed out. Of course, that is not a unique characteristic:
"If you want something done, give it to the busiest person you know."
-Everyone
Unlike Roving Storm dispatches, these posts will not be epics, and they won't interest everyone. But if you know folks who might be interested, or people who would be interested in posting, pass them on. Let's get the discussion going. Because we all have genes, and we all live under the law.
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