Friday, July 17, 2009
20 second time outs, and a post on the MTA
I will be taking a 6 week break from Genetics and the Law. The bar exam is coming up in 10 days, followed by 30 days foraging through the jungles of South America. There may be guest posts in the interim, and should major developments come through in the ACLU case, I will be on top of it as best possible. In the meantime, should any tri-staters be interested, I've written a post covering the panel discussion, "The Future of the MTA" that I attended recently. The post is located at this site's sister blog, The Roving Storm. See you in September.
Tuesday, July 14, 2009
Osborne makes appearance at Sotomayor hearings
Life must be sweet when you are the president's favorite senator. I've never known a whole lot about Illinois Senator Dick Durbin, but at today's hearing for Supreme Court nominee Judge Sonia Sotomayor, he was able to cover the death penalty, the overcrowded prison system, crack versus powder cocaine disparities and the Osborne DNA testing case, all in less than his allotted time.
As any observer can tell, these judicial hearings are largely about showmanship, senators trying to reduce serious legal issues to soundbytes, and nominees working hard to avoid giving any opinions at all. But this site is excited to see the issue of DNA raised at such a high profile hearing. Here is the relevant transcript:
DURBIN: And this is a recent case before the Supreme Court I'd like to make reference to, D.A.'s Office v. Osborne, involving DNA. It turns out there are only three states in the United States that don't provide state legislative access to DNA evidence that might be -- might exonerate someone who is in prison.
I am told that, since 1989, 240 post-conviction DNA exonerations have taken place across this country, 17 involving inmates on death row. Now, the Supreme Court in the Osborne case was asked, what about those three states? Is there a federal right to access to DNA evidence for someone currently incarcerated who questions whether or not they were properly charged and convicted? And the court said, no, there was no federal right, but it was a 5-4 case. So, though I don't quarrel with your premise that it's our responsibility on this side of the table to look at the death penalty, the fact is, in this recent case, this Osborne case, there was a clear opportunity for the Supreme Court right across the street to say, "We think this gets to an issue of due process as to whether someone sitting on death row in Alaska, Massachusetts or Oklahoma, where their state law gives them no access, under the law, to DNA evidence."
So I ask you, either from the issue of DNA or from other perspectives, isn't it clear that the Supreme Court does have some authority in the due process realm to make decisions relating to the arbitrariness of the death penalty?
SOTOMAYOR: The court is not a legislative body. It is a reviewing body of whether a particular act by a state in a particular case is constitutional or not. In a particular situation, the Court may conclude that the state has acted unconstitutionally and invalidate the act, but it's difficult to answer a question about the role of the Court outside of the functions of the Court which is we don't make broad policies. We decide questions based on cases and the principles implicated by that particular case before you.
This answer could have been given by nominee Robers or Alito. I imagine the last thing Sotomayor would want to do during her otherwise smooth confirmation is criticize a very recent and controversial Supreme Court decision. In Osborne, Justice Stevens quite forcefully castigated the state of Alaska's inability to articulate a sound reason for denying Osborne the opportunity to test the DNA evidence at his own expense. Justice Stevens, joined by Justices Ginsburg, Breyer and Souter, asserted that Alaska violated the Due Process Clause by failing to provide Osborne adequate procedural protections for the postconviction relief.
The question that Senator Durbin wanted Sotomayor to answer, however, was whether the Court should find a federal right to DNA evidence. On this issue, Justice Souter defected from his liberal colleagues, disagreeing that the Fourteenth Amendment provided a substantive due process right to DNA evidence. Souter's reasoning was that the Court should proceed cautiously in granting substantive due process rights before the public has had the full opportunity to consider an issue, referencing, among other issues, Roe v. Wade.
This notion of caution is understandable, if not impracticable. The Supreme Court spend most of the first fifty years of the 20th century dreadfully lagging behind public opinion until the Warren Court, when it became far more progressive than the public. The Burger and Rehnquist Courts tacked right, as went the nation, but the Roberts Court looks out of touch in the age of Obama. In short, what Souter is describing is a largely hopeless task, and one antithetical to his ideologically minded colleagues anyway. Justices should not wait for the public to "catch up" when it comes to issues of substantive due process rights; after all, the public is not as informed on the issues as Supreme Court Justices are.
Without reading into Sotomayor's response to Senator Durbin too much, given the extremely cautious environment they were made in, they came off as... cautious. We already know President Obama has been a far more cautious leader than he was a candidate. Without editorializing further on Osborne, Souter, or his presumptive replacement, Sotomayor, I will only say that on the difficult DNA issues the courts will face in the coming years, I would rather defer to wisdom than caution when the two part ways.
As any observer can tell, these judicial hearings are largely about showmanship, senators trying to reduce serious legal issues to soundbytes, and nominees working hard to avoid giving any opinions at all. But this site is excited to see the issue of DNA raised at such a high profile hearing. Here is the relevant transcript:
DURBIN: And this is a recent case before the Supreme Court I'd like to make reference to, D.A.'s Office v. Osborne, involving DNA. It turns out there are only three states in the United States that don't provide state legislative access to DNA evidence that might be -- might exonerate someone who is in prison.
I am told that, since 1989, 240 post-conviction DNA exonerations have taken place across this country, 17 involving inmates on death row. Now, the Supreme Court in the Osborne case was asked, what about those three states? Is there a federal right to access to DNA evidence for someone currently incarcerated who questions whether or not they were properly charged and convicted? And the court said, no, there was no federal right, but it was a 5-4 case. So, though I don't quarrel with your premise that it's our responsibility on this side of the table to look at the death penalty, the fact is, in this recent case, this Osborne case, there was a clear opportunity for the Supreme Court right across the street to say, "We think this gets to an issue of due process as to whether someone sitting on death row in Alaska, Massachusetts or Oklahoma, where their state law gives them no access, under the law, to DNA evidence."
So I ask you, either from the issue of DNA or from other perspectives, isn't it clear that the Supreme Court does have some authority in the due process realm to make decisions relating to the arbitrariness of the death penalty?
SOTOMAYOR: The court is not a legislative body. It is a reviewing body of whether a particular act by a state in a particular case is constitutional or not. In a particular situation, the Court may conclude that the state has acted unconstitutionally and invalidate the act, but it's difficult to answer a question about the role of the Court outside of the functions of the Court which is we don't make broad policies. We decide questions based on cases and the principles implicated by that particular case before you.
This answer could have been given by nominee Robers or Alito. I imagine the last thing Sotomayor would want to do during her otherwise smooth confirmation is criticize a very recent and controversial Supreme Court decision. In Osborne, Justice Stevens quite forcefully castigated the state of Alaska's inability to articulate a sound reason for denying Osborne the opportunity to test the DNA evidence at his own expense. Justice Stevens, joined by Justices Ginsburg, Breyer and Souter, asserted that Alaska violated the Due Process Clause by failing to provide Osborne adequate procedural protections for the postconviction relief.
The question that Senator Durbin wanted Sotomayor to answer, however, was whether the Court should find a federal right to DNA evidence. On this issue, Justice Souter defected from his liberal colleagues, disagreeing that the Fourteenth Amendment provided a substantive due process right to DNA evidence. Souter's reasoning was that the Court should proceed cautiously in granting substantive due process rights before the public has had the full opportunity to consider an issue, referencing, among other issues, Roe v. Wade.
This notion of caution is understandable, if not impracticable. The Supreme Court spend most of the first fifty years of the 20th century dreadfully lagging behind public opinion until the Warren Court, when it became far more progressive than the public. The Burger and Rehnquist Courts tacked right, as went the nation, but the Roberts Court looks out of touch in the age of Obama. In short, what Souter is describing is a largely hopeless task, and one antithetical to his ideologically minded colleagues anyway. Justices should not wait for the public to "catch up" when it comes to issues of substantive due process rights; after all, the public is not as informed on the issues as Supreme Court Justices are.
Without reading into Sotomayor's response to Senator Durbin too much, given the extremely cautious environment they were made in, they came off as... cautious. We already know President Obama has been a far more cautious leader than he was a candidate. Without editorializing further on Osborne, Souter, or his presumptive replacement, Sotomayor, I will only say that on the difficult DNA issues the courts will face in the coming years, I would rather defer to wisdom than caution when the two part ways.
Saturday, July 11, 2009
The Big O and his FDA Regulators
One of the Obama administration’s biggest promises was bringing greater transparency to Washington. Advocacy group Genetic Alliance is trying to make sure the FDA adheres to Obama’s promise brings reform to genetic testing, an area which had unsurprisingly come under criticism for lack of regulation during the Bush years.
At a hearing sponsored by the FDA Transparency Task Force, Genetic Alliance asked that the FDA create a public registry for genetic tests “to enable transparency and promote informed decision making for consumers and providers,” including “the myriad of genetic, genomic, and pharmacogenomic testing available to the US market.” Genetic Alliance believes that the registry should be overseen by FDA and that the information should stored at the National Center for Biotechnology Information so that it could be integrated with other genetic resources. Interestingly, Genetic Alliance also called on the FDA to release warning letters it sent to genetic testers for not following their guidelines, to better inform consumers about which companies should merit concern.
The Genetic Alliance recommendations are good, but they do not address one of the bigger debates- increased FDA scrutiny of lab-developed testing. Currently FDA does not regulate most lab-developed tests (LTDs), which are sold as diagnostic services. The agency consistently regulates in vitro diagnostic test kits (IVDs), sold as packaged products.
Addressing this discrepancy actually began in the 11th hour of the Bush administration. “There is a major gap in the oversight of genetic tests when it comes to the evaluation of clinical validity. ... A truck can drive through that hole,” says Reed V. Tuckson, M.D., an industry man tapped by Bush’s Department of Health and Human Services to head a panel drafting a better model for genetic test oversight.
The fissure here, from what I understand, has pitted certain big pharmas against each other. Manufacturers who devote resources to obtaining FDA approval for their commercial products are understandably frustrated that the FDA’s inability to handle the explosion in labs providing genetic testing may undercut their bottom line.
The arguments against regulation are familiar- not enough resources, not enough legal authority. Industry groups feign concern for “the ability of small labs to handle compliance,”sounding a bit like agribusiness hiding behind the fictional little Iowa farmer. Steve Gutman, director of the FDA’s wordy Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) disputes these claims, noting that the FDA provides plenty of educational workshops on compliance, also noting, “Quality is quality, so if small labs are doing a good job now then they will not have difficulty complying.”
Gutman notes that the main differences in the requirements currently guiding the two types of testing are design control requirements and “the way corrective and preventative action is performed.” That sounds like a pretty big difference in the regulatory context, no?
Various task forces have been working since late 2008 to address these problems, but in the summer of 2009 we don’t seem much closer to a final answer. In a field where one of regulation’s most cited challenged is responding quickly to dynamic changes in the field, the endless panels, task forces and review boards do not paint an encouraging picture.
The final word goes the Director of Public Health Genomics at the Centers for Disease Control and Prevention, Muin Khoury, M.D. “The committee can ... describe what the ideal is, which is truth in advertisement, minimum standards of clinical validity, analytical validity and quality control…Clinical utility is tough. But you need a threshold below which stuff just shouldn't be going to the market.” Amen, Muin. Let’s all get to work on finding that threshold and making it apply to all genetic testers.
Further Reading:
Two posts from Genome Web:
http://www.genomeweb.com/dxpgx/genetic-alliance-asks-fda-public-genetic-test-registry
http://www.genomeweb.com/blog/cms-sheds-light-plan-enhance-oversight-genetic-ldts
Insightful, albeit somewhat dated article (2006) from DNA policy: http://www.dnapolicy.org/resources/Issues_in_Science_and_Technology.pdf
Highly technical debate on lab testing dispute: http://www.medicaldevicestoday.com/2008/02/fda-genetic-tes.html
At a hearing sponsored by the FDA Transparency Task Force, Genetic Alliance asked that the FDA create a public registry for genetic tests “to enable transparency and promote informed decision making for consumers and providers,” including “the myriad of genetic, genomic, and pharmacogenomic testing available to the US market.” Genetic Alliance believes that the registry should be overseen by FDA and that the information should stored at the National Center for Biotechnology Information so that it could be integrated with other genetic resources. Interestingly, Genetic Alliance also called on the FDA to release warning letters it sent to genetic testers for not following their guidelines, to better inform consumers about which companies should merit concern.
The Genetic Alliance recommendations are good, but they do not address one of the bigger debates- increased FDA scrutiny of lab-developed testing. Currently FDA does not regulate most lab-developed tests (LTDs), which are sold as diagnostic services. The agency consistently regulates in vitro diagnostic test kits (IVDs), sold as packaged products.
Addressing this discrepancy actually began in the 11th hour of the Bush administration. “There is a major gap in the oversight of genetic tests when it comes to the evaluation of clinical validity. ... A truck can drive through that hole,” says Reed V. Tuckson, M.D., an industry man tapped by Bush’s Department of Health and Human Services to head a panel drafting a better model for genetic test oversight.
The fissure here, from what I understand, has pitted certain big pharmas against each other. Manufacturers who devote resources to obtaining FDA approval for their commercial products are understandably frustrated that the FDA’s inability to handle the explosion in labs providing genetic testing may undercut their bottom line.
The arguments against regulation are familiar- not enough resources, not enough legal authority. Industry groups feign concern for “the ability of small labs to handle compliance,”sounding a bit like agribusiness hiding behind the fictional little Iowa farmer. Steve Gutman, director of the FDA’s wordy Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) disputes these claims, noting that the FDA provides plenty of educational workshops on compliance, also noting, “Quality is quality, so if small labs are doing a good job now then they will not have difficulty complying.”
Gutman notes that the main differences in the requirements currently guiding the two types of testing are design control requirements and “the way corrective and preventative action is performed.” That sounds like a pretty big difference in the regulatory context, no?
Various task forces have been working since late 2008 to address these problems, but in the summer of 2009 we don’t seem much closer to a final answer. In a field where one of regulation’s most cited challenged is responding quickly to dynamic changes in the field, the endless panels, task forces and review boards do not paint an encouraging picture.
The final word goes the Director of Public Health Genomics at the Centers for Disease Control and Prevention, Muin Khoury, M.D. “The committee can ... describe what the ideal is, which is truth in advertisement, minimum standards of clinical validity, analytical validity and quality control…Clinical utility is tough. But you need a threshold below which stuff just shouldn't be going to the market.” Amen, Muin. Let’s all get to work on finding that threshold and making it apply to all genetic testers.
Further Reading:
Two posts from Genome Web:
http://www.genomeweb.com/dxpgx/genetic-alliance-asks-fda-public-genetic-test-registry
http://www.genomeweb.com/blog/cms-sheds-light-plan-enhance-oversight-genetic-ldts
Insightful, albeit somewhat dated article (2006) from DNA policy: http://www.dnapolicy.org/resources/Issues_in_Science_and_Technology.pdf
Highly technical debate on lab testing dispute: http://www.medicaldevicestoday.com/2008/02/fda-genetic-tes.html
Friday, July 10, 2009
Yikes - Poll Numbers To Make You Pause
At a conference sponsored by the Food and Drug Law Institute (FDLI) and American Association for the Advancement of Sciences (AAAS), the audience of medical professionals were polled for their thoughts on the safety of genetic testing.
Here are some results that struck me:
75% responded “yes” to “Do you have concerns about the ability of the FDA to regulate genetic testing?”
71% believed that the FDA should be regulating genetic testing more stringently, including the lab-developed testing discussed above.
50% were somewhat skeptical that their own doctors knew enough about genetics to incorporate it into their personalized medicine practice, while another 28% said there was “not a chance” that their own doctors knew enough. Only two percent were “very confident” in their doctors. This number is particularly staggering given top medical professionals likelihood of having top personal doctors. I imagine the numbers would be even more drastic for “the average doctor.”
Reuters Article Citing Poll Numbers: http://www.reuters.com/article/pressRelease/idUS182986+22-Jun-2009+PRN20090622
Here are some results that struck me:
75% responded “yes” to “Do you have concerns about the ability of the FDA to regulate genetic testing?”
71% believed that the FDA should be regulating genetic testing more stringently, including the lab-developed testing discussed above.
50% were somewhat skeptical that their own doctors knew enough about genetics to incorporate it into their personalized medicine practice, while another 28% said there was “not a chance” that their own doctors knew enough. Only two percent were “very confident” in their doctors. This number is particularly staggering given top medical professionals likelihood of having top personal doctors. I imagine the numbers would be even more drastic for “the average doctor.”
Reuters Article Citing Poll Numbers: http://www.reuters.com/article/pressRelease/idUS182986+22-Jun-2009+PRN20090622
Wednesday, July 8, 2009
Genetic Testing and Class
The March of Dimes, one of the leading national organizations promoting prenatal and infant care, issued a press release today blasting companies for marketing misleading genetic tests to parents.
“Buyer beware! These tests are marketed to new and expecting parents and take advantage of their dream of having the perfect baby," claims March of Dimes President Dr. Jennifer L. Howse. “Consumers should be extremely cautious before spending the money -- and risking their privacy -- on such tests.”
The March of Dimes held a luncheon entitled “Testing Your Personal Genome: What the Tests Can and Cannot Tell You” featuring a number of academics. The speakers agreed that despite the benefit of genetics tests- their ability to tell women they are carriers of genetic diseases that can be passed on to their children- direct-to-consumer tests are unregulated and “more for entertainment than useful medical information.” Oversimplified test results can make exaggerate some genetic warning signs, and inadequately others, giving parents misleading impressions of their infants’ health.
Direct to consumer anythings are obviously ripe for scams, from get rich quick schemes to super cheap fitness sets. The speakers pointed out the complications associated with genetic testing, such as a growing awareness of the impact environment has interacting with genetic predispositions to disease, but the more interesting takeaway is the growing market for “genetic tests”.
The technology to study a pre-born’s genetics is advancing rapidly, as we have noted and will continue to evaluate at this site. But as with any set of technologies, and as with any health service, access will come to certain classes of people before others. This time, however, we aren’t just talking about access to a nerdy “computer” or unfamiliar cancer screenings. Every parent will instantly recognize how dramatically their child’s genetic makeup will affect everything from their risk of disease to athletic potential.
As thorough, expensive tests conducted at top clinics begin to deliver mindblowing, yet reliable, results to affluent parents, other parents are going to want in. These parents will lack the financial resources to undergo the same premier testing, and will be vulnerable to "on the cheap" variations. "On the cheap" will still cost them though, and depending on what they are being promised, they could be throwing away money that they don't have. Credit card companies lick their lips at such situations. Finally, people in economically vulnerable positions are also more likely to be undereducated, and less aware of pitfalls, like what these companies will do with their childrens' genetic information.
Yes, marketers who will promise parents access to this info on the cheap will thrive in the coming years. Parents will trip over each other to hand over their cash and their children’s genetic information. March of Dimes says the practice is “unregulated.” How do people think such a practice should be regulated? Tomorrow I will post on some of the problems that have emerged in regulation, such as the limited role the FDA has played, though genetic tests falls under its jurisdiction.
You can read the full March of Dimes press release here: http://sev.prnewswire.com/health-care-hospitals/20090708/DC4348008072009-1.html
“Buyer beware! These tests are marketed to new and expecting parents and take advantage of their dream of having the perfect baby," claims March of Dimes President Dr. Jennifer L. Howse. “Consumers should be extremely cautious before spending the money -- and risking their privacy -- on such tests.”
The March of Dimes held a luncheon entitled “Testing Your Personal Genome: What the Tests Can and Cannot Tell You” featuring a number of academics. The speakers agreed that despite the benefit of genetics tests- their ability to tell women they are carriers of genetic diseases that can be passed on to their children- direct-to-consumer tests are unregulated and “more for entertainment than useful medical information.” Oversimplified test results can make exaggerate some genetic warning signs, and inadequately others, giving parents misleading impressions of their infants’ health.
Direct to consumer anythings are obviously ripe for scams, from get rich quick schemes to super cheap fitness sets. The speakers pointed out the complications associated with genetic testing, such as a growing awareness of the impact environment has interacting with genetic predispositions to disease, but the more interesting takeaway is the growing market for “genetic tests”.
The technology to study a pre-born’s genetics is advancing rapidly, as we have noted and will continue to evaluate at this site. But as with any set of technologies, and as with any health service, access will come to certain classes of people before others. This time, however, we aren’t just talking about access to a nerdy “computer” or unfamiliar cancer screenings. Every parent will instantly recognize how dramatically their child’s genetic makeup will affect everything from their risk of disease to athletic potential.
As thorough, expensive tests conducted at top clinics begin to deliver mindblowing, yet reliable, results to affluent parents, other parents are going to want in. These parents will lack the financial resources to undergo the same premier testing, and will be vulnerable to "on the cheap" variations. "On the cheap" will still cost them though, and depending on what they are being promised, they could be throwing away money that they don't have. Credit card companies lick their lips at such situations. Finally, people in economically vulnerable positions are also more likely to be undereducated, and less aware of pitfalls, like what these companies will do with their childrens' genetic information.
Yes, marketers who will promise parents access to this info on the cheap will thrive in the coming years. Parents will trip over each other to hand over their cash and their children’s genetic information. March of Dimes says the practice is “unregulated.” How do people think such a practice should be regulated? Tomorrow I will post on some of the problems that have emerged in regulation, such as the limited role the FDA has played, though genetic tests falls under its jurisdiction.
You can read the full March of Dimes press release here: http://sev.prnewswire.com/health-care-hospitals/20090708/DC4348008072009-1.html
Tuesday, July 7, 2009
Osborne: When the DA's got your genes to freedom
In today’s “better late than never” segment we’ll look at the June 18 Supreme Court decision, District Attorney's Office for Third Judicial District v. Osborne. In a 5-4 decision, with the usual suspects in their respective corners, the Court ruled that prison inmates have no constitutional right to DNA testing that may exonerate them.
William Osborne may or may not have kidnapped and murdered a prostitute. The truth very well could be found by testing a DNA sample in Alaskan prosecutor’s possession, with Osborne willing to fund the necessary test, post-conviction. To be clear, Osborne is not the second coming of Troy Davis. There are many circumstantial facts against him, and his lawyer avoided certain DNA tests earlier in the trial out of fear that they would implicate, not exonerate him. We should and will spend a whole ‘nother post talking about the moral and strategic issues a defense lawyer faces in handling DNA evidence.
There is a condom left from the crime scene, where the victim was left shot and raped (she survived). DNA testing done early in the trial showed that Osborne was in fact a potential suspect. Osborne eventually pled guilty in the hopes of securing an earlier release. Today there is more sophisticated DNA testing than Osborne had at the time of his trial, and Osborne has offered to pay for the opportunity to prove his innocence.
Four states do not allow post-conviction DNA testing remedies: Alabama (though they will soon for death row inmates), Alaska, Massachusetts (?) and Oklahoma. Many of the other 46 states, however, have restrictions such as timing allowing for plea bargainers to test. According to the Innocence Project, 35% of the 240 individuals who have been exonerated by DNA evidence confessed to their murders, probably due to police coercion at the time of arrest. Additionally, the New York Times article points out that even in states permitting post-conviction testing, prosecutors fight tooth and nail to block access to DNA evidence.
The conservative justices, as is occasionally their wont, determined that the matter was best left to the states. You know, the kind of states that elect Sarah Palin governor. Chief Justice Robers seemed satisfied with legislatures being up to handle political softballs like death-row inmate access to DNA evidence.
Justice Souter, on his final tour of duty, noted that Alaska incompetence does not stop at the executive branch: “[Alaska] has demonstrated a combination of inattentiveness and intransigence (in prisoner access to DNA) that add up to “procedural unfairness that violates the Due Process Clause.”
Though Alaska claimed that prisoners do have procedural avenues for accessing their own DNA during cases, Justice Stevens (in dissent) pointed out that no Alaska prisoner had actually succeeded in obtaining their DNA through these procedures.
Justice Alito’s concurrence, joined by Kennedy and Thomas, displayed skepticism of DNA evidence generally (“[it] often fails to provide absolute proof of anything”) and suggested that if prisoners could use DNA evidence to exonerate themselves, they would simply gain the system by not asking for testing at trial, and then asking for testing after trial in the hope that the evidence had become contaminated.
Two things strike me as misguided about Justice Alito’s interpretation. First, a defendant arguing vehemently for his innocence would be more likely to demand the DNA test during the trial, thus expediating his exoneration, than play the kind of games Alito suggests. Second, the Court could simply argue that inconclusive DNA testing conducted post-conviction could not be used to overturn the decision. The Innocence Project has not only exonerated 240 individuals conclusively, but in over 40% of its cases it has also identified the actual guilty party. Alito makes it seem like DNA evidence does nothing but cast a haze on things.
We could talk about tangential issues like whether the death penalty is just all night, but I am tired and goin’ to bed. Here is some further reading:
Supreme Court Decision (not all of you at once…) http://www.supremecourtus.gov/opinions/08pdf/08-6.pdf
A Law Prof Drops Some Case History: http://lawprofessors.typepad.com/science_law/2008/11/osborne-and-the.html
NY Times Article: http://www.nytimes.com/2009/06/19/us/19scotus.html?pagewanted=print
Innocence Project Fact Page: http://www.innocenceproject.org/Content/351.php
William Osborne may or may not have kidnapped and murdered a prostitute. The truth very well could be found by testing a DNA sample in Alaskan prosecutor’s possession, with Osborne willing to fund the necessary test, post-conviction. To be clear, Osborne is not the second coming of Troy Davis. There are many circumstantial facts against him, and his lawyer avoided certain DNA tests earlier in the trial out of fear that they would implicate, not exonerate him. We should and will spend a whole ‘nother post talking about the moral and strategic issues a defense lawyer faces in handling DNA evidence.
There is a condom left from the crime scene, where the victim was left shot and raped (she survived). DNA testing done early in the trial showed that Osborne was in fact a potential suspect. Osborne eventually pled guilty in the hopes of securing an earlier release. Today there is more sophisticated DNA testing than Osborne had at the time of his trial, and Osborne has offered to pay for the opportunity to prove his innocence.
Four states do not allow post-conviction DNA testing remedies: Alabama (though they will soon for death row inmates), Alaska, Massachusetts (?) and Oklahoma. Many of the other 46 states, however, have restrictions such as timing allowing for plea bargainers to test. According to the Innocence Project, 35% of the 240 individuals who have been exonerated by DNA evidence confessed to their murders, probably due to police coercion at the time of arrest. Additionally, the New York Times article points out that even in states permitting post-conviction testing, prosecutors fight tooth and nail to block access to DNA evidence.
The conservative justices, as is occasionally their wont, determined that the matter was best left to the states. You know, the kind of states that elect Sarah Palin governor. Chief Justice Robers seemed satisfied with legislatures being up to handle political softballs like death-row inmate access to DNA evidence.
Justice Souter, on his final tour of duty, noted that Alaska incompetence does not stop at the executive branch: “[Alaska] has demonstrated a combination of inattentiveness and intransigence (in prisoner access to DNA) that add up to “procedural unfairness that violates the Due Process Clause.”
Though Alaska claimed that prisoners do have procedural avenues for accessing their own DNA during cases, Justice Stevens (in dissent) pointed out that no Alaska prisoner had actually succeeded in obtaining their DNA through these procedures.
Justice Alito’s concurrence, joined by Kennedy and Thomas, displayed skepticism of DNA evidence generally (“[it] often fails to provide absolute proof of anything”) and suggested that if prisoners could use DNA evidence to exonerate themselves, they would simply gain the system by not asking for testing at trial, and then asking for testing after trial in the hope that the evidence had become contaminated.
Two things strike me as misguided about Justice Alito’s interpretation. First, a defendant arguing vehemently for his innocence would be more likely to demand the DNA test during the trial, thus expediating his exoneration, than play the kind of games Alito suggests. Second, the Court could simply argue that inconclusive DNA testing conducted post-conviction could not be used to overturn the decision. The Innocence Project has not only exonerated 240 individuals conclusively, but in over 40% of its cases it has also identified the actual guilty party. Alito makes it seem like DNA evidence does nothing but cast a haze on things.
We could talk about tangential issues like whether the death penalty is just all night, but I am tired and goin’ to bed. Here is some further reading:
Supreme Court Decision (not all of you at once…) http://www.supremecourtus.gov/opinions/08pdf/08-6.pdf
A Law Prof Drops Some Case History: http://lawprofessors.typepad.com/science_law/2008/11/osborne-and-the.html
NY Times Article: http://www.nytimes.com/2009/06/19/us/19scotus.html?pagewanted=print
Innocence Project Fact Page: http://www.innocenceproject.org/Content/351.php
Sunday, July 5, 2009
Rudimentary Analysis in ACLU Gene-Owning Case
Yesterday's post talked about the ACLU's big lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office. The ACLU is grounding their argument in the First Amendment, as is their style, claiming the right of an individual to know his own genetic makeup, the right of a doctor to provide his patient with critical medical information, and the right of a scientist to study the human genome precludes Myriad’s patenting of this gene (or any other gene).
This case gets at the very heart of what purpose the patent system is designed to serve. In theory, patents encourage innovation by rewarding inventors for their ingenuity and labor, protecting them from poaching. A person would only take the time to design a computer, for example, if they were assured that Microsoft wouldn’t just copy the design and mass market it without compensating the creator. This logic applies less cleanly to gene patents.
I have spent parts of the last few days perusing the internets for commentary on this case. The most interesting post is certainly this one from a corporate patent lawyer website:
http://www.patentdocs.org/2009/06/falsehoods-distortions-and-outright-lies-in-the-gene-patenting-debate.html
The author, Kevin Noonan, slams the ACLU suit in a highly readable manner. This is my favorite post on the issue because of the extremely lively comment section below the article. The cross-fire involves multiple characters, including David Koepsell, the author of “Who Owns Your Genes” (his website is linked off to the side). Noonan and Koepsell’s debate ranges from intellectually spirited to lame personal attacks. The core argument between them (in super simplified terms) turns on whether a gene, when isolated by “human hands”, is patentable. According to Noonan, this isolation would never happen in nature. This kind of isolation has only been possible in recent decades, and great research costs to big companies, and case law strongly supports this kind of patentability. Koepsell fundamentally disagrees that the genes at the heart of the BRCA debate have had sufficient human intervention to merit patenting, and grounds his arguments largely in policy, acknowledging that the law on this subject is not to his liking. If you don’t have time to read this whole piece, you could probably skip to the comments to get a sense of where the two sides stand. There is a healthy chasm between them.
The ABA Journal recently had a piece on this issue:
http://abajournal.com/magazine/wrangling_genes/
On the merits of this case itself, the ABA article adopts the ACLU’s perspective to a great extent, but when Myriad refused to comment for the article, that was bound to happen. More interesting is the ABA’s delving into some recent case history, including In re Bilski, a D.C Circuit decision requiring patent processes to involve a machine or transformation to a different state. This decision, which overturned a great deal of precedent, seemed to be taking its cue from Justice Breyer’s dissent in Laboratory Corp. of America Holdings v. Metabolite Laboratories Inc. (2006), in which he claimed that “law of nature, natural phenomena and abstract ideas” are excluded from patent protection because “sometimes too much patent protection can impede rather than ‘promote the progress of science and useful arts…’”
For another pro-Myriad perspective, you can check out this amusing rant:
http://www.ipwatchdog.com/2009/06/22/setting-the-record-straight-on-gene-patents/id=4202/
The post drips with condescension and vitriol towards the ACLU position, and at points degenerates completely into an unrelated tirades against the Obama healthcare plan and communism. Quinn compares the ACLU position to that of the Unibomber, which really turns back the clock. Sounds like someone is freaking out.
One post that delves (VERY) deeply into the case is by University of Missouri-Kansas City Law School Professor Chris Holman, who runs a blog dedicated to issues of intellectual property: http://holmansbiotechipblog.blogspot.com/2009/05/aclu-lawsuit-challenges-patenting-of.html
Holman does not believe that the ACLU’s claims are entirely frivolous, but he is skeptical of their constitutional claims, writing, “[T]o my knowledge, a patent claim has never been invalidated solely on the basis of a constitutional violation.” For those interested in the First Amendment argument, this is by far the most even-handed post I have seen on the case. It is also pretty lengthy, and cites to a number of cases that the lay reader will not be familiar with.
What I like most about Holman’s post is his analysis of the issue of standing, which he believes will be the more determinative issue in the case, noting that “[G]enerally, members of the public are not permitted to challenge the validity of issues patents, nore are they permitted to challenge the PTO’s (U.S Patent and Trademark Office) interpretation of substantive patent law.” None of the plaintiffs have actually been sued by Myriad, potentially raising case and controversy issues. However, Holman points out that in a 2007 case, MedImmune v. Genentech, the Supreme Court created a fairly low standard for standing in patent cases, demanding only that plaintiffs bringing declaratory judgments allege “actual controversy…touching the legal relations of parties having adverse legal interest.”
Though none of the plaintiffs are engaged in commercial activity, presumably at least some will be able demonstrate their fear of being sued by Myriad for continuing work on the BRCA genes. Two of the plaintiffs, University of Pennsylvania professors, have received cease and desist letters from Myriad before, albeit eleven years ago.
Given most courts’ unwillingness to plunge into issues that shake the moral foundation of our civilization, I would not be surprised at all if the lower court made this a case about standing. Should that happen, we will all live to debate this topic for another day.
This case gets at the very heart of what purpose the patent system is designed to serve. In theory, patents encourage innovation by rewarding inventors for their ingenuity and labor, protecting them from poaching. A person would only take the time to design a computer, for example, if they were assured that Microsoft wouldn’t just copy the design and mass market it without compensating the creator. This logic applies less cleanly to gene patents.
I have spent parts of the last few days perusing the internets for commentary on this case. The most interesting post is certainly this one from a corporate patent lawyer website:
http://www.patentdocs.org/2009/06/falsehoods-distortions-and-outright-lies-in-the-gene-patenting-debate.html
The author, Kevin Noonan, slams the ACLU suit in a highly readable manner. This is my favorite post on the issue because of the extremely lively comment section below the article. The cross-fire involves multiple characters, including David Koepsell, the author of “Who Owns Your Genes” (his website is linked off to the side). Noonan and Koepsell’s debate ranges from intellectually spirited to lame personal attacks. The core argument between them (in super simplified terms) turns on whether a gene, when isolated by “human hands”, is patentable. According to Noonan, this isolation would never happen in nature. This kind of isolation has only been possible in recent decades, and great research costs to big companies, and case law strongly supports this kind of patentability. Koepsell fundamentally disagrees that the genes at the heart of the BRCA debate have had sufficient human intervention to merit patenting, and grounds his arguments largely in policy, acknowledging that the law on this subject is not to his liking. If you don’t have time to read this whole piece, you could probably skip to the comments to get a sense of where the two sides stand. There is a healthy chasm between them.
The ABA Journal recently had a piece on this issue:
http://abajournal.com/magazine/wrangling_genes/
On the merits of this case itself, the ABA article adopts the ACLU’s perspective to a great extent, but when Myriad refused to comment for the article, that was bound to happen. More interesting is the ABA’s delving into some recent case history, including In re Bilski, a D.C Circuit decision requiring patent processes to involve a machine or transformation to a different state. This decision, which overturned a great deal of precedent, seemed to be taking its cue from Justice Breyer’s dissent in Laboratory Corp. of America Holdings v. Metabolite Laboratories Inc. (2006), in which he claimed that “law of nature, natural phenomena and abstract ideas” are excluded from patent protection because “sometimes too much patent protection can impede rather than ‘promote the progress of science and useful arts…’”
For another pro-Myriad perspective, you can check out this amusing rant:
http://www.ipwatchdog.com/2009/06/22/setting-the-record-straight-on-gene-patents/id=4202/
The post drips with condescension and vitriol towards the ACLU position, and at points degenerates completely into an unrelated tirades against the Obama healthcare plan and communism. Quinn compares the ACLU position to that of the Unibomber, which really turns back the clock. Sounds like someone is freaking out.
One post that delves (VERY) deeply into the case is by University of Missouri-Kansas City Law School Professor Chris Holman, who runs a blog dedicated to issues of intellectual property: http://holmansbiotechipblog.blogspot.com/2009/05/aclu-lawsuit-challenges-patenting-of.html
Holman does not believe that the ACLU’s claims are entirely frivolous, but he is skeptical of their constitutional claims, writing, “[T]o my knowledge, a patent claim has never been invalidated solely on the basis of a constitutional violation.” For those interested in the First Amendment argument, this is by far the most even-handed post I have seen on the case. It is also pretty lengthy, and cites to a number of cases that the lay reader will not be familiar with.
What I like most about Holman’s post is his analysis of the issue of standing, which he believes will be the more determinative issue in the case, noting that “[G]enerally, members of the public are not permitted to challenge the validity of issues patents, nore are they permitted to challenge the PTO’s (U.S Patent and Trademark Office) interpretation of substantive patent law.” None of the plaintiffs have actually been sued by Myriad, potentially raising case and controversy issues. However, Holman points out that in a 2007 case, MedImmune v. Genentech, the Supreme Court created a fairly low standard for standing in patent cases, demanding only that plaintiffs bringing declaratory judgments allege “actual controversy…touching the legal relations of parties having adverse legal interest.”
Though none of the plaintiffs are engaged in commercial activity, presumably at least some will be able demonstrate their fear of being sued by Myriad for continuing work on the BRCA genes. Two of the plaintiffs, University of Pennsylvania professors, have received cease and desist letters from Myriad before, albeit eleven years ago.
Given most courts’ unwillingness to plunge into issues that shake the moral foundation of our civilization, I would not be surprised at all if the lower court made this a case about standing. Should that happen, we will all live to debate this topic for another day.
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