On Tuesday Florida executed its second condemned man with the use of midazolam in its three-drug protocol. The drug is still the subject of a lawsuit by death row inmates because of concerns midazolam (intended as an anesthetic) may leave prisoners in extreme pain as their lives are ended. The reasoning is that such pain would violate the Eighth Amendment prohibition against cruel and unusual punishment.
Florida has turned to midazolam because of restrictions on other drugs have limited supplies. Ohio was scheduled to use midazolam for the first time in an execution on the 14th, but the inmate requested that his organs be donated. This prompted the governor to stay the execution pending an examination of how inmates could donate their organs post-execution.
But, as might be expected, Texas continues to execute with only small adjustments. They are not using midazolam, but their reliance on compounding pharmacies and heightened secrecy surrounding how its drugs are acquired have prompted a lawsuit. Missouri, which had delayed an execution due to concerns over how it obtained propofol, will move forward with that execution later this month. It will use pentobarbital, but there are similar concerns over how it obtains its drugs.
If there is to be action from these court cases around compounding pharmacies, it will be over possible violations of existing state laws around public information and/or state procurement of resources. Courts have not been sympathetic to concerns over how effectively drugs have been tested. There will be more opportunities to check this hypothesis as states continue to execute prisoners.
Not that it was really expected, but recent action in the courts suggests that the Myriad Genetics case has not settled the legal standing of patents on testing of genetic sequences.
The new matter involves two companies in a lawsuit over the patenting of a genetic test for Down Syndrome (H/T ScienceInsider). On the 30th, a Federal judge in California invalidated the patent licensed by Sequenom since 2011. The test Sequenom developed and patented is new and different, utilizing a different technique and demonstrating marked increases in efficiency compared to other methods. They were sued by Ariosa Diagnostics for a declaration that a test Ariosa developed did not infringe on Sequenom’s patent.
The judge’s order, which granted Ariosa’s motion for summary judgment (and rejected Sequenom’s motion), focuses on whether various claims of the underlying patent address eligible subject matter. Specifically, whether or not patenting the uses of paternally-derived cell-free fetal DNA in the test constitutes the patenting of something novel and therefore patent-worthy. The judge was persuaded that the test constituted the application of conventional techniques to a new natural phenomenon, and did not pass the patent-worthy threshold. Relying on the decisions in both the Myriad case and the other recent medical test patenting case, Mayo v. Prometheus, the court found that the only inventive part of the patent was the use of cell-free fetal DNA, and thus not patentable.
This case is only at the District Court level, and Sequenom has stated it will appeal the decision. Ariosa is pleased with the decision, and given the tenor of its press release, would likely meet Sequenom’s ‘vigorous’ defense with vigor of its own. A visit to the Supreme Court in 2016 or so is plausible.
While propofol appears to be on the wane for use in executions by lethal injection, midazolam is on the upswing. Florida will use the drug as part of its three-drug execution protocol on November 12 (assuming a court hearing on the 6th doesn’t delay things), and Ohio will follow suit on November 14.
The Buckeye state is turning to a combination of midazolam and hydromorphone, due to a lack of pentobarbital. The two-drug combination is Ohio’s designated backup protocol in the event of a shortage of pentobarbital. The November 14 execution would be the first using that combination of drugs.
As usual, the concern over a new execution drug is about how effective the new sedative – midazolam – will be in sedating the prisoner. As this requires a deeper sedation than the typical use for the drug, it has not been clinically tested. There is speculation that midazolam is not as effective, based on the observations of a reporter who witnessed the latest Florida execution. He felt that it took longer for the inmate to lose consciousness compared to an execution involving pentobarbital. His execution did take twice as long as other executions, but the drugs may be only one possible explanation. One observation does not a scientific conclusion make, but the circumstances of executions make it difficult to conduct a meaningful experiment (and certainly not a large sample size).
For what it’s worth, not all recent lethal injections have received scrutiny for the drugs used. Arizona’s latest execution was appealed for traditional reasons connected to the handling of the case. It was carried out last week.
While shortages will continue, the increasing reliance of states on compounding pharmacies (which are not tightly regulated) to develop the drugs they need is likely a second front in stopping executions. It won’t stop states from innovating ways around these barriers, at least not for a while.
Last Tuesday Florida executed a man. While not unusual, it was the first time the state used midazolam hydrochloride as one of the three drugs in its usual protocol. This replaces sodium pentobarbital, the sedative that is the latest drug under scrutiny for its use in executions. Florida’s supplies of pentobarbital are dwindling, and clearly they lacked sufficient supply for this execution. There is another one scheduled for later this year, and the state felt it had to find an alternative.
It is not clear whether or not midazolam would serve its intended purpose in the execution – to prevent the condemned man from feeling extreme pain as the other drugs are administered to kill him. Florida state authorities are confident that it would, but the next person scheduled to die has appealed the use of midazolam on the grounds that it might not. A hearing is scheduled for November 6.
I don’t know how this is going to eventually turn out. I think it more likely that drug manufacturers will effectively cut off states rather than a court determine these drugs represent cruel and unusual punishment. Of course, this is mildly informed speculation, so keep that in mind.
While Rocket Girl went from play to movie, Rocket Boys is trying to go from book to movie to Broadway musical. Rocket Boys is the memoir of NASA rocket scientist Homer Hickam and was made into the 1999 film October Sky. Hickam worked with Carl Anthony Traman on the book for a musical based on Rocket Boys. There have been small productions of the musical in Hunstville, Los Angeles and New York prior to a series of three more substantial productions at a regional theater in West Virginia (where Hickam grew up). That third production starts next week. The next step is finding a developmental theater to ensure the play is ready for a proper Broadway run. If all goes well, that may happen in 2015.
Alan Alda continues his massively productive career as science communicator (I think he’s in the top tier worldwide). His Flame Challenge ended its second run in the spring, recognizing the best efforts of scientists to explain time to an 11-year old. Alda’s science communications work was recently recognized with a lifetime achievement award at the recent Executive STEM Summit on Learning in the Digital Age (co-sponsored by Scientific American). Here’s video of Alda at the event:
Alda will return to PBS, where he hosted Scientific American Frontiers for 11 years, this fall with a new science special. Continue reading
Last week The U.S. Circuit Court of Appeals for the D.C. Circuit ruled in a case involving the Food and Drug Administration (FDA). The FDA was subject to a lawsuit on the issue of whether or not the agency should allow the importation of drugs that it cannot (or will not) test for safety.
The drug at issue is sodium thiopental, a drug often used in a three drug combination to execute prisoners in the United States. The drug is an anesthetic, which is why there is still a demand for the product outside of prisons. As I have posted about in 2011 and 2012, supplies of the drug in the United States have dried up through a combination of factors. Domestic manufacturing capacity has disappeared, foreign suppliers have started refusing to export to the United States, and the demand to execute has not diminished.
The appellate court decision affirms the lower court decision in part, that the FDA did not act in accordance with the law to allow the import of sodium thiopental – which it has not approved for use in executions – into the country. The court argued that the agency has other means at its disposal to address such a drug shortage. The appeals court did reverse part of the District court’s decision and will allow states to retain possession of their existing stocks of the drug.
The FDA may still appeal the decision.
Earlier today the Supreme Court announced its ruling in the case Association for Molecular Pathology vs. Myriad Genetics, Inc. (Remember, I am not a lawyer.) The case involves patents on genes (BRCA1 and BRCA2) that correlate with higher incidence of breast cancer and a genetic test that focuses on those genes.
SCOTUSBlog has collected a lot of coverage and analysis on the case, and I recommend you spend some time there. I need to do the same before writing a lot about the case, if I end up finding something that doesn’t get covered elsewhere. Again, I am not a lawyer.
The Court ruled 9-0 to affirm part of the case and reverse part of it. What the court upheld was the ability to patent cDNA (complementary DNA), which is DNA synthesized or cloned from messenger RNA. While cDNA is produced naturally, it is common to develop it in the lab to help express proteins and perform other functions. The Court appears to conclude that the level of process to produce cDNA makes the end result distinct enough from ‘natural’ DNA to be eligible for patent protection, to not be a ‘product of nature’. In the context of the Myriad Genetics tests, what remains legally patented are the right to synthetically create cDNA of the two BRCA genes.
By comparison, the Chakrabarty case (referenced on page 12 of the opinion), which opened up the possibility of patenting various forms and/or pieces of life, four plasmids were added to a bacterium that enabled the organism to break down components of crude oil. If you care to analogize to a science fiction example, the Supreme Court would have ruled that Data, the android from Star Trek: The Next Generation, was patentable, even though Starfleet’s Judge Advocate General determined him to be alive (second season episode The Measure of a Man”). It’s not the strongest analogy, as Data lacks biological components (I welcome better examples).
What was reversed were the patent claims addressing isolated sequences of the BRCA1 and BRCA2 genes. Continue reading
As should be noted for all court case analysis, I am not a lawyer.
On Monday the Supreme Court issued its opinion in Bowman v. Monsanto, a case involving a farmer (Bowman) attempting to use seeds that were descended from Monsanto-engineered seeds. Monsanto believes that its intellectual property covers not only the original seeds and any of their descendants. Bowman argued that the patents do not cover seeds replicated from the patented seeds. The doctrine of patent exhaustion typically means that the intellectual property rights cover only the first sale of a product (this preserves the possibility of used markets in a variety of goods).
The Court ruled unanimously in favor of Monsanto. Instead of considering what Bowman did as resale, the Court considered the replanting and harvesting of Monsanto-engineered seeds as copying, which does not fall under the protection of patent exhaustion. When Monsanto sells the seeds originally, the licensing agreement that must be signed permits selling the resulting seeds as a commodity, and while Bowman purchased the seeds from a grain elevator, he used them for a different purpose, thus violating the license.
The Court makes a point of stating it is limiting its ruling to this particular kind of ‘self-replicating product’
“Our holding today is limited — addressing the situation before us, rather than every one involving a self-replicating product. We recognize that such inventions are becoming ever more prevalent, complex, and diverse. In another case, the article’s self-replication might occur outside the purchaser’s control. Or it might be a necessary but incidental step in using the item for another purpose.”
While the opinion specifically mentions software programs, I can see the possibility that gene patents could be considered as self-replicating products. How that argument might fare legally is unclear to me. I can see it being interpreted as like making copies, but since the associated uses of the gene patents like the Myriad case is not in discrete products like seeds, I’d resist making such a clear parallel. We should see how the Court looks at this very soon.
In what Nature has characterized as the first time a scientist has gone to trial over an academic laboratory accident, University of California, Los Angeles faculty member Patrick Harran will stand trial over the 2008 accident involving research assistant Sheharbano Sangji. Sangji died as a result of burns suffered as a result of handling tert-butylilithiumm. Chemical and Engineering News has covered the case extensively, and I would encourage you to read it to better understand the specifics of the accident and associated charges.
Harran and the University of California Regents were charged in late 2011 with willful violation of laboratory health and safety guidelines. In the summer of 2012 the Regents were dismissed from the case after a plea agreement. This agreement included an admission of responsibility for substandard lab conditions, improved support of comprehensive lab safety, a scholarship in the victim’s name, and monetary penalties (in addition to fines already assessed). Harran’s attorneys have offered a vigorous defense, and given that the charges in question involve willful violation of regulations (rather than negligence, which could be an easier charge to prove), the outcome of the trial is far from certain. A settlement/plea bargain may still take place, Dr. Harran may be found not guilty, or he could serve as many as four and one-half years if convicted.
What is even less clear is the impact this case may have on the behavior of universities, lab directors and supervisory researchers. Lab safety seems to an afterthought in way too many labs. Perhaps someone going to jail may prompt a change in action, but I’m afraid it won’t be sufficient. It could be too easy to dismiss this case as an outlier, and continue with the lax attitude toward safety that has claimed too many lives.
Courts in the United States have been perhaps the biggest entity that has resisted the intrusion of technology into its proceedings. Even in instances where the technology has been adopted, making the results of it widely available has not been a priority. The U.S. Supreme Court is perhaps the best known example, where only in 2010 were recordings of oral arguments released in the same week as the session. However, the Court had been recording arguments for decades, making them available long after the sessions that were recorded, and typically not for duplication.
NPR has reported (H/T Language Log/Twitter) that the archive, which dates back to 1955, has been digitized and made available at the Oyez Project (more recent recordings have been available via the Supreme Court website). A cursory review indicates that recordings are not available for every case, something more clear the further back you go. Presumably this is due at least in part to there not being recordings for all cases since 1955. Oyez is looking to expand the availability of these recordings, and is working on smartphone application versions of the archive.