Lethal Lab Safety Could Get You Community Service

That’s the message you might take from the recent announcement of a deferred prosecution agreement reached between the Los Angeles County District Attorney’s Office and UCLA chemistry professor Patrick Harran.  The agreement resolves the criminal charges Harran faced resulting from the death of research assistant Sheharbano Sangji.  She died in January 2009 as a result of burns suffered in the lab in December 2008.  UCLA reached a settlement agreement with the District Attorney back in 2012.

For the most thorough coverage, go read what Chemical and Engineering News has been writing on its safety blog since at least 2010.  Their reporting deserves wider readership and recognition – if for no better reason than to help shame some people who seem to think .

The agreement requires Harran to perform community service in the L.A. Hospital, pay $10,000 to a burn center, and teach organic chemistry courses to incoming college students from inner-city schools for five years.  For all this Harran avoids a trial, and admits no wrongdoing.  This press release from UCLA suggests Harran will continue to run a lab.

If you’re upset at this, like Sangji’s family is, I don’t blame you.  It certainly seems like a slap on the wrist.  For better or for worse, Harran was up on charges of willfully violating occupational health and safety standards.  This would be harder to prove than simple negligence, and might have prompted the District Attorney’s office to settle.

But it’s hard – at least on a visceral level – for me to accept that the best way forward is to keep Harran around running a lab as a cautionary tale.  Time may prove me wrong, but given the consequences of the kind of rigor his lab applied to safety, this might be a situation where a second chance isn’t reasonable.  Continue reading

Court Takes The Procedural Way Out Of Ruling On Stem Cell Patent

Consumer Watchdog will apparently need to get into stem cell research in order to get Courts to act on the validity of stem cell patents.  The U.S. Court of Appeals for the Federal Circuit has dismissed Consumer Watchdog’s challenge to a stem cell patent granted in 2007 to the Wisconsin Alumni Research Foundation (WARF).  The court did not rule on the merits of the challenge, but dismissed it based on Consumer Watchdog not being involved in the work on human embryonic stem cells.  As they weren’t directly involved or affected by stem cell research, the court decided that Consumer Watchdog lacked standing to challenge the patent.  The U.S. Patent and Trademark Office (USPTO) made that argument in filings earlier this year.

Consumer Watchdog filed the case because it felt that aggressive defense of the patent by WARF could effectively pre-empt research on stem cells in the State of California.  Perhaps the challenge would have met the court’s requirements for standing if a California research university, or the California Institute for Regenerative Medicine (which supports stem cell research in the state) had filed it.  At least for now, the patent stands.  As it expires in 2015, the window of opportunity to successfully challenge it, and change related patent law, is small.  The decision also suggests, as one of the legal experts quoted by ScienceInsider implies, that challenges by consumer groups like California Watchdog (or the ACLU) may not get much further than the USPTO.

Oklahoma Forced To Delay Second Execution Due To Adverse Drug Reaction

Clayton Lockett, an inmate on Oklahoma’s death row, was put to death last night.  Fellow death row inmate Charles Warner was not put to death last night, due to how Lockett died.

It’s worth noting that there have been a lot of legal actions related to lethal injections, and in the cases of Lockett and Warner, it nearly paralyzed the Oklahoma government.  The lawsuits and appeals have revolved around secrecy associated with the manufacture and distribution of drugs used for executions, and have not focused on the unknowns surrounding the new drug protocols Oklahoma and other states have been using as their traditional sources have shrunk or disappeared.

In short, the drugs used to execute Lockett did not have the intended impact.  They had been used in executions before, but not at the lower dosage levels used Tuesday night.  Lockett did die of an apparent heart attack.  A drug cocktail usually sedates and then paralyzes a condemned prisoner before stopping the heart.  But it should not take 43 minutes from initial injection for an inmate to die, even though the Oklahoma Department of Corrections noted this execution might take longer due to the lower doses used.  During those 43 minutes, according to witnesses, Lockett stirred and moved on the gurney, which doesn’t sit well with state assertions that Lockett was unconscious throughout the process – which was halted by the state prior to Lockett’s death.

While last night’s failed execution is getting a great deal of attention, it is part of a longer trend of dubious practices in the procurement and application of drugs.  Continue reading

Back When We Last Checked In On The Myriad

The Supreme Court ruled on the Myriad Genetics case last summer.  Since the case was decided, the company has been engaged in litigation with companies that started offering testing for the subject genes after the ruling.  Robert Cook-Deegan has summarized the post-decision for those of us, like me, who thought the Supreme COurt ruling ended things.  He’s also outlined some possible reasons for why Myriad Genetics launched a patent offensive in the wake of a decision that would seem – at least to a layman like me – to have foreclosed the company’s control over two genes.

Six companies have been sued by Myriad, with one settlement so far.  The cases have been consolidated and are currently working through a Federal District court in Utah.  Hearings were held in September and October.  On March 10, the judge in the case denied a motion for a preliminary injunction filed by Myriad.  This means that the company wanted the judge to stop competition on the medical tests of the BRCA1 and BRCA2 genes while the lawsuit went through the judicial process.  Usually these injunctions are granted because the side requesting relief could be reasonably seen to prevail on the merits of its case.  That doesn’t automatically mean that Myriad would lose, but it suggests that the company’s case is far from obvious.

It’s worth noting that these cases, as Cook-Deegan describes them, could be more complicated than the underlying case that opened up this competition over genetic testing.  Among the possible wrinkles include government involvement, because underlying research relied on research funds from the National Institutes of Health.  Of course, the path of litigation is tough to predict.  As one company has already settled, it’s possible none of this comes to trial.  Or not.

While we’re on the subject of the BRCA genes, it’s interesting to note this development reported earlier today.  BRCA1, besides controlling the development of proteins that can help prevent DNA damage, could control brain development.  As the research is only at the mice level, it will be a while before Myriad Genetics or other companies may be able to take advantage of their breast cancer work on BRCA in a new context.

Texas Innovates In How To Deal With Science In The Courts

The Innocence Project is focused on exonerating wrongfully convicted individuals, mainly through the use of DNA evidence.  In many instances, at the time the people were convicted, DNA evidence was not sufficiently mature in order to demonstrate a person’s innocence.  For better or for worse, there is not a simple way in which criminal convictions based on inaccurate (or updated) scientific methodology can be overturned.

Texas (yep, that Texas) has passed a law that could make the process easier.  Signed last June (and effective since September 1), the law addresses the right to habeas corpus (literally, you may have the body) in the context of new and/or changed scientific evidence.  Convicted individuals can apply for relief from the court if there is relevant scientific evidence now available that was either not reasonably ascertainable at the time of trial, or conflicts with evidence asserted by the state at trial.

Since the law went into effect, three cases have used the law to obtain release for the convicted individuals (pending procedures to prove innocence per Texas law), or a hearing for a new trial.  And that’s in six months.

There is certainly the opportunity for abuse.  The law does not define what is meant by relevant scientific evidence, leaving that to the courts to determine.  That the law is referred to in some reports as the ‘junk science’ bill is problematic, because not all instances where the law could be used cover instances of inaccurate, misleading or just plain wrong scientific claims.  It also covers instances where new scientific theories or refinements in analysis and measurement could warrant reopening a case to demonstrate someone’s innocence.  What the law does is reinforce the validity of scientific knowledge (or at least changes in same) to provide cause to reopen criminal cases.

Whether Stem Cells Can Be Patentable May Be The Least Of Commercial Challenges

Two recent actions involving the Food and Drug Administration (FDA) suggest to me that the matter of whether stem cell patents are valid may not be so critical.

The D.C. Circuit Court of Appeals ruled last week that the FDA has jurisdiction over stem cells cultured for therapeutic use (H/T The Scientist).  This decision upheld a lower court ruling that considered the act of culturing the cells more than ‘minimal manipulation,’ and therefore subject to FDA drug oversight regulations.

(IANAL, but I think this decision could be used to strengthen the case that stem cell patents – at least for cultures of said cells – would be valid.  After all, if there was more than minimal manipulation, wouldn’t that be sufficiently transformative to make the cultures no longer products of nature?  Again – I Am Not A Lawyer.)

Aside from the legal matters, there appears to be a big regulatory mismatch that will hinder commercialization of stem cell treatments.  In the February 6 edition of Cell Stem Cell researchers note (H/T The Scientist) that differing regulations between the National Institutes of Health (NIH) and the FDA may reduce the number of stem cell lines that could be used in clinical practice.

FDA regulations require that stem cell donors be screened for various diseases (so that treatments derived from those cells cannot infect others).  NIH regulations – not focused on commercial applications of stem cell research – do not have this requirement.  Now it is possible, as the article from The Scientist notes, for the FDA to allow some treatments to be approved without such a screening, but some alternative measure will likely be needed to mitigate the risk of infection.

Stem Cell Patents Getting Additional Scrutiny Post-Myriad

While recent Supreme Court activity (like the Myriad case) focused on the validity of gene patents, other biotechnology patents have been the object of scrutiny.

Consumer Watchdog asked the U.S. Patent and Trademark Office (USPTO) to review the patent it granted the University of Wisconsin-Madison in 2006 related to in vitro cultures of human embryonic stem cell lines.  The USPTO agreed to review the patent, but ultimately upheld the patent after several reviews and appeals.  In July 2013 Consumer Watchdog filed a brief with the U.S. Circuit Court of Appeals to have the patent invalidated.  (February 9 – Edited To Add – I had posted about the matter back in 2010 as it worked its way through appeal(s))

As with many patent cases, there are a number of different arguments that can be made for deciding the case.  But one of the arguments in the brief draws comparisons with the Supreme Courts arguments in the Myriad and related cases.  Specifically Consumer Watchdog is arguing that like the isolated gene sequences, the stem cell cultures are isolated products of nature and should not be eligible for patent protection.

Now, the Court of Appeals may opt to let the USPTO’s decision stand.  It will hear the case (it requested all parties submit briefs by January 16), and decide to validate or invalidate the patent based on any other claims put forth in the argument.  There are any number of procedural questions (in the courts or at the USPTO) that could stop the case cold.  And should the case make it through the Court of Appeals, a visit to the Supremes could certainly happen.