Appeals Court Rules in Myriad Genetics Case; Excellent Example of Mixed Bag

On Friday, the U.S. Court of Appeals for the Federal Circuit ruled (H/T ScienceInsider and The Wall Street Journal) in the Myriad Genetics lawsuit, which questioned the validity of the patents the company uses in its tests for two genes that factor in many cases of breast cancer.

Again, I am not a lawyer, but the ruling does not appear to be a clear-cut case for either side in the big question about the ability to patent genetic material.  It does appear that the Appeals Court found some overreach in Myriad Genetics’ patents.  While patenting of genetic material like the two cancer genes is permissible per this ruling, the aspects of the company’s patents that focus on comparing DNA strands are not patent-eligible.  Without a better understanding of the mechanics of the test, I can’t begin to speculate how that might affect things.  There have been concerns that Myriad Genetics has been restricting access to the samples to the point of interfering with second opinions, and this ruling might affect that.

Those who live in this policy are much more than I do suspect an appeal of this decision is likely, perhaps by both sides.

Jack Marburger, 1941-2011

John H. “Jack” Marburger III, presidential science adviser for President George W. Bush and the third president of the State University of New York, Stony Brook (where he was working as Vice President for Research), has lost his battle with non-Hodgkins lymphoma.  He was 70.  (H/T ScienceInsider)

As is often the case with those who serve as presidential science advisers, Dr. Marburger had a lengthy career often removed from the national spotlight.  His academic training was in physics, and served in faculty and administrative positions at the University of Southern California prior to coming to Stony Brook.  He was Director of the Brookhaven National Laboratory when President Bush appointed him in late 2001.  Marburger is the longest-serving presidential science adviser, and his work helping to shape the Science of Science Policy effort within the federal government is presently undervalued (Marburger was one of the editors and authors of the recent Science of Science Policy: A Handbook).  My limited dealings with him following his term suggested a man who was giving careful and thorough thought to how scientific and technical knowledge relate (or don’t) with political authority and political decision-making.  Some collections of his thoughts in this area are available, and I’ll link to more as I find them.  The latest piece I’ve found from him is this Huffington Post piece from April.  It argues against the deep science funding cuts in Rep. Ryan’s budget plan and the harms to science and technology support caused from budgeting by continuing resolution.

I recommend The New York Times obituary for a fuller explanation of how Marburger approached government service (arguably the foundation of much of the criticism he received on the job), but I find this example from the 1980s illustrative.

“When Gov. Mario M. Cuomo appointed him chairman of a fact-finding commission on the contentious issue of the unfinished Shoreham nuclear power plant on Long Island in 1983, he supervised a group of scientists who arrived at a consensus with which he did not agree. Announcing their findings — that the plant should never open — he told interviewers that he disagreed but added: ‘The governor didn’t want my opinion. He told me that. The governor wanted to know what the situation was. And I delivered that.'”

He received plenty of criticism during his tenure, but in my opinion much of it comes from a misplaced frustration with the President he served and a fundamental misunderstanding of the position of science adviser.

Dr. Marburger will be missed, and hopefully long remembered through the fellowships established in his name.  From the Stony Brook notice:

“In lieu of flowers, the Marburger family requests that memorial gifts in Jack’s name be directed to the John H. Marburger, III Memorial Fund. The Fund will support fellowships for women undertaking graduate study in the physical sciences, engineering or mathematics; fellowships for graduate students in music performance; and the Pollock/Krasner House. Please contact the Office of Advancement at (631)632-6300 for information.”

Some Science Music to Start the Weekend

A science song and a science band to start your weekend right…

N.E.D. is a medical abbreviation for No Evidence of Disease.  It’s also the name of a music group that was featured this week in The Washington Post‘s Science and Technology section.  The band is comprised of gynecologic oncologists – cancer doctors.  They are the subject of a documentary that appears to be still in the production stage, and the filmmakers are looking for donations.

If you prefer your science music in the weeds of peer review statistics, check out this song about impact factors (statistics that assess the ‘value’ of a particular journal in the research landscape).  Apologies to whomever Tweeted this, I failed to note the particular individual.

HHS Proposes Changes to Human Subjects Research Rules

The current federal regulations governing human subjects research oversight – called the Common Rule – have remained essentially the same for twenty years.  Today the Department of Health and Human Services (HHS) announced a proposed rule changing those regulations (H/T ScienceInsider).  The announcement also signaled the beginning of a public comment period that will close on September 26, 2011.  HHS is encouraging submissions via regulations.gov.

This table from HHS summarizes the changes the proposed new rule would make to the Common Rule.  The changes fall into two main categories.  Many changes seek to reflect changes in technology over the last twenty years, and the implications of those changes on human subjects research.  For instance, individual samples that could be rendered ‘de-identified’ by stripping relevant information back in the 1990s could be used without consent, in part because they could not then be tracked back to the individual donor.  Advances in both genomics and information technology make that much harder to do, and as a safeguard, donor consent will be required.  Data security requirements would be strengthened as well.

The other major category of changes focuses on streamlining the management and administration of clinical trials (Given its current work on clinical trial practices, I suspect the Bioethics Commission has either weighed in on the proposed changes, or will during the course of this rulemaking.)  Large research projects that currently require multiple reporting of adverse events or multiple Institutional Review Board (IRB) approval due to using multiple sites would find these requirement centralized.  Consent forms would also be streamlined.

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Embryonic Stem Cell Lawsuit Reaches Summary Judgment; End Not Necessarily in Sight

Earlier today U.S. District Court Judge Royce Lamberth issued a ruling in Sherley v. Sebelius, the lawsuit from two scientists arguing for a ban on federally funded human embryonic stem cell research (H/T Nature News).  This was not the first lawsuit seeking to prevent federal funding, but it was the first to advance within the federal courts, mainly due to two scientists serving as plaintiffs in the case.

Judge Lamberth had issued an injunction against embryonic stem cell funding, which prompted an appeal of the injunction to the Court of Appeals.  That court overturned the injunction, which shifted focus in the case back to the District Court.  Both sides had filed for summary judgment.  These motions had to make the case for or against the idea that .

Judge Lamberth ruled in favor of the Defendants’ Motion for Summary Judgment.  In his opinion, the Judge agreed with the Court of Appeals that the Plaintiffs do have standing – a key point that leaves open the possibility of future appeals.  However, the Court of Appeals opinion that overturned the injunction constrained the District Court.  Its conclusion that research is ambiguous in the context of the Dickey-Wicker Amendment can be overturned by a higher court, but not a lower court.  The Court of Appeals opinion also removed the question of deference to agency actions (whether the National Institutes of Health/NIH acted in good faith) from District Court consideration by deciding deference was due.  As a result, any of Plaintiffs arguments on how Dickey-Wicker should be interpreted fail in the eyes of the District Court.

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State Department Appoints New Science and Technology Adviser (Finally)

On Friday, the State Department appointed E. William Colglazier, long-time Executive Officer at the National Academies, as the newest Science and Technology Adviser to the Secretary of State (H/T ScienceInsider).  He’ll be the fourth person to hold the position.  His academic experience is in physics (the first physicist to hold this position), and in 20 years at the National Academies he directed the Office of International Affairs before serving as Executive Officer and Chief Operating Officer.

As a National Academies report in 1999 encouraged the creation of this position, it was probably just a matter of time before an Academies leader took a turn in the job.  The position has been unfilled for over a year, which is sadly consistent with the Obama Administration’s (in)ability to fill science and technology positions.

Arguably it is this position, alone within the U.S. government, that hews closest to the U.K. Chief Scientific Advisers appointed for each major ministry.  The chief scientist and chief technologist positions in U.S. government are typically filled with civil servants, though not always.

I’m pleased to see the State Department position filled, and hope that the science envoys program may see a jolt of activity once Dr. Colglazier gets settled into the new job.

Science and Technology Guests on Late Night, Week of July 25

Once again, The Daily Show does not have its full week lineup available (nothing announced for Thursday right now), so there may be a late addition.

Tonight one of the hosts of the U.S. edition of Top Gear, Rutledge Wood, will appear on Jimmy Kimmel Live.  I’m cautiously optimistic some car technology will be discussed, especially since Wood is considered the ‘expert’ on the show.  However, the best science and technology content tonight will come from Brian Cox – the British scientist (not the British actor).  His series, Wonders of the Universe, will start on The Science Channel this Wednesday, and Cox will speak with Stephen Colbert tonight.  The Colbert Report will have Missy Cummings, Director of the Humans and Automation Lab at MIT, on Wednesday night.