Those Execution Drugs Will Not Go Quietly

Thanks to my wandering about for yesterday’s post, I was reminded about the challenges facing the execution drug supply in the United States.  A few news items worth passing along in this area, where foreign firms are doing their best to restrict or eliminate the importation of drugs into the U.S. that can be used for executions.

Pancuronium bromide, one of the drugs in the three-drug cocktail that many states use for lethal injection, is on the FDA’s current drug shortage list.  (H/T Reprieve, a legal action charity not keen on the death penalty) Unfortunately, I can’t tell how long the drug has been on the list, only that the listing was reverified earlier this month.  As with the other drugs commonly used in executions, the drug is used for other things, which means there is a possibility that other live saving measures may not be taken as states are stockpiling the drug for executions.

Some states are exploring other execution protocols.  For example, the State of Missouri has decided to shift to the anesthetic propofol (also called Diprovan) as a one-drug protocol (H/T Reprieve).  Propofol is also on the drug shortage list, and perhaps the State of Missouri can be credited for one manufacturer’s report of increased demand.

Finally, the Food and Drug Administration (FDA) has managed to get entangled in court action due to how it did or didn’t handle the foreign importation of execution drugs.  Claiming that reviewing substances intended for executions was outside the scope of the agency’s jurisdiction, the FDA still had to decide whether to allow the importation of the drugs.  So they allowed the import of the drugs, but would not judge the quality, reliability or safety of those drugs.  Even those of us not on death row can see the loophole here, which several inmates opted to pursue with a lawsuit (H/T Pharmalot) filed last year.  The complaint alleges several violations of the law by the FDA, mostly around the notion that the FDA should not allow the importation of a drug that they cannot (or will not) judge to be safe and unadulterated.

In March of this year, the judge in the case ruled in favor of the Plaintiffs’ motion for summary judgement (and denied the Defendants’ motion).  Just this month the FDA has filed an appeal of that judgment, prompted in part by several states’ attorneys general who were ordered to return their foreign supplies (usually meaning all of their supplies) of thiopenthal.  They subsequently wrote to the Justice Department to encourage an appeal.  The letter notes that the March decision runs counter to FDA practice to defer to law enforcement where execution drugs are concerned.

With this appeal, the case continues.  Whether the Plaintiffs will all survive to see a final resolution is unclear (three of 24 have been executed so far).

The Congressional Outrage Didn’t Take Long

Not a week after I suspected it would happen, Iowa Senator Charles Grassley expressed his disappointment that Charles Nemeroff can still receive federal grant money.  In a letter to the National Institutes of Health (NIH) (H/T Nature News and Pharmalot), Senator Grassley acknowledges recent changes in NIH conflict of interest guidelines, but is justifiably concerned that Nemeroff’s latest grant sends the wrong signal.  After all, there is still an open Department of Justice investigation on Nemeroff (the Health and Human Services Inspector General has concluded its investigation, but is waiting for the Justice Department before announcing its findings).

“It’s troubling that NIH continues to provide limited federal dollars to individuals who have previously had grant funding suspended for failure to disclose conflicts of interest and even more troubling that the Administration chose not to require full, open, and public disclosure of financial interests on a public website.”

Yes, it is.  Grassley goes on to request several things of NIH, mostly along the lines of who at NIH was aware of the investigation(s) involving Dr. Nemeroff, including those who reviewed the grant.  He finishes by asking what guidance NIH has for grant applications submitted by convicted felons.  Whether this is wishful thinking on behalf of Senator Grassley, or a hinting at something coming out in the investigation, I don’t know (both could be possible).

But the Senator’s question about peer reviewers knowing about open investigations on grant applicants intrigues me.  I suspect many would object to the peer review process being a place for weighing in on ethical and/or criminal investigations.  But it seems reasonable to prevent or put on hold applications from those who have pending investigations related to scientific research.  We’ll see what the NIH thinks about that when it responds to the letter.

Italian Earthquake Focus Shifts North; What Influence Does L’Aquila Quake Have?

The Emilia Romagna region of northern Italy has been rocked by quakes, with a 6.0 magnitude quake on May 20, a 5.8 magnitude quake earlier today, and hundreds of aftershocks in between.  By some accounts, this is the first significant seismic activity in this part of Italy in over four centuries.  While the death toll is, thankfully, much lower than that of the 2009 L’Aquila quake, the economic costs could be comparable or higher, thanks to the presence of heavy manufacturing and agricultural activity in the region (the region is home to sports cars and cheese, among other high-value goods).

I mention this in part because of some of the consequences of the 2009 L’Aquila quake.  Not only have reconstruction efforts progressed slowly, but there is a manslaughter case against several scientists based on their recommendations on the severity of quake activity in the region prior to the April 2009 quake.  I have not seen any indications that the same thing occurred here, but I can’t help but wonder if this item from The Guardian‘s coverage was influenced by the L’Aquila quake.

“Residents were told by experts that there was no telling when the spate of earthquakes would subside.

“‘It is likely they could continue for years,’ said Giuliano Panza, professor of seismology at the University of Trieste.”

The quake today occurred on a separate fault from the May 20 quake, and at the moment there are over 14,000 homeless and more than 20 dead.  By comparison, over 300 died in the single L’Aquila quake and over 60,000 made homeless.  It’s not clear that Italy has changed its seismic preparation practices in the light of the L’Aquila quake, I hope that will change.

Please consider donating to the relief organization of your choice (but do be on the lookout for the inevitable scams).

Science and Technology Guests on Late Night, Week of May 29

Much like Congress, most of the late night programs are in repeats this week.  Unfortunately, none of the repeats offer science or technology guests for you to revisit.

Of the few new programs this week, you can catch Jim Parsons, who plays a physicist on The Big Bang Theory, on several programs (Live with Kelly on Monday, The Daily Show on Thursday).  On Thursday, author Jack Hitt will appear with Stephen Colbert to discuss his new book on tinkerers in America.

If you are seeking some science and technology content, the film Hysteria is opening in more theaters in the U.S. and is getting reasonably positive reviews.  They rarely mention the technology content, but that’s to be expected.

Argentina and Egypt Set Markers For Science Policy

Two short items of note, courtesy of Nature, about science policy outside of this blog’s usual haunts.

The lower house of the Argentinian legislature has approved a bill (en Español) that would require research results funded by the government be placed in institutional repositories once published.  There would be exceptions for studies involving confidential information and the law is not intended to undercut intellectual property or patent rights connected to research.  Additionally, primary research data must be published within 5 years of their collection.  This last point would, as far as I can tell, would be new ground for national open access policies, depending on how quickly the U.S. and U.K. may act on this issue.  Additionally, there should be an announcement from the European Union on open access requirements for its Horizon 2020 program (what would have been Framework Programme 8).  The expectation is that open access will be highly incentivized for research receiving Horizon funding.

The Argentinian law still needs to be approved by the upper legislative chamber and the executive branch.

Nature’s Middle East website has this commentary from Mohamed Abdel-Mottaleb, director of the nanotechnology research center at Nile University, and a recent candidate in the 2012 Egyptian Parliamentary elections.  In it he complains that the Supreme Council for Science and Technology has not been particularly effective in influencing policy during the two years it has been in existence.  He describes the Council as having a “brief…to provide the government with sound scientific advice and to inform policymakers” but he wants the Council to serve a more active role:

“But despite having existed for at least two years, the council’s effectiveness at influencing policy is still unclear. It has managed to communicate the government’s needs to scientists, but failed to engage scientists in decisions leading to the creation of policy. The council has created a top down effect. As it currently stands, different ministries, such as industry, agriculture and water resources, indicate their needs to the ministry of scientific research. The ministry, in turn, offers funding grants for potential research to meet these needs.”

While the general thrust is similar to the urges of many to see scientists helping make policy, Abdel-Mottaleb seems focused on developing research agendas connected to national goals rather than implying that scientific evidence leads to particular policy choices.

“Such a crude approach [how the research ministry crafts research calls] – with no clear technical specifications provided nor a roadmap for applications – is short-sighted. Such issues must be addressed in future calls for proposals.

NASA Updates Moon Visit Guidelines; X Prize Foundation Publicly Likes Them

WIRED Science has reported that the X Prize Foundation has offered its support to NASA’s guidelines for visiting historic sites on the moon (NASA press release).  With 26 teams trying to visit the moon (and receiving bonuses for visiting historic sites), it’s a good sign that the landing sites of the various American missions that visited will remain relatively intact.  The guidelines discuss safe distances for both landings and robotic visits.  The guidelines cover not only the Apollo missions, but unmanned landings and impacts from other U.S. missions.  While the guidelines note the existence of various Soviet landing sites and hardware, NASA has no authority (it certainly claims none) to extend its guidelines to non-U.S. sites and material.

The NASA guidelines have been updated since I posted about them earlier this year, mainly to include additional photos and information on equipment that would likely be at the various landing sites.  Apparently I managed to stumble onto something way before it was publicly available.  Good on me?

There’s This Open Access Petition At We The People

I’m still mildly bemused that the expansion of open access seems to have found some traction, or at least many more vocal proponents, over the last few months.  Such enthusiasm has been met by actions in the U.K., internationally, and by many universities and funding groups to increase the incentives to publish scientific research under various forms of open access publishing.

Now we have a petition on the We The People portion of the White House website.  The full text (there’s a limit of 800 characters, vagueness of goals and realism of promises is not necessarily an indication of intent):

“Require free access over the Internet to scientific journal articles arising from taxpayer-funded research.

“We believe in the power of the Internet to foster innovation, research, and education. Requiring the published results of taxpayer-funded research to be posted on the Internet in human and machine readable form would provide access to patients and caregivers, students and their teachers, researchers, entrepreneurs, and other taxpayers who paid for the research. Expanding access would speed the research process and increase the return on our investment in scientific research.

“The highly successful Public Access Policy of the National Institutes of Health proves that this can be done without disrupting the research process, and we urge President Obama to act now to implement open access policies for all federal agencies that fund scientific research.”

Uploaded to the petition site on May 13, the petition hit the publicly searchable threshold this past weekend, and thanks to a concerted effort to publicize the petition, there are now over 17,000 signatures as of late on May 25.  The petition will need 25,000 signatures by June 19 in order to get a response from the Administration.  If the publicity keeps up, I suspect the goal will be met.

A Rare Fast Science and Technology Appointment

Not that it means there will be a quick confirmation, but the Obama Administration announced that it will nominate Allison Mcfarlane to become Chair of the Nuclear Regulatory Commission (NRC).  Mcfarlane is currently an Associate Professor of Environmental Science and Policy at George Mason University.  She will replace Gregory Jaczko, who has served on the NRC since 2005, and has been chair since 2009.

Jaczko’s departure, while sudden, is arguably not unexpected.  As this New York Times article notes, Jaczko has drawn a number of complaints during his tenure, including an incredibly rare letter to Congress from the four other Commissioners at the agency complaining of his management.  It would be surprising if this departure (and the recruitment of Macfarlane) hasn’t been in the works for months.  Even though there is a pending nomination of a Republican Commissioner (most federal commissions have a 3-2 split of commissioners by party, which means these days that nominations stand a chance of advancing if they move forward in dual-partisan pairs), I have little faith in the Senate to act quickly.

In other appointment news, Arun Majumdar, the first director of the Advanced Research Projects Agency – Energy (ARPA-E) will step down next month.  As his nomination as Undersecretary at the Department of Energy was effectively killed, this departure is understandable.  ARPA-E and other direct technology support from the Department of Energy has been a consistent target of skepticism in Congress from those who think the federal government has no business supporting anything besides basic research (usually out of concern for crowding out private capital).

On the Pointless Exercise of a U.S. Science Debate

Undeterred by the utter unlikelihood of actually having a debate, the ScienceDebate folks are wrapping up their question selection process as I type.  Before any official announcement, the best indication of what might be chosen can be found in a the submitted questions online.

In an apparently parallel process, Scientific American has announced its selections for science debate questions.  They broke down the submitted questions into three categories: Science Education, Evolution and Climate Change.  Assuming that there could be a debate focused on science related topics, I suggest that the last two categories are too colored by political fights that no longer care much about the relevant science to be of use in a science debate.  Perhaps if those with a dog in this fight would be willing to hitch their science concerns to an education debate, there may be an opportunity.  Maybe.  Until those who want science on the debate agenda target the Commission, this all seems to Sisyphean to me.

Ethically Challenged Psychiatrist Gets NIH Grant

If I had a list of favorite targets on this blog, Charles Nemeroff is near the top.  Click on his name to get a longer version of the following summary.

Nemeroff failed to report several hundred thousand dollars of speaking and consulting fees he received (total figures range from $800,000 to $1.2 million), as well as payments made to other psychiatrists.  This failure to disclose a possible conflict of interest is a serious ethical problem.  The National Institutes of Health (NIH) grant Nemeroff had at the time was pulled, and his then-institution, Emory University, banned him from applying for funding for 2 years.  Nemeroff soon decamped for the University of Miami, possibly with an assurance from senior NIH staff that Nemeroff would be able to receive funding.  Slaps on the wrist all around.

Yes, I realize I am a hard-ass about this kind of thing, possibly unproductively so.  But with graphics and articles charting bad science, or un-replicable science, on the rise, scientists need to do better in resembling the high ideals of the profession and practice that are foundational to the trust placed in scientifically generated knowledge.  Incentives need to change so that the kind of conduct highlighted here and in those articles and graphics is dissuaded, not begrudgingly accepted.  Nemeroff doesn’t seem to have learned his lesson.  He didn’t lose anything from his bad conduct.

Per ScienceInsider and the NIH RePORTER database, Nemeroff has returned to the land of the grant-holders.  As of last week, he now manages a standard 5-year R01 grant, dealing with post-traumatic stress disorder.

While the ban from Emory would have expired prior to applying for this grant, I think the failure to disclose over a million dollars worth of payments that give the appearance of bias for Nemeroff and others deserved a bigger sanction.  I would be surprised if Senator Grassley doesn’t raise a stink about this, as he was involved in a 2007 Senate investigation connected to Dr. Nemeroff.

Sadly, it seems that Nemeroff’s failure to understand (or perhaps he understands all too well) the appearance of conflicts of interest has been forgotten by more than just the University of Miami and NIH.  Last month The Scientist reported that a petition was circulating protesting Dr. Nemeroff’s appointment to the Board of the Anxiety Disorders Association of America (recently renamed the Anxiety and Depression Association of America).  The protest, if it attracted any attention at all, did not prompt the association to rescind the appointment.

Whatever happens, I continue to recommend that prospective psychiatry students stay far, far away from Nemeroff’s institution, the University of Miami.