On November 22, the President’s Council of Advisers on Science and Technology issued a letter report on cybersecurity. It is concerned with providing cybersecurity in a frequently changing threat environment. As the overarching recommendation reads:
Cybersecurity will not be achieved by a collection of static precautions that, if taken by Government and industry organizations, will make them secure. Rather, it requires a set of processes that continuously couple information about an evolving threat to defensive reactions and responses.
The other recommendations address government’s own information technology practices, information sharing across the private sector and the government, and auditing cybersecurity practices in the private sector. This report follows up on a Feburary 2013 classified briefing provided by PCAST, so the recommendations are perhaps more for public consumption at this point
Also of note are two new faces on PCAST. Ernest Moniz had to step down when he became Secretary of Energy, and David Shaw and Ahmed Zewail are no longer on the Council. The new members recently appointed by the President to replace them are Susan Graham, an emerita professor of electrical engineering and computer science at the University of California, Berkeley; and Michale McQuade, vice president at United Technologies Corporation. McQuade has also worked for 3M and Eastman Kodak and has a physics background.
The Environmental Protection Agency announced yesterday that it has appointed Francesca Grifo as the agency’s Scientific Integrity Official (SIO) (H/T ScienceInsider). This position is required by the agency’s scientific integrity policy, last updated in early 2012. There have been two interim SIOs since the policy was last updated, and the office is still engaged in implementing employee training and other programs to help make sure EPA staff are aware of the policy and its requirements. This Office of the Inspector General (OIG) Report from August 2013 indicates that the office has been focused on getting things operational, but perhaps not as quickly as the OIG (or even the Administrator) might want.
Grifo comes to the job from the Union of Concerned Scientists (UCS), and scientific integrity policies were a notable part of her work there. She begins her EPA work at the same time as the Scientific Integrity Office has released its first employee training module on the scientific integrity policy.
It will be interesting to see what happens at Grifo’s former employer once the agency makes a decision that UCS feels didn’t follow what it considers to be sound science. Trust me, it will happen.
That said, I think it worth reposting part of the UCS blog post connected with Grifo’s departure. Continue reading
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.
The Departure of former Energy Secretary Steven Chu earlier this year was one of several departures from the Energy Department, primarily amongst science and technology positions. While we have a new Energy Secretary and a nominee for the Advanced Research Projects Administration – Energy, there are still two positions currently unfilled.
One is the Director of the Office of Science, which has been empty since William Brinkman left in April of this year. Marc Kastner, a physicist involved in semiconductor research at MIT, will be nominated to take over the office, which supervises the agency’s research portfolio and its research labs. He would take leave from the institution where he serves as Dean of the School of Science (and where Secretary Moniz directed the Laboratory for Energy and Environment before re-joining the Department).
The Undersecretary of Science position has been vacant for over two years. The President will nominate Franklin Orr to the position, which is responsible for the Office of Science along with the Department’s programs in education and training, research and development, and functions as the Secretary’s science and technology adviser. Orr is a chemical engineer at Stanford, where he directs the Precourt Institute for Energy.
There’s a draft resolution at the United Nations General Assembly concerning space (reports indicate it may have been approved, but I cannot find a final version on the UN website as of this posting). This isn’t unusual, as the U.N. Committee on the Peaceful Uses of Outer Space (COPUOS) has been around almost as long as the U.N. itself. What a lot of writers picked up on is in paragraph 8:
“Welcomes with satisfaction the recommendations for an international response to the near-Earth object impact threat, endorsed by the Scientific and Technical Subcommittee at its fiftieth session and endorsed by the Committee at its fifty-sixth session;”
The recommendations by the committee were augmented by a recent presentation
at the Association of Space Explorers. Members of the B612 Foundation were out in force at the presentation, but it’s too early to say whether or not its Sentinel mission
will play a part in a U.N. effort to coordinate asteroid detection and deflection efforts.
Details on what these coordination efforts might look at can be found in the Scientific and Technical Committee’s latest report to COPOUS
, specifically Section X starting on page 29 and Annex III starting on page 45. The main recommendations are to develop two groups – an international warning network (which might have the components outlined in this presentation
from February) and a space mission planning group. The recommendations reflect the end of a six-year process by the Working Group on Near-Earth Objects
, but the United Nations has been active on the matter of near-Earth objects since 1995
In the November 8 edition of Science Dr. Takashi Kadowaki, Director of the University of Tokyo Hospital, writes about the efforts to establish a new medical science agency in Japan. Dr. Kadowaki is also Director of the Translational Research Initiative at the University.
The agency would model itself after the National Institutes of Health (NIH) and serve as a major component of Prime MInister Abe’s strategy for health and medical research. Even though this strategy reflects a concerted effort to increase health and medical research in Japan, the total budget for this new agency is less than one tenth of the U.S. NIH budget.
The overall research and development budget will not change, meaning that other areas of research will likely face budget cuts. Dr. Kadowaki is concerned that other fields of life science could suffer in this new budget environment, something he considers counterproductive to improving the ability of Japan to translate biomedical research to clinical and pharmaceutical applications.
Another aspect of this new agency is that its strategy arm will be headed by the Prime Minister. While this level of political ownership is unprecedented – certainly in the United States – I can identify at least two downsides. One is the possibility of political micromanagement. The strategy arm of the new agency is separate for an incorporated entity charged with disbursing research funds. Hopefully that can serve to mitigate the risks of micromanagement (and conflicts of interest). Another concern is that this reform effort may stand a decreased chance of surviving after the Prime Minister steps down. (No, he’s not likely to step down any time soon, but he won’t be in the office forever.) Initiatives strongly identified with a particular politician often fall out of favor once the politician falls out of power, and it’s tough to be more strongly identified with a reform effort if that person is in charge of one large part of it.
Dr. Kadowaki’s column suggests the conversation around what the Japanese version of NIH will be is just beginning. I wish Japan all the luck in what seems a daunting task of administrative renewal and reform.
Since the last round of science and technology nominations I noted in early August, there have been two new nominations. No confirmations, which suggest the new nominees will become old nominees before they become new confirmees.
One new nominee is for a position that has been unfilled for over 18 months: Director of the Advanced Research Projects Agency – Energy. Ellen Williams will remain on leave from the University of Maryland, where she is a University Distinguished Professor of Physics. Her work has been in materials science, and her Ph.D. is in Chemistry.
She’s already on leave because she has been the Chief Scientist for BP (yes, *that* BP) since 2010. (How long the University will allow her to remain on leave may influence the length of her tenure should she be confirmed.)
Also of note is the nomination of Rhea Suh as the Assistant Secretary for Fish and Wildlife and Parks at the Department of Interior. I find it of note because I was not aware of this position, which coordinates policies between the Fish and Wildlife Service and the National Parks Service. Given what I’ve read about the current and previous occupants of the position (both of whom were involved in other tasks and/or held additional positions), it seems likely that the job is not meant to be too involved in day-to-day activities of either agency.
Again, confirmations remain a contentious issue for the current Congress and Administration. As other (higher) profile positions remain subject to holds and delaying tactics, I don’t expect these lower tier positions to be confirmed quickly.
Breaking with recent patterns, the next public meeting of the President’s Council of Advisers on Science and Technology (PCAST) is scheduled for a Thursday. The Council will meet in Washington on November 21, in an even briefer than normal half-day session. As usual, there will be a live webcast, which will be archived shortly after the meeting. Visit the webcasts page on November 21 to catch the meeting starting at 9 a.m. Eastern.
If the current agenda (effective November 4) is suggestive, PCAST may have two reports to release very soon. The meeting will cover a letter report (typically fewer than 10 pages) on Education Information Technology, and a lengthier report on Cybersecurity.
The wild card (at least for me) is the session on Privacy and Technology with Nicole Wong. While her official title may be Deputy Chief Technology Officer, she is considered the first Chief Privacy Officer in the White House. I suspect this may be where PCAST members get engaged with surveillance matters, if they haven’t already done so in a more private setting. But that’s just a guess.
The Consortium of Social Science Associations held its Annual Colloquium on Social And Behavioral Sciences and Public Policy earlier this week. Amongst the speakers was Acting National Science Foundation (NSF) Director Cora Marrett.* As part of her remarks, she addressed how the Foundation was implementing the Coburn Amendment, which added additional criteria to funding political science research projects through NSF.
The first batch of reviews subject to these new requirements tookplace in early 2013. In addition to the usual criteria of intellectual merit and broader impacts, the reviewers looked at the ‘most meritorious’ proposals and examined how they contribute to economic development and/or national security. For the reviews scheduled for early 2014, all three ‘criteria’ will be reviewed at once.
Since researchers don’t like to be told what to do, they aren’t happy. But Marrett asserts through her remarks that this additional review will not really affect the outcomes of the program. From Jeffrey Mervis’ reporting in the Science piece, the research community doesn’t think so, and I suspect Senator Coburn (if he pays attention) wouldn’t be happy to see no change based on his new requirements.
I’ve been posting irregularly about shortages in the production of drugs and other critical elements. But I’ve barely scratched the surface of the drug shortages. The Food and Drug Administration (FDA) is starting to take steps required by a recent federal law to try and get a better handling on drug shortages as they appear (H/T Scientific American).
In Monday’s Federal Register there is a notice of a proposed rulemaking and request for comments from the FDA on changes in reporting on drug shortages. Prompted by the 2012 Food and Drug Administration Safety and Innovation Act, companies will now be required to report six months in advance of discontinuing production or a shortage of production of certain drugs. The FDA will also maintain a list of drugs under shortage conditions.
Much of these actions are putting into law and regulation guidance advanced in a 2011 Executive Order. The rule would require a minimum of 6 months notice, with rare exception. Failure to provide notice would prompt a public noncompliance letter, and the rule would give specifics both to the letter and the notice that companies must provide to the FDA.
The agency is persuaded that better information exchange between manufacturers and the FDA could further mitigate shortages. From the notice:
“Working closely with manufacturers and other stakeholders, FDA was able to help prevent just under 200 drug and biological product shortages in 2011 and more than 280 such shortages in 2012, using tools such as:
“Working with manufacturers to resolve manufacturing and quality issues contributing to short supply.
- Expediting FDA inspections and reviews of submissions from manufacturers to prevent and/or alleviate shortages.
- Identifying and working with manufacturers willing to initiate or increase production to cover expected gaps in supply.
- Exercising enforcement discretion in appropriate circumstances, if this would not cause undue risk to patients.”
An important change is that the proposed rule would require notice for marketers of certain compounds regardless of whether they hold an approved application from the FDA. IANAL, but I wonder if this might be a means of exerting a bit more control over compounding pharmacies, which are not presently under FDA regulatory control. (It is arguably a big stretch to suggest it might allow control of these pharmacies over drugs made for execution purposes.)
Comments will be open for roughly 60 days, closing on January 4, 2014.