Third PCAST Report Advises on Next Pandemic

The first report by the current incarnation of the President’s Council of Advisers on Science and Technology (PCAST) focused on preparations for the recent H1N1 virus.  It makes sense that PCAST would revisit the topic for a post-epidemic analysis.  The report was released last week, in connection with a medical countermeasures report from the Department of Health and Human Services.  You can watch the release event for that report online.

The process of producing enough vaccine for potential need during the pandemic was months slower than it needed to be.  In an effort to cut that gap, PCAST makes several recommendations for the U.S. to improve its vaccine production and distribution system.  They include the following:

Short-term

  • Surveillance: Accelerate identification of newly emerging pandemic viruses, so vaccine production can start sooner.
  • Seed viruses: Develop a collection of stock viral “backbones” to allow faster production of specific vaccine strains.
  • Sterility tests: Develop better and faster tests to ensure sterility during vaccines production.
  • Potency-test reagents: Develop faster and more reliable tests to document vaccine potency.
  • Fill-and-finish: Enlarge capacity and modernize machinery used in final stages of vaccine production, including vial-filling.

Long-term Continue reading

The July PCAST Meeting – Science With an International Flavor

The President’s Council of Advisors on Science and Technology (PCAST) held its sixth meeting of the last 12 months in July.  Attendance continues to be high, with only one member unable to attend this meeting.  As usual, the agenda and webcast of the meeting are available online.  PCAST has been busy, with six meetings of the full Council and several meetings of the 10 working groups.  It works out to an average of several meetings a month.

Continuing the trend of having heads of Cabinet departments and other federal agencies brief the group, Patrick Gallagher, Director of the National Institute of Standards and Technology, appeared.  After reviewing the status of his agency, Gallagher described NIST’s ongoing reorganization.  During the question period, Gallagher was pressed on whether or not NIST should take on a forensic science facility (he deferred to the Department of Justice).  The other major theme of his discussion was advanced manufacturing.

I’ve written several times about the science envoys, senior scientists who have traveled abroad representing the United States.  Each of the three envoys I’ve posted about – Bruce Alberts, Elias Zerhouni, and Ahmed Zewail, spoke before PCAST (Zewail is also a member).  I’ll refer you to previous posts about their trips and emphasize some of the recommendations they had.  They noted that other governments are active in international collaborations and partnerships with the same areas of the world they visited (Indonesia, the Middle East and North Africa).  Unfortunately, there are still cultural challenges in the U.S. foreign service that do not make science and technology an integral part of their work.

The public comments were notable for the heavy emphasis on space policy, as I noted the day of the meeting.  PCAST committee reports suggest that at least one, if not two reports, will be released by the end of the year (a separate one was released last week, so that number is probably low).  A Health Information Technology report is nearly ready for release, and a science, education, mathematics and technology education report should be reviewed by the full Council at the September meeting.

Nature Publishing Group and the University of California Call a Cease-Fire

Earlier this summer the California Digital Library (CDL) (responsible for the University of California library system) was faced with a serious increase in its subscription costs for journals from the Nature Publishing Group (NPG).  Given the difficult budget environment for the university system and the state, the CDL opted to propose a boycott.  The response of the NPG was to hold firm.

It would appear that while there’s not a resolution, there appears to be a pause in tensions.  The two sides met last week and issued a statement.  At the moment, it’s only available on the Nature News blog.  The key paragraph:

“Representatives from the University of California and Nature Publishing Group met on August 17, 2010 to discuss our organizations’ current licensing challenges and the larger issues of scholarly communication sustainability. The discussion was positive, with a full exchange of views and mutual recognition of the value that each of us contributes to the scholarly communication enterprise. Our two organizations have agreed to work together in the coming months to address our mutual short- and long-term challenges, including an exploration of potential new approaches and evolving publishing models. We look forward to a successful planning and experimentation process that results in mutual agreement that serves all stakeholder groups-NPG, the UC libraries, and the scholar community, thus avoiding the need for the boycott that had been discussed at an earlier stage.”

While the results of these discussions/negotiations will no doubt have impacts beyond NPG and the CDL, they are the only ones at the table right now.  Note that the statement says the boycott will not happen at the present time, but it remains on the table.  With no deadline connected to the initial boycott letter, it seems the smart play for now.

What’s Next After the Stem Cell Injunction

Here are some updates on the fallout from Monday’s injuction against the new stem cell guidelines from the National Institutes of Health (NIH).

The Department of Justice will appeal the ruling, most likely this week (H/T Nature News).  The same article notes that Senator Tom Harkin stated that he would look into legislation on the matter after the current Congressional recess ends.

As a reminder that federal policy is targeted at funding for this research, rather than the research directly (something which gets lost in this coverage), NIH Director Collins outlined the immediate consequences for those grants that have been issued under the guidelines.  Money that has already been released will not be affected.  Pending applications are suspended, and renewals or subsequent payments are on hold for the immediate future.  This affects 82 grants that are either in review or pending review.

Adding to the information Jonathan Moreno gathered on adult stem cell research funding, juniorprof has some additional information (scroll to Update II) that suggests the competitive threat posed by embryonic stem cell research is dubious.

The New York Times (via juniorprof) has additional information on the two scientists who were granted standing to contest the matter.  It would seem that their personal objections to the policy seem to be the driving force behind their objections, more than the thin claims of increased competition.  Now they’re entitled to their objections, but it appears that their claims of standing could be decent targets for an appeal.  I’m not saying they’d be successful with respect to this suit, but I’m concerned about a potential precedent for other researchers to sue because agencies decide to start new funding programs (or close others).

The Newest Superbug Laughs at Your Hand Sanitizer

The Washington Post reports on Clostridium difficile (C. diff for short), a new resistant bacteria that appears to be on the rise as MRSA is on the wane. Like MRSA, C. diff is particularly nasty in hospitals, and the drug-resistant version can bounce back in patients that get antibiotics.  Since the drugs work on other bacteria, it clears the way for C. diff to spread.  Hospitals are working on improving practices to isolate and fight this bacteria, including increasing the use of soap and water.  It turns out that this nasty bug is immune to the charms of hand sanitizer (ETA alcohol-based sanitizers).  (Combine this with the complete ineffectiveness of anti-bacterial sanitizer against viruses, and I have to wonder why people use the stuff.)

I don’t want to regurgitate Laura Ungar’s excellent piece, but it’s worth highlighting an important policy-related point.  There is a push to have hospitals report infection rates for C. diff (presumably along with the raters of other infections).  I would have liked to see a more thorough discussion  of the arguments against such disclosure.  I could see the possibility that the rate of infection is not the most important measure in terms of a hospital’s ability to fight infection, but that’s just a guess on my part.  As regular readers may recognize, I am generally in favor of disclosure and transparency, and perhaps reporting these infection rates can speed along the fight against this new resistant bug.  But medical policy is not one of my policy specialties.  If there’s a good reason against disclosure, I’d love to hear it.

Embryonic Stem Cell Research – Harming the Livelihood of Adult Stem Cell Researchers

Today’s evidence that the courts run on different rules and norms than scientific communities comes from the preliminary injunction issued yesterday.  The injunction stops funding of embryonic stem cell research by the National Institutes of Health (NIH).  While I did work as a legal assistant, I am not a lawyer (IANAL).  Please read the following with that in mind.

The case was initially filed by several plaintiffs, including a couple that was seeking to adopt embryos, and several groups objecting to the NIH policy on the basis of ethical grounds.  The primary legal issue in the case is whether or not the policy runs counter to the law that bans the funding the derivation of human embryos for research purposes (the Dickey-Wicker Amendment).  The argument from the plaintiffs – one that appears to be persuasive to the judge that issued the injunction – is that any embryonic stem cell research necessarily involves the destruction of human embryos and violates the law.

The case was initially dismissed for standing – that none of the plaintiffs had an immediate stake in the matter and could not sue for relief.  However, the Court of Appeals reversed the decision on appeal, ruling that two adult stem cell researchers had standing as competitors.  In other words, because the two researchers in a related field might see more competition for funding if embryonic stem cell research would receive federal funding, they could sue to stop the policy.

(H/T to juniorprofvia DrugMonkey for pointing this out.  It only merited a side reference in The Washington Post)

While there’s an interesting hypothetical raised by this action – would the Bush Administration guidelines have held up under the same kind of scrutiny by the same judge – the standing of the two plaintiffs raises a serious question.  Is it OK for researchers to sue the government if its supports competing fields or adjust its policies in such a way that would give the plaintiffs a competitive disadvantage?

Continue reading

19 Months and Still S&T Appointment Vacancies

While the Obama Administration got off to a great start with its science and technology appointments, it has stumbled in getting the second-tier science and technology positions filled.  While the inability of Congress to do its job has something to do with this, it’s been a challenge to find people all the same.

The latest round of recess appointments includes the nominee for the Under Secretary for Food Safety at the Agriculture Department, Elisabeth Hagen.  The position has been open for 18 months.  Hagen is currently the Department’s Chief Medical Officer, and has also worked in the USDA’s Food Safety Inspection Service.  Her background is in medicine, however, and not the consumer safety background considered typical for the position.  But with a growing salmonella outbreak affecting eggs, it would be good to have someone in the position rather than an empty chair.

The empty chair worth noting, particularly with the rulemaking in progress on conflicts of interest policies at the National Institutes of Health, is at the Office of Research IntegrityThe Scientist passes word that there has been no Director of the office since March of 2009.  This position requires no Senate confirmation.  A search is supposedly underway, but no timeline for a selection has been announced.

Science and Technology Guests on Late Night, Week of August 23

Late summer reruns continue…the network show that’s not in repeats this week is The Late Show with David Letterman (though it will be repeating on Friday, as it has much of the summer).  However, there are no science and technology guests on Dave this week.

The place to watch this week is The Colbert Report.  Heidi Cullen, a climatologist with Climate Central, and formerly with the Weather Channel, will promote her book with Stephen on Wednesday.  On Monday science writer Leslie Kean will be on discussing her book about U.F.O. research.

Lessons on Research In the Wake of Disaster

I’ve written before about Mt. St. Helens, in part due to having lived in Washington State during the mountain’s major activity period of the early 1980s, and in part due to recent debates over who should best manage the area.  The combination of resource, recreation, and research interests in the area surrounding the volcano make it a relatively unique place in the United States.

It was no different in the aftermath of the 1980 eruption that transformed the landscape.  Douglas Larson writes at length in the July-August American Scientist (H/T SciTechDaily) about the stop-and-start, stumbling nature of the research efforts focused on Spirit Lake, a lake just to the northeast of the mountain that was in the path of most destruction for the May 1980 eruption.  While Larson spends much of the piece describing how badly the Army Corps of Engineers was set up to support research in a lake choked with lumber and other debris, it’s a careful exploration of how research of a disaster area is very low on the priority list for agencies that aren’t necessarily focused on scientific research.  Reading it makes it a little easier to understand why the big study of oil cleanup workers in the Gulf is a rarity, rather than more common.

(If you’d like a more research-oriented review of Larson’s work at Spirit Lake, look at this 1993 American Scientist article.)

Some Pushback on NIH Conflicts Rules

The deadline for public comment on the National Institutes of Health proposed changes to conflicts of interest disclosure just passedScienceInsider has collected some of the comments submitted to date – that were also released by the commentators – and summarized some of the reactions.  Comments should be available on the NIH website sometime in the next week or so.

If they can be summarized, the best way to describe the responses is a general concern that the proposal is too broad.  Groups like the American Association of Medical Colleges think the requirements on income reporting go too far, and would like to see income not associated with research excluded from reporting requirements.  Personally, I’m in favor of expanding the income reporting requirements to include non-profit and academic teaching hospitals.  Unless it can be demonstrated that conflicts can only be found with for-profit interests, I’m not persuaded that non-profits should be exempted.

There is also the request that conflicts not be posted online to the institution’s website, but to a central database.  The argument is that the costs involved are prohibitive.  I think the posted conflicts need to be in a place where the most people are going to see them.  While I think it likely that people are more likely to go to the university’s website before the NIH in cases of clinical trials and related activities, I may be wrong on this point.

Disappointingly, the comments noted were mixed on the requirement that the sanctions for failing to report would travel with an individual to the following institution.  Charles Nemeroff appears to have exploited the current practice by leaving Emory University for the University of Miami.  He thus avoided his sanctions for failing to report several hundred thousand dollars in payments he received.

It will be some time before the NIH issues a final rule.  While they will take the feedback received for due consideration, I do not expect the agency to narrow the rule in the way some would like to see.