What’s With NASGOF2 and House Ferret?

NASGOF2IsComing

If you’ve been watching my Twitter account, you’ve undoubtedly seen my parody of Game of Thrones over the last week: NASGOF2 is Coming/NASEM. And if you’re a Game of Thrones fan who works in or around gain-of-function/dual-use research of concern, then you likely giggled and nodded and probably planned to if not be at today’s meeting, at least watch it live on the internets.

If you’re a dual use person who isn’t familiar with Game of Thrones, I can’t help you–I don’t watch the show, either. All I know are the memes from the first season’s “Winter is Coming” advertisements, and I happen to both have Photoshop and be married to a fan of the show who is also one of the dual use experts. So when he offered his suggestion (instead of what I was working on), I jumped.

What was this remarkably funny suggestion? The profile of a ferret, because ferrets are what started this all.[note]Ron Fouchier and Yoshi Kawaoka published a series of experiments passing H5N1 through ferrets, ultimately making it very, very transmissable and very, very deadly. While DURC/GOF studies have been going on for a long time–Ramshaw’s mousepox is probably the most famous–this whole brouhaha can really be traced back to 2011/2012. You can read the start of it here.[/note] And because we’re talking the flu, naturally, the ferret is licking it’s sniffly nose (a detail I added and I’m grateful at least one person noticed and laughed about–oddly, not the husband).

So today, the ferrets have come home to do whatever the ferret equivalence of “roost” is, and the summary of a lot of hard work, arguing, publications, and general debate will be presented in front of a divided group of people. And me. I’ll be there with my gifs and giggles, rolling my eyes at the entire process and wondering if it’d help if I just made everyone read All I Really Need to Know I Learned in Kindergarten.


June: National Ship Live Anthrax Month!

ff_anthrax_fbi4_fOkay, I know we’re a bit ahead of June, but we’re within shipping for June, right? And at this point, a rather concerning pattern of “shipping live anthrax” is developing.

Yep! It’s that time again! Er, yet another mishap involving a lab sending a viable select agent to someone who shouldn’t have it. Er, someones. In this case, an unknown number of private commercial labs in nine states. NINE! And that would be alarming in and of itself, without that whole one year ago gift that keeps on giving. Or the previous Oakland Children’s Hospital incident in 2004.

Well. I guess in defense of the CDC, who owns the previous mishaps, this was a Department of Defense lab “mishap.”

Skeptical Scully

Very seriously, it appears there’s an issue here beyond “oh oops, culture of carelessness” – we have three clear and separate incidents of live anthrax being shipped out to people who should not have live anthrax:

    2004 – Oakland Children’s Hospital (should have received inactivated anthrax from the CDC; never did figure out what they were doing with anthrax)
    2014 – Three in-house CDC labs (should have received inactivated anthrax)
    2015 – Unknown number of private, commercial labs (should have received inactivated anthrax for “field-based testing to identify biological threats in the environment”)

Can we perhaps maybe finally agree that we have a massive problem with research laboratories, select agents, and oh, I dunno, what’s the word I want? Culture? Accountability?

Oh right!

Safety.


Last night, after I was entirely too tired to edit this post, it came out that not only were multiple labs in nine U.S. states–California, Delaware, Maryland, New Jersey, New York, Tennessee, Texas, Virginia and Wisconsin–and South Korea. Osan Air Base, which is an American military base, but still. A statement from the base says up to 22 people in a training laboratory were exposed: Five active duty Air Force members, 10 active duty Army members, three civilian officials and four contractors, all of whom are now receiving prophylactic treatment. -KH, 28 May 2015

Ziploc: There’s No Better Way to Protect Your Select Agent Investment

A lot of interesting testimony came out of yesterday’s House Energy and Commerce Oversight and Investigations Subcommittee hearing, which was titled “Review of CDC Anthrax Lab Incident,” but broadly covered the numerous slapstick-‘cept-it-ain’t-funny errors around dangerous pathogens research at the Centers for Disease Control and Prevention.

I don't know about you, but I feel safer already.

I don’t know about you, but I feel safer already.

For those just joining the conversation, these hilarious mishaps have included leaving activated anthrax in unlocked, unsecured refrigerators; mixing high pathogenicity avian influenza with low pathogenicity avian influenza and then shipping it over to the US Department of Agriculture in the worst version of novelty surprise in a can ever; and using ziploc bags to transport petri dishes between labs. And as an added bonus, there was some discussion about the broader issues of the proliferation of biosafety laboratories working on select agents.

In particular, the statement of Nancy Kingsbury, PhD, the Managing Director, Applied Research and Methods, at the Government Accountability office, is worth a read. The statement pulls no punches, saying:

No federal entity is responsible for strategic planning and oversight of high-containment laboratories. … No one agency is responsible for determining the aggregate or cumulative risks associated with the continued expansion of high-containment laboratories; according to experts and federal officials GAO interviewed for prior work, the oversight of these laboratories is fragmented and largely self-policing.

In fact, since 2001, the proliferation of biosafety laboratories has resulted in nearly 1500 laboratories in the United States alone that handle and do research on dangerous pathogens.

If only there were some sort of national advisory board for biosecuri-oh wait!

Except, as has already been noted, the NSABB hasn’t met in nearly two years. But that’s okay, you see; the current chair of the NSABB1 wants you to know that this is intentional! Samuel L. Stanley Jr., MD, says that the NSABB has “been waiting essentially for the new federal guidelines to come out on institutional implementation of DURC policy. We wanted to have a look at what the federal agencies would come up with.”2

PicardOneJob-200One job.

You guys had one job.

Well, wait. Okay. This can easily be clarified by looking at the NSABB charter, which was recently revised, so clearly it is timely and up-to-date and will clarif-

The NSABB will provide advice on and recommend specific strategies for the efficient and effective oversight of federally conducted or supported dual use biological research, taking into consideration both national security concerns and the needs of the research community to foster continued rapid progress in public health and agricultural research.3

Damnit.4

In Stanley’s defense, he argues that these recent “issues” at the CDC are surely concerning as a scientist, but they’re really not about dual-use or gain of function research, so they don’t involve the NSABB. It wasn’t, you see, created to be about biosafety.

It’s really such a bitch when the first bulleted item on the list of “description of duties” on your charter contradicts the interviews you give: Recommend strategies and guidance for enhancing personnel reliability among individuals with access to biological select agents and toxins.5

Funny thing. The last time I looked, anthrax sure as hell was a select agent. Oh look! So is H5N1.

Your move, Stanley. I suggest it involve picking up a phone and dialing 11 different numbers.

Remaining Inaugural Members of NSABB Dismissed Last Night

NSABBHowardFineIt’s not exactly been what one would call a banner month for the National Institutes of Health or the Centers for Disease Control and Prevention. In the last week and change, it’s been revealed that oops, the CDC completely screwed up how it handles anthrax and possibly exposed 86-odd people to anthrax and they accidentally shipped out H9N2 that had been contaminated with H5N1. Then, this morning, a study from the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service–a study that the CDC has known about since July 10–revealed such charming details as anthrax being stored in refrigerators in an unrestricted hallway with the key to one sitting in its lock.2 (I hope you weren’t planning on sleeping ever again.) And of course, in case any of that isn’t close enough to a Richard Preston novel, there was the whole “forgetting those vials of smallpox in cold storage” thing with NIH and the Food and Drug Administration.

As a result of all this Three Stooges-esque mishandling of select agents and scary things, the House Energy and Commerce Oversight and Investigations Subcommittee is convening Wednesday to ask Dr. Thomas Friedan, director of the CDC, and friends (like Joseph Henderson, deputy director of the CDC’s Office of Security and Emergency Preparedness; Jere Dick, associate deputy administrator of APHIS; and Nancy Kingsbury, a managing director of the Government Accountability Office) to come explain exactly how Larry, Moe, and Curly ended up wreaking havoc at the Center.

So naturally, Sunday night was the perfect time to dismiss the remaining inaugural members of the National Science Advisory Board for Biosecurity.
WTELF
Now, apparently the NSABB hadn’t met in two years, and according to Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Twin Cities, his last contact with the NIH regarding the NSABB was in the Spring of 2013.2 Which, if you’ve been following dual-use research of concern or gain of function research news, is concerning, to say the least.

But possibly even worse is how utterly tone deaf and cheerful this “your services are no longer required, you’re dismissed” email is. Apparently Mary Groesch is, in addition to being the Executive Director of the NSABB, the Queen of Perky. Don’t believe me? Lucky for you, I just so happen to have acquired a copy of the dismissal letter.

Dear Members of the NSABB,

Greetings! I hope that all is well with each of you. My purpose in writing to you, the last of the original NSABB members, is several fold. First, I wanted to tell you that a new slate of NSABB members has been approved as your replacements, and thus your service on the board is ending. Since you have all been so gracious as to extend your service for several years beyond your initial term, this may come as welcome news!

Yes, I’m sure it’s welcome news that, after a week of Really Bad Revelations from the CDC, NIH, and FDA, their expertise will no longer be needed. The expertise they bring as inaugural members of the NSABB. SiskoIsNotAmusedThe expertise they bring being the people who had to figure out how to deal with the Fouchier and Kawaoka H5N1 publishing crisis. I can’t imagine how any of that might be necessary or needed now.

But hey, don’t worry. The inaugural members of the NSABB that were dismissed have been invited to join the next NSABB meeting in the fall, where they can watch, as ad hoc members, as the new committee largely goes “nyah nyah” and ignores their recommendations. Of course, that’s just my interpretation of the email, but “I welcome you to attend in an ad hoc capacity the next meeting of the NSABB, where we will recognize your service on the Board,” “We will also recognize your service and introduce the new members to the Board,” and “We also would welcome your attendance at this meeting in a non-voting, ad hoc capacity both to contribute to our discussions and to say farewell” doesn’t exactly inspire confidence, faith, or trust in the now-gutted NSABB. In fact, I’m really only surprised that “YOU CANNOT VOTE AND YOU HAVE NO SAY” wasn’t included in bolded, underlined text.

What in the bloody hell is the NIH thinking? I’d ask if they have no policy or communications advisers on staff, except that I see at least one science policy analyst on the email CC list, so clearly this was signed off by at least one person who should know better.

When the theoretically premier laboratory in the world is as badly compromised by ineptitude as the CDC has stunningly demonstrated that they are, you don’t turn around and dismiss your experts. You hang on to those experts, grateful that they’re still around, and you say help. You say help really loudly. And then you sit down, shut up, and listen.

You don’t fire the people who’ve been around so long that they can say “I told you so.”

Unless, of course, that’s the point.
LowerYourExpectations
And frankly, at the moment, given who was released and their expertise, it’s hard to see how this is anything other than an effort to stack the deck towards people who will be sympathetic to the NIH and CDC, rather than be the critical, independent review board with teeth, a la the National Transportation Safety Board, that biosecurity research needs.

Which is not to say that all is lost, or that there are not people much more impressive and with much bigger sticks who are not willing to sit down and shut up and let the NIH run amok without oversight. While I wish the House committee all the best this Wednesday, my faith more strongly lies with the Cambridge Working Group,3 who ever-so-coincidentally met today in Cambridge,4 and their Consensus Statement on the Creation of Potential Pandemic Pathogens (see below for full text).

The following NSABB members were informed they were no longer needed Sunday evening:
Arturo Casadevall, MD, PhD – Chair, Department of Microbiology & Immunology, Albert Einstein College of Medicine
David R. Franz, DVM, PhD, Colonel, USA (Retired) – Former Commander, United States Army Medical Research Institute for Infectious Diseases
John A. Gordon, General, USAF (Retired) – Former Deputy Director, CIA
Michael J. Imperiale, PhD – Professor and Associate Chair, Department of Microbiology and Immunology, University of Michigan School of Medicine
Paul Keim, PhD – Regents’ Professor and Cowden Chair in Microbiology, Department of Biological Sciences, Northern Arizona University
Stanley M. Lemon, MD – Professor of Medicine, Division of Infectious Diseases, University of North Carolina School of Medicine
John R. Lumpkin, MD, MPH – Senior Vice President and Director, Targeted Teams, Robert Wood Johnson Foundation
Stuart B. Levy, MD – Director, Center for Adaptation Genetics and Drug Resistance, Tufts University
Michael Osterholm, MD, PhD – Director of CIDRAP, University of Minnesota
David Relman, MD – Department of Medicine, Division of Infectious Diseases,
and Department of Microbiology & Immunology, Stanford University
James A. Roth, DVM, PhD – Director, Center for Food Security and Public Health, Iowa State University

Maybe it’s just me, but that’s a list of guys5 and expertise I’d feel better having on the NSABB than off.

Especially right now.

Definitely right now.


The below text has been reprinted with permission. Please share. Please do not credit Kelly Hills for this work. She just happened to get a copy and the permission to post it.6

July 14, 2014

Cambridge Working Group Consensus Statement on the Creation of Potential Pandemic Pathogens (PPPs)

Recent incidents involving smallpox, anthrax and bird flu in some of the top US laboratories remind us of the fallibility of even the most secure laboratories, reinforcing the urgent need for a thorough reassessment of biosafety. Such incidents have been accelerating and have been occurring on average over twice a week with regulated pathogens in academic and government labs across the country. An accidental infection with any pathogen is concerning. But accident risks with newly created “potential pandemic pathogens” raises grave new concerns. Laboratory creation of highly transmissible, novel strains of dangerous viruses, especially but not limited to influenza, poses substantially increased risks. An accidental infection in such a setting could trigger outbreaks that would be difficult or impossible to control. Historically, new strains of influenza, once they establish transmission in the human population, have infected a quarter or more of the world’s population within two years.

For any experiment, the expected net benefits should outweigh the risks. Experiments involving the creation of potential pandemic pathogens should be curtailed until there has been a quantitative, objective and credible assessment of the risks, potential benefits, and opportunities for risk mitigation, as well as comparison against safer experimental approaches. A modern version of the Asilomar process, which engaged scientists in proposing rules to manage research on recombinant DNA, could be a starting point to identify the best approaches to achieve the global public health goals of defeating pandemic disease and assuring the highest level of safety. Whenever possible, safer approaches should be pursued in preference to any approach that risks an accidental pandemic.

Amir Attaran, University of Ottawa
Barry Bloom, Harvard School of Public Health
Arturo Casadevall, Albert Einstein College of Medicine
Richard Ebright, Rutgers University
Nicholas G. Evans, University of Pennsylvania
David Fisman, University of Toronto Dalla Lana School of Public Health
Alison Galvani, Yale School of Public Health
Peter Hale, Foundation for Vaccine Research
Edward Hammond, Third World Network
Michael Imperiale, University of Michigan
Thomas Inglesby, UPMC Center for Health Security
Marc Lipsitch, Harvard School of Public Health
Michael Osterholm, University of Minnesota/CIDRAP
David Relman, Stanford University
Richard Roberts, New England Biolabs
Marcel Salathé, Pennsylvania State University
Silja Vöneky, University of Freiburg Institute of Public Law, Deutscher Ethikrat
Affiliations are for purposes of identification only and do not imply any institutional endorsement