CDC Reports Potential Ebola Exposure At Lab

BSL-4 Lab Worker - Photo Credit –USAMRIID

 

 

# 9485

 

In a late in the day Christmas Eve announcement to the media (as of this writing I’ve not found anything on the CDC website),  the CDC has reported a potential exposure of staff to the Ebola virus at one of their laboratories.  When a full statement becomes a available I’ll post it.  Until then we have this report from NBC News.

 

CDC Reports Possible Ebola Exposure at Containment Lab

A mistake at a CDC biocontainment lab may have exposed one technician, and possibly more, to the Ebola virus, federal health officials said Wednesday.

A sample of material that may have contained the virus was accidentally moved from a high-level containment lab to a lower-level lab this week at the Centers for Disease Control in Atlanta, according to a statement from Sherri Berger, the agency's chief operating officer.

Berger said only one lab technician at the second lab worked with the sample but other staff had contact with the laboratory room where it was processed. The mistake involving a fixed, sealed plate was discovered Tuesday, but by then the sample had been destroyed and the lab decontaminated in routine procedures, Berger said.

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This is unfortunately  the third high-profile mishandling of a select pathogen at a CDC lab this year, with two previous incidents involving anthrax and H5N1 avian flu.  Additionally, smallpox and other dangerous pathogens were found improperly stored at an FDA lab earlier this year (see FDA Statement On Additional 300 Vials Discovered At NIH Campus Lab).

 

Over the summer these incidents led to calls for stricter controls on laboratories, a Laboratory Bio-Safety Backlash, and house subcommittee hearings (see House Subcommittee Hearing on Biosafety). 

The CDC responded to these incidents by temporarily halting the transfer of select pathogens between labs, conducting an extensive internal review, and promising new, more stringent safety protocols (see CDC H5N1 Incident & Lab Safety Progress Reports).

 

CDC Director Dr. Thomas Frieden  is quoted today as saying he is troubled by this most recent incident, stating `"I have directed that there be a full review of every aspect of the incident and that CDC take all necessary measures"

 

The Laboratory Bio-Safety Backlash Continues

Credit CDC

 

# 8892

 

The groundswell of concern over controversial `gain of function’ laboratory experiments, and recent high-profile lapses in biosecurity at the nation’s top labs, continues to grow with a scathing editorial appearing yesterday in the Annals of Internal Medicine penned by Deputy Editor Deborah Cotton, MD, MPH.

 

While much of the editorial is behind a pay wall, you can find a readable scan of the first page at the link below.  Fortunately, Medscape Medical News  published a detailed summary, and interview with the author, yesterday (more on that after you return).

 

Editorials | 29 July 2014

Biocontainment Laboratories: Addressing the Terror Within 

Deborah Cotton, MD, MPH, Deputy Editor

Ann Intern Med. Published online 29 July 2014 doi:10.7326/M14-1668

Recently revealed safety lapses in U.S. government facilities that work with deadly pathogens suggest that, despite efforts to protect us from bioterrorism as well as naturally occurring infectious diseases, there is another grave bioterror threat: the risk emanating from biocontainment laboratories themselves. This commentary discusses possible factors contributing to the safety lapses and strategies to prevent future incidents.

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The following lengthy report from Medscape provides more detail on the above editorial, along with comments from the author, and additional input from by Nancy Kingsbury, PhD, of the Government Accountability Office and  by Richard H. Ebright, PhD, professor of chemistry and chemical biology at Rutgers University  (see House Subcommittee Hearing on Biosafety  for their recent testimony). .

 

Suspend Work, Close Most High-Level Biosafety Labs, Experts Say

Janis C. Kelly

July 29, 2014

( UPDATED July 29, 2014 ) Management of US government bioterrorism research facilities is so lax that work in biosafety level (BSL) 4 laboratories (which house deadly organisms for which there are no effective treatments or vaccines) should be suspended pending a complete safety overhaul, Annals of Internal Medicine deputy editor Deborah Cotton, MD, MPH, writes in an editorial published online July 28 in the journal

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Beyond suspension of work pending a a safety overhaul, experts are calling for a dramatic scale back in the number of BSL-3 and BSL-4 labs in the county that are allowed to work on the most dangerous pathogens.  Currently, there isn’t even a good count on the number of BSL-3 labs in operation, and there is no one single regulatory agency in charge of monitoring their operations.

 

While we continue to get bland assurances from researchers that their work is both safe and essential (“We’re scientists . . . trust us” )  we are also hearing from others – like the Director of the CDC - that there  remains an insufficient `culture of safety’ among research scientists.  

 

We are also seeing reports  that the number of laboratory `incidents’ may be far higher than is reported.

 

While many researchers will be justifiably dismayed by the draconian recommendations made in the above editorial, and I doubt that we’ll see anything close to the reduction in BSL-3 labs they are calling for, it is obvious that serious changes are needed.  

 

For the past ten years – spurred on in part by national security concerns – there’s been an `anything goes’ attitude when it comes to biomedical research.  Since the 9/11 attack, the number of BSL-4 labs in the United States has jumped from 2 to 14, and the number of BSL-3 labs has grown from around 400 to over 1400 (although the exact number is murky).

 

Although BSL-3 and BSL-4 labs are essential parts of national security, biomedical research, and the testing of pathogens - the more of them that are in operation - the better the chance of a seeing a serious accident.

 

How many are too many, will be one of the major decisions facing regulators.

 

Given the money, power, and prestige at stake, I don’t expect to see many BSL-3 labs voluntarily sacrifice themselves on the altar of public safety.  So we should expect more than a little resistance to any reductions.

 

For more on this growing debate, you may wish to revisit:

 

Scientists For Science: GOF Research `Essential’ & Can be Done `Safely’

Updating The Cambridge Working Group

ECDC Comment On Gain Of Function Research

CDC: Press Conference Transcript, Audio & Timelines For Lab Incidents

Cell Host & Microbe: 1918-like Avian Viruses Circulating In Birds Have Pandemic Potential

Lipsitch & Galvani: GOF Research Concerns

Yesterday’s House Subcommittee Hearing on Biosafety

Credit Wikipedia

 

# 8841

 

 

If you missed yesterday’s 2 hour and 40 minute House subcommittee hearing on Biosafety lapses at the CDC and FDA labs, you have two excellent ways to catch up.  

First, Lisa Schnirring at CIDRAP News has put together an excellent summary report, which you can read at:

 

Congress probes lapses at high-containment labs

 

And second, the video of the hearing – along with supporting documents - are now available on the House Energy and Commerce Oversight and Investigations Subcommittee website.

 

Review of CDC Anthrax Lab Incident

Wednesday, July 16, 2014 - 10:00am

Oversight and Investigations

2123 Rayburn

Background Documents and Information:

Hearing Notice

Background Memo

To read a related press release, click here.

Opening Statements:

Oversight and Investigations Subcommittee Chairman Tim Murphy

Energy and Commerce Committee Chairman Fred Upton

Witnesses:

Panel I

Thomas R. Frieden, M.D., M.P.H.

• Director
• Centers for Disease Control and Prevention
• Witness Testimony (Truth in Testimony and CV)
• Accompanied by Joseph Henderson
• Deputy Director
• Office of Security and Emergency Preparedness
• Centers for Disease Control and Prevention
• (Truth in Testimony and CV)

Jere Dick, D.V.M.

• Associate Deputy Administrator
• Animal and Plant Health Inspection Services
• U.S. Department of Agriculture
• Witness Testimony (Truth in Testimony and CV)

Nancy Kingsbury, Ph.D.

• Managing Director
• Applied Research & Methods
• Government Accountability Office
• Witness Testimony (Truth in Testimony and CV)

Panel II

Sean G. Kaufman, M.P.H.

• President and Founding Partner
• Behavioral-Based Improvement Solutions, LLC
• Woodstock, Georgia
• Witness Testimony (Truth in Testimony and CV)

Richard Ebright, Ph.D.

• Rutgers University
• Board of Governors Professor of Chemistry and Chemical Biology
• Witness Testimony (Truth in Testimony and CV)

APHL Statement Regarding Biosafety Incidents At Federal Labs

Credit CDC PHIL

 

# 8840

 

 

The Association of Public Health Laboratories (APHL) is a non-profit organization of long standing that represents local, territorial, county and state public health laboratories of all types, including medical, environmental, agricultural and veterinary with the goal of promoting the safety, training, and excellence of public health laboratories across the United States.

 

With the recent revelations of hundreds of improperly stored vials of potentially deadly pathogens (see FDA Statement On Additional 300 Vials Discovered At NIH Campus Lab) – including smallpox – and reports of serious lab mishaps involving anthrax and bird flu (H5N1) at a CDC lab (see Subcommittee Hearing On CDC Lab Incidents), there are understandably concerns over what other bad biosafety news might be in the offing.

 

Yesterday in his testimony, CDC Director Dr. Thomas Frieden indicated that all CDC, FDA, and NIH labs were conducting (or about to conduct) full inventories to ensure there were no more improperly stored pathogens in government labs, and said it was possible that additional lapses could be discovered.

 

But these federal labs are far from the only research or testing facilities where lapses in protocol, or judgment, could produce potentially serious consequences.  During yesterday’s hearing, the GAO’s managing director for applied research and methods, Dr. Nancy Kingsbury, admitted the government didn’t have a good feel for how many high containment bio labs were were in the United States. 

 

Other panel members suggested that - between Federal, State, academic, and corporate labs - that number could reach as high as 1,000 labs.  And that there is no single regulatory agency in charge of creating safety protocols, and inspecting labs for compliance, across the nation.

 

 

Which brings us to a statement (my thanks to Marion Koopmans for tweeting the link), posted by the APHL that commends the CDC on their quick response to the recent lab incidents, and urges that all labs take immediate steps to `review their protocols and procedures immediately and thoroughly’ and work to `instill a culture of quality and safety’ in labs around the nation.

 

APHL Response to Biosafety Incidents at CDC and Other Federal Laboratories

The recent series of incidents in federal laboratories serves as a wake-up call for all laboratories--governmental, academic and those in the private sector.

APHL commends the CDC for its swift and assertive response to the biosafety incidents discussed in its conference call and report of July 11. We believe that the agency has taken the appropriate steps to improve the culture of safety and quality across CDC laboratories. APHL will work closely with the agency as it hones its biosafety processes and procedures and strengthens its quality management systems to assure that all aspects of laboratory management are administered effectively.

These changes will require sustained effort on the part of CDC leadership, staff, funders and partners. Enhanced federal support may also be needed to bolster oversight systems.

Because CDC is the sole provider of many materials used by public health laboratories to monitor and detect diseases and other health hazards, the moratorium on movement of all biological materials from BSL-3 and BSL-4 laboratories will have an impact on their operations. In the coming week, APHL will be in contact with CDC to determine how and when these materials – which are essential to public health services at the state and local level – can be delivered.

Lastly, the recent series of incidents in federal laboratories serves as a wake-up call for all laboratories--governmental, academic and those in the private sector. APHL urges its members and partner laboratories to review their protocols and procedures immediately and thoroughly. Having strong quality management systems in place, and a culture of quality and safety, is essential to retaining the public’s longstanding trust in laboratory results. The public deserves, and rightly expects, laboratory systerms that merit this confidence.

 

 

 

The sobering revelations from the CDC and FDA regarding biosecurity – while undeniably bad – are at least known problems that have been (quite commendably) publicly identified, and are being dealt with. More troubling are those hidden biosafety lapses – large and small - that are likely lurking in hundreds of other labs in the Untied States (and around the world).

 

One hopes that every lab in the country will heed the APHL’s advice and will go over their procedures and inventories  with a fine toothed comb looking to prevent incidents such as we’ve just witnessed at the CDC and FDA. 

 

Whether we will hear about all of the lapses uncovered, or whether some (perhaps, many) of them will be handled `discreetly’, is something I suspect we will never truly know.  

 

But either way, this summer is a wake up call for labs – both public and private - across the country.  

They need to either find that much vaunted `culture of safety’  within themselves, or some group of politicians and bureaucrats will surely do for – or to -  them. 

 

And that’s a `fix’ that I doubt many of these researchers would want to see arbitrarily imposed. . 

FDA Statement On Additional 300 Vials Discovered At NIH Campus Lab

Transferring H7N9 Into Vials – Credit CDC

 

# 8839

 

Just hours after the House subcommittee hearing on lapses at the CDC labs involving anthrax and avian H5N1 influenza, the FDA has announced details on roughly 300 vials of improperly stored pathogens that were recovered from the same cold storage room on the NIH campus where 6 vials of smallpox were discovered a couple of weeks ago (see CDC Media Statement on Newly Discovered Smallpox Specimens).

 

Among these latest discoveries are vials marked as containing such diverse pathogens as dengue, influenza, Q fever, and rickettsia, and are believed to date back 50 years or more.  

 

While we were aware that additional vials were discovered at the time of the announcement regarding the smallpox discovery, today’s announcement from the FDA provides additional details.

 

Update on findings in the FDA cold storage area on the NIH campus

For Immediate Release

July 16, 2014

Statement

As previously reported, on July 1, 2014, biological samples were found in the cold storage area of U.S. Food and Drug Administration laboratories on the National Institutes of Health campus. The FDA has since acquired additional information from the federal investigative agencies regarding inventories of the materials.

The investigation found 12 boxes containing a total of 327 carefully packaged vials labeled with names of various biological agents such as dengue, influenza, Q fever, and rickettsia. Upon the discovery of these vials on July 1, 2014, FDA employees followed standard protocol and turned them all over to the appropriate NIH safety program officials, who in turn transferred them to the appropriate investigative agencies, as per standard protocols.

As announced on July 8, 2014, six vials labeled “variola” (the causative agent of smallpox) along with ten other samples with unclear labeling were transported safely and securely with the assistance of federal and local law enforcement agencies in a government aircraft to CDC’s high-containment facility in Atlanta. In addition, 32 samples were destroyed following inventory at the NIH facility, including 28 labeled as normal tissue and four labeled as “vaccinia,” the virus used to make the smallpox vaccine. To be clear, vaccinia does not cause smallpox. These vials represented no value to forensic sciences and were destroyed according to standard protocols.

The remaining 279 biological samples were then transferred by the investigating agencies to the U.S. Department of Homeland Security’s National Bioforensic Analysis Center for safeguarding. There were no smallpox samples included in this transfer. The FDA received confirmatory information about the samples yesterday, thus permitting public disclosure of this additional information.

While an investigation continues regarding the origin of these samples, this collection was most likely assembled between 1946 and 1964 when standards for work with and storage of biological specimens were very different from those used today. All of the items labeled as infectious agents found in the collection of samples were stored in glass, heat-sealed vials that were well-packed, intact, and free of any leakage, and there is no evidence that anyone was exposed to these agents.

Overlooking such a sample collection is clearly unacceptable. The FDA has already taken steps to ensure that similar material is not present in its other cold storage areas by initiating a thorough review of all common cold storage spaces. The agency is in the process of reviewing its policies and procedures in order to implement a corrective action plan so that potentially hazardous samples are never overlooked in the future.

Subcommittee Hearing On CDC Lab Incidents Today 10am EDT

BSL-4 Lab Worker - Photo Credit –USAMRIID

 

 

# 8838

 

Like just about everyone else with an interest in the recent lab biosafety lapses at the CDC and FDA, I’ll be tuned into the House House Energy and Commerce Oversight and Investigations Subcommittee hearing, which begins at 10am EDT.    The hearing will be broadcast from room 2123 of the Rayburn building and viewable at:

 

http://energycommerce.house.gov/studio/webcasts

 

You’ll also find a 13-page Background Memo available at:

 

http://docs.house.gov/meetings/IF/IF02/20140716/102479/HHRG-113-IF02-20140716-SD002.pdf

For more on this rapidly evolving story,  I would invite you to revisit:

 

SciAm: Branswell On Lab Biosafety

Reshuffling The NSABB & A New Biosecurity Working Group Emerges

CDC Announces Another Serious Biosecurity Incident

SciAm: Branswell On Lab Biosafety

 

 

 

# 8836

 

I’ve been away from my desk for most of the day, but I wanted to recommend (very highly) the following Scientific American piece by Helen Branswell on the fallout from the recent laboratory incidents involving select agents at the CDC and FDA.

 

 

Bio-Unsafety Level 3: Could the Next Lab Accident Result in a Pandemic?

So-called gain-of-function pathogen research will likely receive closer scrutiny after three U.S. biolab incidents

Jul 14, 2014 |By Helen Branswell

A CDC scientist inoculates a chicken egg with H5N1 in a biosafety level 3 lab. 
Credit: CDC/Greg Knobloch

There had to be a sinking feeling in the chest of every researcher who works in a high-containment research laboratory last Friday when the U.S. Centers for Disease Control and Prevention (CDC) released its report on three worrisome incidents that raised safety questions at two well-respected government facilities. But it is likely the sensation was most acute for the influenza scientists who work in a controversial field known as gain-of-function research.

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Reshuffling The NSABB & A New Biosecurity Working Group Emerges

BSL-4 Lab Worker - Photo Credit –USAMRIID

 

 

# 8834

 

 

 
Although Crof covered both of these stories during the overnight hours (see here & here), they are well worth repeating here.

 

The NSABB or National Science Advisory Board for Biosecurity is a 23-member review panel, first formed in 2005, who meet rather infrequently and at the behest of the NIH to review research projects with possible biosecurity concerns.

 

Their role, as defined in their FAQ, is to

 

` . . . provide advice, guidance, and leadership regarding biosecurity oversight of dual use research to all Federal departments and agencies with an interest in life sciences research.

The NSABB advises on and recommends specific strategies for the efficient and effective oversight of federally conducted or supported dual use biological research, taking into consideration national security concerns and the needs of the research community.’

 

While frequently in the news in 2011-2012 during the controversy over the publication of the Fouchier H5N1 ferret study (see The Furor Over H5N1 Research Continues), they’ve been idle for roughly two years, with no quests from the NIH to reconvene. 

 

Yesterday, we learned via Science Magazine’s ScienceInsider, that 11 of the original board members have been abruptly informed that their services are no longer required.   Gone are such well known (and frequently outspoken) experts as Paul Keim from Northern Arizona University, Arturo Casadevall from Albert Einstein College of Medicine, Michael Imperiale of the University of Michigan, and Michael Osterholm from CIDRAP.

 

 

U.S. biosafety panel to come out of hibernation with new members

By Jon Cohen

14 July 2014 6:45 pm

On the heels of several mishaps involving deadly pathogens, U.S. officials are reconvening an expert advisory panel that hasn’t met in nearly 2 years. But the government has also dismissed 11 of the original members of the 23-person panel, called the National Science Advisory Board for Biosecurity (NSABB).

“We had no inkling it was going to happen this way,” says Paul Keim, a pathogen genomics researcher at Northern Arizona University in Flagstaff who formerly chaired NSABB and has been on the panel since it was formed in 2005. The 11 members learned they were being dismissed Sunday evening in an e-mail from the board’s executive director, Mary Groesch, who works at the U.S. National Institutes of Health (NIH), NSABB’s overseer. The e-mail prompted this tweet from NSABB member Michael Imperiale of the University of Michigan, Ann Arbor: “#NIH just gave remaining inaugural NSABB members pink sheets. Bizarre time to eliminate all institutional memory.”

(Continue . . .)

 

 

In a related matter, yesterday a new initiative appeared online called the Cambridge Working Group, that consists of 17 internationally known experts and researchers (including several former NSABB members) called:

 

The Cambridge Working Group

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

 

A pretty good indication that we can expect continued debate on the topic of lab biosafety, and that many of the recently released members of the NSABB have no intention of going gentle into this good night.

Upcoming House Sub-Committee Hearing On Lab Safety

CDC Anthrax Timeline – Credit CDC

# 8830

 

Even before Friday’s announcement by the CDC that one of their labs had accidentally shipped H5N1 contaminated virus samples to a USDA lab, the House Energy and Commerce Oversight and Investigations Subcommittee had scheduled a hearing on last month’s CDC Anthrax incident (see CDC Statement On Possible Lab Exposure To Anthrax).

 

Hearing Notice: Subcommittee on Oversight and Investigations to Examine Anthrax Incident

July 8, 2014

Director of the Centers for Disease Control and Prevention to Testify on Recent Anthrax Exposure

The Subcommittee on Oversight and Investigations, chaired by Rep. Tim Murphy (R-PA), has scheduled a hearing for Wednesday, July 16, 2014, at 10 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled “Review of CDC Anthrax Lab Incident.” Dr. Tom Frieden, Director of the Centers for Disease Control and Prevention (CDC), will be among the witnesses testifying.

(Continue . . .)

 

An incident which was closely followed by the equally disturbing discovery of six vials of unsecured smallpox at an FDA lab in Bethesda, Md. (see CDC Media Statement on Newly Discovered Smallpox Specimens).

Despite their age (vials dated 1954), and a sub-optimal storage environment for decades, on Friday we learned that samples taken from two of the vials were still viable, and growing in a CDC Lab (see CDC Announces Another Serious Biosecurity Incident).

 

The third - and arguably most serious incident – involved the cross contamination of H9N2 samples with highly pathogenic H5N1, and then shipping them to an unsuspecting USDA lab in Georgia.   Worse, once the discovery was made by the USDA lab, the incident went `unreported’ to upper management at the CDC for another six weeks.

 

March 12

• CDC Influenza Division (ID) shipped low pathogenic avian influenza H9N2 to USDA SEPRL in Athens, Ga
  Genetic analysis confirmed identity of H9N2
• Shipment delivered on March 13 to USDA Southeast Poultry Research Laboratories (SEPRL) (Athens GA)
  SEPRL observed pathogenicity in chickens inconsistent with H9N2 virus
  SEPRL performed molecular analyses on SEPRL virus stock and material sent by CDC
  SEPRL confirmed highly pathogenic H5N1 contamination and destroyed all SEPRL virus stocks in biosafety level 3 (BSL-3) enhanced

May 23

• SEPRL notified CDC ID that SEPRL virus stock was contaminated and destroyed

May 23

• CDC ID confirmed H9N2 virus was contaminated by H5N1 virus

July 9

• CDC Responsible Official was notified; investigation is ongoing

 

A revelation that led to another press release from the House Sub-Committee on Friday, which indicates a widening of the scope of the hearing scheduled for Wednesday.

 

Upton, Murphy Comment On Additional CDC Safety Failures

July 11, 2014

CDC Head Will Testify on Recent Anthrax Incident WEDNESDAY

WASHINGTON, DC – House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) responded to the latest announcement by the Centers for Disease Control and Prevention (CDC) on additional safety breaches. As part of the ongoing investigation into the potential exposure of more than 80 workers at a CDC lab in Atlanta to live anthrax, committee leaders earlier this week sent letters to the CDC and HHS Inspector General seeking documents and information. CDC Director Dr. Tom Frieden is scheduled to testify before the Oversight and Investigations Subcommittee next Wednesday, July 16, at 10 a.m.

Chairman Upton commented, “The repeated breakdown in protocols and safety failures involving the world’s deadliest germs and pathogens is wholly unacceptable. The consequences of such carelessness could not be more dire. This latest revelation underscores the need for our investigation and the importance of next week's hearing to review the safety measures and practices at the CDC. Past fixes by CDC several years ago apparently were not followed and not adequately implemented. We will seek to find out why CDC thinks its latest actions will prove more effective than past efforts, and whether congressional intervention may be necessary. We look forward to hearing directly from Dr. Frieden next Wednesday and will seek his firm commitment that such safety lapses are over.”

Subcommittee Chairman Murphy added, “With the release of today’s report, we’ve learned the dangerous transfer of possible live anthrax bacteria by the CDC’s Atlanta lab was not an isolated incident by a rogue scientist, but rather one of multiple mishaps over the last several years that were violations, or apparent violations, of federal regulations for handling deadly biological material. These repeated safety failures raise grave concerns about the CDC’s ability to ensure strict procedures, protocols, and training are followed and an area we will examine further at Wednesday’s Oversight and Investigations Subcommittee hearing.”

 

House E&C Subcommittee hearings are usually broadcast live at this link:

 

 http://energycommerce.house.gov/studio/webcasts

 

All of this comes after several years of debate over the safety of government and university laboratories, and concerns over potentially dangerous work on DURC (Dual Use of Concern) and GOF (Gain of Function) research projects.

 

For those unfamiliar with the lexicon of biomedical research, GOF research involves the creation of viruses and/or bacteria with enhanced virulence, transmissibility, or host range  while DURC is defined as:

 

. . . life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security

 

Proponents of these types of research projects argue that the risks of an accidental release are small, that they can open up new avenues of knowledge in the world of bioengineering, and perhaps tip us off as to the what pathogens have the most pandemic potential, and even help in the early development of a vaccine. 

 

Opponents argue that these potential benefits are overstated, and the risks of an accidental release from one of the hundreds of labs doing this type of work are underappreciated (see The Debate Over Gain Of Function Studies Continues).

 

While we don’t know what Dr. Frieden will say before the subcommittee on Wednesday, on Friday he did say:

 

“And fundamentally, and this is relation to the previous question from the wall street journal as well, one of the things that we want to do is reduce the number of laboratories that work with dangerous agents to the absolute minimum necessary.  Reduce the number of people who have access to those laboratories to the absolute minimum necessary.  Reduce the number of dangerous pathogens we work with in those laboratories.”

 

This week, you can expect to see a good deal of media coverage of this topic, but a good one to start your week with is this from Reuters:

 

 

ANALYSIS-How to fix U.S. biosecurity leaks? Close some labs

Source: Reuters - Mon, 14 Jul 2014 05:00 GMT

By Sharon Begley and Julie Steenhuysen

July 14 - In the wake of disclosures that top government labs mishandled anthrax, smallpox and avian flu, U.S. health authorities are considering the once unthinkable: cutting the burgeoning number of labs working with the planet's most dangerous microbes.

(Continue . . . )

 

In 2012 we saw a year-long self imposed moratorium on controversial GOF research by a group of major researchers, to allow time for `public discussion and scientific debate’ of the issue, but in the end, very little of that actually took place.

 

Instead – except for the occasional scathing newspaper editorial (see NYTs  An Engineered Doomsday) – this debate has been largely conducted in academic circles or in research journals.

 

Now, the debate finds itself once again on the front page, and this time it will be conducted under the formidable shadow of three very high-profile biosecurity lapses in what are assumed to be the best, and safest, labs in the country. 

 

Which means that advocates of  GOF & DURC research have a big job ahead of them to convince an increasingly skeptical public, and traditionally risk adverse politicians, of the wisdom and safety of continuing – particularly in anything less than the highest biosecurity settings.

Stay tuned.

CDC: Press Conference Transcript, Audio & Timelines For Lab Incidents

H5N1 Photo Credit – CDC PHIL

 

 

# 8827

 

For those who missed yesterday’s bombshell press conference on recent government lab biosafety incidents involving anthrax, smallpox and  avian H5N1, the CDC has posted the audio file, transcript, and some timeline graphics. 

 

While there has been a great deal of excellent media coverage over the past 18 hours (including Helen Branswell’s  What happened at the CDC’s flu lab? & Lisa Schnirring’s More problems shutter CDC labs, prompt review for CIDRAP News), many will still want to hear this press conference in its entirety.

 

Press Briefing Transcript

CDC Press Conference on laboratory quality and safety after recent lab incidents

Friday, July 11, 2014 11:30 a.m. ET

• Audio recording  [MP3, 10.3 MB]

 

 

These incidents are still under investigation, and so there are still large gaps in our understanding of how they occurred.  The H5N1 cross-contamination incident in particular has two large and critical holes in the timeline (see below) that will require filling in. 

 

The first is what transpired between March 12, when the (presumed H9N2) samples are shipped from the CDC to the USDA lab in Athens, Ga and May 23rd, when the USDA determined they were working not with H9N2, but with the highly pathogenic H5N1 virus.  

 

How the virus sample became cross contaminated, and how that went undetected for 40 days, remain open questions.

Even more troubling is how the discovery of this mistake could have been made on May 23rd - and shared between two major government agencies (USDA & CDC) - and yet senior management at the CDC were not informed until July 7th, a gap of more than six weeks.

 

March 12

• CDC Influenza Division (ID) shipped low pathogenic avian influenza H9N2 to USDA SEPRL in Athens, Ga
  Genetic analysis confirmed identity of H9N2
• Shipment delivered on March 13 to USDA Southeast Poultry Research Laboratories (SEPRL) (Athens GA)
  SEPRL observed pathogenicity in chickens inconsistent with H9N2 virus
  SEPRL performed molecular analyses on SEPRL virus stock and material sent by CDC
  SEPRL confirmed highly pathogenic H5N1 contamination and destroyed all SEPRL virus stocks in biosafety level 3
  (BSL-3) enhanced

May 23

• SEPRL notified CDC ID that SEPRL virus stock was contaminated and destroyed

May 23

• CDC ID confirmed H9N2 virus was contaminated by H5N1 virus

July 9

• CDC Responsible Official was notified; investigation is ongoing

 

The H5N1 flu incident, while apparently contained, could have been an economic disaster had the virus escaped the USDA lab and entered the poultry and/or wild bird population of the United States. 

 

Regarding the Anthrax investigation, you’ll also find a graphic timeline available at this link.

 

Although none of these incidents resulted in the infection of lab personnel, or the release of a pathogen outside of the lab, they all had the potential to do so – and in the words of the CDC’s Director, `These events should never have happened.’  

An obviously anguished Dr. Frieden went on to say:

`Together, these events I’m sure have many people asking and questioning government labs.  They may be wondering whether we're doing what we need to do to keep our workers and our communities safe.  And I think it's fair to raise those questions.  I’m disappointed by what happened, and frankly, I’m angry about it.'

 

The post mortem on all of this is likely to be long and messy, and the fallout is likely to extend well beyond the CDC and USDA labs. These incidents show that no matter how sophisticated the laboratory, no matter how detailed the safety protocols, there is always the risk of human error.

 

Something which is sure to re-ignite the debate over the wisdom and safety of GOF (`Gain of Function’) and DURC (`Dual Use of Concern’) research has been simmering for several years.  While I’ll have more on that in future blogs, for now you may wish to revisit:

 

The Call For Urgent Talks On `GOF’ Research Projects

U.S. Issues New DURC Oversight Rules

Nature: H5N1 viral-engineering dangers will not go away