Monday, July 14, 2014

Upcoming House Sub-Committee Hearing On Lab Safety

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CDC Anthrax Timeline – Credit CDC


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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 `unreportedto upper management at the CDC for another six weeks.

 

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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.

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