CASE CLOSED … what really happened in the 2001 anthrax attacks?

* Is CDC going to tell USA Today’s Alison Young about the 2007 probe of the earlier misshipment of anthrax? Bruce Ivins asked: “Does this refer to any material that DPG sent here for irradiation, then was sent back?”

Posted by Lew Weinstein on June 18, 2015

Screen shot 2015-06-18 at 5.55.45 AM

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17 Responses to “* Is CDC going to tell USA Today’s Alison Young about the 2007 probe of the earlier misshipment of anthrax? Bruce Ivins asked: “Does this refer to any material that DPG sent here for irradiation, then was sent back?””

  1. DXer said

    Watch Errol Morris’ Short Demon in the Freezer

    http://filmmakermagazine.com/98517-watch-errol-morris-demon-the-freezer/

  2. DXer said

    FedEx no longer to transport bioterror germs in wake of anthrax lab mishaps
    Alison Young, USA TODAY 8:31 p.m. EDT July 29, 2015
    http://www.usatoday.com/story/news/2015/07/29/fedex-no-longer-transport-bioterror-germs-wake-anthrax-lab-mishaps/30850671/

    FedEx’s refusal to transport these kinds of specimens is drawing concern among officials at major laboratories, who say it was the primary way they sent and received critical samples used to diagnose diseases and for the development of vaccines, treatments, tests and detection equipment. Neither UPS nor the U.S. Postal Servicewill transport the specimens.

    It potentially is a devastating blow,” said James Le Duc, director of the Galveston National Laboratory in Texas, a major high-containment research facility that has two to three shipments a month. Le Duc said much of infectious-disease research involves pathogens found in the wild in other parts of the world, which requires the shipment of specimens.

    “Everybody is kind of dumbfounded that this has happened,” Le Duc said Wednesday.

    f there were an outbreak of disease caused by a potential bioterror pathogen, fast shipments would be critical. “If that were to happen now, most public health labs could not ship specimens overnight to CDC, and the national public health response would be disrupted and delayed,” said Eric Blank, a senior director at the Association of Public Health Laboratories, whose members include state health department labs.

    FedEx’s director of dangerous goods administration sent a letter to the Centers for Disease Control and Prevention on July 17 saying it will no longer accept packages containing “select agents” for transport, according to a copy of the letter.

    Commercial carriers are commonly used for shipping specimens. Since 2003, there have been about 4,250 transfers of select agents, according to the Federal Select Agent Program’s website, with only one confirmed shipping loss.

    The CDC last week notified 310 top officials at labs registered to work with select-agent pathogens that FedEx was no longer an option for shipments. There is currently only one remaining commercial carrier that continues to accept select agents, the CDC said in a statement in response to USA TODAY’s questions. “Another commercial carrier has indicated to CDC it is in the process of establishing a program to handle select-agent packages. Discussions between the carrier and CDC are ongoing,” the agency said. It wouldn’t name the carriers.

    UPS does not accept ‘select agents’ and never has,” said UPS public relations director Susan Rosenberg. “Decisions by our competitor do not change our current processes, since we do not accept these substances into the UPS network.”

    The U.S. Postal Service also won’t transport select agents or infectious substances and has no plans to, said spokeswoman Sue Brennan. Officials at DHL were not immediately available for comment.

    Comment: Don’t shoot the messenger.

  3. DXer said

    Alison Young, “CDC lacked key lab incident reporting policy despite scrutiny, promises,” July 27, 2015
    http://www.usatoday.com/story/news/2015/07/27/cdc-lacked-key-lab-incident-reporting-policy-despite-scrutiny-promises/30749369/

    Ebright said the CDC’s July 20 lab incident reporting policy and a diagram for who decides what should be reported is overly complicated, provides too many layers of bureaucratic review and appears to be designed to avoid — rather than encourage — documentation and independent review of incidents that could prevent future mishaps.

    “This is intentionally designed to ensure that nothing or almost nothing reaches the office,” Ebright said after reviewing the documents released to USA TODAY. He said all potential incidents should be reported directly to the top lab safety office so a consistent review standard is applied.

    “The root cause of all of this is a lack of accountability: Incidents don’t get reported and consequences don’t occur,” Ebright said.

  4. DXer said

    US Army will conduct a formal investigation of the institutions and individuals at DPG, including the chain of command, as well as the actions of DPG that led to the inadvertent widespread shipments of viable anthrax spores.
    Implementation of the Recommendations in the Comprehensive Review Report: Inadvertent Shipment of Live Bacillus anthracis (Anthrax) Spores by Department of Defense
    http://www.defense.gov/home/features/2015/0615_lab-stats/docs/DSD-Memo-Implementation-of-Recommendations-in-Comprehensive-Review-Report.pdf

    But how can Vahid Majidi, head of the Review Committee, offer it up as comprehensive when we don’t yet know the answer about the misshipment of anthrax addressed by Bruce Ivins in his email?

  5. DXer said

    In any “new probe,” will the officials get to the issue of the misshipment of virulent anthrax that Dr. Ivins discussed?

    Officials call for new probe into Army anthrax facility

    Print Email
    1 hour ago • By MIKE STOBBE (Copyright Associated Press)

    NEW YORK (AP) — U.S. officials say systemic problems caused an Army facility to accidentally send live anthrax to other labs for more than a decade.

    At a press briefing Thursday, Pentagon officials said half the lots of anthrax produced at the Army’s Dugway Proving Ground in Utah contained live anthrax after attempts to kill the bacteria failed.

    The Pentagon has ordered a new investigation to determine who at Dugway was responsible.

    The problem was first identified in May, but the investigation provided new details that showed the problem goes back more than a decade.

    The anthrax was supposed to have been killed with radiation before being shipped for use by commercial labs and government facilities.

    No illnesses have been reported but 31 people have been given medications as a precaution.

    http://journaltimes.com/lifestyles/health-med-fit/officials-call-for-new-probe-into-army-anthrax-facility/article_fea17a26-ddc0-58fd-b265-fe60d655713f.html

  6. DXer said

    Note the Amerithrax people on the review committee. The head Amerithrax scientist, not even a microbiologist, was Committee Chairman, followed by Douglas Beecher who was dismissive of Dr. Kiel’s findings about the silicon signature.

    See Appendix C, Primary and Support Member of the Review Committee. Both Dr. Majidi and Dr. Beecher visited the DOD laboratories.

  7. DXer said

    http://www.cbs19.tv/story/29619292/pentagon-poor-testing-led-to-army-shipping-live-anthrax

    “The labs at Dugway have a history of biosafety failures with anthrax: In 2007 they faced potential sanctions from the select agent program for failing to properly kill anthrax with an experimental chemical method – and ignoring test results that indicated the kill process wasn’t effective, USA TODAY reported in June. But it is unclear why CDC lab inspectors over the years apparently didn’t identify Dugway’s other ongoing failures in its use of radiation to kill anthrax specimens.”

  8. DXer said

    CDC to review oversight of bioterror labs after USA TODAY investigation

    Posted: Jul 21, 2015 1:13 PM EDT
    Updated: Jul 21, 2015 1:13 PM EDT

    (USA TODAY) – The Centers for Disease Control and Prevention is launching a comprehensive review of how it regulates safety and security at bioterror labs in the wake of an ongoing USA TODAY Media Network investigation that has prompted congressional probes into the agency’s effectiveness.

    CDC Director Tom Frieden ordered the review last week as USA TODAY prepared to report on newly obtained documents showing that the agency’s inspectors have allowed labs to keep experimenting with bioterror pathogens despite failing to meet key requirements on inspection after inspection, sometimes for years. The action also comes as the agency faces a hearing in the House next week.

    “This review will be wide-ranging and includes a review of regulatory authority and the exercise of that authority so that we can identify potential modifications to the methods used to inspect labs,” the CDC said in a statement this week.

    The review, which is expected to take 90 days, will be directed by Stephen Redd, director of the CDC’s Office of Public Health Preparedness and Response, the CDC said.

    Next Tuesday, a subcommittee of the House Energy and Commerce Committee plans to hold a hearing on the CDC’s oversight of select-agent labs, with an emphasis on recent shipments of live anthrax from a Department of Defense facility in Utah. Committee leaders were not immediately available for comment.

    ***

    A USA TODAY Media Network investigation published in May uncovered hundreds of accidents that have occurred in biological laboratories nationwide in recent years and revealed that pervasive secrecy obscures failures by regulators to ensure research facilities operate safety and don’t unduly put workers and the public at risk. The network’s reporting has prompted questions about the CDC’s regulation of labs from the bipartisan leaders of the Senate Homeland Security and Governmental Affairs Committee.

    The network’s ongoing investigation has raised questions about whether lax oversight and enforcement played a role in allowing an Army biodefense facility to mistakenly ship live anthrax for more than a decade to dozens of labs in the U.S. and abroad. USA TODAY reported in June that the CDC in 2007 referred the Army’s Dugway Proving Ground facility for potential federal enforcement action for failures to deactivate live anthrax with chemicals and for ignoring tests indicating the kill process was ineffective. But no fines were levied, and over the years CDC’s inspectors apparently never detected that similar failures continued at Dugway in its routine use of radiation to kill anthrax.

    ***

    Since January, USA TODAY has sought records, using the Freedom of Information Act (FOIA), from the CDC and USDA about their use of performance improvement plan programs — or PIPPs — as an alternative to suspending or revoking a failing lab’s authorization to experiment with bioterror pathogens.

    The USDA identified 479 pages of records involving letters to labs notifying them they were being put on a PIPP but in March refused to release any of them, citing a secrecy provision in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. USA TODAY has appealed.

    ***

    The CDC recently responded to a similar FOIA request by sending USA TODAY 91 pages of correspondence with various labs about their enrollment or removal from performance improvement plans from 2011 to 2014. The CDC redacted all of the labs’ names — as well as the names of pathogens involved in their safety violations. USA TODAY has appealed the redactions.

    ***

    It’s unclear whether the CDC’s approach to oversight is a result of a lack of authority. The agency did not respond to USA TODAY’s questions since last week about issues raised by the documents.

    Comment: I can appreciate the interest that needs to be balanced. Secrecy reasonably is thought to further security of the pathogens. (There also are privacy interests under FOIPA that sometimes apply). I do not envy CDC (or FBI or USMRMC) the task of balancing the competing considerations or applying the statutory framework.

    On the other hand, sometimes CYA is simply CYA.

    Sometimes money-dominated politics and careerist decision-making in the public sector rules the day. Then commonly those CYA instincts are not overcome where the Congressional oversight is ineffective.

    If there were effective Congressional oversight, there would be a push for resolution of outstanding issues relating to the Fall 2001 anthrax mailings — to include the pre-911 distribution of Ames, both virulent and irradiated.

  9. DXer said

    Power, airflow, safety issues plague high-tech CDC labs
    Alison Young, USA TODAY6:46 p.m. EDT July 9, 2015
    http://www.usatoday.com/story/news/2015/07/09/new-cdc-lab-incidents-airflow/29920917/

  10. DXer said

    • DXer said

      “Editorial: Reckless with anthrax,” Providence Journal, Jun 18, 2015
      http://www.providencejournal.com/article/20150618/OPINION/150619327/13935

    • DXer said

      A Confidential Human Source reported to the FBI in 2007 that Ivins did not use the proper paperwork in irradiating anthrax
      https://vault.fbi.gov/Amerithrax/Amerithrax%20Part%20%2013%20of%2059

    • DXer said

      Amerithrax Part 23 of 59, p 46
      https://vault.fbi.gov/Amerithrax/Amerithrax%20Part%2023%20of%2059/view

      2004 Washington Field memo

      “One entry listed Ba shipped to USAMRIID from Dugway for sterilization by irradiation. This occurred on thirteen different occasions between March 31, 1994 and May 14, 1996.”

    • DXer said

      The CDC has shut me down — even though my request was to USAMRIID, not CDC! — by looking to charge me as a commercial requester! A reporter will have to make the same request.

    • DXer said

      http://aem.asm.org/content/67/8/3665.full

      Bacillus Spore Inactivation Methods Affect Detection Assays
      • Jessica L. Dang1,*,
      • Karen Heroux1,
      • John Kearney2,
      • Ameneh Arasteh3,
      • Mark Gostomski3, and
      • Peter A. Emanuel3

      +Author Affiliations

      • Geo-Centers, Inc., Lanham, Maryland 207061;
      • Department of Microbiology, University of Alabama at Birmingham, Birmingham, Alabama 352942; and
      • Research and Technology Directorate, U.S. Army Edgewood Chemical Biological Center, Aberdeen Proving Ground, Maryland 210103

      ABSTRACT

      Detection of biological weapons is a primary concern in force protection, treaty verification, and safeguarding civilian populations against domestic terrorism. One great concern is the detection of Bacillus anthracis, the causative agent of anthrax. Assays for detection in the laboratory often employ inactivated preparations of spores or nonpathogenic simulants. This study uses several common biodetection platforms to detect B. anthracis spores that have been inactivated by two methods and compares those data to detection of spores that have not been inactivated. The data demonstrate that inactivation methods can affect the sensitivity of nucleic acid- and antibody-based assays for the detection of B. anthracis spores. These effects should be taken into consideration when comparing laboratory results to data collected and assayed during field deployment.

      ***

      Bacillus spores are so resistant and hardy that they have been revived from the abdominal cavity of an extinct bee entombed within Dominican amber 25 to 40 million years ago (2) and isolated from a brine inclusion dated at 250 million years old (14).

      ***

      However, biosafety containment and occupational exposure are of great concern and necessitate inactivating the spores by gamma irradiation with a cobalt source or by thermal treatment such as autoclaving. B. anthracis has two major virulence factors encoded by plasmids pX01 (77 kb) and pX02 (95 kb). The plasmid pX01 codes for the lethal factor, the edema factor, and protective antigen that together form a tripartite protein exotoxin (4, 7, 9,12). Plasmid pX02 codes for the spore capsule (3). Laboratory detection assays often use inactivated spore preparations or nonpathogenic simulants to conduct development and testing of biosensors (6). The optimization of biodetection assays can necessitate handling moderate quantities of dangerous pathogens. Federal regulations limit the movement of pathogens and regulate safety controls that must be employed to protect laboratory personnel. Commonly, biodetection assays can be conducted with inactivated preparations of the pathogens so that parameters can be optimized prior to final testing of viable and virulent targets such as B. anthracis spores.

      In this study, data are presented comparing the reactivity of inactivated spore preparations versus that of viable spore preparations in biodetection assays. We demonstrate the effects of inactivation on populations of Bacillus spores detected by assays such as enzyme-linked immunosorbent assay (ELISA), PCR, and fluorescence-activated cell sorting.

      ***

      MATERIALS AND METHODS

      Growth and processing of Bacillus cultures.Inactivation and biodetection protocols were conducted using B. anthracis NNR1 (pX01+ pX02−), B. anthracis ΔAmes (pX01−pX02+), B. anthracis ΔSterne (plasmid free), and two negative controls,Bacillus subtilisstrain 1031 and Bacillus thuringiensis subsp. kurstaki. Bacillus cultures were generously provided by Alvin Fox (University of South Carolina Medical School) and Bruce Harper (Dugway Proving Grounds, Utah). …

      Frozen glycerol stock cultures were streaked for isolation onto Trypticase soy agar (TSA) plus 5% sheep blood (BD Biosciences, Cockeysville, Md.). Isolated colonies were streaked again for isolation onto TSA + 5% sheep blood and incubated at 37°C for approximately 6 h or until visible growth was evident.

      ***

      Following repeated washes, the three B. anthracis spore preparations and the B. subtilisstrain 1031 spore preparation approached 100% spore content with minimal cellular debris, while the B. cereus and B. thuringiensis subsp. kurstaki preparations were approximately 95% spores. Spore preparations that had been irradiated 60 min or more failed to grow when plated for viability following treatment. No growth was evident from spore preparations that had been autoclaved for 20 min or longer. All spore preparations were examined by phase-contrast microscopy. Spores inactivated by irradiation showed little visible change when compared to the untreated spore samples. However, autoclaved killed preparations showed an increase in the percentage of dark, nonrefractile spores.

      ***

      DISCUSSION

      The data demonstrate that inactivation methods can affect the sensitivity of nucleic acid-based detection and immunoassays for the detection of Bacillus spores. We have observed a differential effect based on the type of assay employed. The need to avoid handling and testing large amounts of potentially harmful spore preparations dictates that we understand the effects of inactivation procedures. We have studied two common spore inactivation procedures and demonstrated how they affect three types of biodetection assays. These effects should be taken into consideration when comparing laboratory results to data collected and assayed during field deployment.

      ***

      Comparisons of inactivated and viable pathogen data suggest that although the use of inactivated preparations is clearly preferable to working with viable pathogens in many circumstances, there may be variations in the results depending on the inactivation methods employed. Data presented using inactivated B. anthracisspore preparations should take into account such effects as sensitivity limits when citing characteristics of biodetection assays. The variations in response of DNA and antibody-based detection systems strongly support final testing of the viable threat agent as a supplement to inactivated testing.

      ***

      As the Chemical and Biological Treaty nears completion, these data have implications for the detection of weapons of mass destruction. The enforcement of any treaty relies upon the verification of compliance and the reliability of methods for determining if a facility has been or is engaged in the production of biological weapons. Our data show that inactivation can either diminish or enhance the ability to detect an agent of biological origin, depending on the assay or reagents employed. It should be noted that although inactivation of spores resulted in a reduction in detection signals for PCR-based assays, this technology is exquisitely sensitive and can detect as few as a single organism (9).

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