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

* Katherine Heerbrandt: the location of biological agents is top secret in Maryland … including the anthrax lab at the Southern Research Institute’s facility in Frederick, Maryland … why?

Posted by Lew Weinstein on April 1, 2011

******

drug discovery research at Southern Research Institute

******

see prior posts …

* Dr. Bruce Ivins, upon the poor quality of Dugway spores being produced, and given that he did not trust Battelle to do the spores, thought Southern Research Institute was a possibility

* when did Southern Research Institute (SRI) first obtain virulent Ames and from whom?

******

Katherine Heerbrandt wrote in Gazette.com (3/28/11) …

  • Maryland state law mandates that the number and location of labs which handle dangerous pathogens  remains confidential, including the Souther Research Institute lab in Frederick. 

read the entire article at … http://www.gazette.net/stories/03282011/frednew161459_32575.php

******

About Southern Research …

  • Southern Research is a self-sustaining contract research organization and an incorporated affiliate of The University of Alabama at Birmingham (UAB).
  • As a leading contract research organization, Southern Research provides preclinical drug development services to pharmaceutical and biotechnology companies on an outsourced basis. Southern Research provides services in all phases of the early-stage drug discovery and development process and provides clients with comprehensive services and support to assist them in streamlining their custom drug discovery and development programs.
  • Southern Research and  its staff are recognized internationally for the discovery and evaluation of anticancer therapeutics and the evaluation of antiviral and antimicrobial drugs, biologics, and vaccines.
  • One of Southern Research’s labs is located at 431 Aviation Way, Frederick, MD
  • Infectious Disease Vaccine Development
    • Available Animal Models for NIAID Category A-C Pathogens

Anthrax – NHP, mouse, and rabbit

Inhalational anthrax – mouse and rabbit

NOTE: all of the above is from the Southern Research Institute’s web site at http://www.southernresearch.org/

LMW COMMENT …

  • So many secrets in this anthrax case.
  • The Maryland law is insane.
  • Any facility that works with dangerous pathogens should be known to the public which lives near it and regulated by appropriate public health agencies.
  • If there is not adequate security to protect the lab from unwanted intruders, the lab should not be in business.

So why does the Maryland secrecy law exist?

what is the history of the law?

who was behind its adoption?

******

About these ads

7 Responses to “* Katherine Heerbrandt: the location of biological agents is top secret in Maryland … including the anthrax lab at the Southern Research Institute’s facility in Frederick, Maryland … why?”

  1. DXer said

    For whatever reason, FBI Director Mueller could not name the lab in addition to Battelle and Dugway that worked with virulent Ames in powdered form.

  2. DXer said

    Is GAO being hampered by the Maryland state law that makes the location of work with the anthrax classified?

  3. DXer said

    Our main interest, it would seem, is what labs in Maryland existed that worked with virulent Ames.

    Were there labs in Maryland working on the anthrax vaccine?

    Let’s consider what we know about non-Ivins, non-Bioport anthrax vaccine research in August 2001 so as to see whether vaccine literature or information would point to some lab in Maryland.

    http://www.ctnow.com/news/local/hc-fda1018.artoct19,0,7233036.story?coll=hc%2Dheadlines%2Dlocal

    FDA Halts Use Of Old Anthrax Vaccine
    October 19, 2002
    By THOMAS D. WILLIAMS, Courant Staff Writer

    As the U.S. gears up for a potential confrontation with Iraq, the U.S. Food and Drug Administration has halted use of older lots of the military’s anthrax vaccine, and officials acknowledge that the vaccine is riskier than once thought.

    In August, the FDA acknowledged that the vaccine manufacturer’s license needed to be updated. That was seven months after the agency ordered that new warnings for consumers be included in the vaccine’s insert package. It said the vaccine could harm people with immunity disorders, could cause a host of serious long-term adverse reactions and could already be responsible for six deaths and a number of birth defects.

    The warnings, developed from complaints by military vaccine users since 1998, state that adverse reactions are expected in 5 percent to 35 percent of people who take the injection. That compares with the previous expected rate of 0.2 percent, established many years ago.

    But the label represents more than a simple warning. It is tantamount to an FDA admission of a licensing problem that began in 1985 and remains unresolved today.

    The Department of Defense has said it is developing a new anthrax vaccine to respond to the concerns connected to the one in use now, but it asserts that the vaccine is both safe and effective.

    In 1985, the FDA began reviewing the anthrax vaccine’s manufacturing process to ensure it complied with federal rules for drugs. Recently, the FDA conceded to two Connecticut Air Force Reserve pilots that the review was never completed. The FDA told Maj. Russell Dingle and Maj. Thomas Rempfer that it would accomplish this, but didn’t set a deadline to do so.

    Dingle, of East Hartford, and Rempfer, of Suffield, who jointly filed a citizen petition with the FDA and a federal lawsuit against the manufacturer challenging the vaccine, said they don’t truly expect the FDA to review the process again. That is because if the agency does, they said, it will have to stop licensing the drug. The central problem is that the drug was never properly tested, said the two pilots, who have been researching the drug since they were ordered to take it while in the Air National Guard in 1998.

    Manufacturers apply for drug licenses with the FDA after testing their products on volunteers. The FDA reviews the tests, the vaccine’s safety and effectiveness and the manufacturing process before approving the license to manufacture the vaccine.

    In 1970, Merck, a pharmaceutical company, obtained the initial federal license to produce the anthrax vaccine. It eventually stopped manufacturing the drug.

    In the 1970s and 1980s, the Pentagon began sponsoring the manufacturing of the vaccine through the state of Michigan’s health department. It used the old Merck testing data, collected from volunteers working in sheep wool mills, to justify the safety and effectiveness of the Michigan-manufactured vaccine.

    Because the FDA never properly scrutinized this testing, and because the manufacturing process was changed in 1990, said Dingle and Rempfer, the drug simply is not properly licensed.

    And its latest adverse reaction rate, they said, shows the vaccine is indeed different from the one tested by Merck.

    In 1998, BioPort Corp. of Lansing, Mich., purchased the state of Michigan’s manufacturing operation and all of its vaccine, then used it to inoculate the first 500,000 of the 2.4 million service members ordered to take it. In the meantime, BioPort sought approval to produce its own new batches of the vaccine.

    In January, the FDA approved BioPort’s facilities and its vaccine manufacturing processes after four years of failed federal inspections and infusion of millions of more taxpayer dollars for plant improvements.

    As a result of Dingle’s and Rempfer’s challenge to the vaccine, the FDA said only the new BioPort batches can be used. In June, the Pentagon had ordered both the old and BioPort’s newer vaccine to be used, in high threat areas only.

    Because of the FDA’s concession that the old vaccine, manufactured by the state of Michigan and sold by BioPort, was not properly tested for safety and effectiveness, Rempfer and Dingle said, the Defense Department should now promptly pardon hundreds of service members punished for refusing to be inoculated with that vaccine. They insist the department should also properly care for the hundreds who became ill from adverse effects of the vaccine.

    • DXer said

      In terms of setting the stage for the period August-September 2001 and the question of anthrax vaccine research, let’s turn to the GAO reports and the testimony of FDA and DOD officials and others before Congress.

      http://www.gao.gov/products/T-NSIAD-00-140

      Contract Management: DOD’s Anthrax Vaccine Manufacturer Will Continue to Need Financial Assistance

      T-NSIAD-00-140 April 14, 2000
      Full Report (PDF, 7 pages)

      Summary

      The Defense Department (DOD) considers the use of anthrax by enemy forces to be the single greatest biological threat to U.S. troops. BioPort, the only company licensed by the Food and Drug Administration to produce the anthrax vaccine in the United States, has experienced financial difficulties that have jeopardized the military’s anthrax vaccination program. In response to the company’s problems, DOD has provided BioPort with financial assistance. This testimony discusses (1) the financial assistance DOD provided BioPort in 1999 and (2) the additional financial assistance DOD is providing BioPort in 2000.

      GAO noted that: (1) last year, DOD provided BioPort financial assistance so that the company would have sufficient operating capital to preclude disrupting, and possibly ending, the anthrax vaccine program; (2) among other things, DOD substantially increased the original contract price and provided an interest-free advance payment to BioPort of $18.7 million; (3) in providing the assistance, DOD believed the Food and Drug Administration (FDA) would approve the company’s vaccine production processes in its renovated facilities by the end of 1999; (4) however, in November 1999, FDA reviewed the company’s manufacturing processes and identified numerous deficiencies; (5) according to DOD officials, BioPort is now not expected to obtain FDA approval until the end of 2000; (6) the delay in obtaining FDA approval has caused BioPort to experience continuing financial problems; (7) recognizing the company’s financial difficulties, DOD has taken a number of additional actions to help improve BioPort’s financial situation; (8) in February 2000, DOD modified BioPort’s contract to provide an additional amount of almost $12 million to, in part, hire technical assistance for obtaining FDA approval; (9) DOD also extended the schedule for BioPort to repay the interest-free advance payment and returned about $7.4 million that the company had repaid; (10) in March 2000, DOD notified BioPort that it wants BioPort to stop anthrax vaccine production for now; (11) this action reduces DOD’s risk of paying for vaccine that the FDA may ultimately not approve and also allows BioPort to focus on obtaining FDA approval; (12) however, the company’s financial condition is worsened because BioPort will no longer receive revenues from producing the vaccine; and (13) to mitigate the consequences of its actions, DOD intends to provide additional financial assistance to BioPort to sustain the production line.

      • DXer said

        http://www.gao.gov/products/GAO-07-333R

        Biological Research Laboratories: Issues Associated with the Expansion of Laboratories Funded by the National Institute of Allergy and Infectious Diseases

        GAO-07-333R February 22, 2007
        Full Report (PDF, 23 pages) Accessible Text

        Summary

        The fall 2001 anthrax attacks revealed gaps in the nation’s preparedness for public health emergencies resulting from bioterrorism. Among the tools needed for responding to such emergencies are vaccines to prevent the spread of disease; tests for rapid diagnosis; and therapeutics, including drugs, for treatment. Because the pathogens that could be used in bioterrorist attacks carry the risk of significant morbidity or are potentially lethal, biological research aimed at providing the tools needed to combat these agents is required to be conducted in facilities known as biocontainment laboratories. These facilities are to be designed, constructed, and operated in a manner to prevent accidental release of infectious or hazardous agents within the laboratory and to protect laboratory workers and the environment external to the laboratory, including the community, from exposure to these research materials. The National Institute of Allergy and Infectious Diseases (NIAID) is the primary institute at the Department of Health and Human Services’ (HHS) National Institutes of Health (NIH) that is responsible for research on pathogens that could be used in a bioterrorist attack and for research on emerging infectious disease pathogens. The Centers for Disease Control and Prevention (CDC) is also responsible for research on such pathogens. Following the anthrax attacks, NIAID expanded its research program to emphasize biodefense research. In February 2002, it issued the NIAID Strategic Plan for Biodefense Research, which outlined a need for research aimed at the development of vaccines, diagnostics, and therapeutics and construction of additional biocontainment laboratories in which to conduct the research. According to NIH, a shortage of high-level biocontainment laboratories exists. In response to the Strategic Plan, NIAID established the National Biocontainment Laboratory (NBL) and Regional Biocontainment Laboratory (RBL) construction programs. The overall objective of the NBL construction program is to provide funding to design and construct state-of-the-art biosafety level (BSL) 4, 3, and 2 laboratories, including associated research and administrative support space, and the objective of the RBL construction program is to provide similar facilities containing BSL-3 and -2 laboratories. As of January 2007, the NBLs and RBLs are at various stages of design and construction and are not yet operational. Because the deliberate or accidental release of biological pathogens from a biocontainment laboratory could have disastrous consequences, concerns exist about the oversight of these laboratories. This report responds to Congress’s November 30, 2005, request that we provide information associated with the construction of NBLs and RBLs funded by NIAID in fiscal years 2003 and 2005. Congress’s questions covered requirements and guidance for these laboratories, funding award factors, communication with the public, and research agendas. Enclosure I provides background information for these questions and our answers to the questions, enclosure II provides lists of infectious agents with the potential to be used in bioterrorism, and enclosure III provides examples of regulations and guidelines applicable to NBL and RBL operations and security procedures.

    • DXer said

      http://www.gao.gov/products/GAO-02-181T

      Anthrax Vaccine: Changes to the Manufacturing Process

      GAO-02-181T October 23, 2001
      Full Report (PDF, 11 pages)

      Summary

      The original anthrax vaccine was developed in the 1950s and was first produced on a large scale by Merck. The BioPort Corporation in Michigan is now the sole facility in the United States capable of producing the vaccine. The Food and Drug Administration (FDA) licenses biological products and their production facilities. The manufacturer is required to comply with current good manufacturing practices, which regulate personnel, buildings, equipment, production controls, records, and other aspects of the vaccine manufacturing process. When there is a major change in the manufacturing process, the manufacturer must submit evidence to FDA showing that the change does not have any adverse effects. The manufacturer must also ensure that the quality of the product is maintained. In the case of the anthrax vaccine, the Michigan facility did not notify FDA of several changes to the manufacturing process in the early 1990s, and no specific studies were done to confirm that vaccine quality was not affected. FDA inspections found several deficiencies, many of which were not corrected in a timely manner.

      • DXer said

        “To conduct our work, we reviewed documents provided to us by FDA, DOD, and the Michigan facility/BioPort Corporation pertaining to the anthrax vaccine. In addition, we reviewed published and unpublished scientific reports on anthrax vaccine and on the safety and efficacy of the vaccine. In addition, we interviewed officials of FDA, DOD, the Michigan facility/BioPort, and experts in anthrax vaccine in U.S. and the U.K.”

        citing related GAO publications

        Gulf War Illnesses: Questions About the Presence of Squalene Antibodies in Veterans Can Be Resolved (GAO/NSIAD-99-5, Mar. 29, 1999).

        Medical Readiness: Safety and Efficacy of the Anthrax Vaccine (GAO/T- NSIAD-99-148, Apr. 29, 1999).

        Contract Management: Observations on DOD’s Financial Relationship with the Anthrax Vaccine Manufacturer (GAO/T-NSIAD-99-214, June 30, 1999).

        Medical Readiness: Issues Concerning the Anthrax Vaccine (GAO/T- NSIAD-99-226, July 21, 1999).

        Anthrax Vaccine: Safety and Efficacy Issues (GAO/T-NSIAD-00-48, Oct. 12, 1999).

        Medical Readiness: DOD Faces Challenges in Implementing Its Anthrax Vaccine Immunization Program (GAO/-NSIAD-00-36, Oct. 1999).

        Medical Readiness: DOD continues to Face Challenges in Implementing Its Anthrax Vaccine Immunization Program (GAO/T-NSIAD-00-157, Apr. 2000).

        Gulf War Illnesses: Questions About the Presence of Squalene Antibodies in Veterans Can Be Resolved (GAO/NSIAD-99-5, March 29, 1999).

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

 
Follow

Get every new post delivered to your Inbox.

%d bloggers like this: