Media Citizen's Blog

Just another WordPress.com weblog

Project BioShield

leave a comment »

…”the BioShield proposal includes provisions for public health emergencies, not just bioterrorism threats. The idea of including public health emergencies in a BioShield makes sense, because infectious diseases that occur in nature can claim many lives, can even become bioterrorist agents if intentionally spread…”

..”Another provision permits products to be distributed without FDA approval.”

https://house.resource.org/108/org.c-span.175961-1.raw.txt

_______________________________

 

The Project BioShield Act of 2004 was signed on July 21, 2004 by GWBush. Its first order of business was reinstating the production of anthrax vaccine : VaxGen became the first recipient of BioShield funding to produce an alternative anthrax vaccine to BioPort’s ‘AVA’, the only available drug prophylactic which was improperly licensed and about to be downgraded to ‘voluntary’ inoculation by the US military.

>>Journalist Gary Matsumoto published the book “Vaccine A” http://www.vaccine-a.com/vaccine-a.pdf, which brought the deadly dangers of the vaccine and the squalene adjuvant to public attention <<

“The Centers for Disease Control and Prevention (CDC) considers Bacillus anthracis, the causative organism of anthrax, to be a category A potential bioterrorism agent. Anthrax vaccine adsorbed (AVA), which is made by BioPort (Lansing, Mich) under the name of Biothrax, is the sole licensed anthrax vaccine in the United States and has been available since 1970.”…”An analysis conducted by the Institute of Medicine found AVA to be safe, but the validity of that report has been sharply criticized by Meryl Nass, a family physician and strong opponent of the vaccine”..  http://ajph.aphapublications.org/cgi/content/full/97/11/1945
Mandatory military anthrax vaccines were suspended for two years between October 2004 and October 2006, when the DoD resumed mandatory vaccinations….. “The Pentagon is looking to set aside the decision of U.S. District Judge Emmet Sullivan, who ruled against mandatory vaccinations in October after finding that the Food and Drug Administration had not fully licensed the BioPort vaccine as effective against inhaled anthrax.” http://mbvic.blogspot.com/2005_05_01_archive.html
*
Project BioShield Report to Congress 2004
                                            ______________________________
http://cidrapbusiness.us/cidrap/content/bt/bioprep/news/may1005bioshield.html
 

May 10, 2005 (CIDRAP News) – Federal health officials yesterday announced 12 grants and contracts worth $27 million to support development of drugs and vaccines for botulism, anthrax, and other diseases that terrorists might try to spread…The grants are the first made by the National Institute of Allergy and Infectious Diseases (NIAID) under Project Bioshield, which Congress enacted last year to promote research on medical defenses against biological, chemical, radiological, and nuclear weapons.

……

The 10 Project Bioshield grant recipients, with the principal investigators and project goals, are as follows:

  • Scripps Research Institute, La Jolla, Calif.; Kim Janda, PhD; drugs to reverse the paralysis caused by botulinum toxin
  • Apath LLC, St. Louis; Paul Olivo, MD, PhD; new drugs for Ebola virus
  • Veterans Affairs San Diego Healthcare System; Karl Hostetler, MD; a new antiviral drug for smallpox
  • Arizona State University; Bertram Jacobs, PhD; ways to optimize the protective effect of smallpox vaccine when given after exposure to smallpox
  • Novobiotic Pharmaceuticals LLC, Cambridge, Mass.; Losee Ling, PhD; new drugs to combat Bacillus anthracis, the anthrax agent
  • Children’s Hospital Oakland Research Institute, Oakland, Calif.; Donald Reason, PhD; development of antibodies for use in postexposure anthrax treatment
  • Nanotherapeutics Inc., Alachua, Fla.; James Talton, PhD; single-dose inhalers to deliver two antibiotics for immediate postexposure protection against pneumonic plague and tularemia
  • University of Chicago, Wei-Jen Tang, PhD; a drug to block the action of anthrax edema toxin, which causes human cells to swell
  • MaxThera Inc., Reading, Mass.; Ania Knap, PhD; new antibacterial agents for a broad range of potential bioterror pathogens
  • Veritas Inc., Rockville, Md.; George Oyler, MD, PHD; tests to screen tens of thousands of drugs to find those that inhibit the activity of botulinum toxin

The two companies receiving contracts are as follows:

  • XOMA (US) LLC, Berkeley, Calif.; Marc Better, PhD; development of antibodies to protect against botulinum toxin type A
  • DVC Dynport LLC, Frederick, Md.; Ian Henderson, PhD; production of a candidate vaccine against botulinum toxin type E

_____________

http://www.nih.gov/news/pr/may2005/niaid-09.htm    “NIAID also announced today the appointment of Michael G. Kurilla, M.D., Ph.D., to the dual positions of NIAID Associate Director for Biodefense Product Development, and Director of the Office of Biodefense Research Activities within NIAID’s Division of Microbiology and Infectious Diseases. Dr. Kurilla’s primary role will be to provide overall Institute coordination for advanced product development of medical countermeasures against bioterror threats. His appointment was made using Bioshield authorities that enable NIAID to streamline the hiring of qualified scientists to carry out the national medical countermeasure research and development program. For more information on Project Bioshield, visit http://www2.niaid.nih.gov/Biodefense/Public/projectbioshield.htm.”

>>Company and personnel profiles on these BioShield grantees/contractors is listed lower on this page<<

Michael G. Kurilla, MD and PhD from Duke U., faculty at UVirginia; authored the science fiction book “Titan” http://www.amazon.com/review/R3LW07Q7AB7B8X

________________________________________

________________________________________

Since the 2001 terrorist attacks on the United States, the U.S. government has spent or allocated nearly $50 billion among 11 federal departments and agencies to address the threat of biological weapons. For Fiscal Year 2009 (FY2009), the Bush Administration proposes an additional $8.97 billion in bioweapons-related spending, approximately $2.5 billion (39%) more than the amount that Congress appropriated for FY2008. U.S. funding for bioweapons-related activities focuses primarily on research, development, and acquisition of medical countermeasures. Additionally, significant biodefense funding goes to purchasing protective equipment, enhancing medical surveillance and environmental detection of biological weapons agents, and improving state, local, and hospital preparedness. The increase in bioweapons related funding in FY2009 is primarily attributed to Project BioShield, a ten-year program to acquire medical countermeasures to biological, chemical, radiological and nuclear agents for civilian use, which will receive an additional $2.175 billion as a result of FY2004 legislation. However, a notable change in funding also appears in the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services, which more than doubles in FY2009. Finally, funding for activities aimed at prevention has more than doubled since FY2007″…
                                  ___________________________________________
                                          __________________________________
VaxGen was the first company to receive a contract under Project BioShield, in 2004, with an $877 million ‘award’.
May 2008, VaxGen sells its anthrax vaccine patent to Emergent BioSolutions. The VaxGen patent was co-invented by Bruce E. Ivins, the last and only suspect in the 2001 post-9/11  anthrax attacks. Shortly after Ivins’s “suicide”, reported August 1, 2008, the anthrax attacks case was closed.
>>see the Bioweapons page for more on the anthrax attacks<<
“The Los Angeles Times reported last December [2007] that a lobbying campaign by Emergent had been a factor in the HHS decision to cancel the VaxGen contract. Emergent has a second-generation anthrax vaccine candidate of its own, called rPA 102. Like VaxGen’s vaccine, its active ingredient is a recombinant form of protective antigen (rPA), an anthrax protein.
VaxGen spent more than $175 million to develop the vaccine, the Post reported. The story said the company laid off three quarters of its remaining 22 employees last month.
   Emergent produces BioThrax—also known as Anthrax Vaccine Adsorbed [AVA]—the licensed anthrax vaccine, developed in the 1950s. The product, which is required for US military personnel serving in high-risk areas such as the Middle East, is given in six doses over 18 months, followed by an annual booster. A number of service members have complained of serious side effects from the vaccine, and it was the subject of a long court battle after some sued to stop the program.”
Emergent BioSolutions — US headquarters in Rockville, Maryland, also known as BioPort of Lansing Michigan — CEO/Chairman, Fuad El-Hibri (from May of 1998 to June of 2004)
*
BioPort was formed in 1998 to take over the assets of the state-owned Michigan Biological Products Institute (MBPI) in Lansing, Mich, the only facility in the United States that had been producing the vaccine. BioPort paid $3.28 million in cash for MBPI, financing the rest of the $25 million cost with loans from the state of Michigan. Eleven days after the sale was finalized, in September 1998, DOD awarded BioPort a $45 million contract to supply anthrax vaccine to the US armed forces. The contract required the government to pay for up to 75% of the cost of the vaccine, even if the vaccine failed to be licensed for use.”….
In 2001, Congress and the Pentagon considered terminating theBioPort contract. A report from DOD on possibly cancelingthe contract was due in September of that year.It was notedthat ending the contract would cripple Bioport.  On December27, 2001, the company received FDA approval to resume licensedproduction.”….
“There is little public information available about the controllingowners of BioPort. The CEO declined to return calls from ABCNews reporters inquiring about Intervac and I & F Holdings.Similarly, the company has declined to answer questions froman American newspaper. The American public’s only newssources on BioPort are a brief laudatory interview with El-Hibriin USA Today  and a short item in the Washington Post.   http://ajph.aphapublications.org/cgi/content/full/97/11/1945
*
In June of 2004, internal reorganization caused BioPort to change its name to Emergent BioDefense Operations Lansing, Inc., as a wholly-owned subsidiary of Emergent BioSolutions.
*
“Emergent BioSolutions sells only one product, an anthrax vaccine called BioThrax, to only one customer, the federal government.”…[June 2006] http://query.nytimes.com/gst/fullpage.html?res=940DE3DA1630F936A15755C0A9609C8B63
*
“Thousands of Gulf War I veterans were poisoned by depleted uranium and the same BioPort vaccine under George H.W. Bush and later under Bill Clinton.  In October of 2003, 80.3 million tax dollars were spent in ordering VaxGen Inc. to develop an experimental anthrax vaccine…. http://www.sourcewatch.org/index.php?title=Emergent_BioSolutions
>>see the VaxGen and BioPort pages for more of the story<<

                                ___________________________________________

June 24, 2006
Bioworld Today
By Aaron Lorenzo
Washington Editor

“The federal government agreed to pay $165 million to Human Genome Sciences Inc. under a contract to supply ABthrax (raxibacumab) to the Strategic National Stockpile……..The award, made under the Project BioShield Act of 2004, was meted out by the Department of Health and Human Services. It follows on the heels of another BioShield contract announced earlier this month, a $362 million award for a botulism treatment from Cangene Corp., of Winnipeg, Manitoba. (See BioWorld Today, June 2, 2006.)”

ABthrax’s efficacy has been demonstrated in multiple animal models,… safety and tolerability has been shown in a Phase I trial that involved 105 healthy adult volunteers. The government decided to move forward with the order after reviewing those findings in conjunction with its own comparative laboratory testing of ABthrax that HGS supplied in October.

The company will produce ABthrax in its manufacturing facilities in Rockville, a 130,000-square-foot site at which it has developed required assays and a scalable purification process…. HGS also will complete additional laboratory and clinical testing required to support a biologics license application with the FDA, and to support the use of ABthrax in patients with inhalational anthrax disease in the event of an emergency prior to agency approval.

“We expect to meet very soon with regulatory authorities to confirm their agreement with the program that we’ve designed,” David Stump, the company’s executive vice president of drug development, said in the conference call….The FDA has conferred fast-track and orphan drug status on the product, which was the first investigational agent against anthrax infection to be evaluated in a clinical study following the 2001 anthrax attacks in the U.S. A human monoclonal antibody to Bacillus anthracis protective antigen, it was discovered and developed by HGS using technology integrated into the company as part of a collaboration with Cambridge Antibody Technology plc, of Cambridge, UK.”

Human Genome Sciences Inc.  http://www.hgsi.com/ of Rockville, Maryland

http://www.hgsi.com/board-of-directors.html
Chairman, Argeris N. Karabelas
CEO/pres., H. Thomas Watkins
*
Cambridge Antibody Technology, plc http://www2.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/06-22-2006/0004385488&EDATE=, CEO Hamish Cameron;
Chairman of CAT Limited, Dr. John Patterson;
acquired by AstraZeneca in 2006
*
Cangene Inc.
APOTEX – Ontario, Canada; Canada’s largest producer of generic drugs; owns 61% of Cangene (US BioShield funding contractor); CEO/Chairman, Bernard Sherman http://en.wikipedia.org/wiki/Apotex
“Bernard Sherman controls Apotex Group which includes Apotex Holdings Inc, Apotex Inc, Apotex Research Inc. and Apotex Holdings Inc. indirectly through the Bernard and Honey Sherman Family Trust, of which he is the Trustee. Dr. Sherman is a director and President of Sherman Foundation and as such controls its holdings indirectly. At October 27, 2005, Dr. Sherman held or controlled 80% of Cangene’s common stock”.

“Cangene Corporation owns 100% of the voting securities of Cangene U.S. Incorporated (“Cangene U.S.”), which is incorporated in the State of Delaware in the United States. Cangene U.S. owns 100% of the voting securities of Chesapeake Biological Laboratories, Inc. (..”CBL”, Baltimore), which is incorporated in the state of Maryland…Cangene U.S. also owns 100% of Biotherapeutic Laboratories, Inc. in [Van Nuys] California and Mid-”Florida Biologicals, Inc. that has operations in [Altamonte Springs] Florida and [Frederick] Maryland. Cangene operates an office in the U.K., Cangene Europe Limited (U.K.)” http://www.cangene.com/pdf/2005/aif05.pdf

_________________________________________

_______________________________________

Company profiles from the May,10, 2005 list of grantees and contractors above:

GRANTEES

#1, Scripps Research Institute, La Jolla, Ca.
____
#2, Apath LLC, St. Louis, Mo.; founded 1997 and based in Brooklyn New York; founder Dr. Charles M. Rice http://investing.businessweek.com/research/stocks/private/snapshot.asp?privcapId=9860872; Dr. Rice is a lab chief at Rockefeller Univ. http://www.rockefeller.edu/research/faculty/abstract.php?id=143; “Head of the Laboratory of Virology and Infectious Disease at The Rockefeller University. He is one of the world’s most accomplished virologists and a prominent figure in research on members of the Flaviviridae including hepatitis C virus (HCV).” http://www.hepccenter.org/rice.php
–West Nile Virus, which entered North America in 1999, is a flavivirus http://en.wikipedia.org/wiki/Flaviviridae
____
#3, Veterans Affairs, San Diego
____
____
#5, Novobiotic Pharmaceuticals LLC, Cambridge, Mass.;  founded in 2003 by Kim Lewis, Slava Epstein and Aram Salzman with a novel method for culturing previously unculturable microbes http://www.novobiotic.com/about.htm; management http://www.novobiotic.com/team.htm
____
#6, Children’s Hospital Oakland Research Institute (CHORI), program leader Donald C. Reason; BioShield funds were granted for anti-anthrax protocols. Sample study citation of Dr. Reason’s work: http://www.biology-direct.com/content/1/1/24
 ____
#7, Nanotherapeutics Inc., Alachua FL;
Nanotherapeutics http://www.nanotherapeutics.com/about_management.php; founded 1999;  $50 million plus inUS funding provided for aerosol vaccines for plague, tularemia, and smallpox, under the direction of David L. Gardner in contract with Gilead Sciences  http://nanotechwire.com/news.asp?nid=8442&ntid=&pg=54
____
#8, University of Chicago
____
#9, Max Thera Inc., Reading, Mass. (Boston); founded in 2005 by its principal scientists and shareholders, Ania Knap and Roger Frechette, veteran pharmaceutical industry drug developers. Max Thera was acquired in Nov.2009 by Australian company Biota Holdings Ltd., developer of Relenza http://www.biota.com.au/uploaded/154/1021588_89biotatoacquiretheantiba.pdf ; Biota’s directors http://www.biota.com.au/?page=1021000&subpage=1021167
____
#10, Veritas Inc, Rockville MD.
President George A. Oyler –medical license revoked for drugging and drinking, Nov.2003
http://www.mbp.state.md.us/forms/Nov_Dec03_sanctions.pdf ; 2009 – president of Synapic Research LLC, George A. Oyler http://www.synapticresearch.com/ , specializing in ubiquitin applications: “Ubiquitin is the subject of intense research in a number of biomolecular fields because researchers believe that control of ubiquitin could allow treatment of diseases by selectively destroying disease-causing proteins. Synapic Research is working to develop a “designer ubiquitin ligase” engineered to attach ubiquitin to a target protein of choice”
UBIQUITIN
Home > Library > Animal Life > Veterinary Dictionary  “Heat shock (cell stress) protein present in mammalian cytosol; attaches to other cytosolic proteins and marks them for degradation either by specific proteases or by lysosomal enzymes.” http://www.answers.com/topic/ubiquitin
______________
CONTRACTORS
*
#11, XOMA LLC, Berkeley, CA
Founded by Patrick J. Scannon, member of DARPA’s advisory board; CEO/Chairman Steven B. Engle http://www.xoma.com/company/executive-team/#item1   XOMA’s Board of Directors http://www.xoma.com/company/board-of-directors/
Steven B. Engle was the former Pres/CEO of La Jolla Pharmaceutical Co., and board member of the Lupus Foundation of America
____
#12, DVC Dynport LLC, Frederick, MD; DynPort Vaccine Company was founded in 1996 by Dr. Zsolt Harsanyi, president of Porton International (1983-2004) founder of Exponential Biotherapies, director of BioPort/Emergent BioSolutions, co-investor with George Soros, and chairman of the American Hungarian Foundation.  http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-emergentbio_pf&ID=158311  >>see the BioPort page<< Dynport  was “a joint venture between CSC [Computer Sciences Corporation] and Porton International”

Written by citizen2009

January 26, 2010 at 8:37 pm

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

%d bloggers like this: