Emergent BioSolutions Inc. formerly BioPort
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Fuad El-Hibri
Executive Chairman of the Board of Directors
Mr. El-Hibri is the founder and executive chairman of the board of Emergent BioSolutions Inc. He served as Emergent’s chief executive officer since its inception in September 1998 until March 2012. His career in life sciences began in the early 90s with Porton Products, Ltd., a private biotechnology company in the U.K. Mr. El-Hibri organized and co-directed a management buyout of Porton and formed Speywood Holdings, Ltd., a recapitalized biopharmaceutical company with marketed biologics pr...
Daniel J. Abdun-Nabi
President and Chief Executive Officer
Mr. Abdun-Nabi has served as chief executive officer since April 2012, as president since March 2007, and as a board member since May 2009. He previously served as chief operating officer from May 2007 through March 2012. Mr. Abdun-Nabi served as senior vice president corporate affairs and general counsel from December 2004 to April 2007, secretary from December 2004 to January 2008, and vice president and general counsel from May 2004 to December 2004. Prior to joining the company, Mr. ...
A. B. Cruz III
Executive Vice President & General Counsel
Mr. Cruz has served as executive vice president and general counsel, Legal Affairs division since December 2013. Prior to joining the company, Mr. Cruz, as a Rear Admiral in the U.S. Navy Reserve, served as the Deputy Director of Maritime Operations at U.S. Fleet Forces Command in Norfolk, VA from 2012 to 2013. Prior to that, Mr. Cruz served as chief legal officer and corporate secretary of Scripps Networks Interactive from 2008 to 2012, and executive vice president and general counsel of The...
Adam R. Havey
Executive Vice President and President, Biodefense Division
Mr. Havey has served as executive vice president and president, Biodefense Division since December 2011, and as executive vice president Biodefense Division since March 2011. He previously served as president of Emergent Biodefense Operations Lansing from January 2009 to February 2011 and vice president of business operations from November 2007 to December 2008. Mr. Havey previously served as senior director manufacturing development from June 2006 to November 2007, as director, facilities, reso...
W. James Jackson, Ph.D.
Senior Vice President and Chief Scientific Officer
Dr. Jackson has served as senior vice president and chief scientific officer since February 2008. Dr. Jackson served as vice president technical support from June 2007 to February 2008 and vice president commercial development from April 2005 to June 2007. Prior to joining the company, Dr. Jackson served as president, Antex Biologics Research and Development Corporation from January 2004 to May 2005. Dr. Jackson served in various research and development positions at Antex Biologics Inc, a biote...
Barry Labinger
Executive Vice President and President, Biosciences Division
Mr. Labinger has served as executive vice president and president, Biosciences Division since August 2013. Prior to joining the company, Mr. Labinger served as executive vice president and chief commercial officer at Human Genome Sciences, Inc. from 2005 to 2012. He has held a number of executive positions, including global head of 3M Pharmaceuticals from 2002 to 2005, and senior vice president and general manager commercial operations, and vice president, Enbrel
Paula M. Lazarich
Senior Vice President Human Resources
Ms. Lazarich has served as senior vice president human resources since March 2011. Ms. Lazarich served as vice president human resources from November 2005 to March 2011. Prior to joining the company, Ms. Lazarich served as vice president human resources for Cardinal Health from 1999 to 2005. Ms. Lazarich served as director human resources for The Mcgraw-Hill Companies from 1993 to 1999, for Datapro Information Services from 1993 to 1996, and for Freedom River, Inc d.b.a. Budget Rent a Car from ...
Allen Shofe
Executive Vice President and President, Corporate Affairs Division
Mr. Shofe has served as executive vice president, Corporate Affairs Division since April 1, 2013. Previously, he served as senior vice president corporate affairs since August 2010. Mr. Shofe served as senior vice president public affairs from January 2008 to August 2010, vice president public affairs from May 2007 to January 2008, and vice president government affairs from 2005 to 2007. Prior to joining the company, Mr. Shofe served as director, federal government affairs for Eli Lil...
Board of Directors
Fuad El-Hibri
Executive Chairman
Daniel J. Abdun-Nabi
Director
Dr. Sue Bailey
Director
General George A. Joulwan
Director
Zsolt Harsanyi, Ph.D.
Director
John E. Niederhuber, M.D.
Director
Ronald B. Richard
Lead Independent Director
Louis W. Sullivan, M.D.
Director
Marvin L. White
Director
Daniel J. Abdun-Nabi
Dr. Sue Bailey
Fuad El-Hibri
Zsolt Harsanyi, Ph.D.
General George A. Joulwan
John E. Niederhuber, M.D.
Ronald B. Richard
Louis W. Sullivan, M.D.
Marvin L. White
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Wikipedia - Emergent BioSolutions, Archived,
Wikipedia - Anthrax attacks of 2001
Wikipedia - Anthrax toxin
Wikipedia - Anthrax Vaccine Immunization Program
Wikipedia - Biotechnology
Wikipedia - Companies listed on the New York Stock Exchange (E)
Wikipedia - List of pharmaceutical companies
Wikipedia - List of vaccine topics
Wikipedia - Pharmaceutical industry
Wikipedia - Fuad_El_Hibri
Wikipedia - Allen_ Shofe
El-Hibri Foundation,
Anthrax Attack Challenged, by Dahbud Mensch,
democraticunderground, Anthrax911Gate
Bin Laden Profits from US Anthrax Vaccine Manufacture?, by Ian Gurney, Author of "The Cassandra Prophecy."
Anthrax and 9/11
Index of What Really Happened
9/11 Index of What Really Happened,
The LaGuardia Incident,
The mysterious deaths of top microbiologists,
The 9/11 Anthrax Frame-Up,
A quick note about anthrax,
Why send anthrax specifically to the media and congress?,
The FBI Anthrax Attacks Cover-Up,
The Great Anthrax Stock Swindle,
Bin Laden Profits from US Anthrax Vaccine Manufacture?,
MedicalCountermeasures.gov, U.S. Department of Health & Human Services, Biomedical Advanced Research and Development Authority (BARDA).
June 17 2003, Business Wire, (Press release) MdBio Foundation Names New Board Members; Executives from BroadOak Capital Partners, Cardiocore and Emergent BioSolutions Join 15 Member Board,
http://www.fiercebiotech.com/story/donald-r-joseph-named-chief-legal-officer-kalobios/2013-06-21
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November 27, 1996, Newsday, page A4, Undisclosed Connection; Scientist On Gulf War Syndrome Linked To Supplier Of Iraqi Anthrax, by Patrick J. Sloyan, Archived,
December 10, 1996, Washington Post, page A1, Gulf War Syndrome; New Look Urged on Gulf Syndrome, by Philip Shenon, Archived,
January 25, 1998, The Observer, page 3, Iraqis given anthrax secrets by Porton Down scientists, by Shyam Bhatia, Archived,
February 16, 1998, Los Angeles Times, Some See Hypocrisy in U.S. Stand on Iraq Arms; Mideast: Officials say American intelligence aided Baghdad's use of chemical weapons against Iran in '80s, by Robin Wright, Times Staff Writer,
February 22, 1998, CBS News - 60 Minutes, Profile: Helping Saddam; Iraqi government ordered anthrax and botulism-producing bacteria from United States in late 1980s, by Morley Safer, Archived,
September 26, 2001, Biloxi Sun Herald, Extremists applaud attacks; Some groups see themselves at war with government, by Jim Nesbitt,
October 10, 2001, AP - The Michigan Daily, Anthrax producer cancels community meeting, Archived,
October 15, 2001, AP - The Michigan Daily, Anthrax vaccine manufacturer seeks to gain approval of FDA, Archived,
October 16, 2001, Seattle Post-Intelligencer, Anthrax threat comes to Congress; Powder tests positive in Senate majority leader's office, by Charles Pope,
October 18, 2001, New York Daily News, U.S. Hate Groups Seen As Bioterror Suspects, by Paul H.B. Shin,
October 21, 2001, Sun Sentinel, Agencies Begin To Work In New Way -- Together,
October 23, 2001, Sun Sentinel, FBI Centralizing Its Anthrax Investigation In Washington,
October 26, 2001, New York Times, Bin Laden Family Liquidates Holdings With Carlyle Group, by Kurt Eichenwald,
October 27, 2001, Washington Post, FBI and CIA Suspect Domestic Extremists; Officials Doubt Any Links to Bin Laden, by Bob Woodward and Dan Eggen,
October 27, 2001, New York Times, Firm Missing $105 Million and Executives After Attacks, by David Cay Johnston and William K. Rashbaum,
November 1, 2001 New York Post, Pre-9/11 'Terrorist' Mail Came From Indy, by Murray Weiss,
November 2, 2001, Sun Sentinel, Russians Dismantle Germ Warfare Plant,
November 5, 2001, New York Times, An Energized Brokaw Is in the Middle of the Story, by Bill Carter,
November 6, 2001, New York Times, The Funeral; A Farewell to a Victim of Anthrax, by Alan Feuer,
November 6, 2001, New York Times, Science Times; Evicting an Unwelcome Tenant: Anthrax, by Andrew C. Revkin,
November 7, 2001, New York Times, The Mystery: Detectives Ask for Help in Tracing Victim's Steps, by Andrew C. Revkin,
November 8, 2001, New York Times, The Disease: Worker Who Died Suspected Anthrax Was Root of Illness, by David E. Rosenbaum,
November 12, 2001, AP - The Michigan Daily, Anthrax vaccine producer protested by 40 in Lansing, Archived,
November 20, 2001, New York Times, Bioterror: U.S. Calls for Global Action to Counter Germ Weapons, by Elizabeth Olson,
November 20, 2001, New York Times, Bioterror: U.S. Calls for Global Action to Counter Germ Weapons, by Elizabeth Olson,
November 21, 2001, New York Times, In Utah, a Government Hater Sells a Germ-Warfare Book; The How-To Book, by Paul Zielbauer with William J. Broad,
November 21, 2001, New York Times, In Utah, a Government Hater Sells a Germ-Warfare Book; The How-To Book, by Paul Zielbauer with William J. Broad,
November 27, 2001, New York Times, With Biotechnology, a Potential to Harm, by Andrew Pollack, Archived,
December 20, 2001, New York Times, Classified Information; Bush Gives Secrecy Power to Public Health Secretary, by Alison Mitchell,
January 13, 2002, New York Post, Webheads Help Hunt the 'Thrax',
January 15, 2002, AP - The Michigan Daily, Anthrax vaccine producer earns approval for lab, Archived,
January 23, 2002, AP - The Michigan Daily, Lansing laboratory may begin anthrax vaccine shipments, Archived,
April 2, 2002, Sun Sentinel, Pesticide Promising Against Anthrax,
April 29, 2002, New York Post, Editorial, Still Waiting For Answers,
April 29, 2002, New York Post, Op-Ed, Why the Bureau Might Go Wrong, by John Podhoretz,
June 7, 2002, Judicial Watch Press Release, FBI & Bush Administration Sued Over Anthrax Documents,
August 13, 2002, New York Post, 'Anthrax' Doctor Failed Lie Test, by Niles Lathem,
September 7, 2002, New York Post, Editorial, Anthrax Scapegoat?,
March 15, 2003, Sun Sentinel, Scientist Ready To Test Pesticide On Anthrax,
February 27, 2003, Sun Sentinel, Test Pits Bug Killer Against Anthrax,
March 7, 2003, The New York Post, Blix Will Bare Iraq’s 'Thrax’,
October 22, 2003, The New York Post, New FBI Section Focuses On WMD, by Brian Blomquist,
May 18, 2004, USA Today, Muslim CEOs of U.S. firms fight terrorism, 'stop evil', by Del Jones, Archived,
July 21, 2004, NARA, The George W. Bush White House Archives, President Bush Signs Project Bioshield Act of 2004,
August 6, 2004, The New York Post, 'Thrax Raid Targets Vaccine Doc, by Don Murray and Andy Geller,
August 7, 2004, New York Post, Ladies and Germs, by Don Murray and Perry Chiaramonte,
September 16, 2005, Washington Post, Little Progress In FBI Probe of Anthrax Attacks; Internal Report Compiled As Agents Hope for a Break, by Allan Lengel, Washington Post Staff Writer, Archived,
December 19, 2006, U.S. law giving legal authority for BARDA (42 U.S. Code § 247d–7e - Biomedical Advanced Research and Development Authority (BARDA) provided by the Cornell University Law School, (July 1, 1944, ch. 373, title III, § 319L, as added Pub. L. 109–417, title IV, § 401, Dec. 19, 2006, 120 Stat. 2865; amended Pub. L. 113–5, title IV, § 402(a)–(d), (f), Mar. 13, 2013, 127 Stat. 194, 195.)
May 5, 2008, San Francisco Business Times, VaxGen wraps up sale of anthrax assets, Archived,
May 5, 2008, Forbes. Thomson Reuters, VaxGen sells anthrax vaccine candidate to Emergent BioSolutions, Archived,
June 28, 2008, New York Times, Scientist Is Paid Millions by U.S. in Anthrax Suit, by Scott Shane and Eric Lichtblau,
August 1, 2008, Los Angeles Times, Apparent suicide in anthrax case, by David Willman, Times Staff Writer, Bruce E. Ivins, a scientist who helped the FBI investigate the 2001 mail attacks, was about to face charges.
August 2, 2008, Los Angeles Times, U.S. officials are mum on news reports; They say only that 'substantial progress' had been made in the anthrax case. Details are expected soon, by Richard B. Schmitt, Times Staff Writer,
September 30, 2008, Bloomberg, Emergent's Anthrax Vaccine Effective With Fewer Doses in Study, by John Lauerman,
February 13, 2009, The Washington Post, Local Briefing, Emergent to Sell Vaccine in India,
Emergent BioSolutions of Rockville said its BioThrax anthrax vaccine is now allowed to be marketed and sold in India. Emergent said it signed a marketing deal with Biological E. Limited for India.
"Today marks a pivotal milestone in Emergent's efforts to expand globally and further our mission of protecting life," Emergent chief executive Fuad El-Hibri said in a statement.
December 2009, Security & Defence Agenda, SDA Biopreparedness Report
March 30, 2012, Gazette.net, Emergent's Fuad El-Hibri, an entrepreneur at heart; CEO turns over the operational reins of his latest venture, Emergent BioSolutions, by Kevin James Shay, Archived,
January 4, 2013, Gazette.net, Emergent licenses flu vaccine for new federal biodefense center,
March 22, 2013, BioPrepWatch, Emergent BioSolutions promotes Shofe to executive vice president of corporate affairs, by Paul Tinder,
August 2, 2013, Yahoo! Finance, Emergent BioSolutions Closes on Its Acquisition of Healthcare Protective Products Division from Bracco Diagnostics Inc, Archived,
September 23, 2013, The Daily News (Delaware, Of procurement and politics: Harris criticism of bio-defense firm could help donor; Rep. Harris' criticism of bio-defense company could benefit donor, by Nicole Gaudiano, Daily Times Washington Writer,
September 23, 2013, delmarvanow.com, Of procurement and politics: Harris criticism of bio-defense firm could help donor; Rep. Harris' criticism of bio-defense company could benefit donor, by Nicole Gaudiano, Daily Times Washington Writer,
December 11, 2013, Washington Post, Emergent BioSolutions pays $222M to acquire life sciences firm Cangene Corp, by Steven Overly, Archived,
February 18, 2014 [5:42 PM ET] Wall Street Journal, Cangene Receives Court Approval of Plan of Arrangement for Acquisition by Emergent BioSolutions, Archived,
April 15, 2014, BioPrepWatch, First of three pandemic manufacturing sites could be ready by 2016, by Lisa Sievers,
May 25, 2014 [1st web capture] Bloomberg Businessweek, Emergent Biosolutions Inc. (EBS:New York): Company Description,
November 7, 2014, New York Times, More Than 600 Reported Chemical Exposure in Iraq, Pentagon Acknowledges, by C. J. Chiversnov,
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Gulf-Chat : Illnesses of Gulf War Veterans
October 3 2001, Sunshine Project, Operation Infinite Contract: Biotech's Impossible, Profitable War to Defeat Nature, by Edward Hammond, Archived,
The author is a Director of the Sunshine Project USA, a non-profit organization working to prevent development and use of biological weapons.
Contrary to what the US public is now being told, biodefense does not offer durable protection from the threat of biological weapons. In order to win, biodefense must overcome the infinite variability of nature itself. That is an impossible task.
It is a disconcerting reality to face, but science is not going provide any long-term solutions to the threat of biological weapons. Heavy investment in biodefense might even have the opposite effect. Enduring solutions are to be found in diplomacy, international cooperation, and vigilance. These tools are not perfect; but they do promise access to suspect facilities, sharing of information, "peer pressure" among countries, and an improved ability to ensure that everyone complies with commitments to not develop or use biological weapons.
Citizens should ask questions about biodefense, and not accept simple answers. The biggest unasked question: What will a successful biotech war on bioterrorism require?
To get an answer, take a moment to ponder being immortal. Now think about biodefense. Both make an arrogant and impossible promise of human mastery over life and its variability.
Would Americans feel safe and secure with, say, 50% of us immune to some kinds of biological weapons? Or, resistance to 50% of biological weapons? No. A biological enemy cannot be deterred. In order to win, it must be overwhelmed. And in a world of infinite variability, that is an impossibility.
The term biodefense can be confusing. It is applied to a bundle of different approaches, some sound and others dubious. Unbundling the biodefense wrapper is important. Some biodefense activities are prudent public health measures, such as training medical staff and monitoring for unusual outbreaks of disease. Nobody would disagree with this kind of biodefense. Other approaches are technical, such as manufacturing protective suits and sensors to detect biological weapons, efforts that have their own particular difficulties (which are not addressed here).
Another set of biodefense activities are closer to those traditionally understood as military biodefense. These approaches are biomedical, such as developing medicines and agent-specific or "multivalent" (i.e. counteracting more than one variant of one agent) vaccines.
It is this latter set of approaches and, among them, those that suppose to defeat attack, that are the subject here. Biological warfare is the use of disease (generally disease-causing microbes and/or toxins they produce) to achieve political and military ends. Unusually lethal anthrax is a bioweapon many have heard about, but biological weapons neither begin or end with the handful of agents widely discussed in recent days.
Biological weapons are many. How many? The answer is uncomfortable to contemplate, but critical to understand. There are many more potential biological weapons than there are diseases that plague humans, animals, their food and industrial crops, and the biological systems that maintain our environment. All diseases are potential weapons.
In other words, biological weapons are infinite. Starting with nature's innate variability, and compounded by genetic engineering, biological weapons agent possibilities are literally endless. There are dozens, maybe hundreds of varieties of smallpox. A genetic cut and paste makes the difference between an E. coli strain that happily assists digestion and one that leaves people dead. Techniques such as mutagenisis and using antibiotic resistance genes can turn relatively or completely benign microbes into major killers.
Because biodefense projects that suppose to eliminate the threat of biological weapons work against an infinite world of potential enemies, in order to vanquish biological weapons, to be effective they must seek to utterly control the systems by which all life reproduces and grows. Otherwise, defenses are continually outflanked.
Put simply, those that promise victory - that meaning a technical elimination of biological weapons, or even a significant subset of them - aspire to the power of a deity. Without omniscience, stopping one threat only points to another, and another, and another, and another, and so on. It is painfully obvious that even the best, enormously funded scientific talent will never overcome biodiversity combined with a determined, sometimes suicidal, enemy.
It is disappointing that relatively few science professionals speak out about this. Even fewer companies do; but then there are profits to consider.
Thinking Ahead
When somebody claims to have a technical solution to a bioweapons attack, it's important to think a step or two ahead. At present, there more purported solutions to anthrax than for malaria, a sad historical commentary on public health priorities; but would the US and its allies be significantly safer if anthrax were mastered?
Effective elimination of this threat to the general population is a decade and billions of dollars away at best. Right now, the US can barely produce enough vaccine to protect its own troops; but even then, the protection is limited and may not work against genetically engineered strains that are known to exist.
For the sake of argument, pretend for a moment that anthrax has disappeared as threat. There is one less bioweapons agent. Anthrax is particularly lethal; but is still only one of an infinite number of possibilities. Infinity minus one is not a real number. What happens next? The focus shifts to genetically-engineered strains of these agents which might outflank our defenses and then to other bioweapons agents, known for years, such as smallpox, botulinum toxin, plague, tularemia, Q fever, brucellosis, glanders, various types of encephalitis and hemorrhagic fevers, Marburg, and Ebola.
Many experts loathe to admit that using some of these diseases as a weapon requires little more than a petri dish, taking personal risks, and minor ingenuity. Using these agents to dramatic effect requires a bit more ingenuity; but pretending the dark science of biological weapons is impenetrable to all but a few superior minds is foolhardy. So, in our technical fix scenario, these diseases must be eradicated too.
Go a step further and, for a moment, be wildly optimistic. Pretend biotech has banished all the diseases mentioned so far, despite the fact that many would be more readily resolved as an issue of public health care and compassion than with the latest gene therapy. All the "typical" biowarfare bugs are gone, at least as a threat to US soldiers. Would the US then be safe from biological weapons? Not at all. Infinity minus twenty, and there are many left to go.
At this point, very difficult and potentially destabilizing political questions must be considered. Who foots the bill, and who gets the protection? Will the US provide these hypothetical vaccinations and treatments to everyone else, or reserve them for close allies and the rich? Biotech companies, beneficiaries of the contracts to develop these hypothetical cures, are very unlikely to give them away. Ask Africa about AIDS medicines. Should the US pay to vaccinate the world? In fact, the US is not even sure if it can afford to protect its own citizens. If the US is not prepared to treat the world, how will it be interpreted? As proof of US cold-heartedness, or even as a threat. The US would be marginally protected, but everyone else, especially the poor, would be vulnerable.
But we're only scratching the surface of possible bioweapons. Among human diseases, for a start there's influenza, which already spreads like wildfire and kills thousands annually. Add HIV, malaria, dengue, cholera, typhoid,
yellow fever, West Nile, Chagas disease, Lyme disease, hepatitis, and river blindness. There are many more. Is the Pentagon and Secretary of Homeland Defense prepared to take these on too? Because they could be used as very damaging weapons. A biodefense technical fix will require mastering them, protecting people, and wherever possible eliminating the agent to keep it out of a tinker's hands.
There are other biological weapons. Crop diseases, livestock diseases, pathogens to attack food supplies, and genetically engineered microbes to destroy material, such as those created by the US Navy. They are no easier to combat and threaten humans by destroying our means to survive. Ask the British agriculture officials about their desperate and extraordinarily expensive battle against an apparently accidental outbreak of hoof and mouth disease.
We haven't really even mentioned genetic engineering. If a bioweaponeer's first course of action doesn't work, old diseases can be made to come back:
Measles, mumps, rubella, or even polio might be induced to outwit vaccinations.
A genetic cut and paste makes the difference between a benign bacteria and one that kills.
Last year, scientists published a genetic sketch showing how a relatively weak disease, say chicken pox or shingles, could be turned into a deadly genetically engineered weapon.
Diseases can be made to exhibit different symptoms, to be more aggressive, to outwit antibiotics, or to evade detection systems.
In security parlance, many of these items are classified as "risks" rather than "threats". Risks are things that might be possible, threats are things that we have good reason to believe could happen. For example, HIV is very deadly; but difficult to weaponize and nobody serious has threatened to do it. Hence it is a risk, not a threat. Threat assessment deals with matters at hand and, in effect, leaves future possibilities to worry about later, if they become more real. Differentiating between risks and threats is the starting point for many analysts. But the analysts are concerned about the immediacies of defense, not about prevention.
The threat assessment methodology for classifying priorities is quite different than, for example, the precautionary principle developed in biosafety. Unfortunately, threat assessment has deeply pervaded not just military, but diplomatic thinking about solutions to biological weapons. Its inherent short-sightedness has stymied the development of effective solutions. Many governments have substituted a short-term military priority-making approach for a methodology to create underlying conditions necessary to prevent the upsurge of new problems. By discounting problems that aren't right on the doorstep, threat assessment leads to half-baked notions of what can be done to promote security, such as the US walking away from the Biological and Toxin Weapons Convention Verification Protocol, and investing heavily in the wrong kinds of biodefense.
Biotech's Gulf of Tonkin Resolution
Presently, the US Congress' biodefense pocketbook is wide open. There's no shortage of outstretched hands. Much of it is pursued by an industry whose public image is staked on the false hope of creating meaningful protection from biological attack. In the past week, almost every major US daily has run articles praising the experimental biodefense "miracle" or "magic" brewing just around the corner at a local university or biotech startup. Did the United States have such a huge and promising biotech defense industry before September 11th and nobody noticed? No. By global standards, our program is big; but it isn't promising and the professor or Chief Technology Officer around the corner is no more likely to save you from a biological attack than a tidal wave.
Through America's preoccupation with homeland biodefense, the biotech industry believes it has been granted a license to proceed into a profitable war with no possibility of producing peace and no durable long-term product but profit. Congress didn't exactly give biotech a Gulf of Tonkin Resolution; but sloppy media coverage and shameless opportunism are creating one.
DynCorp, a spooky US defense contractor best known for blasting Colombia with wide spectrum herbicides in the Drug War, is setting up a bioweapons vaccine business. It's partner is Porton International, a company which sprang forth from Porton Down, the UK's equivalent of Ft. Detrick, MD. Before 1969 Ft. Detrick was the US headquarters of biological weapons research. Now it houses important elements of our biodefense apparatus. DynCorp has its fingers in many pies and also advises the US Army and industry on compliance with biological and chemical weapons agreements.
Another major military contractor, Science Applications International Corporation (SAIC) already has assets at Ft. Detrick through contracts with the military and the National Cancer Institute.
In Texas, Lynntech Inc. proffers organophosphorus hydrolase as part of its quest to, in the soothing words of a local newspaper, discover "a single enzyme that will neutralize all toxic agents." A pipe dream if one ever existed; but on September 11th the Texans got a call from a general at Ft. Detrick.
In Seattle, Corixa Corp. publicly complains that $3.5 million isn't enough for its experimental anthrax vaccine and wants more help from the government. Corixa's stock is up more than 50%. There are legions more.
The Vaccine Push
During the Gulf War, the US realized that it did not have the ability to vaccinate its troops (much less those of allies) against anthrax and other biological weapons possessed by Iraq. Entreaties to the pharmaceutical industry prompted a flood of antibiotics but little vaccine. Treating disease has always been more profitable than preventing it.
After further haggling, industry made clear it wasn't interested in manufacturing bioweapons vaccines without massive subsidies and relief from liability. The military effectively agreed, and SAIC drew up a plan for the government to invest about $3 billion in research and to build vaccine facility costing $370 million. At this government facility, companies will produce eight (8) vaccines against anthrax, smallpox, plague, tularemia, botulinum, "next generation" (read: genetically engineered) anthrax, ricin, and equine encephalitis. This $3 billion plus buys only eight, only to protect the US military and, by agreement, some soldiers from Canada and the UK. US civilians are out of luck, according to SAIC "Beyond the baseline operating scope of the [government-owned, contractor-operated] facility design." Foreign citizens aren't even an afterthought.
Avoiding the Spiral and Invoking Diplomacy
On September 4th, the New York Times revealed that US Central Intelligence Agency biodefense researchers had tested mock biological bombs and built a real bioweapons production facility in Nevada, activities completely indistinguishable from offensive biological warfare research. The US kept these activities secret, and did not divulge them in annual confidence building reports to the Bioweapons Convention.
The US is now pouring billions more into biodefense. In the current climate, it is difficult to believe that potential adversaries will not respond with their own investments. After all, the US itself has failed to comply with its arms control commitments. The situation could very easily spiral out of control.
The sooner the US understands the impossibility of effective biodefense, the sooner pressure will build for the Bush administration to come to its senses and advocate fast conclusion of the Verification Protocol to the Biological and Toxin Weapons Convention.
The Gulf-Chat list is hosted by Verio, Inc. http://www.verio.net Verio claims no responsibility for Gulf-Chat list contents and provides the Gulf-Chat list as a community service.
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November 19, 2001, Gulf Chat, Medium Rare, Anthrax Vaccine - What Reports? What War?, by Jim Rarey,
On October 23rd of this year Nancy Kingsbury from the General Accounting Office (GAO) testified on Anthrax Vaccine before the House Subcommittee on National Security, Veterans’ Affairs, and International Relations Committee on Government Reform. Her testimony has been released as report GAO-02-181T available on the GAO website at www.goa.gov.
The report is a scathing indictment of the handling of the anthrax vaccine issue by the Food and Drug Administration (FDA), the Department of Defense (DOD), the Bioport company in Michigan and before that the Michigan State laboratory. On November 11th (Veterans’ Day) a rally was held on the capitol steps in Lansing, Michigan by a group comprising, for the most part, veterans who were suffering from the effects of the vaccine or had been forced to resign from the service for refusing to take the vaccine.
In attendance at the rally was Michigan National Guard Public Affairs Officer Major James McCrone. In an interview with a TV reporter, he said he was there to see if "these people" had anything new to say. When he said he had heard nothing new, he was asked by one of the speakers at the rally if he had read the latest GAO report on the
vaccine. His response was, "What report?"
Ignorance is just one of the problems associated with the vaccine. Sadly, there has been ten years of stonewalling, obfuscation and outright lies from "experts" and PR flacks both in and outside of government.
Here is a brief recap of information contained in earlier articles.
The vaccine was first licensed by the FDA for production by a Michigan state owned laboratory in 1970 based on vaccine produced and tested by Merck Sharp and Dohme (currently known as Merck and Co., Inc.) in 1962. Prior to 1970 vaccines were licensed by the National Institute of Health (NIH).
The vaccine was certified as effective against cutaneous (skin contact) anthrax and some studies with monkeys suggested some effectiveness against inhaled anthrax (the most dangerous).
Despite changes made in both the composition (recipe) of the vaccine and the method of production, no further testing has been done. The altered vaccine was administered to over 500,000 service men and women before and during the Gulf War. An unacceptable number have had their lives (and lives of their families) ruined by reactions to the vaccine
In 1998, Secretary of Defense William Cohen decided to vaccinate all service members and the program started. Over 400 members have left the service or been subject to discipline for refusing to take the vaccine.
In 1998 the FDA suspended the license for the vaccine shortly after a private company (Bioport) bought the facility and licensing rights from the State of Michigan. The privatization was engineered by Fuad El Hibri, a German citizen at the time and included several former state employees of the lab, Fuad’s wife and father and Admiral William Crowe (a former Chairman of the Joint Chiefs of Staff.
The facilities and the licensing rights were obtained for a sale price of $25 million, however a portion was financed with IOU’s to the state and promises of delivery of several other vaccines and royalties on Bioport’s sales. It was later admitted the licensing rights alone were worth at least $35 million.
Bioport has not been able to pass FDA inspections to date and no vaccine has been shipped since 1998. The DOD has virtually run out of vaccine acquired between 1990 and 1998 and has had to suspend its universal vaccination program.
In the mid-1980’s, El Hibri had also engineered a private buyout of Britain's secret lab involved in production of vaccines and experimentation with chemical and biological weapons materials. The ownership was split among three El Hibri controlled entities; Porton Products, Porton Instruments and Porton International. The Porton laboratory was the sole source of anthrax vaccine used on British troops during the Gulf War.
Vaccinated British troops experienced much the same health problems, as did American troops. It was later disclosed that untested "adjuvants" had been added to the vaccines in both the U.K. and U.S. Both vaccines included toxins generated by anthrax bacteria which were expected to cause antibodies to be formed to fight the infection. The adjuvants increased the toxicity to speed up the body’s reaction.
In the U.K. public health authorities warned that the adjuvants would compound the already significant side effects of the vaccine. In the U.S. the DOD questioned the Michigan lab about the increased toxicity and later (in October 1990) issued a report. However the FDA was not apprised of the change until ten years later by the GOA.
In early 1990 the military (in both the U.K. and U.S.) pressured their respective vaccine suppliers to greatly increase production in anticipation of hostilities in the Middle East. This was some six months before Iraq invaded Kuwait on August 2, 1990. Both Britain and the U.S. had sold equipment/ and/or anthrax vaccine to Iraq during its war with Iran. It was feared that Iraq might use its anthrax capability in the coming war.
That the military was so certain of a war with Iraq lends credence to charges that the U.S. "suckered" Saddam Huessein into the invasion. Eight days before the invasion, according to a tape and transcript obtained by British journalists a month later, the American ambassador to Iraq, April Gilspie, met with Saddam Hussein and told him, " We have no opinion on your Arab – Arab conflicts, such as your dispute with Kuwait. Secretary (of State James) Baker has directed me to emphasize the instruction, first given to Iraq in the 1960’s that the Kuwait issue is not associated with America."
A few days later, Gilspie said in a televised interview, "we have no treaty or other agreement that requires us to come to the aid of Kuwait.
Congress demanded access to diplomatic communications between the State Department and Ambassador Gilspie but was successfully stonewalled by Baker’s State Department.
During negotiations between 1996 and 1998 between the State of Michigan and El Hibri and his partners, a concern was expressed about El Hibri's sale (from his British lab) of anthrax vaccine to Saudi Arabia after they had been turned down by the Pentagon. It was feared he might also have sold anthrax and/or the vaccine to Iraq. A British
scientist had disclosed Iraq had made a specific request for the "Ames" strain of anthrax, although he said the request was denied.
American scientists have determined that the current anthrax attacks by mail are using the same strain (Ames) that was furnished to the British lab at Porton Down years ago by the U.S.
Rather than contact American intelligence, Michigan authorities asked the American Embassy in Germany about El Hibri. The embassy gave him a clean bill of health saying, "he’s one of the good guys." What the embassy didn't tell them, or didn't know, was that two scientists in El Hibri's privatized lab were involved in South Africa as consultants to the infamous chemical and biological weapons program in that country.
The head of South Africa's CBW program was Wouter Basson. Basson was charged with multiple counts of murder and fraud in trial that lasted almost a year. During the course of the trial (in which Basson earned the nickname Africa's Dr. Mengele) a number of witnesses detailed the weapons the program had developed for mass murder as well as assassination of individuals with such things as anthrax laced cigarettes.
One of Basson's lieutenants, Dr. Andre Immelman testified about the Porton Down involvement in the murder of the Reverend Frank Chikane, with an exotic toxin called Paraoxon. He discovered that, without his knowledge, one of his subordinates (Schalk van Rensburg) had hired two consultants from Porton Down on the project. He confronted van Rensburg and accused him of wanting to blow their cover. Van Rensburg responded that Porten Down had been privatised and the consultants were from the private sector.
The October GAO report was not the only one that provided evidence that the anthrax vaccine is the culprit in veterans’ health woes.
In April of this year the GAO submitted a report (GAO 01-13) that had been requested by subcommittee chairman Christopher Shays. He had asked the GAO to find out why French Gulf War veterans were reporting far fewer health problems than their British and American counterparts.
Amid a welter of charts and statistics, the obvious answer was found. British and American troops were inoculated with the anthrax vaccine, the French were not.
There was one other difference between the British and American programs. The British program required "informed consent" from soldiers before the vaccine was administered. The American program was, and still is mandatory.
The GAO surveyed a large group of American national guard and reserve forces who had taken the vaccine to determine how many experienced a reaction from the shots. They found that 85% had some kind of reaction and in 23.8% it was systemic (affecting the body’s systems).
The numbers still being advertised by Bioport and the FDA are 30% experiencing mild reactions, 4% having moderate reactions. They say only .2% or two out of a thousand suffer systemic problems! What they
do not admit is their numbers are based on testing done more than thirty years ago on a different vaccine.
Last week, Bioport revealed that negotiations are being held with DOD to release some of the two million doses embargoed by the FDA to the public. One of the demands of the veterans assembled in Lansing was that those lots be destroyed before they cause further harm.
Permission is granted to reproduce this article in its entirety. The author is a free lance writer based in Romulus, Michigan. He is a former newspaper editor and investigative reporter, a retired customs administrator and accountant, and a student of history and the U.S. Constitution.
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May 18, 2004, USA Today, Muslim CEOs of U.S. firms fight terrorism, 'stop evil', by Del Jones, Archived,
Excerpt
"I'm trusting, not paranoid," says El-Hibri, 46, who became a U.S. citizen in 1999. He was born in Germany and spent his childhood equally in Europe and the Middle East before coming to the USA to get an economics degree from Stanford and an MBA from Yale. "But there is a group who don't think the anthrax vaccine should be in the hands of someone with an Arab or Muslim background."
Scrutiny surrounds anthrax vaccine
Conspiracy-theory Internet sites have taken a special interest in El-Hibri's formative years in Lebanon and Sudan, and a more recent three-year assignment in Saudi Arabia with Citibank. The sites imply crimes ranging from ties to Osama Bin Laden to being the mastermind behind the mailing of anthrax spores that killed five people in 2001. El-Hibri calls the Web sites annoying and jokes that he's lucky to be in the vaccination business so that he can inoculate himself from the pain of accusers who can't be confronted.
Even some members of Congress have objected to BioPort's anthrax role. That criticism reflects ignorance, says retired admiral William Crowe, who served as chairman of the Joint Chiefs of Staff in the Reagan administration and the first George Bush administration and now is on BioPort's board of directors. BioPort recruited Crowe, a friend of El-Hibri's father. Crowe received 8% of BioPort's stock to serve on its board, largely because of his expertise about the key customer, the Defense Department. But Crowe's presence also mitigates the attention on El-Hibri.
BioPort keeps a small supply of anthrax spores under five layers of security to verify the potency of the vaccine, a requirement of the Food and Drug Administration. That makes El-Hibri a suspect of conspiracy theorists, who say the unsolved anthrax mail crime of 2001 increased demand for BioPort's product while El-Hibri and his family were safely inoculated from the fatal bio-threat.
"That's a terrible stretch," says Crowe, who says El-Hibri is straightforward and honest and is one who has "never entertained even the slightest idea of fooling the government" and "bends over backward to make sure the Defense Department is aware."
Muslim executives were careful and measured when responding to most questions but became noticeably uneasy when asked how devout they were to Islam. A typical response: "I attend mosque when I have time," Khalafsaid. "My philosophy is to be good, to live with others and to be equal with others."
"I don't drink alcohol or gamble," said Mesdaq, 32. "I go to mosque," but he emphasized: "I'm not a political Muslim. I'm a normal American. I like to drive nice cars, go out and have fun and dance. I'm very blessed."
El-Hibri says he attends mosque once a year. His mother is German and Catholic. He adopted the faith of his Lebanese father. Islam, Christianity and Judaism are essentially the same, El-Hibri says, with a "belief in one God, what's right and what's wrong. Do the best things in the eyes of God, that's most important."
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March 30, 2012, Gazette.net, Emergent's Fuad El-Hibri, an entrepreneur at heart; CEO turns over the operational reins of his latest venture, Emergent BioSolutions, by Kevin James Shay, Archived,
Brian Lewis/The Gazette “For us, our central mission is to protect life,” says Fuad El-Hibri, CEO of Emergent BioSolutions. “It’s been a great honor to serve the military and protect our active military.”
Fuad El-Hibri
Age: 54.
Position: CEO, chairman, Emergent BioSolutions, Rockville.
Education: Master's in public and private management, Yale University; bachelor's in economics, Stanford University.
Community/professional activities: Board of directors, U.S. Chamber of Commerce; board of trustees, International Biomedical Research Alliance, National Health Museum; advisory board, Yale Healthcare Conference, Heifetz International Music Institute; chairman, El-Hibri Charitable Foundation, Awards: Biotech CEO of the Year, World Vaccine Congress, 2011; International Leadership Award, World Trade Center Institute, 2010; Ernst & Young Entrepreneur of the Year for Greater Washington, 2009; Rene Moawad Foundation Distinguished Community Service and Achievement Award, 2007.
Residence: Naples, Fla.; also has home in Potomac.
Family: Wife, Nancy; three adult children; two grandchildren.
Hobbies: General aviation, equestrian sports, scuba diving.
Fuad El-Hibri has started a financial consulting business. He’s started telecommunications businesses.
But his most challenging venture has been the Rockville biotech he helped launch 14 years ago.
Still, El-Hibri — CEO and board chairman of Emergent BioSolutions — says the challenges are worth it, because the rewards are so great from protecting and saving lives.
Unlike products in many other sectors, vaccines and other bioscience products can take 10 to 15 years to develop. The regulatory climate can drive up costs. The probability of commercial success is relatively low, in the neighborhood of 20 percent.
“You need to have a strong and focused will,” said El-Hibri, 54, who is retiring as CEO as of Sunday, but remaining as executive chairman. “It takes a lot of patience and persistence.”
El-Hibri co-founded Emergent — then called BioPort Corp. — in 1998, and the company has seen annual revenues more than triple in the past eight years to almost $300 million, with a decade-long track record of financial profits. The biotech focuses on several prominent disease areas, with numerous clinical stage product development programs. Its biggest money-maker is its anthrax vaccine.
Emergent's success can be attributed to El-Hibri's vision, his ability to anticipate and overcome challenges, and his unwavering commitment that has motivated others in the company, said Daniel J. Abdun-Nabi, who is taking over as CEO after holding the president and COO posts since 2008.
“Over the years, we have come to appreciate his business acumen, drive to address global unmet medical needs and dedication to creating a workplace environment and culture that is both challenging and rewarding,” Abdun-Nabi said.
El-Hibri's contributions extend beyond Emergent to the biotech and business communities throughout the state, said Henry Bernstein, a board member of the Tech Council of Maryland and senior vice president of Rockville real estate development and management firm Scheer Partners.
“Under his leadership, Emergent BioSolutions became a growth company that has contributed to the business community, attracted top talent to the region and invested heavily into the community overall," said Bernstein, a former COO of the Montgomery County Department of Economic Development.
Emergent did what relatively few biotechs do — turn a profit for an entire year within four years of forming. Gaithersburg biotech giant MedImmune was founded in 1988 and took a decade to see an annual profit. After launching in 1992, Rockville life sciences company Human Genome Sciences saw net income in 1993 and 1994, but has seen only one profitable year since, in 2009.
Even during the Great Recession, Emergent continued to show a profit. A key factor was acquiring a product — BioThrax, the only federally licensed anthrax vaccine — that could generate revenue almost immediately, El-Hibri said. The federal government buys the vaccine to inoculate military personnel.
“It’s been quite a ride,” he said.
Early exposure to other countries
Born in Germany the son of a Lebanese father and German mother, El-Hibri split boyhood time in both nations. Being immersed in different nations gave him an early appreciation for various cultures, he said.
“I learned how you have to get along and respect other cultures,” El-Hibri said. “That’s an important factor to having peace and having a successful business.”
At Emergent, he carried that philosophy into defining five core corporate values: respect, empowerment, commitment, communication and innovation. Having such values is key to building a top-notch company, he said.
“For us, our central mission is to protect life,” El-Hibri said. “It’s been a great honor to serve the military and protect our active military.”
His entrepreneurial career started soon after earning a master's in public and private management from Yale University and a bachelor’s in economics from Stanford University.
Following stints in banking with Citigroup and management consulting with Booz Allen Hamilton, the latter in southeast Asia, El-Hibri started a financial consulting business, East West Resources. Then came three mobile telecommunications companies: Mobile TeleSystems, Digitel and Digicel.
Mobile Telesystems, which he formed in 1993 and later sold, has grown to be a leading telecommunications company in Russia, with $12 billion in sales last year. The other two companies, which he also sold, are good-sized players in South America and Central America, respectively.
During the 1990s, El-Hibri got his first taste of biotechnology when he organized a management buyout of British life sciences company Porton and formed Speywood Holdings, a recapitalized biopharmaceutical company.
In 1998, El-Hibri was among a team that bought the rights to BioThrax, which was being manufactured in Michigan, and its production facilities.
“They only marketed it on a relatively small scale,” he said. “After we acquired the product, we renovated the facilities and increased capacity.”
About 170 Michigan state employees agreed to transition to the privately held business that year, El-Hibri said. BioPort later became Emergent, which went public in 2006 and now has more than 800 employees in 10 locations. Some 250 employees are in Maryland, within the Rockville headquarters, a research and development facility in Gaithersburg and a manufacturing plant in Baltimore.
The company has branched out into combating tuberculosis, cancer and autoimmune disorders. Since 2003, the company has acquired three biotech companies and completed other acquisitions to broaden its product pipeline.
Some reports, including one by a researcher with the Center for American Progress, say that Emergent lobbied hard against a former California biotech, VaxGen, which received a major federal contract to develop a new anthrax vaccine in 2004. VaxGen had never produced a drug before, and the government canceled the contract two years later.
Emergent's lobbyists did not criticize VaxGen but simply stated what their own company could do, El-Hibri said.
"We lobbied using a positive message," he said. “We did not criticize their product. ... The government decided to cancel the contract. It was not because of us."
Emergent also purchased the VaxGen vaccine through a fair process and is working to develop that as a secondary vaccine, El-Hibri said.
Building a better world
El-Hibri has his own charitable foundation, which promotes peace and social justice. In 2007, he started the annual El-Hibri Peace Education Prize, which recognizes educators who teach about peace issues. The organization also has constructed orphanages in Lebanon.
“I have a strong belief in giving back,” he said. “There are so many worthwhile projects and organizations.”
As a member of the U.S. Chamber of Commerce’s board of directors, El-Hibri has the opportunity to discuss national issues with business leaders across the country.
“It’s very interesting to meet business leaders across the nation and get their perspective,” he said. “As you can guess, there is no full agreement on every issue, but there is hope that the economy will turn around soon.”
El-Hibri also serves on the board of trustees of the International Biomedical Research Alliance, an academic venture between the National Institutes of Health in Bethesda, Oxford University and Cambridge University in the U.K., and the National Health Museum, a science institution planned to open in Atlanta in the near future.
He is on the advisory board for the Yale Healthcare Conference, which brings together professionals, academics and students to discuss health care issues, and the Heifetz International Music Institute in Staunton, Va., founded by acclaimed violinist Daniel Heifetz to teach young musicians.
Among the awards El-Hibri has garnered are Biotech CEO of the Year during the 2011 World Vaccine Congress; the International Leadership Award from the World Trade Center Institute in 2010; the Ernst and Young Entrepreneur of the Year Award in Greater Washington in 2009; and the Rene Moawad Foundation Distinguished Community Service and Achievement Award in 2007 for philanthropic work in Lebanon.
In choosing El-Hibri for the honor at the World Vaccine Congress last year, judges cited his “leadership and entrepreneurial spirit” in guiding Emergent to another profitable year, securing some key development contracts, completing an acquisition and arranging collaborations with Pfizer and Abbott, according to business conference organizing company Terrapinn Holdings.
Sometimes hands-on, sometimes not
El-Hibri said he can vary his management style depending on the situation.
"Some managers are new, and I roll up my sleeves and get deep in the weeds,” he said. “Other people are seasoned and don’t need as much supervision.”
His primary residence is now in Naples, Fla., where Emergent has an office. But he also maintains a home in Potomac. He and his wife, Nancy, have three children and two grandchildren.
El-Hibri doesn’t engage in the stereotypical executive hobbies such as golf. He likes to fly single-engine airplanes, scuba dive and participate in equestrian sports. He flies a Diamond Aircraft plane, and has scuba dived in Indonesia, the Red Sea and the Caribbean.
"I seem to like being either very high above sea level or below sea level," he said with a laugh.
http://www.gazette.net/article/20120330/NEWS/703309706/1033/emergent-s-fuad-el-hibri-an-entrepreneur-at-heart&template=gazette
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January 23, 2002, AP - The Michigan Daily, Lansing laboratory may begin anthrax vaccine shipments,
LANSING (AP) In 1998, the buyers of the only U.S. laboratory making the anthrax vaccine thought they had a can’t-miss deal.
The aging state-owned lab in Michigan needed millions in renovations on top of the $24 million purchase price. But the Pentagon already had announced it would require all 2.4 million American military personnel to take a series of six shots of the vaccine, and turning the lab into a profitable enterprise seemed childishly easy.
Four years later, Lansing-based BioPort Corp. has yet to ship a single dose of the vaccine to the Pentagon.
Unable to pass inspections by the Food and Drug Administration, BioPort has intermittently produced the vaccine but has not been able to release it.
Now, the company appears to be on the verge of finally winning FDA approval to begin shipments, possibly as early as this month.
"It"s clearly a very positive story for the company," said BioPort spokeswoman Kim Brennen Root.
A laboratory in Washington state that puts the vaccine into vials still needs FDA approval, and the vaccine still must be tested for purity, potency and sterility before any 200,000-dose lots will be released by the FDA.
The vaccine was held up by contamination, inadequate record-keeping and unapproved procedures at the laboratory.
"I"m glad it took four years. That stuff needed to be done right," said Rep. Mike Rogers (R-Brighton) whose district includes BioPort.
Pressure to get the lab approved has grown since U.S. troops began heading overseas in the war on terrorism and since last fall"s anthrax outbreak killed five people on the East Coast. Because of the standstill at BioPort, the Pentagon stockpile of the vaccine is dwindling.
Although privatizing the lab didn't turn out to be nearly as easy as the new owners expected, it was largely the federal government that sweated and paid while the approval process went on.
Over the past four years, BioPort has received at least $16.8 million from the Pentagon to renovate and expand the lab. It also asked for more money for the vaccine, complaining that the state had never charged enough.
The Pentagon agreed in 1999 to more than double the per-dose payment, from $4.36 to $10.36. Instead of having to supply 8.7 million anthrax vaccine doses for $29.4 million, BioPort had to supply only 4.6 million doses for $53.5 million, in part because the company couldn't make as many doses as it originally promised.
Yet even with the extra money, BioPort's problems continued. Considering who owns BioPort, it was something of a surprise that the project did not turn out to be as easy as the new owners expected.
BioPort's chief executive officer and major investor is Fuad El-Hibri, a German-born businessman of Lebanese descent who now is a U.S. citizen. El-Hibri is a former director of the British maker of a different anthrax vaccine. His father, Ibrahim El-Hibri, also invested in BioPort.
A major shareholder in BioPort is retired Adm. William J. Crowe, former chairman of the Joint Chiefs of Staff, who brought his experience dealing with the Pentagon to the fledgling company. The former director of the state-owned lab, Robert Myers, is BioPort's chief operating officer.
--http://www.michigandaily.com/content/lansing-laboratory-may-begin-anthrax-vaccine-shipments
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November 8, 2001, New York Times, Excerpts From Postal Worker's 911 Call,
Following are excerpts from a 911 call on Oct. 21 by Thomas Morris Jr., a postal worker who died hours after the call, as recorded by The New York Times from CNN:
911 OPERATOR What's the problem?
MR. MORRIS My breathing is very, very labored.
Q. How old are you?
A. I'm 55. Ah, I don't know if I have been, but I suspect that I might have been exposed to anthrax.
Q. You know when or what —
A. Ah, it was last what, last Saturday, a week ago last Saturday [Oct. 13] morning at work. I work for the Postal Service. I've been to the doctor. I went to the doctor Thursday. He took a culture but he never got back to me with the results. I guess there was some hangup over the weekend. I'm not sure. But in the meantime, I went through achiness and headachiness. This started Tuesday. Now I'm having difficulty breathing. And just to move any distance I feel like I'm going to pass out. . . .
It was — a woman found the envelope and I was in the vicinity. It had powder in it. They never let us know whether the thing had — was anthrax or not. They never treated the people who were around this particular individual and the supervisor who handled the envelope. So I don't know if it is or not. I'm just — I've never been able to find out. I've been calling. But the symptoms that I've had are what was described to me in a letter that they put out, almost to the T except I haven't had any vomiting until just a few minutes ago. I'm not bleeding and I don't have diarrhea. The doctor thought that it was just a virus or something. . . . So we went with that and I was taking Tylenol for the achiness. But the shortness of breath, now, I don't know. That's consistent with the — with the anthrax.
Q. But you weren't the one that handled the envelope? It was somebody else?
A. No, I didn't handle it. But I was in the vicinity.
Q. O.K. And do you know what they did with the envelope at work?
A. I don't know anything. I don't know anything. I couldn't even find out if it — if the stuff was or wasn't. I was told that it wasn't, but I have a tendency not to believe these people.
http://www.nytimes.com/2001/11/08/national/08ATEX.html
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December 20, 2001, New York Times, Classified Information; Bush Gives Secrecy Power to Public Health Secretary, by Alison Mitchell,
WASHINGTON, Dec. 19 — President Bush has granted the secretary of health and human services the power to classify information as secret, a step that shows how the battle against terrorism is drawing domestic agencies into the national security apparatus.
William A. Pierce, the spokesman for the Health and Human Services Department, called the new authority a recognition that the agency was now in the forefront of preparations to fight bioterrorism and is sitting in on White House sessions on domestic security.
"The bottom line is relatively simple," Mr. Pierce said. "We are now a homeland security agency, part of the homeland security council."
He said he expected a "narrow subset" of agency documents to be classified, those relating to bioterrorism and the nation's preparedness to respond to it.
Officials said the kind of information that might be classified would be storage sites for vaccine stockpiles, certain laboratory floor plans or some details about emergency medical stocks. Mr. Pierce said the secretary, Tommy G. Thompson, had not used his new authority.
Experts on government classification said they believed it was the first time in several years that a new agency had been given the right to stamp information as secret. The trend had been toward less secrecy.
In 1995 President Bill Clinton issued an executive order that overhauled government secrecy rules, reducing the number of documents made secret and shortening the time such documents were kept classified.
While the health department was the lone agency to get new classification powers, the government has generally been rethinking the balance between security and the right to know since Sept. 11.
Much of the federal government already has the power to classify information. The agencies with such powers include the pillars of national security, like the Pentagon, the State Department and the Central Intelligence Agency, and agencies dealing with energy and nuclear plant regulation. Also on the list are agencies that deal with sensitive economic and trade issues, like the Treasury and Commerce Departments and the United States trade representative.
Officials said that until the Sept. 11 strikes and the subsequent anthrax attacks, it had not been widely assumed that the nation's public health department needed such authority, But that attitude has changed.
"They clearly are a national security agency," one White House official said. "They clearly are a homeland security agency."
He added, "One of the things you do in the homeland security business is deal with classified information."
The president's designation of the department's new classification authority was printed in the Federal Register on Dec. 12 without further explanation from the White House. Mr. Bush cited President Clinton's 1995 executive order on classification, which said classification authority would be held by agency heads and officials designated by the president.
The secretary was granted the right to classify information as secret, but he was not given the power to brand information as top secret. The government defines information as top secret if its disclosure could cause "exceptionally grave damage to the national security."
Secret information is that which could be expected to "cause serious damage to the national security" if disclosed. In general, the higher level of classification means that fewer officials have access to it.
Until now, the department had to turn to other government agencies for assistance if it wanted information in its domain to be classified.
Critics of secrecy policies called the change relatively modest.
"One would have liked to see some explanation of why it was necessary," Steven Aftergood of the Federation of American Scientists said.
But Mr. Aftergood said he did not think the order would greatly expand the scope of government secrecy.
Representative Christopher Shays, a Connecticut Republican and chairman of a House subcommittee on national security, said the department should use the power judiciously. But Mr. Shays said the classification authority was needed "to make sure we don't provide a road map to terrorists" of the nation's vulnerabilities.
Representative Jane Harman of California, the ranking Democrat on a House subcommittee on terrorism, cautioned that information sharing among agencies should be "the crux of any homeland security effort," and that classifying too many documents could hinder the transfer of information among agencies and levels of government.
Under the current secrecy rules, which were put in place by Mr. Clinton, agency heads are required to establish procedures under which employees can challenge classifications that they believe are improper.
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November 12, 2001, AP - The Michigan Daily, Anthrax vaccine producer protested by 40 in Lansing, Archived,
LANSING (AP) About 40 people protested the military"s anthrax vaccination program at the Capitol yesterday.
The protest, which happened just after the dedication of the nearby Vietnam Veterans Memorial, criticized the U.S. Defense Department as well as BioPort Corp., the Lansing company that is the only U.S. manufacturer of the anthrax vaccine.
Protesters said BioPort and the Pentagon are ignoring signs of illness in troops that have been vaccinated. They also say the military has not done enough to investigate the vaccine"s long-term effects, or to see whether the anthrax vaccine can be given safely with other vaccines.
Steve Robinson, a Gulf War veteran who now works for the National Gulf War Resource Center, said Congressional testimony shows that there are many unanswered questions about the vaccine"s effects. A 2000 federal report recommended ending the military"s anthrax vaccine program after six hearings on the vaccine"s effects, he said.--http://www.michigandaily.com/content/anthrax-vaccine-producer-protested-40-lansing
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September 23, 2013, The Daily News (Delaware) Of procurement and politics: Harris criticism of bio-defense firm could help donor; Rep. Harris' criticism of bio-defense company could benefit donor, by Nicole Gaudiano, Daily Times Washington Writer,
Andy Harris
U.S. Rep. Andy Harris, R-1st District, has criticized a division of Pfizer. / AP
WASHINGTON — Rep. Andy Harris has become a vocal critic of a division of Pfizer pharmaceutical company at a time when one of his campaign contributors hopes to make inroads into the drug giant’s market.
The 1st Congressional District Republican says the Pfizer subsidiary, Meridian Medical Technologies of Columbia, Md., has "put our national security preparedness in question" because of manufacturing issues with one of its nerve-agent antidotes.
Harris has pledged to seek answers from Meridian and government agencies about those manufacturing issues. He made his comments following a June 25 fundraiser hosted by lobbyists for Emergent BioSolutions Inc., a Rockville-based pharmaceutical company looking to expand its presence in the biodefense field.
Harris' staff says he is focusing only on the safety of military personnel who might be exposed to sarin or other nerve agents. The Meridian antidote does not compete with Emergent's current line of products.
"When it comes to protecting our soldiers, Congressman Harris, as a veteran himself, will always aggressively hold accountable businesses that provide our soldiers and first responders a defective product," said Chris Meekins, Harris' deputy chief of staff.
But some government watchdog groups say Harris' actions could be an example of a common practice among lawmakers — rewarding campaign contributors. Criticizing or praising government contractors is one way lawmakers work to influence decisions on awarding government contracts, said Craig Holman of Public Citizen, a Washington citizens advocacy group.
"Harris has just received $5,000 from Emergent Bio PAC, raised countless more in bundled contributions orchestrated by Emergent lobbyists and stepped into a public intimidation effort against Emergent's potential competitor for the government contract," said Holman, who lobbies on campaign finance and government ethics. "The close connection between money and official actions is troubling and, very unfortunately, not all that uncommon."
Emergent officials declined to comment on Harris' recent statements. Allen Shofe, Emergent's executive vice president for corporate affairs, said Harris is perhaps the first medical doctor to sit on the House Appropriations subcommittee on health and human services. He said Emergent speaks to Harris and many other members of Congress about the need to protect the nation from biological and chemical attacks.
"He has the knowledge and the understanding of the field," Shofe said.
Meridian is trying to resolve problems with an injectable antidote for nerve agents, including sarin, that surfaced during a March inspection. The company found that a small number of the "autoinjectors" contained less than the intended dose.
Members of the military and first responders carry the product, known as "DuoDote," in its civilian form. The Food and Drug Administration hasn't recalled the product and the agency extended the expiration date so older products could be used to prevent a shortage.
A Wall Street Journal reporter, Alicia Mundy, had first told Harris' office about the glitch in the Meridian production process the week before last. Harris then wrote Meridian on Sept. 12, and was quoted in The Wall Street Journal, which broke the story online Sept. 13.
Harris and his staff subsequently questioned the FDA, the Pentagon and other officials on the issue. He also released a statement to the press on Sept. 16.
"I am going to continue asking questions of the company and government agencies so we can all have confidence in our national defenses," Harris said in a Monday, Sept. 16, statement. "Recent actions in Syria show that chemical and biological defenses can no longer be on the back-burner."
Pfizer, Meridian’s parent company, will work with Harris to address his questions, said Christopher Loder, a Pfizer spokesman. He said Friday the company has reached an agreement with the Defense Logistics Agency to remediate and replace the affected autoinjectors at Meridian's cost.
The autoinjectors are part of a Meridian product line designed to help military and emergency medical personnel respond to crisis situations, similar to Emergent products.
Meridian products counter chemical agents while Emergent's products mainly target biological threats, such as anthrax. The companies currently don't view their products as competing.
However, Emergent hopes to become a competitor as it expands its development of chemical, biological, radiological and nuclear countermeasures. The company's August acquisition of a chemical agent decontamination lotion — one that could complement Meridian products — is viewed as a first step.
"We are looking at various products that would satisfy the needs of our warfighters, our first-responders community and other militaries around the world and our NATO allies," Shofe said. "We are looking to grow our portfolio."
Harris has accepted donations from Pfizer in the past, including $1,000 from the company's PAC in 2010, $500 from a Pfizer lobbyist in 2010 and $1,000 from a different lobbyist in 2012.
However, Emergent's PAC gave Harris the maximum donation in May before Shofe and another Emergent lobbyist hosted a fundraiser for him on the rooftop terrace of the Willard Office Building in downtown Washington. The invitation sought donations of up to $2,500 from political action committees and $500 from individuals.
"It looks like Emergent is getting close to a member of Congress who can help them compete ... who can help them beat a competitor," said Bill Allison of the Sunlight Foundation. "It's smart for them. We don't know how it's working."
Allison said Harris' criticism of Meridian is sure to catch the attention of Pentagon officials, who may take a second look when it's time to renew contracts.
Joe Newman, a spokesman for the Project on Government Oversight, said some of the questions Harris is asking about Meridian "seem to be well-placed," and Emergent's contributions are typical of how the political system operates.
Whether Emergent benefits from Harris' support remains to be seen, Newman said.
"The danger is that if a contracting officer knows they will be on the receiving end of congressional inquiries to defend their contract award decision, it could tip the scale towards the path of least resistance," he said. "Our position is that members of Congress should be careful about inserting themselves in the procurement process."
Editor's note: This story was updated after publication to clarify the chronology describing when Rep. Andy Harris learned of the nerve-agent antidote problem and what occurred in ensuing days.
--http://www.delmarvanow.com/article/20130922/NEWS/309220007/Of-procurement-and-politics-Harris-criticism-of-bio-defense-firm-could-help-donor
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October 10, 2001, AP - The Michigan Daily, Anthrax producer cancels community meeting,
LANSING (AP) The only U.S. manufacturer of an anthrax vaccine canceled a public meeting yesterday, saying it would answer neighbors' questions about safety in writing instead.
The neighborhood association for the north Lansing community that surrounds BioPort Corp. scheduled the meeting several weeks ago and reserved space at an elementary school so residents could question BioPort officials.
Many residents had become uneasy after the U.S. Department of Defense asked Michigan National Guard troops to begin guarding the laboratory, which has an exclusive contract to supply the anthrax vaccine to the Pentagon.
Tom Powers, president of the neighborhood association, said he has received more than 200 calls from residents concerned about the armed National Guard troops or worried if they could be affected by anthrax if BioPort is attacked.
BioPort keeps some live anthrax bacteria on its Lansing campus, but the company has said that the amount is too small and isn't in a form that would be of use to terrorists. Company spokeswoman Kim Brennen Root said there have been no specific threats against BioPort.
BioPort officials and the neighborhood association said they called off the meeting because of the intense media scrutiny surrounding the company right now. Anthrax and BioPort gained attention this week after a Florida man died Friday from anthrax and two of his co-workers were found to have spores of the disease.
Government officials have warned that biological attacks are one possibility as the United States and its allies strike back at terrorists after the Sept. 11 attacks.
State and national media have been flooding the company with questions. On Tuesday, Barbara Walters interviewed BioPort President Bob Kramer for ABC"s newsmagazine "20-20." Yesterday's meeting was expected to draw not just neighbors, but large numbers of reporters and TV crews.
"In the last few days, it had taken on too big of a proportion for what we were prepared to handle," Powers said.
Powers is compiling neighbors' questions and giving them to BioPort. Root says the company could have answers to its neighbors as early as today.
Powers said BioPort has been very cooperative so far, and that he believes neighbors' concerns will be alleviated.
"(We) are confident that this procedure will accomplish the goal of answering our neighbors' questions without being unnecessarily alarmed by inaccuracies and misstatements," Powers and Kramer of BioPort said yesterday in a joint letter.
In the three years since BioPort bought the lab from the state, it has not been allowed to ship a single dose of anthrax vaccine because it has been unable to get U.S. Food and Drug Administration approval.
BioPort on Monday plans to submit new information to FDA showing it has made the changes necessary to be allowed to ship the vaccine it has produced.
Anthrax produces a toxin that can cause fatal damage to the respiratory system and brain, killing untreated patients within days. Treatment with antibiotics is often successful if the infection is caught in time. --http://www.michigandaily.com/content/anthrax-producer-cancels-community-meeting
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January 15, 2002, AP - The Michigan Daily, Anthrax vaccine producer earns approval for lab,
LANSING (AP) The nation's sole producer of the anthrax vaccine has won federal approval for its laboratory.
But a few hurdles still remain before it can ship the vaccine, possibly by later this month.
BioPort Corp. of Lansing received a Dec. 27 letter from the U.S. Food and Drug Administration clearing it to begin shipping the vaccine, provided a Washington state laboratory that puts the vaccine into vials also receives FDA approval.
The vaccine already manufactured by BioPort also must be tested by the company for purity, potency and sterility and be released by the FDA before each lot can be shipped.
BioPort already has conducted tests on three lots of the vaccine manufactured in 2000 as part of the FDA approval process, BioPort spokeswoman Kim Brennen Root said yesterday.
The anthrax vaccine has been licensed by the FDA since the 1970s. But BioPort has been unable to sell the vaccine since buying its labs from the state in 1998 because it failed two FDA inspections after a renovation.
The Pentagon owns all of the vaccine BioPort has been producing and pays the company around $36 million each year, Root said.
In its letter, the FDA said BioPort has made or is in the process of making the seven production-related changes requested by FDA inspectors during their visit last month. The company still must improve monitoring and complete studies showing it can successfully pool batches of the vaccine.http://www.michigandaily.com/content/anthrax-vaccine-producer-earns-approval-lab
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October 15, 2001, AP - The Michigan Daily, Anthrax vaccine manufacturer seeks to gain approval of FDA,
LANSING (AP) Amid reports of new anthrax exposures at the U.S. Capital yesterday, the nation's only maker of an anthrax vaccine filed paperwork asking federal officials for approval to ship the vaccine.
Lansing-based BioPort Corp. has continued to manufacture the vaccine since buying a state-owned laboratory in 1998. But it has been unable to ship any because it has failed to meet U.S. Food and Drug Administration standards after renovating the plant two years ago.
The vaccine has gained attention in recent days as 12 people around the country have either tested positive for anthrax or have been exposed to the bacteria. A piece of mail sent to U.S. Senate Majority Leader Tom Daschle"s office in Washington, D.C., tested positive for anthrax yesterday.
BioPort spokeswoman Kim Brennen Root said yesterday that the company finished submitting several hundred pages of studies and reports to the FDA on Friday. She said the documents prove BioPort can make repeated batches of the anthrax vaccine in a safe, controlled environment.
"We feel that we have fully met our obligations to the agency," she said. "Very clearly, we have the right people doing the right jobs in a timely manner."
An FDA spokeswoman confirmed yesterday that the agency received the documents. She wouldn't say how long it will take the FDA to complete its review. The FDA has four to six months to review the information.
BioPort spent $16.8 million most of it federal dollars to expand and upgrade the facility. Root said last week that it's not unusual for approval of a renovated vaccine plant to take two to three years.
During that time, however, the FDA has found repeated problems at the lab. The company failed FDA inspections in 1999 and 2000. An FDA report issued in October 2000 said BioPort failed to ensure that its facilities were sterile and well-ventilated.
The FDA also said BioPort did not submit complete annual reports in 1998 and 1999 and was failing to keep proper records on people who suffered adverse effects to the anthrax vaccine.
Root said the company is confident it could begin shipping the vaccine early next year if it wins FDA approval. She wouldn't say what the company will do if the FDA refuses to license BioPort.
"Failure is not an option for this company," she said.
BioPort is the Pentagon's sole source of the anthrax vaccine. About 500,000 of the 2.4 million troops and reservists the military wanted to vaccinate have received the vaccine, but the program has basically been put on hold as supplies to vaccinate additional troops have run low.
Anthrax is a bacteria that can cause severe damage to the respiratory system and brain, killing untreated patients within days. Treatment with antibiotics often is successful if the infection is caught in time.
At the Pentagon's request, the Michigan National Guard has been guarding the facility since the beginning of October. No specific threats have been made against the company, which keeps a shoebox-sized container of live anthrax at the site under heavy security.
Last year, the U.S. House Committee on Government Reform issued a report that accused the Pentagon and BioPort of having a relationship that blocked the creation of newer anthrax vaccines and left the vaccine program vulnerable to supply shortages and price increases.
Root insisted yesterday that the company is up to the job. She said the Sept. 11 terrorist attacks and subsequent anthrax scare have strengthened BioPort's resolve.
"We wake up every day and we think we are part of the solution," she said.
The vaccine hasn't been available for civilian use, although Root said yesterday that BioPort employees in direct contact with the anthrax vaccine have been vaccinated.
Once the FDA approves the distribution of the vaccine, she said, the Pentagon and other federal agencies will have to decide whether to expand vaccinations to those not in the military. Most health officials so far have seen little need for a nationwide anthrax immunization program. Anthrax is not contagious.
http://www.michigandaily.com/content/anthrax-vaccine-manufacturer-seeks-gain-approval-fda
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October 27, 2001, Washington Post, FBI and CIA Suspect Domestic Extremists; Officials Doubt Any Links to Bin Laden, by Bob Woodward and Dan Eggen,
Top FBI and CIA officials believe that the anthrax attacks on Washington, New York and Florida are likely the work of one or more extremists in the United States who are probably not connected to Osama bin Laden's al Qaeda terrorist organization, government officials said yesterday.
Senior officials also are increasingly concerned that the bioterrorism is diverting public attention from the larger threat posed by bin Laden and his network, who are believed to be planning a second wave of attacks against U.S. interests here or abroad that could come at any time, officials said.
None of the 60 to 80 threat reports gathered daily by U.S. intelligence agencies has connected the envelopes containing anthrax spores to al Qaeda or other known organized terrorist groups, and the evidence gleaned from the spore samples so far provides no solid link to a foreign government or laboratory, several officials said.
"Everything seems to lean toward a domestic source," one senior official said. "Nothing seems to fit with an overseas terrorist type operation."
The FBI and U.S. Postal Inspection Service are considering a wide range of domestic possibilities, including associates of right-wing hate groups and U.S. residents sympathetic to the causes of Islamic extremists. But investigators have no clear suspects, and are not even certain whether there are other undetected letters that contained the deadly microbe.
But federal health officials said yesterday that a new case of pulmonary anthrax in a man who worked at a State Department mail facility in Northern Virginia has persuaded them that more than one contaminated letter may have been sent to the Washington area. Health experts previously believed that a single letter, sent to the office of Senate Majority Leader Thomas A. Daschle (D-S.D.), likely caused all the anthrax reports in the Washington area as it came in contact with other pieces of mail in the system.
Now the "working hypothesis would be that this is not cross-contamination," said Jeffrey Koplan, director of the Centers for Disease Control and Prevention. "There is not enough infectious material from cross-contamination to do that."
However, ongoing searches of truckloads of undelivered mail to the U.S. Capitol and other government buildings has turned up no other letters laced with anthrax bacteria, leading FBI officials to assume that the Daschle letter may still be the only local source. Two employees at the U.S. Postal Service's Brentwood facility in Washington have died from inhaling the lethal bacteria, and three other local postal workers have contracted inhalational anthrax.
"This envelope, Daschle's envelope, is not watertight or airtight or anything like that," one law enforcement official said. "It's porous. At one or two microns, there's plenty of room for the spores to escape."
Although there is consensus at the FBI and CIA that al Qaeda associates are planning more serious attacks, "nobody believes the anthrax scare we are going through is" the next wave of terrorism, one senior official said. "There is no intelligence on it and it does not fit any [al Qaeda] pattern."
No links between known foreign terrorist groups and the anthrax letters have shown up on the daily Top Secret Threat Matrix, which includes the latest raw intelligence on potential bombings, hijackings or other terrorist attacks, one official said. Though "lots of things are alarming" on the list, there is little agreement on how, when or where an attack might be launched, officials said.
FBI Director Robert S. Mueller III warned earlier this week that additional terror attacks are a "distinct possibility."
President Bush and other top U.S. officials have publicly voiced their suspicion that bin Laden and al Qaeda -- accused of carrying out the Sept. 11 suicide assaults on the World Trade Center and Pentagon -- may be responsible for the anthrax mailings.
But Mueller, Attorney General John D. Ashcroft and other law enforcement officials have said they have discovered no links between the mailings and bin Laden. Authorities, speaking on condition of anonymity yesterday, said they are increasingly doubtful that any connections will be found.
One official said the only significant clue raising the possibility of foreign terrorist involvement is the conclusion of FBI behavioral scientists, who believe that whoever wrote the three letters delivered to Daschle, NBC News and the New York Post did not learn English as a first language.
But the writer could have lived in this country for some time, and the other evidence gathered so far points away from a foreign source, several officials said.
The anti-Israel message in the anthrax letters and bin Laden's statements are echoed by U.S. extremist groups, said Rabbi Abraham Cooper, associate director of the Simon Wiesenthal Center in Los Angeles.
One group, Aryan Action, praises the Sept. 11 attacks on its Web site and declares: "Either you're fighting with the jews against al Qaeda, or you support al Qaeda fighting against the jews."
Cooper said a meeting this year in Beirut was attended by neo-Nazis and Islamic extremists united in their hatred of Jews. "Some extremists are now globalized," he said.
White supremacists have been linked with anthrax in the past, but not in relation to an attack.
Larry Wayne Harris, an Ohio microbiologist and former member of the Aryan Nations, was convicted of wire fraud in 1997 after he obtained three vials of bubonic plague germs through the mail. He was arrested the next year near Las Vegas when the FBI acted on a tip that he was carrying anthrax. But agents found harmless anthrax vaccine in the trunk of his car.
Cooper and officials at the Southern Poverty Law Project, which monitors U.S. hate groups, said they have seen no evidence of a domestic group capable of launching a sophisticated anthrax attack.
One of the challenges that a would-be terrorist faces is learning how to alter the anthrax so that it will float in the air and disperse widely. The Washington Post reported this week that the spores in the Daschle letter had been treated with a chemical additive using technology so sophisticated that it almost certainly came from the United States, Iraq or the former Soviet Union.
White House spokesman Ari Fleischer said yesterday, however, that investigators believe a broad range of people are capable of the crime. "The quality anthrax sent to Senator Daschle's office could be produced by a Ph.D. microbiologist and a sophisticated laboratory," he told reporters.
U.S. officials said the evidence so far does not point to either Russia or Iraq. However, FBI checks of private and government laboratories in the United States have not yet revealed any missing anthrax stockpiles, disgruntled scientists or other suspicious circumstances, one top official said.
Koplan, the CDC director, said he suspects more than one letter was involved based on his understanding of how difficult it is to contract inhalational anthrax. To cause the disease, 8,000 to 10,000 anthrax spores must enter a person's lungs.
Although some officials said it is possible for that many spores to have sloughed off the Daschle letter onto another piece of mail, Koplan said that is hard to imagine. "We all think that would be highly unlikely to virtually impossible," he said.
Koplan speculated that there may have been multiple mailings and that "there may be several places within the federal government that have been deemed targets."
By contrast, the minuscule amounts of anthrax bacteria discovered at Walter Reed Army Medical Center and the CIA "may well represent cross-contamination," Koplan said.
William C. Patrick, who is retired from the U.S. Army installation at Fort Detrick, Md., said extensive studies show that once anthrax spores hit the ground or other surfaces they stick, and are very hard to "re-aerosolize.
There's a theoretical possibility that a few spores picked up by an envelope might cause a skin anthrax infection, but a case of inhalational anthrax "is highly unlikely," Patrick said.
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April 29, 2009, Mathaba, No honest investigation into 'accidental' global release of Spanish Flu virus,
With the current release of 'Swine Flu' this article of 3 years ago and many others published on Mathaba concerning pandemic attempts, and the deliberate release of 'Mad Cow Disease' by Britain's military 'research facility' at Porton Down, it is time to revisit some of these articles. --http://mathaba.net/news/?x=619921?disqus
Saturday, June 4, 2005 by: Mike Adams, the Health Ranger, NaturalNews Editor
What if a terrorist acquired a deadly strain of influenza that had killed millions of people in the past? What if that terrorist were able to replicate that virus, obtain the names and addresses of organizations all around the world, and distribute it across the world? What if that became headline news, and everybody found out about it? You would think that law enforcement officials might be interested, right? You'd think that somebody would investigate how this deadly strain of influenza got shipped to all of these organizations around the world...
In reality, that's not what would happen at all. Such a hypothetical event actually occurred, except it wasn't a terrorist. It was a research company that claimed to have "accidentally" distributed all of these samples of the deadly H2N2 influenza strain, which is most famous for killing millions of people around the world in 1957. It was called the "Spanish Flu" at the time, although that name is not technically accurate.
This company took this deadly virus and replicated it, then put it in kits that were part of an everyday influenza identification testing kit. They overnighted these kits through postal mail or courier services to over 4,000 destinations around the world in many different countries. When this became headline news, however, nobody was interested in finding out whether this was a crime. Nobody thought, "Why is this happening?" Nobody raised the alarm and said, "You know what, this is a threat to human health." This is a deadly virus and people born after 1957 have no immunity whatsoever to this virus. This means you could re-release this old H2N2 influenza strain into today's population, and you could observe the same kill rate experienced back in 1957. You could see the same mess all over again with millions of people dying worldwide.
As if all of these viruses aren't dangerous enough on their own -- for example, Marburg in Angola and the bird flu virus in Southeast Asia -- we actually have companies replicating these deadly strains and distributing them, just to make sure that they're in everybody's labs all over the world.
It gets worse. Some of these shipments were lost. They don't even know where they are! They claim now that virtually all of these shipments have been destroyed, but how do we know? Even then, shouldn't somebody be held responsible for distributing this deadly virus? You could be charged with federal crimes if you were caught with this kind of material. If you sent it out to somebody, who knows how many years you'd do in prison for a stunt like that. In this country, we've been arresting people for putting white powder in envelopes and sending them to Congressmen, claiming it was anthrax. Anthrax doesn't even approach the kill rate of something like H2N2. And as far as I can see, nobody's really being held responsible for this.
This is not a minor issue. This is not "Oops, we just released a level-4 biological agent into the wild. We sent it to 4,000 destinations in over a dozen different countries, and we can't really find 10 percent of those any more. We don't know where they are, and nobody does." To me, this all sounds a little suspicious. If anybody else had pulled a stunt like this, they would have the FBI, the CDC, and the World Health Organization descending upon them instantly. This research company, however, appears to have undergone no such scrutiny. Where are the answers to the really important questions in this matter? How did they get their hands on H2N2? Shouldn't this be a controlled viral specimen? Aren't there restrictions on who has this stuff? Can anybody just order H2N2, H5N1, or any of the other influenza strains that have killed people over the years? Can we just go out and buy this stuff on the internet? Apparently, yes. That's what these people did. Over 4,000 customers bought this kit. They said, "Take my credit card and send me some level 4 biological agents."
It all just strikes me as a little bizarre. What if one of these vials broke open in the shipment? What if a FedEx driver broke one of these containers, contracted the virus, and it suddenly started replicating in that person? It could have been any courier, but what if they then came into contact with other people? Suddenly, you'd have a carrier, and the virus would be spreading. We would have the Spanish Flu all over again.
That scenario is not at all out of the realm of possibility, especially when the virus sample has been sent to 4,000 destinations. If you play the odds long enough, nature is going to clobber you. Nature will survive and viruses, of course, are not even living. A virus is just basically a pattern of DNA. It doesn't have to be alive to be dangerous. The fact that these were "dead" samples did not make it safer for all of us.
Here's another interesting fact in all of this. This deadly strain of influenza was only discovered accidentally by one of the labs that had received this shipment. It took some real detective work for them to figure out they had this deadly influenza strain in this kit. In other words, the research company that was sending these kits out wasn't even aware that they were doing it. They most likely would never have been aware of it if one of their customers hadn't alerted them. There was no mechanism in place to test these outgoing kits. There was no safety net. They could have been shipping these off to anybody, and it could have continued for years. Who knows how many samples would have been out there in the wild?
As a nation, we are frequently worried about the wrong things. For example, we're spending all this money on the fight against terrorists, and we're in Iraq fighting a war, and it seems like every decade we do it again. However, we've got people right here in the United States who are replicating these deadly strains of influenza and shipping them out into the wild. To me, that’s a much bigger threat than any terrorist, real or imagined. I don't mean to minimize the whole international situation, but if one virus like this gets out and the right person contracts it, you'd have a pandemic on your hands. You'd have an outbreak. And you can't fight a pandemic with bullets.
It wasn't too long ago that President Bush signed an order giving the government the right to quarantine air travelers who may be infected with things like the bird flu, or any other infectious disease. Here's the scenario: You've suddenly got H2N2 out in the wild, you've got Marburg going crazy over in Angola, you've got the bird flu virus all over in Korea right now, and you suddenly get people flying back to America exhibiting some upper respiratory symptoms. They get taken off the plane and quarantined, because they're a threat to everyone else in this country. If this gets any worse, or if H2N2 actually gets out into the wild and starts infecting people, we're going to have a lot of people quarantined. You'd better not get sick, because they're going to take you away. Seriously, that's what the order dictates. They're going to take you away and quarantine you for the good of everyone else in society.
I actually agree with that policy. I think that if you are in charge of the safety of a population, you have to make that kind of decision. You cannot let a pandemic just keep growing and spreading. If you're in charge of the CDC, or the World Health Organization, or the US Government, you have to quarantine people who appear to be a threat to public health. But what it means for us in terms of our freedoms is that they're being trampled on. Again, you'd better not get sick, since there are so many infectious disease agents out there now that people are getting increasingly paranoid. You could be pulled off of a plane, you could be pulled out of a line at some kind of a checkpoint, you could be quarantined, and you'd have no say about it. You wouldn't get an attorney, and you'd be quarantined by force. If you resist, you could quickly see firearms being pointed in your face. Gunpoint is the ultimate application of government willpower.
The Spanish Flu should have been over and done with in 1957. We shouldn't have to revisit it again. We've got enough dangerous stuff going around anyway. We've got superbugs in the hospitals. We've got people breeding superbugs in their own kitchens and bathrooms because they're using these antibacterial soaps that actually encourage the creation of resistant bacteria strains. We've got the bird flu virus now becoming a potentially serious threat. We've got Marburg over in Angola, which has a kill rate of anywhere from 90 to 98 percent, depending on how you work the math and which reports you believe. Hopefully, these illnesses will never show up over in North America, Australia, or Europe, but their existence is frightening enough. We don't have to be adding to it by doing nature's job of replicating these dangerous strains. Nature does that well enough on its own. It doesn't need our help.
Modern medicine: doing more harm than good
I want to drive home the point that our current medical research system in this country is absolutely insane. It has lost its mind even beyond the fact that researchers keep claiming they'll find cures for cancer if we only give them another couple of billion dollars. That's completely absurd, by the way. Aside from that fact, and the whole "cure con," as I call it, we have these organizations actually creating threats to our lives.
It's not just the pharmaceutical companies I'm talking about here, although their products are very dangerous for human health. (Let's face it, prescription drugs are killing twice as many Americans every year as the total number of Americans who died in the Vietnam War. This is a statistic from the Journal of the American Medical Association.) You've also got organized medicine killing three-quarters of a million people in the United States each year. That figure is from the "Death By Medicine" research document. In addition, you've got companies like this viral research lab blatantly increasing our risk. They're just rolling the dice, folks. They're rolling the dice with your life on the line. Perhaps this time we'll get lucky. Perhaps they'll find all of these missing vials and destroy them. Even if they do, it's just a lucky narrow escape. If you keep betting against nature, if you keep pushing the odds, sooner or later they're going to come up snake eyes. Sooner or later, nature is going to find a way to make that virus replicate in the wild. We'll only have ourselves to blame.
Vaccines: a channel for spreading infectious disease?
This kind of behavior is a good demonstration of why I don't trust companies that are replicating and distributing these dangerous infectious agents. This is why I don't trust vaccine companies at all. I never get vaccinated, and I don't recommend vaccination for anybody. I think the science behind vaccinations is bad. The mercury content of vaccines is toxic. There is a clear link to autism in children, and I think that a lot of vaccines have been contaminated with various strains of infectious disease over the years. In fact, there's strong evidence that some of the outbreaks we've seen in North America in the past were actually caused by mass vaccination programs.
When you see incidents such as the "accidental" mass distribution of H2N2, it becomes all the more believable. These companies really don't know what they're doing. They don't have adequate safety measures in place. It's being operated like a fast food chain -- "Here's your order. Maybe it's everything you ordered, maybe not. Move on through the drive-thru, there are people behind you." This is the kind of attitude that obviously must be going on at these research labs. It's unacceptable, because we're playing with the lives of millions of people.
Some may say, "It's okay, because it was an accident. This company didn't mean to send that out. It was an accident." Do you think that excuse would fly with a terrorist? Do you think they would say, "Oh, I didn't mean to fly into that building. It was an accident!" Do you think that would be accepted? "We didn't mean to release sarin gas into the subway. That was a complete accident. We had no intention to do that." That excuse wouldn't be acceptable!
A complete lack of leadership and responsibility
It shouldn't matter who it came from. It doesn't matter what their intentions were. What matters is what effect they had. Whose lives did they put at risk through their actions and through their lack of responsibility? It's the same lack of responsibility that we see across modern medicine here in the United States, especially in the pharmaceutical industry and medical research institutions. There's a disturbing lack of responsibility, ethics, and basic understanding of human or animal rights. There's even a lack of recognizing the individuality of human beings. It appears they're living in another world, where they think their actions have no consequences. They think they can just do anything they want, ship out anything they want, and forget about quality control. These are all just various strains of infectious disease. Let's send them out anyway, and we'll worry about it later. That must be the attitude that's taking place. It can only be sloppy quality control and a frightening disregard for human life that allowed something like this to happen.
Personally, I think somebody needs to be nailed for this. Somebody should be held responsible, and we deserve an explanation of more than just saying, "It was an accident. Oops! We just sent out a deadly strain of influenza." I don't buy that. There is more to this story; there's a reason why this happened. There had to be a chain of mistakes all the way through the organization, a chain that could have been stopped by somebody speaking up, or somebody doing their job correctly, or somebody just doing the right thing. There wasn't a whistleblower here. So this situation happened, putting us all at risk. That is unacceptable. We should demand a better explanation than "oops!"
What's to stop them from doing it again? What's to stop another company from doing it? How do we know that other strains aren't being shipped out right now? H2N2 is only one strain among many. You've got H5N1 today, and you've got all kinds of influenza strains from the past, such as the 1929 flu, which was a huge killer. How do we know that these are being contained right now? How do we know that the institutions that claim to be researching these actually have safety measures in place? How do we know that? We don't really.
All we know is what the press tells us, which doesn't seem to be the whole story by any stretch of the imagination. Even if a deadly strain WERE accidentally released, and people were starting to get infected, you can bet the CDC and White House would force mainstream newspapers to keep the lid on the news. Why? They don't want to cause a panic. So even if this virus were in the wild right now, you couldn't count on the mainstream media to tell you the truth about it. Washington would be, "balancing truth with public safety," as they say. Or, perhaps, balancing truth with corporate profits.
Don't trust any "official" news on infectious disease. The official news is shaped to minimize panic and control the public, not to impart accurate information to individual citizens. And I'm willing to be we'll never get the true story about this global release of H2N2 by a lab that can only says, "Oops."
We got lucky this time. But when you're dealing with infectious disease, you can only thumb your nose at nature so many times.
http://mathaba.net/news/?x=619921?disqus
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February 22, 1998, CBS News - 60 Minutes, Profile: Helping Saddam; Iraqi government ordered anthrax and botulism-producing bacteria from United States in late 1980s, by Morley Safer, Archived,
September 26, 2001, Biloxi Sun Herald, Extremists applaud attacks; Some groups see themselves at war with government, by Jim Nesbitt,
October 10, 2001, AP - The Michigan Daily, Anthrax producer cancels community meeting, Archived,
October 15, 2001, AP - The Michigan Daily, Anthrax vaccine manufacturer seeks to gain approval of FDA, Archived,
October 16, 2001, Seattle Post-Intelligencer, Anthrax threat comes to Congress; Powder tests positive in Senate majority leader's office, by Charles Pope,
October 18, 2001, New York Daily News, U.S. Hate Groups Seen As Bioterror Suspects, by Paul H.B. Shin,
October 21, 2001, Sun Sentinel, Agencies Begin To Work In New Way -- Together,
October 23, 2001, Sun Sentinel, FBI Centralizing Its Anthrax Investigation In Washington,
October 26, 2001, New York Times, Bin Laden Family Liquidates Holdings With Carlyle Group, by Kurt Eichenwald,
October 27, 2001, Washington Post, FBI and CIA Suspect Domestic Extremists; Officials Doubt Any Links to Bin Laden, by Bob Woodward and Dan Eggen,
October 27, 2001, New York Times, Firm Missing $105 Million and Executives After Attacks, by David Cay Johnston and William K. Rashbaum,
November 1, 2001 New York Post, Pre-9/11 'Terrorist' Mail Came From Indy, by Murray Weiss,
November 2, 2001, Sun Sentinel, Russians Dismantle Germ Warfare Plant,
November 5, 2001, New York Times, An Energized Brokaw Is in the Middle of the Story, by Bill Carter,
November 6, 2001, New York Times, The Funeral; A Farewell to a Victim of Anthrax, by Alan Feuer,
November 6, 2001, New York Times, Science Times; Evicting an Unwelcome Tenant: Anthrax, by Andrew C. Revkin,
November 7, 2001, New York Times, The Mystery: Detectives Ask for Help in Tracing Victim's Steps, by Andrew C. Revkin,
November 8, 2001, New York Times, The Disease: Worker Who Died Suspected Anthrax Was Root of Illness, by David E. Rosenbaum,
November 12, 2001, AP - The Michigan Daily, Anthrax vaccine producer protested by 40 in Lansing, Archived,
November 20, 2001, New York Times, Bioterror: U.S. Calls for Global Action to Counter Germ Weapons, by Elizabeth Olson,
November 20, 2001, New York Times, Bioterror: U.S. Calls for Global Action to Counter Germ Weapons, by Elizabeth Olson,
November 21, 2001, New York Times, In Utah, a Government Hater Sells a Germ-Warfare Book; The How-To Book, by Paul Zielbauer with William J. Broad,
November 21, 2001, New York Times, In Utah, a Government Hater Sells a Germ-Warfare Book; The How-To Book, by Paul Zielbauer with William J. Broad,
November 27, 2001, New York Times, With Biotechnology, a Potential to Harm, by Andrew Pollack, Archived,
December 20, 2001, New York Times, Classified Information; Bush Gives Secrecy Power to Public Health Secretary, by Alison Mitchell,
January 13, 2002, New York Post, Webheads Help Hunt the 'Thrax',
January 15, 2002, AP - The Michigan Daily, Anthrax vaccine producer earns approval for lab, Archived,
January 23, 2002, AP - The Michigan Daily, Lansing laboratory may begin anthrax vaccine shipments, Archived,
April 2, 2002, Sun Sentinel, Pesticide Promising Against Anthrax,
April 29, 2002, New York Post, Editorial, Still Waiting For Answers,
April 29, 2002, New York Post, Op-Ed, Why the Bureau Might Go Wrong, by John Podhoretz,
June 7, 2002, Judicial Watch Press Release, FBI & Bush Administration Sued Over Anthrax Documents,
August 13, 2002, New York Post, 'Anthrax' Doctor Failed Lie Test, by Niles Lathem,
September 7, 2002, New York Post, Editorial, Anthrax Scapegoat?,
March 15, 2003, Sun Sentinel, Scientist Ready To Test Pesticide On Anthrax,
February 27, 2003, Sun Sentinel, Test Pits Bug Killer Against Anthrax,
March 7, 2003, The New York Post, Blix Will Bare Iraq’s 'Thrax’,
October 22, 2003, The New York Post, New FBI Section Focuses On WMD, by Brian Blomquist,
May 18, 2004, USA Today, Muslim CEOs of U.S. firms fight terrorism, 'stop evil', by Del Jones, Archived,
July 21, 2004, NARA, The George W. Bush White House Archives, President Bush Signs Project Bioshield Act of 2004,
August 6, 2004, The New York Post, 'Thrax Raid Targets Vaccine Doc, by Don Murray and Andy Geller,
August 7, 2004, New York Post, Ladies and Germs, by Don Murray and Perry Chiaramonte,
September 16, 2005, Washington Post, Little Progress In FBI Probe of Anthrax Attacks; Internal Report Compiled As Agents Hope for a Break, by Allan Lengel, Washington Post Staff Writer, Archived,
December 19, 2006, U.S. law giving legal authority for BARDA (42 U.S. Code § 247d–7e - Biomedical Advanced Research and Development Authority (BARDA) provided by the Cornell University Law School, (July 1, 1944, ch. 373, title III, § 319L, as added Pub. L. 109–417, title IV, § 401, Dec. 19, 2006, 120 Stat. 2865; amended Pub. L. 113–5, title IV, § 402(a)–(d), (f), Mar. 13, 2013, 127 Stat. 194, 195.)
May 5, 2008, San Francisco Business Times, VaxGen wraps up sale of anthrax assets, Archived,
VaxGen Inc. finished selling the assets of its anthrax vaccine program for $2 million. The buyer was Emergent BioSolutions Inc., based in Rockville, Md., led by CEO Fuad El-Hibri. Emergent sells the only FDA-approved anthrax vaccine. VaxGen, based in South San Francisco, could also get up to $8 million in milestones and royalties if the program goes forward and is successful. Emergent aims to develop the vaccine to meet a request for proposals from the U.S. Department of Health and Human Services, which seeks to stockpile 25 million doses of anthrax vaccine for bioterrorism defense.
May 5, 2008, Forbes. Thomson Reuters, VaxGen sells anthrax vaccine candidate to Emergent BioSolutions, Archived,
June 28, 2008, New York Times, Scientist Is Paid Millions by U.S. in Anthrax Suit, by Scott Shane and Eric Lichtblau,
August 1, 2008, Los Angeles Times, Apparent suicide in anthrax case, by David Willman, Times Staff Writer, Bruce E. Ivins, a scientist who helped the FBI investigate the 2001 mail attacks, was about to face charges.
August 2, 2008, Los Angeles Times, U.S. officials are mum on news reports; They say only that 'substantial progress' had been made in the anthrax case. Details are expected soon, by Richard B. Schmitt, Times Staff Writer,
September 30, 2008, Bloomberg, Emergent's Anthrax Vaccine Effective With Fewer Doses in Study, by John Lauerman,
February 13, 2009, The Washington Post, Local Briefing, Emergent to Sell Vaccine in India,
Emergent BioSolutions of Rockville said its BioThrax anthrax vaccine is now allowed to be marketed and sold in India. Emergent said it signed a marketing deal with Biological E. Limited for India.
"Today marks a pivotal milestone in Emergent's efforts to expand globally and further our mission of protecting life," Emergent chief executive Fuad El-Hibri said in a statement.
December 2009, Security & Defence Agenda, SDA Biopreparedness Report
March 30, 2012, Gazette.net, Emergent's Fuad El-Hibri, an entrepreneur at heart; CEO turns over the operational reins of his latest venture, Emergent BioSolutions, by Kevin James Shay, Archived,
January 4, 2013, Gazette.net, Emergent licenses flu vaccine for new federal biodefense center,
March 22, 2013, BioPrepWatch, Emergent BioSolutions promotes Shofe to executive vice president of corporate affairs, by Paul Tinder,
August 2, 2013, Yahoo! Finance, Emergent BioSolutions Closes on Its Acquisition of Healthcare Protective Products Division from Bracco Diagnostics Inc, Archived,
September 23, 2013, The Daily News (Delaware, Of procurement and politics: Harris criticism of bio-defense firm could help donor; Rep. Harris' criticism of bio-defense company could benefit donor, by Nicole Gaudiano, Daily Times Washington Writer,
September 23, 2013, delmarvanow.com, Of procurement and politics: Harris criticism of bio-defense firm could help donor; Rep. Harris' criticism of bio-defense company could benefit donor, by Nicole Gaudiano, Daily Times Washington Writer,
December 11, 2013, Washington Post, Emergent BioSolutions pays $222M to acquire life sciences firm Cangene Corp, by Steven Overly, Archived,
February 18, 2014 [5:42 PM ET] Wall Street Journal, Cangene Receives Court Approval of Plan of Arrangement for Acquisition by Emergent BioSolutions, Archived,
April 15, 2014, BioPrepWatch, First of three pandemic manufacturing sites could be ready by 2016, by Lisa Sievers,
May 25, 2014 [1st web capture] Bloomberg Businessweek, Emergent Biosolutions Inc. (EBS:New York): Company Description,
November 7, 2014, New York Times, More Than 600 Reported Chemical Exposure in Iraq, Pentagon Acknowledges, by C. J. Chiversnov,
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Gulf-Chat : Illnesses of Gulf War Veterans
October 3 2001, Sunshine Project, Operation Infinite Contract: Biotech's Impossible, Profitable War to Defeat Nature, by Edward Hammond, Archived,
The author is a Director of the Sunshine Project USA, a non-profit organization working to prevent development and use of biological weapons.
Contrary to what the US public is now being told, biodefense does not offer durable protection from the threat of biological weapons. In order to win, biodefense must overcome the infinite variability of nature itself. That is an impossible task.
It is a disconcerting reality to face, but science is not going provide any long-term solutions to the threat of biological weapons. Heavy investment in biodefense might even have the opposite effect. Enduring solutions are to be found in diplomacy, international cooperation, and vigilance. These tools are not perfect; but they do promise access to suspect facilities, sharing of information, "peer pressure" among countries, and an improved ability to ensure that everyone complies with commitments to not develop or use biological weapons.
Citizens should ask questions about biodefense, and not accept simple answers. The biggest unasked question: What will a successful biotech war on bioterrorism require?
To get an answer, take a moment to ponder being immortal. Now think about biodefense. Both make an arrogant and impossible promise of human mastery over life and its variability.
Would Americans feel safe and secure with, say, 50% of us immune to some kinds of biological weapons? Or, resistance to 50% of biological weapons? No. A biological enemy cannot be deterred. In order to win, it must be overwhelmed. And in a world of infinite variability, that is an impossibility.
The term biodefense can be confusing. It is applied to a bundle of different approaches, some sound and others dubious. Unbundling the biodefense wrapper is important. Some biodefense activities are prudent public health measures, such as training medical staff and monitoring for unusual outbreaks of disease. Nobody would disagree with this kind of biodefense. Other approaches are technical, such as manufacturing protective suits and sensors to detect biological weapons, efforts that have their own particular difficulties (which are not addressed here).
Another set of biodefense activities are closer to those traditionally understood as military biodefense. These approaches are biomedical, such as developing medicines and agent-specific or "multivalent" (i.e. counteracting more than one variant of one agent) vaccines.
It is this latter set of approaches and, among them, those that suppose to defeat attack, that are the subject here. Biological warfare is the use of disease (generally disease-causing microbes and/or toxins they produce) to achieve political and military ends. Unusually lethal anthrax is a bioweapon many have heard about, but biological weapons neither begin or end with the handful of agents widely discussed in recent days.
Biological weapons are many. How many? The answer is uncomfortable to contemplate, but critical to understand. There are many more potential biological weapons than there are diseases that plague humans, animals, their food and industrial crops, and the biological systems that maintain our environment. All diseases are potential weapons.
In other words, biological weapons are infinite. Starting with nature's innate variability, and compounded by genetic engineering, biological weapons agent possibilities are literally endless. There are dozens, maybe hundreds of varieties of smallpox. A genetic cut and paste makes the difference between an E. coli strain that happily assists digestion and one that leaves people dead. Techniques such as mutagenisis and using antibiotic resistance genes can turn relatively or completely benign microbes into major killers.
Because biodefense projects that suppose to eliminate the threat of biological weapons work against an infinite world of potential enemies, in order to vanquish biological weapons, to be effective they must seek to utterly control the systems by which all life reproduces and grows. Otherwise, defenses are continually outflanked.
Put simply, those that promise victory - that meaning a technical elimination of biological weapons, or even a significant subset of them - aspire to the power of a deity. Without omniscience, stopping one threat only points to another, and another, and another, and another, and so on. It is painfully obvious that even the best, enormously funded scientific talent will never overcome biodiversity combined with a determined, sometimes suicidal, enemy.
It is disappointing that relatively few science professionals speak out about this. Even fewer companies do; but then there are profits to consider.
Thinking Ahead
When somebody claims to have a technical solution to a bioweapons attack, it's important to think a step or two ahead. At present, there more purported solutions to anthrax than for malaria, a sad historical commentary on public health priorities; but would the US and its allies be significantly safer if anthrax were mastered?
Effective elimination of this threat to the general population is a decade and billions of dollars away at best. Right now, the US can barely produce enough vaccine to protect its own troops; but even then, the protection is limited and may not work against genetically engineered strains that are known to exist.
For the sake of argument, pretend for a moment that anthrax has disappeared as threat. There is one less bioweapons agent. Anthrax is particularly lethal; but is still only one of an infinite number of possibilities. Infinity minus one is not a real number. What happens next? The focus shifts to genetically-engineered strains of these agents which might outflank our defenses and then to other bioweapons agents, known for years, such as smallpox, botulinum toxin, plague, tularemia, Q fever, brucellosis, glanders, various types of encephalitis and hemorrhagic fevers, Marburg, and Ebola.
Many experts loathe to admit that using some of these diseases as a weapon requires little more than a petri dish, taking personal risks, and minor ingenuity. Using these agents to dramatic effect requires a bit more ingenuity; but pretending the dark science of biological weapons is impenetrable to all but a few superior minds is foolhardy. So, in our technical fix scenario, these diseases must be eradicated too.
Go a step further and, for a moment, be wildly optimistic. Pretend biotech has banished all the diseases mentioned so far, despite the fact that many would be more readily resolved as an issue of public health care and compassion than with the latest gene therapy. All the "typical" biowarfare bugs are gone, at least as a threat to US soldiers. Would the US then be safe from biological weapons? Not at all. Infinity minus twenty, and there are many left to go.
At this point, very difficult and potentially destabilizing political questions must be considered. Who foots the bill, and who gets the protection? Will the US provide these hypothetical vaccinations and treatments to everyone else, or reserve them for close allies and the rich? Biotech companies, beneficiaries of the contracts to develop these hypothetical cures, are very unlikely to give them away. Ask Africa about AIDS medicines. Should the US pay to vaccinate the world? In fact, the US is not even sure if it can afford to protect its own citizens. If the US is not prepared to treat the world, how will it be interpreted? As proof of US cold-heartedness, or even as a threat. The US would be marginally protected, but everyone else, especially the poor, would be vulnerable.
But we're only scratching the surface of possible bioweapons. Among human diseases, for a start there's influenza, which already spreads like wildfire and kills thousands annually. Add HIV, malaria, dengue, cholera, typhoid,
yellow fever, West Nile, Chagas disease, Lyme disease, hepatitis, and river blindness. There are many more. Is the Pentagon and Secretary of Homeland Defense prepared to take these on too? Because they could be used as very damaging weapons. A biodefense technical fix will require mastering them, protecting people, and wherever possible eliminating the agent to keep it out of a tinker's hands.
There are other biological weapons. Crop diseases, livestock diseases, pathogens to attack food supplies, and genetically engineered microbes to destroy material, such as those created by the US Navy. They are no easier to combat and threaten humans by destroying our means to survive. Ask the British agriculture officials about their desperate and extraordinarily expensive battle against an apparently accidental outbreak of hoof and mouth disease.
We haven't really even mentioned genetic engineering. If a bioweaponeer's first course of action doesn't work, old diseases can be made to come back:
Measles, mumps, rubella, or even polio might be induced to outwit vaccinations.
A genetic cut and paste makes the difference between a benign bacteria and one that kills.
Last year, scientists published a genetic sketch showing how a relatively weak disease, say chicken pox or shingles, could be turned into a deadly genetically engineered weapon.
Diseases can be made to exhibit different symptoms, to be more aggressive, to outwit antibiotics, or to evade detection systems.
In security parlance, many of these items are classified as "risks" rather than "threats". Risks are things that might be possible, threats are things that we have good reason to believe could happen. For example, HIV is very deadly; but difficult to weaponize and nobody serious has threatened to do it. Hence it is a risk, not a threat. Threat assessment deals with matters at hand and, in effect, leaves future possibilities to worry about later, if they become more real. Differentiating between risks and threats is the starting point for many analysts. But the analysts are concerned about the immediacies of defense, not about prevention.
The threat assessment methodology for classifying priorities is quite different than, for example, the precautionary principle developed in biosafety. Unfortunately, threat assessment has deeply pervaded not just military, but diplomatic thinking about solutions to biological weapons. Its inherent short-sightedness has stymied the development of effective solutions. Many governments have substituted a short-term military priority-making approach for a methodology to create underlying conditions necessary to prevent the upsurge of new problems. By discounting problems that aren't right on the doorstep, threat assessment leads to half-baked notions of what can be done to promote security, such as the US walking away from the Biological and Toxin Weapons Convention Verification Protocol, and investing heavily in the wrong kinds of biodefense.
Biotech's Gulf of Tonkin Resolution
Presently, the US Congress' biodefense pocketbook is wide open. There's no shortage of outstretched hands. Much of it is pursued by an industry whose public image is staked on the false hope of creating meaningful protection from biological attack. In the past week, almost every major US daily has run articles praising the experimental biodefense "miracle" or "magic" brewing just around the corner at a local university or biotech startup. Did the United States have such a huge and promising biotech defense industry before September 11th and nobody noticed? No. By global standards, our program is big; but it isn't promising and the professor or Chief Technology Officer around the corner is no more likely to save you from a biological attack than a tidal wave.
Through America's preoccupation with homeland biodefense, the biotech industry believes it has been granted a license to proceed into a profitable war with no possibility of producing peace and no durable long-term product but profit. Congress didn't exactly give biotech a Gulf of Tonkin Resolution; but sloppy media coverage and shameless opportunism are creating one.
DynCorp, a spooky US defense contractor best known for blasting Colombia with wide spectrum herbicides in the Drug War, is setting up a bioweapons vaccine business. It's partner is Porton International, a company which sprang forth from Porton Down, the UK's equivalent of Ft. Detrick, MD. Before 1969 Ft. Detrick was the US headquarters of biological weapons research. Now it houses important elements of our biodefense apparatus. DynCorp has its fingers in many pies and also advises the US Army and industry on compliance with biological and chemical weapons agreements.
Another major military contractor, Science Applications International Corporation (SAIC) already has assets at Ft. Detrick through contracts with the military and the National Cancer Institute.
In Texas, Lynntech Inc. proffers organophosphorus hydrolase as part of its quest to, in the soothing words of a local newspaper, discover "a single enzyme that will neutralize all toxic agents." A pipe dream if one ever existed; but on September 11th the Texans got a call from a general at Ft. Detrick.
In Seattle, Corixa Corp. publicly complains that $3.5 million isn't enough for its experimental anthrax vaccine and wants more help from the government. Corixa's stock is up more than 50%. There are legions more.
The Vaccine Push
During the Gulf War, the US realized that it did not have the ability to vaccinate its troops (much less those of allies) against anthrax and other biological weapons possessed by Iraq. Entreaties to the pharmaceutical industry prompted a flood of antibiotics but little vaccine. Treating disease has always been more profitable than preventing it.
After further haggling, industry made clear it wasn't interested in manufacturing bioweapons vaccines without massive subsidies and relief from liability. The military effectively agreed, and SAIC drew up a plan for the government to invest about $3 billion in research and to build vaccine facility costing $370 million. At this government facility, companies will produce eight (8) vaccines against anthrax, smallpox, plague, tularemia, botulinum, "next generation" (read: genetically engineered) anthrax, ricin, and equine encephalitis. This $3 billion plus buys only eight, only to protect the US military and, by agreement, some soldiers from Canada and the UK. US civilians are out of luck, according to SAIC "Beyond the baseline operating scope of the [government-owned, contractor-operated] facility design." Foreign citizens aren't even an afterthought.
Avoiding the Spiral and Invoking Diplomacy
On September 4th, the New York Times revealed that US Central Intelligence Agency biodefense researchers had tested mock biological bombs and built a real bioweapons production facility in Nevada, activities completely indistinguishable from offensive biological warfare research. The US kept these activities secret, and did not divulge them in annual confidence building reports to the Bioweapons Convention.
The US is now pouring billions more into biodefense. In the current climate, it is difficult to believe that potential adversaries will not respond with their own investments. After all, the US itself has failed to comply with its arms control commitments. The situation could very easily spiral out of control.
The sooner the US understands the impossibility of effective biodefense, the sooner pressure will build for the Bush administration to come to its senses and advocate fast conclusion of the Verification Protocol to the Biological and Toxin Weapons Convention.
The Gulf-Chat list is hosted by Verio, Inc. http://www.verio.net Verio claims no responsibility for Gulf-Chat list contents and provides the Gulf-Chat list as a community service.
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November 19, 2001, Gulf Chat, Medium Rare, Anthrax Vaccine - What Reports? What War?, by Jim Rarey,
On October 23rd of this year Nancy Kingsbury from the General Accounting Office (GAO) testified on Anthrax Vaccine before the House Subcommittee on National Security, Veterans’ Affairs, and International Relations Committee on Government Reform. Her testimony has been released as report GAO-02-181T available on the GAO website at www.goa.gov.
The report is a scathing indictment of the handling of the anthrax vaccine issue by the Food and Drug Administration (FDA), the Department of Defense (DOD), the Bioport company in Michigan and before that the Michigan State laboratory. On November 11th (Veterans’ Day) a rally was held on the capitol steps in Lansing, Michigan by a group comprising, for the most part, veterans who were suffering from the effects of the vaccine or had been forced to resign from the service for refusing to take the vaccine.
In attendance at the rally was Michigan National Guard Public Affairs Officer Major James McCrone. In an interview with a TV reporter, he said he was there to see if "these people" had anything new to say. When he said he had heard nothing new, he was asked by one of the speakers at the rally if he had read the latest GAO report on the
vaccine. His response was, "What report?"
Ignorance is just one of the problems associated with the vaccine. Sadly, there has been ten years of stonewalling, obfuscation and outright lies from "experts" and PR flacks both in and outside of government.
Here is a brief recap of information contained in earlier articles.
The vaccine was first licensed by the FDA for production by a Michigan state owned laboratory in 1970 based on vaccine produced and tested by Merck Sharp and Dohme (currently known as Merck and Co., Inc.) in 1962. Prior to 1970 vaccines were licensed by the National Institute of Health (NIH).
The vaccine was certified as effective against cutaneous (skin contact) anthrax and some studies with monkeys suggested some effectiveness against inhaled anthrax (the most dangerous).
Despite changes made in both the composition (recipe) of the vaccine and the method of production, no further testing has been done. The altered vaccine was administered to over 500,000 service men and women before and during the Gulf War. An unacceptable number have had their lives (and lives of their families) ruined by reactions to the vaccine
In 1998, Secretary of Defense William Cohen decided to vaccinate all service members and the program started. Over 400 members have left the service or been subject to discipline for refusing to take the vaccine.
In 1998 the FDA suspended the license for the vaccine shortly after a private company (Bioport) bought the facility and licensing rights from the State of Michigan. The privatization was engineered by Fuad El Hibri, a German citizen at the time and included several former state employees of the lab, Fuad’s wife and father and Admiral William Crowe (a former Chairman of the Joint Chiefs of Staff.
The facilities and the licensing rights were obtained for a sale price of $25 million, however a portion was financed with IOU’s to the state and promises of delivery of several other vaccines and royalties on Bioport’s sales. It was later admitted the licensing rights alone were worth at least $35 million.
Bioport has not been able to pass FDA inspections to date and no vaccine has been shipped since 1998. The DOD has virtually run out of vaccine acquired between 1990 and 1998 and has had to suspend its universal vaccination program.
In the mid-1980’s, El Hibri had also engineered a private buyout of Britain's secret lab involved in production of vaccines and experimentation with chemical and biological weapons materials. The ownership was split among three El Hibri controlled entities; Porton Products, Porton Instruments and Porton International. The Porton laboratory was the sole source of anthrax vaccine used on British troops during the Gulf War.
Vaccinated British troops experienced much the same health problems, as did American troops. It was later disclosed that untested "adjuvants" had been added to the vaccines in both the U.K. and U.S. Both vaccines included toxins generated by anthrax bacteria which were expected to cause antibodies to be formed to fight the infection. The adjuvants increased the toxicity to speed up the body’s reaction.
In the U.K. public health authorities warned that the adjuvants would compound the already significant side effects of the vaccine. In the U.S. the DOD questioned the Michigan lab about the increased toxicity and later (in October 1990) issued a report. However the FDA was not apprised of the change until ten years later by the GOA.
In early 1990 the military (in both the U.K. and U.S.) pressured their respective vaccine suppliers to greatly increase production in anticipation of hostilities in the Middle East. This was some six months before Iraq invaded Kuwait on August 2, 1990. Both Britain and the U.S. had sold equipment/ and/or anthrax vaccine to Iraq during its war with Iran. It was feared that Iraq might use its anthrax capability in the coming war.
That the military was so certain of a war with Iraq lends credence to charges that the U.S. "suckered" Saddam Huessein into the invasion. Eight days before the invasion, according to a tape and transcript obtained by British journalists a month later, the American ambassador to Iraq, April Gilspie, met with Saddam Hussein and told him, " We have no opinion on your Arab – Arab conflicts, such as your dispute with Kuwait. Secretary (of State James) Baker has directed me to emphasize the instruction, first given to Iraq in the 1960’s that the Kuwait issue is not associated with America."
A few days later, Gilspie said in a televised interview, "we have no treaty or other agreement that requires us to come to the aid of Kuwait.
Congress demanded access to diplomatic communications between the State Department and Ambassador Gilspie but was successfully stonewalled by Baker’s State Department.
During negotiations between 1996 and 1998 between the State of Michigan and El Hibri and his partners, a concern was expressed about El Hibri's sale (from his British lab) of anthrax vaccine to Saudi Arabia after they had been turned down by the Pentagon. It was feared he might also have sold anthrax and/or the vaccine to Iraq. A British
scientist had disclosed Iraq had made a specific request for the "Ames" strain of anthrax, although he said the request was denied.
American scientists have determined that the current anthrax attacks by mail are using the same strain (Ames) that was furnished to the British lab at Porton Down years ago by the U.S.
Rather than contact American intelligence, Michigan authorities asked the American Embassy in Germany about El Hibri. The embassy gave him a clean bill of health saying, "he’s one of the good guys." What the embassy didn't tell them, or didn't know, was that two scientists in El Hibri's privatized lab were involved in South Africa as consultants to the infamous chemical and biological weapons program in that country.
The head of South Africa's CBW program was Wouter Basson. Basson was charged with multiple counts of murder and fraud in trial that lasted almost a year. During the course of the trial (in which Basson earned the nickname Africa's Dr. Mengele) a number of witnesses detailed the weapons the program had developed for mass murder as well as assassination of individuals with such things as anthrax laced cigarettes.
One of Basson's lieutenants, Dr. Andre Immelman testified about the Porton Down involvement in the murder of the Reverend Frank Chikane, with an exotic toxin called Paraoxon. He discovered that, without his knowledge, one of his subordinates (Schalk van Rensburg) had hired two consultants from Porton Down on the project. He confronted van Rensburg and accused him of wanting to blow their cover. Van Rensburg responded that Porten Down had been privatised and the consultants were from the private sector.
The October GAO report was not the only one that provided evidence that the anthrax vaccine is the culprit in veterans’ health woes.
In April of this year the GAO submitted a report (GAO 01-13) that had been requested by subcommittee chairman Christopher Shays. He had asked the GAO to find out why French Gulf War veterans were reporting far fewer health problems than their British and American counterparts.
Amid a welter of charts and statistics, the obvious answer was found. British and American troops were inoculated with the anthrax vaccine, the French were not.
There was one other difference between the British and American programs. The British program required "informed consent" from soldiers before the vaccine was administered. The American program was, and still is mandatory.
The GAO surveyed a large group of American national guard and reserve forces who had taken the vaccine to determine how many experienced a reaction from the shots. They found that 85% had some kind of reaction and in 23.8% it was systemic (affecting the body’s systems).
The numbers still being advertised by Bioport and the FDA are 30% experiencing mild reactions, 4% having moderate reactions. They say only .2% or two out of a thousand suffer systemic problems! What they
do not admit is their numbers are based on testing done more than thirty years ago on a different vaccine.
Last week, Bioport revealed that negotiations are being held with DOD to release some of the two million doses embargoed by the FDA to the public. One of the demands of the veterans assembled in Lansing was that those lots be destroyed before they cause further harm.
Permission is granted to reproduce this article in its entirety. The author is a free lance writer based in Romulus, Michigan. He is a former newspaper editor and investigative reporter, a retired customs administrator and accountant, and a student of history and the U.S. Constitution.
If you would like to receive Medium Rare articles directly, please contact us at jimrarey@....
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May 18, 2004, USA Today, Muslim CEOs of U.S. firms fight terrorism, 'stop evil', by Del Jones, Archived,
Excerpt
"I'm trusting, not paranoid," says El-Hibri, 46, who became a U.S. citizen in 1999. He was born in Germany and spent his childhood equally in Europe and the Middle East before coming to the USA to get an economics degree from Stanford and an MBA from Yale. "But there is a group who don't think the anthrax vaccine should be in the hands of someone with an Arab or Muslim background."
Scrutiny surrounds anthrax vaccine
Conspiracy-theory Internet sites have taken a special interest in El-Hibri's formative years in Lebanon and Sudan, and a more recent three-year assignment in Saudi Arabia with Citibank. The sites imply crimes ranging from ties to Osama Bin Laden to being the mastermind behind the mailing of anthrax spores that killed five people in 2001. El-Hibri calls the Web sites annoying and jokes that he's lucky to be in the vaccination business so that he can inoculate himself from the pain of accusers who can't be confronted.
Even some members of Congress have objected to BioPort's anthrax role. That criticism reflects ignorance, says retired admiral William Crowe, who served as chairman of the Joint Chiefs of Staff in the Reagan administration and the first George Bush administration and now is on BioPort's board of directors. BioPort recruited Crowe, a friend of El-Hibri's father. Crowe received 8% of BioPort's stock to serve on its board, largely because of his expertise about the key customer, the Defense Department. But Crowe's presence also mitigates the attention on El-Hibri.
BioPort keeps a small supply of anthrax spores under five layers of security to verify the potency of the vaccine, a requirement of the Food and Drug Administration. That makes El-Hibri a suspect of conspiracy theorists, who say the unsolved anthrax mail crime of 2001 increased demand for BioPort's product while El-Hibri and his family were safely inoculated from the fatal bio-threat.
"That's a terrible stretch," says Crowe, who says El-Hibri is straightforward and honest and is one who has "never entertained even the slightest idea of fooling the government" and "bends over backward to make sure the Defense Department is aware."
Muslim executives were careful and measured when responding to most questions but became noticeably uneasy when asked how devout they were to Islam. A typical response: "I attend mosque when I have time," Khalafsaid. "My philosophy is to be good, to live with others and to be equal with others."
"I don't drink alcohol or gamble," said Mesdaq, 32. "I go to mosque," but he emphasized: "I'm not a political Muslim. I'm a normal American. I like to drive nice cars, go out and have fun and dance. I'm very blessed."
El-Hibri says he attends mosque once a year. His mother is German and Catholic. He adopted the faith of his Lebanese father. Islam, Christianity and Judaism are essentially the same, El-Hibri says, with a "belief in one God, what's right and what's wrong. Do the best things in the eyes of God, that's most important."
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March 30, 2012, Gazette.net, Emergent's Fuad El-Hibri, an entrepreneur at heart; CEO turns over the operational reins of his latest venture, Emergent BioSolutions, by Kevin James Shay, Archived,
Brian Lewis/The Gazette “For us, our central mission is to protect life,” says Fuad El-Hibri, CEO of Emergent BioSolutions. “It’s been a great honor to serve the military and protect our active military.”
Fuad El-Hibri
Age: 54.
Position: CEO, chairman, Emergent BioSolutions, Rockville.
Education: Master's in public and private management, Yale University; bachelor's in economics, Stanford University.
Community/professional activities: Board of directors, U.S. Chamber of Commerce; board of trustees, International Biomedical Research Alliance, National Health Museum; advisory board, Yale Healthcare Conference, Heifetz International Music Institute; chairman, El-Hibri Charitable Foundation, Awards: Biotech CEO of the Year, World Vaccine Congress, 2011; International Leadership Award, World Trade Center Institute, 2010; Ernst & Young Entrepreneur of the Year for Greater Washington, 2009; Rene Moawad Foundation Distinguished Community Service and Achievement Award, 2007.
Residence: Naples, Fla.; also has home in Potomac.
Family: Wife, Nancy; three adult children; two grandchildren.
Hobbies: General aviation, equestrian sports, scuba diving.
Fuad El-Hibri has started a financial consulting business. He’s started telecommunications businesses.
But his most challenging venture has been the Rockville biotech he helped launch 14 years ago.
Still, El-Hibri — CEO and board chairman of Emergent BioSolutions — says the challenges are worth it, because the rewards are so great from protecting and saving lives.
Unlike products in many other sectors, vaccines and other bioscience products can take 10 to 15 years to develop. The regulatory climate can drive up costs. The probability of commercial success is relatively low, in the neighborhood of 20 percent.
“You need to have a strong and focused will,” said El-Hibri, 54, who is retiring as CEO as of Sunday, but remaining as executive chairman. “It takes a lot of patience and persistence.”
El-Hibri co-founded Emergent — then called BioPort Corp. — in 1998, and the company has seen annual revenues more than triple in the past eight years to almost $300 million, with a decade-long track record of financial profits. The biotech focuses on several prominent disease areas, with numerous clinical stage product development programs. Its biggest money-maker is its anthrax vaccine.
Emergent's success can be attributed to El-Hibri's vision, his ability to anticipate and overcome challenges, and his unwavering commitment that has motivated others in the company, said Daniel J. Abdun-Nabi, who is taking over as CEO after holding the president and COO posts since 2008.
“Over the years, we have come to appreciate his business acumen, drive to address global unmet medical needs and dedication to creating a workplace environment and culture that is both challenging and rewarding,” Abdun-Nabi said.
El-Hibri's contributions extend beyond Emergent to the biotech and business communities throughout the state, said Henry Bernstein, a board member of the Tech Council of Maryland and senior vice president of Rockville real estate development and management firm Scheer Partners.
“Under his leadership, Emergent BioSolutions became a growth company that has contributed to the business community, attracted top talent to the region and invested heavily into the community overall," said Bernstein, a former COO of the Montgomery County Department of Economic Development.
Emergent did what relatively few biotechs do — turn a profit for an entire year within four years of forming. Gaithersburg biotech giant MedImmune was founded in 1988 and took a decade to see an annual profit. After launching in 1992, Rockville life sciences company Human Genome Sciences saw net income in 1993 and 1994, but has seen only one profitable year since, in 2009.
Even during the Great Recession, Emergent continued to show a profit. A key factor was acquiring a product — BioThrax, the only federally licensed anthrax vaccine — that could generate revenue almost immediately, El-Hibri said. The federal government buys the vaccine to inoculate military personnel.
“It’s been quite a ride,” he said.
Early exposure to other countries
Born in Germany the son of a Lebanese father and German mother, El-Hibri split boyhood time in both nations. Being immersed in different nations gave him an early appreciation for various cultures, he said.
“I learned how you have to get along and respect other cultures,” El-Hibri said. “That’s an important factor to having peace and having a successful business.”
At Emergent, he carried that philosophy into defining five core corporate values: respect, empowerment, commitment, communication and innovation. Having such values is key to building a top-notch company, he said.
“For us, our central mission is to protect life,” El-Hibri said. “It’s been a great honor to serve the military and protect our active military.”
His entrepreneurial career started soon after earning a master's in public and private management from Yale University and a bachelor’s in economics from Stanford University.
Following stints in banking with Citigroup and management consulting with Booz Allen Hamilton, the latter in southeast Asia, El-Hibri started a financial consulting business, East West Resources. Then came three mobile telecommunications companies: Mobile TeleSystems, Digitel and Digicel.
Mobile Telesystems, which he formed in 1993 and later sold, has grown to be a leading telecommunications company in Russia, with $12 billion in sales last year. The other two companies, which he also sold, are good-sized players in South America and Central America, respectively.
During the 1990s, El-Hibri got his first taste of biotechnology when he organized a management buyout of British life sciences company Porton and formed Speywood Holdings, a recapitalized biopharmaceutical company.
In 1998, El-Hibri was among a team that bought the rights to BioThrax, which was being manufactured in Michigan, and its production facilities.
“They only marketed it on a relatively small scale,” he said. “After we acquired the product, we renovated the facilities and increased capacity.”
About 170 Michigan state employees agreed to transition to the privately held business that year, El-Hibri said. BioPort later became Emergent, which went public in 2006 and now has more than 800 employees in 10 locations. Some 250 employees are in Maryland, within the Rockville headquarters, a research and development facility in Gaithersburg and a manufacturing plant in Baltimore.
The company has branched out into combating tuberculosis, cancer and autoimmune disorders. Since 2003, the company has acquired three biotech companies and completed other acquisitions to broaden its product pipeline.
Some reports, including one by a researcher with the Center for American Progress, say that Emergent lobbied hard against a former California biotech, VaxGen, which received a major federal contract to develop a new anthrax vaccine in 2004. VaxGen had never produced a drug before, and the government canceled the contract two years later.
Emergent's lobbyists did not criticize VaxGen but simply stated what their own company could do, El-Hibri said.
"We lobbied using a positive message," he said. “We did not criticize their product. ... The government decided to cancel the contract. It was not because of us."
Emergent also purchased the VaxGen vaccine through a fair process and is working to develop that as a secondary vaccine, El-Hibri said.
Building a better world
El-Hibri has his own charitable foundation, which promotes peace and social justice. In 2007, he started the annual El-Hibri Peace Education Prize, which recognizes educators who teach about peace issues. The organization also has constructed orphanages in Lebanon.
“I have a strong belief in giving back,” he said. “There are so many worthwhile projects and organizations.”
As a member of the U.S. Chamber of Commerce’s board of directors, El-Hibri has the opportunity to discuss national issues with business leaders across the country.
“It’s very interesting to meet business leaders across the nation and get their perspective,” he said. “As you can guess, there is no full agreement on every issue, but there is hope that the economy will turn around soon.”
El-Hibri also serves on the board of trustees of the International Biomedical Research Alliance, an academic venture between the National Institutes of Health in Bethesda, Oxford University and Cambridge University in the U.K., and the National Health Museum, a science institution planned to open in Atlanta in the near future.
He is on the advisory board for the Yale Healthcare Conference, which brings together professionals, academics and students to discuss health care issues, and the Heifetz International Music Institute in Staunton, Va., founded by acclaimed violinist Daniel Heifetz to teach young musicians.
Among the awards El-Hibri has garnered are Biotech CEO of the Year during the 2011 World Vaccine Congress; the International Leadership Award from the World Trade Center Institute in 2010; the Ernst and Young Entrepreneur of the Year Award in Greater Washington in 2009; and the Rene Moawad Foundation Distinguished Community Service and Achievement Award in 2007 for philanthropic work in Lebanon.
In choosing El-Hibri for the honor at the World Vaccine Congress last year, judges cited his “leadership and entrepreneurial spirit” in guiding Emergent to another profitable year, securing some key development contracts, completing an acquisition and arranging collaborations with Pfizer and Abbott, according to business conference organizing company Terrapinn Holdings.
Sometimes hands-on, sometimes not
El-Hibri said he can vary his management style depending on the situation.
"Some managers are new, and I roll up my sleeves and get deep in the weeds,” he said. “Other people are seasoned and don’t need as much supervision.”
His primary residence is now in Naples, Fla., where Emergent has an office. But he also maintains a home in Potomac. He and his wife, Nancy, have three children and two grandchildren.
El-Hibri doesn’t engage in the stereotypical executive hobbies such as golf. He likes to fly single-engine airplanes, scuba dive and participate in equestrian sports. He flies a Diamond Aircraft plane, and has scuba dived in Indonesia, the Red Sea and the Caribbean.
"I seem to like being either very high above sea level or below sea level," he said with a laugh.
http://www.gazette.net/article/20120330/NEWS/703309706/1033/emergent-s-fuad-el-hibri-an-entrepreneur-at-heart&template=gazette
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January 23, 2002, AP - The Michigan Daily, Lansing laboratory may begin anthrax vaccine shipments,
LANSING (AP) In 1998, the buyers of the only U.S. laboratory making the anthrax vaccine thought they had a can’t-miss deal.
The aging state-owned lab in Michigan needed millions in renovations on top of the $24 million purchase price. But the Pentagon already had announced it would require all 2.4 million American military personnel to take a series of six shots of the vaccine, and turning the lab into a profitable enterprise seemed childishly easy.
Four years later, Lansing-based BioPort Corp. has yet to ship a single dose of the vaccine to the Pentagon.
Unable to pass inspections by the Food and Drug Administration, BioPort has intermittently produced the vaccine but has not been able to release it.
Now, the company appears to be on the verge of finally winning FDA approval to begin shipments, possibly as early as this month.
"It"s clearly a very positive story for the company," said BioPort spokeswoman Kim Brennen Root.
A laboratory in Washington state that puts the vaccine into vials still needs FDA approval, and the vaccine still must be tested for purity, potency and sterility before any 200,000-dose lots will be released by the FDA.
The vaccine was held up by contamination, inadequate record-keeping and unapproved procedures at the laboratory.
"I"m glad it took four years. That stuff needed to be done right," said Rep. Mike Rogers (R-Brighton) whose district includes BioPort.
Pressure to get the lab approved has grown since U.S. troops began heading overseas in the war on terrorism and since last fall"s anthrax outbreak killed five people on the East Coast. Because of the standstill at BioPort, the Pentagon stockpile of the vaccine is dwindling.
Although privatizing the lab didn't turn out to be nearly as easy as the new owners expected, it was largely the federal government that sweated and paid while the approval process went on.
Over the past four years, BioPort has received at least $16.8 million from the Pentagon to renovate and expand the lab. It also asked for more money for the vaccine, complaining that the state had never charged enough.
The Pentagon agreed in 1999 to more than double the per-dose payment, from $4.36 to $10.36. Instead of having to supply 8.7 million anthrax vaccine doses for $29.4 million, BioPort had to supply only 4.6 million doses for $53.5 million, in part because the company couldn't make as many doses as it originally promised.
Yet even with the extra money, BioPort's problems continued. Considering who owns BioPort, it was something of a surprise that the project did not turn out to be as easy as the new owners expected.
BioPort's chief executive officer and major investor is Fuad El-Hibri, a German-born businessman of Lebanese descent who now is a U.S. citizen. El-Hibri is a former director of the British maker of a different anthrax vaccine. His father, Ibrahim El-Hibri, also invested in BioPort.
A major shareholder in BioPort is retired Adm. William J. Crowe, former chairman of the Joint Chiefs of Staff, who brought his experience dealing with the Pentagon to the fledgling company. The former director of the state-owned lab, Robert Myers, is BioPort's chief operating officer.
--http://www.michigandaily.com/content/lansing-laboratory-may-begin-anthrax-vaccine-shipments
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November 8, 2001, New York Times, Excerpts From Postal Worker's 911 Call,
Following are excerpts from a 911 call on Oct. 21 by Thomas Morris Jr., a postal worker who died hours after the call, as recorded by The New York Times from CNN:
911 OPERATOR What's the problem?
MR. MORRIS My breathing is very, very labored.
Q. How old are you?
A. I'm 55. Ah, I don't know if I have been, but I suspect that I might have been exposed to anthrax.
Q. You know when or what —
A. Ah, it was last what, last Saturday, a week ago last Saturday [Oct. 13] morning at work. I work for the Postal Service. I've been to the doctor. I went to the doctor Thursday. He took a culture but he never got back to me with the results. I guess there was some hangup over the weekend. I'm not sure. But in the meantime, I went through achiness and headachiness. This started Tuesday. Now I'm having difficulty breathing. And just to move any distance I feel like I'm going to pass out. . . .
It was — a woman found the envelope and I was in the vicinity. It had powder in it. They never let us know whether the thing had — was anthrax or not. They never treated the people who were around this particular individual and the supervisor who handled the envelope. So I don't know if it is or not. I'm just — I've never been able to find out. I've been calling. But the symptoms that I've had are what was described to me in a letter that they put out, almost to the T except I haven't had any vomiting until just a few minutes ago. I'm not bleeding and I don't have diarrhea. The doctor thought that it was just a virus or something. . . . So we went with that and I was taking Tylenol for the achiness. But the shortness of breath, now, I don't know. That's consistent with the — with the anthrax.
Q. But you weren't the one that handled the envelope? It was somebody else?
A. No, I didn't handle it. But I was in the vicinity.
Q. O.K. And do you know what they did with the envelope at work?
A. I don't know anything. I don't know anything. I couldn't even find out if it — if the stuff was or wasn't. I was told that it wasn't, but I have a tendency not to believe these people.
http://www.nytimes.com/2001/11/08/national/08ATEX.html
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December 20, 2001, New York Times, Classified Information; Bush Gives Secrecy Power to Public Health Secretary, by Alison Mitchell,
WASHINGTON, Dec. 19 — President Bush has granted the secretary of health and human services the power to classify information as secret, a step that shows how the battle against terrorism is drawing domestic agencies into the national security apparatus.
William A. Pierce, the spokesman for the Health and Human Services Department, called the new authority a recognition that the agency was now in the forefront of preparations to fight bioterrorism and is sitting in on White House sessions on domestic security.
"The bottom line is relatively simple," Mr. Pierce said. "We are now a homeland security agency, part of the homeland security council."
He said he expected a "narrow subset" of agency documents to be classified, those relating to bioterrorism and the nation's preparedness to respond to it.
Officials said the kind of information that might be classified would be storage sites for vaccine stockpiles, certain laboratory floor plans or some details about emergency medical stocks. Mr. Pierce said the secretary, Tommy G. Thompson, had not used his new authority.
Experts on government classification said they believed it was the first time in several years that a new agency had been given the right to stamp information as secret. The trend had been toward less secrecy.
In 1995 President Bill Clinton issued an executive order that overhauled government secrecy rules, reducing the number of documents made secret and shortening the time such documents were kept classified.
While the health department was the lone agency to get new classification powers, the government has generally been rethinking the balance between security and the right to know since Sept. 11.
Much of the federal government already has the power to classify information. The agencies with such powers include the pillars of national security, like the Pentagon, the State Department and the Central Intelligence Agency, and agencies dealing with energy and nuclear plant regulation. Also on the list are agencies that deal with sensitive economic and trade issues, like the Treasury and Commerce Departments and the United States trade representative.
Officials said that until the Sept. 11 strikes and the subsequent anthrax attacks, it had not been widely assumed that the nation's public health department needed such authority, But that attitude has changed.
"They clearly are a national security agency," one White House official said. "They clearly are a homeland security agency."
He added, "One of the things you do in the homeland security business is deal with classified information."
The president's designation of the department's new classification authority was printed in the Federal Register on Dec. 12 without further explanation from the White House. Mr. Bush cited President Clinton's 1995 executive order on classification, which said classification authority would be held by agency heads and officials designated by the president.
The secretary was granted the right to classify information as secret, but he was not given the power to brand information as top secret. The government defines information as top secret if its disclosure could cause "exceptionally grave damage to the national security."
Secret information is that which could be expected to "cause serious damage to the national security" if disclosed. In general, the higher level of classification means that fewer officials have access to it.
Until now, the department had to turn to other government agencies for assistance if it wanted information in its domain to be classified.
Critics of secrecy policies called the change relatively modest.
"One would have liked to see some explanation of why it was necessary," Steven Aftergood of the Federation of American Scientists said.
But Mr. Aftergood said he did not think the order would greatly expand the scope of government secrecy.
Representative Christopher Shays, a Connecticut Republican and chairman of a House subcommittee on national security, said the department should use the power judiciously. But Mr. Shays said the classification authority was needed "to make sure we don't provide a road map to terrorists" of the nation's vulnerabilities.
Representative Jane Harman of California, the ranking Democrat on a House subcommittee on terrorism, cautioned that information sharing among agencies should be "the crux of any homeland security effort," and that classifying too many documents could hinder the transfer of information among agencies and levels of government.
Under the current secrecy rules, which were put in place by Mr. Clinton, agency heads are required to establish procedures under which employees can challenge classifications that they believe are improper.
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November 12, 2001, AP - The Michigan Daily, Anthrax vaccine producer protested by 40 in Lansing, Archived,
LANSING (AP) About 40 people protested the military"s anthrax vaccination program at the Capitol yesterday.
The protest, which happened just after the dedication of the nearby Vietnam Veterans Memorial, criticized the U.S. Defense Department as well as BioPort Corp., the Lansing company that is the only U.S. manufacturer of the anthrax vaccine.
Protesters said BioPort and the Pentagon are ignoring signs of illness in troops that have been vaccinated. They also say the military has not done enough to investigate the vaccine"s long-term effects, or to see whether the anthrax vaccine can be given safely with other vaccines.
Steve Robinson, a Gulf War veteran who now works for the National Gulf War Resource Center, said Congressional testimony shows that there are many unanswered questions about the vaccine"s effects. A 2000 federal report recommended ending the military"s anthrax vaccine program after six hearings on the vaccine"s effects, he said.--http://www.michigandaily.com/content/anthrax-vaccine-producer-protested-40-lansing
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September 23, 2013, The Daily News (Delaware) Of procurement and politics: Harris criticism of bio-defense firm could help donor; Rep. Harris' criticism of bio-defense company could benefit donor, by Nicole Gaudiano, Daily Times Washington Writer,
Andy Harris
U.S. Rep. Andy Harris, R-1st District, has criticized a division of Pfizer. / AP
WASHINGTON — Rep. Andy Harris has become a vocal critic of a division of Pfizer pharmaceutical company at a time when one of his campaign contributors hopes to make inroads into the drug giant’s market.
The 1st Congressional District Republican says the Pfizer subsidiary, Meridian Medical Technologies of Columbia, Md., has "put our national security preparedness in question" because of manufacturing issues with one of its nerve-agent antidotes.
Harris has pledged to seek answers from Meridian and government agencies about those manufacturing issues. He made his comments following a June 25 fundraiser hosted by lobbyists for Emergent BioSolutions Inc., a Rockville-based pharmaceutical company looking to expand its presence in the biodefense field.
Harris' staff says he is focusing only on the safety of military personnel who might be exposed to sarin or other nerve agents. The Meridian antidote does not compete with Emergent's current line of products.
"When it comes to protecting our soldiers, Congressman Harris, as a veteran himself, will always aggressively hold accountable businesses that provide our soldiers and first responders a defective product," said Chris Meekins, Harris' deputy chief of staff.
But some government watchdog groups say Harris' actions could be an example of a common practice among lawmakers — rewarding campaign contributors. Criticizing or praising government contractors is one way lawmakers work to influence decisions on awarding government contracts, said Craig Holman of Public Citizen, a Washington citizens advocacy group.
"Harris has just received $5,000 from Emergent Bio PAC, raised countless more in bundled contributions orchestrated by Emergent lobbyists and stepped into a public intimidation effort against Emergent's potential competitor for the government contract," said Holman, who lobbies on campaign finance and government ethics. "The close connection between money and official actions is troubling and, very unfortunately, not all that uncommon."
Emergent officials declined to comment on Harris' recent statements. Allen Shofe, Emergent's executive vice president for corporate affairs, said Harris is perhaps the first medical doctor to sit on the House Appropriations subcommittee on health and human services. He said Emergent speaks to Harris and many other members of Congress about the need to protect the nation from biological and chemical attacks.
"He has the knowledge and the understanding of the field," Shofe said.
Meridian is trying to resolve problems with an injectable antidote for nerve agents, including sarin, that surfaced during a March inspection. The company found that a small number of the "autoinjectors" contained less than the intended dose.
Members of the military and first responders carry the product, known as "DuoDote," in its civilian form. The Food and Drug Administration hasn't recalled the product and the agency extended the expiration date so older products could be used to prevent a shortage.
A Wall Street Journal reporter, Alicia Mundy, had first told Harris' office about the glitch in the Meridian production process the week before last. Harris then wrote Meridian on Sept. 12, and was quoted in The Wall Street Journal, which broke the story online Sept. 13.
Harris and his staff subsequently questioned the FDA, the Pentagon and other officials on the issue. He also released a statement to the press on Sept. 16.
"I am going to continue asking questions of the company and government agencies so we can all have confidence in our national defenses," Harris said in a Monday, Sept. 16, statement. "Recent actions in Syria show that chemical and biological defenses can no longer be on the back-burner."
Pfizer, Meridian’s parent company, will work with Harris to address his questions, said Christopher Loder, a Pfizer spokesman. He said Friday the company has reached an agreement with the Defense Logistics Agency to remediate and replace the affected autoinjectors at Meridian's cost.
The autoinjectors are part of a Meridian product line designed to help military and emergency medical personnel respond to crisis situations, similar to Emergent products.
Meridian products counter chemical agents while Emergent's products mainly target biological threats, such as anthrax. The companies currently don't view their products as competing.
However, Emergent hopes to become a competitor as it expands its development of chemical, biological, radiological and nuclear countermeasures. The company's August acquisition of a chemical agent decontamination lotion — one that could complement Meridian products — is viewed as a first step.
"We are looking at various products that would satisfy the needs of our warfighters, our first-responders community and other militaries around the world and our NATO allies," Shofe said. "We are looking to grow our portfolio."
Harris has accepted donations from Pfizer in the past, including $1,000 from the company's PAC in 2010, $500 from a Pfizer lobbyist in 2010 and $1,000 from a different lobbyist in 2012.
However, Emergent's PAC gave Harris the maximum donation in May before Shofe and another Emergent lobbyist hosted a fundraiser for him on the rooftop terrace of the Willard Office Building in downtown Washington. The invitation sought donations of up to $2,500 from political action committees and $500 from individuals.
"It looks like Emergent is getting close to a member of Congress who can help them compete ... who can help them beat a competitor," said Bill Allison of the Sunlight Foundation. "It's smart for them. We don't know how it's working."
Allison said Harris' criticism of Meridian is sure to catch the attention of Pentagon officials, who may take a second look when it's time to renew contracts.
Joe Newman, a spokesman for the Project on Government Oversight, said some of the questions Harris is asking about Meridian "seem to be well-placed," and Emergent's contributions are typical of how the political system operates.
Whether Emergent benefits from Harris' support remains to be seen, Newman said.
"The danger is that if a contracting officer knows they will be on the receiving end of congressional inquiries to defend their contract award decision, it could tip the scale towards the path of least resistance," he said. "Our position is that members of Congress should be careful about inserting themselves in the procurement process."
Editor's note: This story was updated after publication to clarify the chronology describing when Rep. Andy Harris learned of the nerve-agent antidote problem and what occurred in ensuing days.
--http://www.delmarvanow.com/article/20130922/NEWS/309220007/Of-procurement-and-politics-Harris-criticism-of-bio-defense-firm-could-help-donor
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October 10, 2001, AP - The Michigan Daily, Anthrax producer cancels community meeting,
LANSING (AP) The only U.S. manufacturer of an anthrax vaccine canceled a public meeting yesterday, saying it would answer neighbors' questions about safety in writing instead.
The neighborhood association for the north Lansing community that surrounds BioPort Corp. scheduled the meeting several weeks ago and reserved space at an elementary school so residents could question BioPort officials.
Many residents had become uneasy after the U.S. Department of Defense asked Michigan National Guard troops to begin guarding the laboratory, which has an exclusive contract to supply the anthrax vaccine to the Pentagon.
Tom Powers, president of the neighborhood association, said he has received more than 200 calls from residents concerned about the armed National Guard troops or worried if they could be affected by anthrax if BioPort is attacked.
BioPort keeps some live anthrax bacteria on its Lansing campus, but the company has said that the amount is too small and isn't in a form that would be of use to terrorists. Company spokeswoman Kim Brennen Root said there have been no specific threats against BioPort.
BioPort officials and the neighborhood association said they called off the meeting because of the intense media scrutiny surrounding the company right now. Anthrax and BioPort gained attention this week after a Florida man died Friday from anthrax and two of his co-workers were found to have spores of the disease.
Government officials have warned that biological attacks are one possibility as the United States and its allies strike back at terrorists after the Sept. 11 attacks.
State and national media have been flooding the company with questions. On Tuesday, Barbara Walters interviewed BioPort President Bob Kramer for ABC"s newsmagazine "20-20." Yesterday's meeting was expected to draw not just neighbors, but large numbers of reporters and TV crews.
"In the last few days, it had taken on too big of a proportion for what we were prepared to handle," Powers said.
Powers is compiling neighbors' questions and giving them to BioPort. Root says the company could have answers to its neighbors as early as today.
Powers said BioPort has been very cooperative so far, and that he believes neighbors' concerns will be alleviated.
"(We) are confident that this procedure will accomplish the goal of answering our neighbors' questions without being unnecessarily alarmed by inaccuracies and misstatements," Powers and Kramer of BioPort said yesterday in a joint letter.
In the three years since BioPort bought the lab from the state, it has not been allowed to ship a single dose of anthrax vaccine because it has been unable to get U.S. Food and Drug Administration approval.
BioPort on Monday plans to submit new information to FDA showing it has made the changes necessary to be allowed to ship the vaccine it has produced.
Anthrax produces a toxin that can cause fatal damage to the respiratory system and brain, killing untreated patients within days. Treatment with antibiotics is often successful if the infection is caught in time. --http://www.michigandaily.com/content/anthrax-producer-cancels-community-meeting
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January 15, 2002, AP - The Michigan Daily, Anthrax vaccine producer earns approval for lab,
LANSING (AP) The nation's sole producer of the anthrax vaccine has won federal approval for its laboratory.
But a few hurdles still remain before it can ship the vaccine, possibly by later this month.
BioPort Corp. of Lansing received a Dec. 27 letter from the U.S. Food and Drug Administration clearing it to begin shipping the vaccine, provided a Washington state laboratory that puts the vaccine into vials also receives FDA approval.
The vaccine already manufactured by BioPort also must be tested by the company for purity, potency and sterility and be released by the FDA before each lot can be shipped.
BioPort already has conducted tests on three lots of the vaccine manufactured in 2000 as part of the FDA approval process, BioPort spokeswoman Kim Brennen Root said yesterday.
The anthrax vaccine has been licensed by the FDA since the 1970s. But BioPort has been unable to sell the vaccine since buying its labs from the state in 1998 because it failed two FDA inspections after a renovation.
The Pentagon owns all of the vaccine BioPort has been producing and pays the company around $36 million each year, Root said.
In its letter, the FDA said BioPort has made or is in the process of making the seven production-related changes requested by FDA inspectors during their visit last month. The company still must improve monitoring and complete studies showing it can successfully pool batches of the vaccine.http://www.michigandaily.com/content/anthrax-vaccine-producer-earns-approval-lab
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October 15, 2001, AP - The Michigan Daily, Anthrax vaccine manufacturer seeks to gain approval of FDA,
LANSING (AP) Amid reports of new anthrax exposures at the U.S. Capital yesterday, the nation's only maker of an anthrax vaccine filed paperwork asking federal officials for approval to ship the vaccine.
Lansing-based BioPort Corp. has continued to manufacture the vaccine since buying a state-owned laboratory in 1998. But it has been unable to ship any because it has failed to meet U.S. Food and Drug Administration standards after renovating the plant two years ago.
The vaccine has gained attention in recent days as 12 people around the country have either tested positive for anthrax or have been exposed to the bacteria. A piece of mail sent to U.S. Senate Majority Leader Tom Daschle"s office in Washington, D.C., tested positive for anthrax yesterday.
BioPort spokeswoman Kim Brennen Root said yesterday that the company finished submitting several hundred pages of studies and reports to the FDA on Friday. She said the documents prove BioPort can make repeated batches of the anthrax vaccine in a safe, controlled environment.
"We feel that we have fully met our obligations to the agency," she said. "Very clearly, we have the right people doing the right jobs in a timely manner."
An FDA spokeswoman confirmed yesterday that the agency received the documents. She wouldn't say how long it will take the FDA to complete its review. The FDA has four to six months to review the information.
BioPort spent $16.8 million most of it federal dollars to expand and upgrade the facility. Root said last week that it's not unusual for approval of a renovated vaccine plant to take two to three years.
During that time, however, the FDA has found repeated problems at the lab. The company failed FDA inspections in 1999 and 2000. An FDA report issued in October 2000 said BioPort failed to ensure that its facilities were sterile and well-ventilated.
The FDA also said BioPort did not submit complete annual reports in 1998 and 1999 and was failing to keep proper records on people who suffered adverse effects to the anthrax vaccine.
Root said the company is confident it could begin shipping the vaccine early next year if it wins FDA approval. She wouldn't say what the company will do if the FDA refuses to license BioPort.
"Failure is not an option for this company," she said.
BioPort is the Pentagon's sole source of the anthrax vaccine. About 500,000 of the 2.4 million troops and reservists the military wanted to vaccinate have received the vaccine, but the program has basically been put on hold as supplies to vaccinate additional troops have run low.
Anthrax is a bacteria that can cause severe damage to the respiratory system and brain, killing untreated patients within days. Treatment with antibiotics often is successful if the infection is caught in time.
At the Pentagon's request, the Michigan National Guard has been guarding the facility since the beginning of October. No specific threats have been made against the company, which keeps a shoebox-sized container of live anthrax at the site under heavy security.
Last year, the U.S. House Committee on Government Reform issued a report that accused the Pentagon and BioPort of having a relationship that blocked the creation of newer anthrax vaccines and left the vaccine program vulnerable to supply shortages and price increases.
Root insisted yesterday that the company is up to the job. She said the Sept. 11 terrorist attacks and subsequent anthrax scare have strengthened BioPort's resolve.
"We wake up every day and we think we are part of the solution," she said.
The vaccine hasn't been available for civilian use, although Root said yesterday that BioPort employees in direct contact with the anthrax vaccine have been vaccinated.
Once the FDA approves the distribution of the vaccine, she said, the Pentagon and other federal agencies will have to decide whether to expand vaccinations to those not in the military. Most health officials so far have seen little need for a nationwide anthrax immunization program. Anthrax is not contagious.
http://www.michigandaily.com/content/anthrax-vaccine-manufacturer-seeks-gain-approval-fda
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October 27, 2001, Washington Post, FBI and CIA Suspect Domestic Extremists; Officials Doubt Any Links to Bin Laden, by Bob Woodward and Dan Eggen,
Top FBI and CIA officials believe that the anthrax attacks on Washington, New York and Florida are likely the work of one or more extremists in the United States who are probably not connected to Osama bin Laden's al Qaeda terrorist organization, government officials said yesterday.
Senior officials also are increasingly concerned that the bioterrorism is diverting public attention from the larger threat posed by bin Laden and his network, who are believed to be planning a second wave of attacks against U.S. interests here or abroad that could come at any time, officials said.
None of the 60 to 80 threat reports gathered daily by U.S. intelligence agencies has connected the envelopes containing anthrax spores to al Qaeda or other known organized terrorist groups, and the evidence gleaned from the spore samples so far provides no solid link to a foreign government or laboratory, several officials said.
"Everything seems to lean toward a domestic source," one senior official said. "Nothing seems to fit with an overseas terrorist type operation."
The FBI and U.S. Postal Inspection Service are considering a wide range of domestic possibilities, including associates of right-wing hate groups and U.S. residents sympathetic to the causes of Islamic extremists. But investigators have no clear suspects, and are not even certain whether there are other undetected letters that contained the deadly microbe.
But federal health officials said yesterday that a new case of pulmonary anthrax in a man who worked at a State Department mail facility in Northern Virginia has persuaded them that more than one contaminated letter may have been sent to the Washington area. Health experts previously believed that a single letter, sent to the office of Senate Majority Leader Thomas A. Daschle (D-S.D.), likely caused all the anthrax reports in the Washington area as it came in contact with other pieces of mail in the system.
Now the "working hypothesis would be that this is not cross-contamination," said Jeffrey Koplan, director of the Centers for Disease Control and Prevention. "There is not enough infectious material from cross-contamination to do that."
However, ongoing searches of truckloads of undelivered mail to the U.S. Capitol and other government buildings has turned up no other letters laced with anthrax bacteria, leading FBI officials to assume that the Daschle letter may still be the only local source. Two employees at the U.S. Postal Service's Brentwood facility in Washington have died from inhaling the lethal bacteria, and three other local postal workers have contracted inhalational anthrax.
"This envelope, Daschle's envelope, is not watertight or airtight or anything like that," one law enforcement official said. "It's porous. At one or two microns, there's plenty of room for the spores to escape."
Although there is consensus at the FBI and CIA that al Qaeda associates are planning more serious attacks, "nobody believes the anthrax scare we are going through is" the next wave of terrorism, one senior official said. "There is no intelligence on it and it does not fit any [al Qaeda] pattern."
No links between known foreign terrorist groups and the anthrax letters have shown up on the daily Top Secret Threat Matrix, which includes the latest raw intelligence on potential bombings, hijackings or other terrorist attacks, one official said. Though "lots of things are alarming" on the list, there is little agreement on how, when or where an attack might be launched, officials said.
FBI Director Robert S. Mueller III warned earlier this week that additional terror attacks are a "distinct possibility."
President Bush and other top U.S. officials have publicly voiced their suspicion that bin Laden and al Qaeda -- accused of carrying out the Sept. 11 suicide assaults on the World Trade Center and Pentagon -- may be responsible for the anthrax mailings.
But Mueller, Attorney General John D. Ashcroft and other law enforcement officials have said they have discovered no links between the mailings and bin Laden. Authorities, speaking on condition of anonymity yesterday, said they are increasingly doubtful that any connections will be found.
One official said the only significant clue raising the possibility of foreign terrorist involvement is the conclusion of FBI behavioral scientists, who believe that whoever wrote the three letters delivered to Daschle, NBC News and the New York Post did not learn English as a first language.
But the writer could have lived in this country for some time, and the other evidence gathered so far points away from a foreign source, several officials said.
The anti-Israel message in the anthrax letters and bin Laden's statements are echoed by U.S. extremist groups, said Rabbi Abraham Cooper, associate director of the Simon Wiesenthal Center in Los Angeles.
One group, Aryan Action, praises the Sept. 11 attacks on its Web site and declares: "Either you're fighting with the jews against al Qaeda, or you support al Qaeda fighting against the jews."
Cooper said a meeting this year in Beirut was attended by neo-Nazis and Islamic extremists united in their hatred of Jews. "Some extremists are now globalized," he said.
White supremacists have been linked with anthrax in the past, but not in relation to an attack.
Larry Wayne Harris, an Ohio microbiologist and former member of the Aryan Nations, was convicted of wire fraud in 1997 after he obtained three vials of bubonic plague germs through the mail. He was arrested the next year near Las Vegas when the FBI acted on a tip that he was carrying anthrax. But agents found harmless anthrax vaccine in the trunk of his car.
Cooper and officials at the Southern Poverty Law Project, which monitors U.S. hate groups, said they have seen no evidence of a domestic group capable of launching a sophisticated anthrax attack.
One of the challenges that a would-be terrorist faces is learning how to alter the anthrax so that it will float in the air and disperse widely. The Washington Post reported this week that the spores in the Daschle letter had been treated with a chemical additive using technology so sophisticated that it almost certainly came from the United States, Iraq or the former Soviet Union.
White House spokesman Ari Fleischer said yesterday, however, that investigators believe a broad range of people are capable of the crime. "The quality anthrax sent to Senator Daschle's office could be produced by a Ph.D. microbiologist and a sophisticated laboratory," he told reporters.
U.S. officials said the evidence so far does not point to either Russia or Iraq. However, FBI checks of private and government laboratories in the United States have not yet revealed any missing anthrax stockpiles, disgruntled scientists or other suspicious circumstances, one top official said.
Koplan, the CDC director, said he suspects more than one letter was involved based on his understanding of how difficult it is to contract inhalational anthrax. To cause the disease, 8,000 to 10,000 anthrax spores must enter a person's lungs.
Although some officials said it is possible for that many spores to have sloughed off the Daschle letter onto another piece of mail, Koplan said that is hard to imagine. "We all think that would be highly unlikely to virtually impossible," he said.
Koplan speculated that there may have been multiple mailings and that "there may be several places within the federal government that have been deemed targets."
By contrast, the minuscule amounts of anthrax bacteria discovered at Walter Reed Army Medical Center and the CIA "may well represent cross-contamination," Koplan said.
William C. Patrick, who is retired from the U.S. Army installation at Fort Detrick, Md., said extensive studies show that once anthrax spores hit the ground or other surfaces they stick, and are very hard to "re-aerosolize.
There's a theoretical possibility that a few spores picked up by an envelope might cause a skin anthrax infection, but a case of inhalational anthrax "is highly unlikely," Patrick said.
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April 29, 2009, Mathaba, No honest investigation into 'accidental' global release of Spanish Flu virus,
With the current release of 'Swine Flu' this article of 3 years ago and many others published on Mathaba concerning pandemic attempts, and the deliberate release of 'Mad Cow Disease' by Britain's military 'research facility' at Porton Down, it is time to revisit some of these articles. --http://mathaba.net/news/?x=619921?disqus
Saturday, June 4, 2005 by: Mike Adams, the Health Ranger, NaturalNews Editor
What if a terrorist acquired a deadly strain of influenza that had killed millions of people in the past? What if that terrorist were able to replicate that virus, obtain the names and addresses of organizations all around the world, and distribute it across the world? What if that became headline news, and everybody found out about it? You would think that law enforcement officials might be interested, right? You'd think that somebody would investigate how this deadly strain of influenza got shipped to all of these organizations around the world...
In reality, that's not what would happen at all. Such a hypothetical event actually occurred, except it wasn't a terrorist. It was a research company that claimed to have "accidentally" distributed all of these samples of the deadly H2N2 influenza strain, which is most famous for killing millions of people around the world in 1957. It was called the "Spanish Flu" at the time, although that name is not technically accurate.
This company took this deadly virus and replicated it, then put it in kits that were part of an everyday influenza identification testing kit. They overnighted these kits through postal mail or courier services to over 4,000 destinations around the world in many different countries. When this became headline news, however, nobody was interested in finding out whether this was a crime. Nobody thought, "Why is this happening?" Nobody raised the alarm and said, "You know what, this is a threat to human health." This is a deadly virus and people born after 1957 have no immunity whatsoever to this virus. This means you could re-release this old H2N2 influenza strain into today's population, and you could observe the same kill rate experienced back in 1957. You could see the same mess all over again with millions of people dying worldwide.
As if all of these viruses aren't dangerous enough on their own -- for example, Marburg in Angola and the bird flu virus in Southeast Asia -- we actually have companies replicating these deadly strains and distributing them, just to make sure that they're in everybody's labs all over the world.
It gets worse. Some of these shipments were lost. They don't even know where they are! They claim now that virtually all of these shipments have been destroyed, but how do we know? Even then, shouldn't somebody be held responsible for distributing this deadly virus? You could be charged with federal crimes if you were caught with this kind of material. If you sent it out to somebody, who knows how many years you'd do in prison for a stunt like that. In this country, we've been arresting people for putting white powder in envelopes and sending them to Congressmen, claiming it was anthrax. Anthrax doesn't even approach the kill rate of something like H2N2. And as far as I can see, nobody's really being held responsible for this.
This is not a minor issue. This is not "Oops, we just released a level-4 biological agent into the wild. We sent it to 4,000 destinations in over a dozen different countries, and we can't really find 10 percent of those any more. We don't know where they are, and nobody does." To me, this all sounds a little suspicious. If anybody else had pulled a stunt like this, they would have the FBI, the CDC, and the World Health Organization descending upon them instantly. This research company, however, appears to have undergone no such scrutiny. Where are the answers to the really important questions in this matter? How did they get their hands on H2N2? Shouldn't this be a controlled viral specimen? Aren't there restrictions on who has this stuff? Can anybody just order H2N2, H5N1, or any of the other influenza strains that have killed people over the years? Can we just go out and buy this stuff on the internet? Apparently, yes. That's what these people did. Over 4,000 customers bought this kit. They said, "Take my credit card and send me some level 4 biological agents."
It all just strikes me as a little bizarre. What if one of these vials broke open in the shipment? What if a FedEx driver broke one of these containers, contracted the virus, and it suddenly started replicating in that person? It could have been any courier, but what if they then came into contact with other people? Suddenly, you'd have a carrier, and the virus would be spreading. We would have the Spanish Flu all over again.
That scenario is not at all out of the realm of possibility, especially when the virus sample has been sent to 4,000 destinations. If you play the odds long enough, nature is going to clobber you. Nature will survive and viruses, of course, are not even living. A virus is just basically a pattern of DNA. It doesn't have to be alive to be dangerous. The fact that these were "dead" samples did not make it safer for all of us.
Here's another interesting fact in all of this. This deadly strain of influenza was only discovered accidentally by one of the labs that had received this shipment. It took some real detective work for them to figure out they had this deadly influenza strain in this kit. In other words, the research company that was sending these kits out wasn't even aware that they were doing it. They most likely would never have been aware of it if one of their customers hadn't alerted them. There was no mechanism in place to test these outgoing kits. There was no safety net. They could have been shipping these off to anybody, and it could have continued for years. Who knows how many samples would have been out there in the wild?
As a nation, we are frequently worried about the wrong things. For example, we're spending all this money on the fight against terrorists, and we're in Iraq fighting a war, and it seems like every decade we do it again. However, we've got people right here in the United States who are replicating these deadly strains of influenza and shipping them out into the wild. To me, that’s a much bigger threat than any terrorist, real or imagined. I don't mean to minimize the whole international situation, but if one virus like this gets out and the right person contracts it, you'd have a pandemic on your hands. You'd have an outbreak. And you can't fight a pandemic with bullets.
It wasn't too long ago that President Bush signed an order giving the government the right to quarantine air travelers who may be infected with things like the bird flu, or any other infectious disease. Here's the scenario: You've suddenly got H2N2 out in the wild, you've got Marburg going crazy over in Angola, you've got the bird flu virus all over in Korea right now, and you suddenly get people flying back to America exhibiting some upper respiratory symptoms. They get taken off the plane and quarantined, because they're a threat to everyone else in this country. If this gets any worse, or if H2N2 actually gets out into the wild and starts infecting people, we're going to have a lot of people quarantined. You'd better not get sick, because they're going to take you away. Seriously, that's what the order dictates. They're going to take you away and quarantine you for the good of everyone else in society.
I actually agree with that policy. I think that if you are in charge of the safety of a population, you have to make that kind of decision. You cannot let a pandemic just keep growing and spreading. If you're in charge of the CDC, or the World Health Organization, or the US Government, you have to quarantine people who appear to be a threat to public health. But what it means for us in terms of our freedoms is that they're being trampled on. Again, you'd better not get sick, since there are so many infectious disease agents out there now that people are getting increasingly paranoid. You could be pulled off of a plane, you could be pulled out of a line at some kind of a checkpoint, you could be quarantined, and you'd have no say about it. You wouldn't get an attorney, and you'd be quarantined by force. If you resist, you could quickly see firearms being pointed in your face. Gunpoint is the ultimate application of government willpower.
The Spanish Flu should have been over and done with in 1957. We shouldn't have to revisit it again. We've got enough dangerous stuff going around anyway. We've got superbugs in the hospitals. We've got people breeding superbugs in their own kitchens and bathrooms because they're using these antibacterial soaps that actually encourage the creation of resistant bacteria strains. We've got the bird flu virus now becoming a potentially serious threat. We've got Marburg over in Angola, which has a kill rate of anywhere from 90 to 98 percent, depending on how you work the math and which reports you believe. Hopefully, these illnesses will never show up over in North America, Australia, or Europe, but their existence is frightening enough. We don't have to be adding to it by doing nature's job of replicating these dangerous strains. Nature does that well enough on its own. It doesn't need our help.
Modern medicine: doing more harm than good
I want to drive home the point that our current medical research system in this country is absolutely insane. It has lost its mind even beyond the fact that researchers keep claiming they'll find cures for cancer if we only give them another couple of billion dollars. That's completely absurd, by the way. Aside from that fact, and the whole "cure con," as I call it, we have these organizations actually creating threats to our lives.
It's not just the pharmaceutical companies I'm talking about here, although their products are very dangerous for human health. (Let's face it, prescription drugs are killing twice as many Americans every year as the total number of Americans who died in the Vietnam War. This is a statistic from the Journal of the American Medical Association.) You've also got organized medicine killing three-quarters of a million people in the United States each year. That figure is from the "Death By Medicine" research document. In addition, you've got companies like this viral research lab blatantly increasing our risk. They're just rolling the dice, folks. They're rolling the dice with your life on the line. Perhaps this time we'll get lucky. Perhaps they'll find all of these missing vials and destroy them. Even if they do, it's just a lucky narrow escape. If you keep betting against nature, if you keep pushing the odds, sooner or later they're going to come up snake eyes. Sooner or later, nature is going to find a way to make that virus replicate in the wild. We'll only have ourselves to blame.
Vaccines: a channel for spreading infectious disease?
This kind of behavior is a good demonstration of why I don't trust companies that are replicating and distributing these dangerous infectious agents. This is why I don't trust vaccine companies at all. I never get vaccinated, and I don't recommend vaccination for anybody. I think the science behind vaccinations is bad. The mercury content of vaccines is toxic. There is a clear link to autism in children, and I think that a lot of vaccines have been contaminated with various strains of infectious disease over the years. In fact, there's strong evidence that some of the outbreaks we've seen in North America in the past were actually caused by mass vaccination programs.
When you see incidents such as the "accidental" mass distribution of H2N2, it becomes all the more believable. These companies really don't know what they're doing. They don't have adequate safety measures in place. It's being operated like a fast food chain -- "Here's your order. Maybe it's everything you ordered, maybe not. Move on through the drive-thru, there are people behind you." This is the kind of attitude that obviously must be going on at these research labs. It's unacceptable, because we're playing with the lives of millions of people.
Some may say, "It's okay, because it was an accident. This company didn't mean to send that out. It was an accident." Do you think that excuse would fly with a terrorist? Do you think they would say, "Oh, I didn't mean to fly into that building. It was an accident!" Do you think that would be accepted? "We didn't mean to release sarin gas into the subway. That was a complete accident. We had no intention to do that." That excuse wouldn't be acceptable!
A complete lack of leadership and responsibility
It shouldn't matter who it came from. It doesn't matter what their intentions were. What matters is what effect they had. Whose lives did they put at risk through their actions and through their lack of responsibility? It's the same lack of responsibility that we see across modern medicine here in the United States, especially in the pharmaceutical industry and medical research institutions. There's a disturbing lack of responsibility, ethics, and basic understanding of human or animal rights. There's even a lack of recognizing the individuality of human beings. It appears they're living in another world, where they think their actions have no consequences. They think they can just do anything they want, ship out anything they want, and forget about quality control. These are all just various strains of infectious disease. Let's send them out anyway, and we'll worry about it later. That must be the attitude that's taking place. It can only be sloppy quality control and a frightening disregard for human life that allowed something like this to happen.
Personally, I think somebody needs to be nailed for this. Somebody should be held responsible, and we deserve an explanation of more than just saying, "It was an accident. Oops! We just sent out a deadly strain of influenza." I don't buy that. There is more to this story; there's a reason why this happened. There had to be a chain of mistakes all the way through the organization, a chain that could have been stopped by somebody speaking up, or somebody doing their job correctly, or somebody just doing the right thing. There wasn't a whistleblower here. So this situation happened, putting us all at risk. That is unacceptable. We should demand a better explanation than "oops!"
What's to stop them from doing it again? What's to stop another company from doing it? How do we know that other strains aren't being shipped out right now? H2N2 is only one strain among many. You've got H5N1 today, and you've got all kinds of influenza strains from the past, such as the 1929 flu, which was a huge killer. How do we know that these are being contained right now? How do we know that the institutions that claim to be researching these actually have safety measures in place? How do we know that? We don't really.
All we know is what the press tells us, which doesn't seem to be the whole story by any stretch of the imagination. Even if a deadly strain WERE accidentally released, and people were starting to get infected, you can bet the CDC and White House would force mainstream newspapers to keep the lid on the news. Why? They don't want to cause a panic. So even if this virus were in the wild right now, you couldn't count on the mainstream media to tell you the truth about it. Washington would be, "balancing truth with public safety," as they say. Or, perhaps, balancing truth with corporate profits.
Don't trust any "official" news on infectious disease. The official news is shaped to minimize panic and control the public, not to impart accurate information to individual citizens. And I'm willing to be we'll never get the true story about this global release of H2N2 by a lab that can only says, "Oops."
We got lucky this time. But when you're dealing with infectious disease, you can only thumb your nose at nature so many times.
http://mathaba.net/news/?x=619921?disqus
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