tag:blogger.com,1999:blog-159256872024-02-20T12:31:26.260-05:00MBVP NEWSInformation about Military and Civilian Biodefense/Terrorism Countermeasures, vaccines, laws and policiesMBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comBlogger1033125tag:blogger.com,1999:blog-15925687.post-72964753478957248542009-03-05T13:54:00.000-05:002009-03-19T13:55:22.829-05:00Viral Pandemic H5N1 flu threat: Baxter contaminates European labs by errorhttp://www.lifegen.de/newsip/shownews.php4?getnews=2009-02-25-5123<br /><br />It could be a Hollywood Worst Case Thriller, but it is real: According to the scientific network PROMED, Baxter International Inc. in Austria "unintentionally contaminated samples with the bird flu virus that were used in laboratories in 3 neighboring countries, raising concern about the potential spread of the deadly disease". As PROMED reports, the contamination has been discovered when ferrets at a laboratory in the Czech Republic died after being inoculated with vaccine made from the samples early this month. "The material came from Deerfield, Illinois-based Baxter, which reported the incident to the Austrian Ministry of Health, Sigrid Rosenberger, a ministry spokeswoman, said today in a telephone interview", the network-alert-system is quoting. "This was infected with a bird flu virus," Rosenberger said. "There were some people from the company who handled it." There are severe signs that the long expected pandemic avian influenza could be on its way to conquer the world - even without Baxter's error driven help. <br /><br />First deaths in Asia concern little children, which from virological point of view is a rather new aspect, and could be the evidence for a new spread. While scientists expect this pandemic to happen in the near future, the new President should also stay alert: A coming influenza pandemic would deteriorate the global economy even without financial crisis, recession - or Baxter. <br /><br />Evidence for the global threat comes from China, where a 2 year old girl has been confirmed to be infected with bird flu in the northern Shanxi Province, as government officials said last Saturday. The child was found ill on 7th of January in the central Hunan province - the little patient still is in critical condition. According to the test result of the Chinese Center for Disease Control and Prevention, the girl had been tested positive for the H5N1 strain of avian influenza. <br /><br />On the other site of the globe, the Ministry of Health and Population of Egypt announced a new human case of avian influenza A(H5N1) virus infection last week, the case being a 21 month old girl Kerdasa District. <br /><br />“Infection with the H5N1 avian influenza virus was diagnosed by PCR at the Egyptian Central Public Health Laboratory and subsequently confirmed by the U. S. Naval Medical Research Unit No. 3 (NAMRU-3) laboratories”, reports the special wire PROMED. According to PROMED, investigations into the source of her infection indicate a recent history of contact with sick and dead poultry - 23 similar cases in Egypt have been fatal up to date. <br /><br />Old Europe as leading research power?<br /><br />Given such facts, Mr. Obama should follow European research policy: European research on vaccine development for pandemic influenza has been financed since 2001 by the European Union. Early projects worked to develop an egg-free vaccine, which is faster and safer to produce, along with innovative application techniques. Research is now underway with the objectives of fighting the disease at the source (infected birds) and protecting human populations through pandemic influenza vaccines. Future EU research will improve vaccine efficiency by adding adjuvants, substances that boost the body’s immune response to vaccine antigen. Additionally, research teams are currently focused on developing a universal flu vaccine that could provide a lifetime of protection from influenza.<br /><br />Latest surveillance data coming through the European Centre for Disease Prevention and Control (ECDC) from virologists and clinicians indicates that the influenza A(H3N2) virus is the predominant strain in Europe so far this season (2008/2009). Based on the data published by ECDC the pharmaceutical company Roche confirms that the oral antiviral Tamiflu (oseltamivir) is fully active against influenza A(H3N2) and influenza B, which currently comprise 94 percent of circulating viruses in Europe this year. Tamiflu resistance reported in the 2008-2009 influenza seasons is confined to H1N1. No resistance has been seen with other circulating seasonal viruses - H3N2 and influenza B.<br /><br />"Recent media reporting has elevated awareness of the H1N1 seasonal resistance seen this year in the United States and the Far East. However, in Europe the picture is different with H3N2 being the dominant strain so far. The circulating H3N2 viruses, which often cause a more severe illness than H1N1, are sensitive to oseltamivir, which means that oseltamivir will be active against the vast majority of influenza infections in Europe this season, if current trends continue," comments Prof Albert Osterhaus, Head of Virology, Erasmus Medical Centre, Rotterdam. "It is important that doctors understand that oseltamivir remains an effective treatment for patients across Europe."<br /><br />Flu alert for the new President<br /><br />However, the situation in the United States is more alerting, according to the Centers for Disease Control and Prevention (CDC). A new University of Colorado at Boulder study showed the resistance of the avian flu virus to a major class of antiviral drugs "is increasing through positive evolutionary selection, with researchers documenting the trend in more than 30 percent of the samples tested", as the scientists report. Even if the expected influenza pandemic did not start yet, there is no doubt about the comeback of the lethal virus: The first Pandemic Influenza occurred in three waves in the United States - exactly 90 years ago, between 1918 and 1919.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-28730659161395281852009-02-18T08:43:00.002-05:002009-02-18T08:46:38.791-05:00Inside USA's Biological Warfare CenterInside USA's Biological Warfare Center; <br /><br />Q. & A. With Citizen Activist Barry Kissin <br /><br />HTTP://WWW.AUSTRALIA.TO/INDEX.PHP?OPTION=COM_CONTENT&VIEW=ARTICLE&ID=5594:INSIDE-USAS-BIOLOGICAL-WARFARE-CENTER-Q-A-WITH-CITIZEN-ACTIVIST-BARRY-KISSIN&CATID=71:WORLD-NEWS&ITEMID=30<br /><br />WRITTEN BY SHERWOOD ROSS <br /><br />One legacy of the Bush-Cheney administration is the grandiose expansion of our germ warfare research program. This was declared to be necessary because of the September-October 2001 anthrax letters’ attacks on Congress and the media---attacks the public is now being told came not from the Middle East but from within our own government’s facilities. As a result, developmental work is going forward with deadly and loathsome pathogens capable of triggering plagues and epidemics. <br /><br />Legislation to finance this expansion rolled through Congress after the anthrax attacks killed five persons, sickened 17 others, caused more than 10 million Americans to go on very strong antibiotics, and cost hundreds of millions of dollars to clean up. Laboratories at hundreds of universities and corporations have expanded into biological warfare research centers. More than $50 billion has been lavished on this effort—an effort critics charge is in violation of the existing treaty against bioweapons development ratified by the United States in 1975. So much of the nation’s resources have been shifted into germ warfare research that 750 of our most celebrated scientists signed a petition protesting the adverse effect this is having on research into combating naturally occurring diseases. <br /><br />The Government’s admission the anthrax attacks came not from the Middle East but from its own biowarfare research facilities signifies the anthrax letters constituted a “false flag” operation designed to whip up public sentiment for the “War On Terror.” One man who saw the expansion of the Government’s biological warfare research hub at Ft. Detrick under President Bush as a danger to his community and to the nation was Barry Kissin, a 57-year-old Brooklyn-born attorney who moved to Frederick, Md. in 1981. Kissin and his wife, Dr. Malgorzata Schmidt, make their home just a few miles from the main gate of Ft. Detrick. Kissin has found himself devoting ever more of his time to challenging the expansion of “biodefense” as well as the underlying rationale contained in our government’s mutating story about the anthrax letters. <br /><br />Over the past six years, Kissin has become a leading citizen activist in the struggle to halt the expansion of our “biodefense” program. His work evidently came to the attention of the Homeland Security division of the Maryland State Police. The Washington Post of October 12, 2008, reported that this Homeland Security division had listed Kissin and 52 others as “terrorists,” and furthermore that authorities had acknowledged their wrongdoing and had agreed to purge the files. Kissin, an unsuccessful candidate for Congress in 2006, was in good company. The activists labeled as terrorists included two nuns, a man who challenges military recruiting in high schools, and critics of the Iraq war. <br /><br />Following is my Q. and A. with this passionate opponent of a new biological arms race---a race once shut down by President Richard Nixon only to be stoked anew by the Bush regime. <br /><br />Q: How did you happen to get interested in Ft. Detrick? <br /><br />A: I became a resident of Frederick, MD, home of Ft. Detrick, in 1981. I was aware Ft. Detrick was headquarters for our bio-warfare related programs ever since the first such program commenced in 1943. Before my move to Frederick, I was also conscious of the Silent Vigil that was maintained from July, 1959, until March, 1961, outside Detrick’s main gate that stood for the cessation of our bio-warfare program and the conversion of Detrick’s scientific facilities into a health research center. This Vigil, conceived by a Quaker named Lawrence Scott, is credited with laying the foundation for the decision by President Nixon in 1969 to terminate our offensive bio-warfare program. Two years later, Nixon came to Detrick and announced he was creating the National Cancer Institute (NCI) there which would utilize (and continues to utilize) former Army bio-warfare buildings, thus “sending a clear message that America could beat its swords into plowshares.” I might add that it has since become apparent that the CIA and its “Special Operations Division” at Detrick did not abide by the decision to terminate bio-weapons research. Various bio-warfare related programs continued to function in the 1970s, 1980s and 1990s. <br /><br />During my formative years, I was very active in the movement against the Viet Nam War. Since then I have been very conscious of the terrible workings of our military-industrial-intelligence complex. Upon moving to Frederick, I quickly became aware of how the Army at Detrick manipulated the local community and local media. Ft. Detrick is the largest employer in Frederick County. Its unassailable position in the community is based on a mixture of messages about its contributions to the local economy and its patriotic role in defending against the enemy, once Communist, now terrorist. <br /><br />Q: What steps did the Bush administration take to launch its biological warfare program? <br /><br />A: Upon coming into power, the Bush Administration immediately exercised its strong preference for arms race over international arms control. In the realm of bio-warfare, it promptly withdrew from negotiations to strengthen the 1975 Biological Weapons Convention (BWC), the international treaty that bans the development of biological weapons. This made the United States practically the only country among 150 signatories to the Treaty opposed to a protocol for international inspections and verification. Thereafter, using the anthrax letters attacks of the fall of 2001 as a central pretext, the Bush Administration launched a massive expansion of our so-called “bio-defense” program, much of it at Ft. Detrick. <br /><br />Q: Could you briefly describe the nature of the work going forward at Ft. Detrick and the names of agencies involved? <br /><br />A: One of the programs at Ft. Detrick is under the auspices of the National Cancer Institute (NCI). My focus of course has been upon bio-warfare related activities, which, since termination of the overtly offensive program, have been conducted by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). USAMRIID is a part of the U.S. Army Medical Research and Material Command (USAMRMC) at Ft. Detrick, which also manages activities unrelated to bio-warfare, such as supplying medical materials for use by the Army. <br /><br />The expansion underway at Ft. Detrick contemplates a “National Inter-agency Bio-defense Campus” (NIBC) which upon completion would occupy 200 acres there. The plan is for the NIBC to be the site of a new facility for USAMRIID, designed to measure more than one million square feet (approx. 25 acres of facility space), at a cost of $1 Billion (2005 cost estimate). Construction of two of the new NIBC facilities has already been completed (in 2008) – namely the “National Biodefense Analysis and Countermeasures Center” (NBACC) to be operated by the Department of Homeland Security (DHS), which measures 160,000 square feet, and the “Integrated Research Facility” (IRF) to be operated by the National Institute of Health (NIH), which also measures about 160,000 square feet. After the new USAMRIID facility is completed, the plan is to erect another new facility on the NIBC, to be operated by the Department of Agriculture (USDA). And the Center for Disease Control (CDC) has announced that it also wants to join this campus “confederation.” <br /><br />Q: Please explain what BSL laboratories are and how they are graded. Also, could you describe some of the pathogens government scientists are working on in these labs? <br /><br />A: BSL labs are biocontainment facilities designed for research, development, testing and evaluation (RDT&E) activities involving specific pathogens (germs), exposure to which would be hazardous to lab workers as well as the “outside environment.” BSL stands for Bio-Safety Level --- the higher the level, the more elaborate the safety and security measures, the more dangerous the germs. BSL-4 is for maximum containment. There are dozens of diseases viewed as potential agents for biological weapons. RDT&E upon diseases such as hepatitis A, B and C, influenza A, Lyme disease, dengue fever and salmonella takes place in BSL-2 labs. Anthrax, West Nile virus, Venezuelan equine encephalitis, Eastern equine encephalitis, SARS, tuberculosis, typhus, Coxiella burnetii, Rift Valley fever, Rocky Mountain spotted fever, and yellow fever are dealt with in BSL-3 labs. And Bolivian and Argentine hemorrhagic fevers, Marburg virus, Ebola virus, Lassa fever, and Crimean-Congo hemorrhagic fever are dealt with in BSL-4 labs. <br /><br />The new DHS, NIH and Army facilities at Detrick alone will house approximately 60,000square feet of BSL-4 laboratory space, specifically designed to accommodate work with germs for which there is neither vaccine nor cure. <br /><br />This amount of space is four times the total amount of BSL-4 space that existed in the entire country as of 2004. <br /><br />Q: How have you attempted to slow or stop the expansion of these laboratories? <br /><br />A: Since 2003, I and others in the community have been participating in proceedings under the National Environmental Protection Act (NEPA) designed to examine the environmental impacts posed by new bio-warfare related facilities at Ft. Detrick. Though NEPA treats as a priority the consideration of public input, our input has essentially been ignored as one facility after the other has been approved. I and others have also been conducting demonstrations in downtown Frederick against the expansion. <br /><br />Q: In some ways the community’s activism has paid off, has it not? <br /><br />A: In August, 2007, for the first time in history, an elected official, namely a Frederick County Commissioner, publicly expressed concerns about what was going on at Ft. Detrick. This opened a floodgate. Unprecedented columns and editorials in the local newspapers appeared questioning what was going on at Ft. Detrick. And in November, 2007, upon the occasion of a public meeting hosted by the County Commissioners, more than 150 members of the community filled Frederick City Hall to express their many concerns. <br /><br />Under much pressure, both of Maryland’s U.S. Senators----Barbara Mikulski and Ben Cardin---got behind the demand for a review by the National Academy of Sciences (NAS) of the public health and environmental hazards posed by the new facilities being built at Ft. Detrick. Though the appropriation for this NAS review was passed by Congress in September, 2008, we continue to wait for the Army to fulfill its obligation to enter into a contract with the NAS for this review. <br /><br />Q: Are you a member of any citizen groups concerned about research underway at Ft. Detrick? <br /><br />A: Frederick Citizens for Bio-lab Safety; Frederick Progressive Action Coalition (FredPAC); Frederick County Peace Resource Center (PRC). There are also national organizations concerned about our national “biodefense” program, a central part of which is being implemented at Ft. Detrick. A most important example of such an organization was the “Sunshine Project” based in Austin, Texas. This non-profit organization was instrumental in procuring the Congressional hearing in October, 2007, regarding the alarming (if not reckless) proliferation of high-security bio-laboratories in the U.S. Unfortunately; the Sunshine Project has since ceased its operation for lack of funding. <br /><br />Q: As I understand it, with most of the rest of the world on record as opposed to a new bioweapons arms race, the United States is setting a terrible example by its research at Ft. Detrick. <br /><br />A: In 2004, Milton Leitenberg, Senior Research Scholar at the University of Maryland, James Leonard, head of the U.S. delegation that negotiated the international arms control treaty known as the Biological Weapons Convention (BWC) that bans the development of bio-weapons, and Richard Spertzel, former deputy Commander of USAMRIID and Senior Biologist on the United Nations inspection team in Iraq, co-authored a commentary containing the following statements: <br />“The rapidity of elaboration of American biodefense programs, their ambition and administrative aggressiveness, and the degree to which they push against the prohibitions of the Biological Weapons Convention (BWC), are startling. . . . [The Deputy Director of DHS’s NBACC himself] noted that one NBACC objective, the creation of genetically engineered agents, might raise BWC compliance questions. . . Reportedly, the US intelligence community is under orders to carry out studies. . . . Surely, the ‘intelligence community’ is the least appropriate place in the US government to ‘carry out’ such work — and the most likely to lack adequate oversight.” <br /><br />Q: According to some critics, “biodefense” activity at Ft. Detrick will violate Federal criminal law, is that correct? <br /><br />A: In 2007, International Law Professor Francis Boyle, who drafted the “Biological Weapons Anti-Terrorism Act of 1989” that criminalizes violations of the BWC, stated: <br /><br />“The proposed construction and operation of new facilities at Fort Detrick is an integral part of the program that is referred to as ‘Biodefense for the 21st Century’ in Homeland Security Presidential Directive - HSPD-10, released on April 28, 2004. In my expert opinion, said program constitutes clear violations of the [BWC]. . . . [This] so-called ‘biodefense’ program . . . [has the] unmistakable hallmarks of an offensive weapons program. . . . In my expert opinion, participants in this so-called ‘biodefense’ program are subject to criminal liability [under the Act that I drafted.]” <br /><br />Q: Have you been inside Ft. Detrick? <br /><br />A: Numerous times. As an attorney, I have represented before the Magistrate’s Court at Ft. Detrick individuals charged with misdemeanors committed on post. More to the point, I have attended various “community meetings” on post hosted by the Army for the purpose of answering questions about the expansion. Furthermore, on March 5, 2008, I personally was given a three-hour-long tour of the USAMRIID facility by then USAMRIID Commander Colonel George W. Korch, which included an inspection (through windows) of the “biological containment” laboratories [like the ones portrayed in the Dustin Hoffman film, “Outbreak” (1995)]. <br /><br />Q: How many acres does Ft. Detrick cover and what’s it like? <br /><br />A: Ft. Detrick comprises 1200 acres, (about 10% of the total land area of the City of Frederick, population 60,000). “Area A” contains all of the buildings for the activities summarized above, as well as a substantial number of recently-constructed single-family homes for Army families, a very large gymnasium, commissary, etc. (Though remarkably it still has places in it that would be easy to penetrate), the perimeter fencing has recently been bolstered, which critics describe as contributing to a militaristic presence in the middle of a densely populated community. <br /><br />Q: What is going on in “Area B?” <br /><br />A: “Area B” is about 400 acres and is separated from “Area A,” and has livestock on it used in testing by USAMRIID. Area B was a landfill site. Though questions were raised beginning in the 1970’s about possible leakage from Detrick dumping, it was not until the early 1990’s that monitoring wells were installed that revealed in the ground water the presence of TCE and PCE, both cancer-causing chemicals, at levels between 1,000 and 5,000 times the levels determined to be safe by the EPA. It became clear that the water supplies of nearby residents had been severely contaminated. On July 1, 2003, the local Frederick News-Post published a front-page article “Cancer questions: Residents point finger at Detrick,” based on the statements of many of Detrick’s neighbors about the high incidence of cancer in their families. <br /><br />Q: How have Ft. Detrick authorities and the Army responded? <br /><br />A: The clean-up has dragged along ever since the early 1990s. Two thousand metric tons of hazardous waste have been unearthed. In 2003, sanitation crews were shocked to find vials containing live germs. The discarded biological agents included anthrax, Brucella melitensis, which causes the virulent flu-like disease brucellosis, and klebsiella, a cause of pneumonia. (On May 28, 2003, The Guardian, a prominent English newspaper, published an article entitled “US finds evidence of WMD at last -- buried in a field in Maryland.”) <br /><br />Q: Surely, public officials would raise questions about this situation. <br /><br />A: On November 13, 2008, both of Maryland’s U.S. Senators, ordinarily quite protective with respect to Ft. Detrick, stated in a letter to then President-elect Obama: “[W]e write to draw your attention to the Department of Defense’s (DOD) position that it is not subject to the Environmental Protection Agency’s (EPA) authority to administer federal environmental protection statutes. The Department of Defense has been in flagrant and repeated violation of these statutes at installations in Maryland and around the country. . . . [A]dmitting flaws in its characterization of contamination at Ft. Detrick Maryland as well as the handling of the clean-up there, Secretary Davis promised that the Army would not oppose EPA’s decision to list Area B at Fort Detrick Maryland on the National Priorities List. Yet, we now have a clear sign that DOD appears to be shirking its responsibilities and legal obligations to protect the health and welfare of our constituents, particularly . . . neighbors outside the gate. As recently as November 3, 2008, Secretary Davis wrote to the EPA asking that the Agency refrain from placing Ft. Detrick on the Superfund list in spite of the fact that the site meets all the listing criteria.” <br /><br />Q: Wow. Have there been any injuries or deaths as a result of the biological research at Ft. Detrick? I understand some of its streets are named after fallen employees. <br /><br />A: In general, secrecy in the name of “national security” has concealed the consequences of biological research at Ft. Detrick. <br /><br />According to the official account, three people have died as the result of contracting diseases being cultivated at Ft. Detrick, all before the overtly offensive program was terminated in 1969. A microbiologist and an electrician died from anthrax, and an animal caretaker died from the Machupo virus. The official account does not acknowledge what has come to light about one of the anthrax cases, namely that, at first, the victim was placed by his personal physician in a Frederick hospital, and that “bronchial pneumonia” was listed on his death certificate. <br /><br />Q: Sounds like a cover-up. <br /><br />A: One must study Pulitzer Prize-winning Seymour Hersh’s seminal work, Chemical & Biological Warfare: America’s Hidden Arsenal (Doubleday & Company, 1969) to discover the case of an enlisted laboratory technician at Detrick contracting pneumonic plague. In a memo classified as secret, Detrick officials cautioned that this lab technician was also a life guard at a public swimming pool in the community. But no attempt was made to inform Frederick residents of the danger, or to provide preventative antibiotic treatment. There was also a case of an enlisted man residing off base who contracted meningitis, which can be highly contagious. The Frederick County Health Commissioner was not informed of this case until weeks after it was discovered. Regarding the plague case, this Health Commissioner told Hersh: “I co-operated with [Ft. Detrick officials]. I had an obligation to them – I had a secret clearance. They told me not to report the case [because] we didn’t want to alarm anyone.” Referring to “funny cases” related to Ft. Detrick, this Commissioner also told Hersh about questionable incidents involving typhoid fever and tuberculosis. <br /><br />Then there was the case of Frank Olson, whose death back in 1953 was attributed by officials to suicide. Largely as the result of ongoing efforts by one of Frank Olson’s sons, Eric, it has come to light that Dr. Olson was actually in charge of the CIA’s “Special Operations” at Ft. Detrick, that he was gradually becoming more and more disturbed by the CIA’s secret programs at Ft. Detrick, and that after he expressed some of his misgivings and shortly before his death, he was given LSD by CIA agents. In 1994, Dr. Olson’s son Eric retained Dr. James Starrs, a noted forensic pathologist at the George Washington University Medical Center, to assemble a team of experts to conduct an exhumation and autopsy on Frank Olson. After months of tests and investigation, Dr. Starrs concluded that the circumstances of Dr. Olson’s death had been deliberately covered up by the CIA, and that his death was the result of “homicide deft, deliberate, and diabolical.” (Dr. Olson’s son Eric has also uncovered documents that establish that Dick Cheney became personally involved in this cover-up – see Eric’s website, www.frankolsonproject.org). <br /><br />Q: Are there any other examples of deaths or injuries at Ft. Detrick? <br /><br />A: With regard to injuries resulting from biological research at Ft. Detrick, it is instructive to consider an article written by several medical doctors who work at USAMRIID entitled “Experience in the Medical Management of Potential Laboratory Exposures to Agents of Bioterrorism at USAMRIID” that appeared in the Journal of Occupational and Environmental Medicine: Volume 46(8), August 2004, pp. 801-811: <br />“The large number of exposure incidents reported . . . serves as a reminder that work in a laboratory of this type is inherently hazardous. . . . [W]e recognize that work in containment laboratories is inherently hazardous because of the need to work with sharp objects (ie, needles) and animals, which can be unpredictable. In addition, personal protective equipment may inadvertently increase the potential for incidents by limiting the field of vision, tactile sensation, and communication. . . . A laboratory worker was evaluated for a potential ocular exposure to orthopox viruses resulting from a splash of condensate. . . [A]ll 17 persons involved in the [anthrax] letter handling were considered at potentially significant risk for exposure due to the readily aerosolizable spores. . . . The route of exposure [in another case] was probably inhalational as the result of a malfunction (leak) of the filter in the bio-safety cabinet that was subsequently discovered. . . . As research on the agents of bioterrorism becomes more widespread, an increase in occupational exposures to bioterrorist agents may be expected . . . <br /><br />“Much of our knowledge about biosafety has come from investigations into the mechanisms and activities that caused workers to become infected . . . However, historically the majority of individuals, over 80% in one report, diagnosed with laboratory-acquired infections, could not identify a known incident or breach in laboratory policy responsible for their infection. . . There were 77 individuals evaluated for potential exposures to 107 viral agents . . . [N]o vaccine existed for many of [these] viral agents. . . .” This Journal article also refers to instance after instance of the failure of existent vaccines to prevent infection. <br /><br />The experience of one USAMRIID scientist who accidentally contracted a disease called “glanders” was described in the article as follows: “The individual, after a diagnostic liver biopsy, subsequently went into respiratory failure, necessitating intubation, [followed by] a 6-month course of treatment.” There is explicit acknowledgement in this article of “the risk of introducing communicable illnesses into the community at large.” <br /><br />Also relevant to this question about death and injuries is the apparent incidence of cancer afflicting neighbors of Ft. Detrick due to water contamination, as outlined in my answer to a previous question. Also, there is the matter of the anthrax letters of 2001. It bears pointing out that according to the official account, the anthrax in the letters was developed at Ft. Detrick. <br /><br />Q: Do you know what the budget is for biological research programs? <br /><br />A: Spending on so-called “bio-defense” research greatly increased immediately after the anthrax letters. In the seven fiscal years following the anthrax letters, $48 billion was spent on “bio-defense.” There is another $9 billion budgeted in fiscal year 2009. Much of this is for the stockpiling of pharmaceuticals -- vaccines and remedies such as Cipro for anthrax. <br /><br />The General Accounting Office and scientists like Richard Ebright of Rutgers University have suggested that the spending on research since 2001 has actually made this country less safe by vastly increasing the number of researchers and labs authorized to handle bacteria and viruses of bioterrorism concern, known as “select agents.” <br /><br />Ebright estimates that the number of labs so engaged has increased 20-fold since 2001. Today, there are about 1,400 public and private labs and about 14,000 scientists known to be involved. <br /><br />Q: Arms control expert Milton Leitenberg has said there is no evidence of biowarfare capability on the part of any terrorist group. What do you make of that? <br /><br />A: I have read two books by Mr. Leitenberg that pertain to the bioterrorism threat, and I have spoken to him several times about his work. Mr. Leitenberg is a conservative academic. In Assessing the Biological Weapons and Bioterrorism Threat, Mr. Leitenberg demonstrates that billions of federal expenditures have been appropriated in the absence of virtually any real threat analysis, and that the risk and imminence of the use of biological agents by non-state actors/terrorist organizations has been “systematically and deliberately exaggerated” by our government. It is noteworthy that this book was published in December, 2005, by none other than the Strategic Studies Institute of the U.S. Army War College. On its title page can be found the following statement: “This publication is a work of the United States Government . . .” <br /><br />Q: Turning to the anthrax letters, what is Amerithrax? <br /><br />A: Amerithrax is the FBI’s name for its investigation into the anthrax letters attacks of September-October, 2001. This investigation has become a cover-up and a fraud, a systematic and deliberate fraud that now attempts to pin exclusive responsibility for the attacks upon a USAMRIID immunologist named Bruce Ivins. After months of intense harassment by the FBI, Ivins died in July, 2008, it appears by suicide. <br /><br />Q: Do you believe the anthrax attacks on Congress and the media in 2001 emanated from Ft. Detrick? <br /><br />A: The anthrax in the letters was of a particularly pernicious strain called the “Ames strain” of anthrax. After being discovered in a dead cow from Texas in 1981, the Ames strain made its way to Ft. Detrick, where it was originally cultivated as a potential bio-weapon. Bruce Ivins worked with the Ames strain at Ft. Detrick in the course of his efforts to derive an effective vaccine. According to the FBI’s genetic analysis, the anthrax in the letters was of a specific genotype designated RMR-1029. RMR-1029 was created by Bruce Ivins in 1997. Thereafter, Dr. Ivins was called upon to send RMR-1029 to various laboratories, including those at the Army’s Dugway Proving Ground in Utah, as well as those in Ohio owned and operated by the company named Battelle. So, it is likely that the anthrax came from Ft. Detrick. But the attacks “emanated” from either Battelle or Dugway, where the anthrax was converted from the “wet slurry” form it was in at Detrick to the powdered weaponized form found in the letters addressed to the Senators. <br /><br />Since the FBI announced that Dr. Ivins was the lone culprit, two articles of mine have been published on the internet that set forth the strong evidence that the real source of the anthrax letters was one of our own secret anthrax weaponization projects being conducted by the CIA and the DIA at Battelle’s labs in Ohio and at the Army’s labs in Utah. “FBI Sweeps Anthrax Under the Rug” can be accessed at http://rockcreekfreepress.tumblr.com/post/46413512/fbi-sweeps-anthrax-under-the-rug. <br /><br />“Amerithrax Hoax” can be accessed at <br />http://www.opednews.com/articles/AMERITHRAX-HOAX-by-Barry-Kissin-090113-263.html <br />or at <br />http://anthraxvaccine.blogspot.com/2009/01/critique-of-chemical-signature.html. <br /><br />Q: The anthrax letters had “Death to Israel,” “Death to America” and “Allah is Great” printed in them. This seems like a crude propaganda plant to make the public believe the letters were sent by persons from the Middle East or their sympathizers. I’ve also heard it said the Bush Administration leaked information at the time of the anthrax attacks that the letters came from the Muslim world. What do you make of that? <br /><br />A: This aspect of the anthrax letters is what makes the anthrax letters a “false flag” operation. A “false flag” operation is one wherein a country stages an attack made to look like an attack by an enemy, so as to justify an (aggressive) attack upon that enemy. Clearly, elements in the Bush administration and in the media, for as long as they could get away with it, pretended that the anthrax letters came from Iraq. This played an unmistakable role in gathering support for the invasion of Iraq. <br /><br />Q: What do you believe was the motivation for the anthrax attacks? <br /><br />A: The practice of inventing or exaggerating an attack or a threat in order to stimulate demand for military build-up and war has been in place forever. (The Gulf of Tonkin incident and the fabrication of Iraqi soldiers throwing Kuwaiti babies out of incubators before the first Gulf War are important, relatively recent examples.) In his 1961 Farewell Address, President Eisenhower warned about the "unwarranted influence" and “misplaced power” of the “military-industrial complex.” Before that, General Douglas MacArthur declaimed: “Our country is now geared to an arms economy bred in an artificially induced psychosis of war hysteria and an incessant propaganda of fear.” And before that, General Smedley Butler: “War is a racket. It always has been. It is possibly the oldest, easily the most profitable, surely the most vicious.” And while we are at it, let’s also heed James Madison, the primary author of our Constitution: “The means of defense against foreign danger historically have become the instruments of tyranny at home.” And: “If Tyranny and Oppression come to this land, it will be in the guise of fighting a foreign enemy.” <br /><br />Q: Are you saying the motivation traces back to the profit motive of the military-industrial complex? <br /><br />A: For many involved in this practice of inventing/exaggerating threat, this is part of an effort to maximize profits. Others are believers in the need for a military build-up, and justify the invention/exaggeration as necessary to establish priority among competing demands for appropriations. No matter the quality of the motivation, the practice is fraudulent, and is directly responsible for the ignored phenomenon that the U.S. spends more on its military than all of the other countries in the world combined. <br /><br />Q: And is the world’s No. 1 arms merchant as well, plus the U.S. has ringed the globe with 700-800 military installations, all for “defense” of course but, taken together, giving the appearance very much of an aggressive posture, the stance of an imperialist superpower. <br /><br />A: The neocons who controlled policy under Bush were of course very closely connected to the “defense” sector of our economy, and the profits made in that sector have of course skyrocketed during the past eight years. What distinguished the neocons in this context was that they did not only rely upon inventing/exaggerating threat, they also explicitly espoused “full-spectrum dominance” for the sake of the ascendance of American empire. <br /><br />Q: So where do the anthrax letters fit in? <br /><br />A: The anthrax letters must be viewed in this historical context. In the case of the anthrax letters, the invention/exaggeration of threat took the perverse form of an inside job. The Bush Administration has had to officially acknowledge that the anthrax letters were an inside job. But in order to minimize the implications of this fact, the official account resorts to the flimsy claim that the insider was a lone nut named Bruce Ivins, peculiarly driven to stimulate demand for his anthrax vaccine. <br /><br />The obvious cover-up in Amerithrax, which depends on the complicity of not only our FBI and Department of Justice, but also of our mainstream media, demonstrates how economically and politically powerful are our military-industrial-intelligence forces. Remarkably, despite the admission of inside job, the anthrax letters continue to serve their dual purpose of generating profits and of achieving dominance in the ghastly realm of bioweapons. <br /><br />Q: Thank you, Barry Kissin. <br /><br />(Sherwood Ross is a Miami-based public relations consultant who formerly reported for the Chicago Daily News and wire services. He is the author of the article, “America The Beautiful’s Germ Warfare Rash” published in The Humanist magazine. Reach him at sherwoodr1@yahoo.com. Reach Kissin at barrykissin@hotmail.com.) <br /><br />(Picture)<br />Barry Kissin leads a march in downtown Frederick to protest plans for the new “biodefense” campus at Fort Detrick. A variety of peace groups came together to express concerns that this campus will threaten local health and safety as well as international arms control.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-79335045240308784082009-02-17T08:54:00.000-05:002009-02-18T08:55:06.604-05:00UK Researchers Create Anthrax Vaccine Pillhttp://news.softpedia.com/news/UK-Researchers-Create-Anthrax-Vaccine-Pill-104738.shtml<br /><br />UK Researchers Create Anthrax Vaccine Pill<br />Tests on mice have been very promising<br /><br />Up to this point in time, administering anthrax vaccines has only been possible through needles. In other words, an eatable pill has been impossible to manufacture, simply because the acidic gastric liquids in the stomach would have disintegrated the vaccine molecules within a matter of seconds, and all its efficacy would have been lost. But now, researchers in the United Kingdom have managed to devise a new way of getting the cure through the stomach, and namely by “packing” it inside small bacteria.<br /><br />These types of organisms are very common and can be found in products such as milk and cheese. Mice tests have shown minimal damage to the structure of the vaccine, meaning that, in their new “transport” vessel, the precious molecules have safely endured the hardships of the acids each human has in his or her stomach.<br /><br />“Using 'food grade' lactic acid bacteria as a vehicle provides a safe way of getting the vaccine into the small intestine without losing any of the drug's efficacy,” US researcher Todd Klaenhammer, from North Carolina State University, who has been the co-author of the current study, says.<br /><br />Finding a cure for anthrax is paramount, at least in America, where terrorists threats have people and authorities on their toes. The bacteria usually causes only minor skin lesions, which can be easily treated. However, if spores are inhaled, they rapidly and silently take hold of people's inner organs, and, by the time they start showing symptoms, it's usually too late for antibiotics to take effect and reverse the contamination.<br /><br />The only current way to fight this pathogen is through injections, but because the vaccine is made of proteins, multiple shots must be administered, and not all have the desired effect on the body. However, the UK-US team has managed to disguise the proteins of the vaccine into regular bacteria, which can withstand the rigors of passing through a highly-acidic environment.<br /><br />“Can we make these generally recognized as safe lactic bacteria into a premier delivery system for vaccines and biotherapeutics? That's the question we are now trying to answer,” Klaenhammer opines. The team is currently concentrating its efforts on finding out if other such organisms can carry other types of cures. If so, we could soon see a wide range of antibiotics delivered in the form of pills, and not through injections.<br /><br />The results of the current research have been published in a recent edition of the journal Proceedings of the National Academy of Sciences. The US Army Medical Research of Infectious Diseases has also participated in the new study.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-49577263140381158662009-02-17T07:28:00.000-05:002009-02-18T07:31:42.843-05:00Court still undecided on report of anthrax testing on soldiershttp://www.jpost.com/servlet/Satellite?cid=1233304811263&pagename=JPost%2FJPArticle%2F<br /><br />NOTE:(Most vaccinated Israeli soldiers received US anthrax vaccine)<br /><br />The Jerusalem Post Internet Edition<br /><br />Court still undecided on report of anthrax testing on soldiers<br /><br />Feb. 17, 2009<br />Judy Siegel-Itzkovich , THE JERUSALEM POST<br /><br />The High Court of Justice once again deferred a decision Tuesday on whether to allow the publication of a report prepared by an Israel Medical Association committee investigating the giving of anthrax vaccine to over 700 soldiers who served as "guinea pigs" to determine side effects.<br /><br />The story was initially disclosed by Ilana Dayan's Uvda TV program in 2007 after she received complaints from soldiers who claimed to suffer from side effects that affected various systems in their bodies.<br /><br />The IDF's then-surgeon general, Dr. Chezy Levy, asked Prof. Avinoam Reches, then head of the IMA's ethics bureau, to set up a voluntary committee of experts to study the matter. Levy is today deputy director-general in charge of medical services at the Health Ministry, which has not taken any action regarding the vaccinations.<br /><br />The IMA committee was chaired by Prof. Reuven Porat, chief of internal medicine at Tel Aviv Sourasky Medical Center (Ichilov). The committee members heard testimony from hundreds of soldiers who had been vaccinated, allegedly without being warned about possible side effects.<br /><br />Although the report is ready for publication, the Defense Ministry's office in charge of state security petitioned the High Court to prevent its publication, arguing that its release would "endanger public security."<br /><br />The IMA denied this. No one knows what is in the 100-page report (plus documents) except for the judges, IMA committee members and Reches.<br /><br />On Tuesday, Justice Asher Gronis, who headed the three-judge panel, said he read the report and did not get the impression that its publication might hurt national security, but that perhaps there was a legitimate reason for the Defense Ministry's objections. He dispatched thanks (via the IMA lawyers) for working hard to prepare the report.<br /><br />The court did not issue an opinion or ruling, but apparently may decide to send the report again to the Defense Ministry's office in charge of state security for an additional examination.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-37296777834283600012009-02-07T09:24:00.000-05:002009-02-10T09:25:32.381-05:00U.S. Army Lab Freezes Research on Dangerous Pathogenshttp://blogs.sciencemag.org/scienceinsider/2009/02/us-army-lab-fre-1.html<br />Proposed Law Would Make NIH Less "Open" <br /><br />February 7, 2009<br /><br />U.S. Army Lab Freezes Research on Dangerous Pathogens<br /><br />The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has suspended research activities involving biological select agents and toxins. Army officials took the step on Friday after discovering apparent problems with the system of accounting for high-risk microbes and biomaterials at the Fort Detrick, Maryland, facility. <br /><br />The lab has been under intense scrutiny since August, when the Federal Bureau of Investigation (FBI) named former USAMRIID researcher Bruce Ivins as the perpetrator of the 2001 anthrax letter attacks. Although the case never went to trial because of Ivins's suicide on 29 July 2008, FBI officials have claimed that the evidence against him is indisputable and that he carried out the mailings using anthrax stolen from a flask at USAMRIID.<br /><br />Officials have begun a complete inventory of all select agents and toxins at the facility. All experiments using select agents will remain suspended until the accounting is finished, which could take several weeks. Several USAMRIID researchers have been grumbling about the decision, which seems to have caught them by surprise, according to a government official not connected to the lab. <br /><br />The decision was announced by institute commander Col. John Skvorak in a 4 February memo to employees. The memo, which ScienceInsider has obtained, says the standard of accountability that USAMRIID had been applying to its select agents and toxins was not in line with the standard required by the Army and the Department of Defense. USAMRIID officials believed that a satisfactory accounting involved finding all the items listed on its database; the Army and DOD wanted the converse—that is, all select agents and toxins needed to be matched to the database. <br /><br />According to the memo, any materials found without a corresponding record in the database must be reported to the Vice Chief of Staff of the Army. "I believe that the probability that there are additional vials of BSAT [biological select agents and toxins] not captured in our … database is high," Skvorak wrote. <br /><br />A former USAMRIID scientist told ScienceInsider that in the past, inventorying of biological materials at the institute routinely turned up items that had not been listed on the database before. Those items would be added to the database without shutting down research.<br /><br />—Yudhijit BhattacharjeeMBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-70511430330756962382009-01-23T15:27:00.000-05:002009-01-29T15:28:58.593-05:00Deadly Bio-Weaponry Build Up Comes to the Heart of the U.S.Deadly Bio-Weaponry Build Up Comes to the Heart of the U.S.<br />http://www.naturalnews.com/025385.html<br /><br />(NaturalNews) The powers of the world are in a new arms race far more terrifying in its scope than the race for nuclear weapons. Bio-weaponry and bio-wars are now real threats to the future of the human race. What sounds like the stuff of futuristic science fiction is already a quiet reality. The recent announcement of the new site for the National Bio and Agro Defense Facility brings this reality to light, particularly as this site will house level 4 pathogens, some of which are zoonotic, meaning they can jump the species barrier and infect humans.<br /><br />The new facility, to be built near Manhattan, Kansas will be classified as Biological Safety Level 4 (BSL-4), a designation that allows for the study of the most deadly, most contagious diseases known, diseases for which there are no cures. It will replace the Plum Island Animal Disease Center, located 100 miles northeast of New York City in the Long Island Sound, just six miles off the Connecticut coastline and accessible only by ferry or helicopter, a location where prevailing winds blow out to sea. That facility is closing under the rationale that it does not have the security in place for this higher level of usage. Plum Island carries a lesser BSL-3 classification.<br /><br />Connecticut residents knowledgeable about what goes on at Plum objected to the creation of a new facility where the old one stands, fearing that lethal viruses could escape onto the mainland.<br /><br />The Department of Agriculture ran the Plum Island lab until 2003, when it was turned over to the Homeland Security Department as part of the nation's biological defense program. The public's perception of the research at Plum Island, created by government public relations releases, has centered on its mandate to protect herds from hoof-and-mouth disease, a highly contagious virus that is deadly to animals. According to government PR, researchers at Plum work on detection of disease, epidemic control strategies, vaccines and drugs, tests of imported animals, and training of professionals.<br /><br />A large body of evidence suggests there is much more than this going on at Plum. Circumstantial and factual data has presented the likelihood that Plum is responsible for a number of disease outbreaks that have proven to be national public health and agricultural nightmares. Many see Plum Island as responsible for the re-introduction of the hoof-and-mouth disease it now claims to control. Some point to bio-containment mechanisms at Plum that were allowed to deteriorate and remain non-functional for several years, and lax security that allowed accidents to happen. Others suspect more deliberate actions.<br /><br />While the stated mission of the new site continues to be the control of such animal diseases, the location for the new facility in Kansas places it near 542,507 head of livestock, over three times the amount in the vicinity of other sites that were considered. An outbreak of hoof-and-mouth disease could require the destruction of tens of millions of farm animals and devastate the livestock industry.<br /><br />The diseases being researched at Plum are not necessarily contained in glass viles. There are a number of infected live animals for study there with diseases having incubation periods extending for several days. This means it is very possible for a researcher to be infected on Friday, take the ferry home to Connecticut and spend the weekend spreading the infection before any signs of it are visible in him. The government maintains that there has never been a leak to the mainland, and apparently the first appearance of Lyme disease just 13 miles from the facility falls under the category of coincidence, as does the still unexplained initial U.S. appearance of West Nile virus in Long Island and New York.<br /><br />Bio-weaponry in the U.S. is nothing new<br /><br />The development of bio-weapons in the U.S. dates back at least to the 1930's when the U.S. Public Health Service conducted an experiment on 399 black men in the late stages of syphilis, called the Tuskegee Experiment. The experiment was designed to see how long it took for men to die from infection by the syphilis spirochete.<br /><br />During the 1950s and 60s, bio-warfare attacks took place in many parts of America, the most noted being the six day attack on San Francisco during which potentially harmful bacteria were sprayed over the city. In this attack, reported in the September 17, 1979 Los Angeles Times, twelve people developed pneumonia and one man died.<br /><br />In 1954, Plum scientists looked for ways to inflict bio-damage on Soviet livestock. According the Cuban government, in the 1960s and 70s bio-weapons developed at Plum were deployed against Cuban agriculture, targeting pork, tobacco and sugar cane.<br /><br />During the Cold War years, thousands of U.S. citizens were used in radiation experiments conducted by the Atomic Energy Commission and other government agencies.<br /><br />In 2001 the U.S. Department of Defense (DOD) issued a press release admitting it conducted over one hundred tests in which thousands of American servicemen were intentionally dosed with chemical and biological weapons during the period from 1962 to 1973. Dozens of harmful agents like VX, Sarin gas, E-coli bacteria and Bacillus globigii, a cousin to anthrax and bubonic plague, were used on completely unaware and unprotected men. The announcement by the DOD was strategically placed just two days after the mind-numbing 9/11 attacks, at a time when it was given little to no attention by the national media.<br /><br />Bio-warfare development intensified in the 1970's particularly in the areas of genetic engineering. Much of it was euphemistically referred to as cancer research. During this period cancer causing viruses began to jump from one species of animal to another, a characteristic that signals the viruses are man made. New immunodeficiency diseases were then seen in lab animals.<br /><br />Although generally regarded as conspiracy theory, some AIDS researchers believe the Special Virus Cancer Program and its connection to bio-warfare development spawned an immunosuppressive virus that was seeded into the gay community via the government sponsored experimental hepatitis B vaccine drive.<br /><br />The Washington Times, October 19, 1998 reported bio-warfare experiments that took place at Fort Detrick between 1954 and 1973, utilizing volunteers who were exposed to germs causing tularemia, malaria, anthrax, Rocky Mountain spotted fever, encephalitis, and other diseases. Prevention, diagnosis and vaccine development were cited as the reasons for the experiments.<br /><br />The Los Angeles Times, March 9, 1977, reported other experiments during which the military sprayed bacteria in New York City subways, in a Washington D.C. airport, and on highways in Pennsylvania. Military bases in Virginia, Key West, and off the coasts of Southern California and Hawaii have used live bacteria tests on U.S. civilians.<br /><br />In 1992, a strike at Plum of union engineers was responsible for a loss of essential support services such as decontamination, waste-water treatment, generator maintenance, and other maintenance and safety-oriented functions. For the duration of the strike, temporary workers were brought in to replace the sentinels and technicians of the infrastructure. The water pressure fell precipitously disabling decontamination facilities and the necropsy rooms where dead animals were examined. In the fifth month of the strike a power failure occurred during which a worker called a Hillary Clinton staffer to complain that the facility was completely out of hand. Without power, the air filtration systems were inoperable, and the decontamination procedures stopped. The seals in the pressurized airlock doors deflated, and workers reportedly tried to seal them with duct tape.<br /><br />In 1999, the administrator of the Agriculture Research Service persuaded President Clinton to include Plum in his expanded bio-terrorism program based on the possibility of a biological attack on the nation's agricultural base.<br /><br />In 2001 it was discovered that Plum was involved in an effort to develop vaccine resistant forms of anthrax. Two years later a virologist at St. Louis University announced he was creating a more lethal form of mousepox, a relative of smallpox, and intended to extend his work to cowpox which can infect humans. The problem with research of countermeasures is that they need the lethal measure to go against. Creating deadly bio-weapons to determine how well they can be thwarted gives rise to the potential of more potent plagues. The government's budget for chemical/biological warfare has recently doubled, with $10 billion allocated to bio-weaponry projects.<br /><br />These incidents are a record of what has become known in spite of all attempts to retain security and secrecy. It is obviously not the full extent of the U.S. government's bio-warfare or bio-weapon testing on its citizens. The full extent of this involvement is hidden in classified documents or is reported to be unavailable.<br /><br />The increase of new bizarre diseases and organisms raises questions<br /><br />The appearance in the past several years of AIDS, Legionnaire's disease, hepatitis C, mad cow, hemorrhagic viruses, Lassa fever, chronic fatigue syndrome, Persian Gulf War illness and others have made people question their sources. Older diseases such as tuberculosis, malaria and cholera have re-emerged in more virulent forms that are drug resistant. A study published in the January 6, 1999 JAMA reported infectious disease mortality in the U.S. declined during the first eight decades of the 20th century. From 1981 to 1995, there was an increase in infectious disease mortality of fifty-eight percent. The researchers concluded that recent increases emphasize the dynamic nature of infectious diseases and the need for preparedness to address them.<br /><br />The official list of excuses for this rising mortality rate makes no mention of the infectious material produced for biological warfare purposes. The anthrax mailings following the attacks of 9/11 have been the only wake-up call that has reached many Americans. It raised the level of public fear enough to spark congressional increase in spending on bio-defense, but it quickly faded from the public mind.<br /><br />About the same time as this funding was increased, the West Nile virus was dismissed by a government report as not being bio-warfare, a move surprising many people given the government's long and documented history of bio-warfare experimentation on its own citizens.<br /><br />Bio-weaponry is for sale to the highest bidder<br /><br />Killer microbes have been for sale to any person or country having the buying power. While the U.S. was still friendly with Iraq, the Education Ministry bought 70 shipments of anthrax and other disease-causing organisms from the U.S. Officials here continued to supply Iraq with bio-warfare material during the prelude to the Gulf War according to the September 24, 2002 Seattle Post Intelligencer.<br /><br />Was the West Nile virus lab created?<br /><br />People wonder whether the West Nile virus could be the result of animal experimentation and the laboratory manipulation of the African virus. In September, 2002, the media reported that some West Nile patients exhibited signs and symptoms of polio, although that disease is caused by a different virus. They ask if this means the virus has been laboratory altered. West Nile is generally only fatal in the old and the sick, groups being eyed by the government for their use of entitlements.<br /><br />Fiction often portrays life's greatest truths<br /><br />The Poison Plum (2006) is a novelized historical treatise of the Lyme disease now sweeping across the U.S. Recorded incidence of this puzzling illness without a cure shows it to be the fastest spreading disease in America today. From the politics of disease to the agenda of the powerful, the book reveals the betrayal of the nation and its people by their own most trusted institutions. It is a dark portent of the pain and suffering to come as Lyme disease and the escalation of bio-warfare continue.<br /><br />The book is a testimony to the veil of secrecy surrounding Lyme, a veil that took ten years for the author to penetrate before he finally received his own Lyme diagnosis. It is a mesmerizing and powerful tale that speaks of truths that are only palatable when presented in the form of a story. The connections between Lyme and Plum are probed, as well as the involvement of government laboratories in engineering germs for use in biological warfare. Other questions raised involve the possibility of massive government cover-ups to deny the true severity of Lyme disease and the fact that there is no cure, as well as the involvement of insurance companies denying the complexity of the disease to avoid liability for costly long term treatment protocols.<br /><br />Sources:<br /><br />Barbara Minton, Deadly Animal Virus May Soon Come to U.S. Mainland, naturalnews.com.<br /><br />Patricia Doyle, PhD., Plum Island Lab Moving to Kansas, Goes BSL-4, rense.com.<br /><br />Alan Cantwell, Jr., M.D., The New West Nile Virus Epidemic: Bioterrorism? Or Mother Nature (Again)? Paranoiamagazine.com.<br /><br />Patricia Doyle PhD., The Deadly Fools of Plum Island, rense.com.<br /><br />Poisoned Plum, Primate Freedom, February 3, 2007.<br /><br />U.S. Uses Bio-Weapons on Their Own People, americasveterans.org.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-67837577859772272222009-01-22T15:24:00.000-05:002009-01-29T15:24:39.411-05:00Revisiting the anthrax attackshttp://www.eurekalert.org/pub_releases/2009-01/uops-rta012209.php<br /> <br />Contact: Clare Collins<br />CollCX@upmc.edu<br />412-647-3555<br />University of Pittsburgh Schools of the Health Sciences <br /><br />Revisiting the anthrax attacks<br />PITTSBURGH, Jan. 22 – When anthrax was sent through the U.S. Postal Service in 2001, an overwhelming majority of postal workers elected not to be inoculated with the available vaccine because of confusion and distrust, according to a University of Pittsburgh Graduate School of Public Health study. Although the FBI officially closed the case on the attacks this year, lingering suspicion and uncertainty remain, say study authors, which could influence the public's reactions to future emergencies. <br />According to the report, reactions from postal workers were shaped partially by fears of being experimental "guinea pigs," disagreements among public health agencies about whether the vaccine should be recommended, physician advice, low perceived risk of infection and conflicting reports from national media organizations. <br />The study was based on interviews and focus groups conducted with 65 postal workers in Trenton, N.J., New York and Washington, and published in the December 2008 issue of Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science.<br />"The reaction of postal workers demonstrates the essential need to build trust and educate the public before the uncertainty, confusion and time pressures of a bioterrorism or pandemic emergency create major barriers for clear communication," said study author, Sandra Quinn, Ph.D., associate dean for Student Affairs and Education and associate professor at the University of Pittsburgh's Graduate School of Public Health. These concerns may be particularly relevant given that, in October 2008, the Department of Health and Human Services declared anthrax as a continuing bioterrorism threat through the end of 2015, she said. <br />During the 2001 anthrax attacks, which resulted in five deaths, 10,000 postal workers and others who were suspected or confirmed to have been exposed received a two-month dose of antibiotics. The Centers for Disease Control and Prevention (CDC) then recommended people who failed to complete the regimen or who were at high risk for exposure take antibiotics for an additional 40 days with or without a supplemental anthrax vaccine. Only 11.5 percent of postal workers who took the additional 40-day dose of antibiotics agreed to take the anthrax vaccine as a precautionary measure. <br />"Scientific knowledge about the effectiveness of the vaccine after exposure to anthrax was uncertain at the time, making it an almost impossible task to communicate precise and proper health information to postal workers and other affected groups, including Senate staff," said Dr. Quinn. "Given the evolving nature of the crisis, postal workers were unsure whose advice they should trust and as a result, many decided to do without the recommended vaccination," she said. <br />In 2004, with the passage of legislation to establish Project Bioshield, the federal government created a mechanism for declaring public health emergencies. This authority also allows the Food and Drug Administration to authorize the use of experimental or "off label" drugs to address bioterrorism or public health emergencies. According to Dr. Quinn, communication about the use of these counter measures will present significant challenges for public health authorities in the future. <br />To address these challenges, she suggests public health experts openly acknowledge disagreements between health agencies, develop partnerships with trusted community agencies and work with media partners to address inaccuracies, misconceptions or other issues that may arise in news reports. <br />"We need to engage and educate the public before an emergency occurs to prevent unnecessary risk, disease and even death. Only by doing this can individuals make informed decisions about accepting or rejecting counter measures," she said.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-53483038151078773602009-01-16T10:53:00.003-05:002009-01-29T10:55:44.882-05:00Litigants Argue U.S. Regulators Lacked Basis to OK Anthrax VaccineGlobal Security Newswire<br />National Journal Group<br />Jan. 16, 2009<br /><br />Litigants Argue U.S. Regulators Lacked Basis to OK Anthrax Vaccine<br /><br />Friday, Jan. 16, 2009<br />By Elaine M. Grossman<br /><br />Global Security Newswire<br /><br />WASHINGTON -- The Food and Drug Administration violated its own regulations three years ago in approving the anthrax vaccine to prevent infection by a "weaponized" form of the disease, attorneys for eight Defense Department employees alleged in a brief filed last week at the U.S. Court of Appeals (see GSN, March 3, 2008).<br /><br />(Jan. 16) - The anthrax vaccine received approval in late 2005 as a protective measure against inhaled anthrax (Emergent BioSolutions photo).<br /><br />The Pentagon began a vaccination program for more than 1 million service personnel in 1998, during the Clinton administration, and continued the effort under President George W. Bush. However, compulsory shots were suspended from late 2003 through early 2007, after a federal judge found the Pentagon lacked the legal authority to <br />compel inoculations for an unapproved use of the vaccine.<br /><br />Critics have voiced concern that it is unclear how useful anthrax vaccine is in preventing the highly lethal disease from being contracted through inhalation, and have called attention to the possible risks associated with giving the inoculations to a large population.<br /><br />The U.S. government recently moved to shield itself from liability in distributing the vaccine in the event of a bio-warfare attack, just as a key advisory panel to the Centers for Disease Control and Prevention approved extending the shots to emergency first-responders nationwide (see GSN, Oct. 17, 2008, and Oct. 23, 2008).<br /><br />A December 2005 FDA ruling allowed a vaccine previously labeled for use solely in inhibiting anthrax contracted through the skin or the digestive system to also be administered to prevent acquiring the disease via the lungs.<br /><br />The decision paved the way for the Defense Department to resume mandatory inoculations for service members whose assignments are believed to put them at increased risk of exposure to anthrax during a potential biological attack (see GSN, Sept. 5, 2007).<br /><br />However, two attorneys who succeeded in temporarily shutting down the mandatory shots program in 2003 remain dissatisfied. They alleged in a second lawsuit, filed in December 2006, that the Food and Drug Administration had not followed its own standards for reviewing a vaccine for approval in issuing its 2005 go-ahead.<br /><br />The result, they are alleging, is that the vaccine has not been shown to be safe and effective for preventing inhaled anthrax.<br /><br />U.S. District Judge Rosemary Collyer last year ruled against the plaintiffs, saying the court "will not substitute its own judgment when the FDA made no clear error of judgment."<br /><br />Plaintiff attorneys Mark Zaid and John Michels took their case to federal appeals court, and the 73-page brief filed last week constitutes their written argument.<br /><br />"There are ... internal inconsistencies in the [FDA-reviewed] record showing that nobody believed this vaccine was adequate for preventing inhalation anthrax until the DOD decided they were going to conduct this mass inoculation, " Michels said in an interview yesterday. "The FDA's failure [in its 2005 action] to explain all of these contradictory statements [in] their own documents is a violation of the Administrative Procedures Act."<br /><br />The 1946 federal law controls how government agencies draft and issue regulations.<br /><br />A Defense Department spokesman praised the federal judge's decision.<br /><br />"We owe it to our service members to give them every possible protection," Bryan Whitman said last year. "Force protection is the No. 1 priority in the Defense Department and the anthrax inoculation program is an important force-protection measure."<br /><br />In their Jan. 7 brief to the U.S. Court of Appeals, though, Michels and Zaid took issue with the notion that the vaccine has been proven to protect humans from contracting inhaled anthrax.<br /><br />If the court invalidates the FDA authorization for this use, the Defense Department could be required to obtain informed consent from any personnel receiving the five-shot series (see GSN, Dec. 22, 2008).<br /><br />In the case, called Rempfer vs. von Eschenbach, the two lawyers are representing Thomas Rempfer and seven other Defense Department personnel ordered to take the vaccines. Defendants are led by FDA Commissioner Andrew von Eschenbach and include the health and human services and defense secretaries.<br /><br />"The regulatory history of the [anthrax vaccine] was nothing if not convoluted and contradictory, " according to the plaintiffs' new court submission. "The main basis" for Collyer's decision to dismiss the case "was the FDA's reliance on a single human test of [the anthrax vaccine] that occurred more than 50 years ago, using an admittedly different vaccine," the complainants stated.<br /><br />The district court judge's Feb. 29, 2008, decision "ignored the significant disparities" in vaccine testing as well as plaintiff allegations that "undercut" the key medical study's "validity and scientific basis," the brief reads.<br /><br />"We are alleging," Michels told Global Security Newswire, "the FDA has not done its job."<br /><br />Agency records show a "significant failure by FDA to follow its own procedures with regard to licensing of the current version of the vaccine using data from a vaccine that was manufactured using different standards, a different anthrax strain, and different methodology, " according to the brief. "The District Court's simple acceptance of the representations made by the government was improper and factually unsupportable. "<br /><br />An FDA spokeswoman today declined to offer comment on the court case.<br /><br />Pending a possible extension in due date, the government has 30 days to issue its own written brief for the appeals court. After that, the plaintiffs will have an opportunity to submit their response. The appeals panel may then request to hear oral arguments on the case before issuing its decision.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-84500314776212434802009-01-11T09:13:00.001-05:002009-01-29T09:14:55.761-05:00AIG Plasma Donation Programhttp://www.cangene.com/AIGPDP.2.1.2008-1.htm?_show<br /><br />By becoming a plasma donor for this program, you will help ensure that the country has an adequate supply of a drug called Anthrax Immune Globulin (AIG). Your plasma donation is needed so AIG can be available to potentially protect the safety of Americans in the event of an anthrax attack or exposure.<br /><br />Regardless of whether or not you have been previously vaccinated against anthrax, you are still eligible to participate in the AIG Plasma Donation Program. At most of our plasma center locations, donors can begin anthrax immunizations or receive a booster vaccination to become eligible for plasma donation. View our Frequently Asked Questions for more detailed information on donor participation requirements or contact your nearby plasma center. <br /><br />Click here to view our AIG brochure if you have been previously vaccinated against anthrax. <br /><br />Click here to view our AIG brochure if you have never received an anthrax vaccination.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-61772951802492305182009-01-10T08:47:00.001-05:002009-01-29T08:48:53.883-05:00Top Stock Picks ‘09: Emergent BioSolutions (EBS)Top Stock Picks ‘09: Emergent BioSolutions (EBS) <br /><br />http://macroaxis.com/blog/2009/01/10/top-stock-picks-09-emergent-biosolutions-ebs/<br /> <br />January 10th, 2009 By Steven Halpern <br />Filed under: Newsletters, Stocks to Buy, Best Stocks for 2009<br /><br />This post is part of a special annual report -- Top Stock Picks '09 -- in which TheStockAdvisors.com asked 75 leading newsletter advisors to select their favorite investment for the new year.<br /><br />"Emergent BioSolutions (NYSE: EBS) -- my top 2009 pick -- makes the only FDA-licensed vaccine for the prevention of anthrax," says Timothy Lutts in his The Cabot Stock of the Month.<br /><br />"Located in Rockville, Maryland, the company is currently filling a $448 million government order for 18.75 million doses, and in October, the U.S. government contracted to purchase 14.5 million additional doses valued at up to $404 million, to add to the Strategic National Stockpile.<br /><br />"The vaccine is named BioThrax, and it accounts for 97% of the revenues of Emergent BioSolutions. However, the company has a full pipeline including two 'next generation' anthrax vaccines.<br /><br />"Also in development are two anthrax therapeutics (immunoglobulin and monoclonal), two botulinum vaccines and a botulinum therapeutic (botulinum is the nasty form of Botox), an oral typhoid vaccine, a next generation tuberculosis vaccine, a hepatitis B immunotherapy and a chlamydia vaccine.<br /><br />Continue reading Top Stock Picks '09: Emergent BioSolutions (EBS)<br /><br />Top Stock Picks '09: Emergent BioSolutions (EBS) originally appeared on BloggingStocks on Sat, 10 Jan 2009 11:00:00 EST.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-35006603631844773672008-12-19T12:27:00.001-05:002008-12-19T12:29:16.046-05:00Mutating Bird Flu VirusFarms may not be using 'right vaccines' <br />http://www.chinadaily.com.cn/china/2008-12/17/content_7311877.htm <br /><br />HONG KONG - The re-emergence of bird flu in Asia and Egypt was partly because poultry farms were not using the right vaccines and that the virus is mutating, experts said on Tuesday. <br /><br />Guan Yi, of the University of Hong Kong and an expert on H5N1 virus, warned that poultry farms in some parts of the world were using vaccines that did not provide full protection against the H5N1 and can't keep up with its mutation process. <br /><br />"The vaccine (used in Hong Kong) was made to fight an American strain of the H5N2, and it is very different from the Guangdong strain of the H5N1 virus here," he said. <br /><br />"When there were no outbreaks, we just assumed it was protective. Now that there is an outbreak (on a Hong Kong farm), we assume it is useless," he said. <br /><br />Since late November, the virus has infected two children in Indonesia, killing one of them. <br /><br />Earlier this week, it killed a 16-year-old girl in Egypt, too. And a youth in Cambodia tested positive for the virus after eating chicken. <br /><br />"The virus is definitely mutating," Guan said, warning that authorities in some areas were using batches of vaccine that may no longer be effective. <br /><br />Since 1997, when H5N1 was identified in Hong Kong, scientists have discovered 10 strains of the virus, which shows the speed and extent at which it is mutating, though it has not mutated to pass from human to human. <br /><br />The strain found in Indonesia, for example, is very different from the H5N1 strain in Europe, the Middle East and Africa. <br /><br />"There is a theoretical possibility that the strain being used in the vaccine is too different from the one circulating," said Albert Osterhaus, a leading virologist with Erasmus Medical Center in Rotterdam, the Netherlands. <br /><br />China Daily - AgenciesMBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-82287188835221599582008-12-18T12:25:00.000-05:002008-12-19T12:26:49.375-05:00Emergent BioSolutions Receives FDA approval for Supplemental Biologics License Application for BioThraxEmergent BioSolutions Receives FDA approval for Supplemental Biologics License Application for BioThrax - Quick Facts <br /><br />http://www.rttnews.com/Content/QuickFacts.aspx?Node=B1&Id=807804%20&Category=Quick%20Facts <br /><br />Emergent BioSolutions Inc. (EBS: News ) announced that FDA has approved its supplemental Biologics License Application or sBLA for Anthrax Vaccine Adsorbed or BioThrax to prevent disease caused by Bacillus anthracis. The approval for supplement license was based on an interim analysis of data from a large multicenter study initiated in 2002.<br /><br />The company said the supplement provides for a change in the route of administration and a reduction in the total number of vaccinations. The new schedule for BioThrax is five intramuscular doses at 0, 1, 6, 12 and 18 months, compared with the former schedule of six subcutaneous doses.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-1576287602677048792008-11-21T07:36:00.000-05:002008-11-25T07:56:06.939-05:00Gulf War Illness and the Health of Gulf War Veterans: Scientific Findings and RecommendationsGulf War Illness and the Health of Gulf War Veterans: Scientific Findings and Recommendations<br /><br />A major report on Gulf War Illness written by the VA Research Advisory Committee on Gulf War Veterans' Illnesses (RAC) was made public on November 17. This is the most important document available on Gulf War illnesses yet produced. About 1800 references are cited. The report gets it right about how many have developed the syndrome (25% of those deployed during 1990-1991) and the medical conditions they are experiencing. It emphasizes the desperate need for effective treatments to be developed and used in this population. The report also discusses a number of potential causes of the syndrome, and rules them in or out as significant factors in the report's executive summary.<br /><br />This report expands on many issues discussed in my September 2007 Senate Veterans Affairs testimony on Gulf War Syndrome. I discussed a greater number of soldiers' exposures (for several of which only limited evidence is available) that were not considered in this report. Overall, my testimony and this report agree on most areas.<br /><br />However, I weighed the existing evidence differently than the RAC did. Yet we both took a weight of evidence approach. How does one weigh evidence? Imho, it always involves subjectivity.<br /><br />I used an approach which gave more weight to researchers whose work appeared to be of higher quality, and to evidence derived from 3 or more different groups that used different study methods but yielded the same conclusion. I gave less weight to researchers whose work received substantial criticism, was not internally consistent, or used weak methodologies. I disregarded studies whose results conflicted with those of multiple other researchers. I factored in less tangible factors as well: how politicized choices led to certain research being performed (such as a large body of research favoring psychiatric causes, which was also dismissed by the report) while other valid research was omitted or buried. With respect to anthrax vaccine, in the face of limited and contradictory data we drew very different conclusions.<br /><br />From the Executive Summary: "About 150,000 Gulf War veterans are believed to have received one or two anthrax shots, most commonly troops who were in fixed support locations during the war. Although recent studies have demonstrated that the anthrax vaccine is highly reactogenic, there is no clear evidence from Gulf War studies that links the anthrax vaccine to Gulf War illness. Taken together, limited findings from Gulf War epidemiologic studies, the preferred administration to troops in support locations, and the lack of widespread multisymptom illness resulting from current deployments, combine to indicate that the anthrax vaccine is not a likely cause of Gulf War illness for most ill veterans. However, limited evidence from both animal research and Gulf War epidemiologic studies indicates that an association between Gulf War illness and receipt of a large number of vaccines cannot be ruled out.<br /><br />...There is little reliable information from Gulf War studies concerning an association of DU or anthrax vaccine to Gulf War illness. The prominence of both exposures in more recent deployments, in the absence of widespread unexplained illness, suggests these exposures are unlikely to have been major causes of Gulf War illness for the majority of affected veterans."<br /><br />Yet the RAC cited another study of self-reports indicating that approximately 300,000 GW veterans received anthrax vaccine. According to self-reports, the vaccine correlates highly with GWS. According to (only) DoD, most of these self-reports are wrong. But other studies indicate that self-reports in GW veterans are highly reliable. Four studies (presented by the RAC at meetings I attended) show that anthrax vaccine is correlated with GWS, with a relative risk of 1.5-1.92. A Senate report of 1995 noted that more veterans in support locations had developed GWS, a reason to suspect anthrax vaccine. Which report is correct on this point?<br /><br />Why are there limited findings from epidemiologic studies? The RAND report on vaccines, first completed in 1999 and later revised, is the only one of eight RAND reports on Gulf War exposures that has never been released. The two studies billed as investigating the long-term effects of the vaccine (the Tripler and CDC studies) have so far not released the long-term safety data. The Defense Medical Surveillance System data have been hidden since 2001, despite a promise to release quarterly analyses wrt anthrax vaccine. Why have eight expert groups during the last ten years called for long-term safety studies, but none are available? The reason is political.<br /><br />Due to lack of hard data, the report ignores the many soldiers since the Gulf War who received anthrax vaccine and developed an identical illness as GWS. It also seems to have ignored limited data that current OIF/OEF veterans are developing undiagnosed illnesses at a rate of 15-40%.<br /><br />Without these data, the RAC has drawn at least one insupportable conclusion.<br /><br />Meryl<br /><br />http://anthraxvaccine.blogspot.comMBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-34800042541099850222008-11-20T14:07:00.002-05:002008-11-20T14:17:24.481-05:00Sickening resultshttp://www.baltimoreexaminer.com/local/112008anthraxpart2.html#comments<br />By Deborah Rudacille<br />Examiner Correspondent 11/20/08 <br /><br />Editor’s note: This is the second of two parts. <br />Eddie Norman is only 43 years old, but he gets confused when he tries to remember important dates. The Fort Meade veteran walks with an old man’s shuffle and has twice experienced kidney failure. To combat this misery, he takes 13 pills a day.<br /><br />“What anthrax has done to me, I can’t put a number on,” he says. “It really destroyed me.”<br /><br />Norman is not a victim of the anthrax letter attacks of 2001. He is a casualty of the Army’s Anthrax Vaccine Immunization Program, instituted in 1998 to protect American troops from the threat of biological warfare. About 2.1 million troops have received the vaccine.<br /><br />The number of troops who have died, been disabled or suffered chronic health problems after receiving the vaccine easily eclipses the five dead and 17 sickened by the bio-terror attack that began just a week after the Sept. 11 attacks.<br /><br />Between 1998 and 2000, the first two years of the mandatory vaccination program, approximately 20,765 troops were hospitalized, according to vaccination data that the Pentagon long withheld from lawmakers. The illnesses ranged from systemic reactions such as numbness, joint pain and extreme fatigue to autoimmune diseases such as lupus, musculo-skeletal disorders and other chronic conditions.<br /><br />It is impossible to say with certainty how many have fallen ill after getting the shots because no one is keeping exact count.<br /><br />The Food and Drug Administration, however, has confirmed 21 deaths following anthrax vaccination, including Richard Dunn, an employee of the anthrax manufacturer — 16 more than the number of people killed in the letter attacks. <br /><br />The FDA does not say the troops died because of the vaccine, only that they died after taking the shots.<br /><br />A troubled program<br /><br />In the summer of 2001, the Department of Defense’s Anthrax Vaccine Immunization Program was on life support, with veterans, members of Congress and even high-level staff in the newly installed Bush administration all itching to pull the plug.<br /><br />Active duty military personnel risked court-martial and reservists resigned en masse rather than take the vaccine. According to a 2002 General Accounting Office study that interviewed about 1,200 troops, the reserves were bleeding air crews, as more than half of the 301st Air Squadron at Travis Air Force Base in California had quit or planned to resign rather than take the shots. An Air Guard unit in Connecticut lost a third of its pilots.<br /><br />Two-thirds of the Guard and Reserve pilots in that study told the GAO they did not support the vaccination program, and as many as 85 percent of those who received the shots said they had experienced side effects. Most admitted they had not reported their symptoms to medical personnel or supervisors for fear of being grounded.<br /><br />The Pentagon told the GAO that “several hundred” active duty personnel also had refused the vaccine.<br /><br />In April 2001, White House Deputy Chief of Staff Karl Rove sent a memo to Deputy Secretary of Defense Paul Wolfowitz that the anthrax vaccination program was “a political problem for us.”<br /><br />Four months later, Sen. Tom Daschle, D-S.D., wrote to Secretary of Defense Donald Rumsfeld challenging the program. A House of Representatives committee report already had recommended suspending the program because of its “experimental” status.<br /><br />In the midst of the turmoil, the FDA shut down the vaccine’s manufacturer, BioPort Corp. of Lansing, Mich., after citing the company with 84 violations in the manufacturing process. The touted Pentagon program was on the ropes.<br /><br />But by the fall of 2001, the anthrax attacks breathed new life into BioPort, as the vaccine was in demand not only by the military, but also by consumers, who suddenly were willing to roll up their sleeves. Eight years later, BioPort — now Rockville-based Emergent BioSolutions Inc. — has netted nearly $1 billion in government contracts to produce a vaccine that some biosafety experts call “antiquated.” <br /><br />Emergent Biosolutions spokeswoman Tracey Schmitt rebutted the allegations made by sick veterans who took the vaccine.<br /><br />“Biothrax, which is the only FDA-approved vaccine to prevent the infection of anthrax, has been studied more than just about any vaccine in the United States and has been deemed safe and effective,” said Schmitt, who noted that the Institute of Medicine of the National Academies found the vaccine safe and effective in its 2002 report.<br /><br />Last month, Secretary of Health and Human Services Michael Leavitt declared a seven-year “anthrax emergency,” contracting for another 14.5 million doses of the controversial vaccine for the civilian stockpile at a cost of about $404 million. Leavitt also extended blanket immunity from legal liability for anthrax vaccine-related injuries and deaths to Emergent as well as to government officials and agencies recommending use of its vaccine.<br /><br />“In the summer of 2001 we were on the verge of getting the entire program canceled,” says an Air Guard pilot whose commander forbids him from speaking publicly about the vaccine. “After the anthrax letter attacks, everyone looked the other way.”<br /><br />Shot down<br /><br />In 1988, Norman joined the Army and served in Operations Desert Shield and Desert Storm. He received numerous vaccinations while deployed overseas. Shortly after returning home, he got so sick that he had to be treated at the Gulf War clinic in El Paso, Texas.<br /><br />Nonetheless, he advanced from private first class to staff sergeant over the next decade. “I have a folder this thick, full of awards,” he says proudly. “That’s the kind of person I was.”<br /><br />After the implementation of AVIP in 1998, he underwent his second round of anthrax vaccinations and immediately experienced muscle pain and stiffness and ringing in his ears, which grew progressively worse with each shot.<br /><br />After the fourth shot, Norman says, he started suffering from tremors and involuntary muscle jerks. Following the fifth shot, “I couldn’t get myself out of the bathtub. I couldn’t get in and out of a car.”<br /><br />He was flown to the Walter Reed Vaccine Health Center and discharged from the Army three years later without ever returning to work. His request for a disability retirement was recently denied. “When I went into the military my goal was to retire from the military,” he says. “Anthrax stopped me. I want that on my record.”<br /><br />Capt. Kelli Donley’s military career also crash landed after she received the vaccine. Donley, of Beloit, Kan., joined the Air Force in October 1998 and received the first of three anthrax shots before being deployed to South Korea in 2000. Because the vaccine supply was low in the States, due to BioPort’s difficulties with the FDA, she received the other shots overseas from stockpiled supplies.<br /><br />Like many troops, Donley, a former military lawyer, had a localized reaction to the shots. “My entire right arm went numb,” she says.<br /><br />“They told me that was normal and that it would go away, and it did. But soon afterward, I started getting clumsy.”<br /><br />A few months after her last shot, she was gripped by an attack of vertigo and began slurring words. She sought help from a military doctor, but a thyroid test produced normal results, and no further tests were ordered.<br /><br />It was only after she returned to the States in 2003 that another military doctor ordered an MRI. “It confirmed that I wasn’t making it up.<br /><br />My cerebellum [that part of the brain that’s critical to coordination and motor control] had shrunk,” Donley says. A civilian neurologist diagnosed her disease as sporadic spinocerebellar ataxia, which occurs when various parts of the nervous system that control movement are damaged.<br /><br />Donley won a 100 percent disability retirement in 2006, after showing up with 238 pages of evidence. “My records were tight,” she says. “How many can say that?”<br /><br />Woodbridge, Va., resident Steve Fisher received shots before being deployed to the Persian Gulf in 1999. The former aircraft mechanic spent 26 years in the military and was stationed at McConnell Air Force Base in Wichita, Kan., when he was vaccinated.<br /><br />“After the first [shot], I got a big lump on my arm,” Fisher said. “After the second one, it swelled again, and I started having flu symptoms. After the third one, my arm swelled up like a peach, and I started having muscular problems, ringing in my ears, vertigo. I’d be walking, and I’d just fall over.”<br /><br />A base physician diagnosed chronic fatigue syndrome and fibromyalgia and sent him to be tested for allergenicity to the vaccine, he says. Without his consent, the technician, who was administering the test, gave him a fourth shot.<br /><br />“Then I got really sick,” he says. “I got lesions, lost my hair, couldn’t shake hands, couldn’t walk. For a while, I was worried that I would never walk again.”<br /><br />Nearly a decade after receiving his last dose of anthrax vaccine, Fisher still suffers from chronic fatigue syndrome, fibromyalgia, an eroded esophagus, asthma, tinnitus and other chronic conditions associated with the vaccine.<br /><br />“I wish I was an isolated case,” he says, “but I’m not.” Of the 150 men in his unit who got the shots, he says, “seven of us were completely disabled.”<br /><br />Passive surveillance<br /><br />Was the Pentagon aware of the serious health risks that came with the anthrax vaccine?<br /><br />“No question,” says D.A. Henderson, former dean of the Johns Hopkins School of Public Health and former chief of public health emergency preparedness. “There were a series of reports of very severe problems.”<br /><br />“We used to say that if we gave 10,000 people a glass of water, some number would get a rash and a headache,” says Henderson, who headed the World Health Organization’s campaign to eradicate smallpox through a mass vaccination in the 1970s. “The problem is, how do you sort this out and figure out what is attributable to the vaccine.”<br /><br />Serious reactions to any type of vaccination are supposed to be monitored through the Vaccine Adverse Events Reporting System, a “passive surveillance” system set up in 1990 to alert the Centers for Disease Control and Prevention and the FDA to potential health problems. Slightly fewer than 6,000 reports of adverse events following anthrax vaccination had been filed through July 2008, according to the FDA.<br /><br />However, servicemen and women treated in military clinics say clinic staff failed to file VAERS reports. Fisher filled out his own report and faxed it to the FDA, only to be reprimanded by a clerk at the clinic where he was being treated. “She said, ‘You shouldn’t have filled out that form. We’re supposed to do that.’ ”<br /><br />The same woman later admitted that she had not been sending in the forms. Fisher says she told him directly, “I was directed not to.”<br /><br />For years, the Pentagon limited the recording of vaccine events to reactions leading to either hospitalization or loss of 48 hours or more of duty time. The Pentagon also rejected a GAO recommendation in 2002 that it institute an active surveillance program to identify and monitor adverse events associated with the vaccine.<br /><br />Physicians at the Walter Reed Vaccine Health Center preparing letters for sick soldiers filing for disability will say only that their symptoms are “temporally related” to anthrax vaccination. Fisher, Donley and Norman all have copies.<br /><br />Scientists are fond of pointing out that correlation does not prove causality, and no study has yet proven a causal relationship between the vaccine and the more than 40 side effects reported on the product’s label. That may be because none of the agencies tasked with monitoring the vaccine’s safety has conducted a large epidemiological study of vaccine recipients.<br /><br />At this late date, even the mechanism by which the vaccine creates immunity is not well understood, says George Mason University professor Serguei Popov. “The vaccine is a very crude precipitate,” he says, “a kind of complex biological soup that contains some protective antigen,” together with proteins and “a certain amount of toxins.” <br /><br />Popov says that he is suspicious of the vaccine not just because of the health problems reported by veterans, but because it requires so many shots to build and maintain immunity. “Six shots in a year,” he points out. “It’s ridiculous.”<br /><br />Go to "Scientific impossibility: Did FBI get their man in Bruce Ivins?" for Part I of this seriesMBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-55627868148967125402008-11-20T09:00:00.000-05:002008-11-25T09:08:29.594-05:00Costly program with a shady pastCostly program with a shady past<br />http://www.baltimoreexaminer.com/local/112008anthrax.html <br />By Deborah Rudacille<br />Examiner Correspondent 11/20/08 <br /><br />Bacillus anthracis vegetative cells and spores are pictured in this undated photomicrograph from the official U.S. Department of Defense anthrax information Web Site. <br /><br />Anthrax is an infectious disease caused by the spore-forming bacteria Bacillus anthracis. <br /><br />The FBI on Monday, Oct. 8, 2001, took over the investigation into the anthrax death of a Florida man after the germ was found in the nose of a co-worker and on a computer keyboard in their office. <br /><br />Anthrax Vaccine Immunization Program <br /><br />The Food and Drug Administration licensed Anthrax Vaccine Adsorbed in 1970, based on a 1950s study of textile mill workers who processed imported goat hair. Each year, several mill workers contracted anthrax, a disease that humans get by touching, breathing or ingesting the pathogen bacillus anthracis from infected animals. <br /><br />Of the 400 vaccinated workers, three contracted anthrax, and all of them developed cutaneous anthrax, a skin infection that is rarely fatal if treated with antibiotics. <br /><br />The FDA then approved AVA as safe and effective against cutaneous anthrax. <br /><br />When anthrax is inhaled, however, its spores germinate in the lungs, releasing toxins that cause internal bleeding and death. <br /><br />For nearly two decades, scientists studying B. anthracis in biodefense programs — like the one at Fort Detrick in Frederick — received the vaccine that the Michigan State Department of Public Health produced under contract to the Pentagon. <br /><br />During the first Gulf War the fear of billowing clouds of weaponized anthrax engulfing U.S. troops led to mass immunization. About 150,000 troops received AVA in 1990-91, although the vaccine had never been licensed by the FDA for that purpose. <br /><br />“There were those who were against it and who made a great fuss about this being an experimental vaccine,” says D.A. Henderson, former chief of the Office of Public Health Emergency Preparedness. <br /><br />“But it was the only vaccine we had.” <br /><br />In 1998, the Pentagon mandated all active duty and reserve troops to receive the shots. <br /><br />That same year BioPort Corp. bought the Michigan plant and the state’s license to manufacture AVA. The newly formed company was facilitated by the late Adm. William Crowe, former chairman of the Joint Chiefs of Staff under Presidents Reagan and George H.W. Bush. <br /><br />Crowe was friendly with Fuad al-Hibri, the Lebanese-German businessman who became a naturalized American citizen while bidding for the vaccine production facility. <br /><br />With a limited stockpile, BioPort secured a $45.1 million contract with the Pentagon to ramp up production of a new vaccine, with $16 million upfront for renovations to the aging Michigan facility. <br /><br />Despite the gush of cash, from 1999 through 2001 the company failed a series of FDA inspections and failed to ship a single dose of new vaccine. The new product also failed potency tests, but the contract signed with BioPort obliged the Pentagon to pay for the unusable product. <br /><br />The cost was steep: $10.64 per dose versus the previous price of $4.36 per dose under Michigan’s ownership. <br /><br />With supplies short, the government then injected troops with the old vaccine. Some troops developed symptoms similar to those of Desert Storm veterans suffering from the mysterious collection of maladies lumped together as “Gulf War syndrome.” <br /><br />In April 2000, the Department of Defense assigned a team of anthrax researchers from the Army Medical Research Institute for Infectious Diseases in Frederick to work on BioPort’s vaccine. The team included Bruce E. Ivins, who, with two of his colleagues, was awarded the Decoration for Exceptional Civilian Service for the role they played in getting production moving again. <br /><br />Ivins’ job was enhancing the potency of the formulation. <br /><br />The FBI later accused Ivins of salvaging the program by creating “a situation, a scenario, where people all of a sudden realize the need to have this vaccine.” <br /><br />That “situation” was the anthrax letter attacks of 2001, which killed five people and sickened at least 17 others. <br /><br />Sen. Tom Daschle, D.-S.D., received one of the anthrax-loaded letters, nearly two months after he wrote to Secretary of Defense Donald Rumsfeld challenging the vaccination program and punishment of soldiers rejecting the anthrax vaccine. <br /><br />The FBI insists Ivins sent the letter, even though several leading scientists say it would have been impossible for Ivins, who died this past July 28 after overdosing on prescription Tylenol, to have committed the crime. (Read Part I of this series at baltimoreexaminer.com.) <br /><br />“The case is solved. We are 100 percent sure that Dr. Ivins was the sole perpetrator of the anthrax mailings,” said FBI spokeswoman Debbie Weierman. <br /><br />While doubt about Ivins’ guilt lingers in the science community, there is strong evidence the attacks saved the program. <br /><br />Three months after the attacks, the FDA relicensed BioPort’s Michigan plant, and by the end of 2003, the company (now Emergent BioSolutions Inc.) signed a new $245 million contract with the Pentagon. The next year the company built a $95 million anthrax vaccine plant in Frederick and secured a $122.7 million contract from the Department of Health and Human Services to provide five million doses of the vaccine for civilian use in the event of an emergency. <br /><br />In December 2005, the FDA issued a final order declaring the vaccine (now called BioThrax) safe and effective for use against inhalation anthrax. <br /><br />To date, no enemy has assaulted U.S. troops overseas with anthrax.<br /><br />Anthrax vaccine timeline <br /><br />» February 1998 — Michigan Biologics Products Institute halts production of anthrax vaccine to renovate facility after stockpiled vaccine fails Food and Drug Administration tests for potency and contamination. <br /><br />» September 1998 — Facility and license sold to BioPort Corporation for $25 million and $7.9 million of stockpiled vaccine. BioPort signs a Pentagon contract for $45 million worth of vaccine, including $16 million in immediate cash for renovations. FDA suspends shipments from the facility because of quality-control problems. <br /><br />» September 1999 — Pentagon approves a $24.1 million bailout of the new company after the facility fails FDA inspections. <br /><br />» April 2000 — Bruce Ivins is appointed to the Anthrax Potency Integrated Product Team from the U.S. Army Medical Research Institute of Infectious Diseases assigned to assist BioPort. <br /><br />» July 2000 — Pentagon curtails vaccine program because of supply problems. Committee on Government Reform recommends suspension of anthrax vaccination program. <br /><br />» April 2001— White House Chief of Staff Karl Rove concedes to Deputy Defense Secretary Paul Wolfowitz that AVIP is a “political problem.” <br /><br />» June 2001 — Sen. Tom Daschle (D-SD) and Rep. Richard Gephardt (D-Mo.) write to Defense Secretary Donald Rumsfeld challenging AVIP. <br /><br />» August 2001 — Two undersecretaries of defense recommend minimizing use of the vaccine. <br /><br />» September 2001 — Chairman of the Joint Chiefs of Staff Gen. Henry H. Shelton rejects the recommendation, insisting that AVIP is the centerpiece of a bio-defense program. <br /><br />» September, October 2001 — Anthrax letters mailed, killing five and sickening 17. Daschle receives one of the letters. <br /><br />» January 2001 — FDA approves BioPort license to manufacture and distribute anthrax vaccine under new trade name BioThrax. <br /><br />» June 2002 — Pentagon restarts AVIP. All military personnel required to receive anthrax vaccinations in run-up to Iraq war. <br /><br />» March 2003 — Ivins wins award for work on BioPort’s vaccine. <br /><br />» November 2004 — VaxGen of San Francisco awarded a contract to produce 75 million doses of next-generation anthrax vaccine, for which Ivins holds two patents. <br /><br />» October 2004 — U.S. District Judge Emmett Sullivan suspends AVIP, ruling troops cannot be forced to comply with mandatory vaccination. <br /><br />» May 2005 — Pentagon appeals judge’s order, seeks to resume mandatory vaccinations. <br /><br />» May 2006 — Government Accountability Office report says vaccine has not been adequately tested on humans, long-term safety has not been studied and data on short-term reactions is limited. <br /><br />» October 2006 — Pentagon begins voluntary vaccination program for select personnel. <br /><br />» December 2006 — VaxGen’s contract for new vaccine canceled after it misses clinical trial deadline. <br /><br />» February 2007 — Pentagon resumes mandatory vaccination of select troops. <br /><br />» May 5, 2008 — Emergent BioSolutions Inc. (formerly BioPort) buys rights to VaxGen vaccine. <br /><br />» July 29, 2008 — Ivins commits suicide. <br /><br />» August 2008 — Ivins is fingered as culprit in anthrax attacks. FBI says he was concerned that Congress would end the vaccine program. <br /><br />» September 2008 — PharmaThene Inc. of Annapolis and Emergent win government vaccine contracts worth more than $1 billion; Rep. Rush Holt, D-N.J., proposes a bipartisan commission to investigate the anthrax attacks and the government's response and investigation. <br /><br />» Oct. 1, 2008 — Emergent wins second order from Department of Health and Human Services for 14.5 million doses of BioThrax worth $404 million. <br /><br />» Oct. 9, 2008 — Emergent shielded from lawsuits related to anthrax vaccine by Department of Health and Human Services.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-82491923790949953242008-11-16T07:56:00.001-05:002008-11-25T08:59:38.564-05:00Scientific impossibility: Did FBI get their man in Bruce Ivins?http://www.baltimoreexaminer.com/local/crime/Scientific_impossibility.html<br /><br />Scientific impossibility: Did FBI get their man in Bruce Ivins?<br />By Deborah Rudacille<br />Examiner Correspondent 11/16/08 <br /><br />Bruce Ivins was a cold-blooded murderer, a deranged psycho-killer, who in the fall of 2001, cooked up a virulent batch of powdered anthrax, drove to Princeton, N.J., and mailed letters loaded with the lethal mix to five news organizations and two U.S. senators. <br /><br />At least, that’s what the FBI says. <br /><br />Frederick Police talk with a woman who they identified as Diane Ivins, the widow of Bruce E. Ivins, 62, who died of an apparent overdose of prescription Tylenol mixed with codeine, at their home, Friday, Aug. 1, 2008, in Frederick, Md. <br /><br />The letters infected 22 people, killing five, including two Maryland postal workers. <br /><br />The sixth victim of the madness was Ivins himself, a 62-year-old biodefense researcher at the U.S. Army Medical Research Institute of Infectious Diseases, who committed suicide rather than face charges. <br /><br />Case closed? Neatly wrapped up? Not so fast. <br /><br />Married for 33 years — and a father of two — with a 35-year career as a civilian microbiologist at Fort Detrick in Frederick, Ivins, a devout Catholic, worked as a senior research scientist and an expert in animal models of anthrax. In 2003 he received the Army’s Decoration for Exceptional Civilian Service for work on an anthrax vaccine — an assignment the FBI now says provided a motive for the attacks. <br /><br />Ivins apparently was obsessed with the investigation. According to the FBI, on Sept. 7, 2007, he sent an e-mail to himself, claiming to have figured out who mailed the anthrax letters. “I should have it TOTALLY nailed down within the month,” he wrote. “I should have been a private eye.” <br /><br />Ivins, who did not name anyone in the e-mail, died on July 29, 2008, at Frederick Memorial Hospital after overdosing on prescription Tylenol with codeine. The FBI says he killed himself. The presence of the drug was determined from a blood sample. No autopsy was ordered. <br /><br />Before his death, he was under 24-hour police surveillance, which included interrogations about his research and work habits, searches of his home and office, and intense questioning of family members and co-workers. Friends say that the FBI offered Ivins’ son $2.5 million and a sports car to hand over evidence implicating his father in the attacks. <br /><br />The month before Ivins’ death, the federal government agreed to pay $5.8 million to another former Fort Detrick researcher, Steven Hatfill, for “improperly identifying him as a suspect in the case.” <br /><br />When he learned the FBI was going to charge him with the crime after clearing Hatfill, Ivins swallowed a bottle of Tylenol. <br /><br />Rush to judgment<br /><br />In exclusive interviews with The Examiner, two former directors of the bacteriology division at Fort Detrick challenged the science underlying the case against Ivins. They argue it would have been impossible for Ivins to have produced the powdered anthrax in the contaminated letters in the time frame proposed by the FBI — the two weeks following the attacks on the World Trade Center and Pentagon on Sept. 11, 2001<br /><br />. The BSL-3 (biosafety level 3) suite where Ivins worked at the Institute was composed of a series of laboratories and an office where access was restricted to trained personnel who were required to log in and out. <br /><br />“Knowing the layout of the BSL-3 suite, the implication that Bruce could have whipped out [anthrax mixture] in a couple of weeks without detection is ridiculous,” says Gerald P. Andrews, director of the bacteriology division and Ivins’ supervisor from 2000 to 2003. <br /><br />The first anthrax letters were mailed to the New York offices of ABC, NBC and CBS, the New York Post and the National Inquirer in Boca Raton, Fla., on Sept. 18, 2001. The second letters were mailed to Sens. Tom Daschle (D-S.D.) and Patrick Leahy (D-Vt.) on Oct. 9. <br /><br />Infectious disease specialist W. Russell Byrne, who preceded Andrews as the division’s director, said he “never believed Ivins’ could have produced the preparations used in the anthrax letters working in the bacteriology division area of Building 1425.” <br /><br />Departmental policy prohibits Institute employees from speaking with the media. But one researcher, speaking anonymously, told The Examiner: “It would have been impossible for Ivins to have grown, purified and loaded the amount of material in the letters in just six days. It simply could not be done.” <br /><br />Claire Fraser-Liggett, professor at the University of Maryland School of Medicine and director of the University of Maryland Institute for Genome Sciences, asked, “What would have happened in this investigation had Dr. Hatfill not been so forceful in his response to being named a person of interest. What if he, instead of fighting back, had committed suicide because of the pressure? Would that have been the end of the investigation?” <br /><br />The smoking flask<br /><br />Fraser-Liggett’s genetic analysis of the anthrax spores in the letters led to a flask of hybrid anthrax bacillus (known as RMR-1029) created and managed by Ivins at Fort Detrick — a preparation the Justice Department says is the murder weapon. <br /><br />“The key breakthrough was the science that then focused their attention laserlike onto that flask and the person who had control of that flask and the person who made the spores in that flask,” U.S. Attorney Jeffrey Taylor claimed in laying out the evidence against Ivins on Aug. 6, 2008. <br /><br />The DNA evidence linking the dry anthrax spores in the contaminated letters to the “wet” anthrax spores in the flask of RMR-1029 is not in dispute. “The part that seems still hotly debated is whether there was sufficient evidence to name Dr. Ivins as the perpetrator,” Fraser-Liggett says. <br /><br />Ivins kept the one-liter flask of RMR-1029, but some 300 people within the Institute also had access to the flask, according to those familiar with operations there. Before 1999, the preparation was stored in a separate containment area, about 100 yards from the main building. At that time, “access was more vague, because the flask wasn’t under Ivins’ direct custodial control,” Andrews says. <br /><br />Ivins also shared samples of RMR-1029 with researchers at other facilities. <br /><br />“Another lab might take a couple of milliliters of that spore preparation and create a daughter preparation,” Andrews says. “How many [samples] Ivins gave out I have no idea, but he did it through official channels, and there is a chain of custody records that indicates which labs got RMR-1029 and how much of the material they got.” <br /><br />It was those “daughter preps” that ultimately led Fraser-Liggett to Ivins’ flask. Her team at the Institute for Genomic Research began DNA sequencing of the spores in the four anthrax-loaded letters recovered after the 2001 attacks. The team spent two years analyzing 20 different samples of B. anthracis to create a group of tests capable of genetically fingering the distinctive variety of anthrax found in the letters. <br /><br />They screened nearly 1,000 samples of B. anthracis collected from labs around the world. “The results identified only eight samples that contained all four of the genetic mutations,” she says. “Each of those could be traced back to this one flask at USARMRIID-RMR-1029.” <br /><br />“I have complete confidence in the accuracy of our data,” Fraser-Liggett says, but she concedes it fails to prove Ivins is guilty. <br /><br />One reason for doubt is the sheer volume of powdered anthrax Ivins is alleged to have grown. Nearly 1 gram per contaminated letter would have required months of intensive labor and hundreds of agar “plates,” on which the spores are grown, Byrne says. <br /><br />“This number of plates is impossible to handle inconspicuously,” says George Mason University professor and former Soviet bioweapons researcher Sergei Popov. <br /><br />“It would be impossible to cover up these activities.” <br /><br />Prosecutors insist Ivins carried out the work secretly at night and on weekends. <br /><br />That scenario is patently impossible, Andrews says. “You can’t just throw a flask up in the air and have dry weaponized spores come down. One preparation may take between three and five days — Day 1 to prepare the materials and start seed cultures, Day 2 to inoculate the spores, Day 3 to harvest, centrifuge and purify the spores. And those are the wet spores,” he says, which then need to be dried into a powder. And that would take at least another day. <br /><br />“So for 10 envelopes, 100 preparations would be required to make all the mailed material at three to five days for each preparation,” he says. “Months of continuous spore preparation without doing any other work and avoiding detection? It’s ridiculous.” <br /><br />Taylor also insists Ivins had access to a lyophilizer — a sophisticated machine used to dry anthrax. <br /><br />Andrews mocks the suggestion that Ivins produced the fine powdered anthrax by freeze-drying the newly harvested pores in the lab’s lyophylizer. “The only lyophylizer available was a speed vac,” he says. “That’s a low-volume instrument that you can’t even fit under a hood” used to contain toxic vapors and debris. <br /><br />Even with the proper equipment, mass producing a sufficient volume of spores remained dangerous. It had the potential to contaminate not only the person doing the work, but also the lab environment. “Certainly if you had makeshift equipment you wouldn’t be able to pull it off without making a mess,” Andrews says. <br /><br />Popov said that the only way the FBI scenario works is if someone else provided the spores to Ivins. “What if somebody fermented the spores for him?” he asks. “What’s in favor of this hypothesis is the presence of silica in the spores. This is a signature of a large-scale fermentation process.” In other words, the evidence points to a high-volume, mechanized operation and not to a lone madman cackling over agar plates at night in an empty lab. <br /><br />Lack of evidence<br /><br />The anthrax-laced letters contained no traces of DNA. There is no evidence indicating Ivins visited Princeton, N.J., at the time the letters were mailed — no fingerprints or hair samples from the “smoking mailbox,” no time-stamped photos at New Jersey automated teller machines or convenience stores, no gas receipts. <br /><br />Apart from the flask of RMR-1029, the case against Ivins is this: He was depressed, working long nights and weekends in September 2001, and had the time to drive to New Jersey. <br /><br />Ivins’ therapist, Jean Duley, who had a history of drug and alcohol-related charges, treated him for six months. She told authorities he threatened to kill her and his co-workers after learning he faced indictment. He was committed for a few days and released five days before his death. <br /><br />“Dr. Ivins had a history of mental health problems and was facing a difficult time professionally in the summer and fall of 2001 because an anthrax vaccine he was working on was failing,” Taylor said in August. “He was very concerned, according to the evidence, that the vaccination program he was working on may come to an end.” <br /><br />For more than a year, Ivins and other institute researchers had been working out the kinks on a 30-year-old anthrax vaccine suspected of causing serious health problems in Gulf War vets. He also was working on a next-generation vaccine for which he already had secured two patents. But in the fall of 2001, the Pentagon’s vaccine program for 2.4 million troops faced fierce opposition by lawmakers — including Daschle, pushing to end the program. <br /><br />Taylor insists Ivins was the “sole culprit” and wanted “to create a situation, where people all of a sudden realized the need to have this vaccine.” <br /><br />If that was indeed the anthrax killer’s motive, it worked. <br /><br />Ivins’ innocence could rest on weird science<br /><br />The single most important piece of scientific evidence that raises doubt on whether Bruce Ivins was the mastermind behind the anthrax attacks could very well prove his innocence. <br /><br />The high silicon content of the spores and the presence of a bacterium B. subtilis in two of the recovered letters are significant scientific factors that have yet to be satisfactorily explained. <br /><br />The FBI says that the silicon in the spores accumulated naturally during the growth process — important to its case against Ivins, who co-workers say did not have knowledge of the specialized techniques used to weaponize anthrax spores by coating them in silicon. <br /><br />Silicon creates an electrostatic charge between particles that helps the lethal powder disperse more readily. <br /><br />“The silicon is probably the most important scientific evidence that would lead anybody to question whether Bruce was capable of making these spores,” says Gerald P. Andrews, Ivins’ former boss. <br /><br />Andrews and George Mason University professor and former Soviet bioweapons researcher Sergei Popov believe the silicon was purposely added, due to unnaturally high levels of the mineral in the spores. <br /><br />Also unexplained is the presence of a unique genetic strain of the bacterium B. subtilis in the anthrax letters. <br /><br />“Why wasn’t this unique B. subtilis strain looked for in Bruce’s lab — or any other lab in the BSL-3 suite?” Andrews asks. “It may, in fact, serve as a marker for where those preparations were really made.” <br /><br />So far, FBI scientists have failed to produce a powdered anthrax equivalent to the toxic mix that Ivins is alleged to have turned out in the course of a few late nights and weekends in the lab at Fort Detrick. <br /><br />“The only opinions that I would place any confidence in would have to come from individuals who have made the stuff, in the same quantity of the letters,” said infectious disease specialist W. Russell Byrne. “And then I would ask them to go into B3 in building 1425, work there for a couple of weeks and reproduce what they say Bruce did. That’s the only way I could, in good conscience and in the spirit of objective scientific inquiry, believe them.”<br /> <br /> <br />Bruce Edwards Ivins<br />• Born: April 22, 1946 in Lebanon, Ohio.<br />• Died: July 29, 2008 in Frederick, Md.<br />• Family: Married for 33 years to Diane Ivins (homemaker, day care provider and former president of Frederick County’s Right to Life). Two grown children, Andrew and Amanda<br />• Work: Senior biodefense researcher at the United States Army Medical Institute of Infectious Diseases at Fort Detrick in Frederick<br />• Education: B.A. (1968); M.A. (1971) and Ph.D. (1976) in microbiology, University of Cincinnati<br />• Hobbies: Played keyboards and sang in a folk group at St. John the Evangelist Catholic Church in Frederick; founded the Frederick • Jugglers, who performed at nursing homes, schools and festivals.<br />• Volunteer work: Frederick County Chapter of American Red Cross<br />• Political party: DemocratMBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-32022894227120133242008-11-05T07:29:00.000-05:002008-11-07T07:30:11.970-05:00Vaccinations Against Bird Flu Should Happen Now, Say ExpertsThe report says that if pre-priming with an H5N1 vaccine becomes an acceptable strategy, thought should be given to including this in the regular seasonal flu vaccines. <br /><br />The experts say that although it is still unclear if a bird flu pandemic will emerge, because of the potential high death rate and huge economic cost "we simply cannot afford to ignore it as a major global threat." They point out that estimates of global deaths from bird flu have suggested that up to 350 million people could die. <br /><br />The candidate vaccine contains the bird flu strain H5N1 and an adjuvant called MF59.<br /><br />He added: "If governments are thinking about stockpiling vaccine, you could actually be stockpiling it in people's arms." <br /><br /> <br /><br />http://www.medicalnewstoday.com/articles/128049.php<br /><br />Vaccinations Against Bird Flu Should Happen Now, Say Experts<br /><br />People should be vaccinated now against bird flu rather than waiting for a global pandemic to erupt, an international panel of experts - including a leading British influenza specialist - say in a new report. 1<br /><br />The influenza researchers say the World Health Organisation (WHO) and national governments should give "urgent consideration" to the idea of priming people in advance of bird flu with a preparatory vaccination. <br /><br />The idea is to give people a vaccination now against bird flu to build up the immune system, while there is still plenty of time to organise the programme, then give them a booster shot when the pandemic is imminent. The primed people could be protected in a week as opposed to six weeks. 2<br /><br />The experts, including Professor Karl Nicholson, from Leicester University, state: "We think that WHO and governments should give urgent consideration to the potential risks and benefits of priming people who would be at greatest risk of infection if a pandemic of H5N1 influenza were to emerge (frontline laboratory and health-care workers), with the view to cautiously introducing a programme of immunisation." <br /><br />In a report in the latest edition of the journal Lancet Infectious Diseases the researchers point out that a conventional vaccination policy against bird flu requires two doses of H5N1 vaccine before people are protected "which may be logistically difficult to organise". <br /><br />They say there may be no warning before a pandemic suddenly appears, as the early danger signs may be missed. <br /><br />"However, pre-pandemic priming has the potential to evoke a more rapid antibody (defence cell) response that might ameliorate the disease, cutting hospital admissions, deaths, and onward transmission of the virus," say the doctors. <br /><br />The report says that if pre-priming with an H5N1 vaccine becomes an acceptable strategy, thought should be given to including this in the regular seasonal flu vaccines. <br /><br />The experts say that although it is still unclear if a bird flu pandemic will emerge, because of the potential high death rate and huge economic cost "we simply cannot afford to ignore it as a major global threat." They point out that estimates of global deaths from bird flu have suggested that up to 350 million people could die. <br /><br />The report concludes: "The maximum benefit from using a pre-pandemic vaccine may be gained from priming populations before there is evidence of a novel virus emerging and spreading, when systematic supply, distribution and vaccination strategies can be put in place." <br /><br />Just a few weeks ago a team of researchers from Leicester University, including Professor Nicholson, together with vaccination experts from the Health Protection Agency, gave details of a British study showing that pre-priming people could give protection against bird flu within a week. 2<br /><br />That study, released in a letter to the New England Journal of Medicine, looked at an experimental pre-pandemic vaccine being developed by Novartis Vaccines. <br /><br />The candidate vaccine contains the bird flu strain H5N1 and an adjuvant called MF59. (An adjuvant is a substance used to improve the response of the immune system to a vaccine.) <br /><br />The study looked at how quickly people mounted a protective immune response against H5N1 if they had already been pre-vaccinated with a different kind of flu vaccine, using a strain known as H5N3 together with MF59. <br /><br />The pre-vaccinated people received their first vaccination between 1999 and 2001 as part of earlier studies. <br /><br />Two groups, involving around 60 British patients, were involved in the study - one set who had been pre-vaccinated and another set that had not. <br /><br />By day seven 80% of the primed group showed a protective response after one shot of the adjuvanted vaccine compared to 20% in the un-primed group. <br /><br />Study investigator Dr Iain Stephenson, from University Hospitals Leicester, said: "With the pre-priming approach you could choose certain groups in advance, for instance health care workers, and almost vaccinate at leisure. Then you would only a need a week to provide protection." <br /><br />The New England Journal of Medicine study was welcomed by other flu experts. <br /><br />Dr John Wood, from the National Institute for Biological Standards and Control, a government funded body which helps in the production and testing of vaccines for emerging flu strains, told the BBC: "The fact that they seem to have this protection after eight years is really interesting." <br /><br />He added: "If governments are thinking about stockpiling vaccine, you could actually be stockpiling it in people's arms." <br /><br />An influenza pandemic occurs when a new influenza strain emerges (one to which humans have no immunity), mutates and spreads globally as a virus. Although it is not possible to predict the actual pandemic influenza strain, global health authorities have identified H5N1 avian influenza as a strain with the greatest pandemic potential in humans. 3 <br /><br />H5N1 is currently circulating in birds and has caused serious illness in more than 380 people worldwide with a mortality rate, among people known to have been infected, of greater than 60 percent. 4. <br /><br />The purpose of pre-pandemic vaccination is to prime the immune system to better defend against infections from an H5N1 influenza virus and is intended for use before the World Health Organization (WHO) declares an influenza pandemic. <br /><br />MF59 is used in a vaccine against seasonal flu specially designed for older people who have weaker immune systems so do not respond so well to traditional vaccines, although this particular vaccine is not currently available in the UK. More than 40 million doses have been distributed worldwide since 1997. 5<br /><br />References <br /><br />1 Jennings LC et al. Stockpiling prepandemic influenza vaccines: a new cornerstone of pandemic preparedness plans. Lancet Infectious Diseases 2008; 8: 650-658<br /><br />2. Stephenson I et al. Antigenically distinct MF59-adjuvanted vaccine to boost immunity to H5N1. New England Journal of Medicine 2008; October 9: 1631-1633<br /><br />3. World Health Organization Avian influenza H5N1 infection in humans, WHO Web site: http://www.who.int/csr/don/2004_01_22/en/index.html, accessed August 22, 2008 <br /><br />4. World Health Organization Cumulative Number of Confirmed Human Cases of Avian Influenza, WHO Web site, accessed August 19, 2008 <br /><br />5. Company data on file. <br /><br />Source<br /><br />Zarina Baloch<br />Public Relations Department <br />Novartis Vaccines and Diagnostics UK<br />Frimley Business Park<br />Frimley, Camberley, Surrey GU16 7SR<br />United Kingdom<br />http://www.novartis.comMBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-65534451162905389972008-10-31T07:58:00.000-05:002008-11-07T07:59:31.297-05:00Panel OKs Anthrax Shots for First RespondersVolume 322, Number 5902, Issue of 31 October 2008<br />©2008 by The American Association for the Advancement of Science.<br /><br />Panel OKs Anthrax Shots for First Responders<br /><br />A U.S. scientific panel thinks that police, firefighters, people who work with hazardous materials, and others running the risk of exposure to an anthrax infection may be offered the vaccine against the fatal disease. That suggestion, from an advisory panel to the U.S. Centers for Disease Control and Prevention (CDC), is a departure from current policies.<br /><br />Anthrax vaccination is compulsory for military personnel serving in risk areas overseas. Although most experts believe the vaccine--six shots over a period of 18 months--is safe, some service members believe it has made them ill, and some have filed lawsuits. Relying on new safety data, CDC's Advisory Committee on Immunization Practices agreed on 22 October that first-responder agencies "may choose to offer" their staff the vaccines on a voluntary basis--but it stopped short of recommending they do so.<br /><br />That caution reflects the panel's inability to assess the risk of future attacks, says the committee's chair, Dale Morse, who adds that the job site and duties affect a worker's risk of contracting anthrax as well. "We believe it's very low, but we can't say it's zero," Morse says. Meryl Nass, an internist at Mount Desert Island Hospital in Bar Harbor, Maine, who strongly opposes the military program, believes the recommendations will put more people at risk for adverse events. No first responders became infected during the 2001 anthrax letter attacks, which killed five people.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-48846694325246484752008-10-19T08:51:00.000-05:002008-10-20T08:52:42.194-05:00PREPA - and what this means to youOctober 17, 2008<br /><br />The Public Readiness and Emergency Preparedness Act (PREPA) has reared its ugly head again in the wake of Mike Leavitt, Secretary of the Department of Health and Human Services (DHHS) declaring a seven-year anthrax emergency through the end of 2015.<br /><br />PREPA goes beyond the anthrax vaccine and it is imperative all Americans, military or not, understand what our government has done to us. PREPA, which is completely unconstitutional, will be discussed further below.<br /><br />First, let’s focus on the Anthrax vaccine.<br /><br />Anthrax<br /><br />A declaration of an anthrax emergency for seven years is another case by this administration of the “Boy who Cried Wolf”. The Advisory Committee on Immunization Practices (ACIP), an advisory to the CDC regarding vaccinations, are poised to meet and vote on October 22nd, 2008, to expand the anthrax vaccine to civilians.<br /><br />The latest study conducted by the CDC published October 1st, 2008 and reported in a JAMA article consisted of 1,564 subjects. The report barely mentions the adverse events implying that the vaccine is safe, but in fact, 229 severe adverse events and 7 deaths occurred during this trial. For further information on serious adverse events reported following receipt of the anthrax vaccine, one need not look further than the product label, pages 5-6. http://bioport.com/pdf/emergent_biothrax_us.pdf<br /><br />The declaration of an anthrax emergency, through PREPA, has been invoked as an attempt to push the anthrax vaccine on an unsuspecting public, while single-handedly perform tort reform for the anthrax vaccine in the absence of legislative approval, because the administration knows that there will be injuries. The emergency declaration for the anthrax vaccine is disastrous for Americans, but it is sure sweet for the manufacturer, Emergent Biosolutions, aka: Bioport. Mike Leavitt contracted to buy an additional $400 million worth of anthrax vaccine to add to the current $500 million currently in the nation’s stockpile. It is unclear how, or even if, the current stockpile is still valid given that the shelf-life for the vaccine has expired, but we at least know according to the GAO that 12 months ago, $100 million worth of vaccine was lost due to expiration at the taxpayer’s expense.<br /><br />Interestingly enough, in the October 6th, 2008, Federal register; Mike Leavitt also gives blanket immunity for liability for use of the anthrax vaccine (and anthrax countermeasures) to not only the manufacturer, but specifically giving government officials immunity for even recommending the anthrax vaccine, should injuries or deaths result from a recipient. (http://edocket.access.gpo.gov/2008/E8-23547.htm)<br /> <br />"Whereas, immunity under section 319-F3(a) of the Act should be available to governmental program planners for distribution of covered countermeasures..." <br /><br /><br />Diseases/Vaccinations<br /><br />PREPA (which will be addressed below) gives the Department of Health and Human Services, Secretary (currently Mike Leavitt) the authority to declare any disease an act of emergency. <br /><br />The latest measles outbreak which was deemed an “epidemic” consisted of approximately 131 cases in the United States of America out of a population of more than 300,000,000. (By the way, no deaths occurred from this “epidemic”). According to PREPA, the Secretary of DHHS could have declared this to be an emergency, utilizing mass vaccinations. Unless a person who suffered an injury could have “proven” the injury resulted from the vaccination (a near impossible task), no compensation could be received and no one held accountable. <br /><br />Taken in part from a news article regarding PREPA and using vaccinations/drugs on American citizens in a “state of emergency”: (it should also be noted it wouldn’t matter if these drugs/vaccines were approved by the FDA or not)<br /><br />“But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with consumer groups such as Public Citizen, derided the liability provision as a giveaway to the drug industry. Kennedy said the bill makes it "essentially impossible" for injured parties to sue for damages. He also argued that the measure allows the HHS secretary to use many common diseases as a reason to activate the liability shield. "Without a real compensation program, the liability protection in the defense bill provides a Christmas present to the drug industry and bag of coal to everyday Americans," stated a Dec 21 <br />news release issued by Kennedy and Sens. Tom Harkin, D-Iowa, and Chris Dodd,<br />D-Conn.”<br /><br />Public Readiness and Emergency Preparedness Act (PREPA)<br /><br />PREPA was passed by Congress and signed into law on December 30, 2005. Probably few in Congress read it before approving it along with defense spending. You can read the bill at: <br />ftp://ftp.hrsa.gov/countermeasurescomp/Public_Readiness_and_Emergency_Preparedness_Act.pdf<br /><br />The original bill under which Secretary Leavitt made his Declaration, the Public Readiness and Emergency Preparedness Act (PREPA, part of P.L. 109-148) gave the DHHS Secretary the right to declare any disease an emergency, triggering immunity from liability for any and all injuries due to countermeasures for that illness, unless "willful misconduct" by those who made or administered the product could be proven. The Act fails to specify any criteria for determining that an emergency exists, and fails to fund a compensation mechanism. It was tacked on to the end of the 2006 Defense Appropriations Bill during the night, after being removed from another bill due to its controversial nature. <br /><br />It is unclear under PREPA should an individual refuse what that would entail. Quarantine? Maybe. Forced vaccination/drug intake with or without your consent? Maybe. It is unknown and answers have tried to be sought to no avail.<br />In a news release issued after the bill passed, Senator Frist, R-TN said the<br />measure "extends limited protections to manufacturers, distributors, and first responders, so that life-saving countermeasures, such as an H5N1 avian flu vaccine, will be developed, deployed and administered." <br />http://www.cidrap.umn.edu/cidrap/content/influenza/biz-lan/news/dec2805liability.html <br /><br />The Democratic Senators introduced a new bill to supersede PREPA in <br />February 2006, http://www.fas.org/biosecurity/resource/legislation/s2291.htm, but it never passed.<br /><br />Take Action Now<br /><br />Such measures may be deemed acceptable if this country was an anarchy, an autocracy, an oligarchy, or a democracy. However, the United States of America is a Republic, meaning it is ruled by law, as opposed to one, the minority or majority.<br /><br />It is past time the United States of America gets back to its roots. The roots are the citizens of this country, not the government, we as the people, and the government have seemed to have forgotten that.<br /><br />So what do we need to do in regards to PREPA:<br /><br />Four particular senators that initially tried to overturn PREPA needs to be contacted again now that the democrats are in the majority to resurrect a bill to rescind PREPA. These Senators are Senator Kennedy, (D-MA), Senator Dodd (D-CT), Senator Harkin (D-IA) and Senator Bingaman (D-NM). Their contact information is:<br /><br />Senator Tom Harkins Senator Chris Dodd<br />Washington DC Washington DC<br />(202) 224-3254 Phone (202) 224-2823 Phone<br />(202) 224-9369 Fax (202) 224-1083 Fax<br /><br />Senator Edward Kennedy Senator Jeff Bingaman<br />Washington DC Washington DC<br />(202) 224-4543 Phone (202) 224-5521 Phone<br />(202) 224-2417 Fax (800) 43-8658 Phone (from NM only)<br /><br />Take the opportunity to not only call the above Senators expressing your concerns, call your own Senator. In each call, express what you want him or her to do. A few examples are:<br /><br />1. To introduce a bill to rescind PREPA, as they tried to do in 2006. <br /><br />2. Let them know the only emergency there is, is the ending of this administration, and its final opportunity to expand the anthrax vaccine market which is not acceptable. Should you be asked how you know there is no emergency to use the anthrax vaccine, have your Senator contact the Department of Homeland Security him/herself. According to Secretary Chertoff, in a September 23, 2008 memo:<br /><br />“There is not currently a domestic emergency involving anthrax. Additionally, there is not currently a heightened risk of an anthrax attack. We have no credible information indicating an imminent threat of an attack involving Bacillus anthracis.”<br /><br />http://74.125.45.104/search?q=cache:1CfmoQ4r6NAJ:www.dhs.gov/xlibrary/assets/ofsec_signed_determination092308.pdf+credible+information+indicating+an+imminent+threat+of+an+attack.&hl=en&ct=clnk&cd=3&gl=us<br /><br />3. To promise an investigation into the “anthrax emergency” and to investigate how such a law like PREPA could have been passed in our republic, and who is responsible.<br /><br />4. To act to halt CDC's plan to approve civilian anthrax vaccinations. They have the power to do this. Remind them that CDC’s latest clinical trial of anthrax vaccine resulted in 229 serious adverse events and 7 deaths, but they will not be revealed until late 2009, while CDC's plan to expand vaccinations goes through without proper attention to vaccine side effects.<br /><br />5. Let them know you will not surrender your constitutional rights or that of your child’s to an appointed unelected official for any reason.<br /><br />Then, call your local media and ask them to carry stories about this frightening turn of events. Only through awareness and action can change occur.<br /><br />If you have any other thoughts or ideas, please share them with me, Dr. Meryl Nass (mnass@gwi.net) or Randi Airola (randiceaj@sbcglobal.net)<br /><br />The time to act is now. Remember, CDC’s vote will take place around noon on Wednesday, October 22nd, 2008.<br /><br />Thank you for publicizing this cynical use of "government against the people"<br /><br />Meryl Nass, MD<br />Mount Desert Island Hospital<br />Bar Harbor, Maine 04609<br />Cell: 207 522-5229<br />Home: 207 244-9165<br />Pager: 207 818-0708<br />http://anthraxvaccine.blogspot.com<br />http://www.anthraxvaccine.org<br /><br />Randi Airola<br />http://www.military-biodefensevaccines.org<br /><br />Permission is both granted and encouraged to disseminate this letter in its entirety as written to anyone that cares about life, liberty, freedom and this great country, a republic.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-19203008069159382492008-10-19T07:00:00.000-05:002008-10-20T07:15:14.013-05:00Contact Your Reps: DHHS designates an anthrax emergency as a means to protect--- ITSELF!DHHS designates an anthrax emergency as a means to protect--- ITSELF!<br /><br />A series of coordinated moves designed to encourage new uses for anthrax vaccine (whose safety record is terrible and effectiveness unknown)—while excluding any manufacturer liability for its use, preempting state and local laws designed to protect citizens, and extending blanket immunity to government officials who came up with the plan--- is in process.<br /><br />First, DHHS Secretary Leavitt declared that the US is in an anthrax emergency. This invoked the Public Readiness and Emergency Preparedness Act, giving blanket immunity from liability to all entities involved with the manufacturer and distribution of anthrax countermeasures, including “government program planners”. <br /><br />Second, Leavitt contracted to buy $400 million worth of anthrax vaccine, in addition to over $500 million currently in DHHS’ stockpile. <br /><br />Third, CDC (a DHHS agency) asked its vaccine advisory committee to vote on changing its previous recommendation for anthrax vaccine on October 22, potentially expanding its use to civilian “first responders”. <br /><br />Fourth, the vaccine’s manufacturer is constructing a new manufacturing plant to supply up to 30 million vaccine doses yearly. <br /><br />Fifth, CDC conducted a clinical trial of anthrax vaccine in 1564 subjects, but released only partial information on the trial in a JAMA article published October 1st, implying that the vaccine is safe. Yet 229 severe adverse events and 7 deaths occurred in trial participants, but were barely mentioned in CDC’s report.<br /><br />Background<br /><br />The original bill under which Secretary Leavitt made his Declaration, the Public Readiness and Emergency Preparedness Act (PREPA, part of P.L. 109-148) gave the DHHS Secretary the right to declare any disease an emergency, triggering immunity from liability for any and all injuries due to countermeasures for that illness, unless “wilfull misconduct” by those who made or administered the product could be proven. The Act fails to specify any criteria for determining that an emergency exists, and fails to fund a compensation mechanism. It was tacked on to the end of the 2006 Defense Appropriations Bill during the night, after being removed from another bill due to its controversial nature. It was passed by Congress and signed into law on December 30, 2005. Probably few in Congress read it before approving it along with defense spending. <br />You can read the bill at: ftp://ftp.hrsa.gov/countermeasurescomp/Public_Readiness_and_Emergency_Preparedness_Act.pdf <br /><br />In a news release issued after the bill passed, Senator Frist, R-TN said the measure "extends limited protections to manufacturers, distributors, and first responders, so that life-saving countermeasures, such as an H5N1 avian flu vaccine, will be developed, deployed and administered." http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liability.html <br /><br />But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with consumer groups such as Public Citizen, derided the liability provision as a giveaway to the drug industry. Kennedy said the bill makes it "essentially impossible" for injured parties to sue for damages. He also argued that the measure allows the HHS secretary to use many common diseases as a reason to activate the liability shield. "Without a real compensation program, the liability protection in the defense bill provides a Christmas present to the drug industry and bag of coal to everyday Americans," stated a Dec 21 news release issued by Kennedy and Sens. Tom Harkin, D-Iowa, and Chris Dodd, D-Conn.<br /><br />The Democratic Senators introduced a new bill to supercede PREPA in February 2006, http://www.fas.org/biosecurity/resource/legislation/s2291.htm but it never passed.<br /><br />Where is the Anthrax Emergency?<br /><br />Over the past month, in the waning days of the Bush administration, and with no emergency in sight, DHHS is using PREPA against Americans to shield not only manufacturers and medical professionals, but also to immunize everyone in government who worked on the plan from any liability for problems that arise.<br /><br />Yes, you heard correctly: although the media never reported on this provision when PREPA was passed, the bill specifically shields “government program planners” who deal with PREPA’s emergencies from all potential liability.<br /><br />On October 1, 2008 DHHS Secretary Mike Leavitt declared an anthrax emergency under the PREPA Act, through the end of 2015. (That sounds like a very long emergency—or a very long time to enjoy liability protection.) <br />http://edocket.access.gpo.gov/2008/E8-23547.htm <br />Despite the current absence of anthrax infections in Americans, the “emergency” has been declared, and the liability shield is already in effect for anthrax vaccine and other anthrax countermeasures, including antiserum, monoclonal antibodies and multiple antibiotics.<br /><br />$500 million in new anthrax vaccine spending<br /><br />October 1, 2008 was a busy day in the anthrax world. DHHS announced it was going to purchase an additional 14.5 million doses of anthrax vaccine, for a cost between $364and $404 million, to add to its existing stockpile of about 25 million doses. http://www.washingtonpost.com/wp-dyn/content/article/2008/10/01/AR2008100102951.html<br /><br />The manufacturer, Emergent BioSolutions, crowed about the liability protection it had just received for the purchase. <br />http://www.bizjournals.com/baltimore/stories/2008/10/06/daily45.html<br /><br />Furthermore, on September 26, DHHS announced contracts for a total $113.6 million with Emergent BioSolutions and Pharmathene for development of “Third Generation” anthrax vaccines. These too are covered under Secretary Leavitt’s Declaration. What vaccines are these? Emergent bought its competitor VaxGen’s vaccine for $2 <br />million, after taxpayers and investors paid over $200 million for its development. When in 2006 VaxGen failed to meet DHHS-specified milestones, its contract was cancelled and the company folded.<br /><br />Pharmathene bought Avecia’s vaccine, after Avecia received a $100 million DHHS contract for early vaccine development, but failed to get a more lucrative contract later.<br /><br />Bottom line: both these vaccines were rejected by DHHS during the past five years, only to suddenly arise again, and consume additional taxpayer largesse. Yet if the current vaccine were truly acceptable, a newer vaccine would be unnecessary.<br /><br />Expanding the anthrax vaccine market<br /><br />If DHHS simply planned to stockpile more anthrax vaccine, its purchase would just be another example case of government waste. The current stockpile is expiring at a rate of $10 million per month, as pointed out by GAO last year. http://www.washingtonpost.com/wp-dyn/content/article/2007/10/22/AR2007102202111.html<br /><br />But DHHS had bigger plans than this. It eyed a new market for the vaccine, one that might double or quadruple the amount of vaccine now used by the military, justifying a new manufacturing plant that Emergent is building in Maryland. There are up to 3 million “First Responders” in the US: Police, Firefighters, Emergency Medical <br />Technicians and others. Maybe they could profitably use the vaccine, since they might someday face an anthrax emergency.<br /><br />On October 22, the CDC ‘s Advisory Committee on Immunization Practices (ACIP) will vote on whether to overturn its anthrax vaccine recommendations of 2000 and 2002. http://www.cdc.gov/vaccines/recs/ACIP/downloads/min-jun08.pdf <br /><br />Back then, ACIP stated that neither the benefit nor the risk for using anthrax vaccine could not be calculated, and therefore ACIP recommended against its use for civilians, unless they would be repeatedly exposed to anthrax spores.<br /><br />2000 Recommendations: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm<br />2002 recommendations: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5145a4.htm<br /><br />Risk-Benefit Analyisis, the Basis for Public Health Policy—Except Here<br /><br />But, you might argue, first responders and other citizens still cannot assess the risks and benefits of anthrax vaccination. Let that be no deterrent. As CDC’s Nancy Messonier pointed out to ACIP members in June,<br /><br />“The intent of the workgroup was to open the door, knowing that the vaccine is commercially available and that first responder groups are at liberty to call the manufacturer to obtain the vaccine themselves. This is really meant to give them more impetus by saying that even if they do not have a calculated risk assessment, individuals or groups can assess their own risk, and weigh the risks and benefits of the vaccine with their occupational health and safety programs.” <br />http://www.cdc.gov/vaccines/recs/ACIP/downloads/min-jun08.pdf<br /><br />CDC’s Messonier tossed aside the most basic public health requirement, by suggesting that first responders can weigh their own risk, even though the vaccine’s safety and efficacy remain in doubt, and the risk of anthrax is unknown! CDC doesn’t want that little omission to stand in the way of receiving the vaccine: especially when ACIP members and all CDC, FDA and DHHS employees are shielded from liability for uninformed and ill-considered recommendations. CDC seems to have accurately calculated its own risk/benefit equation.<br /><br />Meryl Nass, MD<br />October 14, 2008<br /><br />Here is an excellent discussion of the 2005 PREPA Bill:<br />http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liability.html<br /><br />Pandemic funding, liability shield clear Congress<br /><br />Dec 28, 2005 (CIDRAP News) – Before adjourning last week, the US Senate passed and sent to President Bush a bill providing $3.8 billion for pandemic influenza preparedness and a controversial liability shield for those who produce and administer drugs and vaccines used in a declared public health emergency.<br /><br />The preparedness funding and liability protection were part of the fiscal year 2006 defense spending bill passed by the Senate on the evening of Dec 21. The bill had cleared the House 2 days earlier.<br /><br />The $3.8 billion for pandemic preparedness is a little more than half of the $7.1 billion Bush had requested in early November. House Republican leaders said last week the measure would fund roughly the fiscal year 2006 portion of Bush's request.<br /><br />As reported previously, the amount includes $350 million to improve state and local preparedness and directs the Department of Health and Human Services (HHS) to use most of the rest on "core preparedness activities," including increasing vaccine production capacity, developing vaccines, and stockpiling antiviral drugs.<br /><br />The liability provision offers broad legal protection for the makers of drugs, vaccines, and other medical "countermeasures" used when the HHS secretary declares an emergency. The provision says people claiming injury from a medical countermeasure can sue only if they prove "willful misconduct" by those who made or administered it. The bill calls for Congress to set up a compensation program for injuries, but it provides no funds for that purpose.<br /><br />Senate Majority Leader Bill Frist, R-Tenn., and other Republican leaders argued that the liability measure was necessary to induce biotechnology companies to develop products to counter pandemic flu and other disease threats.<br /><br />In a news release issued after the bill passed, Frist said the measure "extends limited protections to manufacturers, distributors, and first responders, so that life-saving countermeasures, such as an H5N1 avian flu vaccine, will be developed, deployed and administered."<br /><br />He added that the bill "strikes a reasonable balance where those who are harmed will be fairly compensated and life-saving products will be available in ample supply to protect and treat as many Americans as possible."<br /><br />But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with consumer groups such as Public Citizen, derided the liability provision as a giveaway to the drug industry. Kennedy said the bill makes it "essentially impossible" for injured parties to sue for damages. He also argued that the measure allows the HHS secretary to use many common diseases as a reason to activate the liability shield.<br /><br />"Without a real compensation program, the liability protection in the defense bill provides a Christmas present to the drug industry and bag of coal to everyday Americans," stated a Dec 21 news release issued by Kennedy and Sens. Tom Harkin, D-Iowa, and Chris Dodd, D-Conn.<br /><br />The liability protection language, called the Public Readiness and Emergency Preparedness Act, was tacked onto the end of the huge defense-spending bill (H.R. 2863).<br /><br />It gives the HHS secretary authority to trigger the liability protection by declaring an emergency if he or she determines that a disease or other health threat represents an emergency or may constitute an emergency in the future. The act does not list any criteria for determining the existence of an emergency. The declaration would have to list the diseases, populations, and geographic areas covered and when the emergency would end.<br /><br />Such an emergency declaration is not subject to court review, and it preempts any conflicting laws or regulations of states or local communities, the act says.<br /><br />The measure says those who make and administer medical countermeasures covered by an emergency declaration are immune to lawsuits unless the plaintiff can provide clear evidence of willful misconduct that resulted in death or serious physical injury. "Willful misconduct" is ruled out if the party who administered the treatment followed HHS recommendations and notified health authorities of the relevant injury within 7 days.<br /><br />In addition, the act instructs the HHS secretary to write regulations "that further restrict the scope of actions or omissions by a covered person" that constitute willful misconduct.<br /><br />A party alleging "willful misconduct" can file suit only in US District Court in Washington, DC. The plaintiff must have an affidavit supporting the suit from a physician who did not treat the injured person. Before any suit can go to trial, a three-judge panel will consider any pretrial motions.<br /><br />The act says that an HHS emergency declaration will trigger the establishment of a fund to provide "timely, uniform, and adequate compensation" to anyone injured by covered medical countermeasures. However, the measure does not appropriate money for the fund.<br /><br />A person claiming injury from a covered treatment may not sue without first trying to collect from the compensation fund. But that requirement applies only if the compensation program has been funded. A person can sue if HHS fails to act on the request for compensation within 240 days.<br /><br />If a plaintiff accepts an award from the compensation fund, he or she is barred from suing anyone, the act provides.<br /><br />In arguing that the liability shield is too broad, Kennedy said in his news release, "The Bush administration could identify Vioxx as a needed countermeasure to treat the arthritis epidemic or to treat pain associated with flu, and completely immunize Merck [the manufacturer] from lawsuits currently pending against it."<br /><br />Meryl Nass, MD<br />Mount Desert Island Hospital<br />Bar Harbor, Maine 04609<br />W 207 288-5081 ext. 1220<br />C 207 522-5229<br />H 207 244-9165<br />pager 207 818-0708<br />http://anthraxvaccine.blogspot.com<br />http://www.anthraxvaccine.orgMBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-9009448451281774392008-10-18T07:43:00.000-05:002008-10-20T07:51:52.465-05:00Emergency declarations smooth way for vaccine makersBy ALAN BAVLEY<br />The Kansas City Star<br />http://www.kansascity.com/105/story/846427.html<br /><br />Sure, the economy is causing a crisis, but what about anthrax? How about smallpox?<br /><br />In a little noticed move, federal officials this month have declared a series of public health emergencies relating to potential weapons of biological terror.<br /><br />On Oct. 1, Health and Human Services Secretary Mike Leavitt declared an anthrax public health emergency. On Oct. 10, he declared health emergencies for smallpox, radiation sickness from the detonation of a nuclear device and poisoning from botulinum toxins, the active ingredient of Botox.<br /><br />There’s no clear evidence that terrorists have managed to weaponize anthrax or stolen large caches of Botox from cosmetic surgeons in Beverly Hills.<br /><br />But by declaring these public health emergencies, HHS has granted manufacturers of anti-terrorism drugs and vaccines and others involved with the products protection from lawsuits if the drugs were to cause unfortunate side effects.<br /><br />In the past, drug companies have shied from vaccine development because of low profit margins and legal risks. The actions of HHS are a necessary reassurance to persuade companies to make the drugs, and doctors and other providers to administer them, federal officials and some terrorism experts say.<br /><br />But consumer advocates see it as a giveaway to the drug industry that strips the public of legal protections.<br /><br />“It gives the manufacturers and other people involved a ‘get out of jail free’ card,” said Joan Claybrook, president of Washington-based Public Citizen.<br /><br />“These are potentially dangerous products. There could be a bad vaccine, and suppose people relied on that?” Claybrook asked. “There is no deterrent if there’s no liability.”<br /><br />The emergency declarations cover a host of antibiotics to fight anthrax infection, anthrax and smallpox vaccines, and a drug to stimulate white blood cell production in people harmed by radiation.<br /><br />Concerns about the safety of vaccines against potential bioweapons have been raised repeatedly in recent years. Some soldiers, for example, have balked at anthrax vaccinations. And a federal effort to inoculate 500,000 doctors, nurses and other health care workers against smallpox resulted in only about 40,000 volunteering for the vaccine.<br /><br />Health and Human Services’ authority to grant drugmakers liability protection comes from a controversial measure that Senate Majority Leader Bill Frist and House Speaker Dennis Hastert added to a Defense Department appropriations bill in the waning days of 2005.<br /><br />The Public Readiness and Emergency Preparedness Act targets liability protections for products used during epidemics and pandemics, or as security countermeasures.<br /><br />The HHS secretary can trigger the protections by declaring that a public health emergency exists or that there’s a “credible risk” of one in the future.<br /><br />And legal immunity can apply to anyone involved in the development, testing, manufacture or distribution of the drugs. Also covered is anyone who prescribes, dispenses or administers the drugs, including state and local government officials.<br /><br />Public Citizen and the Consumer Federation of America were among the groups that protested the bill.<br /><br />In a letter to Frist and Hastert, Sen. Ted Kennedy and 20 other members of Congress called the measure “a stealth provision to shield manufacturers from responsibility for making faulty drugs and vaccines.”<br /><br />As the law was written, it could be applied to virtually any drug or vaccine, Kennedy and the others said, and not just to the medications needed to fight pandemic flu or bioterrorism.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-12874217165173675322008-10-17T08:38:00.002-05:002008-10-20T08:41:29.760-05:00Chertoff Memo: How to Declare an Anthrax Emergency with no basis and make liability *vanish*On October 1, 2008 DHHS Secretary Mike Leavitt declared an anthrax emergency, which will last through 2015. It was published in the Federal Register Volume 73, Number 194, pages 58239-58242, and can be read here: <br />http://edocket.access.gpo.gov/2008/E8-23547.htm <br /><br />What was the basis for the emergency declaration? Nothing. A must-read (short) memo<br />is attached <br />http://www.dhs.gov/xlibrary/assets/ofsec_ signed_determination092308.pdf, in which DHS Secretary Chertoff told DHHS Secretary Leavitt the following:<br /><br />"That statute authorizes the Secretary of Health and Human Services to declare an emergency on the basis of, among other things,<br /><br />A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biologial, chemical, radiological or nuclear agent or agents.<br /><br />There is not currently a domestic emergency involving anthrax. Additionally, there is not currently a heightened risk of an anthrax attack. We have no credible <br />information indicating an imminent threat of an attack involving Bacillus anthracis.<br /><br />But these findings are not necessary to make a determination under 5 564(b)(l)(A). Rather, a significant potential for a future domestic emergency involving a heightened risk of attack with anthrax is a sufficient basis for such a determination. "<br /><br />Here is a discussion of the Public Readiness and Emergency Preparedness Act under which the Declaration was made:<br />http://www.cidrap.umn.edu/cidrap/content/influenz a/biz-plan/news/dec2805liability.html <br /><br />"The liability provision offers broad legal protection for the makers of drugs, vaccines, and other medical "countermeasures" used when the HHS secretary declares an emergency. The provision says people claiming injury from a medical countermeasure can sue only if they prove "willful misconduct" by those who made or administered it. The bill calls for Congress to set up a compensation program for injuries, but it provides no funds for that purpose." The bill also grants immunity specifically to "government program planners" who are involved with declared emergencies.<br /><br />Here is the actual December 2005 bill:<br /><br />ftp://ftp.hrsa.gov/countermeasurescomp/Public_Readiness_and_Emergency_Preparedness_Act.pdf<br /><br />Here is Secretary Leavitt's October 1, 2008 Declaration:<br /><br />http://edocket.access.gpo.gov/2008/E8-23547.htm <br /><br />And on October 22, 2008 the CDC's Advisory Committee on Immunization Practices will vote on expanding its recommendation for anthrax vaccinations to civilian first responders, now that the threat of liability for vaccine injuries or vaccine failure is a thing of the past.<br />http://gsn.nti.org/gsn/ts_20081016_1491.phpMBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-1152632475602775032008-10-17T07:33:00.000-05:002008-10-20T07:35:22.709-05:00Emergent Biosolutions Hits New 52-Week High On Positive Outlookhttp://anthraxvaccine.blogspot.com<br /><br />Emergent Biosolutions Hits New 52-Week High On Positive Outlook<br />Mayur Pahilajani - iStockAnalyst Writer<br />New York, NY<br /><br />Shares of Emergent Biosolutions Inc (NYSE: EBS) topped 52-week mark after the bell on Friday as investors gained confidence in the company after the Rockville-based biotech's profitable anthrax treatments won emergency protection.<br /><br />On October 9, the firm announced that the vaccine Biothrax and its Anthrax Immune Globulin, both have been included as covered countermeasures to a public health emergency under the Public Readiness and Emergency Preparedness Act.<br /><br />The U.S. Department of Health and Human Services (HHS) said in a declaration, which will remain in effect until December 31, 2015, that there is a credible risk that the threat of exposure to anthrax and the resulting disease constitutes a public health emergency.<br /><br />"This PREP Act declaration is further evidence of the U.S. Government’s commitment to our efforts to develop a portfolio of medical countermeasures to address the threat to public health posed by the use of anthrax as a weapon of biological warfare," Daniel J. Abdun-Nabi, president of Emergent BioSolutions, said in a statement.<br /><br />The measure came after the company gained a new multi-year contract with the U.S. HHS to supply additional doses of its anthrax vaccine. The contract is valued in the range of between $364 million to $404 million. Under the agreement, the company will supply HHS with the second order of 14.5 million doses of Biothrax vaccine. The first order of 19.75 million doses of the vaccine is currently being delivered, which will provide the company with $448 million...MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-65309048021931662892008-10-17T07:21:00.002-05:002008-10-20T07:32:13.316-05:00U.S. Limits Anthrax Vaccine LiabilityGlobal Security Newswire<br />Elaine Grossman<br /><br />WASHINGTON - The U.S. Health and Human Services Department early this month moved to shield government, industry and business officials from lawsuits filed by those who have received the anthrax vaccine (see GSN http://www.nti.org/d_newswire/issues/2007/9/5/14e90604-dd3f-42d1-9285-34ea695db21a.html, Sept. 5, 2007).<br /><br />Health and Human Services Secretary Michael Leavitt established legal immunity for public and private officials who oversee the production or distribution of the anthrax vaccine by declaring a "public health emergency" due to the risk of a bioterrorism attack. He said the emergency began on Oct. 1 and would run through Dec. 31, 2015.<br /><br />U.S. law provides protection from lawsuits to individuals responsible for selected countermeasures, including antibiotics, during a declared emergency. Under the Public Readiness and Emergency Preparedness Act, which President George W. Bush signed into law in December 2005, a health and human services secretary's emergency declaration can limit financial risk for government program planners and the manufacturers or distributors of pharmaceutical countermeasures. One exception to <br />this immunity would be willful misconduct on the part of covered individuals. The ramifications, in this instance, could be to prevent individuals who have received one or more anthrax inoculations from taking grievances to court, based on claims that the vaccine caused severe adverse reactions or did not work. The anthrax vaccine has proven particularly controversial following reports of serious adverse <br />events, including some deaths, among U.S. recipients <br />(see GSN <http://www.nti.org/d_newswire/issues/2005/11/21/e6ab1e9c-4ae3-42ff-b9fa-87b14ca99111.html. Nov. 21, 2005).<br /><br />In addition, there are some doubts about the vaccine's efficacy in protecting people from developing anthrax after breathing in spores during a biological attack. A 2003 lawsuit - based on lapses in the Food and Drug Administration' s drug-approval process for the vaccine - temporarily shut down the Defense Department's compulsory anthrax shots program. Mandatory inoculations resumed in 2006 for personnel whose assignments are judged to put them at heightened risk of exposure to anthrax (see GSN <http://www.nti.org/d_newswire/issues/2005/12/16/da976f97-51ae-4b2c-a63f-b6a5fd592234.html, Dec. 16, 2005).<br /><br />Leavitt's declaration <http://edocket.access.gpo.gov/2008/E8-23547.htm was published in the Federal Register and quietly heralded at the end of a two-page news release http://www.hhs.gov/news/press/2008pres/10/20081001a.html devoted largely to another anthrax-related initiative (see GSN <http://www.nti.org/d_newswire/issues/2008/10/2/bf39cf1b-7298-474d-86f1-11d56160bd70.html, Oct. 2).<br /><br />Among the activities now afforded liability protection are those "related to developing, manufacturing, distributing, prescribing, dispensing, administering and using anthrax countermeasures in preparation for, and in response to, a potential anthrax attack," the HHS news release states. "This includes entities, such as large 'big- box' retail stores, retail pharmacies, and other private sector businesses, that help to deliver and distribute medicines." Health and Human Services argued the legal shield is essential to guarantee that countermeasures are there if U.S. citizens need them. "Providing liability protection to all involved in such efforts will help ensure their full participation and bolster response efforts," according to the news release. "Preparedness is a shared responsibility that must involve all sectors of society, including the private sector, community groups, families and individuals, " Leavitt stated in the release. "We are using the authorities available to us to do all we can to support preparedness at all levels."<br /><br />The move comes as a pivotal advisory group convened by the U.S. Centers for Disease Control and Prevention prepares to decide whether state and local health officials should consider giving anthrax vaccines to as many as 3 million civilian first responders nationwide (see GSN http://www.nti.org/d_newswire/issues/2008/10/16/55608b41-33c1-4553-8ce0-7a70426c4771.html, Oct. 16).<br /><br />Millions of U.S. military personnel have already received the vaccines since the Pentagon's shots program began in 1997, but the law prohibits service members or their families from holding the government liable for injury or death. Now that the population of vaccine recipients could expand to include millions of civilians - who <br />normally do have a right to take medical injury claims to court - federal response planners and government contractors might be growing nervous about their potential legal vulnerability, according to vaccine critics. "There are people still getting ill from side effects and from the vaccine," John Michels, an attorney in litigation <br />targeting the Pentagon's inoculation program, told Global Security Newswire this week. "When they expand this vaccine from the military population to a civilian population, they're going to have people who sue."<br /><br />Emergent BioSolutions of Rockville, Md. - the nation's only manufacturer of an FDA-approved anthrax vaccine - recently announced <http://www.emergentbiosolutions.com/NewsReleases.aspx?ReleaseID=1204156 that Health and Human Services had ordered 14.5 million doses of its BioThrax vaccine, worth as much as $404 million. The company is already under a $448 million contract to produce 18.8 million doses of the vaccine. The vaccine regimen calls for six shots over an 18 month period, plus annual boosters.<br /><br />Michels said commercial interests appear to be playing a role in the legal immunity issue. He questioned whether there had been any bona fide escalation in the anthrax threat sufficient to justify the declaration of an emergency. "We have no indications [now] ... that we're much more likely to be attacked by anthrax," Michels said. "But [government officials] see the writing on the wall. They see ... an erosion of [lawsuit] immunity for vaccine manufacturers as a result of widespread civilian use."<br /><br />Meryl Nass, a bioterrorism expert who has been highly critical of federal handling of anthrax vaccine issues, accused Leavitt of taking more interest in protecting bureaucrats from legal action than in protecting the public from health threats. "How do you decide there is an emergency when there is no evidence of one?" she asked in e-mailed comments last week. Noting the HHS secretary's designation of <br />"governmental program planners" as among those afforded legal immunity by the declaration, Nass asserted that the agency "designates an emergency as a means to protect itself."<br /><br />Leavitt's declaration, though, states that "targeted liability protections for anthrax countermeasures" are "based on a credible risk that the threat of exposure to [anthrax] and the resulting disease constitutes a public health emergency." The document does not offer additional details on the nature or level of threat. A request that Health and Human Services elaborate on the basis for the public health <br />emergency declaration went unanswered at press time.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.comtag:blogger.com,1999:blog-15925687.post-86816883686844664602008-10-16T08:08:00.000-05:002008-10-20T08:30:25.796-05:00CDC Panel May Advise Anthrax Shots for First Respondershttp://gsn.nti. org/gsn/ts_ 20081016_ 1491.php<br /><br />CDC Panel May Advise Anthrax Shots for First Responders<br />Elaine Grossman<br />Global Security Newswire: Oct. 16, 2008<br /><br />WASHINGTON - A U.S. government advisory panel next week could recommend that state and local public health officials consider administering anthrax vaccines to as many as 3 million first responders nationwide, Global Security Newswire has learned. The <br />panel, convened by the Centers for Disease Control and Prevention, would leave it to regional and local authorities to determine whether the risks of biological terrorism - weighed against the potential benefits of a controversial inoculation - justify vaccinating emergency personnel.<br /><br />In an anthrax attack, victims could inhale tiny airborne particles capable of infecting them with a highly fatal disease. The 2001 mailings that targeted congressional and media offices, launched just days after the Sept. 11 terrorist strikes, killed five people and sickened another 17 (see GSN <http://www.nti.org/d_newswire/issues/2008/10/1/5c85159e-7129-4ca0-b957-2fcc95aa144a.html>, Oct. 1).<br /><br />The CDC panel decision, slated for release at an Oct. 22 meeting in Atlanta, could reverse a nearly 8-year-old recommendation against pre-exposure vaccinations for first responders. By contrast, U.S. military personnel operating in assignments considered at risk of exposure to anthrax attack have been subject to mandatory inoculation for several years (see GSN <http://www.nti.org/d_newswire/issues/2007/9/5/c0469347-f23c-4248-a063-c5a57ceafd57.html>, Sept. 5, 2007). While the compulsory program was suspended at one point under court order, the Defense Department has administered millions of shots since the late 1990s.<br /><br />The CDC Advisory Committee on Immunization Practices said in December 2000 that it could not recommend anthrax shots for civilian first responders as a matter of national policy because "the risk of exposure cannot be calculated." Even if the threat were considered higher in one city or another, the panel concluded that precautionary vaccines were unnecessary. For emergency personnel who enter an attack <br />site, "studies suggest an extremely low risk for exposure related to secondary aerosolization of previously settled [anthrax] spores," the group wrote at the time. If a first responder were exposed to anthrax, the "initiation of prophylaxis should be considered with antibiotics alone or in combination with vaccine," the panel concluded. Post-exposure treatment with these drugs is standard for unvaccinated <br />patients.<br /><br />In 2002, the panel updated other aspects of its anthrax vaccine recommendations but refrained from changing its guidance for first responders. However, at a meeting in Atlanta four months ago, a working group convened by the advisory committee said the full panel should alter its 2000 statement. "Post-event vaccination in combination with antibiotics is an effective intervention following exposure to [anthrax] spores, but the workgroup felt that pre-event vaccination could offer additional protection beyond that afforded by antibiotics and post-vaccination by providing early priming of the immune system," according to a CDC summary of the review group's presentation to the panel. In addition, some first-responder organizations "have stated that their members would be more willing to respond to a bioterrorism event if they were vaccinated prior to the occurrence of the event," working group member Jennifer Gordon Wright told the committee, according to the meeting summary. "The workgroup felt that implementing a recommendation for pre-event vaccination of first responders would be difficult, but it may have a positive impact on first-responder preparedness, " she reportedly said.<br /><br />If embraced by the expert panel next week, the new statement would read: "Groups for whom potential contact with aerosolized anthrax is a reasonable expectation based on occupation and duties (e.g. first responders expected to be called to the scene of a bioterrorism event) and for whom a calculable risk is not available may consider pre-event vaccination on the basis of an estimated risk benefit and in the context of an occupational health and safety program."<br /><br />A Host of Challenges<br /><br />Among the challenges facing any mass inoculation effort for first responders would be finding a method of tracking a complicated anthrax shot regimen for millions of personnel who might come and go from their jobs, according to the June meeting minutes. The schedule for the existing vaccine calls for six priming shots over an 18-month period, followed by annual boosters. Recent medical research suggests <br />that fewer shots might be needed to establish immunity, but the official regimen has not yet changed (see GSN <http://www.nti.org/d_newswire/issues/2008/10/1/0ede5e29-59ab-4680-a2db-b1191e85f631.html>, Oct. 1).<br /><br />Another hurdle could be organizing a vaccine campaign in the absence of any single organization representing the first-responder community nationwide, according to the June meeting summary. "There are multiple types of first responders and defining this group can be difficult," Wright told the CDC panel.<br /><br />Litigation pending in federal court could pose another complication for state and local officials who might contemplate setting out a requirement that their first responders take the anthrax shots. Two attorneys who in 2004 won a 16-month injunction against the Pentagon's initial mandatory vaccine effort filed a second lawsuit in late 2006, challenging the science behind a 2005 Food and Drug Administration decision allowing the drug to be used for protection against an attack (see GSN <http://www.nti.org/d_newswire/issues/2004/10/28/54b0cd56-007b-42fc-b035-d2dcb3329d6e.html>, Oct. 28, 2004). They argue that the vaccine has been proven only in the prevention of anthrax contracted through the skin or digestive system, but has not been shown to work against a more serious form of inhaled anthrax posed by biological weapons.<br /><br />The second case is now on appeal following a federal judge's move to dismiss it in late February (see GSN <http://www.nti.org/d_newswire/issues/2008/3/3/7228bc90-da71-477a-9828-92bfbe0725ed.html>, March 3). If the lawsuit moves forward in the U.S. Court of Appeals, "it would affect the current thinking of CDC and FDA" regarding the advisability of giving the vaccine to millions of first responders, said Mark Zaid, plaintiffs' co-counsel in both legal actions. The CDC advisory panel's working group reported in June that "available vaccine efficacy data suggested that the vaccine is effective and provides protection against inhalation anthrax." However, Zaid said state and local authorities should think twice before requiring the shots for emergency personnel, in the absence of a substantial threat. "It would be virtually unprecedented in modern times to mandate any vaccination on civilian populations without the clear existence of a current outbreak of disease," he told GSN yesterday.<br /><br />Critics of the vaccine have alleged that officials at the Centers for Disease Control and Prevention - an arm of the U.S. Health and Human Services Department - have underemphasized the risk of severe adverse reactions carried by the anthrax vaccine. For example, a new CDC study of the anthrax vaccine's safety and efficacy logged 229 "serious adverse events" - including seven deaths - in 186 out of 1,563 <br />volunteer participants receiving inoculations since May 2002. Such instances might include events that are life-threatening, require hospitalization or surgical intervention or cause significant disability or birth defects. Results were published in the Oct. 1 issue of the Journal of the American Medical Association.<br /><br />However, the researchers concluded that just nine of these serious events - none resulting in death - were "possibly related" to the vaccine. Analysis of the research data will remain "double-blind" through next year, meaning the medical investigators and patients do not know which participants received anthrax inoculations and which received a placebo, according to CDC officials.<br /><br />Until the serious-event data can be correlated with an understanding of which patients actually received the anthrax vaccine, an empirical analysis of the drug's safety in this study cannot be done, according to Meryl Nass, a longtime critic of the U.S. government's handling of the vaccine. An internist who has consulted with the U.S. government on bioterrorism issues, Nass questioned how CDC researchers could have concluded that just nine of the 229 serious adverse events might have <br />been connected to the vaccine. In e-mail comments sent to GSN last week, she accused the agency of "glossing over" the severe reactions potentially related to the vaccine and of offering few details about them.<br /><br />The working group's June presentation to the CDC advisory group identified vaccine safety as a possible issue for consideration in treating first responders, but voiced confidence in the research findings. "While the workgroup [members] believe the vaccine is safe, rare adverse events do occur and a serious adverse event is not a small matter, regardless of whether it is vaccine-associated, " Wright told the panel, according to the CDC minutes.<br /><br />The government advisory panel "has been given a one-sided picture from the working group at the CDC," Nass said in an interview this week. She rued the fact that few, if any, of the advisory panel's current members took part in the committee's debate nearly eight years ago, which resulted in its initial guidance against mass inoculations for first responders. This year, Nass said, the committee has heard nearly no critical perspectives about the safety and efficacy of the anthrax vaccine, and the group might similarly be unaware of skepticism about biowarfare threats facing the United States. The CDC panel has scheduled just five minutes of public comment about the issue during its upcoming meeting, she said.<br /><br />A review of the committee's membership shows that none of the advisory panel's 15 voting members sat on the group in 2000, so there is little track record on which to base projections about how it will decide the issue this time. Eight liaisons from medical associations and industry organizations, "ex officio" members and others associated with the Advisory Committee on Immunization Practices served in similar roles in 2000, but none of them have a vote. Of the voting advisory panel members, several voiced support at the June meeting for making what they termed a "reasonable" change in the group's guidance regarding anthrax shots for first responders.<br /><br />One of them, Jonathan Temte - a faculty member at the University of Wisconsin's School of Medicine and Public Health in Madison - said "allowing smaller [state and local] groups to consider their own risks is a very worthwhile approach," according to the CDC summary. Others expressed a degree of concern. For example, Franklyn Judson - a professor at the University of Colorado Health Sciences Center in Denver -said he would support the new statement but thought "practically it would do little at the local level," the summary states. Another, Ciro Sumaya of Texas A&M Health Center in College Station, "was uncomfortable with the wording" in the statement about assessing a risk-benefit tradeoff, adding that "there should be some type of algorithm to make risk determinations that can be useful to the practitioner and at the local level," according to the CDC minutes.MBVIChttp://www.blogger.com/profile/02597432037765603057noreply@blogger.com