November 25, 2004
Anthrax Vaccine
This is a MUST READ if you are involved in bio-trerrorism or vaccinations. If you are a veteran who has had the Anthrax Vaccine you will want to "read and weep."
Thomas Barnes
HSPIG
Managing Director
Vaccine-A uncovers a story of betrayal—the betrayal of the men and women who serve in the armed forces, the betrayal of medical ethics, and the betrayal of the American people by military and civilian leaders sworn to defend and protect. Veteran journalist Gary Matsumoto shows that the worst friendly-fire incident in military history came from something no soldier had any reason to think would harm him: a vaccine administered by the military's own medics. When troops went to the Middle East to fight the Gulf War in 1991 and the Iraq War in 2003, many—perhaps thousands—received an experimental anthrax vaccine instead of the FDA-approved vaccine. Without their knowledge or consent, the U. S. government used them as human guinea pigs in a massive medical experiment that went disastrously wrong.
About the Author
Gary Matsumoto, a journalist based in New York City, has reported from thirty-two different countries on five continents, covered two wars and five popular uprisings, and won ten journalism awards. He has been the London Bureau Manager and Chief Foreign Correspondent for NBC Radio News; a National Correspondent for NBC's Weekend Today Show and Senior Correspondent for the Fox News Channel. As a broadcaster, he has covered events ranging from the toppling of the Communist Party in Eastern Europe to Desert Storm, the Tiananmen Square massacre to the death of Princess Diana. He has written about the anthrax letter attacks for the Washington Post and Science magazine. His 1998 article in Vanity Fair was the first to draw the connection between the anthrax vaccine and Gulf War Syndrome.
The Greatest Story Never Told
For the past 17 years, the Army has been working on a new anthrax vaccine that contains no anthrax, and is made with an ingredient that it does not want to name. That ingredient is called squalene. Squalene is an oil. Without it, the new vaccine will not work any better than the old one. In fact, for all intents and purposes, without squalene the new vaccine is the old one. What makes squalene so important is its proven ability to stimulate a strong response from the immune system. That is something the main ingredient of the new vaccine, the now ultra-purified protein secreted by the anthrax microbe—recombinant protective antigen—cannot do by itself. It is too weak.
Immunologists have a special name for substances used to boost feeble vaccines. They are called adjuvants. Adjuvants are arguably the most extensively researched pharmaceutical product in the last quarter century that you never heard of. I have used the word adjuvant three times in this paragraph so far and that is probably three times more than you have ever seen it in print before. This is partly because the most effective adjuvants, those formulated with oils, are too dangerous for human use. That is squalene's other proven ability, causing incurable disease, which is why it is such a touchy subject with the Department of Defense.
The word adjuvant comes from a Latin word that means "to help." But with oil adjuvants like squalene that term is misleading. Today, only one adjuvant—an aluminum salt called alum—is licensed for human use. All the oil adjuvants are so noxious that their use is restricted to experiments with animals, and even then, governments have written strict regulations to govern how they are used. The classic oil adjuvant, called Freund's Complete Adjuvant, is considered too inhumane to even inject into animals. It does a terrific job of stimulating the immune system, though. Unfortunately, Freund's Complete Adjuvant can cause permanent organ damage and incurable disease. As early as the 1930s, these oil additives were notorious for inducing illness. By the 1950s, scientists knew these illnesses were specifically autoimmune. Today that is their chief use in research—inducing disease instead of preventing it. Scientists studying autoimmune disease cannot wait around for its spontaneous appearance in a lab animal; they inject it with Freund's Complete Adjuvant to reproduce autoimmunity on demand. Oil adjuvants made with squalene equally effective at this job, and regrettably according to Dutch scientists, equally inhumane. , ,
Autoimmune diseases are chronic and progressively debilitating ailments; some, like multiple sclerosis and lupus, can be fatal. They occur when the immune system loses its ability to distinguish what is "self" from what is foreign. Under normal circumstances, your immune system ignores the constituents of your own body; immunologists call this "tolerance." But if tolerance is broken, the immune system turns relentlessly self-destructive, attacking the body it is supposed to defend.
Adjuvants can break tolerance. In 1956, Dr. Jules Freund, the Hungarian born scientist who gave his name to the adjuvant he created, warned that animals injected with Freund's developed terrible conditions: allergic aspermatogenesis (stoppage of sperm production), experimental allergic encephalomyelitis (the animal version of multiple sclerosis) and allergic neuritis (inflammation of nerves that can lead to paralysis), allergic uveitis (an inflammation in the eye that can cause blindness). There was no reversing any of these conditions.
Scientists are still unsure why oil adjuvants do this. One theory is that oils have the ability to hyperactivate the immune system. "The cause is probably that when injecting these molecules, you create a chaos in the immune system," says Dr. Johnny C. Lorentzen, and immunologist with the Karolinska Institute, which awards the annual Nobel Prize for Medicine. He says these oils induce "an extremely powerful response," so powerful, in fact, that the immune system goes haywire and starts attacking things it would otherwise leave alone. Another possibility, which has not been explored very much, is that this harmful phenomenon actually has something to do with one of the greatest distinguishing characteristics of the immune system—its specificity. Over eons in time, this extraordinarily elegant and powerful system has evolved to respond very precisely to what it deems potentially harmful to the body. Our bodies contain all sorts of oily molecules. It could be that when an oil is injected, the immune system actually responds to it with a high degree of precision - just as it responds to everything else - but because the adjuvant resembles too closely those oils found in the body, the immune system begins attacking those too. In immunology this is called a "cross reaction." Neither proposition - chaos or specificity - has been proven so far. But however oils do their damage, it is well known that they do.
Army scientists have been as aware as anyone else of the harm that injecting oils can do. The problem for military personnel is that these scientists learned this lesson by injecting oils into troops in experiments that in some cases they did not agree to participate in. The central question in this book is whether such an experiment has been done again with the new anthrax vaccine and squalene.
Round One
Despite their dangers, oil adjuvants have come to exert an irresistible, almost magical allure on researchers. If they could truly stimulate the immune system safely, oil additives could help defend mankind from diseases like malaria and HIV. For germs such as these, no one dared make a classic vaccine - the kind made from the germ itself - for fear of accidentally infecting someone with an incurable, if not fatal infection. By splicing off just little bit of such a germ - not enough to make anyone sick - and combining that shard with an adjuvant, scientists hoped to protect people from lethal microbes. If they could do it for HIV, they reasoned, they could do it for any germ in creation. This siren song was so powerful that it did more than induce researchers to indulge in cynical risk/benefit calculations; in some cases, it made them forget the risks altogether.
The first time Army scientists succumbed to this allure was in 1951 at Fort Dix, New Jersey in an experiment that involved 44,459 troops. More than 18,000 of them got injected without their informed consent with a newly formulated oil additive for vaccines. The Army thought it had something new and safe. The world's best additive that no one dared inject into humans, Freund's Complete Adjuvant, was more than just mineral oil. It also contained Mycobacterium tuberculosis, the germ that caused TB. The mycobacteria were dead, but scientists thought they still might be in some way responsible for the problems associated with this concoction. So they removed the mycobacteria in hopes that the oil alone could do the trick; they called this new adjuvant "Freund's Incomplete Adjuvant." The incomplete adjuvant was just mineral oil in water, and a detergent to keep the oil evenly dispersed. Using it was a risky thing to do, but the Army considered the risks of not running this experiment even higher. This "incomplete" additive had been incorporated into an experimental flu vaccine. It was the flu that really worried the Army.
By all accounts, the great Spanish Flu pandemic of 1918 wasn't really Spanish at all. It was American. In fact, it was an Army flu. The first victim, the "index patient," was an Army private named Albert Gitchell who worked as a cook at the Army's Camp Funston on the vast Fort Riley military reservation in Kansas. It is believed that U.S. troops heading to Europe brought this flu with them. Before it was over, more than 20 MILLION people had died of influenza around the world—the deadliest natural disaster in world history. Army scientists wanted to prevent another global killer from emerging from an Army post where new recruits might become an unintended hatchery for some vicious new flu strain that once again could wipe out millions of people. Trying out a new oil additive on troops seemed like a relatively modest risk in comparison to the benefits of a better flu vaccine.
The Fort Dix experiment took place with the blessing of Fort Detrick. It was funded by the U.S. Army Medical Research and Development Command (USAMRDC), which would later oversee the development of the new anthrax vaccine and newer oil additives too. The Armed Forces Epidemiological Board (AFEB), which would be sponsor a large number of the experiments conducted on military personnel, would later recommend the injecting an experimental flu vaccine containing oil into every man and woman in the U.S. military without their informed consent. The risk of an outbreak of killer flu seemed too great to do otherwise. To run this experiment, the Army would contract none other than Jonas Salk. Salk had already tested Freund's Incomplete Adjuvant on medical students at the University of Pittsburgh under the sponsorship of the Armed Forces Epidemiological Board, and with funding from the Army Surgeon General. Based on this study, Salk thought it was safe.
Over the next two decades, the entire U.S. public health establishment - civilian and military - kept watch on what happened to the troops from Fort Dix. Everyone wanted in on the act. USAMRDC funded this study and its follow-ups. The National Academy of Sciences, the Walter Reed Army Institute of Research (WRAIR) and the Walter Reed Army Medical Center (WRAMC) did the initial round of surveys. Then the list started to grow. The National Academy of Sciences and the National Research Council organized more studies at the request of the Veteran's Administration, the Army and the U.S. Public Health Service "in collaboration with the Armed Forces Epidemiological Board." At the 17-year mark, academia got involved too. An AFEB scientist on the faculty of the University of Michigan School of Public Health organized yet another follow-up. No one, it seemed, wanted to be left out of such an important experiment.
And the experiment that seemingly had no end. Twenty-one years after Salk first injected unsuspecting soldiers with a theoretically new and improved flu vaccine, the Fort Dix troops were under the microscope yet again. The list of sponsors included many of America's most respected public health institutions: the National Academy of Sciences-National Research Council, the American Cancer Society, the Veterans Administration, the Department of Defense, the U.S. Public Health Service and the Commission on Influenza of the Armed forces Epidemiological Board. USAMRDC bankrolled this study, just as it did the first one. What was remarkable about this 21-year project - involving the military, civilian public health authorities and a major university - is that at no time during its execution did any of the scientists involved publicly discuss whether it was ethical to run a medical experiment on people without telling them. If these doctors had any concerns, they did not publish them.
Long before the last study was completed, AFEB proposed the adoption of an experimental flu vaccine with oil for everyone in the military. In 1963 and 1964, AFEB recommended injecting every man and woman in the armed forces with the new vaccine. The board also recommended that Department of Defense also commence studies with oil added to tetanus and diphtheria toxoids, and polio vaccines. , Army doctors seemed determined to add oil to every vaccine they could.
Here is what they were not telling anybody. By 1964, the year when everyone in the military was supposed to get immunized with an oil-boosted influenza vaccine, the Army already knew the risks this vaccine presented for a very specific type of illness. AFEB's Colonel Abram S. Benenson had drawn up a list of diseases that investigators should watch out for in veterans injected with the oily flu vaccine at Fort Dix. Benenson's list read like the contents of a chapter on autoimmune disease in an immunology textbook. It included multiple sclerosis, myelitis, Guillain-Barré syndrome, uveitis, neurodermatitis circumscripta and disseminata, amyloidosis, lupus erythematosus, dematomyositis, scleroderma, chronic pericarditis, Raynaud's disease, rheumatoid arthritis, rheumatoid myositis and acute glomerulonephritis—all of them autoimmune diseases.
The final study on the Fort Dix troopers had data that none of the previous ones had: autopsy results. The soldiers had grown older and many of them had died. Epidemiologists, mainly working for the National Research Council and the American Cancer Society, reported a "significant excess of deaths" in soldiers given the oil-boosted vaccine, which the investigators related to "ill-defined vascular lesions of the central nervous system." They attributed this fact to the greater number of autopsies available for the soldiers given the oil-boosted vaccine. But there were hints of a problem with autoimmunity. Ten percent of the soldiers studied, who were injected with the oil-boosted vaccine, developed a "collagen disease," which is a term doctors used to use interchangeably with autoimmune disease. Still, the number of patients in this study was too low to extrapolate any reliable conclusions from the data. That did not prevent government and military doctors from doing just that. They concluded that the oily flu vaccine was safe. Nevertheless, what the government then did not do was telling. The FDA never licensed the vaccine, or the oil adjuvant, for human use.
The Fort Dix experiment was the first time Army doctors and scientists injected an oil-boosted vaccine into U.S. troops without informed consent; there is now clinical evidence that it was far from the last. For more than a half century, factions in military medicine and in the U.S. public health establishment have actively campaigned to get an oily vaccine additive licensed, seemingly at any cost.
The Emperor's New Clothes
When scientists at Fort Detrick, following Joe Jemski's 1992 talk, reviewed the existing literature on the Wright vaccine, it didn't look good. Even with 6 shots, the vaccine did not protect very well. Guinea pigs vaccinated with the licensed human vaccine died when exposed to certain strains of anthrax. In 1986 the bad news got worse. In discovering that the licensed vaccine protected against the Army's old weapons strain, Vollum - from which the vaccine had been derived - Stephen Little and Gregory Knudson also discovered 8 more anthrax strains for which the PA vaccine did not work. Among them was the now notorious Ames strain that was mailed in 2001 anthrax letter attacks. Like the Army's previous research, the data confirmed that a live spore vaccine provided better protection against more strains. "The fact that the spore vaccine provided protection against all isolates tested suggests that other antigens may play a role in active immunity," they concluded. Which would argue for a live anthrax vaccine, but Fort Detrick's scientists expressed an age old concern about problem with living vaccines that could be traced all the way back to Pasteur: "Since this vaccine is a live immunogen," they warned, "safety factors must be considered before its use." Little and Knudson did not rule out the possibility of resorting to a live spore vaccine, but that is not what they then chose to pursue.
When they, along with Fort Detrick scientists Bruce Ivins and Sue Welkos, began working on a new anthrax vaccine, they chose a design that was all the rage at the NIH—subunit plus adjuvant. "Subunit" refers to small fragments of a germ. For safety, NIH scientists were using subunits of lethal viruses like HIV to be the chief component of their new generation of genetically engineered vaccines. These ultra-pure vaccines, which reduced an immunization to mere molecules from a microbe, were safe, but at a price. They were weak. In some cases, they afforded no detectable level of protection at all. This is why the NIH wanted an adjuvant more robust than alum for its new vaccines.
The subunit that Little, Knudson, Ivins and Welkos chose for the Army's new anthrax vaccine was a little surprising. It was protective antigen—the same main ingredient in the vaccine they were trying to replace. Although all the data from both U.S. and British military experiments from the 60's forward indicated that more components of the anthrax microbe needed to be in any effective anthrax vaccine—a fact that even Little and Knudson acknowledge in their 1986 paper—Fort Detrick's newest generation of anthrax investigators did just the opposite. In fact, they did one better. With recombinant DNA technology, their new vaccine would eliminate every extra molecule of anthrax unrelated to protective antigen. It would be purest PA formulation ever made, and would hence be the weakest anthrax vaccine ever made. Remember, in immunology, purity equals weakness.
Yet when Fort Detrick's scientists traveled to England in 1989 to report on their new vaccine to the International Workshop on Anthrax, they had some startling results to announce: Fort Detrick had found what everyone had been looking for: a single-shot anthrax vaccine. In guinea pigs, the new anthrax vaccine produced complete protection against the Ames strain with just one dose.
If this was completely at odds with everything Army scientists had found over the previous three decades, it was because the Fort Detrick team had added something new to the formula. It was a kind of trick, though not in the sense of something fraudulent or deceptive. The Army's scientists made no effort to conceal what they did. Quite the contrary, they reported this trick in great detail. It was an old trick. In the 80s, scientists at NIH had been promoting the use of oils in vaccines again. By now, there was a new crop of oily vaccine boosters hot off the lab bench. It was the oil emulsions that helped transform the Army's hapless protective antigen formula into a potent single-shot vaccine.
Dr. Bruce Ivins informed the workshop gathering in old cathedral city of Winchester that he had added three different adjuvants to his one-shot wonders. One was called "Tri-Mix," another "DeTox," and a third was "SAF-1," which stood for Syntex Adjuvant Formula I. They were all made with bacterial scraps from truly noxious microbes like Salmonella typhimurium and Mycobacteria tuberculosis. The British scientists from Porton Down tried a different tack—adding a preparation to the British anthrax vaccine made from the whooping cough germ, Bordetella pertussis. At Winchester, the Porton contingent called their approach "microbial supplementation." All of these adjuvants relied on bacteria, or portions of them, to stimulate the immune system.
The three additives used by Fort Detrick, however, differed from Porton Down's in one very significant way. The Fort Detrick additives were all emulsified in oil. The oils were only supposed to be "vehicles" that conveyed the bits of bacteria through the bloodstream. SAF-I, which provided less protection than the other two, contained the oil squalane. The two adjuvants that helped provide complete protection from Ames in guinea pigs, Tri-Mix and DeTox, were emulsified in squalene. At the time, no one at Fort Detrick or the NIH seems to have been aware that these oils were themselves immunostimulants.
Having invested decades into refining protective antigen to a singular purity, Ivins et al. were essentially polluting this new ultra-pure vaccine with extraneous antigens to make it work. That is what an adjuvant was—extra antigenic material for a vaccine that had been purified to such an extent that it could no longer do the job it was designed to do. Perhaps it was the importance of their apparent breakthrough that blinded these scientists to what they had done. Whatever it was, it prevented them from seeing the absurdity of their new creation, or its risks. A fully intact microbe presents dozens of different chemical binding sites an antibody can latch onto. Each of these sites is a separate target for a multi-front attack by the immune system. In pursuit of purity, Army scientists had removed all of the targets of anthrax germ but one. Now they had a dubious product that they were determined to improve, and they did it by adding targets from germs other than B. anthracis. Instead of adding more antigenic material from the anthrax microbe - as Lincoln had suggested in the 60s and as Turnbull and Melling had done in the 80s—the Fort Detrick team incorporated pieces of completely different germs.
This was Rube Goldberg immunology. The Army's vaccine whiz kids had devised the most convoluted, expensive and time-consuming way conceivable to make a virtually identical product—protective antigen—and then added material that essentially diverted the immune system's attention away to antigens unrelated to anthrax. Fort Detrick's new, souped-up single protein vaccine, like the old one, did nothing to induce an immune response to the organism itself, which could still feed, secrete toxins and multiply inside a vaccinated host. There was also one more flaw in this design: oils are potentially toxic, and the Fort Detrick team knew it. In Bruce Ivins' frequently cited paper on the Army's pursuit of an improved human anthrax vaccine, he noted that oil adjuvants "can provoke toxic, allergic, ulcerative, or lethal reactions." This should have prevented him from committing Fort Detrick to an oil-boosted anthrax vaccine in the first place, but for reasons that Ivins has never publicly disclosed, it did not deter him. Neither he nor anyone else who worked on this vaccine at Fort Detrick has published an explanation for why they did this.
Round Two
Anyone even remotely familiar with oil additives for vaccines could have told you that they were a big problem. For reasons science has yet to fully explain, oils and other fatty substances found in the body, like cholesterol and phosopholipids, are potent stimulants to the immune system. Try as they might, scientists trying to harness this property have yet to come up with an oil adjuvant safe enough to use in humans. Since the 1930's, the gold standard has been the aforementioned Freund's Complete Adjuvant—an elixir banned from human use because of its toxicity. When Freund's Incomplete Adjuvant, a vaccine additive made chiefly from mineral oil, proved too risky as well, scientists tried changing the oil.
In the early 1970s, scientists at UCLA Medical Center, including one of the most respected rheumatologists in the country at the time, Carl M. Pearson, started looking for a less toxic alternative to Freund's. They ran a series of experiments with a variety of edible oils on the assumption that because they were "metabolizable" the body could process them safely. In other words, if you could ingest them, you could inject them. Intuitively, this premise seems somewhat dubious: your body could metabolize a cheeseburger, for instance, but you couldn't liquefy it in a blender and inject the resulting slurry, and then expect to feel well in the morning. Pearson's associates, Michael Whitehouse and Frances W. Beck, injected more than dozen of these metabolizable oils into rats, including castor oil, coconut oil, olive oil, sesame seed oil, cottonseed oil, corn oil, wheat germ oil, safflower oil, cod liver oil, oleomargarine, and the commercial lubricating oil, silicone. When these were mixed with heat-killed Mycobacteria tuberculosis, the UCLA group got results it didn't expect. All of the oils were toxic; they all induced arthritis in rats with varying degrees of severity. The data changed Whitehouse's views on the safety of metabolizable oils. "To summarize very simply, I think most oils are dangerous," he now says. Based on their ability to cause arthritis, the researchers assigned the oils "arthritis scores," ranging from (+), which was moderately toxic, to (++++), which was guaranteed to cripple. Of all the metabolizable oils tested by Pearson's group, two were better than all the others at causing arthritis: squalene and squalane, the same emulsifying oils that Bruce Ivins used in his single shot anthrax vaccines.
Squalene and squalane scored (+++) and (++++) respectively. Between these two oils, squalene is the one you could definitely eat. Olive oil contains squalene; in theory, you could drizzle it onto a salad along with a little vinegar and have no worries. Your body would metabolize it along with the arugula and endive without as much as a hiccup. Injecting squalene, though, was another story. To make sure it was the oils that did the damage, Beck, Whitehouse and Pearson tried injecting rats with squalene and squalane without mycobacteria in the formula. Rats injected with either squalene or squalane all developed experimental allergic encephalomyelitis—the same MS-like disease caused by Freund's. The injected animals were left hobbled, dragging their paralyzed hindquarters through the wood chips in their cages. , The UCLA team had found what it was looking for: oils that induced autoimmune disease, but with less inflammation. Between the two of them, squalene was less desirable for UCLA's purposes. "Squalene was more arthritogenic," Beck recalls, "but it also produced a greater inflammation."
Risk v. Benefit
Given these oils proven ability to induce autoimmune disease, the Army's decision to put either of them in its second generation anthrax vaccine only makes sense when you put it in the context of the times, and in this case, a specific location. When he cancelled America's offensive biological warfare program, President Nixon also freed up some building for a more popular research effort. Arriving by helicopter at Fort Detrick's Blue and Grey Field in October 1971, President Nixon personally announced the creation of the Frederick Cancer Research Facility of the National Cancer Institute (NCI). Nixon had Fort Detrick allocate about 68 acres and 70 of its buildings as a new research campus for NCI. It was a fateful decision that would have consequences that even a president as forward-thinking as Nixon could not have foreseen. It would set in motion a series of decisions that would lead, almost inevitably, to the use of a substance that would endanger the health of hundreds of thousands of U.S. troops.
It is unclear how squalene first came to the attention of Army scientists at Fort Detrick, but one possibility is through the National Cancer Institute, now on its doorstep. Eliyahu Yarkoni and Herbert Rapp of NCI published a paper in 1979 that stirred national and international interest in the alleged therapeutic benefits of squalene and squalane. When combined with fragments of a particular bacterium, squalene and squalane had an astonishing effect. Yarkoni and Rapp reported complete tumor regression in mice injected with squalane, and nearly complete regression (92%) in mice injected with squalene. When they injected these oils directly into mouse tumors, the tumors either shrank or disappeared completely. The more oil in the mixture, the better it worked. Based on these early experiments, oils looked like they might hold the keys to the kingdom—a cure for cancer. There was, however, a hitch.
Yarkoni and Rapp knew about the UCLA data; citing the Beck and Whitehouse paper, Yarkoni and Rapp reported that squalene and squalane both caused autoimmune disease in rats—a fact that you will not find mentioned in any Army paper concerning Fort Detrick's work with squalene emulsions in the new anthrax vaccine. Even Yarkoni and Rapp barely mentioned the problem with squalene and squalane; it was limited to a single sentence at the end of their short paper. Although causing debilitating and ultimately fatal neurological damage in animals was a big downside, their concern, after all, was cancer.
Several more factors emerged in the 1980s that would affect the direction of the Army's anthrax vaccine research. The first was HIV. After the discovery of the human immunodeficiency virus in 1984, the cause of Acquired Immune Deficiency Syndrome (AIDS), the National Institutes of Health would devote billions to develop a vaccine. That year, the Centers for Disease Control reported 7,699 AIDS cases with 3,665 dead. By 1988, the number of diagnosed U.S. cases was 82,764 with 46,344 dead. That was a jump of more than 1000% in just 4 years. Mortality was 100%; for someone with AIDS, drugs could prolong life but not save it. Public health officials doing the math were horrified. No one dared make a whole virus vaccine, living or dead, from a germ like HIV. Vaccine researchers embraced gene-splicing as their only alternative—inserting HIV genes into non-lethal organisms like vaccinia. But the results were disappointing: these microbial hybrids barely elicited an immune response. That's why a new adjuvant was essential to NIH. Because of Yarkoni and Rapp's work, squalene and squalane emulsions had by then established themselves as NIH's adjuvants of choice.
HIV was threatening to become the great plague of the 20th century, worse even than the flu pandemic of 1918 that claimed more than 20 million lives. It was the public health cause célèbre of the 1980s. Rock Hudson had it; so did Liberace. When an Indiana school banned 14 year-old Ryan White from classes because he had HIV, Elton John and Michael Jackson became his friends and offered their support. Vice-President George Bush called for mandatory HIV testing. No other disease made as many headlines or pushed as many political buttons. For NIH, that translated into wide open government coffers. For researchers, it offered a shot at immortality. Any scientist who found a way to stop this new global scourge could reserve a seat in Stockholm for a Nobel Prize ceremony. A successful recombinant HIV vaccine would be just a start. The goal was to roll back all infectious diseases through immunization . if that were possible. But it wasn't going to happen without a more powerful vaccine booster. The FDA, stung by criticism from dying AIDS patients who wanted access to new drugs that could keep them alive even a few months longer, started to "fast-track" drugs through its licensing labyrinth, including experimental vaccines containing squalene. This was not without risks. The problem with the fast track was knowing when someone was playing it fast and loose.
Even NATO got on this bandwagon by sponsoring a conference in Cape Sounion, Greece, on vaccine adjuvants in the summer of 1988. The search for a new adjuvant was now a matter of national security. The U.S. Army sent a contingent from its Walter Reed Army Institute of Research led by Dr. Carl R. Alving, a proponent of vaccine boosters emulsified in squalene, in addition to his own favorite: liposomes. Liposomes are microscopic vesicles containing vaccine antigens. Think bath oil beads. Encapsulating bath oil in soluble beads makes it possible to transport measured doses of oil from the drug store where you bought them to where you ultimately want to put them—in your bathtub. Alving's liposomes were made from cholesterol, another oily substance closely related to squalene.
The Soviets Again
If anyone in the military had been inclined to ask questions about squalene's toxicity in the late 1980's, something else happened around that then that might have diverted them. In October 1989, a high-ranking Soviet biological weapons scientist defected to the West—the first one to do so. This was an extraordinary intelligence coup. At the invitation of a French pharmaceutical equipment maker, Dr. Vladimir Pasechnik of the Leningrad Institute of Ultra-Pure Biopreparations went to Paris for a conference and never went home. He left his family behind in Russia and wound up in Britain. One of the scientists who debriefed Pasechnik for the British was Jack Melling. "Pasechnik chose Britain," says Melling, "because he thought the U.S. still had an active biological warfare program and he didn't want anything more to do with making weapons. He didn't think the same of Britain." According to Melling, what Pasechnik told Britain's MI-6 raised even more alarm about the U.S. and British chemical anthrax vaccines. Pasechnik said that Moscow had created antibiotic-resistant super-strains of anthrax, plague and tularemia. Although Pasechnik's British handlers couldn't verify this, it sounded plausible enough to them; in part because making germs antibiotic-resistant was relatively easy to do, and in part because the Soviets had published several papers in the 1980's disclosing that they had developed a veterinary vaccine that immunized against all three of these microbes. Intelligence analysts had been asking themselves why Soviet livestock would need to be vaccinated against plague, tularemia and anthrax—the three agents regarded by bioweapons specialists as the most likely ones to be used in a biological warfare attack. They could not come up with a good answer.
Back in Maryland, Fort Detrick now had at least four viable prototypes of a single shot vaccine that they thought was safe. All were made from the protective antigen protein or pieces of it. Three others were recombinant vaccines; Fort Detrick had cloned the protective antigen gene into Bacillus subtilis, baculovirus and vaccinia. All of these prototypes were formulated with squalene or squalane. The ones showing the most promise were the protective antigen vaccines combined with these oils. According to Ivins and his Fort Detrick colleagues, just one dose of these new vaccines gave protection equivalent to three doses of the licensed U.S. vaccine . and the new vaccines were ready for clinical trials. All Fort Detrick needed now was the right time and place to test them.
Go to: www.vaccine-a.com
Posted by hspig at November 25, 2004 06:40 PM
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Comments
The blogoshphere is a great forum for discussion, what we all need to remind ourselves is that because someone say's "it's so" doesn't mean it is correct........Dan Rather found that out by putting common sense behind personal ideals.
Now for GWS this is a very serious subject to me as I am 100% disabled and have listened and been open to any and all who could come up with a common sense reason backed with documentation for my GWS symptoms.
Gary Matsamoto's book Vaccine-A, was that rare document which just made sense. The more I read and looked and the documentation the more I was convinced. I have 35 years of service, I do not take casually the thought that I could have been a "Lab Rat" I hate to even use the term BUT I am a realist not an idealist, middle management are the people who advise the TOWER if middle management can be corrupted by the enticement of a job once they retire I believe SOME will look the other way.
Those that are honest and principled then are left with a bag of no win decisions......Blow the whistle, and loose my job........Keep quite as LONG AS POSSIBLE...then if asked speak out.
The blogoshphere is now giving these individuals another option to speak out and get their message out without fear of retaliation.
I have a habit of looking for a motive for any action taken by a person, why would a journalist with the credentials of Gary Matsamoto’s stick his neck and reputation out on an issue that he felt wasn't true......I don't think these types of books make that much money??
On the other hand I keep seeing self serving documents and statements from Government Health employees which when researched are a stretch at best from the truth.
I don't think GWS was exposure to petrol chemicals, the reason I feel this way is none of the people living still in the area have GWS. The one compelling answer is that the troops who were not given the Anthrax shot do not have GWS....
The Government states that squalene was ONLY found in part per billion, well lets think about that......if part per billion can make your body respond so that you can test positive for a test that you have been exposed then it appears that it most be enough to cause a reaction.
This is somewhat like what causes cancer...we know what it does how to detect it and in some cases but not all what causes it...
Common sense not political correctness is the call for action in GWS possibly we need people who have some other skills should be used to help in the investigation???
We are the GREATEST Country in the world; those that hate us do so because they envy us. Lets see if possibly "squalene" is the cause of GWS, I personally don't care who finds it out and probably won't be alive because of it to know the answer but lets keep blogging and WE will find the answer, let the "chips fall" were they may. We need some Radio talk hosts to pick up on this issue where are you guys??????
We fought for our Country now support the controversy this is to big to be up-staged by pedophiles and a few wife killers.
Major USA
Posted by: Major USA at December 24, 2004 08:00 PM
The War Within: The Anthrax Vaccine Story
My name is Marilyn Wright. I hold a doctorate in public health education and I wrote this document. I have skeptically and carefully evaluated the evidence presented by Matsumoto and others. I believe this essay accurately summarizes the key points. I am not a veteran nor am I married to one. My son is currently serving in the military. He is not sick. My expertise is translating complex medical information into material the general public can better understand. I teach college classes including medical ethics.
Do not change this document in any way. Otherwise, please DO share it. You can reach me at voyagerheim@yahoo.com.
At the start of Gulf War One, our military leaders believed anthrax attacks against the troops on the ground were a real and potentially devastating possibility. When they looked in their pantry of vaccines, they found only a few doses of an anthrax vaccine that takes six shots over a long period to instill immunity to attack. Further, the pantry had no battlefield detection devices to even know if soldiers had been exposed. Casualties could be very high, the deaths would be ghastly, and press cameras were always at the ready. The military leadership ordered subordinates to find a solution.
Coincidentally, some military and civilian researchers had been working on a new, second generation vaccine for anthrax. One or two shots would do it. Immunity developed quickly and strongly. Soldiers would live to fight another day. It was safer to manufacture since whole anthrax particles were not used, only bits and pieces. As the saying goes, any port in a [desert] storm. The researchers knew that it would be a bargain with the devil. The new vaccine was not approved by the FDA and there was no time to get the approval. It seemed OK, at least it worked. Protecting the troops was a matter of national security, of wartime readiness and of avoiding bad press from lots of dead young Americans. And there was a prime opportunity to test the new vaccine out by vaccinating troops that badly needed the vaccine.
Besides not having FDA approval, there was the reaction problem. It was possible that a number of troops would have symptoms from the new fast-acting vaccine. Some reactions would be mild, some immediate, some later, and some severe. The reactions were due to the very thing that pushed the immune system to hurry up and make antibodies to anthrax. The additive supercharged the immune system, leading to the immune system attacking its own body. But in combat, deaths and injuries are calculated into the formula. The good of the many outweigh the good of any one individual. Some soldiers would possibly be sacrificed to protect the larger group.
Batches of the new vaccine were made up with varying strengths of the immune boosting agent. This is typically done to see which strength of the ingredient works best. In this case the ingredient was squalene, an oil. It also goes by the name MF59. Without this immune system super booster, the new vaccine was essentially useless. Unfortunately squalene, even in tiny amounts when injected into the body, overcharges the immune system. Experiments had been published clearly proving that squalene injections caused the immune system to attack its own muscles and nerves and other parts of the body.
A seemingly logical defense for using squalene is that squalene can be safely eaten. You can swallow it and not have a problem. Like hot sauce, eating it is one thing, but injecting it can lead to an entirely different response. The amount was very tiny, but as is the same with many other injectables, when you start counting molecules, even a tiny amount contains millions of invading molecules. Squalene is a powerful immune system stimulant; it doesn’t take much. The information that squalene was safe enough to eat or be rubbed on the skin, lead researchers to decide that injecting it would be an acceptable risk given the circumstances of imminent warfare.
To avoid political problems, the vaccination program was kept quiet. Most soldiers did not know, or probably much care, what this next shot contained. Until they started getting ill. Soldiers were under orders to take the shot, coded as Vaccine A, and could not refuse at the risk of dishonorable discharge. They were not told what the vaccine was, often it was not recorded on their shot record, or their record was ‘lost’ by the establishment. Then soldiers in specific base locations started getting sick. Some had been to war, others had not. Some were able to document that they had been given Vaccine A, with the magic immune system booster squalene. Symptoms of an immune system consuming itself appeared and the CDC recognized Gulf War Syndrome.
So, good intentions, faulty intelligence, failure to follow vaccine licensing rules, and arrogance combined to allow vaccination of troops with a hazardous substance. Someone had forgotten or ignored solid research showing squalene was very bad news for the lab animals injected with it. And now the same symptoms were showing up in veterans. And only veterans who got the shot got sick, whether or not they were exposed to ground conditions in Iraq. Some sick vets had never even left the U.S. It was the vaccine that was the common denominator.
In the meantime, the government and the manufacturer of squalene were moving forward with plans to develop other vaccines using the new wonder ingredient. Scientists with big reputations were on board. Government agencies and private manufacturers became entangled with one another, including the hiring of retired government personnel to work in the laboratory. This black hole of duplicity drew in more and more government agencies. A few agencies tried to look objectively at the situation, and they were mostly told the truth, but not the whole truth. The topic is so complex that the average legislator or investigator could not recognize the partial truths for what they were. For example, the partial truth was that squalene had been proven safe to use for humans. The whole truth was that the study documenting its safety was a study of cosmetic application to the skin, a far cry from injecting the substance.
Meanwhile, government supported research on the mysterious Gulf War Syndrome included testing ideas of toxic chemical exposure, bug bites, flea collars and other possible causes until the media and researchers tired of the circus and abandoned the sick veterans. Physicians labeled victims of Gulf War Syndrome as hysterics and malingerers. The story is so twisted, complex and huge that it easily overwhelms most attempts to comprehend its entirety. Researchers with pocketfuls of government grants were not particularly inclined to turn their keen skills on to an issue that would bite the hand that provided the grants. Few scientists or organizations are able to live without federal funds. However, several people that were not beholden to the US government did start to look at the situation. Dr. Pam Asa and reputable investigative journalist Gary Matsumoto were among those that took a more careful look at the events. They discovered the immune system booster was squalene and looked up the research on its side effects. Published literature was clear that squalene caused the immune system to attack its own body. These self-attacks by the immune system were leading to rheumatoid arthritis, fibromyalgia (a muscle disorder), chronic fatigue, cysts and a host of other problems.
Dr. Asa with the help of others developed a new blood test that could spot antibodies to squalene. Sure enough, squalene antibodies were present in those vets complaining of Gulf War Syndrome. Regular people do not have this antibody since antibodies are only made after the blood is exposed to the invader molecule. News reporters standing alongside the troops did not have squalene antibodies (or Gulf War Syndrome), but then they had not received the unlicensed, experimental, secret Vaccine A.
To summarize: the documentation is exacting, the threat is real, the program is about to resume using the same excuse that protecting the troops is worth it. But the sacrifice of a few troops for herd immunity really counts if it is your son or husband or significant other who withers and declines from the peak of physical health to a weak, exhausted, mentally confused shell.
Bodily reactions to squalene are surprising common. Some are devastating; some are gruesomely fatal. The Supreme Court has ruled that even obvious negligence by the military does not allow soldiers to sue for damages, but contracted manufacturers may not be immune from lawsuits. Generally if the military breaks you they are responsible for fixing you. Besides refusing to recognize they broke these vets, the big problem here is that there IS no ‘fix’ for autoimmune disorders. Some can be controlled. Others are fatal.
What to Do?
Here are some suggested steps you can take to help yourself and others.
p If you or your loved one is ordered to take the second generation (not the six shot) Anthrax vaccine, decide ahead of time what you will do.
p If you decide to comply, have a sample of your blood taken by a private physician before the shot to document the lack of squalene in your blood. If you have symptoms, have your blood taken again to look for the presence of squalene antibodies. This will help you as a participant in any class action lawsuits.
p Demand documentation in your vaccination card that you received anthrax vaccine and the lot number of the vaccine.
p Don’t wait for the military or VA medical system to decide what sickness you have. Go to an immunologist or rheumatologist since they are accustomed to dealing with autoimmune disorders.
p Keep copies of all your medical records.
p Check in with the Homeland Security Policy Institute Group, a nonprofit that does NOT take government funds, to get the latest information on medical care, legal care, and support. Available at http://www.hspig.org
p Check the web and blog sites for information.
p Contact your congressional representatives and tell them what happened to you. Do it in writing. Keep a copy. Send it certified, return receipt.
p Even if you are not in the military and have not had the shot, tell your congressional representative to put their body where their mouth is and take the shot themselves.
p Tell your representatives to stop the vaccines containing squalene.
p Do not take flu shots from overseas, some contain squalene.
p Read Vaccine A by Gary Matsumoto. Research PubMed for your own interest and proof on the negative effects of squalene on living things.
p Complain to medical ethics panels that this vaccine is harming people.
p Put the word out however you can to alert Gulf War vets, to alert current military personnel and to alert elected officials, that the cat is out of the bag, that the public is aware and alarmed about this harmful ingredient in the ‘new’ vaccines.
p Don’t take government reassurances at face value; there are documented instances of the government lying by omission of crucial information on this topic.
Posted by: Marilyn Wright at December 18, 2004 08:01 AM
GOVEEXEC.COM
*****
December 15, 2004
Defense seeks emergency authority to resume anthrax vaccinations
By Chris Strohm
cstrohm@govexec.com
The Defense Department has asked the Health and Human Services Department for emergency authority to resume its anthrax vaccination program for military personnel, Government Executive has learned.
Deputy Defense Secretary Paul Wolfowitz issued a Dec. 10 memo asking HHS Secretary Tommy Thompson to declare an emergency in order to justify using the vaccine for protection against inhaled anthrax. The military's anthrax vaccination program was suspended in late October by a federal judge in response to a lawsuit filed by six anonymous plaintiffs. The lawsuit argued that the vaccine was not proven to protect against inhaled anthrax, and led to health problems.
In the memo, Wolfowitz said he has "determined there is a significant potential for a military emergency involving a heightened risk to United States military forces of attack with anthrax."
[...]
Full text also posted in HSPIG Forums Site at:
Ron Wright, Moderator
HSPIG Forums Site
www.hspig.org
Posted by: Ron Wright at December 16, 2004 05:10 PM
I had read about the squalene "contamination" before,and had assumed it was due to carelessness.
(!)
I note Chiron has been having problems with its flu vaccine. Squalene related ?
Final note: The use of the term "informed consent" with respect to members of the armed forces seems a bit disingenuous.If you are an enlisted person, NOBODY asks your consent for ANYTHING ! You are herded through a "reception line",swabbed,injected,and sent on your way.
Posted by: mrmeangenes at December 14, 2004 12:56 PM
Posted: Mon Nov 29, 2004 6:05 pm Post subject: Reply to GulfVet2, RE: Coincidence?
--------------------------------------------------------------------------------
Dear GulfVet2: I obviously didn't think it was purely coincidental either. The trail of evidence is too complicated for TV, and almost too complicated for newspapers; hence the book. The DOD/FDA stonewalling on this issue - which has been documented by the GAO, Congressman Jack Metcalf, and the House Government Reform Committee - has been so formidable that I felt it necessary to write a book to lay it all out. Even pressure from Congress couldn't pry loose the facts that you've read in VACCINE A.
I took a page from my old employer's play book at Fox News Channel - "We Report. You Decide." I reported; now you decide.
What I reported in VACCINE A, you won't hear from the Department of Defense or the FDA. I think officials from DOD/FDA/NIH - the three federal agencies working in concert to "fast track" the second generation anthrax vaccine with squalene - will continue to stonewall, obfuscate and lie about squalene and its injurious effects until they are forced to testify about it under oath. With the help of veterans like yourself - the people who arguably need the most protection from unethical human experimentation - that could happen.
Sincerely,
Gary Matsumoto
Posted by: Gary Matasumoto at November 29, 2004 02:55 PM
Posted: Mon Nov 29, 2004 12:56 pm Post subject: Reply to GulfVet2, RE: Update to your list
--------------------------------------------------------------------------------
Dear GulfVet2: Thanks for helping make the list (of what went where) more comprehensive. I find the "SQ" annotation in your records very odd. SQ is a routinely used abbreviation for subcutaneous, which is utterly redundant in this case because the licensed protocol for the administration of Anthrax Vaccine Adsorbed (AVA) is subcutaneous. Unless other people were getting the shot by a different method. Interestingly, all the embedded reporters I know from Gulf War 2 say they were injected IM, or intramuscularly. In 1996-97, Fort Detrick began a study protocol to investigate a new two-dose priming schedule, which involved lengthening the time interval between shots and changing the "route of administration" from SQ to IM. IM is not the FDA-approved way to inject AVA. Coincidentally, the following year, 1998, the year the NIH formed the NIH Working Group with the FDA and DOD to "fast track" rPA102 with squalene, all these squalene "contaminated" vaccine lots turned up in the vaccine supply administered to U.S. troops. As I am sure you are all too painfully aware, FAV 038 contained a 27 parts per billion concentration of squalene; FAV 047 contained 83 parts per billion. In pharmacology, scientists "dose range" with twofold serial dilutions (as I describe in the book); they also conduct "dose escalation" studies to observe the effects on a patient of incremental increases inthe dosage of a drug.
Given DOD's track record of experimenting on troops, and the fact that there exists in the code of federal regulations rules (Title 21, Part 50.23) that make the administration of experimental drugs and vaccine to troops without informed consent perfectly legal, do you think the "SQ" annotation in your records, and the escalating dosages of squalene that you received in anthrax vaccine, are merely coincidental?
Sincerely,
Gary Matsumoto
Posted by: Gary Matasumoto at November 29, 2004 02:54 PM
Posted: Sun Nov 28, 2004 8:05 pm Post subject: Update to your list
--------------------------------------------------------------------------------
Gary,
For your list ... I received shots from lots 38 and 47 at Westover ARB in Massachusetts.
Also, in your book you mention "SQ" as an annotation behind the dose on one persons shot record. I have that annotation once in mine too. It was behind my 3rd anthrax shot which was from lot #38. It is the only place I have an annotation like that in any of my shot records for nearly 20 yea
Posted by: GulfVet2 at November 29, 2004 02:53 PM
Posted: Sun Nov 28, 2004 5:27 pm Post subject: Reply to DKehl and twill, RE: FAV 070, FAV 071, FAV 073
--------------------------------------------------------------------------------
Dear Dkehl and twill: Thank you for letting me know about FAV 071 and FAV 073 being administered at the Naval/Marine Corps Reserve Center in Reading, Pennsylvania and FAV 070 and FAV 073 being administered at Fort McCoy, Wisconsin.
FYI: Rachael Lacy - who died after anthrax immunization at Fort McCoy, Wisconsin - received shots from anthrax vaccine lot number FAV 073. The autopsy report from the Mayo Clinic (where she died) said Lacy had a "lupus-like illness." The Mayo Clinic medical examiners said Lacy also had pneumonia and the same eosinophil infiltration in her lungs(eosinophils are a specific type of immune cell) - the same immune cells found in the lungs of soldiers in Iraq suffering from the "mysterious" outbreaks of pneumonia that did not respond to antibiotics. These cases of aseptic pneumonia did, in fact, respond to steroids, which are the standard medication for the treatment of autoimmunity.
Sincerely,
Gary Matsumoto
Posted by: Gary Matasumoto at November 29, 2004 02:51 PM
Posted: Sun Nov 28, 2004 5:13 pm Post subject: Reply to forrest shalom, RE: israeli batch FAV 008
--------------------------------------------------------------------------------
Dear forrest shalom: According to an inventory from the Michigan Biologic Products Institute (MBPI), now BioPort, a total 360 doses of squalene-positive anthrax vaccine lot # FAV 008 were sent in three shipments to Israel. MBPI sent the first batch of 120 doses there on 30 June 1991. MBPI sent the second batch of 120 doses a year later on 15 June 1992. The third batch of 120 doses went to Israel about a year after that on 9 August 1993.
Based on information from the website run by the Assistant Secretary of Defense for Health Affairs, DOD subcontractor SRI (Stanford Research International) found 1-9 ppb concentrations in three separate doses of FAV 008. This was a significant finding because that meant a squalene-positive lot was, in fact, distributed for the first time on 22 January 2002, during Desert Storm. In other words, this was evidence that Desert Storm veterans could have received anthrax vaccine administered during the Gulf War. Batches of FAV 008, again, went to Israel, Germany, Taiwan and Canada.
FYI: The Departments of Biochemistry and Molecular Genetics, Infectious Diseases and Analytical Chemistry at the Israel Institute for Biological Research (Ness-Ziona, Israel) engineered a recombinant anthrax vaccine that contained anthrax spores derived from an anthrax strain that does not produce toxin or capsules. The Israeli spore vaccine contained no adjuvant. Israeli reseachers demonstrated that this vaccine made from a spore-forming strain conferred protection (in female Hartley guinea pigs and mice) that was superior to the U.S. licensed protective antigen-based vaccine. Here's the reference:
Cohen S, Mendelson I, Altboum Z, Kobiler D, Elhanany E, Bino T, Leitner M, Inbar I, Roseberg H, Gozes Y, Barak R, Fisher M, Kronman C, Velan B, Shafferman A, Attenuated nontoxinogenic and nonencapsulated recombinant Bacillus anthrax spore vaccine protect against anthrax, Infection and Immunity, 2000 Aug; Volume 68, Number 8, pgs. 4549-58.
Yours sincerely,
Gary Matsumoto
Posted by: Gary Matasumoto at November 29, 2004 02:50 PM
Posted: Sun Nov 28, 2004 2:34 pm Post subject:
--------------------------------------------------------------------------------
I received lots FAV 070 and 073 and Ft McCoy Wi. Just more to add to your list
Posted by: twill at November 29, 2004 02:49 PM
Posted: Sun Nov 28, 2004 3:21 am Post subject: israeli batch: FAV008
--------------------------------------------------------------------------------
i am in contact with an israeli who may have been given anthrax shots.
do you have any more data on FAV-008? i am going to ask my friend to
notify the israeli government about this. any more information that you may have on this batch sent to israel would be appreciated greatly!
todah rabah (thank you very much)
forrest shalom
Posted by: forrest shalom at November 29, 2004 02:49 PM
Posted: Sun Nov 28, 2004 5:27 pm Post subject: Reply to DKehl and twill, RE: FAV 070, FAV 071, FAV 073
--------------------------------------------------------------------------------
Dear Dkehl and twill: Thank you for letting me know about FAV 071 and FAV 073 being administered at the Naval/Marine Corps Reserve Center in Reading, Pennsylvania and FAV 070 and FAV 073 being administered at Fort McCoy, Wisconsin.
FYI: Rachael Lacy - who died after anthrax immunization at Fort McCoy, Wisconsin - received shots from anthrax vaccine lot number FAV 073. The autopsy report from the Mayo Clinic (where she died) said Lacy had a "lupus-like illness." The Mayo Clinic medical examiners said Lacy also had pneumonia and the same eosinophil infiltration in her lungs(eosinophils are a specific type of immune cell) - the same immune cells found in the lungs of soldiers in Iraq suffering from the "mysterious" outbreaks of pneumonia that did not respond to antibiotics. These cases of aseptic pneumonia did, in fact, respond to steroids, which are the standard medication for the treatment of autoimmunity.
Sincerely,
Gary Matsumoto
Posted by: Gary Matasumoto at November 29, 2004 02:46 PM
Posted: Sun Nov 28, 2004 5:13 pm Post subject: Reply to forrest shalom, RE: israeli batch FAV 008
--------------------------------------------------------------------------------
Dear forrest shalom: According to an inventory from the Michigan Biologic Products Institute (MBPI), now BioPort, a total 360 doses of squalene-positive anthrax vaccine lot # FAV 008 were sent in three shipments to Israel. MBPI sent the first batch of 120 doses there on 30 June 1991. MBPI sent the second batch of 120 doses a year later on 15 June 1992. The third batch of 120 doses went to Israel about a year after that on 9 August 1993.
Based on information from the website run by the Assistant Secretary of Defense for Health Affairs, DOD subcontractor SRI (Stanford Research International) found 1-9 ppb concentrations in three separate doses of FAV 008. This was a significant finding because that meant a squalene-positive lot was, in fact, distributed for the first time on 22 January 2002, during Desert Storm. In other words, this was evidence that Desert Storm veterans could have received anthrax vaccine administered during the Gulf War. Batches of FAV 008, again, went to Israel, Germany, Taiwan and Canada.
FYI: The Departments of Biochemistry and Molecular Genetics, Infectious Diseases and Analytical Chemistry at the Israel Institute for Biological Research (Ness-Ziona, Israel) engineered a recombinant anthrax vaccine that contained anthrax spores derived from an anthrax strain that does not produce toxin or capsules. The Israeli spore vaccine contained no adjuvant. Israeli reseachers demonstrated that this vaccine made from a spore-forming strain conferred protection (in female Hartley guinea pigs and mice) that was superior to the U.S. licensed protective antigen-based vaccine. Here's the reference:
Cohen S, Mendelson I, Altboum Z, Kobiler D, Elhanany E, Bino T, Leitner M, Inbar I, Roseberg H, Gozes Y, Barak R, Fisher M, Kronman C, Velan B, Shafferman A, Attenuated nontoxinogenic and nonencapsulated recombinant Bacillus anthrax spore vaccine protect against anthrax, Infection and Immunity, 2000 Aug; Volume 68, Number 8, pgs. 4549-58.
Yours sincerely,
Gary Matsumoto
Posted by: Gary Matasumoto at November 29, 2004 02:45 PM
Posted: Sun Nov 28, 2004 2:34 pm Post subject:
--------------------------------------------------------------------------------
I received lots FAV 070 and 073 and Ft McCoy Wi. Just more to add to your list
Posted by: twill at November 29, 2004 02:44 PM
Posted: Sun Nov 28, 2004 3:21 am Post subject: israeli batch: FAV008
--------------------------------------------------------------------------------
i am in contact with an israeli who may have been given anthrax shots.
do you have any more data on FAV-008? i am going to ask my friend to
notify the israeli government about this. any more information that you may have on this batch sent to israel would be appreciated greatly!
todah rabah (thank you very much)
forrest shalom
p.s thanks a million for the info on how much and when squalene tainted anthrax vaccine was sent to ft. bliss.
Posted by: forrest shalom at November 29, 2004 02:43 PM
Posted: Sat Nov 27, 2004 9:00 pm Post subject:
--------------------------------------------------------------------------------
I received lot #'s FAV 071 and FAV 073 at the Naval/Marine Corps Reserve Center in Reading, PA. Just an FYI to your list.
DKehl
Posted by: DKehl at November 29, 2004 02:42 PM
Posted: Sat Nov 27, 2004 7:11 pm Post subject: Reply to forrest shalom
--------------------------------------------------------------------------------
Dear forrest shalom:
According to a confidential inventory from Michigan Biologic Products Institute (MBPI), MBPI sent a shipment of 2,900 doses of anthrax vaccine lot # FAV 030 (a lot confirmed by FDA tests to contain squalene) to the Army's Fort Bliss on September 10, 1998.
Based on Tulane University Medical School's anti-squalene antibody data from military personnel recently injected with anthrax vaccine for deployment to Iraq, there are reasons to believe that some of the current lots #'s in the vaccine supply administered to U.S. military personnel contains squalene.
It is impossible to know with any degree of certainty if your cousin received injections from a squalene-positive lot without having those lots tested for squalene, or without having other people injected with those lots test positive for the antibodies.
Sincerely,
Gary Matsumoto
Posted by: Gary Matasumoto at November 29, 2004 02:41 PM
Posted: Sat Nov 27, 2004 4:26 am Post subject: fort bliss?
--------------------------------------------------------------------------------
gary,
when was the "bad" anthrax sent to ft. bliss?
my cousin is in the marines and i just found out he has taken two
anthrax shots so far (within the past two months or so). he is scheduled
to take 4 remaining for a total of six.).
do you think it has squalene?
thanks,
forrest
Posted by: forrest at November 29, 2004 02:40 PM
Posted: Fri Nov 26, 2004 3:53 am Post subject: SQUALENE-LACED ANTHRAX VACCINE AND WHERE IT WAS GIVEN
--------------------------------------------------------------------------------
FYI: Here again are the lot numbers for squalene-laced anthrax vaccine (and lots suspected of containing it). Following the lot numbers are some of the locations where these lots were administered. The location list is only partial, and based on available information from patient medical records, a Michigan Biologics Product Institute (MBPI) inventory and data from Tulane University Medical School.
LOT NUMBERS
Squalene-Positive [per FDA and SRI]:
FAV 008, FAV 020, FAV 030, FAV 038, FAV 043, FAV 047
Have Induced Anti-Squalene Antibodies [per Tulane Med School]:
FAV 041, FAV 070 and FAV 071
Associated with Autoimmune-Related Symptoms or Fullly Diagnosed Autoimmune Diseases in Troops [per Tulane]:
FAV 017, FAV 048b, FAV 066, FAV 068, FAV 069, FAV 073, FAV 074, FAV 075, FAV 078
LOCATIONS
FAV 008
Dover AFB (Delaware); fort Bragg (North Carolina), BioPort (administered to workers); Shipments of FAV 008 were also sent to Israel, Germany, Taiwan and Canada.
FAV 017
Osan, South Korea; Tripler Army Medical Center (Hawaii); Camp Lejeune (North Carolina); Fort Stewart (Georgia); 18th MEDCOM APO AP; Grand Forks AFB (North Dakota); Eleleson AFB (Arkansas), U.S. Air Force Academy (Colorado); Fort Drum (New York); Fort Campbell (Kentucky); Langley AFB (Virginia); Ellsworth AFB (South Dakota); Mountain Home AFB (Idaho); MacDill AFB (Florida); Pearl Harbor (Hawaii); Offut AFB (Nebraska); Barksdale AFB (Arkansas); Portsmouth (Virginia); Moody AFB (Georgia); Buckley ANG (Colorado); Malmstrom AFB (Montana); Fort Lewis (Washington); Davis-Monthan AFB (Arizona); Beale AFB (California); Fairchild AFB (Washington); Barkdale AFB (Arkansas); Virgnia Beach (Virginia)
FAV 020
Al Jaber, Kuwait; U.S.S. Independence (Persian Gulf); U.S.S. San Jacinto (Persian Gulf); Saudi Arabia; A shipment of FAV 020 was also sent to Australia.
FAV 030
Al Jaber, Kuwait; Dover AFB (Delaware); Michigan ANG (Michigan); Holloman AFB (New Mexico); Perry Point (Maryland); Naval Station Everett (Washington); Norfolk (Virginia); Cannon AFB (New Mexico); Holloman AFB (New Mexico); McChord AFB (Washington); Shaw AFB (South Carolina); Nellis AFB (Nevada); Fort Lewis (Washington); Travis AFB (California); Fort Bliss (Texas); Fort Dix (New Jersey); Grand Forks AFB (North Dakota); Seymour-Johnson AFB (North Carolina); Hickham AFB (Hawaii); Peterson AFB (Colorado); McConnell AFB (Kansas); Camp Pendleton (California); Naval Air Station Joint Reserve Base Willow Grove (Pennsylvania); Redstone Arsenal (Alabama); F.E. Warren AFB (Wyoming); Shipments of FAV 030 were also sent to Germany and Canada.
FAV 038
Osan, South Korea; U.S.S. Roosevelt; Hill AFB (Utah); Fort Benning (Georgia); BioPort (administered to workers)
FAV 041
Al Jaber, Kuwait; Westover AFB (Massachusetts); Dover AFB (Delaware); Michigan ANG (Michigan); Dharhan, Saudi Arabia; Tyndall AFB (Florida)
FAV 043
Osan, South Korea; Wright-Patterson AFB (Ohio); Tennessee ANG (Tennessee); Dover AFB (Delaware); Fort Bragg (North Carolina); Oklahoma ANG (Oklahoma); Grand Forks AFB (North Dakota); Travis AFB (California); Naval Air Station Joint Reserve Base Willow Grove (Pennsylvania); Fort Sill (Oklahoma); Key Field (Mississippi)
FAV 047
Travis AFB (California); Dover AFB (Delaware); BioPort (administered to workers)
FAV 048b
Grand Forks AFB (North Dakota)
FAV 070
Dyess AFB (Texas)
FAV 071
Dover AFB (Delaware); Camp Lejeune (North Carolina)
FAV 073
Fort Hood (Texas); Fort McCoy (Wisconsin)
FAV 078
Al Jaber, Kuwait
Posted by: Gary Matasumoto at November 29, 2004 02:39 PM
: Tue Nov 23, 2004 12:30 am Post subject: Reply to da phritzi
--------------------------------------------------------------------------------
Dear da phritzi: In addition to allergic and autoimmune diseases, oil adjuvants have been known to cause degenerative bone and joint disease. Unfortunately, if you got an anthrax shot during the Gulf War, you didn't win the lottery; you lost it. And that's painful for me to say. Your afflictions are all too familiar.
As someone who was out there at the time, I can say that all the men and women I met were highly motivated; you had jobs to do, a war to fight. You kicked Republican Guard butt. Iraqi pilots were so scared they wouldn't even engage. The kind of people I met were not the types to come home and feign illness for money or psychologically crumble from stress. Just the opposite; they were tough and ambitious. They were fighters, not whiners.
Thanks for writing. You've still got a warfighter's spirit; they broke your body, but not your will. Stay strong inside 'cause there's still more fighting to do. It's been nearly fourteen years, and government officials are only now admitting that Gulf War illness is a real physical ailment. They should not be allowed another fourteen years before they acknowledge that an untold number of these ailments have resulted from vaccine-induced autoimmunity with accompanying neurological injuries.
Sincerely,
Gary Matsumoto
Posted by: Gary Matasumoto at November 29, 2004 02:00 PM
Posted: Sat Nov 20, 2004 11:06 am Post subject: found book thanks
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Dear Da Phritzi,
Please go to http://www.milvacs.org/Sick/AdverseReactions.html
Posted by: DaRocksMom at November 29, 2004 02:00 PM
Posted: Fri Nov 19, 2004 6:58 pm Post subject: found book thanks
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found your book( someone left it in the wrong place at the book store)bought it immidiately. read time 4hours served in reyad & alcars saudia rabia fall 92 &95 took one predeployment shot each time i threw away my shot records after i realized that the gov screwed me up, i do remember an anotation for anthrax scribble 43. at the current time i am diagnosed with the auti immune disorder psoriatic(skin rashes) arthritus spondiloanthropy(degenerative bone and joint condition culminating in the fusing of the spine) this condition typically affects 1 in 500,000 people. iguess i won the lottery. i have noticed that a great many vets suffer from the cover all of degenerative bone/joint disorder. i have fibromyalgia, cfs, hyperaccusis(bionic hearing), as well as upper and lower ibs. my veiw point on my condition is simply this, there was nothing that i ran into in sa that i did not run into any where else, before or since, that was abnormal to my envoronment, except for the anthrax vacccine. i arived after the main conflict, didnt use ptabs, wasnt radid, gased, or toxed, i did eat some horse meat but the french chef said it was ok if i can be of assistance to anyone write me at bop3291, 71133-3291 i think that the book is right on target ant the va/dod/gov/other responsible parties are upset that science and the internet is preventing them from hidding their dirty little secrets like they did for agent orange and shad. and dont forget that the va doesnt like to admit to any service related condition until 80% of the participants are dead. i also find it ironic that the flu shortage we are currently experiancing is related to both chiron and squaline. if you are a vet or family member reading this, dont give up fighting the va, since they reopened claims and are reconsidering previously denied claimes if resubmitted. claimes can be proven by a single diagnosis, symptomology, history, condition, eye witnesses, or prescibed medicine grouping nexus. this book, vaccine a is a blessing to all pgw I era vets
in the fact that it clearly documents the madrid of associations causing our condition. each veteran family should have one for referance. the only drawback i could say about the book is that it could have listed a much larger symptom/condition listing than it did. could someone out there start a sypmtom/ condition servay. gm, we cant express our gratitude enough, and im a bitchy guy, definatly not an ass kisser. will buy more books later.
Posted by: da phritzi at November 29, 2004 01:58 PM
Posted: Fri Nov 19, 2004 2:01 pm Post subject: Reply to ex-WRAMC staff
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Dear ex-WRAMC staff: Yikes! I wish I had a chance to talk to you while I was writing Vaccine A. I'm disturbed, but not surprised, to hear that Dr. Roy was disingenuous with me about the somatoform and somatization disorder diagnoses being WRAMC "committee" decisions. FYI: I suspect that Pam Asa and Paul Rodriguez (Insight Magazine, 1997) might have been right about HIV vaccines being administered to troops during Gulf War I, but I could not find any documents or specific clinical evidence to support this idea.
Two things leave me suspicious about the possibility: (1) the contagiousness of GWS in some families, and (2) the birth defects. Oil adjuvants cause allergic and autoimmune disease which are not contagious. Oil adjuvants have been shown cause miscarriage (due to the induction of anti-phopholipid antibodies), but have not been demonstrated to cause birth defects.
There is something that might be a problem. An HIV vaccine using a recombinant live vector and the HIV envelope gene. A recombinant live vector, using vaccinia, is contagious. Peer reviewed data shows that patients inoculated with vaccinia shed virus for nine months or more. That means family members could catch a vaccinia infection from anyone who'd been immunized with it for smallpox, or immunized with vaccine as a recombinant live vector for the HIV envelope gene. Fort Detrick also made a recombinant vaccinia vector for anthrax protective antigen, but I'm not sure there's a good case to be made for its risks.
Where birth defects are concerned, the issue is the aforementioned HIV envelope gene - one the most highly conserved portions of the genome. As Dr. Asa explains it, this gene is a potential cause of birth defects. As you will recall, there was an unusually high number of babies with Goldenhaar Syndrome born to Gulf War vets. A recombinant PA vaccine could not, based on what I've read so far, account for any birth defects. Dr. Asa suspects that a recombinant HIV vaccine is another story.
If the recombinant HIV vaccine with the env gene (as opposed to the gag gene) is a problem, it would not have shown up in at least one of the populations to which is prototypes were administered as "immunotherapy" (in other words, as a possible cure for someone already sick, as opposed a classic vaccine that's supposed to prevent the illness from occurring in the first place) - homosexual men who were already HIV positive. As a rule, I think, homosexual men do not have children unless they adopt them, so birth defects would not have shown up in this population. If there is such a problem with this vaccine, however, it could have shown up among healthy heterosexual men. In one Goldenhaar case examined by Dr. Asa, a woman gave birth to a Goldenhaar baby after being impregnated by her Gulf War veteran husband before he deployed, but after his immunizations.
Again, I did not feel I had enough evidence to get into all this in Vaccine A, but that doesn't mean it didn't happen.
Sincerely,
Gary Matsumoto
Posted by: Gary Matasumoto at November 29, 2004 01:57 PM
Posted: Thu Nov 18, 2004 11:50 pm Post subject: psychosomatic disorder (somatization disorder)
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The first Gulf War Illness Center was opened on the Infectious Disease/HIV ward at WRAMC. Ever wonder why? refer to Insight Mag's reference to tainted HIV vaccinations. Veteran's beware, there are more than just tainted anthrax. vax.
98% of the patients that went through CCEP, (comprehensive clinical evaluation program) were given the somatization disorder diagnosis and deemed problem patients, personality disordered characters drawing the press into hushed up territory. Believe me, there was an unspoke of tension among staff, that things there were not to be talked about.
Michael Roy was the clinical director in name only, Col. Chung, who headed the infectious disease department really ran the show. under Gen. Blanck. They were looking for leishmeniosus (sp?). Patients who came through were given basic blood tests, which we all knew was to be sent to WRAIR for research, and then sent to subspecialty clinics for particular problems, back in '94 we saw a lot of G.I. problems. These patients were not staffed (talked about) in big meetings with other subspeciality doctors as Roy stated in your book. They were brought into this clinic to be controlled, and to control the G.I. outcry. Then they were hand stamped as crazy, and sent out unvalidated. I was the mental health officer that completed all the patient historys as they came into the clinic, and I never diagnosed one of them having somatization disorder. Maj. Roy made that diagnosis.
This was the beginning of deterring the masses from the truth, that of course still exists today, now in Round 3 with the squalene in anthrax.
Posted by: ex-WRAMC staff at November 29, 2004 01:56 PM
Posted: Sun Nov 14, 2004 12:45 pm Post subject: ROTC Cadets
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In the summer of 2000, higher doses than indicated of anthrax vaccine were accidentally administered to cadets participating in ROTC advanced camp at Fort Lewis, Washington. The nature, rates and severity of short-term side effects in relation to vaccine doses were assessed.
In total, 73 cadets with orders for follow-on training in Korea were scheduled to begin the anthrax vaccine series during Advanced Camp 2000 at Fort Lewis, Washington. On 16 June 2000, 25 cadets received 1.0 milliliter (ml) of the vaccine as their first doses, twice the amount (0.5 ml) recommended by the Food and Drug Administration. The accidental “doubled” doses were given when medical personnel administering the vaccine misunderstood instructions provided by a physician who explained how some residual vaccine remains in the needle hub after, for example, administering 1.0 ml of a vaccine. The medical personnel, who had substantial previous experience in giving anthrax vaccine in 0.5 ml doses, interpreted this guidance to mean that they were to give 1.0 ml of the vaccine. After 25 doubled doses had been administered, clinic personnel realized that they did not have enough vaccine to immunize all cadets who were scheduled. The problem was immediately identified, and actions were implemented to assure correct subsequent dosing.
In summary, cadets who received doubled first doses of anthrax vaccine had higher rates of several self-reported reactions. All reactions to the vaccine were mildand self-limiting, and none affected cadet training.
This was hushed very quickly in the media and a congressional hearing followed.
Gary, how are these cadets today? Long-term side effects reported? Were any of these reported to VAERS? I do NOT believe the studies or the reporting! Can you somehow find out for me how these cadets are today? I have waited almost 5 years for the TRUTH.
Thank you for your time and efforts!
Posted by: DaRocksMom at November 29, 2004 01:54 PM
Posted: Sat Oct 16, 2004 11:29 pm Post subject: Reply to Guest
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Dear Guest: While I am grateful to people such as yourself who might think that I am brave for having written this book, I was driven to write it less by courageousness than by a sense of indebtedness. I believe that I am in your debt, and in debt to the other men and women like you, who are this nation's strong arm in war ... and in peace, a great deterrent to our enemies. It is you who are brave, and I thank you.
Posted by: Gary Matasumoto at November 29, 2004 01:52 PM
Posted: Sat Oct 16, 2004 10:54 pm Post subject: Reply to "an airmen"
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Dear "an airmen": Over the past half century, unethical human experiments have been carried all too often out on people considered "expendable" (the poor, the terminally ill and the mentally handicapped). What greatly concerned me as I researched this book was the possibility that the military doctors and scientists who planned these experiments might have considered troops at war expendable precisely because some unknown percentage of them would die in battle anyway. The men and women who pledged themselves to defend this nation and its Constitution by serving in the armed forces did so with the understanding that they might one day die from an enemy's bullet or bomb. But just because airmen such as yourself have chosen a career that has you "dodging SCUDS in Dharhan or SAMs over Baghdad" does not mean that you are expendable. Your life counts. Although you've chosen a career in which you stand a greater chance than most Americans of being asked to surrender your life in the performance of your duties, I've yet to read any regulation that says your duties include being the unwitting subject of potentially lethal medical experiments. Americans fought a war of independence partly in defense an individual's right to self-determination. On those grounds alone, I would argue that human experimentation without informed consent is not only illegal, it is un-American. Thank you for the decades that you spent in the service of our country
Posted by: Gary Matasumoto at November 29, 2004 01:51 PM
Posted: Sat Oct 16, 2004 5:34 am Post subject:
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Mr. Matsumoto,
I also want to thank you for writing this book. My experiences have not been unlike the airman's in the previous post, only that mine were more recent. I am so grateful that people like you and Dr. Asa have the courage amidst the challenges that the government has thrown at you to stand up for what is right and expose the truth.
Posted by: Guest at November 29, 2004 01:50 PM
Posted: Fri Oct 15, 2004 12:44 pm Post subject: thank you
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Mr Matsumoto
I have recently retired from the United States Air Force. And I believe I was one of many at my base to be part of this "experiment". Apparently, back in the late 90s, our base got a "bad batch" and suffered an inordinate amount of problems with the vaccine.
Dr Asa forwarded me this link and I plan to buy the book immediately.
I had the anthrax series beginning in 1998 and concluding in 2003. Two weeks after my final vaccination I started to experience peripheral neuropathy in my toes/feet and fingers/hands. I have been to many specialist in 18 months. Fortunately, they have ruled out MS, Lupus and other auto-immune problems. But as you know, the incubation period could be years. I feel like I have a ticking bomb inside of me.
In the past few years I have seen members of a small military community suffer massive strokes, heart attacks and contract MS and Lupus.
I am a loyal patriot....I support our cause overseas and my brothers/sisters in arms. But I never thought that after twenty years in the military and dodging SCUDs in Dhahran or SAMs over Baghdad..that my scariest threat would come from within.
Thank you for your work. Sometimes it takes just as much courage to stand up to the system as it does to march into battle.
Godspeed
Posted by: An Airman at November 29, 2004 01:49 PM
: Wed Nov 17, 2004 1:18 am Post subject: Reply to gulfvet2
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Dear gulfvet2: Vaccine A lays out the case, and cites the evidence, for why the information propogated on the FRONTLINE website (to which you are directing people) is ludicrous. The FRONTLINE film, The Last Battle of the Gulf War, merely promotes the annointed government narrative on Gulf War illness promulgated from 1996 until very recently. Its message can be summarized this way: Gulf War illness does not exist. Gulf War veterans have been reporting a wide range of unrelated symptoms with only one factor common to all: stress.
I believe this particular FRONTLINE report is a journalistic travesty, and an affront to all the Gulf War veterans who have demonstrable physical illness; specifically, fully diagnosed autoimmune diseases accompanied by neurological injury. Stress, as I maintain in Vaccine A, is - along with chemical weapons, mycoplasma infections and depleted uranium exposures - a red herring.
So gulfvet2, the question is why would you direct the readers and contributors to this forum to a FRONTLINE website that propogates information that my book not only discredits, but website that is manifestly outdated, propogating information that is now being openly abandoned by government researchers who are admitting in 2004, with what I consider unconscionable tardiness, that there are sick Gulf War vets who suffer from neurological damage as opposed to the effects of psychosomatic illness?
How can you, at this late date, and with what is presumably a passing familiarity with the subject matter of this forum (given that you even know of its existence), still find a website asserting that Gulf War illness does not exist "very interesting?"
Would you care to explain why?
Sincerely,
Gary Matsumoto
Posted by: Gary Matasumoto at November 29, 2004 01:48 PM
Posted: Tue Nov 16, 2004 1:47 pm Post subject: Link to the media report
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I don't know about the MSNBC link, but here is one for frontline that is very interesting.
http://www.pbs.org/wgbh/pages/frontline/shows/syndrome/
Posted by: GulfVet2 at November 29, 2004 01:47 PM
Posted: Wed Oct 20, 2004 3:17 pm Post subject: Link to the media report
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Do you know if a link to the news report on Tuesday with MSNBC is available online? I heard about the interview, but I didn't get a chance to see it.
Posted by: Guest at November 29, 2004 01:46 PM
Posted: Thu Nov 18, 2004 3:43 am Post subject: P.S. TO SLATE ON SQUALENE EMULSION RC529-SE
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RC529-SE is a squalene emulsion from Corixa Corporation. RC529-SE’s squalene contents can be confirmed in two patents: (1) U.S. Patent 6,303,347 (Oct. 2001), and (2) 6,764,840 (June 2004).
Sincerely,
Gary Matsumoto
Posted by: Gary Matasumoto at November 29, 2004 01:44 PM
Posted: Thu Nov 18, 2004 3:39 am Post subject: FACTUAL ERRORS IN SLATE REVIEW OF VACCINE A
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TO THE EDITOR OF SLATE, RE: “ANTHRAX SCARE: Did the military secretly doctor its anthrax vaccine?”
Dear Sir:
I would like to correct the following errors in Mr. Cohen’s review of my book VACCINE A: The Covert Government Experiment That’s Killing Our Soldiers and Why GIs are Only the First Victims. Jon Cohen’s text is highlighted:
Paragraph Four: “Although it is not currently in any FDA-licensed vaccines and has caused autoimmunity in some animal experiments, it is, as we learn two-thirds of the way into the narrative, in a flu vaccine that’s licensed in Europe and has been safely injected into tens of millions of people.”
Correction: Cohen incorrectly attributes to me the assertion that the squalene emulsion flu vaccine, FLUAD™, has been safely injected into “tens of millions of people” in Europe. Mr. Cohen may have gotten this figure from some other source, but not from my book, and not from the reference that he cites in his review. The only figure that I have seen (published in a scientific paper on FLUAD™) puts the number of recipients of this vaccine the late 1990s somewhere around 600,000. The weblink in the body of his text, provided by Cohen to support the assertion that “tens of millions of people” have been safely injected with FLUAD™, connects SLATE readers to a Chiron Corporation (Chiron makes FLUAD™) press release, which says nothing about the number of people injected with FLUAD™. The phrase “tens of millions” or even the word “millions” does not appear anywhere in this document.
Paragraph Eight: “the trace amounts, they suggested [FDA officials], could have come from a technician’s fingertip.”
Correction: When FDA officials disclosed in September 2000 that they found squalene in anthrax vaccine, the agency’s Mark Ellengold suggested to Congress that the trace amounts of squalene probably came from the organism. They did not suggest that it could have come from someone’s fingertips. I clearly state this in the book. What’s more, I interviewed the FDA scientist who performed the GC/Mass spec analysis of seven lots of vaccine (five anthrax lots, one diphtheria and one tetanus); he said he wore gloves, which is standard operating procedure in this lab when running a GC analysis. He also ran “blanks” (plain water); these blanks did not contain squalene. Thus no one’s skin came in contact with the vaccine, or the water in blanks, or the glassware.
Suggesting that the squalene contents of anthrax vaccine is a result of fingertip contamination, an assertion for which FDA provides no supporting data. It is also, on the face of it, a counter-intuitive assertion; given squalene’s hydrophobicity (it repels water and won’t go into solution without being turned into micro-droplets, which must then be treated with a surfactant, a kind of detergent, to remain in suspension).
Greasy fingertips are just the latest in a long series of unsupported explanations for squalene contamination in anthrax vaccine from DOD and FDA. In 1998, the year the NIH formed the NIH Working Group with DOD and FDA to “fast track” the licensure of the new vaccine, FDA officials suggested to Senate investigators that any squalene in the vaccine could have come from eggs because many vaccine antigens are grown in eggs and eggs are rich in cholesterol (and theoretically the cholesterol precursor, squalene). In fact, anthrax is grown in a non-protein broth which contains no eggs or egg products. Later, DOD stated correctly, but misleadingly, that squalene is found in many plants and animals. Still later, both DOD and FDA stated for several years that squalene is “probably” found in the organism. Squalene is, indeed, found in many plants and animals. One place it is not found, however, is in Bacillus anthracis. Bacteria do not biosynthesize lipids as complex as squalene. This has been demonstrated with atomic precision. According to GC/Mass spec analyses of bacteria, they do not make lipids with more than 17 carbons atoms and are monounsaturated (1 double bond); squalene contains 30 carbon atoms and polyunsaturated (6 double bonds).
Paragraph Ten: “Wyeth made an FDA-licensed tetanus vaccine until it dropped out of the business in 2001, and Connaught is part of what’s now called Aventis Pasteur, which has an FDA licensed diphtheria vaccine.”
Correction: In this one sentence alone, Cohen makes three errors:
(1) Wyeth did not make an FDA-licensed tetanus vaccine;
(2) Wyeth did not drop out the vaccine business;
(3) Connaught did not make an FDA-licensed diphtheria vaccine.
We both made errors here. I had a dyslexic moment and transposed Wyeth diphtheria and Connaught tetanus; I referred to Wyeth tetanus and Connaught diphtheria. Cohen did the same thing. As he a result, he made three errors in one sentence (I made two).
In my book, I erroneously state that the FDA found trace quantities of squalene in an unlicensed Wyeth tetanus vaccine and an unlicensed Connaught diphtheria vaccine. In fact, the FDA tested an unlicensed monovalent diphtheria vaccine from Wyeth, which is still in the vaccine business. Cohen would have been correct had he stated that Connaught made an FDA-licensed tetanus vaccine, and was later bought out by Aventis-Pasteur.
As Cohen neglects to mention in his review, I cite several peer-reviewed studies that report data showing that bacteria (including Bacillus anthracis, Corynbacterium diphtheriae and Clostridium tetani) do not biosynthesize complex lipids like squalene. As stated previously, and I think it bears repeating here, there is, in fact, atomically precise evidence that bacteria do not make lipid molecules containing more than 17 to 19 carbon atoms, and have more than 1 double bond. Squalene is a 30-carbon molecule with 6 double bonds. I report this in my book. He also omits from his attack any reference to the incontrovertible evidence that bacteria do not make squalene. In light of this peer-reviewed data, repeatedly in other laboratories, I have argued in my book that it is incumbent upon the FDA to explain how it found squalene in the seven lots of vaccine (five anthrax, one diphtheria and one tetanus) that it tested in June 1999.
Paragraph Eleven: “He [Matsumoto] writes that “by questioning the safety of squalene, Asa imperiled more than 80 percent of the existing NIH-sponsored clinical trials to prevent HIV. This is fiction. Here is a list of 2001 list of AIDS vaccines in clinical trials and in the pipeline. Only one product, not yet tested in humans, uses squalene, and many don’t use adjuvants at all. Chiron Corp. did use squalene in earlier human tests of an experimental AIDS vaccine, but that project crashed and burned because of the unimpressive results with the HIV ingredients in the vaccine, not the adjuvant.”
Correction: Cohen’s assertions, once again, are incorrect. In making this particular attack, he takes what I have written in Chapter Eight (pg. 145) out of context. He refers in this paragraph to information specific to a period in time, 1991-1997, not 2001. From 1991-97, the GAO reports there were nineteen clinical studies with HIV vaccines, sponsored by NIAID and AVEG (AIDS Vaccine Evaluation Group), or NIAID and DIR (Division Intramural Research). GAO investigators got their information directly from NIAID officials. This information can be found in the GAO report, GULF WAR ILLNESSES: Questions About The Presence of Squalene Antibodies in Veterans Can Be Resolved (GAO/NSIAD-99-5, pg. 21). According to the GAO, there were nineteen trials with prototype HIV vaccines in this time period. All of them contained Chiron’s squalene emulsion adjuvant MF59. That’s 100 percent. If anything, then, based on the GAO’s reporting, me saying Asa’s antibody evidence “imperiled more than 80 percent of existing NIH-sponsored clinical trials to prevent HIV” was a rather generous underestimation. The GAO Appendix, citing data provided by NIAID and AVEG, not only specifies nineteen different NIAID clinical trials with an HIV vaccine emulsified in MF59 (a squalene emulsion), NIAID provided the GAO with the dates of each trial, the IND numbers for each trial, and the number of subjects in each.
When I informed Cohen of the GAO’s information during a telephone on Wednesday, November 18th, Cohen, without seeing the GAO report, flatly declared the GAO “wrong.” An unwillingness to review a document before declaring it wrong is, to me, a clear demonstration of bias.
In a weblink, Cohen directs SLATE readers to a 2001 survey paper on HIV vaccines, then misinforms readers when he writes, based on this paper, that “only one product, not yet tested in humans, uses squalene, and many don’t use adjuvants at all” (Johnston M, Flores J, Progress in HIV Vaccine Development, Current Opinion in Pharmacology, 2001(1): pg. 504-510) . To the contrary, in Table 2, the authors list Candidate vaccines in pre-clinical development. At least four of these vaccines, maybe more, rely on squalene emulsions:
(1) DNA, Sindbis replicons expressing multiple genes, novel recombinant envelope proteins [NIAID/Chiron];
(2) DNA expressing multiple HIV genes, DNA expressing cytokine gene and peptide boost [NIAID/Wyeth-Lederle];
(3) Vaccinia-env and envelope proteins [NIAID/St. Jude];
(4) Gp120 and regulatory proteins in novel adjuvants [GlaxoSmithKline].
In a cursory search of NIAID databases for current HIV vaccine trials involving a prototype HIV vaccines emulsified in squalene, I found several of them in quick succession:
(1) A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59, Sponsor: NIAID/Biocine, Study ID Numbers: AVEG 005C, ClinicalTrials.gov Identifier: NCT00000632 [Study Completed ca. 2002];
(2) Safety and Immune Response to a Combination HIV Vaccine Regiment in HIV Uninfected Adults, Sponsor: NIAID, Clade B Recombinant, Oligomeric gp 140/MF59 Adjuvant, Study ID Numbers: HTVN 049, ClinicalTrials.gov Identifier NCT00073216 [Currently recruiting];
(3) Safety of and Immune Response to a New HIV Vaccine HIV CTL MEP, Sponsor: NIAID, HIV CLT MEP administered with RC529-SE adjuvant, Study ID Numbers: HTVN 056, ClinicalTrials.gov Identifier: NCT00076037 [Currently recruiting].
Additionally, in a cursory search of PubMed, the data for the National Library of Medicine, I found many recently published papers on HIV vaccines emulsified in squalene. Here’s just one of them, concerning a Duke University pre-clinical trial with a HIV vaccine and squalene administered to monkeys:
(1) Egan MA, et al., A comparative evaluation of nasal and parenteral vaccine adjuvants to elicit systems mucosal HIV-1 peptide specific humoral immune responses in cynomolgus monkeys, Vaccine, 22 (2004), pgs. 3774-3788. (These particular researchers were at Duke University).
That NIH-funded HIV vaccine investigators rely on squalene emulsion adjuvants to create viable HIV vaccine prototypes is extremely well documented, and easily verifiable.
Cohen incorrectly asserts that I wrote “fiction.” Contrary to the impression that he tried hard to convey in this paragraph, replete with a weblink, Cohen’s reference does not support his assertion. I can provide you with hard copies of all the above documents.
Paragraph Twelve: “The shaky premise of Vaccine A falls apart completely when Asa and Garry—and, separately, military researchers—compare squalene antibody levels in people who received the anthrax vaccine and controls who did not. Logically, if the vaccine contained different amounts of squalene, vaccinated people should have higher levels of squalene antibodies than the unvaccinated. Asa and Garry found the antibodies in eight of 25 vaccinated people (32 percent) and three of 19 controls (15.8 percent). “This difference is not statistically significant in this size sample,” they reported in a 2002 paper.
Correction: Cohen takes this information out of context, omitting the critically important data that immediately follows the sentence that he quotes in order to bolster his case against my book and its allegedly “shaky premise.” Asa and Garry state: “Further analysis revealed that ASA [anti-squalene antibodies] were associated with specific lots of vaccine. The incidence of ASA in personnel in the blinded study receiving these lots was 47% (8/17) compared to an incidence of 0% (0/8; P
(Asa PB, Wilson RB, Garry RF, Antibodies to Squalene in Recipients of Anthrax Vaccine, Experimental and Molecular Pathology, 73; 2002, pgs. 19-27).
SUMMARY:Cohen makes an astonishing number of factual errors in a scant four pages. In at least two instances, he imputes information to me that I did not report. To support his argument, he selectively reports facts taken out of context, from my book, as well as from other sources. The references that I single out for criticism above do not support his assertions.
It is Cohen's prerogative to embrace DOD’s unsupported ex cathedra pronouncements on the amount of squalene required to initiate an immune response (the equivalent of “2000 pounds of mayonnaise”—relative to what the FDA found in anthrax vaccine), but I have quoted many scientists in the book who have concluded otherwise; not to mention Chiron Corporation, the manufacturer of the squalene emulsion licensed for use in flu vaccine in Europe, MF59. According to Chiron’s published data, its scientists have initiated an immune response in animals with 80 ppb concentration of MF59. Anthrax vaccine lot FAV 047 contained 83 ppb.
Cohen is entitled to disbelieve my book, and there’s no mistaking that he does, but he’s not entitled to invent facts, or misrepresent them, in order to persuade others to share his disbelief. Please make the appropriate corrections. If you require hard copies of documents to verify my corrections, please contact my publicist, Jamie Brickhouse, at Basic Books. His number is (212) 340-8000.
Thank you for your attention in this matter.
Sincerely,
Gary Matsumoto
Posted by: Gary Matasumoto at November 29, 2004 01:44 PM
Posted: Wed Nov 17, 2004 7:42 pm Post subject: VA Dovcumentation regarding MS
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DKehl wrote:
Does the VA have any documentation online showing that MS within 7 years of service is considered service related? If so, where can I find a copy?
Thanks!
Here is a link on information of what the VA has on service connection regarding MS. The top section is general rating information, but a little further down, it lists Neurological Disorders: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=6cb88841cd27ce5e4e7c3ff0eb4c4073&rgn=div5&view=text&node=38:1.0.1.1.5&idno=38
Here is a link to the only information I can find on the VA website regarding presumptive eligibility of MS: http://www.va.gov/ms/vfaq/afmviewfaq.asp?faqid=53
I hope this helps.
Posted by: emidan611 at November 29, 2004 01:42 PM
Posted: Tue Nov 16, 2004 5:41 am Post subject:
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Does the VA have any documentation online showing that MS within 7 years of service is considered service related? If so, where can I find a copy?
Thanks!
Posted by: DKel at November 29, 2004 01:40 PM
Posted: Mon Nov 15, 2004 3:36 pm Post subject: Re: Anthrax Vaccination timeline
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For whatever reason, the VA automatically associates MS as being service connected if it occurs within 7 years of separation of service. I found this interesting, and surely someone has to ask "why"?
Posted by: Guest at November 29, 2004 01:39 PM
Posted: Mon Nov 01, 2004 3:10 am Post subject: Anthrax vaccination timeline...
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In the last paragraph of Chapter 5 on page 88, it states, " On January 5, 1991, the U.S. military finally started immunizing its troops against anthrax." That is incorrect. While stationed at Hurlburt Field Air Force Base (Special Ops), right before being deployed to Saudi Arabia for Operation Desert Shield, I received an Anthrax vaccination on August 29, 1990. They were going to send me with no gas mask, and when the commander found out, she pulled me from the deployment. I never deployed and in February 1991, I left the service. Within a year from the administration of the Anthrax shot, I started to notice certain symptoms happening to me. After a few years, through the VA healthcare system, I was diagnosed with Multiple Sclerosis. I am now a service connected disabled veteran (without them admitting the shot caused my disability).
Posted by: Guest at November 29, 2004 01:39 PM
Posted: Wed Nov 17, 2004 2:34 am Post subject: Hives and miscarriage
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I have an increasing number of people reporting the hives which respond to standard treatments for allergic reactions and they seem to be chronic. Of interest is the fact that when tested for what these patients are allergic to, they have no reaction which is puzzling for all concerned. We do not know what this will mean for the future for these patients. It is always best to work with your physicians and keep them informed of any new or different symptoms.
It is believed that about 33% of all pregnancies are lost in miscarriages due to no known reasons. Many women go on to have successful pregnancies. Having said that, any medical condition can have an impact on pregnancies and may affect the ability to have a successful pregnancy. It is important to get as much information about your physical condition, discuss it with your OB and weigh the options. For example, if a patient has antiphospholipid antibodies either as a condition alone or in association with lupus, the blood clots more readily. These can lead to strokes, other blood clots, and miscarriages. It is important to determine if this or some other autoimmune condition is present and how to best deal with it. It is important when you have multiple Drs. to help facilitate communication among all of them in partnership in your medical care. I hope you will get the help and answers that you need. I wish you the very best in your efforts.
Posted by: Dr. Asa at November 29, 2004 01:37 PM
Posted: Wed Nov 03, 2004 3:00 am Post subject: Reply to Army Reservist
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Dear Army Reservist: I am upset to hear about your persistent rash and miscarriage, especially because I believe there is a strong possibility that both resulted from your squalene-tainted anthrax vaccinations. My suspicions are based on more than the fact that both occurred post-immunization; and that you were healthy and had no known allergies before your injection with squalene. They are based on the known effects of oil adjuvants in animals and humans. Here's what Army doctors and FDA scientists are not telling you: (1) urticaria has not only been observed in patients injected with squalene emulsion adjuvants in approved NIH-funded clinical trials, it has been observed in military personnel who've received injections from the squalene-positive anthrax vaccine lots (FAV 008, FAV 020, FAV 030, FAV 038, FAV 043, FAV 047). Urticaria, as you are now probably aware, is one of the symptoms associated with the allegedly undiagnosable Gulf War Syndrome; (2) pregnant animals injected with oil adjuvants have spontaneously aborted their fetuses. As you have read in this forum, both men and woman have experienced reproductive difficulties following anthrax vaccination. The vaccine's manufacturer, BioPort, even warns pregnant women not to take it. According to BioPort's January 2002 package insert, an unpublished Department of Defense study shows that women who received anthrax vaccinations during their pregnancies subsequently gave birth to children with defects. As for the prospects of your urticaria going away, and of having a risk-free pregnancy in the future, I am going to ask Dr. Asa to comment on that. I can say this much. Both urticaria and miscarriage are, in fact, associated with anthrax vaccination; BioPort has already admitted this. As stated in the aforementioned package insert, BioPort says patients injected with anthrax vaccine have suffered "hypersensitivity reactions" (allergic reactions such as urticaria) and have developed autoimmune diseases following anthrax vaccinations. The insert also states vaccine recipients have also suffered "spontaneous abortions" - in other words, they have miscarried. Tellingly, these phenomena were only observed in patients injected with anthrax vaccine after 1990 when the Army's second generation anthrax vaccine was first ready for clinical trials. As someone injected with two of the vaccine lots confirmed by the FDA to contain squalene, and because both your complaints - urticaria, a hypersensitivity reaction, and miscarriage - are both known consequences of injection with an oil adjuvant - I believe you have suffered injury from an unethical experiment. Whether the Department of Defense or the FDA concede this in the near term, both have publicly referred to squalene as a "contaminant." Therefore, by their own admission, you have been injected with "contaminated" vaccine. Scientific data from laboratories on four continents have shown that injecting squalene into animals causes autoimmune disease. At a minimum, then, the Army should be paying for your medications. If you are not yet being treated by a board certified rheumatologist, please ask your primary care physician for a referral. Your problem requires a specific kind of intervention, monitoring and management. If you have an autoimmune process underway in your body, you need to know about it. There are tests that can determine that. Please get those tests. Dr. Asa can tell you which ones to request. Autoimmune diseases - undiagnosed and untreated - can get progressively worse. Clinical testing can rule out autoimmunity, or alert you to a problem that requires attention. Some people, by virtue of their unique genetic makeup, are less susceptible to the ravages of chronic, adjuvant-induced autoimmunity. I hope you are among these fortunate peop
Posted by: Gary Matasumoto at November 29, 2004 01:36 PM
Posted: Sun Oct 31, 2004 10:03 pm Post subject: Hives and miscarriage
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I just finished reading the book. I picked it up in a bookstore last night, and I could not put it down. I am an Army Reservist, and I was given three anthrax vaccine shots in 1999, just prior to and during a 2/3 week TDY trip to Korea. At the time, I was very healthy and had never had any allergies or other medical problems. Several weeks after the third shot, I started getting unexplained systemic hives all over my body. Several months later, I had a miscarriage. To this day, I have to take medication to keep the hives under control (otherwise, I cannot sleep or otherwise function, I just itch all over my body). I have not tried to have another baby because I'm afraid to get pregnant when I seem to have an unexplained auto-immune disorder. The Army is not paying for my medication, which is pretty expensive (lucky for me I have insurance, but I must still make the co-payments). Army doctors have told me that the hives are not due to the anthrax vaccine, but that I must have an allergy to something, and that when people get older, they can suddenly develop allergies. I have gone to an allergist and he could not figure out what I was allergic to. When I read your book, I realized that I was shot with vaccine from lots FAV043 and FAV038, which contained squalene. I saw mention in your book about urticaria (hives), but I'm wondering if you have more information about this. Am I really going to have hives for the rest of my life as a result of this? And has anyone looked into the impact of this vaccine on females of child-bearing age? I was told that taking the vaccine would not harm my future ability to bear children.
Posted by: Army Reservist at November 29, 2004 01:35 PM
Posted: Tue Oct 26, 2004 4:10 pm Post subject: Infertility after anthrax shot
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Adjuvants are indeed known to cause testicular dysfunction. Additionally, if your husband received squalene in his anthrax shots and developed antisperm antibodies, the sperm would be damaged resulting in infertility. The fact that you all did have a healthy child prior to the immunizations, but now have this problem afterward, would suggest a possible connection. Your husband may wish to explore the issue of antisperm antibodies with his Dr. I wish you the best and hope you get the answers you need.
Posted by: Dr. Asa at November 29, 2004 01:34 PM
Posted: Tue Oct 26, 2004 2:54 pm Post subject: Reply to SSGTSWife