Guest guest Posted March 5, 2002 Report Share Posted March 5, 2002 THE VACCINE REACTION - Ken Tuesday, March 05, 2002 7:19 AM THE VACCINE REACTION THE VACCINE REACTION “When it happens to you or your child, the risks are 100%” Published by the National Vaccine Information Center Barbara Loe Fisher, Editor Special Report Winter 2002 SMALLPOX AND FORCED VACCINATION: WHAT EVERY AMERICAN NEEDS TO KNOW In this time of great sadness, fear and confusion, Americans have a choice to make: either we defend the individual freedoms our forefathers fought and died to give us, or we sacrifice those freedoms and let the terrorists win. What we choose to do will define who we are as a nation for many years to come. - Barbara Loe Fisher The terrorist attacks on New York City and Washington, D.C. on September 11, 2001 and the subsequent threats of biological warfare against US citizens have prompted calls by public health officials to prepare for mass vaccination campaigns for anthrax and smallpox.1,2 National vaccination programs targeting civilians, including children, are being proposed in model state legislation that would give public health officials the power to use the state militia to enforce vaccination during state-declared health emergencies.3,4 While it is critical for the US to have a sound, workable plan to respond to an act of bioterrorism, as well as enough safe and effective vaccines stockpiled for every American who wants to use them, there are legitimate concerns about a plan which forces citizens to use vaccines without their voluntary, informed consent. All mass vaccination campaigns result in casualties because every vaccine, like every drug, carries an inherent risk of injury or death.5,6,7,8,9 Some individuals are genetically or biologically more vulnerable to vaccine reactions than others,10 but there are few reliable biomarkers to predict who they are5,6,7,8,9 which is why legally protecting the informed consent rights of all citizens becomes a moral imperative. The human right to be fully informed about all known and unknown risks, as well as benefits, of any medical intervention and make a voluntary decision about whether to take the risk, has been the centerpiece of bioethics ever since the Nuremberg Code was adopted after World War II 11 and the doctrine of informed consent was introduced into U.S. case law in 1957.12 In evaluating the potential risk of a bioterrorism attack with real, as well as unpredictable, risks of exposing large numbers of children and adults to a prophylactic mass vaccination program for smallpox, some health officials have already concluded that the risks of mass vaccination outweigh the theoretical benefits.13,14,15 However, even in the event of a proven biological weapons assault and smallpox outbreak, sacrifice of the informed consent ethic would result in state-forced vaccine-induced injury and death of a biologically vulnerable minority in service to the majority, posing serious constitutional and moral questions. Although there have been suggestions that federal vaccine testing regulations should be curtailed in an effort to get a national supply of smallpox vaccine produced quickly,16,17 no mass vaccination campaign should be initiated without sound scientific evidence proving the vaccines to be used are safe and effective in protecting against an organism that may be used in a bioterrorism attack. This is particularly important if the organism, such as the smallpox virus, may have been genetically engineered to be vaccine and treatment resistant.18 Untested vaccines have the potential to give the illusion of safety and efficacy to the public when, in fact, they may cause far greater harm and be far less effective than predicted. The old live vaccinia virus vaccine for smallpox was never tested for safety or efficacy in controlled trials prior to mandates19,20 and it may have caused more reactions, injuries and deaths than any vaccine ever used by humans on a mass basis. Those recently vaccinated become infected with vaccinia virus and can transmit the virus to others, leading to injury and death for some.13,20,21,22,23,24,25 Unless the old vaccine for smallpox or a newly formulated vaccine is fully tested for safety and efficacy before being released for public use, legally and ethically the vaccine would have to be considered experimental and the mandated use of it a state-enforced national scientific experiment. Public Health Different Today: Scientific evaluation of the mass use of any new vaccine must be viewed in context with the other vaccines Americans are getting today and in consideration of the general health of different segments of our population. The most significant difference between the health of the U.S. population today compared to 1971, when routine vaccination for smallpox was halted in America, is that the numbers of Americans suffering with autoimmune and neurological disorders has increased significantly.21,26,27 In the past three decades, the numbers of children and young adults with asthma, learning disabilities and attention deficit hyperactivity disorder (ADHD) have doubled; diabetes has tripled; and autism has increased 200 to 600 percent in nearly every state.29,30, 31,32,33,34,35,36,37,38 Live vaccinia virus vaccine for smallpox, for example, would be given to children already receiving 37 doses of 11 other live virus and killed bacterial vaccines, including diphtheria, pertussis, tetanus (DTaP), polio, measles, mumps, rubella (MMR), haemophilus influenzae B, hepatitis B, chicken pox, and pneumococcal vaccines.39 In 1971, most American children were only receiving DPT, polio, measles and rubella vaccines.40 In addition, today there are many more adults suffering with HIV, lupus,41 herpes42 and other diseases affecting the immune system. Without appropriate safety studies evaluating the risks of an old or a new vaccine in the real world of today, there is no reliable way to predict the potential negative impact on the health of children and adults, especially on the tens of millions of Americans already suffering with chronic autoimmune and neurological disorders. BIOLOGICAL WARFARE Biological warfare is not a new phenomenon. History is full of examples of warring factions trying to weaken each other’s troops or civilian populations by making them sick. From the ancient Greeks and Romans, who polluted the water supplies of their enemies with dead animals, to warriors in medieval times who catapulted corpses of people infected with bubonic plague into the castles of their enemies, to European conquerors who came to the New World and used smallpox contaminated blankets to kill native Indians with no natural immunity to smallpox, there is a long history of man using disease as a weapon. 43 Modern biological weapons using lethal microorganisms were developed in the 1930’s by Japanese scientists, including aerosolized anthrax that was designed to be used in a specially designed fragmentation bomb. US and British scientists developed biological weapons during World War II using anthrax, botulinum toxin, encephalitis virus, staph enterotoxin and other deadly organisms. Even though the US has had biological weapons capability, the US has never used biological weapons on any nation and, since the Biological Weapons Convention in 1972, has supported a worldwide ban on development and use of biological weapons. There is evidence, however, that other nations have not stopped making biological weapons and that the Soviet Union, in particular, may have weaponized smallpox virus after 1972 in large quantities and that some of the virus may have been supplied to other countries such as Iraq, North Korea and China. There are still outstanding questions about whether Soviet scientists succeeded in making the smallpox virus a more lethal weapon by genetically engineering it so that any vaccine or drug would be ineffective. 1,18 SMALLPOX DISEASE Smallpox is a highly contagious, serious disease caused by the variola virus, a double stranded DNA virus which belongs to the genus orthopoxvirus that includes cowpox, monkeypox, and vaccinia. Poxviruses primarily affect the skin and cause disease in both humans (smallpox) and animals (swinepox, camelpox, sheeppox, goatpox, fowlpox).19 History: The first recorded cases of smallpox were in Asia in the first century A.D. but there is evidence the disease was present in China, India and Africa before that time. Smallpox was rarely seen in Europe until the Crusades, when Crusaders invaded the Holy Land during the Middle Ages and brought the disease back home with them. The Americas did not see smallpox until the Spanish invaders brought the disease to native Indian populations, who had no experience with the virus at all, which resulted in high mortality and significant destruction of tribes. In 18th century England, smallpox caused one in 10 deaths and was the leading cause of death in children.43,46 After worldwide mass vaccination campaigns in the 20th century, in 1979 the World Health Organization declared wild smallpox virus eradicated from the earth. The only remaining smallpox virus at that time was reported to exist in secure labs in the Soviet Union and the United States. However, since then, there have been reports that Soviet scientists developed the capacity to produce large quantities of the virus modified to survive delivery by missile warhead and that some of these stocks were supplied to countries hostile to the US.47 In addition, there is the possibility that the smallpox virus has been genetically or otherwise biologically altered to make it an even more lethal bioterrorism weapon, which may limit the effectiveness of the vaccinia virus vaccine used to prevent smallpox in the past.18,48 Viability As A Bioterrorist Weapon: Variola is a relatively stable virus in the natural environment and may retain its infectivity for as long as 24 to 48 hours if it is aerosolized and not exposed to sunlight or ultraviolet light. 49 There are several delivery routes that have been discussed if smallpox were to be used as a bioterrorist weapon to cause large numbers of infections in a population: release of the virus into a building, subway or airplane ventilation system or an area-wide drop of the virus by a plane or missile. Each of these theoretical scenarios requires that the terrorists: (1) have succeeded in obtaining the smallpox virus from one of the official laboratory storage facilities in the US or Russia or from a country which has secretly obtained the virus; (2) have the technical expertise and laboratory facilities to culture and maintain the viability of the virus; (3) have the ability to transport the virus in liquid or powder form without destroying its effectiveness; (4) have the technology to deliver it to large numbers of susceptible people. 45,50 Some have hypothesized that several “volunteer” infected carriers could silently transmit the disease,18 perhaps in large cities during the first week of the contagious period before the characteristic smallpox lesions appeared on their faces and limbs. Theoretically, this could happen although it would not be as effective as delivery of the organism to large numbers of people in a wide area. Still, even one person carrying smallpox could cause others to become infected who, in turn, could infect others. Reportedly, in 1970 a single smallpox infected man returning to Germany from Pakistan caused the direct or indirect infection of 19 others in a German hospital.51 In 1970, virtually everyone in Europe and the U.S. had been vaccinated against smallpox. Variola Virus: The variola virus which causes smallpox is an orthopoxvirus and has not been documented to infect animals or insects. Cowpox, monkey pox and vaccinia are the three other orthopoxviruses and all three of these viruses can cause disease in both animals and humans.49 Two Kinds of Smallpox: There are two kinds of smallpox: variola minor and variola major. Variola minor causes a milder case of the disease resulting in a case-fatality ratio of less than one percent. Variola major is much more serious with a case fatality of between 20 and 30 percent. The variola virus causing both variations of smallpox are biologically and immunologically indistinguishable from each other in the laboratory and a mild case of variola major can look like a case of variola minor. Endemic variola major was eradicated from the US in 1926 and variola minor disappeared from the US in the 1940’s.19,22 Infection and Contagion: According to the Working Group on Civilian Biodefense, “Historically, the rapidity of smallpox contagion was generally slower than for such diseases as measles and chickenpox. Patients spread smallpox primarily to household members and friends; large outbreaks in schools, for example, were uncommon.”49 Face-to-face contact with an infected person is usually required to transmit smallpox, which is spread from one person to another through nasal secretions and saliva by coughing and sneezing.52 A person usually becomes infected by inhaling the virus, which enters the respiratory tract and multiplies there and in the spleen, bone marrow and lymph nodes. The liver, spleen and lymph nodes can become enlarged.19,49 Coming into direct contact with the secretions from open smallpox skin lesions can also spread the disease. Secretions from smallpox lesions can contaminate clothing, bedding, or other materials, which have been used by an infected person, so disinfection of articles used by an infected person is necessary. Hot water containing hypochlorite bleach and quaternary ammonia has been used to decontaminate clothing, bedding and cleaning surfaces possibly exposed to the virus and formaldehyde has been used to fumigate contaminated areas.52 No Contagion for One or Two Weeks: A person with smallpox is infectious from a day before the rash appears (about 10 to 14 days after infection) until all lesions have healed and the scabs have fallen off. In the incubation period of the disease during the two weeks prior to the appearance of a fever and flu-like symptoms, there is no evidence that the smallpox virus sheds and can be transmitted to others and the person looks and feels healthy. Only after the fever and flu-like symptoms begin and then disappear before the outbreak of a rash, will the person be highly contagious and able to infect others through the release of virus in the mouth, throat and respiratory tract. The large amounts of virus shed from the skin lesions can be infectious but are not as infectious as the virus released by the respiratory tract.49.52 Although persons suffering from variola major, the more severe smallpox, are visibly sick and often bedridden even before the outbreak of the rash, those who have variola minor, the milder smallpox, may not know they are sick until the rash and lesions erupt. Therefore, unsuspecting carriers of a less severe form of smallpox could spread the disease more easily during the early part of the contagious period. There are estimates that one infected person may transmit the disease to between 5 and 10 other persons in populations with no natural or vaccine-induced immunity.52 Those persons can, in turn, infect 5 to 10 others and that is how an epidemic can begin. Incubation and Symptoms: The incubation period of smallpox from the time of infection to the time that symptoms begin to appear is about 12 to 14 days at which time the person develops a fever of 102 to 106 F., extreme fatigue, severe headache and back pain, and, occasionally, abdominal pain and vomiting. After 3 or 4 days the fever goes down and the patient may appear to recover but then a rash appears on the face and forearms and spreads to the trunk, legs, and, sometimes, appears on the palms and soles of the feet.20,22,49,52 On the third or fourth day after the rash appears, hard lumps (papules) form under the skin. These papules swell and turn into vesicles (sacs under the skin filled with fluid) that eventually turn into pustules (open skin lesions containing clear, then cloudy fluid filled with pus). A fever often accompanies the rash and formation of papules and vesicles. The pustules, which can resemble chicken pox lesions but are much deeper in the skin, also develop and ulcerate in the mucous membranes of the nose, mouth and throat and release large amounts of virus into the mouth and throat. 20,22,49,52 The deep ulcerative skin lesions eventually form crusts and scabs that usually fall off within three weeks after the beginning of the illness. The patient can be left with small scars or deep pits in the skin if the sebaceous glands of the skin are destroyed.20,22,49,52 Rare Types of Smallpox: A milder illness may occur both in those who have been vaccinated and those who have not been vaccinated, including cases that include a rash but no eruption of any lesions (variola sine eruptione). But in another rare form of smallpox, known as malignant smallpox, the disease remains in the rash stage and pustular lesions do not erupt. Malignant smallpox is almost always fatal, as is another rare form of smallpox, known as hemorrhagic smallpox. A person with hemorrhagic smallpox develops fever, bone marrow depression, a drop in platelets (thrombocytopenia) and uncontrollable bleeding into the skin and mucous membranes leading to death.22,49 Complications and Mortality: The smallpox lesions can become infected, leading to bacterial superinfections usually caused by staphylococcus aureus. Other complications include conjunctivitis (inflammation of the membrane covering the eyeball); bacterial pneumonia; viral arthritis; sepsis (blood infection); encephalomyelitis (inflammation of the brain) and osteomyelitis (inflammation of the bone). Permanent damage can include blindness, brain damage, and severe facial and body scarring. In the past, smallpox killed between one percent and 30 percent of those infected, depending upon whether the person had variola minor or variola major, and mortality was highest in infants and the elderly.19,22,46,49 Misdiagnosis Can Occur: Before smallpox was eradicated in 1977, doctors sometimes confused chicken pox with smallpox. During the first two to three days of the rash, it is almost impossible to distinguish between the two diseases. The main symptomatic difference between the two is that smallpox lesions are all in the same stage of development while chickenpox lesions can be in various stages of development on different parts of the body. Also, the smallpox rash primarily affects the face and limbs of the body and the chickenpox rash is primarily on the trunk of the body and almost never affects the palms of the hand or soles of the feet like smallpox. Lab tests can distinguish between a herpes group infection (chicken pox) and a poxvirus infection (smallpox).19,22,52 Other diseases that can mimic smallpox are eczema vaccinatum, eczema herpeticum, rickettsialpox, drug reactions, contact dermatitis, and erythema multiforme (inflammation of the skin and mucous membranes). Meningococcemia, typhus and hemorrhagic fevers can also be mistaken for the more severe fulminant, hemorrhagic smallpox.22 Human monkeypox, which occurs in Africa, is difficult to distinguish from smallpox. Also, sometimes disseminated vaccinia virus infection (from the vaccine) can be confused with smallpox.19 Definitive Lab Diagnosis: Lab detection of smallpox can occur within a few hours but definitive identification requires growth of the virus in cell culture or on the chorioallantoic egg membrane and characterization of strains by use of biologic assays, such as polymerase chain reaction (PCR) techniques.22,49 Treatment for Smallpox Limited: Vaccinia virus vaccine given up to four days after exposure to the virus reportedly can provide protection or lessen the severity of smallpox.49 Antibiotics will not cure smallpox because it is a viral, not a bacterial, infection. There are a number of anti-viral medications being investigated, such as cidofovir, but there is no drug currently on the market licensed as a specific treatment for smallpox.52 Like with chicken pox, preventing bacterial infection of the skin lesions is important. Sterile sheets, clothing and other sterile procedures can help reduce complicating bacterial skin infections. Antibiotics to treat secondary infections are given by injection or orally as topical antibiotics are not used. Antihistamines may reduce itching and scratching of the lesions and help prevent their spread to other parts of the body, such as the eyes.22,52 LIVE VACCINIA VIRUS (SMALLPOX) VACCINE Early History of Smallpox Prevention: The idea of deliberately exposing a healthy person to biological matter from smallpox lesions of an infected person in order to confer immunity dates back to China several centuries B.C., when Chinese doctors dried and ground up the crusts of smallpox scabs and used tubes to blow the material into the noses of healthy persons. In Africa, Asia Minor and parts of Europe, people swallowed smallpox scabs or had doctors scratch smallpox lymph into their skin (variolation).46 In 17th and 18th century England and America, it was common practice to scrape smallpox pus from lesions of a person infected with smallpox and then scrape it onto the skin of healthy children and adults in the hope of causing a mild, rather than a severe, form of smallpox. This process became known as variolation. Although smallpox variolation worked for some, it left one in 300 dead and others with severe enough smallpox that they were permanently scarred or blinded from the intervention. Many others were unknowingly infected with syphilis, tuberculosis and hepatitis because the biological matter from smallpox lesions was taken from persons also suffering from those serious diseases. Variolation also contributed to the spread of smallpox throughout populations.46 Jenner Uses Cowpox Virus: In 1796, British physician Edward Jenner observed that milkmaids who contracted the generally mild cowpox never came down with the more severe smallpox. (Cowpox is a disease of the teats and udders of cows and when cowpox infects humans it causes low-grade fever, lymph node swelling, and superficial lesions that are much milder than smallpox and heal without scarring. Sometimes cowpox can cause encephalitis and, in persons with a history of eczema, there is a risk of serious infection).22 Jenner experimented on an eight year old boy. He infected him with cowpox by scraping pus from lesions of a child infected with cowpox onto the skin of the boy. Later, Jenner twice challenged the boy’s immunity to smallpox by scraping pus from the lesions of a person with smallpox onto the boy’s skin. The boy never came down with smallpox and Jenner widely promoted his discovery and advocated cowpox inoculation as a prevention for smallpox.46 Vaccinia Virus Emerges: Eventually, Jenner’s method for preventing smallpox was modified and standardized for mass production by the pharmaceutical industry. Apparently, as Jenner refined the cowpox inoculation process, a new virus called vaccinia evolved. To this day, it is unknown exactly how the vaccinia virus came into being but theories are that it is a weakened form of the smallpox or cowpox virus or, more likely, a hybrid of the two viruses.19,47,53,54 Jenner’s smallpox prevention method became known as “vaccination” and was endorsed by government health officials in Europe and America in the 19th and 20th centuries. Vaccinia Virus Vaccine Never Tested: The currently licensed vaccine for smallpox contains live vaccinia virus, a double stranded virus with a broad host range. According to Harrison’s Principles of Internal Medicine (1994), “Vaccinia virus never underwent controlled trials to establish safety and efficacy before licensing. Nevertheless, the vaccine was highly effective, despite considerable adverse effects.”19 There are now multiple strains of vaccinia virus with varying degrees of virulence for humans and animals. Scientists working on new vaccines for diseases, such as HIV, have created recombinant vaccinia viruses from several strains of vaccinia virus.19,20,53 Wyeth Vaccine From 1970’s Used Calves: When vaccinia virus was used to make smallpox vaccine in the past, it was prepared from the vesicle fluid taken from live calves deliberately infected with vaccinia virus. After the calves were slaughtered, the pustules were scraped to recover fluid and the scrapings were freeze dried. This is how the approximately 15.4 million doses of smallpox vaccine currently stockpiled in the US was manufactured by Wyeth Laboratories in the 1970’s.21,47 Wyeth used calf vesicle fluid containing a seed virus derived from a New York City Board of Health strain of vaccinia virus.20 This stockpiled vaccine, known as Dryvax, contains trace amounts of polymyxcin B sulfate, streptomycin sulfate, chlortetracycline hydrochloride and neomycin sulfate, as well as glycerin (50%) and phenol (.25%).55 Phenol is an extremely poisonous compound obtained by distillation of coal tar and used as an antimicrobial. Ingestion or absorption of phenol through the skin can cause colic, weakness, collapse and local irritation and corrosion.56 Stockpiles Have Deteriorated: Reportedly, Dryvax stockpiles have been stored in glass tubes in the form of freeze dried crystals that would be mixed with a liquid diluent just before vaccination using a bifurcated needle that allows droplets of the vaccine to be scratched onto the skin. In 1999 the CDC discovered that some of the U.S. Dryvax smallpox vaccine stockpiles had badly deteriorated: rubber stoppers on the glass storage tubes had decayed and vacuum pressure had been lost while the liquid diluent had changed color and there were only one million bifurcated needles to administer more than 15 million doses.57 Old Vaccine Now Being Tested in Volunteers: However, in response to the fear generated after September 11 that smallpox virus stored in the Soviet Union may have fallen into the hands of terrorists in other countries, some of these old stocks of vaccinia virus vaccine are being diluted to one in ten or one in five and given to volunteers at the University of Maryland, St. Louis University, University of Rochester School of Medicine and Baylor College of Medicine to test its effectiveness.14,15,58 The goal is to increase the numbers of doses of old vaccinia virus vaccine currently available in order to buy time for new vaccine production. New Vaccines To Use Different Cell Tissues: According to the Working Group on Civilian Biodefense, “The traditional method for producing vaccines on the scarified flank of a calf is no longer acceptable because the product inevitably contains some microbial contaminants, however stringent the purification measures.”49 New vaccinia virus vaccines reportedly will not use vaccinia virus cultured from calf vesicle fluid but will be grown in laboratories using other cell tissues such as human fibroblasts (from fetal connective tissue cells).21 In the June 22, 2001 MMWR, the CDC confirms that previous methods of vaccine production using calves are no longer being used and that vaccinia virus for new production of smallpox vaccine must be grown using a Food and Drug Administration approved cell culture substrate. The CDC indicates that new cell-culture vaccinia virus vaccine will be evaluated for safety and efficacy by direct comparison with Dryvax using appropriate animal models, serologic and cell-mediated immunity methods and cutaneous indicators of successful vaccination.20 Antibody Level for Protection Unknown: Live vaccinia virus vaccine produces neutralizing antibodies that are genus specific and cross-protective for orthopoxviruses (monkeypox, cowpox, variola). According to the CDC, the efficacy of vaccinia vaccine to prevent smallpox has never been measured precisely during controlled trials and the level of antibody required for protection against smallpox infection is unknown. The level of antibody required for protection against vaccinia virus infection is also unknown. However, more than 95 percent of first-time vaccinees are reported to experience neutralizing or hemagglutination inhibition antibody.20 Duration of Immunity Estimates Vary: According to the CDC, the live vaccinia virus vaccine is protective for five to 10 years.20 The CDC recommends that lab and medical personnel at high risk of being exposed to vaccinia viruses be revaccinated every 10 years.24 However, analysis of a 1902-1903 smallpox outbreak in Liverpool, England as well as a study conducted at the University of Massachusetts Medical Center and published in a 1996 article in the Journal of Virology suggests that varying degrees of immunity from vaccinia virus vaccination may persist for up to 50 years.59,60 If true, then the oldest half of the US population, which was vaccinated before 1970, may have some remaining immunity to the smallpox virus. Vaccinia Virus Vaccination Procedure: The method of vaccinia virus vaccination is to withdraw reconstituted vaccine from the vial with a sterile bifurcated (forked) needle, then release a droplet of vaccine onto the skin over the deltoid muscle in the upper arm; then repeatedly press (15 times) the forked needle into the superficial layer of skin covered with vaccine hard enough to draw traces of blood. A loose, porous bandage or gauze held with tape is then applied to help prevent the person from touching the vaccination site and transferring the live virus to other parts of the body or to other persons.20,52 Two to five days after inoculation, a red papule (lump) at the site should appear. On day five or six, the papule should swell and fill with fluid (turn into a vesicle). Between days seven and 11, the vesicle should turn into a pustule (become an open, pus-filled lesion). About two weeks after vaccination, the pustule dries and develops a crust that falls off by the end of the third week and leaves the characteristic smallpox scar on the skin.22 If a person is already partially immune to smallpox (either through previous experience with the disease or vaccination), there may be an accelerated process that includes a papule that appears within 3 days, vesiculates in 5 to 7 days, and heals with little scarring. If only a papule develops without vesiculation and without leaving some kind of scar, it is considered a failed vaccination and many times the person is revaccinated in an attempt to get a “Jennerian vesicle” that is considered proof of successful vaccination.22 VACCINIA VACCINE REACTION RATE VERY HIGH The live vaccinia virus vaccine to prevent smallpox may be the most highly reactive vaccine that has ever been used in humans. As with most vaccines, when complications occurred with the vaccinia virus vaccine, they were quite similar to the complications of the disease they were designed to prevent. According to the World Health Organization “existing vaccines have proven efficacy but also have a high incidence of adverse side-effects. The risk of adverse events is sufficiently high that vaccination is not warranted if there is no or little real risk of exposure. Vaccine administration is warranted in individuals exposed to the virus or facing a real risk of exposure. A safer vaccinia-based vaccine, produced in cell culture is expected to become available shortly. There is also interest in developing monoclonal antivariola antibody for passive immunization of exposed and infected individuals, which could also be safely administered to persons infected with HIV.”52 Potential 70,000 Severe Reactions Requiring VIG: According to the Working Group on Civilian Biodefense “It has been estimated that if 1 million persons were vaccinated [with live vaccinia virus vaccine], as many as 250 persons would experience adverse reactions of a type that would require administration of VIG [vaccinia immune globulin].”49 Using these vaccine risk estimates would yield a serious vaccine reaction rate of 1 in 4,000 persons. This would mean that out of 280 million Americans who receive the vaccinia virus vaccine there could be approximately 70,000 persons who would experience reactions severe enough to require VIG. VIG is ineffective in treating postvaccinal encephalitis.20 Estimates are that postvaccinal encephalitis following live vaccinia vaccine occurs in between 1 in 81,000 to 1 in 345,000 persons receiving their first smallpox vaccination,20,22 which would add thousands of cases of postvaccinal encephalitis in the initial mass vaccination of all Americans, for whom VIG treatment is not beneficial. Potential Neurological Reactions in the Young: One 1992 study by the State Research Institute of Standardization and Control of Medical Biologics in Russia reported a neurological complication rate of 1 in 3,200 persons aged five years and older who received a first live vaccinia virus vaccination.61 Approximately 120 million Americans are between the ages of 5 and 35 according to the US 2000 census. If all those Americans were first-time vaccinees, approximately 37,500 of them could suffer a neurological reaction. Re-Introducing Vaccinia Virus A Risk: The vaccinia virus vaccine has not been used on a mass basis in the U.S. since the early 1970’s so the virus is not circulating in our population and no one under age 30 has had any experience with it. Because live vaccinia virus vaccine can cause vaccinia viral infection in the vaccine recipient or in a close contact of the recently vaccinated person, those who get vaccinated will be exposing themselves and others to the vaccinia virus and potential complications. The CDC reports that one 10-state survey revealed that transmission of vaccinia virus infection occurred in 27 per million total vaccinations (1 in 37,000 vaccinations) and 44 percent of those contact cases occurred among children. Approximately 60 percent of contact transmissions in the survey resulted in the inadvertent inoculation of otherwise healthy persons. About 30 percent of the eczema vaccinatum cases were a result of contact transmission.20,62 Common Vaccinia Virus Vaccine Reactions: Fever, fatigue and irritability are common, especially in children, during the vesicular and pustular stages and swollen lymph glands may persist for months after vaccinia virus vaccination.22 Inadvertent inoculation at other body sites: According to the CDC: “Inadvertent inoculation at other sites is the most frequent complication of vaccinia vaccination and accounts for approximately half of all complications of primary vaccination and revaccination.” Autoinoculation occurs when the recently vaccinated person touches or scratches the lesion at the vaccination site and transfers the live vaccinia virus to other parts of the body, such as the face, eyelid, nose, mouth, genitalia and rectum, and more lesions form. Most lesions heal without therapy but vaccinia immunoglobulin (VIG) can be used when the eye is involved, unless there is inflammation of the cornea (because VIG can increase corneal scarring). The CDC estimates inadvertent inoculation occurs in 1 in 1,890 first time vaccinations.20 Fever: According to the CDC, approximately 70 percent of children experience temperatures under 100 F. for 4-14 days after the first vaccination and 15-20 percent will experience temperatures under 102 F. After revaccination, 35 percent of children experience temperatures under 100 F. and 5 percent experience temperatures under 102 F. Fever is less common in adults. 20 Rashes and Hives: A raised rash (erythema) or hives (urticaria) can occur approximately 10 days after a first vaccination, which usually does not involve a fever and resolves within two to four days. Sometimes erythema and urticaria can be confused with generalized vaccinia. 20 More Severe Reactions: Moderate and severe immune and neurological complications of live vaccinia vaccination occur more than ten times more often among first-time vaccinees than among those who are revaccinated and are more frequent among infants. 20 Well known serious complications of live vaccinia virus vaccination include progressive vaccinia, postvaccinal encephalomyelitis; eczema vaccinatum; and generalized vaccinia, and reaction rates for these serious vaccine complications vary. Progressive Vaccinia (vaccinia gangrenosa, vaccinia necrosum): When the live vaccinia virus continues to grow in the body and healing of the primary vaccinal lesion caused by smallpox vaccination does not occur, there can be a slowly progressive destruction of large areas of skin (necrosis), subcutaneous tissue, viscera (internal organs) and bone. Progressive vaccinia almost always occurs in persons with a severe immune deficiency caused by cancer, radiation or chemotherapy, and AIDS or other serious immune system disorders such as lupus. Those who develop progressive vaccinia almost always die within six months.19,20,22,49 In the past, it was estimated that this reaction occurred in 1 in 1 million to 1.6 in 1 million vaccinations with a case fatality ratio of almost 90 percent.20,22,53 However, this severe reaction to live vaccinia virus vaccine will most likely occur more often today if mass smallpox vaccination campaigns are introduced in populations with a high incidence of undiagnosed HIV/AIDS or other immune system deficiencies. Postvaccinal Encephalitis/Encephalomyelitis: Inflammation of the brain can develop two to 25 days after vaccination.22 It occurs most frequently in children under age one or two years and in older children and adults receiving their first smallpox vaccination.20,53,61 Symptoms can appear suddenly and include fever, vomiting, drowsiness, restlessness, confusion, convulsions, hemiplegia (partial paralysis), aphasia (loss of speech), loss of consciousness and coma. Recovery is often incomplete, with residual brain damage and paralysis, which occurs most frequently in children under two years old.53 Death rates following post vaccinal encephalitis range from 25 percent to 50 percent of patients, usually within a week of onset.20,53 Conservative estimates of frequency range from 1 in 345,00022 to 1 in 81,000 persons receiving their first-vaccination.20 Eczema Vaccinatum: This reaction is seen in persons with a history of eczema or other types of chronic skin conditions like contact dermatitis. The person develops high fever, swollen lymph nodes and widespread inflammation and appearance of lesions on areas of skin previously affected by eczema that can spread to areas of healthy skin. Especially severe cases can occur when persons, who have active eczema or a history of eczema, come in contact with those recently vaccinated with live vaccinia virus.20,22 The CDC states “Eczema vaccinatum might be more severe among contacts than among vaccinated persons.”20 Eczema vaccinatum can be mild and self limited but also can be severe and fatal. Estimates of frequency ranges from 1 in 100,00019 to 1 in about 26,000 first time vaccinations.20 Generalized Vaccinia: This reaction involves a vesicular rash similar to but milder than smallpox that can be localized around the vaccination site or cover the body and can occur among healthy persons without underlying illness. It is most serious in those who have underlying immunosuppressive illness. The CDC estimates that 241.5 cases of generalized vaccinia per 1 million first time vaccinations occurs (about 1 in 4,100 vaccinations).20 Death: Death from vaccinia vaccination is most often the result of postvaccinal encephalitis or progressive vaccinia. Death has been estimated to occur in 1 in 1 million vaccinated persons.22 Other Serious Vaccinia Vaccine Reaction Reports: There are a number of other serious vaccinia vaccine reactions reported in the medical literature, including progressive or generalized vaccinia in persons with genital herpes,63,64,65 HIV,66 and active acne;67 development of skin cancer;68 basal cell carcinoma in a smallpox vaccination scar;69 discoid lupus erythematosus in a smallpox vaccination scar;70 diabetes;71 thrombocytopenia purpura;72 cardiac complications leading to heart damage;73,74 clubfoot in babies whose mother’s were vaccinated in the first trimester;75 and chromosomal breakage and changes in children after revaccination.76,77 VIG Treatment and Prevention of Vaccine Complications: Treatment for and prevention of vaccinia complications is limited. Vaccine Immune Globulin (VIG), which is composed of preformed antibody to vaccinia virus taken from the blood of persons who have already been vaccinated with vaccinia virus, has been used in cases of autoinoculation of the eye, progressive vaccinia, eczema vaccinatum and generalized vaccinia. VIG is of no use in cases of postvaccinal encephalitis.20 VIG has also been used to try to prevent serious vaccine reactions by giving persons with contraindications (such as immune suppression) VIG before vaccination.20,49. Although VIG has been useful in treating some cases of vaccinia vaccine reactions, there is no assurance that VIG will either prevent or modify the course of every serious reaction. The stockpiled supply of old VIG reportedly has deteriorated over the years and is limited.26,57 There is not enough VIG to treat the number of serious vaccine reactions that are estimated would occur if all of the 15.4 million doses of stockpiled Dryvax vaccine were used.14,20,26,49 The blood from volunteers in current Dryvax trials using diluted old vaccine may be able to be utilized to make more VIG.14,15,58 Contraindications: According to Harrison’s Principles of Internal Medicine, contraindications to vaccinia virus vaccine include: B or T cell immune system disorders, eczema, pregnancy, disorders of the central nervous system, neoplasms of the reticuloendothelial system, and use of immunosuppressive drugs.19 The CDC now lists the following contraindications in the absence of an emergency (actual exposure to smallpox):20 · Persons who experience anaphylactic reactions to polymyxin B sulfate, streptomycin sulfate, chlortetracycline hydrochloride and neomycin sulfate should not be vaccinated with Dryvax; · Persons with eczema or other skin conditions: “Vaccinia vaccine should not be administered to persons with eczema of any degree, those with a past history of eczema, those whose household contacts have active eczema, or whose household contacts have a history of eczema. Persons with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo or varicella zoster) might also be at higher risk for eczema vaccinatum and should not be vaccinated until the condition resolves.” · Persons Infected with HIV; · Persons with immunosuppression (leukemia, lymphoma, generalized malignancy, solid organ transplantation, cellular or humoral immunity disorders, therapy with akylating agents, antimetabolites, radiation or high-dose corticosteroid therapy); · Infants and Children under age 18; · Pregnant Women: “Vaccinia virus has been reported to cause fetal infection on rare occasions, almost always after primary vaccination of the mother. Cases have been reported as recently as 1978. When fetal vaccinia does occur, it usually results in stillbirth or death of the infant soon after delivery.” Other contraindication considerations : Although the CDC does not list herpes infection as a contraindication in non-emergencies, the case reports of progressive vaccinia in persons with herpes suggest that use of the vaccinia virus vaccine today may result in many more cases of progressive vaccinia than in the past. Herpes infection, like HIV, is more widespread today than it was prior to the early 1970’s, when routine vaccinia virus vaccination was discontinued. CDC Eliminates Absolute Contraindications In Emergency: The CDC states that: “No absolute contraindications exist regarding vaccination of a person with a high-risk exposure to smallpox. Persons at greatest risk for experiencing serious vaccination complications are also at greatest risk for death from smallpox. If a relative contraindication to vaccination exists, the risk for experiencing serious vaccination complications must be weighed against the risk for experiencing a potentially fatal smallpox infection. When the level of exposure risk is undetermined, the decision to vaccinate should be made after prudent assessment by the clinician and the patient of the potential risks versus the benefits of smallpox [vaccinia virus] vaccination.” Other Considerations: Whether a person dies from a disease or a vaccine, a death is a death and one cause of death is no more important than another when individual human life is valued. Because there are no genetic or other biomarkers to definitively predict ahead of time who will be harmed by vaccination, there must be strict adherence to the informed consent ethic, especially during times of emergencies when all contraindications are officially suspended. To do any less, places public health officials and anyone, who forces vaccination on a person without that person’s informed consent, in the role of judge and executioner of the genetically and biologically vulnerable. Preventing Contact Transmission of Vaccinia Virus: Care must be taken to prevent spread of the vaccine virus from the vaccination lesion site to other areas of the body or to another person. Use of gauze or porous bandages (to allow air to dry the site lesion) is advised with bandages changed every 1 to 2 days. No salves or ointments should be placed on the vaccination lesion. The most important action for preventing vaccinia virus transmission is frequent hand washing with soap and water or disinfecting agents after contact with the vaccination site. Disposal of bandages that have covered the site in sealed plastic bags and decontaminating clothing or materials that have contact with the site by laundering in hot water with bleach is also important.20,52 Recombinant Vaccinia Virus Vaccine Transmission: Scientists are using vaccinia virus as a vehicle for creating new vaccines. Genes from herpes simplex virus, hepatitis B virus, HIV and malaria reportedly have been inserted into the vaccinia genome.19 In the 1970’s and 1980’s, as researchers began experimenting with genetically engineering different strains of vaccinia viruses to contain and express foreign DNA to induce protection against infectious agents such as HIV, there were reports of laboratory-acquired infections with vaccinia or recombinant viruses.20,24 In 1991 the CDC’s Advisory Committee on Immunization Practices (ACIP) advised that health care workers, who were exposed to volunteers in new vaccine trials using genetically engineered vaccinia virus, be vaccinated with vaccinia virus vaccine. The CDC recommendations stated that:: “With the initiation of human trials of recombinant vaccines, physicians, nurses and other health-care personnel who provide clinical care to recipients of these vaccines could be exposed to both vaccinia and recombinant viruses. The exposure could occur from contact with dressings contaminated with the virus or through exposure to the vaccine. The risk of transmission of recombinant viruses to exposed health care workers is unknown…however, because of the potential for transmission of vaccinia or recombinant vaccinia viruses to such persons, the ACIP suggests that health care personnel who have direct contact with contaminated dressings or other infectious material from volunteers in clinical studies be considered for vaccination.”24 Health Secretary Orders 300 Million Doses of Vaccine: One month after the September 11 terrorist attacks on the World Trade Center and the Pentagon, DHHS Secretary Tommy Thompson called on industry and government to produce and stockpile 300 million doses of vaccinia virus vaccine by the end of 2002. He said that all Americans should know they “have their name on a vaccine shot in our inventory.” Cost estimates range from $500 million to nearly $2 billion.1,15,78 In order to be able to accomplish this goal, some in industry are calling for cutting the number of participants in vaccine trials and bypassing standard safety and efficacy requirements to quickly create a stockpile of vaccine.16,17,25 Industry Asks for Immunity From Lawsuits: Drug companies competing for the multi-million dollar contract to produce enough vaccinia virus vaccine to vaccinate every American are asking Congress to pass legislation shifting all liability for vaccine injuries and deaths to the government (American taxpayer). Already, there are bills being drafted in Congress to create a federal fund to compensate victims of bioterrorism vaccines, such as vaccinia virus vaccine.79 New Office of Preparedness Created: DHHS Secretary Thompson has appointed D.A. Henderson, founding director of the Center for Civilian Biodefense Studies at Johns Hopkins University and architect of the worldwide smallpox eradication effort, as well as Philip Russell, a retired Army major general specializing in vaccine development, to head a new Office of Preparedness that will expand new vaccine programs and develop strategies to respond to public health emergencies. Dr. Henderson has been quoted as saying his top priority is to improve the “communications system” that will allow the medical community and government to mount a coordinated response.80 Emergency Plan Will Militarize Public Health System: The Working Group on Civilian Biodefense has stated “The discovery of a single suspected case of smallpox must be treated as an international health emergency.”49 Although it is very important to have a well crafted bioterrorism emergency response plan in place, along with enough vaccine for everyone who wants to use it, it is difficult to envision the necessity for giving public health officials the kind of sweeping police powers now being advocated by the Centers for Disease Control (CDC). With funding and direction provided from the CDC, a lawyer at the Georgetown University Center for Law and the Public’s Health, Lawrence Gostin, has created model state legislation that will allow public health officials to mobilize and use “all or any part of the organized militia” to isolate, quarantine and force vaccination and medical treatment on American citizens in states where a Governor has called a “state of emergency” for 30 days or more. (Go to www.publichealthlaw.net to read the law). Public health officials would be given the power to “coordinate all matters pertaining to the public health emergency,” including the right to seize private property such as “communications devices, carriers, real estate, fuels, food, clothing and health care facilities” and take control of “the use, sale, dispensing, distribution and transportation of food, fuel, clothing and other commodities, alcoholic beverages, firearms, explosives and combustibles” as well as take control of roads and public areas. If passed by the states, the law would give unprecedented police powers to public health officials and those they designate to charge citizens with misdemeanors and imprison them if they refuse to comply with vaccination, medical treatment or isolation orders without being able to go to court first. Those who participate in enforcing the law would not be held liable for any injury, death or loss of property which resulted. In the preface to this model state legislation, Gostin justified the law he wrote for the CDC by referring to the 1905 Supreme Court decision Jacobsen v Massachusetts, which upheld the right of US states to pass mandatory vaccination laws. Gostin, who is a longtime forced vaccination proponent, will be working with the National Governors Association, National Conference of State Legislatures, Association of State and Territorial Health Officials, National Association of City and County Health Officers, and National Association of Attorneys General to get this legislation passed in every state. It has already been introduced in Massachusetts. Jacobsen v Massachusetts Revisited: How did we get to this point in America, where public health officials would presume to appropriate the kind of police power they are now saying they should be given? It all goes back to a man name Jacobsen who, in 1905, sued the state of Massachusetts for requiring him and his son to get a second vaccinia virus (smallpox) vaccination or pay a $5 fine. Jacobsen refused to get revaccinated or pay the fine, saying that he and his son had had a bad reaction to a previous vaccination for smallpox and were afraid they would be injured or die from a second one. Jacobsen maintained that forcing him to be revaccinated was “an assault upon his person” and violated his constitutional rights. In its majority opinion in Jacobsen v Massachusetts, 197 U.S. 11(1905), the Supreme Court rejected the evidence Jacobsen presented to show that the vaccine can cause injury and death and that doctors cannot distinguish between those who will be harmed and those who will not be harmed. The Court concluded, “The matured opinions of medical men everywhere, and the experience of mankind, as all must know, negative the suggestion that it is not possible in any case to determine whether vaccination is safe.” Doctors Cannot Predict Who Will Be Harmed: The fact the Supreme Court at the turn of the 20th century did not have accurate medical information upon which to base their precedent-setting decision is unfortunate. It has been proven in the succeeding 96 years, most recently in the US Court of Claims in Washington, D.C. where nearly two billion dollars has been awarded to families whose children have been killed or been injured by mandated childhood vaccines, that often doctors cannot predict ahead of time which individuals will react to vaccines and die or be left with mental retardation, medication-resistant seizure disorders, paralysis, learning disabilities, ADHD, autism, chronic arthritis, or other immune and brain dysfunction.6 Cruel and Inhuman To The Last Degree: This is a critical point in measuring the consequences of assigning police powers to public health officials for the purpose of enforcing vaccination, particularly in cases where parents suspect their children are at increased risk for reacting to vaccines - even though government health officials, anxious to achieve a 100 percent vaccination rate, disagree. In their opinion, the 1905 Supreme Court justices acknowledged that vaccination must not be forced on a person whose physical condition would make vaccination “cruel and inhuman to the last degree. We are not to be understood as holding that the statute was intended to be applied in such a case or, if it was so intended, that the judiciary would not be competent to interfere and protect the health and life of the individual concerned.” Therefore, when interpreting Jacobsen v Massachusetts in 2002, it is important to remember that, although the Court agreed that states may enact “such reasonable regulations established directly by legislative enactment as will protect the public health and the public safety,” the Supreme Court made it clear that mandatory vaccination laws must not be applied unreasonably so as to result in harm to individuals. In other words, the state does not have the right to command that an individual sacrifice his or her life in the name of the public health. Utilitarianism Was in Fashion: What, then, did the 1905 Supreme Court mean when it went on to declare that “it was the duty of the constituted authorities primarily to keep in view the welfare, comfort and safety of the many, and not permit the interests of the many to be subordinated to the wishes or convenience of the few?” The “wishes or convenience” of the few certainly does not translate into the ”lives” of the few, but still, the historical context in which this declaration was made is very important. In 1905, the political doctrine known as “utilitarianism” was a popular philosophical tenet, which judged the rightness or wrongness of an action by its consequences and held that an action that is moral or ethical results in the greatest happiness for the greatest numbers of people. With its emphasis on numbers of people, utilitarianism became a convenient way to justify state legislative policy. Karl Marx used utilitarian principles to formulate his economic theories and modern cost benefit analyses are also descendents of utilitarianism.12 Individual Autonomy Must Come First: In 1927, jurist Oliver Wendall Holmes embraced the utilitarian rationale when he used Jacobsen v Massachusetts to justify the forced sterilization of a mentally retarded woman to, in effect, protect the public welfare. Writing for the majority in a 8-1 Supreme Court decision, Buck v Bell, 274 U.S. 200 (1927), Holmes said “The principle that sustains compulsory vaccination is broad enough to cover cutting the Fallopian tubes.” Not long after, Hitler would embrace the same kind of rationalization used by Holmes in that stunning 1927 legal opinion and go on to pursue his own brand of social engineering to eliminate from society those persons the Third Reich had judged to be genetically inferior, physically or mentally compromised, or socially unacceptable (homosexuals, political dissidents) because they were thought to be a threat to the public health and welfare.81 The tragic moral failure of utilitarianism was finally revealed at the Doctor’s Trial at Nuremberg after World War II, where it was discredited by the Nuremberg Tribunal as a pseudo-ethic.11 In its place stands the Nuremberg Code, which places the right of individuals to self determination and autonomy above the right of the state, science and medicine to derive benefits from them. The human right to informed consent to medical interventions that can injure or kill is the centerpiece of modern bioethics. It insures that the individual has control over decisions and actions involving life and death, which are the most sacred of all decisions and actions humans are ever called upon to make. EDITORIAL: Vaccinating America at Gunpoint by Barbara Loe Fisher Like every American, I never imagined that I would experience the kind of shock and horror that came on September 11 with the terrorist attacks on New York and Washington, D.C. While our world has changed forever, there are some things that never change. Truth does not change. What it means to be free does not change. In response to the fear and anxiety that still hangs like a bad dream over our nation, in the mad scramble to “do something” to make Americans feel safe again, government officials employed by the Centers for Disease Control (CDC) have stepped forward to suggest that they and their state health department counterparts are the only ones who can keep us safe whenever they decide there is a “public health” emergency – if only we will give them the power to use the state militia to arrest, quarantine and forcibly vaccinate and medicate us. Not satisfied with that, they also want the power to seize our private property, including our homes, as well as our telephones, fax machines, computers, cars, fuel, food, clothing, firearms, prescription drugs and the alcoholic beverages in our refrigerator. Just in case you were thinking you could make it to the border before the public health militia comes to get you, they want the power to take over all roads in and out of your city and state, too. And to make sure they can’t get sued by anyone for anything they do, they are asking for total legal immunity for destroying your property or killing you or your children when they enforce the law. They are joined in this quest by the drug companies making “bioterrorism” vaccines, like the notoriously reactive smallpox vaccine never tested for safety in clinical trials. Not only are the drug companies demanding that Congress give them total legal immunity for all vaccine-induced injuries and deaths, they are also demanding that the bioterrorism vaccines they produce be exempt from normal federal safety and efficacy standards. What is wrong with this picture? Certainly, America should have enough smallpox vaccine or other “bioterrorism” vaccines for everyone who voluntarily wants to use them: but not ones that haven’t been properly tested. Certainly, America should have a sound, workable emergency plan in place in the event of a bioterrorism attack: but not one that places the life and liberty of the majority of citizens in the hands of an elite few, who will have the power to take both from citizens without their consent. This CDC-funded and initiated legislation treats us like runaway slaves in need of subjugation. The law’s proposed elimination of the informed consent principle, which has governed the ethical use of medical interventions that can injure or kill ever since the Doctor’s Trial at Nuremberg after World War II, is clear indication that public health officials want the sole authority to decide who will live and who will die and under what conditions. No state of emergency in a free society justifies the sacrifice of the most sacred human right: the right to voluntarily decide what you are willing to risk your life for or your child’s life for. What it means to be free doesn’t get more basic than that. I have said many times during the past decade, that if the state can tag, track down and force citizens to be injected with biologicals of unknown toxicity today, then there will be no limit on what individual freedoms the state can take away in the name of the greater good tomorrow. Now, tomorrow is here. In this time of great sadness, fear and confusion, Americans have a choice to make: either we defend the individual freedoms our forefathers fought and died to give us, or we sacrifice those freedoms and let the terrorists win. What we do will define who we are as a nation for many years to come. REFERENCES: 1. Miller J, Stolberg SG. October 22, 2001. Sept. 11 Attacks led to push for more smallpox vaccine. The New York Times. 2. Hudson A. October 10, 2001. Anthrax, smallpox vaccines called for. The Washington Times. 3. Gostin Lawrence, J.D., Georgetown University, for the CDC: The Model State Emergency Health Powers Act (www.publichealthlaw.net). 4. Gillis J. November 19, 2001. States weighing laws to fight bioterrorism. The Washington Post. 5. Coulter HL, Fisher BL. 1985. DPT: A Shot in the Dark. San Diego: Harcourt Brace Jovanovich. 6. National Childhood Vaccine Injury Act of 1986 (Public Law 99-660; 42 USC 300aal et seq.) 7. Institute of Medicine. 1991. Adverse Effects of Pertussis and Rubella Vaccines. Washington, D.C: National Academy Press. 8. Institute of Medicine. 1994. Adverse Effects Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, D.C: National Academy Press. 9. Institute of Medicine. 1994. DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis. Washington, D.C: National Academy Press. 10. Centers for Disease Contro1. 1987. Pertussis immunization: family history of convulsions and use of antipyretics – Supplementary ACIP Statement. Morbidity and Mortality Weekly Report 11. Annas GJ, Grodin MA. 1992. The Nazi Doctors and the Nuremberg Code. New York: Oxford University Press. 12. Arras JD, Steinbock B., eds. Ethical Issues in Modern Medicine. Mountain View: Mayfield Publishing Co. 13. Kolata G. October 22, 2001. ‘Cure’ for bioterror may be worse than the disease. The New York Times. 14. Landers SJ. November 12, 2001. Smallpox vaccine: balancing the benefits and the risks. American Medical News. 15. Connolly C. November 7, 2001. HHS set to order smallpox vaccine for all Americans. The Washington Post. 16. Appleby J. November 7, 2001. Smallpox vaccine will face hurdles. USA Today. 17. Dyer G., Cookson, C. October 11, 2001. Spreading calm in small doses. Financial Times. 18. Garrett L. December 2001. Unprepared for the worst. Vanity Fair. 19. Isselbacher KJ, Braunwald E et al, eds. 1994. Harrison’s Principles of Internal Medicine. Thirteenth Edition. New York: McGraw-Hill. 20. Centers for Disease Control. June 22, 2001. Vaccinia (Smallpox) Vaccine Recommendations of the Advisory Committee on Immunization Practices (ACIP) 2001. Morbidity and Mortality Weekly Report. 21. Gillis, J, Okie S. October 28, 2001. US mounts smallpox vaccine push. The Washington Post. 22. Braunwald E, Isselbacher KJ et al, eds. 1987. Harrison’s Principles of Internal Medicine. New York: McGraw-Hill. 23. Centers for Disease Control. June 14, 1985. Recommendation of the Immunization Practices Advisory Committee: Smallpox Vaccine. Morbidity and Mortality Weekly Report. 24. Centers for Disease Control. December 13, 1991. Vaccinia (Smallpox) Vaccine Recommendations of the Immunization Practices Advisory Committee (ACIP). Morbidity and Mortality Weekly Report. 25. Gillis J. November 8, 2001. Scientists race for vaccines. The Washington Post. 26. Bradsher K. October 22, 2001. US begins search for medicine used to treat adverse reactions to smallpox vaccine. The New York Times. 27. Disability Statistics Rehabilitation Research and Training Center, University of California, San Francisco. November 1996. Trends in disability rates in the United States, 1970-1994. US Department of Education, National Institute on Disability and Rehabilitation Research Disability Statistics Abstract. 28. Cookson WO, Moffatt MF. January 1997. Asthma: an epidemic in the absence of infection? Science. 29. Centers for Disease Control. 1995. Asthma-United States, 1982-1992. Morbidity and Mortality Weekly Report. 30. Centers for Disease Control. 1995. Disabilities among children aged less than or equal to 17 years – United States 1991-1992. Morbidity and Mortality Weekly Report. 31. US Department of Education, Office of Special Education and Rehabilitative Services. 1997. 20th Annual Report to Congress on the Implementation of the Individuals with Disabilities Education Act. 32. Sears W, Thompson L. 1998. The A.D.D. Book. New York: Little, Brown & Co. 33. Zito JM, Safer DJ et al. 2000. Trends in prescribing psychotropic medications to preschoolers. Journal of the American Medical Association. 34. Cowart VS. 1998. Attention-deficit hyperactivity disorder: physicians helping parents pay more heed. Journal of the American Medical Association. 35. Centers for Disease Control. 1997. Trends in the prevalence and incidence of self-reported diabetes mellitus – United States 1980-1994. Journal of the American Medical Association. 36. Marwick C. April 7,1999. Diabetes research plan presented to congress. Journal of the American Medical Association. 37. Department of Developmental Services. March1,1999. Changes in the Population of Persons with Autism and Pervasive Developmental Disorders in California’s Developmental Services System: 1987 through 1998: A Report to the Legislature. (www.dds.ca.gov) 38. US Department of Education. 1998. Twentieth Annual Report to Congress on the Implementation of the Individuals with Disabilities Education Act. 39. Centers for Disease Control. January 12, 2001. Recommended Childhood Immunization Schedule – US, 2001. Morbidity and Mortality Weekly Report. 40. American Academy of Pediatrics. 1970. A Report of the Committee on Infectious Diseases: Sixteenth Edition. 41. www.webmd.com 42. www.webmd.com 43. Diamond J. 1999. Guns, Germs and Steel. New York: W.W. Norton & Co. 44. Porter R. 1997. The Greatest Benefit to Mankind. New York: W.W. Norton & Co. 45. Spencer J, Scardaville M. October 11, 2001. Understanding the bioterrorist threat: facts and figures. The Heritage Foundation Backgrounder (www.heritage.org/library/backgrounder) 46. Chase A. 1982. Magic Shots. New York: William Morrow & Co. 47. Brownlee S. October 28, 2001. Clear and present danger. The Washington Post Magazine. 48. Miller J. November 16, 2001. US set to retain smallpox stocks. The New York Times. 49. Henderson DA, Inglesby TV et al. June 9,1999. Smallpox as a biological weapon (Consensus Statements of the Working Group on Civilian Biodefense). Journal of the American Medical Association. 50. U.S. General Accounting Office. September1999. GAO Report: The Department of Health Combating Terrorism: Need for a Comprehensive Threat and Risk Assessments of Chemical and Biological Attack, GAO/NSIAD-99-163. 51. Henderson DA. July-September 1998. Bioterrorism as a public health threat. Emerging Infectious Diseases. 52. World Health Organization. 2001. Smallpox. Weekly Epidemiological Record 76. 53. Kaplan C. 1989. Vaccinia virus: a suitable vehicle for recombinant vaccines? Archives of Virology. 54. Stanford University. Vaccinia virus. (www.stanford.edu) 55. Physicians Desk Reference (PDR). 1983. Oradell: Medical Economics Co. 56. Dorland’s Medical Dictionary. 1980. Philadelphia: The Saunders Press. 57. Garrett L. 2000. Betrayal of Trust. New York: Hyperion. 58. Argetsinger A. October 27,2001. Smallpox vaccine studies swamped with volunteers. The Washington Post. 59. Demkowicz WE, Littalia RA et al. 1996. Human cytotoxic T-cell memory: long lived responses to vaccinia virus. Journal of Virology: 60. Cohen J. October 28, 2001. And now, the good news about smallpox. (http://slate.msn.com) 61. Gurvich EB. 1992. The age-dependent risk of post-vaccination on complications in vaccinees with smallpox vaccine. Vaccine. 62. Lane JM, Ruben FL et al. 1970. Complications of smallpox vaccination, 1968: results of ten statewide surveys. Journal of Infectious Diseases. 63. Funk EA, Strausbaugh LJ. March 1981. Vaccinia necrosum after smallpox vaccination for herpes labialis. Southern Medical Journal. 64. FDA Drug Bulletin. August 12,1982. Inappropriate use of smallpox vaccine. 65. Lane JM. May 21,1982. Hazards of smallpox vaccination. Journal of the American Medical Association. 66. Redfield RR, Wright DC et al. March 12,1987. Disseminated vaccinia in a military recruit with human immunodeficiency virus (HIV) disease. New England Journal of Medicine. 67. Centers for Disease Control. December 24, 1982. Epidemiologic Notes and Reports: Disseminated vaccinia infection in a college student – Tennessee. Morbidity and Mortality Weekly Report. 68. Michel N, Aguilera A. March 1976. Vaccinia virus: the possibilities of its oncogenicity in humans. Cancer Letters. 69. Riberio R, Labareda JM. 1988. Basocellular carcinoma in a smallpox vaccination scar. Medicina Cutanea Ibero Latino Americana. 70. Lupton GP. October 1987. Discoid lupus erythematosus occurring in a smallpox vaccination scar. Journal of the American Academy of Dermatology. 71. Schneider H. March 1975. Manifestation of diabetes after smallpox vaccination. Kinderarztliche Praxis. 72. Burke PJ, Shah NR. September 1981. Thrombocytopenic purpura after smallpox vaccination. Pennsylvania Medicine. 73. Moschos A., Papaioannou AC. October 1976. Cardiac complications after vaccination for smallpox. Helvetica Paediatrica Acta. 74. Feery BJ. August 6,1977. Adverse reactions after smallpox vaccination. Medical Journal of Australia. 75. Naderi S. August 1975. Smallpox vaccination during pregnancy. Obstetrics and Gynecology. 76. Knuutila S, Maki-Paakkanen J et al. 1978. An increased frequency of chromosomal changes and SCE’s in cultured blood lymphocytes of 12 subjects vaccinated against smallpox. Human Genetics. 77. Kucerova M, Polivkova Z. 1980. Chromosomal aberrations and SCE in lymphocytes of children revaccinated against smallpox. Mutation Research. 78. Bradsher K. November 7, 2001. Smallpox vaccine costlier than expected. The New York Times. 79. Bradsher K. November 8, 2001. Three smaller companies say their vaccines are cheaper. The New York Times. 80. Connolly C. November 8, 2001. . US officials reorganize strategy on bioterrorism. The Washington Post. 81. Weindling P. 1989. Health, Race and German Politics Between National Unification and Nazism 1870-1945. Cambridge: Cambridge University Press. For More Information: At this NVIC website, http://www.909shot.com, you can access links to other vaccine and health information resources, as well as sign up to to NVIC’s free Vaccine E-News Service or become a member of the National Vaccine Information Center. About the Editor Barbara Loe Fisher is co-founder and president of the National Vaccine Information Center. She is co-author of DPT: A Shot in the Dark (Harcourt Brace Jovanovich, 1985; Warner, 1986; Avery, 1991), a book which made an important contribution to public support for development of the purified pertussis vaccine licensed by the FDA for American babies in 1996. She is author of The Consumer’s Guide to Childhood Vaccines (NVIC, 1997) and editor of THE VACCINE REACTION and The Vaccine Hotline newsletters. During the 1980’s, she helped lead a national grassroots effort to bring the issue of vaccine safety to public attention, including leading demonstrations at the Centers for Disease Control in Atlanta and at the White House in 1986. Later that year, Congress passed the National Childhood Vaccine Injury Act. She served on the National Vaccine Advisory Committee for four years, where she was chair of the subcommittee on adverse events. She was appointed to the Vaccine Safety Forum at the Institute of Medicine in 1995, where she helped to coordinate five public workshops on vaccine safety. She has served as the consumer voting member of the FDA Vaccines and Related Biological Products Advisory Committee since 1999. She is a frequent public speaker at educational health conferences, where she defends the right to informed consent to medical interventions which can cause injury or death, including vaccination. The mother of three children, in 1980 her two and a half year old son reacted within four hours of his fourth DPT and polio vaccinations with a convulsion, collapse shock and six hour state of unconsciousness. He was left with minimal brain dysfunction, including multiple learning disabilities and attention deficit disorder. About the National Vaccine Information Center The National Vaccine Information Center (NVIC), founded in 1982 by parents of vaccine injured children, is a non-profit, educational organization (501C3) dedicated to preventing vaccine injuries and deaths through public education. NVIC promotes scientific research into the biological causes of vaccine injury and death in order to identify biomarkers which place individuals at high risk for suffering vaccine reactions. NVIC advocates the institution of informed consent protections in mass vaccination laws and serves as a watchdog on vaccine research, development, regulation and promotion activities of public health agencies. After launching the vaccine safety and informed consent movement in the U.S. in the early 1980’s, NVIC’s co-founders worked with Congress to create the National Childhood Vaccine Injury Act of 1986. This historic law set up a vaccine injury compensation program and included vaccine safety provisions, such as mandatory reporting of hospitalizations, injuries and deaths following vaccination. In 1989, NVIC sponsored an International Scientific Workshop on Pertussis and Pertussis Vaccines and, in 1996, one of NVIC’s major goals was realized when a purified pertussis vaccine was licensed for American babies after a decade and a half of advocacy work. In 1997, NVIC held the First International Public Conference on Vaccination and sponsored the Second International Public Conference on Vaccination on Sept. 8-10, 2000 in Washington, D.C. The Third International Public Conference on Vaccination will be held on November 7-10, 2002 in Arlington, Virginia. ______________ THE VACCINE REACTION is a publication of the National Vaccine Information Center (NVIC), a national, nonprofit organization dedicated to preventing vaccine injuries and deaths through public education. All rights reserved. Barbara Loe Fisher, Co-founder & President Kathi Williams, Co-founder and Vice President Geeta Choppala, Editorial Assistant The National Vaccine Information Center 421-E Church Street, Vienna, VA 22180 1-800-909SHOT (orders and donations only) 703-938-0342 (phone) 703-938-5768 (fax) www.909shot.com Bottom Line: What You Need to Know About Smallpox Vaccine · It spreads vaccinia virus from one person to another, which can kill or injure people · It causes reactions in almost everyone who gets it (fever, spread of vaccine virus to other parts of body) and causes extremely severe reactions in 1 in 4,000 persons which can lead to death or injury; · It was never tested in clinical trials before it was used on a mass basis and mandated; · Drug companies making old and new smallpox vaccines want normal federal vaccine safety and efficacy standards to be suspended so the vaccines can be licensed quickly; · Drug companies do not want to be held liable for any injuries and deaths caused by old and new smallpox vaccines. Bottom Line: What You Need To Know About Proposed Laws in Your State When federal and state public health officials convince your Governor to declare a “public health” emergency, they want to be able to use the “state militia” to: · take control of all roads leading into and out of your cities and state; · seize your house, car, telephones, computers, food, fuel, clothing, firearms and alcoholic beverages for their own use (and not be held liable if these actions result in the destruction of your personal property); · arrest, imprison and forcibly examine, vaccinate and medicate you and your children without your consent (and not be held liable if these actions result in your death or injury). What You Can Do: The most important action you can take is to give this information to as many people as you can and let your individual voice be heard. Let people know where you stand: · Call and write your federal and state legislators; · Write to Attorney General John Ashcroft, Health Secretary Tommy Thompson and President and Mrs. Bush; · Contact your local newspaper, radio and television stations and give them a copy of this report; · Talk to as many people as you can in your community, especially your community leaders. · Sign up for NVIC’s free Vaccine E-News so you can keep up-to-date on the latest news in the development of vaccines and forced vaccination laws. -- NVIC Home ©Copyright 1996-01 National Vaccine Information Center 421-E Church St, Vienna, VA 22180 (703) 938-DPT3 FAX: 938-5768 1-800-909-SHOT email: info Quote Link to comment Share on other sites More sharing options...
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