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|Immunizations: Misconception #11, 27/5/2011|
|A few physicians have been promoting the idea that the mercury content of vaccines is a cause of autism and that autistic children should undergo chelation therapy to be detoxified. Lawsuits have been filed, and several attorneys are advertising on the Internet for more clients. The situation arose because until recently, certain vaccines contained thimerosal, a mercury-containing preservative that is no longer used in most of the vaccines now recommended for children. However, there are several reasons why concerns about the use of thimerosal in vaccines are misguided:|
No link between mercury and autism has been proven. If the thimerosal in vaccines caused mercury poisoning, the symptoms would affect all parts of the nervous system.
Thimerosal has been used as preservative in biologics and vaccines since the 1930s because it prevents bacterial and fungal contamination, particularly in multidose containers. In 1997, the US Food and Drug Administration Modernization Act mandated identification and quantification of mercury in all food and drugs. The subsequent FDA review noted that with the increased number of vaccines then recommended for infants, the total amount of mercury in vaccines containing thimerosal might exceed the levels recommended by other federal agencies . The mercury limits imposed by these agencies have a wide margin of safety; and there was no information suggesting that any infant had been harmed. Nevertheless, to be super-cautious, the U.S. Public Health Service (PHS) and the American Academy of Pediatrics (AAP) asked doctors to minimize exposure to thimerosal-containing vaccines and manufacturers to remove thimerosal from vaccines as soon as possible .
By mid-2000, thimerosal-free vaccines against hepatitis B and bacterial meningitis were widely available. A combination vaccine for diphtheria, pertussis, and tetanus is also available today without thimerosal. Measles/mumps/rubella (MMR), chickenpox, inactivated polio, and pneumococcal conjugate vaccines have never contained thimerosal. Thus, except for some influenza vaccine, none of the vaccines now used to protect preschool children against 12 infectious diseases contain thimerosal as a preservative. Certain flu vaccines and tetanus-diphtheria vaccines (Td) given to children age 7 and older still contain thimerosal as a preservative.
Before the recent reductions, the maximum cumulative exposure to mercury via routine childhood vaccinations during the first six months of life could have been 187.5 micrograms (which averages to about 1 microgram per day. With the newly formulated vaccines, the maximum cumulative exposure during the first six months of life should now total no more than 3 micrograms of mercury .
The U.S. Centers for Disease Control and Prevention has compared the incidence of autism with the amount of thimerosal received from vaccines. Preliminary results indicated no change in autism rates relative to the amount of thimerosal a child received during the first six months of life (from 0 micrograms to greater than 160 micrograms). A weak association was found with thimerosal intake and certain neurodevelopmental disorders (such as attention deficit hyperactivity disorder) in one study, but was not found in a subsequent study . Additional studies are planned, but it is unlikely that any significant association will be found.
An Institute of Medicine (IOM) committee, which issued a comprehensive report in October 2001, found no proof of a link between thimerosal-containing vaccines and autism, attention deficit-hyperactivity disorder, speech or language delays, or other neurodevelopmental disorders .
A study published in 2002 of infants who were 6 months of age or younger compared the levels of mercury in the blood, hair, urine, and stool of 40 who received vaccines containing thimerosal and 20 who received vaccines without thimerosal. The study found:
Mercury levels in the stool of infants receiving vaccines containing thimerosal were relatively high compared to mercury levels in the stool of infants who were not exposed to thimerosal, providing evidence that mercury from thimerosal is eliminated in the stool of infants.
The researchers concluded that, "Administration of vaccines containing thimerosal does not seem to raise blood concentrations of mercury above safe values in infants." .
Seven studies reported between 2003 and 2006 found no association between exposure to thimerosal in vaccines and the incidence of autism .
Thimerosal was eliminated from most vaccines in 2001. If it actually caused autism, the removal would be followed by a sharp drop in the number of newly diagnosed cases. However, in 2007, a study of autism rates in California found that no drop occurred . The data were published in the Archives of General Psychiatry accompanied by an editorial that stated:
Ball L and others. An assessment of thimerosal in childhood vaccines. Pediatrics 107:1147-1154, 2001.
Thimerosal in vaccines: A joint statement of the American Academy of Pediatrics and the Public Health Service. Mortality and Morbidity Weekly Report 48:563-565, 1999.
Thimerosal & vaccines: Q&A. CDC Immunization Program Web site, revised May 18, 2004.
Thimerosal in vaccines. FDA Center for Drug Evaluation and Research, Nov 13, 2001.
Immunization Safety Review Committee. Thimerosal-Containing Vaccines and Neurodevelopmental Disorders. National Academy Press, 2001.
Pichichero ME and others. Mercury concentrations and metabolism in infants receiving vaccines containing thimerosal: a descriptive study. Lancet 360:1737-1741, 2002.
Gerber JS, Offit PA. Vaccines and autism: A tale of shifting hypotheses. Clinical Infectious Diseases 48:456-461, 2009.
|A Critical Look at Defeat Autism Now! and the "DAN! Protocol", 2/4/2016|
|Defeat Autism Now! (DAN!), which was closed down in 2011, was a project of the Autism Research Institute (ARI), a nonprofit organization founded in 1967 by Bernard Rimland, Ph.D. (1928-2006). Rimland, who was a research psychologist, helped to dispel the long-held view that autism was caused by faulty mothering . But later in his career, he incorrectly concluded that autism was caused by vaccines and could be effectively treated with detoxification and dietary supplements.|
The "DAN! protocol" was centered around the belief that autism is caused by a combination of lowered immune response; external toxins from vaccines and other sources; and problems caused by certain foods. The underlying philosophy, which was posted to the Center for the Study of Autism Web Web site for several years , included the following ideas:
Microbial overgrowth including viral infections in susceptible children after a) certain vaccines, b) intestinal parasites, and c) bacterial and yeast overgrowths in the gut.
Toxins, such as PCB's, and particularly heavy metals, such as mercury from environmental sources and certain childhood vaccines.
DAN!'s most harmful activities were its promotion of chelation therapy and opposition to vaccination. In 2001, DAN! convened a Detoxification Consensus Conference and issued a position paper which claimed that mercury in some vaccines could cause autism and that treating autistic children with chelation therapy could cause many of them to improve . The paper was supported in part by a grant from Kirkman Laboratories. Following another conference, the paper was updated in 2005 . Both versions of the statement claim (falsely) that "body burden" of mercury can be measuring the urinary mercury concentration after a chelating drug is administered. This procedure, called provoked or challenge testing, has been denounced as meaningless by the American College of Medical Toxicologists and labeled as "below the standard of care" by the Oregon Medical Board . The 2005 version of the DAN! mercury-detoxification paper also stated that children can be exposed to mercury through maternal seafood consumption, maternal dental fillings (amalgam), and childhood vaccines.
It is prudent for pregnant women to avoid or minimize consumption of fish known to contain mercury, but the other two sources are insignificant. The mercury in amalgam fillings is tightly bound so that the amount absorbed into the body is not significant. Years ago, children were exposed to tiny amounts of mercury through the use of thimerosal as a preservative in some vaccines. There was never any evidence that the exposure was harmful but, in 2001, as a precautionary measure, U.S. manufacturers eliminated it from nearly all vaccines routinely given to children. Well-designed studies have found no evidence that thimerosal exposure of children from vaccines is associated with autism or any other developmental disorder . Nor is there any logical reason to believe that autism is cased by heavy metal toxicity. Curiously, the 2005 paper actually admitted that nothing unique to the DAN! protocol had been proven useful by appropriate scientific studies:
The Omnibus Autism Proceeding offered the people who blamed autism on vaccines an opportunity to prove their case in court. In 2001, parents began filing petitions alleging that MMR vaccinations, the thimerosal ingredients in certain other vaccines, or a combination of factors might be causing or contributing to autism. When it became clear that thousands of cases would have similar allegations, the Omnibus Autism Proceeding was established. To proceed efficiently, the parties agreed to process "test cases" for each "general causation" theory presented by the Petitioners’ Steering Committee. Ultimately, two such theories were advanced: (1) MMR (measles/mumps/rubella) vaccines and thimerosal-containing vaccines can combine to cause autism, and (2) thimerosal-containing vaccines can cause autism. Three Special Masters were each assigned one case for each theory. Evidentiary hearings on the first theory were conducted in 2007, after which the parties filed additional documents and briefs. In addition to 5,000 pages of transcripts and well over 700 pages of post-hearing briefs, the records in the first three cases contain 939 medical articles (a typical vaccine case presents about 10). A total of 50 expert reports were filed and 28 experts testified, whereas typical vaccine cases present 2-6 experts. Evidentiary hearings on the second causation theory were conducted in 2008 and generated 3,200 pages of transcripts. The evidence included over 1,200 articles and excerpts from the medical literature and testimony from 20 experts.
During the proceedings, pediatrician Elizabeth A. Mumper, M.D, testified several times in support of the families who were seeking to prove that vaccines could have caused their children to become autistic. Mumper, who said she had treated between 400 and 500 autistic children, also served as ARI's medical director and director of physician training and has signed onto the 2005 mercury detoxification paper. In 2008, under cross-examination, (a) it was still true that no well-controlled outcome studies had been performed on the components of the DAN! approach, and (b) the theory that thimerosal can contribute to autism is not accepted by the scientific community . But she also said that because children on the autistic spectrum are not all alike, the fact that a study of many children would find no effect would not rule out the possibility that a subset of children would benefit from that method .
In 2009, in a stunning trio of decisions, Special Masters concluded that no credible evidence exists that MMR or thimerosal-containing vaccines can combine to to cause autism. In 2010, in three more cases, the Special Masters concluded that the thimerosal itself was not a causative factor. The decisions also criticized doctors who base their treatments on these notions . When I reviewed the transcripts, I found that at least three of the six families had attended DAN! conferences where they met the doctors who treated their children.
Government actions against three anti-vaccination scaremongers may help to reduce the level of belief among parents that vaccines and/or heavy metal toxicity can trigger autism:
Taylor LE and others. Vaccines are not associated with autism: An evidence-based meta-analysis of case-control and cohort studies. Vaccine 17:3623-3629, 2014.
|Do Children Get Too Many Immunizations? The Answer is No., 11/9/2016|
|Some vaccination opponents try to look respectable by stating that they are not against vaccination but believe that fewer vaccines should be given at once and that the shot schedule should be spaced out. On a recent episode of "Good Morning America," for example, actors Jenny McCarthy and Jim Carrey—with help from hostess Diane Sawyer—promoted the idea that vaccines have a "cumulative effect" and that giving several at once could provoke adverse interactions . Pediatrician Jay Gordon, M.D., whom McCarthy consulated about her son, also advocates delaying certain vaccines . This article explains why the "too many immunizations" claim does not have the slightest basis in reality.|
Vaccines deliver either small amounts of antigen (substances that provoke antibody responses) or genetically weakened germs that multiply more slowly and for a shorter period of time than their disease-producing counterparts. As a result, rather than being exposed to full-blown infections over a 7 to 14 day illness, the body "sees" just enough antigen to develop protective antibodies. For example, whereas a hepatitis B infection exposes the body to 1,100 micrograms of antigen per hour for a week, the hepatitis vaccine series provides a total of 30 micrograms . Thus if any alleged ill effects of a vaccine were due to too many antigens, too much antigen, or too frequent antigens, the diseases would still cause far more trouble than the vaccines.
The capacity of the immune system to respond to antigens is vast and far greater than most people realize. Experts estimate that humans can generate about 10 billion different antibodies and that, due to exposures to germs and other foreign material, people make between 1 million and 100 million different antibodies during our lifetime . The vaccine schedule produces a total of about 30 antibodies. It is also estimated that (a) each infant has the theoretical capacity to respond to about 10,000 vaccines at any one time and (b) if the 11 routinely recommended vaccines were administered together, the immune system would need to use only about 0.1% of its capacity to process them .
Life Provides Far More Microorganism Exposure Than Vaccines
Even though the number of shots has risen in recent years, the actual load on the immune system has gone down. That's because today's vaccines are "smarter" and better engineered than the shots from a few decades ago. For example, before 1991, the whooping cough (pertussis) vaccine had 3,000 different antigens. Today's whooping cough shot has no more than five particles—just as effective, but much better designed to be easy on your immune system .
In May 2010, the journal Pediatrics published a study that compared more than 40 variables related to mental and neurological function among a large group of children to see whether delaying vaccination provided any benefit. After finding that no statistically significant differences favored the less-vaccinated children, the researchers concluded: "Timely vaccination during infancy has no adverse effect on neuropsychological outcomes 7 to 10 years later. These data may reassure parents who are concerned that children receive too many vaccines too soon." Delay Can Harm
Delaying vaccines increases the time during which children are susceptible to certain diseases, some of which are still fairly common. Chickenpox, whooping cough, influenza, and pneumococcus still cause hospitalizations and deaths in previously healthy children. Spacing out or separating vaccines will also require more doctor visits, which will increase overall costs as well as the number of times the children must experience any associated discomfort and stress.
No matter how you slice it, the vaccine schedule represents a miniscule exposure to antigens and organisms compared to what people encounter as part of life. Worrying about too many vaccines is like worrying about a thimble of water getting you wet when you are swimming in an ocean.
Offit P and others. Addressing parents’ concerns: Do multiple vaccines overwhelm or weaken the infant’s immune system? Pediatrics 109:124-129, 2003.
Offit PA. Bell LM. Too many vaccines? What you should know. Vaccine Education Center, Children's Hospital of Philadelphia, Fall 2008.
Composition of nine DTaP vaccines evaluated in efficacy trials. Clinical Microbiology Reviews, April 2005, p 356.
|Misconceptions about Immunization, 20/1/2008|
| Vaccines cause autism|
If measles vaccine or any other vaccine causes autism, it would have to be a very rare occurrence, because millions of children have received vaccines without ill health effects. The only "evidence" linking MMR vaccine and autism was published in the British journal Lancet in 1998 . An editorial published in the same issue, however, discussed concerns about the validity of the study . Based on data from 12 patients, Dr. Andrew Wakefield (a British gastroenterologist) and colleagues speculated that MMR vaccine may have been the possible cause of bowel problems which led to a decreased absorption of essential vitamins and nutrients which resulted in developmental disorders like autism. No scientific analyses were reported, however, to substantiate the theory. Whether this series of 12 cases represent an unusual or unique clinical syndrome is difficult to judge without knowing the size of the patient population and time period over which the cases were identified.
Other recent investigations also do not support a causal association between MMR (or other measles-containing vaccines) and autism or inflammatory bowel disease (IBD) . In one investigation, a Working Party on MMR Vaccine of the United Kingdom's Committee on Safety of Medicines (1999) was charged with the evaluation of several hundred reports, collected by a firm of lawyers, of autism, Crohn's disease, or similar disorders developing after receipt of MMR or MR vaccines. The Working Party conducted a systematic, standardized review of parental and physician information. Although acknowledging that it is impossible to prove or refute the suggested associations (because of variable data quality, biased selection of cases, and lack of a control group), the Working Party concluded that the information available "... did not support the suggested causal associations or give cause for concern about the safety of MMR or MR vaccines." In March 2000, a Medical Research Council report concludes that between March 1998 and September 1999 no new evidence had suggested a causal link between MMR and autism or IBD . The American Medical Association has reached the same conclusion.
The most frequent vaccines cited in the reports were diphtheria, tetanus, pertussis (DPT), oral polio vaccine (OPV), and MMR. Other vaccines reported as having a possible association with autism were Haemophilus influenzae type B and Hepatitis B.
Although the possible association with MMR vaccine has received much public and political attention and there are many who have derived their own conclusions based on personal experiences, the available evidence does not support the hypothesis that MMR vaccine causes autism or associated disorders or IBD. Separate administration of measles, mumps, and rubella vaccines to children provides no benefit over administration of the combination MMR vaccine and would result in delayed or missed immunizations.
Most people have no adverse reaction after receiving a MMR vaccination. About 5%-15% of vaccines may develop a fever 5-12 days after MMR vaccination and 5% may develop a rash. Central nervous system conditions, including encephalitis and encephalopathy, have been reported with a frequency of less than one per million doses administered. In July 2002, after Wakefield testified before a U.S. Congressional committee chaired by a vaccine opponent, Dr. Michael Fitzpatrick (a British general physician and parenbt of an autistic child) charged that Wakefield "has opted out of medical science to join the world of pseudoscientific dogma, media celebrity and populist campaigning." In a devastating review of the conduct of Wakefield and Paul Shattock, a pharmacist and vaccine opponent who runs the so-called Autism Research Unit at the University of Sunderland, Fitzpatrick stated:
There are other beneficiaries of the anti-MMR campaign. Private GPs are now making profits of several hundred percent from selling separate vaccines. Lawyers are eagerly collecting legal aid fees by inflating the hopes of parents that they may gain substantial compensation for the alleged damages from MMR through the pursuit of litigation. It is not surprising that both are enthusiastic supporters of Dr Wakefield's crusade. It seems that Britain's investigative journalists are so smitten by Dr Wakefield's charisma and so credulous towards junk science, that they are reluctant to investigate the real abuses generated around the anti-MMR campaign .
To assure the safety of vaccines, the CDC, the FDA, the National Institutes of Health (NIH), and other federal agencies routinely examine any new evidence that would suggest possible problems with the safety of vaccines. Currently, CDC is conducting a study in the metropolitan Atlanta area to further evaluate any possible association between MMR vaccination and autism.
Duclos P, Ward BJ. Measles vaccines: A review of adverse events. Drug Safety 19:435-454, 1998.
Howson CP and others, editors. Adverse Effects of Pertussis and Rubella Vaccines, Washington, DC: National Academy Press, 1991.
Tan LJ. Vaccines do not cause autism. American Medical Association position statement, posted April 3, 2000.
|Hawaii Governor Vetoes Anti-Thimerosal Bill, 13/7/2006|
|Hawaii Governor Linda Lingle has vetoed a bill ban the use of thimerosal in pediatric vaccines. Flu vaccine is the only one to which it would have applied. Bills to block thimerosal use in pediatric vaccines have been enacted in California, Delaware, Illinois, Iowa, Missouri, New York, and Washington. As noted by Governor Lingle, such bills are "a step backward in our efforts to encourage families to participate in vaccination and to reduce or eliminate preventable illness and deaths from communicable diseases."|
The purposes of this bill are to establish a Hawaii health commission within the Department of Commerce and Consumer Affairs that would develop a comprehensive health plan for people in Hawaii and to restrict the use in Hawaii of vaccines that contain mercury.
This bill is objectionable because it restricts the use of FDA-approved vaccines for no scientifically sound reason. This restriction will put the health and well-being of Hawaii residents at risk, particularly in the event of an influenza pandemic.
Thimerosal, an organic mercury compound, has been used as a preservative in some vaccines for many years. The FDA requires that vials of vaccines that provide multiple doses, such as many flu vaccines, contain preservatives to prevent contamination as individual doses are withdrawn from the vial. When thimerosal is processed by the body, it breaks down into ethyl mercury, one form of mercury. Others are pure mercury, such as that formerly used in thermometers, and methyl mercury, which is produced by microorganisms in water and soil and can accumulate in fish. Exposure to high levels of methyl mercury is toxic.
In 1999, the FDA determined that on a regular vaccination schedule some infants might be exposed to accumulated doses of ethyl mercury that would exceed some guidelines for methyl mercury. These forms of mercury are different and are processed differently by the body. Ethyl mercury breaks down much more rapidly and is eliminated more quickly than methyl mercury. But as a precaution, the United States Department of Health and Human Services, the American Academy of Pediatrics, and vaccine manufacturers decided that thimerosal should be reduced or eliminated in vaccines. As a result, the vaccines routinely recommended for childhood immunization no longer contain thimerosal. However, some immunizations for adolescents and adults still do. Further, much of the flu vaccine supply does as well.
Two years after that precautionary decision, the Immunization Safety Review Committee of the Institute of Medicine in the National Academies of Science reported that there was not enough evidence to say that vaccines with thimerosal either do or do not cause various disorders in children such as autism, hyperactivity, and delayed speech. By 2004 enough additional studies had been done for the committee to conclude that there is no causal relationship between thimerosal-containing vaccines and autism.
This bill ignores the body of current scientific evidence on thimerosal-containing vaccines. It also ignores the American Academy of Pediatrics, the Hawaii Academy of Family Practice, the Hawaii Medical Association, the Hawaii Chapter of the American College of Obstetrics and Gynecology, and numerous physicians who are on record opposing this legislation. Its enactment could cause some parents to doubt the general safety of vaccines and to decline vaccinations for their children, a step backward in our efforts to encourage families to participate in vaccination and to reduce or eliminate preventable illness and deaths from communicable diseases.
|Misconceptions about Immunization, 1/7/2012|
Vaccines cause many harmful side effects, and even death--|
Vaccines are actually very safe, despite implications to the contrary in many anti-vaccine publications. These sometimes contain the number of reports received by the Vaccine Adverse Events Reporting System (VAERS) and suggest that all of them represent genuine vaccine side-effects. The mere number can be misleading because most vaccine adverse events are minor and temporary, such as a sore arm or mild fever. These can often be controlled by taking acetaminophen before or after vaccination. More serious adverse events occur rarely (on the order of one per thousands to one per millions of doses), and some are so rare that risk cannot be accurately assessed. As for vaccines causing death, again so few deaths can plausibly be attributed to vaccines that it is hard to assess the risk statistically. Of all deaths reported to VAERS between 1990 and 1992, only one is believed to be even possibly associated with a vaccine. Each death reported to VAERS is thoroughly examined to ensure that it is not related to a new vaccine-related problem, but little or no evidence suggests that vaccines have contributed to any of the reported deaths. The Institute of Medicine in its 1994 report states that the risk of death from vaccines is "extraordinarily low."
But looking at risk alone is not enough—you must always look at both risks and benefits. Even one serious adverse effect in a million doses of vaccine cannot be justified if there is no benefit from the vaccination. If there were no vaccines, there would be many more cases of disease, and along with them, more serious side effects and more deaths. For example, according to an analysis of the benefit and risk of DTP immunization, if we had no immunization program in the United States, pertussis cases could increase 71-fold and deaths due to pertussis could increase 4-fold. Comparing the risk from disease with the risk from the vaccines can give us an idea of the benefits we get from vaccinating our children. The following table compares these risk for six diseases.
The fact is that a child is far more likely to be seriously injured by one of these diseases than by any vaccine. While any serious injury or death caused by vaccines is too many, it is also clear that the benefits of vaccination greatly outweigh the slight risk, and that many, many more injuries and deaths would occur without vaccinations. In fact, to have a medical intervention as effective as vaccination in preventing disease and not use it would be unconscionable.
The U.S. Public Health Service is conducting research to better understand which vaccine adverse events are truly caused by vaccines and how to reduce even further the already low risk of serious vaccine-related injury.
|Misconceptions about Immunization, 1/7/2012|
|Children are exposed to many foreign antigens every day. (An antigen is a substance that stimulates an immune response.) Eating food introduces new bacteria into the body, and numerous bacteria live in the mouth and nose, exposing the immune system to still more antigens. An upper respiratory viral infection exposes a child to 4-10 antigens, and a case of "strep throat" to 25-50. According to Adverse Events Associated with Childhood Vaccines, a 1994 report from the Institute of Medicine, "In the face of these normal events, it seems unlikely that the number of separate antigens contained in childhood vaccines . . . would represent an appreciable added burden on the immune system that would be immunosuppressive." And, indeed, available scientific data show that simultaneous vaccination with multiple vaccines has no adverse effect on the normal childhood immune system.|
Studies have been conducted to examine the effects of giving various combinations of vaccines simultaneously. In fact, neither the Advisory Committee on Immunization Practices (ACIP) nor the American Academy of Pediatrics (AAP) would recommend the simultaneous administration of any vaccines until such studies showed the combinations to be both safe and effective. These studies have shown that the recommended vaccines are as effective in combination as they are individually, and that such combinations carry no greater risk for adverse side effects. Consequently, both the ACIP and AAP recommend simultaneous administration of all routine childhood vaccines when appropriate. Research is under way to find ways to combine more antigens in a single vaccine injection (for example, MMR and chickenpox). This will provide all the advantages of the individual vaccines, but will require fewer shots.
Two practical factors favor giving a child several vaccinations during the same visit. First, immunizing children as early as possible provides protection during the vulnerable early months of life. This generally means giving inactivated vaccines beginning at 2 months and live vaccines at 12 months. The various vaccine doses thus tend to fall due at the same time. Second, giving several vaccinations at the same time will mean fewer office visits for vaccinations, which saves parents both time and money and may be less traumatic for the child.
|George Kindness Facing Criminal Charges, 28/4/2004|
|In 1999, the FDA discovered that Amscot had been making "vaccines" from blood and tumor tissues of cancer patients and shipping them to an unidentified co-conspirator who used them to treat patients.|
Throughout 2000, Amscot continued to prepare and ship Theracine vaccines.
4. Certain autologous vaccines manufactured by Defendant AMSCOT MEDICAL LABS, INC., commonly known as Gene Activated Therapy (GAT) and Theracine, (hereinafter one or more of these substances are sometimes referred to generically as "Defendant AMSCOT's autologous vaccines") were intended for use in the cure, mitigation, treatment, or prevention of disease in man and were drugs within the meaning of the Act, 21 U.S.C. §§ 321(g)(1)(b);
10. On or about April 12 -13,1999, FDA conducted an inspection of Defendant AMSCOT, located at 11365 Williamson Road., Cincinnati, Ohio, pursuant to its regulatory authority, 21 U.S.C. 374. The FDA discovered that Defendant AMSCOT had been and was currently manufacturing autologous vaccines from cancer patients' own tumor tissue and blood samples. The vaccines were intended as a treatment for cancer. The patients were administered these vaccines. The vaccine was being administered to patients as part of a study known as the Gene Activated Therapy (GAT) study.
16. On or about May 2 - 10, 2000, the FDA inspected Defendant AMSCOT and found evidence that since June 1999 Defendant AMSCOT had been manufacturing Theracine. Defendant GEORGE KINDNESS acknowledged in a sworn statement to FDA investigators on May 10, 2000, that an IND for Theracine had not been submitted to the FDA. The inspection also revealed that 63 Theracine vaccines had been processed since November 14, 1999, all of which were shipped to unnamed co-conspirator 1 and others prior to performing sterility, endotoxin and mycoplasma testing.
17. It was the object of the conspiracy: (A) to produce and distribute in interstate commerce to health care professionals and consumers misbranded drugs, Le. one or more autologous vaccines, with the intent to deceive or defraud, and (2) to produce and distribute in interstate commerce to health care professionals and consumers adulterated drugs, i.e. one or more of autologous vaccines, with the intent to deceive or defraud, in violation of 21 U.S.C., Section 331(a) and 333(a}(2).
|Delta Airlines Permits Anti-Vax Video, 12/11/2011|
|Odd until you consider the source: the National Vaccine Information Center. The NVIC was founded by former pubic relations executive Barbara Loe Fisher, its current president, who dispenses advice in the video. Fisher is described by journalist Seth Mnookin as "the grand dame of the American anti-vaccine movement." According to Mnookin's 2011 book, The The Panic Virus, Fisher stated in a 2009 talk that (a) vaccines are a "de facto selection of the genetically vulnerable for sacrifice," (b) doctors who administer vaccines the moral equivalent of "doctors tried at Nuremberg," and (c) the U.S. government vaccine policy is comparable to medical experiments conducted by Nazis during World War II. These views are still displayed on the NVIC Web site.|
The NVIC site is prominently displayed in the video as a source of flu vaccine information. One shot of the site shows scary headlines like "Mercury in Vaccines" and "Aluminum in Vaccines," proclamations that invite readers to further explore the NVIC's misinformation campaign on vaccine safety and effectiveness.
As Dr. Winchester explained in an e-mail message to me, "my concern is that while the ad does have some helpful medical information . . . it ignores the fact that influenza is a potentially deadly illness and that vaccines are highly effective at protecting people from the flu." He added that NVIC's "website promotes fear by linking vaccines to diabetes, learning disabilities, autism and asthma."
NVIC's website is full of testimonials from people who claim they or their children have been injured by vaccines. Anyone can report a purported injury to the NVIC without a shred of medical evidence that it is connected in any way with vaccination. These reports are published on the "International Memorial for Vaccine Victims" page of the NVIC website. There is also the florid "Cry for Vaccine Freedom Wall" where, again, without any independent confirmation required, one can report "harassment" for "making independent vaccine choice." In one report posted a few days ago, a grandmother said she does not want her grandson immunized because "I have educated myself and found out that influenza vaccines are mostly ineffective and dangerous."
|British Courts Side with Vaccination in Parental Dispute, 8/8/2003|
|"..this is an independent medico-legal report based on my opinion, knowledge and research on the diseases, their vaccines and taking into account the particular cases of the children involved. I understand that the court will use it in coming to a decision as to what is in the best interests of the children involved. I have indicated my sources extensively. The facts and opinions expressed in this report are true and accurate to the best of my knowledge. I confirm that any fees are independent of the outcome of the case."|
Two other papers relied upon by Dr Donegan did not question the efficacy of the vaccination programme in the results that they considered. Equally Dr Conway takes issue with Dr Donegan's claim that the SV40 virus which contaminated polio vaccines in 1961 may still be causing a problem. No large-scale studies had been undertaken. Controlled tissues had often been inadequate and findings have not been replicated in all laboratories.
She claims that of the 5 available vaccines depending upon which they are joined with, the 2 most effective are not available in the UK. There are side effects and she says there are reports of causing a neurological disease. It was not introduced for children over 4 because they were regarded as already immune.
Dr Donegan argues that the percentage of cases of disease rose from 30% to 40% in the late 1980s. She says that children are having more vaccines and this may be affecting their immune system. When the vaccine was introduced in November 1999 there were unprecedented numbers of side effects reported.
New claims were made by Dr Wakefield and colleagues. Professor Kroll has reviewed a series of papers about this topic since then. He has looked at a link with autism and the effect of combining the 3 vaccines together.
On the evidence before me the benefits of having the 3 vaccinations at one time outweigh any risks there may be. A child's immunity is not overloaded by receiving 3 vaccinations in one. It is daily exposed to a vast array of potential infections. The risk is I am satisfied as Professor Kroll said rather the reverse, namely that the effectiveness of the vaccinations may be reduced. On the evidence I see no advantage and much disadvantage in staging the administration of the 3 vaccines over a period of time.
3. There is no evidence to support the suggestion that combining measles, mumps and rubella vaccines in a single injection is harmful, or that giving the components separately is safer. On the contrary, the delivery of the vaccine components in stages increases the risk of an unprotected child contracting one or other of the infections it is intended to prevent.
The father saw the issue as one where the mother was exercising control. C was hers and he appeared to be challenging that. He understood that the mother was concerned about the quality of vaccines and he would discuss it. He was happy to go along with single injections if this would help. He did not consider MMR a risk. Finally I note the father is somewhat isolated, finding it difficult to find like minded people in the area.
|Misconceptions about Immunization, 21/9/2016|
| Cases per year before vaccines|
Misconception #1: Because of better hygiene and sanitation, diseases had already begun to disappear before vaccines were introduced.
Misconception #3: There are hot lots of vaccine that have been associated with more adverse events and deaths than others. Parents should find the numbers of these lots and not allow their children to receive vaccines from them.
Misconception #4: Vaccines cause many harmful side effects, and even death—and may cause long-term effects we don't even know about.
Misconception #9: Vaccines cause autism.
The Promise of Vaccines: The Science and the Controversy: American Council on Science and Health booklet
National Immunization Program offers answers to common questions.
The "Pink Book" Epidemiology & Prevention of Vaccine-Preventable Diseases
Vaccine information statements: 1-page summaries for each vaccine
ImmYounity: Vaccine information from Sanofi Pasteur, Inc.
National Institute of Allergy and Infectious Diseases: Jordan Report 2000: Accelerated Development of Vaccines
|Lack of Evidence that Hepatitis B Vaccine Causes Multiple Sclerosis, 20/8/2006|
|Many neurologists and immunologists believe that MS is an autoimmune disease whereby the immune system attacks myelin. One hypothesis of how this may occur is called "molecular mimicry", where an immune system attack on myelin is induced by a foreign antigen which has an immunogenic region resembling human myelin. One investigator found an amino acid sequence on the hepatitis B DNA polymerase molecule similar to a sequence in rabbit myelin. However, it is unlikely that this has clinical relevance, because rabbit and human myelin differ in this region, HB infection is not associated with MS, and, most relevant to this discussion, HB vaccines do not contain any DNA polymerase.|
The environmental factors "triggering" exacerbations are unknown. Dozens of factors have been proposed (but never proven) including infectious diseases (at least 17 viruses have been suggested), vaccines, climate, latitude, stress, trauma, pregnancy, dogs as pets, occupational exposures, contaminated food, and metals. An association between MS exacerbations and infectious diseases has been suggested, but there is little evidence to support this. Aside from hypotheses and individual case reports, there is no actual evidence supporting a causal association between MS exacerbations and any vaccine.
(2) Published and unpublished studies looking for an increased rate of MS, exacerbations of MS, or other demyelinating disease in recipients of HB vaccines have found no such increase. Among the more than 550 million individuals who have been immunized with HB vaccines since 1982, no evidence of a causal association with MS or other demyelinating diseases has ever been demonstrated. Post-marketing surveillance (reports of adverse events following licensure of a vaccine) data from the United States of America were examined in 1987 and 1996, and from Canada in 1992. No increased rate of MS or other neurological diseases was found compared to background. The sensitivity of passive reporting of adverse events, however, is low, and population-based controlled studies are currently planned or under way.
(3) Analysis of the reported cases in France The results of an official pharmacovigilance study on the neurological tolerance of all HB vaccines available in France (Engerix B, GenHevac and HB-VAX DNA) were presented to the National Commission of Pharmacovigilance in December 1994 and in December 1996. The data showed the following:
While any risk of MS following HB immunization is hypothetical, the risk of HB infection and disease in nonimmunized individuals is real. HB causes an estimated 4 million acute infections worldwide each year, and currently there are more than 350 million chronic carriers of HBV, approximately 25% of whom will die from cirrhosis of the liver or primary liver cancer, diseases which kill more than 1 million persons per year. For these reasons, WHO has called for all countries to include routine HB immunization in their national immunization programmes. More than 85 countries have done so and many more are planning for the introduction of the vaccine. HB vaccines are safe, more than 90% effective in preventing disease, and very cost-effective. It is extremely unfortunate that unsubstantiated claims that HB vaccines might cause MS are reducing the uptake of this important vaccine.
|Naturopathy: Opposition to Immunization, 21/8/2003|
|The contemporary fashion of healing disease is that of serums, inoculations and vaccines, which, instead of being an improvement on the fake medicines of former ages are of no value in the cure of disease, but on the contrary introduce lesions into the human body of the most distressing and deadly import. . . .|
The Academic Dean of the National College of Naturopathic Medicine, Jared Zeff, N.D., said, in reference to such products, that some naturopaths give conventional vaccines and some give homeopathic pills that "stimulate the immune system."
A "review article" claims that certain vaccine production methods involve virus contaminants that may "have the capacity to transform human cells into cancer cells." Many of the references date back 40 to 60 years, long before modern vaccine preparation techniques were developed. The author notes this but cites speculations from a 40-year-old book to suggest that "the pertinence of viral contamination of vaccines may be seen for generations to come."
Another article, written by a "research journalist" who is not a health professional, concludes: "A number of vaccines that are routinely given in infancy and childhood are promoted as safe and effective. Scientific findings, however, dispute these claims." The article even suggests that germs don't cause disease but merely seek and multiply in unhealthy tissues .
Another article acknowledges that "most currently used vaccines do confer varying degrees of immunity, with little known risk." But it also states that "we are creating more and more immunizations without an adequate understanding of the far-reaching effects on the immune system."
It depends on the vaccination -- some have serious side effects for sensitive individuals. . . . Medical literature from the last 70 years shows a high incidence of vaccination-related injuries and deaths. . . . My own sense is that most vaccines unnaturally stimulate and imbalance the immune system, eventually allowing many more immunological disorders like M.S., lupus, chronic fatigue syndrome, candida and herpes infections
Miller NZ. Vaccines and natural health. Journal of Naturopathic Medicine 5(1):32-39, 1994.
|Naturopathic Misrepresentations, 30/8/2002|
|"Some naturopaths espouse an 'immunization kit' containing homeopathic solutions and pills that supposedly protect against polio, measles, pertussis, tetanus, and other lethal diseasesThe Academic Dean of the National College of Naturopathic Medicine, Jared Zeff, N.D., said, in reference to such products, that some naturopaths give conventional vaccines and some give homeopathic pills that 'stimulate the immune system.'" |
"The fifth , which attacks immunization, contains papers suggesting that vaccines may be a factor in causing cancer and that homeopathic prophylaxis using nosodes would be effective and safer than standard vaccines. (Nosodes are homeopathic products made from pathological organs or tissues: causative agents such as bacteria, fungi, ova, parasites, virus particles and yeast; disease products; or excretions.)" [Review by Stephen Barrett, M.D., of the 1994 issue of the Journal of Naturopathic Medicine (the "official publication of the American Association of Naturopathic Physicians").
"In view of the valid questions about the efficacy of modern vaccines and growing concerns about harmful side effects, which appear to be greatly underestimated..."
"When arbitrary decisions in the mandating of vaccines are made by government bureaucracies, which frequently work hand-in-glove with the pharmaceutical industry, with no recourse open to parents, we have all the potential ingredients for a tragedy of historic proportions."
Comment: The side effects of vaccines are not greatly underestimated. Serious ones are well recognized but very rare, much rarer than the incidence of serious infectious diseases in the absence of vaccines. The naturopathic representative to the Commission denied that present-day naturopaths are opposed to childhood vaccinations. The quotations above, which show a consistent historical pattern, prove otherwise.
|with MS, and, most relevant to this discussion, HB vaccines do not contain|
diseases (at least 17 viruses have been suggested), vaccines, climate, latitude,
HB vaccines have found no such increase. Among the more than 550 million
individuals who have been immunized with HB vaccines since 1982, no evidence
pharmacovigilance study on the neurological tolerance of all HB vaccines
many more are planning for the introduction of the vaccine. HB vaccines
It is extremely unfortunate that unsubstantiated claims that HB vaccines
|Misconceptions about Immunization, 1/7/2012|
begun to disappear before vaccines were introduced|
Statements like this are very common in anti-vaccine literature, the intent apparently being to suggest that vaccines are not needed. Improved socioeconomic conditions have undoubtedly had an indirect impact on disease. Better nutrition, not to mention the development of antibiotics and other treatments, have increased survival rates among the sick; less crowded living conditions have reduced disease transmission; and lower birth rates have decreased the number of susceptible household contacts. But looking at the actual incidence of disease over the years can leave little doubt of the significant direct impact vaccines have had, even in modern times. Here, for example, is a graph showing the reported incidence of measles since 1920.
Hib vaccine is another good example, because Hib disease was prevalent until just a few years ago, when conjugate vaccines that can be used for infants were finally developed. (The polysaccharide vaccine previously available could not be used for infants, in whom most of cases of the disease were occurring.) Since sanitation is not better now than it was in 1990, it is hard to attribute the virtual disappearance of Hib disease in children in recent years (from an estimated 20,000 cases a year to 1,419 cases in 1993, and dropping) to anything other than the vaccine.
Finally, we can look at the experiences of several developed countries after they let their immunization levels drop. Three countries—Great Britain, Sweden, and Japan—cut back the use of pertussis vaccine because of fear about the vaccine. The effect was dramatic and immediate. In Great Britain, a drop in pertussis vaccination in 1974 was followed by an epidemic of more than 100,000 cases of pertussis and 36 deaths by 1978. In Japan, around the same time, a drop in vaccination rates from 70% to 20%-40% led to a jump in pertussis from 393 cases and no deaths in 1974 to 13,000 cases and 41 deaths in 1979. In Sweden, the annual incidence rate of pertussis per 100,000 children 0-6 years of age increased from 700 cases in 1981 to 3,200 in 1985. It seems clear from these experiences that not only would diseases not be disappearing without vaccines, but if we were to stop vaccinating, they would come back.
|Misconceptions about Immunization, 1/7/2012|
children to receive vaccines from them.|
1. VAERS (the Vaccine Adverse Events Reporting System) is a system for reporting events that occur after the administration of any vaccine. VAERS reports should not be interpreted to imply causality. In other words, a VAERS report does not mean that the vaccine caused the event. Statistically, a certain number of serious illnesses, even deaths, can be expected to occur by chance alone among children recently vaccinated. Although vaccines are known to cause minor, temporary side effects such as soreness or fever, there is little, if any, evidence linking vaccination with permanent health problems or death. The point is that just because an adverse event has been reported to VAERS does not mean it was caused by a vaccine.
2. Vaccine lots are not the same. The sizes of vaccine lots might vary from several hundred thousand doses to several million, and some are in distribution much longer than others. Naturally a larger lot or one that is in distribution longer will be associated with more adverse events, simply by chance. Also, more coincidental deaths are associated with vaccines given in infancy than later in childhood, since the background death rates for children are highest during the first year of life. So knowing that lot A has been associated with x number of adverse events while lot B has been associated with y number would not necessarily say anything about the relative safety of the two lots, even if the vaccine did cause the events.
Reviewing published lists of "hot lots" will not help parents identify the best or worst vaccines for their children. If the number and type of VAERS reports for a particular vaccine lot suggested that it was associated with more serious adverse events or deaths than are expected by chance, the Food and Drug Administration (FDA) has the legal authority to immediately recall that lot. No vaccine lot in the modern era has been found to be unsafe on the basis of VAERS reports.
All vaccine manufacturing facilities and vaccine products are licensed by the FDA. In addition, every vaccine lot is safety-tested by the manufacturer. The results of these tests are reviewed by FDA, who may repeat some of these tests as an additional protective measure. FDA also inspects vaccine-manufacturing facilities regularly to ensure adherence to manufacturing procedures and product-testing regulations, and reviews the weekly VAERS reports for each lot searching for unusual patterns. FDA would recall a lot of vaccine at the first sign of problems. There is no benefit to either the FDA or the manufacturer in allowing unsafe vaccine to remain on the market. The American public would not tolerate vaccines if they did not have to conform to the most rigorous safety standards. The mere fact is that a vaccine lot is still in distribution indicates that the FDA considers it safe.
|An Open Letter to the Congress about Immunization Policy, 3/6/2008|
| As advocates for public health, we are writing to express support for immunization and concern about those who decide not to vaccinate their children based on unsubstantiated claims about vaccine risks. No medical intervention is risk-free, but vaccines have an exemplary safety record and significant adverse reactions are very rare. Vaccines are tested in large clinical trials, are thoroughly regulated by the Food and Drug Administration (FDA), and are subject to comprehensive ongoing surveillance by the FDA, the Centers for Disease Control and Prevention (CDC), and the international public health community.|
It is indisputable that immunization has been one of the greatest medical success stories in history. The scourge of smallpox has been eradicated completely, while polio, which once crippled and killed tens of thousands of children annually, now only circulates in a few countries and is targeted for eradication. Bacterial meningitis incidence has dropped dramatically thanks to the introduction of three vaccines that combat various forms of this deadly disease. The list of diseases that have been nearly eliminated by vaccines is long, and millions of lives have been saved as a result. Yet, with the exception of smallpox, any of these diseases can and will return if immunization rates lag.
Voices For Vaccines
|OTA Report: Pharmacologic and Biologic Treatments, 13/1/2006|
|A large and diverse group of unconventional cancer treatments has as its central component a pharmacologic or biologic substance, including biochemical agents, vaccines, blood products, and synthetic chemicals. Some of these pharmacologic and biologic treatments are offered at single sites under the direction of a developer or other chief proponent. Others are more widely available, are not necessarily associated with particular proponents, and may be used in combination with a variety of other unconventional and conventional treatments.|
Thereafter, new cultures were obtained periodically for the production of new vaccines, so that the treatment continued to correspond to any changes in the patient's P. cryptocides levels as treatment progressed (559). Gradually, the frequency of autogenous vaccine administration was decreased and eventually, only occasional booster shots were given. Livingston also gave a "purified antigen" vaccine made at the clinic, consisting of a cell wall extract of a general P. cryptocides culture (562).
Other immunologic treatments included in the regimen are mixed bacterial vaccines, antibiotics, and various commercially prepared nonspecific immune stimulators, such as levamisole (a conventional antiparasitic agent also used as an immune stimulant and recently shown effective in treating patients with colon cancer), and tuftsin (an experimental agent noted for various immune stimulating properties).
There have been no reports in the literature of direct adverse effects from the Livingston regimen. There are some potential risks, however. As with any injection into the body of a foreign substance, the injection of the autogenous vaccine carries the associated risk of sepsis or anaphylaxis. Some risk of contamination in the preparation of the material is also possible, depending on the processes and procedures used to make and assure the sterility of the vaccines manufactured at the clinic. In addition, in any setting, the use of whole blood transfusion, even with directed donors' blood, carries a small risk of transmitting various infectious agents. Livingston's "custom formula," consisting of an extract of sheep liver and spleen, carries certain risks associated with all types of cellular treatment (see discussion of cellular treatment earlier in this chapter).
Speckhart and Johnson's full results may contribute information to the further evaluation of the efficacy of such vaccines in cancer treatment.
|Lyme Disease: Questionable Diagnosis and Treatment, 23/12/2016|
|The demise of Lymerix has not ended research on new Lyme vaccine candidates and vaccines against tick vectors. It may be difficult, however, to field-test new vaccines due to anti-vaccination organizations and the lingering hostility of Lyme activists to a vaccine .|
Despite the lawsuits and the website tales of personal anguish, repeated studies failed to find any evidence of specific adverse events associated with Lymerix . A CDC study published in the February 2002 issue of Vaccine also failed to detect any "unexpected or unusual patterns" of adverse reactions to vaccination . (Reports of adverse reactions to Lymerix, and other vaccines, can be searched for on the Vaccine Adverse Event Reporting System (VAERS) website.)
Robinson, MB. Senators urge haste on Lyme vaccines. Bergen Record, Dec 7, 1997.
|Misconceptions about Immunization, 1/7/2012|
|This is another argument frequently found in anti-vaccine literature—the implication being that this proves vaccines are not effective. In fact it is true that in an outbreak those who have been vaccinated often outnumber those who have not—even with vaccines such as measles, which we know to be about 98% effective when used as recommended.|
This apparent paradox is explained by two factors. First, no vaccine is 100% effective. To make vaccines safer than the disease, the bacteria or virus is killed or weakened (attenuated). For reasons related to the individual, not all vaccinated persons develop immunity. Most routine childhood vaccines are effective for 85% to 95% of recipients. Second, in a country such as the United States the people who have been vaccinated vastly outnumber those who have not. How these two factors work together to result in outbreaks in which the majority of cases have been vaccinated can be more easily understood by looking at a hypothetical example:
|Vaccination Undermined, 20/8/2006|
| For more than 200 years, vaccines have made an unparalleled contribution to public health. The writer and commentator Samuel Butler (1835-1902) wrote: "Vaccination is the medical sacrament corresponding to baptism." Considering the list of killer diseases that once held terror and are now under control, including polio, measles, diphtheria, pertussis, rubella, mumps, tetanus, and Haemophilus influenzae type b (Hib), one might expect vaccination to have achieved miracle status, not just sacramental.|
Vaccines are unattractive targets for industry, underappreciated from the public health perspective, underfunded by basic research organizations, and treated with suspicion by the public. Multiple reasons exist for this, but the one that gets me steamed is the malign influence of three groups: antivaccine lobbyists, journalists, and lawyers.
A prime example is this quote from a respected UK daily: "Do we need so many vaccines? Could they be causing more health problems than they solve by overloading immature immune systems? Could they even be contributing to long-term problems such as MS or cancer in ways we don't yet understand?"
A vaccine act would help greatly. It could set rules for demonstrating adverse reactions--yes, these do occur -- and provide a framework for compensation to affected parties. Within this stable framework, companies could be attracted to compete in the development of safe and effective new vaccines that would benefit public health programs throughout the world.
|Homeopathy: The Ultimate Fake, 25/8/2016|
|Many proponents claim that homeopathic products resemble vaccines because both provide a small stimulus that triggers an immune response. This comparison is not valid. The amounts of active ingredients in vaccines are much greater and can be measured.|
Moreover, immunizations produce antibodies whose concentration in the blood can be measured, but high-dilution homeopathic products produce no measurable response. In addition, vaccines are used preventively, not for curing symptoms.
|Induced Remission Therapy (Sam Chachoua), 31/1/2016|
|IRT's chief promoter, Sam Chachoua, claims that cancer is a manifestation of the body's protective response to infectious organisms. He also claims to have developed vaccines and other technologies with a "preliminary test efficacy (greater than 99%) against cancer and AIDS." One Web site promoting IRT states:|
His vaccines include tagging agents capable of attaching themselves to the cancer cells and making them immunologically tempting targets as well as a battery of specific, non-toxic therapies. The shrinkage of large cancer lesions within days and the disappearance of symptoms can be expected and delivered.
At its biological horizon, Induced Remission Therapy is represented by vaccines and sera that both target the cause of disease and correct cell damage at its genetic level. Cancers are allowed to then activate differentiation cycles or fulfill a programmed cell death. This allows for removal of diseased tissue and return to normal structure without trauma or toxicity. . . .
|"Autism Specialist"Blasted by Omnibus Special Master, 28/6/2015|
|Jeff Bradstreet, M.D. has been described by his fans as a "cutting edge doctor" who specialized in treating autistic children. However, a Special Master of the U.S. Court of Federal Claims who looked closely at Bradstreet's work concluded that he habitually misdiagnosed and mistreated autistic children . The 293-page report, issued in 2009, dissected Bradstreet's management of Colten Snyder, whose family—based on the belief that vaccines caused the boy to develop autism—had petitioned the court for compensation . The court ruled that no such connection existed. This article highlights the Special Master's observations. that Bradstreet had improperly diagnosed and treated Colten for "mercury toxicity."|
More than 5,000 families who claimed that vaccines caused their children to become autistic sought compensation through the U.S. Court of Federal Claims. Bradstreet treated many of these children and also offered expert testimony in the proceedings. In February 2008, three Special Masters concluded that no credible evidence existed that vaccines could combine to to cause autism . The decisions completely debunked this notion and implied that doctors who based their treatments on them were unscientific and unethical. The decisions came in three cases selected to "test" how similar cases should be handled. One of the children was Colten Snyder, whom Bradstreet began treating in 1999. After stating that Colten's medical records with Bradstreet encompassed over 650 pages, Special Master Vowell noted:
Limit of 25 files reached.