Autism in a Needle?
The toxic tale of vaccinations and mercury poisoning
By Annette Fuentes
Nov 11, 2003
Lyn Redwood’s son Will was a healthy, happy baby who met all the normal developmental standards—he was walking and talking by one year. About three months later, however, he began to regress, losing speech, avoiding eye contact and appearing miserable. “He didn’t seem happy anymore,” Redwood said in a recent interview. “He just wanted to sit in his infant seat and watch videos over and over again.”
Doctors initially blamed hearing problems for Will’s decline. Neurologists told the parents that their son had global and receptive speech delay. At age 5, the boy was diagnosed as autistic by his school.
Seeking answers to her son’s condition, Redwood turned to the Internet in 1999 and began a search that led to startling discoveries about thimerosal. This vaccine preservative is composed of nearly 50 percent mercury, which is a known neurotoxin especially harmful to fetuses, infants and children. What’s more, it has been linked to a range of symptoms collectively known as Autism Spectrum Disorders. At one end is severe autism, in which children are socially withdrawn, do not speak and exhibit bizarre, repetitive, sometimes aggressive behaviors. At the other end are Asperger’s Syndrome, a high-functioning form of autism, Pervasive Developmental Disorder (PDD), Attention Deficit Disorder (ADD) and Attention Deficit Hyperactivity Disorder (ADHD).
Thimerosal was widely used since the ’40s in over-the-counter medicines until that use was banned in 1998. It’s still found in some vaccines for adults and infants. Its medical, political, economic and international implications represent a chilling chapter in the history of public health, in which regulatory agencies were negligent, if not guilty, in covering up health hazards, by failing to act quickly to protect millions of children. Said Redwood, a nurse practitioner and a board of health member in her Georgia county, where vaccination is a major public health program: “If someone had told me prior to 1999 that vaccines were responsible for my son’s disabilities, I would have thought they were crazy.”
Regulators ‘asleep at the switch’
Before 1980, autism was diagnosed in 1 in 10,000 children; in 2002, the National Institutes of Health raised that figure to 1 in 250 children. The Autism Society of America now estimates that autism disorders are growing by 10 percent or more annually. Some scientists believe boys are afflicted by the neurological disorders of autism at a rate three to six times that of girls because the female hormone estrogen protects against mercury toxicity.
In a sad twist, scientists increasingly believe that the mercury-laced vaccines meant to protect children from illness are at the root of this spike. In 1985, four of the shots recommended for infants in their first 18 months contained thimerosal. By 1991, the Centers for Disease Control and Prevention (CDC) added three Hepatitis B shots (each containing 12.5 micrograms of thimerosal) and four Hib shots (each with 25 micrograms of mercury). As a result, the number of vaccines containing thimerosal jumped to 11, and the amount of mercury exposure mushroomed to 237.5 micrograms, an amount that exceeded all federal limits.
Neither the Food and Drug Administration (FDA) nor the CDC, the nation’s chief regulatory agencies for pharmaceutical products and the watchdogs of public health, added up the micrograms. The regulatory spotlight was finally fixed on thimerosal in 1997 when Congress passed the FDA Modernization Act. Part of the act required the FDA to investigate all drugs that contained mercury and determine their effects on humans. Within a year, the FDA had called for the removal of all thimerosal-containing products from over-the-counter products. Thimerosal remained in more than 50 vaccines, however, until the Public Health Service (which includes the FDA, the CDC and the National Institutes of Health) and the American Academy of Pediatrics issued a statement in July 1999 “urging” vaccine makers to reduce or eliminate thimerosal because of “theoretical potential for neurotoxicity.”
Last year, the staff for Rep. Dan Burton (R-Ind.) obtained an internal e-mail written June 29, 1999, by former FDA scientist Peter Patriarca. In that e-mail Patriarca offered his colleagues a “pros and cons” assessment of the thimerosal statement shortly before its release:
Will raise questions about FDA being ‘asleep at the switch’ for decades, by allowing a potentially hazardous compound to remain in many childhood vaccines, and not forcing manufacturers to exclude it from new products. Will also raise questions about various advisory bodies about aggressive recommendations for use. We must keep in mind that the dose of ethyl mercury was not generated by ‘rocket science’: conversion of the % of thimerosal to actual ug [micrograms] of mercury involves 9th grade algebra. What took the FDA so long to do the calculations? Why didn’t CDC and the advisory bodies do these calculations while rapidly expanding the childhood immunization schedule?
Roger Bernier, of the CDC’s national immunization program, received the e-mail. In a recent interview he explained why the cumulative amount of mercury was never figured. “Vaccines tend to be evaluated on an individual basis, the requirements for safety and efficacy on an individual basis,” Bernier said. “This holistic view of safety was not part of the review.” Bernier said the health agencies did not order vaccine makers to stop using thimerosal and to recall existing vaccines containing it because “this was a theoretical concern, it was conceived as precautionary measure, not because evidence showed a risk. There wasn’t a sense of urgency. It was viewed as something to be done—not because we had to, but because it should be done.”
Toxicity and plausibility
While the FDA and CDC moved glacially slow on mercury, the EPA had been since the early ’70s aggressively educating the public about ingesting mercury in food, especially fish, and setting standards for exposure. The inconsistent approach to mercury is reflected in the standards agencies set for maximum daily consumption. Set in micrograms per kilogram of body weight, the EPA’s standard is lowest, at .1 micrograms, the FDA’s is .4 micrograms. Those guidelines are for methylmercury, the toxic cousin of ethylmercury, which is in thimerosal. While some government scientists defending the use of thimerosal have argued that ethyl is less toxic than methyl, both forms will harm living tissue, according to Boyd Haley, chair of the department of chemistry at the University of Kentucky and an expert on toxic metals. “Some parents of autistic children called me and asked me to look at thimerosal. We did some experiments with human brain tissue and it was dramatic,” Haley said. “It penetrates the proteins in the brain. It is toxic to neurons and enzymes.” Haley co-authored an August 2003 study that showed autistic children retained more mercury in their bodies than normal children, evidenced by higher levels of the toxin in their hair. That means the ethylmercury from thimerosal had been absorbed into their brain and other body tissue, likely causing neurological damage.
The July 1999 statement on thimerosal hardly put the issue to rest. For Redwood, it was the catalyst that led to the creation of SAFE MINDS, a parents’ group that has conducted research on the thimerosal-autism disorders link. With several other parents of autistic children, in 2001 Redwood published “Autism: A Novel Form of Mercury Poisoning” in the journal Medical Hypotheses. Their study showed that the symptoms of mercury poisoning mirrored those of autism and concluded that early exposure to mercury from thimerosal had caused many cases of autism, while genetic and environmental factors made some children more vulnerable than others. “Once we got the paper together, we contacted the NIH, CDC and FDA,” Redwood said. “We got mixed responses. We petitioned the FDA on three occasions to take thimerosal off the market. They turned us down.”
The CDC launched its own study of thimerosal safety in vaccines in fall 1999, tasking Dr. Thomas Verstraeten to analyze the agency’s Vaccine Safety Datalink, which gathers information on vaccine safety from several health maintenance organizations. Verstraeten’s first report in February 2000 found a statistically significant risk for neurological developmental disorders at age 3 months as the amount of thimerosal that babies received increased. And he found a risk of autism 2.48 times greater for infants getting higher amounts of thimerosal in vaccines, compared to infants who received thimerosal-free vaccines. A June 2000 analysis by Verstraeten found a link between thimerosal and language, speech and developmental delays during the child’s first 6 months. Verstraeten’s initial findings were never publicly released, and SAFE MINDS obtained copies of his reports only through Freedom of Information Act filings in 2001. For Robert Krakow, whose son is autistic, Verstraeten’s findings were a bittersweet discovery. “If the Verstraeten report had been publicized, my wife would have read about it because she was up on these things and our son wouldn’t have had thimerosal-containing vaccines,” he said. “Why is the public not told? To protect the vaccine makers.” Verstraeten left the CDC shortly after his presentation to work for vaccine maker GlaxoSmithKline in Belgium. He declined to comment for this article, citing “ongoing litigation in the U.S. regarding thimerosal.”
The thimerosal issue continues to reverberate in the scientific and public health community. The Institute of Medicine (IOM), an advisory body created by the National Academies of Science, convened in fall 2001 to assess thimerosal’s potential to cause autism and other neurological problems in children. The IOM’s statement, after assessing Verstraeten’s research and hearing testimony of scientists such as Haley and others linking autism and thimerosal, walked a fine line. It said in part: “Although the hypothesis that exposure to thimerosal-containing vaccines could be associated with neurodevelopmental disorders is not established … the hypothesis is biologically plausible.”
In the past year, further studies of thimerosal’s connection to autism have been churned out in scientific journals, primarily denying any link. A December 2002 study funded by the National Institutes of Health and published in The Lancet claimed thimerosal was safe for babies. An October 2003 study from Denmark also purported to disprove the thimerosal-autism link. The most recent study, published November 1 in Pediatrics by Thomas Verstraeten and a CDC colleague, uses the same CDC database but this time erases any connection between thimerosal and neurological damage to children.
If the CDC and FDA seemed to acknowledge the risks of thimerosal four years ago and the need to get mercury out of medical products, today the official stance is to circle the wagons against mounting public and scientific criticism about its handling of the thimerosal issue. “Rational people can think differently, but to resolve this issue they must be honest to the American people,” Haley said of the regulators. “They could come out and say we’ve cleaned it up, we’ll keep it out. But what they do is come up with cockamamie articles and fight back.”
The stakes are high for the pharmaceutical industry. Eli Lilly, inventor of thimerosal, was granted protection from lawsuits by parents of autistic children under a short-lived provision slipped into the Homeland Security Act in November 2002 (see sidebar). But hundreds of lawsuits now have been filed against it and other companies, including Merck, GlaxoSmithKline, Aventis Pasteur and American Home Products, which have used thimerosal in children’s vaccines. An additional 4,000 claims are pending in the federal Vaccine Injury Compensation Program. “These kids are not going to die. They are going to live 50, 60 years and the cost will be monumental,” said Krakow, a New York attorney who filed a case with the vaccine compensation program on behalf of his son. “The political hurdles are the bigger problem. This is so big and gets to the heart of lots of issues, like what I call the government-pharmaceutical complex.”
Thimerosal is global
Today, vaccine makers have removed thimerosal from almost all childhood vaccines or created thimerosal-free alternatives. But some still have trace amounts, such as GlaxoSmithKline’s Pediatrix, and its DTaP-Hepatitis B vaccine. Aventis Pasteur manufactures six vaccines for adults using thimerosal, including tetanus and flu, each with 25 micrograms of ethylmercury. Merck’s Hepatitis B for adults contains 25 micrograms of ethylmercury. While the health effects of that amount of mercury for adults are unknown, limiting exposure in all forms—in foods and environmentally—should be a priority of the FDA and CDC, according to Kentucky researcher Haley. “They should be working on getting all the mercury out. Thimerosal suppresses the immune system, and if you have some elderly person who has a compromised immune system, a flu shot with thimerosal can pose a risk,” Haley said. “They are saying its OK to give to Third World countries where children have compromised immune systems to begin with.” (Representatives for Aventis and Merck did not respond to requests for comment on their companies’ policies on thimerosal use.) But to date, neither the FDA nor the CDC has issued a clear preference for thimerosal-free vaccines. Many critics believe that is a politically defensive, not a scientifically sound one.
The Third World is the next frontier in the thimerosal debate. Eli Lilly has licensing agreements with drug companies in 40 countries that make thimerosal and market it under the trade name Merthiolate. In countries where sanitary conditions are questionable, vaccine preservatives become crucial. Single-dose vials rather than multi-dose containers have provided one solution in the United States, but in the developing world that strategy poses challenges and costs. The World Health Organization (WHO), which has a vast vaccination program, assessed the thimerosal issue in 1999, prompted by the U.S. health agencies’ review. The agency echoed the U.S. position and declared in its weekly newsletter: “With the weight of public opinion against the use of mercury of any sort, WHO and other agencies has begun the process of reducing and removing [thimerosal] from vaccines.” The WHO outlined a three-year plan for creating alternative preservatives and new vaccine delivery technologies with the goal of eventually eliminating mercury.
Yet in 2003, WHO abandoned this aggressive plan and issued a revised policy on thimerosal, citing its own vaccine advisory committee’s decision that ethylmercury is less harmful than methylmercury, and that “there is no reason on grounds of safety to change immunization practices with [thimerosal]-containing vaccines since the benefit outweighs any risks.” What happened over four years, according to Dr. Philippe Duclos, coordinator of WHO’s Immunization Safety Project, was a dose of reality. “Taking thimerosol away was more tricky than originally thought,” he said. “Taking it away might have created a vaccine with a lower safety profile. And the use of monodose vaccines in many places is difficult because of production capacity. Changing the capacity is a major investment, and you can’t just assume things will be done correctly. It takes time.”
Duclos insisted that recent research has shown risks associated with thimerosal are more theoretical than real—and so far alternatives are elusive. “Vaccine distribution in developing countries is a tricky thing. If you use monodose, products will overload the cold chain [the process by which vaccines are maintained at between 2 and 8 degrees Celsius]. Expanding that capacity would take a tremendous amount of time and money and it becomes a matter of priorities.”
For U.S. pharmaceuticals, though, the global market for vaccines containing thimerosal is a goldmine. UNICEF, the WHO’s parent body, purchases 40 percent of all vaccines used in developing countries and Merck is its sole supplier. Merck makes Recombivax HB, a Hepatitis B vaccine that contains thimerosal.
Beyond the issue of thimerosal’s link to autism and developmental disorders lies the larger question of public trust in national vaccination programs—in the United States and the developing world, where global agencies like the WHO and its health programs can be viewed as politically suspect. The thimerosal debacle at the FDA and CDC, with its taint of conflicts of interest with big drug companies and compromised research, does more harm than good, given that the medical community’s primary directive is “First, do no harm.”
“I am a farm boy. I own a farm today. I am a person who knows the value of vaccinations,” [Haley] said. “But if the American people realize how the CDC and the vaccine boards work, they are going to lose faith, and that isn’t my doing. Its their own doing.”
April 9, 2006
More Cases of Illness Linked to Meningitis Vaccine
More cases of illness linked to meningitis vaccine
Thu Apr 6, 1:48 PM ET
Three more cases of Guillain-Barre syndrome (GBS), a neurological disorder involving temporary paralysis, have been reported in people given the Menactra vaccine to prevent meningitis.
The additional cases bringing the total number reported to eight, according to an article in the Morbidity and Mortality Weekly Report, published by the Centers for Disease Control and Prevention.
Still, when the eight cases of Menactra-related GBS were compared against the expected rates of GBS in populations in the same age group, no significantly increased risk was seen, suggesting that the association may have been due to chance alone.
The CDC continues to recommend Menactra for people who run a high risk for contracting meningitis, such as first-year college students living in dormitories, military recruits, and travelers to regions where meningitis is epidemic.
The possible link between the vaccine and GBS first surfaced in October 2005. At that time, five confirmed cases of the syndrome had been reported to the Vaccine Adverse Events Reporting System. In the present report, researchers from the CDC describe in detail two of the three cases that occurred between October 2005 and February 2006.
The first case involved a 19-year-old man who began experiencing numbness and weakness in his extremities, difficulty running, and decreased dexterity 25 days after being vaccinated with Menactra. Test results were consistent with GBS, and other possible causes of the neurologic symptoms were ruled out. He was treated and had made a full recovery by eight weeks after symptoms began.
The second case, which involved a 17-year-old male, was similar to the first, but disease onset occurred just 11 days after he was given the Menactra vaccine. Treatment resulted in a complete recovery two weeks after he has admitted to the hospital.
SOURCE: Morbidity and Mortality Weekly Report, April 6, 2006.
Thu Apr 6, 1:48 PM ET
Three more cases of Guillain-Barre syndrome (GBS), a neurological disorder involving temporary paralysis, have been reported in people given the Menactra vaccine to prevent meningitis.
The additional cases bringing the total number reported to eight, according to an article in the Morbidity and Mortality Weekly Report, published by the Centers for Disease Control and Prevention.
Still, when the eight cases of Menactra-related GBS were compared against the expected rates of GBS in populations in the same age group, no significantly increased risk was seen, suggesting that the association may have been due to chance alone.
The CDC continues to recommend Menactra for people who run a high risk for contracting meningitis, such as first-year college students living in dormitories, military recruits, and travelers to regions where meningitis is epidemic.
The possible link between the vaccine and GBS first surfaced in October 2005. At that time, five confirmed cases of the syndrome had been reported to the Vaccine Adverse Events Reporting System. In the present report, researchers from the CDC describe in detail two of the three cases that occurred between October 2005 and February 2006.
The first case involved a 19-year-old man who began experiencing numbness and weakness in his extremities, difficulty running, and decreased dexterity 25 days after being vaccinated with Menactra. Test results were consistent with GBS, and other possible causes of the neurologic symptoms were ruled out. He was treated and had made a full recovery by eight weeks after symptoms began.
The second case, which involved a 17-year-old male, was similar to the first, but disease onset occurred just 11 days after he was given the Menactra vaccine. Treatment resulted in a complete recovery two weeks after he has admitted to the hospital.
SOURCE: Morbidity and Mortality Weekly Report, April 6, 2006.
New FAIR clip of Imus and Lieberman
From FAIR:
Hi folks,
FAIR Autism Media has just posted a clip from a recent "Imus in the Morning" interview on MSNBC where Don Imus speaks with Senator Joseph Lieberman (D-CT) regarding thimerosal in vaccines and the autism epidemic.
If you would like to see this clip, visit:
http://www.autismmedia.org/media11.html
Enjoy,
Erik Nanstiel
CDC is "Disapointed" with USA Today Ad
Statement
For Immediate Release
April 6, 2006 Contact:
Division of Media Relations
404-639-3286
CDC Statement regarding autism-related advertisement in USA Today
We know that autism is a heart-wrenching situation for many families and many children and it presents special challenges that we would certainly want to prevent and do anything we could to avoid. When it comes to the nation’s immunization recommendations, the CDC and Public Health Service are always guided by one overriding goal and interest—all our recommendations are designed to protect the health and well being of all children.
We are very disappointed in an advertisement that appears in today’s edition of USA Today. The advertisement completely mischaracterizes the efforts of CDC, the American Academy of Pediatrics, the Institute of Medicine, and others to protect the health and well being of the nation’s children. CDC has sponsored multiple public meetings and scientific reviews, we’ve involved numerous outside organizations and experts in our research and recommendations, and we’ve made continued investments in research designed to discover factors which may place children at risk for developing autism. Importantly, if levels of thimerosal found in vaccines, including influenza vaccines, were associated with harm, CDC, the Public Health Service, and the nation’s physicians (e.g., the American Academy of Pediatrics, the American Medical Association, and American Academy of Family Physicians) would not recommend their use.
We’ve made substantial progress in removing thimerosal from vaccines – and have done so without placing infants and children at risk for potentially serious vaccine preventable diseases. As we continue in our efforts to further reduce the use of thimerosal in vaccines, we must also ensure, particularly in the case of influenza, that our efforts do not create serious undesirable outcomes, such as vaccine shortages that would place people, including children, at risk. History has shown that disruptions in vaccine supplies can render the population more vulnerable to diseases we know we can prevent.
We don't know, unfortunately, for children with autism what caused it, nor do we have sound, scientifically valid information on effective treatments. That's a fact. We just simply don't have answers to the cause of this disorder or the disorders that fall into the autism spectrum. We don't have a complete picture of the scope of the problem. We're just learning about the subtleties that can be early signs of autism, we're learning about the importance of early detection, and we're learning about the importance of early treatment, but we have a long way to go before we really understand the scope and magnitude of this problem in our country and what the trends really mean.
As we're looking for answers related to the causes and effective treatments for autism, we have to also be careful not to base our health recommendations on unproven hypotheses or fear. We have to base our decisions on the best available science that we have in front of us, and today the best available science indicates to us that vaccines save lives, and that's a very, very important message for all of us to remember.
For more information about autism, immunizations, or thimerosal, we encourage you to visit the CDC website: www.cdc.gov
For Immediate Release
April 6, 2006 Contact:
Division of Media Relations
404-639-3286
CDC Statement regarding autism-related advertisement in USA Today
We know that autism is a heart-wrenching situation for many families and many children and it presents special challenges that we would certainly want to prevent and do anything we could to avoid. When it comes to the nation’s immunization recommendations, the CDC and Public Health Service are always guided by one overriding goal and interest—all our recommendations are designed to protect the health and well being of all children.
We are very disappointed in an advertisement that appears in today’s edition of USA Today. The advertisement completely mischaracterizes the efforts of CDC, the American Academy of Pediatrics, the Institute of Medicine, and others to protect the health and well being of the nation’s children. CDC has sponsored multiple public meetings and scientific reviews, we’ve involved numerous outside organizations and experts in our research and recommendations, and we’ve made continued investments in research designed to discover factors which may place children at risk for developing autism. Importantly, if levels of thimerosal found in vaccines, including influenza vaccines, were associated with harm, CDC, the Public Health Service, and the nation’s physicians (e.g., the American Academy of Pediatrics, the American Medical Association, and American Academy of Family Physicians) would not recommend their use.
We’ve made substantial progress in removing thimerosal from vaccines – and have done so without placing infants and children at risk for potentially serious vaccine preventable diseases. As we continue in our efforts to further reduce the use of thimerosal in vaccines, we must also ensure, particularly in the case of influenza, that our efforts do not create serious undesirable outcomes, such as vaccine shortages that would place people, including children, at risk. History has shown that disruptions in vaccine supplies can render the population more vulnerable to diseases we know we can prevent.
We don't know, unfortunately, for children with autism what caused it, nor do we have sound, scientifically valid information on effective treatments. That's a fact. We just simply don't have answers to the cause of this disorder or the disorders that fall into the autism spectrum. We don't have a complete picture of the scope of the problem. We're just learning about the subtleties that can be early signs of autism, we're learning about the importance of early detection, and we're learning about the importance of early treatment, but we have a long way to go before we really understand the scope and magnitude of this problem in our country and what the trends really mean.
As we're looking for answers related to the causes and effective treatments for autism, we have to also be careful not to base our health recommendations on unproven hypotheses or fear. We have to base our decisions on the best available science that we have in front of us, and today the best available science indicates to us that vaccines save lives, and that's a very, very important message for all of us to remember.
For more information about autism, immunizations, or thimerosal, we encourage you to visit the CDC website: www.cdc.gov
April 7, 2006
Parents of Autistic Kids March Against Mercury
Parents of Autistic Kids March Against Mercury
Lindsay Puccio
April 6, 2006
Almost a thousand parents and physicians marched their way through the streets of Washington, DC to get the government's attention.
Parents said they want more research done to find out if mercury, which is found in children's vaccines, caused their sons and daughters to become Autistic.
"It empowers us as parents, it gives us some power to do something," said Kathy Young, a Charlottesville mother of an Autistic daughter.
Young walked in the "Mercury Generation March" to support her daughter. For years research showed Autism was a genetic disorder. But Young believes her daughter developed the disorder because of a known toxin that is in most vaccines. There has been some studies to prove it.
"No more lies from the CDC," parents chanted. These parents feel if more research is done to find the true cause of Autism, they can possibly find a cure.
"The main goal for all of us is that our kids get the proper treatment because currently with the government refusing to look at the issue seriously, little research is being done," said Young.
Right now, there isn't much parents can do if they believe mercury is responsible for their child's Autism. They feel this rally is their last hope to get the government on their side.
"The FDA and the CDC are making it very difficult for researchers to get the facts so that they can help our kids," said Young.
The CDC denies any cover-up. Currently, one out of every 166 kids are diagnosed with Autism.
Lindsay Puccio
April 6, 2006
Almost a thousand parents and physicians marched their way through the streets of Washington, DC to get the government's attention.
Parents said they want more research done to find out if mercury, which is found in children's vaccines, caused their sons and daughters to become Autistic.
"It empowers us as parents, it gives us some power to do something," said Kathy Young, a Charlottesville mother of an Autistic daughter.
Young walked in the "Mercury Generation March" to support her daughter. For years research showed Autism was a genetic disorder. But Young believes her daughter developed the disorder because of a known toxin that is in most vaccines. There has been some studies to prove it.
"No more lies from the CDC," parents chanted. These parents feel if more research is done to find the true cause of Autism, they can possibly find a cure.
"The main goal for all of us is that our kids get the proper treatment because currently with the government refusing to look at the issue seriously, little research is being done," said Young.
Right now, there isn't much parents can do if they believe mercury is responsible for their child's Autism. They feel this rally is their last hope to get the government on their side.
"The FDA and the CDC are making it very difficult for researchers to get the facts so that they can help our kids," said Young.
The CDC denies any cover-up. Currently, one out of every 166 kids are diagnosed with Autism.
April 6, 2006
"What You Have Done Unto The Least of These, You Have Done Unto Me"
Scott man extends religious experience to autistic
Thursday, April 06, 2006
By Margaret Smykla, Tri-State Sports and News Service
A few years ago, two Catholic families Larry Sutton knew had trouble finding proper religious instruction for their children with autism to receive the sacraments.
About the same time, Mr. Sutton, a child psychologist and a deacon at Our Lady of Grace Church in Scott, read about an autistic boy who was suffocated during a prayer service in a Milwaukee church as members tried to exorcise what they said were evil spirits. That incident occurred in a small Christian church called Faith Temple, which was in a strip mall.
He said both instances emphasized the lack of knowledge in society, including the religious community, about autism and the subsequent need for a program to help autistic children live fuller spiritual lives.
Autism is a neurodevelopmental disorder and children with it often have problems in social interactions and in communicating.
"The church is really to serve all people," said Mr. Sutton, of Mt. Lebanon. "People with disabilities need to be equal partners in our Christian community."
Along with help from Sister Michelle Grgurich, director of the Department for Persons with Disabilities for the Diocese of Pittsburgh, Mr. Sutton hopes to begin at his church a religious education program for autistic children up to age 18.
Six children have signed on, but more are needed for a viable program. Students will prepare for the sacraments of Penance, Eucharist and Confirmation.
Classes will be held in a nearby room during the 9:30 a.m. Sunday services at Our Lady of Grace.
Instruction will be based on the Rose Fitzgerald Kennedy Program to Improve Catholic Religious Education for Children and Adults with Mental Retardation, a program which includes religious instruction, lesson plans on the liturgical year, prayer services and a parents' handbook.
That nationwide program was developed in the diocese in 1996 under the direction of the Kennedy Foundation and Grace Harding, who was then director of the diocese's Department for Persons with Disabilities.
"It is comprehensive and has every topic in terms of the Catholic faith," Sister Michelle said.
The program has been in use at St. Anne Church in Castle Shannon for four years. There are five children, age 10 to 12, but it is open to anyone, including adults with special needs who never received the sacraments.
"It takes the basic tenets of the Catholic faith and puts them on a level children with special needs can understand," said St. Anne Director of Religious Education Katie Tarcson, of Bridgeville.
Classes are held from 6:15 to 7:30 p.m. Mondays from September through May at St. Anne school.
High school students serve as aids in the classroom for the St. Anne program, and Mr. Sutton said he wanted to increase that interaction in the Scott program.
He said he had seen the mutual benefits of high school students serving as models for younger people in his work for the state Bureau of Juvenile Justice.
Student mentors will be chosen after interviews with the child and his family.
For class, Mr. Sutton will read the daily Gospel, followed by the Kennedy curriculum, with the high schoolers acting as instructors.
The high school students will receive community service credit at their schools for their work.
To learn more about the Our Lady of Grace program, call 412-276-0277; for St. Anne's program, call 412-561-0101.
Thursday, April 06, 2006
By Margaret Smykla, Tri-State Sports and News Service
A few years ago, two Catholic families Larry Sutton knew had trouble finding proper religious instruction for their children with autism to receive the sacraments.
About the same time, Mr. Sutton, a child psychologist and a deacon at Our Lady of Grace Church in Scott, read about an autistic boy who was suffocated during a prayer service in a Milwaukee church as members tried to exorcise what they said were evil spirits. That incident occurred in a small Christian church called Faith Temple, which was in a strip mall.
He said both instances emphasized the lack of knowledge in society, including the religious community, about autism and the subsequent need for a program to help autistic children live fuller spiritual lives.
Autism is a neurodevelopmental disorder and children with it often have problems in social interactions and in communicating.
"The church is really to serve all people," said Mr. Sutton, of Mt. Lebanon. "People with disabilities need to be equal partners in our Christian community."
Along with help from Sister Michelle Grgurich, director of the Department for Persons with Disabilities for the Diocese of Pittsburgh, Mr. Sutton hopes to begin at his church a religious education program for autistic children up to age 18.
Six children have signed on, but more are needed for a viable program. Students will prepare for the sacraments of Penance, Eucharist and Confirmation.
Classes will be held in a nearby room during the 9:30 a.m. Sunday services at Our Lady of Grace.
Instruction will be based on the Rose Fitzgerald Kennedy Program to Improve Catholic Religious Education for Children and Adults with Mental Retardation, a program which includes religious instruction, lesson plans on the liturgical year, prayer services and a parents' handbook.
That nationwide program was developed in the diocese in 1996 under the direction of the Kennedy Foundation and Grace Harding, who was then director of the diocese's Department for Persons with Disabilities.
"It is comprehensive and has every topic in terms of the Catholic faith," Sister Michelle said.
The program has been in use at St. Anne Church in Castle Shannon for four years. There are five children, age 10 to 12, but it is open to anyone, including adults with special needs who never received the sacraments.
"It takes the basic tenets of the Catholic faith and puts them on a level children with special needs can understand," said St. Anne Director of Religious Education Katie Tarcson, of Bridgeville.
Classes are held from 6:15 to 7:30 p.m. Mondays from September through May at St. Anne school.
High school students serve as aids in the classroom for the St. Anne program, and Mr. Sutton said he wanted to increase that interaction in the Scott program.
He said he had seen the mutual benefits of high school students serving as models for younger people in his work for the state Bureau of Juvenile Justice.
Student mentors will be chosen after interviews with the child and his family.
For class, Mr. Sutton will read the daily Gospel, followed by the Kennedy curriculum, with the high schoolers acting as instructors.
The high school students will receive community service credit at their schools for their work.
To learn more about the Our Lady of Grace program, call 412-276-0277; for St. Anne's program, call 412-561-0101.
Thimerosal and Autism in India
Heavy Metal
Vaccines with mercury can cause autism, but removing the metal is uneconomical for developing countries such as India
VIBHA VARSHNEY
In the 1980s, worried parents and medical researchers in the us alleged that mercury in vaccines was responsible for the growing number of autism cases among children in the country. The issue was debated in medical circles, wheels moved in many western countries, but developing countries still don’t have a choice — because without mercury, vaccination is expensive.
There was pressure on the us government for legislation against mercury in vaccines. At the same time, a combative vaccine industry brandished studies vouching the safety of mercury in vaccines. Nonetheless, the us states of Iowa and California passed legislations in favour of mercury-free vaccines. The uproar was not restricted to the us: the Danish parliament, in 1992, banned the heavy metal from vaccines.
The uk has recently passed a similar legislation. At the root of the problem is thimerosal: this preservative with a 50 per cent mercury constituent is a key ingredient of multi-dose vaccines. These vials are about 10 times cheaper than single-dose vials, making it easier for international agencies to procure vaccines for programmes in developing countries including India. In 2000, for instance, about 80 per cent of vaccines administered globally were supplied in multi-dose vials.
But these vials require preservatives because they are used over longer periods. Thimerosal fits this requirement. So, it’s not surprising that international bodies such as the World Health Organization (who) and unicef recommend this preservative. Even those vaccine manufacturers based in developed countries who make mercury-free vaccines for domestic consumption use this heavy metal in their products for developing countries.
What are the implications?
Most vaccines used for the country’s universal immunisation programme (uip) have a thimerosal content of 25 µg per five millilitres. Half of that, 12.5 µg, is mercury. A six-week old infant in many parts of the country is administered two vaccines, dpt ( diphtheria, pertussis and tetanus ) and Hepatitis b. T his exposes the child to 25 µg of mercury. Infants getting vaccinated at a private clinic are also administered the haemophilus influenza type b vaccine, as per the Indian Academy of Paediatricians’ protocol. This results in a total exposure of 37.5 µg. According to the us Environment Protection Agency, the human body can, in a day, safely tolerate 0.1 µg of mercury for every kg of its body weight. So, an average six-week infant, weighing 7 kg, can tolerate an exposure of 0.7 µg of mercury. The child is exposed to mercury levels much higher than this recommended amount on innoculation day.
The risk of mercury is even higher for the undernourished — and underweight — Indian children. At a who meet of the Global Advisory Committee on Vaccine Safety in 2003, it was pointed out that little is known of susceptibility to thimerosal in infants who weigh less than 2.5 kg. Moreover, children are less equipped to handle the toxic load because they do not produce sufficient levels of bile, needed to remove mercury from the body.
However, many experts contend that ethyl mercury used in vaccines is not as toxic as methyl mercury, commonly blamed for maladies such as the Minamata disease. But there are others who dispute this argument.
Dubious methods
Thimerosal was developed in the 1930s by the us- based vaccine major, El Lilly and Company. For years the company has manipulated studies to demonstrate the safety of this mercury-based preservative. In fact, when thimerosal was introduced, the company did have it tested, but only on 22 patients with terminal meningitis. And quite conveniently meningitis was blamed for the death of all those injected with the preservative.
More recently, Eli Lilly used the us government’s paranoia against bio-terrorism to its advantage. Along with other vaccine companies, it persuaded the us government to introduce a clause in the Homeland Security Act — brought in response to the 9/11 attacks — stipulating that these companies can be challenged only in vaccine courts, and not in civil courts. Anxious to ensure vaccine supplies against any anthrax or smallpox attacks, the us government complied.
Heavy metal
On vaccination day, a child’s exposure to mercury is many times more than safety levels permit. Undernourished Indian children are at greater risk
The clause substantially reduces Eli Lilly’s — and other vaccines companies’ — liability if it were to lose a thimerosal-related litigation. In such an event, the company would have to pay us $5 billion in damages, six times less than what it would be liable for if the case was fought in a civil court.
Thimerosal has other supporters as well in the us. In 2004, the us health authority, Institute of Medicine (iom), came out with a report, which claimed to have used epidemiological studies from around the world, to suggest that there were no links between the preservative and autism.
But as journalist David Kirby notes in Evidence of Harm — a compelling study on the politics of mercury in vaccines — many experts who had exonerated thimerosal had received research grants and even donations from vaccine manufacturers.
Mounting evidence
While many us experts gave a clean chit to thimerosal, cases of autism increased in the country. In the early 1980s, only one among 10,000 children in the us was autistic. By the late 1990s, one in 500 children had the disease; currently there is one autistic child per 166 newborns in the us. Experts who incriminate thimerosal for this rise point out that mercury in vaccines more than doubled between 1988 and 1992. They also cite the contrasting example of Denmark, where autism afflicts one in 13,000 children — the country banned thimerosal in vaccines in 1992.
In another study, David Geier and Mark Geier of MedCon, Inc — a us- based private research laboratory — evaluated neurodevelopment disorders reported to the country’s Vaccine Adverse Event Reporting System. They categorised the data into groups of those who had been administered dpt vaccines with thimerosal and those who received thimerosal-free vaccines between 1997 and 2001. The former demonstrated a significantly higher incidence of autism, speech disorder, mental retardation, personality disorders and thinking abnormalities. The evidence against mercury has not always been epidemiological. For example, a study by Mary Hornig of the Mailman School of Public Health, Columbia University, published in Molecular Psychiatry in June 2004, just months after the iom report, showed that thimerosal caused autism-like damage in genetically-susceptible mice. Another study by Boyd Haley of the University of Kentucky, usa, showed that mercury reduced an essential protein in nerve cells, tubulin. The protein is important for the growth of neurons and its depletion has been linked to the Alzheimer’s disease.
Thimerosal has also been implicated in other nerve disorders. For instance in 2003, David Baskin of the department of neurosurgery at Baylor College of Medicine demonstrated that this preservative can cause membrane and dna damage, and kill nerve cells, even when administered in small amounts.
Difficult decision
The debate has some positive fallout in the us. W ith legislation to remove mercury from vaccines, the levels of the heavy metal in vaccines administered to infants in their first six-months has currently come down to 3 µg from 187.5 µg in the 1980s. Experts are waiting to see if this intervention reduces the incidence of autism.
The debate can, however, compound the vaccine-related predicaments of developing countries like India, especially with the increasing awareness on the link between mercury and autism. A senior-Delhi-based paediatrician sums this apprehension quite aptly: “The fear of mercury in vaccines might deter people from innoculating their children”.
But what about alternatives to thimerosal? We do have alternative preservatives like 2-phenoxyethanol. Drug manufacturers around the world are also considering the use of other preservatives like benzalkonium chloride and benzethonium chloride. But says Varaprasad Reddy, ceo of Shantha Biotechnics, a Hyderabad-based pharmaceutical company, “We have manufactured vaccines withot thimerosal. It’s not difficult to produce them. But the who does not permit us to supply such vaccines to the unicef ” .
Besides, the use of these alternatives would require a complete change in the licensing regime. For, Indian Pharmacoepia — a document that contains guidelines on drug constituents — makes it mandatory for vaccines to have mercury.
That’s not all. Extensive safety data would be needed for licensing. In fact, in the us, 2-phenoxyethanol is used in dpt vaccines manufactured by Aventis Pasteur. But a study dating back to 2000 indicates that this preservative also has neurotoxic properties. Occupational exposure to this chemical for more than a year can lead to cognitive impairments.
Vial tinkering
There are some other alternatives as well For example, the U niject device developed by the international ngo path, obviates the need for preservative-dependant multi-dose vials. But many experts are not too sure if the device could be a viable alternative. The device is costlier than even conventional single-dose vaccines, says Reddy. The latter costs about Rs 25 per vial, while the new device costs as much as Rs 34. Apathy and concern
There is another problem far graver than costs of alternative preservatives. Many experts do not see the need to shift over to mercury-free vaccines. One of them Suresh Jadhav, executive director, Serum Institute of India Ltd, Pune, asserts, “There is no proof of the harm done by vaccines, only perceptions. Using mercury-free, single-dose vaccines is also not feasible as multi-dose vaccines are far cheaper,” he adds.
Indian Pharmacoepia is quite categorical that even single-dose vaccines contain thimerosal. Reddy agrees that this anomaly should be corrected, but is not sure that this would make much difference considering the expenses involved in manufacturing single-dose vaccines.
There are other problems. It’s not incumbent on vaccine manufacturers to put down information about the presence of thimerosal in the literature that accompanies the vaccine vials. So, some of the vaccines produced in the country such as those produced by, gsk Bharat Biotech do not mention the presence of preservative. This lack makes it difficult for parents to take the kind of action taken by their counterparts in the us.
The Union minister of health and family welfare is not totally impervious to such problems. The national technical advisory group on immunisation, a body of this ministry, is supposed to convene a meeting soon to assess the safety data related to vaccines. If needed, the group will put an alternative vaccination strategy in place. But this meeting is long overdue. “There should be policy changes. But these should be implemented quickly without creating a scare,” suggests a senior paediatrician. Other experts assert that the government should quickly develop a low cost, effective preservative that is safer than thimerosal.
Exposure to mercury in any case is quite high in India. An autistic person needs treatment for life and the cost is very high. It’s time corrective measures are taken.
Vaccines with mercury can cause autism, but removing the metal is uneconomical for developing countries such as India
VIBHA VARSHNEY
In the 1980s, worried parents and medical researchers in the us alleged that mercury in vaccines was responsible for the growing number of autism cases among children in the country. The issue was debated in medical circles, wheels moved in many western countries, but developing countries still don’t have a choice — because without mercury, vaccination is expensive.
There was pressure on the us government for legislation against mercury in vaccines. At the same time, a combative vaccine industry brandished studies vouching the safety of mercury in vaccines. Nonetheless, the us states of Iowa and California passed legislations in favour of mercury-free vaccines. The uproar was not restricted to the us: the Danish parliament, in 1992, banned the heavy metal from vaccines.
The uk has recently passed a similar legislation. At the root of the problem is thimerosal: this preservative with a 50 per cent mercury constituent is a key ingredient of multi-dose vaccines. These vials are about 10 times cheaper than single-dose vials, making it easier for international agencies to procure vaccines for programmes in developing countries including India. In 2000, for instance, about 80 per cent of vaccines administered globally were supplied in multi-dose vials.
But these vials require preservatives because they are used over longer periods. Thimerosal fits this requirement. So, it’s not surprising that international bodies such as the World Health Organization (who) and unicef recommend this preservative. Even those vaccine manufacturers based in developed countries who make mercury-free vaccines for domestic consumption use this heavy metal in their products for developing countries.
What are the implications?
Most vaccines used for the country’s universal immunisation programme (uip) have a thimerosal content of 25 µg per five millilitres. Half of that, 12.5 µg, is mercury. A six-week old infant in many parts of the country is administered two vaccines, dpt ( diphtheria, pertussis and tetanus ) and Hepatitis b. T his exposes the child to 25 µg of mercury. Infants getting vaccinated at a private clinic are also administered the haemophilus influenza type b vaccine, as per the Indian Academy of Paediatricians’ protocol. This results in a total exposure of 37.5 µg. According to the us Environment Protection Agency, the human body can, in a day, safely tolerate 0.1 µg of mercury for every kg of its body weight. So, an average six-week infant, weighing 7 kg, can tolerate an exposure of 0.7 µg of mercury. The child is exposed to mercury levels much higher than this recommended amount on innoculation day.
The risk of mercury is even higher for the undernourished — and underweight — Indian children. At a who meet of the Global Advisory Committee on Vaccine Safety in 2003, it was pointed out that little is known of susceptibility to thimerosal in infants who weigh less than 2.5 kg. Moreover, children are less equipped to handle the toxic load because they do not produce sufficient levels of bile, needed to remove mercury from the body.
However, many experts contend that ethyl mercury used in vaccines is not as toxic as methyl mercury, commonly blamed for maladies such as the Minamata disease. But there are others who dispute this argument.
Dubious methods
Thimerosal was developed in the 1930s by the us- based vaccine major, El Lilly and Company. For years the company has manipulated studies to demonstrate the safety of this mercury-based preservative. In fact, when thimerosal was introduced, the company did have it tested, but only on 22 patients with terminal meningitis. And quite conveniently meningitis was blamed for the death of all those injected with the preservative.
More recently, Eli Lilly used the us government’s paranoia against bio-terrorism to its advantage. Along with other vaccine companies, it persuaded the us government to introduce a clause in the Homeland Security Act — brought in response to the 9/11 attacks — stipulating that these companies can be challenged only in vaccine courts, and not in civil courts. Anxious to ensure vaccine supplies against any anthrax or smallpox attacks, the us government complied.
Heavy metal
On vaccination day, a child’s exposure to mercury is many times more than safety levels permit. Undernourished Indian children are at greater risk
The clause substantially reduces Eli Lilly’s — and other vaccines companies’ — liability if it were to lose a thimerosal-related litigation. In such an event, the company would have to pay us $5 billion in damages, six times less than what it would be liable for if the case was fought in a civil court.
Thimerosal has other supporters as well in the us. In 2004, the us health authority, Institute of Medicine (iom), came out with a report, which claimed to have used epidemiological studies from around the world, to suggest that there were no links between the preservative and autism.
But as journalist David Kirby notes in Evidence of Harm — a compelling study on the politics of mercury in vaccines — many experts who had exonerated thimerosal had received research grants and even donations from vaccine manufacturers.
Mounting evidence
While many us experts gave a clean chit to thimerosal, cases of autism increased in the country. In the early 1980s, only one among 10,000 children in the us was autistic. By the late 1990s, one in 500 children had the disease; currently there is one autistic child per 166 newborns in the us. Experts who incriminate thimerosal for this rise point out that mercury in vaccines more than doubled between 1988 and 1992. They also cite the contrasting example of Denmark, where autism afflicts one in 13,000 children — the country banned thimerosal in vaccines in 1992.
In another study, David Geier and Mark Geier of MedCon, Inc — a us- based private research laboratory — evaluated neurodevelopment disorders reported to the country’s Vaccine Adverse Event Reporting System. They categorised the data into groups of those who had been administered dpt vaccines with thimerosal and those who received thimerosal-free vaccines between 1997 and 2001. The former demonstrated a significantly higher incidence of autism, speech disorder, mental retardation, personality disorders and thinking abnormalities. The evidence against mercury has not always been epidemiological. For example, a study by Mary Hornig of the Mailman School of Public Health, Columbia University, published in Molecular Psychiatry in June 2004, just months after the iom report, showed that thimerosal caused autism-like damage in genetically-susceptible mice. Another study by Boyd Haley of the University of Kentucky, usa, showed that mercury reduced an essential protein in nerve cells, tubulin. The protein is important for the growth of neurons and its depletion has been linked to the Alzheimer’s disease.
Thimerosal has also been implicated in other nerve disorders. For instance in 2003, David Baskin of the department of neurosurgery at Baylor College of Medicine demonstrated that this preservative can cause membrane and dna damage, and kill nerve cells, even when administered in small amounts.
Difficult decision
The debate has some positive fallout in the us. W ith legislation to remove mercury from vaccines, the levels of the heavy metal in vaccines administered to infants in their first six-months has currently come down to 3 µg from 187.5 µg in the 1980s. Experts are waiting to see if this intervention reduces the incidence of autism.
The debate can, however, compound the vaccine-related predicaments of developing countries like India, especially with the increasing awareness on the link between mercury and autism. A senior-Delhi-based paediatrician sums this apprehension quite aptly: “The fear of mercury in vaccines might deter people from innoculating their children”.
But what about alternatives to thimerosal? We do have alternative preservatives like 2-phenoxyethanol. Drug manufacturers around the world are also considering the use of other preservatives like benzalkonium chloride and benzethonium chloride. But says Varaprasad Reddy, ceo of Shantha Biotechnics, a Hyderabad-based pharmaceutical company, “We have manufactured vaccines withot thimerosal. It’s not difficult to produce them. But the who does not permit us to supply such vaccines to the unicef ” .
Besides, the use of these alternatives would require a complete change in the licensing regime. For, Indian Pharmacoepia — a document that contains guidelines on drug constituents — makes it mandatory for vaccines to have mercury.
That’s not all. Extensive safety data would be needed for licensing. In fact, in the us, 2-phenoxyethanol is used in dpt vaccines manufactured by Aventis Pasteur. But a study dating back to 2000 indicates that this preservative also has neurotoxic properties. Occupational exposure to this chemical for more than a year can lead to cognitive impairments.
Vial tinkering
There are some other alternatives as well For example, the U niject device developed by the international ngo path, obviates the need for preservative-dependant multi-dose vials. But many experts are not too sure if the device could be a viable alternative. The device is costlier than even conventional single-dose vaccines, says Reddy. The latter costs about Rs 25 per vial, while the new device costs as much as Rs 34. Apathy and concern
There is another problem far graver than costs of alternative preservatives. Many experts do not see the need to shift over to mercury-free vaccines. One of them Suresh Jadhav, executive director, Serum Institute of India Ltd, Pune, asserts, “There is no proof of the harm done by vaccines, only perceptions. Using mercury-free, single-dose vaccines is also not feasible as multi-dose vaccines are far cheaper,” he adds.
Indian Pharmacoepia is quite categorical that even single-dose vaccines contain thimerosal. Reddy agrees that this anomaly should be corrected, but is not sure that this would make much difference considering the expenses involved in manufacturing single-dose vaccines.
There are other problems. It’s not incumbent on vaccine manufacturers to put down information about the presence of thimerosal in the literature that accompanies the vaccine vials. So, some of the vaccines produced in the country such as those produced by, gsk Bharat Biotech do not mention the presence of preservative. This lack makes it difficult for parents to take the kind of action taken by their counterparts in the us.
The Union minister of health and family welfare is not totally impervious to such problems. The national technical advisory group on immunisation, a body of this ministry, is supposed to convene a meeting soon to assess the safety data related to vaccines. If needed, the group will put an alternative vaccination strategy in place. But this meeting is long overdue. “There should be policy changes. But these should be implemented quickly without creating a scare,” suggests a senior paediatrician. Other experts assert that the government should quickly develop a low cost, effective preservative that is safer than thimerosal.
Exposure to mercury in any case is quite high in India. An autistic person needs treatment for life and the cost is very high. It’s time corrective measures are taken.
April 5, 2006
The Hill: Autism Parents Allege CDC Cover-up
Autism parents allege CDC cover-up
By Jeffrey Young
Officials at the Centers for Disease Control and Prevention (CDC) conspired to cover up information linking vaccines to developmental disorders in children, organizations representing parents of autistic children allege.
The advocacy groups have long contended that mercury and a mercury-based substance called thimerosal, which were commonly used as preservatives in vaccines, cause some children to develop autism or similar disorders.
The autism groups sponsored a full-page ad in today’s USA Today that reads, “If you caused a 6,000% increase in autism, wouldn’t you try to cover it up, too?” The ad alleges that the CDC “knows that the ambitious immunization schedule begun in the 1990s, nearly tripling the amount of mercury injected into our children, created an epidemic of autism in America.”
The organizations are holding a rally and press conference this morning to highlight their charges. Reps. Dan Burton (R-Ind), Dave Weldon (R-Fla.) and Carolyn Maloney (D-N.Y.) are scheduled to speak at the event in the park next to the Russell Senate Office Building.
The CDC, other federal authorities and even the American Academy of Pediatrics contest this theory and say there is no scientific evidence that vaccinations contribute to autism. Federal authorities also argue that the benefits of immunization against diseases such as mumps outweigh the risk of vaccines.
Autism groups say that one out of every 166 children has an autistic disorder. The CDC’s website says, “While it is clear that more children than ever before are being classified as” autistic, the agency does not know why, nor does it know exactly how many children have autistic disorders.
Based on internal e-mails written by officials at the CDC, the Food and Drug Administration (FDA) and others, the parents groups contend that federal authorities knew the vaccines were causing autism but failed to act.
Generation Rescue, one of the parents groups, has posted the documents on the website www.putchildrenfirst.org. Generation Rescue obtained the documents via the Freedom of Information Act.
“These are our federal health agencies that we trust … and they’re poisoning us,” said Wendy Fournier of the National Autism Association. “They’ve poisoned an entire generation of children,” she said. The CDC spearheaded an aggressive push to expand childhood vaccinations in the early 1990s.
Burton seconded the accusations in a statement yesterday. He has been relentless in his criticisms of the health agencies.
“I truly feel that the HHS [Department of Health and Human Services], CDC, [the Institute of Medicine] and the FDA have deliberately misled the American public on the dangers of mercury in vaccines, and I wholeheartedly support a thorough and independent investigation into the evident link between mercury and autism,” Burton said.
The CDC denied any cover-up and defended its policies. “We’ve taken this issue and the concerns very seriously from the beginning,” said CDC spokesman Glen Nowak.
The allegations of a conspiracy represent an intensification of a years-long campaign by these organizations.
The groups want Congress to investigate and will demand that criminal charges be brought against officials involved. The Senate Health, Education, Labor and Pensions Committee is investigating the agencies, a spokesman for the panel said. Last July, parents groups recommended to the committee that HHS, CDC and FDA officials should be charged with criminal negligence and criminal obstruction of justice.
In addition to the National Autism Association and Generation Rescue, A-Champ, NoMercury, Moms Against Mercury and AutismOne organized the rally and press conference. Today’s press conference will be followed by a conference on autism issues that will run through Monday.
Maloney said the agencies should respond better to the concerns of these parents and Congress but stopped short of endorsing the allegations of a cover-up.
“When it comes to mercury, autism and the government’s response, there are still more questions than answers. … I know that there are some in Congress who want to work to get those answers,” she said.
“While I cannot answer the question of an alleged cover-up, it is obvious to even the casual observer that the CDC has failed miserably investigating this matter,” Weldon said.
The organizations representing parents of autistic children have been vocal and aggressive in their campaigns to get mercury and thimerosal removed from all vaccines and to get the CDC and other agencies to change their policies related to childhood vaccines.
Their strategies have attracted the interest of many members of Congress over the years, notably Burton and Weldon. The conference report that accompanied the appropriations bill that funds HHS this year includes a provision requesting another study on the issue by the National Institutes of Health.
A scientific review issued by the National Academies’ Institute of Medicine in 2004 was intended to put the question of mercury and autism to rest but served only to fuel the fire.
The institute’s panel concurred with the CDC position. “Neither the mercury-based vaccine preservative thimerosal nor the measles-mumps-rubella (MMR) vaccine are associated with autism,” according to the press release that accompanied the report.
The parents groups alleged that the CDC pressured the committee that carried out the review to support its policies.
The chairwoman of the panel rejected that charge, which she characterized as an explicit attack on her integrity. Asked if CDC officials attempted to sway the committee’s deliberations, Harvard School of Public Health professor Marie McCormick said, “Absolutely not.”
By Jeffrey Young
Officials at the Centers for Disease Control and Prevention (CDC) conspired to cover up information linking vaccines to developmental disorders in children, organizations representing parents of autistic children allege.
The advocacy groups have long contended that mercury and a mercury-based substance called thimerosal, which were commonly used as preservatives in vaccines, cause some children to develop autism or similar disorders.
The autism groups sponsored a full-page ad in today’s USA Today that reads, “If you caused a 6,000% increase in autism, wouldn’t you try to cover it up, too?” The ad alleges that the CDC “knows that the ambitious immunization schedule begun in the 1990s, nearly tripling the amount of mercury injected into our children, created an epidemic of autism in America.”
The organizations are holding a rally and press conference this morning to highlight their charges. Reps. Dan Burton (R-Ind), Dave Weldon (R-Fla.) and Carolyn Maloney (D-N.Y.) are scheduled to speak at the event in the park next to the Russell Senate Office Building.
The CDC, other federal authorities and even the American Academy of Pediatrics contest this theory and say there is no scientific evidence that vaccinations contribute to autism. Federal authorities also argue that the benefits of immunization against diseases such as mumps outweigh the risk of vaccines.
Autism groups say that one out of every 166 children has an autistic disorder. The CDC’s website says, “While it is clear that more children than ever before are being classified as” autistic, the agency does not know why, nor does it know exactly how many children have autistic disorders.
Based on internal e-mails written by officials at the CDC, the Food and Drug Administration (FDA) and others, the parents groups contend that federal authorities knew the vaccines were causing autism but failed to act.
Generation Rescue, one of the parents groups, has posted the documents on the website www.putchildrenfirst.org. Generation Rescue obtained the documents via the Freedom of Information Act.
“These are our federal health agencies that we trust … and they’re poisoning us,” said Wendy Fournier of the National Autism Association. “They’ve poisoned an entire generation of children,” she said. The CDC spearheaded an aggressive push to expand childhood vaccinations in the early 1990s.
Burton seconded the accusations in a statement yesterday. He has been relentless in his criticisms of the health agencies.
“I truly feel that the HHS [Department of Health and Human Services], CDC, [the Institute of Medicine] and the FDA have deliberately misled the American public on the dangers of mercury in vaccines, and I wholeheartedly support a thorough and independent investigation into the evident link between mercury and autism,” Burton said.
The CDC denied any cover-up and defended its policies. “We’ve taken this issue and the concerns very seriously from the beginning,” said CDC spokesman Glen Nowak.
The allegations of a conspiracy represent an intensification of a years-long campaign by these organizations.
The groups want Congress to investigate and will demand that criminal charges be brought against officials involved. The Senate Health, Education, Labor and Pensions Committee is investigating the agencies, a spokesman for the panel said. Last July, parents groups recommended to the committee that HHS, CDC and FDA officials should be charged with criminal negligence and criminal obstruction of justice.
In addition to the National Autism Association and Generation Rescue, A-Champ, NoMercury, Moms Against Mercury and AutismOne organized the rally and press conference. Today’s press conference will be followed by a conference on autism issues that will run through Monday.
Maloney said the agencies should respond better to the concerns of these parents and Congress but stopped short of endorsing the allegations of a cover-up.
“When it comes to mercury, autism and the government’s response, there are still more questions than answers. … I know that there are some in Congress who want to work to get those answers,” she said.
“While I cannot answer the question of an alleged cover-up, it is obvious to even the casual observer that the CDC has failed miserably investigating this matter,” Weldon said.
The organizations representing parents of autistic children have been vocal and aggressive in their campaigns to get mercury and thimerosal removed from all vaccines and to get the CDC and other agencies to change their policies related to childhood vaccines.
Their strategies have attracted the interest of many members of Congress over the years, notably Burton and Weldon. The conference report that accompanied the appropriations bill that funds HHS this year includes a provision requesting another study on the issue by the National Institutes of Health.
A scientific review issued by the National Academies’ Institute of Medicine in 2004 was intended to put the question of mercury and autism to rest but served only to fuel the fire.
The institute’s panel concurred with the CDC position. “Neither the mercury-based vaccine preservative thimerosal nor the measles-mumps-rubella (MMR) vaccine are associated with autism,” according to the press release that accompanied the report.
The parents groups alleged that the CDC pressured the committee that carried out the review to support its policies.
The chairwoman of the panel rejected that charge, which she characterized as an explicit attack on her integrity. Asked if CDC officials attempted to sway the committee’s deliberations, Harvard School of Public Health professor Marie McCormick said, “Absolutely not.”
AJC: Autism Controversy Eats at Credibility of CDC
Autism controversy eats at credibility of CDC
By ALISON YOUNG
The Atlanta Journal-Constitution
Published on: 04/06/06
The Centers for Disease Control and Prevention, rarely the subject of public controversy, is facing an emerging credibility crisis on the emotional issue of whether old-style vaccines containing a mercury preservative caused autism in thousands of children.
The agency is being accused of cover-ups and scientific manipulations by a vocal group of autism advocates and is facing questions from some high-profile members of Congress.
As the debate and controversy increasingly finds its way into pediatricians' offices, average parents of healthy children are questioning whether vaccines are safe, sometimes even refusing inoculations.
The CDC and other public health officials insist such questions lack a basis in fact or science. Their greatest concern is that the broadening debate holds the potential to put a new generation of children at certain risk of deadly diseases if confidence in the safety of vaccines is lost and they don't receive recommended shots.
"I think it's huge," said Dr. Julia McMillan, a member of the American Academy of Pediatrics committee that makes vaccine recommendations. "There's no pediatrician in practice that doesn't confront this on a weekly basis: families who are questioning the need for – and in some cases refusing — vaccines for their children."
But the academy and the CDC are in agreement: They say there is no evidence to support a connection between autism and the mercury-based preservative thimerosal, which they stress is no longer used in most pediatric vaccines.
"We simply don't know what the cause of autism is," Dr. Bob Davis, the CDC's director of immunization safety, said Wednesday. Nonetheless, the CDC finds itself at the center of criticism.
A full-page ad scheduled to run in today's editions of USA Today, the nation's largest-circulation newspaper, accuses the CDC of "causing an epidemic of autism" by recommending that children receive a series of vaccines that until 2001 contained thimerosal.
The ad, placed by a group of autism advocacy groups, quotes environmental lawyer Robert F. Kennedy Jr. as saying: "It's time for the CDC to come clean with the American public."
But what stings public health advocates more is a letter sent Feb. 22 by Sen. Joseph Lieberman (D-Conn.) and seven other members of Congress. The bipartisan group asks that the CDC not take the lead on a new study examining the vaccine-autism issue.
"If the federal government is going to have a study whose results will be broadly accepted, such a study cannot be led by the CDC," the group wrote Dr. David Schwartz, new director of the National Institute of Environmental Health Sciences. The institute, a part of the National Institutes of Health, will convene a panel in May to discuss how to analyze a key CDC database to determine whether autism rates have dropped since thimerosal was removed from vaccines.
The letter was also signed by Sen. Debbie Stabenow, (D-Mich.), Rep. Dave Weldon, (R-Fla.,) Rep. Chris Smith, (R-N.J.), Rep. Carolyn Maloney, (D-N.Y.), Rep. Dan Burton, (R-Ind.), Rep. Joseph Crowley, (D-N.Y,), and Rep. Maurice Hinchey, (D-N.Y.).
Agency officials said Wednesday they are proud of the CDC's work on thimerosal safety issues and that they have looked hard to find a link as well as to find any other cause of autism.
"It was an unfortunate choice of language," Davis said of the Lieberman letter. "They and everyone else are certainly entitled to their opinion. We stand by all the research we have done."
Public health officials who work with CDC are more blunt.
"I think it's shocking," said Dr. Martin Myers, executive director of the National Network for Immunization Information and a professor of pediatrics at the University of Texas medical branch in Galveston.
"The loss of public trust in one of the most extraordinary institutions in the world. I'm not quite sure how that has occurred, but it has, and that's one of the unfortunate consequences," Myers said.
The controversy, which erupted as some autism advocates rallied on Capitol Hill today in conjunction with National Autism Month, is gaining political traction, moving well beyond an initial core of autism activists, CDC, public health and congressional officials all agree.
There are many parents of autistic children who believe, as do most pediatricians and scientists, that there is no scientific evidence that thimerosal caused autism and other neurological disorders. That issue was settled for most in a widely publicized 2004 report by an expert panel convened by the National Academy of Sciences Institute of Medicine.
But the report has been the subject of controversy and intense scrutiny since it was published.
Parents of many autistic children insist that thimerosal caused the disorder, because it appeared around the time their children received vaccinations. Their advocates also point to what they say is intriguing new research in animal models indicating that some individuals may be more sensitive to thimerosal than others. Martin Cowen, whose family lives in Jonesboro, is one such parent.
Cowen is convinced thimerosal-containing vaccines caused his son Lindsey's autism. Lindsey, who turned 8 last week, does not speak, has not been toilet trained and cannot be allowed outdoors without being restrained for fear he'll run into traffic, his father said.
Cowen is highly skeptical of the CDC, a position shared by a cohort of parents and advocates across the country.
"An enormous effort is being made to deny the connection," he said of the CDC. "What do I think their motive is? They are very interested in having the herd vaccinated... They don't think of people as people suffering individually. It's the greatest good for the greatest number."
The National Immunization Program, run by the CDC, coordinates immunization activities across the country. Increasing the rate of immunization against disease is a cornerstone of public health.
At the same time, the CDC also is charged with monitoring vaccine safety. It's an inherent conflict of interest, said Weldon, a doctor before he was elected to Congress.
"They really do have a credibility problem," said Weldon, who serves on the committee that decides the CDC's budget. "Part of the credibility problem is it's asking them to investigate a problem that they may have created."
Weldon became involved in the thimerosal issue seven years ago. "Honestly, at first I was very dubious," he said. "As I looked at it more and more, I began to feel there is some validity to this."
Weldon said the recent interest by Lieberman and others on Capitol Hill is a sign the issue is gaining political traction. Lieberman was unavailable for comment.
The controversy and public debate is likely to be further fueled by the full-page ad being paid for by a coalition of the autism activist groups led by Generation Rescue. The ad promotes a sophisticated Web site, www.PutChildren First.org, which includes links to CDC documents, e-mails and transcripts the groups say support their contention of an agency cover-up.
CDC spokesman Glen Nowak said many of the documents on the site have been in the public domain for years, and are presented out of context and in ways that may "look quite ominous" – when they're not.
"It's a very challenging issue," he said. The CDC is bracing for a spike in calls today from parents with questions and is increasing staffing at its public help line, 1-800-232-4636.
By ALISON YOUNG
The Atlanta Journal-Constitution
Published on: 04/06/06
The Centers for Disease Control and Prevention, rarely the subject of public controversy, is facing an emerging credibility crisis on the emotional issue of whether old-style vaccines containing a mercury preservative caused autism in thousands of children.
The agency is being accused of cover-ups and scientific manipulations by a vocal group of autism advocates and is facing questions from some high-profile members of Congress.
As the debate and controversy increasingly finds its way into pediatricians' offices, average parents of healthy children are questioning whether vaccines are safe, sometimes even refusing inoculations.
The CDC and other public health officials insist such questions lack a basis in fact or science. Their greatest concern is that the broadening debate holds the potential to put a new generation of children at certain risk of deadly diseases if confidence in the safety of vaccines is lost and they don't receive recommended shots.
"I think it's huge," said Dr. Julia McMillan, a member of the American Academy of Pediatrics committee that makes vaccine recommendations. "There's no pediatrician in practice that doesn't confront this on a weekly basis: families who are questioning the need for – and in some cases refusing — vaccines for their children."
But the academy and the CDC are in agreement: They say there is no evidence to support a connection between autism and the mercury-based preservative thimerosal, which they stress is no longer used in most pediatric vaccines.
"We simply don't know what the cause of autism is," Dr. Bob Davis, the CDC's director of immunization safety, said Wednesday. Nonetheless, the CDC finds itself at the center of criticism.
A full-page ad scheduled to run in today's editions of USA Today, the nation's largest-circulation newspaper, accuses the CDC of "causing an epidemic of autism" by recommending that children receive a series of vaccines that until 2001 contained thimerosal.
The ad, placed by a group of autism advocacy groups, quotes environmental lawyer Robert F. Kennedy Jr. as saying: "It's time for the CDC to come clean with the American public."
But what stings public health advocates more is a letter sent Feb. 22 by Sen. Joseph Lieberman (D-Conn.) and seven other members of Congress. The bipartisan group asks that the CDC not take the lead on a new study examining the vaccine-autism issue.
"If the federal government is going to have a study whose results will be broadly accepted, such a study cannot be led by the CDC," the group wrote Dr. David Schwartz, new director of the National Institute of Environmental Health Sciences. The institute, a part of the National Institutes of Health, will convene a panel in May to discuss how to analyze a key CDC database to determine whether autism rates have dropped since thimerosal was removed from vaccines.
The letter was also signed by Sen. Debbie Stabenow, (D-Mich.), Rep. Dave Weldon, (R-Fla.,) Rep. Chris Smith, (R-N.J.), Rep. Carolyn Maloney, (D-N.Y.), Rep. Dan Burton, (R-Ind.), Rep. Joseph Crowley, (D-N.Y,), and Rep. Maurice Hinchey, (D-N.Y.).
Agency officials said Wednesday they are proud of the CDC's work on thimerosal safety issues and that they have looked hard to find a link as well as to find any other cause of autism.
"It was an unfortunate choice of language," Davis said of the Lieberman letter. "They and everyone else are certainly entitled to their opinion. We stand by all the research we have done."
Public health officials who work with CDC are more blunt.
"I think it's shocking," said Dr. Martin Myers, executive director of the National Network for Immunization Information and a professor of pediatrics at the University of Texas medical branch in Galveston.
"The loss of public trust in one of the most extraordinary institutions in the world. I'm not quite sure how that has occurred, but it has, and that's one of the unfortunate consequences," Myers said.
The controversy, which erupted as some autism advocates rallied on Capitol Hill today in conjunction with National Autism Month, is gaining political traction, moving well beyond an initial core of autism activists, CDC, public health and congressional officials all agree.
There are many parents of autistic children who believe, as do most pediatricians and scientists, that there is no scientific evidence that thimerosal caused autism and other neurological disorders. That issue was settled for most in a widely publicized 2004 report by an expert panel convened by the National Academy of Sciences Institute of Medicine.
But the report has been the subject of controversy and intense scrutiny since it was published.
Parents of many autistic children insist that thimerosal caused the disorder, because it appeared around the time their children received vaccinations. Their advocates also point to what they say is intriguing new research in animal models indicating that some individuals may be more sensitive to thimerosal than others. Martin Cowen, whose family lives in Jonesboro, is one such parent.
Cowen is convinced thimerosal-containing vaccines caused his son Lindsey's autism. Lindsey, who turned 8 last week, does not speak, has not been toilet trained and cannot be allowed outdoors without being restrained for fear he'll run into traffic, his father said.
Cowen is highly skeptical of the CDC, a position shared by a cohort of parents and advocates across the country.
"An enormous effort is being made to deny the connection," he said of the CDC. "What do I think their motive is? They are very interested in having the herd vaccinated... They don't think of people as people suffering individually. It's the greatest good for the greatest number."
The National Immunization Program, run by the CDC, coordinates immunization activities across the country. Increasing the rate of immunization against disease is a cornerstone of public health.
At the same time, the CDC also is charged with monitoring vaccine safety. It's an inherent conflict of interest, said Weldon, a doctor before he was elected to Congress.
"They really do have a credibility problem," said Weldon, who serves on the committee that decides the CDC's budget. "Part of the credibility problem is it's asking them to investigate a problem that they may have created."
Weldon became involved in the thimerosal issue seven years ago. "Honestly, at first I was very dubious," he said. "As I looked at it more and more, I began to feel there is some validity to this."
Weldon said the recent interest by Lieberman and others on Capitol Hill is a sign the issue is gaining political traction. Lieberman was unavailable for comment.
The controversy and public debate is likely to be further fueled by the full-page ad being paid for by a coalition of the autism activist groups led by Generation Rescue. The ad promotes a sophisticated Web site, www.PutChildren First.org, which includes links to CDC documents, e-mails and transcripts the groups say support their contention of an agency cover-up.
CDC spokesman Glen Nowak said many of the documents on the site have been in the public domain for years, and are presented out of context and in ways that may "look quite ominous" – when they're not.
"It's a very challenging issue," he said. The CDC is bracing for a spike in calls today from parents with questions and is increasing staffing at its public help line, 1-800-232-4636.
FDA Public Hearing On Dental Mercury
Joint Meeting of the Dental Products Panel of the Medical Devices Advisory Committee of the Center for Devices and Radiological Health and the Peripheral and Central Nervous System Drugs Advisory Committee of the Center for Drug Evaluation and Research
CDRH
September 06, 2006
September 07, 2006
8:00 a.m. - 5:00 p.m.
Holiday Inn
Walker/Whetstone Rm.
Two Montgomery Village Ave.
Gaithersburg, MD
Agenda:
This joint committee will review and discuss peer-reviewed scientific literature on dental amalgam devices. Dental amalgam, also called "encapsulated amalgam," consists of dental mercury and amalgam alloys. This joint committee will review and discuss peer-reviewed scientific literature on dental amalgam and its potential mercury toxicity, specifically as it relates to neurotoxic effects. Certain consumer groups have raised concerns about the effects of using mercury as a component of dental restorative materials; therefore, we are combining the expertise of the Dental Products Panel of the Medical Device Advisory Committee with the neurology expertise of the Peripheral and Central Nervous System Drugs Advisory Committee.
Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).
Procedure:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by August 23, 2006. On September 6 and 7, 2006, Oral presentations from the public will be scheduled at the beginning of committee deliberations and near the end of the deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person by August 23, 2006, and include the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Ann Marie Williams, Conference Management Staff, 240-276-0450 ext. 113, at least 7 days in advance of the meeting.
Contact Person:
Michael E. Adjodha, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283, ext. 123, e-mail: Michael.Adjodha@fda.hhs.gov
Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512518.
CDRH
September 06, 2006
September 07, 2006
8:00 a.m. - 5:00 p.m.
Holiday Inn
Walker/Whetstone Rm.
Two Montgomery Village Ave.
Gaithersburg, MD
Agenda:
This joint committee will review and discuss peer-reviewed scientific literature on dental amalgam devices. Dental amalgam, also called "encapsulated amalgam," consists of dental mercury and amalgam alloys. This joint committee will review and discuss peer-reviewed scientific literature on dental amalgam and its potential mercury toxicity, specifically as it relates to neurotoxic effects. Certain consumer groups have raised concerns about the effects of using mercury as a component of dental restorative materials; therefore, we are combining the expertise of the Dental Products Panel of the Medical Device Advisory Committee with the neurology expertise of the Peripheral and Central Nervous System Drugs Advisory Committee.
Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).
Procedure:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by August 23, 2006. On September 6 and 7, 2006, Oral presentations from the public will be scheduled at the beginning of committee deliberations and near the end of the deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person by August 23, 2006, and include the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Ann Marie Williams, Conference Management Staff, 240-276-0450 ext. 113, at least 7 days in advance of the meeting.
Contact Person:
Michael E. Adjodha, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283, ext. 123, e-mail: Michael.Adjodha@fda.hhs.gov
Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512518.
Eli Lilly Withholds Info From Child Test Subjects on Strattera
Eli Lilly withheld disastrous effects of Strattera from parents and children
The wording of the parent and children information in an ongoing clinical trial of Strattera has been revealed. Eli Lilly withheld the drug's disastrous effects in order to get children to participate in the study.
/24-7PressRelease/ - HAGERSTEN, SWEDEN, April 05, 2006 - The "ADHD medication" Strattera is not approved in Sweden. Eli Lilly decided to do a one-year clinical trial of the drug on children. The purpose of the study was to get Strattera approved by the Medical Products Agency (MPA). The company hired the psychiatric authority Bjorn Kadesjö to lead the trial.
The 100 participating children and their parents needed information about the adverse effects of the drug in order to sign the consent form. They thought they got it. They did not.
Eli Lilly deliberately withheld information about disastrous effects of Strattera - information which could have made the parents and children want to withdraw from the study; information which could have made the Regional Ethical Review Board want to disapprove the application; information which could "disturb" the result of the trial.
The "updated" information given to parents and children about adverse effects was from January 31, 2005. The only serious adverse effect mentioned was liver injury in very rare cases.
But documents now made public show that Eli Lilly knew about several serious effects from Strattera at that time.
Take the FDA report Psychiatric Adverse Events Associated with Drug Treatment of ADHD: Review of Postmarketing Safety Data, released for the FDA Pediatric Advisory Committee meeting, March 22. It says that Eli Lilly (and other pharmaceutical companies) were asked to provide information about a) signs and/or symptoms of psychosis or mania; b) suicidal ideation and behavior; c) aggression and violent behavior, (for Strattera for the period November 2002 - June 2005). In that period Lilly had received 350 reports of psychosis or mania, 900 reports of aggression and violent behavior and 400 reports of suicidality. In a Preliminary Assessment Report from December 2005, written by the British medical regulatory agency MHRA, it is mentioned that Lilly from November 2002 to September 2005 had received 766 reports of heart disorders connected to the use of Strattera. (It should be noted that credible estimates of the percent of adverse reactions that are reported range from 1-10%.)
It is certainly not so that Eli Lilly had received these reports in the period February - June 2005. Almost all of reports had been received in the foregoing 26-month period and only a minor part in the 5 month up to June 2005.
This means that Eli Lilly deliberately withheld Strattera's disastrous effects of psychosis and mania, aggression and violent behavior, suicidality and heart disorder, in the information to parents and children in the clinical trial.
Janne Larsson
writer from Sweden - investigating psychiatry
The wording of the parent and children information in an ongoing clinical trial of Strattera has been revealed. Eli Lilly withheld the drug's disastrous effects in order to get children to participate in the study.
/24-7PressRelease/ - HAGERSTEN, SWEDEN, April 05, 2006 - The "ADHD medication" Strattera is not approved in Sweden. Eli Lilly decided to do a one-year clinical trial of the drug on children. The purpose of the study was to get Strattera approved by the Medical Products Agency (MPA). The company hired the psychiatric authority Bjorn Kadesjö to lead the trial.
The 100 participating children and their parents needed information about the adverse effects of the drug in order to sign the consent form. They thought they got it. They did not.
Eli Lilly deliberately withheld information about disastrous effects of Strattera - information which could have made the parents and children want to withdraw from the study; information which could have made the Regional Ethical Review Board want to disapprove the application; information which could "disturb" the result of the trial.
The "updated" information given to parents and children about adverse effects was from January 31, 2005. The only serious adverse effect mentioned was liver injury in very rare cases.
But documents now made public show that Eli Lilly knew about several serious effects from Strattera at that time.
Take the FDA report Psychiatric Adverse Events Associated with Drug Treatment of ADHD: Review of Postmarketing Safety Data, released for the FDA Pediatric Advisory Committee meeting, March 22. It says that Eli Lilly (and other pharmaceutical companies) were asked to provide information about a) signs and/or symptoms of psychosis or mania; b) suicidal ideation and behavior; c) aggression and violent behavior, (for Strattera for the period November 2002 - June 2005). In that period Lilly had received 350 reports of psychosis or mania, 900 reports of aggression and violent behavior and 400 reports of suicidality. In a Preliminary Assessment Report from December 2005, written by the British medical regulatory agency MHRA, it is mentioned that Lilly from November 2002 to September 2005 had received 766 reports of heart disorders connected to the use of Strattera. (It should be noted that credible estimates of the percent of adverse reactions that are reported range from 1-10%.)
It is certainly not so that Eli Lilly had received these reports in the period February - June 2005. Almost all of reports had been received in the foregoing 26-month period and only a minor part in the 5 month up to June 2005.
This means that Eli Lilly deliberately withheld Strattera's disastrous effects of psychosis and mania, aggression and violent behavior, suicidality and heart disorder, in the information to parents and children in the clinical trial.
Janne Larsson
writer from Sweden - investigating psychiatry
PutChildrenFirst.org
A new website, www.putchildrenfirst.org , details the CDC's bad behavior.
There will be a full page ad in USA Today on Thursday April 6th announcing the site:
Here is the Press Release that will come out tomorrow morning:
New Internal Documents Reveal Deception by the Centers for Disease Control about Vaccines Role in Autism
New Web Site Displays Documents Acquired through Freedom of Information Act by Parents of Autistic Children.
Full-page Ad in USA Today Alleging a Cover Up Runs as Parents of Autistic Children March on Washington.
WASHINGTON, D.C., April 5, 2006
Generation Rescue, a national organization of parents of autistic children, today launched a Web site (www.PutChildrenFirst.org) and full-page ad detailing newly-released internal documents about the Centers for Disease Control's (CDC) efforts to minimize or cover up the connection between child vaccines and autism.
The ad is also supported by the non-profit groups The National Autism Association, NoMercury, Moms Against Mercury, AutismOne, and ACHAMP.
Many parents and scientists believe that autism and other developmental disorders are caused by the toxic metal mercury, a key ingredient in a vaccine preservative called Thimerosal.
Tomorrow, autism organizations and parents will march to the Capitol in Washington, D.C., in the Mercury Generation March to demand answers. The controversy has been recently fueled by high-profile figures publicly calling for similar answers from the CDC, such as Senators Joe Lieberman (D-CT) and John Kerry (D-MA); Representatives Dave Weldon (R-FL), Carolyn Maloney (D-NY) and Dan Burton (R-IN); Robert F. Kennedy, Jr.; and radio and television host Don Imus of MSNBC.
The CDC is the agency responsible for the National Immunization Program. In the 1990s, the CDC dramatically increased the number of immunizations for children, which nearly tripled the amount of mercury injected into children, exceeding Federal safety standards by as much as 125-times. Rates of autism also greatly increased during this period.
The CDC estimates that more than 1 in 166 children are diagnosed with autism, up from 1 in 10,000 in the 1970s. According to the CDC, autism is a life-long disorder that is not treatable.
"Autism is a devastating disorder that affects millions of families," said J.B. Handley, one of Generation Rescue's founding parents and father of an autistic son. "To help children with autism and to prevent others from acquiring it, we need the CDC to stand up for our children. Sadly, the CDC would rather protect its own skin than our kids."
The full-page advertisement running in tomorrow's (Thursday 4/6) USA Today delivers a similarly blunt message: "If you caused a 6,000% increase in autism, wouldn't you try to cover it up, too?"
To view the ad, visit: www.PutChildrenFirst.org
Through the Freedom of Information Act, parents of autistic children
acquired numerous emails, memos, transcripts and reports from the CDC, Food and Drug Administration, Institute of Medicine, and U.S. Congress.
Some findings from the documents include
- A private memo from an FDA official lamenting that the revelation that children were receiving up to 125x the safe level of mercury would create a perception that CDC and FDA were "asleep at the switch".
- A private email and spreadsheet from a CDC epidemiologists showing an extremely high correlation between mercury received through vaccines and autism, with the researcher writing the correlation "just won't go away".
- A secret transcript from an emergency meeting held by the CDC where health officials say "the number of dose-related relationships [between thimerosal and autism] are linear and statistically significant" and the CDC's data should be kept out of "less responsible hands".
- A contract from CDC, paying a lobbying firm $190 million to maintain the Vaccine Safety Datalink data, in order to insulate the data from the Freedom of Information Act.
- Emails from the CDC frantically searching for evidence to exonerate
Thimerosal. California data ends up being incriminating and is buried, data from Denmark has a fatal flaw, which a Danish researcher highlights, but the data is pursued anyway.
- An email from the CDC rejecting British data because the mercury received by British children is too low, despite this being the same issue in Denmark, where studies written by CDC employees are ultimately produced.
- A letter from a Director of the CDC recommending publication of a Danish study exonerating Thimerosal (and the CDC) for publication to the American Academy of Pediatrics' medical journal, Pediatrics.
- Transcripts from Committee proceedings of the Institute of Medicine (which in 2004 would exonerate Thimerosal), where committee members note that CDC, who is paying for the study, "wants us to declare these things are pretty safe on a population basis."
- Handwritten notes from Committee proceedings outlining explicit conflicts of interest of Committee members, despite assurances from the IOM President that members were "free of financial conflicts of interest".
- A private email from the Chairperson of the 2004 IOM Committee, after the report was published, saying that Thimerosal can "injure the nervous system".
- A secret memo summarizing the cover up and a statement of charges recently shared with the Senate Help Committee and recommending Senate Hearings.
"These internal documents prove that the CDC knew that its ambitious vaccine schedule in the 1990s created America's autism epidemic," said Handley. "Every day the CDC denies that mercury from vaccines causes autism is another day proper treatment is ignored for the more than one million American children who could be treated."
The parents of Generation Rescue have helped heal their children through individualized medical treatments that remove mercury and treat the damages it causes young bodies. Generation Rescue's 300 families also serve as "Rescue Angels" and have helped 7,500 other families looking for advice on treating autism.
"The worst part about the CDC's deception is that parents are not hearing about real, medical treatments that can heal their children," said Lisa Handley, co-founder of Generation Rescue. "In the last year alone, we have seen the inspiring improvements treatments can bring to our three-year-old son Jamie. He is talking more than ever, socializing and even has a best friend- all things doctors rule out for autistic children."
Thousands of children are recovering from autism through the Defeat Autism Now! Protocol; safe medical treatments that remove the mercury and other toxic metals and live viruses that vaccines inject into our children's bodies.
Mercury, the second most toxic element after plutonium, is estimated to be 500 to 1,000 times more toxic than lead. The heavy metal burrows into the cells of the brain and other organs and can lead to serious central nervous system damage and neurological disorders.
"The symptoms of early infant mercury poisoning and autism are virtually identical," said Dr. Boyd Haley, chairman of the chemistry department at the University of Kentucky. "Furthermore, research indicates that autistic children genetically have a harder time excreting mercury from their bodies and that many of their biomedical problems could be caused by mercury."
"In a time when pregnant women are told not to eat fish because it might contain mercury, why in the world are we still injecting mercury into our children's bloodstream through vaccines?", asked Kevin Barry, President of Generation Rescue. "We are completely mystified about why the CDC and the American Academy of Pediatrics are fighting state laws trying to ban mercury in vaccines."
Generation Rescue is calling on Congress to:
- Support the Combating Autism Act
- Ban Thimerosal from all vaccines Nationwide
- Recall any vaccines with Thimerosal in them immediately
- Create a National Task Force of Doctors versed in the biomedical treatment of autism to establish national priorities for treating as many children as possible
- Initiate trials immediately, in consultation with the Autism Research Institute (sponsor of DAN!), on the most promising forms of biomedical treatment for autism, including the GF/CF diet, nutritional therapy, B12 therapy, anti-viral therapy, and chelation therapy
- Enact legislation to provide health insurance for the biomedical treatment of autism
- Support Congresswoman Carolyn Maloney's recently introduced bill to "conduct or support a comprehensive study comparing total health outcomes, including risk of autism, in vaccinated populations in the United States with such outcomes in unvaccinated populations..."
- Issue a Senatorial subpoena to gain access to the Vaccine Safety Datalink information, still not released after 6 years of requests, so that it can be reviewed by outside researchers
- Commission a new IOM Committee, paid for by Congress, with input from the Autism Community on charter and membership
- Hold Senate hearings on the cover-up of the autism epidemic by the CDC and FDA.
About Generation Rescue
Generation Rescue (www.GenerationRescue.org) is a nonprofit formed by parents of children diagnosed with autism and other development disorders. Through thorough research, medical consultation and the use of medical treatments, the parents of Generation Rescue have seen tremendous improvements in their children- including complete recoveries. Generation Rescue's mission is to provide parents the information and support to understand the cause of autism
and treatment options. The Web site gives background to make informed decisions about treatment and connects families with "Rescue Angels", more than 300 families of autistic children who voluntarily provide support and guidance on treatment options.
Generation Rescue is a 501(c)(3) founded in 2005.
There will be a full page ad in USA Today on Thursday April 6th announcing the site:
Here is the Press Release that will come out tomorrow morning:
New Internal Documents Reveal Deception by the Centers for Disease Control about Vaccines Role in Autism
New Web Site Displays Documents Acquired through Freedom of Information Act by Parents of Autistic Children.
Full-page Ad in USA Today Alleging a Cover Up Runs as Parents of Autistic Children March on Washington.
WASHINGTON, D.C., April 5, 2006
Generation Rescue, a national organization of parents of autistic children, today launched a Web site (www.PutChildrenFirst.org) and full-page ad detailing newly-released internal documents about the Centers for Disease Control's (CDC) efforts to minimize or cover up the connection between child vaccines and autism.
The ad is also supported by the non-profit groups The National Autism Association, NoMercury, Moms Against Mercury, AutismOne, and ACHAMP.
Many parents and scientists believe that autism and other developmental disorders are caused by the toxic metal mercury, a key ingredient in a vaccine preservative called Thimerosal.
Tomorrow, autism organizations and parents will march to the Capitol in Washington, D.C., in the Mercury Generation March to demand answers. The controversy has been recently fueled by high-profile figures publicly calling for similar answers from the CDC, such as Senators Joe Lieberman (D-CT) and John Kerry (D-MA); Representatives Dave Weldon (R-FL), Carolyn Maloney (D-NY) and Dan Burton (R-IN); Robert F. Kennedy, Jr.; and radio and television host Don Imus of MSNBC.
The CDC is the agency responsible for the National Immunization Program. In the 1990s, the CDC dramatically increased the number of immunizations for children, which nearly tripled the amount of mercury injected into children, exceeding Federal safety standards by as much as 125-times. Rates of autism also greatly increased during this period.
The CDC estimates that more than 1 in 166 children are diagnosed with autism, up from 1 in 10,000 in the 1970s. According to the CDC, autism is a life-long disorder that is not treatable.
"Autism is a devastating disorder that affects millions of families," said J.B. Handley, one of Generation Rescue's founding parents and father of an autistic son. "To help children with autism and to prevent others from acquiring it, we need the CDC to stand up for our children. Sadly, the CDC would rather protect its own skin than our kids."
The full-page advertisement running in tomorrow's (Thursday 4/6) USA Today delivers a similarly blunt message: "If you caused a 6,000% increase in autism, wouldn't you try to cover it up, too?"
To view the ad, visit: www.PutChildrenFirst.org
Through the Freedom of Information Act, parents of autistic children
acquired numerous emails, memos, transcripts and reports from the CDC, Food and Drug Administration, Institute of Medicine, and U.S. Congress.
Some findings from the documents include
- A private memo from an FDA official lamenting that the revelation that children were receiving up to 125x the safe level of mercury would create a perception that CDC and FDA were "asleep at the switch".
- A private email and spreadsheet from a CDC epidemiologists showing an extremely high correlation between mercury received through vaccines and autism, with the researcher writing the correlation "just won't go away".
- A secret transcript from an emergency meeting held by the CDC where health officials say "the number of dose-related relationships [between thimerosal and autism] are linear and statistically significant" and the CDC's data should be kept out of "less responsible hands".
- A contract from CDC, paying a lobbying firm $190 million to maintain the Vaccine Safety Datalink data, in order to insulate the data from the Freedom of Information Act.
- Emails from the CDC frantically searching for evidence to exonerate
Thimerosal. California data ends up being incriminating and is buried, data from Denmark has a fatal flaw, which a Danish researcher highlights, but the data is pursued anyway.
- An email from the CDC rejecting British data because the mercury received by British children is too low, despite this being the same issue in Denmark, where studies written by CDC employees are ultimately produced.
- A letter from a Director of the CDC recommending publication of a Danish study exonerating Thimerosal (and the CDC) for publication to the American Academy of Pediatrics' medical journal, Pediatrics.
- Transcripts from Committee proceedings of the Institute of Medicine (which in 2004 would exonerate Thimerosal), where committee members note that CDC, who is paying for the study, "wants us to declare these things are pretty safe on a population basis."
- Handwritten notes from Committee proceedings outlining explicit conflicts of interest of Committee members, despite assurances from the IOM President that members were "free of financial conflicts of interest".
- A private email from the Chairperson of the 2004 IOM Committee, after the report was published, saying that Thimerosal can "injure the nervous system".
- A secret memo summarizing the cover up and a statement of charges recently shared with the Senate Help Committee and recommending Senate Hearings.
"These internal documents prove that the CDC knew that its ambitious vaccine schedule in the 1990s created America's autism epidemic," said Handley. "Every day the CDC denies that mercury from vaccines causes autism is another day proper treatment is ignored for the more than one million American children who could be treated."
The parents of Generation Rescue have helped heal their children through individualized medical treatments that remove mercury and treat the damages it causes young bodies. Generation Rescue's 300 families also serve as "Rescue Angels" and have helped 7,500 other families looking for advice on treating autism.
"The worst part about the CDC's deception is that parents are not hearing about real, medical treatments that can heal their children," said Lisa Handley, co-founder of Generation Rescue. "In the last year alone, we have seen the inspiring improvements treatments can bring to our three-year-old son Jamie. He is talking more than ever, socializing and even has a best friend- all things doctors rule out for autistic children."
Thousands of children are recovering from autism through the Defeat Autism Now! Protocol; safe medical treatments that remove the mercury and other toxic metals and live viruses that vaccines inject into our children's bodies.
Mercury, the second most toxic element after plutonium, is estimated to be 500 to 1,000 times more toxic than lead. The heavy metal burrows into the cells of the brain and other organs and can lead to serious central nervous system damage and neurological disorders.
"The symptoms of early infant mercury poisoning and autism are virtually identical," said Dr. Boyd Haley, chairman of the chemistry department at the University of Kentucky. "Furthermore, research indicates that autistic children genetically have a harder time excreting mercury from their bodies and that many of their biomedical problems could be caused by mercury."
"In a time when pregnant women are told not to eat fish because it might contain mercury, why in the world are we still injecting mercury into our children's bloodstream through vaccines?", asked Kevin Barry, President of Generation Rescue. "We are completely mystified about why the CDC and the American Academy of Pediatrics are fighting state laws trying to ban mercury in vaccines."
Generation Rescue is calling on Congress to:
- Support the Combating Autism Act
- Ban Thimerosal from all vaccines Nationwide
- Recall any vaccines with Thimerosal in them immediately
- Create a National Task Force of Doctors versed in the biomedical treatment of autism to establish national priorities for treating as many children as possible
- Initiate trials immediately, in consultation with the Autism Research Institute (sponsor of DAN!), on the most promising forms of biomedical treatment for autism, including the GF/CF diet, nutritional therapy, B12 therapy, anti-viral therapy, and chelation therapy
- Enact legislation to provide health insurance for the biomedical treatment of autism
- Support Congresswoman Carolyn Maloney's recently introduced bill to "conduct or support a comprehensive study comparing total health outcomes, including risk of autism, in vaccinated populations in the United States with such outcomes in unvaccinated populations..."
- Issue a Senatorial subpoena to gain access to the Vaccine Safety Datalink information, still not released after 6 years of requests, so that it can be reviewed by outside researchers
- Commission a new IOM Committee, paid for by Congress, with input from the Autism Community on charter and membership
- Hold Senate hearings on the cover-up of the autism epidemic by the CDC and FDA.
About Generation Rescue
Generation Rescue (www.GenerationRescue.org) is a nonprofit formed by parents of children diagnosed with autism and other development disorders. Through thorough research, medical consultation and the use of medical treatments, the parents of Generation Rescue have seen tremendous improvements in their children- including complete recoveries. Generation Rescue's mission is to provide parents the information and support to understand the cause of autism
and treatment options. The Web site gives background to make informed decisions about treatment and connects families with "Rescue Angels", more than 300 families of autistic children who voluntarily provide support and guidance on treatment options.
Generation Rescue is a 501(c)(3) founded in 2005.
April 4, 2006
The Age of Autism: Mercury Ban Opposed
Opponents of a mercury ban say that it is detrimental because, "Parents may see the banning of thimerosal as an admission that vaccine safety oversight is inadequate."
They will, and they should, because it is.
Here is the Letter:
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The National Autism Association and SafeMinds have responded to the pro-mercury letter:
They will, and they should, because it is.
The Age of Autism: Mercury ban opposed
By DAN OLMSTED
Representatives of 22 medical organizations have written to all members of Congress opposing efforts to ban the mercury-based preservative thimerosal from vaccines.
"Our organizations respectfully wish to state our opposition to all legislative efforts at the federal and state levels to restrict access to vaccines containing thimerosal, an ethylmercury-based preservative," said the letter dated April 3 from "Multiple National Organizations that Support Safe and Effective Vaccines."
The groups said that banning the preservative in vaccines for children and pregnant women -- as several states have done and legislation in Congress proposes -- would "perpetuate false and misleading information that vaccines are not safe. Parents may see the banning of thimerosal as an admission that vaccine safety oversight is inadequate."
In fact, the letter said, "There has been considerable research on this issue since the 1999 precautionary statement of the U.S. Public Health Service and the American Academy of Pediatrics and there is no documented scientific evidence that ethylmercury in the form of thimerosal in the doses administered in vaccines causes any risk to health."
The letter also cited concerns that bans could trigger "ongoing vaccine shortages or inability to deliver care. ... Limit the nation's inability to quickly administer influenza vaccine in the U.S. when a pandemic strikes. ... Lead to increased costs for vaccines. ... Add more complexity to our present vaccine delivery system. ... Profoundly affect global immunization programs, as do many U.S. vaccine policy decision."
At issue are concerns raised by parents and some scientists that increasing exposure to thimerosal in childhood vaccines during the 1990s may have triggered a huge rise in autism diagnoses. In 1999 the Centers for Disease Control and Prevention and others recommended manufacturers phase out thimerosal as soon as possible to limit exposure.
In 2004 the Institute of Medicine of the National Academies said it found no connection and that future research should go to "more promising" areas.
Yet concerns have persisted, in part because some flu vaccines still contain thimerosal, and the CDC has recommended the vaccines for all pregnant women and for children ages 6 months to 5 years.
Those concerns have prompted several states -- including New York, Illinois, California, Iowa, Delaware and most recently Washington state -- to enact bans over the opposition of the CDC and state medical associations.
At the same time, pressure has mounted for more studies of potential health problems of thimerosal and vaccines in general. Last week U.S. Rep. Carolyn Maloney, D-N.Y., said she will introduce a bill this month to force the federal government to study the autism rate in never-vaccinated American children.
In a letter to Congressional health policy staff that accompanied the groups' statement opposing a thimerosal ban, Diane C. Peterson of the Immunization Action Coalition said: "As you may be aware, recent media attention has been given to the role of thimerosal in vaccines and the development of autism. The 22 national organizations that have signed this letter, as well as many others, stand behind the enormous amount of scientific evidence that shows no link exists between thimerosal in vaccines and the development of autism.
"Please oppose all anti-thimerosal legislative proposals and help further (the) nation's work in protecting children and adults against vaccine-preventable diseases."
The signers include representatives of the following groups:
Ambulatory Pediatric Association; American Academy of Family Physicians; American Academy of Physician Assistants; American College of Allergy, Asthma, and Immunology; American College of Preventive Medicine; American Liver Foundation; American Medical Directors Association; American Pharmacists Association; Association of Immunization Program Managers; Council of State and Territorial Epidemiologists; Every Child by Two; Hepatitis B Foundation; Hepatitis Foundation International; Immunization Action Coalition; Infectious Diseases Society of America; National Coalition on Adult Immunization; National Foundation for Infectious Diseases; Parents of Kids with Infectious Diseases; Pediatric Infectious Disease Society; Society for Adolescent Medicine; Society of Teachers of Family Medicine; Vaccine Education Center at the Children's Hospital of Philadelphia.
E-mail: dolmsted@upi.com
Here is the Letter:
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Ambulatory Pediatric Association American Academy of Family Physicians
American Academy of Physician Assistants
American College of Allergy, Asthma, and Immunology
American College of Preventive Medicine American Liver Foundation
American Medical Directors Association American Pharmacists Association
Association of Immunization Program Managers
Council of State and Territorial Epidemiologists Every Child by Two
Hepatitis B Foundation Hepatitis Foundation International
Immunization Action Coalition Infectious Diseases Society of America
National Coalition on Adult Immunization National Foundation for Infectious Diseases
Parents of Kids with Infectious Diseases Pediatric Infectious Diseases Society
Society for Adolescent Medicine Society of Teachers of Family Medicine
Vaccine Education Center at the Children’s Hospital of Philadelphia
Date: April 3, 2006
To: All Members of Congress
From: Multiple National Organizations that Support Safe and Effective Vaccines
Subject: Opposition to Efforts to Restrict Access to Vaccines
Our organizations respectfully wish to state our opposition to all legislative efforts at the federal and state levels to restrict access to vaccines containing thimerosal, an ethylmercury-based preservative. If enacted, we believe such legislation has the potential to do the following:
1. Perpetuate false and misleading information that vaccines are not safe. Parents may see the banning of thimerosal as an admission that vaccine safety oversight is inadequate. The issue of thimerosal’s ill effects on the neurologic development of infants is based on studies of methylmercury and not the ethylmercury that is in the preservative thimerosal used in some vaccines. According to the U.S. Environmental Protection Agency, nearly all methylmercury exposures in the U.S. occur through eating fish and shellfish. The mercury that is contained in the preservative thimerosal is known as ethylmercury. There has been considerable research on this issue since the 1999 precautionary statement of the U.S. Public Health Service (USPHS) and the American Academy of Pediatrics (AAP) and there is no documented scientific evidence that ethylmercury in the form of thimerosal in the doses administered in vaccines causes any risk to health.
2. Potentially result in on-going vaccine shortages or inability to deliver care as healthcare providers are forced to seek vaccine formulations that are either free of thimerosal or contain only reduced quantities both of which would be in short supply. As an example, only 10% of a projected total of 80 million doses of injectable influenza vaccine will be available for the 2005-06 vaccination season in a thimerosal-free formulation. Other vaccines, such as vaccine used to prevent Japanese encephalitis in travelers to certain Asian countries, are not available in reduced thimerosal or thimerosal-free formulations.
3. Limit the nation’s ability to quickly administer influenza vaccine in the U.S. when a pandemic strikes. Vaccine containing no thimerosal or reduced quantities can be packaged only in single-dose units, and we are far short of the capacity necessary to fill enough single-dose units to quickly respond to a nation in need of immediate protection against influenza at the pandemic level (e.g., Avian flu). The only way we can more quickly build our vaccine delivery capacity is to fill multidose vials and these vials must contain a thimerosal-containing preservative.
4. Lead to increased costs for vaccines. Where alternative vaccines containing no thimerosal or only reduced quantities are available, they can be as much as 25-30% higher in cost, due to production losses and to single dose packaging. These additional costs will directly impact Medicare, the federal Vaccines for Children Program, state-administered Medicaid programs, as well as private health insurance costs.
5. Add more complexity to our present vaccine delivery system. With new vaccines being introduced, changes in vaccination scheduling, and all of the other complexities of vaccination delivery, it is already difficult for providers to stay current with the ever-changing nature of immunization. Adding a requirement that providers can only use vaccines with no or reduced amounts of thimerosal would add more complexity.
6. Profoundly affect global immunization programs, as do many U.S. vaccine policy decisions. Vaccines sold in the international market require multi-dose packaging because it reduces manufacturing costs significantly, a vital consideration for nations with fewer resources than the U.S. Multidose vials also conserve space in refrigerated containers (vaccines often require refrigeration when shipped to remote areas). If the U.S. adopts a policy restricting access to vaccines, it could adversely affect the health and well-being of children all over the world in ways that you would not intend. The negative political consequences of the U.S. using vaccines “allegedly safer” than those it supports for other countries are very worrisome. Vaccine manufacturers have revised their manufacturing processes to allow production of most vaccines in either a reduced thimerosal or thimerosal-free formulation. This was done as a precaution to address theoretical concerns noted in the USPHS/AAP joint request of July, 1999 and not because any evidence suggested that thimerosal was harmful. One fact we know for certain: in the U.S., 10.5 million cases of vaccine-preventable disease and 33,000 deaths are prevented each year by vaccinations. We therefore urge the members of the U.S. House of Representatives and the U.S. Senate to trust in the conclusions of the scientific community, including the Institute of Medicine, that the scientific evidence does not identify any connection between vaccines and autism. Please oppose all such legislative proposals and help us further our work in protecting our nation’s children and adults against vaccine-preventable diseases.
Diane Kittridge, MD, President
Ambulatory Pediatric Association
www.ambpeds.org
Mary E. Frank, MD, Board Chair
American Academy of Family Physicians
www.aafp.org
Marie-Michelle Leger, MPH, PA-C
Clinical and International Affairs
American Academy of Physician Assistants
www.aapa.org
William K. Dolen, MD, President
American College of Allergy, Asthma, and
Immunology
www.acaai.org
David A. Smith, MD, President
American Medical Directors Association
www.amda.org
Mitchel C. Rothholz, RPh, Vice President
Professional Practice & Member Services
American Pharmacists Association
www.aphanet.org
Paul Bonta, Associate Director
Policy & Government Affairs
American College of Preventive Medicine
www.acpm.org
Marie P. Bresnahan, MPH
Vice President for Programs
American Liver Foundation
www.liverfoundation.org
Dan Hopfensperger, Chair
Association of Immunization Program Managers
www.immunizationmanagers.org
C. Mack Sewell, MD, President
Council of State and Territorial Epidemiologists
www.cste.org
Amy Pisani, Executive Director
Every Child by Two
www.ecbt.org
Molli C. Conti, Vice President of Community Outreach
Hepatitis B Foundation
www.hepb.org
Thelma King Thiel, Chair and CEO
Hepatitis Foundation International
www.hepfi.org
Deborah L. Wexler, MD,
Executive Director Immunization Action Coalition
www.immunize.org
Martin J. Blaser, MD, President
Infectious Diseases Society of America
www.idsociety.org
Kristin L. Nichol, MD, Chair
National Coalition for Adult Immunization
www.nfid.org
Len Novick, Executive Director
National Foundation for Infectious Diseases
www.nfid.org
Trish Parnell, Executive Director
Parents of Kids with Infectious Diseases
www.pkids.org
Joseph W. St. Geme, III, MD, President
Pediatric Infectious Diseases Society
www.pids.org
Robert T. Brown, MD, President
Society for Adolescent Medicine
www.adolescenthealth.org
Donald Middleton, MD, Chair
Group on Immunization Education and
William Mygdal, EdD, President
Society of Teachers of Family Medicine
www.stfm.org
Paul A. Offit, MD, Center Director
Vaccine Education Center
Children’s Hospital of Philadelphia
www.chop.edu
The National Autism Association and SafeMinds have responded to the pro-mercury letter:
Opposition to Anti-Thimerosal Legislation
We have just received a copy of a letter that has been sent to the majority of health care staffers on Capitol Hill that promotes the continued use of thimerosal in vaccines. Incredibly, this letter has been endorsed by a large number of health care organizations. We must be ready to discuss this during our meetings in Washington this week. We find it highly unlikely to be coincidental that this letter was sent just before our rally and meetings with legislators to discuss the thimerosal/autism connection.
We've prepared arguments against continued use of thimerosal that can be printed out, along with the pro-mercury letter from Offit et al, and taken with you to any meetings you've arranged with your legislators. We hope this will help you be prepared to discuss the health threats from use of mercury-containing vaccines with your representative's staff.
Date: April 4th, 2006
To: All Members of Congress
From: Multiple Scientists and National Autism Organizations
Subject: Support for efforts to remove neurotoxin mercury from vaccines administered to pregnant women and children
Honorable Members of the 109th Congress
We feel legislation specifically delineating the removal of thimerosal (ethyl mercury) from vaccines is necessary in an effort to restore public confidence in vaccines and to prevent the potential for injury in our most vulnerable citizens; the fetus, infants and children. We base our concerns with the policy of exposing pregnant women and children to ethyl mercury on scientific facts and current policy.
The purpose of this letter is to make known our support for the efforts to remove ethyl mercury, a known neurotoxin, from vaccine preparations currently recommended for administration to pregnant women, infants and children.
1. The EPA recently reported that 1 in every 6 women of childbearing age is predicted to already have levels of mercury in their bodies that could cause neurodevelopmental harm to their unborn children. Of additional concern is the fact that the unborn fetus is known to accumulate mercury at levels higher than their mother by as much as 70%. Pregnant women are therefore counseled to avoid mercury exposure from seafood (methyl mercury) due to these concerns. Toxicological data recently provided by NIH funded research found that ethyl mercury, the type in the vaccine preservative thimerosal may be even more dangerous to the developing brain than methyl mercury. In this investigation it was documented that ethyl mercury resulted in twice as much inorganic mercury deposited in the brains of infant primates who received equal amounts of both ethyl mercury and methyl mercury modeled to mimic the early infant vaccine schedule from the 1990’s. Inorganic mercury in the brains of primates is known to result in neuroinflammation, a finding recently documented in brain tissue from those suffering with autism.
2. All flu vaccine manufacturers have a mercury-free or reduced mercury product. Sanofi, one of the leading flu vaccine producers is on record stating that they can make enough mercury-free vaccine to meet the needs of infants and pregnant women. Sanofi has also said that the amount of mercury-free product they produce is based on demand, so if more purchasers request it, they will increase production.
3. In December 2005 a provision was added to the Defense Bill giving Health & Human Services Secretary Michael Leavitt the ability to override state bans on mercury in the event of a human pandemic. Therefore, state and Federal legislation banning the use of thimerosal would be suspended should a pandemic occur. In addition, FDA does require the use of a preservative in multi-dose vials. There are several FDA approved preservatives, including 2- phenoxyethanol currently used in the Infanrix DTaP vaccine, that could be utilized that do not contain mercury.
4. According to vaccine manufacturers, the cost for a thimerosal free flu vaccine is approximately $3.30 or the cost of a “Happy Meal” from McDonalds. Although costs are a concern, American children deserve to receive the safest and most effective vaccine available, which clearly would be one that does not contain mercury. For example, the amount of mercury in a vial of flu vaccines that contains thimerosal is equal to a concentration of 50,000 parts per billion (ppb). To put this in perspective, liquid waste that exceeds 200 ppb of mercury must be disposed of in a special hazardous waste landfill and drinking water cannot exceed 2 ppb mercury. Unused flu vaccine must be disposed of as a hazardous waste. One must ask if most Americans would want to their infant to be the recipient of a product that can be classified as a hazardous waste?
5. Although the argument has been made that recommending thimerosal free vaccines for pregnant women, infants and children would increase the complexity of the vaccine schedule, complexity is something that health care providers deal with successfully on a daily basis. At present health care providers are dealing with a barrage of phone calls and questions from consumers who are desperate to find mercury free flu vaccines for their children. Should all flu vaccine be mercury free this issue would become a moot point for consumers and heath care providers alike.
6. Vaccine recommendations and formulations vary by country and in some countries the Government is the vaccine manufacturer. In fact, pharmaceutical companies have continued to sell off their mercury-based supplies to third world countries. When thimerosal was removed from vaccines in the United States, vaccine manufacturers even made a generous donation to the Global Alliance for Vaccines and Immunization of their thimerosal-containing vaccines. Global Policy in the U.S does not dictate policy in other countries.
In summary: The National Academy of Sciences acknowledges “windows of vulnerability” to mercury toxicity during neurological development. Specific types of neurodevelopmental outcomes may have different (and specific) windows. These critical periods for mercury effects have not been established and may be relatively short in duration. Because thimerosal from vaccines has been documented to cross the blood brain barrier and result in significant accumulation of inorganic mercury in the brains of infant primates, excessive exposure during one or more windows of neurodevelopmental vulnerability may have occurred. The fact that thimerosal may contribute to adverse neurodevelopmental outcomes is compounded by the recognition that even relatively minor effects early in life can have profound affects on society when amortized across the entire population and life span.
Therefore; in the interest of precaution, removal of mercury from vaccines given to vulnerable populations is warranted and actions that lead to such removal, especially since sufficient supplies of mercury free vaccines are readily available, should be actively supported.
Attached is a brief summary for the Committee of the recently published research on thimerosal at low doses close to or equal to that found in vaccines or at concentrations that are likely to result from vaccine administration.
RESEARCH SUMMARY
Note: the mercury dose from vaccines produces acute ethylmercury blood levels in the nanomolar range. The half life is 5-7 days, meaning that half the injected dose of mercury leaves the blood in that time period, on average. There is considerable individual variation. Any background mercury exposures from non-vaccine sources would increase the blood mercury levels.
1. Baskin (2003) – thimerosal disrupts cell membranes, damages DNA, and alters cell shape at concentrations only 4 times those expected from vaccines. Greater effects were seen as the length of time of exposure grew, suggesting that under real conditions the concentration needed for the observed alterations would be much lower. This has been shown in subsequent research, that exposure of cells to nanomolar levels of thimerosal after 24 hours results in cell alterations.
2. Burbacher (2005): infant monkeys dosed with vaccine-level thimerosal were compared with infant monkeys dosed with equal levels of methylmercury. The thimerosal dose resulted in lower blood levels but more than twice the inorganic, or long term, mercury levels in the brain, relative to the methylmercury. The study showed the potential for significant brain accumulation from thimerosal and demonstrated that exposure/safety assessments for methylmercury may not apply to thimerosal.
3. Havarinasab & Hultman (2005): thimerosal given to mice alters immune function more than equal doses of methylmercury.
4. Hornig (2005): dosing of autoimmune-prone infant mice with thimerosal-containing vaccines, at the dose given to humans adjusted for mouse weight, resulted in a number of observable effects including growth delay, reduced movement, exaggerated responses, and brain alterations such as increased neuron density and changes in receptors and transporters.
5. Humphrey & Kiningham (2005): after only short (2 hour) exposures, thimerosal at micromolar concentrations caused neuronal membrane damage and alterations leading to cell death.
6. James (2005): the viability of neuronal cell lines was decreased after just 3 hour exposure to 2.5 micromolar concentrations of thimerosal.
7. Makani & Yel (2002) – thimerosal at micromolar amounts causes cell death (apoptosis) in immune cells (T cells).
8. Mutkus & Aschner (2005) – thimerosal alters glutamate transporter function at low micromolar concentrations. Glutamate is a neurotransmitter and is necessary for proper brain functioning.
9. Parran (2005)- thimerosal causes DNA fragmentation of neuronal cells and disrupts neuronal growth factor signaling at micromolar and even nanomolar concentrations.
10. Ueha-Ishibashi (2004: thimerosal at low concentrations is as toxic to rat neurons as methylmercury. The FDA and EPA use methylmercury as their toxicity standard, so demonstration of equivalence shows the potential of thimerosal to cause the same harm as methylmercury, for which more research exists.
11. Waly & Deth (2004): thimerosal inhibits critical DNA methylation and attentional pathways at nanomolar concentrations, leading to alterations in brain function.
12. Westphal (2003) – thimerosal at nanomolar concentrations causes DNA damage in immune cells (lymphocytes) leading to cell death.
REFERENCES
1. Baskin DS, Ngo H, Didenko VV.Thimerosal induces DNA breaks, caspase-3 activation, membrane damage, and cell death in cultured human neurons and fibroblasts. Toxicological Sciences. 2003 Aug;74(2):361-8. Epub 2003 May 28.
2. Burbacher TM, Shen DD, Liberato N, Grant KS, Cernichiari E, Clarkson T.Comparison of blood and brain mercury levels in infant monkeys exposed to methylmercury or vaccines containing thimerosal. Environmental Health Perspectives. 2005 Aug;113(8):1015-21.
3. Havarinasab S, Hultman P. Organic mercury compounds and autoimmunity. Autoimmune Rev. 2005 Jun;4(5):270-5. Epub 2005 Jan 5.
4. Hornig M, Chian D, Lipkin WI. Neurotoxic effects of postnatal thimerosal are mouse strain dependent. Molecular Psychiatry. 2004 Sep;9(9):833-45.
5. Humphrey ML, Cole MP, Pendergrass JC, Kiningham KK. Mitochondrial mediated thimerosal-induced apoptosis in a human neuroblastoma cell line (SK-N-SH). Neurotoxicology. 2005 Jun;26(3):407-16.
6. James SJ, Slikker W 3rd, Melnyk S, New E, Pogribna M, Jernigan S. Thimerosal neurotoxicity is associated with glutathione depletion: protection with glutathione precursors. Neurotoxicology. 2005 Jan;26(1):1-8.
7. Makani S, Gollapudi S, Yel L, Chiplunkar S, Gupta S. Biochemical and molecular basis of thimerosal-induced apoptosis in T cells: a major role of mitochondrial pathway.
Genes & Immunity. 2002 Aug;3(5):270-8.
8. Mutkus L, Aschner JL, Syversen T, Shanker G, Sonnewald U, Aschner M. In vitro uptake of glutamate in GLAST- and GLT-1-transfected mutant CHO-K1 cells is inhibited by the ethylmercury-containing preservative thimerosal. Biological Trace Element Research. 2005 Summer;105(1-3):71-86.
9. Parran DK, Barker A, Ehrich M. Effects of thimerosal on NGF signal transduction and cell death in neuroblastoma cells. Toxicological Sciences. 2005 Jul;86(1):132-40. Epub 2005 Apr 20.
10. Ueha-Ishibashi T, Oyama Y, Nakao H, Umebayashi C, Nishizaki Y, Tatsuishi T, Iwase K, Murao K, Seo H. Effect of thimerosal, a preservative in vaccines, on intracellular Ca2+ concentration of rat cerebellar neurons. Toxicology. 2004 Jan 15;195(1):77-84.
11. Waly M, Olteanu H, Banerjee R, Choi SW, Mason JB, Parker BS, Sukumar S, Shim S, Sharma A, Benzecry JM, Power-Charnitsky VA, Deth RC. Activation of methionine synthase by insulin-like growth factor-1 and dopamine: a target for neurodevelopmental toxins and thimerosal. Molecular Psychiatry. 2004 Apr;9(4):358-70.
12. Westphal GA, Asgari S, Schulz TG, Bünger J, Müller M, Hallier E. Thimerosal induces micronuclei in the cytochalasin B block micronucleus test with human lymphocytes. Archives of Toxicology. 2003 Jan; 77(1):50 – 55.
RESEARCH ABSTRACTS
Baskin DS, Ngo H, Didenko VV.Thimerosal induces DNA breaks, caspase-3 activation, membrane damage, and cell death in cultured human neurons and fibroblasts. Toxicological Sciences. 2003 Aug;74(2):361-8. Epub 2003 May 28.
Thimerosal is an organic mercurial compound used as a preservative in biomedical preparations. Little is known about the reactions of human neuronal and skin cells to its micro- and nanomolar concentrations, which can occur after using thimerosal-containing products. A useful combination of fluorescent techniques for the assessment of thimerosal toxicity is introduced. Short-term thimerosal toxicity was investigated in cultured human cerebral cortical neurons and in normal human fibroblasts. Cells were incubated with 125-nM to 250-microM concentrations of thimerosal for 45 min to 24 h. A 4', 6-diamidino-2-phenylindole dihydrochloride (DAPI) dye exclusion test was used to identify nonviable cells and terminal transferase-based nick-end labeling (TUNEL) to label DNA damage. Detection of active caspase-3 was performed in live cell cultures using a cell-permeable fluorescent caspase inhibitor. The morphology of fluorescently labeled nuclei was analyzed. After 6 h of incubation, the thimerosal toxicity was observed at 2 microM based on the manual detection of the fluorescent attached cells and at a 1-microM level with the more sensitive GENios Plus Multi-Detection Microplate Reader with Enhanced Fluorescence. The lower limit did not change after 24 h of incubation. Cortical neurons demonstrated higher sensitivity to thimerosal compared to fibroblasts. The first sign of toxicity was an increase in membrane permeability to DAPI after 2 h of incubation with 250 microM thimerosal. A 6-h incubation resulted in failure to exclude DAPI, generation of DNA breaks, caspase-3 activation, and development of morphological signs of apoptosis. We demonstrate that thimerosal in micromolar concentrations rapidly induce membrane and DNA damage and initiate caspase-3-dependent apoptosis in human neurons and fibroblasts. We conclude that a proposed combination of fluorescent techniques can be useful in analyzing the toxicity of thimerosal.
Burbacher TM, Shen DD, Liberato N, Grant KS, Cernichiari E, Clarkson T.Comparison of blood and brain mercury levels in infant monkeys exposed to methylmercury or vaccines containing thimerosal. Environmental Health Perspectives. 2005 Aug;113(8):1015-21.
Thimerosal is a preservative that has been used in manufacturing vaccines since the 1930s. Reports have indicated that infants can receive ethylmercury (in the form of thimerosal) at or above the U.S. Environmental Protection Agency guidelines for methylmercury exposure, depending on the exact vaccinations, schedule, and size of the infant. In this study we compared the systemic disposition and brain distribution of total and inorganic mercury in infant monkeys after thimerosal exposure with those exposed to MeHg. Monkeys were exposed to MeHg (via oral gavage) or vaccines containing thimerosal (via intramuscular injection) at birth and 1, 2, and 3 weeks of age. Total blood Hg levels were determined 2, 4, and 7 days after each exposure. Total and inorganic brain Hg levels were assessed 2, 4, 7, or 28 days after the last exposure. The initial and terminal half-life of Hg in blood after thimerosal exposure was 2.1 and 8.6 days, respectively, which are significantly shorter than the elimination half-life of Hg after MeHg exposure at 21.5 days. Brain concentrations of total Hg were significantly lower by approximately 3-fold for the thimerosal-exposed monkeys when compared with the MeHg infants, whereas the average brain-to-blood concentration ratio was slightly higher for the thimerosal-exposed monkeys (3.5 +/- 0.5 vs. 2.5 +/- 0.3). A higher percentage of the total Hg in the brain was in the form of inorganic Hg for the thimerosal-exposed monkeys (34% vs. 7%). The results indicate that MeHg is not a suitable reference for risk assessment from exposure to thimerosal-derived Hg. Knowledge of the toxicokinetics and developmental toxicity of thimerosal is needed to afford a meaningful assessment of the developmental effects of thimerosal-containing vaccines.
Havarinasab S, Hultman P. Organic mercury compounds and autoimmunity. Autoimmun Rev. 2005 Jun;4(5):270-5. Epub 2005 Jan 5.
Based on in vitro studies and short-term in vivo studies, all mercurials were for a long time considered as prototypic immunosuppressive substances. Recent studies have confirmed that organic mercurials such as methyl mercury (MeHg) and ethyl mercury (EtHg) are much more potent immunosuppressors than inorganic mercury (Hg). However, Hg interacts with the immune system in the presence of a susceptible genotype to cause immunostimulation, antinucleolar antibodies targeting fibrillarin, and systemic immune-complex (IC) deposits, a syndrome called Hg-induced autoimmunity (HgIA). Recent studies in mice with a susceptible genotype has revealed that the immunosuppressive effect of MeHg and EtHg will within 1-3 weeks be superseded by immunostimulation causing an HgIA-like syndrome. At equimolar doses of Hg, MeHg has the weakest immunostimulating, autoimmunogen, and IC-inducing effect, while the effect of thimerosal is similar to that of inorganic mercury. The immunosuppression is caused by the organic mercurials per se. Since they undergo rapid transformation to inorganic Hg, studies are being undertaken to delineate the importance of the organic substances per se and the newly formed inorganic Hg for induction of autoimmunity.
Hornig M, Chian D, Lipkin WI. Neurotoxic effects of postnatal thimerosal are mouse strain dependent. Molecular Psychiatry. 2004 Sep;9(9):833-45.
The developing brain is uniquely susceptible to the neurotoxic hazard posed by mercurials. Host differences in maturation, metabolism, nutrition, sex, and autoimmunity influence outcomes. How population-based variability affects the safety of the ethylmercury-containing vaccine preservative, thimerosal, is unknown. Reported increases in the prevalence of autism, a highly heritable neuropsychiatric condition, are intensifying public focus on environmental exposures such as thimerosal. Immune profiles and family history in autism are frequently consistent with autoimmunity. We hypothesized that autoimmune propensity influences outcomes in mice following thimerosal challenges that mimic routine childhood immunizations. Autoimmune disease-sensitive SJL/J mice showed growth delay; reduced locomotion; exaggerated response to novelty; and densely packed, hyperchromic hippocampal neurons with altered glutamate receptors and transporters. Strains resistant to autoimmunity, C57BL/6J and BALB/cJ, were not susceptible. These findings implicate genetic influences and provide a model for investigating thimerosal-related neurotoxicity.
Humphrey ML, Cole MP, Pendergrass JC, Kiningham KK. Mitochondrial mediated thimerosal-induced apoptosis in a human neuroblastoma cell line (SK-N-SH). Neurotoxicology. 2005 Jun;26(3):407-16.
Environmental exposure to mercurials continues to be a public health issue due to their deleterious effects on immune, renal and neurological function. Recently the safety of thimerosal, an ethyl mercury-containing preservative used in vaccines, has been questioned due to exposure of infants during immunization. Mercurials have been reported to cause apoptosis in cultured neurons; however, the signaling pathways resulting in cell death have not been well characterized. Therefore, the objective of this study was to identify the mode of cell death in an in vitro model of thimerosal-induced neurotoxicity, and more specifically, to elucidate signaling pathways which might serve as pharmacological targets. Within 2 h of thimerosal exposure (5 microM) to the human neuroblastoma cell line, SK-N-SH, morphological changes, including membrane alterations and cell shrinkage, were observed. Cell viability, assessed by measurement of lactate dehydrogenase (LDH) activity in the medium, as well as the 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) assay, showed a time- and concentration-dependent decrease in cell survival upon thimerosal exposure. In cells treated for 24 h with thimerosal, fluorescence microscopy indicated cells undergoing both apoptosis and oncosis/necrosis. To identify the apoptotic pathway associated with thimerosal-mediated cell death, we first evaluated the mitochondrial cascade, as both inorganic and organic mercurials have been reported to accumulate in the organelle. Cytochrome c was shown to leak from the mitochondria, followed by caspase 9 cleavage within 8 h of treatment. In addition, poly(ADP-ribose) polymerase (PARP) was cleaved to form a 85 kDa fragment following maximal caspase 3 activation at 24 h. Taken together these findings suggest deleterious effects on the cytoarchitecture by thimerosal and initiation of mitochondrial-mediated apoptosis.
James SJ, Slikker W 3rd, Melnyk S, New E, Pogribna M, Jernigan S. Thimerosal neurotoxicity is associated with glutathione depletion: protection with glutathione precursors. Neurotoxicology. 2005 Jan;26(1):1-8.
Thimerosol is an antiseptic containing 49.5% ethyl mercury that has been used for years as a preservative in many infant vaccines and in flu vaccines. Environmental methyl mercury has been shown to be highly neurotoxic, especially to the developing brain. Because mercury has a high affinity for thiol (sulfhydryl (-SH)) groups, the thiol-containing antioxidant, glutathione (GSH), provides the major intracellular defense against mercury-induced neurotoxicity. Cultured neuroblastoma cells were found to have lower levels of GSH and increased sensitivity to thimerosol toxicity compared to glioblastoma cells that have higher basal levels of intracellular GSH. Thimerosal-induced cytotoxicity was associated with depletion of intracellular GSH in both cell lines. Pretreatment with 100 microM glutathione ethyl ester or N-acetylcysteine (NAC), but not methionine, resulted in a significant increase in intracellular GSH in both cell types. Further, pretreatment of the cells with glutathione ethyl ester or NAC prevented cytotoxicity with exposure to 15 microM Thimerosal. Although Thimerosal has been recently removed from most children's vaccines, it is still present in flu vaccines given to pregnant women, the elderly, and to children in developing countries. The potential protective effect of GSH or NAC against mercury toxicity warrants further research as possible adjunct therapy to individuals still receiving Thimerosal-containing vaccinations.
Makani S, Gollapudi S, Yel L, Chiplunkar S, Gupta S. Biochemical and molecular basis of thimerosal-induced apoptosis in T cells: a major role of mitochondrial pathway. Genes Immun. 2002 Aug;3(5):270-8.
The major source of thimerosal (ethyl mercury thiosalicylate) exposure is childhood vaccines. It is believed that the children are exposed to significant accumulative dosage of thimerosal during the first 2 years of life via immunization. Because of health-related concerns for exposure to mercury, we examined the effects of thimerosal on the biochemical and molecular steps of mitochondrial pathway of apoptosis in Jurkat T cells. Thimerosal and not thiosalcylic acid (non-mercury component of thimerosal), in a concentration-dependent manner, induced apoptosis in T cells as determined by TUNEL and propidium iodide assays, suggesting a role of mercury in T cell apoptosis. Apoptosis was associated with depolarization of mitochondrial membrane, release of cytochrome c and apoptosis inducing factor (AIF) from the mitochondria, and activation of caspase-9 and caspase-3, but not of caspase-8. In addition, thimerosal in a concentration-dependent manner inhibited the expression of XIAP, cIAP-1 but did not influence cIAP-2 expression. Furthermore, thimerosal enhanced intracellular reactive oxygen species and reduced intracellular glutathione (GSH). Finally, exogenous glutathione protected T cells from thimerosal-induced apoptosis by upregulation of XIAP and cIAP1 and by inhibiting activation of both caspase-9 and caspase-3. These data suggest that thimerosal induces apoptosis in T cells via mitochondrial pathway by inducing oxidative stress and depletion of GSH.
Mutkus L, Aschner JL, Syversen T, Shanker G, Sonnewald U, Aschner M. In vitro uptake of glutamate in GLAST- and GLT-1-transfected mutant CHO-K1 cells is inhibited by the ethylmercury-containing preservative thimerosal. Biological Trace Element Research. 2005 Summer;105(1-3):71-86.
Thimerosal, also known as thimersal, Merthrolate, or sodiumethyl-mercurithiosalicylate, is an organic mercurial compound that is used in a variety of commercial as well as biomedical applications. As a preservative, it is used in a number of vaccines and pharmaceutical products. Its active ingredient is ethylmercury. Both inorganic and organic mercurials are known to interfere with glutamate homeostasis. Brain glutamate is removed mainly by astrocytes from the extracellular fluid via high-affinity astroglial Na+-dependent excitatory amino acid transporters, glutamate/ aspartate transporter (GLAST) and glutamate transporter-1 (GLT-1). The effects of thimerosal on glutamate homeostasis have yet to be determined. As a first step in this process, we examined the effects of thimerosal on the transport of [3H]-d-aspartate, a nonmetabolizable glutamate analog, in Chinese hamster ovary (CHO) cells transfected with two glutamate transporter subtypes, GLAST (EAAT1) and GLT-1 (EAAT2). Additionally, studies were undertaken to determine the effects of thimerosal on mRNA and protein levels of these transporters. The results indicate that thimerosal treatment caused significant but selective changes in both glutamate transporter mRNA and protein expression in CHO cells. Thimerosal-mediated inhibition of glutamate transport in the CHO-K1 cell line DdB7 was more pronounced in the GLT-1-transfected cells compared with the GLAST- transfected cells. These studies suggest that thimerosal accumulation in the central nervous system might contribute to dysregulation of glutamate homeostasis.
Parran DK, Barker A, Ehrich M. Effects of thimerosal on NGF signal transduction and cell death in neuroblastoma cells. Toxicological Sciences. 2005 Jul;86(1):132-40. Epub 2005 Apr 20.
Signaling through neurotrophic receptors is necessary for differentiation and survival of the developing nervous system. The present study examined the effects of the organic mercury compound thimerosal on nerve growth factor signal transduction and cell death in a human neuroblastoma cell line (SH-SY5Y cells). Following exposure to 100 ng/ml NGF and increasing concentrations of thimerosal (1 nM-10 microM), we measured the activation of TrkA, MAPK, and PKC-delta. In controls, the activation of TrkA MAPK and PKC-delta peaked after 5 min of exposure to NGF and then decreased but was still detectable at 60 min. Concurrent exposure to increasing concentrations of thimerosal and NGF for 5 min resulted in a concentration-dependent decrease in TrkA and MAPK phosphorylation, which was evident at 50 nM for TrkA and 100 nM for MAPK. Cell viability was assessed by the LDH assay. Following 24-h exposure to increasing concentrations of thimerosal, the EC50 for cell death in the presence or absence of NGF was 596 nM and 38.7 nM, respectively. Following 48-h exposure to increasing concentrations of thimerosal, the EC50 for cell death in the presence and absence of NGF was 105 nM and 4.35 nM, respectively. This suggests that NGF provides protection against thimerosal cytotoxicity. To determine if apoptotic versus necrotic cell death was occurring, oligonucleosomal fragmented DNA was quantified by ELISA. Control levels of fragmented DNA were similar in both the presence and absence of NGF. With and without NGF, thimerosal caused elevated levels of fragmented DNA appearing at 0.01 microM (apoptosis) to decrease at concentrations >1 microM (necrosis). These data demonstrate that thimerosal could alter NGF-induced signaling in neurotrophin-treated cells at concentrations lower than those responsible for cell death.
Ueha-Ishibashi T, Oyama Y, Nakao H, Umebayashi C, Nishizaki Y, Tatsuishi T, Iwase K, Murao K, Seo H. Effect of thimerosal, a preservative in vaccines, on intracellular Ca2+ concentration of rat cerebellar neurons. Toxicology. 2004 Jan 15;195(1):77-84.
The effect of thimerosal, an organomercurial preservative in vaccines, on cerebellar neurons dissociated from 2-week-old rats was compared with those of methylmercury using a flow cytometer with appropriate fluorescent dyes. Thimerosal and methylmercury at concentrations ranging from 0.3 to 10 microM increased the intracellular concentration of Ca2+ ([Ca2+]i) in a concentration-dependent manner. The potency of 10 microM thimerosal to increase the [Ca2+]i was less than that of 10 microM methylmercury. Their effects on the [Ca2+]i were greatly attenuated, but not completely suppressed, under external Ca(2+)-free condition, suggesting a possibility that both agents increase membrane Ca2+ permeability and release Ca2+ from intracellular calcium stores. The effect of 10 microM thimerosal was not affected by simultaneous application of 30 microM L-cysteine whereas that of 10 microM methylmercury was significantly suppressed. The potency of thimerosal was similar to that of methylmercury in the presence of L-cysteine. Both agents at 1 microM or more similarly decreased the cellular content of glutathione in a concentration-dependent manner, suggesting an increase in oxidative stress. Results indicate that thimerosal exerts some cytotoxic actions on cerebellar granule neurons dissociated from 2-week-old rats and its potency is almost similar to that of methylmercury.
Waly M, Olteanu H, Banerjee R, Choi SW, Mason JB, Parker BS, Sukumar S, Shim S, Sharma A, Benzecry JM, Power-Charnitsky VA, Deth RC. Activation of methionine synthase by insulin-like growth factor-1 and dopamine: a target for neurodevelopmental toxins and thimerosal. Molecular Psychiatry. 2004 Apr;9(4):358-70.
Methylation events play a critical role in the ability of growth factors to promote normal development. Neurodevelopmental toxins, such as ethanol and heavy metals, interrupt growth factor signaling, raising the possibility that they might exert adverse effects on methylation. We found that insulin-like growth factor-1 (IGF-1)- and dopamine-stimulated methionine synthase (MS) activity and folate-dependent methylation of phospholipids in SH-SY5Y human neuroblastoma cells, via a PI3-kinase- and MAP-kinase-dependent mechanism. The stimulation of this pathway increased DNA methylation, while its inhibition increased methylation-sensitive gene expression. Ethanol potently interfered with IGF-1 activation of MS and blocked its effect on DNA methylation, whereas it did not inhibit the effects of dopamine. Metal ions potently affected IGF-1 and dopamine-stimulated MS activity, as well as folate-dependent phospholipid methylation: Cu(2+) promoted enzyme activity and methylation, while Cu(+), Pb(2+), Hg(2+) and Al(3+) were inhibitory. The ethylmercury-containing preservative thimerosal inhibited both IGF-1- and dopamine-stimulated methylation with an IC(50) of 1 nM and eliminated MS activity. Our findings outline a novel growth factor signaling pathway that regulates MS activity and thereby modulates methylation reactions, including DNA methylation. The potent inhibition of this pathway by ethanol, lead, mercury, aluminum and thimerosal suggests that it may be an important target of neurodevelopmental toxins.
Götz A. Westphal, Soha Asgari, Thomas G. Schulz, Jürgen Bünger, Michael Müller, Ernst Hallier Thimerosal induces micronuclei in the cytochalasin B block micronucleus test with human lymphocytes. Archives of Toxicology. 2003 Jan; 77(1):50 – 55.
Thimerosal is a widely used preservative in health care products, especially in vaccines. Due to possible adverse health effects, investigations on its metabolism and toxicity are urgently needed. An in vivo study on chronic toxicity of thimerosal in rats was inconclusive and reports on genotoxic effects in various in vitro systems were contradictory. Therefore, we reinvestigated thimerosal in the cytochalasin B block micronucleus test. Glutathione S-transferases were proposed to be involved in the detoxification of thimerosal or its decomposition products. Since the outcome of genotoxicity studies can be dependent on the metabolic competence of the cells used, we were additionally interested whether polymorphisms of glutathione S-transferases (GSTM1, GSTT1, or GSTP1) may influence the results of the micronucleus test with primary human lymphocytes. Blood samples of six healthy donors of different glutathione S-transferase genotypes were included in the study. At least two independent experiments were performed for each blood donor. Significant induction of micronuclei was seen at concentrations between 0.05-0.5 µg/ml in 14 out of 16 experiments. Thus, genotoxic effects were seen even at concentrations which can occur at the injection site. Toxicity and toxicity-related elevation of micronuclei was seen at and above 0.6 µg/ml thimerosal. Marked individual and intraindividual variations in the in vitro response to thimerosal among the different blood donors occurred. However, there was no association observed with any of the glutathione S-transferase polymorphism investigated. In conclusion, thimerosal is genotoxic in the cytochalasin B block micronucleus test with human lymphocytes. These data raise some concern on the widespread use of thimerosal.
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