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
April 5, 2006
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:
>
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:
>
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.
Conflict of Interest in Autism Rate Study from NAA
News Release
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Contacts:
Wendy Fournier (Portsmouth, RI) 401.632.7523
Rita Shreffler (Nixa, MO) 417.818.9030
National Autism Association Points Out Possible Conflicts of Interest in New Study Denying Epidemic Rise in Autism Rates
New research relying on evolving diagnostic criteria to explain huge autism numbers fails to mention author’s potential conflicts
Nixa, MO - A study published today in Pediatrics, “The Contribution of Diagnostic Substitution to the Growing Administrative Prevalence of Autism in US Special Education,” suggests that autism diagnoses haven’t actually risen over the past two decades, despite growing and credible scientific evidence to the contrary. In addition to the study’s weak methods and erroneous conclusions, questions have now arisen over possible failure to disclose conflicts of interest and recent findings that data from previous autism projects with which current study author Paul Shattuck has been associated were fabricated.
Although he was not personally implicated, Dr. Shattuck’s former research partner, a graduate student at the University of Wisconsin’s Waisman Center, was recently disciplined by the Health and Human Services Office of Research Integrity for scientific misconduct due to fabrication of data. Dr. Shattuck and others published several articles and delivered scientific presentations using data from the project in question. “We need to know the ramifications of the falsified information,” said Ann Brasher, NAA Vice President. “The autism community demands that the University of Wisconsin clearly identify all published documents that potentially contain false information.”
Additionally, Pediatrics failed to disclose a potential or actual conflict of interest. Although the article states that Dr. Shattuck has indicated he has no financial relationships relevant to the article, NAA has learned that he was a Merck Scholar Pre-doctoral Trainee from 1999-2003, and in 2003-2004 he successfully applied for $530,000 from the Centers for Disease Control and Prevention (CDC).
“Given the rocky history of the CDC and the autism community, failing to mention the author’s ties to this agency is a glaring omission that requires an explanation,” commented NAA board chair Claire Bothwell. “Clearly, the CDC has a vested interest in deflecting attention from the possibility that children injured by mercury-containing vaccines ended up with autism diagnoses which fueled autism rates off the charts. It can’t come as a surprise to the Pediatrics board that any autism researcher’s relationship with the CDC is certainly noteworthy and should have been disclosed to readers. It’s unclear at this time whether the failure to disclose is on the part of the researcher or the journal, but these issues must be resolved.”
For more information, go to www.nationalautism.org
For immediate release
Contacts:
Wendy Fournier (Portsmouth, RI) 401.632.7523
Rita Shreffler (Nixa, MO) 417.818.9030
National Autism Association Points Out Possible Conflicts of Interest in New Study Denying Epidemic Rise in Autism Rates
New research relying on evolving diagnostic criteria to explain huge autism numbers fails to mention author’s potential conflicts
Nixa, MO - A study published today in Pediatrics, “The Contribution of Diagnostic Substitution to the Growing Administrative Prevalence of Autism in US Special Education,” suggests that autism diagnoses haven’t actually risen over the past two decades, despite growing and credible scientific evidence to the contrary. In addition to the study’s weak methods and erroneous conclusions, questions have now arisen over possible failure to disclose conflicts of interest and recent findings that data from previous autism projects with which current study author Paul Shattuck has been associated were fabricated.
Although he was not personally implicated, Dr. Shattuck’s former research partner, a graduate student at the University of Wisconsin’s Waisman Center, was recently disciplined by the Health and Human Services Office of Research Integrity for scientific misconduct due to fabrication of data. Dr. Shattuck and others published several articles and delivered scientific presentations using data from the project in question. “We need to know the ramifications of the falsified information,” said Ann Brasher, NAA Vice President. “The autism community demands that the University of Wisconsin clearly identify all published documents that potentially contain false information.”
Additionally, Pediatrics failed to disclose a potential or actual conflict of interest. Although the article states that Dr. Shattuck has indicated he has no financial relationships relevant to the article, NAA has learned that he was a Merck Scholar Pre-doctoral Trainee from 1999-2003, and in 2003-2004 he successfully applied for $530,000 from the Centers for Disease Control and Prevention (CDC).
“Given the rocky history of the CDC and the autism community, failing to mention the author’s ties to this agency is a glaring omission that requires an explanation,” commented NAA board chair Claire Bothwell. “Clearly, the CDC has a vested interest in deflecting attention from the possibility that children injured by mercury-containing vaccines ended up with autism diagnoses which fueled autism rates off the charts. It can’t come as a surprise to the Pediatrics board that any autism researcher’s relationship with the CDC is certainly noteworthy and should have been disclosed to readers. It’s unclear at this time whether the failure to disclose is on the part of the researcher or the journal, but these issues must be resolved.”
For more information, go to www.nationalautism.org
Coming up on Autism One Radio
From the Schafer Report:
Autism One Radio Schedule Apr 1-Apr 9 Three Debuts! Five Specials! Rally!
A Worldwide, Internet-Based Radio Station for the Care, Treatment, and
Recovery of All Children with Autism
http://www.autismone.org/radio
Sat, Apr 1:
Debut!
12pm-12:30 ET Andrea Unruh Sovern, DD: Ensuring Your Child’s
Future-The Ways and Means of Working towards Independence for Children with
Autism. Andrea and guests discuss the ways of obtaining appropriate services
and supports without going bankrupt, so that their children will be able to
live independently in society. Today: introducing Andrea Unruh Sovern and
her efforts with her son. Diagnosed with severe autism at 2 yrs 9 mo, Kolin
lost the medical diagnosis of autism completely at age 7. Andrea discusses
how she navigated the systems Tricare, Insurance, Medicaid and Special
Education in financing the multifaceted approach she used to ensure Kolin
could achieve independence, while maintaining financial solvency.
Sun, Apr 2:
11am–11:30 Jack & Rebecca Sytsema: Children of Destiny: Spiritual
Strength and Hope for Families Struggling with Autism. Topic: Living in the
Joy of the Lord. A look at ways to help us maintain a joyful, abundant life.
Mon, Apr 3:
Special: Combating Autism Act
10:30am-11:30 Elizabeth Emken, board member and legislative consultant
of Cure Autism Now discusses the Combating Autism Act with Teri Small. Why
is the CAA needed? How will it help children with autism?
12pm-12:30 Phillip C. DeMio, MD: First Monday of the Month at Noon:
Biomedical Treatments for the Spectrum. Topic: Gastrointestinal Treatments
Special: Early Downward Trends
1:30pm-2:30 Dr. Mark Geier and David Geier discuss their new study
entitled Early Downward Trends in Neurodevelopmental Disorders Following
Removal of Thimerosal-Containing Vaccines with Teri Small.
Tues, Apr 4:
Special: Double edition
10am–11:30 Teri Small: Autism: Help, Hope, and Healing. Guest Carline
Banks talks about the low-oxalate diet and about how she helped her son.
12pm-1 Guest Dr. Boyd Haley talks about the urinary porphyrin profile,
indicator of mercury exposure, as well as other substantiation of
Thimerosal’s involvement in the autism epidemic.
New Book Release/Upcoming Movie
1:30pm–2 Chantal Sicile-Kira: The Real World of Autism with Chantal.
Topic: “Daniel Isn't Talking” Guest: Author Marti Leimbach, mother of a boy
with autism. “Daniel Isn't Talking” is taken very much from her real life,
accurately cataloguing the struggle she had convincing anyone that her child
is able to learn, and that there is a great deal we can do to mitigate the
core deficits of autism and help a boy like him move toward a more promising
future. Marti's book “Dying Young” went to number 5 on the New York Times
bestseller list and was the basis of a film by the same name starring Julia
Roberts, who is also in the final stages of negotiations to star in the film
version of “Daniel Isn't Talking.”
Wed, Apr 5:
10am–10:30 Peta Cohen, MS, RD: Nutritional Approaches to Treating
Autism
11:30am–12 Seth D. Pearl, DC, CCN, CNS: Health and Wellness with Dr.
Seth Pearl
Debut!
12:30pm-1 Betty Jarusiewicz, PhD, LCADC and Bob Patterson, PT:
Consider Neurotherapy. Both experienced clinicians using Neurotherapy (also
known as EEG Biofeedback and Neurofeedback) will be inviting other
clinicians, including MDs, psychologists, and other health professionals to
discuss how they use this exciting modality in the treatment of people on
the spectrum. Today: what neurotherapy is about and how it has been used.
9pm–9:30 Judyth Reichenberg-Ullman, ND, LCSW, DHANP and Robert Ullman,
ND, DHANP: A Drug-Free Approach to Asperger Syndrome and Autism. Topic:
Treating the Whole Family of the ASD Child with Homeopathy
Thurs, Apr 6:
Special: Live: Mercury Generation March and Rally
9am-11 Live coverage from Washington, DC at the Mercury Generation
March, Rally and press conference. Host Teri Small.
12:30pm–1:30 Rhonda Brunett: Unlocking the Door to Autism. Topic: What
it’s like to be on the inside looking out – meet guest Marty Murphy who has
autism.
3:30pm-4 Nicki Fischer: Get Real. Topic: “Working it Through.” Guest
Stephen Shore, author and adult on the autism spectrum, talks about how he
has met various challenges in life. Discussion includes how to thoughtfully
consider whether efforts put towards overcoming some challenges may be worth
putting elsewhere. Stephen Shore was viewed as "too sick" to be treated on
an outpatient basis and recommended for institutionalization. Nonverbal
until 4, with much help from parents, teachers, and others, Stephen Shore is
now completing his doctoral degree in special education with a focus on
helping people on the spectrum develop their capacities to the fullest
extent possible.
Fri, Apr 7:
12pm-12:20 Rob Sidell and Teri Small: Autism Global Week in Review
1pm–1:30 Lisa Ackerman: Coffee Talk with Lisa Ackerman
3pm-3:30 Alyson Beytien: Family to Family
9pm–9:30 Suzanne Messina: ASIA Café: Addressing Special Issues in
Autism
10pm–11 John Hicks, MD, FAAP: Integrative Medical Approach to Autism.
Guest: Dan Marko. Topic: Understanding the Mind and Body connection.
Sat, Apr 8
Debut!
12pm-12:30 Dan Coulter: Life in the Asperger Lane. Dan and guests
discuss practical tips and techniques to help people with Asperger Syndrome
and similar ASDs succeed in the world-and help others accept and appreciate
them. Dan draws on his family’s experiences raising a son with Asperger
Syndrome and on his research as a producer of educational videos about AS
and other special needs. Today: Dan and Julie Coulter discuss strategies for
helping students with Asperger Syndrome and similar conditions who are in
mainstream classrooms succeed in grades K-12.
Sun, Apr 9
11am–11:30 Jack & Rebecca Sytsema: Children of Destiny: Spiritual
Strength and Hope for Families Struggling with Autism.
Special: Part 1 of 2
8pm–8:30 Patricia S. Lemer, M.Ed., NCC, MS Bus: After the Diagnosis,
Then What? Guest Dietrich Klinghardt, MD, PhD speaks about the 5 Levels of
Healing in Part 1 and the 7 factors in autism in Part 2 (Apr 23).
9pm–9:30 Michael Lang, MFA: Pathways of Recovery
Autism One Radio Schedule Apr 1-Apr 9 Three Debuts! Five Specials! Rally!
A Worldwide, Internet-Based Radio Station for the Care, Treatment, and
Recovery of All Children with Autism
http://www.autismone.org/radio
Sat, Apr 1:
Debut!
12pm-12:30 ET Andrea Unruh Sovern, DD: Ensuring Your Child’s
Future-The Ways and Means of Working towards Independence for Children with
Autism. Andrea and guests discuss the ways of obtaining appropriate services
and supports without going bankrupt, so that their children will be able to
live independently in society. Today: introducing Andrea Unruh Sovern and
her efforts with her son. Diagnosed with severe autism at 2 yrs 9 mo, Kolin
lost the medical diagnosis of autism completely at age 7. Andrea discusses
how she navigated the systems Tricare, Insurance, Medicaid and Special
Education in financing the multifaceted approach she used to ensure Kolin
could achieve independence, while maintaining financial solvency.
Sun, Apr 2:
11am–11:30 Jack & Rebecca Sytsema: Children of Destiny: Spiritual
Strength and Hope for Families Struggling with Autism. Topic: Living in the
Joy of the Lord. A look at ways to help us maintain a joyful, abundant life.
Mon, Apr 3:
Special: Combating Autism Act
10:30am-11:30 Elizabeth Emken, board member and legislative consultant
of Cure Autism Now discusses the Combating Autism Act with Teri Small. Why
is the CAA needed? How will it help children with autism?
12pm-12:30 Phillip C. DeMio, MD: First Monday of the Month at Noon:
Biomedical Treatments for the Spectrum. Topic: Gastrointestinal Treatments
Special: Early Downward Trends
1:30pm-2:30 Dr. Mark Geier and David Geier discuss their new study
entitled Early Downward Trends in Neurodevelopmental Disorders Following
Removal of Thimerosal-Containing Vaccines with Teri Small.
Tues, Apr 4:
Special: Double edition
10am–11:30 Teri Small: Autism: Help, Hope, and Healing. Guest Carline
Banks talks about the low-oxalate diet and about how she helped her son.
12pm-1 Guest Dr. Boyd Haley talks about the urinary porphyrin profile,
indicator of mercury exposure, as well as other substantiation of
Thimerosal’s involvement in the autism epidemic.
New Book Release/Upcoming Movie
1:30pm–2 Chantal Sicile-Kira: The Real World of Autism with Chantal.
Topic: “Daniel Isn't Talking” Guest: Author Marti Leimbach, mother of a boy
with autism. “Daniel Isn't Talking” is taken very much from her real life,
accurately cataloguing the struggle she had convincing anyone that her child
is able to learn, and that there is a great deal we can do to mitigate the
core deficits of autism and help a boy like him move toward a more promising
future. Marti's book “Dying Young” went to number 5 on the New York Times
bestseller list and was the basis of a film by the same name starring Julia
Roberts, who is also in the final stages of negotiations to star in the film
version of “Daniel Isn't Talking.”
Wed, Apr 5:
10am–10:30 Peta Cohen, MS, RD: Nutritional Approaches to Treating
Autism
11:30am–12 Seth D. Pearl, DC, CCN, CNS: Health and Wellness with Dr.
Seth Pearl
Debut!
12:30pm-1 Betty Jarusiewicz, PhD, LCADC and Bob Patterson, PT:
Consider Neurotherapy. Both experienced clinicians using Neurotherapy (also
known as EEG Biofeedback and Neurofeedback) will be inviting other
clinicians, including MDs, psychologists, and other health professionals to
discuss how they use this exciting modality in the treatment of people on
the spectrum. Today: what neurotherapy is about and how it has been used.
9pm–9:30 Judyth Reichenberg-Ullman, ND, LCSW, DHANP and Robert Ullman,
ND, DHANP: A Drug-Free Approach to Asperger Syndrome and Autism. Topic:
Treating the Whole Family of the ASD Child with Homeopathy
Thurs, Apr 6:
Special: Live: Mercury Generation March and Rally
9am-11 Live coverage from Washington, DC at the Mercury Generation
March, Rally and press conference. Host Teri Small.
12:30pm–1:30 Rhonda Brunett: Unlocking the Door to Autism. Topic: What
it’s like to be on the inside looking out – meet guest Marty Murphy who has
autism.
3:30pm-4 Nicki Fischer: Get Real. Topic: “Working it Through.” Guest
Stephen Shore, author and adult on the autism spectrum, talks about how he
has met various challenges in life. Discussion includes how to thoughtfully
consider whether efforts put towards overcoming some challenges may be worth
putting elsewhere. Stephen Shore was viewed as "too sick" to be treated on
an outpatient basis and recommended for institutionalization. Nonverbal
until 4, with much help from parents, teachers, and others, Stephen Shore is
now completing his doctoral degree in special education with a focus on
helping people on the spectrum develop their capacities to the fullest
extent possible.
Fri, Apr 7:
12pm-12:20 Rob Sidell and Teri Small: Autism Global Week in Review
1pm–1:30 Lisa Ackerman: Coffee Talk with Lisa Ackerman
3pm-3:30 Alyson Beytien: Family to Family
9pm–9:30 Suzanne Messina: ASIA Café: Addressing Special Issues in
Autism
10pm–11 John Hicks, MD, FAAP: Integrative Medical Approach to Autism.
Guest: Dan Marko. Topic: Understanding the Mind and Body connection.
Sat, Apr 8
Debut!
12pm-12:30 Dan Coulter: Life in the Asperger Lane. Dan and guests
discuss practical tips and techniques to help people with Asperger Syndrome
and similar ASDs succeed in the world-and help others accept and appreciate
them. Dan draws on his family’s experiences raising a son with Asperger
Syndrome and on his research as a producer of educational videos about AS
and other special needs. Today: Dan and Julie Coulter discuss strategies for
helping students with Asperger Syndrome and similar conditions who are in
mainstream classrooms succeed in grades K-12.
Sun, Apr 9
11am–11:30 Jack & Rebecca Sytsema: Children of Destiny: Spiritual
Strength and Hope for Families Struggling with Autism.
Special: Part 1 of 2
8pm–8:30 Patricia S. Lemer, M.Ed., NCC, MS Bus: After the Diagnosis,
Then What? Guest Dietrich Klinghardt, MD, PhD speaks about the 5 Levels of
Healing in Part 1 and the 7 factors in autism in Part 2 (Apr 23).
9pm–9:30 Michael Lang, MFA: Pathways of Recovery
The Age of Autism: Hot potato on the Hill
The Age of Autism: Hot potato on the Hill
By DAN OLMSTED
The newly proposed legislation to study the autism rate in never-vaccinated American kids could settle the debate over vaccines and autism once and for all. Does that mean it will never happen?
This week U.S. Rep. Carolyn Maloney, D-N.Y., stepped out front on the issue. She announced at a briefing at the National Press Club that she is drafting legislation to mandate that the federal government find the answer to that question.
Notice the word "mandate" -- as in "direct," which is the language the bill uses. As in, quit making excuses and just do it.
Bureaucrats and lobbyists and "experts" sometimes forget that the power in this country resides with the people, who express their will through their elected representatives. This may sound rather grand, but the point is that legislators are not some "special interest" who must be humored while the permanent ruling class goes on its merry way.
That's why putting a bill before the Congress -- which Maloney says she will do by the end of April after getting as much public comment as possible -- could be a bigger threat than people realize.
After all, as Maloney said this week, "Maybe someone in the medical establishment will show me why this study is a bad idea, but they haven't done it yet."
Maloney, who credits this column with the idea to look at the never-vaccinated, also critiqued the studies that supposedly have ruled out any link between vaccines -- particularly the mercury-based preservative thimerosal -- and autism.
"The one major government study to date, the Institute of Medicine's 2004 review, has been met with skepticism from a lot of people," she said. "There are serious questions about the data set and methodology.
"Meanwhile, there is new biological evidence published in top journals, and from major U.S. universities, to support the mercury-autism hypothesis. Just last week we saw the study out of UC Davis, which found that thimerosal disrupts normal biological signals within cells, causes inflammation and even cell death.
"In short," the congresswoman concluded, "I believe that there are still more questions than answers. But answers are what we desperately need."
Surely everyone's in favor of answers, aren't they? Well, no, they're not. Already, doubts are being raised about whether there are enough never-vaccinated kids to do such a study (there are); whether it's worth doing (it is); and what the results would really show (well, let's find out).
In fact, if the feds hadn't been contentedly dozing for the last decade as the autism rate inexplicably soared, we'd already have our answer.
Back in 2002 a woman named Sandy Gottstein, who does not even have an affected child, came all the way from Anchorage, Alaska, to raise this issue at a congressional hearing.
"My question is, is the National Institutes of Health ever planning on doing a study using the only proper control group, that is, never-vaccinated children?" Gottstein asked.
Dr. Steve Foote of NIH responded: "I am not aware of a proposed study to use a suitably constructed group of never-vaccinated children. ... Now CDC would be more likely perhaps to be aware of such an opportunity."
Responded Dr. Melinda Wharton of the CDC: "The difficulty with doing such a study in the United States, of course, is that a very small portion of children have never received any vaccines, and these children probably differ in other ways from vaccinated children. So performing such a study would, in fact, be quite difficult."
Another futile effort is recounted in David Kirby's book, "Evidence of Harm," which recounts parents' compelling stories that their children's regressive autism was triggered by vaccine reactions.
The book -- just out in paperback and winner of this year's prize from the prestigious Investigative Reporters and Editors -- describes how in 2004 Lyn Redwood of the advocacy group SafeMinds sent a list of proposed studies to Rep. Dave Weldon, R-Fla.
Weldon, a strong advocate of banning thimerosal, sent the list on to Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention. Redwood's proposal No. 1: "An investigation into the rates of neurodevelopmental disorders including autism in vaccinated and unvaccinated populations (e.g., Amish, Christian Scientists.)"
Last year this column set out to test that theory among the Amish, in an unvaccinated subset of homeschooled kids and in a large medical practice in Chicago with thousands of never-vaccinated children. In this admittedly unscientific and anecdotal reporting, we didn't find very many kids with autism.
That's certainly not conclusive, but we did conclude there are plenty of never-vaccinated kids in this country, and not all of them are riding around in buggies and reading by candlelight. The total number of appropriate "controls" -- reasonably typical never-vaccinated kids -- is well into the tens of thousands, at least.
Nor is the issue pro-vaccines vs. no vaccines, as some who oppose such a study are subtly suggesting. It's safety vs. complacency.
After all, the CDC switched to an inactivated polio vaccine in 2000 when it became clear that the live polio virus was causing a handful of polio cases each year. And kids today are still protected from polio -- only now with zero chance of actually contracting it from the vaccine.
Switching to a safer vaccine did not cause a collapse in public confidence in childhood immunizations -- probably quite the contrary.
Expect to hear all kinds of excuses, including that one, from the powers that be as to why such a conclusive study couldn't, shouldn't and really mustn't be done. Then ask yourself, Why?
E-mail: dolmsted@upi.com
By DAN OLMSTED
The newly proposed legislation to study the autism rate in never-vaccinated American kids could settle the debate over vaccines and autism once and for all. Does that mean it will never happen?
This week U.S. Rep. Carolyn Maloney, D-N.Y., stepped out front on the issue. She announced at a briefing at the National Press Club that she is drafting legislation to mandate that the federal government find the answer to that question.
Notice the word "mandate" -- as in "direct," which is the language the bill uses. As in, quit making excuses and just do it.
Bureaucrats and lobbyists and "experts" sometimes forget that the power in this country resides with the people, who express their will through their elected representatives. This may sound rather grand, but the point is that legislators are not some "special interest" who must be humored while the permanent ruling class goes on its merry way.
That's why putting a bill before the Congress -- which Maloney says she will do by the end of April after getting as much public comment as possible -- could be a bigger threat than people realize.
After all, as Maloney said this week, "Maybe someone in the medical establishment will show me why this study is a bad idea, but they haven't done it yet."
Maloney, who credits this column with the idea to look at the never-vaccinated, also critiqued the studies that supposedly have ruled out any link between vaccines -- particularly the mercury-based preservative thimerosal -- and autism.
"The one major government study to date, the Institute of Medicine's 2004 review, has been met with skepticism from a lot of people," she said. "There are serious questions about the data set and methodology.
"Meanwhile, there is new biological evidence published in top journals, and from major U.S. universities, to support the mercury-autism hypothesis. Just last week we saw the study out of UC Davis, which found that thimerosal disrupts normal biological signals within cells, causes inflammation and even cell death.
"In short," the congresswoman concluded, "I believe that there are still more questions than answers. But answers are what we desperately need."
Surely everyone's in favor of answers, aren't they? Well, no, they're not. Already, doubts are being raised about whether there are enough never-vaccinated kids to do such a study (there are); whether it's worth doing (it is); and what the results would really show (well, let's find out).
In fact, if the feds hadn't been contentedly dozing for the last decade as the autism rate inexplicably soared, we'd already have our answer.
Back in 2002 a woman named Sandy Gottstein, who does not even have an affected child, came all the way from Anchorage, Alaska, to raise this issue at a congressional hearing.
"My question is, is the National Institutes of Health ever planning on doing a study using the only proper control group, that is, never-vaccinated children?" Gottstein asked.
Dr. Steve Foote of NIH responded: "I am not aware of a proposed study to use a suitably constructed group of never-vaccinated children. ... Now CDC would be more likely perhaps to be aware of such an opportunity."
Responded Dr. Melinda Wharton of the CDC: "The difficulty with doing such a study in the United States, of course, is that a very small portion of children have never received any vaccines, and these children probably differ in other ways from vaccinated children. So performing such a study would, in fact, be quite difficult."
Another futile effort is recounted in David Kirby's book, "Evidence of Harm," which recounts parents' compelling stories that their children's regressive autism was triggered by vaccine reactions.
The book -- just out in paperback and winner of this year's prize from the prestigious Investigative Reporters and Editors -- describes how in 2004 Lyn Redwood of the advocacy group SafeMinds sent a list of proposed studies to Rep. Dave Weldon, R-Fla.
Weldon, a strong advocate of banning thimerosal, sent the list on to Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention. Redwood's proposal No. 1: "An investigation into the rates of neurodevelopmental disorders including autism in vaccinated and unvaccinated populations (e.g., Amish, Christian Scientists.)"
Last year this column set out to test that theory among the Amish, in an unvaccinated subset of homeschooled kids and in a large medical practice in Chicago with thousands of never-vaccinated children. In this admittedly unscientific and anecdotal reporting, we didn't find very many kids with autism.
That's certainly not conclusive, but we did conclude there are plenty of never-vaccinated kids in this country, and not all of them are riding around in buggies and reading by candlelight. The total number of appropriate "controls" -- reasonably typical never-vaccinated kids -- is well into the tens of thousands, at least.
Nor is the issue pro-vaccines vs. no vaccines, as some who oppose such a study are subtly suggesting. It's safety vs. complacency.
After all, the CDC switched to an inactivated polio vaccine in 2000 when it became clear that the live polio virus was causing a handful of polio cases each year. And kids today are still protected from polio -- only now with zero chance of actually contracting it from the vaccine.
Switching to a safer vaccine did not cause a collapse in public confidence in childhood immunizations -- probably quite the contrary.
Expect to hear all kinds of excuses, including that one, from the powers that be as to why such a conclusive study couldn't, shouldn't and really mustn't be done. Then ask yourself, Why?
E-mail: dolmsted@upi.com
EOH Wins IRE Award
For Immediate Release – March 28, 2006
CONTACT: Elizabeth Coxe, St. Martin’s Press -- 646-307-5563
EVIDENCE OF HARM RECEIVES INVESTIGATIVE
REPORTERS AND EDITORS AWARD
Author David Kirby is cited for “careful and meticulous reporting” in his book on thimerosal and autism
PLEASE NOTE: DAVID KIRBY WILL APPEAR LIVE AT A MEDIA BRIEFING THIS THURSDAY, MARCH 30TH, AT THE NATIONAL PRESS CLUB IN WASHINGTON. FOR MORE INFO, CALL 718-230-4250
NEW YORK, March 28, 2006 – “Evidence of Harm – Mercury in Vaccines and the Autism Epidemic” (St. Martin’s Press – Paperback edition March, 2006) has been awarded the “Investigative Reporters and Editors 2005 Award for Outstanding Investigative Reporting in a Book,” the organization announced today.
“I am honored to be recognized by such a prestigious jury of my peers,” Kirby said. “I hope this award will inspire other investigative writers to follow their leads and their hunches, and to report on all controversial topics that warrant a closer look. Thankfully, freedom of the press survives in America.”
In their comments, award judges – comprised of some of the most experienced investigative journalists in the country – noted that, “Kirby told the story of stonewalling, denial and cover-up by federal regulators, medical groups and the pharmaceutical industry.” And, they added, “He documents covert efforts by some of those same powerful forces - along with the U.S. Congress - to grant blanket immunity for drug companies that put mercury in vaccines.”
“Like so many scientific controversies involving complex science and big business, the topic is controversial. Kirby's careful and meticulous reporting is exemplary in its balance, accuracy and documentation,” the judges said.
IRE, founded in 1975, is a nonprofit professional organization dedicated to training and supporting journalists who pursue investigative stories and operates the National Institute for Computer-Assisted Reporting, a joint program of IRE and the Missouri School of Journalism. IRE Awards will be presented during the Saturday, June 17, luncheon at the 2006 IRE Annual Conference in Fort Worth. More information on IRE and the awards can be found at http://www.ire.org/contest/05winners.html.
“Evidence of Harm” is also a finalist for the The New York Public Library Helen Bernstein Book Award for Excellence in Journalism. The winner will be announced at a special luncheon at the Library on May 10, 2006.
From the Investigative Reporters and Editors Awards web site:
CONTACT: Elizabeth Coxe, St. Martin’s Press -- 646-307-5563
EVIDENCE OF HARM RECEIVES INVESTIGATIVE
REPORTERS AND EDITORS AWARD
Author David Kirby is cited for “careful and meticulous reporting” in his book on thimerosal and autism
PLEASE NOTE: DAVID KIRBY WILL APPEAR LIVE AT A MEDIA BRIEFING THIS THURSDAY, MARCH 30TH, AT THE NATIONAL PRESS CLUB IN WASHINGTON. FOR MORE INFO, CALL 718-230-4250
NEW YORK, March 28, 2006 – “Evidence of Harm – Mercury in Vaccines and the Autism Epidemic” (St. Martin’s Press – Paperback edition March, 2006) has been awarded the “Investigative Reporters and Editors 2005 Award for Outstanding Investigative Reporting in a Book,” the organization announced today.
“I am honored to be recognized by such a prestigious jury of my peers,” Kirby said. “I hope this award will inspire other investigative writers to follow their leads and their hunches, and to report on all controversial topics that warrant a closer look. Thankfully, freedom of the press survives in America.”
In their comments, award judges – comprised of some of the most experienced investigative journalists in the country – noted that, “Kirby told the story of stonewalling, denial and cover-up by federal regulators, medical groups and the pharmaceutical industry.” And, they added, “He documents covert efforts by some of those same powerful forces - along with the U.S. Congress - to grant blanket immunity for drug companies that put mercury in vaccines.”
“Like so many scientific controversies involving complex science and big business, the topic is controversial. Kirby's careful and meticulous reporting is exemplary in its balance, accuracy and documentation,” the judges said.
IRE, founded in 1975, is a nonprofit professional organization dedicated to training and supporting journalists who pursue investigative stories and operates the National Institute for Computer-Assisted Reporting, a joint program of IRE and the Missouri School of Journalism. IRE Awards will be presented during the Saturday, June 17, luncheon at the 2006 IRE Annual Conference in Fort Worth. More information on IRE and the awards can be found at http://www.ire.org/contest/05winners.html.
“Evidence of Harm” is also a finalist for the The New York Public Library Helen Bernstein Book Award for Excellence in Journalism. The winner will be announced at a special luncheon at the Library on May 10, 2006.
From the Investigative Reporters and Editors Awards web site:
Evidence of Harm: Mercury in Vaccines and the Autism Epidemic — A Medical Controversy — David Kirby
Judges' comments: Autism, rare in the past, is exploding in the United States , where it is now found in one in 166 children. Attention-deficit disorder also has skyrocketed. And 1 in 6 children today has a learning disability. David Kirby investigated whether one of the causes of these childhood afflictions is thimerisol, a vaccine preservative that contains mercury, a well-documented neurotoxin. In the 1990s, the mercury-containing additive was injected into children far in excess of federal safety levels. Kirby told the story of stonewalling, denial and cover-up by federal regulators, medical groups and the pharmaceutical industry. And he documents covert efforts by some of those same powerful forces — along with the U.S. Congress — to grant blanket immunity for drug companies that put mercury in vaccines. Like so many scientific controversies involving complex science and big business, the topic is controversial. Kirby's careful and meticulous reporting is exemplary in its balance, accuracy and documentation.
Overview of Chelation Agents
From the Schafer Autism Report:
Chelation Agents
Some pros and cons in three of the most commonly used chelating agents in
autistic children:
DMSA Sodium 2,3 dimercaptopropane- 1 sulfate In the oral form,
approved by the FDA for treating lead poisoning in children as young as 1.
It can remove a wide range of metals, including lead and mercury. Long- term
use can potentially cause bonemarrow suppression or liver damage. It strips
zinc, a beneficial mineral, and supplements may be needed. It can cause
gastrointestinal problems to worsen.
DMPS 2,3 dimercaptosuccinic acid It causes fewer gastrointestinal
problems than other agents and may be more effective at eliminating mercury
than DMSA. It now comes in a cream form, which is easier to use. DMPS is not
FDA-approved although physicians can have it individually compounded for
patients. It has potentially serious side effects and blood and urine need
to be regularly monitored.
TTFD Thiamine tetrahydrofurfuryl disulfide In studies, it had a good
safety record. In a small study of 10 children on the autism spectrum, most
improved clinically. It comes in cream form. It is not approved by the FDA,
although physicians can have it individually compounded for patients. It has
a strong odor described as "skunklike" even in cream form, and has a bad
taste in powdered form making it difficult to give to children who cannot
swallow a capsule.
Source: Autism Research Institute's Defeat Autism Now Project
Chelation Agents
Some pros and cons in three of the most commonly used chelating agents in
autistic children:
DMSA Sodium 2,3 dimercaptopropane- 1 sulfate In the oral form,
approved by the FDA for treating lead poisoning in children as young as 1.
It can remove a wide range of metals, including lead and mercury. Long- term
use can potentially cause bonemarrow suppression or liver damage. It strips
zinc, a beneficial mineral, and supplements may be needed. It can cause
gastrointestinal problems to worsen.
DMPS 2,3 dimercaptosuccinic acid It causes fewer gastrointestinal
problems than other agents and may be more effective at eliminating mercury
than DMSA. It now comes in a cream form, which is easier to use. DMPS is not
FDA-approved although physicians can have it individually compounded for
patients. It has potentially serious side effects and blood and urine need
to be regularly monitored.
TTFD Thiamine tetrahydrofurfuryl disulfide In studies, it had a good
safety record. In a small study of 10 children on the autism spectrum, most
improved clinically. It comes in cream form. It is not approved by the FDA,
although physicians can have it individually compounded for patients. It has
a strong odor described as "skunklike" even in cream form, and has a bad
taste in powdered form making it difficult to give to children who cannot
swallow a capsule.
Source: Autism Research Institute's Defeat Autism Now Project
WSJ Looks at Chelation
WSJ Looks at Chelation
By Amy Dockser Marcus for The Wall Street Journal
One of the most frustrating struggles in children's medicine has been the long-running, and often controversial, effort to treat autism.
Now, some parents and physicians are touting an approach that could be the most controversial yet: using drugs that strip the body of metals.
The treatment, called chelation therapy, has been used for decades to detoxify people contaminated with metals through industrial accidents or environmental exposure. The drugs have potentially serious side effects -- including bone-marrow and liver problems -- because they also strip necessary minerals such as iron and zinc from the body.
But advocates of the technique say the drugs can significantly reduce autism's devastating symptoms such as lack of emotion and repetitive behaviors. Some go so far as to say that autistic children treated with chelation can return to normal health.
Chelation Agents
The practice grew out of the belief among many autism experts that heavy metals -- especially mercury-based preservatives in childhood vaccines -- are to blame for autism. An Institute of Medicine report in May 2004 found no link between autism and vaccines. But the theory got a boost last year after a toxicologist who treated his own son with a chelating medication testified before a congressional subcommittee chaired by Congressman Dan Burton of Indiana. Rashid A. Buttar told the committee that 19 of the 31 patients in his North Carolina clinic using the medication, called TD-DMPS, for more than a year had a complete loss of their autistic symptoms. The results haven't been published, though Dr. Buttar says he is working toward that.
The practice of chelation as a treatment for autism has been greeted with anger by many in the mainstream medical establishment, who decry the potential side effects and note that there are no published clinical trials demonstrating that it works. Some contend that children who seem to improve after therapy were likely misdiagnosed as autistic to begin with, or simply have a milder form of autism.
Many autistic children who have been treated with chelation were undergoing numerous other treatments as well, including in Dr. Buttar's research.
That makes it "difficult to tease out the effect of chelation," says Marie McCormick, professor of maternal and children's health at the Harvard School of Public Health. Only clinical trials are likely to resolve the debate, adds Dr. McCormick, chairwoman of the committee that wrote last year's IOM report on vaccines.
The traditional approach to treating autism has focused on intensive behavioral therapy, special education and speech training. Autism, which affects as many as one of every 166 U.S. children, according to the Centers for Disease Control and Prevention, is a developmental disorder that affects a child's communication, creative play and social interaction.
There is no way to know how many autistic children are undergoing chelation. The CDC reported last year that 60,000 Americans use some form of chelation therapy. But it isn't known how many are being treated for lead poisoning or other diagnoses. Representatives for the CDC and the federal Food and Drug Administration said they had no comment on the use of chelation therapy for autism.
Word-of-Mouth
Thus parents embarking on chelation are relying primarily on anecdotal reports through the Internet and other word-of-mouth avenues. The story of Lenny Hoover, 6 years old, from Royal Palm Beach, Fla., is one that advocates of chelation therapy often cite.
Lenny Hoover's parents say chelation helped reverse his autism. He now attends regular kindergarten.
Charles Hoover, Lenny's father, says his son was diagnosed with mild to moderate autism at the age of 2. The Hoovers first put Lenny on a wheat- and dairy-free diet, in the hope this would reduce his gastrointestinal problems, which are a common issue for autistic patients. They started him on intensive behavioral therapy. When he was 28 months, they also began chelating him after tests showed Lenny had elevated tin, nickel and arsenic in his urine. They mixed a medicine called DMSA into his juice, which he had to drink every eight hours for three days, with 11 days off. He did 38 rounds of chelation following this schedule.
"We had a heck of a time getting him to drink it," said Mr.Hoover. "It smells like sulfur and is horrendous."
But Lenny started making such rapid gains that they eventually stopped behavioral therapy. By the time Lenny was 5, the local school determined that he had no developmental delays. He started a regular kindergarten last fall. Says Mr. Hoover, "We lost our son, then we got him back."
A number of Web sites and autism support groups offer information to parents on chelation. A Yahoo chat group about chelation and other biomedical treatments for autism, Chelatingkids2, has more than 1,800 subscribers, according to co-founder Ann Brasher. The Autism Research Institute, an advocacy group in San Diego that supports the idea that vaccines are the primary source of mercury poisoning in autistic kids, says that in its most recent parent survey, 73% of the 187 parents who said they use chelation therapy reported that it was helpful. Today, the institute, which says it is funded mainly by individual contributions, is set to release a report recommending chelation as "one of the most beneficial treatments for autism and related disorders."
Question of Diagnosis
Some critics argue that patients such as Lenny Hoover may have been misdiagnosed -- that such children were actually at the high- functioning end of the spectrum of autistic disorders or were never even autistic. Mr. Hoover says that Lenny demonstrated typical autistic behavior. Lenny had lost his speech ability, slept only a few hours at night, and in home videos he is seen spinning around in a circle, over and over again.
Mr. Hoover acknowledges that it is difficult to say conclusively which of the therapies used on Lenny was helpful. He says that the diet, behavioral therapy and chelation all helped his son, but that he believes chelation was a key. At this point, Lenny eats a regular diet and hasn't done any chelation since July 2003, when his parents decided he wasn't making further gains from the therapy.
Off-Label Use
There are many medications used for chelation. Some, such as DMSA -- a chemical compound made by a variety of manufacturers including Epochem Co. in Shanghai -- are FDA-approved for other treatments including lead poisoning. Doctors who prescribe these to treat autism are using them off-label, which is allowed for already-approved medications. Others aren't FDA-approved. But pharmacists can compound them for individual use at a physician's request. The drugs can be given in several ways, as creams, pills or via shots or intravenous infusions. Regimens vary in frequency,
dosage and length of treatment.
Before starting chelation, patients undergo testing to measure their exposure to heavy metals. Doctors disagree on the best way of testing metal exposure. Options include hair, urine and blood tests. Critics say these tests can have high false-positive rates. The Autism Research Institute supports the use of a so-called provocation test, which involves giving a chelating agent followed by urine or stool collection to see whether heavy metals were excreted.
Chelation therapy isn't cheap, with medications running $100 to $200 a month. Testing also can be expensive, costing $1,000 to $2,000 to get started, and $1,200 to $2,400 a year in monitoring. Insurers don't cover chelation therapy for autism or other off-label uses.
New Studies
The metal-cleansing treatment also is gaining ground as a treatment for a range of conditions besides autism, including Alzheimer's and heart disease. A preliminary study published in Archives of Neurology in December 2003 found that removing metals accumulating in the brain of Alzheimer's disease patients using the chelating drug, clioquinol, appeared to slow the progress of the disease. Two institutes of the National Institutes of Health last year opened a clinical trial that so far has enrolled more than 500 patients to test whether chelation therapy benefits patients with heart disease.
Later this year, investigators at Arizona State University in Tempe, Ariz., will launch a clinical trial involving 80 autistic children ages 3 to 9. Half of the children will receive DMSA, the treatment approved by the FDA for lead poisoning. The other half will receive a placebo. The trial aims to demonstrate whether chelation therapy can improve the symptoms of autism.
By Amy Dockser Marcus for The Wall Street Journal
One of the most frustrating struggles in children's medicine has been the long-running, and often controversial, effort to treat autism.
Now, some parents and physicians are touting an approach that could be the most controversial yet: using drugs that strip the body of metals.
The treatment, called chelation therapy, has been used for decades to detoxify people contaminated with metals through industrial accidents or environmental exposure. The drugs have potentially serious side effects -- including bone-marrow and liver problems -- because they also strip necessary minerals such as iron and zinc from the body.
But advocates of the technique say the drugs can significantly reduce autism's devastating symptoms such as lack of emotion and repetitive behaviors. Some go so far as to say that autistic children treated with chelation can return to normal health.
Chelation Agents
The practice grew out of the belief among many autism experts that heavy metals -- especially mercury-based preservatives in childhood vaccines -- are to blame for autism. An Institute of Medicine report in May 2004 found no link between autism and vaccines. But the theory got a boost last year after a toxicologist who treated his own son with a chelating medication testified before a congressional subcommittee chaired by Congressman Dan Burton of Indiana. Rashid A. Buttar told the committee that 19 of the 31 patients in his North Carolina clinic using the medication, called TD-DMPS, for more than a year had a complete loss of their autistic symptoms. The results haven't been published, though Dr. Buttar says he is working toward that.
The practice of chelation as a treatment for autism has been greeted with anger by many in the mainstream medical establishment, who decry the potential side effects and note that there are no published clinical trials demonstrating that it works. Some contend that children who seem to improve after therapy were likely misdiagnosed as autistic to begin with, or simply have a milder form of autism.
Many autistic children who have been treated with chelation were undergoing numerous other treatments as well, including in Dr. Buttar's research.
That makes it "difficult to tease out the effect of chelation," says Marie McCormick, professor of maternal and children's health at the Harvard School of Public Health. Only clinical trials are likely to resolve the debate, adds Dr. McCormick, chairwoman of the committee that wrote last year's IOM report on vaccines.
The traditional approach to treating autism has focused on intensive behavioral therapy, special education and speech training. Autism, which affects as many as one of every 166 U.S. children, according to the Centers for Disease Control and Prevention, is a developmental disorder that affects a child's communication, creative play and social interaction.
There is no way to know how many autistic children are undergoing chelation. The CDC reported last year that 60,000 Americans use some form of chelation therapy. But it isn't known how many are being treated for lead poisoning or other diagnoses. Representatives for the CDC and the federal Food and Drug Administration said they had no comment on the use of chelation therapy for autism.
Word-of-Mouth
Thus parents embarking on chelation are relying primarily on anecdotal reports through the Internet and other word-of-mouth avenues. The story of Lenny Hoover, 6 years old, from Royal Palm Beach, Fla., is one that advocates of chelation therapy often cite.
Lenny Hoover's parents say chelation helped reverse his autism. He now attends regular kindergarten.
Charles Hoover, Lenny's father, says his son was diagnosed with mild to moderate autism at the age of 2. The Hoovers first put Lenny on a wheat- and dairy-free diet, in the hope this would reduce his gastrointestinal problems, which are a common issue for autistic patients. They started him on intensive behavioral therapy. When he was 28 months, they also began chelating him after tests showed Lenny had elevated tin, nickel and arsenic in his urine. They mixed a medicine called DMSA into his juice, which he had to drink every eight hours for three days, with 11 days off. He did 38 rounds of chelation following this schedule.
"We had a heck of a time getting him to drink it," said Mr.Hoover. "It smells like sulfur and is horrendous."
But Lenny started making such rapid gains that they eventually stopped behavioral therapy. By the time Lenny was 5, the local school determined that he had no developmental delays. He started a regular kindergarten last fall. Says Mr. Hoover, "We lost our son, then we got him back."
A number of Web sites and autism support groups offer information to parents on chelation. A Yahoo chat group about chelation and other biomedical treatments for autism, Chelatingkids2, has more than 1,800 subscribers, according to co-founder Ann Brasher. The Autism Research Institute, an advocacy group in San Diego that supports the idea that vaccines are the primary source of mercury poisoning in autistic kids, says that in its most recent parent survey, 73% of the 187 parents who said they use chelation therapy reported that it was helpful. Today, the institute, which says it is funded mainly by individual contributions, is set to release a report recommending chelation as "one of the most beneficial treatments for autism and related disorders."
Question of Diagnosis
Some critics argue that patients such as Lenny Hoover may have been misdiagnosed -- that such children were actually at the high- functioning end of the spectrum of autistic disorders or were never even autistic. Mr. Hoover says that Lenny demonstrated typical autistic behavior. Lenny had lost his speech ability, slept only a few hours at night, and in home videos he is seen spinning around in a circle, over and over again.
Mr. Hoover acknowledges that it is difficult to say conclusively which of the therapies used on Lenny was helpful. He says that the diet, behavioral therapy and chelation all helped his son, but that he believes chelation was a key. At this point, Lenny eats a regular diet and hasn't done any chelation since July 2003, when his parents decided he wasn't making further gains from the therapy.
Off-Label Use
There are many medications used for chelation. Some, such as DMSA -- a chemical compound made by a variety of manufacturers including Epochem Co. in Shanghai -- are FDA-approved for other treatments including lead poisoning. Doctors who prescribe these to treat autism are using them off-label, which is allowed for already-approved medications. Others aren't FDA-approved. But pharmacists can compound them for individual use at a physician's request. The drugs can be given in several ways, as creams, pills or via shots or intravenous infusions. Regimens vary in frequency,
dosage and length of treatment.
Before starting chelation, patients undergo testing to measure their exposure to heavy metals. Doctors disagree on the best way of testing metal exposure. Options include hair, urine and blood tests. Critics say these tests can have high false-positive rates. The Autism Research Institute supports the use of a so-called provocation test, which involves giving a chelating agent followed by urine or stool collection to see whether heavy metals were excreted.
Chelation therapy isn't cheap, with medications running $100 to $200 a month. Testing also can be expensive, costing $1,000 to $2,000 to get started, and $1,200 to $2,400 a year in monitoring. Insurers don't cover chelation therapy for autism or other off-label uses.
New Studies
The metal-cleansing treatment also is gaining ground as a treatment for a range of conditions besides autism, including Alzheimer's and heart disease. A preliminary study published in Archives of Neurology in December 2003 found that removing metals accumulating in the brain of Alzheimer's disease patients using the chelating drug, clioquinol, appeared to slow the progress of the disease. Two institutes of the National Institutes of Health last year opened a clinical trial that so far has enrolled more than 500 patients to test whether chelation therapy benefits patients with heart disease.
Later this year, investigators at Arizona State University in Tempe, Ariz., will launch a clinical trial involving 80 autistic children ages 3 to 9. Half of the children will receive DMSA, the treatment approved by the FDA for lead poisoning. The other half will receive a placebo. The trial aims to demonstrate whether chelation therapy can improve the symptoms of autism.
March 29, 2006
Back
Hello blog friends.
I am back, and here to offer an apology for my sudden and extended absence. I am finding out how hard it is to both be the parent of an autistic child and write about being the parent of an autistic child.
God willing, I will be ramping the blog back up over the next week or so. I literally have more than 6000 emails/articles to go through so it will take a while to get back up to speed. For all I know, autism could have been cured in the last three months and I will be the last one to hear about it.
I have decided to just post everything I would have posted in the last few months had I been writing, so if you run into old information here over the next week or two, that is why. I will make sure to date the articles so you know if you are re reading something you may have read already.
I have gotten lots of nice email, but have responded to none, so if you have written to me, thank you, and please forgive the non-response. I will be answering all the email that has come in. Thanks for your patience.
I am back, and here to offer an apology for my sudden and extended absence. I am finding out how hard it is to both be the parent of an autistic child and write about being the parent of an autistic child.
God willing, I will be ramping the blog back up over the next week or so. I literally have more than 6000 emails/articles to go through so it will take a while to get back up to speed. For all I know, autism could have been cured in the last three months and I will be the last one to hear about it.
I have decided to just post everything I would have posted in the last few months had I been writing, so if you run into old information here over the next week or two, that is why. I will make sure to date the articles so you know if you are re reading something you may have read already.
I have gotten lots of nice email, but have responded to none, so if you have written to me, thank you, and please forgive the non-response. I will be answering all the email that has come in. Thanks for your patience.
FAIR: Politics of Autism
From FAIR:
New Politics of Autism Video:
November, 2005: F.A.I.R. Autism Media
Interviews Attorney James Moody
FAIR Autism Media has just posted a new interview with Jim Moody, a practicing attorney and founder of Citizens for a Competitive Economy. He sits on the executive boards of both SAFEMINDS and the National Autism Association. He is very active in cause related advocacy.
In this interview, filmed Nov. 2005, Mr. Moody discusses recent political issues of concern to parents with autistic children. Some topics covered include the CDC, the FDA, the 2004 IOM (Institute of Medicine) report and some industry-friendly legislation that curtails the rights of vaccine-injured children.
New Politics of Autism Video:
November, 2005: F.A.I.R. Autism Media
Interviews Attorney James Moody
FAIR Autism Media has just posted a new interview with Jim Moody, a practicing attorney and founder of Citizens for a Competitive Economy. He sits on the executive boards of both SAFEMINDS and the National Autism Association. He is very active in cause related advocacy.
In this interview, filmed Nov. 2005, Mr. Moody discusses recent political issues of concern to parents with autistic children. Some topics covered include the CDC, the FDA, the 2004 IOM (Institute of Medicine) report and some industry-friendly legislation that curtails the rights of vaccine-injured children.
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