Press Briefing:
Thank you all for your time today. My name is JB Handley. Along with
my wife, Lisa, I am the co-founder of putchildrenfirst, the sponsor
of this survey of over 9,000 Americans on mercury in the flu shot.
Here's a quick test for all of you. We all know household paint is a
bit toxic. Would you rather A, spill some paint on your skin? Or, B,
take that same amount of paint, pop it in a syringe, and mainline it?
If you chose A, as our survey revealed, you are like most Americans.
If you chose B, you're like the FDA, who made it a high priority to
get mercury out of topical products we use on our skin in the 1990s,
but continued to allow mercury to be injected into humans at levels
exceeding any available safety standard. In fact, we don't even have
safety standards for injected mercury, because no one considered
someone would be crazy enough to inject a well-known neurotoxin into
their bloodstream. It's actually the preposterous nature of the
situation we find ourselves in today that contributes to the public's
confusion. I find that the first time I tell people mercury is in
their flu shot, they simply don't believe me.
Our health authorities realized mercury in vaccines was a mistake in
1999 and made a public statement to warn Americans and encourage
manufacturers to change their formulations. Seven years later, we're
still talking about mercury. That's part of the problem. Our survey
showed that almost no one realizes mercury is STILL in over 90% of
this year's flu shot supply. When they find out the truth, more than
three-quarters know to stay away from mercury and even more think
children and pregnant women should avoid it.
The CDC provides a number of answers for why mercury is still used in
vaccines, none of which can be supported with any facts or evidence.
They will characterize Thimerosal's toxicity as theoretical when in
fact there is nothing theoretical about mercury's dangers. They will
tell you ethyl-mercury, the kind used in Thimerosal, is less toxic.
There is no data to support this and in fact a recent biological
study disproved this completely. They will tell you that the flu can
kill which should certainly trump any danger posed by mercury. Yet,
they fail to mention their own recent admission in an October 2006
study in the Journal of the American Medical Association where four
CDC authors write: "It is also important to note that there is scant
data on the efficacy and effectiveness of influenza vaccine in young
children." And a British Medical Journal article the same month,
October 2006, noted "Evidence from systematic reviews shows that
[flu vaccines] have little or no effect on the effects measured." If
a company sold a product that didn't work and left behind a
neurotoxin they would already be bankrupt.
Anytime Thimerosal is mentioned, autism is brought up. We are not
here to talk about autism today. We are here to tell you that
Americans do not want mercury in their shots but few know it's there.
The CDC tries to make an argument that because they believe, through
their research, that Thimerosal is not responsible for the autism
epidemic, that makes Thimerosal safe. That is one high threshold for
safety. Interestingly, CDC never mentions that in the 2003 study they
authored in Pediatrics, they did find a correlation between
Thimerosal and both "tics" and "language delay." So, here's another
test for you. You bring your child in for a flu shot. The Doctor
tells you this shot has mercury, and that CDC found shots with
mercury lead to tics and language delay. What do you do?
The CDC wants you, the journalists, to report on the dire need for
all Americans to get a flu shot. In 2004, at a Vaccine Summit, the
British Medical Journal wrote the following, in criticizing what they
called the CDC's "marketing of fear"
"Glen Nowak, associate director for communications at the NIP, spoke
on using the media to boost demand for the vaccine. One step of
a "Seven-Step `Recipe' for Generating Interest in, and Demand for,
Flu Vaccination" occurs when "medical experts and public health
authorities publicly...state concern and alarm (and predict dire
outcomes) - and urge influenza vaccination"
My four year old son suffered an adverse reaction to a mercury
containing flu shot. That's why I'm here talking to you. His symptoms
included, and I quote, "brain damage, incoordination, seizures,
inability to speak and problems of his nervous and digestive system."
Those were my son's symptoms, but that quote is not from his medical
records. It's from the CDC's own website, discussing the harmful side-
effects of mercury, where they go on to warn all Americans to "keep
all mercury-containing medicines away from children."
Our survey proves that Americans understand this. Why doesn't the CDC?
Showing posts with label Mercury. Show all posts
Showing posts with label Mercury. Show all posts
November 13, 2006
From PutChildrenFirst.com
October 31, 2006
Mercury Triggers Premature Birth
Both my boys came into the world early.
Hankooki.com > The Korea Times > Nation
Mercury Triggers Premature Birth
By Kim Rahn
Staff Reporter
The more mercury pregnant women are exposed to, the greater chance they have of giving premature birth to babies, according to a study.
Research on 85 pregnant women conducted by Ha Eun-hee, a professor of Ewha Womans University's preventive medicine department, showed that women with high levels of mercury in cord blood are three to five times more likely to give premature birth, which is to deliver a child in less than 37 weeks of pregnancy.
Ha announced the study results on Friday during a meeting of the Korean Society for
Preventive Medicine.
According to the study, the 50 percent of the 85 people with the highest levels of mercury had a 3.1 times greater chance of having a premature delivery than the lower 50 percent. The upper 25 percent had a 5.3 times more of a chance than the lower 75 percent.
"Mercury in cord blood, which connects the mother and the fetus, is critical to the child, as it directly flows to the fetus," Ha said.
The study disclosed two main reasons for the mercury concentration _ dental treatment
with amalgam and fish consumption.
Pregnant women who had treatments with amalgam during the pregnancy had an average of 5.15 micrograms of mercury per 1 liter of blood, 1.3 times more than the 3.98 micrograms in women who hadn't had the treatment.
The mercury level increased in proportion to the frequency of treatment. Women undergoing the amalgam treatment fewer than three times had an average 4.8 micrograms of mercury in their blood, while those having undergone the treatment hree to six times had 5.04 micrograms, and seven times or more 5.2 micrograms.
Also, a woman who never had fish during pregnancy had 4.6 micrograms of mercury per 1 liter of blood, while the mercury level of women who consumed fish more than four times per week had an average mercury level of 8.3 micrograms.
"The nation should prepare education programs for pregnant women, advising them not to undergo dental treatments with amalgam," Ha said.
Professor Yi Seung-muk at Seoul National University's graduate school of public health said a great deal of mercury in the air above the Korean Peninsula is from China's industrial areas.
Yi's team measured mercury levels in the air and followed the path of wind to China. "We obtained Chinese institutes' data about the industrial locations emitting mercury and compared them with our data, which correlated with the Chinese data," Yi said.
It was the first South Korean research about mercury pollution from China, although international academic circles have presented studies about the issue. It is said hat half of the world's mercury pollutants in the air come from the country with the largest populace.
"Mercury is contained not only in the air, but also in fish. Korea and Japan, which are near China and consume large amounts of fish, have a greater chance of being exposed to mercury than other countries," Yi said.
The research was announced at a meeting of the Korean Society for Atmospheric
Environment on Friday. Yi will soon present the amount and ratio of pollutants carried to Korea.
rahnita@koreatimes.co.kr
__._,_.___
Hg in Flu Vaccines - Print This Helpful Guide Out And Take To The Doc
List of flu shots that contain mercury:
Autism, mercury poisoning, thimerosal and the flu vaccine
public_health@8:22 am PST email to the editor
by Michael Dorausch, DC
planetc1.com news staff
About two weeks ago, news reports began showing up online suggesting that the flu vaccine was found safe to be used in children under the age of two.
The study looked at immunization records for more than 45,000 children and researchers determined that the intramuscular flu vaccine was safe to be used in children under the age of two.
According to the Centers for Disease Control and Prevention (CDC), "the single best way to protect against the flu is to get vaccinated each year" and the CDC now recommends children under the age of two receive the flu vaccine.
Hundreds of news articles began appearing on major web sites such as Google News, MSN, and Yahoo, touting the recently reported study and suggesting the vaccine was now safe for babies. The message was clear... get the shot, get the shot, get the shot. However, there was something missing that was not appearing in any of the news articles... flu shots contain thimerosal.
That may come as no big deal to some, but to a parent that has been fighting with vaccine manufacturers and/or government officials to get mercury compounds out of vaccines, it's a very big deal.
Thimerosal
After increased pressure from consumers, parents of autistic children groups, and government elected officials, vaccine manufacturers and the FDA have collectively agreed to begin removing thimerosal from childhood vaccines. Problem is, up until these recent recommendations, the flu vaccine was not considered a childhood vaccine.
Here is a list of FDA links with PDF document information on various intramuscular flu vaccines being used in 2006. Fluzone "No Preservative" pediatric dose by Aventis Pasteur, reports not to use thimerosal in the manufacturing process. Below that are some links to get more information about Thimerosal.
Fluvirin™ (Chiron Vaccines Ltd.)
Thimerosal (mercury derivative, =0.98 mcg mercury per 0.5 mL dose) is used in manufacture of the unit dose preservative free presentation but is reduced by the purification process to trace amounts.
http://www.fda.gov/cber/label/inflchi091405LB2.pdf
Fluarix™ (Influenza Virus Vaccine for intramuscular use)
Thimerosal is used at the early stages of manufacture and is removed by subsequent purification steps to <1.25 mcg mercury per dose.
http://www.fda.gov/CbER/label/inflgla083105LB.pdf
FLULAVAL™ (Influenza Virus Vaccine) ID Biomedical Corporation of Quebec (IDB)
FLULAVAL is an influenza virus vaccine indicated for active immunization of adults 18 years of age and older. Thimerosal, a mercury derivative, is added as a preservative. Each 0.5 mL dose contains 25 mcg mercury.
http://www.fda.gov/Cber/label/inflidb100506LB.pdf
Fluzone (Aventis Pasteur, Inc.)
Fluzone vaccine is supplied in four different presentations: a 5 mL vial of vaccine which contains the preservative thimerosal [(mercury derivative), (25 µg mercury/dose)]; a 0.25 mL prefilled syringe (No Preservative: Pediatric Dose, for 6 – 35 months of age) distinguished by a pink syringe plunger rod; a 0.5 mL prefilled syringe (No Preservative, for 36 months of age and older); and a 0.5 mL vial (No Preservative, for 36 months of age and older). There is no thimerosal used in the manufacturing process of the No Preservative unit dose presentations of Fluzone vaccine.
http://www.fda.gov/CbER/products/inflave071405.htm
Thimerosal in Vaccines (from the FDA)
http://www.fda.gov/Cber/vaccine/thimerosal.htm
Thimerosal (from Wikipedia) -- Thiomersal is a very toxic compound which is harmful by inhalation and ingestion.
http://en.wikipedia.org/wiki/Thimerosal
National Vaccine Information Center - Mercury Calculator
http://www.nvic.org/Issues/HgCalculator.htm
October 23, 2006
LAT: Study Links Air Pollutants With Autism
Study Links Air Pollutants With Autism
Bay Area children with the disorder are 50% likelier to be from areas high in several toxic substances. Scientists say more research is needed.
By Marla Cone, LA Times Staff Writer
June 23, 2006
Children with autism disorders in the San Francisco Bay Area were 50% more likely to be born in neighborhoods with high amounts of several toxic air contaminants, particularly mercury, according to a first-of-its-kind study by the California Department of Health Services.
The new findings, which surprised the researchers, suggest that a mother's exposure to industrial air pollutants while pregnant might increase her child's risk of autism, a neurological condition increasingly diagnosed in the last 10 years.
But the scientists cautioned that the link they found in the Bay Area is uncertain and that more definitive evidence would be needed before concluding that mercury or any other pollutant could trigger autism.
Gayle Windham, the study's lead researcher and senior epidemiologist in the department's environmental health investigations branch, called it "a single small study" and "a first look" at whether toxic pollutants play a role in the neurological disorder, which is often marked by poor verbal and communication skills and withdrawal from social interaction.
Scientists have long wondered if the surge in diagnoses is due, in part, to environmental causes. Some of the increase comes from growing doctor and parent awareness, but experts say that cannot explain all of it.
"Clearly this suggests that there may be correlations between autism onset and environmental exposures, especially as it relates to metal exposures," said Isaac Pessah, a toxicologist who heads UC Davis' Center for Children's Environmental Health and Disease Prevention. Pessah, who was not involved in the study, is also a researcher at the university's MIND (Medical Investigation of Neurodevelopmental Disorders) Institute, which studies autism.
"It would be prudent to reserve judgment until we see if this study can be replicated and whether it's of general significance" by looking for the same link outside the Bay Area, he said.
About 300,000 U.S. children have been diagnosed with autism and often need special education. The study compared 284 children from six Bay Area counties who were diagnosed as having so-called autism spectrum disorders — which include a less-severe syndrome called Asperger's — with 657 children from the same counties without the disorders. All were born in 1994.
The scientists reviewed data for 19 hazardous air pollutants that are known or suspected neurotoxins: chemicals that have a toxic effect on the brain.
They found that the children with the autism disorders were 50% more likely than the non-autistic children to be born in areas with higher estimated levels of three metals and two chlorinated solvents: mercury, cadmium, nickel, trichloroethylene and vinyl chloride. No significant link was found with 14 other solvents and metals, including compounds such as lead, benzene and chromium.
The national autism rate is six children per 1,000, so a 50% increase would elevate that rate to nine per 1,000.
The biggest increase came with heavy metals including mercury, a pollutant from power plants, factories and mines that can disrupt brain development.
The Bay Area was chosen for the study because extensive data are readily available there because of a federally funded program to count and track autistic children. The region's toxic air pollution is considered typical for urban areas.
San Francisco County had the highest estimated levels of metals and solvents, including mercury, and Marin County had the lowest of those studied. But the researchers did not compare autism prevalence by county.
In their report, published online Wednesday in the journal Environmental Health Perspectives, the authors said their research "suggests that living in areas with higher ambient levels of hazardous air pollutants, particularly metals and chlorinated solvents, during pregnancy or early childhood, may be associated with a moderately increased risk of autism. These findings illuminate the need for further scientific investigation, as they are biologically plausible but preliminary and require confirmation."
The study is the first to look for a connection between autism among children and levels of hazardous air pollutants at birth. Last year, scientists who compared volumes of industrial mercury emissions in Texas with autism in schoolchildren reported a similar link.
Autism is believed to start in the womb, early in pregnancy, when the brain develops. Genetic factors determine who is susceptible, but experts theorize that environmental factors contribute.
The new study found that mercury was the "most significant correlation with autism," Pessah said, "but every family may not be affected the same way because of their genetic makeup."
Many parents of autistic children blame vaccines that contained a type of mercury called thimerosal. Expert reviews have found no link between vaccines and autism, but some scientists do not consider them definitive.
No assumptions about vaccines can be made on the basis of the air pollution study. "Mercury in the air is a different type than in vaccines," Windham said.
The new study examined elemental mercury, which is released into the air from coal-burning power plants, chlorine factories and gold mines. It spreads globally and builds up in food chains, particularly in oceans. Levels of mercury are increasing in many parts of the world, largely from power plants in China and India.
The researchers had not expected to be able to discern a relationship between autism and the air pollution data.
The five metals and solvents are common industrial pollutants, but air is only one source of exposure, because they also contaminate water and food.
Some experts say that if there is a link between mercury and autism, it most likely comes from fish consumption, the main route of mercury exposure. A 20-year, ongoing study in Denmark's Faroe Islands has shown that children have slightly reduced intelligence when mothers consumed excessive mercury in seafood.
The largest limitation or uncertainty in the Bay Area study is that the pollution data did not come from measurements of compounds to which the mothers were actually exposed. Instead, they were based on estimates calculated by the U.S. Environmental Protection Agency using computer modeling of industrial emissions.
Windham said that "there could be other explanations" for the link they found. For example, it could be that women who live in the worst-polluted areas also smoke more or eat more contaminated seafood. The scientists did not track down the mothers to compare lifestyles.
Researchers at Johns Hopkins University's School of Public Health are conducting a similar study in the Baltimore area to see if they replicate the findings.
May 30, 2006
Heavy Metals May Be Implicated In Autism
Heavy Metals May Be Implicated In Autism
National Autism Association
URINE samples from hundreds of French children have yielded evidence for a link between autism and exposure to heavy metals. If validated, the findings might mean some cases of autism could be treated with drugs that purge the body of heavy metals.
Samples from children with autism contained abnormally high levels of a family of proteins called porphyrins, which are precursors in the production of haem, the oxygen-carrying component in haemoglobin. Heavy metals block haem production, causing porphyrins to accumulate in urine. Concentrations of one molecule, coproporphyrin, were 2.6 times as high in urine from children with autism as in controls.
Autism is thought to have a number of unknown genetic and environmental causes. Richard Lathe of Pieta Research in Edinburgh, UK, says he has found one of these factors. "It's highly likely that heavy metals are responsible for childhood autistic disorder in a majority of cases," he claims. The study will appear in Toxicology and Applied Pharmacology.
Lathe says these porphyrin metabolites bind to receptors in the brain and have been linked with epilepsy and autism.
The researchers restored porphyrin concentrations to normal in 12 children by treating them with "chelation" drugs that mop up heavy metals and are then excreted. It is not yet known whether the children's symptoms have eased, but Lathe cites anecdotal reports suggesting the drugs might do some good.
--------------------------------------------
The study is available online at: http://filariane.org/anglais/DOC/MSFINAL.pdf
National Autism Association
URINE samples from hundreds of French children have yielded evidence for a link between autism and exposure to heavy metals. If validated, the findings might mean some cases of autism could be treated with drugs that purge the body of heavy metals.
Samples from children with autism contained abnormally high levels of a family of proteins called porphyrins, which are precursors in the production of haem, the oxygen-carrying component in haemoglobin. Heavy metals block haem production, causing porphyrins to accumulate in urine. Concentrations of one molecule, coproporphyrin, were 2.6 times as high in urine from children with autism as in controls.
Autism is thought to have a number of unknown genetic and environmental causes. Richard Lathe of Pieta Research in Edinburgh, UK, says he has found one of these factors. "It's highly likely that heavy metals are responsible for childhood autistic disorder in a majority of cases," he claims. The study will appear in Toxicology and Applied Pharmacology.
Lathe says these porphyrin metabolites bind to receptors in the brain and have been linked with epilepsy and autism.
The researchers restored porphyrin concentrations to normal in 12 children by treating them with "chelation" drugs that mop up heavy metals and are then excreted. It is not yet known whether the children's symptoms have eased, but Lathe cites anecdotal reports suggesting the drugs might do some good.
--------------------------------------------
The study is available online at: http://filariane.org/anglais/DOC/MSFINAL.pdf
April 5, 2006
AJC: Autism Controversy Eats at Credibility of CDC
Autism controversy eats at credibility of CDC
By ALISON YOUNG
The Atlanta Journal-Constitution
Published on: 04/06/06
The Centers for Disease Control and Prevention, rarely the subject of public controversy, is facing an emerging credibility crisis on the emotional issue of whether old-style vaccines containing a mercury preservative caused autism in thousands of children.
The agency is being accused of cover-ups and scientific manipulations by a vocal group of autism advocates and is facing questions from some high-profile members of Congress.
As the debate and controversy increasingly finds its way into pediatricians' offices, average parents of healthy children are questioning whether vaccines are safe, sometimes even refusing inoculations.
The CDC and other public health officials insist such questions lack a basis in fact or science. Their greatest concern is that the broadening debate holds the potential to put a new generation of children at certain risk of deadly diseases if confidence in the safety of vaccines is lost and they don't receive recommended shots.
"I think it's huge," said Dr. Julia McMillan, a member of the American Academy of Pediatrics committee that makes vaccine recommendations. "There's no pediatrician in practice that doesn't confront this on a weekly basis: families who are questioning the need for – and in some cases refusing — vaccines for their children."
But the academy and the CDC are in agreement: They say there is no evidence to support a connection between autism and the mercury-based preservative thimerosal, which they stress is no longer used in most pediatric vaccines.
"We simply don't know what the cause of autism is," Dr. Bob Davis, the CDC's director of immunization safety, said Wednesday. Nonetheless, the CDC finds itself at the center of criticism.
A full-page ad scheduled to run in today's editions of USA Today, the nation's largest-circulation newspaper, accuses the CDC of "causing an epidemic of autism" by recommending that children receive a series of vaccines that until 2001 contained thimerosal.
The ad, placed by a group of autism advocacy groups, quotes environmental lawyer Robert F. Kennedy Jr. as saying: "It's time for the CDC to come clean with the American public."
But what stings public health advocates more is a letter sent Feb. 22 by Sen. Joseph Lieberman (D-Conn.) and seven other members of Congress. The bipartisan group asks that the CDC not take the lead on a new study examining the vaccine-autism issue.
"If the federal government is going to have a study whose results will be broadly accepted, such a study cannot be led by the CDC," the group wrote Dr. David Schwartz, new director of the National Institute of Environmental Health Sciences. The institute, a part of the National Institutes of Health, will convene a panel in May to discuss how to analyze a key CDC database to determine whether autism rates have dropped since thimerosal was removed from vaccines.
The letter was also signed by Sen. Debbie Stabenow, (D-Mich.), Rep. Dave Weldon, (R-Fla.,) Rep. Chris Smith, (R-N.J.), Rep. Carolyn Maloney, (D-N.Y.), Rep. Dan Burton, (R-Ind.), Rep. Joseph Crowley, (D-N.Y,), and Rep. Maurice Hinchey, (D-N.Y.).
Agency officials said Wednesday they are proud of the CDC's work on thimerosal safety issues and that they have looked hard to find a link as well as to find any other cause of autism.
"It was an unfortunate choice of language," Davis said of the Lieberman letter. "They and everyone else are certainly entitled to their opinion. We stand by all the research we have done."
Public health officials who work with CDC are more blunt.
"I think it's shocking," said Dr. Martin Myers, executive director of the National Network for Immunization Information and a professor of pediatrics at the University of Texas medical branch in Galveston.
"The loss of public trust in one of the most extraordinary institutions in the world. I'm not quite sure how that has occurred, but it has, and that's one of the unfortunate consequences," Myers said.
The controversy, which erupted as some autism advocates rallied on Capitol Hill today in conjunction with National Autism Month, is gaining political traction, moving well beyond an initial core of autism activists, CDC, public health and congressional officials all agree.
There are many parents of autistic children who believe, as do most pediatricians and scientists, that there is no scientific evidence that thimerosal caused autism and other neurological disorders. That issue was settled for most in a widely publicized 2004 report by an expert panel convened by the National Academy of Sciences Institute of Medicine.
But the report has been the subject of controversy and intense scrutiny since it was published.
Parents of many autistic children insist that thimerosal caused the disorder, because it appeared around the time their children received vaccinations. Their advocates also point to what they say is intriguing new research in animal models indicating that some individuals may be more sensitive to thimerosal than others. Martin Cowen, whose family lives in Jonesboro, is one such parent.
Cowen is convinced thimerosal-containing vaccines caused his son Lindsey's autism. Lindsey, who turned 8 last week, does not speak, has not been toilet trained and cannot be allowed outdoors without being restrained for fear he'll run into traffic, his father said.
Cowen is highly skeptical of the CDC, a position shared by a cohort of parents and advocates across the country.
"An enormous effort is being made to deny the connection," he said of the CDC. "What do I think their motive is? They are very interested in having the herd vaccinated... They don't think of people as people suffering individually. It's the greatest good for the greatest number."
The National Immunization Program, run by the CDC, coordinates immunization activities across the country. Increasing the rate of immunization against disease is a cornerstone of public health.
At the same time, the CDC also is charged with monitoring vaccine safety. It's an inherent conflict of interest, said Weldon, a doctor before he was elected to Congress.
"They really do have a credibility problem," said Weldon, who serves on the committee that decides the CDC's budget. "Part of the credibility problem is it's asking them to investigate a problem that they may have created."
Weldon became involved in the thimerosal issue seven years ago. "Honestly, at first I was very dubious," he said. "As I looked at it more and more, I began to feel there is some validity to this."
Weldon said the recent interest by Lieberman and others on Capitol Hill is a sign the issue is gaining political traction. Lieberman was unavailable for comment.
The controversy and public debate is likely to be further fueled by the full-page ad being paid for by a coalition of the autism activist groups led by Generation Rescue. The ad promotes a sophisticated Web site, www.PutChildren First.org, which includes links to CDC documents, e-mails and transcripts the groups say support their contention of an agency cover-up.
CDC spokesman Glen Nowak said many of the documents on the site have been in the public domain for years, and are presented out of context and in ways that may "look quite ominous" – when they're not.
"It's a very challenging issue," he said. The CDC is bracing for a spike in calls today from parents with questions and is increasing staffing at its public help line, 1-800-232-4636.
By ALISON YOUNG
The Atlanta Journal-Constitution
Published on: 04/06/06
The Centers for Disease Control and Prevention, rarely the subject of public controversy, is facing an emerging credibility crisis on the emotional issue of whether old-style vaccines containing a mercury preservative caused autism in thousands of children.
The agency is being accused of cover-ups and scientific manipulations by a vocal group of autism advocates and is facing questions from some high-profile members of Congress.
As the debate and controversy increasingly finds its way into pediatricians' offices, average parents of healthy children are questioning whether vaccines are safe, sometimes even refusing inoculations.
The CDC and other public health officials insist such questions lack a basis in fact or science. Their greatest concern is that the broadening debate holds the potential to put a new generation of children at certain risk of deadly diseases if confidence in the safety of vaccines is lost and they don't receive recommended shots.
"I think it's huge," said Dr. Julia McMillan, a member of the American Academy of Pediatrics committee that makes vaccine recommendations. "There's no pediatrician in practice that doesn't confront this on a weekly basis: families who are questioning the need for – and in some cases refusing — vaccines for their children."
But the academy and the CDC are in agreement: They say there is no evidence to support a connection between autism and the mercury-based preservative thimerosal, which they stress is no longer used in most pediatric vaccines.
"We simply don't know what the cause of autism is," Dr. Bob Davis, the CDC's director of immunization safety, said Wednesday. Nonetheless, the CDC finds itself at the center of criticism.
A full-page ad scheduled to run in today's editions of USA Today, the nation's largest-circulation newspaper, accuses the CDC of "causing an epidemic of autism" by recommending that children receive a series of vaccines that until 2001 contained thimerosal.
The ad, placed by a group of autism advocacy groups, quotes environmental lawyer Robert F. Kennedy Jr. as saying: "It's time for the CDC to come clean with the American public."
But what stings public health advocates more is a letter sent Feb. 22 by Sen. Joseph Lieberman (D-Conn.) and seven other members of Congress. The bipartisan group asks that the CDC not take the lead on a new study examining the vaccine-autism issue.
"If the federal government is going to have a study whose results will be broadly accepted, such a study cannot be led by the CDC," the group wrote Dr. David Schwartz, new director of the National Institute of Environmental Health Sciences. The institute, a part of the National Institutes of Health, will convene a panel in May to discuss how to analyze a key CDC database to determine whether autism rates have dropped since thimerosal was removed from vaccines.
The letter was also signed by Sen. Debbie Stabenow, (D-Mich.), Rep. Dave Weldon, (R-Fla.,) Rep. Chris Smith, (R-N.J.), Rep. Carolyn Maloney, (D-N.Y.), Rep. Dan Burton, (R-Ind.), Rep. Joseph Crowley, (D-N.Y,), and Rep. Maurice Hinchey, (D-N.Y.).
Agency officials said Wednesday they are proud of the CDC's work on thimerosal safety issues and that they have looked hard to find a link as well as to find any other cause of autism.
"It was an unfortunate choice of language," Davis said of the Lieberman letter. "They and everyone else are certainly entitled to their opinion. We stand by all the research we have done."
Public health officials who work with CDC are more blunt.
"I think it's shocking," said Dr. Martin Myers, executive director of the National Network for Immunization Information and a professor of pediatrics at the University of Texas medical branch in Galveston.
"The loss of public trust in one of the most extraordinary institutions in the world. I'm not quite sure how that has occurred, but it has, and that's one of the unfortunate consequences," Myers said.
The controversy, which erupted as some autism advocates rallied on Capitol Hill today in conjunction with National Autism Month, is gaining political traction, moving well beyond an initial core of autism activists, CDC, public health and congressional officials all agree.
There are many parents of autistic children who believe, as do most pediatricians and scientists, that there is no scientific evidence that thimerosal caused autism and other neurological disorders. That issue was settled for most in a widely publicized 2004 report by an expert panel convened by the National Academy of Sciences Institute of Medicine.
But the report has been the subject of controversy and intense scrutiny since it was published.
Parents of many autistic children insist that thimerosal caused the disorder, because it appeared around the time their children received vaccinations. Their advocates also point to what they say is intriguing new research in animal models indicating that some individuals may be more sensitive to thimerosal than others. Martin Cowen, whose family lives in Jonesboro, is one such parent.
Cowen is convinced thimerosal-containing vaccines caused his son Lindsey's autism. Lindsey, who turned 8 last week, does not speak, has not been toilet trained and cannot be allowed outdoors without being restrained for fear he'll run into traffic, his father said.
Cowen is highly skeptical of the CDC, a position shared by a cohort of parents and advocates across the country.
"An enormous effort is being made to deny the connection," he said of the CDC. "What do I think their motive is? They are very interested in having the herd vaccinated... They don't think of people as people suffering individually. It's the greatest good for the greatest number."
The National Immunization Program, run by the CDC, coordinates immunization activities across the country. Increasing the rate of immunization against disease is a cornerstone of public health.
At the same time, the CDC also is charged with monitoring vaccine safety. It's an inherent conflict of interest, said Weldon, a doctor before he was elected to Congress.
"They really do have a credibility problem," said Weldon, who serves on the committee that decides the CDC's budget. "Part of the credibility problem is it's asking them to investigate a problem that they may have created."
Weldon became involved in the thimerosal issue seven years ago. "Honestly, at first I was very dubious," he said. "As I looked at it more and more, I began to feel there is some validity to this."
Weldon said the recent interest by Lieberman and others on Capitol Hill is a sign the issue is gaining political traction. Lieberman was unavailable for comment.
The controversy and public debate is likely to be further fueled by the full-page ad being paid for by a coalition of the autism activist groups led by Generation Rescue. The ad promotes a sophisticated Web site, www.PutChildren First.org, which includes links to CDC documents, e-mails and transcripts the groups say support their contention of an agency cover-up.
CDC spokesman Glen Nowak said many of the documents on the site have been in the public domain for years, and are presented out of context and in ways that may "look quite ominous" – when they're not.
"It's a very challenging issue," he said. The CDC is bracing for a spike in calls today from parents with questions and is increasing staffing at its public help line, 1-800-232-4636.
February 11, 2006
The Age of Autism: Doctors for mercury
The Age of Autism: Doctors for mercury
By DAN OLMSTED
UPI Senior Editor
WASHINGTON, Feb. 9 (UPI) -- As doctors and health authorities fight state bans on mercury in vaccines and keep giving it to kids and pregnant women, one fact stands out: their certainty.
The image of pediatricians and public officials as valiant defenders of mercury takes a bit of getting used to, given their longstanding efforts to keep the toxic element out of our food, our bodies and the environment.
No reasonable person -- let alone health professional -- would advocate keeping mercury in childhood vaccines unless they were absolutely certain it was an exception to this lethal legacy.
That's especially so because vaccines can be made without the mercury preservative, called thimerosal. You can take it out and still protect the health of American children through vaccination, and if you had a shred of doubt about its safety, surely you would.
If you keep it in, you had better be right.
But what is the real degree of certainty that thimerosal is safe? Is it absolute? Beyond a reasonable doubt? A preponderance of the evidence -- the lesser standard that applies in civil cases but not when someone's freedom (or life) is at stake?
Here's the kind of thing that makes doctors -- most of whom have no more ability than you or I to investigate the safety of vaccines for themselves -- feel so certain. It's a paper titled "Vaccine Safety Controversies and the Future of Vaccination Programs," and it appears in the November 2005 issue of The Pediatric Infectious Disease Journal.
The authors are from the U.S. Centers for Disease Control and Prevention, which recommends the childhood immunization schedule; the United Nations World Health Organization, which oversees the vaccination of tens of millions of people worldwide every year, and several big universities. The report was supported by "unrestricted grants from GlaxoSmithKline Biologicals, Sanofi Pasteur MSD, several universities and other institutions."
"Thimerosal has been used for (more than) 60 years in infant vaccines and in other applications and has not been associated with adverse health effects in the general population, except when persons have been exposed to amounts many orders of magnitude greater than found in vaccines or pharmaceuticals," the authors write.
That's a ringing endorsement of safety (whether it's supported by the data is an issue I'll address in upcoming columns). But keep reading: "It should also be borne in mind that the risks of thimerosal-containing vaccines to the fetus, premature infant and low-weight infant have insufficiently been studied."
Whoa. "Insufficiently studied" -- after more than 60 years of giving thimerosal to pregnant women and babies of every size and shape? Nonetheless, the CDC recommends flu shots for pregnant women and 6-to-23-months-olds and won't recommend thimerosal-free versions. As a result, most flu shots still contain mercury.
Another new study is condescendingly titled, "When science is not enough -- a risk/benefit profile of thimerosal-containing vaccines," by Australians C. John Clements and Peter B. McIntyre in the journal Expert Opinion on Drug Safety:
"Thimerosal is safe as a vaccine preservative, and should continue to be used in settings where accessibility and cost require that multi-dose vials of vaccine are available."
Clements advises the WHO on vaccine policy; McIntyre is director of Australia's National Center for Immunization Research and Surveillance of Vaccine-Preventable Diseases.
"The overwhelming weight of scientific opinion rejects the hypothesis that neurodevelopmental abnormalities are causally related to the use of thimerosal in vaccines," they point out.
This is the kind of ammunition public health officials and the American Academy of Pediatrics are firing back at proponents of mercury bans --"overwhelming" evidence that thimerosal is safe. In Illinois, the state AAP vigorously opposed the ban.
"Though well intended, these bills do not advance public health and could inadvertently diminish our state's efforts at fighting influenza," the AAP said. "Though it is a mercury-containing compound, thimerosal does not pass from the bloodstream into the brain to any significant degree."
The state legislators listened politely to that dubious assertion -- and voted to limit thimerosal in childhood vaccines anyway. But that was not the last word.
As reported by R. L. Nave in the Illinois Times last month: "Citing cost concerns and a potential shortfall for the upcoming flu season, the Illinois Department of Public Health filed for a 12-month exemption to the Mercury-Free Vaccine Act, passed last summer to limit the use of vaccines containing mercury. However, child-health-care advocates who lobbied for the bill's passage are upset by what they believe was a premeditated attempt by IDPH to circumvent state law."
This is what you call chutzpah -- public health authorities thwarting the express will of the people, certain that flu shots will save humanity and mercury never hurt anybody. Does the governor never fire anyone?
Almost lost in this crossfire is the simple fact that in 1999, these selfsame health authorities -- the CDC, the Public Health Service, the pediatricians, the family physicians -- urged drug companies to remove thimerosal from childhood immunizations in the United States as soon as possible.
Most childhood vaccines -- in the United States, not overseas -- are now thimerosal-free. But that's hardly a blanket reassurance, because most flu shots do contain thimerosal.
Yet the CDC is still studying whether thimerosal causes autism.
"We do agree the preponderance of evidence to date suggests there is no association between thimerosal and autism," CDC spokesman Glen Nowak told us last month. But he said CDC Director Dr. Julie Gerberding is committed to exploring all possibilities until the cause or causes of the disorder are identified.
"Dr. Gerberding has made it clear the CDC has not ruled out anything as possible causes of autism, including thimerosal," Nowak said. "Science is a dynamic process. We have continued to fund studies to look at the role, if any, of thimerosal."
Given these caveats, what would you do? Well, there are two maxims of medicine that might apply. "First, do no harm," is the obvious one.
The second, related concept is the precautionary principle which, according to wikipedia.org, "is the idea that if the consequences of an action are unknown, but are judged to have some potential for major or irreversible negative consequences, then it is better to avoid that action."
So: Vaccines don't need mercury. Even government experts acknowledge some possible risks -- to the fetus, for example -- are insufficiently studied 60 years on. A link to autism has not been ruled out. They're continuing to investigate, as they should.
But the doctors and their public and private allies are battling state by state to stop mercury bans, and the CDC won't recommend a thimerosal-free flu shot for kids and pregnant woman. There's a phrase for this approach:
Bombs away.
By DAN OLMSTED
UPI Senior Editor
WASHINGTON, Feb. 9 (UPI) -- As doctors and health authorities fight state bans on mercury in vaccines and keep giving it to kids and pregnant women, one fact stands out: their certainty.
The image of pediatricians and public officials as valiant defenders of mercury takes a bit of getting used to, given their longstanding efforts to keep the toxic element out of our food, our bodies and the environment.
No reasonable person -- let alone health professional -- would advocate keeping mercury in childhood vaccines unless they were absolutely certain it was an exception to this lethal legacy.
That's especially so because vaccines can be made without the mercury preservative, called thimerosal. You can take it out and still protect the health of American children through vaccination, and if you had a shred of doubt about its safety, surely you would.
If you keep it in, you had better be right.
But what is the real degree of certainty that thimerosal is safe? Is it absolute? Beyond a reasonable doubt? A preponderance of the evidence -- the lesser standard that applies in civil cases but not when someone's freedom (or life) is at stake?
Here's the kind of thing that makes doctors -- most of whom have no more ability than you or I to investigate the safety of vaccines for themselves -- feel so certain. It's a paper titled "Vaccine Safety Controversies and the Future of Vaccination Programs," and it appears in the November 2005 issue of The Pediatric Infectious Disease Journal.
The authors are from the U.S. Centers for Disease Control and Prevention, which recommends the childhood immunization schedule; the United Nations World Health Organization, which oversees the vaccination of tens of millions of people worldwide every year, and several big universities. The report was supported by "unrestricted grants from GlaxoSmithKline Biologicals, Sanofi Pasteur MSD, several universities and other institutions."
"Thimerosal has been used for (more than) 60 years in infant vaccines and in other applications and has not been associated with adverse health effects in the general population, except when persons have been exposed to amounts many orders of magnitude greater than found in vaccines or pharmaceuticals," the authors write.
That's a ringing endorsement of safety (whether it's supported by the data is an issue I'll address in upcoming columns). But keep reading: "It should also be borne in mind that the risks of thimerosal-containing vaccines to the fetus, premature infant and low-weight infant have insufficiently been studied."
Whoa. "Insufficiently studied" -- after more than 60 years of giving thimerosal to pregnant women and babies of every size and shape? Nonetheless, the CDC recommends flu shots for pregnant women and 6-to-23-months-olds and won't recommend thimerosal-free versions. As a result, most flu shots still contain mercury.
Another new study is condescendingly titled, "When science is not enough -- a risk/benefit profile of thimerosal-containing vaccines," by Australians C. John Clements and Peter B. McIntyre in the journal Expert Opinion on Drug Safety:
"Thimerosal is safe as a vaccine preservative, and should continue to be used in settings where accessibility and cost require that multi-dose vials of vaccine are available."
Clements advises the WHO on vaccine policy; McIntyre is director of Australia's National Center for Immunization Research and Surveillance of Vaccine-Preventable Diseases.
"The overwhelming weight of scientific opinion rejects the hypothesis that neurodevelopmental abnormalities are causally related to the use of thimerosal in vaccines," they point out.
This is the kind of ammunition public health officials and the American Academy of Pediatrics are firing back at proponents of mercury bans --"overwhelming" evidence that thimerosal is safe. In Illinois, the state AAP vigorously opposed the ban.
"Though well intended, these bills do not advance public health and could inadvertently diminish our state's efforts at fighting influenza," the AAP said. "Though it is a mercury-containing compound, thimerosal does not pass from the bloodstream into the brain to any significant degree."
The state legislators listened politely to that dubious assertion -- and voted to limit thimerosal in childhood vaccines anyway. But that was not the last word.
As reported by R. L. Nave in the Illinois Times last month: "Citing cost concerns and a potential shortfall for the upcoming flu season, the Illinois Department of Public Health filed for a 12-month exemption to the Mercury-Free Vaccine Act, passed last summer to limit the use of vaccines containing mercury. However, child-health-care advocates who lobbied for the bill's passage are upset by what they believe was a premeditated attempt by IDPH to circumvent state law."
This is what you call chutzpah -- public health authorities thwarting the express will of the people, certain that flu shots will save humanity and mercury never hurt anybody. Does the governor never fire anyone?
Almost lost in this crossfire is the simple fact that in 1999, these selfsame health authorities -- the CDC, the Public Health Service, the pediatricians, the family physicians -- urged drug companies to remove thimerosal from childhood immunizations in the United States as soon as possible.
Most childhood vaccines -- in the United States, not overseas -- are now thimerosal-free. But that's hardly a blanket reassurance, because most flu shots do contain thimerosal.
Yet the CDC is still studying whether thimerosal causes autism.
"We do agree the preponderance of evidence to date suggests there is no association between thimerosal and autism," CDC spokesman Glen Nowak told us last month. But he said CDC Director Dr. Julie Gerberding is committed to exploring all possibilities until the cause or causes of the disorder are identified.
"Dr. Gerberding has made it clear the CDC has not ruled out anything as possible causes of autism, including thimerosal," Nowak said. "Science is a dynamic process. We have continued to fund studies to look at the role, if any, of thimerosal."
Given these caveats, what would you do? Well, there are two maxims of medicine that might apply. "First, do no harm," is the obvious one.
The second, related concept is the precautionary principle which, according to wikipedia.org, "is the idea that if the consequences of an action are unknown, but are judged to have some potential for major or irreversible negative consequences, then it is better to avoid that action."
So: Vaccines don't need mercury. Even government experts acknowledge some possible risks -- to the fetus, for example -- are insufficiently studied 60 years on. A link to autism has not been ruled out. They're continuing to investigate, as they should.
But the doctors and their public and private allies are battling state by state to stop mercury bans, and the CDC won't recommend a thimerosal-free flu shot for kids and pregnant woman. There's a phrase for this approach:
Bombs away.
January 6, 2006
The Age of Autism: CDC Probes Vaccines
The Age of Autism: CDC probes vaccines
By DAN OLMSTED
UPI Senior Editor
The CDC is continuing to investigate whether a mercury preservative in childhood immunizations has caused cases of autism -- despite the fact a report it paid for said such research should end.
The agency wants to determine whether exposure to the vaccine preservative, called thimerosal, can be linked to autism spectrum disorders, Glen Nowak, director of media relations at the Centers for Disease Control and Prevention, told Age of Autism on Friday.
The study includes 300 children with ASDs, 200 of whom have full-syndrome autism, as well as a comparison group of children who do not have the disorders.
In 2004 a CDC-funded report by the independent Institute of Medicine concluded there was no evidence of a vaccine-autism link and efforts should go instead to "promising" autism research.
"Further research to find the cause of autism should be directed toward other lines of inquiry," the immunization review panel said. "It's really terrifying, the scientific illiteracy that supports these suspicions," said Dr. Marie McCormick, chairwoman of the IOM panel, in a New York Times article in June.
And the head of the CDC's immunization program said the same year that only "junk scientists and charlatans" take such a link seriously.
Nevertheless, spokesman Nowak said the CDC -- which sets the childhood immunization schedule that states adopt -- has not eliminated thimerosal as a suspect.
"We do agree the preponderance of evidence to date suggests there is no association between thimerosal and autism," said Nowak when asked why the CDC was continuing to pursue the issue. But he said CDC Director Dr. Julie Gerberding is committed to exploring all possibilities until the cause or causes of the disorder are identified.
"Dr. Gerberding has made it clear the CDC has not ruled out anything as possible causes of autism, including thimerosal," Nowak said. "Science is a dynamic process. We have continued to fund studies to look at the role, if any, of thimerosal."
The study was designed in 2003 and data collection -- which includes evaluation of each child and their immunization history -- began last year, Nowak said. A letter dated Nov. 8 and an accompanying brochure were provided by a parent who received them.
"In this study, the CDC wants to find out if children who received vaccines and medicines with Thimerosal as infants are more likely to later have developmental problems such as Asperger's Syndrome or autism," says the letter, sent on behalf of the CDC by a research firm and Kaiser Permanente, one of three HMOs involved.
"Your participation in this study may help doctors learn about the possible risks of vaccines and medicines that contained thimerosal."
The mother who received the letter expressed dismay because most medical experts and federal health authorities have reassured parents thimerosal does not cause autism and is not responsible for the large increase in diagnoses beginning in the 1990s.
In 1999 the CDC and the American Academy of Pediatrics urged manufacturers to phase out thimerosal from childhood immunizations as soon as possible, based on the concern that the total amount of mercury received by a child could exceed some government guidelines.
But, citing five subsequent epidemiological studies, the CDC and other health authorities now say there is no evidence of an association.
The CDC continues to recommend flu shots -- most of which contain thimerosal -- for pregnant women and for children 6 to 23 months of age. The agency has declined to express a preference for the thimerosal-free version, citing concern that it might cause some parents to forego immunizing their children against flu if they cannot obtain it.
In addition, tens of millions of children around the world are being injected with thimerosal-containing vaccines, based heavily on the assurances of U.S. health authorities that it is safe and does not cause autism.
Results of the study should be available in September 2007, Nowak said.
By DAN OLMSTED
UPI Senior Editor
The CDC is continuing to investigate whether a mercury preservative in childhood immunizations has caused cases of autism -- despite the fact a report it paid for said such research should end.
The agency wants to determine whether exposure to the vaccine preservative, called thimerosal, can be linked to autism spectrum disorders, Glen Nowak, director of media relations at the Centers for Disease Control and Prevention, told Age of Autism on Friday.
The study includes 300 children with ASDs, 200 of whom have full-syndrome autism, as well as a comparison group of children who do not have the disorders.
In 2004 a CDC-funded report by the independent Institute of Medicine concluded there was no evidence of a vaccine-autism link and efforts should go instead to "promising" autism research.
"Further research to find the cause of autism should be directed toward other lines of inquiry," the immunization review panel said. "It's really terrifying, the scientific illiteracy that supports these suspicions," said Dr. Marie McCormick, chairwoman of the IOM panel, in a New York Times article in June.
And the head of the CDC's immunization program said the same year that only "junk scientists and charlatans" take such a link seriously.
Nevertheless, spokesman Nowak said the CDC -- which sets the childhood immunization schedule that states adopt -- has not eliminated thimerosal as a suspect.
"We do agree the preponderance of evidence to date suggests there is no association between thimerosal and autism," said Nowak when asked why the CDC was continuing to pursue the issue. But he said CDC Director Dr. Julie Gerberding is committed to exploring all possibilities until the cause or causes of the disorder are identified.
"Dr. Gerberding has made it clear the CDC has not ruled out anything as possible causes of autism, including thimerosal," Nowak said. "Science is a dynamic process. We have continued to fund studies to look at the role, if any, of thimerosal."
The study was designed in 2003 and data collection -- which includes evaluation of each child and their immunization history -- began last year, Nowak said. A letter dated Nov. 8 and an accompanying brochure were provided by a parent who received them.
"In this study, the CDC wants to find out if children who received vaccines and medicines with Thimerosal as infants are more likely to later have developmental problems such as Asperger's Syndrome or autism," says the letter, sent on behalf of the CDC by a research firm and Kaiser Permanente, one of three HMOs involved.
"Your participation in this study may help doctors learn about the possible risks of vaccines and medicines that contained thimerosal."
The mother who received the letter expressed dismay because most medical experts and federal health authorities have reassured parents thimerosal does not cause autism and is not responsible for the large increase in diagnoses beginning in the 1990s.
In 1999 the CDC and the American Academy of Pediatrics urged manufacturers to phase out thimerosal from childhood immunizations as soon as possible, based on the concern that the total amount of mercury received by a child could exceed some government guidelines.
But, citing five subsequent epidemiological studies, the CDC and other health authorities now say there is no evidence of an association.
The CDC continues to recommend flu shots -- most of which contain thimerosal -- for pregnant women and for children 6 to 23 months of age. The agency has declined to express a preference for the thimerosal-free version, citing concern that it might cause some parents to forego immunizing their children against flu if they cannot obtain it.
In addition, tens of millions of children around the world are being injected with thimerosal-containing vaccines, based heavily on the assurances of U.S. health authorities that it is safe and does not cause autism.
Results of the study should be available in September 2007, Nowak said.
November 1, 2005
The Age of Autism: The Amish Elephant
The Age of Autism: The Amish Elephant
By Dan Olmsted
UPI Senior Editor
Oct. 29, 2005 at 2:34PM
A specter is haunting the medical and journalism establishments of the United States: Where are the unvaccinated people with autism?
That is just about the only way to explain what now appears to be a collective resistance to considering that question. And like all unanswered questions, this raises another one: Why?
What is the problem with quickly and firmly establishing that the autism rate is about the same everywhere and for everybody in the United States, vaccinated or unvaccinated? Wouldn't that stop all the scientifically illiterate chatter by parents who believe vaccinations made their children autistic? Wouldn't it put to rest concerns that -- despite the removal of a mercury-containing preservative in most U.S. vaccines -- hundreds of millions of children in the developing world are possibly at risk if that preservative is in fact linked to autism?
Calling this issue The Amish Elephant reflects reporting earlier this year in Age of Autism that the largely unvaccinated Amish may have a relatively low rate of autism. That apparent dissimilarity is, in effect, a proverbial elephant in the living room -- studiously ignored by people who don't want to deal with it and don't believe they will have to.
Here are a few cases in point.
Earlier this month the National Consumers League conference in Washington held a session on communicating issues around vaccine safety. I was on the panel and talked about the Amish and autism. In the Q&A session that followed, the first question was for me.
"Is this a proper role for a journalist, or is this just a straw dog set up there with a preliminary answer? It not only showed up where you wrote it. It was all over the place. You did very, very well for UPI (at which point I said, 'Thank you -- please tell my bosses that!') but the question is, did you do very, very well for America?
"Is it appropriate for a journalist -- you weren't reporting, you were investigating. And I just wonder if you think it's an appropriate role for you to play."
My answer: "There's different roles for the press. That's certainly a reasonable question. That is investigative reporting. This idea is something that's already been discarded -- that there's any reason why you would want to look in an unvaccinated population.
"One of my favorite comments about journalism is that it's the wild card of American democracy. The First Amendment says we can do (in the sense of reporting about) whatever we want. So one of our privileges is to get an idea in our head and go look at it."
My questioner was not finished. "I wasn't questioning whether you have a First Amendment right to do it. I think this is more of a question of the ethics, of what value we are bringing to the debate."
My response: "That's probably not a good one for me to answer. Obviously I thought it was ethical."
At that point a fellow panelist, Dr. Louis Cooper, former president of the American Academy of Pediatrics and a staunch vaccine defender, spoke up. "I would jump in and say I thought it was ethical and I think it was useful," said Cooper, a courtly and unfailingly courteous Manhattan pediatrician.
"As you've learned, it was annoying to many people. I wasn't annoyed by it because I thought you kept the process and the debate and the discussion going forward. And we have to do that for one another."
That did not end the discussion. A few minutes later a public-health professor from -- where else? Harvard -- did her own version of Jeopardy!, offering the correct "answer" in the form of a question.
"This question is for Dan. Did you mention the outbreak of polio that happened in the Amish community in the Netherlands that caused widespread problems there, and also the fact that there'd been some context with respect to history in our country in trying to reach out to the Amish to actually encourage them to try to benefit from some of the vaccine technology to the extent that we could?
"So there's been a long history in this country of the CDC trying to reach out to them to the extent that they could. Also with respect to polio, I think what's really amazing is it's such a great story, this is such an exciting time, in the sense that we are very close to global eradication. What that means is we've gone from 1988 when we had 350,000 estimated paralytic polio cases in the world every year to roughly a thousand. It's very exciting that in fact we don't have the terror or the hysteria and all of the fear that surrounded disease.
"I just want to remind everyone that one thing that's very important in the context of reporting these stories is making sure that people do remember and also realize with infectious disease is these things can come back, and until they are eradicated they can come back and devastate us just as much as they did before, except now there are a lot more people.
"There's some related news that people might find interesting. A headline in the Washington Post today, 'Polio outbreak occurs among Amish families.' So I thought people might be interested in that."
At that point the moderator, Dr. Roger Bernier of the Centers for Disease Control, said time was getting short -- why was I not surprised? -- and asked for the next "question."
One thing I've noticed is the more that people want to lecture instead of learn, the more they speak in breathless run-on sentences that are hard to stop, slow down or even diagram. They leave one with the unspoken idea that dialogue -- opening the door to new information -- is somehow dangerous.
These exchanges reminded me of the response I got from Dr. Julie Gerberding, the CDC director, when I asked her this summer, verbatim: "Has the government ever looked at the autism rate in an unvaccinated U.S. population, and if not, why not?"
Her answer, verbatim:
--
In this country, we have very high levels of vaccination as you probably know, and I think this year we have record immunization levels among all of our children, so to (select an unvaccinated group) that on a population basis would be representative to look at incidence in that population compared to the other population would be something that could be done.
But as we're learning, just trying to look at autism in a community the size of Atlanta, it's very, very difficult to get an effective numerator and denominator to get a reliable diagnosis.
I think those kind of studies could be done and should be done. You'd have to adjust for the strong genetic component that also distinguishes, for example, people in Amish communities who may elect not to be immunized (and) also have genetic connectivity that would make them different from populations that are in other sectors of the United States. So drawing some conclusions from them would be very difficult.
I think with reference to the timing of all of this, good science does take time, and it's part of one of the messages I feel like I've learned from the feedback that we've gotten from parents groups this summer (in) struggling with developing a more robust and a faster research agenda, is let's speed this up. Let's look for the early studies that could give us at least some hypotheses to test and evaluate and get information flowing through the research pipeline as quickly as we can.
So we are committed to doing that, and as I mentioned, in terms of just measuring the frequency of autism in the population some pretty big steps have been taken. We're careful not to jump ahead of our data, but we think we will be able to provide more accurate information in the next year or so than we've been able to do up to this point. And I know that is our responsibility.
We've also benefited from some increased investments in these areas that have allowed us to do this, and so we thank Congress and we thank the administration for supporting those investments, not just at CDC but also at NIH and FDA.
--
The latest response to my pesky persistence comes not from academia or government but from my own profession. Last week the prestigious Columbia Journalism Review published an article whose main thrust -- with which I concur -- was that a vigorous debate over a possible link between vaccines and autism was being thwarted by the self-induced timidity of the press.
Some reporters told the author, Daniel Schulman, that they have basically given up on the story because the criticism -- some of it from their own editors -- was so fierce, and the story was so complicated.
Schulman described Age of Autism's efforts to come at the issue "sideways," looking for possible clues to the cause of the disorder in the natural history of autism. And he mentioned our reporting on the Amish:
"Privately, two reporters told me that, while intriguing, Olmsted's reporting on the Amish is misguided, since it may simply reflect genetic differences among an isolated gene pool. ... Both reporters believed that Olmsted has made up his mind on the question and is reporting the facts that support his conclusions."
Ouch. Being slammed by one's peers is never enjoyable, although reporters need to have thick skins and realize they dish this kind of thing out every day. (And those anonymous sources really are annoying, especially when I am happy to be quoted by name about everything.)
What's interesting about the reporters' "private" remarks is the degree of presumed expertise they suggest -- that looking at the Amish is misguided "since it may simply reflect genetic differences among an isolated gene pool." Really? Where did these guys get their doctorate in genetics, Harvard?
This assertion -- that the Amish gene pool could explain everything, based on no data that I'm aware of -- is the kind of self-interested speculation masquerading as expertise that has beset the autism-vaccines discussion for far too long. The term I learned for it long ago is "convenient reasoning," and it does not always have to be conscious.
The Amish have all kinds of standard genetic mental and developmental disorders -- from bipolar to retardation -- and a lot more genetic issues to boot from this supposedly protective "isolated gene pool." The doctors who actually know something about the Amish have never suggested to me that genes have anything to do with a low rate of autism. They seem perplexed.
In upcoming columns, we'll put that question to the right people -- geneticists -- and tell you what we find. It's called reporting.
By Dan Olmsted
UPI Senior Editor
Oct. 29, 2005 at 2:34PM
A specter is haunting the medical and journalism establishments of the United States: Where are the unvaccinated people with autism?
That is just about the only way to explain what now appears to be a collective resistance to considering that question. And like all unanswered questions, this raises another one: Why?
What is the problem with quickly and firmly establishing that the autism rate is about the same everywhere and for everybody in the United States, vaccinated or unvaccinated? Wouldn't that stop all the scientifically illiterate chatter by parents who believe vaccinations made their children autistic? Wouldn't it put to rest concerns that -- despite the removal of a mercury-containing preservative in most U.S. vaccines -- hundreds of millions of children in the developing world are possibly at risk if that preservative is in fact linked to autism?
Calling this issue The Amish Elephant reflects reporting earlier this year in Age of Autism that the largely unvaccinated Amish may have a relatively low rate of autism. That apparent dissimilarity is, in effect, a proverbial elephant in the living room -- studiously ignored by people who don't want to deal with it and don't believe they will have to.
Here are a few cases in point.
Earlier this month the National Consumers League conference in Washington held a session on communicating issues around vaccine safety. I was on the panel and talked about the Amish and autism. In the Q&A session that followed, the first question was for me.
"Is this a proper role for a journalist, or is this just a straw dog set up there with a preliminary answer? It not only showed up where you wrote it. It was all over the place. You did very, very well for UPI (at which point I said, 'Thank you -- please tell my bosses that!') but the question is, did you do very, very well for America?
"Is it appropriate for a journalist -- you weren't reporting, you were investigating. And I just wonder if you think it's an appropriate role for you to play."
My answer: "There's different roles for the press. That's certainly a reasonable question. That is investigative reporting. This idea is something that's already been discarded -- that there's any reason why you would want to look in an unvaccinated population.
"One of my favorite comments about journalism is that it's the wild card of American democracy. The First Amendment says we can do (in the sense of reporting about) whatever we want. So one of our privileges is to get an idea in our head and go look at it."
My questioner was not finished. "I wasn't questioning whether you have a First Amendment right to do it. I think this is more of a question of the ethics, of what value we are bringing to the debate."
My response: "That's probably not a good one for me to answer. Obviously I thought it was ethical."
At that point a fellow panelist, Dr. Louis Cooper, former president of the American Academy of Pediatrics and a staunch vaccine defender, spoke up. "I would jump in and say I thought it was ethical and I think it was useful," said Cooper, a courtly and unfailingly courteous Manhattan pediatrician.
"As you've learned, it was annoying to many people. I wasn't annoyed by it because I thought you kept the process and the debate and the discussion going forward. And we have to do that for one another."
That did not end the discussion. A few minutes later a public-health professor from -- where else? Harvard -- did her own version of Jeopardy!, offering the correct "answer" in the form of a question.
"This question is for Dan. Did you mention the outbreak of polio that happened in the Amish community in the Netherlands that caused widespread problems there, and also the fact that there'd been some context with respect to history in our country in trying to reach out to the Amish to actually encourage them to try to benefit from some of the vaccine technology to the extent that we could?
"So there's been a long history in this country of the CDC trying to reach out to them to the extent that they could. Also with respect to polio, I think what's really amazing is it's such a great story, this is such an exciting time, in the sense that we are very close to global eradication. What that means is we've gone from 1988 when we had 350,000 estimated paralytic polio cases in the world every year to roughly a thousand. It's very exciting that in fact we don't have the terror or the hysteria and all of the fear that surrounded disease.
"I just want to remind everyone that one thing that's very important in the context of reporting these stories is making sure that people do remember and also realize with infectious disease is these things can come back, and until they are eradicated they can come back and devastate us just as much as they did before, except now there are a lot more people.
"There's some related news that people might find interesting. A headline in the Washington Post today, 'Polio outbreak occurs among Amish families.' So I thought people might be interested in that."
At that point the moderator, Dr. Roger Bernier of the Centers for Disease Control, said time was getting short -- why was I not surprised? -- and asked for the next "question."
One thing I've noticed is the more that people want to lecture instead of learn, the more they speak in breathless run-on sentences that are hard to stop, slow down or even diagram. They leave one with the unspoken idea that dialogue -- opening the door to new information -- is somehow dangerous.
These exchanges reminded me of the response I got from Dr. Julie Gerberding, the CDC director, when I asked her this summer, verbatim: "Has the government ever looked at the autism rate in an unvaccinated U.S. population, and if not, why not?"
Her answer, verbatim:
--
In this country, we have very high levels of vaccination as you probably know, and I think this year we have record immunization levels among all of our children, so to (select an unvaccinated group) that on a population basis would be representative to look at incidence in that population compared to the other population would be something that could be done.
But as we're learning, just trying to look at autism in a community the size of Atlanta, it's very, very difficult to get an effective numerator and denominator to get a reliable diagnosis.
I think those kind of studies could be done and should be done. You'd have to adjust for the strong genetic component that also distinguishes, for example, people in Amish communities who may elect not to be immunized (and) also have genetic connectivity that would make them different from populations that are in other sectors of the United States. So drawing some conclusions from them would be very difficult.
I think with reference to the timing of all of this, good science does take time, and it's part of one of the messages I feel like I've learned from the feedback that we've gotten from parents groups this summer (in) struggling with developing a more robust and a faster research agenda, is let's speed this up. Let's look for the early studies that could give us at least some hypotheses to test and evaluate and get information flowing through the research pipeline as quickly as we can.
So we are committed to doing that, and as I mentioned, in terms of just measuring the frequency of autism in the population some pretty big steps have been taken. We're careful not to jump ahead of our data, but we think we will be able to provide more accurate information in the next year or so than we've been able to do up to this point. And I know that is our responsibility.
We've also benefited from some increased investments in these areas that have allowed us to do this, and so we thank Congress and we thank the administration for supporting those investments, not just at CDC but also at NIH and FDA.
--
The latest response to my pesky persistence comes not from academia or government but from my own profession. Last week the prestigious Columbia Journalism Review published an article whose main thrust -- with which I concur -- was that a vigorous debate over a possible link between vaccines and autism was being thwarted by the self-induced timidity of the press.
Some reporters told the author, Daniel Schulman, that they have basically given up on the story because the criticism -- some of it from their own editors -- was so fierce, and the story was so complicated.
Schulman described Age of Autism's efforts to come at the issue "sideways," looking for possible clues to the cause of the disorder in the natural history of autism. And he mentioned our reporting on the Amish:
"Privately, two reporters told me that, while intriguing, Olmsted's reporting on the Amish is misguided, since it may simply reflect genetic differences among an isolated gene pool. ... Both reporters believed that Olmsted has made up his mind on the question and is reporting the facts that support his conclusions."
Ouch. Being slammed by one's peers is never enjoyable, although reporters need to have thick skins and realize they dish this kind of thing out every day. (And those anonymous sources really are annoying, especially when I am happy to be quoted by name about everything.)
What's interesting about the reporters' "private" remarks is the degree of presumed expertise they suggest -- that looking at the Amish is misguided "since it may simply reflect genetic differences among an isolated gene pool." Really? Where did these guys get their doctorate in genetics, Harvard?
This assertion -- that the Amish gene pool could explain everything, based on no data that I'm aware of -- is the kind of self-interested speculation masquerading as expertise that has beset the autism-vaccines discussion for far too long. The term I learned for it long ago is "convenient reasoning," and it does not always have to be conscious.
The Amish have all kinds of standard genetic mental and developmental disorders -- from bipolar to retardation -- and a lot more genetic issues to boot from this supposedly protective "isolated gene pool." The doctors who actually know something about the Amish have never suggested to me that genes have anything to do with a low rate of autism. They seem perplexed.
In upcoming columns, we'll put that question to the right people -- geneticists -- and tell you what we find. It's called reporting.
August 13, 2005
Here's Why the Disdain...
This post is a response to a post by JP on his new blog, SupportVaccination.org.
[Update: JP has decided to leave the vaccine discussion and take his blog down, so the link no longer works. I wish I had saved a copy of the initial post that this was written in response to, but alas, I was not forward thinking enough to save a copy.]
[Update: John Cartan is the man! He found a cashed version for me. Here ya go: http://tinyurl.com/7celt ]
In his post, he ask questions of parents like me, that I am eager to answer. Parents have been accused of being "scientifically illiterate" and dismissing "well designed" population studies that show that there is no link between autism and thimerosal. I thought this was a good opportunity to tell the blogesphere, at least in part, why we are not so hot on the IOM’s epidemiological studies.
Dear JP,
As one of those parents with… well ‘distain’ is a harsh word, lets call it an ‘unwillingness to rely on’ the epidemiological studies cited by the IOM, it probably falls upon the likes of me to answer the question you pose in the title of your piece.
Why the disdain for epidemiology...
Since I am the likes of me, I will take this on and answer your questions and challenges from my point of view.
I am going to break up my response to your post into a few separate posts, as there are several things to address.
I am the mother of an autistic 3 year old boy and a marriage and family therapist, with a masters degree from Johns Hopkins. The statistics courses that I took in grad school were designed to educate me on how to evaluate the research of others to see if it was something we should incorporate into the treatment of a client. This education has turned out to be useful in evaluating the epidemiological studies that have been offered up to prove that thimerosal is safe.
I have been looking at these studies with two basic questions in mind:
I want to start first with what an epidemiological study is and what it can do.
Any question like this starts with case studies. Some one notices two things occurring together (smoking and lung cancer, vaccine reaction and autism) and they look at the plausibility of a relationship (smoke filling the lungs could cause damage, neurotoxic mercury in vaccines could cause brain damage).
Next they want to see if what they are observing in their setting could be happening else where and after conferring with associates and finding that others see the possibility of a link as well, they commission a large population study.
Epidemiological studies are limited in their use. They can be used to spot patterns and trends, but they can almost never be used to prove or disprove anything. They are one of the first stages of a medical inquiry and act as a divining rod to tell researchers where to start digging.
They are very vulnerable to confounders, because they are asking broad questions over huge numbers of people; so they should not be used to make definitive statements as much as to help researchers shape the next question that should be asked.
Those next questions are taken to smaller population studies (where confounders can be more easily controlled), lab studies (in vitro), and actual case studies (in vivo). The results of those studies, helps to further refine the questions being asked, which can be sent back up to large population studies, and so on, and so on until, (hopefully) the results of your epidemiological, in vitro and in vivo studies all line up like tumblers in a lock and the lock opens with one key.
This is not what we are seeing yet when we look at totality of autism/thimerosal research, as the IOM report shows. In fact the large epidemiological studies relied on for the conclusions in the report are at odds with other in vitro and in vivo research also in the report. The tumblers do not line up and therefore all of the research should be scrutinized to see what is throwing things off.
The scrutiny of the epidemiological studies has shown that they do not measure what they purport to measure, and even if they did, they cannot be applied in the way that they are being applied.
Your example of how epidemiological studies were used in the 50’s a nice example of how they can be used well and lead researchers to determine the source of a terrible illness like lung cancer, unfortunately it seems that what is going on today in this inquiry is a very different scenario.
What we know so far about autism tells us that it is not as straight forward as, smoke cigarettes get lung cancer. The thimerosal studies seem to have multiple confounders (genetic, environmental, etc) that cut into the reliability of epidemiological studies.
The two studies that are relied upon the most heavily are the Danish Study and the Verstraten Study. Both of these studies were designed and carried out very poorly and are being used very badly.
Here is why I treat them with such skepticism. (Quoting myself in part from an earlier post that responded to a piece by Dr. Laidler)
One of the problems that complicates the search for the causes and cures of autism is the assumption that it is a single disorder and that all cases are caused by the same thing. This is in contrast to a disease like AIDS in which all cases are brought on by the HIV virus.
What is diagnosed as ‘Autism’ is actually likely to be more than one physical syndrome. Because Autism is a DSM diagnosis and based solely on behavioral criteria, the diagnosis does not address the different sets of physical anomaly clusters that researchers are finding when they look at the biology of ‘autistic’ patients.
One research group has recently made a distinction between two types of autistic profiles. One, labeled complex autism and occurring in about 30% of autism cases, presents with smaller head size, greater chance of low IQ, lower rate of siblings with the disorder and seems to have close to a 1:1 ratio of occurrence between boys and girls.
The other, essential autism, presents with larger head size, few structural brain abnormalities and has a ratio of 7:1 boys to girls.
This is a huge confounder to any epidemiological study, even a well designed one, that looks at all cases of diagnosed autism with out differentiating between groups with different phenotypes.
In discussing research into the causes of autism (in this case the genetic cause), one of the researchers commented, “…Studies haven’t found anything because they’re looking at a big heterogeneous group — a mishmash of people with different etiologies,” Takahashi said.”
One could postulate that only the larger head size group displays autistic symptoms because of mercury poisoning, as mercury toxicity does not always present with impaired IQ; and because in vitro thimerosal toxicity studies preformed at the University of Kentucky showed that estrogen has a protective effect against, and testosterone exacerbates the damage of, ethlymercury as a neurotoxin.
In light of this new information it seems that a better question than, “is autism is caused by mercury toxicity” which is the question largely being asked in these epidemiological studies, would be, “are cases of mercury toxicity being misdiagnosed as autism”.
The answer to that question cannot be found in a large epidemiological study.
The authors of the the final IOM report on the thimerosal/autism relationship in 2004 stated themselves that the epidemiological research it was relying on to clear thimerosal as a cause of autism would not pick up on a sub-set of the population that was genetically vulnerable to mercury poisoning.
If that is the case, then how much more so to these studies fail to give us meaningful data if the children who may be mercury poisoned are members of two different subsets being confused with one another?
Since the working theory in biomedical treatment of autism is that many of the children diagnosed with autism are genetically vulnerable sub set who cannot excrete heavy metals, and since this treatment is bringing about successes in the abatement of many children's autistic symptoms, does that not throw into question the use of these large scale studies to find the correlation between thimerosal and autism as easily as they would between smoking and cancer?
What causes further problems for people who want to use these studies to show that the case is closed on thimerosal and NDDs (as the conclusion in the IOM study does) is that these studies are not well designed and are very poorly applied.
The findings in the Denmark study have come under serious criticism. When the data of study was reviewed, it was found that the sampling presented fatal flaws.
The low incidence of autism during the use of thimerosal can be attributed to the fact that the database that was used only tracked inpatient cases of autism at the time. At the point in time where thimerosal was removed, the database was expanded to include cases that were diagnosed at a large clinic outside of Copenhagen where 20% of the countries autistic patents were diagnosed. At the point in time where thimerosal was no longer used, but the cases of autism seem to have skyrocketed, the database had expanded further to include all cases of autism, inpatient and outpatient, in the country.
The sample size of the study was only 956 children. That is the number of people that their disability database had on record as being diagnosed with autism in Denmark between 1971 and 2000. 956 people in 29 years. That is 33 people a year in the entire country. [Hyperbole warning] I have that many autistic kids in my kitchen right now!
The study is further compromised by the fact that several of the coauthors were employed by the Statens Serums Institut, the countries sole vaccine manufacturer who would presumably be held liable if it was indeed found that the use of thimerosal in vaccines contributed to autism.
[Update: Kristjan has pointed out here that the Danish health care system and liability laws are different from ours and no such legal liability exists for the Statens Serums Institut. I still wonder what might motivate these researchers to stand buy this study and not protest its poor use. More on that in the comments here, here and here.]
Further, even if the study were reliable, applying it to the U.S. population as the IOM has done presents problems. Children in Denmark were administered less than half the amount of thimerosal of US children, and it was administered later and over a longer period of time.
Finally, American children, like my sons, are subject to an autism rate at least 10 times that of Denmark, so this study should not be applied to determine their risk of autism from thimerosal exposure.
It seems to me to be like doing a population study of Sickle Cell Anemia in Denmark and applying it to the population of Baltimore. Clearly U.S. children have some other intervening factors that increases the threat of NDDs, be they genetic, environmental or the thimerosal dosage and age of administration.
The problems with the Verstraten study, the only epidemiological study that the CDC has done in the U.S. to examine the possible link between thimerosal containing vaccines and neurodevelopmental disorders, are severe. It is such a badly designed and executed study that I can hardly do it justice in a blog post. I started working on a review of it about 6 weeks ago for my blog and I still have not finished.
In fact, it is currently the subject of a Senate investigation that may result in hearings on Capitol Hill.
I will try to do a quick review of my ‘distain’ for it, as I actually think the harshness of your term might apply to my attitude in this case.
Verstraten started with a nice, simple study. He had medical records of about 180,000 kids in California, a good sized sample. He broke them up into four main groups, kids who received no thimerosal, a little thimerosal, a moderate amount, and a high amount. He checked to see if the amount of thimerosal that they got, and when they got it (two months of age, six months of age, etc) corresponded to an increased risk for different types of neurodevelopmental disorders, and NDDs in general.
The study began in November of 1999 and was supposed to be finished in 4 months.
What he found was that the more thimerosal a child got, the higher their chance of an NDD, with children who got the highest doses had a huge risk of having a disorder, more than 600% in one case. He also found that the age at which it was administered determined the type of disorder that a child would develop.
Verstraten sent an email to another CDC employee, Dr. Davis, and said that no matter what he tried, could not make the relationship go away.
In December the two men, and additional researchers at the CDC, began to change the parameters of the study. When you do this, you are supposed to document all the changes and justify why they are needed to properly answer the question you are asking. They did not.
The changes they began to make to the statistical analysis of the study are now described by the CDC as “improvements”. How they could see some of these changes as improvements is unbelievable to me. Here are some of the changes:
They took the zero thimerosal group, and tucked them into the low thimerosal group. Now they only have three groups and in effect they have brought up the bottom, so the top does not seem as high.
That did not bring down the risk enough, so they decided to get rid of the no thimerosal group all together, so now you are only comparing the low, middle and high groups, bring up the bottom further.
They got rid of a catch all group of NDDs so the study no longer addressed the question, ‘does an increase thimerosal increase the risk of a neurodevelopmental disorder’. Now it only looked at each disorder separately.
Still not dampening the signal enough, the decided to go into and change some of the actual medical records of the patients they were studying. The CDC reports that these were correcting errors in patient records, but will not offer any proof of this claim, saying instead that the data that would confirm their claim was ‘lost’.
This brought the risk down, but still showed a link between thimerosal and NDDs, so they then started dropping children from the study. They used about 20 different ICD9 codes to exclude any child from the study that had almost any birth complication or whose mother had almost any pregnancy complication. This included serious problems like premature birth and birth defects, but went all the way down to moms who took an antibiotic while pregnant. In effect this removes from the study many children who are likely to go on to develop NDDs.
This is fine to do in your study if you want, but it renders it almost completely useless for application to vaccine policy. This policy covers all U.S. children, and lots and lots of those children were subject to pregnancy and birth complications.
This study now no longer applies to my children as both of my pregnancies had complications.
At this point it is safe to say that this study no longer addressed the question of whether or not an increase in the dose of thimerosal increases the chance of an NDD in American children. But the ‘improvements’ don’t stop there.
Many more people are given a chance to make suggestions, the Simpsonwood meeting was held, comments are made that the study never should have been done in the first place, and the research is further bastardized.
A stop date was put in place so that children who were initially diagnosed with something like a speech delay, were then always considered to be speech delayed, even if they went on to be diagnosed with a more serious disorder like full blown autism. This is important as a large number of kids diagnosed with autism at ages 3 and 4 are diagnosed with some milder developmental delay at 18 months or two years of age. Doctors don’t like giving the autism diagnosis early, and the state of California (where the study was done) won’t even formally evaluate children for autism, or diagnose it before the age of 3.
I live in California. My son was evaluated at 2 and found to have ‘speech delays’ and offered early start services. To all involved in his treatment, he was autistic, but he did not become officially “Autistic” according to the state and his own records until age 3. Chandler would not have been considered Autistic for the purposes of the Verstraeten study.
My favorite ‘improvement’ was to add into the study children who were only a year or so old at the cut off date of the study. No child is diagnosed with autism, or indeed much of anything, this early. They all could have gone on to be diagnosed with a neurodevelopmental disorder but in the Verstraeten study, they are all considered healthy and unaffected by thimerosal.
Even with all these shenanigans, they STILL could not completely get rid of the relationship between thimerosal and NDDs. They then employed a tactic that served to make their own findings in the study irrelevant.
They split the whole group up into two, one large one from one HMO and one smaller group from another HMO (I think it was around 16,000). The small group was now too small to be of any statistical power. They used that group to say that the results in the first group could not be replicated in the second.
Then they bought another database from an HMO in New England, which was odd because they already owned dozens of them at the cost of millions of dollars in tax payer money. The HMO had failed and was in receivership due in part to poor record keeping on out of date computers. The HMO also used their own diagnostic system that didn’t even implement ICD9 codes and the researchers used completely different parameters to study this database than they did in the first. They used this third group of only 12,000 or so patients, as yet another example of how they could not replicate the results of the first, large group, which they were now referring to as ‘the screening study’.
The 4 month study took 4 years and, in my opinion, came out looking like something akin to Frankenstein’s Monster.
This study does not offer a meaningful measure of anything and cannot be applied to any group that I can think of.
Add to this the fact Verstraten himself became an employee of Glaxo (currently being sued by parents of autistic children) half way through the study, which was not disclosed when the study was published, and it becomes easy to see why where the distain comes from.
When asked to justify all the changes and publish the data so that the study could be confirmed and replicated, the CDC repeated the claim that the original data was ‘lost’. A private contractor testified before congress that he had been ordered to destroy the data sets, “to insure patient confidentiality”. This is a violation of federal law and is what sparked the congressional investigation currently underway.
It is practice in the scientific community that if a study can not be confirmed or replicated, that it should be withdrawn. Despite parent requests for such action, the CDC stands by this study and refuses to pull it.
As a parent who is looking at this issue as hard as I can, I am upset that the IOM, who should know better, keeps calling these studies ‘well designed’ and has used them to show that the case is closed on thimerosal and autism.
Verstraeten himself says that the study is a ‘neutral study’ and does not find for or against thimerosal in the implication that it is involved with NDDs.
In grad school, in order to pass statistics we had to take studies and break them down, justifying if and how they could be used for us to make treatment decisions. The Institute of Medicine would have failed my 600 level stats courses.
ADDENDUM:
People have asked for citations. What hasn't been referenced above can be found in David Kirby's book, Evidence Of Harm as this post just attempts to squish his big fat book into a blog post.
Additional addendum:
Julie Gerberding was asked by Congress to defend Verstraeten and had to reply that it was a useless study. She did so in secret, but the document was leaked by a congressional staffer. Even though everyone knows it is garbage, Pediatrics has not retracted it, and some still claim it clears the vaccine/autism theory. However CDC removed it from their list of research that refutes the theory in by the end of 2008 when news of the Congressional/CDC exchange went public.
[Update: JP has decided to leave the vaccine discussion and take his blog down, so the link no longer works. I wish I had saved a copy of the initial post that this was written in response to, but alas, I was not forward thinking enough to save a copy.]
[Update: John Cartan is the man! He found a cashed version for me. Here ya go: http://tinyurl.com/7celt ]
In his post, he ask questions of parents like me, that I am eager to answer. Parents have been accused of being "scientifically illiterate" and dismissing "well designed" population studies that show that there is no link between autism and thimerosal. I thought this was a good opportunity to tell the blogesphere, at least in part, why we are not so hot on the IOM’s epidemiological studies.
Dear JP,
As one of those parents with… well ‘distain’ is a harsh word, lets call it an ‘unwillingness to rely on’ the epidemiological studies cited by the IOM, it probably falls upon the likes of me to answer the question you pose in the title of your piece.
Why the disdain for epidemiology...
Since I am the likes of me, I will take this on and answer your questions and challenges from my point of view.
I am going to break up my response to your post into a few separate posts, as there are several things to address.
I am the mother of an autistic 3 year old boy and a marriage and family therapist, with a masters degree from Johns Hopkins. The statistics courses that I took in grad school were designed to educate me on how to evaluate the research of others to see if it was something we should incorporate into the treatment of a client. This education has turned out to be useful in evaluating the epidemiological studies that have been offered up to prove that thimerosal is safe.
I have been looking at these studies with two basic questions in mind:
Can this study be applied to entire population of children in the U.S. and thereby be useful for guidance in setting vaccine policy? If so, how?
Can I use this study to make a determination as to the safety of vaccinating my sons, one who is autistic and one who is (mostly) neurotypical. If so, how?
I want to start first with what an epidemiological study is and what it can do.
Any question like this starts with case studies. Some one notices two things occurring together (smoking and lung cancer, vaccine reaction and autism) and they look at the plausibility of a relationship (smoke filling the lungs could cause damage, neurotoxic mercury in vaccines could cause brain damage).
Next they want to see if what they are observing in their setting could be happening else where and after conferring with associates and finding that others see the possibility of a link as well, they commission a large population study.
Epidemiological studies are limited in their use. They can be used to spot patterns and trends, but they can almost never be used to prove or disprove anything. They are one of the first stages of a medical inquiry and act as a divining rod to tell researchers where to start digging.
They are very vulnerable to confounders, because they are asking broad questions over huge numbers of people; so they should not be used to make definitive statements as much as to help researchers shape the next question that should be asked.
Those next questions are taken to smaller population studies (where confounders can be more easily controlled), lab studies (in vitro), and actual case studies (in vivo). The results of those studies, helps to further refine the questions being asked, which can be sent back up to large population studies, and so on, and so on until, (hopefully) the results of your epidemiological, in vitro and in vivo studies all line up like tumblers in a lock and the lock opens with one key.
This is not what we are seeing yet when we look at totality of autism/thimerosal research, as the IOM report shows. In fact the large epidemiological studies relied on for the conclusions in the report are at odds with other in vitro and in vivo research also in the report. The tumblers do not line up and therefore all of the research should be scrutinized to see what is throwing things off.
The scrutiny of the epidemiological studies has shown that they do not measure what they purport to measure, and even if they did, they cannot be applied in the way that they are being applied.
Your example of how epidemiological studies were used in the 50’s a nice example of how they can be used well and lead researchers to determine the source of a terrible illness like lung cancer, unfortunately it seems that what is going on today in this inquiry is a very different scenario.
What we know so far about autism tells us that it is not as straight forward as, smoke cigarettes get lung cancer. The thimerosal studies seem to have multiple confounders (genetic, environmental, etc) that cut into the reliability of epidemiological studies.
The two studies that are relied upon the most heavily are the Danish Study and the Verstraten Study. Both of these studies were designed and carried out very poorly and are being used very badly.
Here is why I treat them with such skepticism. (Quoting myself in part from an earlier post that responded to a piece by Dr. Laidler)
One of the problems that complicates the search for the causes and cures of autism is the assumption that it is a single disorder and that all cases are caused by the same thing. This is in contrast to a disease like AIDS in which all cases are brought on by the HIV virus.
What is diagnosed as ‘Autism’ is actually likely to be more than one physical syndrome. Because Autism is a DSM diagnosis and based solely on behavioral criteria, the diagnosis does not address the different sets of physical anomaly clusters that researchers are finding when they look at the biology of ‘autistic’ patients.
One research group has recently made a distinction between two types of autistic profiles. One, labeled complex autism and occurring in about 30% of autism cases, presents with smaller head size, greater chance of low IQ, lower rate of siblings with the disorder and seems to have close to a 1:1 ratio of occurrence between boys and girls.
The other, essential autism, presents with larger head size, few structural brain abnormalities and has a ratio of 7:1 boys to girls.
This is a huge confounder to any epidemiological study, even a well designed one, that looks at all cases of diagnosed autism with out differentiating between groups with different phenotypes.
In discussing research into the causes of autism (in this case the genetic cause), one of the researchers commented, “…Studies haven’t found anything because they’re looking at a big heterogeneous group — a mishmash of people with different etiologies,” Takahashi said.”
One could postulate that only the larger head size group displays autistic symptoms because of mercury poisoning, as mercury toxicity does not always present with impaired IQ; and because in vitro thimerosal toxicity studies preformed at the University of Kentucky showed that estrogen has a protective effect against, and testosterone exacerbates the damage of, ethlymercury as a neurotoxin.
In light of this new information it seems that a better question than, “is autism is caused by mercury toxicity” which is the question largely being asked in these epidemiological studies, would be, “are cases of mercury toxicity being misdiagnosed as autism”.
The answer to that question cannot be found in a large epidemiological study.
The authors of the the final IOM report on the thimerosal/autism relationship in 2004 stated themselves that the epidemiological research it was relying on to clear thimerosal as a cause of autism would not pick up on a sub-set of the population that was genetically vulnerable to mercury poisoning.
If that is the case, then how much more so to these studies fail to give us meaningful data if the children who may be mercury poisoned are members of two different subsets being confused with one another?
Since the working theory in biomedical treatment of autism is that many of the children diagnosed with autism are genetically vulnerable sub set who cannot excrete heavy metals, and since this treatment is bringing about successes in the abatement of many children's autistic symptoms, does that not throw into question the use of these large scale studies to find the correlation between thimerosal and autism as easily as they would between smoking and cancer?
What causes further problems for people who want to use these studies to show that the case is closed on thimerosal and NDDs (as the conclusion in the IOM study does) is that these studies are not well designed and are very poorly applied.
The findings in the Denmark study have come under serious criticism. When the data of study was reviewed, it was found that the sampling presented fatal flaws.
The low incidence of autism during the use of thimerosal can be attributed to the fact that the database that was used only tracked inpatient cases of autism at the time. At the point in time where thimerosal was removed, the database was expanded to include cases that were diagnosed at a large clinic outside of Copenhagen where 20% of the countries autistic patents were diagnosed. At the point in time where thimerosal was no longer used, but the cases of autism seem to have skyrocketed, the database had expanded further to include all cases of autism, inpatient and outpatient, in the country.
The sample size of the study was only 956 children. That is the number of people that their disability database had on record as being diagnosed with autism in Denmark between 1971 and 2000. 956 people in 29 years. That is 33 people a year in the entire country. [Hyperbole warning] I have that many autistic kids in my kitchen right now!
The study is further compromised by the fact that several of the coauthors were employed by the Statens Serums Institut, the countries sole vaccine manufacturer who would presumably be held liable if it was indeed found that the use of thimerosal in vaccines contributed to autism.
[Update: Kristjan has pointed out here that the Danish health care system and liability laws are different from ours and no such legal liability exists for the Statens Serums Institut. I still wonder what might motivate these researchers to stand buy this study and not protest its poor use. More on that in the comments here, here and here.]
Further, even if the study were reliable, applying it to the U.S. population as the IOM has done presents problems. Children in Denmark were administered less than half the amount of thimerosal of US children, and it was administered later and over a longer period of time.
Finally, American children, like my sons, are subject to an autism rate at least 10 times that of Denmark, so this study should not be applied to determine their risk of autism from thimerosal exposure.
It seems to me to be like doing a population study of Sickle Cell Anemia in Denmark and applying it to the population of Baltimore. Clearly U.S. children have some other intervening factors that increases the threat of NDDs, be they genetic, environmental or the thimerosal dosage and age of administration.
The problems with the Verstraten study, the only epidemiological study that the CDC has done in the U.S. to examine the possible link between thimerosal containing vaccines and neurodevelopmental disorders, are severe. It is such a badly designed and executed study that I can hardly do it justice in a blog post. I started working on a review of it about 6 weeks ago for my blog and I still have not finished.
In fact, it is currently the subject of a Senate investigation that may result in hearings on Capitol Hill.
I will try to do a quick review of my ‘distain’ for it, as I actually think the harshness of your term might apply to my attitude in this case.
Verstraten started with a nice, simple study. He had medical records of about 180,000 kids in California, a good sized sample. He broke them up into four main groups, kids who received no thimerosal, a little thimerosal, a moderate amount, and a high amount. He checked to see if the amount of thimerosal that they got, and when they got it (two months of age, six months of age, etc) corresponded to an increased risk for different types of neurodevelopmental disorders, and NDDs in general.
The study began in November of 1999 and was supposed to be finished in 4 months.
What he found was that the more thimerosal a child got, the higher their chance of an NDD, with children who got the highest doses had a huge risk of having a disorder, more than 600% in one case. He also found that the age at which it was administered determined the type of disorder that a child would develop.
Verstraten sent an email to another CDC employee, Dr. Davis, and said that no matter what he tried, could not make the relationship go away.
In December the two men, and additional researchers at the CDC, began to change the parameters of the study. When you do this, you are supposed to document all the changes and justify why they are needed to properly answer the question you are asking. They did not.
The changes they began to make to the statistical analysis of the study are now described by the CDC as “improvements”. How they could see some of these changes as improvements is unbelievable to me. Here are some of the changes:
They took the zero thimerosal group, and tucked them into the low thimerosal group. Now they only have three groups and in effect they have brought up the bottom, so the top does not seem as high.
That did not bring down the risk enough, so they decided to get rid of the no thimerosal group all together, so now you are only comparing the low, middle and high groups, bring up the bottom further.
They got rid of a catch all group of NDDs so the study no longer addressed the question, ‘does an increase thimerosal increase the risk of a neurodevelopmental disorder’. Now it only looked at each disorder separately.
Still not dampening the signal enough, the decided to go into and change some of the actual medical records of the patients they were studying. The CDC reports that these were correcting errors in patient records, but will not offer any proof of this claim, saying instead that the data that would confirm their claim was ‘lost’.
This brought the risk down, but still showed a link between thimerosal and NDDs, so they then started dropping children from the study. They used about 20 different ICD9 codes to exclude any child from the study that had almost any birth complication or whose mother had almost any pregnancy complication. This included serious problems like premature birth and birth defects, but went all the way down to moms who took an antibiotic while pregnant. In effect this removes from the study many children who are likely to go on to develop NDDs.
This is fine to do in your study if you want, but it renders it almost completely useless for application to vaccine policy. This policy covers all U.S. children, and lots and lots of those children were subject to pregnancy and birth complications.
This study now no longer applies to my children as both of my pregnancies had complications.
At this point it is safe to say that this study no longer addressed the question of whether or not an increase in the dose of thimerosal increases the chance of an NDD in American children. But the ‘improvements’ don’t stop there.
Many more people are given a chance to make suggestions, the Simpsonwood meeting was held, comments are made that the study never should have been done in the first place, and the research is further bastardized.
A stop date was put in place so that children who were initially diagnosed with something like a speech delay, were then always considered to be speech delayed, even if they went on to be diagnosed with a more serious disorder like full blown autism. This is important as a large number of kids diagnosed with autism at ages 3 and 4 are diagnosed with some milder developmental delay at 18 months or two years of age. Doctors don’t like giving the autism diagnosis early, and the state of California (where the study was done) won’t even formally evaluate children for autism, or diagnose it before the age of 3.
I live in California. My son was evaluated at 2 and found to have ‘speech delays’ and offered early start services. To all involved in his treatment, he was autistic, but he did not become officially “Autistic” according to the state and his own records until age 3. Chandler would not have been considered Autistic for the purposes of the Verstraeten study.
My favorite ‘improvement’ was to add into the study children who were only a year or so old at the cut off date of the study. No child is diagnosed with autism, or indeed much of anything, this early. They all could have gone on to be diagnosed with a neurodevelopmental disorder but in the Verstraeten study, they are all considered healthy and unaffected by thimerosal.
Even with all these shenanigans, they STILL could not completely get rid of the relationship between thimerosal and NDDs. They then employed a tactic that served to make their own findings in the study irrelevant.
They split the whole group up into two, one large one from one HMO and one smaller group from another HMO (I think it was around 16,000). The small group was now too small to be of any statistical power. They used that group to say that the results in the first group could not be replicated in the second.
Then they bought another database from an HMO in New England, which was odd because they already owned dozens of them at the cost of millions of dollars in tax payer money. The HMO had failed and was in receivership due in part to poor record keeping on out of date computers. The HMO also used their own diagnostic system that didn’t even implement ICD9 codes and the researchers used completely different parameters to study this database than they did in the first. They used this third group of only 12,000 or so patients, as yet another example of how they could not replicate the results of the first, large group, which they were now referring to as ‘the screening study’.
The 4 month study took 4 years and, in my opinion, came out looking like something akin to Frankenstein’s Monster.
This study does not offer a meaningful measure of anything and cannot be applied to any group that I can think of.
Add to this the fact Verstraten himself became an employee of Glaxo (currently being sued by parents of autistic children) half way through the study, which was not disclosed when the study was published, and it becomes easy to see why where the distain comes from.
When asked to justify all the changes and publish the data so that the study could be confirmed and replicated, the CDC repeated the claim that the original data was ‘lost’. A private contractor testified before congress that he had been ordered to destroy the data sets, “to insure patient confidentiality”. This is a violation of federal law and is what sparked the congressional investigation currently underway.
It is practice in the scientific community that if a study can not be confirmed or replicated, that it should be withdrawn. Despite parent requests for such action, the CDC stands by this study and refuses to pull it.
As a parent who is looking at this issue as hard as I can, I am upset that the IOM, who should know better, keeps calling these studies ‘well designed’ and has used them to show that the case is closed on thimerosal and autism.
Verstraeten himself says that the study is a ‘neutral study’ and does not find for or against thimerosal in the implication that it is involved with NDDs.
In grad school, in order to pass statistics we had to take studies and break them down, justifying if and how they could be used for us to make treatment decisions. The Institute of Medicine would have failed my 600 level stats courses.
ADDENDUM:
People have asked for citations. What hasn't been referenced above can be found in David Kirby's book, Evidence Of Harm as this post just attempts to squish his big fat book into a blog post.
Additional addendum:
Julie Gerberding was asked by Congress to defend Verstraeten and had to reply that it was a useless study. She did so in secret, but the document was leaked by a congressional staffer. Even though everyone knows it is garbage, Pediatrics has not retracted it, and some still claim it clears the vaccine/autism theory. However CDC removed it from their list of research that refutes the theory in by the end of 2008 when news of the Congressional/CDC exchange went public.
July 30, 2005
File under: Things That Call For A CDC Study
The following is an article on Chelation that was brought to my attention by Skeptico and I thought that it was a great article to address as a parent who is currently chelating their child.
One of the problems that complicates the search for the causes and cures of autism is the assumption that it is a single disorder and that all cases are caused by the same thing. This is in contrast to a disease like AIDS in which all cases are brought on by the HIV virus.
What is diagnosed as ‘Autism’ is actually likely to be more than one physical syndrome. Because Autism is a DSM diagnosis and based solely on behavioral criteria, the diagnosis does not address the different sets of physical anomaly clusters that researchers are finding when they look at the biology of ‘autistic’ patients.
One research group has recently made a distinction between two types of autistic profiles. One, labeled complex autism and occurring in about 30% of autism cases, presents with smaller head size, greater chance of low IQ, lower rate of siblings with the disorder and seems to have close to a 1:1 ratio of occurrence between boys and girls.
The other, essential autism, presents with larger head size, few structural brain abnormalities and has a ratio of 7:1 boys to girls.
This is a huge confounder to any epidemiological study, even a well designed one, that looks at all cases of diagnosed autism with out differentiating between groups with different phenotypes.
In discussing research into the causes of autism (in this case the genetic cause), one of the researchers commented, “…Studies haven’t found anything because they’re looking at a big heterogeneous group — a mishmash of people with different etiologies,” Takahashi said.”
One could postulate that only the larger head size group displays autistic symptoms because of mercury poisoning, as mercury toxicity does not always present with impaired IQ; and because in vitro thimerosal toxicity studies preformed at the University of Kentucky showed that estrogen has a protective effect against, and testosterone exacerbates the damage of, ethlymercury as a neurotoxin.
In light of this new information it seems that a better question than, “is autism is caused by mercury toxicity” which is the question largely being asked in these epidemiological studies, would be, “are cases of mercury toxicity being misdiagnosed as autism”.
The answer to that question cannot be found in a large epidemiological study.
The authors of the the final IOM report on the thimerosal/autism relationship in 2004 stated themselves that the epidemiological research it was relying on to clear thimerosal as a cause of autism would not pick up on a sub-set of the population that was genetically vulnerable to mercury poisoning.
If that is the case, then how much more so to these studies fail to give us meaningful data if the children who may be mercury poisoned are members of two different subsets being confused with one another?
Well designed studies do take time to complete and publish.
This is further delayed that by the fact that health authorities are neither attempting to complete or publish them. Despite years of parents requests, the public health authorities have not yet begun to design, fund or even discuss studying the effects of thimerosal on developing children, nor the safety and effectiveness of chelation on autistic patients.
[Update: I have heard that there are 2 government funded studies getting underway on the effects of thimerosal. I will try to find them and confirm exactly what they are. Still no govenment funded chelation/autism studies.]
Thimerosal was invented in the 1920’s and it’s only safety test was carried out in 1930 on 22 patients with terminal meningococcal meningitis. Patients were followed for several days until their deaths. No long term health problems were noted in the study because the patients had no long term health.
When the FDA was created, thimerosal was grandfathered in and has never been safety tested it to this day despite the fact that it has been implicated in toxic illness every few years going back to 1947.
I will be repeating this point through out my critique of this paper.
The findings in the Denmark study have come under serious criticism. When the data of study was reviewed, it was found that the sampling presented fatal flaws. The low incidence of autism during the use of thimerosal can be attributed to the fact that the database that was used only tracked inpatient cases of autism at the time. At the point in time where thimerosal was removed, the database was expanded to include cases that were diagnosed at a large clinic outside of Copenhagen where 20% of the countries autistic patents were diagnosed. At the point in time where thimerosal was no longer used, but the cases of autism seem to have skyrocketed, the database had expanded further to include all cases of autism, inpatient and outpatient, in the country.
The study is further compromised by the fact that several of the coauthors were employed by the Statens Serums Institut, the government owned vaccine manufacturer who would be held liable if it was indeed found that the use of thimerosal in vaccines contributed to autism.
[Update: Kristjan has pointed out here that the Danish health care system and liability laws are different from ours and no such legal liability exists for the Statens Serums Institut. I still wonder what might motivate these researchers to stand buy this study and not protest its poor use. More on that in the comments here, here and here.]
Finally, even if the study were reliable, applying it to the U.S. population as the IOM has done presents problems. Children in Denmark were administered less than half the amount of thimerosal of US children and it was given over a longer period of time.
Further, American children are subject to an autism rate at least 10 times that of Denmark. It seems to me to be like doing a study of Sickle Cell Anemia in Denmark and applying it to the population of Baltimore. Clearly children here have some other intervening factor that increases the threat, be it genetic, environmental or even the thimerosal dosage.
As for Canada, I have seen this mentioned in several places, but I have never seen the actual study. If you have it or know where I can find it, can you please email me so I can look at it? Thanks in advance.
Update: Shannon from British Columbia reports that there is no Canada study or even any Canada data to be studied. She reports that they don't keep track of autism rates and don't offer services. She also reports that thimerosal removal from vaccines was left up to the provinces and that many are still on the shelves. See her comment in the section below for a more detailed explanation.
I think that it is clear that the VAERS is a poor source for such studies. The CDC’s Vaccine Safety Datalink is a much better source, but the CDC has blocked it from being reviewed by independent researches despite the fact that congress has directed it to do so and claims that disallowing such access is a violation of federal law. The one team granted access in 2003 was severely limited in what they could do and thus their research effort, although it found a dramatic link, was completely tainted by the process and seems to me somewhat of a false start.
The CDC claims that they welcome research applications, but at last check they had not accepted any.
Dr. Laidler seems to be saying that contamination during collection and overnight shipping can skew results, but I don’t feel that he has properly addressed the possible process by which mercury would begin to appear in urine samples that had none at the time of excretion.
What is not mentioned in this discussion of “provoked” excretion studies, is the context in which the study becomes valuable. The working theory in this case is that some autistic children are actually members of a sub-set with a genetic impairment to excrete heavy metals such as mercury. Straight forward blood, urine and hair tests for mercury that would identify mercury toxicity in typical subjects who have been victims of a large mercury exposure would be useless in identifying mercury toxicity in people who have no ability to excrete mercury.
In order to find out if these types of subjects have mercury in their tissue, it must be stimulated. If it is excreted in the urine after the introduction of a chelating agent, then it was present in the body tissue.
“Normal values” seem to mean little in these results. When mercury is excreted during a DMSA challenge, it cannot be taken as a true measure of how much mercury is in the tissues. Like clowns coming out of a car, you don’t know how much is in the body until you count all of it when it comes out.
Several factors complicate a getting a true picture of how much is in the body, one being that DMSA binds to lead more readily than to mercury, so if lead is present, the mercury level may be artificially depressed.
Doctors have reported patients excreting up to three and four hundred times the mercury that the baseline showed on the initial challenge.
The only thing that can be said with much certainty is that if you give a chelating agent, and mercury comes out, then it was in there and treatment should continue until it stops being excreted.
Being a parent that has paid $300 for such urine metal tests, I am all for lowering the price. However, if I woulda known then what I know now, that the first time I did such a test on my son I would find mercury and lead, and that the chelation we have done as a result would help my son make the progress that he has made, I would happily sign my car over to the lab that delivered me these results.
But that's just me.
[scarcasm alert]I believe a good way to lower the costs of the test in this free market, would be many labs offering this standardized test, and doctors regularly screening children with ASD, ADHD, verbal and developmental delays, and those who have exhibited symptoms of vaccine injury after thimerosal containing vaccines, for mercury poisoning. That might be something that the government could look into.
[Update 2007 - the free market prevails. My son's last urine toxic metals test this month cost $65]
I need more information from Dr. Laidler on this point. Does “no clinical data” mean that studies have been done and no connection has been found, or that no studies have been done?
I don’t know any families who have relied on fecal mercury levels in order to make a decision on whether or not to chelate, nor have I read of doctors relying on them. It seems an inaccurate measure of mercury toxicity for all the reasons you mention. Can anyone point me towards a source that recommends relying on it so I can further look into this?
[Update 2007: I have not heard of fecal mercury levels being used in the two years since this was written.]
The role that glutathione may play in autism is still emerging. Just a few months ago a study was released that found that 80% of autistic test subjects had some degree of glutathione depletion. After reading this I began supplementing over the counter oral l-glutathione and his speech began to progress more rapidly. He went from taking several minutes to put together a simple three word sentence, to spontaneous three and four word sentences in the matter of two months, and a week ago he began pointing things out to me (with his finger), saying, “look, look. Rain”.
I am genuinely interested to know specifics about exactly what it is doing and why such a weak chelator would be so helpful to him. I am looking forward to the question being studied further by federal health authorities.
There is now a product call Detoxamin that is EDTA in suppository form. Is this well absorbed form? Just curious.
I am grateful to Dr. Laidler for pointing out that DMSA has a good safety record and is the standard treatment for lead poisoning. I have read many poorly researched reports that claim that all chelation is dangerous and it is quite frustrating.
In my experience, this is becoming more generally agreed upon in the autism community, although there are some doctors that have used EDTA and DMPS. I think that the trend seems to be coming back around to the use of DMSA.
While it is true that a sulfur odor does present itself, it has never occurred to me that it was a ‘problem’ or even something that a parent might take into account when deciding whether or not to chelate a child with mercury poisoning. Changing diapers more often or airing out the bathroom is little price to pay for a chance to get back your healthy, thriving child.
I did read about one family whose son carried an incredibly strong, unpleasant odor at all times during the first 6 weeks of his chelation. They lived with all the windows open and joked about all the stinky toxins that he was shedding.
They seemed really happy to have his odor problem replace their little boy’s autistic symptoms.
Many doctors use this in conjunction with or following DMSA chelation because of its presumed ability to better penetrate into the brain. We have found adding ALA to our son’s chelation accelerated his progress.
Dr. Laidler again notes that ALA has not been tested. I would like to note that parents have been requesting chelation studies be conducted or funded by the national health authorities to no avail.
[Update 2007: We used ALA for a time with Chandler, but it seemed to feed the yeast in his gut and lead to hyperactivity so we did not use it for long. It has fallen out of favor with most DAN docs for this reason.]
My son, like many autistic children with intestinal yeast, can have an increase in hyperactivity while on oral DMSA, so rounds of chelation are spaced out so that a healthy gut can be maintained. Such breaks in chelation also allow for mineral supplementation to assure that the body is not stripped of necessary nutrients during chelation.
DMSA is available only by prescription and should only be administered under a doctor’s care for just such reasons. Unfortunately, so few doctors are treating autistic patients, for what is ultimately a medical disorder, there are just not enough good doctors to go around.
[UPDATE: Apparently you can get DMSA with out a perscription, which seems odd to me. IMO it should be only used under a doctors care.]
Also... long term studies of chelation should be undertaken by the CDC... but you knew I was going to say that.
Until the mercury/autism connection is properly studied and the results are treated with honesty and transparency, chelation for children diagnosed with autism will remain to be part science, part guesswork. Yet another reason that the health authorities should do its due diligence and investigate chelation as a treatment for autism related mercury poisoning.
To say that there is "no data to support the connection" is not correct. There is a great deal of data, but the data is not conclusive. It consists of in vetro studies, primate and rodent studies, case studies and small population studies.
Many authors and investigators can still make the point, as Dr. Laidler does, that there is “no convincing data” because the health authorities charged with funding and disseminating such studies (on the scale that people are 'convinced' by) are not doing their job.
Chelation remains one of the most promising medical treatments for what is commonly diagnosed as ‘autism’, yet the government chooses to spend money instead on long term genetic research that will be of no benefit to children who were diagnosed with autism today.
The first large scale research project into chelation for those with autism is just getting underway at the University of Arizona. It is being funded by anonymous private donors.
I don't think that Dr. Laidler has made his case that the information you get for your $300 is "of questionable accuracy and minimal utility". It was mighty accurate and useful to us.
It is true that there are no guarantees that getting the mercury out of your child will cure their autistic symptoms, just as there is no guarantee that chemotherapy will cure cancer. Most parents faced with either situation are likely to give their child the chance at recovery even if the odds are not 100%. I do know of two children who did not respond to chelation therapy. Neither child was harmed by it and neither of their mothers regret trying it.
We have no guarantee that tomorrow, the last drop of Hg won't tumble out of our boy and his wonderful progress will come to an end. If it does, we will make yet another one of those course corrections that parents of special kids have to make. But at least we will know that we got him as healthy as we could.
This makes logical sense. But this has not been my experience.
My son called me mommy until he regressed at 18 months in the fall of 2003. In June of 2004 I gave him 300mg of DMSA for his chelation challenge to see if he had mercury toxicity. He was given the dose around 8am and about 6 hours later he called me ‘Mommy’ for the first time in almost a year.
I was in my bedroom cleaning, and he came in and started pulling on my hand. I was trying to finish my task before I went with him to see what he wanted, so I was looking away from him. I thought I heard him say ‘mommy’ so I looked down, and instead of pulling my hand toward the door and looking toward where he wanted me to go, he was looking at my face and called me ‘Mommy’ three more times. I was completely stunned.
At that point I expected that his tests would come back positive for mercury, and they did. There was no question after that whether or not we would try chelation on him.
To respond to Autism Diva’s very good point, I no idea as to why DMSA would have an effect like this if his mercury has caused brain damage. It makes no sense that my son would improve that drastically in 6 hours.
I would REALLY like the federal government to clear this up for Autism Diva and me. They could... oh I don't know... do a study or something?
Again I must repeat my mantra. There is no evidence that Rhogam plays a role in the development of autism because it has never been studied.
A year ago Lyn Redwood, the head of Safe Minds, was invited personally by Dr. Julie Gerberding, head of the CDC, to submit a wish list of research proposals to her. Among the requested research was a study to see if Rhogam could be involved with the development of autism. I spoke with Lyn last week and she said that neither the CDC nor Dr. Gerberding has never responded to the list that they asked be submitted to them.
I am a Rhogam mom and was surprised that this had not been looked at yet. I am waiting for the CDC and the FDA to go ahead and do this very necessary safety study on an injection that that they have already approved on pregnant women.
Autism Diva will get no argument from me (except for the part where she suggests that as the parent of an autistic child I am clueless about brain development).
Why did my son respond so quickly?
I think that the government should study it and find out.
As in Bonnie's case, the anecdotal evidence I have seen seems to suggest the older you are, the less effective chelation is on autistic symptoms. The best results seem to be for children under five and progress seems to really slow down as children age.
I have read several stories though from people who have tried it on their teenagers and even on adults and some progress has been made.
Say it with me:
Sounds like something that the government should study.
Chelation & Autism
Jul 27, 10:41 AM
by James R. Laidler, M.D.
Can chelation help autism?
Chelation is a legitimate medical therapy for disorders caused by an excess of certain metals. Copper, iron, mercury, arsenic and lead are all metals that can cause toxicity disorders that are successfully treated by chelation. Since about 1985, when the idea that autism might be caused by mercury poisoning first arose, many practitioners and groups have promoted chelation as a treatment for autism.
Clearly, the first question that must be settled is whether autism is caused by mercury (or other metal) toxicity—if it is not, then there is no point in treating it with chelation. Unfortunately, this question has become one of many “hot topics” in autism, with much heat and emotion obscuring the scientific data. The first step, then, is to look past the emotion and political maneuvering and examine the data.
When it was first proposed, the idea that autism might be due to mercury poisoning showed a good deal of promise. After all, mercury is a well-known neurotoxin and, additionally, was used as a preservative (thimerosal) in the vaccines children received. With a degree of biological plausibility and a known exposure, the next step was to look for epidemiological data.
One of the problems that complicates the search for the causes and cures of autism is the assumption that it is a single disorder and that all cases are caused by the same thing. This is in contrast to a disease like AIDS in which all cases are brought on by the HIV virus.
What is diagnosed as ‘Autism’ is actually likely to be more than one physical syndrome. Because Autism is a DSM diagnosis and based solely on behavioral criteria, the diagnosis does not address the different sets of physical anomaly clusters that researchers are finding when they look at the biology of ‘autistic’ patients.
One research group has recently made a distinction between two types of autistic profiles. One, labeled complex autism and occurring in about 30% of autism cases, presents with smaller head size, greater chance of low IQ, lower rate of siblings with the disorder and seems to have close to a 1:1 ratio of occurrence between boys and girls.
The other, essential autism, presents with larger head size, few structural brain abnormalities and has a ratio of 7:1 boys to girls.
This is a huge confounder to any epidemiological study, even a well designed one, that looks at all cases of diagnosed autism with out differentiating between groups with different phenotypes.
In discussing research into the causes of autism (in this case the genetic cause), one of the researchers commented, “…Studies haven’t found anything because they’re looking at a big heterogeneous group — a mishmash of people with different etiologies,” Takahashi said.”
One could postulate that only the larger head size group displays autistic symptoms because of mercury poisoning, as mercury toxicity does not always present with impaired IQ; and because in vitro thimerosal toxicity studies preformed at the University of Kentucky showed that estrogen has a protective effect against, and testosterone exacerbates the damage of, ethlymercury as a neurotoxin.
In light of this new information it seems that a better question than, “is autism is caused by mercury toxicity” which is the question largely being asked in these epidemiological studies, would be, “are cases of mercury toxicity being misdiagnosed as autism”.
The answer to that question cannot be found in a large epidemiological study.
The authors of the the final IOM report on the thimerosal/autism relationship in 2004 stated themselves that the epidemiological research it was relying on to clear thimerosal as a cause of autism would not pick up on a sub-set of the population that was genetically vulnerable to mercury poisoning.
If that is the case, then how much more so to these studies fail to give us meaningful data if the children who may be mercury poisoned are members of two different subsets being confused with one another?
Unfortunately, well-designed studies take a while to complete and publish.
Well designed studies do take time to complete and publish.
This is further delayed that by the fact that health authorities are neither attempting to complete or publish them. Despite years of parents requests, the public health authorities have not yet begun to design, fund or even discuss studying the effects of thimerosal on developing children, nor the safety and effectiveness of chelation on autistic patients.
[Update: I have heard that there are 2 government funded studies getting underway on the effects of thimerosal. I will try to find them and confirm exactly what they are. Still no govenment funded chelation/autism studies.]
Thimerosal was invented in the 1920’s and it’s only safety test was carried out in 1930 on 22 patients with terminal meningococcal meningitis. Patients were followed for several days until their deaths. No long term health problems were noted in the study because the patients had no long term health.
When the FDA was created, thimerosal was grandfathered in and has never been safety tested it to this day despite the fact that it has been implicated in toxic illness every few years going back to 1947.
I will be repeating this point through out my critique of this paper.
This delay left an information vacuum that a number of people immediately began to fill with assertions that autism definitely was or certainly was not caused by the thimerosal in vaccines. This did not make any progress toward settling the question, but instead polarized the issue before the arrival of any real data.
Lurking in the background, undetected in the tumult, were data that could have pointed the way. At least two countries—Canada and Denmark—had removed thimerosal from their vaccines in the 1990’s (Canada 1994, Denmark 1992) and yet had both experienced rises in autism prevalence similar to those in the US and UK.
The findings in the Denmark study have come under serious criticism. When the data of study was reviewed, it was found that the sampling presented fatal flaws. The low incidence of autism during the use of thimerosal can be attributed to the fact that the database that was used only tracked inpatient cases of autism at the time. At the point in time where thimerosal was removed, the database was expanded to include cases that were diagnosed at a large clinic outside of Copenhagen where 20% of the countries autistic patents were diagnosed. At the point in time where thimerosal was no longer used, but the cases of autism seem to have skyrocketed, the database had expanded further to include all cases of autism, inpatient and outpatient, in the country.
The study is further compromised by the fact that several of the coauthors were employed by the Statens Serums Institut, the government owned vaccine manufacturer who would be held liable if it was indeed found that the use of thimerosal in vaccines contributed to autism.
[Update: Kristjan has pointed out here that the Danish health care system and liability laws are different from ours and no such legal liability exists for the Statens Serums Institut. I still wonder what might motivate these researchers to stand buy this study and not protest its poor use. More on that in the comments here, here and here.]
Finally, even if the study were reliable, applying it to the U.S. population as the IOM has done presents problems. Children in Denmark were administered less than half the amount of thimerosal of US children and it was given over a longer period of time.
Further, American children are subject to an autism rate at least 10 times that of Denmark. It seems to me to be like doing a study of Sickle Cell Anemia in Denmark and applying it to the population of Baltimore. Clearly children here have some other intervening factor that increases the threat, be it genetic, environmental or even the thimerosal dosage.
As for Canada, I have seen this mentioned in several places, but I have never seen the actual study. If you have it or know where I can find it, can you please email me so I can look at it? Thanks in advance.
Update: Shannon from British Columbia reports that there is no Canada study or even any Canada data to be studied. She reports that they don't keep track of autism rates and don't offer services. She also reports that thimerosal removal from vaccines was left up to the provinces and that many are still on the shelves. See her comment in the section below for a more detailed explanation.
Additionally, while the childhood vaccines in the US included three (DTP, HiB, HepB) with thimerosal, in the UK, for the past two decades, only the DTP vaccine contained thimerosal. This meant that, despite having a constant thimerosal exposure for nearly twenty years, children in the UK experienced the same rise in autism prevalence.
In 2003, the first study, from Denmark, showed that the prevalence of autism in that country had risen steeply even though thimerosal had been removed from vaccines in the early 1990’s. This study was greeted by howls of outrage from some that advocated the connection between thimerosal/mercury and autism—the authors were roundly disparaged and their integrity and objectivity were impugned. This did not change the fact that the autism prevalence in Denmark has continued to rise, following the same pattern as autism in the US and the UK.
In September 2004, a study from the UK showed no association between thimerosal exposure and autism . At the same time, a review of ten epidemiological studies of autism and thimerosal found that the few studies that found an association between thimerosal exposure and autism had serious methodological flaws. Chief among these flaws was using the Vaccine Adverse Event Reporting System (VAERS) as a source of data.
The chief problem with the VAERS data is that reports can be entered by anyone and are not routinely verified. To demonstrate this, a few years ago I entered a report that an influenza vaccine had turned me into The Hulk. The report was accepted and entered into the database.
Because the reported adverse event was so… unusual, a representative of VAERS contacted me. After a discussion of the VAERS database and its limitations, they asked for my permission to delete the record, which I granted. If I had not agreed, the record would be there still, showing that any claim can become part of the database, no matter how outrageous or improbable.
Since at least 1998 (and possibly earlier), a number of autism advocacy groups have, with all the best intentions, encouraged people to report their autistic children—or autistic children of relatives and friends—to VAERS as injuries from thimerosal-containing vaccines. This has irrevocably tainted the VAERS database with duplicate and spurious reports.
I think that it is clear that the VAERS is a poor source for such studies. The CDC’s Vaccine Safety Datalink is a much better source, but the CDC has blocked it from being reviewed by independent researches despite the fact that congress has directed it to do so and claims that disallowing such access is a violation of federal law. The one team granted access in 2003 was severely limited in what they could do and thus their research effort, although it found a dramatic link, was completely tainted by the process and seems to me somewhat of a false start.
The CDC claims that they welcome research applications, but at last check they had not accepted any.
Testing for mercury
What, then, about the parents who have tested their children and found their mercury levels high? These children may have a legitimate problem with mercury poisoning…if the testing is valid. While laboratory accuracy—and cost—is an issue with many of the “mail-order” labs, a more serious problem is the manner in which the specimen is collected.
Dr. Laidler seems to be saying that contamination during collection and overnight shipping can skew results, but I don’t feel that he has properly addressed the possible process by which mercury would begin to appear in urine samples that had none at the time of excretion.
Many practitioners who advocate chelation routinely use “provoked” or “stimulated” excretion studies. To do this, they administer a dose of a chelating agent (more about them later) and test the urine a few hours later. This practice will routinely and predictably elevate the urine mercury level to several times the “unprovoked” or “unstimulated” level.
What is not mentioned in this discussion of “provoked” excretion studies, is the context in which the study becomes valuable. The working theory in this case is that some autistic children are actually members of a sub-set with a genetic impairment to excrete heavy metals such as mercury. Straight forward blood, urine and hair tests for mercury that would identify mercury toxicity in typical subjects who have been victims of a large mercury exposure would be useless in identifying mercury toxicity in people who have no ability to excrete mercury.
In order to find out if these types of subjects have mercury in their tissue, it must be stimulated. If it is excreted in the urine after the introduction of a chelating agent, then it was present in the body tissue.
Since the normal values listed on the laboratory report are for “unprovoked” specimens, the results will be much higher than normal and can appear alarming.
“Normal values” seem to mean little in these results. When mercury is excreted during a DMSA challenge, it cannot be taken as a true measure of how much mercury is in the tissues. Like clowns coming out of a car, you don’t know how much is in the body until you count all of it when it comes out.
Several factors complicate a getting a true picture of how much is in the body, one being that DMSA binds to lead more readily than to mercury, so if lead is present, the mercury level may be artificially depressed.
Doctors have reported patients excreting up to three and four hundred times the mercury that the baseline showed on the initial challenge.
The only thing that can be said with much certainty is that if you give a chelating agent, and mercury comes out, then it was in there and treatment should continue until it stops being excreted.
The cost of many of the mail-order labs is also a significant concern. A brief survey of some of the bigger mail-order labs revealed that they charge between $175 and $300 for a “panel” of urine metal tests, including mercury. The local hospital lab charges $35 for a urine mercury test.
Being a parent that has paid $300 for such urine metal tests, I am all for lowering the price. However, if I woulda known then what I know now, that the first time I did such a test on my son I would find mercury and lead, and that the chelation we have done as a result would help my son make the progress that he has made, I would happily sign my car over to the lab that delivered me these results.
But that's just me.
[scarcasm alert]I believe a good way to lower the costs of the test in this free market, would be many labs offering this standardized test, and doctors regularly screening children with ASD, ADHD, verbal and developmental delays, and those who have exhibited symptoms of vaccine injury after thimerosal containing vaccines, for mercury poisoning. That might be something that the government could look into.
[Update 2007 - the free market prevails. My son's last urine toxic metals test this month cost $65]
In most cases, the other metals included in the “panel” or of little or no use—there is no research or clinical data that connects some of these other metals to any disorder whatsoever.
I need more information from Dr. Laidler on this point. Does “no clinical data” mean that studies have been done and no connection has been found, or that no studies have been done?
Another questionable practice is the use of fecal mercury levels. The mercury in feces is a combination of ingested mercury (minus the amount that was absorbed) and any mercury excreted into the feces (usually in the bile)—there is no way to truly know how much mercury is being excreted without knowing the amount ingested and the amount absorbed. One thing that is certain, however, is that the fecal mercury level will be higher than the actual amount of excreted mercury, because of the mercury in the food we eat, the water we drink and the air we breathe.
I don’t know any families who have relied on fecal mercury levels in order to make a decision on whether or not to chelate, nor have I read of doctors relying on them. It seems an inaccurate measure of mercury toxicity for all the reasons you mention. Can anyone point me towards a source that recommends relying on it so I can further look into this?
[Update 2007: I have not heard of fecal mercury levels being used in the two years since this was written.]
This brings us (at long last) to chelation.
Chelation—what it is and how it works
Chelation works by using a compound has a stronger attraction (affinity) for mercury than the tissues of the body. Since mercury has a very strong affinity for sulfur, all the effective mercury-chelating agents contain sulfur. This does not mean that any sulfur-containing molecule can act as a chelator, since body tissues also have sulfur-containing components, which are what the mercury binds to. An effective chelator needs to have a higher affinity than body tissues.
This simple fact eliminates some of the compounds that are being touted as chelating agents for mercury. Glutathione, for instance, which has a sulfur-containing amino acid, is not sufficiently greater in its affinity for mercury than the body tissues to be an effective chelator.
The role that glutathione may play in autism is still emerging. Just a few months ago a study was released that found that 80% of autistic test subjects had some degree of glutathione depletion. After reading this I began supplementing over the counter oral l-glutathione and his speech began to progress more rapidly. He went from taking several minutes to put together a simple three word sentence, to spontaneous three and four word sentences in the matter of two months, and a week ago he began pointing things out to me (with his finger), saying, “look, look. Rain”.
I am genuinely interested to know specifics about exactly what it is doing and why such a weak chelator would be so helpful to him. I am looking forward to the question being studied further by federal health authorities.
Another widely used chelating agent, EDTA, not only has little affinity for mercury, but is also not absorbed when taken orally—it must be given intravenously.
There is now a product call Detoxamin that is EDTA in suppository form. Is this well absorbed form? Just curious.
The two agents that are most effective for chelating mercury are 2,3-dimercaptosuccinic acid (DMSA) and 2,3-dimercaptopropane-1-sulfonate (DMPS)
. DMSA has been widely used in the US—primarily for lead poisoning—and has a good safety record.
I am grateful to Dr. Laidler for pointing out that DMSA has a good safety record and is the standard treatment for lead poisoning. I have read many poorly researched reports that claim that all chelation is dangerous and it is quite frustrating.
DMPS has a long history of use in the Soviet Union, but has more toxicity problems. DMPS is popular with some practitioners because it causes a very large rise in mercury excretion, primarily by prompt clearance of kidney mercury stores, making it very useful for “provoked” mercury testing.
DMPS is not approved by the USFDA for any purpose, primarily because it offers no medical advantages over DMSA and is more toxic. Both can be given by mouth, but only DMPS is available in an intravenous form. Given that there is little or no difference in their effectiveness, a practitioner who wants to use DMPS should be viewed with suspicion.
In my experience, this is becoming more generally agreed upon in the autism community, although there are some doctors that have used EDTA and DMPS. I think that the trend seems to be coming back around to the use of DMSA.
The sulfur-containing groups in DMSA (there are two) are mercaptans, relatives of the odorant that is put in natural gas to make it smell bad. In short, it stinks. This can be a problem not only for the child who has to take it, but also for the entire family, as urine that contains DMSA will also have a foul, sulfurous smell. While some manufacturers claim to have overcome the smell “issue”, if the urine doesn’t smell foul, there is no DMSA being excreted and, therefore, no chelation happening.
While it is true that a sulfur odor does present itself, it has never occurred to me that it was a ‘problem’ or even something that a parent might take into account when deciding whether or not to chelate a child with mercury poisoning. Changing diapers more often or airing out the bathroom is little price to pay for a chance to get back your healthy, thriving child.
I did read about one family whose son carried an incredibly strong, unpleasant odor at all times during the first 6 weeks of his chelation. They lived with all the windows open and joked about all the stinky toxins that he was shedding.
They seemed really happy to have his odor problem replace their little boy’s autistic symptoms.
One preparation that deserves comment is transdermal DMSA (or DMPS)—a cream or ointment that is rubbed onto the skin, presumably to chelate mercury. Both DMSA and DMPS are highly water-soluble and do not dissolve well in fat or oil, which means that they most likely won’t be absorbed through intact skin. It is interesting to note that none of the individuals or corporations selling this preparation has—to my knowledge—performed the simple test necessary to prove that it is absorbed. In the absence of this simple bit of data, it must be assumed that it is not absorbed.
Lipoic acid—a sulfur-containing fatty acid—has also been touted as a chelating agent, although its effectiveness has not been well studied. It has the advantage of being considered a “natural” substance, but the few studies that have examined it have found it less effective than DMSA . It is fat-soluble and can potentially cross the skin, but this has not been tested. Its fat-solubility may (or may not) allow it to penetrate the brain tissue better, but this has also not been demonstrated.
Many doctors use this in conjunction with or following DMSA chelation because of its presumed ability to better penetrate into the brain. We have found adding ALA to our son’s chelation accelerated his progress.
Dr. Laidler again notes that ALA has not been tested. I would like to note that parents have been requesting chelation studies be conducted or funded by the national health authorities to no avail.
[Update 2007: We used ALA for a time with Chandler, but it seemed to feed the yeast in his gut and lead to hyperactivity so we did not use it for long. It has fallen out of favor with most DAN docs for this reason.]
A number of naturopathic remedies claim to remove mercury and heavy metals, but this claim is often based on the parent plant’s ability to remove mercury from the environment. As a result, these naturopathic remedies may themselves have a high degree of mercury contamination. At any rate, none of the naturopathic “chelating agents” have been tested to support their claims. In the final evaluation, only DMSA offers the combination of safety and effectiveness that would warrant its use. DMPS is a close second, limited only by higher toxicity.
Safety of chelation
Common less serious side effects of DMSA include nausea, vomiting and diarrhea. Skin rashes have also been reported—these are often erroneously referred to as “mercury rashes” and attributed to the removal of mercury. Regrettably, the same rashes are seen in people who have no mercury toxicity and are merely due to a drug reaction. A rare and unpredictable reaction (and potentially lethal, if not treated promptly) is Stevens-Johnson Syndrome, a severe drug reaction that presents with lesions on the skin and in the mouth and gastrointestinal tract.
My son, like many autistic children with intestinal yeast, can have an increase in hyperactivity while on oral DMSA, so rounds of chelation are spaced out so that a healthy gut can be maintained. Such breaks in chelation also allow for mineral supplementation to assure that the body is not stripped of necessary nutrients during chelation.
No significant adverse drug interactions have been reported with DMSA, but most of the children who received DMSA for lead poisoning were not taking other medications—and most of this experience predates many of the medications used
for autism. Increased zinc and copper excretion has been noticed in animal studies, but this is apparently easily corrected by moderate zinc supplementation. Copper supplementation is generally not needed.
The more serious side effects of DMSA are primarily bone marrow suppression and liver injury. In the thousands of children who received DMSA for lead poisoning, somewhere between 1% and 3% developed either elevated liver enzymes (a sign of liver cell injury), low white blood cell and/or platelet counts (a sign of bone marrow suppression) or both. In all cases, these abnormalities resolved after DMSA was stopped. However, these children were being monitored with frequent blood tests and received treatment for less than three months.
There is a danger that long-term use of DMSA without close monitoring could lead to irreversible bone marrow or liver damage. This has not yet been reported, but is a compelling reason to limit the duration of DMSA therapy and to have blood tests done every one to three months. The safety of DMSA—taken for less than six months—is well-established, but this safety has not been demonstrated over the long-term.
DMSA is available only by prescription and should only be administered under a doctor’s care for just such reasons. Unfortunately, so few doctors are treating autistic patients, for what is ultimately a medical disorder, there are just not enough good doctors to go around.
[UPDATE: Apparently you can get DMSA with out a perscription, which seems odd to me. IMO it should be only used under a doctors care.]
Also... long term studies of chelation should be undertaken by the CDC... but you knew I was going to say that.
Finally, there are as many dosing schedules for DMSA as there are practitioners who make claims about it. As perhaps a ridiculous extreme, one practitioner has asserted that DMSA must be given every two to three hours around the clock! This person also insists that failure to follow this schedule will result in more mercury being deposited in the brain. Fortunately, this is absolutely wrong! Doses as infrequent as once a week have been effective at removing mercury and lead, although at a much slower rate than the recommended dosing schedule of three times a day.
Until the mercury/autism connection is properly studied and the results are treated with honesty and transparency, chelation for children diagnosed with autism will remain to be part science, part guesswork. Yet another reason that the health authorities should do its due diligence and investigate chelation as a treatment for autism related mercury poisoning.
Summary:
[1] Is autism due to mercury?
There is no convincing data supporting a link between mercury or thimerosal and autism. This is not to say that mercury and thimerosal cannot cause autism, just that there is no data to support the connection.
To say that there is "no data to support the connection" is not correct. There is a great deal of data, but the data is not conclusive. It consists of in vetro studies, primate and rodent studies, case studies and small population studies.
Many authors and investigators can still make the point, as Dr. Laidler does, that there is “no convincing data” because the health authorities charged with funding and disseminating such studies (on the scale that people are 'convinced' by) are not doing their job.
Chelation remains one of the most promising medical treatments for what is commonly diagnosed as ‘autism’, yet the government chooses to spend money instead on long term genetic research that will be of no benefit to children who were diagnosed with autism today.
The first large scale research project into chelation for those with autism is just getting underway at the University of Arizona. It is being funded by anonymous private donors.
[2] Mercury testing.
Mercury testing, especially if done with a mail-order lab, can be both misleading and overly expensive. If you truly suspect mercury poisoning, spend $35 for a urine mercury test at your local clinic or hospital—don’t spend up to $300 to get information of questionable accuracy and minimal utility.
I don't think that Dr. Laidler has made his case that the information you get for your $300 is "of questionable accuracy and minimal utility". It was mighty accurate and useful to us.
[3] Chelating agents.
Many of the remedies promoted to remove mercury and other heavy metals are either not effective, not safe or both. Of the available chelating agents for mercury, DMSA offers the best safety and the best effectiveness.
[4] Safety.
Despite its impressive safety record, DMSA is not without side effects. Long-term treatment with DMSA has not been studied (insert comment about how the government should study this-ed) and may result in serious problems. Close medical monitoring is strongly recommended if you decide to use
DMSA therapy on your child.
* * *
Comments
1. Is it not also true that even in the legitimate use of chelation for lead poisoning, there is no expectation of reversing whatever neurological damage has already occurred? I would think this would be another strike against the credibility of chelation for autism.
— Lisa Randall Jul 27, 03:37 PM
It is true that there are no guarantees that getting the mercury out of your child will cure their autistic symptoms, just as there is no guarantee that chemotherapy will cure cancer. Most parents faced with either situation are likely to give their child the chance at recovery even if the odds are not 100%. I do know of two children who did not respond to chelation therapy. Neither child was harmed by it and neither of their mothers regret trying it.
We have no guarantee that tomorrow, the last drop of Hg won't tumble out of our boy and his wonderful progress will come to an end. If it does, we will make yet another one of those course corrections that parents of special kids have to make. But at least we will know that we got him as healthy as we could.
2. The studies that have looked at removal of lead by chelation (that Autism Diva has looked at on pubmed) showed no improvement in IQ or behavior, (or both?)
Brain damage in general is not seen as reversible.
This makes logical sense. But this has not been my experience.
My son called me mommy until he regressed at 18 months in the fall of 2003. In June of 2004 I gave him 300mg of DMSA for his chelation challenge to see if he had mercury toxicity. He was given the dose around 8am and about 6 hours later he called me ‘Mommy’ for the first time in almost a year.
I was in my bedroom cleaning, and he came in and started pulling on my hand. I was trying to finish my task before I went with him to see what he wanted, so I was looking away from him. I thought I heard him say ‘mommy’ so I looked down, and instead of pulling my hand toward the door and looking toward where he wanted me to go, he was looking at my face and called me ‘Mommy’ three more times. I was completely stunned.
At that point I expected that his tests would come back positive for mercury, and they did. There was no question after that whether or not we would try chelation on him.
To respond to Autism Diva’s very good point, I no idea as to why DMSA would have an effect like this if his mercury has caused brain damage. It makes no sense that my son would improve that drastically in 6 hours.
I would REALLY like the federal government to clear this up for Autism Diva and me. They could... oh I don't know... do a study or something?
Some of the autism/mercury parents think their kids got toxified while in the womb from a rhogam shot that had thimerosal in it.
There’s no evidence for that...
Again I must repeat my mantra. There is no evidence that Rhogam plays a role in the development of autism because it has never been studied.
A year ago Lyn Redwood, the head of Safe Minds, was invited personally by Dr. Julie Gerberding, head of the CDC, to submit a wish list of research proposals to her. Among the requested research was a study to see if Rhogam could be involved with the development of autism. I spoke with Lyn last week and she said that neither the CDC nor Dr. Gerberding has never responded to the list that they asked be submitted to them.
I am a Rhogam mom and was surprised that this had not been looked at yet. I am waiting for the CDC and the FDA to go ahead and do this very necessary safety study on an injection that that they have already approved on pregnant women.
but besides that, they think that they can chelate the kid NOW and affect proposed damage do when the brain was developing? They obviously have no clue about brain development and probably have never looked into Fetal Alchohol Syndrome. There’s nothing that undoes that, but the kid can learn to use what he has to the best possible extent.
— Autism Diva Jul 27, 03:46 PM
Autism Diva will get no argument from me (except for the part where she suggests that as the parent of an autistic child I am clueless about brain development).
Why did my son respond so quickly?
I think that the government should study it and find out.
3. Because there’s no way of knowing how much improvement in a child’s behavior and abilities is the result of natural developmental processes, the only accurate way to test chelation would be to perform double-blind studies with autistic adults.
If you’re interested in an unscientific anecdote, I had all of my amalgam fillings removed 10 years ago and took chelation supplements for a few weeks. It was my dad’s idea; he is a major health faddist, antivax, supplements out the wazoo, toxic fumes in the woodwork, you get the idea.
I noticed some improvement in my sense of smell after having the amalgams taken out, but the main benefit was just the nice new pretty composite fillings.
I’m still just as autistic as ever.
So is my dad…
— Bonnie Ventura Jul 28, 09:38 AM
As in Bonnie's case, the anecdotal evidence I have seen seems to suggest the older you are, the less effective chelation is on autistic symptoms. The best results seem to be for children under five and progress seems to really slow down as children age.
I have read several stories though from people who have tried it on their teenagers and even on adults and some progress has been made.
Say it with me:
Sounds like something that the government should study.
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