Athletes Against Autism
Sometimes hockey players have more important goals on their minds than the ones that are scored on the ice. Take Olaf Kolzig, Byron DaFoe and Scott Mellanby for example. The three NHLers had their lives turned upside down when their kids were diagnosed with autism.
But the three courageous players didn't let the developmental disability bring them down, even though there is no known cause or cure. The players got together to form Athletes Against Autism (AAA), an initiative of the Cure Autism Now Foundation (CAN), a non-profit organization dedicated to accelerating the pace of scientific research with the goal of finding the cause, effective treatments and a cure for autism.
AAA is a group of athletes who were personally touched by the developmental disability, who are banding together to help raise awareness and funds for autism research, treatment and education programs. As fathers of children with autism, they realized the importance of using their status and influence to make an impact on the over 1.5 million people in the United States alone affected by autism.
Studies show that every 21 minutes, a child is diagnosed with autism. So what that means is that every 21 minutes another family is introduced to the disability. All people with autism demonstrate impairments in communication and social skills.
Because of the efforts of Kolzig, DaFoe and Mellanby, NHL teams are pitching in to help out. Autism Awareness Nights have been held in Washington, Anaheim, Nashville and Long Island this season, raising funds for the worthy cause and growing awareness to the disability. Two more events in Philadelphia and Atlanta on April 15 are scheduled before the end of the regular season. AAA will hold a celebrity golf tournament in Santa Barbara, Calif. — its major fundraising event — in June. The goals of the event will be to raise awareness, and to raise funds in support of the research initiatives of Cure Autism Now.
According to the AAA website, autism is believed to currently affect 1 in every 166 people. The rate of people being diagnosed with autism has increased substantially over the past two decades. Although this may be in part due to improved diagnostic techniques and to changes in the criteria for autism spectrum disorders, the majority of experts agree these changes are not enough to explain the epidemic rates at which autism is being diagnosed. It is four times more prevalent in males than females.
For more info on autism, go to AAA's official website: www.athletesagainstautism.org or email them at aaa@cureautismnow.org
April 17, 2006
Anchorage Daily News
Anchorage Daily News
Concerns over vaccines leave parents stuck in the middle
Award-winning author of book on vaccines and autism to speak in Anchorage
By DEBRA McKINNEY
Anchorage Daily News
(Published: April 13, 2006)
Twenty-some years ago, autism was relatively rare in this country, affecting one in 10,000 children. Today, one in 166 are diagnosed with autism spectrum disorder, and everyone, from parents to officials at the U.S. Centers for Disease Control and Prevention, wants to know why.
Study after study comes up empty-handed. Even so, some parents and others are convinced they have the answer. They believe a preservative once widely used in vaccines is responsible for this explosion of autism as well as attention deficit disorder and other developmental impairments. That preservative is thimerosal, developed in the 1920s, before the U.S. Food and Drug Administration existed, and later grandfathered onto a list of FDA-approved additives without extensive agency testing. And thimerosal, it turns out, is 50 percent mercury, a well-documented neurotoxin.
The medical establishment is adamant there's no science-based connection between mercury and autism and that the benefit of vaccinating children, sparing them from a host of horrible diseases, far outweighs the risks.
This issue, long considered the territory of conspiracy theorists and zealots, has never had a higher profile than now. Nor has the credibility of the CDC been under such attack.
Last week, an advocacy group placed a full-page ad in USA Today accusing the CDC of a cover-up. And some lawmakers have recently taken up the cause, pushing for more studies, more access to data and definitive answers. The medical establishment thought it had provided that answer, in 2004, when the Institute of Medicine released of review of study data showing "no evidence of harm."
BOOK REVIEWS BOTH SIDES
Whether there's something to this or not, now is ripe timing for a visit by David Kirby, author of the provocative New York Times best seller on the topic, "Evidence of Harm -- Mercury in Vaccines and the Autism Epidemic: A Medical Controversy." He'll be speaking in Anchorage on Monday and Tuesday. (See Page D-1 for details.)
Kirby knew nothing of this controversy until a couple of weeks before he became completely immersed in it. A freelance journalist and contributor to The New York Times and other publications, Kirby was researching story ideas to pitch to magazines in November 2002 when he heard about families in Los Angeles who were treating their autistic children with vitamins, special diets and other alternative therapies.
"One of the mothers happened to mention that there was mercury in vaccines and some people thought there might be a connection," he said in a telephone interview from his home in New York. "I really thought that sounded farfetched."
Then a week later, the House of Representatives passed the Homeland Security bill, and that changed his mind.
"That's when everyone found out this rider had been slipped in at the last minute that would have dismissed all lawsuits against Eli Lilly (which developed the additive) and vaccine makers because of a preservative called thimerosal, which is 50 percent mercury.
"That was a big ah-ha moment. The mother in Los Angeles wasn't crazy; there really was mercury in vaccines."
Kirby dug into the matter, thinking he'd be doing a magazine piece centered on the politics behind the issue.
"I wanted to know why someone was so worried about this to go to such extraordinary lengths to protect drug companies from liability," he said.
He quickly realized what he had was a book. Several stories in one, as he sees it.
"There's the human drama and tragedy, because (autism) is a real terrible thing that's happened, that's happening, to families in every community in this country," he said. "And then there's the scientific mystery:Why are we seeing so much more today than we did in the past?
"Then we have the political story, starting with the Homeland Security bill, a political whodunit. And it continues to be an interesting political story about the influence of pharmaceutical money in our system. And then, finally, it's a courtroom drama."
BACK STORY
Thimerosal has been used for decades, without much notice, in vaccines and other medical products to prevent contamination. That changed as childhood vaccines were added to the immunization schedule in the late '80s and early '90s. Good for disease prevention.
But as Kirby says in his book, no one bothered to add up the cumulative doses of mercury associated with those vaccines.
"So yes, we've been given mercury in vaccines many, many years," he said. "But we ended up basically tripling the amount of mercury we were giving, and we started giving it much younger -- and, in some cases, prenatally."
Due to public pressure, beginning in 1999, thimerosal was phased out, or reduced to only trace amounts, in childhood vaccines, with the exception of the influenza vaccine. (Parents can request a mercury-free flu shot.) Children born between roughly 1992 and 2002 had the peak exposure, according to Kirby.
Kirby's book has created quite a stir, and last month it received the prestigious Investigative Reporters and Editors Award for Outstanding Investigative Reporting in the book category.
Judges had this to say about "Evidence of Harm:
"Kirby told the story of stonewalling, denial and cover-up by federal regulators, medical groups and the pharmaceutical industry. And he documents covert efforts by some of those same powerful forces -- along with the U.S. Congress -- to grant blanket immunity for drug companies that put mercury in vaccines. ... Kirby's careful and meticulous reporting is exemplary in its balance, accuracy and documentation."
"Evidence of Harm" is also one of five finalists for the New York Public Library Helen Bernstein Book Award for Excellence in Journalism, which honors journalists and their role in "drawing the attention of the public to important current issues."
QUESTION OF BALANCE
Naturally, not everyone is happy with this book.
"I'm sure I'm cursed in some medical circles," Kirby said.
Among other complaints is that it's biased toward the parents' point of view, an emotionally charged one.
Kirby said he tried.
"I started by contacting everyone on the other side -- the FDA, the CDC, the American Academy of Pediatrics, the drug companies and the IOM. The IOM and CDC responded favorably, agreeing to be interviewed. The AAP turned me down, the FDA and the drug companies as well. And the CDC canceled my interview 20 minutes before our scheduled time, after I had flown all the way down to Atlanta."
" 'Cover-up' is a very loaded word," he said. "I don't use that word. But definitely there's a lack of transparency."
Kirby's visit is sponsored by the Anchorage-based nonprofit Vaccination News, a Web site launched by Sandy Gottstein, known in the vaccine safety movement by her former married name, Sandy Mintz. She first got involved in vaccine issues in 1982.
"I'm a 'take charge of your own health' kind of person," Gottstein said. "And when my first child was born, I just started researching it. I have a background in psychology research, and the more I read, the more concerned I became."
Although her own children were not autistic, she has fought long and hard for informed consent and the right of parents to choose not to vaccinate their children. She has also pushed for more meaningful studies involving kids who have never been vaccinated.
"I truly support informed choice. That means having good information, which we really don't have because proper studies have never been conducted."
Gottstein said she's thrilled to be bringing Kirby here.
"I can't thank him enough for writing this book," she said.
Kirby is grateful to her too.
"I used her Web site extensively as a resource when I wrote the book," he said. "It's probably the most comprehensive daily roundup of what's being reported in the media around the vaccination safety issue."
VALUE OF VACCINATION
Immunization officials here hope this controversy won't make parents afraid to vaccinate their children.
When Dr. Richard Mandsager, director of the Alaska Division of Public Health, first came to Alaska 1985, every day he saw babies and young children suffering meningitis in the pediatrics ward. He has no desire to go back to those times.
Nor does Laurel Wood, Immunization Program director for the Alaska Division of Public Health.
Before the polio vaccine, for instance, as many as 20,000 children developed the crippling disease each year. Now, a case of polio would be extremely rare. There are many more such examples.
"I think the majority of people, particularly in Alaska, where we've seen some of these diseases, are highly supportive of immunization and understand that they have an amazing benefit to our entire way of life," Wood said. "Vaccines have been incredible lifesavers. I think it's important that we remember how incredibly valuable they have been.
"People should not be afraid of vaccines; they should remain fearful of these diseases. They have not gone away. The reason we have not seen a lot of them in the past 20 years is because of vaccines."
If Kirby had children, would he have them vaccinated?
He would.
"You don't want your child getting measles or polio or pertussis (whooping cough). They can be very serious, and if you can prevent them, why wouldn't you? That's my own personal opinion.
"We just need to make sure we're vaccinating safely and appropriately and in a way that builds confidence in parents, so they feel good about taking their kids in for vaccinations. But a lack of transparency is not a good way to build confidence. In fact, I think it's the opposite.
"This question is not settled," Kirby added. "It's still very much an open question, and we have to find the answer as soon as possible. Yes or no: Does mercury contribute to autism or not?
"And if it does, we have a lot of work to do in terms of eliminating exposure, developing treatments and trying to help these families financially. And if it doesn't, we have even more work to do. Because then we're back to square one."
Daily News reporter Debra McKinney can be reached at dmckinney@adn.com.
DAVID KIRBY, journalist and author of "Evidence of Harm -- Mercury in Vaccines and the Autism Epidemic: A Medical Controversy," will talk about his work and sign books from 5:30 to 7 p.m. Monday at the University of Alaska Anchorage bookstore and 7:30 to 9:30 p.m. Monday in Wilda Marston Theater at Loussac Library. Both events are free and open to the public. Kirby also will be the featured speaker at the Downtown Rotary luncheon for members and guests at noon Tuesday. (566-0401)
WEB SITES WITH INFORMATION ON BOTH SIDES OF THE VACCINE MERCURY CONTROVERSY:
U.S. Centers for Disease Control and Prevention: www.cdc.gov
Alaska's immunization program: epi.alaska.gov
Sandy Gottstein's Vaccination News: vaccinationnews.com
Author David Kirby's site: evidenceofharm.com
See the controversial ad placed in USA Today by an advocacy group: putchildrenfirst.org
Concerns over vaccines leave parents stuck in the middle
Award-winning author of book on vaccines and autism to speak in Anchorage
By DEBRA McKINNEY
Anchorage Daily News
(Published: April 13, 2006)
Twenty-some years ago, autism was relatively rare in this country, affecting one in 10,000 children. Today, one in 166 are diagnosed with autism spectrum disorder, and everyone, from parents to officials at the U.S. Centers for Disease Control and Prevention, wants to know why.
Study after study comes up empty-handed. Even so, some parents and others are convinced they have the answer. They believe a preservative once widely used in vaccines is responsible for this explosion of autism as well as attention deficit disorder and other developmental impairments. That preservative is thimerosal, developed in the 1920s, before the U.S. Food and Drug Administration existed, and later grandfathered onto a list of FDA-approved additives without extensive agency testing. And thimerosal, it turns out, is 50 percent mercury, a well-documented neurotoxin.
The medical establishment is adamant there's no science-based connection between mercury and autism and that the benefit of vaccinating children, sparing them from a host of horrible diseases, far outweighs the risks.
This issue, long considered the territory of conspiracy theorists and zealots, has never had a higher profile than now. Nor has the credibility of the CDC been under such attack.
Last week, an advocacy group placed a full-page ad in USA Today accusing the CDC of a cover-up. And some lawmakers have recently taken up the cause, pushing for more studies, more access to data and definitive answers. The medical establishment thought it had provided that answer, in 2004, when the Institute of Medicine released of review of study data showing "no evidence of harm."
BOOK REVIEWS BOTH SIDES
Whether there's something to this or not, now is ripe timing for a visit by David Kirby, author of the provocative New York Times best seller on the topic, "Evidence of Harm -- Mercury in Vaccines and the Autism Epidemic: A Medical Controversy." He'll be speaking in Anchorage on Monday and Tuesday. (See Page D-1 for details.)
Kirby knew nothing of this controversy until a couple of weeks before he became completely immersed in it. A freelance journalist and contributor to The New York Times and other publications, Kirby was researching story ideas to pitch to magazines in November 2002 when he heard about families in Los Angeles who were treating their autistic children with vitamins, special diets and other alternative therapies.
"One of the mothers happened to mention that there was mercury in vaccines and some people thought there might be a connection," he said in a telephone interview from his home in New York. "I really thought that sounded farfetched."
Then a week later, the House of Representatives passed the Homeland Security bill, and that changed his mind.
"That's when everyone found out this rider had been slipped in at the last minute that would have dismissed all lawsuits against Eli Lilly (which developed the additive) and vaccine makers because of a preservative called thimerosal, which is 50 percent mercury.
"That was a big ah-ha moment. The mother in Los Angeles wasn't crazy; there really was mercury in vaccines."
Kirby dug into the matter, thinking he'd be doing a magazine piece centered on the politics behind the issue.
"I wanted to know why someone was so worried about this to go to such extraordinary lengths to protect drug companies from liability," he said.
He quickly realized what he had was a book. Several stories in one, as he sees it.
"There's the human drama and tragedy, because (autism) is a real terrible thing that's happened, that's happening, to families in every community in this country," he said. "And then there's the scientific mystery:Why are we seeing so much more today than we did in the past?
"Then we have the political story, starting with the Homeland Security bill, a political whodunit. And it continues to be an interesting political story about the influence of pharmaceutical money in our system. And then, finally, it's a courtroom drama."
BACK STORY
Thimerosal has been used for decades, without much notice, in vaccines and other medical products to prevent contamination. That changed as childhood vaccines were added to the immunization schedule in the late '80s and early '90s. Good for disease prevention.
But as Kirby says in his book, no one bothered to add up the cumulative doses of mercury associated with those vaccines.
"So yes, we've been given mercury in vaccines many, many years," he said. "But we ended up basically tripling the amount of mercury we were giving, and we started giving it much younger -- and, in some cases, prenatally."
Due to public pressure, beginning in 1999, thimerosal was phased out, or reduced to only trace amounts, in childhood vaccines, with the exception of the influenza vaccine. (Parents can request a mercury-free flu shot.) Children born between roughly 1992 and 2002 had the peak exposure, according to Kirby.
Kirby's book has created quite a stir, and last month it received the prestigious Investigative Reporters and Editors Award for Outstanding Investigative Reporting in the book category.
Judges had this to say about "Evidence of Harm:
"Kirby told the story of stonewalling, denial and cover-up by federal regulators, medical groups and the pharmaceutical industry. And he documents covert efforts by some of those same powerful forces -- along with the U.S. Congress -- to grant blanket immunity for drug companies that put mercury in vaccines. ... Kirby's careful and meticulous reporting is exemplary in its balance, accuracy and documentation."
"Evidence of Harm" is also one of five finalists for the New York Public Library Helen Bernstein Book Award for Excellence in Journalism, which honors journalists and their role in "drawing the attention of the public to important current issues."
QUESTION OF BALANCE
Naturally, not everyone is happy with this book.
"I'm sure I'm cursed in some medical circles," Kirby said.
Among other complaints is that it's biased toward the parents' point of view, an emotionally charged one.
Kirby said he tried.
"I started by contacting everyone on the other side -- the FDA, the CDC, the American Academy of Pediatrics, the drug companies and the IOM. The IOM and CDC responded favorably, agreeing to be interviewed. The AAP turned me down, the FDA and the drug companies as well. And the CDC canceled my interview 20 minutes before our scheduled time, after I had flown all the way down to Atlanta."
" 'Cover-up' is a very loaded word," he said. "I don't use that word. But definitely there's a lack of transparency."
Kirby's visit is sponsored by the Anchorage-based nonprofit Vaccination News, a Web site launched by Sandy Gottstein, known in the vaccine safety movement by her former married name, Sandy Mintz. She first got involved in vaccine issues in 1982.
"I'm a 'take charge of your own health' kind of person," Gottstein said. "And when my first child was born, I just started researching it. I have a background in psychology research, and the more I read, the more concerned I became."
Although her own children were not autistic, she has fought long and hard for informed consent and the right of parents to choose not to vaccinate their children. She has also pushed for more meaningful studies involving kids who have never been vaccinated.
"I truly support informed choice. That means having good information, which we really don't have because proper studies have never been conducted."
Gottstein said she's thrilled to be bringing Kirby here.
"I can't thank him enough for writing this book," she said.
Kirby is grateful to her too.
"I used her Web site extensively as a resource when I wrote the book," he said. "It's probably the most comprehensive daily roundup of what's being reported in the media around the vaccination safety issue."
VALUE OF VACCINATION
Immunization officials here hope this controversy won't make parents afraid to vaccinate their children.
When Dr. Richard Mandsager, director of the Alaska Division of Public Health, first came to Alaska 1985, every day he saw babies and young children suffering meningitis in the pediatrics ward. He has no desire to go back to those times.
Nor does Laurel Wood, Immunization Program director for the Alaska Division of Public Health.
Before the polio vaccine, for instance, as many as 20,000 children developed the crippling disease each year. Now, a case of polio would be extremely rare. There are many more such examples.
"I think the majority of people, particularly in Alaska, where we've seen some of these diseases, are highly supportive of immunization and understand that they have an amazing benefit to our entire way of life," Wood said. "Vaccines have been incredible lifesavers. I think it's important that we remember how incredibly valuable they have been.
"People should not be afraid of vaccines; they should remain fearful of these diseases. They have not gone away. The reason we have not seen a lot of them in the past 20 years is because of vaccines."
If Kirby had children, would he have them vaccinated?
He would.
"You don't want your child getting measles or polio or pertussis (whooping cough). They can be very serious, and if you can prevent them, why wouldn't you? That's my own personal opinion.
"We just need to make sure we're vaccinating safely and appropriately and in a way that builds confidence in parents, so they feel good about taking their kids in for vaccinations. But a lack of transparency is not a good way to build confidence. In fact, I think it's the opposite.
"This question is not settled," Kirby added. "It's still very much an open question, and we have to find the answer as soon as possible. Yes or no: Does mercury contribute to autism or not?
"And if it does, we have a lot of work to do in terms of eliminating exposure, developing treatments and trying to help these families financially. And if it doesn't, we have even more work to do. Because then we're back to square one."
Daily News reporter Debra McKinney can be reached at dmckinney@adn.com.
DAVID KIRBY, journalist and author of "Evidence of Harm -- Mercury in Vaccines and the Autism Epidemic: A Medical Controversy," will talk about his work and sign books from 5:30 to 7 p.m. Monday at the University of Alaska Anchorage bookstore and 7:30 to 9:30 p.m. Monday in Wilda Marston Theater at Loussac Library. Both events are free and open to the public. Kirby also will be the featured speaker at the Downtown Rotary luncheon for members and guests at noon Tuesday. (566-0401)
WEB SITES WITH INFORMATION ON BOTH SIDES OF THE VACCINE MERCURY CONTROVERSY:
U.S. Centers for Disease Control and Prevention: www.cdc.gov
Alaska's immunization program: epi.alaska.gov
Sandy Gottstein's Vaccination News: vaccinationnews.com
Author David Kirby's site: evidenceofharm.com
See the controversial ad placed in USA Today by an advocacy group: putchildrenfirst.org
April 14, 2006
LA Times: Battle Lines Drawn Over Mercury in Shots
Battle Lines Drawn Over Mercury in Shots
States push for bans in children's vaccines. But leading medical groups are pushing back.
By Myron Levin, Times Staff Writer
April 10, 2006
As lawmakers in about 20 states press for bans on mercury in children's vaccines, they are meeting stiff resistance from influential health and medical organizations, including groups that get substantial funding from drug makers and the Centers for Disease Control and Prevention.
Seven states have adopted the anti-mercury bills — California being one of the first.
California's law, passed in 2004 and to take effect July 1, will prohibit shots with more than a trace of thimerosal for pregnant women and children younger than 3. In recent weeks, similar bills have been defeated in at least five states.
The push for legislation comes long after the uproar over continued use of thimerosal, a mercury-based antibacterial agent, appeared to subside in 1999, when manufacturers began phasing it out of routine pediatric vaccines.
But the controversy flared anew when flu shots containing thimerosal were added to the childhood immunization schedule in 2004 and the CDC refused to recommend thimerosal-free shots for infants and pregnant women.
Angered by the CDC's refusal — and fearing a backslide into more thimerosal use — state lawmakers and anti-mercury advocates began pushing for outright thimerosal bans.
The legislation faces opposition from groups such as the American Academy of Pediatrics and the Immunization Action Coalition — a stance that anti-mercury advocates say defies logic.
"We're trying to get [mercury] out of the environment," said Marilyn Rasmussen, a Washington state senator and sponsor of a thimerosal bill that was signed into law last month.
"Why would we be injecting it into babies? We've got to be smarter than that."
Mercury can damage the nervous system, and infants and toddlers are thought to be particularly at risk because of their low body weight and rapidly developing brains. That concern is behind wide-ranging initiatives to cut mercury pollution from industrial plants and warn pregnant women to limit intake of some types of fish.
The American Academy of Pediatrics and its allies, including some state health departments, say there is no proof that the small amount of mercury in vaccines is harmful. They argue that legal restrictions could undermine confidence in vaccines — causing people to skip their shots — and lead to shortages.
The academy, an organization of 60,000 pediatricians, has generally taken a zero tolerance stance on mercury, even joining a federal lawsuit seeking stricter controls on power plant emissions. Its official policy, published in July 2001 in its journal Pediatrics, states in part:
"Mercury in all of its forms is toxic to the fetus and children, and efforts should be made to reduce exposure to the extent possible to pregnant women and children as well as the general population."
Dr. Louis Z. Cooper, the academy's former president and chairman of its Center for Child Health Research, acknowledged the group's stand on thimerosal "does appear to be a paradox."
But Cooper said he did not believe "the science justifies codifying in state law that we ban all mercury-containing vaccines."
He also voiced concern about the effect on immunization programs in the developing world. The World Health Organization relies heavily on thimerosal to immunize millions of children in poor nations, and could face cost and logistical problems if forced to abandon it.
"If we banned mercury-containing vaccines by statute in the United States," Cooper said, "it would make it a lot harder to explain in other parts of the world" why they should accept them.
Vaccine producers generally oppose the bills but have kept a low profile, leaving health groups to lead the charge. Last year, pharmaceutical companies contributed about $1.54 million to the academy out of a budget of $68.2 million. Among the donors were vaccine giants Merck & Co., GlaxoSmithKline and Sanofi Pasteur Inc., according to tax filings and academy officials.
The group also got about $1.55 million from the CDC for several health programs.
Although CDC officials are not permitted to lobby states, they have warned that thimerosal bans could create confusion about which vaccines are acceptable and lead some parents to delay or forgo immunization of their children.
Cooper said financial ties to drug makers and the CDC had not influenced the academy. "The bottom line has always been what would be best for the child," he said.
Another opponent of bans, the Immunization Action Coalition, based in St. Paul, Minn., runs websites and newsletters promoting immunization. The group has been dispensing strategy advice and materials to critics of the anti-mercury bills.
"We're scaring people away needlessly from very safe vaccines," said Diane Peterson, the group's associate director.
The coalition last year got about $628,000 from the CDC, about 42% of its $1.51-million budget. Industry donors listed on the coalition's website — including Merck, GlaxoSmithKline, Sanofi Pasteur, Chiron Corp. and Wyeth Pharmaceuticals — appear to contribute most of its remaining funds, though the group would not disclose total industry support.
Along with California and Washington, New York, Iowa, Illinois, Missouri and Delaware have passed thimerosal bills. The laws permit a waiving of restrictions in a public health emergency. Bipartisan federal legislation to ban thimerosal has 73 co-sponsors in the House of Representatives.
Introduced long before current standards for safety testing, thimerosal came into wide use in vaccines sold in multi-dose vials to prevent bacterial contamination from repeated insertion of needles. Single-dose vials don't need thimerosal, but doctors and clinics historically preferred multi-dose containers for ease of storage and lower price.
Exposure to thimerosal rose sharply in the early 1990s when the CDC added five new shots for infants in their first six months. Many of these shots, as well as some already prescribed, contained thimerosal. The chemical is nearly 50% ethyl mercury, considered somewhat less toxic than the methyl mercury in fish and power plant emissions.
The thimerosal issue erupted in 1999 when it became known that U.S. health authorities for the first time had totaled the cumulative dose of mercury from multiple shots. The calculation showed that infants who got their shots on time could be exposed to mercury in excess of an Environmental Protection Agency guideline.
As a precaution, the CDC and the American Academy of Pediatrics called on vaccine makers in 1999 to phase out thimerosal. By 2002, the chemical had been removed or cut to trace levels in all routine children's shots through a switch to single-dose vials. But then mercury made a comeback in 2004, when the CDC added flu shots to the list of prescribed vaccines.
The only supplier for children younger than 2, Sanofi Pasteur, then known as Aventis Pasteur, marketed most of its vaccine in multi-dose vials. Then, as now, the CDC decided not to recommend that doctors select thimerosal-free shots for pregnant women and children.
Sanofi Pasteur since has increased its capacity to make mercury-free vaccine, yet because the government has expressed no preference, some of the capacity has gone unused.
In a pivotal moment in the debate, a committee of the prestigious Institute of Medicine rebuffed claims that thimerosal was responsible for an increase in autism cases.
In its May 2004 report, the panel declared that "the body of epidemiological evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism."
But parent activists and some scientists criticized the report — contending, among other things, that the institute had given too much weight to research in countries where thimerosal exposures had been lower than in the U.S. Either way, the report considered only autism and not potential risks of subtler developmental effects.
The CDC is engaged in a study of 7- to 10-year-olds to see if thimerosal exposures might have influenced language development, physical coordination and IQ.
And while rejecting the thimerosal-autism link, a report in November in the Pediatric Infectious Disease Journal stated that risks to "the fetus, premature infant and low-birth-weight infant have insufficiently been studied."
Some say the resistance by medical groups to bans on thimerosal reflects a profession in denial.
Cooper, of the American Academy of Pediatrics, said he could understand why people had come to see the academy as overly defensive. "But I hope we're big enough to be open to science," he said.
States push for bans in children's vaccines. But leading medical groups are pushing back.
By Myron Levin, Times Staff Writer
April 10, 2006
As lawmakers in about 20 states press for bans on mercury in children's vaccines, they are meeting stiff resistance from influential health and medical organizations, including groups that get substantial funding from drug makers and the Centers for Disease Control and Prevention.
Seven states have adopted the anti-mercury bills — California being one of the first.
California's law, passed in 2004 and to take effect July 1, will prohibit shots with more than a trace of thimerosal for pregnant women and children younger than 3. In recent weeks, similar bills have been defeated in at least five states.
The push for legislation comes long after the uproar over continued use of thimerosal, a mercury-based antibacterial agent, appeared to subside in 1999, when manufacturers began phasing it out of routine pediatric vaccines.
But the controversy flared anew when flu shots containing thimerosal were added to the childhood immunization schedule in 2004 and the CDC refused to recommend thimerosal-free shots for infants and pregnant women.
Angered by the CDC's refusal — and fearing a backslide into more thimerosal use — state lawmakers and anti-mercury advocates began pushing for outright thimerosal bans.
The legislation faces opposition from groups such as the American Academy of Pediatrics and the Immunization Action Coalition — a stance that anti-mercury advocates say defies logic.
"We're trying to get [mercury] out of the environment," said Marilyn Rasmussen, a Washington state senator and sponsor of a thimerosal bill that was signed into law last month.
"Why would we be injecting it into babies? We've got to be smarter than that."
Mercury can damage the nervous system, and infants and toddlers are thought to be particularly at risk because of their low body weight and rapidly developing brains. That concern is behind wide-ranging initiatives to cut mercury pollution from industrial plants and warn pregnant women to limit intake of some types of fish.
The American Academy of Pediatrics and its allies, including some state health departments, say there is no proof that the small amount of mercury in vaccines is harmful. They argue that legal restrictions could undermine confidence in vaccines — causing people to skip their shots — and lead to shortages.
The academy, an organization of 60,000 pediatricians, has generally taken a zero tolerance stance on mercury, even joining a federal lawsuit seeking stricter controls on power plant emissions. Its official policy, published in July 2001 in its journal Pediatrics, states in part:
"Mercury in all of its forms is toxic to the fetus and children, and efforts should be made to reduce exposure to the extent possible to pregnant women and children as well as the general population."
Dr. Louis Z. Cooper, the academy's former president and chairman of its Center for Child Health Research, acknowledged the group's stand on thimerosal "does appear to be a paradox."
But Cooper said he did not believe "the science justifies codifying in state law that we ban all mercury-containing vaccines."
He also voiced concern about the effect on immunization programs in the developing world. The World Health Organization relies heavily on thimerosal to immunize millions of children in poor nations, and could face cost and logistical problems if forced to abandon it.
"If we banned mercury-containing vaccines by statute in the United States," Cooper said, "it would make it a lot harder to explain in other parts of the world" why they should accept them.
Vaccine producers generally oppose the bills but have kept a low profile, leaving health groups to lead the charge. Last year, pharmaceutical companies contributed about $1.54 million to the academy out of a budget of $68.2 million. Among the donors were vaccine giants Merck & Co., GlaxoSmithKline and Sanofi Pasteur Inc., according to tax filings and academy officials.
The group also got about $1.55 million from the CDC for several health programs.
Although CDC officials are not permitted to lobby states, they have warned that thimerosal bans could create confusion about which vaccines are acceptable and lead some parents to delay or forgo immunization of their children.
Cooper said financial ties to drug makers and the CDC had not influenced the academy. "The bottom line has always been what would be best for the child," he said.
Another opponent of bans, the Immunization Action Coalition, based in St. Paul, Minn., runs websites and newsletters promoting immunization. The group has been dispensing strategy advice and materials to critics of the anti-mercury bills.
"We're scaring people away needlessly from very safe vaccines," said Diane Peterson, the group's associate director.
The coalition last year got about $628,000 from the CDC, about 42% of its $1.51-million budget. Industry donors listed on the coalition's website — including Merck, GlaxoSmithKline, Sanofi Pasteur, Chiron Corp. and Wyeth Pharmaceuticals — appear to contribute most of its remaining funds, though the group would not disclose total industry support.
Along with California and Washington, New York, Iowa, Illinois, Missouri and Delaware have passed thimerosal bills. The laws permit a waiving of restrictions in a public health emergency. Bipartisan federal legislation to ban thimerosal has 73 co-sponsors in the House of Representatives.
Introduced long before current standards for safety testing, thimerosal came into wide use in vaccines sold in multi-dose vials to prevent bacterial contamination from repeated insertion of needles. Single-dose vials don't need thimerosal, but doctors and clinics historically preferred multi-dose containers for ease of storage and lower price.
Exposure to thimerosal rose sharply in the early 1990s when the CDC added five new shots for infants in their first six months. Many of these shots, as well as some already prescribed, contained thimerosal. The chemical is nearly 50% ethyl mercury, considered somewhat less toxic than the methyl mercury in fish and power plant emissions.
The thimerosal issue erupted in 1999 when it became known that U.S. health authorities for the first time had totaled the cumulative dose of mercury from multiple shots. The calculation showed that infants who got their shots on time could be exposed to mercury in excess of an Environmental Protection Agency guideline.
As a precaution, the CDC and the American Academy of Pediatrics called on vaccine makers in 1999 to phase out thimerosal. By 2002, the chemical had been removed or cut to trace levels in all routine children's shots through a switch to single-dose vials. But then mercury made a comeback in 2004, when the CDC added flu shots to the list of prescribed vaccines.
The only supplier for children younger than 2, Sanofi Pasteur, then known as Aventis Pasteur, marketed most of its vaccine in multi-dose vials. Then, as now, the CDC decided not to recommend that doctors select thimerosal-free shots for pregnant women and children.
Sanofi Pasteur since has increased its capacity to make mercury-free vaccine, yet because the government has expressed no preference, some of the capacity has gone unused.
In a pivotal moment in the debate, a committee of the prestigious Institute of Medicine rebuffed claims that thimerosal was responsible for an increase in autism cases.
In its May 2004 report, the panel declared that "the body of epidemiological evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism."
But parent activists and some scientists criticized the report — contending, among other things, that the institute had given too much weight to research in countries where thimerosal exposures had been lower than in the U.S. Either way, the report considered only autism and not potential risks of subtler developmental effects.
The CDC is engaged in a study of 7- to 10-year-olds to see if thimerosal exposures might have influenced language development, physical coordination and IQ.
And while rejecting the thimerosal-autism link, a report in November in the Pediatric Infectious Disease Journal stated that risks to "the fetus, premature infant and low-birth-weight infant have insufficiently been studied."
Some say the resistance by medical groups to bans on thimerosal reflects a profession in denial.
Cooper, of the American Academy of Pediatrics, said he could understand why people had come to see the academy as overly defensive. "But I hope we're big enough to be open to science," he said.
April 13, 2006
The Age of Autism: Christian's Mom Speaks
Do you feel the wind shifting?
The Age of Autism: Christian's Mom Speaks
By Dan Olmsted for UPI
A small earthquake rumbled through the autism world shortly after 7:30 a.m. on April 11, and the aftershocks are going to be felt for a long time.
NBC Universal Chairman Bob Wright, said she is concerned her young son Christian's autism might be related to vaccines he received, that he is getting better through treatments that include biomedical interventions, and that it's time for parents to follow their own "common sense" when they get their kids vaccinated.
Big deal? Yes, big deal.
It's hard to overstate the buzz circulating through the autism community over the past few months as it became known that Katie Wright was among those with concerns about vaccines playing a role in her child's autism -- and that she was trying to help him recover accordingly.
"I think it's a huge story," one autism activist e-mailed me in February. "This child triggered a weeklong series on NBC and the most well-funded autism organization on the planet (Autism Speaks)," not to mention the high-profile heft of the Wrights in lobbying for more money, more research and more awareness of a disorder that afflicts 1 in every 166 American kids.
Thousands of parents with concerns just like Katie Wright's have been all but ostracized, as have the small but growing minority of doctors trying to help them. I know two MDs who lost faculty appointments shortly after I wrote about them, and I hear story after story about pediatricians rolling their eyes when they hear vaccine- related health concerns of any kind from parents. Many ban families who balk from their practices.
Sitting right next to Katie Wright on "Imus in the Morning" on MSNBC was her father, who also is vice chairman and executive officer of GE, one of the world's biggest corporations. His comments were understandably more general -- nobody knows what causes autism, he said; vaccines are in the mix of possibilities that need urgent research; as are other environmental issues, as are genetic factors.
But does anybody think he would have been there if he vehemently objected to his daughter expressing her concerns? (For that matter, does anybody think Katie Wright would have been there? After all, he runs the joint.)
After Christian's diagnosis, Bob Wright and his wife, Suzanne, founded Autism Speaks, an advocacy group. Some longtime autism activists consider it a bit namby-pamby, but after Tuesday that impression may be due for an update.
Regardless, what Katie Wright had to say extends a thoroughly bad spell for the nation's health bureaucrats and medical trade associations in their efforts to stamp out discussion of a possible vaccine link to autism.
Major newspapers such as the Atlanta Journal-Constitution and the Los Angeles Times, which has been the best by far on this topic, published articles on such groups' relentless opposition to banning thimerosal -- the mercury-based preservative some believe triggered a huge rise in autism
diagnoses in the 1990s -- from childhood vaccinations.
Last week 22 health organizations sent a letter to every member of the U.S. Congress putting themselves on record that such bans are a danger to public health -- yes, banning mercury from childhood vaccines is dangerous, keeping it in is not. Several states have banned it anyway, including heavyweights Illinois, California and New York.
Meanwhile, Katie Wright said, the American Academy of Pediatrics has not endorsed a pending bill in Congress called Combating Autism -- backed by Autism Speaks and numerous other organizations -- which includes funding for research into possible causes of the epidemic, not excluding vaccines. Some apparently take that as a threat to the third rail of public-health policy: the U.S. childhood immunization schedule.
Katie Wright zinged 'em on that one -- she called the AAP's stance "shameful and disgraceful." And she said that whatever caused Christian's autism, she wishes she hadn't let her doctor give him six vaccines on one day at age 2 months. Parents need to use "common sense," she said -- would you, an adult, want six vaccines in one day?
Then she raised the stakes. Parents should insist that doctors "separate the vaccines." You know, give them over several office visits rather than all at once to minimize chances of a bad reaction.
That doesn't sound terribly threatening to public health, does it? Yet it's heresy -- completely contrary to the position of the Centers for Disease Control and Prevention.
"Use of licensed combination vaccines ... is preferred to separate injection of their equivalent component vaccines," says the CDC's authoritative Pink Book of vaccine-preventable diseases.
And they should all be administered "as soon as the child becomes eligible for vaccination."
And they should contain mercury, if we say so.
By putting her foot down, Katie Wright joins thousands of other parents putting the "father-knows-best" branch of medicine on notice that it's not nutty to use common sense when your child's health is at stake.
Others will differ, but that's what I call a public service announcement.
April 9, 2006
Mercury in Medicine - Taking Unnecessary Risks
Mercury in Medicine - Taking Unnecessary Risks
A Report Prepared by the Staff of the Subcommittee on Human Rights and Wellness Committee on Government Reform, United States House of Representatives
By Chairman Dan Burton, 3/31/2003 10:37:32 AM
Editor's Note: This Report Is the Result of a Three Year Investigation Initiated in the Committee on Government Reform.
Executive Summary
Vaccines are the only medicines that American citizens are mandated to receive as a condition for school and day care attendance, and in some instances, employment. Additionally, families who receive federal assistance are also required to show proof that their children have been fully immunized. While the mandate for which vaccines must be administered is a state mandate, it is the Federal Government, through the Centers for Disease Control and Prevention (CDC) and its Advisory Committee for Immunization Practices that make the Universal Immunization Recommendations to which the majority of states defer when determining mandates. Since the early to mid-1990’s, Congress has been concerned about the danger posed by mercury in medical applications, and in 1997, directed the Food and Drug Administration (FDA) to evaluate the human exposure to mercury through foods and drugs.
In 1999, following up on the FDA evaluation and pursuant to its authority, the House Committee on Government Reform initiated an investigation into the dangers of exposure to mercury through vaccination. The investigation later expanded to examine the potential danger posed through exposure to mercury in dental amalgams. This full committee investigation complemented and built upon the investigations initiated by two of its subcommittees. In January 2003, the investigation continued in the newly formed Subcommittee on Human Rights and Wellness.
A primary concern that arose early in the investigation of vaccine safety was the exposure of infants and young children to mercury, a known toxin, through mandatory childhood immunizations. This concern had been raised as a possible underlying factor in the dramatic rise in rates of late-onset or "acquired" autism. The symptoms of autism are markedly similar to those of mercury poisoning.
Significant concern has been raised about the continued use of mercury in medical applications decades after the recognition that mercury can be harmful, especially to our most vulnerable population – our children. This report will address one form of mercury in medical applications, Thimerosal , as a preservative in vaccines.
In July 2000, it was estimated that 8,000 children a day were being exposed to mercury in excess of Federal guidelines through their mandatory vaccines.
One leading researcher made the following statement to the Committee in July 2000:
There's no question that mercury does not belong in vaccines.
There are other compounds that could be used as preservatives. And everything we know about childhood susceptibility, neurotoxicity of mercury at the fetus and at the infant level, points out that we should not have these fetuses and infants exposed to mercury. There's no need of it in the vaccines.
The Food and Drug Administration’s (FDA) mission is to "promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use." However, the FDA uses a subjective barometer in determining when a product that has known risks can remain on the market. According to the agency, "at the heart of all FDA's product evaluation decisions is a judgment about whether a new product's benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great -- especially for products used to treat serious, life-threatening conditions."
This argument – that the known risks of infectious diseases outweigh a potential risk of neurological damage from exposure to thimerosal in vaccines, is one that has continuously been presented to the Committee by government officials. FDA officials have stressed that any possible risk from thimerosal was theoretical: that no proof of harm existed. Upon a thorough review of the scientific literature and internal documents from government and industry, the Committee did in fact find evidence that thimerosal posed a risk. The possible risk for harm from either low dose chronic or one time high level (bolus dose) exposure to thimerosal is not "theoretical," but very real and documented in the medical literature.
Congress has long been concerned about the human exposure to mercury through medical applications. As a result of these concerns, in 1997, Congress instructed the FDA to evaluate the human exposure to mercury through drugs and foods. Through this Congressionally mandated evaluation, the FDA realized that the amount of ethylmercury infants were exposed to in the first six months of life through their mandatory vaccinations exceeded the Environmental Protection Agency’s (EPA) limit for a closely associated compound methylmercury. The FDA and other Federal agencies determined that in the absence of a specific standard for ethylmercury, the limits for ingested methylmercury should be used for injected ethylmercury. The Institute of Medicine, in 2000, evaluated the EPA’s methylmercury standard and determined that based upon scientific data that it, rather than the FDA’s, was the scientifically validated safe exposure standard.
Rather than acting aggressively to remove thimerosal from children’s vaccines, the FDA and other agencies within the Department of Health and Human Services (HHS) adopted an incremental approach that allowed children to continue to be exposed to ethylmercury from vaccines for more than two additional years. In fact, in 2001,the Centers for Disease Control and Prevention (CDC) refused even to express a preference for thimerosal-free vaccines, despite the fact that thimerosal had been removed from almost every childhood vaccine produced for use in the United States.
On three occasions in the last 15 years, changes have been made to vaccine policies to reduce the risk of serious adverse effects. First, a transition from oral polio vaccine to injected polio was accomplished in the United States to reduce the transmission of vaccine-induced polio. Second, an acellular pertussis vaccine was developed and a transition from DTP to DTaP was accomplished to reduce the risk of pertussis – induced seizures in children. And third, when the Rotashield vaccine for rotavirus was linked to a serious bowel condition (intersucception), it was removed from the U.S. market. Ethylmercury has been largely removed from every major childhood vaccine manufactured for use in the United States, except the influenza vaccine, which continues to contain trace amounts.
This success, however, does not change the fact that millions of American children were exposed to levels of mercury through vaccines that exceeded comparable federal guidelines. Many parents, and a growing number of scientists, believe that this mercury exposure may have contributed to the explosive growth in autism spectrum disorders, and neurological and behavioral disorders that this country has experienced. The scientific evidence in this area is considered by some to still be inconclusive, in large part due to the lack of serious, effective inquiry by our health agencies. The federal government has an obligation to vigorously pursue the necessary research to determine the extent of the impact of these heightened exposures to ethylmercury on our population.
A second concern that arose during the investigation was the continued use of mercury in dental amalgams. Mercury has been used as a component in dental fillings since the Civil War era. The American Dental Association and its member dentists have taken a position that the mercury in fillings, which are considered toxic until placed in the tooth, and is considered toxic when removed from the mouth, is completely safe while in the human mouth. This position seems counter even to the ADA-funded research that shows the daily release of small amounts of mercury vapors in the human mouth where dental amalgams are present, as well as minute chipping and swallowing of the mercury fillings over time.
Babies and young children are exposed to this additional mercury. As developing fetuses, babies are exposed to mercury through the placenta. If pregnant women have mercury amalgams, they are unknowingly excreting low levels of mercury on a daily basis to their fetuses. Additionally, children who receive dental services through Medicaid are also potentially exposed to mercury. When these children need dental fillings, because of the low cost, only mercury amalgams are available for use. This concern remains under investigation by the Subcommittee on Human Rights and Wellness.
Findings and Recommendations
Findings
Through this investigation of pediatric vaccine safety, the following findings are made:
* 1. Mercury is hazardous to humans. Its use in medicinal products is undesirable, unnecessary and should be minimized or eliminated entirely.
* 2. For decades, ethylmercury was used extensively in medical products ranging from vaccines to topical ointments as preservative and an anti-bacteriological agent.
* 3. Manufacturers of vaccines and thimerosal, (an ethylmercury compound used in vaccines), have never conducted adequate testing on the safety of thimerosal. The FDA has never required manufacturers to conduct adequate safety testing on thimerosal and ethylmercury compounds.
* 4. Studies and papers documenting the hypoallergenicity and toxicity of thimerosal (ethylmercury) have existed for decades.
* 5. Autism in the United States has grown at epidemic proportions during the last decade. By some estimates the number of autistic children in the United States is growing between 10 and 17 percent per year. The medical community has been unable to determine the underlying cause(s) of this explosive growth.
* 6. At the same time that the incidence of autism was growing, the number of childhood vaccines containing thimerosal was growing, increasing the amount of ethylmercury to which infants were exposed threefold.
* 7. A growing number of scientists and researchers believe that a relationship between the increase in neurodevelopmental disorders of autism, attention deficit hyperactive disorder, and speech or language delay, and the increased use of thimerosal in vaccines is plausible and deserves more scrutiny. In 2001, the Institute of Medicine determined that such a relationship is biologically plausible, but that not enough evidence exists to support or reject this hypothesis.
* 8. The FDA acted too slowly to remove ethylmercury from over-the-counter products like topical ointments and skin creams. Although an advisory committee determined that ethylmercury was unsafe in these products in 1980, a rule requiring its removal was not finalized until 1998.
* 9. The FDA and the CDC failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to the immunization schedule. When the Hepatitis B and Haemophilus Influenzae Type b vaccines were added to the recommended schedule of childhood immunizations, the cumulative amount of ethylmercury to which children were exposed nearly tripled.
* 10. The amount of ethylmercury to which children were exposed through vaccines prior to the 1999 announcement exceeded two safety thresholds established by the Federal government for a closely related substance – methylmercury. While the Federal Government has established no safety threshold for ethylmercury, experts agree that the methylmercury guidelines are a good substitute. Federal health officials have conceded that the amount of thimerosal in vaccines exceeded the EPA threshold of 0.1 micrograms per kilogram of bodyweight. In fact, the amount of mercury in one dose of DTaP or Hepatitis B vaccines (25 micrograms each) exceeded this threshold many times over. Federal health officials have not conceded that this amount of thimerosal in vaccines exceeded the FDA’s more relaxed threshold of 0.4 micrograms per kilogram of body weight. In most cases, however, it clearly did.
* 11. The actions taken by the HHS to remove thimerosal from vaccines in 1999 were not sufficiently aggressive. As a result, thimerosal remained in some vaccines for an additional two years.
* 12. The CDC’s failure to state a preference for thimerosal-free vaccines in 2000 and again in 2001 was an abdication of their responsibility. As a result, many children received vaccines containing thimerosal when thimerosal-free alternatives were available.
* 13. The Influenza vaccine appears to be the sole remaining vaccine given to children in the United States on a regular basis that contains thimerosal. Two formulations recommended for children six months of age or older continue to contain trace amounts of thimerosal. Thimerosal should be removed from these vaccines. No amount of mercury is appropriate in any childhood vaccine.
* 14. The CDC in general and the National Immunization Program in particular are conflicted in their duties to monitor the safety of vaccines, while also charged with the responsibility of purchasing vaccines for resale as well as promoting increased immunization rates.
* 15. There is inadequate research regarding ethylmercury neurotoxicity and nephrotoxicity.
* 16. There is inadequate research regarding the relationship between autism and the use of mercury-containing vaccines.
* 17. To date, studies conducted or funded by the CDC that purportedly dispute any correlation between autism and vaccine injury have been of poor design, under-powered, and fatally flawed. The CDC’s rush to support and promote such research is reflective of a philosophical conflict in looking fairly at emerging theories and clinical data related to adverse reactions from vaccinations.
Recommendations
* 1. Access by independent researchers to the Vaccine Safety Datalink database is needed for independent replication and validation of CDC studies regarding exposure of infants to mercury-containing vaccines and autism. The current process to allow access remains inadequate.
* 2. A more integrated approach to mercury research is needed. There are different routes that mercury takes into the body, and there are different rates of absorption. Mercury bioaccumulates; the Agency for Toxic Substances and Disease Registry (ATSDR) clearly states: "This substance may harm you." Studies should be conducted that pool the results of independent research that has been done thus far, and a comprehensive approach should be developed to rid humans, animals, and the environment of this dangerous toxin.
* 3. Greater collaboration and cooperation between federal agencies responsible for safeguarding public health in regard to heavy metals is needed.
* 4. The President should announce a White House conference on autism to assemble the best scientific minds from across the country and mobilize a national effort to uncover the causes of the autism epidemic.
* 5. Congress needs to pass legislation to include in the National Vaccine Injury Compensation Program (NVICP) provisions to allow families who believe that their children’s autism is vaccine-induced the opportunity to be included in the program. Two provisions are key: First, extending the statute of limitations as recommended by the Advisory Commission on Childhood Vaccines from 3 to 6 years. Second, establishing a one to two-year window for families, whose children were injured after 1988 but who do not fit within the statute of limitations, to have the opportunity to file under the NVICP.
* 6. Congress should enact legislation that prohibits federal funds from being used to provide products or pharmaceuticals that contain mercury, methylmercury, or ethylmercury unless no reasonable alternative is available.
* 7. Congress should direct the National Institutes of Health to give priority to research projects studying causal relationships between exposure to mercury, methylmercury, and ethylmercury to autism spectrum disorders, attention deficit disorders, Gulf War Syndrome, and Alzheimer’s Disease.
A Report Prepared by the Staff of the Subcommittee on Human Rights and Wellness Committee on Government Reform, United States House of Representatives
By Chairman Dan Burton, 3/31/2003 10:37:32 AM
Editor's Note: This Report Is the Result of a Three Year Investigation Initiated in the Committee on Government Reform.
Executive Summary
Vaccines are the only medicines that American citizens are mandated to receive as a condition for school and day care attendance, and in some instances, employment. Additionally, families who receive federal assistance are also required to show proof that their children have been fully immunized. While the mandate for which vaccines must be administered is a state mandate, it is the Federal Government, through the Centers for Disease Control and Prevention (CDC) and its Advisory Committee for Immunization Practices that make the Universal Immunization Recommendations to which the majority of states defer when determining mandates. Since the early to mid-1990’s, Congress has been concerned about the danger posed by mercury in medical applications, and in 1997, directed the Food and Drug Administration (FDA) to evaluate the human exposure to mercury through foods and drugs.
In 1999, following up on the FDA evaluation and pursuant to its authority, the House Committee on Government Reform initiated an investigation into the dangers of exposure to mercury through vaccination. The investigation later expanded to examine the potential danger posed through exposure to mercury in dental amalgams. This full committee investigation complemented and built upon the investigations initiated by two of its subcommittees. In January 2003, the investigation continued in the newly formed Subcommittee on Human Rights and Wellness.
A primary concern that arose early in the investigation of vaccine safety was the exposure of infants and young children to mercury, a known toxin, through mandatory childhood immunizations. This concern had been raised as a possible underlying factor in the dramatic rise in rates of late-onset or "acquired" autism. The symptoms of autism are markedly similar to those of mercury poisoning.
Significant concern has been raised about the continued use of mercury in medical applications decades after the recognition that mercury can be harmful, especially to our most vulnerable population – our children. This report will address one form of mercury in medical applications, Thimerosal , as a preservative in vaccines.
In July 2000, it was estimated that 8,000 children a day were being exposed to mercury in excess of Federal guidelines through their mandatory vaccines.
One leading researcher made the following statement to the Committee in July 2000:
There's no question that mercury does not belong in vaccines.
There are other compounds that could be used as preservatives. And everything we know about childhood susceptibility, neurotoxicity of mercury at the fetus and at the infant level, points out that we should not have these fetuses and infants exposed to mercury. There's no need of it in the vaccines.
The Food and Drug Administration’s (FDA) mission is to "promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use." However, the FDA uses a subjective barometer in determining when a product that has known risks can remain on the market. According to the agency, "at the heart of all FDA's product evaluation decisions is a judgment about whether a new product's benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great -- especially for products used to treat serious, life-threatening conditions."
This argument – that the known risks of infectious diseases outweigh a potential risk of neurological damage from exposure to thimerosal in vaccines, is one that has continuously been presented to the Committee by government officials. FDA officials have stressed that any possible risk from thimerosal was theoretical: that no proof of harm existed. Upon a thorough review of the scientific literature and internal documents from government and industry, the Committee did in fact find evidence that thimerosal posed a risk. The possible risk for harm from either low dose chronic or one time high level (bolus dose) exposure to thimerosal is not "theoretical," but very real and documented in the medical literature.
Congress has long been concerned about the human exposure to mercury through medical applications. As a result of these concerns, in 1997, Congress instructed the FDA to evaluate the human exposure to mercury through drugs and foods. Through this Congressionally mandated evaluation, the FDA realized that the amount of ethylmercury infants were exposed to in the first six months of life through their mandatory vaccinations exceeded the Environmental Protection Agency’s (EPA) limit for a closely associated compound methylmercury. The FDA and other Federal agencies determined that in the absence of a specific standard for ethylmercury, the limits for ingested methylmercury should be used for injected ethylmercury. The Institute of Medicine, in 2000, evaluated the EPA’s methylmercury standard and determined that based upon scientific data that it, rather than the FDA’s, was the scientifically validated safe exposure standard.
Rather than acting aggressively to remove thimerosal from children’s vaccines, the FDA and other agencies within the Department of Health and Human Services (HHS) adopted an incremental approach that allowed children to continue to be exposed to ethylmercury from vaccines for more than two additional years. In fact, in 2001,the Centers for Disease Control and Prevention (CDC) refused even to express a preference for thimerosal-free vaccines, despite the fact that thimerosal had been removed from almost every childhood vaccine produced for use in the United States.
On three occasions in the last 15 years, changes have been made to vaccine policies to reduce the risk of serious adverse effects. First, a transition from oral polio vaccine to injected polio was accomplished in the United States to reduce the transmission of vaccine-induced polio. Second, an acellular pertussis vaccine was developed and a transition from DTP to DTaP was accomplished to reduce the risk of pertussis – induced seizures in children. And third, when the Rotashield vaccine for rotavirus was linked to a serious bowel condition (intersucception), it was removed from the U.S. market. Ethylmercury has been largely removed from every major childhood vaccine manufactured for use in the United States, except the influenza vaccine, which continues to contain trace amounts.
This success, however, does not change the fact that millions of American children were exposed to levels of mercury through vaccines that exceeded comparable federal guidelines. Many parents, and a growing number of scientists, believe that this mercury exposure may have contributed to the explosive growth in autism spectrum disorders, and neurological and behavioral disorders that this country has experienced. The scientific evidence in this area is considered by some to still be inconclusive, in large part due to the lack of serious, effective inquiry by our health agencies. The federal government has an obligation to vigorously pursue the necessary research to determine the extent of the impact of these heightened exposures to ethylmercury on our population.
A second concern that arose during the investigation was the continued use of mercury in dental amalgams. Mercury has been used as a component in dental fillings since the Civil War era. The American Dental Association and its member dentists have taken a position that the mercury in fillings, which are considered toxic until placed in the tooth, and is considered toxic when removed from the mouth, is completely safe while in the human mouth. This position seems counter even to the ADA-funded research that shows the daily release of small amounts of mercury vapors in the human mouth where dental amalgams are present, as well as minute chipping and swallowing of the mercury fillings over time.
Babies and young children are exposed to this additional mercury. As developing fetuses, babies are exposed to mercury through the placenta. If pregnant women have mercury amalgams, they are unknowingly excreting low levels of mercury on a daily basis to their fetuses. Additionally, children who receive dental services through Medicaid are also potentially exposed to mercury. When these children need dental fillings, because of the low cost, only mercury amalgams are available for use. This concern remains under investigation by the Subcommittee on Human Rights and Wellness.
Findings and Recommendations
Findings
Through this investigation of pediatric vaccine safety, the following findings are made:
* 1. Mercury is hazardous to humans. Its use in medicinal products is undesirable, unnecessary and should be minimized or eliminated entirely.
* 2. For decades, ethylmercury was used extensively in medical products ranging from vaccines to topical ointments as preservative and an anti-bacteriological agent.
* 3. Manufacturers of vaccines and thimerosal, (an ethylmercury compound used in vaccines), have never conducted adequate testing on the safety of thimerosal. The FDA has never required manufacturers to conduct adequate safety testing on thimerosal and ethylmercury compounds.
* 4. Studies and papers documenting the hypoallergenicity and toxicity of thimerosal (ethylmercury) have existed for decades.
* 5. Autism in the United States has grown at epidemic proportions during the last decade. By some estimates the number of autistic children in the United States is growing between 10 and 17 percent per year. The medical community has been unable to determine the underlying cause(s) of this explosive growth.
* 6. At the same time that the incidence of autism was growing, the number of childhood vaccines containing thimerosal was growing, increasing the amount of ethylmercury to which infants were exposed threefold.
* 7. A growing number of scientists and researchers believe that a relationship between the increase in neurodevelopmental disorders of autism, attention deficit hyperactive disorder, and speech or language delay, and the increased use of thimerosal in vaccines is plausible and deserves more scrutiny. In 2001, the Institute of Medicine determined that such a relationship is biologically plausible, but that not enough evidence exists to support or reject this hypothesis.
* 8. The FDA acted too slowly to remove ethylmercury from over-the-counter products like topical ointments and skin creams. Although an advisory committee determined that ethylmercury was unsafe in these products in 1980, a rule requiring its removal was not finalized until 1998.
* 9. The FDA and the CDC failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to the immunization schedule. When the Hepatitis B and Haemophilus Influenzae Type b vaccines were added to the recommended schedule of childhood immunizations, the cumulative amount of ethylmercury to which children were exposed nearly tripled.
* 10. The amount of ethylmercury to which children were exposed through vaccines prior to the 1999 announcement exceeded two safety thresholds established by the Federal government for a closely related substance – methylmercury. While the Federal Government has established no safety threshold for ethylmercury, experts agree that the methylmercury guidelines are a good substitute. Federal health officials have conceded that the amount of thimerosal in vaccines exceeded the EPA threshold of 0.1 micrograms per kilogram of bodyweight. In fact, the amount of mercury in one dose of DTaP or Hepatitis B vaccines (25 micrograms each) exceeded this threshold many times over. Federal health officials have not conceded that this amount of thimerosal in vaccines exceeded the FDA’s more relaxed threshold of 0.4 micrograms per kilogram of body weight. In most cases, however, it clearly did.
* 11. The actions taken by the HHS to remove thimerosal from vaccines in 1999 were not sufficiently aggressive. As a result, thimerosal remained in some vaccines for an additional two years.
* 12. The CDC’s failure to state a preference for thimerosal-free vaccines in 2000 and again in 2001 was an abdication of their responsibility. As a result, many children received vaccines containing thimerosal when thimerosal-free alternatives were available.
* 13. The Influenza vaccine appears to be the sole remaining vaccine given to children in the United States on a regular basis that contains thimerosal. Two formulations recommended for children six months of age or older continue to contain trace amounts of thimerosal. Thimerosal should be removed from these vaccines. No amount of mercury is appropriate in any childhood vaccine.
* 14. The CDC in general and the National Immunization Program in particular are conflicted in their duties to monitor the safety of vaccines, while also charged with the responsibility of purchasing vaccines for resale as well as promoting increased immunization rates.
* 15. There is inadequate research regarding ethylmercury neurotoxicity and nephrotoxicity.
* 16. There is inadequate research regarding the relationship between autism and the use of mercury-containing vaccines.
* 17. To date, studies conducted or funded by the CDC that purportedly dispute any correlation between autism and vaccine injury have been of poor design, under-powered, and fatally flawed. The CDC’s rush to support and promote such research is reflective of a philosophical conflict in looking fairly at emerging theories and clinical data related to adverse reactions from vaccinations.
Recommendations
* 1. Access by independent researchers to the Vaccine Safety Datalink database is needed for independent replication and validation of CDC studies regarding exposure of infants to mercury-containing vaccines and autism. The current process to allow access remains inadequate.
* 2. A more integrated approach to mercury research is needed. There are different routes that mercury takes into the body, and there are different rates of absorption. Mercury bioaccumulates; the Agency for Toxic Substances and Disease Registry (ATSDR) clearly states: "This substance may harm you." Studies should be conducted that pool the results of independent research that has been done thus far, and a comprehensive approach should be developed to rid humans, animals, and the environment of this dangerous toxin.
* 3. Greater collaboration and cooperation between federal agencies responsible for safeguarding public health in regard to heavy metals is needed.
* 4. The President should announce a White House conference on autism to assemble the best scientific minds from across the country and mobilize a national effort to uncover the causes of the autism epidemic.
* 5. Congress needs to pass legislation to include in the National Vaccine Injury Compensation Program (NVICP) provisions to allow families who believe that their children’s autism is vaccine-induced the opportunity to be included in the program. Two provisions are key: First, extending the statute of limitations as recommended by the Advisory Commission on Childhood Vaccines from 3 to 6 years. Second, establishing a one to two-year window for families, whose children were injured after 1988 but who do not fit within the statute of limitations, to have the opportunity to file under the NVICP.
* 6. Congress should enact legislation that prohibits federal funds from being used to provide products or pharmaceuticals that contain mercury, methylmercury, or ethylmercury unless no reasonable alternative is available.
* 7. Congress should direct the National Institutes of Health to give priority to research projects studying causal relationships between exposure to mercury, methylmercury, and ethylmercury to autism spectrum disorders, attention deficit disorders, Gulf War Syndrome, and Alzheimer’s Disease.
The Sting of Thimerosal in Autism
The Sting of Thimerosal in Autism
By James Ottar Grundvig
The Epoch Times
Apr 01, 2006
In the summer of 1980, I worked with a former New York City homicide detective on a construction crew. He had patrolled and survived the drug-infested streets of the South Bronx for two decades. But I remember him not for his toughness, but for something I will never forget: he was hyper-allergic to bees.
A bee sting was more of a death sentence to that ex-policeman than a knife or gunshot wound. If he didn't get immediate medical care after being stung, he would suffocate from the hives that closed his throat and blew up his skin like a strawberry.
I recall that story every day when I see my six-year-old autistic son struggle to make out a word, fail to use the laptop glidepad with his fingers, or stay focused for long stretches of time. Most people do not have life-threatening reactions to the venom in a bee's stinger; so too, most people do not have the immune reactions such as produced autism in my son. But the differences between the rare few whose immune systems are susceptible to bee stings and the children of the autism epidemic are as night and day.
For instance, people who have the genetic flaw that makes them defenseless against bees are numbers that grow at a constant rate with the population.
That, however, cannot be said of the vacccine-thimerosal-autism triangle that began in 1929, when the population of autistic spectrum disorder children (ASD) was zero. Fourteen years after the introduction of thimerosal (a mercury-based preservative then under the trade name Merthiolate) by the pharmaceutical giant Eli Lilly, Leo Kanner at John Hopkins Medical Center diagnosed the peculiar behavior associated with autism in eleven kids for the first time. That was 1943. The following year in Switzerland, Hans Asperger identified another subgroup of high-functioning autistic children with Asperger's Syndrome.
Coincidence? Hardly. The circumstantial evidence between the timeline of thimerosal's introduction in vaccines and children having the disorder fourteen years later, and then further amplified by the parallel rise in the quantity of vaccines given and the explosion of the autism epidemic makes it overwhelming. Thimerosal and autism throughout the past century go hand and hand.
For the thirty years after autism was identified, it grew at the constant rate of 1-in-10,000 babies born. Although more prevalent than individuals who were allergic to bee stings, the number of autistic infants only grew if the population did. So when my generation had one or two vaccines in the 1960's, the rate of children having autism stayed the same. That would change, however, not from an increase in population, but due to the growing number of vaccines given to babies, most of which contained thimerosal.
In 1978, the CDC added the triple shot MMR (measles, mumps, rubella) to the growing baby immunization program. Although MMR as a "live-cell" vaccine does not contain thimerosal—because the mercury-based preservative as an antibacterial agent would kill the deactivated virus in the vaccine and thus render it impotent—it started a frightening, irreversible, and detrimental trend: Doctors began giving more vaccines, at younger ages, for many diseases to which babies wouldn't be exposed until later in life (hepatitis B), with the new vaccination protocols all blessed and sanctioned by the CDC. None of the new baby vaccines was backed by a single study on its individual safety; nor was a single study done on the safety of the multiple vaccinations now given.
By the 1980s, my nieces and nephews received 8-9 vaccines when the U.S. resident population was 236 million people. By 1978, the rate of autism had increased four times, going from the previous rate of 1-in-10,000 to 1-in-2,500. Over the next ten years, the autism rate would climb again to 1-in-1,000 in 1991, when the DTP triple shot and hepatitis B were added to the vaccine chart, both of which contained thimerosal.
By the end of 2000, the year when my son was born, the rate mushroomed yet again to 1-in-250. Not only did the population of ASD children grow, so did the total number of vaccines given to babies, including my son, from about ten in 1990 to 22 vaccines or more today. The result of this ill-advised, force-fed mandate has been catastrophic. The rate of children born with ASD has increased again to 1-in-166, or 1-in-150 in many parts of California, Florida, and New Jersey.
In short, the occurrence of autism has increased at a rate of 1,700% over the past twenty years or more than 6,000% over the past thirty years. Meanwhile, the U.S. population during the past twenty years has grown from 236 to 300 million people, or at the rate of 21%. Still, the U.S. government, which has allowed to this very day the continued use of mercury (in infant flu shots) and thereby sanctioned the poisoning of infant's bodies, doesn't get the one underlying fact about autism: ASD children have disastrous reactions to thimerosal.
Once they are contaminated, they cannot excrete heavy metals out of the system.
Like the bee sting that could topple a Goliath or a hardnosed NYPD detective, no amount of thimerosal, no matter how minute, would ever be safe in the bodies of infants predisposed to autism. Trace amounts in susceptible newborns can damage a nervous system at once vulnerable and beginning to develop. But unlike bee stings, there is no serum or medication to reverse the poison. That's because thimerosal is even more insidious—it is a neurotoxin embedded in the brains, organs and tissues in its heavy metals form.
So if the rape of a child is against the law, then why isn't poisoning babies a crime? If an individual chose to poison another person with ricin, rat poison, anthrax, or even mercury from a thermometer, that individual would be sent to jail. So why is the use of thimerosal in 2006 not banned as a toxin in babies?
To answer this question and to see why the immunization mandates were imposed that caused the recent explosion in autism rates, one needs to understand the incestuous relationship between the agencies and institutions that should be protecting our children: the FDA, CDC, and the big pharmaceutical companies. The key to that relationship is greed.
By shielding big pharmaceutical companies from prosecution, by preserving the continued use of thimerosal in vaccines, by passing the financial liability from the perpetrators to the victims and their states, the U.S. Government, from the CDC and the FDA to Congress and the White House, have failed an entire generation of children.
The ugly truth about autism—it's here to stay.
By James Ottar Grundvig
The Epoch Times
Apr 01, 2006
In the summer of 1980, I worked with a former New York City homicide detective on a construction crew. He had patrolled and survived the drug-infested streets of the South Bronx for two decades. But I remember him not for his toughness, but for something I will never forget: he was hyper-allergic to bees.
A bee sting was more of a death sentence to that ex-policeman than a knife or gunshot wound. If he didn't get immediate medical care after being stung, he would suffocate from the hives that closed his throat and blew up his skin like a strawberry.
I recall that story every day when I see my six-year-old autistic son struggle to make out a word, fail to use the laptop glidepad with his fingers, or stay focused for long stretches of time. Most people do not have life-threatening reactions to the venom in a bee's stinger; so too, most people do not have the immune reactions such as produced autism in my son. But the differences between the rare few whose immune systems are susceptible to bee stings and the children of the autism epidemic are as night and day.
For instance, people who have the genetic flaw that makes them defenseless against bees are numbers that grow at a constant rate with the population.
That, however, cannot be said of the vacccine-thimerosal-autism triangle that began in 1929, when the population of autistic spectrum disorder children (ASD) was zero. Fourteen years after the introduction of thimerosal (a mercury-based preservative then under the trade name Merthiolate) by the pharmaceutical giant Eli Lilly, Leo Kanner at John Hopkins Medical Center diagnosed the peculiar behavior associated with autism in eleven kids for the first time. That was 1943. The following year in Switzerland, Hans Asperger identified another subgroup of high-functioning autistic children with Asperger's Syndrome.
Coincidence? Hardly. The circumstantial evidence between the timeline of thimerosal's introduction in vaccines and children having the disorder fourteen years later, and then further amplified by the parallel rise in the quantity of vaccines given and the explosion of the autism epidemic makes it overwhelming. Thimerosal and autism throughout the past century go hand and hand.
For the thirty years after autism was identified, it grew at the constant rate of 1-in-10,000 babies born. Although more prevalent than individuals who were allergic to bee stings, the number of autistic infants only grew if the population did. So when my generation had one or two vaccines in the 1960's, the rate of children having autism stayed the same. That would change, however, not from an increase in population, but due to the growing number of vaccines given to babies, most of which contained thimerosal.
In 1978, the CDC added the triple shot MMR (measles, mumps, rubella) to the growing baby immunization program. Although MMR as a "live-cell" vaccine does not contain thimerosal—because the mercury-based preservative as an antibacterial agent would kill the deactivated virus in the vaccine and thus render it impotent—it started a frightening, irreversible, and detrimental trend: Doctors began giving more vaccines, at younger ages, for many diseases to which babies wouldn't be exposed until later in life (hepatitis B), with the new vaccination protocols all blessed and sanctioned by the CDC. None of the new baby vaccines was backed by a single study on its individual safety; nor was a single study done on the safety of the multiple vaccinations now given.
By the 1980s, my nieces and nephews received 8-9 vaccines when the U.S. resident population was 236 million people. By 1978, the rate of autism had increased four times, going from the previous rate of 1-in-10,000 to 1-in-2,500. Over the next ten years, the autism rate would climb again to 1-in-1,000 in 1991, when the DTP triple shot and hepatitis B were added to the vaccine chart, both of which contained thimerosal.
By the end of 2000, the year when my son was born, the rate mushroomed yet again to 1-in-250. Not only did the population of ASD children grow, so did the total number of vaccines given to babies, including my son, from about ten in 1990 to 22 vaccines or more today. The result of this ill-advised, force-fed mandate has been catastrophic. The rate of children born with ASD has increased again to 1-in-166, or 1-in-150 in many parts of California, Florida, and New Jersey.
In short, the occurrence of autism has increased at a rate of 1,700% over the past twenty years or more than 6,000% over the past thirty years. Meanwhile, the U.S. population during the past twenty years has grown from 236 to 300 million people, or at the rate of 21%. Still, the U.S. government, which has allowed to this very day the continued use of mercury (in infant flu shots) and thereby sanctioned the poisoning of infant's bodies, doesn't get the one underlying fact about autism: ASD children have disastrous reactions to thimerosal.
Once they are contaminated, they cannot excrete heavy metals out of the system.
Like the bee sting that could topple a Goliath or a hardnosed NYPD detective, no amount of thimerosal, no matter how minute, would ever be safe in the bodies of infants predisposed to autism. Trace amounts in susceptible newborns can damage a nervous system at once vulnerable and beginning to develop. But unlike bee stings, there is no serum or medication to reverse the poison. That's because thimerosal is even more insidious—it is a neurotoxin embedded in the brains, organs and tissues in its heavy metals form.
So if the rape of a child is against the law, then why isn't poisoning babies a crime? If an individual chose to poison another person with ricin, rat poison, anthrax, or even mercury from a thermometer, that individual would be sent to jail. So why is the use of thimerosal in 2006 not banned as a toxin in babies?
To answer this question and to see why the immunization mandates were imposed that caused the recent explosion in autism rates, one needs to understand the incestuous relationship between the agencies and institutions that should be protecting our children: the FDA, CDC, and the big pharmaceutical companies. The key to that relationship is greed.
By shielding big pharmaceutical companies from prosecution, by preserving the continued use of thimerosal in vaccines, by passing the financial liability from the perpetrators to the victims and their states, the U.S. Government, from the CDC and the FDA to Congress and the White House, have failed an entire generation of children.
The ugly truth about autism—it's here to stay.
JB Handley's response to RFK piece
`Til Death Do Us Part
By JB Handley
www.generationrescue.org
March 2, 2006
Exclusive to the Evidence Of Harm Discussion Group and Lenny.
I wept when I read RFK Jr's piece yesterday on the Huffington Post. CDC could have had DTP vaccines in the market as early as 1999 or 2000, cutting mercury levels immediately in vaccines by 40% for young children. CDC chose not to. I wept for my autistic son, born in 2002. And, I wept with rage for the unimaginable skin-saving behavior of a bunch of bureaucrats I've never met who, with their selfishness, completely altered the course of my son and family's life.
It's been a long time since I've cried. When my son was diagnosed with Autism, in July of 2004, I cried for a full month, for hours on end. Then one day, I just stopped. It wasn't helping him, and there was work to do. Months later, to my astonishment, he began to get better. And better. And better. Astonished? Hell, yes! You see, I put the "M" in mainstream. All this garbage about vaccines and autism was Hippy stuff, nothing more. But, every time a test came back it matched what all these DAN! Doctors and Dr. Rimland kept telling us: my son was very, very sick, and he needed medical treatment.
It's hard for any rational person to understand how long the CDC will keep up this charade. I'll tell you what, with friends like Dan Olmsted, David Kirby, Don & Dierdre Imus, Dan Burton, Dave Weldon, Carolyn Maloney, and RFK Jr., I know who I'm betting on. Dr. Offit, you're looking a little lonely these days over there, as you wait to collect your royalty checks from your new vaccine.
I know this is a very public discussion group. I know "moles" read what's here to see how we "anti-vaxers" are organizing ourselves. I thought I'd let you know about who you're up against.
First off, we're parents. And you, in covering your ass, have kidnapped our children's souls. In the wild, the consequence for what you've done is obvious, but being civilized, we will get you with the violence of truth. You see, unlike other body-snatchers, you've made a number of mistakes and left some very clear calling cards. You've left the measles virus in our children' guts, you've left mercury in their brains, and you forgot about the parents who never vaccinated their children who will willingly help us compare autism rates. You also never realized, because it's not your specialty, that autism is not only treatable, its reversible. You didn't take our children's souls, you just buried them. They're still there, waiting to come out.
Our kids are getting better. But, you don't want to know this. You sound an autism ALARM, we're documenting thousands of recoveries, but you don't ever come and see? We're going to show you anyway. We're videotaping our kids, we're documenting the excretion of metals from their delicate little bodies, and we're sharing our stories with every reporter in the free world. And, they're finally listening. You know why? Because you snatched some kids in some very high places. And everyone's a parent first.
The 8 million pound gorilla is awake. We're tens of thousands of parents unified to get our children medical treatment as soon as possible and to make sure every parent understands the truth and understands your treachery. If you sit in your little cubicle, hoping we'll finally go away because you paid for one more study trying to refute our position, you are sorely, sorely mistaken. You will have to kill us all to shut us up. And while you've stood by and tried to take our children away, it's unlikely you could get us all before we get you. With truth.
`til death do us part, CDC, `til death do us part.
By JB Handley
www.generationrescue.org
March 2, 2006
Exclusive to the Evidence Of Harm Discussion Group and Lenny.
I wept when I read RFK Jr's piece yesterday on the Huffington Post. CDC could have had DTP vaccines in the market as early as 1999 or 2000, cutting mercury levels immediately in vaccines by 40% for young children. CDC chose not to. I wept for my autistic son, born in 2002. And, I wept with rage for the unimaginable skin-saving behavior of a bunch of bureaucrats I've never met who, with their selfishness, completely altered the course of my son and family's life.
It's been a long time since I've cried. When my son was diagnosed with Autism, in July of 2004, I cried for a full month, for hours on end. Then one day, I just stopped. It wasn't helping him, and there was work to do. Months later, to my astonishment, he began to get better. And better. And better. Astonished? Hell, yes! You see, I put the "M" in mainstream. All this garbage about vaccines and autism was Hippy stuff, nothing more. But, every time a test came back it matched what all these DAN! Doctors and Dr. Rimland kept telling us: my son was very, very sick, and he needed medical treatment.
It's hard for any rational person to understand how long the CDC will keep up this charade. I'll tell you what, with friends like Dan Olmsted, David Kirby, Don & Dierdre Imus, Dan Burton, Dave Weldon, Carolyn Maloney, and RFK Jr., I know who I'm betting on. Dr. Offit, you're looking a little lonely these days over there, as you wait to collect your royalty checks from your new vaccine.
I know this is a very public discussion group. I know "moles" read what's here to see how we "anti-vaxers" are organizing ourselves. I thought I'd let you know about who you're up against.
First off, we're parents. And you, in covering your ass, have kidnapped our children's souls. In the wild, the consequence for what you've done is obvious, but being civilized, we will get you with the violence of truth. You see, unlike other body-snatchers, you've made a number of mistakes and left some very clear calling cards. You've left the measles virus in our children' guts, you've left mercury in their brains, and you forgot about the parents who never vaccinated their children who will willingly help us compare autism rates. You also never realized, because it's not your specialty, that autism is not only treatable, its reversible. You didn't take our children's souls, you just buried them. They're still there, waiting to come out.
Our kids are getting better. But, you don't want to know this. You sound an autism ALARM, we're documenting thousands of recoveries, but you don't ever come and see? We're going to show you anyway. We're videotaping our kids, we're documenting the excretion of metals from their delicate little bodies, and we're sharing our stories with every reporter in the free world. And, they're finally listening. You know why? Because you snatched some kids in some very high places. And everyone's a parent first.
The 8 million pound gorilla is awake. We're tens of thousands of parents unified to get our children medical treatment as soon as possible and to make sure every parent understands the truth and understands your treachery. If you sit in your little cubicle, hoping we'll finally go away because you paid for one more study trying to refute our position, you are sorely, sorely mistaken. You will have to kill us all to shut us up. And while you've stood by and tried to take our children away, it's unlikely you could get us all before we get you. With truth.
`til death do us part, CDC, `til death do us part.
Robert F. Kennedy Jr.: Time for CDC to Come Clean
Robert F. Kennedy Jr.: Time for CDC to Come Clean
HuffPo
March 1, 2006
Correspondence newly obtained under the Freedom of Information Act raises
troubling new questions about CDC's role in the Thimerosal scandal. Thimerosal is the mercury-based vaccine preservative that has been linked to epidemics of neurological disorders, including autism, in American children born after 1989.
Responding to scientific studies linking dangerous levels of mercury to a range of health disorders, the CDC in July 1999 recommended that the nation's vaccine makers eliminate Thimerosal as a preservative, "as soon as possible."
But the newly released documents show that behind the scenes CDC was quietly discouraging Thimerosal's removal. In a July 1999 letter, vaccine producer SmithKline Beecham tells CDC that it is ready to produce non-Thimerosal DTP (Diptheria/Tetanus/Pertussis) vaccines immediately and has sufficient inventories to supply the entire U.S. market during the remainder of 1999 and the first half of 2000, by which time other vaccine manufacturers would have their Thimerosal-free DTP vaccines on line.
Thimerosal-laden DTP vaccines containing 25 micrograms of mercury apiece were then being administered to American infants at two months, four months and six months -- far exceeding EPA's recommended safe level for mercury. Had CDC accepted SmithKline's offer, it could have immediately reduced the mercury exposures to vaccinated six-month-old children by 40%.
However, in November, CDC mysteriously sent a letter back rejecting SmithKline's offer. Then, on July 14, 2000 CDC published a deceptive press release promising to require that all vaccines be Thimerosal-free as soon as "adequate supplies are available." This was a full 12 months after the agency had denied SmithKline's proposal.
"If CDC were basing its decision on safety alone, it would have taken SmithKline up on its offer. That's a no-brainer," said a federal health official who requested anonymity. "So there were other considerations beside safety that were guiding their decision making."
Among these "other considerations" were CDC's important concerns for the preservation of the vaccine program, a bureaucratic impulse for self-preservation, and protecting the economic interests of its vaccine industry friends.
"Immediate withdrawal would send a strong message; 'We messed up!'" the health official told me. "And I don't think they wanted to send that message to parents, the public or those considering legal action."
"There was also concern," says the federal official, "that an immediate withdrawal might discredit the international vaccine programs for which CDC is an important partner." The World Health Organization has urged CDC against the banning of Thimerosal in U.S. vaccines since that prohibition might discredit WHO's third world inoculation programs. WHO, with U.S. funding, is now injecting children in developing countries with the same amounts of Thimerosal we were giving American kids at their highest exposures, but in a shorter time period. In May 2001, WHO committed to "develop a strong advocacy campaign to support the ongoing use of Thimerosal."
But CDC insiders argue that CDC's primary concern was the economic impacts on its pharmaceutical industry partners. "The big consideration was cost," says the federal health official. "A lot of CDC's friends in the vaccine industry had stockpiled Thimerosal-based vaccines. If they couldn't sell them the costs would total in the tens of millions of dollars."
On July 14, 2000 CDC promised to complete the transition to Thimerosal-free vaccines for children by first quarter 2001. But, probably for the reasons stated above, its commitment sometimes seems half-hearted. CDC continues to promote the use of Thimerosal in vaccines. The agency continues to send its top spokesman Roger Bernier around the country to testify before state legislatures to derail state efforts to ban Thimerosal in vaccines. Last week Bernier was testifying against a proposed Thimerosal ban in Maryland.
CDC continues to exert muscular efforts to derail studies of American cohorts -- the Amish, Christian Scientists, and home-schooled children -- who were not exposed to Thimerosal vaccines. Preliminary studies of these groups indicate very low levels of the neurological disorders, including autism, that have been associated with Thimerosal in vaccinated populations.
It's time for the CDC to come clean with the American public. Its tactics of deception and obfuscation are jeopardizing the credibility of the entire vaccine program, and therefore posing an enormous danger to public health.
HuffPo
March 1, 2006
Correspondence newly obtained under the Freedom of Information Act raises
troubling new questions about CDC's role in the Thimerosal scandal. Thimerosal is the mercury-based vaccine preservative that has been linked to epidemics of neurological disorders, including autism, in American children born after 1989.
Responding to scientific studies linking dangerous levels of mercury to a range of health disorders, the CDC in July 1999 recommended that the nation's vaccine makers eliminate Thimerosal as a preservative, "as soon as possible."
But the newly released documents show that behind the scenes CDC was quietly discouraging Thimerosal's removal. In a July 1999 letter, vaccine producer SmithKline Beecham tells CDC that it is ready to produce non-Thimerosal DTP (Diptheria/Tetanus/Pertussis) vaccines immediately and has sufficient inventories to supply the entire U.S. market during the remainder of 1999 and the first half of 2000, by which time other vaccine manufacturers would have their Thimerosal-free DTP vaccines on line.
Thimerosal-laden DTP vaccines containing 25 micrograms of mercury apiece were then being administered to American infants at two months, four months and six months -- far exceeding EPA's recommended safe level for mercury. Had CDC accepted SmithKline's offer, it could have immediately reduced the mercury exposures to vaccinated six-month-old children by 40%.
However, in November, CDC mysteriously sent a letter back rejecting SmithKline's offer. Then, on July 14, 2000 CDC published a deceptive press release promising to require that all vaccines be Thimerosal-free as soon as "adequate supplies are available." This was a full 12 months after the agency had denied SmithKline's proposal.
"If CDC were basing its decision on safety alone, it would have taken SmithKline up on its offer. That's a no-brainer," said a federal health official who requested anonymity. "So there were other considerations beside safety that were guiding their decision making."
Among these "other considerations" were CDC's important concerns for the preservation of the vaccine program, a bureaucratic impulse for self-preservation, and protecting the economic interests of its vaccine industry friends.
"Immediate withdrawal would send a strong message; 'We messed up!'" the health official told me. "And I don't think they wanted to send that message to parents, the public or those considering legal action."
"There was also concern," says the federal official, "that an immediate withdrawal might discredit the international vaccine programs for which CDC is an important partner." The World Health Organization has urged CDC against the banning of Thimerosal in U.S. vaccines since that prohibition might discredit WHO's third world inoculation programs. WHO, with U.S. funding, is now injecting children in developing countries with the same amounts of Thimerosal we were giving American kids at their highest exposures, but in a shorter time period. In May 2001, WHO committed to "develop a strong advocacy campaign to support the ongoing use of Thimerosal."
But CDC insiders argue that CDC's primary concern was the economic impacts on its pharmaceutical industry partners. "The big consideration was cost," says the federal health official. "A lot of CDC's friends in the vaccine industry had stockpiled Thimerosal-based vaccines. If they couldn't sell them the costs would total in the tens of millions of dollars."
On July 14, 2000 CDC promised to complete the transition to Thimerosal-free vaccines for children by first quarter 2001. But, probably for the reasons stated above, its commitment sometimes seems half-hearted. CDC continues to promote the use of Thimerosal in vaccines. The agency continues to send its top spokesman Roger Bernier around the country to testify before state legislatures to derail state efforts to ban Thimerosal in vaccines. Last week Bernier was testifying against a proposed Thimerosal ban in Maryland.
CDC continues to exert muscular efforts to derail studies of American cohorts -- the Amish, Christian Scientists, and home-schooled children -- who were not exposed to Thimerosal vaccines. Preliminary studies of these groups indicate very low levels of the neurological disorders, including autism, that have been associated with Thimerosal in vaccinated populations.
It's time for the CDC to come clean with the American public. Its tactics of deception and obfuscation are jeopardizing the credibility of the entire vaccine program, and therefore posing an enormous danger to public health.
NAA/A-CHAMP Fundraiser in Memory Of Liz Birt
Raising the Bar for Autism Awareness
A New York City Fundraiser in Memory of Liz Birt
A night to raise funds and awareness in memory of Elizabeth Birt. Proceeds will benefit SafeMinds and the National Autism Association and will be allocated to research projects to honor Liz.
nycfundraiser
Saturday, April 29, 2006 from 6:00 p.m. to Midnight
Antarctica Bar 287 Hudson Street at Spring
$50 donation
* All you can eat and drink
* The Voltaires Band
* The Dark Marbles Band
* Comedians Maria Shehata and Eliza Faria- Santos
* Celebrity bartenders behind the bar working hard to earn your tips which will also benefit the charities.
RSVP to Heidi Roger at (201) 906-3475 or by e-mail at elevatordance@msn.com
For more information please visit SafeMinds and the NAA .
Elizabeth Kilpatrick
SafeMinds
A New York City Fundraiser in Memory of Liz Birt
A night to raise funds and awareness in memory of Elizabeth Birt. Proceeds will benefit SafeMinds and the National Autism Association and will be allocated to research projects to honor Liz.
nycfundraiser
Saturday, April 29, 2006 from 6:00 p.m. to Midnight
Antarctica Bar 287 Hudson Street at Spring
$50 donation
* All you can eat and drink
* The Voltaires Band
* The Dark Marbles Band
* Comedians Maria Shehata and Eliza Faria- Santos
* Celebrity bartenders behind the bar working hard to earn your tips which will also benefit the charities.
RSVP to Heidi Roger at (201) 906-3475 or by e-mail at elevatordance@msn.com
For more information please visit SafeMinds and the NAA .
Elizabeth Kilpatrick
SafeMinds
Kirby In Alaska
AUTHOR OF BESTSELLING BOOK ON MERCURY AND AUTISM TO VISIT ANCHORAGE, ALASKA
ON MONDAY & TUESDAY, APRIL 17 & 18, 2006
Schedule:
Book-signing and short talk at UAA bookstore, Monday 5:30-7:00PM (free
lecture)
Longer talk at Wilda Marston Theater, Z.J. Loussac Library, Monday
7:30-9:30PM (free lecture, donations accepted)
Featured speaker at Downtown Rotary, Tuesday at noon (members and their
guests)
NEW YORK - David Kirby, author of the New York Times bestselling book,
"Evidence of Harm, Mercury in Vaccines and The Autism Epidemic" (St.
Martin's Press) will be in Anchorage, Alaska April 17 & 18, 2006 (Monday &
Tuesday), to give a series of talks.
Kirby's book details the burning controversy over whether the use of mercury
in vaccines has contributed to the autism epidemic in America, which has
left 1-in-166 children with some form of the disorder. He will be discussing
recent developments in science, in the media, and on Capitol Hill, as well
as the recent numbers out of California, which show a decline in new autism
cases for the first time in 35 years. This drop could be a result of the
gradual removal of mercury from vaccines, which began in 1999.
Evidence of Harm has been awarded the "Investigative Reporters and Editors
2005 Award for Outstanding Investigative Reporting in a Book," the
organization announced today. In their comments, award judges - comprised of
some of the most experienced investigative journalists in the country -
noted that, "Kirby told the story of stonewalling, denial and cover-up by
federal regulators, medical groups and the pharmaceutical industry." And,
they added, "He documents covert efforts by some of those same powerful
forces - along with the U.S. Congress - to grant blanket immunity for drug
companies that put mercury in vaccines. Like so many scientific
controversies involving complex science and big business, the topic is
controversial. Kirby's careful and meticulous reporting is exemplary in its
balance, accuracy and documentation," the judges said.
FOR MORE INFORMATION ON THE BOOK:
www.evidenceofharm.com
Local contact and sponsor: Sandy Gottstein, President of Vaccination News,
A Non-Profit Corporation,
www.vaccinationnews.com, 907-566-0401
Sandy Gottstein (Mintz), President
Vaccination News, A Non-Profit Corporation
PO Box 111818
Anchorage, AK 99511-1818
http://www.vaccinationnews.com/
http://www.vaccinationnews.com/Scandals/past_scandals.htm
http://www.vaccinationnews.com/Out_of_Control/past_ool.htm
SPONSOR OF SBS, VACCINES, AUTISM and other ONLINE CONFERENCES AT
http://www.redflagsdaily.com
"Eternal vigilance is the price of liberty." - Wendell Phillips (1811-1884),
paraphrasing John Philpot Curran (1808)
DISCLAIMER: All information, data, and material contained, presented, or
provided here is for general information purposes only and is not to be
construed as reflecting the knowledge or opinions of the publisher, and is
not to be construed or intended as providing medical or legal advice. The
decision whether or not to vaccinate is an important and complex issue and
should be made by you, and you alone, in consultation with your health care
provider.
In addition, the fact that this email has been forwarded in no way
necessarily implies endorsement of the point of view of the author or
authors of the particular email.
ON MONDAY & TUESDAY, APRIL 17 & 18, 2006
Schedule:
Book-signing and short talk at UAA bookstore, Monday 5:30-7:00PM (free
lecture)
Longer talk at Wilda Marston Theater, Z.J. Loussac Library, Monday
7:30-9:30PM (free lecture, donations accepted)
Featured speaker at Downtown Rotary, Tuesday at noon (members and their
guests)
NEW YORK - David Kirby, author of the New York Times bestselling book,
"Evidence of Harm, Mercury in Vaccines and The Autism Epidemic" (St.
Martin's Press) will be in Anchorage, Alaska April 17 & 18, 2006 (Monday &
Tuesday), to give a series of talks.
Kirby's book details the burning controversy over whether the use of mercury
in vaccines has contributed to the autism epidemic in America, which has
left 1-in-166 children with some form of the disorder. He will be discussing
recent developments in science, in the media, and on Capitol Hill, as well
as the recent numbers out of California, which show a decline in new autism
cases for the first time in 35 years. This drop could be a result of the
gradual removal of mercury from vaccines, which began in 1999.
Evidence of Harm has been awarded the "Investigative Reporters and Editors
2005 Award for Outstanding Investigative Reporting in a Book," the
organization announced today. In their comments, award judges - comprised of
some of the most experienced investigative journalists in the country -
noted that, "Kirby told the story of stonewalling, denial and cover-up by
federal regulators, medical groups and the pharmaceutical industry." And,
they added, "He documents covert efforts by some of those same powerful
forces - along with the U.S. Congress - to grant blanket immunity for drug
companies that put mercury in vaccines. Like so many scientific
controversies involving complex science and big business, the topic is
controversial. Kirby's careful and meticulous reporting is exemplary in its
balance, accuracy and documentation," the judges said.
FOR MORE INFORMATION ON THE BOOK:
www.evidenceofharm.com
Local contact and sponsor: Sandy Gottstein, President of Vaccination News,
A Non-Profit Corporation,
www.vaccinationnews.com, 907-566-0401
Sandy Gottstein (Mintz), President
Vaccination News, A Non-Profit Corporation
PO Box 111818
Anchorage, AK 99511-1818
http://www.vaccinationnews.com/
http://www.vaccinationnews.com/Scandals/past_scandals.htm
http://www.vaccinationnews.com/Out_of_Control/past_ool.htm
SPONSOR OF SBS, VACCINES, AUTISM and other ONLINE CONFERENCES AT
http://www.redflagsdaily.com
"Eternal vigilance is the price of liberty." - Wendell Phillips (1811-1884),
paraphrasing John Philpot Curran (1808)
DISCLAIMER: All information, data, and material contained, presented, or
provided here is for general information purposes only and is not to be
construed as reflecting the knowledge or opinions of the publisher, and is
not to be construed or intended as providing medical or legal advice. The
decision whether or not to vaccinate is an important and complex issue and
should be made by you, and you alone, in consultation with your health care
provider.
In addition, the fact that this email has been forwarded in no way
necessarily implies endorsement of the point of view of the author or
authors of the particular email.
WebMD: Debate Flares Over Vaccines and Autism
Debate Flares Over Vaccines and Autism:
Activist Groups Spar With CDC Over Claims of Link Between Autism and Thimerosal
By Todd Zwillich
WebMD Medical News
Reviewed By Louise Chang, MD
on Friday, April 07, 2006
April 7, 2006 -- Debate over a possible tie between mercury-containing vaccines and autism flared up this week as activist groups launched a campaign accusing federal health agencies and prominent researchers of manipulating scientific findings on the link.
Some parents of autistic children have long blamed vaccines containing the preservative thimerosal for an alarming rise in the disorder. Thimerosal contains a type of mercury. A series of reports by the Institute of Medicine (IOM) ending in 2004 concluded no evidence could be found linking the vaccines to neurological diseases, including autism.
But groups this week mounted a campaign to publicize previously undisclosed transcripts and emails that they say point to efforts by the CDC to manipulate the IOM's scientific conclusions on the safety of vaccines containing thimerosal. The groups accuse the CDC of trying to defend a long-held policy promoting childhood vaccinations.
"In the interest of protecting the immunization program, they forgot about child safety. They are continuing that pattern of behavior and denial that thimerosal causes harm," Bobbie Manning, vice president of Advocates for Children's Health Affected by Mercury, tells WebMD.
According to the CDC, all vaccines recommended for children are available in thimerosal-free versions. But some parents say millions of previous exposures helped caused a spike in autism cases since the 1980s.
The CDC contracted with the IOM in 2001 to generate a series of reports on possible links between vaccines and a variety of health problems. An IOM committee of outside experts, led by Harvard researcher Marie McCormick, MD, found no evidence of a link and concluded that proposed biological explanations for a mercury-autism relationship were "theoretical."
Allegations of Bias
Activist groups released transcripts of closed-door conversations in 2001 between McCormick and Kathleen Stratton, the study director. Groups say the conversation suggests that the committee would fashion its findings to meet the CDC's desires to play down a link between thimerosal and autism.
"[The CDC] wants us to declare, well, these things are pretty safe on a population basis," McCormick said to Stratton, according to the transcript, posted on a web site called Putchildrenfirst.com.
Thirty-four pages later in the transcript, McCormick states, "...we are not ever going to come down that [autism] is a true side effect."
Manning said the transcript shows that the CDC "directed that committee to find what they wanted to find, which was no causation" between vaccines and autism.
In an interview, McCormick confirmed that the statements in the transcript are "accurate and true." But she said there was "no truth" to allegations that CDC officials influenced the IOM or that the committee reached conclusions before its scientific review.
McCormick said her comments reflected a debate over whether the committee would look at vaccine effects in individuals or across populations, and not what any specific findings would be.
The conversation also took place in late 2001, before the committee's final 2004 report on vaccines and autism was planned, McCormick said.
"In 2001 we did not know we were going to look at autism again. To use those as evidence for what we did in 2004 is really inappropriate," she said.
McCormick added that the committee's experts were chosen specifically for their scientific independence and for a lack of ties to both pharmaceutical manufacturers and the CDC.
CDC Perspective
Parents groups alleged that CDC officials had worked to dissuade agency scientists from looking more deeply into links between thimerosal and autism.
The groups also alleged that CDC officials narrowed the scope of the IOM's report to include a handful of studies, most of which the agency had a role in funding or planning. Those studies generally showed little evidence of a link between vaccination and autism.
Tom Skinner, a CDC spokesman, said the agency has been "very transparent" about its ongoing studies of autism and vaccines and that the emails have been taken "out of context." He said the agency closely guards its scientific credibility and "in no way" tried to influence IOM experts.
"We stand behind our science that's been done to this date and we will certainly do more in the future," he said.
Louis Z. Cooper, MD, an emeritus professor of pediatrics at Columbia University and a founder of the National Network for Immunization Information, said in an interview that some of the emails and transcripts "cause some anxiety" because they may help fuel fear among parents about the safety of vaccines and the motivations of health officials.
Still, Cooper, who noted he's known McCormick professionally for at least 20 years, called accusations of bias against her or other members of IOM's committee "rubbish, scurrilous, and awful."
"If I wanted a group who were committed to objectivity and were committed to science, I couldn't have asked for a better group of people," said Cooper, a former president of the American Academy of Pediatrics.
Manning said her group and others would continue to push for congressional investigations into how the IOM conducted the studies and whether they were influenced by the CDC. "We believe that this is a serious issue that needs to be examined," she said.
Activist Groups Spar With CDC Over Claims of Link Between Autism and Thimerosal
By Todd Zwillich
WebMD Medical News
Reviewed By Louise Chang, MD
on Friday, April 07, 2006
April 7, 2006 -- Debate over a possible tie between mercury-containing vaccines and autism flared up this week as activist groups launched a campaign accusing federal health agencies and prominent researchers of manipulating scientific findings on the link.
Some parents of autistic children have long blamed vaccines containing the preservative thimerosal for an alarming rise in the disorder. Thimerosal contains a type of mercury. A series of reports by the Institute of Medicine (IOM) ending in 2004 concluded no evidence could be found linking the vaccines to neurological diseases, including autism.
But groups this week mounted a campaign to publicize previously undisclosed transcripts and emails that they say point to efforts by the CDC to manipulate the IOM's scientific conclusions on the safety of vaccines containing thimerosal. The groups accuse the CDC of trying to defend a long-held policy promoting childhood vaccinations.
"In the interest of protecting the immunization program, they forgot about child safety. They are continuing that pattern of behavior and denial that thimerosal causes harm," Bobbie Manning, vice president of Advocates for Children's Health Affected by Mercury, tells WebMD.
According to the CDC, all vaccines recommended for children are available in thimerosal-free versions. But some parents say millions of previous exposures helped caused a spike in autism cases since the 1980s.
The CDC contracted with the IOM in 2001 to generate a series of reports on possible links between vaccines and a variety of health problems. An IOM committee of outside experts, led by Harvard researcher Marie McCormick, MD, found no evidence of a link and concluded that proposed biological explanations for a mercury-autism relationship were "theoretical."
Allegations of Bias
Activist groups released transcripts of closed-door conversations in 2001 between McCormick and Kathleen Stratton, the study director. Groups say the conversation suggests that the committee would fashion its findings to meet the CDC's desires to play down a link between thimerosal and autism.
"[The CDC] wants us to declare, well, these things are pretty safe on a population basis," McCormick said to Stratton, according to the transcript, posted on a web site called Putchildrenfirst.com.
Thirty-four pages later in the transcript, McCormick states, "...we are not ever going to come down that [autism] is a true side effect."
Manning said the transcript shows that the CDC "directed that committee to find what they wanted to find, which was no causation" between vaccines and autism.
In an interview, McCormick confirmed that the statements in the transcript are "accurate and true." But she said there was "no truth" to allegations that CDC officials influenced the IOM or that the committee reached conclusions before its scientific review.
McCormick said her comments reflected a debate over whether the committee would look at vaccine effects in individuals or across populations, and not what any specific findings would be.
The conversation also took place in late 2001, before the committee's final 2004 report on vaccines and autism was planned, McCormick said.
"In 2001 we did not know we were going to look at autism again. To use those as evidence for what we did in 2004 is really inappropriate," she said.
McCormick added that the committee's experts were chosen specifically for their scientific independence and for a lack of ties to both pharmaceutical manufacturers and the CDC.
CDC Perspective
Parents groups alleged that CDC officials had worked to dissuade agency scientists from looking more deeply into links between thimerosal and autism.
The groups also alleged that CDC officials narrowed the scope of the IOM's report to include a handful of studies, most of which the agency had a role in funding or planning. Those studies generally showed little evidence of a link between vaccination and autism.
Tom Skinner, a CDC spokesman, said the agency has been "very transparent" about its ongoing studies of autism and vaccines and that the emails have been taken "out of context." He said the agency closely guards its scientific credibility and "in no way" tried to influence IOM experts.
"We stand behind our science that's been done to this date and we will certainly do more in the future," he said.
Louis Z. Cooper, MD, an emeritus professor of pediatrics at Columbia University and a founder of the National Network for Immunization Information, said in an interview that some of the emails and transcripts "cause some anxiety" because they may help fuel fear among parents about the safety of vaccines and the motivations of health officials.
Still, Cooper, who noted he's known McCormick professionally for at least 20 years, called accusations of bias against her or other members of IOM's committee "rubbish, scurrilous, and awful."
"If I wanted a group who were committed to objectivity and were committed to science, I couldn't have asked for a better group of people," said Cooper, a former president of the American Academy of Pediatrics.
Manning said her group and others would continue to push for congressional investigations into how the IOM conducted the studies and whether they were influenced by the CDC. "We believe that this is a serious issue that needs to be examined," she said.
Autism in a Needle?
Autism in a Needle?
The toxic tale of vaccinations and mercury poisoning
By Annette Fuentes
Nov 11, 2003
Lyn Redwood’s son Will was a healthy, happy baby who met all the normal developmental standards—he was walking and talking by one year. About three months later, however, he began to regress, losing speech, avoiding eye contact and appearing miserable. “He didn’t seem happy anymore,” Redwood said in a recent interview. “He just wanted to sit in his infant seat and watch videos over and over again.”
Doctors initially blamed hearing problems for Will’s decline. Neurologists told the parents that their son had global and receptive speech delay. At age 5, the boy was diagnosed as autistic by his school.
Seeking answers to her son’s condition, Redwood turned to the Internet in 1999 and began a search that led to startling discoveries about thimerosal. This vaccine preservative is composed of nearly 50 percent mercury, which is a known neurotoxin especially harmful to fetuses, infants and children. What’s more, it has been linked to a range of symptoms collectively known as Autism Spectrum Disorders. At one end is severe autism, in which children are socially withdrawn, do not speak and exhibit bizarre, repetitive, sometimes aggressive behaviors. At the other end are Asperger’s Syndrome, a high-functioning form of autism, Pervasive Developmental Disorder (PDD), Attention Deficit Disorder (ADD) and Attention Deficit Hyperactivity Disorder (ADHD).
Thimerosal was widely used since the ’40s in over-the-counter medicines until that use was banned in 1998. It’s still found in some vaccines for adults and infants. Its medical, political, economic and international implications represent a chilling chapter in the history of public health, in which regulatory agencies were negligent, if not guilty, in covering up health hazards, by failing to act quickly to protect millions of children. Said Redwood, a nurse practitioner and a board of health member in her Georgia county, where vaccination is a major public health program: “If someone had told me prior to 1999 that vaccines were responsible for my son’s disabilities, I would have thought they were crazy.”
Regulators ‘asleep at the switch’
Before 1980, autism was diagnosed in 1 in 10,000 children; in 2002, the National Institutes of Health raised that figure to 1 in 250 children. The Autism Society of America now estimates that autism disorders are growing by 10 percent or more annually. Some scientists believe boys are afflicted by the neurological disorders of autism at a rate three to six times that of girls because the female hormone estrogen protects against mercury toxicity.
In a sad twist, scientists increasingly believe that the mercury-laced vaccines meant to protect children from illness are at the root of this spike. In 1985, four of the shots recommended for infants in their first 18 months contained thimerosal. By 1991, the Centers for Disease Control and Prevention (CDC) added three Hepatitis B shots (each containing 12.5 micrograms of thimerosal) and four Hib shots (each with 25 micrograms of mercury). As a result, the number of vaccines containing thimerosal jumped to 11, and the amount of mercury exposure mushroomed to 237.5 micrograms, an amount that exceeded all federal limits.
Neither the Food and Drug Administration (FDA) nor the CDC, the nation’s chief regulatory agencies for pharmaceutical products and the watchdogs of public health, added up the micrograms. The regulatory spotlight was finally fixed on thimerosal in 1997 when Congress passed the FDA Modernization Act. Part of the act required the FDA to investigate all drugs that contained mercury and determine their effects on humans. Within a year, the FDA had called for the removal of all thimerosal-containing products from over-the-counter products. Thimerosal remained in more than 50 vaccines, however, until the Public Health Service (which includes the FDA, the CDC and the National Institutes of Health) and the American Academy of Pediatrics issued a statement in July 1999 “urging” vaccine makers to reduce or eliminate thimerosal because of “theoretical potential for neurotoxicity.”
Last year, the staff for Rep. Dan Burton (R-Ind.) obtained an internal e-mail written June 29, 1999, by former FDA scientist Peter Patriarca. In that e-mail Patriarca offered his colleagues a “pros and cons” assessment of the thimerosal statement shortly before its release:
Will raise questions about FDA being ‘asleep at the switch’ for decades, by allowing a potentially hazardous compound to remain in many childhood vaccines, and not forcing manufacturers to exclude it from new products. Will also raise questions about various advisory bodies about aggressive recommendations for use. We must keep in mind that the dose of ethyl mercury was not generated by ‘rocket science’: conversion of the % of thimerosal to actual ug [micrograms] of mercury involves 9th grade algebra. What took the FDA so long to do the calculations? Why didn’t CDC and the advisory bodies do these calculations while rapidly expanding the childhood immunization schedule?
Roger Bernier, of the CDC’s national immunization program, received the e-mail. In a recent interview he explained why the cumulative amount of mercury was never figured. “Vaccines tend to be evaluated on an individual basis, the requirements for safety and efficacy on an individual basis,” Bernier said. “This holistic view of safety was not part of the review.” Bernier said the health agencies did not order vaccine makers to stop using thimerosal and to recall existing vaccines containing it because “this was a theoretical concern, it was conceived as precautionary measure, not because evidence showed a risk. There wasn’t a sense of urgency. It was viewed as something to be done—not because we had to, but because it should be done.”
Toxicity and plausibility
While the FDA and CDC moved glacially slow on mercury, the EPA had been since the early ’70s aggressively educating the public about ingesting mercury in food, especially fish, and setting standards for exposure. The inconsistent approach to mercury is reflected in the standards agencies set for maximum daily consumption. Set in micrograms per kilogram of body weight, the EPA’s standard is lowest, at .1 micrograms, the FDA’s is .4 micrograms. Those guidelines are for methylmercury, the toxic cousin of ethylmercury, which is in thimerosal. While some government scientists defending the use of thimerosal have argued that ethyl is less toxic than methyl, both forms will harm living tissue, according to Boyd Haley, chair of the department of chemistry at the University of Kentucky and an expert on toxic metals. “Some parents of autistic children called me and asked me to look at thimerosal. We did some experiments with human brain tissue and it was dramatic,” Haley said. “It penetrates the proteins in the brain. It is toxic to neurons and enzymes.” Haley co-authored an August 2003 study that showed autistic children retained more mercury in their bodies than normal children, evidenced by higher levels of the toxin in their hair. That means the ethylmercury from thimerosal had been absorbed into their brain and other body tissue, likely causing neurological damage.
The July 1999 statement on thimerosal hardly put the issue to rest. For Redwood, it was the catalyst that led to the creation of SAFE MINDS, a parents’ group that has conducted research on the thimerosal-autism disorders link. With several other parents of autistic children, in 2001 Redwood published “Autism: A Novel Form of Mercury Poisoning” in the journal Medical Hypotheses. Their study showed that the symptoms of mercury poisoning mirrored those of autism and concluded that early exposure to mercury from thimerosal had caused many cases of autism, while genetic and environmental factors made some children more vulnerable than others. “Once we got the paper together, we contacted the NIH, CDC and FDA,” Redwood said. “We got mixed responses. We petitioned the FDA on three occasions to take thimerosal off the market. They turned us down.”
The CDC launched its own study of thimerosal safety in vaccines in fall 1999, tasking Dr. Thomas Verstraeten to analyze the agency’s Vaccine Safety Datalink, which gathers information on vaccine safety from several health maintenance organizations. Verstraeten’s first report in February 2000 found a statistically significant risk for neurological developmental disorders at age 3 months as the amount of thimerosal that babies received increased. And he found a risk of autism 2.48 times greater for infants getting higher amounts of thimerosal in vaccines, compared to infants who received thimerosal-free vaccines. A June 2000 analysis by Verstraeten found a link between thimerosal and language, speech and developmental delays during the child’s first 6 months. Verstraeten’s initial findings were never publicly released, and SAFE MINDS obtained copies of his reports only through Freedom of Information Act filings in 2001. For Robert Krakow, whose son is autistic, Verstraeten’s findings were a bittersweet discovery. “If the Verstraeten report had been publicized, my wife would have read about it because she was up on these things and our son wouldn’t have had thimerosal-containing vaccines,” he said. “Why is the public not told? To protect the vaccine makers.” Verstraeten left the CDC shortly after his presentation to work for vaccine maker GlaxoSmithKline in Belgium. He declined to comment for this article, citing “ongoing litigation in the U.S. regarding thimerosal.”
The thimerosal issue continues to reverberate in the scientific and public health community. The Institute of Medicine (IOM), an advisory body created by the National Academies of Science, convened in fall 2001 to assess thimerosal’s potential to cause autism and other neurological problems in children. The IOM’s statement, after assessing Verstraeten’s research and hearing testimony of scientists such as Haley and others linking autism and thimerosal, walked a fine line. It said in part: “Although the hypothesis that exposure to thimerosal-containing vaccines could be associated with neurodevelopmental disorders is not established … the hypothesis is biologically plausible.”
In the past year, further studies of thimerosal’s connection to autism have been churned out in scientific journals, primarily denying any link. A December 2002 study funded by the National Institutes of Health and published in The Lancet claimed thimerosal was safe for babies. An October 2003 study from Denmark also purported to disprove the thimerosal-autism link. The most recent study, published November 1 in Pediatrics by Thomas Verstraeten and a CDC colleague, uses the same CDC database but this time erases any connection between thimerosal and neurological damage to children.
If the CDC and FDA seemed to acknowledge the risks of thimerosal four years ago and the need to get mercury out of medical products, today the official stance is to circle the wagons against mounting public and scientific criticism about its handling of the thimerosal issue. “Rational people can think differently, but to resolve this issue they must be honest to the American people,” Haley said of the regulators. “They could come out and say we’ve cleaned it up, we’ll keep it out. But what they do is come up with cockamamie articles and fight back.”
The stakes are high for the pharmaceutical industry. Eli Lilly, inventor of thimerosal, was granted protection from lawsuits by parents of autistic children under a short-lived provision slipped into the Homeland Security Act in November 2002 (see sidebar). But hundreds of lawsuits now have been filed against it and other companies, including Merck, GlaxoSmithKline, Aventis Pasteur and American Home Products, which have used thimerosal in children’s vaccines. An additional 4,000 claims are pending in the federal Vaccine Injury Compensation Program. “These kids are not going to die. They are going to live 50, 60 years and the cost will be monumental,” said Krakow, a New York attorney who filed a case with the vaccine compensation program on behalf of his son. “The political hurdles are the bigger problem. This is so big and gets to the heart of lots of issues, like what I call the government-pharmaceutical complex.”
Thimerosal is global
Today, vaccine makers have removed thimerosal from almost all childhood vaccines or created thimerosal-free alternatives. But some still have trace amounts, such as GlaxoSmithKline’s Pediatrix, and its DTaP-Hepatitis B vaccine. Aventis Pasteur manufactures six vaccines for adults using thimerosal, including tetanus and flu, each with 25 micrograms of ethylmercury. Merck’s Hepatitis B for adults contains 25 micrograms of ethylmercury. While the health effects of that amount of mercury for adults are unknown, limiting exposure in all forms—in foods and environmentally—should be a priority of the FDA and CDC, according to Kentucky researcher Haley. “They should be working on getting all the mercury out. Thimerosal suppresses the immune system, and if you have some elderly person who has a compromised immune system, a flu shot with thimerosal can pose a risk,” Haley said. “They are saying its OK to give to Third World countries where children have compromised immune systems to begin with.” (Representatives for Aventis and Merck did not respond to requests for comment on their companies’ policies on thimerosal use.) But to date, neither the FDA nor the CDC has issued a clear preference for thimerosal-free vaccines. Many critics believe that is a politically defensive, not a scientifically sound one.
The Third World is the next frontier in the thimerosal debate. Eli Lilly has licensing agreements with drug companies in 40 countries that make thimerosal and market it under the trade name Merthiolate. In countries where sanitary conditions are questionable, vaccine preservatives become crucial. Single-dose vials rather than multi-dose containers have provided one solution in the United States, but in the developing world that strategy poses challenges and costs. The World Health Organization (WHO), which has a vast vaccination program, assessed the thimerosal issue in 1999, prompted by the U.S. health agencies’ review. The agency echoed the U.S. position and declared in its weekly newsletter: “With the weight of public opinion against the use of mercury of any sort, WHO and other agencies has begun the process of reducing and removing [thimerosal] from vaccines.” The WHO outlined a three-year plan for creating alternative preservatives and new vaccine delivery technologies with the goal of eventually eliminating mercury.
Yet in 2003, WHO abandoned this aggressive plan and issued a revised policy on thimerosal, citing its own vaccine advisory committee’s decision that ethylmercury is less harmful than methylmercury, and that “there is no reason on grounds of safety to change immunization practices with [thimerosal]-containing vaccines since the benefit outweighs any risks.” What happened over four years, according to Dr. Philippe Duclos, coordinator of WHO’s Immunization Safety Project, was a dose of reality. “Taking thimerosol away was more tricky than originally thought,” he said. “Taking it away might have created a vaccine with a lower safety profile. And the use of monodose vaccines in many places is difficult because of production capacity. Changing the capacity is a major investment, and you can’t just assume things will be done correctly. It takes time.”
Duclos insisted that recent research has shown risks associated with thimerosal are more theoretical than real—and so far alternatives are elusive. “Vaccine distribution in developing countries is a tricky thing. If you use monodose, products will overload the cold chain [the process by which vaccines are maintained at between 2 and 8 degrees Celsius]. Expanding that capacity would take a tremendous amount of time and money and it becomes a matter of priorities.”
For U.S. pharmaceuticals, though, the global market for vaccines containing thimerosal is a goldmine. UNICEF, the WHO’s parent body, purchases 40 percent of all vaccines used in developing countries and Merck is its sole supplier. Merck makes Recombivax HB, a Hepatitis B vaccine that contains thimerosal.
Beyond the issue of thimerosal’s link to autism and developmental disorders lies the larger question of public trust in national vaccination programs—in the United States and the developing world, where global agencies like the WHO and its health programs can be viewed as politically suspect. The thimerosal debacle at the FDA and CDC, with its taint of conflicts of interest with big drug companies and compromised research, does more harm than good, given that the medical community’s primary directive is “First, do no harm.”
“I am a farm boy. I own a farm today. I am a person who knows the value of vaccinations,” [Haley] said. “But if the American people realize how the CDC and the vaccine boards work, they are going to lose faith, and that isn’t my doing. Its their own doing.”
The toxic tale of vaccinations and mercury poisoning
By Annette Fuentes
Nov 11, 2003
Lyn Redwood’s son Will was a healthy, happy baby who met all the normal developmental standards—he was walking and talking by one year. About three months later, however, he began to regress, losing speech, avoiding eye contact and appearing miserable. “He didn’t seem happy anymore,” Redwood said in a recent interview. “He just wanted to sit in his infant seat and watch videos over and over again.”
Doctors initially blamed hearing problems for Will’s decline. Neurologists told the parents that their son had global and receptive speech delay. At age 5, the boy was diagnosed as autistic by his school.
Seeking answers to her son’s condition, Redwood turned to the Internet in 1999 and began a search that led to startling discoveries about thimerosal. This vaccine preservative is composed of nearly 50 percent mercury, which is a known neurotoxin especially harmful to fetuses, infants and children. What’s more, it has been linked to a range of symptoms collectively known as Autism Spectrum Disorders. At one end is severe autism, in which children are socially withdrawn, do not speak and exhibit bizarre, repetitive, sometimes aggressive behaviors. At the other end are Asperger’s Syndrome, a high-functioning form of autism, Pervasive Developmental Disorder (PDD), Attention Deficit Disorder (ADD) and Attention Deficit Hyperactivity Disorder (ADHD).
Thimerosal was widely used since the ’40s in over-the-counter medicines until that use was banned in 1998. It’s still found in some vaccines for adults and infants. Its medical, political, economic and international implications represent a chilling chapter in the history of public health, in which regulatory agencies were negligent, if not guilty, in covering up health hazards, by failing to act quickly to protect millions of children. Said Redwood, a nurse practitioner and a board of health member in her Georgia county, where vaccination is a major public health program: “If someone had told me prior to 1999 that vaccines were responsible for my son’s disabilities, I would have thought they were crazy.”
Regulators ‘asleep at the switch’
Before 1980, autism was diagnosed in 1 in 10,000 children; in 2002, the National Institutes of Health raised that figure to 1 in 250 children. The Autism Society of America now estimates that autism disorders are growing by 10 percent or more annually. Some scientists believe boys are afflicted by the neurological disorders of autism at a rate three to six times that of girls because the female hormone estrogen protects against mercury toxicity.
In a sad twist, scientists increasingly believe that the mercury-laced vaccines meant to protect children from illness are at the root of this spike. In 1985, four of the shots recommended for infants in their first 18 months contained thimerosal. By 1991, the Centers for Disease Control and Prevention (CDC) added three Hepatitis B shots (each containing 12.5 micrograms of thimerosal) and four Hib shots (each with 25 micrograms of mercury). As a result, the number of vaccines containing thimerosal jumped to 11, and the amount of mercury exposure mushroomed to 237.5 micrograms, an amount that exceeded all federal limits.
Neither the Food and Drug Administration (FDA) nor the CDC, the nation’s chief regulatory agencies for pharmaceutical products and the watchdogs of public health, added up the micrograms. The regulatory spotlight was finally fixed on thimerosal in 1997 when Congress passed the FDA Modernization Act. Part of the act required the FDA to investigate all drugs that contained mercury and determine their effects on humans. Within a year, the FDA had called for the removal of all thimerosal-containing products from over-the-counter products. Thimerosal remained in more than 50 vaccines, however, until the Public Health Service (which includes the FDA, the CDC and the National Institutes of Health) and the American Academy of Pediatrics issued a statement in July 1999 “urging” vaccine makers to reduce or eliminate thimerosal because of “theoretical potential for neurotoxicity.”
Last year, the staff for Rep. Dan Burton (R-Ind.) obtained an internal e-mail written June 29, 1999, by former FDA scientist Peter Patriarca. In that e-mail Patriarca offered his colleagues a “pros and cons” assessment of the thimerosal statement shortly before its release:
Will raise questions about FDA being ‘asleep at the switch’ for decades, by allowing a potentially hazardous compound to remain in many childhood vaccines, and not forcing manufacturers to exclude it from new products. Will also raise questions about various advisory bodies about aggressive recommendations for use. We must keep in mind that the dose of ethyl mercury was not generated by ‘rocket science’: conversion of the % of thimerosal to actual ug [micrograms] of mercury involves 9th grade algebra. What took the FDA so long to do the calculations? Why didn’t CDC and the advisory bodies do these calculations while rapidly expanding the childhood immunization schedule?
Roger Bernier, of the CDC’s national immunization program, received the e-mail. In a recent interview he explained why the cumulative amount of mercury was never figured. “Vaccines tend to be evaluated on an individual basis, the requirements for safety and efficacy on an individual basis,” Bernier said. “This holistic view of safety was not part of the review.” Bernier said the health agencies did not order vaccine makers to stop using thimerosal and to recall existing vaccines containing it because “this was a theoretical concern, it was conceived as precautionary measure, not because evidence showed a risk. There wasn’t a sense of urgency. It was viewed as something to be done—not because we had to, but because it should be done.”
Toxicity and plausibility
While the FDA and CDC moved glacially slow on mercury, the EPA had been since the early ’70s aggressively educating the public about ingesting mercury in food, especially fish, and setting standards for exposure. The inconsistent approach to mercury is reflected in the standards agencies set for maximum daily consumption. Set in micrograms per kilogram of body weight, the EPA’s standard is lowest, at .1 micrograms, the FDA’s is .4 micrograms. Those guidelines are for methylmercury, the toxic cousin of ethylmercury, which is in thimerosal. While some government scientists defending the use of thimerosal have argued that ethyl is less toxic than methyl, both forms will harm living tissue, according to Boyd Haley, chair of the department of chemistry at the University of Kentucky and an expert on toxic metals. “Some parents of autistic children called me and asked me to look at thimerosal. We did some experiments with human brain tissue and it was dramatic,” Haley said. “It penetrates the proteins in the brain. It is toxic to neurons and enzymes.” Haley co-authored an August 2003 study that showed autistic children retained more mercury in their bodies than normal children, evidenced by higher levels of the toxin in their hair. That means the ethylmercury from thimerosal had been absorbed into their brain and other body tissue, likely causing neurological damage.
The July 1999 statement on thimerosal hardly put the issue to rest. For Redwood, it was the catalyst that led to the creation of SAFE MINDS, a parents’ group that has conducted research on the thimerosal-autism disorders link. With several other parents of autistic children, in 2001 Redwood published “Autism: A Novel Form of Mercury Poisoning” in the journal Medical Hypotheses. Their study showed that the symptoms of mercury poisoning mirrored those of autism and concluded that early exposure to mercury from thimerosal had caused many cases of autism, while genetic and environmental factors made some children more vulnerable than others. “Once we got the paper together, we contacted the NIH, CDC and FDA,” Redwood said. “We got mixed responses. We petitioned the FDA on three occasions to take thimerosal off the market. They turned us down.”
The CDC launched its own study of thimerosal safety in vaccines in fall 1999, tasking Dr. Thomas Verstraeten to analyze the agency’s Vaccine Safety Datalink, which gathers information on vaccine safety from several health maintenance organizations. Verstraeten’s first report in February 2000 found a statistically significant risk for neurological developmental disorders at age 3 months as the amount of thimerosal that babies received increased. And he found a risk of autism 2.48 times greater for infants getting higher amounts of thimerosal in vaccines, compared to infants who received thimerosal-free vaccines. A June 2000 analysis by Verstraeten found a link between thimerosal and language, speech and developmental delays during the child’s first 6 months. Verstraeten’s initial findings were never publicly released, and SAFE MINDS obtained copies of his reports only through Freedom of Information Act filings in 2001. For Robert Krakow, whose son is autistic, Verstraeten’s findings were a bittersweet discovery. “If the Verstraeten report had been publicized, my wife would have read about it because she was up on these things and our son wouldn’t have had thimerosal-containing vaccines,” he said. “Why is the public not told? To protect the vaccine makers.” Verstraeten left the CDC shortly after his presentation to work for vaccine maker GlaxoSmithKline in Belgium. He declined to comment for this article, citing “ongoing litigation in the U.S. regarding thimerosal.”
The thimerosal issue continues to reverberate in the scientific and public health community. The Institute of Medicine (IOM), an advisory body created by the National Academies of Science, convened in fall 2001 to assess thimerosal’s potential to cause autism and other neurological problems in children. The IOM’s statement, after assessing Verstraeten’s research and hearing testimony of scientists such as Haley and others linking autism and thimerosal, walked a fine line. It said in part: “Although the hypothesis that exposure to thimerosal-containing vaccines could be associated with neurodevelopmental disorders is not established … the hypothesis is biologically plausible.”
In the past year, further studies of thimerosal’s connection to autism have been churned out in scientific journals, primarily denying any link. A December 2002 study funded by the National Institutes of Health and published in The Lancet claimed thimerosal was safe for babies. An October 2003 study from Denmark also purported to disprove the thimerosal-autism link. The most recent study, published November 1 in Pediatrics by Thomas Verstraeten and a CDC colleague, uses the same CDC database but this time erases any connection between thimerosal and neurological damage to children.
If the CDC and FDA seemed to acknowledge the risks of thimerosal four years ago and the need to get mercury out of medical products, today the official stance is to circle the wagons against mounting public and scientific criticism about its handling of the thimerosal issue. “Rational people can think differently, but to resolve this issue they must be honest to the American people,” Haley said of the regulators. “They could come out and say we’ve cleaned it up, we’ll keep it out. But what they do is come up with cockamamie articles and fight back.”
The stakes are high for the pharmaceutical industry. Eli Lilly, inventor of thimerosal, was granted protection from lawsuits by parents of autistic children under a short-lived provision slipped into the Homeland Security Act in November 2002 (see sidebar). But hundreds of lawsuits now have been filed against it and other companies, including Merck, GlaxoSmithKline, Aventis Pasteur and American Home Products, which have used thimerosal in children’s vaccines. An additional 4,000 claims are pending in the federal Vaccine Injury Compensation Program. “These kids are not going to die. They are going to live 50, 60 years and the cost will be monumental,” said Krakow, a New York attorney who filed a case with the vaccine compensation program on behalf of his son. “The political hurdles are the bigger problem. This is so big and gets to the heart of lots of issues, like what I call the government-pharmaceutical complex.”
Thimerosal is global
Today, vaccine makers have removed thimerosal from almost all childhood vaccines or created thimerosal-free alternatives. But some still have trace amounts, such as GlaxoSmithKline’s Pediatrix, and its DTaP-Hepatitis B vaccine. Aventis Pasteur manufactures six vaccines for adults using thimerosal, including tetanus and flu, each with 25 micrograms of ethylmercury. Merck’s Hepatitis B for adults contains 25 micrograms of ethylmercury. While the health effects of that amount of mercury for adults are unknown, limiting exposure in all forms—in foods and environmentally—should be a priority of the FDA and CDC, according to Kentucky researcher Haley. “They should be working on getting all the mercury out. Thimerosal suppresses the immune system, and if you have some elderly person who has a compromised immune system, a flu shot with thimerosal can pose a risk,” Haley said. “They are saying its OK to give to Third World countries where children have compromised immune systems to begin with.” (Representatives for Aventis and Merck did not respond to requests for comment on their companies’ policies on thimerosal use.) But to date, neither the FDA nor the CDC has issued a clear preference for thimerosal-free vaccines. Many critics believe that is a politically defensive, not a scientifically sound one.
The Third World is the next frontier in the thimerosal debate. Eli Lilly has licensing agreements with drug companies in 40 countries that make thimerosal and market it under the trade name Merthiolate. In countries where sanitary conditions are questionable, vaccine preservatives become crucial. Single-dose vials rather than multi-dose containers have provided one solution in the United States, but in the developing world that strategy poses challenges and costs. The World Health Organization (WHO), which has a vast vaccination program, assessed the thimerosal issue in 1999, prompted by the U.S. health agencies’ review. The agency echoed the U.S. position and declared in its weekly newsletter: “With the weight of public opinion against the use of mercury of any sort, WHO and other agencies has begun the process of reducing and removing [thimerosal] from vaccines.” The WHO outlined a three-year plan for creating alternative preservatives and new vaccine delivery technologies with the goal of eventually eliminating mercury.
Yet in 2003, WHO abandoned this aggressive plan and issued a revised policy on thimerosal, citing its own vaccine advisory committee’s decision that ethylmercury is less harmful than methylmercury, and that “there is no reason on grounds of safety to change immunization practices with [thimerosal]-containing vaccines since the benefit outweighs any risks.” What happened over four years, according to Dr. Philippe Duclos, coordinator of WHO’s Immunization Safety Project, was a dose of reality. “Taking thimerosol away was more tricky than originally thought,” he said. “Taking it away might have created a vaccine with a lower safety profile. And the use of monodose vaccines in many places is difficult because of production capacity. Changing the capacity is a major investment, and you can’t just assume things will be done correctly. It takes time.”
Duclos insisted that recent research has shown risks associated with thimerosal are more theoretical than real—and so far alternatives are elusive. “Vaccine distribution in developing countries is a tricky thing. If you use monodose, products will overload the cold chain [the process by which vaccines are maintained at between 2 and 8 degrees Celsius]. Expanding that capacity would take a tremendous amount of time and money and it becomes a matter of priorities.”
For U.S. pharmaceuticals, though, the global market for vaccines containing thimerosal is a goldmine. UNICEF, the WHO’s parent body, purchases 40 percent of all vaccines used in developing countries and Merck is its sole supplier. Merck makes Recombivax HB, a Hepatitis B vaccine that contains thimerosal.
Beyond the issue of thimerosal’s link to autism and developmental disorders lies the larger question of public trust in national vaccination programs—in the United States and the developing world, where global agencies like the WHO and its health programs can be viewed as politically suspect. The thimerosal debacle at the FDA and CDC, with its taint of conflicts of interest with big drug companies and compromised research, does more harm than good, given that the medical community’s primary directive is “First, do no harm.”
“I am a farm boy. I own a farm today. I am a person who knows the value of vaccinations,” [Haley] said. “But if the American people realize how the CDC and the vaccine boards work, they are going to lose faith, and that isn’t my doing. Its their own doing.”
More Cases of Illness Linked to Meningitis Vaccine
More cases of illness linked to meningitis vaccine
Thu Apr 6, 1:48 PM ET
Three more cases of Guillain-Barre syndrome (GBS), a neurological disorder involving temporary paralysis, have been reported in people given the Menactra vaccine to prevent meningitis.
The additional cases bringing the total number reported to eight, according to an article in the Morbidity and Mortality Weekly Report, published by the Centers for Disease Control and Prevention.
Still, when the eight cases of Menactra-related GBS were compared against the expected rates of GBS in populations in the same age group, no significantly increased risk was seen, suggesting that the association may have been due to chance alone.
The CDC continues to recommend Menactra for people who run a high risk for contracting meningitis, such as first-year college students living in dormitories, military recruits, and travelers to regions where meningitis is epidemic.
The possible link between the vaccine and GBS first surfaced in October 2005. At that time, five confirmed cases of the syndrome had been reported to the Vaccine Adverse Events Reporting System. In the present report, researchers from the CDC describe in detail two of the three cases that occurred between October 2005 and February 2006.
The first case involved a 19-year-old man who began experiencing numbness and weakness in his extremities, difficulty running, and decreased dexterity 25 days after being vaccinated with Menactra. Test results were consistent with GBS, and other possible causes of the neurologic symptoms were ruled out. He was treated and had made a full recovery by eight weeks after symptoms began.
The second case, which involved a 17-year-old male, was similar to the first, but disease onset occurred just 11 days after he was given the Menactra vaccine. Treatment resulted in a complete recovery two weeks after he has admitted to the hospital.
SOURCE: Morbidity and Mortality Weekly Report, April 6, 2006.
Thu Apr 6, 1:48 PM ET
Three more cases of Guillain-Barre syndrome (GBS), a neurological disorder involving temporary paralysis, have been reported in people given the Menactra vaccine to prevent meningitis.
The additional cases bringing the total number reported to eight, according to an article in the Morbidity and Mortality Weekly Report, published by the Centers for Disease Control and Prevention.
Still, when the eight cases of Menactra-related GBS were compared against the expected rates of GBS in populations in the same age group, no significantly increased risk was seen, suggesting that the association may have been due to chance alone.
The CDC continues to recommend Menactra for people who run a high risk for contracting meningitis, such as first-year college students living in dormitories, military recruits, and travelers to regions where meningitis is epidemic.
The possible link between the vaccine and GBS first surfaced in October 2005. At that time, five confirmed cases of the syndrome had been reported to the Vaccine Adverse Events Reporting System. In the present report, researchers from the CDC describe in detail two of the three cases that occurred between October 2005 and February 2006.
The first case involved a 19-year-old man who began experiencing numbness and weakness in his extremities, difficulty running, and decreased dexterity 25 days after being vaccinated with Menactra. Test results were consistent with GBS, and other possible causes of the neurologic symptoms were ruled out. He was treated and had made a full recovery by eight weeks after symptoms began.
The second case, which involved a 17-year-old male, was similar to the first, but disease onset occurred just 11 days after he was given the Menactra vaccine. Treatment resulted in a complete recovery two weeks after he has admitted to the hospital.
SOURCE: Morbidity and Mortality Weekly Report, April 6, 2006.
New FAIR clip of Imus and Lieberman
From FAIR:
Hi folks,
FAIR Autism Media has just posted a clip from a recent "Imus in the Morning" interview on MSNBC where Don Imus speaks with Senator Joseph Lieberman (D-CT) regarding thimerosal in vaccines and the autism epidemic.
If you would like to see this clip, visit:
http://www.autismmedia.org/media11.html
Enjoy,
Erik Nanstiel
CDC is "Disapointed" with USA Today Ad
Statement
For Immediate Release
April 6, 2006 Contact:
Division of Media Relations
404-639-3286
CDC Statement regarding autism-related advertisement in USA Today
We know that autism is a heart-wrenching situation for many families and many children and it presents special challenges that we would certainly want to prevent and do anything we could to avoid. When it comes to the nation’s immunization recommendations, the CDC and Public Health Service are always guided by one overriding goal and interest—all our recommendations are designed to protect the health and well being of all children.
We are very disappointed in an advertisement that appears in today’s edition of USA Today. The advertisement completely mischaracterizes the efforts of CDC, the American Academy of Pediatrics, the Institute of Medicine, and others to protect the health and well being of the nation’s children. CDC has sponsored multiple public meetings and scientific reviews, we’ve involved numerous outside organizations and experts in our research and recommendations, and we’ve made continued investments in research designed to discover factors which may place children at risk for developing autism. Importantly, if levels of thimerosal found in vaccines, including influenza vaccines, were associated with harm, CDC, the Public Health Service, and the nation’s physicians (e.g., the American Academy of Pediatrics, the American Medical Association, and American Academy of Family Physicians) would not recommend their use.
We’ve made substantial progress in removing thimerosal from vaccines – and have done so without placing infants and children at risk for potentially serious vaccine preventable diseases. As we continue in our efforts to further reduce the use of thimerosal in vaccines, we must also ensure, particularly in the case of influenza, that our efforts do not create serious undesirable outcomes, such as vaccine shortages that would place people, including children, at risk. History has shown that disruptions in vaccine supplies can render the population more vulnerable to diseases we know we can prevent.
We don't know, unfortunately, for children with autism what caused it, nor do we have sound, scientifically valid information on effective treatments. That's a fact. We just simply don't have answers to the cause of this disorder or the disorders that fall into the autism spectrum. We don't have a complete picture of the scope of the problem. We're just learning about the subtleties that can be early signs of autism, we're learning about the importance of early detection, and we're learning about the importance of early treatment, but we have a long way to go before we really understand the scope and magnitude of this problem in our country and what the trends really mean.
As we're looking for answers related to the causes and effective treatments for autism, we have to also be careful not to base our health recommendations on unproven hypotheses or fear. We have to base our decisions on the best available science that we have in front of us, and today the best available science indicates to us that vaccines save lives, and that's a very, very important message for all of us to remember.
For more information about autism, immunizations, or thimerosal, we encourage you to visit the CDC website: www.cdc.gov
For Immediate Release
April 6, 2006 Contact:
Division of Media Relations
404-639-3286
CDC Statement regarding autism-related advertisement in USA Today
We know that autism is a heart-wrenching situation for many families and many children and it presents special challenges that we would certainly want to prevent and do anything we could to avoid. When it comes to the nation’s immunization recommendations, the CDC and Public Health Service are always guided by one overriding goal and interest—all our recommendations are designed to protect the health and well being of all children.
We are very disappointed in an advertisement that appears in today’s edition of USA Today. The advertisement completely mischaracterizes the efforts of CDC, the American Academy of Pediatrics, the Institute of Medicine, and others to protect the health and well being of the nation’s children. CDC has sponsored multiple public meetings and scientific reviews, we’ve involved numerous outside organizations and experts in our research and recommendations, and we’ve made continued investments in research designed to discover factors which may place children at risk for developing autism. Importantly, if levels of thimerosal found in vaccines, including influenza vaccines, were associated with harm, CDC, the Public Health Service, and the nation’s physicians (e.g., the American Academy of Pediatrics, the American Medical Association, and American Academy of Family Physicians) would not recommend their use.
We’ve made substantial progress in removing thimerosal from vaccines – and have done so without placing infants and children at risk for potentially serious vaccine preventable diseases. As we continue in our efforts to further reduce the use of thimerosal in vaccines, we must also ensure, particularly in the case of influenza, that our efforts do not create serious undesirable outcomes, such as vaccine shortages that would place people, including children, at risk. History has shown that disruptions in vaccine supplies can render the population more vulnerable to diseases we know we can prevent.
We don't know, unfortunately, for children with autism what caused it, nor do we have sound, scientifically valid information on effective treatments. That's a fact. We just simply don't have answers to the cause of this disorder or the disorders that fall into the autism spectrum. We don't have a complete picture of the scope of the problem. We're just learning about the subtleties that can be early signs of autism, we're learning about the importance of early detection, and we're learning about the importance of early treatment, but we have a long way to go before we really understand the scope and magnitude of this problem in our country and what the trends really mean.
As we're looking for answers related to the causes and effective treatments for autism, we have to also be careful not to base our health recommendations on unproven hypotheses or fear. We have to base our decisions on the best available science that we have in front of us, and today the best available science indicates to us that vaccines save lives, and that's a very, very important message for all of us to remember.
For more information about autism, immunizations, or thimerosal, we encourage you to visit the CDC website: www.cdc.gov
April 7, 2006
Parents of Autistic Kids March Against Mercury
Parents of Autistic Kids March Against Mercury
Lindsay Puccio
April 6, 2006
Almost a thousand parents and physicians marched their way through the streets of Washington, DC to get the government's attention.
Parents said they want more research done to find out if mercury, which is found in children's vaccines, caused their sons and daughters to become Autistic.
"It empowers us as parents, it gives us some power to do something," said Kathy Young, a Charlottesville mother of an Autistic daughter.
Young walked in the "Mercury Generation March" to support her daughter. For years research showed Autism was a genetic disorder. But Young believes her daughter developed the disorder because of a known toxin that is in most vaccines. There has been some studies to prove it.
"No more lies from the CDC," parents chanted. These parents feel if more research is done to find the true cause of Autism, they can possibly find a cure.
"The main goal for all of us is that our kids get the proper treatment because currently with the government refusing to look at the issue seriously, little research is being done," said Young.
Right now, there isn't much parents can do if they believe mercury is responsible for their child's Autism. They feel this rally is their last hope to get the government on their side.
"The FDA and the CDC are making it very difficult for researchers to get the facts so that they can help our kids," said Young.
The CDC denies any cover-up. Currently, one out of every 166 kids are diagnosed with Autism.
Lindsay Puccio
April 6, 2006
Almost a thousand parents and physicians marched their way through the streets of Washington, DC to get the government's attention.
Parents said they want more research done to find out if mercury, which is found in children's vaccines, caused their sons and daughters to become Autistic.
"It empowers us as parents, it gives us some power to do something," said Kathy Young, a Charlottesville mother of an Autistic daughter.
Young walked in the "Mercury Generation March" to support her daughter. For years research showed Autism was a genetic disorder. But Young believes her daughter developed the disorder because of a known toxin that is in most vaccines. There has been some studies to prove it.
"No more lies from the CDC," parents chanted. These parents feel if more research is done to find the true cause of Autism, they can possibly find a cure.
"The main goal for all of us is that our kids get the proper treatment because currently with the government refusing to look at the issue seriously, little research is being done," said Young.
Right now, there isn't much parents can do if they believe mercury is responsible for their child's Autism. They feel this rally is their last hope to get the government on their side.
"The FDA and the CDC are making it very difficult for researchers to get the facts so that they can help our kids," said Young.
The CDC denies any cover-up. Currently, one out of every 166 kids are diagnosed with Autism.
April 6, 2006
"What You Have Done Unto The Least of These, You Have Done Unto Me"
Scott man extends religious experience to autistic
Thursday, April 06, 2006
By Margaret Smykla, Tri-State Sports and News Service
A few years ago, two Catholic families Larry Sutton knew had trouble finding proper religious instruction for their children with autism to receive the sacraments.
About the same time, Mr. Sutton, a child psychologist and a deacon at Our Lady of Grace Church in Scott, read about an autistic boy who was suffocated during a prayer service in a Milwaukee church as members tried to exorcise what they said were evil spirits. That incident occurred in a small Christian church called Faith Temple, which was in a strip mall.
He said both instances emphasized the lack of knowledge in society, including the religious community, about autism and the subsequent need for a program to help autistic children live fuller spiritual lives.
Autism is a neurodevelopmental disorder and children with it often have problems in social interactions and in communicating.
"The church is really to serve all people," said Mr. Sutton, of Mt. Lebanon. "People with disabilities need to be equal partners in our Christian community."
Along with help from Sister Michelle Grgurich, director of the Department for Persons with Disabilities for the Diocese of Pittsburgh, Mr. Sutton hopes to begin at his church a religious education program for autistic children up to age 18.
Six children have signed on, but more are needed for a viable program. Students will prepare for the sacraments of Penance, Eucharist and Confirmation.
Classes will be held in a nearby room during the 9:30 a.m. Sunday services at Our Lady of Grace.
Instruction will be based on the Rose Fitzgerald Kennedy Program to Improve Catholic Religious Education for Children and Adults with Mental Retardation, a program which includes religious instruction, lesson plans on the liturgical year, prayer services and a parents' handbook.
That nationwide program was developed in the diocese in 1996 under the direction of the Kennedy Foundation and Grace Harding, who was then director of the diocese's Department for Persons with Disabilities.
"It is comprehensive and has every topic in terms of the Catholic faith," Sister Michelle said.
The program has been in use at St. Anne Church in Castle Shannon for four years. There are five children, age 10 to 12, but it is open to anyone, including adults with special needs who never received the sacraments.
"It takes the basic tenets of the Catholic faith and puts them on a level children with special needs can understand," said St. Anne Director of Religious Education Katie Tarcson, of Bridgeville.
Classes are held from 6:15 to 7:30 p.m. Mondays from September through May at St. Anne school.
High school students serve as aids in the classroom for the St. Anne program, and Mr. Sutton said he wanted to increase that interaction in the Scott program.
He said he had seen the mutual benefits of high school students serving as models for younger people in his work for the state Bureau of Juvenile Justice.
Student mentors will be chosen after interviews with the child and his family.
For class, Mr. Sutton will read the daily Gospel, followed by the Kennedy curriculum, with the high schoolers acting as instructors.
The high school students will receive community service credit at their schools for their work.
To learn more about the Our Lady of Grace program, call 412-276-0277; for St. Anne's program, call 412-561-0101.
Thursday, April 06, 2006
By Margaret Smykla, Tri-State Sports and News Service
A few years ago, two Catholic families Larry Sutton knew had trouble finding proper religious instruction for their children with autism to receive the sacraments.
About the same time, Mr. Sutton, a child psychologist and a deacon at Our Lady of Grace Church in Scott, read about an autistic boy who was suffocated during a prayer service in a Milwaukee church as members tried to exorcise what they said were evil spirits. That incident occurred in a small Christian church called Faith Temple, which was in a strip mall.
He said both instances emphasized the lack of knowledge in society, including the religious community, about autism and the subsequent need for a program to help autistic children live fuller spiritual lives.
Autism is a neurodevelopmental disorder and children with it often have problems in social interactions and in communicating.
"The church is really to serve all people," said Mr. Sutton, of Mt. Lebanon. "People with disabilities need to be equal partners in our Christian community."
Along with help from Sister Michelle Grgurich, director of the Department for Persons with Disabilities for the Diocese of Pittsburgh, Mr. Sutton hopes to begin at his church a religious education program for autistic children up to age 18.
Six children have signed on, but more are needed for a viable program. Students will prepare for the sacraments of Penance, Eucharist and Confirmation.
Classes will be held in a nearby room during the 9:30 a.m. Sunday services at Our Lady of Grace.
Instruction will be based on the Rose Fitzgerald Kennedy Program to Improve Catholic Religious Education for Children and Adults with Mental Retardation, a program which includes religious instruction, lesson plans on the liturgical year, prayer services and a parents' handbook.
That nationwide program was developed in the diocese in 1996 under the direction of the Kennedy Foundation and Grace Harding, who was then director of the diocese's Department for Persons with Disabilities.
"It is comprehensive and has every topic in terms of the Catholic faith," Sister Michelle said.
The program has been in use at St. Anne Church in Castle Shannon for four years. There are five children, age 10 to 12, but it is open to anyone, including adults with special needs who never received the sacraments.
"It takes the basic tenets of the Catholic faith and puts them on a level children with special needs can understand," said St. Anne Director of Religious Education Katie Tarcson, of Bridgeville.
Classes are held from 6:15 to 7:30 p.m. Mondays from September through May at St. Anne school.
High school students serve as aids in the classroom for the St. Anne program, and Mr. Sutton said he wanted to increase that interaction in the Scott program.
He said he had seen the mutual benefits of high school students serving as models for younger people in his work for the state Bureau of Juvenile Justice.
Student mentors will be chosen after interviews with the child and his family.
For class, Mr. Sutton will read the daily Gospel, followed by the Kennedy curriculum, with the high schoolers acting as instructors.
The high school students will receive community service credit at their schools for their work.
To learn more about the Our Lady of Grace program, call 412-276-0277; for St. Anne's program, call 412-561-0101.
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