Posts
David Kirby
CDC: Vaccine Study Design "Uninformative and Potentially Misleading"
Posted June 20, 2008 | 06:43 PM (EST)
CDC Director Dr. Julie Gerberding has delivered a potentially explosive report to the powerful House Appropriations Committee, in which she admits to a startling string of errors in the design and methods used in the CDC's landmark 2003 study that found no link between mercury in vaccines and autism, ADHD, speech delay or tics.
Gerberding was responding to a 2006 report from the National Institute of Environmental Health Sciences (NIEHS), which concluded that the CDC's flagship thimerosal safety study was riddled with "several areas of weaknesses" that combined to "reduce the usefulness" of the study.
"CDC concurs," Dr. Gerberding wrote in an undated mea culpa to Congress, (provided to me through a Capital Hill staffer) adding that her agency "does not plan to use" the database in question, the Vaccine Safety Datalink, (VSD) for any future "ecological studies" of autism.
In fact, Gerberding's report said, any continued use of the VSD for similar ecological studies of vaccines and autism "would be uninformative and potentially misleading."
Ecological vaccine studies are large, epidemiological analyses of risks and trends using computerized data from large populations -- in this case children enrolled at several big HMOs -- without ever examining a single patient in person.
CDC officials conducted at least five separate analyses of the data over a four-year period from 1999-2003. The first analysis showed that children exposed to the most thimerosal by one month of age had extremely high relative risks for a number of outcomes, compared with children who got little or no mercury: The relative risk for ADHD was 8.29 times higher, for autism, it was 7.62 times higher, ADD, 6.38 times higher, tics, 5.65 times, and speech and language delays were 2.09 more likely among kids who got the most mercury.
Over time, however, all of these risks declined into statistical insignificance, statistical inconsistency or else outright oblivion: The relative risk for autism plummeted from 7.62 in the first analysis, to 2.48 in the second version, to 1.69 in the third round, to 1.52 in the fourth, and down to nothing at all in the fifth, final, and published analysis printed in the Journal Pediatrics in November of 2003.
Vaccine officials attributed the steady drop to the elimination of "statistical noise" from the data through due diligence and the endeavor for excellence in governmental statistical analysis.
Indeed, the VSD study was the main pillar of a hugely influential 2004 report by the Institute of Medicine, which also concluded that there was no evidence of link between mercury, vaccines and autism.
To this day, public health officials routinely point to five "large epidemiological studies" representing the "highest quality science," none of which found any link to thimerosal.
In fact, the American VSD study has long been held up as the best and brightest of them all (the others were in Sweden, the UK, and two in Denmark). And this reputation has stuck in the minds of medicine and the media.
Curiously though, even the study's lead author -- Dr. Thomas Verstraeten, an employee of vaccine maker GlaxoSmithKline -- protested that the VSD study "found no evidence against an association, as a negative study would. In fact, he said that additional study was needed, which "is the conclusion to which a neutral study must come."
That's when Congress stepped in.
In 2005, a group of Senators and Representatives headed by Sen. Joe Lieberman wrote to the NIEHS (an agency of the National Institutes of Health) saying that many parents no longer trusted the CDC to conduct independent minded studies of its own vaccine program. Lieberman et al asked NIEHS to review the CDC's work on the vaccine database and report back with critiques and suggestions.
The final NIEHS report was a serious and thoughtful critique of where the CDC went wrong in its design, conduct and analysis of the study. The NIEHS panel "identified several serious problems," with the CDC's effort, criticism to which the agency had not responded -- until now.
In her letter to the House Appropriations Committee, the CDC Director responded directly to many -- though not all -- of the most important criticisms and recommendations contained in the NIEHS panel report.
For example, the NIEHS had criticized CDC for failing to account for other mercury exposures, including maternal sources from flu shots and immune globulin, as well as mercury in food and the environment.
"CDC acknowledges this concern and recognizes this limitation," the Gerberding reply says.
The NIEHS also took CDC to task for eliminating 25% of the study population for a variety of reasons, even though this represented, "a susceptible population whose removal from the analysis might unintentionally reduce the ability to detect an effect of thimerosal." This strict entry criteria likely led to an "under-ascertainment" of autism cases, the NIEHS reported.
"CDC concurs," Gerberding wrote, again noting that its study design was "not appropriate for studying this vaccine safety topic. The data are intended for administrative purposes and may not be predictive of the outcomes studied."
Another serious problem was that the HMOs changed the way they tracked and recorded autism diagnoses over time, including during the period when vaccine mercury levels were in decline. Such changes could "affect the observed rate of autism and could confound or distort trends in autism rates," the NIEHS warned.
"CDC concurs," Dr. Gerberding wrote again, "that conducting an ecologic analysis using VSD administrative data to address potential associations between thimerosal exposure and risk of ASD is not useful."
Read that sentence one more time. The head of the CDC is saying that its most powerful and convincing piece of exonerating evidence for thimerosal is, in effect, "useless."
I hope everyone will read it, including the recommendations to make the VSD better, and the CDC's agreement with all of the suggestions.
As questionable at the US thimerosal study was, "it was an improvement on other studies, including the two in Denmark, both of which had serious weaknesses in their designs," Dr. Irva Hertz-Picciotto, Professor of Public Health at UC Davis Medical School and Chair of the NIEHS panel, told reporter Dan Olmsted at UPI.
That leaves very little for the CDC to go on in terms of proving that thimerosal and autism are not associated in any way.
Yes, there is always the study of disability services data from California -- which seem to be rising among the youngest cohorts of kids, who presumably received little or no mercury because thimerosal was largely removed from childhood shots.
But California is an "ecological study" with problems of its own.
"Although (this) information is often used by media and research entities to develop statistics and draw conclusions, some of these findings may misrepresent the quarterly figures," cautions the website of the California Department of Developmental Services (DDS). "Increases in the number of persons reported from one quarter to the next do not necessarily represent persons who are new to the DDS system."
Even the CDC admits that "there are several limitations" with linking a VSD study design with the California data, Gerberding wrote to Congress, because, among other things, California only counts "persons who were referred to and/or voluntarily entered" the disability system."
It will be interesting to see how the House Committee -- and the mainstream media -- react to this rather breathtaking confession by the CDC, which does seem to want to conduct the best vaccine-autism science possible (see Gerberding's replies to NIEHS recommendations for improving the VSD: CDC officials are currently conducting in- depth follow up studies with VSD patients).
As the waning months of the Bush administration get underway, I can't help but wonder if a little housecleaning might be going on at some of our top health agencies.
(And on that note, please see my blog about the upcoming HHS/FDA/CDC/NIH workshop on autism triggers in mitochondrial disorders (ie, Hannah Poling and her five vaccines).
Friday, June 20, 2008
Sunday, June 15, 2008
FDA issues precautionary note on silver fillings
FDA issues precautionary note on silver fillings
Jun 12, 11:37 PM (ET)
By LAURAN NEERGAARD
WASHINGTON (AP) - Silver dental fillings contain mercury, and the government for the first time is warning that they may pose a safety concern for pregnant women and young children. The Food and Drug Administration posted the precaution on its Web site earlier this month, to settle a lawsuit - making the move a victory for anti-mercury activists.
The warning is not aimed at the general population, only at two groups already urged to limit mercury from another source - seafood - because too much can harm a developing brain.
The fillings, formally known as dental amalgams, "contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses," reads the FDA Web posting.
That doesn't mean it truly harms, and the FDA advises against removing existing fillings.
The agency still is studying whether the small amount of mercury vapor released by chewing and brushing is enough to cause neurologic disorders or other problems in youngsters. There have been only a handful of rigorous studies comparing children given either amalgam fillings or tooth-colored resin composite fillings that are mercury-free - and those studies haven't detected any brain problems.
Nor has that research settled the long-simmering scientific controversy. Two years ago, the FDA's own independent scientific advisers said that while amalgam fillings were safe for most people, more research was needed about potential effects on fetuses and children under 6.
And this spring, the FDA put dentists on notice that it is considering additional controls, including whether to require warnings that would advise consumers of the mercury in amalgams before they have a cavity filled, or perhaps even restrict use in small children and certain other patients. It is accepting public comments until July 28.
"It's an open question what we will do," FDA Deputy Commissioner Randall Lutter told The Associated Press. But, "what this says is there's a clear intent on our part on labeling for sensitive subpopulations."
Expect a final ruling by July 28, 2009, a date set by that legal settlement.
"It's a watershed moment," said Michael Bender of the Mercury Policy Project, who with other advocacy groups had sued the FDA in hopes of forcing restrictions on amalgams.
"This court settlement signals the death knell for mercury fillings," added Charles Brown, an attorney for Consumers for Dental Choice.
Not so fast, say dentists who point to medically crucial reasons to use amalgams - and worry that people who can't afford more expensive alternatives might avoid dental care.
"We don't want these choices taken away based on junk science. We don't want them taken away based on misguided fears," said Dr. Edmond Hewlett, a dental professor at the University of California , Los Angeles , and an American Dental Association adviser.
Amalgam fillings are about 50 percent mercury, joined with silver, copper and tin. The hardened mixture makes the mercury less absorbable by the body than the kind found in fish, said Hewlett, who chose an amalgam filling for his own 7-year-old son.
Used since the 1800s, amalgams' popularity already is dropping. They account for about 30 percent of U.S. fillings, still millions of people a year.
They're cheaper than alternatives - roughly $100 for an amalgam filling versus $150 or more for a composite, Hewlett estimates - and they're known as particularly durable. Hewlett said two conditions that demand amalgams: Spots on back teeth that dentists can't keep dry long enough for a composite filling to bond, and in people who forcefully grind their teeth.
Science operates on "a precautionary principle," said Dr. Karl Kieburtz, a University of Rochester neurologist who co-chaired the 2006 FDA advisory committee and praised the new warning.
"For 99 percent-plus of people, there probably isn't harm. But if there is a group of people who might be at risk, they should at least have the knowledge that may be so," he said.
Several other countries limit amalgams, either as a precaution in pregnant women and small children or because of environmental concern. Dental workers make amalgam fillings by mixing liquid mercury with powdered ingredients, requiring special safety steps and filters to limit waste seeping back into the environment.
Jun 12, 11:37 PM (ET)
By LAURAN NEERGAARD
WASHINGTON (AP) - Silver dental fillings contain mercury, and the government for the first time is warning that they may pose a safety concern for pregnant women and young children. The Food and Drug Administration posted the precaution on its Web site earlier this month, to settle a lawsuit - making the move a victory for anti-mercury activists.
The warning is not aimed at the general population, only at two groups already urged to limit mercury from another source - seafood - because too much can harm a developing brain.
The fillings, formally known as dental amalgams, "contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses," reads the FDA Web posting.
That doesn't mean it truly harms, and the FDA advises against removing existing fillings.
The agency still is studying whether the small amount of mercury vapor released by chewing and brushing is enough to cause neurologic disorders or other problems in youngsters. There have been only a handful of rigorous studies comparing children given either amalgam fillings or tooth-colored resin composite fillings that are mercury-free - and those studies haven't detected any brain problems.
Nor has that research settled the long-simmering scientific controversy. Two years ago, the FDA's own independent scientific advisers said that while amalgam fillings were safe for most people, more research was needed about potential effects on fetuses and children under 6.
And this spring, the FDA put dentists on notice that it is considering additional controls, including whether to require warnings that would advise consumers of the mercury in amalgams before they have a cavity filled, or perhaps even restrict use in small children and certain other patients. It is accepting public comments until July 28.
"It's an open question what we will do," FDA Deputy Commissioner Randall Lutter told The Associated Press. But, "what this says is there's a clear intent on our part on labeling for sensitive subpopulations."
Expect a final ruling by July 28, 2009, a date set by that legal settlement.
"It's a watershed moment," said Michael Bender of the Mercury Policy Project, who with other advocacy groups had sued the FDA in hopes of forcing restrictions on amalgams.
"This court settlement signals the death knell for mercury fillings," added Charles Brown, an attorney for Consumers for Dental Choice.
Not so fast, say dentists who point to medically crucial reasons to use amalgams - and worry that people who can't afford more expensive alternatives might avoid dental care.
"We don't want these choices taken away based on junk science. We don't want them taken away based on misguided fears," said Dr. Edmond Hewlett, a dental professor at the University of California , Los Angeles , and an American Dental Association adviser.
Amalgam fillings are about 50 percent mercury, joined with silver, copper and tin. The hardened mixture makes the mercury less absorbable by the body than the kind found in fish, said Hewlett, who chose an amalgam filling for his own 7-year-old son.
Used since the 1800s, amalgams' popularity already is dropping. They account for about 30 percent of U.S. fillings, still millions of people a year.
They're cheaper than alternatives - roughly $100 for an amalgam filling versus $150 or more for a composite, Hewlett estimates - and they're known as particularly durable. Hewlett said two conditions that demand amalgams: Spots on back teeth that dentists can't keep dry long enough for a composite filling to bond, and in people who forcefully grind their teeth.
Science operates on "a precautionary principle," said Dr. Karl Kieburtz, a University of Rochester neurologist who co-chaired the 2006 FDA advisory committee and praised the new warning.
"For 99 percent-plus of people, there probably isn't harm. But if there is a group of people who might be at risk, they should at least have the knowledge that may be so," he said.
Several other countries limit amalgams, either as a precaution in pregnant women and small children or because of environmental concern. Dental workers make amalgam fillings by mixing liquid mercury with powdered ingredients, requiring special safety steps and filters to limit waste seeping back into the environment.
Monday, June 9, 2008
OP/Ed from Vindy.com
People step up to wage vaccine fight while media watches and doctors look the other way
Published:Sunday, June 8, 2008
EDITOR:
On Wednesday we attended a rally in Washington, D.C., headed by celebrities Jenny McCarthy and Jim Carrey urging the government and the vaccine industry to “green our vaccines.” Most people aren’t aware that vaccines contain various toxic ingredients — aluminum, formaldehyde, ether, and some still contain mercury, contrary to what you may have heard. It should be more then obvious to anyone (that is unless you work at the CDC) that toxins have no place in things we inject into our babies. Besides requesting a “greening of vaccines” Jim and Jenny’s message was simple, “Too many, Too soon”.
Reflect on this for a moment: Autism was 1 in 10,000 in 1983; it’s 1 in 150 in 2008. In 1983 children received 10 vaccines before school age. Today, it is an astounding 36 doses of various vaccines in the same time frame. Autism rates have risen simultaneously as the vaccine schedule has grown.
Vaccines have never been tested in combination. Some children are given an alarming eight shots at one time. Babies should never be vaccinated while they are sick — an all-too-common practice which has led many parents to report their child never being the same again after receiving shots while ill. The CDC provides a recommended list of vaccines, not a mandatory list. It is imperative that parents’ educate themselves on what exactly the diseases are that are being “recommended” for their child to be vaccinated against. Parents need to start making fully informed decisions when it comes to vaccines. The American Academy of Pediatrics has done nothing to address the autism epidemic. It’s done nothing to quell growing parental fears of what makes a child suddenly become autistic after receiving multiple vaccines. The AAP along with the CDC declined invitations to address the concerns of rally goers. Frankly, our community has lost faith in them. Over 8, 000 people attended the rally to lend a voice over concerns of toxins in vaccines. Every state in the union was represented along with Canada, Mexico, and the Philippines. What was so very disappointing was the poor media coverage this rally received by the mainstream media.
Our politicians need to be held accountable to us and our children. Any person holding office or running for public office should know our children are being damaged from toxic vaccines and they had better be willing to craft and support legislation that works to correct this problem and spare future generations from harm. In addition, they need to be prepared to create legislation that secures the funding needed to support the hordes of soon-to-be adults that will need lifelong care because they have been rendered autistic and unable to care for themselves. Robert Kennedy Jr. informed the crowd that the Iraq war is projected to cost us 3 trillion dollars. Yet, caring for all these autistic people will make that figure look small in comparison.
Our most precious commodity — our children — are literally being destroyed by government controlled propaganda and a profit driven medical establishment.
MATT and ANDREA KELLER
CANFIELD
Published:Sunday, June 8, 2008
EDITOR:
On Wednesday we attended a rally in Washington, D.C., headed by celebrities Jenny McCarthy and Jim Carrey urging the government and the vaccine industry to “green our vaccines.” Most people aren’t aware that vaccines contain various toxic ingredients — aluminum, formaldehyde, ether, and some still contain mercury, contrary to what you may have heard. It should be more then obvious to anyone (that is unless you work at the CDC) that toxins have no place in things we inject into our babies. Besides requesting a “greening of vaccines” Jim and Jenny’s message was simple, “Too many, Too soon”.
Reflect on this for a moment: Autism was 1 in 10,000 in 1983; it’s 1 in 150 in 2008. In 1983 children received 10 vaccines before school age. Today, it is an astounding 36 doses of various vaccines in the same time frame. Autism rates have risen simultaneously as the vaccine schedule has grown.
Vaccines have never been tested in combination. Some children are given an alarming eight shots at one time. Babies should never be vaccinated while they are sick — an all-too-common practice which has led many parents to report their child never being the same again after receiving shots while ill. The CDC provides a recommended list of vaccines, not a mandatory list. It is imperative that parents’ educate themselves on what exactly the diseases are that are being “recommended” for their child to be vaccinated against. Parents need to start making fully informed decisions when it comes to vaccines. The American Academy of Pediatrics has done nothing to address the autism epidemic. It’s done nothing to quell growing parental fears of what makes a child suddenly become autistic after receiving multiple vaccines. The AAP along with the CDC declined invitations to address the concerns of rally goers. Frankly, our community has lost faith in them. Over 8, 000 people attended the rally to lend a voice over concerns of toxins in vaccines. Every state in the union was represented along with Canada, Mexico, and the Philippines. What was so very disappointing was the poor media coverage this rally received by the mainstream media.
Our politicians need to be held accountable to us and our children. Any person holding office or running for public office should know our children are being damaged from toxic vaccines and they had better be willing to craft and support legislation that works to correct this problem and spare future generations from harm. In addition, they need to be prepared to create legislation that secures the funding needed to support the hordes of soon-to-be adults that will need lifelong care because they have been rendered autistic and unable to care for themselves. Robert Kennedy Jr. informed the crowd that the Iraq war is projected to cost us 3 trillion dollars. Yet, caring for all these autistic people will make that figure look small in comparison.
Our most precious commodity — our children — are literally being destroyed by government controlled propaganda and a profit driven medical establishment.
MATT and ANDREA KELLER
CANFIELD
Wednesday, June 4, 2008
Act Today to Stop Worst Vaccine Bill Ever in New York
Act Today to Stop Worst Vaccine Bill Ever in New York
ALL FEDERAL SHOTS WILL BECOME MANDATORY
Take action now to stop the worst state vaccine bill ever. Assembly Bill 10942 would make all vaccines recommended by the CDC mandatory for all children to attend school and, and for the first time vaccines would become mandatory for infants and toddlers.
Click on the Link below and use our email tool to contact your Assemblymember and your State Senator.
http://capwiz. com/a-champ/ issues/alert/ ?alertid= 11428606&type=ML
The bill was introduced in Rules Committee at the request of Richard Daines, the Commissioner of the New York State Department of Health. The Rules Committee in the personal committee of the Assembly Speaker Sheldon Silver (D-Manhattan) .
A-CHAMP is calling for rejection of this bill and is demanding the passage of A5468/S3031, a bill that would give individuals a right to a philosophical exemption from vaccine mandates. This is no time to transfer vaccine decisions away from individuals and elected officials answerable to the voters and give it to obscure bureaucrats with financial ties to the vaccine industry.
Here are just a few features of the proposed bill:
Our elected New York representatives would no longer determine the mandatory schedule of vaccines to attend school; decisions made by the federal Advisory Committee on Immunization Practices would automatically become mandatory.
All children, infants and toddlers included, in New York would be required to get all vaccines recommended by the ACIP according to the ACIP schedule
Religious exemptions may not apply to children younger than school age
All children in New York up to age 18 would be required to get annual flu shots.
All girls in New York would be required to get a human papilloma virus shot.
All junior high school children and college students would be required to get meningococcal shots.
Doctors would be required to issue certificates for every shot given and parents would be required to maintain the records and provide them to school and other authorities.
The rules committee claims that the new laws would have no fiscal impact on the state despite the necessity of the state to spend tens of millions on purchasing new vaccines, a vast increase in mandatory record keeping and enforcement for schools, and a huge increase that could be expected in the number of cases of neurological damage, Guillian Barré syndrome and other vaccine-caused injuries.
We only have a few weeks to defeat this bill. Let your Assemblymember and State Senator know immediately that a vote for this bill guarantees that you will do everything you can to get them un-elected.
Click on the link to find out who your representatives are and send them a message. And forward this at any friends or family or anyone else who would support protecting our rights and children.
http://capwiz. com/a-champ/ issues/alert/ ?alertid= 11428606&type=ML
ALL FEDERAL SHOTS WILL BECOME MANDATORY
Take action now to stop the worst state vaccine bill ever. Assembly Bill 10942 would make all vaccines recommended by the CDC mandatory for all children to attend school and, and for the first time vaccines would become mandatory for infants and toddlers.
Click on the Link below and use our email tool to contact your Assemblymember and your State Senator.
http://capwiz. com/a-champ/ issues/alert/ ?alertid= 11428606&type=ML
The bill was introduced in Rules Committee at the request of Richard Daines, the Commissioner of the New York State Department of Health. The Rules Committee in the personal committee of the Assembly Speaker Sheldon Silver (D-Manhattan) .
A-CHAMP is calling for rejection of this bill and is demanding the passage of A5468/S3031, a bill that would give individuals a right to a philosophical exemption from vaccine mandates. This is no time to transfer vaccine decisions away from individuals and elected officials answerable to the voters and give it to obscure bureaucrats with financial ties to the vaccine industry.
Here are just a few features of the proposed bill:
Our elected New York representatives would no longer determine the mandatory schedule of vaccines to attend school; decisions made by the federal Advisory Committee on Immunization Practices would automatically become mandatory.
All children, infants and toddlers included, in New York would be required to get all vaccines recommended by the ACIP according to the ACIP schedule
Religious exemptions may not apply to children younger than school age
All children in New York up to age 18 would be required to get annual flu shots.
All girls in New York would be required to get a human papilloma virus shot.
All junior high school children and college students would be required to get meningococcal shots.
Doctors would be required to issue certificates for every shot given and parents would be required to maintain the records and provide them to school and other authorities.
The rules committee claims that the new laws would have no fiscal impact on the state despite the necessity of the state to spend tens of millions on purchasing new vaccines, a vast increase in mandatory record keeping and enforcement for schools, and a huge increase that could be expected in the number of cases of neurological damage, Guillian Barré syndrome and other vaccine-caused injuries.
We only have a few weeks to defeat this bill. Let your Assemblymember and State Senator know immediately that a vote for this bill guarantees that you will do everything you can to get them un-elected.
Click on the link to find out who your representatives are and send them a message. And forward this at any friends or family or anyone else who would support protecting our rights and children.
http://capwiz. com/a-champ/ issues/alert/ ?alertid= 11428606&type=ML
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