CDC: Vaccine Study Design "Uninformative and Potentially Misleading"
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 methodology such as that used in the CDC's flagship thimerosal safety study is riddled with "several areas of weaknesses" that combine to "reduce the usefulness" of using the data in such a way.
"CDC concurs," Dr. Gerberding wrote in an undated report 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 (though that is exactly what they did in the 2003 study).
In fact, Gerberding's report said, use of the VSD for an ecological study now, comparing autism rates before and after the removal of most mercury from vaccines, "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 linking results to actual individual outcomes.
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.
Among the official tasks given to the NIEHS panel were to "Identify the strengths and weaknesses of the VSD for evaluating the possible association between exposures to thimerosal-containing vaccines and AD/ASD." Another was to "Advise NIEHS and CDC on the feasibility of a new VSD study to compare autism rates before and after removal of thimerosal from most US childhood vaccines, using an ecologic study (an epidemiologic design where there is no linkage between individual-level data on exposure and health outcome).
The final NIEHS report was a serious and thoughtful critique of if an how the CDC improve on the design, conduct and analysis of VSD data in the future. Still, the NIEHS panel "identified several serious problems," with using VSD data for ecological studies -- including the 2003 study - something 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 critiques and recommendations contained in the NIEHS panel report.
For example, the NIEHS had said the VSD data failed 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. This limitation would have applied to the 2003 Verstraeten study, as well as any future ecological analyses.
The NIEHS also questioned why CDC investigators eliminated 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 would likely lead to an "under-ascertainment" of autism cases, the NIEHS reported. Again, this would have been an issue in the Verstraeten data as well.
"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 is that the HMOs have 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 was based on anecological analysis of data whose methodology would be, in effect, "useless" for future study.
I hope everyone will read these documents, including the recommendations to make the VSD better, and the CDC's agreement with all of the suggestions. Hopefully, this data can still be used in some effective way.
As questionable as the US thimerosal methodology 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).
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I have neurological problems which have never been diagnosed (doctors and neurologists call my problems "tics"); however I am not the typical candidate for Tourette's as I developed the symptoms very late in life--strangely around the time I had a lot of dental work done and for reasons too long to explain had almost every tooth in my mouth filled with mercury fillings in a short amount of time, many of them fell out, were drilled into and refilled with more mercury, once amalgam was spilled into my mouth during the many procedures, etc, etc....
I tried to have my mercury levels tested and was told by the doctor straight faced that mercury is inert in the human body............ummm.....it's a neuro-toxin, which OK, he didn't know, so anyhow, no doctor since then has been willing to test me for mercury poisoning, even if I offer to pay out of pocket, they say it's medically not necessary and therefor won't agree to it.
Again, I know my story sounds hard to believe on the outset, that I had almost every tooth filled and refilled within a short amount of time with amalgam--it's a long story, and easier to just to let it be unsaid.
The bottom line is that mercury is nasty to our bodies and has no place in medicine! The American Dental Association actually formed in opposition to American Society of Dental Surgeons which banned the use of mercury back in the 1840s!!!
Hope you get feeling better.
You are not alone-
Mercury Tooth Fillings: FDA Does an About Face
Newsweek - Jun 10, 2008
http://www.blog.newsweek.com/blogs/labnotes/archive/2008/06/10/mercury-tooth-fillings-fda-does-an-about-face.aspx
or
http://tinyurl.com/4bvkd5
Thank you! I will show that to my dentist. I now have a dentist who as time goes on and my old fillings have to be replaced agrees to use white filling and although he will not acknowledge mercury in fillings is dangerous--he gets about as close to being sympathetic as any dentist I have ever met. I have very mixed feelings on having them all replaced at once. Part of me thinks it's less toxic to my body to do it slowly as I am so that I don't have all these old ones drilled into at once which of course releases the most vapor.
For the time being I *guess* I just have late onset Tourette's. No neurologist has ever been considered with a label. They just call it tics. But do people just have tics out of the blue? I don't understand how so many people in the medical profession can have so little curiosity. Why don't they wonder about what causes things? If I were a neurologist, I wouldn't be content to say, "Well, you're making ticking sounds. You can take these sedatives to slow them down." That's honestly all the neurologists I have seen have ever said. Absolutely not curiosity. I could have had a bartender tell me to get wasted to slow down the tics.
I am trying to contact folks who have neurological disorders due to amalgams in their mouths.
I was also diagnosed with a neurological disorder shortly after receiving
dental work and having several mercury fillings put in.
I want to try to chelation. However, I can not afford
to remove my fillings. There are too many and could cause me more
adverse affects in trying to remove them.
So my question is can I still try and chelate the mercury that is
affecting me neurologically without removing the amalgam fillings?
Please send your story or advice to my e-mail address jackycat3 @ aim . com
Any information will be greatly appreciated.
Jacky
I am trying to contact folks who have neurological disorders due to amalgams in their mouths.
I was also diagnosed with a neurological disorder shortly after receiving
dental work and having several mercury fillings put in.
I want to try chelation. However, I can not afford
to remove my fillings. There are too many and could cause me more
adverse affects in trying to remove them.
So my question is can I still try and chelate the mercury that is
affecting me neurologically without removing the amalgam fillings?
Please send your story or advice to my e-mail address jackycat3 @ aim . com (spaces added in the e-mail on this post so I will not receive spam mail)
Any information will be greatly appreciated.
Jacky
Wow...this is....WOW!!
David, again you leave me speechless. Is this admission as incredibly huge as I think it is?
Wait, I know what's going to happen now! The vaccine-thugs will say that Gerberding, one of their leading vaccine advocates and one of the people they worship fanatically, is a quack and her statements shouldn't be taken seriously. Her data is obviously flawed and tainted by a conflict of interest.
Craig, I hate to have to agree. I do believe that this is what is going to happen to her too. This is how insane this world is!
Lin
LOL, Craig, I finally disagree with you:) I doubt that Miss Gerberding will ever be belittled as other doctor's have. She simply knows too much. Yes the other doc's do, too. But there really isn't any way to argue taht JG is truly a person in the "know". She is disgusting. And I can only hope that she is now being honest. I just don't believe it.
Ah, Mr. Kirby, on top of things as usual. We can never fully thank you for all you've done, do and will do in the future.
It sure will be interesting to see what the media does with this information.
Forget the media (think almost total blackout on the Green Our Vaccines Rally):
Anne needs to pressure Congressman Obey to conduct a hearing in follow up to this letter!
He's got the position and power to do it!
Maybe a mass call-in is in order?
Kelli Ann Davis
Kelli Ann,
I like the way you think. We could do something similar to the "Julie Gerberding Must Go" day. Who do we call? Let's get a list going. Maybe we should get this up over at Age of Autism (where are peeps are). Email Kim maybe?
I have mercury poisoning I believe and just met someone who had it and needed 4 yrs to get rid of it (she seems quite normal now and has an ad hoc group of those with the problem). I don't think this is some weird coincidence. Something is going wrong with this society and perhaps all "modern" societies. And it isn't being looked into nearly enough.
The House Appropriations Committee Chairman is Dave Obey (D-WI). And he's also Chairman of that committee's subcommittee on Labor, Health and Education. Best of all, Dave Obey is MY REPRESENTATIVE!
Rep Dave Weldon (R-FL) is also on this subcommittee and he has long been an advocate for our children.
Since I've been in contact with Obey's office for years and have twice gone to Washington to try and get someone there interested in the autism crisis, I'm hoping that after hearing this information from the CDC he's wising up. The facts that I provided didn't seem to impact his office. Barely any attention was paid to me in the past when I challenged the official denials. Maybe, just maybe, Obey'll realize that the mom from back home in WI wasn't wrong.
Anne Dachel
Media editor Age of Autism
Thanks again David Kirby for reporting on this. This impacts so many families and it is again on the front burner where it belongs.
and..
cafehunk- (these names are sort of ridiculous btw)
Spare me your blithering, typical shades of vaccine McCarthyism. Vaccine injuries are real. What do you think the Vaccine Compensation Fund is for? And yes, autism and it's lesser known "autism-like" misnomer have been compensated meaning that it has been shown that children have become autistic (toxic encephalopathy) from their vaccines. Don't you want safe vaccines for your children and grandchildren?
Teresa
What gets me is how doctors and scientists will go on about having to protect babies and young children from this and that, chemicals, meds, now many are saying from cell phone radiation, they go on about how delicate and vulnerable their little, still-developing nervous and other systems are, we have to be oh-so-careful. And then they plug the littlest babies with an astounding array of vaccines, with seemingly no concerns at all about what THE VACCINES might be doing to their vulnerable, still-developing systems. It make no sense at all.
"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."
I sure hope so, David! I am also concerned that when and if they do some housecleaning, the next group of people are not like the ones that are in there now. I sure would like to know what ever happened to honesty! We sure could use some for a change!
Could be housecleaning would be really important if this happened-
"Hagel Says He'd Consider An Obama VP Offer"
CBS News, NY - 4 hours ago
http://www.cbsnews.com/blogs/2008/06/20/politics/horserace/entry4199454.shtml
and to refresh Ms Gerberding's memory-
Aug 02, 2005
http://www.poac-nova.org/newsmanager/news_article.cgi?news_id=358
"Senator Chuck Hagel of Nebraska has introduced legislation to ban Thimerosal, a mercury containing preservative, from use in vaccines. The Senate Bill, S. 1422, is a companion to H.R. 881, introduced earlier this year in the House of Representatives Congressman Dave Weldon of Florida. "
Kirby's a one-note fearmonger. Thimerosol has been eliminated from vaccines for years now and, autism rates haven't declined among the cohort of people born since then. It should be obvious to all far and wide that this vaccine theory is bunk. Autism and autistic-spectrum disorders are real, and treating this issue with compassion for those affected and with support for the parents that will always shoulder the burden or treating these kids is what's important. All the sound and fury about vaccines is worse than useless - we need to get on with solving the problem and not wasting resources on an obvious dead end. Worse, this fearmongering about vaccines is causing parents to forgo vaccination, causing a reemergence of previously well-controlled childhood diseases, and hindering effective use of new vaccines.
http://www.cdc.gov/vaccines/vac-gen/additives.htm
I recommend that you check out this, then note the date this was last updated, April 2008. You will notice that it has not been removed. Check out the facts on the CDC's OWN web site then maybe you will understand. This has never been a DEAD HORSE. You may want to consider this as well.
http://www.whale.to/a/mercury7.html
No parent is interested in not vaccinating their children, just want to have toxin free vaccines.
EXACTLY!! Thank you!
You know when I went through all this 20 years ago with my daughter.. it was about 10 vaccines by the time she hit 5 years old.
MUCH HAS CHANGED since those days..
Our twin boys now almost 5 years old received about 36 by the time they hit 4 years old! The last bout of 5 vaccines were given to them ALL at once (when they could have spread them out from ages 4 to 6 years old) was on the SAME DAY our pediatrician told us one of our twins has ASD... something we never heard of before.
If only I could have had the courage to tell them to spread out those shots without getting chastised as I was last March for refusing to give them the FLU vaccine.
If only I could turn back the hands of time....
This is how WE learned about Autism... the hard way:
http://www.whatkindofworlddoyouwant.com/videos/view/id/664709
Keep up the outstanding work David Kirby! I wished I had known about you 5 years ago.
Okay, cafehunk, let's see some facts. You know, data that proves that there is a re emergence of previous well-controlled childhood diseases. Also, thimerosol has NOT been eliminated from vaccines, and that is a fact that is readily admitted by all concerned- so how did you miss finding that out? And how can you have effective use of new vaccines, if you do not know first of all what harm they cause? You say that it should be obvious that this vaccine theory is bunk, but you now are totally disregarding the fact that the CDC is admitting that it isn't. You need to actually research your topic before you go off repeating government talking points - you will find a whole world of information out there that you aren't getting any exposure to.. you know, in the REAL world.
Thimerosal has NOT been eliminated from vaccines, it has been reduced (and it took five years to do because it was voluntary). It's in all the multi-dose flu shots now "recommended" for all babies at 6 months old, trace amounts in several routine shots and in shots given to pregnant women...you should check your facts cafehunk.
We are well aware of the importance of vaccines, the diseases they prevent and the lives they save, but damaging the brains of thousands of children is not an acceptable compromise.
We are well aware of the importance of vaccines, the diseases they prevent and the lives they save, but damaging the brains of thousands of children is not an acceptable compromise.
EXACTLY, dannyvoice!
Thimerosal has been gone from scheduled childhood vaccines since 2002. So why haven't we seen a decline in autism among today's 3-5 year olds?
Sorry, but you are dead wrong! Thimerosal is still used in the vast majority of flu shots. I know because I give the shots! Also many other childhood vaccines contain "trace" amounts of thimerosal. So go tell your lies somewhere else!
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Posted June 20, 2008 | 06:43 PM (EST)