The Age of Autism: March of the experts
Dan Olmstead
Aug 17, 2005, 21:49 GMT
WASHINGTON, DC, United States (UPI) -- The news that
the first child diagnosed with autism got better after
medical treatment -- while leading experts didn`t make
the connection -- suggests how research and reality
have been distorted for decades.
As The Age of Autism reported Monday, the child known
as Case 1 is alive and doing remarkably well in the
same small Mississippi town he grew up in. Although we
didn`t talk directly to "Donald T.," his brother told
us that he had a "miraculous response" to gold salts
treatment at the age of 12.
It cleared up a devastating case of juvenile arthritis
and -- astonishingly -- made a marked difference in
Donald`s autism, he said.
"When he was finally released, the nervous condition
he was formerly afflicted with was gone," his brother
said of the two- to three-month gold salts treatment
in 1947.
"The proclivity to excitability and extreme
nervousness had all but cleared up, and after that he
went to school and had one more little flare-up (of
arthritis) when in junior college." He also became
"more sociable," his brother said, and was invited to
join a college fraternity.
That was 58 years ago, yet we`re not aware of any
mention in the millions of words written about autism
that this very first case may have gotten better
following a novel medical treatment.
Instead, today`s mainstream medical experts dismiss
the idea of biomedical interventions such as
anti-inflammation and detoxification therapies as
dangerous hooey perpetrated by quacks and charlatans.
Yet the treatment Donald got was patently biomedical:
Medicine prescribed by a doctor to treat a physical
illness appears to have had a positive effect on his
mental disorder.
The official hostility to such approaches is currently
so great that the only research under way on the topic
is funded by parents. An official at the National
Institutes of Mental Health told The New York Times
last month that it "isn`t responsible" to prescribe
chelation, which is designed to eliminate heavy metals
from children with autism.
Yet dozens of parents -- and, for that matter, dozens
of doctors outside the mainstream treatment community
-- say the treatments have made huge improvements.
Some of them have banded together at
generationrescue.org; they argue that autism is
mercury poisoning (primarily from a preservative that
was used in vaccines) and that getting the mercury out
has cured some children of autism and vastly improved
the condition of others.
Other doctors, many of them connected with Defeat
Autism Now!, a project of the Autism Research
Institute, are using everything from special diets to
B vitamins to folinic acid. They cite similar
successes, and many parents agree.
These parents and doctors get the modern equivalent of
what awaited the parents of early autistic children --
skepticism and scorn.
In the beginning, there was strong suspicion -- in
many quarters, certainty -- that bad parenting caused
autism. This came in part from the striking fact that
so many of the parents of those early cases were
successful, affluent, career-oriented professionals.
Even more suspiciously, many of the mothers had
college degrees and -- alert the mental-health
authorities! -- their own careers.
"One other fact stands out prominently," wrote Leo
Kanner, the child psychiatrist who first identified
autism, beginning with D onaldT.,inhislandmark1943BR paper on the disorder. "In the whole group, there are
very few really warmhearted fathers and mothers. ...
The question arises whether or to what extent this
fact has contributed to the condition of the
children."
While Kanner also noted that the children appeared to
have been autistic from birth -- and thus the parents`
personalities could not entirely explain their
children`s disorder -- it set the stage for a tragic
morality play over the next several decades.
The worst was Bruno Bettelheim, who wrote in "The
Empty Fortress" in 1967: "I believe the initial cause
of withdrawal is rather the child`s correct
interpretation of the negative emotions with which the
most significant figures in his environment approach
him. ... The tragedy of children fated to become
autistic is that such a view of the world happens to
be correct for their world."
We couldn`t help thinking of all that when Donald`s
brother told us Kanner suggested "the best thing that
could happen" would be to place Donald with another
family -- a childless farm couple. The parents
complied, but it was only after the juvenile-arthritis
attack four years later, and the subsequent gold-salts
treatment, that Donald dramatically improved.
Yet Kanner attributed the change to "the intuitive
wisdom of a tenant farmer couple, who knew how to make
him utilize his futile preoccupations for practical
purposes and at the same time helped him to maintain
contact with his family."
It wasn`t until Bernard Rimland wrote Infantile Autism
in 1964 that the idea of the "refrigerator mother"
began to change -- slowly.
What makes Donald`s case all the more interesting is
that none of the specialists his family took him to --
including the Mayo Clinic -- could identify the cause
of his uncontrollable fever and joint pain when he was
12, his brother said. It wasn`t until Donald`s father
happened to mention the affliction to a practicing
physician in a nearby small town that juvenile
arthritis, a rare autoimmune disorder, was identified.
Here is how one of our correspondents summarized this
sequence:
1. The world expert (Kanner) was incompetent with
respect to medical assessment of illness.
2. He assumed that they needed to get Donald away from
his parents. They really did think it was a parental
abuse problem back then.
3. Kanner mistakenly attributed Donald`s progress to
the "therapist" when it was really the medicine.
4. Recovery is possible with biomedical treatment.
5. Biomedical treatment ideas are not likely to come
from the autism experts (Kanner) or the prestigious
clinics (Mayo). They come from real medical doctors
who know how to recognize real illness and
autoimmunity in the kids.
Contrast that analysis with the standard dismissals
when parents claim biomedical treatments have helped:
-- They may be indulging in wishful thinking --
wanting their child to improve so badly that they
delude themselves;
-- They may have tried another treatment such as
behavior therapy that is actually responsible;
-- Their child may not have been very autistic in the
first place.
Does anyone think Donald T., the first child diagnosed
with autism, was not very autistic in the first place?
Surely, Donald`s family was not "imagining" his
improvement, since they weren`t even trying to treat
his autism.
Of course, that intuitive, wise, childless farm couple
may have made all the difference -- that is, if you
think autism is caused by unwise, non-intuitive
mothers and fathers (bad parents).
We don`t know what to make of Donald`s evident
improvement -- and the fact that it has stayed buried
for so long even as parents and researchers
frantically turn over every stone to uncover
treatments for this burgeoning, awful disorder.
We acknowledge we have not met Donald and are unable
to vouch for his brother`s account, although we
certainly found him credible and convincing.
But it does make us wonder whether much has changed.
These days, parents aren`t condemned for having
autistic children -- just for doing something about it
without the permission of experts who are certain
nothing can be done.
In upcoming columns we`ll look at the implications of
Donald`s treatment.
E-mail: dolmsted@upi.com
August 19, 2005
How the Hell Did Johns Hopkins Miss This!
I am so incredibly angry.
Apparently the first person ever diagnosed with Autism by Leo Kanner at age 5 in 1938, was cured of it accidentally in 1947! He had a horrible bought of juvenile arthritis that they treated for three months with gold salts, apparently the standard treatment for the ailment at the time, and when the treatment was over, his arthritis and his autism were both gone!
His name is Donald and he is a retired bank teller, AND HE IS ALIVE AND WELL AND PLAYING GOLF IN MISSISSIPPI!
Johns Hopkins has been in touch with him to "follow up" with him every few years, but they never bothered to note his dramatic reaction to the treatment.
WHAT THE FUCK IS FOLLOW UP FOR THEN!
How does the world find this out??? Dogged Hopkins researcher pouring over old files and pounding the pavement to find a cure for autism??? An esteemed medical journal??? New announcement from the CDC???
NO! Dan Olmstead, UPI reporter, bothered to call the guy's brother last weekend!
I don't want to hear any more about how mainstream medicine is looking for a cure. Patient Zero recovers 58 years ago and the best hospital and medical school in the world, my alma mater, doesn't even fucking care.
Apparently the first person ever diagnosed with Autism by Leo Kanner at age 5 in 1938, was cured of it accidentally in 1947! He had a horrible bought of juvenile arthritis that they treated for three months with gold salts, apparently the standard treatment for the ailment at the time, and when the treatment was over, his arthritis and his autism were both gone!
His name is Donald and he is a retired bank teller, AND HE IS ALIVE AND WELL AND PLAYING GOLF IN MISSISSIPPI!
Johns Hopkins has been in touch with him to "follow up" with him every few years, but they never bothered to note his dramatic reaction to the treatment.
WHAT THE FUCK IS FOLLOW UP FOR THEN!
How does the world find this out??? Dogged Hopkins researcher pouring over old files and pounding the pavement to find a cure for autism??? An esteemed medical journal??? New announcement from the CDC???
NO! Dan Olmstead, UPI reporter, bothered to call the guy's brother last weekend!
I don't want to hear any more about how mainstream medicine is looking for a cure. Patient Zero recovers 58 years ago and the best hospital and medical school in the world, my alma mater, doesn't even fucking care.
The Age of Autism: Case 1 revisited
By Dan Olmsted
UPI Health
Editor
Published 8/15/2005 9:45 AM
The first person ever diagnosed with autism lived in a small town in Mississippi. He still does.
"Donald T." is now 71, and after a "miraculous response" to medical treatment at age 12, he appears to have recovered significantly since his original diagnosis as a 5-year-old.
His improvement is so striking, in fact, that it raises new questions about the disorder and its treatment.
Donald went on to graduate from college, where he joined a fraternity. He worked as a bank teller and belongs to the Kiwanis Club. He owns a handsome house with a large well-tended yard, drives a car, plays golf several times a week and travels the world solo. Recent itinerary: Rome; Palermo, Sicily; Corsica and Sardinia. This past weekend he was returning from Branson, Mo.
In short, he doesn't seem terribly autistic anymore.
"It sounds like he moved right off the spectrum," said one doctor whose practice includes scores of children with autism.
The treatment Donald received in 1947 was not intended to help his disorder, but to save his life. Donald had come down with an uncontrollable fever, stopped eating and had severe joint pain and stiffness that was finally diagnosed as juvenile arthritis, a rare autoimmune condition. Such problems occur when the body's own defense mechanisms go haywire, in this case causing inflammation that was destroying his joints.
After being treated for several months with gold salts -- then the standard therapy and still in use -- not only his arthritis but some of his most disabling autistic traits cleared up simultaneously.
We learned all this after we determined Donald's identity and that of his brother, whose law office is on the second floor of a building across the town square from the courthouse. The brother, although understandably taken aback when we showed up last Friday, was cordial and said he didn't mind being quoted by name, but because Donald has not responded to our request for an interview -- and we do not wish to intrude on his privacy -- we decided not to identify the family or the town at this time.
Medical researchers certainly know where to find Donald -- his brother said Johns Hopkins University medical personnel check in "about once a decade" to observe Donald's progress. It is not clear whether anyone at Johns Hopkins, where Donald was diagnosed, ever considered whether his striking improvement was related to the gold-salts treatment.
Upwards of a quarter-million U.S. children have autism, and diagnoses are rising. The cause is unknown. Medical groups and federal health officials have dismissed the "biomedical" approaches being tried by some parents and doctors as unproven and irresponsible.
"You have to keep in mind that the history of medicine is strewn with discarded treatments that people at one time believed in very, very strongly," Dr. Harvey Fineberg, president of the Institute of Medicine, said on NBC's "Meet the Press" earlier this month in response to a question about those treatments.
Such an approach, however, appears to have made the difference for Donald, at least according to the brother, who is his closest living relative -- and who was clearly unfamiliar with the current debate.
Donald's parents took him to Johns Hopkins in Baltimore at age 5 in 1938 to be evaluated by Leo Kanner, the leading child psychiatrist of his day. Kanner realized that Donald's behavior syndrome -- which included repetitive actions, limited and odd use of language and profound social disengagement -- was "markedly and uniquely different from anything reported so far."
Over the next four years Kanner saw 10 more such children, and in 1943 he published their case histories in a landmark paper titled "Autistic Disturbances of Affective Contact."
"There was a marked limitation of spontaneous activity," Kanner observed about "Case 1, Donald T."
"He wandered about smiling, making stereotyped movements with his fingers, crossing them about in the air. He shook his head from side to side, whispering or humming the same three-note tune. He spun with great pleasure anything he could seize upon to spin."
He also had what would prove to be characteristic speech patterns of autism, including affirmation by repetition. For example, if he wanted to get down after his nap, he said, "Boo (his word for his mother) say, 'Don, do you want to get down?'" Yet he could recite 25 questions and answers of the Presbyterian catechism and had perfect pitch (he still does).
In our interview, Donald's brother outlined what happened after Kanner's diagnosis.
"My brother was extremely nervous and excitable. Dr. Kanner, when they took Don up there, told my mother and father that the treatment he was going to recommend was, if they knew a couple out in the country -- a childless couple -- in his opinion (having Donald live with them) would be the best thing that could happen."
They found such a couple, and Donald began living on a farm about 10 miles from town in 1944, when he would have been 9 years old.
"In 1947, one February day I think it was, they came to (town) with Don. He had a bad fever and was obviously sick. My father and mother took him to all various places for examination -- they went to the Mayo Clinic, brought him back."
Because Donald's family was affluent -- his father was a Yale-educated lawyer -- they could afford the best doctors and knew where to find them, but nothing seemed to help.
"He lost his appetite and was terribly emaciated," his brother recounted, comparing his appearance to a concentration-camp survivor. "But anyway, my father was talking to a doctor (in a nearby small town) he happened to run into." He told the doctor, "It looks like Don's getting ready to die."
That doctor, without having examined his son, said, "What you're describing sounds like a rare case of juvenile arthritis."
Armed with that tentative diagnosis, his parents took Donald to a clinic in Memphis, where they "began to treat my brother with gold salts for 2 to 3 months."
The results were spectacular.
"He just had a miraculous response to the medicine. The pain in his joints went away." Donald has one fused knuckle to show for the nearly fatal affliction.
There was more good news.
"When he was finally released, the nervous condition he was formerly afflicted with was gone," his brother said. "The proclivity to excitability and extreme nervousness had all but cleared up, and after that he went to school and had one more little flare-up (of arthritis) when in junior college. They treated it with cortisone."
The interview with Donald's brother significantly adds to the information known about him and establishes a new timeline -- one in which the gold-salts treatment now appears to be a pivotal but previously undocumented event.
In a 1970 letter cited by Kanner, Donald's mother mentions "he had an acute attack of rheumatoid arthritis in 1955. Fortunately, this lasted only a few weeks. Physically, since that time he has been in perfect health. ... Since receiving his AB degree in 1958, he has worked in the local bank as a teller."
She was evidently describing the "one more little flare-up" that Donald's brother described as occurring in junior college. We found no reference in Kanner's writing to the life-threatening first onset of juvenile arthritis at age 12 or to the treatment that followed.
Instead, Kanner attributed Donald's standout success in later life -- most of the 11 initial patients were ultimately institutionalized or lived in extremely sheltered circumstances -- to the couple with whom he stayed for those four years.
Kanner wrote in 1971:
"Donald, because of the intuitive wisdom of a tenant farmer couple, who knew how to make him utilize his futile preoccupations for practical purposes and at the same time helped him to maintain contact with his family, is a regularly employed bank teller; while living at home, he takes part in a variety of community activities and has the respect of his fellow townspeople."
Yet, in our interview, Donald's brother cited the medical treatment and said it made a permanent difference in Donald.
"It sure did," he said. "He became more social," noting that just a few years later Donald was asked to join the college social fraternity, whereas people with autism are prone to isolation and do not usually acquire friends.
Would he call his brother autistic now, we asked? "It's just in certain areas," he said, citing a total lack of interest in dating or a life companion.
Donald's transformation, his brother said, "is the most amazing thing I've ever seen."
--
E-mail: dolmsted@upi.com
August 18, 2005
Autism: Thinking the Unthinkable
"To cling to a purely genetic explanation of autism is a desperate attempt to maintain the illusion that one lives in a comfortable and rational world where new chemicals and technologies always mean progress, experts are always objective and thorough, corporations are honest, and authorities can be trusted. That human actions rather than genetics, might be responsible for compromising the health of a significant proportion of a whole generation is so painful as to be, for many, unthinkable."
Martha Herbert, MD PhD
Harvard School of Medicine
Martha Herbert, MD PhD
Harvard School of Medicine
Giving the Milk Away for Free
So the last several weeks I have spent a great deal more time writing in the comments sections of other peoples blogs than I have on my own.
During this dearth of new posts, please feel free to venture out and read my writing elsewhere:
http://skeptico.blogs.com/skeptico/2005/06/lies_damn_lies_.html
http://skeptico.blogs.com/skeptico/2005/07/kennedy_admits_.html
http://skeptico.blogs.com/skeptico/2005/08/sticking_up_for.html
http://www.supportvaccination.org/2005/08/why-disdain-for-epidemiology.html
http://oracknows.blogspot.com/2005/08/dispatches-from-road-part-ii-danish.html
During this dearth of new posts, please feel free to venture out and read my writing elsewhere:
[All the posts are mercury related, so if you are not interested in that topic, skip it.]
http://skeptico.blogs.com/skeptico/2005/06/lies_damn_lies_.html
http://skeptico.blogs.com/skeptico/2005/07/kennedy_admits_.html
http://skeptico.blogs.com/skeptico/2005/08/sticking_up_for.html
http://www.supportvaccination.org/2005/08/why-disdain-for-epidemiology.html
http://oracknows.blogspot.com/2005/08/dispatches-from-road-part-ii-danish.html
August 16, 2005
A Little Vacation
I was going to write a post about why I am not posting, but I saw Manolo's and decided to steal his. He has the way with the words that the Ginger, she does not have.
Manolo on the Go
August 12th, 2005
Manolo says, for the next few days, as with last few days, the Manolo he will be travelling, and so as the consequence, the bloggings they will be thin and the emails they will go sadly unanswered. However, have not the fear, the Manolo he will soon return in all of his splendor.
Muchos Besos to the many internet friends of the Manolo!
P.S. You are indeed all super fantastic!
August 14, 2005
Mercury In Action
I you have not yet seen this video from the University of Calgary, you need to.
How Mercury Causes Brain Neuron Degeneration - video of mercury damaging a neuron.
It is difficult for me to see how health officials can justify mercury's use in medicine at all in light of this.
How Mercury Causes Brain Neuron Degeneration - video of mercury damaging a neuron.
It is difficult for me to see how health officials can justify mercury's use in medicine at all in light of this.
The Hurry-up Offense
Dear JP,
To finish addressing your concerns about ‘mercury moms’:
Just an aside, the working theory is that these children have a genetic inability to excrete heavy metals from the body, so it may be that no amount of any kind of mercury can be tolerated by children like mine. In Chandler’s case, the treatment that he is receiving and responding to seem to fit that hypothesis.
This paragraph seems to suggest that you take issue with these studies, but it may just be that you have concerns about the way they are being used or that their conclusions are being overstated and poorly used by those in the anti-thimerosal group.
Can you offer clarification as to which position you are taking or if you are asserting both? I was not quite clear.
Can you give an example of your concerns so I can get a concrete understanding of the problem as you see it?
If your concern is that people are overstating the conclusions of one or more of these studies, I say, well of course they are. That’s what people do. They want to make more or less of studies depending on what they want to see and believe. That is human nature.
I think that our job in tackling this issue is to try to dial things back, look at what the studies really say and what they really don’t say, and respectfully remind people of that.
For example, in my previous comment, I mentioned many of the things that I found wrong with the Denmark Study, its conclusions and its application in the U.S.
What I didn’t mention is what it DOES tell us and what it CAN say.
What it can be used for is to study the prevalence of inpatient cases of autism in the country of Denmark between 1971 and sometime in the 1990’s (up until they began to make changes to the database). It can also tell us about the prevalence of autism in the entire country (inpatient and outpatient) from the point in time in the 1990’s that the database stabilized in what it measured, until the study was completed in 2000. (This is all assuming of course that the researchers’ conflict of interest did not lead them to skew the study in other ways, but for the purposes of this conversation we will give them the benefit of the doubt).
It is not really one study, but two. It comes apart at the point in time when the database changed what it actually measured, but it came back together. Unfortunately for the purposes of the question it purports to answer, the change was made at the same time that thimerosal was removed, so it screws up measuring what we want it to.
This makes good sense in the context of the real world. A country begins to be worried that thimerosal might be contributing to autism. The responsible thing to do is get rid of the thimerosal and start keeping better track of cases of autism. To do otherwise would have been wrong.
Oh, the research we could do if we didn’t have to worry about pesky ethics.
Another question that the database could be used to measure would be the rate of inpatient autism from 1971 to 2000. After all, the database should be able to sort out any outpatients so that they could be excluded from the study. It is not as powerful a question as the original one, but the results would be reliable.
My suspicion is that the researchers must have thought of that, but decided against it for some reason.
To emphasize the point I made in my last post about Verstraeten’s Monster, when you take that study and try to see what it can be used for, you find that, in contrast to the Danish Study, it cannot be used for anything.
Then you would think that the HMOs would do a few of these themselves, as it would exonerate the medical industry from liability if a plethora of American studies showed no relationship. Why aren’t they being done by those who want to show there is no link?
Except that there is a chance it could prove liability and they would have to spend a fortune fighting off law suits of parents and patients. It may also drive up their costs as vaccine manufacturers would certainly have to pay through the nose to those injured. Those costs would likely be passed onto said HMOs.
In addition, insurance does not currently cover costs of autism, so it may be that the status quo is an attractive position at the moment for them.
They won’t, and they shouldn’t. Here’s why.
The Verstraten Study took 4 years, something like 25 million dollars and the best researchers the government had to offer, and could not come up with a decent study to show that there was no link between thimerosal and NDDs, despite the fact that they were highly motivated to do so as my last post demonstrates.
Since that is the case, and since epidemiological studies are for the purpose of formulating questions for in vitro and in vivo studies, it would be a waste of time and money for Safe Minds to spend the small amount of research funds that they have on proving an answer to a question that will not get them one step close to a cure for autism.
As I have mentioned, epidemiological studies are somewhere around step 2 in the process of answering a question as to what is causing a disease and how to cure it. The state of current research into autism is now around step 5 or 6. Why would anyone want to go back to step 2? Step 2 is not even their job. It is the CDC’s job.
The assumption has been made by parents that if all the governments best efforts add up to Denmark and Verstraten, then we should go ahead and assume that they don’t really want to know the truth about what is going on in the population, or that don’t really want to know what the true effect of thimerosal are on children.
If they did, there is a whole lot of research they would be doing, research that would put this question to bed. Despite parents pleading for years for them to do this research, they just won’t.
Since our government, who has many reasons not to indict thimerosal, cannot in its best efforts exonerate it, that there is probably an epidemiological study that would find a link, but the government will not carry it out.
Therefore, parents like me have assumed that there probably is some sort of epidemiological link, and moved on with out them.
We have skipped stepped 2 and decided that instead of working from the top down, we will start with the case studies and work our way up. This approach is yielding real results. Results like I am seeing in my son’s recovery.
Please forgive my frankness in addressing this.
It is not our job to get that answer and we don’t have time to get that answer.
It is all well and good for you and Skeptico and Orac to debate epidemiological studies for another 5 years, but we have children that need treatment now. The more time that passes, the lesser their chance of recovery.
Here is what the scenario looks like from my side of the issue:
My child is in a burning house, and you seems to be suggesting that I should, at my own expense, commission a study to see how often house fires are the result of faulty wiring.
I hope that you can understand why, at this point, I am going to go ahead and start ignoring you and go straight to the floor plans to find a way to get in and rescue my child.
To finish addressing your concerns about ‘mercury moms’:
Sure, activists can point to studies of "autistic" mice and overstate their relevance to human autism. They can claim the Burbacher study shows that mercury harms the brain, when there's a substantial debate as to whether the amount of inorganic mercury found in that study is in any way significant. (or moreover, if the rapid clearance of ethlymercury from the body is MORE relevant to CNS protection).
Just an aside, the working theory is that these children have a genetic inability to excrete heavy metals from the body, so it may be that no amount of any kind of mercury can be tolerated by children like mine. In Chandler’s case, the treatment that he is receiving and responding to seem to fit that hypothesis.
And when they get really bold, they can even mine the VAERS database like the Geiers did, knowing that 80 percent of the VAERS claims that vaccines cause autism came AFTER the joint AAP-CDC statement on thimerosal in 1999.
This paragraph seems to suggest that you take issue with these studies, but it may just be that you have concerns about the way they are being used or that their conclusions are being overstated and poorly used by those in the anti-thimerosal group.
Can you offer clarification as to which position you are taking or if you are asserting both? I was not quite clear.
Can you give an example of your concerns so I can get a concrete understanding of the problem as you see it?
If your concern is that people are overstating the conclusions of one or more of these studies, I say, well of course they are. That’s what people do. They want to make more or less of studies depending on what they want to see and believe. That is human nature.
I think that our job in tackling this issue is to try to dial things back, look at what the studies really say and what they really don’t say, and respectfully remind people of that.
For example, in my previous comment, I mentioned many of the things that I found wrong with the Denmark Study, its conclusions and its application in the U.S.
What I didn’t mention is what it DOES tell us and what it CAN say.
What it can be used for is to study the prevalence of inpatient cases of autism in the country of Denmark between 1971 and sometime in the 1990’s (up until they began to make changes to the database). It can also tell us about the prevalence of autism in the entire country (inpatient and outpatient) from the point in time in the 1990’s that the database stabilized in what it measured, until the study was completed in 2000. (This is all assuming of course that the researchers’ conflict of interest did not lead them to skew the study in other ways, but for the purposes of this conversation we will give them the benefit of the doubt).
It is not really one study, but two. It comes apart at the point in time when the database changed what it actually measured, but it came back together. Unfortunately for the purposes of the question it purports to answer, the change was made at the same time that thimerosal was removed, so it screws up measuring what we want it to.
This makes good sense in the context of the real world. A country begins to be worried that thimerosal might be contributing to autism. The responsible thing to do is get rid of the thimerosal and start keeping better track of cases of autism. To do otherwise would have been wrong.
Oh, the research we could do if we didn’t have to worry about pesky ethics.
Another question that the database could be used to measure would be the rate of inpatient autism from 1971 to 2000. After all, the database should be able to sort out any outpatients so that they could be excluded from the study. It is not as powerful a question as the original one, but the results would be reliable.
My suspicion is that the researchers must have thought of that, but decided against it for some reason.
To emphasize the point I made in my last post about Verstraeten’s Monster, when you take that study and try to see what it can be used for, you find that, in contrast to the Danish Study, it cannot be used for anything.
As far as anyone knows, nobody other than the Geiers have come from the "outside" to apply to use the Vaccine Safety Datalink, which is now being administered by the National Center for Health Statistics. And while access to that data might be harder to come by these days, it's not like that's the only avenue to do such a study. Basically all Managed care organizations have statisticians and epidemiologists on staff, and most have foundations in place to support this kind of research.
Then you would think that the HMOs would do a few of these themselves, as it would exonerate the medical industry from liability if a plethora of American studies showed no relationship. Why aren’t they being done by those who want to show there is no link?
(And believe me, if a study illustrated childhood vaccination was NOT cost-effective or increased risk of chronic, intractable conditions, managed care organizations would be all over that.)
Except that there is a chance it could prove liability and they would have to spend a fortune fighting off law suits of parents and patients. It may also drive up their costs as vaccine manufacturers would certainly have to pay through the nose to those injured. Those costs would likely be passed onto said HMOs.
In addition, insurance does not currently cover costs of autism, so it may be that the status quo is an attractive position at the moment for them.
So maybe Safe Minds could take the $100,000+ per year they're using to fund studies on cancer cells and mice and put it towards doing their own epidemiological study to disprove the ones done in the U.S., Denmark, Sweden, and the U.K.
They won’t, and they shouldn’t. Here’s why.
The Verstraten Study took 4 years, something like 25 million dollars and the best researchers the government had to offer, and could not come up with a decent study to show that there was no link between thimerosal and NDDs, despite the fact that they were highly motivated to do so as my last post demonstrates.
Since that is the case, and since epidemiological studies are for the purpose of formulating questions for in vitro and in vivo studies, it would be a waste of time and money for Safe Minds to spend the small amount of research funds that they have on proving an answer to a question that will not get them one step close to a cure for autism.
As I have mentioned, epidemiological studies are somewhere around step 2 in the process of answering a question as to what is causing a disease and how to cure it. The state of current research into autism is now around step 5 or 6. Why would anyone want to go back to step 2? Step 2 is not even their job. It is the CDC’s job.
The assumption has been made by parents that if all the governments best efforts add up to Denmark and Verstraten, then we should go ahead and assume that they don’t really want to know the truth about what is going on in the population, or that don’t really want to know what the true effect of thimerosal are on children.
If they did, there is a whole lot of research they would be doing, research that would put this question to bed. Despite parents pleading for years for them to do this research, they just won’t.
Since our government, who has many reasons not to indict thimerosal, cannot in its best efforts exonerate it, that there is probably an epidemiological study that would find a link, but the government will not carry it out.
Therefore, parents like me have assumed that there probably is some sort of epidemiological link, and moved on with out them.
We have skipped stepped 2 and decided that instead of working from the top down, we will start with the case studies and work our way up. This approach is yielding real results. Results like I am seeing in my son’s recovery.
But they're not doing true epidemiological research, are they? Do they not want to know the answer?
Please forgive my frankness in addressing this.
It is not our job to get that answer and we don’t have time to get that answer.
It is all well and good for you and Skeptico and Orac to debate epidemiological studies for another 5 years, but we have children that need treatment now. The more time that passes, the lesser their chance of recovery.
Here is what the scenario looks like from my side of the issue:
My child is in a burning house, and you seems to be suggesting that I should, at my own expense, commission a study to see how often house fires are the result of faulty wiring.
I hope that you can understand why, at this point, I am going to go ahead and start ignoring you and go straight to the floor plans to find a way to get in and rescue my child.
August 13, 2005
Here's Why the Disdain...
This post is a response to a post by JP on his new blog, SupportVaccination.org.
[Update: JP has decided to leave the vaccine discussion and take his blog down, so the link no longer works. I wish I had saved a copy of the initial post that this was written in response to, but alas, I was not forward thinking enough to save a copy.]
[Update: John Cartan is the man! He found a cashed version for me. Here ya go: http://tinyurl.com/7celt ]
In his post, he ask questions of parents like me, that I am eager to answer. Parents have been accused of being "scientifically illiterate" and dismissing "well designed" population studies that show that there is no link between autism and thimerosal. I thought this was a good opportunity to tell the blogesphere, at least in part, why we are not so hot on the IOM’s epidemiological studies.
Dear JP,
As one of those parents with… well ‘distain’ is a harsh word, lets call it an ‘unwillingness to rely on’ the epidemiological studies cited by the IOM, it probably falls upon the likes of me to answer the question you pose in the title of your piece.
Why the disdain for epidemiology...
Since I am the likes of me, I will take this on and answer your questions and challenges from my point of view.
I am going to break up my response to your post into a few separate posts, as there are several things to address.
I am the mother of an autistic 3 year old boy and a marriage and family therapist, with a masters degree from Johns Hopkins. The statistics courses that I took in grad school were designed to educate me on how to evaluate the research of others to see if it was something we should incorporate into the treatment of a client. This education has turned out to be useful in evaluating the epidemiological studies that have been offered up to prove that thimerosal is safe.
I have been looking at these studies with two basic questions in mind:
I want to start first with what an epidemiological study is and what it can do.
Any question like this starts with case studies. Some one notices two things occurring together (smoking and lung cancer, vaccine reaction and autism) and they look at the plausibility of a relationship (smoke filling the lungs could cause damage, neurotoxic mercury in vaccines could cause brain damage).
Next they want to see if what they are observing in their setting could be happening else where and after conferring with associates and finding that others see the possibility of a link as well, they commission a large population study.
Epidemiological studies are limited in their use. They can be used to spot patterns and trends, but they can almost never be used to prove or disprove anything. They are one of the first stages of a medical inquiry and act as a divining rod to tell researchers where to start digging.
They are very vulnerable to confounders, because they are asking broad questions over huge numbers of people; so they should not be used to make definitive statements as much as to help researchers shape the next question that should be asked.
Those next questions are taken to smaller population studies (where confounders can be more easily controlled), lab studies (in vitro), and actual case studies (in vivo). The results of those studies, helps to further refine the questions being asked, which can be sent back up to large population studies, and so on, and so on until, (hopefully) the results of your epidemiological, in vitro and in vivo studies all line up like tumblers in a lock and the lock opens with one key.
This is not what we are seeing yet when we look at totality of autism/thimerosal research, as the IOM report shows. In fact the large epidemiological studies relied on for the conclusions in the report are at odds with other in vitro and in vivo research also in the report. The tumblers do not line up and therefore all of the research should be scrutinized to see what is throwing things off.
The scrutiny of the epidemiological studies has shown that they do not measure what they purport to measure, and even if they did, they cannot be applied in the way that they are being applied.
Your example of how epidemiological studies were used in the 50’s a nice example of how they can be used well and lead researchers to determine the source of a terrible illness like lung cancer, unfortunately it seems that what is going on today in this inquiry is a very different scenario.
What we know so far about autism tells us that it is not as straight forward as, smoke cigarettes get lung cancer. The thimerosal studies seem to have multiple confounders (genetic, environmental, etc) that cut into the reliability of epidemiological studies.
The two studies that are relied upon the most heavily are the Danish Study and the Verstraten Study. Both of these studies were designed and carried out very poorly and are being used very badly.
Here is why I treat them with such skepticism. (Quoting myself in part from an earlier post that responded to a piece by Dr. Laidler)
One of the problems that complicates the search for the causes and cures of autism is the assumption that it is a single disorder and that all cases are caused by the same thing. This is in contrast to a disease like AIDS in which all cases are brought on by the HIV virus.
What is diagnosed as ‘Autism’ is actually likely to be more than one physical syndrome. Because Autism is a DSM diagnosis and based solely on behavioral criteria, the diagnosis does not address the different sets of physical anomaly clusters that researchers are finding when they look at the biology of ‘autistic’ patients.
One research group has recently made a distinction between two types of autistic profiles. One, labeled complex autism and occurring in about 30% of autism cases, presents with smaller head size, greater chance of low IQ, lower rate of siblings with the disorder and seems to have close to a 1:1 ratio of occurrence between boys and girls.
The other, essential autism, presents with larger head size, few structural brain abnormalities and has a ratio of 7:1 boys to girls.
This is a huge confounder to any epidemiological study, even a well designed one, that looks at all cases of diagnosed autism with out differentiating between groups with different phenotypes.
In discussing research into the causes of autism (in this case the genetic cause), one of the researchers commented, “…Studies haven’t found anything because they’re looking at a big heterogeneous group — a mishmash of people with different etiologies,” Takahashi said.”
One could postulate that only the larger head size group displays autistic symptoms because of mercury poisoning, as mercury toxicity does not always present with impaired IQ; and because in vitro thimerosal toxicity studies preformed at the University of Kentucky showed that estrogen has a protective effect against, and testosterone exacerbates the damage of, ethlymercury as a neurotoxin.
In light of this new information it seems that a better question than, “is autism is caused by mercury toxicity” which is the question largely being asked in these epidemiological studies, would be, “are cases of mercury toxicity being misdiagnosed as autism”.
The answer to that question cannot be found in a large epidemiological study.
The authors of the the final IOM report on the thimerosal/autism relationship in 2004 stated themselves that the epidemiological research it was relying on to clear thimerosal as a cause of autism would not pick up on a sub-set of the population that was genetically vulnerable to mercury poisoning.
If that is the case, then how much more so to these studies fail to give us meaningful data if the children who may be mercury poisoned are members of two different subsets being confused with one another?
Since the working theory in biomedical treatment of autism is that many of the children diagnosed with autism are genetically vulnerable sub set who cannot excrete heavy metals, and since this treatment is bringing about successes in the abatement of many children's autistic symptoms, does that not throw into question the use of these large scale studies to find the correlation between thimerosal and autism as easily as they would between smoking and cancer?
What causes further problems for people who want to use these studies to show that the case is closed on thimerosal and NDDs (as the conclusion in the IOM study does) is that these studies are not well designed and are very poorly applied.
The findings in the Denmark study have come under serious criticism. When the data of study was reviewed, it was found that the sampling presented fatal flaws.
The low incidence of autism during the use of thimerosal can be attributed to the fact that the database that was used only tracked inpatient cases of autism at the time. At the point in time where thimerosal was removed, the database was expanded to include cases that were diagnosed at a large clinic outside of Copenhagen where 20% of the countries autistic patents were diagnosed. At the point in time where thimerosal was no longer used, but the cases of autism seem to have skyrocketed, the database had expanded further to include all cases of autism, inpatient and outpatient, in the country.
The sample size of the study was only 956 children. That is the number of people that their disability database had on record as being diagnosed with autism in Denmark between 1971 and 2000. 956 people in 29 years. That is 33 people a year in the entire country. [Hyperbole warning] I have that many autistic kids in my kitchen right now!
The study is further compromised by the fact that several of the coauthors were employed by the Statens Serums Institut, the countries sole vaccine manufacturer who would presumably be held liable if it was indeed found that the use of thimerosal in vaccines contributed to autism.
[Update: Kristjan has pointed out here that the Danish health care system and liability laws are different from ours and no such legal liability exists for the Statens Serums Institut. I still wonder what might motivate these researchers to stand buy this study and not protest its poor use. More on that in the comments here, here and here.]
Further, even if the study were reliable, applying it to the U.S. population as the IOM has done presents problems. Children in Denmark were administered less than half the amount of thimerosal of US children, and it was administered later and over a longer period of time.
Finally, American children, like my sons, are subject to an autism rate at least 10 times that of Denmark, so this study should not be applied to determine their risk of autism from thimerosal exposure.
It seems to me to be like doing a population study of Sickle Cell Anemia in Denmark and applying it to the population of Baltimore. Clearly U.S. children have some other intervening factors that increases the threat of NDDs, be they genetic, environmental or the thimerosal dosage and age of administration.
The problems with the Verstraten study, the only epidemiological study that the CDC has done in the U.S. to examine the possible link between thimerosal containing vaccines and neurodevelopmental disorders, are severe. It is such a badly designed and executed study that I can hardly do it justice in a blog post. I started working on a review of it about 6 weeks ago for my blog and I still have not finished.
In fact, it is currently the subject of a Senate investigation that may result in hearings on Capitol Hill.
I will try to do a quick review of my ‘distain’ for it, as I actually think the harshness of your term might apply to my attitude in this case.
Verstraten started with a nice, simple study. He had medical records of about 180,000 kids in California, a good sized sample. He broke them up into four main groups, kids who received no thimerosal, a little thimerosal, a moderate amount, and a high amount. He checked to see if the amount of thimerosal that they got, and when they got it (two months of age, six months of age, etc) corresponded to an increased risk for different types of neurodevelopmental disorders, and NDDs in general.
The study began in November of 1999 and was supposed to be finished in 4 months.
What he found was that the more thimerosal a child got, the higher their chance of an NDD, with children who got the highest doses had a huge risk of having a disorder, more than 600% in one case. He also found that the age at which it was administered determined the type of disorder that a child would develop.
Verstraten sent an email to another CDC employee, Dr. Davis, and said that no matter what he tried, could not make the relationship go away.
In December the two men, and additional researchers at the CDC, began to change the parameters of the study. When you do this, you are supposed to document all the changes and justify why they are needed to properly answer the question you are asking. They did not.
The changes they began to make to the statistical analysis of the study are now described by the CDC as “improvements”. How they could see some of these changes as improvements is unbelievable to me. Here are some of the changes:
They took the zero thimerosal group, and tucked them into the low thimerosal group. Now they only have three groups and in effect they have brought up the bottom, so the top does not seem as high.
That did not bring down the risk enough, so they decided to get rid of the no thimerosal group all together, so now you are only comparing the low, middle and high groups, bring up the bottom further.
They got rid of a catch all group of NDDs so the study no longer addressed the question, ‘does an increase thimerosal increase the risk of a neurodevelopmental disorder’. Now it only looked at each disorder separately.
Still not dampening the signal enough, the decided to go into and change some of the actual medical records of the patients they were studying. The CDC reports that these were correcting errors in patient records, but will not offer any proof of this claim, saying instead that the data that would confirm their claim was ‘lost’.
This brought the risk down, but still showed a link between thimerosal and NDDs, so they then started dropping children from the study. They used about 20 different ICD9 codes to exclude any child from the study that had almost any birth complication or whose mother had almost any pregnancy complication. This included serious problems like premature birth and birth defects, but went all the way down to moms who took an antibiotic while pregnant. In effect this removes from the study many children who are likely to go on to develop NDDs.
This is fine to do in your study if you want, but it renders it almost completely useless for application to vaccine policy. This policy covers all U.S. children, and lots and lots of those children were subject to pregnancy and birth complications.
This study now no longer applies to my children as both of my pregnancies had complications.
At this point it is safe to say that this study no longer addressed the question of whether or not an increase in the dose of thimerosal increases the chance of an NDD in American children. But the ‘improvements’ don’t stop there.
Many more people are given a chance to make suggestions, the Simpsonwood meeting was held, comments are made that the study never should have been done in the first place, and the research is further bastardized.
A stop date was put in place so that children who were initially diagnosed with something like a speech delay, were then always considered to be speech delayed, even if they went on to be diagnosed with a more serious disorder like full blown autism. This is important as a large number of kids diagnosed with autism at ages 3 and 4 are diagnosed with some milder developmental delay at 18 months or two years of age. Doctors don’t like giving the autism diagnosis early, and the state of California (where the study was done) won’t even formally evaluate children for autism, or diagnose it before the age of 3.
I live in California. My son was evaluated at 2 and found to have ‘speech delays’ and offered early start services. To all involved in his treatment, he was autistic, but he did not become officially “Autistic” according to the state and his own records until age 3. Chandler would not have been considered Autistic for the purposes of the Verstraeten study.
My favorite ‘improvement’ was to add into the study children who were only a year or so old at the cut off date of the study. No child is diagnosed with autism, or indeed much of anything, this early. They all could have gone on to be diagnosed with a neurodevelopmental disorder but in the Verstraeten study, they are all considered healthy and unaffected by thimerosal.
Even with all these shenanigans, they STILL could not completely get rid of the relationship between thimerosal and NDDs. They then employed a tactic that served to make their own findings in the study irrelevant.
They split the whole group up into two, one large one from one HMO and one smaller group from another HMO (I think it was around 16,000). The small group was now too small to be of any statistical power. They used that group to say that the results in the first group could not be replicated in the second.
Then they bought another database from an HMO in New England, which was odd because they already owned dozens of them at the cost of millions of dollars in tax payer money. The HMO had failed and was in receivership due in part to poor record keeping on out of date computers. The HMO also used their own diagnostic system that didn’t even implement ICD9 codes and the researchers used completely different parameters to study this database than they did in the first. They used this third group of only 12,000 or so patients, as yet another example of how they could not replicate the results of the first, large group, which they were now referring to as ‘the screening study’.
The 4 month study took 4 years and, in my opinion, came out looking like something akin to Frankenstein’s Monster.
This study does not offer a meaningful measure of anything and cannot be applied to any group that I can think of.
Add to this the fact Verstraten himself became an employee of Glaxo (currently being sued by parents of autistic children) half way through the study, which was not disclosed when the study was published, and it becomes easy to see why where the distain comes from.
When asked to justify all the changes and publish the data so that the study could be confirmed and replicated, the CDC repeated the claim that the original data was ‘lost’. A private contractor testified before congress that he had been ordered to destroy the data sets, “to insure patient confidentiality”. This is a violation of federal law and is what sparked the congressional investigation currently underway.
It is practice in the scientific community that if a study can not be confirmed or replicated, that it should be withdrawn. Despite parent requests for such action, the CDC stands by this study and refuses to pull it.
As a parent who is looking at this issue as hard as I can, I am upset that the IOM, who should know better, keeps calling these studies ‘well designed’ and has used them to show that the case is closed on thimerosal and autism.
Verstraeten himself says that the study is a ‘neutral study’ and does not find for or against thimerosal in the implication that it is involved with NDDs.
In grad school, in order to pass statistics we had to take studies and break them down, justifying if and how they could be used for us to make treatment decisions. The Institute of Medicine would have failed my 600 level stats courses.
ADDENDUM:
People have asked for citations. What hasn't been referenced above can be found in David Kirby's book, Evidence Of Harm as this post just attempts to squish his big fat book into a blog post.
Additional addendum:
Julie Gerberding was asked by Congress to defend Verstraeten and had to reply that it was a useless study. She did so in secret, but the document was leaked by a congressional staffer. Even though everyone knows it is garbage, Pediatrics has not retracted it, and some still claim it clears the vaccine/autism theory. However CDC removed it from their list of research that refutes the theory in by the end of 2008 when news of the Congressional/CDC exchange went public.
[Update: JP has decided to leave the vaccine discussion and take his blog down, so the link no longer works. I wish I had saved a copy of the initial post that this was written in response to, but alas, I was not forward thinking enough to save a copy.]
[Update: John Cartan is the man! He found a cashed version for me. Here ya go: http://tinyurl.com/7celt ]
In his post, he ask questions of parents like me, that I am eager to answer. Parents have been accused of being "scientifically illiterate" and dismissing "well designed" population studies that show that there is no link between autism and thimerosal. I thought this was a good opportunity to tell the blogesphere, at least in part, why we are not so hot on the IOM’s epidemiological studies.
Dear JP,
As one of those parents with… well ‘distain’ is a harsh word, lets call it an ‘unwillingness to rely on’ the epidemiological studies cited by the IOM, it probably falls upon the likes of me to answer the question you pose in the title of your piece.
Why the disdain for epidemiology...
Since I am the likes of me, I will take this on and answer your questions and challenges from my point of view.
I am going to break up my response to your post into a few separate posts, as there are several things to address.
I am the mother of an autistic 3 year old boy and a marriage and family therapist, with a masters degree from Johns Hopkins. The statistics courses that I took in grad school were designed to educate me on how to evaluate the research of others to see if it was something we should incorporate into the treatment of a client. This education has turned out to be useful in evaluating the epidemiological studies that have been offered up to prove that thimerosal is safe.
I have been looking at these studies with two basic questions in mind:
Can this study be applied to entire population of children in the U.S. and thereby be useful for guidance in setting vaccine policy? If so, how?
Can I use this study to make a determination as to the safety of vaccinating my sons, one who is autistic and one who is (mostly) neurotypical. If so, how?
I want to start first with what an epidemiological study is and what it can do.
Any question like this starts with case studies. Some one notices two things occurring together (smoking and lung cancer, vaccine reaction and autism) and they look at the plausibility of a relationship (smoke filling the lungs could cause damage, neurotoxic mercury in vaccines could cause brain damage).
Next they want to see if what they are observing in their setting could be happening else where and after conferring with associates and finding that others see the possibility of a link as well, they commission a large population study.
Epidemiological studies are limited in their use. They can be used to spot patterns and trends, but they can almost never be used to prove or disprove anything. They are one of the first stages of a medical inquiry and act as a divining rod to tell researchers where to start digging.
They are very vulnerable to confounders, because they are asking broad questions over huge numbers of people; so they should not be used to make definitive statements as much as to help researchers shape the next question that should be asked.
Those next questions are taken to smaller population studies (where confounders can be more easily controlled), lab studies (in vitro), and actual case studies (in vivo). The results of those studies, helps to further refine the questions being asked, which can be sent back up to large population studies, and so on, and so on until, (hopefully) the results of your epidemiological, in vitro and in vivo studies all line up like tumblers in a lock and the lock opens with one key.
This is not what we are seeing yet when we look at totality of autism/thimerosal research, as the IOM report shows. In fact the large epidemiological studies relied on for the conclusions in the report are at odds with other in vitro and in vivo research also in the report. The tumblers do not line up and therefore all of the research should be scrutinized to see what is throwing things off.
The scrutiny of the epidemiological studies has shown that they do not measure what they purport to measure, and even if they did, they cannot be applied in the way that they are being applied.
Your example of how epidemiological studies were used in the 50’s a nice example of how they can be used well and lead researchers to determine the source of a terrible illness like lung cancer, unfortunately it seems that what is going on today in this inquiry is a very different scenario.
What we know so far about autism tells us that it is not as straight forward as, smoke cigarettes get lung cancer. The thimerosal studies seem to have multiple confounders (genetic, environmental, etc) that cut into the reliability of epidemiological studies.
The two studies that are relied upon the most heavily are the Danish Study and the Verstraten Study. Both of these studies were designed and carried out very poorly and are being used very badly.
Here is why I treat them with such skepticism. (Quoting myself in part from an earlier post that responded to a piece by Dr. Laidler)
One of the problems that complicates the search for the causes and cures of autism is the assumption that it is a single disorder and that all cases are caused by the same thing. This is in contrast to a disease like AIDS in which all cases are brought on by the HIV virus.
What is diagnosed as ‘Autism’ is actually likely to be more than one physical syndrome. Because Autism is a DSM diagnosis and based solely on behavioral criteria, the diagnosis does not address the different sets of physical anomaly clusters that researchers are finding when they look at the biology of ‘autistic’ patients.
One research group has recently made a distinction between two types of autistic profiles. One, labeled complex autism and occurring in about 30% of autism cases, presents with smaller head size, greater chance of low IQ, lower rate of siblings with the disorder and seems to have close to a 1:1 ratio of occurrence between boys and girls.
The other, essential autism, presents with larger head size, few structural brain abnormalities and has a ratio of 7:1 boys to girls.
This is a huge confounder to any epidemiological study, even a well designed one, that looks at all cases of diagnosed autism with out differentiating between groups with different phenotypes.
In discussing research into the causes of autism (in this case the genetic cause), one of the researchers commented, “…Studies haven’t found anything because they’re looking at a big heterogeneous group — a mishmash of people with different etiologies,” Takahashi said.”
One could postulate that only the larger head size group displays autistic symptoms because of mercury poisoning, as mercury toxicity does not always present with impaired IQ; and because in vitro thimerosal toxicity studies preformed at the University of Kentucky showed that estrogen has a protective effect against, and testosterone exacerbates the damage of, ethlymercury as a neurotoxin.
In light of this new information it seems that a better question than, “is autism is caused by mercury toxicity” which is the question largely being asked in these epidemiological studies, would be, “are cases of mercury toxicity being misdiagnosed as autism”.
The answer to that question cannot be found in a large epidemiological study.
The authors of the the final IOM report on the thimerosal/autism relationship in 2004 stated themselves that the epidemiological research it was relying on to clear thimerosal as a cause of autism would not pick up on a sub-set of the population that was genetically vulnerable to mercury poisoning.
If that is the case, then how much more so to these studies fail to give us meaningful data if the children who may be mercury poisoned are members of two different subsets being confused with one another?
Since the working theory in biomedical treatment of autism is that many of the children diagnosed with autism are genetically vulnerable sub set who cannot excrete heavy metals, and since this treatment is bringing about successes in the abatement of many children's autistic symptoms, does that not throw into question the use of these large scale studies to find the correlation between thimerosal and autism as easily as they would between smoking and cancer?
What causes further problems for people who want to use these studies to show that the case is closed on thimerosal and NDDs (as the conclusion in the IOM study does) is that these studies are not well designed and are very poorly applied.
The findings in the Denmark study have come under serious criticism. When the data of study was reviewed, it was found that the sampling presented fatal flaws.
The low incidence of autism during the use of thimerosal can be attributed to the fact that the database that was used only tracked inpatient cases of autism at the time. At the point in time where thimerosal was removed, the database was expanded to include cases that were diagnosed at a large clinic outside of Copenhagen where 20% of the countries autistic patents were diagnosed. At the point in time where thimerosal was no longer used, but the cases of autism seem to have skyrocketed, the database had expanded further to include all cases of autism, inpatient and outpatient, in the country.
The sample size of the study was only 956 children. That is the number of people that their disability database had on record as being diagnosed with autism in Denmark between 1971 and 2000. 956 people in 29 years. That is 33 people a year in the entire country. [Hyperbole warning] I have that many autistic kids in my kitchen right now!
The study is further compromised by the fact that several of the coauthors were employed by the Statens Serums Institut, the countries sole vaccine manufacturer who would presumably be held liable if it was indeed found that the use of thimerosal in vaccines contributed to autism.
[Update: Kristjan has pointed out here that the Danish health care system and liability laws are different from ours and no such legal liability exists for the Statens Serums Institut. I still wonder what might motivate these researchers to stand buy this study and not protest its poor use. More on that in the comments here, here and here.]
Further, even if the study were reliable, applying it to the U.S. population as the IOM has done presents problems. Children in Denmark were administered less than half the amount of thimerosal of US children, and it was administered later and over a longer period of time.
Finally, American children, like my sons, are subject to an autism rate at least 10 times that of Denmark, so this study should not be applied to determine their risk of autism from thimerosal exposure.
It seems to me to be like doing a population study of Sickle Cell Anemia in Denmark and applying it to the population of Baltimore. Clearly U.S. children have some other intervening factors that increases the threat of NDDs, be they genetic, environmental or the thimerosal dosage and age of administration.
The problems with the Verstraten study, the only epidemiological study that the CDC has done in the U.S. to examine the possible link between thimerosal containing vaccines and neurodevelopmental disorders, are severe. It is such a badly designed and executed study that I can hardly do it justice in a blog post. I started working on a review of it about 6 weeks ago for my blog and I still have not finished.
In fact, it is currently the subject of a Senate investigation that may result in hearings on Capitol Hill.
I will try to do a quick review of my ‘distain’ for it, as I actually think the harshness of your term might apply to my attitude in this case.
Verstraten started with a nice, simple study. He had medical records of about 180,000 kids in California, a good sized sample. He broke them up into four main groups, kids who received no thimerosal, a little thimerosal, a moderate amount, and a high amount. He checked to see if the amount of thimerosal that they got, and when they got it (two months of age, six months of age, etc) corresponded to an increased risk for different types of neurodevelopmental disorders, and NDDs in general.
The study began in November of 1999 and was supposed to be finished in 4 months.
What he found was that the more thimerosal a child got, the higher their chance of an NDD, with children who got the highest doses had a huge risk of having a disorder, more than 600% in one case. He also found that the age at which it was administered determined the type of disorder that a child would develop.
Verstraten sent an email to another CDC employee, Dr. Davis, and said that no matter what he tried, could not make the relationship go away.
In December the two men, and additional researchers at the CDC, began to change the parameters of the study. When you do this, you are supposed to document all the changes and justify why they are needed to properly answer the question you are asking. They did not.
The changes they began to make to the statistical analysis of the study are now described by the CDC as “improvements”. How they could see some of these changes as improvements is unbelievable to me. Here are some of the changes:
They took the zero thimerosal group, and tucked them into the low thimerosal group. Now they only have three groups and in effect they have brought up the bottom, so the top does not seem as high.
That did not bring down the risk enough, so they decided to get rid of the no thimerosal group all together, so now you are only comparing the low, middle and high groups, bring up the bottom further.
They got rid of a catch all group of NDDs so the study no longer addressed the question, ‘does an increase thimerosal increase the risk of a neurodevelopmental disorder’. Now it only looked at each disorder separately.
Still not dampening the signal enough, the decided to go into and change some of the actual medical records of the patients they were studying. The CDC reports that these were correcting errors in patient records, but will not offer any proof of this claim, saying instead that the data that would confirm their claim was ‘lost’.
This brought the risk down, but still showed a link between thimerosal and NDDs, so they then started dropping children from the study. They used about 20 different ICD9 codes to exclude any child from the study that had almost any birth complication or whose mother had almost any pregnancy complication. This included serious problems like premature birth and birth defects, but went all the way down to moms who took an antibiotic while pregnant. In effect this removes from the study many children who are likely to go on to develop NDDs.
This is fine to do in your study if you want, but it renders it almost completely useless for application to vaccine policy. This policy covers all U.S. children, and lots and lots of those children were subject to pregnancy and birth complications.
This study now no longer applies to my children as both of my pregnancies had complications.
At this point it is safe to say that this study no longer addressed the question of whether or not an increase in the dose of thimerosal increases the chance of an NDD in American children. But the ‘improvements’ don’t stop there.
Many more people are given a chance to make suggestions, the Simpsonwood meeting was held, comments are made that the study never should have been done in the first place, and the research is further bastardized.
A stop date was put in place so that children who were initially diagnosed with something like a speech delay, were then always considered to be speech delayed, even if they went on to be diagnosed with a more serious disorder like full blown autism. This is important as a large number of kids diagnosed with autism at ages 3 and 4 are diagnosed with some milder developmental delay at 18 months or two years of age. Doctors don’t like giving the autism diagnosis early, and the state of California (where the study was done) won’t even formally evaluate children for autism, or diagnose it before the age of 3.
I live in California. My son was evaluated at 2 and found to have ‘speech delays’ and offered early start services. To all involved in his treatment, he was autistic, but he did not become officially “Autistic” according to the state and his own records until age 3. Chandler would not have been considered Autistic for the purposes of the Verstraeten study.
My favorite ‘improvement’ was to add into the study children who were only a year or so old at the cut off date of the study. No child is diagnosed with autism, or indeed much of anything, this early. They all could have gone on to be diagnosed with a neurodevelopmental disorder but in the Verstraeten study, they are all considered healthy and unaffected by thimerosal.
Even with all these shenanigans, they STILL could not completely get rid of the relationship between thimerosal and NDDs. They then employed a tactic that served to make their own findings in the study irrelevant.
They split the whole group up into two, one large one from one HMO and one smaller group from another HMO (I think it was around 16,000). The small group was now too small to be of any statistical power. They used that group to say that the results in the first group could not be replicated in the second.
Then they bought another database from an HMO in New England, which was odd because they already owned dozens of them at the cost of millions of dollars in tax payer money. The HMO had failed and was in receivership due in part to poor record keeping on out of date computers. The HMO also used their own diagnostic system that didn’t even implement ICD9 codes and the researchers used completely different parameters to study this database than they did in the first. They used this third group of only 12,000 or so patients, as yet another example of how they could not replicate the results of the first, large group, which they were now referring to as ‘the screening study’.
The 4 month study took 4 years and, in my opinion, came out looking like something akin to Frankenstein’s Monster.
This study does not offer a meaningful measure of anything and cannot be applied to any group that I can think of.
Add to this the fact Verstraten himself became an employee of Glaxo (currently being sued by parents of autistic children) half way through the study, which was not disclosed when the study was published, and it becomes easy to see why where the distain comes from.
When asked to justify all the changes and publish the data so that the study could be confirmed and replicated, the CDC repeated the claim that the original data was ‘lost’. A private contractor testified before congress that he had been ordered to destroy the data sets, “to insure patient confidentiality”. This is a violation of federal law and is what sparked the congressional investigation currently underway.
It is practice in the scientific community that if a study can not be confirmed or replicated, that it should be withdrawn. Despite parent requests for such action, the CDC stands by this study and refuses to pull it.
As a parent who is looking at this issue as hard as I can, I am upset that the IOM, who should know better, keeps calling these studies ‘well designed’ and has used them to show that the case is closed on thimerosal and autism.
Verstraeten himself says that the study is a ‘neutral study’ and does not find for or against thimerosal in the implication that it is involved with NDDs.
In grad school, in order to pass statistics we had to take studies and break them down, justifying if and how they could be used for us to make treatment decisions. The Institute of Medicine would have failed my 600 level stats courses.
ADDENDUM:
People have asked for citations. What hasn't been referenced above can be found in David Kirby's book, Evidence Of Harm as this post just attempts to squish his big fat book into a blog post.
Additional addendum:
Julie Gerberding was asked by Congress to defend Verstraeten and had to reply that it was a useless study. She did so in secret, but the document was leaked by a congressional staffer. Even though everyone knows it is garbage, Pediatrics has not retracted it, and some still claim it clears the vaccine/autism theory. However CDC removed it from their list of research that refutes the theory in by the end of 2008 when news of the Congressional/CDC exchange went public.
August 11, 2005
Thymerasol Filtering
Subject: Thymerasol Filtering
From: "Timothy S O'Neill" <tsoneill@iastate.edu>
Date: Fri, 9 Jan 1998 09:38:31 -0500 (EST)
List-Name: P2Tech
Reply-To: p2tech@great-lakes.net
Hello.
My name is Tim O'Neill and I am a graduate assistant at the Industrial Assessment Center at Iowa State University. We are currently in the process of performing an audit an animal vaccine company in our region and we have come up against a problem which involves the disposal of a hazardous chemical.
Here is a description of the problem:
Currently the vaccine company has a policy to buy back any vaccine which goes past the expiration date while in the possession of a customer. This vaccine, upon being received back at the facility, must be disposed of.A large portion of these vaccines contain a chemical called "Thymerasol," a mercury based preservative, as an ingredient. Because of this mercury content, the returned material must be disposed of as hazardous waste.
The current method of disposal consists of throwing the individual vials of vaccine, container and all, into 55-gallon drums which are in turn taken off-site by a haz. waste disposal firm (this waste stream totalled 9,600 gallons in 1996, at a cost of $600/55-gallon drum).
We were wondering if there exists any type of a filtering system (activated carbon, ion exchange, etc.) which would be able to handle this type of application. Another alternative which may exist would be to somehow separate and recover the mercury itself. For example, is there some way to cause the mercury to separate and percipitate out of the solution?
Also, would someone be willing to give me a rough estimate on what such a system--if it exists--would cost?
I thank everyone in advance for your help. If you need any more information, feel free to email or call me here at the office (515.294.0079).
Tim O'Neill
Industrial Assessment Center
Iowa State
University
...nuff said.
Craig Westover Ruins Summer
Heather is a former scientist who worked with FDA regulations and the mom of a 4 year old with ASD. She was planning on having a nice, relaxing summer until Capt. Fishstick’s column in June prompted her to look into the thimerosal controversy.
Read her letter to him.
Read her letter to him.
Duffy's Dilemma
Duffy is a dad that is beginning to take a look at the biomed approach to autism. He has expressed feeling conflicted in a way that I think people in his stage come by naturally. It is an experience that I went through myself in the spring of 2004. As this debate gets more and more attention, many more parents will find themselves in this place. I wanted to share the advice I am offering to him.
The problem I am having is knowing who to rely on for information. The author of the Salon article sounded authoritative and cites some reputable sources. He cast dispersions on the Geiers research, again, with foundations. Others support the Geiers wholeheartedly. I find myself at a loss.
It took me almost a full year of reading (and seeing my son get better and better) before I had enough information under my belt to start making public assertions about autism research. You might feel a sense of urgency to get this whole thing sorted out in your mind before you try anything with your son, but this issue is so huge that if you try to do it all at once, your brain will melt.
Brilliant scientists who have spent their careers on it have not figured it all out yet.
Do yourself a favor, just focus on your son. Get the book I mentioned, Children with Starving Brains, sort through that information, which is a lot of information, then come back to this whole discussion.
You have heard what the CDC has to say. You have heard what most mainstream pediatricians have to say. Take a few weeks, look at what the big picture of the biomedical theory and approach, then take a hard look at your son and see if any of it seems to apply to him.
If you get an understanding of the illness through the biomed lens and an understanding of the treatment, then you can come back to the 'main stream' medical view and ask the right questions of them. If they can answer your questions sufficiently, and describe their problems with the biomed approach adequately, then throw the book in the trash, get off the internet and go tickle your son.
If after looking at the biomed picture, the CDC’s stance that 'we don't really know what causes autism or what the mechanism could be' rings hollow (as it did for me) then find a DAN doctor and get your son tested.
If they find the usual problems, metals, digestive yeast, vitamin and mineral deficiencies food allergies, then try the GFCF diet for a week.
If you see an improvement, then try adding fish oil.
If those help, try whatever supplements the doctor recommends.
If they help, try chelating.
Do things one step at a time and trust the great parental instincts God gave you. If something does not seem right, stop. You are the expert on your son. You know him best.
Go ask a million questions about it. Talk to other doctors. If you buy the book off of her website, you can join her yahoo group and ask her questions there directly. She is on every day giving parents advice.
Talk to other parents. They love to share their experience, good and bad, and will be a huge help.
If you hear something from a mainstream doctor that gives you pause, take the question to the biomed community and see if they can address your concern.
If you hear something from a DAN doctor that gives you pause, take the question to your mainstream pediatrician and see if they can address your concern.
Ask questions of everyone, you will begin to see by people’s answers who is really taking a thoughtful look at the problem, and who is just paying lip service.
Sorting through this stuff is like drinking from a fire hose, just take it one sip at a time.
Most importantly, keep checking back with your child. Remember that he is different from every other boy with autism. Do what works for him.
The problem I am having is knowing who to rely on for information. The author of the Salon article sounded authoritative and cites some reputable sources. He cast dispersions on the Geiers research, again, with foundations. Others support the Geiers wholeheartedly. I find myself at a loss.
It took me almost a full year of reading (and seeing my son get better and better) before I had enough information under my belt to start making public assertions about autism research. You might feel a sense of urgency to get this whole thing sorted out in your mind before you try anything with your son, but this issue is so huge that if you try to do it all at once, your brain will melt.
Brilliant scientists who have spent their careers on it have not figured it all out yet.
Do yourself a favor, just focus on your son. Get the book I mentioned, Children with Starving Brains, sort through that information, which is a lot of information, then come back to this whole discussion.
You have heard what the CDC has to say. You have heard what most mainstream pediatricians have to say. Take a few weeks, look at what the big picture of the biomedical theory and approach, then take a hard look at your son and see if any of it seems to apply to him.
If you get an understanding of the illness through the biomed lens and an understanding of the treatment, then you can come back to the 'main stream' medical view and ask the right questions of them. If they can answer your questions sufficiently, and describe their problems with the biomed approach adequately, then throw the book in the trash, get off the internet and go tickle your son.
If after looking at the biomed picture, the CDC’s stance that 'we don't really know what causes autism or what the mechanism could be' rings hollow (as it did for me) then find a DAN doctor and get your son tested.
If they find the usual problems, metals, digestive yeast, vitamin and mineral deficiencies food allergies, then try the GFCF diet for a week.
If you see an improvement, then try adding fish oil.
If those help, try whatever supplements the doctor recommends.
If they help, try chelating.
Do things one step at a time and trust the great parental instincts God gave you. If something does not seem right, stop. You are the expert on your son. You know him best.
Go ask a million questions about it. Talk to other doctors. If you buy the book off of her website, you can join her yahoo group and ask her questions there directly. She is on every day giving parents advice.
Talk to other parents. They love to share their experience, good and bad, and will be a huge help.
If you hear something from a mainstream doctor that gives you pause, take the question to the biomed community and see if they can address your concern.
If you hear something from a DAN doctor that gives you pause, take the question to your mainstream pediatrician and see if they can address your concern.
Ask questions of everyone, you will begin to see by people’s answers who is really taking a thoughtful look at the problem, and who is just paying lip service.
Sorting through this stuff is like drinking from a fire hose, just take it one sip at a time.
Most importantly, keep checking back with your child. Remember that he is different from every other boy with autism. Do what works for him.
August 9, 2005
Ladies and Gentilemen, Meet David Taylor
... no relation.
David has said more about the thimerosal/autism debate in his second post than my blog has in a year.
Don't miss the Top 10 Reasons Parents of Autistic Children are Pissed Off.
David has said more about the thimerosal/autism debate in his second post than my blog has in a year.
Don't miss the Top 10 Reasons Parents of Autistic Children are Pissed Off.
August 8, 2005
Beginning at the Other Beginning
Yesterday I wrote about the history of thimerosal since its beginning in 1930.
Today Dan Olmstead wrote about the history of autism since its beginning in 1931.
I will be posting his next few articles as he explores the genesis of the diagnosis. Please keep my piece in mind while reading his.
Today Dan Olmstead wrote about the history of autism since its beginning in 1931.
I will be posting his next few articles as he explores the genesis of the diagnosis. Please keep my piece in mind while reading his.
The Age of Autism: But what about 1930?
By Dan Olmsted
UPI Consumer Health Editor
Aug. 8, 2005 at 1:06PM
Washington, Aug. 8 (UPI) — Sunday's debate on NBC's "Meet the Press" over vaccines and autism gave welcome exposure to an issue that won't go away quietly.
Moderator Tim Russert asked Dr. Harvey Fineberg, president of the Institute of Medicine -- part of the National Academy of Sciences -- this question: "Do you think there's an epidemic of autism or do you think it's simply a change in defining it?"
Fineberg answered: "There's definitely a huge number of cases diagnosed with autism. ... It's also clear that the definition was broadened markedly in the 1980s and 1990s, and there were increased incentives to recognize children from increased awareness and availability of services.
"No one knows with certainty what part of the increase is genuine, a genuine increase in numbers, and what part is from increased recognition of people who were already there but not previously recognized."
As readers of this column know, we believe this is the core issue in trying to understand the disorder. If in fact autism has strikingly increased in prevalence -- not just in recognition -- the idea that autism is primarily a genetic disorder doesn't hold up. No genetic illness could rise so rapidly.
But if there have always been people with autism in reasonably similar numbers, then the idea that some new trigger -- vaccines, for example -- is behind autism begins to look implausible if not impossible.
Fineberg appeared on the show with David Kirby, author of "Evidence of Harm," a new book that looks at the debate through the eyes of parents who believe vaccines triggered their child's autism. Because of the flow of the conversation, Kirby did not have a chance to address the "epidemic" issue directly.
If he had, he could have pointed to a number of studies that suggest the increase -- to 1 in 166 children -- is real; he could have cited the Centers for Disease Control and Prevention's own statement that one in six children has some kind of neurodevelopmental disorder. He could have noted the parents and education professionals who believe something bad has happened to this generation of children -- not just autism, but learning disabilities and behavior problems, asthma and diabetes that have never occurred in such numbers.
Still, it's a complicated topic, one that is not easily resolved merely by citing statistics and diagnostic categories. That's why our approach has been slightly different: We've set out to describe the natural history of autism from the beginning.
That means we looked at where and when autism was first diagnosed as a separate disorder; what kind of families had autistic children; how that demographic broadened to include a wider swath of society; and whether autism is as prevalent in some communities -- the Amish being our prime example -- as it is in others.
What we can't get past is this: The first person to diagnose autism said he'd never seen it before, and neither had anyone else. His name was Leo Kanner, and he was not some country doctor; he was the leading psychiatrist of his day, a professor at Johns Hopkins University in Baltimore. He wrote the book "Child Psychiatry." In
fact, he's been called the dean or father of modern child psychiatry.
Beginning in 1938 he saw children with a behavioral syndrome that differed "markedly and repeatedly from anything reported so far." Kanner wrote the landmark 1943 paper, "Autistic Disturbances of Affective Contact," about the first 11 cases.
Kanner became the world's authority on autism and saw children referred from North America and South America and as far away as South Africa.
Yet by 1958 -- 15 years after he first created the diagnosis -- he had seen just 150 autism cases. Another doctor who became the European authority on the disorder saw only 10 cases in the decade after his first paper was published; a third "found only one true case of infantile autism in 36,500 clinical cases," according to
Bernard Rimland's 1964 book, "Infantile Autism."
No matter how you slice or dice the diagnostic categories, something doesn't compute -- how can there be half a million children with Autism Spectrum Disorders living in the United States today, when the man who identified the disorder could only find 150 in the first 15 years?
What's more, the oldest child Kanner diagnosed with autism was born in 1931. We found no evidence of a child diagnosed with autism who was older than that. True, some autism cases are due to organic causes -- Fragile X Syndrome or rubella in a pregnant mother -- and Kanner acknowledged that.
Still, in 1978, looking back on his career, Kanner said the first child he saw in 1938 "made me aware of a behavior pattern not known to me or anyone else theretofore."
We don't understand how a genetic model of autism fits with that. Never mind the 1990s; what happened in the 1930s? Today's medical mainstream pretty much skips over that issue, repeating the mantra of better diagnosis.
We're not so willing to dismiss the eyewitness expertise of the man who first identified the disorder -- we think his observations cannot simply be cast aside if they become inconvenient or inconsistent with a prevailing point of view. That's not a mainstream thing to do at all.
For that reason, we've gone back again to the beginning, looking for clues to the roots and rise of autism in Kanner's first cases.
We think we may have found something, which will be the subject of the next several columns.
--
E-mail: dolmsted@upi.com
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