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Crist backer Gary Kompothecras bullies Florida health officials

28 Sep

Crist backer Gary Kompothecras bullies Florida health officials, a story in the Miami New Times, discusses how a wealthy man is attempting to exert influence to get Dr. Mark and Mr. David Geier access to Florida Department of Health records.

Here are the first three paragraphs:

“This madness has got to stop. No more double talk. This should be a fairly straightforward study. I feel that there are hidden agendas going on and I will not stand by [and] let it continue!! I will not wait any longer,” reads an email dated August 6 from Dr. Gary Kompothecras to Dr. Julia Gill, director of the Florida Department of Health’s (DOH) Division of Disease Control.

Coming from anyone else, the blustery email threat might be easily dismissed. But “Dr. Gary,” as Kompothecras is known, is the self-styled “Rainmaker,” a Sarasota chiropractor who has raised more than $1 million over the years for Senate candidate and soon-to-be ex-governor Charlie Crist.

So it’s bound to turn heads when the man known to occasionally lend his private jet to the governor uses his political clout to try to bully Florida health officials into turning over scores of the state’s sealed immunization records. Especially when they’re for a father-son team, Dr. Mark and David Geier, infamous for injecting autistic children with Lupron, a drug used to chemically castrate prostate cancer patients and pedophiles.

Dr. David Gorski, who blogs at Science Based Medicine, was quoted:

According to Dr. David Gorski, founding fellow of the Institute for Science in Medicine and an NIH-funded cancer researcher, the Geiers’ Lupron treatment is “in essence, chemical castration in order to treat autism based on no reliable science.” Says Gorski: “The concept that [the Geiers] embraced isn’t even bad science. It’s just not science.”

As I commented on the webpage for the story, when it comes to thimerosal in vaccines and autism, the recent study in Pediatrics far surpasses anything the Geiers could accomplish with the data from Florida.

If the information I have is accurate, Mr. Kompothecras filed in the Court of Federal Claims (vaccine court) for two children. One case has been closed and the other is still pending. (correction–there appear to have been three cases opened. One has been closed)

Barbara Loe Fisher discusses her failed lawsuit against Paul Offit and Amy Wallace

22 Sep

Amy Wallace wrote an article on the vaccine/autism discussion entitled An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All. In it she quotes both Dr. Paul Offit of the Children’s Hospital of Philadelphia and Barbara Loe Fisher of the National Vaccine Information Center. As part of that article, Ms. Wallace quoted Dr. Offit discussing Ms. Fisher:

Offit is quick-witted, funny, and — despite a generally mild-mannered mien — sometimes so assertive as to seem brash. “Scientists, bound only by reason, are society’s true anarchists,” he has written — and he clearly sees himself as one. “Kaflooey theories” make him crazy, especially if they catch on. Fisher, who has long been the media’s go-to interview for what some in the autism arena call “parents rights,” makes him particularly nuts, as in “You just want to scream.” The reason? “She lies,” he says flatly.

Ms. Fisher sued Dr. Offit, Amy Wallace and Conde Nast Publications (who publishes Wired) over the statement “she lies”, claiming it was defamatory.

Ms. Fisher’s suit was dismissed before it could be heard. Ms. Fisher has now blogged her experiences as Amy Wallace & Yellow Journalism.

Much of that account struck me, but allow me to discuss a few here:

Ms. Fisher states in regard to Ms. Wallace’s response to the suit: Instead of providing one piece of solid evidence to support Offit’s defamatory statement, Wallace claimed I could not sue her because she is a resident of California.

Well, I looked up the MOTION TO DISMISS BY AMY WALLACE AND CONDÉ NAST PUBLICATIONS INC.. Yes, in point 4 they do state that there is a problem with jurisdiction. But that is not the whole story. Ms. Fisher seems to have forgotten point 3 of the “Motion to Dismiss”. I’ll quote it below:

It is evident, however, that plaintiff cannot obtain the relief she seeks even if all well-pleaded factual allegations are accepted as true and the reasonable inferences derived therefrom are viewed in the light most favorable her. Under controlling state and federal law in this jurisdiction, the challenged remark by Dr. Offit, about a matter of substantial public concern, is not actionable as defamation because it is neither capable of being understood as stating actual facts nor of being proven true or false. It is, therefore, an expression of opinion that is immune from civil liability under the common law of Virginia, the Constitution of this Commonwealth, and the First Amendment of the United States Constitution.

Ms. Wallace’s defense was not just that she is a resident of California.

Ms. Fisher conitinues:

And Offit, who has no trouble keeping a straight face when he states flatly that it is absolutely safe for a child to get 10,000 vaccines at once and 100,000 vaccines in a lifetime, claimed he was simply having an emotional meltdown when he hysterically told Wallace “flatly” that I lie. And to draw attention away from the seriousness of engaging in libel per se, the defendants’ attorneys argued that “the quoted remark ‘she lies’ is not capable of being proven true or false” because the civil court system cannot prove whether vaccines do or do not cause harm.

I don’t know what video Ms. Fisher is referencing when she states that Dr. Offit can’t keep a straight face. I mean, she wouldn’t say that unless she actually saw him talking (each and every time he has done it) and noticed that he had such troubles, would she? In Dr. Offit’s Motion to Dismiss, I don’t see any mention of the words “emotional meltdown”. Perhaps it was in some other document I was unable to pick up from PACER? I don’t recall the Wired article claiming that Dr. Offit was “hysterical”. I mean, this couldn’t possibly be an expression of opinion of Ms. Fisher in a heated debate and not a statement of actual facts? As such, wouldn’t Ms. Fisher’s statements be protected speech, even if they aren’t completely factual?

As to the actual statement “She lies” that is the basis for Ms. Fisher’s failed suit? In her blog piece Ms. Fisher writes:

Third, Hilton offered the opinion that Offit’s allegation “cannot be reasonably understood to suggest” that I am “a person lacking honesty and integrity” and that Wallace and Wired magazine were only reporting Offit’s “personal opinion” about my “views” and none of the defendants intended to make a “literal assertion of fact” that I lie.

In other words, they really didn’t mean it.

Is that really what was argued and decided? From a response Dr. Offit filed with the court:

Accordingly, the question is not whether Dr. Offit could provide a list of specific “lies” stated by Plaintiff in the past – an exercise he will undergo to establish “truth” if this case is not dismissed on this initial motion – but whether Dr. Offit’s vague statement in the context of the Article will merely be understood as a loose expression of disagreement with Plaintiff, not an assertion of specific actual fact, and thus constitutes protected opinion immune from suit.

He seems to be willing to provide a list of specific “lies” stated by [Ms. Fisher] in the past. I don’t see that as the same thing as “they didn’t really mean it.” (as an aside, why “they”? Amy Wallace wasn’t saying that Ms. Fisher lies. She was reporting what Dr. Offit said.)

In response to Ms. Wallace’s argument that Virginia was the incorrect jurisdiction, Ms. Fisher requested discovery information:

Plaintiff requests discovery concerning all facts germane to personal jurisdiction including, but not limited to, traffic on the defendants’ various websites, including, for example, the geographic locations of all who have transmitted comments in association with those websites; all who have sent correspondence in response to Wallace’s Wired article; the Virginia state Wired magazine subscriptions obtained through Wired.com; and Wallace’s communications with CNP concerning the Wired.com blog, as well as any and all interactions between Wallace and Virginia sources, Virginia media, and Virginia readers.

Yep. Any and all interactions between Amy Wallace and people in Virginia (the state of jurisdiction for this case) and all communications with CNP (Conde Naste Publications. Essentially her employer on this piece).

This sounds like a fishing expedition to me (is that protected speech?). Especially the part about “Wallace’s communications with CNP concerning the Wired.com blog.”

Ms. Fisher notes in her piece that she has been a proponent of vaccine education for many years. Earlier this year she put out a YouTube video discussing the presence of “fatal pig viruses” in the rotavirus vaccines. At that time I emailed them, seeking some education on the subject. I asked a simple question:

I saw your recent video. You mention “fatal pig viruses”. Could you please point me to your data indicating that these viruses are fatal in humans?

The email remains unanswered.

Safeminds comments on the latest thimerosal-autism study

21 Sep

SafeMinds is an organization which has long promoted the idea that thimerosal caused an autism epidemic. They may be the single greatest force that got the idea into the public’s eye, and got research funding focused on looking at the question.

SafeMinds has shown themselves to be very resistant to the very research they called for. Studies which show a lack of association between thimerosal containing vaccines (TCV’s) and autism are always rejected by SafeMinds. They are not alone in this, groups such as Generation Rescue and the National Autism Association (NAA) have also refused to accept the science.

So it was with no surprise that I read that SafeMinds had issued a statement against the study. The statement starts by pointing out that the study was funded and performed by those with conflicts–the CDC, Abt (an organization which does contract research for groups including the CDC), and HMO’s “which receive substantial funding from vaccine manufacturers to conduct vaccine licensing research”.

If we can’t use the HMO’s to work on such project, that sort of takes away the VSD as a tool. It certainly takes away the opportunity to do anything more than passive surveillance of the VSD data. One of the strengths of the Price study was the effort to do more than just review the medical charts. They worked with the children, both cases and controls, to verify that the autism counts were accurate. I bring this up because groups like SafeMinds frequently request access to VSD data.

SafeMinds also discusses the study methodology:

The study sample did not allow an examination of an exposed versus an unexposed group, or even a high versus a low exposed group, but rather the study mostly examined the effect of timing of exposure on autism rates.

There is much wrong with the above statement. Let’s start with where they are close to correct. The study sample did not allow for a direct comparison (with good statistics) of exposed vs. unexposed. This is true. This is because there are few unexposed kids (unexposed=no thimerosal exposure in this study. Unexposed does not mean no vaccines). If you look at exhibit 9.1.4 from the technical reports by Abt associates (the detailed reports on the study), you will see about 20-30 “unexposed” children. I.e. children with no thimerosal exposure. Of those, about 3-4 (out of 1,000) had no HiB, HepB or DTP vaccine vaccine at all (MMR isn’t listed as it is not a source of thimerosal). This is in line with estimates by the CDC of how many children are unvaccinated (typically about 0.4%). (as an aside–this points out how difficult it would be to do a good study of vaccinated vs. unvaccinated children using the VSD. Seriously, with 99.6% of kids receiving at least one vaccine, you would need a huge number of kids to get the number of unvaccinated needed for good statistics).

Here is that exhibit, with the no-exposure kids circled. (click to enlarge)

It would appear to this reader that the issue of unexposed vs. exposed isn’t so much one of “study design” as the limitations of the VSD itself. There just aren’t that many autistic kids to make a good statistical comparison of unexposed vs. exposed populations.

And, it should be noted, an unexposed vs. exposed comparison wasn’t the purpose of this study. One big question posed by SafeMinds and later picked up by groups such as Generation Rescue was simple: did the increase in thimerosal exposure from vaccines in the 1990’s result in an “epidemic” of autism? This is the question this study addressed.

I am at a loss as to why SafeMinds wrote this: “….or even a high versus a low exposed group, but rather the study mostly examined the effect of timing of exposure on autism rates”. Contrary to SafeMinds’ assertion, there is a large variation on thimerosal exposure in the study subjects. One of the surprising facts from this study was the number of children receiving thimerosal-free vaccines. This, together with variations in the number of vaccines administered, led to a much larger distribution in thimerosal exposures than one would expect based on the vaccine schedule alone.

Thus, the study was not on “timing” at all. It was, as advertised, on variation of exposure of thimerosal. The question is (at least to me), does the range of exposure amount to significant number of kids having “low” levels of exposure by SafeMinds’ definition?

The answer, it turns out, is yes.

Safeminds has the following statement on their website:

[Autism] remained rare (1 in 10,000) until the rapid escalation of vaccines beginning in the late 1980’s (from 10 shots of 7 antigens in 1983 to 36 shots of 15 antigens). Vaccines are a likely candidate to explain some, if not most of the rise in autism cases and possibly other chronic childhood disorders linked to immune system malfunction.

In one of the seminal papers on the thimerosal was co-written by SafeMinds founder Lyn Redwood Autism: a novel form of mercury
poisoning. In it, the authors state:

The discovery and rise in prevalence of ASD mirrors the introduction and spread of TMS in vaccines. Autism was first described in 1943 among children born in the 1930s (123). Thimerosal was first introduced into vaccines in the 1930s (7). In studies conducted prior to 1970, autism prevalence was estimated, at 1 in 2000; in studies from 1970 to 1990 it averaged 1 in 1000 (124). This was a period of increased vaccination rates of the TMS containing DPT vaccines among children in the developed world. In the early 1990s, the prevalence of autism was found to be 1 in 500 (125), and in 2000 the CDC found 1 in 150 children affected in one community, which was consistent with reports from other areas in the country (126). In the late 1980s and early 1990s, two new TMS vaccines, the HIB and Hepatitis B, were added to the recommended schedule (7).

I know I am spending a lot of time on this point, but it is important. The idea that there is a dose-response relationship between thimerosal and the presumed risk of autism is fundamental to the arguments made by groups like SafeMinds.

A sister organization to SafeMinds, Generation Rescue, says the same thing. In their take, “This is the schedule from 1983. If it worked for kids then, why doesn’t it work for kids now?”. Generation Rescue leader and spokesperson Jenny McCarthy wrote in her book, Healing and Preventing Autism: A Complete Guide, “In 1983, we had 10 shots on the vaccine schedule and autism was one in 10,000. Today there are 36 given and autism is nearing one in 100”. I.e. if we go back to the 1983 vaccine schedule, autism rates should drop to 1 in 10,000.

The 1983 schedule, as graphically presented in expensive full page newspaper ads by Generation Rescue, included 4 DPT shots (yes, the old whole cell pertussis vaccine). Each of those shots included 25 micrograms of mercury.

It strikes this reader that the thimerosal exposure from 4 DPT shots, the amount in the 1983 schedule that supposedly only resulted in 1 in 10,000 kids having autism, should be a “low” exposure amount. If groups are going to point to 1983 as a safer schedule and point to the increases in thimerosal exposure in the 1990’s as the major sign of the “epidemic”, we should be able to take their word that the levels in 1983 were somehow safer.

Let’s look at that figure from the Price study again, shall we? I will highlight how many kids have “low exposure” (i.e. comparable to the 1983 vaccine schedule) to thimerosal. Again, click to enlarge if you wish.

By my eye, something approaching 50% of the kids in the study received the thimerosal exposure of the 1983 schedule. Certainly more than 25%. Those highlighted in red have the same thimerosal exposure as kids did in 1983, so they should have the same autism prevalence that SafeMinds and Generation Rescue claim for that time period: 1 in 10,000.

If that group has a prevalence of 1 in 10,000–or even anything significantly lower than the prevalence of those with higher thimerosal exposure– this study would have found it.

In other words, a thimerosal-induced epidemic of autism didn’t happen. Even using the logic that SafeMinds used to hypothesize it in the first place:that, somehow, the thimerosal exposures in 1983 resulted in a low autism prevalence.

Yes, this is far from rigorous. But, so is the logic that claims that increased thimerosal exposure led to an autism epidemic.

If we read further into the SafeMinds response, we see some of the confusion:

The study sample did not allow an examination of an exposed versus an unexposed group, or even a high versus a low exposed group, but rather the study mostly examined the effect of timing of exposure on autism rates. There were virtually no subjects who were unvaccinated and few who were truly less vaccinated; rather, the low exposed group was mostly just late relative to the higher exposed group, ie, those vaccinating on time.

SafeMinds seems to be assuming this is a study on the number of vaccines, not the amount of thimerosal. They also don’t appear to have read the study thoroughly enough to note that, yes, there is a large fraction who were “less vaccinated” and, more importantly to this study, a large fraction who had lower thimerosal exposures. As noted above, the low thimerosal exposures result from the fact that many of the children received thimerosal free vaccines.

It is unfortunate that SafeMinds (and other groups like them) can not adapt to science as it comes out. Science which clearly shows that many of their hypotheses were wrong.

The Respectful Insolence blog also discusses some of the failings of the SafeMinds response.

Hannah Poling and the Pediatrics thimerosal study: two “big” stories with little press response

18 Sep

Two stories which are “big” news in some segments of the online autism community are the settlement amount for Hannah Poling and the recent study showing no link between autism and thimerosal in vaccines. While these have caused a fair amount of discussion on blogs (like this one), they didn’t generate that much press coverage.

We broke the Hannah Poling award story here on LeftBrainRightBrain on September 3. The story was ignored, even by such pro autism-as-vaccine-injury blogs as the Age of Autism until September 9th, when Sharyl Attkisson (who has some connection to the people at the Age of Autism blog) wrote about it for CBS.

There are a couple of dozen entries in Google News on Hannah Poling. Few major outlets. One that did carry it is the Atlanta Journal Constitution, the home town newspaper for the Poling family. In Settlement reached in autism-vaccine case the AJC quoted Dr. John Shoffner:

Dr. John Shoffner, a neurologist and national expert who has conducted research on autism and its causes, said researchers have found no link between vaccines and autism. And he said he strongly favors vaccination.

“The preponderance of data shows that vaccines are important and safe for children to prevent preventable and sometimes life-threatening infectious diseases,” Shoffner said. “I certainly am in favor and support the CDC’s as well as the American Academy of Pediatrics’ recommendation of vaccination.”

Shoffner is a co-author of a journal article that describes Poling’s case without naming her.

Edited to add: I forgot to include this quote from the Atlanta Journal Constitution:

“It’s critical to remember that the government has never compensated, nor has it ever been ordered to compensate, any case based on a determination that autism was actually caused by vaccines,” said Martin Kramer, communications director for the Health Resources and Services Administration. The National Vaccine Injury Compensation Program is part of the administration. The U.S. Court of Federal Claims decides who will be paid damages for injuries that result from vaccines, under a 1988 law that created a program.

Another so-called “big” story from the last few weeks is the study on autism and thimerosal in Pediatrics, Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism. Sometimes when an important paper comes out (that I am aware of) I watch Google News as the embargo is lifted. I did so with this paper. Nothing happened. OK, I think Disability Scoop had a story out right at midnight (this one, if I recall correctly). Heck, it wasn’t until Friday that the CDC added the study to their website (it isn’t mentioned on the main cdc.gov webpage). Even SafeMinds (who are, in cases like this SafeBet–as in, it is a safe bet they will put out a critique of the paper) didn’t respond for days.

Sure, I was interested. And, yes, these stories sparked some of the most active conversations on this blog in a while. But I am still left with the basic conclusion: the general public has already absorbed these stories. The government conceded the Hannah Poling case 2 years ago. It isn’t new. The idea that mercury in vaccines cause autism–no longer part of the front line public discussion.

I’m not the only one to make this comment. The Washington Post had this to say four days after the paper was made public:

But when the journal Pediatrics published on Monday a study that found no increased risk of autism among more than 1,000 babies who’d been exposed prenatally or in the first 20 months of life to ethylmercury from vaccines, it was met with a general shrug. Neither The Washington Post nor The New York Times even reported on it, though the Los Angeles Times did, in its Booster Shots blog.

Sure, these stories will never completely go away. The vaccine/autism story will never go completely away. But the heyday is over.

Autism causation and the Hepatitis B vaccine: no link

16 Sep

One of the primary subjects for those promoting vaccines as a primary cause of autism is the Hepatitis B vaccine. This vaccine is given at birth and represents a child’s first exposure outside the womb to a vaccine and, in the old days, to thimerosal. David Kirby attempted to link the rise in autism prevalence to the introduction of the HepB vaccine. Others have claimed that the rates of special education placements are 9 times higher amongst children given the HepB vaccine at birth. Here is the abstract for (Hepatitis B triple series vaccine and developmental disability in US children aged 1–9 years rel=”nofollow”)

This study investigated the association between vaccination with the Hepatitis B triple series vaccine prior to 2000 and developmental disability in children aged 1– 9 years (n¼1824), proxied by parental report that their child receives early intervention or special education services (EIS). National Health and Nutrition Examination Survey 1999–2000 data were analyzed and adjusted for survey design by Taylor Linearization using SAS version 9.1 software, with SAS callable SUDAAN version 9.0.1. The odds of receiving EIS were approximately nine times as great for vaccinated boys (n¼46) as for unvaccinated boys (n¼7), after adjustment for confounders. This study found statistically significant evidence to suggest that boys in United States who were vaccinated with the triple series Hepatitis B vaccine, during the time period in which vaccines were manufactured with thimerosal, were more susceptible to developmental disability than were unvaccinated boys.

The recent study on thimerosal and autism gives us a look at how the Hepatitis B vaccine might (or might not) be linked to autism. Exhibit 16.1 on page 82 of volume 2 of the technical report is a graph of HepB vaccine uptake among autistic children (AD) and non-autistic children (controls)

Here is that exhibit, showing the total number of vaccines (count) and amount of thimerosal (amt) for all vaccines and for HepB alone:

Price-HepBGraphs1-copy[1]

The top right graph shows the number of HepB vaccines for autistic kids (solid line) and non-autistic kids (dotted line). They are, to all intents and purposes, the same.

Take a look at the birth dose. Not every kid got it. Maybe about 1/2 got the birth dose at birth, and about 2/3 got it within the first few days.

If the birth dose of HepB caused autism to any significant degree, I would expect to see a higher percentage of autistic kids than non-autistic kids getting that shot. It just didn’t happen. Take a closer look at that graph:

Price-HepBGraphs2[1]

The same percentage of got the HepB shots–all 3 of them– as non-autistic kids.

Still wondering about that birth dose? Let’s zoom in on the graph:

Price-HepBGraphs3[1]

Those lines are right on top of each other.

The HepB hypothesis won’t go away. Just like the thimerosal hypothesis or the MMR hypothesis. Just today, Mark Blaxill and Dan Olmsted put out a very long post at the Age of Autism blog pushing the idea. They use the bad and worse studies from Thoughtful House on infant macaques to bolster their arguments.

The funny thing about evidence is, some people never accept it.

Further results from the thimerosal-autism study

14 Sep

The recent study on thimerosal and autism was extensive. Much data and many results were included in two technical reports (nearly 400 pages total, volume 1 and volume 2). I haven’t had the time to read them thoroughly yet, but I did catch some interesting pieces of information.

The authors give the ASD prevalence (cases/1000) as a function of HMO and year of birth:

This is pretty flat. No huge increase seen over that 6 year time span. No evidence for an “epidemic”. The prevalence is about 1.1%. This is consistent with the current value quoted by the CDC.

There are remarkably a big variation by parents educational status (63% kids born to mothers who graduated from college). However, since the researchers are working with kids who are enrolled in an HMO, it seems likely this is due to some bias. I.e. the HMO participants could be better educated (and higher income) than the average.

There are indications that increasing parental age is related to increased autism risk. 36% of mothers were in the 30-34 age bracket, 35% were in the 35+ age bracket. So, about 70% of mothers were over 30 years of age. They list father’s age with different brackets, but 79% were 30 years old or older at the time of birth of their child. Again, could be some bias due to HMO membership, but a large fraction of the parents were older.

Some children (both ASD and controls) received no vaccines. Many received vaccines but no thimerosal–i.e. all their vaccines were thimerosal free.

The use of prenatal vitamins is given as having an increased risk of autism, but the odds ratio is not given.

Being a first-born or second-born child has a significant increased risk for autism (hazard ratios of about 1.6). They may discuss this, but I don’t know right now how much of this is due to parents of autistic kids deciding not to have larger families.

One of the stranger results–there is an increased risk of autism when mothers were using prenatal vitamins with folic acid. The hazard ratio was 2.3 with a p value of 0.0176

Pica and childhood lead exposures had very high hazard ratios: 3.7. This is a good case where it is worth asking if this is causal–does pica cause autism or, as is more likely, does autism cause pica and, with it, higher lead exposures.

Poverty was slightly protective for autism (hazard ratio of 0.92). Again, one has to question if this is real or whether poverty just results in a greater likelihood that a child’s autism will be misdiagnosed.

The authors list coexisting conditions for the autistic, ASD and control children:

Epilepsy is much higher at about 5%, compared to 1.6% for controls. Reports of the prevalence of epilepsy amongst autistics are often much higher, though.

Developmental delay (by parent report) is at about 18% for autistics, compared to about 0.66% in controls.

Gi disorder prevalence is about 2% amongst autistics. It is the same (or slightly higher) for controls. This is very interesting given the anecdotal reports of a high prevalence of GI disorders amongst autistics. I suspect this will form some of the complaints about this study–some will say they aren’t looking at the correct population and that a specific study on autism/regression/GI complaints needs to be done.

Cases (those with ASD) were more likely to get thimerosal free HepB and HIB vaccines.

Infants in this study do not get flu vaccines (near zero). Unless that habit has changed dramatically in the past few years–and that most doctors are giving infants flu vaccines with thimerosal–flu vaccines are not likely to be a reason for the continued climb in autism prevalence.

There is a lot more information there. If/when I get the chance to give the reports a more thorough read I’ll post what I find.

Questions and answers with the thimerosal-autism study author

13 Sep

It is a safe bet that there would be a lot of questions arising from the latest study, which shows no link between thimerosal exposure and autism. I thought there would be some interviews in the press covering most of the obvious questions, so I decided to ask some questions of my own of the study’s lead author, Cristofer Price of Abt associates.

I was very interested in the more complete discussion in their Techical Reports and data. I was also interested in how these results might apply to the idea that there are “too many” vaccines given “too soon”. Mostly I was interested in why this study took so long to get published give the CDC’s statements after the Thompson study of 2007–statements which indicated that this follow-on study should be available within about a year or so.

Below is the exchange:

First: you cite two Abt reports from 2009 on the subject:

Price C, Robertson A, Goodson B. Thimerosal
and Autism. Technical report. Vol I. Bethesda,
MD: Abt Associates Inc; 2009

I can’t find them on your site at this time. Are they there or will they be made available when the embargo is lifted?

[Response: The tech reports will be up on the CDC and Abt web sites on Monday. ]

Will the data be made available as was done with the Thomson(2007) study? If so, how would one access it?

[Response: Yes, the process for obtaining the data will be very much like the process that was in place for the Thompson(2007) study. Instructions for how to access the data and a data use agreement, etc. will be up on the CDC web site on Monday. The terms specified in the data use agreement are similar to those from the prior study. ]

As to the paper, I see that the results are the same for autism with and without regression. Are there any other issues of severity which were checked (e.g. level of intellectual disability, seizures) which were also monitored?

[Response: We did do a sub-analysis where AD cases with low cognitive functioning were excluded (see technical report on Monday for full details and results) Analysis of the subgroup of AD cases where children with low cognitive functioning were excluded was motivated by the following concern. Because children who are non-responsive during the assessment process are more difficult to assess, it can sometimes be difficult to determine whether children with severe developmental delay actually have autistic disorder. If the imprecision of the assessment process for such children resulted in inclusion of children without AD in the AD group, then we would expect that the estimate of the relationship of exposure to AD risk could be attenuated. Therefore, an outcome category for AD with low cognitive functioning excluded was created and its relationship to exposure was estimated. The results for this subgroup were very similar to those for the overall analysis.]

There are children (both case and control) who have 0 mercury exposure from vaccines in all categories. Are there children in all these categories who are unvaccinated?

[Response: I don’t have the answer to this handy. I know that there were a few kids in the sample that had zero vaccine receipts, but I don’t think they were in all of the categories because there were few of them. Most of the kids with 0 mercury exposure received at least some vaccines, but they were thimerosal free.]

To some extent, mercury exposure from vaccines could be used as a proxy variable for vaccine exposures. I.e. the amount of mercury would be somewhat proportional to the number of vaccines received. Are there any trends in just number of vaccines and autism? I.e. anything that would address the “too many, too soon” slogan? I do see that you discuss this somewhat on page 661

[Response: In the technical report (Volume II, Chapter 16) I show data on the the cumulative numbers of vaccines recieved as children aged. It shows that the cases and controls got the same numbers of vaccines. That chapter was not designed specifically to address your question about “too many too soon”, but it does show cases did not get more, sooner than controls.]

After Thomson(2007) came out, I recall that the CDC webpage suggested that your present study would be out in about a year. Why has this study taken so long to reach the public?

[Response: I’m not sure why the CDC web page had the overly optimistic suggestion that it would be out in about a year. To understand the timeline, I will need to explain some things about the phases of analysis, then the process of drafting the paper and getting it published. This is going to be a bit long winded, but part of it I am cutting and pasting from the technical report:

The study protocol was developed by a design group led by Abt Associates, Inc. working in close consultation with Principal Investigators from the
Centers for Disease Control and Prevention (CDC), Principal Investigators, Data Managers, and Study Managers from the each of the three HMOs, and with the study’s External Expert Consultants. Prior to recruitment and data collection, a detailed analysis plan was written for the study that specified the research questions, study design, eligibility criteria, sampling plan and target sample sizes, the form of the statistical models that would be used, the specific hypotheses to be tested, decision rules for categorizing outcome classifications, the coding of exposure variables,
the list of covariates to be used as statistical control variables, the coding of each of those variables, and decision rules for the retention or omission of each covariate in the final analysis models.

By agreement among the members of the design group, data analysis for the study was to be completed in two phases. In the first analysis phase, analysts at Abt Associates were to carry out as closely as possible the analyses specified in the plan and to do only the analyses specified in the plan. At the end of this phase, all members of the design group were invited to a meeting in Washington, DC where the first round, preliminary results were presented to the group. Prior to that meeting, the results of analyses linking exposures to outcomes had not been shared with anyone outside of Abt Associates. The second phase of analysis began with the meeting in Washington, DC. At that meeting, the design group considered the results and generated new hypotheses and questions that were to be pursued in the second phase. Over the ensuing months design team members provided written comments on the results of the preliminary analyses and made suggestions for additional analyses. The current report includes results from both phases.

The meeting in DC described in the paragraph above took place in May of 2008. We gave all of the members of the design group a couple of months to give feedback and suggestions on the analyses that they wanted in Phase II. There was a lot of back and forth there. The technical report includes results from both phases. We were well into 2009 before we (at Abt) had made it all the way through those second phase analyses. Then, drafts of the manuscript had contributions from a large number of authors (which takes a lot of time) and we sent drafts to our External Expert Consultants, made changes, replied to queries etc, then a draft had to go through CDC review which takes time, then we the publication process (getting a manuscript published in a peer-reviewed journal) takes a surprisingly long time. So, here we are in 2010.]

New thimerosal/autism paper – signal vs noise

13 Sep

The new thiomersal paper that Sully has blogged will be attacked by the antivaxxers in at least one key area. The area that will be attacked is – to those well schooled in the way good science operates – a standard way to improve the signal to noise ratio of the results. Or to put it another way, ensures ‘cleaner’ results.

From the paper:

…Children were excluded if they had the following medical conditions with known links to ASD traits: fragile X syndrome; tuberous sclerosis; Rett syndrome; congenital rubella syndrome; or Angelman syndrome…

So first of all why were children that fell within these groups excluded? As I said, the answer is to ensure better data. In order to get a cleaner signal, the more noise that can be eradicated the better.

In this instance, children who already have existing medical conditions known to be related to autism would produce noise. We already know what caused their autistic traits hence establishing a clear link to thiomersal would not be possible. In a very meaningful way, doing this does a large favour for antivax group. If these children were eradicated from the study and a clear link to thiomersal _had_ been established then denying the link would be very much more difficult.

However don’t expect the antivaxxers to see this. Or even if they _do_ see it, they will look away purposefully. They will use the fact that these children were excluded and say _”See? ‘They’ have to hide the autistic children!”_ .

When you see this tactic – and you will see it – see it for what it is. It’s simple noise generation to obscure the clear signal coming through. Thimerosal in vaccines doesn’t cause autism. And it never did.

Congenital Rubella Syndrome: a Novel Form of Mercury Poisoning?

13 Sep

I considered titling this: A peak into the upcoming book “Age of Autism?” as this seems to show us the sorts of arguments that will be made in that book.

One of the known environmental causes of autism is Congenital Rubella Syndrome, or CRS. This was discussed as part of a presentation to the IACC, What Causes Autism? The Case for an Environmental Contribution, by Dr. Philip Landrigan. (video is here, starting at about minute 79. Sorry it doesn’t embed).

In the question/answer session for that presentation on at about 114 minutes into the IACC meeting) Lyn Redwood of SafeMinds brought up a new argument–that CRS induced autism may be due to mercury. It turns out that in the 1950’s gamma globulin therapy was started as a means of preventing CRS. Gamma Globulin was injected into pregnant mothers who to prevent or reduce the rubella infections. This exposed the mother and fetus to mercury and should be considered the cause of the autism according to Ms. Redwood.

I must admit that when I heard this question I thought: “Well, here is one of the talking points we will hear from the upcoming book, ‘Age of Autism’, by Mark Blaxill and Dan Olmsted”. Their book appears to be an attempt to tie all of autism (and many other conditions) to mercury, including, I suspect now, CRS. There are other loose ends they will undoubtedly bring up and tie into the mercury hypothesis (like the existence of autistics who were born before thimerosal was invented. That will be interesting to read).

There is at least one big reason why CRS was possibly not linked to autism before Stella Chase’s work in the 1970’s. Congenital Rubella Syndrome causes major disability. Severe to profound mental retardation. There are big spikes in the California Department of Developmental Services data for severe and profound mental retardation corresponding to the CRS outbreaks of the 1960s. Why bring this up? Because for the first two decades after Kanner’s original paper, many people considered intellectual disability (mental retardation) and autism to be completely separate.

From Infantile autism reviewed: a decade of research, a review article written in 1981:

One of the chief problems has been how to handle the questions of mental retardation and organic brain disease, issues especially troublesome with regard to infantile autism. When Kanner (1943) first described the diagnostic features, he also remarked that the condition bore no resemblance to any known neurological condition and implied that autistic children had a basically normal intelligence. For over two decades afterwards, diagnosticians generally believed that the presence of mental retardation or neurologic signs ruled out the diagnosis of infantile autism in the Kannerian sense, even if the child met all behavioral criteria (Eisenberg 1966). Thus diagnosis was frequently one dimensional; a child was labeled as afflicted with either infantile autism or mental retardation, not both.

Or, to put it another way, what many people today call “Kanner’s Autism”, with intellectual disability and/or apraxia, is not what Kanner and most of the people of his time thought of as autism.

But, data, as they say, there’s a funny thing about evidence. Real data is worth more than all these blogger discussions. The paper out today from Pediatrics included immune globulins in their analysis and showed that mercury exposure prenatally and in infancy and found that these exposures did not increase the risk of autism.

Then again, the funny thing about evidence is that it is repeatable. Two previous papers showed no link between immune globulins and autism:

Maternal Rh D status, anti-D immune globulin exposure during pregnancy, and risk of autism spectrum disorders


Lack of association between Rh status, Rh immune globulin in pregnancy and autism.

So, if I am correct and “Age of Autism” the book claims immune globulins *are* a cause of autism, what can we say? We can say that the funny thing about evidence is that some people are not swayed by it. Some people will continue to push the mercury hypothesis forever.

Thimerosal in vaccines did not cause an autism epidemic

13 Sep

There have been two main theories linking vaccines to an “epidemic” of autism. Both theories have been studied. Both have been heard in the courts. Neither theory had a sound scientific basis and epidemiological data has shown that neither theories explained the increase in autism prevalence in the last 20 years.

First it was proposed that the MMR vaccine resulted in persistent measles infections that lodged in the intestines of children leading to “leaky guts” and that harmful substances were leaked into the blood, traveled to the brain and resulted in autism symptoms. This was proposed by Dr. Andrew Wakefield and has since been shown in epidemiological and other studies to be unsound. (This theory morphed for the Omnibus Autism Proceeding, the vaccine court. The argument there was that the measles virus itself traveled to the brain. Again, it is not supported by epidemiological data and is not scientifically sound).

The second theory was that mercury in vaccines from a compound called thimerosal caused autism. In that theory, it was proposed that autism symptoms were similar to mercury poisoning (autism was a “novel” form of mercury poisoning). This theory was not scientifically sound as autism symptoms are not like mercury poisoning. Previous epidemiological studies have also shown thimerosal was not behind the rising numbers of people diagnosed with autism.

In 2007 there was a study which looked at 1,000 kids aged 7-10 to see if various neurological symptoms were more prevalent in those who received higher exposures to thimerosal. Orac at Respectful Insolence blogged it and Kev posted that piece here on LeftBrainRightBrain as well. That study showed indications that in some measures children may perform more poorly with thimerosal exposure. It also showed that in some measures children may perform better with thimerosal exposure. This mixed result is (a) not very strong in either direction and (b) not very surprising when you look at a lot of different measures at the same time. Chance will result in some measures positive, some negative.

The 2007 study was published in the New England Journal of Medicine as Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years, by Thompson, et al.. (Thompson (2007))

What was missing in that report was a direct study of autism. Given the numbers of children (1,047) selected, there would only be about 10 kids with ASD expected in the group. This is too few for a strong conclusion on autism. At the time of that study it was noted that another study would follow concentrating on autism alone.

That study has just been published in the journal Pediatrics as Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism. They studied “256 children with ASD and 752 controls matched by birth year, gender, and [managed care organizations]”. I will give some details here. I expect the treatment on the Science Based Medicine and Steven Novela’s Neurologica blogs to cover the science thoroughly should you wish more detail.

Short answer: thimerosal exposure doesn’t cause an increased risk of autism. Neither thimerosal from vaccines given to the children nor thimerosal from products like Rhogam are behind the increase in autism prevalence we have seen.

It is worth noting that the authors looked at autism with and without regression.

Here is the abstract:

OBJECTIVE: Exposure to thimerosal, a mercury-containing preservative that is used in vaccines and immunoglobulin preparations, has been hypothesized to be associated with increased risk of autism spectrum disorder (ASD). This study was designed to examine relationships between prenatal and infant ethylmercury exposure from thimerosal containing vaccines and/or immunoglobulin preparations and ASD and 2 ASD subcategories: autistic disorder (AD) and ASD with regression.

METHODS: A case-control study was conducted in 3 managed care organizations (MCOs) of 256 children with ASD and 752 controls matched by birth year, gender, and MCO. ASD diagnoses were validated through standardized in-person evaluations. Exposure to thimerosal in vaccines and immunoglobulin preparations was determined from electronic immunization registries, medical charts, and parent interviews. Information on potential confounding factors was obtained from the interviews and medical charts. We used conditional logistic regression to assess associations between ASD, AD, and ASD with regression and exposure to ethylmercury during prenatal, birth-to-1 month, birthto-7-month, and birth-to-20-month periods.

RESULTS: There were no findings of increased risk for any of the 3 ASD outcomes. The adjusted odds ratios (95% confidence intervals) for ASD associated with a 2-SD increase in ethylmercury exposure were 1.12 (0.83–1.51) for prenatal exposure, 0.88 (0.62–1.26) for exposure from birth to 1 month, 0.60 (0.36–0.99) for exposure from birth to 7 months, and 0.60 (0.32– 0.97) for exposure from birth to 20 months.

CONCLUSIONS: In our study of MCO members, prenatal and early-life exposure to ethylmercury from thimerosal-containing vaccines and immunoglobulin preparations was not related to increased risk ASDs. Pediatrics 2010;126:656–664

My guess is that there will be much discussion of the methods on many websites. For now, here are the data from Table 2 and Table 3.

Table 2 (click to enlarge)

Table 3 (click to enlarge)

As with Thompson (2007) the authors will make longer reports available on their website and will allow access to the data.

This study is not the first of its kind. Here are a few of the large studies which have shown a lack of association between thimerosal exposure and autism in the past.

Thimerosal and the Occurrence of Autism: Negative Ecological Evidence From Danish Population-Based Data

Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Database

Thimerosal Exposure in Infants and Developmental Disorders: A Prospective Cohort Study in the United Kingdom Does Not Support a Causal Association

Autism and Thimerosal-Containing Vaccines Lack of Consistent Evidence for an Association

There are more.

One question is whether this will finally quiet those claiming an autism epidemic caused by mercury in vaccines. Unfortunately, I sincerely doubt it. This study included Sallie Bernard of SafeMinds in the acknowledgments. Ms. Bernard was also involved in the Thompson study of 2007. At that time she was listed as a “dissenting” member of the team. She submitted a letter to the NEJM discussing the reasons for her dissention, Perhaps the lack of the word “dissenting” this time is a good sign. I’ll wait and see.

The main question is how much impact this will have on the next generation of families with autistic children. I can’t but wonder that the age of the mercury hypothesis has seen its peak. Not only in research but in general acceptance.

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