May 24, 2010

Thomas Maugh Can't Read (or just doesn't wanna)

Wanna know how the media tries to trick ya into believing that vaccines don't cause autism? Watch closely.

Today in the LA Times, biased health reporter Thomas Maugh wrote that a new research study had been published that showed that Delaying Childhood Vaccinations Does Not Improve Children's Health. Take a moment and read it... it is quite convincing.

Booster Shots
Oddities, musings and news from the health world

Delaying childhood vaccinations does not improve children's health, study finds
May 24, 2010 | 12:11 pm

Now that the thimerosal-autism link has been thoroughly discredited, some autism advocates argue that neurodevelopmental problems are caused by overloading children's immune systems with too many vaccines too early in life. As a result, a growing number of parents are asking pediatricians to use alternative vaccination schedules that spread out the shots, even though there is no evidence to suggest that the practice may be helpful. In fact, common sense suggests that it is more likely to be harmful because the highest incidence of infection and mortality from pertussis, for example, occurs in the first six months of life. Failure to vaccinate also exposes other children in the community to infectious diseases that they might otherwise avoid.

Researchers cannot ethically conduct a clinical trial of delayed vaccinations because of the potential risks to the children involved. In an effort to circumvent this problem, pediatric infectious disease specialists Dr. Michael J. Smith and Dr. Charles R. Woods, both of the University of Louisville School of Medicine, analyzed data on 1,047 children enrolled in a previous study designed to determine whether thimerosal produced an autism risk. The children were born between 1993 and 1997, vaccinated by their parents on a schedule of the parents' choosing, and then subjected to a series of 42 neuropsychological tests between the ages of 7 and 10.

Just under half of the children (491 or 47%) received their vaccines on a timely basis, within 30 days of schedule. An additional 235 (23%) received all vaccinations, but not on schedule, and the remaining children received some but not all vaccines. On-time vaccination was most likely to occur among households in which the mother was highly educated and in which household income was higher.

The Louisville duo reported Monday in the journal Pediatrics that delayed vaccinations did not improve outcomes. In fact, outcomes in this group might have been worse. The researchers found that children vaccinated on time performed higher on 15 of the 42 tests than those who were not vaccinated on time. The latter group did not perform higher on any test. The researchers did not offer a potential explanation for this finding, but it may be linked to the higher household incomes.

Current vaccination schedules call for even more shots, so the results are not directly translatable, the authors conceded. But even with the added shots on the new schedule, children are actually exposed to lower doses of antigens because of improvements in the vaccines, they said, so the safety should remain the same.

"This study provides the strongest clinical outcomes evidence to date that on-time receipt of vaccines during infancy has no adverse effect on neurodevelopmental outcomes 7 to 10 years later," the authors wrote. "These results offer reassuring information that physicians and public health officials may use to communicate with parents who are concerned that children receive too many vaccines too soon."

The study was funded internally at the university. Woods has received honoraria from pharmaceutical companies for speeches and has received research funding from them for other projects.

-- Thomas H. Maugh II


He reviewed (badly) a study that reported that a sample of children who were both vaccinated according to the CDC schedule, and their peers who were unvaccinated or vaccinated selectively, and found that there was no difference in neuropsychological outcomes. The study, according to the authors, was needed in part because:
"as the visible threats of vaccine-preventable diseases have decreased, parental concerns about vaccine safety have increased. Most recently, these concerns have focused on the now debunked links between autism and the measles-mumps-rubella vaccine as well as concerns about the ethyl mercury–
containing preservative thimerosal..."

Well no, the thimerosal link has not been debunked, but lets skip that for now and note that parents greatest vaccine concern these days is autism. So that suggests that this study will address that concern, right?

Thomas Maugh certainly sees it that way. He wrote that the study, "analyzed data on 1,047 children enrolled in a previous study designed to determine whether thimerosal produced an autism risk."

Well GREAT! This looks like one of those studies that I personally have been begging Main Stream Medicine to do! Except that it actually isn't, it doesn't do what Maugh is telling you it does, and it looks to be just another PR stunt.

Maugh might see this too, if he read the whole study carefully. Curiously, the word "autism" only appears twice in the paper. Once in the intro, where I quoted above, and once a full nine pages in, tucked in the last paragraph before the conclusion that curiously reads:

Finally, our analyses were limited to publicly available data from the original study. Future VSD studies without this restriction would be able to assess a wider range of outcomes. These include putative vaccine adverse effects such as neurodevelopmental delay, autism, and autoimmune disorders.

What's that? Neurodevelopmental delay, autism and autoimmune disorders weren't measured? I am confused. I thought that this study was supposed to allay my fears about those things too?

You see this study is not really a new, good study, it is just a rehash of an old, bad study that the New England Journal of Medicine published to make it look like vaccines didn't cause autism. In the fall of 2007, they published a study called, "Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years.", which reported that getting more thimerosal in vaccines didn't cause adverse neuropsych outcomes 7 to 10 years later. (except that if you read the whole study you find that it did cause verbal tics and speech delay). But here is where the sleight of hand takes place... pay close attention.

The abstract of that first study contains this very important note (that none of the media seemed to see):

"(We did not assess autism-spectrum disorders.)"

That's right readers... NONE of these wonderful, fab, illuminating, reassuring studies have anything to do with autism! Autism was part of the EXCLUSION criteria for the first study, therefore it was also not measured in the second study. No children in these two studies had autism. If you had autism, you were not allowed in these studies! (* see note regarding these last two sentences)

NOT AUTISM STUDIES!

(wanted to make sure I got my point across)

But you wouldn't know that from reading Maugh or from the Pediatrics study... you would have to have read the abstract in the New England Journal of Medicine yourself (not the press on it, as that was left out of the media), know that it was not an autism study, to know that this Pediatrics study is not an autism study, to know that Thomas Maugh has no idea what he is talking about. He is either incompetent to report on health research or he is purposefully lying to the public when he claims that this is based on a "previous study designed to determine whether thimerosal produced an autism risk".

You might try to point that out to him, but I have found that he is not really open to discussing the problems in his writing.

So that is how they do it folks... they do a vaccine study, not on autism, but something autism sounding and phrase it so the reader assumes that autism is included, don't mention that autism is not measured in the press release, let journalists print that it actually DOES study autism, then base more studies on that initial study that never mention that autism is not even on the menu, and viola! The public hears lots of stories about how vaccines don't cause autism.

But that one small sentence "(We did not assess autism-spectrum disorders.)" is like the pea under the mattresses for the autism mom princess. It pokes at us and keeps us awake all night, but few others will ever even notice it is there.


* Update:
While I was out of town this week an interesting conversation has taken place in the comments section on this last claim of mine that autism was in the exclusion criteria. I think that I may have made an assumption here. As you can see, it is not explicitly stated that those with autism were excluded from the study. I think I made that leap when reading that autism was not measured.

But it brought up more interesting questions about potential shenanigans in the sampling. To reasoning, this study should have NO ONE with and ASD diagnosis in the sample (as it is not measured) or should have a representative sample of ASD (to the rate in the gen pop of the birth cohort) as would a true random sample.

But neither is stated and as the discussion notes, children were dropped from the study with no explanation of why.

I would like to know the answer to a simple question... how many children with an ASD diagnosis are in this sample?

Mind you, even if there was a representative sample of kids with ASD in it (which I will shocked if there are) it is still not an autism study, so comments sentence "Autism was part of the EXCLUSION criteria for the first study... No children in these two studies had autism. If you had autism, you were not allowed in these studies!" would need to be dropped from this article to make it accurate.

Read the discussion below and thanks to those who held this exchange in my absence.

ANOTHER NOTE:

Another potential problems is the cessation of vaccination following autistic regression.

If you use the sample of my two sons, you would get results that the fewer vaccines one has, the higher the chance of having autism. Because when Chandler regressed after 18 months and 21 doses of vaccines, we stopped vaccinating him. While his older brother received more shots because:

1. He was older and was on the recommended schedule for twice the time his little brother was and
2. We allowed him to have two additional shots after his brother's regression (but he is now done).

So any study would need to take into account vaccination stoppage following regression, which is probably now the norm.

Which is why I think that only a fully vaccinated, completely unvaccinated study would really give us true insight into autism risk according to vaccine intake.

31 comments:

Minority said...

But here is where the slight of hand takes place... pay close attention.

That should be sleight of hand.

Great job though, this is a wonderful article.

Minority said...

Autism was part of the EXCLUSION criteria for the first study, therefor it was also not measured in the second study. Not children in these two studies had autism.

Sorry, two more typos:

should be therefore (I think?)

and None of the children

Ginger Taylor said...

Thanks... my husband always says I shouldn't type angry.

K Fuller said...

Cut and paste...insert study that might fool a few. Damn it my Mom and my husbands Mom's read the Times. Both will cut it out and send it to me. After all it's in the Times. Gag.

nhokkanen said...

Thanks, Ginger, for your excellent summation. I posted the link and a quoted paragraph onto my state's biomed listserv.

You're right about Maugh. He's as stubborn as a mule even when he's totally, completely, embarrassingly wrong.

sdtech said...

Ginger, good work!

This is spreading throughout the media with apparently no editorial review. Look at http://online.wsj.com/article/SB10001424052748704113504575264421687548864.htm .

Google the phrase: Dr. Michael J. Smith and Dr. Charles R. Woods pediatrics , then see how many May 24, 2010 media sites show up. This is timed right after the Matt Lauer unfair faux interview of Dr. Wakefield.

sdtech said...

http://online.wsj.com/article
/SB10001424052748704113
504575264421687548864.html

Minority said...

Hi Ginger,
I've skimmed through the original study (round one on this data, not what Maugh reviewed just now) and it is clear that autism wasn't studied, but it doesn't say anywhere (that I could find) that children with autism were excluded.

Do you have more info that isn't from the published study?

sdtech said...

No where is autism considered per the following:

Smith and Woods (2010) re-visited data from Thompson, Price, Goodson et al (2007)


Smith and Woods (2010) said:

“Publicly available data, including age at vaccination, from a previous VaccineSafety Datalink study of thimerosal exposure and 42 neuropsychological outcomes were analyzed.

In summary, these include assessments of speech and language, verbal memory, achievement, fine motor coordination, visuospatial ability, attention and executive-functioning tasks, behavior regulation, tics, and general intellectual functioning. Page 1135

See Page 1134 at http://pediatrics.aappublications.org/cgi/reprint/peds.2009-2489v1


Thompson, Price, Goodson et al (2007) said

“We enrolled 1047 children between the ages of 7 and 10 years and administered standardized tests assessing 42 neuropsychological outcomes. (We did not assess autism-spectrum disorders.)”

See http://content.nejm.org/cgi/content/full/357/13/1281 .

sdtech said...

Smith and Woods (2010): Drs Smith and Woods are or have been unfunded subinvestigators for cross-coverage purposes on vaccine clinical trials for which their colleagues receive funding
from Wyeth, Sanofi Pasteur, GSK, MedImmune, and Novartis; and Dr Woods has received honoraria for speaking engagements from Merck, Sanofi Pasteur, Pfizer, and MedImmune and has received research funding from Wyeth and Sanofi Pasteur.

sdtech said...

Thompson, Price, Goodson et al (2007): Dr. Thompson reports being a former employee of Merck; Dr. Marcy, receiving consulting fees from Merck, Sanofi Pasteur, GlaxoSmithKline, and MedImmune; Dr. Jackson, receiving grant support from Wyeth, Sanofi Pasteur, GlaxoSmithKline, and Novartis, lecture fees from Sanofi Pasteur, and consulting fees from Wyeth and Abbott and serving as a consultant to the FDA Vaccines and Related Biological Products Advisory Committee; Dr. Lieu, serving as a consultant to the CDC Advisory Committee on Immunization Practices; Dr. Black, receiving consulting fees from MedImmune, GlaxoSmithKline, Novartis, and Merck and grant support from MedImmune, GlaxoSmithKline, Aventis, Merck, and Novartis; and Dr. Davis receiving consulting fees from Merck and grant support from Merck and GlaxoSmith-Kline. No other potential conflict of interest relevant to this article was reported.

Minority said...

Hi SDtech,
I saw what you saw. And I agree that autism wasn't assessed in either study. But I still can't find anything which actually says that children with autism were excluded from the original study.

Excluded is different from not being assessed.

sdtech said...

Seven children were omitted with no clear discussion as to their specific case history or the influence on the data.

See page 1 at http://198.246.98.21/vaccinesafety/00_pdf/Tech_Rept_Thimerosal_Vol_2_090607.pdf .

sdtech said...
This comment has been removed by the author.
sdtech said...

http://198.246.98.21/vaccinesafety/
00_pdf/Tech_Rept_Thimerosal_
Vol_2_090607.pdf

sdtech said...

Thompson et al also excluded children if “… they had certain conditions recorded in their medical records that could bias neuropsychological testing (e.g., encephalitis, meningitis, or hydrocephalus) or if their birth weight was less than 2500 g.”

See page 1282 at http://content.nejm.org/cgi/content/full/357/13/1281 .

So the question “Did they exclude children with autism?” is unanswered to the readers.

This is an excellent question. There is possible fraud on the part of the authors if they willfully excluded children with autism and failed to disclose that exclusion.

Minority said...

Thank you for the research, SDtech. So we don't know for sure about children with autism. Either they were included, and didn't have any effect on the analysis...

Or they were excluded, but not listed as excluded, which, as you point out, would be fraud.

Perhaps they were excluded for the other reasons listed in the exclusion list, which just happened to cover all the children in the study group who just happened to have autism: they were all children who were also premature or twins or...

sdtech said...

“The primary weakness of the current study is that exposure levels were not determined in a randomized controlled trial (RCT) design. Although the study measured and controlled for a wide range of potential confounders, it is impossible to know with certainty whether the threat of selection bias has been eliminated. Selection bias will have affected the results if one or more unmeasured factors have causal effects on both the amount of exposure that children receive, and outcome measures. Given this important limitation of the design of the study, results can only be judged as informative, not conclusive. The study was intended to be an important contribution to a growing literature regarding the possible effects of ethylmercury, and was not intended to be a definitive concluding statement of whether the ethylmercury in thimerosal-containing vaccine sand immune globulins does or does not cause harm.”

See Technical report. Vol. I. Bethesda, MD: Abt, 2007, page 1 at

http://www.cdc.gov/vaccinesafety/00_pdf/Tech_Rept_Thimerosal_Vol_1_090607.pdf

Also 60 out of 1,107 children were excluded after FINAL ASSESSMENT. See page 18.

sdtech said...

http://www.cdc.gov/
vaccinesafety/00_pdf/
Tech_Rept_Thimerosal_Vol_1_
090607.pdf

sdtech said...

correction

"...The study was intended to be an important contribution to a growing literature regarding the possible effects of ethylmercury, and was not intended to be a definitive concluding statement of whether the ethylmercury in thimerosal-containing vaccine and immune globulins does or does not cause harm.”

http://www.cdc.gov/
vaccinesafety/00_pdf/
Tech_Rept_Thimerosal_Vol_1_
090607.pdf

sdtech said...

“Paul Offit, a vaccine expert and chief of the division of infectious diseases at the Children's Hospital of Philadelphia, who wasn't involved in the study, says, ‘When you watch your kids get five shots, it's perfectly reasonable to ask if it's too much.’ Dr. Offit helped develop Merck & Co.'s Rotateq rotavirus vaccine and served on the U.S. panel overseeing children and adult vaccination schedules.”

See http://online.wsj.com/article
/SB1000142405274870411
3504575264421687548864.html

Offit = $ $ $ !

See

http://www.ageofautism.com/
2010/05/paul-offits-message-cdc-fda-nih-iom-aap-
who-and-merck-engaged-in-pseudoscience.
html?cid=6a00d8357f3f2969e20133ee6b439d970b


And Rototeq = Oink!?!

See


http://www.nasdaq.com/aspx/company-news-
story.aspx?storyid=201005061420
dowjonesdjonline000791

Ginger Taylor said...

Hey guys... sorry to have missed this discussion... and thank you for having it in my absence (and pointing out that I too made an assumption on the study because of their vague phrasing). It raises new questions about sampling in this study that should be answered. Especially if they are going to keep using it to do misleading research.

Any one wanna call them and ask how many kids with an ASD diagnosis were in this sample and why those kids were dropped?

Minority said...

I'm not writing to them, sorry!

sdtech said...

Ginger Taylor:

That is a good idea. Here is a start on the questions.

1) Why doesn’t the study use controls?

There are no significant amounts of zero exposure children because 97 percent of the children had 50 micrograms or more of mercury by 7 months of age. The average mercury intake from birth to 7 months was 118 micrograms and the Standard Deviation is 41 micrograms (calculated using Table 1 Cumulative Exposure to Ethyl Mercury According to Age Range). See http://content.nejm.org/cgi/content/full/357/13/1281 .


2) Why does the study use bias in selection?

“We enrolled 1047 children between the ages of 7 and 10 years and administered standardized tests assessing 42 neuropsychological outcomes. (We did not assess autism-spectrum disorders.)” See page 1281.

“Of 3648 children selected for recruitment…512 did not meet one or more of the eligibility criteria...Of the 1107 children who were tested, 60 were excluded from the final analysis for the following reasons…[including] discovery of an exclusionary medical condition during record abstraction, 47. Thus, 1047 children were included in the final analyses.” See page 1284.

3) Why are there no thimerosal based mercury intake data from between 7 months and 6 to 7 years of age?

4) Why doesn’t the study (even though its weaknesses include lack of controls and bias) state in the conclusion that there is significant evidence of neurological harm for thimerosal based mercury exposure from birth to seven months?


“We measured tics and stuttering dichotomously, and we estimated odds ratios for a 2-SD increase in mercury exposure.” See page 1283.

The increased odds ratios are given on pages 1288 and 1290.




The standard deviation (SD), calculated from Table 1, is 41 micrograms for children exposed from birth to 7 months (for birth to 1 month of age the calculated standard deviation of 6 micrograms).

sdtech said...

See http://content.nejm.org
/cgi/content/full/357/13/1281

sdtech said...
This comment has been removed by the author.
sdtech said...

Question no. 5:

What are the values that the authors actually used for Standard Deviation (SD) of Thimerosal based mercury exposure for the children in this study?



Question no. 6:

What are the raw Odds Ratios for stuttering, motor tics, and phonic tics, and the raw regression coefficients for verbal IQs on Table 3, pages 1288 and 1290?

Question no. 7:

Why were these parameters (SD, raw values for Odds Ratios, and raw values for regression coefficients) not published?

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sdtech said...
This comment has been removed by the author.
sdtech said...

Final Question:

Why did the authors use evidence of vaccine harm to infer safety?

On the last page of the report the authors state that “The one deleterious association [from a referenced study by Andrews et al] involved an increased risk of tics, a finding similar to that in our study.”

And yet three paragraphs later, the Thompson et al paper concludes that “The weight of the evidence in this study does not support a causal association between early exposure to mercury from thimerosal-containing vaccines and immune globulins administered prenatally or during infancy and neuropsychological functioning at the age of 7 to 10 years.” See page 1291.

The term “weight of evidence” is not a scientific term. It is a legal term. A definition is found at http://legal-dictionary.thefreedictionary.com/preponderance+of+the+evidence:

“Preponderance of the evidence n. the greater weight of the evidence required in a civil (non-criminal) lawsuit for the trier of fact (jury or judge without a jury) to decide in favor of one side or the other.”


Quite the opposite, a “Safety Factor” in scientific design requires recognition of failure of design--not just a “50 percent plus a feather” weight of evidence required for a civil case in a legal court of law.

Richard Feynman addressed these issues in the Rogers Commission report on the Challenger Shuttle fatal disaster.


“If a bridge is built to withstand a certain load without the beams permanently deforming, cracking, or breaking, it may be designed for the materials used to actually stand up under three times the load. This ‘safety factor’ is to allow for uncertain excesses of load, or unknown extra loads, or weaknesses in the material that might have unexpected flaws, etc. If now the expected load comes on to the new bridge and a crack appears in a beam, this is a failure of the design. There was no safety factor at all; even though the bridge did not actually collapse because the crack went only one third of the way through the beam. The O-rings of the Solid Rocket Boosters were not designed to erode. Erosion was a clue that something was wrong. Erosion was not something from which safety can be inferred.”

See paragraph 8 at
http://science.ksc.nasa.gov/shuttle
/missions/51-l/docs/rogers-commission
/Appendix-F.txt

Similarly there is no safety factor at all with these vaccines because tics were a clue that something was wrong—“a failure of the design.” Tics were not something from which vaccine safety can be inferred.

Loudtodd said...

wow your a complete idiot! How do you feel 6 years later to know he was right