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Two clinical trials for autism

18 Mar

I am, and will continue to be, highly critical of therapies used to treat autistics (typically children) which are potentially dangerous and which are hyped beyond any actual proof. Since many often misinterpret this to say that I am against any treatment of autistics, I thought I would discuss two clinical trials caught my eye this week, one completed and one starting. These are studies which I am happy to see made.

What separates these from other studies and, worse, the
1) They can give answers to the anecdotal reports that these work
2) The drugs are known, so the safety concerns (including adverse reactions) can be weighed by parents before hand. The side effects are reversible and, for the most part, the side effects are minor.
3) They are being studied under controlled conditions, so results have the potential to give useful information.

Digestive Enzyme Supplementation for Autism Spectrum
Disorders: A Double-Blind Randomized Controlled Trial
by
Sujeeva A. Munasinghe, Carolyn Oliff, Judith Finn, John A. Wray

Just came out in the Journal of Autism and Developmental Disabilities.

The abstract from this paper states:

Abstract To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3–8 years. Outcome measurement tools included monthly Global Behaviour Rating Scales, Additional Rating Scales of other symptoms by parents and therapists, and monthly completion of the Rescorla Language Development Survey. Compared with placebo, treatment with enzyme was not associated with clinically significant improvement in behaviour, food variety, gastrointestinal symptoms, sleep quality, engagement with therapist, or the Language Development Survey Vocabulary or Sentence Complexity Scores. A small statistically significant improvement on enzyme therapy was seen for the food variety scores. No clinically significant effect improvement of autism symptoms with enzyme use was shown with this trial, however, possible effects on improvement in food variety warrants further detailed investigation.

The basis for using digestive enzymes is the so-called “leaky gut” theory, or “opiod excess” theory, whereby the digestive tract is permeable (leaky gut) and chemicals leak into the bloodstream which cause autistic behavior (opiod excess). It is not a theory which I give much weight, but it is commonly accepted and the use of digestive enzymes is not uncommon in the alternative medical autism community.

The authors found, not surprisingly in my opinion, that digestive enzymes were not effective. The sample size was relatively small (43), but the study was a “crossover” type, so that all the children spent some of the study time on the enzyme and some time on placebo.

The second study was announced this week in a press release:

Autism Research Study Announced By Children’s Health Council

Dr. Glen Elliott of Children’s Health Council leads clinical research for local patients

The press release is quoted below:

Autism is an exceptionally complex illness. Autism is a developmental disorder with impairments in social interaction and communication, in addition to restricted, repetitive behaviors. Once considered quite rare, 1 in every 150 children in the United States is now diagnosed with the illness, making it a common developmental disability.

Diagnosis of Autism typically occurs at about 3 years of age. The treatment of the condition is complex, as there is no single known cause or cure. Early childhood is the period during which the symptoms of Autism are clearly observable and children are experiencing rapid developmental changes. Researchers continue to look for more effective behavioral, educational and medical treatments to improve the lives of children with Autism. Therefore, a key to overcoming some of the challenges associated with the condition is early diagnosis and intervention.

A clinical research study is now underway in the Bay Area for children between the ages of 3 and 6 with Autistic Disorder. The goal of the study is to evaluate the safety and effectiveness of an investigational medication for children with this condition.

Dr. Glen Elliott of Children’s Health Council (CHC) is conducting this clinical research study. CHC believes all children deserve the opportunity to reach their full emotional, educational and developmental potential. CHC seeks participants for this clinical study, based on the following: the children must be at least 3 years old and less than 7 years old; candidates for the study must meet the criteria for Autistic Disorder; and, she or he must have an IQ or developmental quotient (DQ) of at least 50.

Parents must give informed consent for their child to participate in this clinical research study, and must also be willing and able to comply with all study requirements. All clinical study-related care will be provided at no cost, including physical exams, psychological testing, and study medication. Compensation may be available to eligible parents or guardians. Health insurance is not required to participate.

If your child or a child you know has Autism, additional information about this clinical research study and how to participate is available at (800) 314-2597 and at www.chcautism.com.

If one follows the links, one finds that the study is for Sapropterin. The trial is on clinicaltrials.gov.

The Children’s Health Council is an established, well respected, private clinic and school based near Stanford University in California. The lead researcher is Dr. Glen Elliott, formerly of the University of California San Francisco. Sapropterin (Kuvan) is a drug used for the treatment of some forms of Phenylketonuria (PKU), a rare but severe developmental disorder. Most children in developed countries are tested for PKU at birth. A discussion of the use of Sapropterin for PKU is here.

As an aside, PKU results from a genetic disorder. I often hear autism parents say things like, “Doctors tell us that autism is genetic and, thus, untreatable”. Genetic doesn’t mean untreatable, and here is a classic example.

Back to the clinical trial. I don’t understand the proposed mechanism by which Sapropterin is supposed to work. What I do know is that there are at least two studies on the use of Sapropterin in treating autistic children (I will try to link to them soon). The studies were small and not conclusive, but the thought is that Sapropterin helps communication. There are at least a couple of doctors already using Sapropterin in the U.S., and I expect we would hear more about this if it weren’t for the fact that the drug is incredibly expensive. As in, about $50,000 per year. If I understand it correctly, Sapropterin was invented as much as 20 years ago, but has only recently been applied to PKU and that under an “orphan drug” patent. Since clinical trials have already been held on Sapropterin for PKU, one can find the side effects. Additional side effects include seizures in seizure prone patients.

Any drug, any therapy carries with it the potential for an adverse reaction. This is especially true in a clinical trial where the effects of the drug on the population studied are untested. The need for caution is compounded when the study subjects are children, and doubly compounded when the subjects are disabled children.

I do not take the idea of clinical trials on autistic children lightly. However, I will again list the reasons why these particular studies were interesting to me:

1) The drugs are relatively safe
2) the risks, especially for Sapropterin, are documented
3) the studies are controlled, so the contributions of the children involved are not wasted as with some of the flimsy studies we see periodically
4) the studies can answer questions about drugs already in use.

Bogus Urine Metals Testing Fails In Vaccine Court

13 Mar

The Thimersoal “test cases” in the OAP relied on bogus urine mercury testing. Among many other common problems the petitioners had in providing any sound scientific support for the notion that mecury can cause autism, that, was at least in part, the apparent conclusion of all three of the special masters.

I just skimmed through the recent decisions by the US Court Of Federal Claims in the Thimerosal “test cases” that were part of the Omnibus Autism Proceeding, and the expert testimony provided by Dr. Brent (respondent) in this regard is pretty clear:

From the Mead Decision

When specifically asked about the urine mercury tests that were performed on William, Dr. Brent said that the tests “showed pretty much exactly what you’d expect for the normal population, that their unprovoked specimens are normal. Yet, when they give chelators, most of [mercury excretion results] are increased.” Id. at 1852-1853. Dr. Brent expressed a concern about the use of data in this way to suggest that a condition exists that, in fact, does not. See id. at 1853. He stated that “it’s data like this that has been used as an excuse to subject these children to chelation therapy where the data supports [a finding] that their urine mercury status is totally normal.” Id. at 1853.

From the King Decision

Moreover, Dr. Brent explained that when the results of mercury testing of Jordan, both provoked and non-provoked, are viewed in their entirety, they are exactly what one would expect from an individual without any mercury-related problem. That is, Jordan’s non-provoked test results were within the normal range for non-provoked testing. (Tr. 1852-53, 4340.) At the same time, while his provoked results were outside the normal range for non-provoked testing, that is not surprising since the provocation/chelation process is designed to specifically provoke an increased excretion of metals. (Tr. 1852-53, 4340-41, 4347.) As Drs. Brent and Fombonne explained, administration of a chelating agent to anyone, autistic or not, mercury-poisoned or not, will always be followed by increased excretion of mercury.118 (Ex. M, p. 74; Tr. 1852, 4340-41, 4343.)

Interestingly, the added scientific clarity of the special masters with regard to bogus urine metals testing is also present to some degree in all three test cases:

Here’s one example from the Mead Decision

Moreover, a subsequent study, as reported in the 2007 Soden article filed as RMRL 458,150 could not confirm the 2003 Bradstreet study results. See Mead Tr. at 1844. The investigators found that “DMSA provoked excretion testing did not produce evidence of an excess chelatable body burden among the autistic [study] participants.” RMRL 458 at 480. The investigators concluded that “[i]n the absence of a novel mechanism of heavy metal toxicity or an alternate therapeutic action of chelators, the data presented provide[d] no justification for chelation therapy for the [study] participants.”

Many will remember the conclusion of Soden et al.

“In the absence a proven novel mode of heavy metal toxicity, the proportion of autistic participants in this study whose DMSA provoked excretion results demonstrate an excess chelatable body burden of As, Cd, Pb, or Hg is zero.”

But perhaps the most interesting of all, is the common thread that the reliance upon the bogus mercury testing seems pretty much acknowledged for what it is by both the special masters and the petitioners’ expert:

From the Dwyer Decision

Doctor Mumper’s willingness to rely on Colin’s mercury test results as evidence of high levels of mercury in his body was particularly troubling. She admitted that his results were not typical of those she saw in other autistic children. She admitted that she knew of no research into normal mercury excretion levels after chelation against which Colin’s one positive mercury test could be measured.741 It appeared that regardless of the results for mercury levels, Dr. Mumper was willing to opine that they reflected mercury’s role in ASD.

From the King Decision

In short, a careful analysis of the record demonstrates that there is no valid basis for Dr. Mumper’s view that the results of mercury excretion testing on Jordan King offer support for a conclusion that thimerosal-containing vaccines played a role in causing Jordan’s autism. To the contrary, the evidence supports a conclusion that Dr. Mumper’s reliance on such mercury tests has no basis in science or logic. Indeed, upon cross-examination even Dr. Mumper acknowledged that there is no particular profile or pattern of post-provocation test results that points to a finding that a child has mercury-induced autism. (Tr. 1555-60, 1568-69.) When pressed, Dr. Mumper could not even suggest an example of any type of result on a post-provocation mercury urine test that would not, in her analysis, support a claim of mercury-induced autism. (Tr. 1558-60.) Dr. Mumper’s analysis in this regard was illogical, and completely unpersuasive.119

Yep, regardless of the results of a scientifically meaningless test, it’s the mercury. Right.

Remember, these were the three Thimerosal “test cases”, presumably chosen by the Petitioner’s Steering Committee (PSC) because they offered the best opportunity to introduce good, and representative scientific evidence for the hypothesized role of thimerosal in the etiology of autism. It looks like they failed miserably, and this doesn’t seem surprising when it’s clear the cases leaned on at least one form of laboratory testing that’s clearly scientifically meaningless.

It won’t be surprising when many of the die-hard anti-vaccine and “alternative” autism medicine brigade ignore the fact that bogus urine toxic metals testing just had a bright light shined on it by the vaccine court. They’ll be likely to claim some form of conspiracy or politics about the cases, despite the fact that the spotlight revealed an apparent decision-making tool of many a “DAN! doctor” to not only be worthless in medicine, but also worthless in court.

On a related note, there has been recent news that a couple of “DAN! doctors” are facing a lawsuit in which bogus urine toxic metals testing is called out directly. Aside from numerous other problems they face in the complaint, it should be interesting to see how the defendants (Dr. Dan Rossignol, Dr. Anjum Usman, and Doctors Data, Inc.) explain the potential role of comparing chelator-provoked urine metals levels to a non-provoked reference range. If the three test cases in the OAP are an indication of the state of actual scientific support for such testing, the defendants would seem to have plenty to worry about.

Additional reading:

Mead v. Secretary of Health and Human Services Case No. 03-215V
King v. Secretary of Health and Human Services Case No. 03-584V
Dwyer v. Secretary of Health and Human Services Case No. 03-1202V
Thimerosal-Autism Test Cases Dismissed
Doctors sued over ‘dangerous’ autism treatment
Suing DAN! practitioners for malpractice: It’s about time
How the “Urine Toxic Metals” Test Is Used to Defraud Patients
24-hour provoked urine excretion test for heavy metals in children with autism and typically developing controls, a pilot study

Autism-study doctor facing grant probe

13 Mar

A story in the Philadelphia Inquirer today sheds some light on the situation involving Dr. Poul Thorsen.

Background for anyone who needs it: Dr. Thorsen is a Danish researcher who is co-author on a number of important studies. These include epidemiological studies on vaccines and autism. Dr. Thorsen did this work at the University of Aarhus, and has since left. There is an investigation ongoing apparently implicating Dr. Thorsen in a possible shortfall of about US$2M from the University.

Dr. Thorsen’s work was funded largely by the CDC. He started working for Emory University before leaving Aarhus (and this is a point of contention with Aarhus, as they state that Dr. Thorsen was not allowed a joint full-time appointment). He was also listed as adjunct faculty at Drexel University. Dr. Thorsen has also left Emory and his adjunct appointment at Drexel.

There has been a lot of speculation and discussion on this for the past week or so. The story has broken into the mainstream media, who have been good enough to get us some facts to work with. I have sent many emails over the past week, and almost all have been unanswered. I finally heard from one group in Denmark yesterday, and they to are unaware of the details of this case.

Today’s Philadelphia Inquirer has a story about Dr. Thorsen, Autism-study doctor facing grant probe by Jeff Goldstein:

A Danish scientist involved in two major studies that debunked any linkage of vaccines to autism is suspected of misappropriating $2 million in U.S. grants at his university in Denmark.

He also notes that Dr. Thorsen’s appointment at Drexler was unpaid, and he resigned it this week. (Drexel University is local to Philadelphia, where Mr. Goldstein works). Also of note, Dr. Thorsen was working with Emory University for about 6 years, much of that part time. The complaint by Aarhus involves him working “full time” in both Aarhus and Emory. This may go to the fact that it was pretty clear that Dr. Thorsen was at both Emory and Aarhus from his publication record. The complaint may not be about working in both places but, rather, having changed to full time status at Emory.

Mr. Goldstien notes that some groups have “seized” on these allegations to discredit the studies Dr. Thorsen worked on:

Anti-vaccine groups have seized on the allegations to contend that scientific studies disproving the vaccine link to autism are wrong. Those groups have long argued that thimerosal, a preservative in some vaccines, can cause autism, as can the MMR vaccine for measles, mumps, and rubella.

“I think it is quite significant,” said Dan Olmsted of the Age of Autism. “I think someone allegedly capable of ripping off his own university by forging documents from the CDC is capable of pulling off anything.”

And this is where the this situation becomes very important. If these allegations are true, does this negate the studies Dr. Thorsen worked on?

Mr. Goldstein addresses this with quotes from Mr. Olmsted (above) and people at the CDC and Denmark.

“Poul Thorsen had absolutely no influence on the conclusions regarding this paper,” wrote Mads Melbye, head of the division of epidemiology at the Statens Serum Institut in Copenhagen and senior author of the study, in response to e-mailed questions.

“Thorsen was not actively involved in the analysis and interpretation of the results of this paper,” Melbye said.

The second study, published in Pediatrics in 2003, examined 956 Danish children diagnosed with autism from 1971 to 2000. It concluded the incidence of autism increased in Denmark after thimerosal was removed from vaccines.

Kreesten Meldgaard Madsen, the lead author, said Thorsen played a minor role.

“Dr. Thorsen was not in a position to change or compromise the data,” Madsen wrote. “Dr. Thorsen was part of the review cycle, but never very active in giving input. Dr. Thorsen never had access to the raw data nor the analysis of the data.”

I doubt these statements will mollify Mr. Olmsted’s readers.

In a piece on WHYY (a public radio station in Philadelphia) has a story, Investigation of autism researcher’s conduct sparks controversy.

Dr. David Mandell of the Center for Autism Research agrees the studies Thorsen worked on should be reviewed. But he doesn’t believe the research has been compromised. He noted that Thorsen was not a lead researcher, the studies used government data, and they were peer-reviewed. This view is echoed in a statement from the Centers for Disease Control, which partly funded the vaccine research.

So, where does this leave us? With a lot more questions than answers still. One question in my mind at least is whether Dr. Thorsen is accused of transferring money to his own use or if he is accused of transferring money to fund his research at Emory when he left Aarhus. That aside, no matter what happens from here, this will be used to imply that vaccine-autism research (and not just that by Dr. Thorsen) is performed by corrupt individuals and should not be trusted.

Assume that the allegations are real. I can state that I am very angry at that possibility. I do not like dishonest people. I do not like dishonest researchers.

Mostly, I don’t like the fact that this will be (and already is being) used to put doubt in a lot of people’s minds about the role of thimerosal and MMR and autism. $2M is a small sum compared to the amount of suffering that will go on as this breaths a little life back into that movement.

My guess is that some readers are now ready to blame me of bias, of believing that Dr. Thorsen’s studies are accurate when I should be questioning everything he did. Let’s ignore the statements by his collaborators that Dr. Thorsen didn’t have access to the data to manipulate. Let’s just stick with the fact that the studies Dr. Thorsen worked on agree with the results of multiple other studies. The surprising outcome would be if on review the conclusions changed.

I am sure this story isn’t going away. And it should not. We need to know and we deserve to know what the details are here. Beyond that, I am sure that this will be forever in the lore of the vaccines-cause-autism community and will be used to convince ever more people to join.

For that, whoever is responsible for this mess, I am angry.

NIH to study recovered autistics

10 Mar

A clinical trial has been started to study and compare autistics (children to young adults) who have “remitted” autism. These are people who would be called “recovered” by the autism parent community.

The trial can be found on clinicaltrials.gov The purpose of the trial is given as:

Autism is defined as a lifelong pervasive developmental disability, as such, symptom recovery is considered rare. Reports by Lovaas and McEachin, Smith & Lovaas and more recently by Cohen, Amerine-Dickens, & Smith, Smith Groen et al. and Sutera Pandey et al suggest that intensive behavioral intervention programs during preschool years may result in improvement to the point where some children no longer meet criteria for autism by the time they reach school age. Similarly, there are a large number of anecdotal reports of children with autism who, following intensive biomedical intervention (e.g., gluten/casein free diets, vitamin supplements, chelation), are indistinguishable from their typically developing peers. The goal of the current research is to characterize the behavioral and biological profiles of children with autism who show significant symptom reduction such that they no longer meet criteria for autism (Remitted Autism [REM-AUT]) and to contrast them with a group of children who continue to meet criteria for autism (AUT) and to typically developing (TD) group of children. Examining whether neurobiological and neurobehavioral symptoms commonly reported in autism are as frequent and severe in children who have responded to treatment is an important first step in determining what factors may contribute to symptom remission in autism. In addition, understanding how children with remitted autism compare to typically developing children will help us better understand whether symptom improvement is through remediation (normalization of function) or compensation (achieving the same behavioral/adaptive outcome but through an alternative process)

Three groups will be compared: “remitted autism” (REM-AUT), “autism” (AUTISM) and “typically developing” (TD).

The inclusion criteria are given below. As you can imagine, the criteria are extensive for the “remitted” group.

Remitted Autism (REM-AUT) Group:

1. Diagnosis of autism prior to symptom improvement
1. valid administration of ADI and/or ADOS with accompanying interpretive report yielding an autism diagnosis
OR
2. clinical/developmental evaluation including a detailed review of the child’s history and direct observation of current behavioral functioning resulting in a documented diagnosis of autism by a child developmental specialist experienced with autism spectrum disorders such as a developmental pediatrician, developmental psychologist, child clinical psychologist, or a child psychiatrist
3. measure of cognitive ability from within 1 year of initial autism diagnosis
4. objective measure indicative of prominent autism symptoms using a recognized and standardized assessment of autism symptoms such as the Social Responsiveness Scale (SRS), Childhood Autism Rating Scale (CARS), or the Modified Checklist for Autism in Toddlers (MCHAT) or video tapes of assessments
5. initial diagnosis of autism prior to age 6
AND
6. Medical, educational, treatment record review by PDN branch clinicians to confirm diagnostic impressions including a detailed description of child’s behaviors that support an autism diagnosis
7. The final decision for meeting diagnostic and treatment history inclusion criteria is based on PDN branch staff review of the case
8. Treatment history: all participants must have received adequate treatment intervention for their autism symptoms. Participant medical and treatment records will be carefully reviewed to ascertain their treatment history

2. Current functioning:

a. Parent report and report of at least one professional that child is no longer autistic

3. At screening visit (after meeting initial eligibility), will not meet criteria for autism
1. Must not meet criteria for autism per overall clinical impression based on information collected from administration of the ADOS, current ADI-R symptoms, and other clinical observations made the assessment.
2. Teacher/informant report of autism symptoms (such as results from the SRS) not indicative of autism diagnosis
3. Minimum improvement of symptoms required from group assignment: approximately 2 point CGI severity of illness change (or equivalent) based on PDN impression of change in illness severity from initial diagnosis (estimated based on review of past medical records) and current functioning
OR
4. Current assessment of functional impairment due to autism symptoms using a standardized assessment measure such as the Developmental Disability-Children’s Global Assessment Scale will reflect adequate functioning in all areas and/or a clinically significant improvement in functioning, consistent with common psychiatric treatment definitions for treatment response

4. Able to participate in study procedures.

AUTISM Group:

1. Diagnosis of autism following the same criteria as described above
2. Treatment history: all study participants must have received adequate treatment intervention. Treatment history will be matched to treatment provided to children in the REM-AUT group.
3. Screening visit (after meeting initial eligibility): will meet criteria for autistic disorder using the same diagnostic process described for the REM-AUT group above
4. Matched to REM-AUT group on IQ, age of diagnosis, and treatment history. IQ matching between the AUT and REM-AUT groups will be based on pretreatment estimates of cognitive level obtained from the medical record review.
5. Able to participate in study procedures.

TD Group:

1. IQ matched to a sub-sample of children in the REM-AUT group with normal range intellectual functioning. IQ matching between the TD and REM-AUT groups will be based on current intellectual functioning at the time of study participation.
2. Able to participate in study procedures.

EXCLUSION CRITERIA:

All groups: May not be pregnant or have a known genetic disorder, mitochondrial disease, history of birth trauma, or current uncontrolled seizures

TD Group:

1. Current diagnosis or significant history of pervasive developmental disorder, language delay or disorder (except articulation), attention or learning issues, or major psychiatric condition.
2. Prematurity at birth less than 36 weeks gestation); or birth weight significantly below normal for gestational age (SGA- small for gestational age).

This is a study that should be done, in my opinion. I will note that this study has supposedly been one of the key pieces being sought by multiple parent groups. I will further note that I have not seen any of them mention this study. Quite the opposite, in fact. I see comments occasionally on blogs about how their frustration that such a study is not being performed. Perhaps I missed it, but I am curious why their leadership doesn’t make a big deal out of this.

Lawsuit against alternative medical practitioners Usman and Rossignal

5 Mar

A lawsuit has been filed in Chicago claiming that a child has been harmed by the treatments prescribed by Dr. Dan Rossignol and Dr. Anju Usman.

This is being reported in a story, Father of 7-year-old autistic boy says treatment harmed son. (also now on the Chicago Tribune’s website)

Doctor’s Data has also been named:

Coman also alleged that Doctor’s Data Inc., the St. Charles laboratory that performed the tests Usman and Rossignol used to justify these treatments, was negligent for using an “improper method” of testing.

We here at LeftBrainRightBrain have commented many times about the concept of “challenge” testing to “prove” heavy metal toxicity.

The suit spotlights a test often used to diagnose metal poisoning in children with autism. To conduct the test, doctors give children a chelation drug that forces the body to let go of some of the metals that exist in everyone – healthy or sick – in trace amounts. Those metals show up in urine, which is sent to a lab for screening.

In the case of Coman’s son, Doctor’s Data then compared those drug-provoked results to a reference range calculated for people who had never been given a chelation drug. Based on this apples-to-oranges comparison, Coman’s son was found to have elevated levels of lead, aluminum, tin and mercury – some with results Doctor’s Data listed in the “90% range of metal contamination,” according to the lawsuit.

According to the story, there are no comments from Doctor’s Data, Dr. Rossignol’s office nor Dr. Usman’s office.

Vaccines Don’t Cause Autism

4 Mar

That’s the title of an article at Smithsonian.com. The introduction spells out one of the dilemmas that face skeptics to the “vaccines cause autism” story:

It’s rare in science and science writing to make definitive statements, particularly about causation. We like to add what I call “wishy washy” words like “may” and “probably” and “perhaps.”

It’s the “you can’t prove a negative” thing. Can someone say that in all of history, for every person, vaccines have not caused autism through some mechanism not yet described? No. But, is there “overwhelming evidence”?

So when scientists or science writers make definitive statements like “vaccines don’t cause autism” and “vaccines save lives,” it’s because we have overwhelming evidence to back it up.

I expect that soon the author, Sarah Zielinski, will see what happens to blogs that dare make such bold statements. Links to the embarrassingly bad “fourteen studies” website will be posted. Comments that “only one vaccine and one ingredient” will be trotted out by people who lack the courage to acknowledge that the studies clear that vaccine (MMR) and that ingredient (thimerosal). “Too many too soon” will be spouted as though this is some real hypothesis rather than a mere slogan.

Ms. Zielinski finishes with:

Vaccines work. They don’t cause autism. Now, perhaps, scientists can spend their resources on figuring out what does instead of wasting them on a debunked theory.

And that is where the frustration comes in. Groups like SafeMinds and Generation Rescue, while they claim to be interested in environmental causes of autism, really only care about vaccines.

Sorry for yet another vaccine story, but it is nice to see people coming down with hard, clear statements. Real people use strong language all the time. Those pushing the vaccine-causation story use language that is completely unsupported by the facts.

Sometime scientists need to speak like regular people, as Sarah Zielinski has just done.

Parental Vaccine Safety Concerns in 2009

1 Mar

A paper in today’s issue of pediatrics looks at vaccine safety concerns amongst parents. The paper

Parental Vaccine Safety Concerns in 2009
by
Gary L. Freed, Sarah J. Clark, Amy T. Butchart, Dianne C. Singer, and Matthew M. Davis. All of the University of Michigan.

the abstract states:

OBJECTIVE: Vaccine safety concerns can diminish parents’ willingness to vaccinate their children. The objective of this study was to characterize the current prevalence of parental vaccine refusal and specific vaccine safety concerns and to determine whether such concerns were more common in specific population groups.

METHODS: In January 2009, as part of a larger study of parents and nonparents, 2521 online surveys were sent to a nationally representative sample of parents of children who were aged ?17 years. The main outcome measures were parental opinions on vaccine safety and whether the parent had ever refused a vaccine that a doctor recommended for his or her child.

RESULTS: The response rate was 62%. Most parents agreed that vaccines protect their child(ren) from diseases; however, more than half of the respondents also expressed concerns regarding serious adverse effects. Overall, 11.5% of the parents had refused at least 1 recommended vaccine. Women were more likely to be concerned about serious adverse effects, to believe that some vaccines cause autism, and to have ever refused a vaccine for their child(ren). Hispanic parents were more likely than white or black parents to report that they generally follow their doctor’s recommendations about vaccines for their children and less likely to have ever refused a vaccine. Hispanic parents were also more likely to be concerned about serious adverse effects of vaccines and to believe that some vaccines cause autism.

CONCLUSIONS: Although parents overwhelmingly share the belief that vaccines are a good way to protect their children from disease, these same parents express concerns regarding the potential adverse effects and especially seem to question the safety of newer vaccines. Although information is available to address many vaccine safety concerns, such information is not reaching many parents in an effective or convincing manner. Pediatrics 2010;125:654–659

The study was a survey of households with children. They contacted extra Hispanic and African-American households to get better statistics on those groups. But they normalized the data to account for this “oversampling”.

Table 3 shows that 11.5% of parents have rejected at least one recommended vaccine. Most listed the HPV (human papillomavirus) as the rejected vaccine. HPV is new, and is given to teenage girls to prevent a viral infection known to be a cause of cervical cancer. (click to enlarge)

Parental Vaccine Refusal

Table 4 shows parental attitudes for a number of vaccines. Reasons for rejecting vaccines vary from “I would rather my child got this disease” to “I personally know someone who experienced a harmful adverse event”. (click to enlarge)

Parent experiences and attitudes on childhood vaccines

The survey explored the views of parents on the autism/vaccine question:

One current specific immunization safety concern has been the spurious association of vaccines with autism. Although peer-reviewed original scientific research and multiple expert committees that have reviewed all available data on this issue have failed to show any association between vaccines and autism, anecdotally the concern continues to affect parents. Our study indicates that a disturbingly high proportion of parents, >1 in 5, continue to believe that some vaccines cause autism in otherwise healthy children. This finding indicates that current public health education campaigns on this issue have not been effective in allaying the concerns of many parents. Officials must attempt to develop more effective and targeted education campaigns that focus directly on this issue if their goal is to match parents’ level of concern with the available scientific evidence. Recently, the use of newer social marketing techniques have been suggested as potential strategies to address vaccine safety concerns.

>1 in 5 believe the “vaccines cause autism” story. Amazing. I’m sure that will be seen as a both a victory and a challenge to the groups pushing that message.

I hate to say it, but someone needs to. This study may be the most valuable study the trial lawyers working on autism/vaccine cases have seen. Much more so than the bad science of the Geiers or the speculation in Medical Hypotheses. Where this will be valuable will be in helping select a jury that is as sympathetic to their cause as possible.

A Nasty Little Franchise

15 Feb

Wakefield may have the highest public profile but he is just one of many who seek to profit from autism and he is by no means the worst. Remember the Geiers? This father and son team from Silver Springs in Maryland have an unsavoury record that makes Wakefield seem almost reasonable.

Wakefield breached the terms of his hospital’s ethics committee. The Geiers, operating out of the family home, invented their own IRB and granted themselves ethical approval for experiments on children with a powerful drug called Lupron. Lupron is used to treat precocious puberty, a rare condition in young children. It is also used is also used to treat prostate cancer in men, to treat endometriosis in women, and to chemically castrate sex offenders. The Geiers use it on autistic children and young adults.

Kathleen Seidel has catalogued their bad science, plagiarism, inflated academic resumes, the fraudulent IRB, cruel and unnecessary blood draws, attempted deals with TAP pharmaceuticals and the Lupron Protocol itself on her Neurodiversity website. Trine Tsouderos at the Chicago Tribune covers all the basics in her recent profile of the Geiers,  ‘Miracle drug’ called junk science.

The most disturbing part of Tsouderos’ story was the news that the Geiers were rolling out a franchise for others to cash in on their unproven and dangerous protocol. According to their website they offer the following

  • Genetic Markers (DNA Fragile X Syndrome, Blood Chromosome, Chromosome Microarrays, DNA Rett Syndrome, Angelman/Prader Willi Syndrome)
  • Mitochondrial Dysfunction (Carnitine, Lactic Acid, Ammonia, Hand Muscle Testing)
  • Hormone Imbalances (Total Testosterone, Free Testosterone, DHEA, DHEA-S, Androstenedione, Dihydrotestosterone, Total Estrogens, Estrone, Estradiol, ACTH, Aldosterone, Prolactin, FSH, LH)
  • Oxidative Stress/Inflammation (Neopterin, Lipid Peroxides)
  • Detoxification Pathways (Glutathione, Cystathionine, Homocysteine, Methionine)
  • Immune System Function (Immune Deficiency Profile, HLA-Testing, Immune Complexes, Food Allergies, Celiac’s Disease)
  • Heavy Metals (Porphyrins, Blood Metals, Urinary Metals)
  • Neurological Dysfunction (Brain MRI scans, Brain SPECT scans)
  • General Health Status (Comphrensive Metabolic Panel)

And this is the team that will deliver these services.

  • Maryland: Mark Geier MD, geneticist and David Young MD, Obstetrician and gynaecologist.
  • Springfield, llinois: Mary Young MD, psychiatrist and neurologist.
  • Ft. Lauderdale, Florida: David Claymore, neuroradiologist.
  • Parsippany, New Jersey: Paul King, industrial chemist.
  • Indianapolis, Indiana: Melissa Troutman, radiologic technologist.
  • Dallas, Texas: Janet Kern, RN, neuroscientist.
  • Louisville, Kentucky: Janet Pope, RN

And that is it. The only member of the American Academy of Pediatrics is Mary Young who has worked as a child psychiatrist. There are no board certified endocrinologists or anybody with the board certification to diagnose and treat precocious puberty in children.

And what of David Geier BA? He remains vice-president of the non-profit 501(c)3 Institute of Chronic Illnesses, Inc. and the non-profit 501(c)3 CoMeD, Inc. Much of the profit from the franchise will be directed to “these corporations dedicated to
autism research and advocacy efforts.” sure. So families or their insurers will be paying for treatments for their children that have been condemned by real autism experts as junk science. And the profits from this enterprise will be used to fund more junk science. Do they have a GMC in America? Do they want to borrow ours?

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California’s Invisible Autism Epidemic Continues

13 Feb

Over a year ago, I wrote a post at Autism Street titled,
“California’s Invisible Autism Epidemic“.

At the time, IDEA child count and population data was available through 2007. Admittedly, what follows is a bit of a repeat, but there is updated information included too.

That January 2009 post asked the following question:

It would seem that many an “autism advocate” has warned us of an impending “crisis” that looms for California’s healthcare systems and schools. If autism caseload is increasing, and it represents a real increase in autism itself, then a next logical conclusion is that, ceteris paribus, similar increases will also be seen in the total numbers of children in special education in California’s schools, right?

And suggested an answer:

Wrong – well, maybe wrong.

Another year has passed, and IDEA data for 2008 is beginning to become available. Here’s what the preliminary IDEA data for California kids in elementary, middle, and high schools shows for autism now:

Autism

To borrow a phrase from Bev over at Asperger Square 8, “Don’t Panic!”.

Also, please remember, that like the CDDS client data, the IDEA is not descriptive epidemiology.

The USDE data are not reliable for tracking the prevalence of autism, and they in fact never were meant to fill this need.

Source

What we can actually learn from this, is that the increase in the number of kids receiving special education services who wear an “autism” category label continues to increase.

Of course the, “not so fast” is next.

The Invisible Epidemic

The next graph shows a bigger picture in California. It’s the number of students (age 6-17) receiving special education services, as a percentage of the population (age 6-17) for all disability categories.

All Disabilities

The percentage has been flat, at a little under 9.2%, for 11 straight years. How is this possible? If there have been “epidemic” increases in the autism category, all things being equal, we should have seen this number rise, shouldn’t we? And therein lies one potential answer – all things are probably not equal. It’s true that within the IDEA data for California, the increase in the use of the “Autism” category label is not offset by decreases in the use of the category label “Mental Retardation”. The increase is also not offset by a corresponding decrease in use of the label “Speech or Language Impairment”.

Speech or Language Impairment

A communication disorder such as stuttering, impaired articulation, a language impairment, or a voice impairment that adversely affects a child’s educational performance.

Source

So what else is there? Something big in California?

Autism and SLD's

Specific Learning Disability

A disorder in one or more of the basic psychological processes involved in understanding or in using language, spoken or written, that may manifest itself in an imperfect ability to listen, think, speak, read, write, spell, or to do mathematical calculations, including conditions such as perceptual disabilities, brain injury, minimal brain dysfunction, dyslexia, and developmental aphasia. The term does not include learning problems that are primarily the result of visual, hearing, or motor disabilities, of mental retardation, of emotional disturbance, or of environmental, cultural, or economic disadvantage.

Source

I can still see how, in days of lower awareness and recognition of autism among parents and educators, an autistic child could easily be placed in this category (as a kind of catch-all), based on the first portion alone – “A disorder in one or more of the basic psychological processes involved in understanding or in using language, spoken or written…”. It could even be the case, that alongside less awareness and recognition, there was also some degree of unwillingness to use a category label like “Autism” on the part of both parents and educators.

Interestingly, the apparent in increase of .09% of the resident population categorized under “autism” appears to be offset by a .09% of the resident population decrease for “specific learning disabilities” in 2008.

Source data can be found at http://www.ideadata.org

Autism Science Foundation offering places at IMFAR 2010

11 Feb

Funds will enable parents and other stakeholders to attend the leading autism research conference and share what they’ve learned with the broader autism community.

The Autism Science Foundation today announced that is offering a limited number of grants to parents of children with autism and other stakeholders to support attendance at the International Meeting for Autism Research (IMFAR), to be held in Philadelphia, May 20-22, 2010. Awards of up to $1000 can be used to cover registration, travel, accommodations, meals and other directly related expenses, including childcare.

After the conference, grant recipients will be expected to share what they’ve learned with families in their local communities and/or online.

IMFAR is an annual scientific meeting, convened each spring, to promote, exchange and disseminate the latest scientific findings in autism research and to stimulate research progress in understanding the nature, causes, and treatments for autism spectrum disorders. IMFAR is the annual meeting of the International Society for Autism Research (INSAR).

“We are thrilled to be able to give back directly to the autism community in a research-focused way,” said Alison Singer, president of the Autism Science Foundation. “The award recipients will bring critical new research information to their communities, increasing the speed with which the latest data are shared with the broader autism community.”

“These scholarships are a wonderful opportunity to bring more stakeholders to the IMFAR and improve dissemination of the latest research findings presented at the conference,” said Dr. David Amaral, president of INSAR and director of research at the University of California at Davis M.I.N.D. Institute.

To apply, send a letter to grantsATautismsciencefoundationDOTorg describing why you want to attend IMFAR and, most importantly, explaining how you would share what you learn there with the broader autism community. Letters should be sent as Microsoft Word attachments of no more than 2 pages, 12-point type, “Arial” font, with standard margins. In the subject line please write: IMFAR Grant. Letters must be received by March 15, 2010. Recipients will be announced in April.

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