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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.

Blogger Shannon Rosa on the radio talking about “My Baby Rides the Short Bus”

18 Mar

I just linked to Shannon Rosa’s blog yesterday and here I go again. Her blog, Squidalicious, the adventures of Leelo and his potty mouthed mom, is a good read. She contributed to a new book, “My Baby Rides the Short Bus”.

I haven’t read the book yet. I heard about it a while back but I wasn’t really aware that it came out already. So, I was glad to get the podcast and listen about it. She is joined by Jennifer Byde Myers (who also contributed to the book) and Sarah Talbot (co-editor of the book).

http://www.kqed.org/assets/flash/kqedplayer.swf

The book, My Baby Rides the Short Bus, is available.

Shannon Rosa talks about the facts and myths of the “perfect mom” that many outside the disability community have as an expectation. She talks about the adjustment as her child grows from a young child to an adolescent and how the

To me, Ms. Rosa, Ms. Myers and Ms. Talbot present a good balance in talking about how there are extra difficulties parenting a disabled child.

Holly Robinson Peete on Huffington Post

18 Mar

Here’s something refreshing: an autism post on the Huffington Post that I would recommend people to read. Shifting Focus: 8 Facts About Autism the Media Is Not Covering is by Holly Robinson Peete.

I don’t agree with everything there. But, hey, I don’t agree with everything anyone writes (even some of what I’ve written!). Ms. Peete is known partly for her association with another celebrity autism mom, one whose methods and stances I find little to support. But, so what? Ms. Peete is a supporter of biomed. But, so what? Read her post. That is far from her main focus. Ms. Peete’s post is largely from a parent’s perspective and focuses on child autistics. Again, so what? She has some good things to say.

Here are her eight points:

1. Autism Is Unaffordable

Ms. Peete doesn’t put this in terms of being a burden. Instead she points out that therapies can be expensive. She doesn’t mention which ones specifically, but just speech and occupational therapy can be well beyond the means of most families. Figure 3-4 sessions a week at $100 or more a session.

Getting insurance to help out is far from easy.

2. Parental Guilt

So if you are blessed enough to afford it, in my experience it seems that some kids can improve tremendously with a mix of intensive behavioral, biomedical and other treatments. But the fact is so many likely will never be “recovered” and nothing, I mean nothing, makes a parent feel more guilty than thinking you could’ve “fixed” your kid but… well you didn’t or couldn’t afford to.

OK, I would have felt better with “helped” than “fixed”, but the idea is there. And, yeah, we could get into the whole “guilt is what drives the biomed movement” thing, but let’s not for now.

3. Puberty Plus Autism Can Be a Volatile Mix

Still in my future, but it is a future I have strong worries about.

4. Minority Children are Diagnosed with Autism Years Later Than Other Children

I think I’ve made it clear in the past few years that this is a major issue for me. Minority children are diagnosed later, and often never diagnosed. This is just plain wrong.

5. Autism Can Be Tough on A Marriage

This is a subject that I won’t go into. Ms. Peete points out that her husband has a book on the subject coming out.

6. Autism’s Effect on Siblings

Again, I won’t go into this much. I wish Ms. Peete didn’t put it in terms of what the siblings of autism “endure”, but life as the sibling of a disabled child is different from what we read about 99.99% of the time

7. Adults Living with Autism

Ms. Peete points out that the “face of autism is changing”. Well, let’s take it that the face the public sees is changing. Whether one believes in the “epidemic” or not, one thing everyone should be able to work together on is making life better for autistic adults.

8. Autism Advocates Who Actually Have Autism:

Hey, we just had a post about one. I wonder if Ms. Peete would join me in welcoming this

That said, my view is that it is time to shift the balance in advocacy. Autistic advocates should be the standard, not something worth commenting upon. Autism is spectrum, and there must be room for non-austistic advocates who stand for autistic family members or friends.

Squidalicious has a good post on this, Holly Robinson Peete: Autism Style, Towards Clarity and Grace.

Again, I think it is easy to fixate on what divides us. But, for me, if more of the biomed movement sounded like Ms. Peete, I think coalitions would be much easier to form.

Arthur Allen in Readers Digest and the false claims of false vaccine safety groups

17 Mar

For some reason I like Arthur Allen. Something about his approach appeals to me. This was solidified when he covered the Green our Vaccines rally in Washington DC. I thought Mr. Allen demonstrated pretty clearly that Jim Carrey didn’t really understand the subject, with one simple question. Mr. Allen was removed from the rally for no other reason than he disagrees. What has stuck in my mind is this phrase from his piece:

I walked over to the little retaining wall around the monument and greeted Dan Olmstead, a former UPI editor who runs Age of Autism, a Website that champions the vaccines-cause-autism line and belittles those who disagree. Despite our profound differences, Dan’s an old journalist like me, and he thought it was wrong they’d sic’d the cops on me.

I like the idea of both Arthur Allen and Dan Olmsted recognizing the fact that they are both “old journalists” and finding common ground. That’s stuck in my mind.

Arthur Allen has a new piece, H1N1: The Report Card, in Reader’s Digest. In it he interviews Secretary Kathleen Sebelius, Secretary of the Department of Health and Human Services in the U.S.. I wouldn’t know about the piece except for the fact that two bloggers (both from the Age of Autism) covered it claiming censorship. One piece, Sebelius Asks Media to Censor Autism Debate and another Did Kathleen Sebelius Pressure Media to Deny Vaccine Safety Voices?

What caused this concern on their parts? Well, this quote from Secretary Sebelius:

There are groups out there that insist that vaccines are responsible for a variety of problems despite all scientific evidence to the contrary. We have reached out to media outlets to try to get them to not give the views of these people equal weight in their reporting to what science has shown and continues to show about the safety of vaccines.

I agree with what Secretary Sebelius says–don’t give equal weight. As Orac at Respectful Insolence says: “Censorship.” You keep using that word. I do not think it means what you think it means. Asking the media to not give equal weight to groups whose science is poor at best (consider the decisions from the Omnibus hearings–“these are not close cases”) is not censorship. A well-researched article on the “vaccine debate” would be, precisely because it is well researched, clear that this is not a debate of groups with an equal standing. The science used to promote, say, the vaccines-cause-autism idea is of very poor quality (again, read the Omnibus decisions).

I have to say, I even take issue with the idea that this is some suppression of the voices of the “Vaccine Safety Voices”. Really? Vaccine safety?

The section of the Reader’s Digest article that stuck in my mind is this:

[Reader’s Digest]: You recently took part in the ribbon-cutting for a new Holly Springs, N.C., factory that will produce cell culture-based flu vaccines as early as 2012. Do you think cell culture vaccines will help?

[Kathleen Sebelius]: That plant is a big deal for two reasons, not the least of which is that it brings manufacturing capacity back to the United States. That’s a significant step forward—we’re not so reliant on production elsewhere. During the current epidemic, two companies had to fill orders in their own countries before they could make the vaccines available to us. Secondly, cell-based culture doesn’t necessarily speed the growth time, but it is more reliable. Once the growth is there, you have yield that is much more stable than with egg-based technology. It isn’t a silver bullet, but egg-based technology is 50 years old and we need to get to a variety of approaches that could be used in the future. So the investments need to continue: What are the alternative growth strategies? What else should we be looking at?

Why would a cell-based flu vaccine plant catch my eye? Because it would likely reduce adverse events from flu vaccines. Egg based technology leaves the risk for allergic reactions to egg proteins that might remain in the vaccine. By moving away from this technology, the U.S. could have a safer vaccine in place.

Did the “Vaccine Safety Voices” mention this at all in their pieces? Not at all.

Have the loudest voices in the so-called “Vaccine-Safety” movement in the U.S. ever stressed simple improvements such as this?

Quite simply: no.

This is one reason why I don’t consider groups like those represented by the Age of Autism or the “National Vaccine Information Center” to be true vaccine safety advocates.

Senate Committee approves nominations for National Council on Disability

17 Mar

I received this from Meg Evans of the Autistic Self Advocacy Network (ASAN) on the 12th. Sorry for the delay in posting it. Ari Ne’eman (of ASAN) has been nominated by President Obama to serve on the National Council on Disability. This nomination was approved by a Senate committee and will now go on to the full senate for a final vote.

Nominees for Disability Council, Other Federal Boards Approved by Committee

The following seven nominations for members of the National Council on Disability were approved by committee and will go on to the full senate for vote:

o) Gary Blumenthal, the executive director for the Associated of Developmental Disabilities Providers. Blumenthal previously served as director of the President’s Committee on Mental Retardation under President Clinton.

o) Chester Alonzo Finn, a special assistant with the New York State Office of Mental Retardation and Developmental Disabilities. Finn is blind and developmentally disabled and is president of the national board of Self-Advocates Becoming Empowered, according to the White House.

o) Sara A. Gesler, a state representative in the Oregon State House of Representatives and the youngest woman in the Oregon State Legislature. She founded the non-profit FG Syndrome Family Alliance, which serves families dealing with the rare developmental disability FG Syndrome.

o) Ari Ne’eman, the founding president of the Autistic Self-Advocacy Network. He also serves as vice chairman of the New Jersey Adults with Autism Task Force.

o) Dongwoo Joseph Pak, vice president and loan officer of the Farmers & Merchants Bank and board member of Acacia Adult Day Health Care Services. He has also serviced on the Special Needs Advisory Board for the Orange County Transit Authority and on the California State Rehabilitation Council.

o) Carol Jean Reynolds, the executive director of the Disability Center for Independent Living. She is also a member of the governing board of the National Council on Independent Living. She has faced several mental health and substance abuse issues and has been in recovery for 26 years, according to the White House.

o) Fernando Torres-Gill, the associate dean for academic affairs at the UCLA School of Public Affairs. He was the first assistant secretary for aging in the Department of Health and Human Services, and is a polio survivor, according to the White House.

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.

Vaccine Court Decision: thimerosal containing vaccines do not cause autism

12 Mar

The decisions are in for the second phase of the Omnibus Autism Proceedings–the “vaccine court” trials to determine if autism can be considered as a vaccine injury. The first set of decisions were handed down last year (those regarding the MMR as a causative agent). This set explored whether thimerosal, the mercury containing preservative formerly used in childhood vaccines, could cause autism.

The decisions are long, and I expect there to be much discussion. Below are the final paragraphs from the decisions. These are for the three “test cases”, the hearings held for three specific children who petitioned for compensation on the basis of autism as a vaccine injury. They are clear and decisive: the evidence does not support thimerosal containing vaccines as causing autism, in general or in these three children in specific.

Mead:

Petitioners’ theory of vaccine-related causation is scientifically unsupportable. In the absence of a sound medical theory causally connecting William’s received vaccines to his autistic condition, the undersigned cannot find the proposed sequence of cause and effect to be logical or temporally appropriate. Having failed to satisfy their burden of proof under the articulated legal standard, petitioners cannot prevail on their claim of vaccine-related causation. Petitioners’ claim is dismissed, and the Clerk of the Court SHALL ENTER JUDGMENT accordingly.

King:

Thus, I feel deep sympathy for the King family. Further, I find it unfortunate that my ruling in this case means that the Program will not be able to provide funds to assist this family, in caring for their child who suffers from a serious disorder. It is certainly my hope that our society will find ways to ensure that generous assistance is available to the families of all autistic children, regardless of the cause of their disorders. Such families must cope every day with tremendous challenges in caring for their autistic children, and all are deserving of sympathy and admiration. However, I must decide this case not on sentiment, but by analyzing the evidence. Congress designed the Program to compensate only the families of those individuals whose injuries or deaths can be linked causally, either by a Table Injury presumption or by a preponderance of “causation-in-fact” evidence, to a listed vaccine. In this case, the evidence advanced by the petitioners has fallen far short of demonstrating such a link. Accordingly,

Dwyer:

Petitioners have not demonstrated by a preponderance of the evidence that Colin’s condition was either caused or significantly aggravated by his vaccinations. Thus, they have failed to establish entitlement to compensation and the petition for compensation is therefore DENIED. In the absence of a motion for review filed pursuant to RCFC, Appendix B, the clerk is directed to enter judgment accordingly.

AOL Health interviews Jeanette O’Donnell

12 Mar

America Online (AOL) has a series of articles on autism recently added to their site. They have 5 articles, including one on Jeanette O’Donnell. Ms. O’Donnell is very active online with her blog What are they thinking? and commenting as mom26children.

Ms. O’Donnel describes herself as:

I am the proud mother of 6 children. 5 of our children have autism. We do not feel our world has ended, but just begun. We do not chelate, intervene biochemically, give shots of any kind, practice ABA, etc. We treat them as we treat any humanbeing. We treat them with kindness and respect and expect the same from them. They are exceptional children.

The article, Caring for — and Blogging About — Her Five Autistic Children

I’ve always liked reading her posts and her comments. She’s a straight shooter, she doesn’t hold back, and she stays friendly.

Here is a section from the AOL piece (but take the time to go and read it)

O’Donnell:… But you still haven’t asked the question.

AOL: What is the question?

O’Donnell: People ask why I had six when I knew the first was autistic. First, the doctor told us there was no chance that a second kid would have it, so we didn’t know. But I want the people who question them to meet them. And I want them to tell me which one shouldn’t be here. Every one of my kids belongs. They are here for a reason. I don’t know what it is, but there’s a reason. Well, actually, I do know the reason.

O’Donnell: What’s the reason?

O’Donnel: So I could be their mama, that’s why they’re here! It’s very selfish. No, the truth is: They’re gonna teach the world a lot.

The Boston Globe defends the Judge Rotenberg Center

12 Mar

The United States Department of Justice has opened an investigation on the Judge Rotenberg Center. The investigation is to determine whether certain methods of the JRC violate the Americans with Disabilities Act (ADA).

An Op-ed piece in the Boston Globe defended the JRC

Shocking truths
The Rotenberg Center’s methods are undoubtedly unorthodox. But they work.
by Lawrence Harmon

You can read the article at the Boston Globe site. Here is the final paragraph:

THE JUDGE Rotenberg Center in Canton, which stands alone in its use of painful skin shocks to eradicate self-mutilation and sudden assault, is a storehouse of ethical and medical dilemmas. But it’s no shock – and no shame – that the parents of some autistic and mentally retarded children embrace this controversial school.

There are some very impassioned comments after the article. I won’t quote the JRC parents who posted without permission, but I would encourage you to read the comments.

One comment is by Nancy Weiss, who worked with the coalition of disability advocacy groups that filed the complaint against JRC is below:

The Judge Rotenberg Center likes to make the point that there are no other options for people with severe, dangerous behaviors, however not only are there people just like the people at the Judge Rotenberg Center who are being supported humanely and effectively all over the United States; there are people who were at the Judge Rotenberg Center who are doing wonderfully with positive behavior supports in community settings across the country. These are people who JRC warned would never make it outside of their center, people they said would need to be hooked to the shock devices for life, people who were moved in spite of the Judge Rotenberg Center’s dire warnings that they would be violent and dangerous. As I said to Mr. Harmon in a lengthy conversation prior to his writing his column, logic tells us that the 193 people at JRC can’t be the only people in the country with behaviors this severe. I’m sorry he didn’t take me up on the contacts I provided him so he could learn how people with behaviors just as severe are supported successfully without resorting to painful methods.

The Judge Rotenberg Center would like visitors to believe that painful electric shocks are used only infrequently and only for the kinds of extreme behaviors Harmon lists in his article: eye gouging, head banging and the like – but a New York State report found students as young as nine years old subjected to sudden, painful, repeated electric shocks for such harmless behaviors as “refusing to follow staff directions”, “failing to maintain a neat appearance”, “stopping work for more than ten seconds”, “getting out of seat”. “interrupting others”, “nagging”, “swearing”, “whispering” and “slouching in chair”, and “moving conversation away from staff..” The Boston Globe itself reported on the testimony of former employees who spoke about a student who received as many as 350 shocks in one day, a figure the Globe reported was confirmed by the school. That Globe article reported a former employee to testify, “the shock is more painful than described by school officials. I got hit accidentally on my thumb and I had a tingling up to my elbow, on the inner part of my arm, I would say for four hours. I was saying I can’t believe these kids can do this. My hand was shaking. I wanted to go home, that’s how bad it was.”1

The director of the Judge Rotenberg Center testified at a Massachusetts legislative hearing that one student received 5,300 electric shocks in one day. In his testimony, he stated that over a 24-hour period, this student, a teenager who weighed only 52 pounds, was strapped to a board and subjected to an average of one shock every 16 seconds.2 A 2007 New York Times article notes, “a former teacher from the school …said he had seen children scream and writhe on the floor from the shock.” The Times article also speaks to how painful the shocks are, “Technically, the lowest shock given by Rotenberg is roughly twice what pain researchers have said is tolerable for most humans, said James Eason, a professor of biomedical engineering at Washington and Lee University”.3 And, even more frightening, all of the statements above were made before JRC came out with its newest shock device – the GED-4 which, according to a 2006 Boston Globe article, “deliver(s) 45 milliampere shocks — 4 1/2 times stronger than the standard shocks” According to that article, ”Greg Miller, a former teacher’s assistant for more than three years, said one boy with autism was shocked by the higher-powered device so often that he had ‘burn scabs all over his torso, legs, and arms,’ forcing nurses to remove the electrodes for weeks so that his skin could heal”

Just a bee sting, used only occasionally in the most extreme circumstances? Harmon may have bought this but the facts don’t support it.

Harmon seems to think that these practices are OK because they are approved by parents and a probate judge. Let’s be clear that the Judge Rotenberg Center is a lucrative business. On their 2008 IRS forms (the most recent ones publicly available) JRC reported $390,301 in compensation for their Director. The Center was so beholding to the Judge who approved all the aversive procedures for their students that when he died, they re-named their facility in his honor. The facility used to be called the Behavior Research Institute but advocates would ask, “where’s the research?” Yes, the courts approve these practices, but one wonders how much they know about humane, effective alternatives.

And, in terms of parents approving the electric shock? Just ask parents like Evelyn Nicholson. In 2006, The Boston Globe reported that, “Evelyn Nicholson initially approved the shocks, but said she changed her mind as her son became more desperate, complaining that the shocks knocked him to the floor. Previously, she said, ‘I was advised that the shock . . . felt like a small pinch,’ and that the devices were rarely used.” Nicholson, like numbers of parents, when they found out what was being done to their sons and daughters, told JRC that they did not have their permission to use painful procedures on their kids and were told that if permission for the shock was not given they could come and take their son or daughter home. Parents giving permission? Not with any element of the free will that the term ‘permission’ usually implies.

Harmon speaks of other schools – schools he was told kids like these might be at if not for the Judge Rotenberg Center; schools where these kinds of students would instead be subjected to mechanical restraints. That might make a reader think that the Judge Rotenberg Center doesn’t use these restrictive techniques. The New York State investigational report on JRC states, “With mechanical movement limitation the student is strapped into/onto some form of physical apparatus. For example, a four-point platform board designed specifically for this purpose; or a helmet with thick padding and narrow facial grid that reduces sensory stimuli to the ears and eyes. Another form of mechanical restraint occurs when the student is in a five-point restraint in a chair. Students may be restrained for extensive periods of time (e.g., hours or intermittently for days) when restraint is used as a punishing consequence. Many students are required to carry their own “restraint bag” in which the restraint straps are contained.”4 The same report notes, “Some of these students were observed to be fully restrained in restraint chairs and wearing movement limiting helmets. One student left the school building in full restraint (hands and feet restrained with Velcro straps in a restraint chair), clearly agitated and upset, and returned the following morning carried to the conference room fully restrained in what appeared to be the same chair.”5

When I spoke to Mr. Harmon he seemed particularly swayed by the video called “Before and After” that almost every visitor sees. A 2007 Mother Jones article described the “before” footage shot in 1977, “An 11-year-old girl named Caroline arrives at the school strapped down onto a stretcher, her head encased in a helmet. In the next shot, free from restraints, she crouches down and tries to smash her helmeted head against the floor.” The Mother Jones reporter goes on to say, “Considering how compelling the “After” footage is, I am surprised to learn that five of the six children featured in it are still here. ‘This is Caroline,’ one of my escorts says an hour or two later as we walk down a corridor. Without an introduction, I would not have known. Caroline, 39, slumps forward in a wheelchair, her fists balled up, head covered by a red helmet. ‘Blow me a kiss, Caroline,’ Israel says. She doesn’t respond.”

And here we have perhaps the most important point that Mr. Harmon missed. If these methods worked – if their inhumanity was justified by their success, you wouldn’t have students still there after 33 years. You wouldn’t need to continually develop devices that deliver a stronger and stronger shock or methods to spread the electrodes so the electrical current passes through more flesh for the purpose of assuring greater and greater amounts of pain. Positive behavioral approaches are proven to have more staying power; they give people tools that they can use for life and they help them to change dangerous behaviors in ways that value, enhance, and include people rather than through the use of methods that are coercive, controlling, and inhumane. While the “after” portion of the tape Mr. Harmon watched might have seemed compelling, did he ask why, if these methods worked, people are still there 33 years later, still hooked up to the devices that are touted as being so effective?

I’m sorry Harmon was taken in, as so many casual visitors before him have been. It’s easy to spend a few hours and accept what you’re being told at face value. It’s easy when you’re under deadline to buy into the belief that no alternatives exist. Mr. Harmon said he feels that the concerns of the 31 disability organizations that signed the letter that motivated the Department of Justice investigation seem “too pat.” I hope it is clear that these organizations did not take lightly the decision to sign this letter. These groups represent the major, mainstream developmental disability organizations in the country including the American Association on Intellectual and Developmental Disabilities, The Arc of the United States, Easter Seals, United Cerebral Palsy and 27 others which together represent the most respected researchers in the country.

No one should be deluded into thinking that Mr. Harmon’s visit to the Judge Rotenberg Center told the whole story. The Judge Rotenberg Center has a business to run; they are not going to tell a reporter that humane options exist, but the several hundred thousand professionals and advocates represented by the 31 disability organizations that called for the Department of Justice investigation, know full well that they do. And because they do, this treatment of our most vulnerable citizens should not be tolerated by a society grounded in a commitment to the ethical treatment of all people.

Nancy Weiss

March, 2010

I would make a simple statement: the Judge Rotenberg Center is paid with over $50M of taxpayer money. Why shouldn’t the taxpayers spend a little more money (and a little more than the few hours Mr. Harmon spent) to insure that the Center is within the laws? For all it’s clients. All the time.

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