Clinical trial of Donepezil for improving REM sleep in autistic children

23 Mar

A recent lecture I heard discussed how as many as 25% of autistic children get little or no REM (rapid eye movement) sleep. REM sleep is an important sleep phase and it is thought this could contribute to cognition and behavior problems in these children.

Anecdotally (and probably confirmed by studies is my guess) many autistic children have sleep problems. Children are reported to sleep fewer hours, have problems getting to sleep and wake up in the middle of the night. This new result, to me at least, is the first I’ve heard of reduction or lack in REM sleep.

In response to this finding, a clinical trial is underway to study the use of Donepezil (Aricept) with autistic children.

The clinical trial description is:

Detailed Description:

Autism spectrum disorders are defined by aberrant development of communication and socialization in the presence of restrictive and/or repetitive behaviors. Recent epidemiologic studies have documented an increase in the number of children identified with autism spectrum disorder over the past decade and according to some, the current numbers indicate a prevalence of 1 per 150 (CDC, MMWR 2007, Feb 9th release). Despite the pressing need to identify causal factors, etiology remains elusive. Furthermore, the heterogeneity of presentation complicates attempts to locate autism’s home in the brain.

Polysomnography is a reliable non-invasive tool that can be used to study the basic pathophysiological mechanisms of autism and other developmental and neuropsychiatric disabilities. Our preliminary data in young children with autism supports a growing body of literature demonstrating that sleep architecture is abnormal in this disorder. Previous studies in children with autism have identified various abnormalities in REM sleep including the following: immature organization, decreased quantity, abnormal twitches, undifferentiated sleep and REM sleep behavior disorder characterized by the absence of the muscle atonia that is normal in REM sleep and resulting in an acting out of dreams phenomenon (Tanguay et al ,.1976, Elia et al., 2000, Diomedi et al. 1999, and Thirumalai et al., 2002).

Our cohort spent an abnormally short time in the REM sleep stage of sleep compared to total sleep time (hereafter referred to as SPT REM% for REM sleep as a percent of sleep period time), and had a prolonged latency to REM sleep. The function of REM sleep and its relationship to cognition and overall neurological health is unknown and a subject of ongoing research. We know from animal studies that REM sleep increases after intensive learning sessions. These laboratory findings formed the basis for the hypothesis that this sleep stage is important for cognitive processes and that REM sleep may be useful as an indicator of brain plasticity. Current studies continue to add support for this idea. REM sleep has most recently been implicated in the process of human memory consolidation and several studies suggest that it is crucial to normal cognitive function and in the processing of emotion in memory systems. Acetylcholine (Ach) is one of the major neurotransmitters necessary for normal sleep transitions and abnormalities in Ach have been implicated in REM deficient sleep in other populations, most notably Alzheimer’s disease.

This proposal is for a 6 to 20 week, single arm, open-label study to evaluate the ability of donepezil hydrochloride to enhance REM sleep in children with autism spectrum disorder found to have a low SPT REM% (defined as below 2 standard deviations of observed normative data for age). All patients will come through the screening protocol 06-M-0065. Those who meet a research diagnosis of autism spectrum disorder and are ages 2 to 11 (through the tenth year) will be evaluated for inclusion/exclusion criteria for the study.

The primary outcome measure of this protocol is to increase the SPT REM% in children with autism such that their REM/non-REM ratios begin to approach normative values. Donepezil enhanced REM sleep has been achieved in young healthy adults, in elderly, healthy adults and in elderly, demented adults with Alzeheimer’s disease. Furthermore, the studies in Alzheimer disease by Mizuno et al showed a positive correlation between improved cognition and increased SPT REM %. If REM sleep is necessary for normal cognition, and its deficiency or absence can be remedied by pharmacologic intervention, then it may follow that improvement of REM sleep correlates with improved short and long term cognition in children with autism. Donepezil enhanced REM sleep has not been documented in children. Polysomnography provides a non-invasive tool to assess the effects of enhancing cholinergic tone on the abnormal sleep architecture we have documented in our pediatric, autistic population.

My guess is that some are thinking, “why look at this drug when many already use melatonin to help autistic children sleep”. After all, Aricept is an Alzheimer’s drug, with little study in children.

OK, I admit I did. So I did a quick search and found that melatonin has not been found to increase REM sleep.

Aside from my reservations about giving an Alzheimer’s drug to 2 year olds, this is the type of clinical trial I like to see. A clear question is presented that is supported by data. A clear outcome (increased REM sleep) is measurable. Secondary outcomes, improved cognition and behavior, are also measurable and defined.

Trine Tsouderos and Patricia Callahan honored by the Association of Health Care Journalists for autism series

23 Mar

The Chicago Tribune has run a series of articles lately on alternative medicine and autism. The stories include OSR#1: Industrial chemical or autism treatment? (about a chelation chemical invented for mining operations, now labeled as a supplement and sold for “oxidative stress relief”), the self explanatory titled Autism treatment: Science hijacked to support alternative therapies, Autism’s risky experiments Some doctors claim they can successfully treat children, but the alternative therapies lack scientific proof and Autism treatment: Success stories more persuasive to some than hard data One dad, a doctor, says he was “fooled”

This is part of a series that won the Chicago Tribune one of two awards. Writers Patricia Callahan and Trine Tsuderos were honored.

“This powerful series combines first rate medical writing and rigorous investigative reporting to expose doctors who perform what the authors rightly call “uncontrolled experiments on vulnerable children” with autism,” commented the judges. “Writing with the authority that comes from total command of the material, Tsouderos and Callahan bring new clarity to a notoriously murky subject-autism treatments. They document a horrifying brand of bad science perpetrated by bad doctors on desperate families, but they do it without a hint of hyperbole or sensationalism. Their straightforward, professional tone lets the facts tell the story. The result is an important-and devastating-piece.”

With a tip of the hat to Autism News Beat for his story, Tribune investigation takes first place

addendum:

here is the text of the announcement about the Tribune team:

Chicago Tribune reporters examine Lupron – a testosterone inhibitor used to treat precocious puberty and to chemically castrate sex offenders – and its reputed ability to be a “miracle medicine” for a disease with few mainstream medical answers: autism. In looking into Lupron, the Tribune found a world of alternative treatments for autism with fervent supporters who made big claims they said were backed by science. But when reporters evaluated the treatments, painstakingly analyzing each claim, each paper, each therapy through a lengthy dialogue with scores of medical experts, parents and doctors, they found the therapies were risky and unproven and the science backing them was junk. The Tribune provided readers and parents with hard evidence and some difficult truths, concluding that thousands of children with autism are being subjected to mass uncontrolled experimentation every day.

Judges comments: This powerful series combines first rate medical writing and rigorous investigative reporting to expose doctors who perform what the authors rightly call “uncontrolled experiments on vulnerable children” with autism. Writing with the authority that comes from total command of the material, Tsouderos and Callahan bring new clarity to a notoriously murky subject-autism treatments. They document a horrifying brand of bad science perpetrated by bad doctors on desperate families, but they do it without a hint of hyperbole or sensationalism. Their straightforward, professional tone lets the facts tell the story. The result is an important-and devastating-piece.

For their piece Dubious Medicine

Does The NIH Want To Study Jenny McCarthy’s Son?

22 Mar

Why would the National Institutes Of Health want to study Jenny McCarthy’s son?

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.

Jenny McCarthy seems to have pretty much claimed she cured her son’s autism.

Yeah, I know, she’s apparently claimed a lot of stupid things though:

You know, I could in two months turn Evan completely autistic again. I could do it completely through diet. And maybe getting some vaccine boosters.

I really can’t keep up with Jenny McCarthy’s anti-vaccination and autism nonsense.

If you’re one of those types who’s attracted to McCarthy’s silliness like many are to a car accident, but are smart enough to just keep driving and later try to catch a thumbnail report of what much of the nonsense seems to be about, I recommend reading Kev’s recent piece in response to an article of hers in the Huffington Post.

An Open Letter To Jenny McCarthy

In that Huffington Post article, she wrote the following:

Parents of recovered children, and I’ve met hundreds, all share the same experience of doubters and deniers telling us our child must have never even had autism or that the recovery was simply nature’s course. We all know better, and frankly we’re too busy helping other parents to really care.

Uh huh.

And remember when Jenny McCarthy wrote this a couple of years ago at a CNN blog?

Evan is now 5 years old and what might surprise a lot of you is that we’ve never been contacted by a single member of the CDC, the American Academy of Pediatrics, or any other health authority to evaluate and understand how Evan recovered from autism. When Evan meets doctors and neurologists, to this day they tell us he was misdiagnosed — that he never had autism to begin with. It’s as if they are wired to believe that children can’t recover from autism.

So where’s the cavalry? Where are all the doctors beating down our door to take a closer look at Evan? We think we know why they haven’t arrived. Most of the parents we’ve met who have recovered their child from autism as we did (and we have met many) blame vaccines for their child’s autism.

Source (and emphasis mine)

Autism research was being funded and conducted by U.S. “health authorities” long before Jenny McCarthy entered and re-entered the public eye (rebranded from IndigoMoms.com to Generation Rescue back sometime between 2006 and 2008), of course. But I suppose it’s quite possible they weren’t interested in stories like Jenny’s. That’s apparently a thing of the past (and so should be McCarthy’s claim that they aren’t interested).

While it might not meet McCarthy’s apparent expectation of a personal contact, indeed the NIH is interested in the subject.

Identification of Characteristics Associated With Symptom Remission in Autism

Additional detail here.

This study has apparently been listed since June, and it’s still recruiting!

LBRB blogger, Sullivan, noted this not too long ago:

NIH to study recovered autistics

He had an interesting observation too:

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.

To repeat, a component of this study (which is also looking at other possible reasons for remission) is looking for Jenny McCarthy:

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 Sponsor and Researcher for this study? The NIH.
(Note to Jenny: that’s a “Health Authority: United States: Federal Government”)

They’re looking for Jenny. They want to hear her/Evan’s story (they’ll want substantiating detail too, but that won’t be a problem).

I wonder how many of the “Rescue Angels” or other AoA followers have signed up to participate? Did Jenny McCarthy get the word out to her people? I’m sure she did, right? Like Sullivan, did I miss it too? I could have.

If you don’t think she might have, and if you know Jenny McCarthy (cause lord knows, I don’t), please make sure she gets this info:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Shocking news from Danish autism epidemiolgists!

18 Mar

Danish epidemiolgists have looked at criminal behavior in autistics, and the results are nothing short of startling:

In their paper, Pervasive developmental disorders and criminal behaviour: A case control study, authors S.E. Mouridsen, B. Rich, T. Isager, and N.J. Nedergaard, show:

The prevalence and pattern of criminal behaviour in a population of 313 former child psychiatric in-patients with pervasive developmental disorders were studied. The patients were divided into three subgroups and compared with 933 matched controls from the general population. Age at follow-up was between 25 years and 59 years. An account of convictions in the nationwide Danish Register of Criminality was used as a measure of criminal behaviour. Among 113 cases with childhood autism,.9% had been convicted. In atypical autism (n = 86) and Asperger’s syndrome (n = 114) the percentages were 8.1% and 18.4%, respectively. The corresponding rate of convictions in the comparison groups was 18.9%, 14.7%, and 19.6% respectively. Particular attention is given to arson in Asperger’s syndrome (p =.0009). © 2008 Sage Publications.

Yes, autsitics are as much as 20 times less likely to be convicted of crimes as their “typical” counterparts (0.9% compared to 18.9%).

I ran across this abstract and, given the current hype over Danish epidemiologists I couldn’t resist presenting it in this sensational mode. Besides, the title may draw some readers from the contingent bent on portraying child autistics as a looming threat to the well being of society.

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

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