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Tell Legislators that Interagency Autism Coordinating Committee is Massive Waste of Tax Dollars

Older Drug Reinvented for Autism

Old dogBy Teresa Conrick

In 2011, I wrote about how drug makers were thrilled about the money expectations in treating glutamate receptor issues and Autism.    Ironically, another new study will be again showing that glutamate receptors [ mGluR1] are not working properly in those who have an Autism diagnosis.  This from The Wall Street Journal:

"ZURICH—Changes in the brain caused by autism can be reversed in mice, a new preclinical study showed, opening a potential path to develop a treatment for the incurable disorder.

Roche Holding AG,ROG VX +17%  a Swiss drug maker, and the University of Basel's Biozentrum said Friday the study identified a way to reverse a dysfunction in the brain's wiring typically caused by the disorder, which stumps intellectual development and can cause aggressive and anti-social behavior, and becomes evident in early childhood.

The study results will be published in the Oct. 5 issue of Science.

Researchers found that reactivating a gene involved in the formation of synapses, or junctions between nerve cells, can scale down the excessive production of a receptor called mGluR1. In some autistic people this gene is not working. Controlling production of the receptor ultimately makes structural defects in the brain--which are typical of autism—disappear."

Yet we are not told WHY there are changes in the brain.  Instead we are whisked off into the land of genes and structural defects.  Here's another, from the NYT, heralding the big release of this study AND the money:

Competitors Form Partnership to Develop Autism Drugs 

"Two of the front-runners in the race to develop drugs to treat mental retardation [WOW - guess Mr. Pollack missed this back in 2010 ] and autism are joining forces, hoping to save money and get to the market sooner......“This deal will establish the biggest effort to date” in autism drugs, Luca Santarelli, head of neuroscience for Roche, said before the announcement. Financial terms are not being disclosed."

...The mechanism that has perhaps shown the most promise, at least in mice, is to damp signaling in the brain by blocking a receptor called mGluR5. [Note that the WSJ said mGluR1]

Roche will provide money to help Seaside complete its clinical trials of arbaclofen. Seaside will halt development of its own mGluR5 antagonist, which it licensed from Merck, and will instead receive royalties on sales of Roche’s drug.

The alliance could pose a challenge to Novartis. “This is No. 2 and No. 3 ganging up on No. 1,” said Dr. Michael Tranfaglia, medical director of the Fraxa Research Foundation, which sponsors research into treatments for fragile X syndrome.

Dr. Randall L. Carpenter, chief executive of Seaside, said the money from Roche was a needed diversification of the company’s funding. Virtually all of the $90 million Seaside has raised has come from the Barony Trust, which is run by Peter Whipp, a British investment manager."

The picture that is emerging is that there is going to be loads of money - a BONANZA - in treating all of these symptoms!  And it's all GENES!  Well, not really though you would not know that from all of these articles.  Autism is a HUGE money ticket for drug development but the reality is that much of the mechanism of action from many drugs always takes us back to the scene of the autism epidemic.

I have posted before about certain drugs targeting Autism symptoms and how each also targets MERCURY toxicity and damage:

Namenda (Memantine HCL)
Rilutek (Riluzole)
N-acetyl cysteine (NAC)   [This is an OTC antioxidant supplement that some companies are hoping to "investigate" for Autism. ]



The issue of researching and targeting drugs for Autism and glutamate dysfunction is not new yet the infomercials keep coming:

Universität Basel (2012, September 14). Disorder of neuronal circuits in autism is reversible, new study suggests. ScienceDaily

"In collaboration with Roche the research groups from the Biozentrum at the University of Basel have now identified a defect in synaptic signal transmission that interferes with the function and plasticity of the neuronal circuits. These negative effects are associated with increased production of a specific neuronal glutamate receptor, which modulates the signal transmission between neurons. An excess of these receptors inhibits the adaptation of the synaptic signal transmission during the learning process, thus disrupting the development and function of the brain in the long term."

Now this part is just dramatic - like a bad reality show - heavy on genes and zero on environmental causation - it's also the farthest thing from the epicenter of the immune and gut issues ,,,,,,,"Autism is a hereditary developmental disorder of the brain. A central risk factor for the development of autism are numerous mutations in over 300 genes that have been identified, including the gene neuroligin-3, which is involved in the formation of synapses, the contact junction between nerve cells"

Now for REALITY.  Mercury IS a big player in regression into an Autism diagnosis. Autism has increased into an epidemic as environmental mercury and vaccine mercury aka Thimerosal have increased since the generation of children born in the 1990's.  Thimerosal has been shown to be a significant producer of autoimmunity, thus, viral and bacterial vaccines as well as environmental infections trigger behaviors as many victims cannot clear these microbes which then trigger a whole host of medical issues involving mitochondria, GI and brain inflammation. It is a glaring reality that the first cases of Autism were children born in the 1930's, when Thimerosal was first used in both medical (vaccines) and environmental (pesticides) products. It may be important to note that vaccines today, like MMR [Measles-Mumps-Rubella]  contain glutamate. In addition, it may be of interest to know that this upcoming drug being developed is a new version of an older drug, Baclofen, which has showed much aid in severe gastrointestinal issues, a true core issue in Autism and one that many patients developed after the MMR vaccine: Effect of the GABAB agonist baclofen in patients with symptoms and duodeno-gastro-oesophageal reflux refractory to proton pump inhibitors 

Effect of baclofen on esophagogastric motility and gastroesophageal reflux in children with gastroesophageal reflux disease: a randomized controlled trial.

Here is that pertinent research to again show that the glutamate system can be directly harmed by Thimerosal:

Study implicates thimerosal in glutamate dysfunction

"...the effects of thimerosal on the expression, function, and transport activity of two types of cellular transporters, GLAST and GLT-1, that remove glutamate from synapses (the spaces between neurons) after its release from neuronal receptors. These transporters
must function correctly in “cleaning up” glutamate, in order to keep the glutamate system in proper balance....“Overall, the study provides direct evidence for the potential of thimerosal to alter glutamate homeostasis in the central nervous system.”

Hornig et al. -- ".....thimerosal caused ...abnormal hippocampal neurons with altered glutamate receptors and transporters."

NOTE also, from that same 2005 ARI article, the post regarding Fragile X and mGluR.  This is not new information. I am all for looking into treatments and cures for Autism but the repeated "NEW" research on "MANY GENES" and "NEW" drugs to target "CHANGES IN THE BRAIN" is complete and utter nonsense and we should not stand for it!  Millions of dollars are going into the same rerun rabbit hole with an attempt to blame the genes.  The theme it appears is to try and fix a profound injury that modern medicine caused.

Shhh.  It's a secret.

Teresa Conrick is Contributing Editor to Age of Autism.

Comments

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aspie

So SICK OF MEDICATIONS that do NOT work in our children with autism. Fed up. I'm so done done done with medications. It's a colossal FAILURE in the treatment of autism. And cannabis is a scam. There's 1000's of different strains. And don't think for a second some strung out hippie in a dispensary is going to tell you which strain is best for your autistic child. It's a joke. This dude can't even find his way to the snack machine without help.

Terri Lewis

No vac,

And all,

One last comment on NAC and/or Risperidone, because it might help others.

The NAC is great--and in line with what I typically go for--vitamins, minerals, etc. True healing.

For the record, I have always SWORN that I would NEVER give my child any pharmaceuticals, and only did so: After everything else I could find had worked/stopped working/petered out, whatever AND. . .we were truly desperate to just take the edge off long enough so that our son could learn. . .AND he was getting big enough and old enough that we felt that stopping the aggression was a big deal. (Age 10 and kind of big.) Etc.

We will be weaning him off said Risperidone over several months, since I doubt that it continues to do much/any good.

Still. . .

Just sharing for anyone else in those shoes and I know lots of people are.

Sarah

I think it always good to hear postive and negative whe it comes to drugs for our kids so parents can feel informed. Here is another story of a boy with Fragile X who had postive results on arbalofen


Special Report: New drugs, fresh hope for autism patients

http://www.reuters.com/article/2012/05/31/us-usa-autism-drugs-idUSBRE84U0II20120531

Kim No-Vac

Question to Rainneexcepted : how far off neurotypical would you say your son now is because your comments sounded quite upbeat ? 70% ? I ask because for my 6.5 year old child , the education is going very well , the diet is going well , bodily strength is improving , overall health is good , talking is improving all the time . Just the behaviours , the tantrums , the screaming , the wildness , but if i could fix those issues , the child might be nearly indistinguishable , so I might be tempted to say the child is at 80% if I were in an optimistic mood .

MercuryAluminium poisoning eh , who needs it !
Criminal prosecutions coming soon to all those involved - forget that immunity nonsense - we are going to tear up that rubbish first thing.
I know they read what we say , so like to frighten them regularly for they must be cowards to do as they have done !

Rainneexcepted

Our sixteen year old has been taking baclofen for the last year and a half. Absolutely has made monumental changes in anxiety and learning which was evident shortly after starting. Is he now neurotypical? No, but his (and our), quality of life is vastly improved. We cannot foresee discontinuing it except to perhaps switch to arbaclofen when it is available.

no vac

@Terri,

I would never give a neuroleptic to any child. They are too toxic and have long lasting or permanent side effects, which would add to the existing problems of autistic children. NAC is a different story, it is beneficial and safe supplement, helping in detox of vaccine poisons. If you are giving your child really very, very low dose of risperidone, may be he would be better off without any.

Adriana

From http://www.Rxisk.org , warnings about the baclofen (same diff) component of arbaclofen:

Baclofen: Side Effects
Nervous System

Nervous system side effects have been common. They have included transient drowsiness and sedation in as many as 63% of treated patients. Dizziness, weakness, and fatigue have been reported commonly. Akathisia, ataxia, opisthotonos, nystagmus, somnolence, dystonia, and decreased reflexes have also been reported. At high doses, coma and respiratory depression may occur. Dystonia, dyskinesia, chorea, encephalopathy, seizures (including generalized nonconvulsive status epilepticus), catatonia, and frontal lobe syndrome have been reported rarely. A case of recurrent transient global amnesia has also been reported.

Most of the side effects listed above were reported following intrathecal injection of baclofen. In addition, patients receiving intrathecal baclofen may be at risk for baclofen toxicity or withdrawal due to pump/catheter malfunction, patient position (facilitating rostral spread) and other factors.

Other 1

Abrupt withdrawal of intrathecal baclofen (regardless of the cause) has resulted in sequelae that includes high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity that in rare cases progressed to rhabdomyolysis, multiple organ system failure, and death. Sudden discontinuation of baclofen may result in neuropsychiatric signs and symptoms of withdrawal including confusion, seizures, psychosis, hallucinations, disorientation, dyskinesia, and visual disturbances.

A case has been reported of a febrile reaction to subarachnoid baclofen administration.

Cases of intrathecal mass at the tip of the implanted catheter have been reported, most of them involving pharmacy compounded analgesic admixtures.

In the first 9 years of postmarketing experience, 27 cases of withdrawal temporally related to the cessation of baclofen therapy were reported. Six of the patients died. In most cases, symptoms of withdrawal appeared within hours to a few days following interruption of baclofen therapy. Common reasons for abrupt interruption of intrathecal baclofen therapy included malfunction of the catheter (especially disconnection), low volume in the pump reservoir, and end of pump battery life. Human error may have also played a causal or contributing role in some cases.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal.

All patients receiving intrathecal baclofen therapy are potentially at risk for withdrawal. Early symptoms of baclofen withdrawal may include return of baseline spasticity, pruritus, hypotension, and paresthesias. Some clinical characteristics of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexia, infection (sepsis), malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.

Rapid, accurate diagnosis and treatment in an emergency room or intensive care setting are important in order to prevent the potentially life-threatening central nervous system and systemic effects of intrathecal baclofen withdrawal.

The suggested treatment for intrathecal baclofen withdrawal is the restoration of intrathecal baclofen at or near the same dosage as before therapy was interrupted. However, if restoration of intrathecal delivery is delayed, treatment with GABA-ergic agonist drugs such as oral or enteral baclofen, or oral, enteral, or intravenous benzodiazepines may prevent potentially fatal sequelae. Oral or enteral baclofen alone should not be relied upon to halt the progression of intrathecal baclofen withdrawal.

Seizures have been reported during overdose and with withdrawal from baclofen intrathecal as well as in patients maintained on therapeutic doses of baclofen intrathecal.

Psychiatric

Psychiatric side effects have been reported including paranoia, mania, euphoria, depression, anxiety, psychosis, hallucinations, paresthesias, hysteria, and personality disorder.

One small study has reported, however, that the frequency of depression and anxiety in baclofen-treated patients is not different from patients not taking baclofen.

Cardiovascular

Cardiovascular side effects including hypertension, bradycardia, and orthostatic hypotension have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, constipation, abdominal pain, diarrhea, dysphagia, fecal incontinence, gastrointestinal hemorrhage, and tongue disorder have been reported (especially with rapid dose increases).

Genitourinary

Genitourinary side effects including urinary frequency have been reported in 2% to 6% of treated patients. Enuresis, urinary retention, dysuria, abnormal ejaculation, kidney calculus, oliguria, vaginitis and impotence have also been reported.

Endocrine

Endocrine side effects including ovarian cysts have been palpable in 4% of women treated with baclofen for up to one year.

Respiratory

Respiratory side effects including apnea, dyspnea, and hyperventilation have been reported. Cases of acute bronchospasm (particularly in patients with asthma) have been reported rarely.

Hepatic

Hepatic side effects including elevated liver function tests have been reported rarely.

Dermatologic

Dermatologic side effects including rash, sweating, alopecia, contact dermatitis, and skin ulcer have been reported.

Hematologic

Hematologic side effects including leukocytosis and petechial rash have been reported.

Other 2

Other effects including fever, malaise, hypothermia, slurred speech, nightmares, confusion, headache, memory impairment, insomnia, and excitement have been reported.

Oncologic

Oncologic side effects including carcinoma have been reported.

Musculoskeletal

Musculoskeletal side effects including ataxia and muscle pain have been reported.

General

General side effects have included effects on sleep. One study has reported that a single, therapeutic dose of baclofen alters sleep architecture and produces a small reduction in mean sleep oxygen saturation, but does not significantly increase sleep disordered breathing.

And that's not all... In pregnancy, may cause omphaloceles -- baby born with intestines, liver, etc., outside the body. Also disintegration of seizure control and baclofen is on the Merck manual list of hepatotoxic drugs (damage via mito pathways?). And more..

Baclofen: Warnings: General
Baclofen therapy should not be discontinued abruptly. Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ system failure, and death. Abrupt discontinuation may result in withdrawal symptoms including seizures, auditory or visual hallucinations, and confusion. (A case has been reported of severe hyperthermia and spasticity due to abrupt withdrawal of intrathecal baclofen, which was unresponsive to high-dose oral baclofen, but was responsive to dantrolene.)

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to proper programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplantation clinician and patient information.

There have been reports of intrathecal mass developing at the tip of the implanted catheter, most of them involving pharmacy compounded analgesic admixtures. The most frequently reported symptoms of intrathecal mass are: decreased therapeutic response (worsening spasticity, return of previously well controlled spasticity, withdrawal symptoms, poor response despite increased doses of drug, or frequent or large dose increases); pain; or neurological deficit or dysfunction. Patients on intraspinal therapy should be carefully monitored for any new neurological signs or symptoms. In patients experiencing symptoms of an intrathecal mass, a neurosurgical consultation should be considered to rule out the disease progression itself. An imaging procedure may be appropriate to confirm or rule out the diagnosis of an intrathecal mass.

Baclofen should be used with caution in patients who require spasticity or rigidity to maintain upright posture or locomotion.

Baclofen should be used with caution in patients with a history of seizures because it may cause deterioration of seizure control.

Intrathecal baclofen should be administered and titrated only by individuals trained and experienced in the use of this therapy. Initial intrathecal dosing should occur under close medical supervision. Personnel and equipment necessary for treatment of baclofen toxicity should be immediately available.

The manufacturer considers baclofen to be contraindicated in patients with skeletal muscle spasm resulting from rheumatologic disorders.

Baclofen has not been shown to have benefit in the treatment of muscle spasm related to stroke, cerebral palsy or Parkinson's Disease and therefore should generally not be used in patients with these disorders.

Sarah

Here is a more in depth article that talks in more detail about the response of children with autism while on arbaclofen

A Drug Shows Promise in Autism
by Karen Weintraub

A chemical that alters chemical signaling seems to ease anxiety and other symptoms.


http://www.technologyreview.com/news/420794/a-drug-shows-promise-in-autism/

Sarah

Below is a link to a video interview Dr. Jeremy Veenstra-VanderWeele who is doing research on arbaclofen. He receives funding from Seaside Therapeutics, Novartis, and Roche Pharmaceuticals

Experimental Autism Spectrum Drug Improves Symptoms-

http://www.clinicalpsychiatrynews.com/specialty-focus/childadolescent-psychiatry/single-article-page/experimental-autism-spectrum-drug-improves-symptoms.html


An excerpt from the article:

"Children showed significant improvement on the Aberrant Behavior Checklist social withdrawal subscale, from a mean 18.1 at baseline to 12.6 after 8 weeks, based on an intent-to-treat analysis. In addition, the researchers rated more than half – 20 of the 32 kids – as "much improved" or "very much improved" on the Clinical Global Impression for Improvement measure.

At the same time, mean scores on the Aberrant Behavior Checklist Irritability subscale significantly improved from 24.7 to 17.3.

"We saw a lot of promising improvements in people who were taking the medicine," said Dr. Veenstra-VanderWeele, assistant professor in psychiatry at Vanderbilt University in Nashville.

"We did see some adverse events, as you would expect. None of these were terribly severe, and most of them looked similar to fluctuations in peoples’ baseline behavior," Dr. Veenstra-VanderWeele said. One severe adverse event was increased aggression during a planned taper of arbaclofen.

"The medicine was very well tolerated, especially in contrast to available medicines in autism, which, unfortunately, can have significant side effects," Dr. Veenstra-VanderWeele said.

Two participants discontinued because of increased agitation or aggression, and another five discontinued for other reasons, so 25 children and adolescents aged 6 years to 17 years completed the 8-week study. All participants met DSM-IV and Autism Diagnostic Interview (ADI-R) for autism spectrum disorder.

A double-blind, placebo-controlled study with up to 150 people is underway to confirm these results, Dr. Veenstra-VanderWeele said. When the Food and Drug Administration might approve arbaclofen for treatment of ASD is difficult to determine, he added. "The study initiating now will probably take about 6 months. Then I would anticipate there would be one more follow-up study if that study is positive."

"One really positive thing is this agent ... is closely related to a medication that has been available for decades: baclofen," Dr. Veenstra-VanderWeele said. "Because of that, the safety profile is fairly easy to predict, in contrast to a lot of investigational agents where you really have no idea going in."

Seaside Therapeutics funded the study. Dr. Veenstra-VanderWeele said he receives research funding from Seaside Therapeutics, Novartis, and Roche Pharmaceuticals."

Donna K

Just a word of caution of experience in the use of this Rx. My mother, having MS, was prescribed oral baclofen for her spasticity and the end result was a significant weakening of the muscles in her legs that put her right into a wheelchair. This weakening was proximate and of significant effect to the use of the baclofen. She was on it for about two years. We did not know at the time that baclofen's effect at GABA receptors are also irreversible.

The use of baclofen as a treatment in studies with children for GERD has also resulted in muscle weakness in some of those children. Something to consider as a contraindication for some of our mito kids.

Terri Lewis

No vac,

And anyone interested,

NAC not only shows potential, it's helping my son NOW. And yes, we are using it in addition to a very (very) small, daily amount of Risperidone.

We have used 600 mg., then 900 mg., of the NAC, twice or even three times a day, for a total daily amount of 1,800 mg. to 2,400 mg.

CureNOW

Sarah, Amen to that! I don't care if the motivation is money, either. Principle is a luxury my family can't afford. We just need a cure.

Benedetta

Hmmm Kim No-Vac that was interesting; If baclofen can help it the cravings for --- alcohol and probably other drugs too - then maybe they can load it up on the helicopters that buzzes the whole community in search of Mary Jane and spray us all down with it. Since, the whole community seems to have a strong undercurrent of drug abuse.

Thank you Teresa for the article.
This drug probably only helps if given close to the injury - I am sure.

I wonder if this drug will also take care of the diabeties,thyroid, and obsesity problems that the vaccines have caused?

Any guesses on that?

no vac

Riluzole & memantine are drugs searching for a disease. Drug companies are manufacturing diseases, such as autism, to find use for their products. I think these drugs will make autistic children even sicker. However, supplements such as NAC may have potential. I would never give a hard drug to an autistic child, they need detox, anti-inflammatory vitamins Vit E+C, fish oil, Mg, and for excessive anxiety rather quieting herbs (e.g. chamomile, melissa, valerian) than toxic drugs.

Sarah

I don't care if money is the motivation anymore. I just want a treatment that helps our kids. I'm keeping a close eye on Seaside Therapeutics research for use of this drug to treat autism. Here is a recent presentation Mark Bear, Co-founder of Seaside Therapeutics did before the US Congress. It's very interesting.

http://www.seasidetherapeutics.com/video

CureNOW

Kim No-Vac, thanks for the info! I appreciate it! :)

Kim No-Vac

correction to the authors name : Olivier Ameisen's
apologies

Kim No-Vac

Baclofen has been on the market for a long time , cheap as chips .
Historically baclofen was designed[by whom?] as a drug for treating epilepsy. It was synthesized for the first time in Ciba-Geigy by the Swiss chemist Heinrich Keberle in 1962.[19][20] The effect on epilepsy was disappointing but it was found that in certain patients spasticity decreased. Baclofen was and is still given orally with variable effects. In severely affected children, the oral dose is so high that side-effects appear and the treatment loses its benefit. How and when baclofen came to be used in the spinal sac remains unclear, but as of 2012[update] this has become an established method for the treatment of spasticity in many conditions.

[edit] Alcohol and other addictionsInspired by reading Olivier Ameisen's The End of My Addiction (2009), an anonymous donor gave $750,000 to the University of Amsterdam (UvA) in the Netherlands to initiate the clinical trial of high-dose baclofen which Ameisen had called for since 2004.[21] The trial started in January 2011, led by the team of Pr. Dr. Reinout Wiers. Ameisen has been contacted by the team.[22]

In May 2011 a Scottish team from Glasgow presented: "Baclofen at a Tailored Dose Reduces Alcohol Use, Craving and Consequences of Drinking in Alcoholics with Medical Disease due to Alcohol Dependence" at the "Royal College of Psychiatrists Faculty of Addictions Psychiatry Annual Meeting". They used doses between 15 and 360 mg of baclofen per day and winning the conference prize for the best poster raised the profile and increased interest[citation needed] in baclofen as anti-craving drug.

Kim No-Vac

I read a book by Dr Frank Arnesen "the end of my addiction" , his battle with alcohol and how he conquered it using high does Balcofen .
And I suggested Balcofen might be useful in the autism field to stave off the anxiety I see my child suffer with .
I first mentioned this to my physician back in august 2011 and never really got a response to that . So am interested to see it here in this article now .

CureNOW

Any word when baclofen will be on the market? It sounds promising and our kids need help now.

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