Behind the Vaccine Court: Zero Accountability
Las Vegas Sun Reports: CDC Admits Autism is Environmental

Prozac Study Fails to Show Effective Reduction of Autism Behaviors

Band aid By Kim Stagliano

Those of us in the autism treatment community seem to know instinctively that you can not simply "drug away" (mask) the behaviors associated with autism.  It was disappointing to read Autism Speaks' Peter Bell's statement about "treating the core symptoms" of autism. No. We need to determine what is causing the symptoms.  It's time for autism to be treated as a true medical diagnosis and get it OUT of the psychology-psychiatric-behavioral ghetto. We've done that in the treatment community. Come on, Autism Speaks. Join us.

Autism Speaks Announces Results Reported for the Study of Fluoxetine in Autism (SOFIA)  First Industry-Sponsored Trial for the Autism Clinical Trials Network (ACTN)

NEW YORK, N.Y. (February 18, 2009) – Autism Speaks today announced initial results reported for the first industry-sponsored trial of the Autism Clinical Trials Network (ACTN), the Study of Fluoxetine in Autism (SOFIA). These results showed that fluoxetine was not effective for reducing repetitive behaviors in children and adolescents with Autistic Disorder as compared to placebo (non-medicinal sugar pill).

The study was carried out in collaboration with study sponsor, Neuropharm Group Plc., a specialty pharmaceutical company focused on neurodevelopmental disorders.

The study evaluated the efficacy and safety of Neuropharm's new low-dose form of fluoxetine, known as NPL-2008, which is designed specifically for the treatment of Autistic Disorders in children and adolescents. NPL-2008 uses the Zydis® melt-in-the-mouth formula, intended to be an easier form of the medication for children. The study showed that repetitive behaviors were reduced when children were given either NPL-2008 or a placebo, but no differences between groups were found in terms of the level of reduction of repetitive behaviors. Thus, it was concluded that NPL-2008 was not more efficacious than the placebo. The new formulation was generally well tolerated by patients and no serious adverse events were reported.

Geraldine Dawson, Ph.D., Autism Speaks' Chief Science Officer remarked, "The development of effective drugs that are easily taken by individuals with autism is an important goal. While it is disappointing that NPL-2008 was not found to be effective for reducing repetitive behaviors, this study does highlight the importance of high quality, rigorously controlled clinical trials. Studies like this help build the evidence-base and offer parents guidance in making more informed decisions about their child's clinical care."

The Autism Speaks ACTN was launched in 2005 to address the need for more thoroughly tested biological treatments for autism. The ACTN provides a platform to rigorously test the safety and efficacy of existing compounds, most of which do not have specific indications or specific dosing instructions for their use in autism. These treatments are prescribed by medical practitioners for "off-label" use.

Fluoxetine is one of the most widely prescribed central nervous system (CNS) drugs for disorders such as anxiety, depression, and obsessive-compulsive disorder. It has been prescribed "off-label" by physicians to alleviate repetitive behavioral symptoms in autism. Smaller studies in children and adults showed promising results, but there had not been a large scale study of this type to systematically confirm the efficacy of the drug for reducing these behaviors in autism. Currently, there is only one treatment with a specific FDA-approved indication for autism, but it does not target the core symptoms of autism.

The SOFIA study is the largest trial ever conducted in patients with Autistic Disorder. The study was carried out across 19 ACTN medical centers and clinical sites throughout the US. A total of 158 patients between the ages of 5 and 17 were enrolled into the SOFIA study in which patients received either NPL-2008 or placebo during a 14 week treatment period. The full analysis of the primary and secondary data from the study is ongoing.

Peter Bell, Executive Vice President for Programs and Services commented, "Finding safe and effective medications that treat the core symptoms of autism is one of the greatest challenges facing our community. One of our primary goals at Autism Speaks is to help identify effective treatments that lead to improved quality of life for all those affected by autism."

Robert Mansfield, Neuropharm's CEO, stated "These initial results are both unexpected and disappointing, and we await the results of the full analysis which is currently ongoing. We would like to thank Autism Speaks' Autism Clinical Trials Network who facilitated the timely completion of this study and to thank the teams at the sites involved in SOFIA."

Comments

maggie

when I had finished reading all of posts I got more confused about it:S

Terri Lewis

Prozac doesn't work for depression, either.

Just google "Prozac doesn't work" for links to studies that show it: Prozac is no more effective than a placebo.

And it can make you suicidal, too.

But--they still sell it! Buyer, beware.

mlinn

Everyone should go and rate the article in Medical News Today here: http://www.medicalnewstoday.com/articles/139653.php

I gave it one star because zero wasn't an option. Here's the comment I posted:

This research is not valuable to families (like mine) affected by autism. My neurologist told me the results of this 10 years ago from his own practice and experience - - prozac and other SSRIs don't consistently provide results for children with autism, but occasionally they can help. Autism Speaks research agenda is misguided and wasteful. They should be ashamed for taking charitable donations nationally for this type of work.

Lin

This reminds me of when we were at odds with our son's educational model (one of many, btw). I spoke to his diagnosing doctor about their concerns....and ours. I'll never forget how I felt when the doctor's nurse called me at school. She had a prescription for our then four year old son, who has autism. She told me the Rx was for fluoxetine. I didn't understand. She said that it is the generic form of Prozac. I immediately began to cry! We were desperately searching for help for him. I couldn't believe that was the very best they had to offer us for our young child with ASD was Prozac. I was shocked and angry!! They were failing us and I knew it. The really frightening reality is they didn't know it! I would imagine they still don’t “get it.” I wouldn’t know; we no longer doctor there.

Diane

Kim -- thanks for refreshing my memory.

ElizaCassandra

"There is no such thing as a Prozac deficiency."

Magnificent, Ginger, magnificent. Thanks for raising my low spirits.

Gatogorra

I didn't know that about orphan drug patents-- that they were meant for rare diseases. How the rules get bent when there's a profit to be made.

I've been set off again-- sorry. Sadine is probably right, there's more coming down the pike as far as the "latest rage" in supposedly therapeutic psychotropes for autism. There's a lot of buzz around a glutamate theory of psychosis (which will always be extrapolated to autism) that, of course, neatly corresponds to something called "mGluRs-targeted" drugs.

In September 2007, Eli Lilly announced
results of a 4-week Phase II trial of their
metabotropic glutamate receptor 2/3
(mGluR2/3) agonist LY2140023 for
schizophrenia. Eli Lilly, Merck, Johnson
& Johnson and Pfizer (as well as partners
Addex and Taisho) are all tripping over themselves to develop mGluR "antipsychotics" (all the fun of a chemical straight jacket with yet unknown risks and less diabetes!).

Digression...There seems to be as big a fuss around the mGlUR theory as there was around serotonin "brain chemical imbalance" hypothesis. Look how that turned out: http://tinyurl.com/2g4kzy

Pharma is certainly looking for a new blockbuster since the atypical antipsychotic market is expected the flatten by 2012 (I have to ask, how is this factored? Are they expecting the market peak to correspond with a plateau in vaccine-induced autism rates?). In the meantime, the market for antipsychotics has been boom since the nineties:
http://tinyurl.com/lp9lz

Some sources report (if I'm getting this right) that sales for antipsychotics in the U.S. are over $10 billion a year of a $17 billion world market. For atypical antipsychotics sales, ground zero for profits was 1990, with the invention of the first atypical, clozaril.

So, bearing in mind what's at stake, bearing in mind that sales for just one class of drug typically used to "treat" children with autism (atypical antipsychotics) rose in almost perfect and direct proportion to skyrocketing autism rates and perhaps along with the rates of other, subclinical vaccine-induced brain injuries, I wonder if the big picture here can partly explain Thomas Insel's IACC shenanigans. Aside from the fact that Insel once headed an HIV vaccine research program.

The NIMH, like the CDC (but less officially and more sneakily), doesn't just oversee mental health science but also has the dual role of promoting psychiatric drugs.

Bruce Levine wrote about the "revolving door" of employment between the NIMH and phychopharmaceutical manufacturers (several directors and a parade of employees go on to lucrative jobs with Big Pharma) and that "To the delight of Big Pharma, NIMH uses taxpayer monies to fund researchers who are financially connected to pharmaceutical companies". http://tinyurl.com/2beln6

For the sake of the people who put Insel in power at the NIMH, Insel can't support vaccine safety research because, as we all know and as he must know, the outcomes would not only ravage the vaccine market but would eventually ravage sales in Insel's particular bull ring-- the psychopharmaceutical market.

Ginger Taylor

There is no such thing as a Prozac deficiency.

Sadine T

I think that Autism Speaks in conjonction most likely with Johnson & Johnson (Peter Bell was a Director in that company before moving to "Cure Autism Now", the old name of Autism Speaks) has already the "drug" that will work for Autism.
This initial research on a product that is non-effective was just a teaser before the next big discovery of a drug that will somehow work. Basically, by publishing the results of this research, they are trying to show that we can trust them after that.
Be ready (I will guess in the next 6 months) for a big marketing and media campaign showing the biggest breakthrough for a "drug discovery" to treat Autism.

Kathy Blanco

Some SSRI's have known to be somewhat antibacterial/immune modulatory? Some autistics really need that? I don't think personally it's the solution to autism however? I think the main three things to hit are infections, toxins, and inflammation. If at all possible, in natural forms...but sometimes the big guns are necessary. How about his one, don't cause autism in the first place..gee what concept? Personally, we have had a turn around by addressing thyroid function (my kids had hypo, I have hashimotos), addressing lyme disease with abx's (minocycline/biaxin, etc), and addressing inflammation (minocycline, celery juice juiced by juicer (see google news on that), and of course detox pathways, sauna, Hbot, etc. DMPS was a disaster for us (www.dmpsbackfire.com), and I think the best thing is building glutathione with immunocal or Iv glutathione or nebulized. Build zinc pathways, reduce copper if high, reduce iron if high, get cholesterol in control if high or low, etc..Of course the diet, free of GMO, MSG, no gluten, casein, corn or soy or preservatives. (yeah, good luck with that, it is in every food practically). Also addressing VIT D3. Dr Walsh found no mercury in the brain of autistics, did you all know that? He found in girls HIGH CALCIUM and boys had HIGH IRON. These mimic mercury poisoning symptoms. I think this is the result of the mercury, hit and run and damage. The resultant high calcium and iron, are probalby from damaged mitochondria in the brain? Who knows?

Stagmom

What I found appalling was that generic Prozac got an orphan drug patent at all. I'm no attorney - but an orphan drug patent is meant to protect a drug that has a very limited market - and therefore would NOT get much R&D or marketing support from a company due to its limited sales potential. Typically for a rare disease. Of course, autism WAS once rare - did Hollander know the numbers would skyrocket? Prozac is a blockbuster drug, so WHY an orphan drug patent at all?

Perhaps a lawyer can explain it to me.

KIM

Dan, tx

I think I understand this. Eric Hollander is using Autism Speaks and the Autism Clinical Trials Network (ACTN) as his own little piggy bank to validate his patent? If Eric Hollander owns the patent then why does the autism community (Autism Speaks) need to pay for this study? If the study was positive would Autism Speaks profit in any way? I would have expected Eric Hollander to fund this study, not the autism community.

Ray Gallup


Many years ago Eric was on Prozac for a short time and it didn't work and fortunately he wasn't on it for long.

A person recommended Eric try Fampridine-SR
so I requested that Eric's residential center look into trying it for Eric since he tested positive for myelin basic protein antibodies (in a blood test...similiar to MS).

In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged

Per.........
http://www.drugs.com/nda/fampridine_sr_090202.html

Gatogorra

Thank you for posting this and for making the point that there's a definite conflict to actually curing and preventing autism when so much money can be made in drugging the disorder. I think that's pretty much the definition of disaster capitalism, right? What surprised me when I saw this study was that they admitted the drug didn't work. That's very unusual for psychopharmaceutical studies.

Unfortunately, I don't think some on the science board of AS are going to stop grappling around for some psychoactive drug "for autism" that they can profit by. That profit motive and link to some of the very same companies which injured our kids in the first place is the reason I doubt this organization will ever really represent the vaccine-injury community. Things could change, but the tangled web is woven. Part of the tangle is that the drugs actually make autism worse in the long run.

For one, yes, like someone mentioned here, the "fluo" in fluoxetine is flourine (as in fluoride). Fluorine sequesters in bone indefinitely and its neurotoxic effects and potential for causing cancer aren't well studied (or studied at all). Furthermore, fluoxetine, like other SSRIs, in a mechanism which may have more to do with serotonin channels than its fluorine content, has been used as an adjunct to chemotherapy, specifically because some in this class of drugs are very effective at increasing the porosity of the blood-brain barrier (theoretically allowing more chemo drugs to get to the brain).

The problem with increasing BBB porosity is obvious, particularly for children who may already have damaged blood-brain barriers and efflux disorder-- the drugs may very well allow more environmental toxins and metals to reach the brain. Furthermore, the drugs may help the toxins *stay* in the brain. SSRIs in general and fluoride specifically have been shown to reduce levels of glutathione. Studies by David Thompson [Monsanto...published in "Chemico-Biological Interactions" 126(1):1-14 (2000)] showed intracellular glutathione levels decreased in rats exposed to fluoride. This is also true of neuroleptics: http://www.nature.com/bjp/journal/v136/n2/abs/0704717a.html

Some SSRIs, including Prozac, have been used as chemotherapy agents for brain tumors on their own because of their effectiveness in killing rapidly dividing cells. Unfortunately, the drugs are apparently more effective at killing healthy brain cells than cancer cells. Part of the process of apoptosis in drug induced brain cell death is damage to mitochondria. This might explain why the drugs, at least in the "honeymoon" phase at the start of "treatment", seem to suppress anxiety and improve behavior in some people: euphoria is often the sensation that accompanies mass brain cells death-- the reason that people sniff glue and solvents to get "high".

Industry funded studies consistently try to suppress and counter research showing that these drugs induce apoptosis, are toxic to mitochondria and have a negative impact on immune regulation. The ongoing research "argument" can be seen in any Pubmed or google search (see all the contradictory studies which come up for any search on "mitochondria and SSRIs", "TNF-alpha and SSRIs", etc.). As more attention is paid to the routes of damage of vaccine-induced autism, the industry denial studies will probably increase accordingly. For example, some industry studies make general claims that the drugs decrease pro-inflammatory cytokines, the idea being that the drugs are "good" for people with inflammatory brain damage (these "denial of damage" studies were tailored to sell the drugs for Alzheimers and neurological autoimmune diseases initially). But further studies show the reverse, that fluoxetine increases tumor necrosis factor alpha (TNF-alpha) and other pro-inflammatory cytokines which have been implicated in autistic regression, both by Wakefield et al and in studies of the effects of thimerosal.

Just to review: SSRIs increase blood brain barrier, theoretically allowing more mercury to reach the brain. The drugs deplete glutathione, trapping mercury, etc., in the brain and body. The drugs are shown to increase the pro-inflammatory cytokines implicated in regressive autism and are mito-toxic. Makes one ask, who needs vaccines when half the disorder can be reproduced with the psychotropes used to treat it?

For this screamingly obvious reason, any organization which promotes the use of these drugs wouldn't be likely to support research into and disclosure of the mechanisms of vaccine injury and environmentally induced autism-- because it appears that the routes of damage of both classes of medical product are very similar and overlap in places. If these interested parties can't suppress information on routes of damage in environmental autism, they might go to plan B and promote false research showing that the drugs "improve" vaccine and environmentally-induced damage in regressive autism.

Either way, I can't think of a bigger conflict of interest to getting the truth out and helping our kids than this. Risperdal and the other neuroleptics, benzodiazepines and psychostimulants have been shown to be even more guilty of these various modes of brain/immunological damage.

prozacispoison

There is an article today on Science Daily about how alzheimers research might start looking at the (gasp) liver. You know the organ that detoxifies environmental toxins. Maybe Autism Speaks might go in that direction instead of poisoning the liver with prozac.

karenatlanta

We went through a solid year of constant meltdowns.
We found out they were:
zinc deficiency
low dopamine/adrenal stress
mitochondrial dysfunction
I am so glad we investigated and tested because just a few basic supplements that were lacking stopped this.
5 HTP has been researched for effectiveness side by side with Prozac and found to be just as effective w/o all the nasty side effects.

Vax Sins

What will Autism Speaks try next, homeopathic crack ??
Doesn't Prozac sounds like Eli Lilly to them too ?? Like in Thimerosal??????

Stagmom

Yes, Eric Hollander is affiliated with NeuroPharm and has owned the orphan drug patent on fluoxetine since the 1990's. If that trial had been successful, he and perhaps Autism Speaks, would have made a bundle on the "new miraculous treatment!" So where's the incentive to "cure" autism if you stand to make billions on a drug to treat it, but never cure it?

HEre's part of an piece that ran on the old Rescue Post:

Eric Hollander is another bigwig with AS and owns the orphan patent for the generic of Prozac. He is also a psychiatrist. His affiliated company in England is running a huge trial for Autism Speaks to see if Prozac can become an approved autism treatment. This Eric believes there are two approaches to treating autism, behavioral and medication. We hope you can open this link http://www.medscape.com/viewarticle/497979 for his actual wording. If you can't open it, try pasting it into your browser. You can read the article from Google. Also, see Rescue Post July 6th, Snape, Good or Evil for details about his Prozac link.

The current Autism Speaks NAAR team has never believed in the biomedical treatment of the causes of autism. They are psychiatrists. They know about behavioral conditioning and psych meds. That is their area of expertise. Would you invite a proctologist to launch a brain surgery clinic? Only if you had your head up your......


Elucidatus

There will never be a cure for Aids, Autism and Cancer as long as we have knuckleheads searching for useless treatments rather than trying to find the cause.

Why fix it when we can just continue to treat it for hundreds of dollars a prescription. We can make Millions... wait make that Billions....

Stagmom

Natasa, that's why many of us referred to CAN! as "Cure Autism Never." Well, they lived up to their name - and continue to do so while resting comfortable within the luxurious confines of Autism Speaks.

Kim

Diane

Gee...I wonder how much money they spent on this study. I know that I received phone calls from clinics asking that my daughter participate. (No, thank you.) Too bad that money wasn't spent on areas that have already showed promise. But wasn't an AS guy one of the patent holders for that drug? DIdn't he stand to make a big load of money had it been approved as a treatment?

Natasa

Peter Bell ... commented, "Finding safe and effective medications that treat the core symptoms..."

Just summed up the core problem of modern 'medicine'. Treating symptoms instead of causes.

This study would be the equivalent of conducing trials of ever bigger band-aids to treat external symptoms of AIDS.

Stagmom

And next we'll learn that Risperdal doesn't treat food allergies. Shocking, but true. ;)

Holly M.

I guess this study proves that Prozac does not treat mercury poisoning - the cause of repetitive behaviors.

maggie

I learned yesterday that prozac has fluoride in it. Like dumbing down fluoride. Thanks Autism Speaks. How about studying chelation, it's the only thing that helps/helped my son.

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