FDA Steps Up to the Plate on OSR#1

Back in January,Tsouderos wrote on OSR#1, and I covered her article, some of the most outrageous comments, and Stagliano's defense of her use of and shilling for OSR#1; that blogpost is below this updated information.

Tsouderos breaks the story today that the FDA has sent a letter to Haley, which  "details five violations of the Federal Food, Drug and Cosmetic Act related to his product, OSR#1. Failing to correct such violations can result in fines, seizure of products and even criminal prosecution." **Sullivan from LBRB links to the FDA letter.**

Unfortunately, not even this can wake Stagliano up. Tsouderos writes: "In an e-mail, Stagliano wrote that she continues to support Haley, a regular speaker at autism recovery conferences. 'Having met Dr. Haley at conferences, including Autism One in Chicago last month, I continue to trust his science,'she wrote on Wednesday. 'I'm sure CTI Science will address the letter appropriately.'"

Yes, meeting someone trumps safety studies. Promises of a cure (hmm, and maybe a discount to write that yum, it's wonderful on waffles?) apparently outweighs consideration of everything else, like the double standards those at AoA hold for vaccines, where no amount of studies will ever be enough, but one page is good enough for a heavy-duty mining chelator to be given to kids. No problem there.

Undoubtedly, the original posters and AoA supporters will soon be out in full force at the Tribune, and the bat shit crazy detailed below will be back on display. It certainly explains the cupcake hit piece on AoA today. Why is it that they see no hypocrisy in attacking female journalists and their credentials to interview and report on stories and yet believe that two mothers with no science background are absolutely qualified to 1) deconstruct the "14 studies" and 2) speculate that being a red head makes one susceptible to autism (oh, and Rett's in neurodegenerative, but Asperger's, PDD-NOS, and autistic disorder are most emphatically NOT)?

At any rate, here's my January piece, looking at OSR#1, crazy comments, and the insane defense of what is obviously untested, potentially dangerous wooquackery.

Recovery at All Costs, No Matter the Cost: After All, Autism is "a potentially deadly disorder"

Bensmyson, in response to my comment on Trine Tsouderos's article "OSR#1: Industrial chemical or autism treatment? Parents giving kids compound created for use in mining, sold as supplement," writes:

"I believe a parent has the right to do what they feel is best for their child and I support those who take the steps to recover their child from a potentially deadly disorder."
My response to that:

So, a parent thinking prayer is good for type 1 diabetes or cancer in their child is something you support? Lupron, chelation, HBOT, marijuanana, nicotine? That's all good? First autism parents who come out saying crack cured autism, you'll be behind because they recovered their child?

As Ken writes at Autism News Beat, this new story by Tsouderos is the latest in the Tribune's series of potentially dangerous, scientifically unwarranted treatments that desperate parents are using on their children. 

Tsouderos, in her investigation of this miracle supplement that AoA's Stagliano swears by, found that OSR#1 is: 

"An industrial chemical developed to help separate heavy metals from polluted soil and mining drainage."
Stagliano assures AoA readers in December 2008, though, that it is a good thing, and folks should help Haley give it to families for free:

"My three girls take OSR with positive results. (Remember when Gianna learned to tie her shoes?)"

In April 2009, Stagliano really endorses the product, calling for readers to get their doctors or dentists to register with Haley's company so they can provide it. Ummm, parents thinking that dentists can "treat" autism? But big pharma is evil and out to condemn a generation of children to being autistic? Logic, reason, rationality, critical thinking are all offline. But, hey, Stagliano is sure that this miracle DRUG is responsible for all the gains her daughters are making! 

"My three girls began taking OSR several months ago. OSR has been the only recent addition to their treatment. I can tell you that Gianna is now in two mainstream classes in school, Mia is telling me what day it is and what's on her schedule at school and Bella is.... well, Bella is cuter than ever and her receptive speech has improved to where she can follow directions and communicate with her PECS. "
Everybody should be on it! The title is "Unlock Your Health with OSR, The Powerful Antioxidant From CTI Science."

September 2009, Age of Autism is singing  OSR#1's praises: "CTI Science's OSR1 Boosts ORAC Score Better than Acai and other Touted Foods." Well, I say, AoA is, but it appears to be a straight sales pitch from CTI Science/Lee Silsby, and once again, it isn't aimed at recovering autism, but as a powerful tool for health for everyone.

Stagliano writes again about OSR this last week, explaining that she's turned down the interview request with Tsouderos for this week's Tribune article on OSR#1. For Stagliano, it's good enough that CTI Science insists that "OSR is less toxic than aspirin and Vitamin E." 

Yeah, see, here's what I'm not getting. Why are the big pharmaceuticals not trustworthy, but some Joe Schmoes who come up with some "supplements" that will fix autism (and everything else) trustworthy? Why? 

The safety information that CTI Science provides ought to make a rational parent deciding on various treatment options for their autistic children take pause. They tested it on rats and 10 people. It's not been tested on children with autism. No plausible mechanism for why it would help autistic children is offered.

I love this:

So, is it a "single pure compound" or is it "two natural compounds found in fluids of humans and other mammals"? Oooh, what fluid? Pee? Blood? Interstitial fluid? Huh?

They may promise it is "toxicity free" but are quick to warn of allergic reactions:

"Allergic or other adverse reactions may occur at any time with any food or dietary supplement as well as OSR#1®. If you experience allergic or other adverse reactions while taking OSR#1®, discontinue its use immediately and contact your medical professional. Do not resume taking OSR#1®."

I get that some parents are just chockful of desperation to help their kids improve and willing to go down any possible trail to help, especially when they buy into the inaccurate, misguided ideas regarding cause and continue that with elaborate conspiracy theories as to how the government and big pharma are colluding together to cause the most harm possible. It's easy to go that way when you won't stop and engage that frontal lobe and think things through. The anti-vaccine parents rage that there aren't enough studies proving the safety of vaccines, but Haley's OSR gets a pass. All the quack treatments get a pass, because damnit, folks like Stagliano are out there trumpeting how it works, and they've all proven that theirs is a science of one.

Bensmyson writes:

"Wombles, I believe in parental rights. if a parent chooses to pray for a child rather than subject him to chemotherapy or injections of a toxin to keep him safe find, that's their right. let parents decide what is best for their child not the government. I am not anti-vaccine, I am for informed consent. Where are the posters in the waiting rooms of the pediatricians offices warning of potential adverse reactions? Where is the brochure handed to a parent after a vaccination listing the cautionary signs and symptoms to watch for? Where is the contact information for VAERS? Since when is your child's safety and health worth more than mine? Who signed my son up to be sacrificed for the betterment of the herd?" 

No, bensmyson, it's not their right. You obviously don't understand informed consent either. There is a CDC handout given when you are vaccinated detailing adverse effects and the VAERS information.

The rest of his response, not posted here, shows that 1. facts are not important to him, 2. details aren't either.

Title should be changed to, only if it's autism. Bensmyson is good with parents withholding lifesaving medicine for their religious beliefs:

"Wombles - If a parent chooses not to give their child chemo for religious beliefs fine with me. If an adult refused chemo would be be forced to take it? The parent is the guardian of the child, no one has the right to tell them what is best for their child when it comes to putting poison into their body. Chemo or vaccines no difference."

We all know there's a world of difference, of course. In this country, in this culture, we do not believe that parents have the right to do anything they like to and with their children.

It's obvious, though, that many of the AoAers believe they have this right. It's one Stagliano has expressed before:

Note especially the last paragraph. Parents should have the right, within reason, within medical soundness, to decide. But when the child's best interests are not being met, when the child is denied necessary, life-saving measures or given dangerous, life-threatening non-warranted procedures or drugs, the court system has an obligation to step in.

Just because our children came from our bodies doesn't mean they are ours to do with as we wish. We have an obligation to make the best decisions for them, in their best interests, not our own. Well, that's if we've realized it isn't about us, it's about our children.

(As for her first paragraph, well, we know that was crap, too, as no one science-based asserts that vaccines are without risk.)


David said...

"speculate that being a red head makes one susceptible to autism"

Actually, this strikes me as plausible. If one's immediate heritage is favorable to the expression of a gene for red hair, then it could also be favorable toward the expression of a recessive gene for autism.

The most significant thing about this is, it makes more sense than vaccines being a cause of autism.

Mom26children said...

The AoA crowd is going to rush over to the comment board at the Tribune.
They put Trine down because she was a food writer at one time.
I guess they forgot David Kirby was once a "travel" writer. What makes them think he is any more qualified to write about Autism?
Oh Yeah!!
He writes what they want to read...
As far as red hair..too funny..
the ONLY child in our house WITHOUT autism is our red-head.
Explain that Teresa C....

KWombles said...


You missed the point of the problem with her speculation. She believes autism to be a neurodegenerative disease and she still brought it right back to vaccines. And somehow she's qualified to interpret complex, dense medical studies, but Trine, because she once wrote about cupcakes is unqualified to interview and write about autism treatments.

Margaret Romao Toigo said...

I keep reading all about parents' rights, as if children are property.

But children are people, not property, which is why the authorities will intervene when a child is not given proper medical care.

Anonymous said...

Well done, Kim "Orac in a skirt" Wombles!

It's about time the FDA did something about this.

David said...

"It's about time the FDA did something about this."
No, they should have been given an open season on Apothecure and Lee Silsby first. Top priority for reform: Change laws to place compounding pharmacies under federal regulation!

Roger Kulp said...

KWombles said...

You missed the point of the problem with her speculation.She believes autism to be a neurodegenerative disease,and she still brought it right back to vaccines."

I didn't.I know exactly how these people's minds work.I spent too much time in the Yahoo! groups,at first just soaking it all in,and then later trying to convince them there were other causes than vaccines,but I eventally wised up, and learned it can't be done.The convoluted theories they come up with to blame "metals" for everything,blows your mind at first.Then it just gets tiresome.

More than likely these children are sick,but it isn't autism causing this.There are conditions that can cause neurodegeneration in children,some of which can occur with "autism", or features of autism.I know,I experienced it first hand.But these are either external immune/infection based or underlying genetic/metabolic conditions,all of which the antivaxers have become increasingly hostile towards as a cause of their children's problems.
The "deadly disorder" bensmyson writes about is real,but it isn't "autism",if your child is in the hospital for a rare pneumonia,or an acute metablolic crisis,or needs a G-tube,for feeding,it isn't because they are "autistic", or "overloaded with metals".

More and more,I am coming to see that these antivaxer parents are no different than hardcore Christian Scientists,who deny their children needed medical care.The devout antivaxers,really do believe it like a religion.