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A sense of civil discourse

8 Oct

Mark Blaxill and Dan Olmsted have been on a book tour for their new book, The Age of Autism. In a radio interview they were asked about being attacked, Mr. Blaxill responded:

“We get attack on a regular basis. I think we have become accustomed to that. I think that one things we really need to recover in this debate is a sense of civil discourse”

Mr. Blaxill made a similar call for a more civil discourse about a year ago. This was in regards to a post that was so offensive that the Age of Autism blog had to pull it down. Before it was pulled, Mr. Blaxill defended the piece. Mark Blaxill’s comment? He supported the attack as “edgy”.

The irony is fairly thick. Toadies who do hit jobs in the media?!? What was that blog piece but a hit job in a form of the media?

What is strange is the repeat of the statement that the discourse should be more civil. In that, I agree with Mr. Blaxill’s commentsl. Where we part ways is in the definition of civil discourse. I just don’t think he and his team at the Age of Autism blog have promoted a civil discourse in the last year (or ever).

Dan Olmsted owns/runs the Age of Autism blog. Mark Blaxill is an “editor” blogger there and frequent commenter. They are

Shall we go down the list of the people who have been personally attacked by that blog? Peter Bearman, Tom Insel, Story Landis, Richard Grinker (and his wife), Ari Ne’eman…the list goes on.

These are not “edgy” blog posts. These have included false claims of pharmaceutical ties levied against a blogger combined with an effort by Age of Autism readers to make the blogger lose his day job.

A more civil discourse would be welcomed. Even an edgy discourse would be welcomed. I encourage Mr. Blaxill and Mr. Olmsted to put substance behind the words. Stop the hot pieces. Stop the attacks.

Katie Wright demonstrates AoA mentality

30 Sep

Over at the Clown Blog, Katie Wright pens a sulky screed targeting Peter Bearman. Lets go through it.

Dr. Peter Bearman, a professor of sociology at Columbia University, recently released a research paper alleging that half of the meteoric rise in ASD cases is an artifact. You know- “better diagnosis” and “greater awareness.” A blind, non-medical professional, could have diagnosed my son. Nevertheless in the case of HF ASD and aspergers (which comprise a small % of overall ASD) certainly greater awareness has played a role in the increasing number of those diagnoses. Still- 50%? Ridiculous.

And why ridiculous? Well….just because. Wright offers no evidence to counteract Bearman’s. No science is referenced to challenge Bearman’s work. It simply is ridiculous apparently. One can almost hear the foot stomp of a poor little rich girl out of her league intellectually.

After Dr. Bearman concludes that 50% of the increase cannot be attributed to greater awareness Insel asks what Bearman believes is driving the other 50%. Bearman answers: “genes, old parents and possibly a virus.” This is the best he has got? The NIH gave this guy millions to come with that?

Well no Katie, thats not what the NIH gave him his research money for. According to _you_ Insel asked Bearman what he _believed_ was driving the other 50%. He gave his answer as to what he _believed_ . But these beliefs were just that – beliefs. He presented the science he had done and then shut up on the evidence and opined and on what he was asked to opine on by Insel.

And even his opinion, his beliefs, are rooted in science. There _is_ a genetic component to autism, thats simply a fact. There _is_ research that links ASD to older parents. Katie Wright’s beliefs revolve around one extremely unscientific thing. Vaccines.

Yes, Bearman does acknowledge the possible role of some kind of toxin. Bearman is not sure what that toxin is but he is sure what it isn’t. Take a guess.

See what I mean. If it ain’t a vaccine, it ain’t worth considering according to Katie Wright.

…unbelievably Bearman says: “it isn’t autism that parents are worried about. They know they can deal with that, they know they can help their child, (and he would know this a non parent of an ASD child?) but it is autism organizations scaring parents!” I had no idea that a bunch of stay at home Moms with no money, no federal backing, no million dollar grants- who are already busy parenting autistic kids- have this kind of extraordinary power! Wow, what’s next for us? Ending the recession, solving the mortgage crisis, creating electric cars?

And hot damn Katie Wright, guess what? In my opinion he _is_ right! I’m not scared of autism. I’m scared of one note zealots stealing away research monies, scaring away legitimate researchers with their threats of violence and scaring the public into believing that autism is some kind of tsunami of evil ready to engulf them all in a tide of social security claims.

As for Katie Wright personally, it makes me sick to think of this little rich girl, who’s children will want for nothing, playing the ‘poor little me’ card. There are families out there struggling to get by on a day to day basis and she has the temerity to liken herself to a ‘stay at home mom’. Feh.

As far as blaming the parents for the national crisis of confidence in vaccine safety- grow up Dr. Bearman. The problem is the problem- not people talking about the problem.

Nice quote from that intellectual giant Jim Carrey there. Oh and guess what Katie Wright? You and people like you *are the problem* . Whilst you play offended at legitimate science, there’s a whooping cough outbreak in California that is killing children. You do know that don’t you Katie Wright?

Here’s what you need to do Katie Wright. You need to accept the fact that the science is against you. You need to accept the fact that you are a small scaremongering minority of the autism community. Sounding off about stuff that you clearly have absolutely zero knowledge about (science) makes you look foolish and all it does is show you to be frightened. You are behind the times. Get out of the way of progress.

The Age of Autism before thimerosal

28 Sep

Dan Olmsted and Mark Blaxill have written a book, The Age of Autism. It expands on Mr. Olmsted’s UPI series of the same name and uses the same logic: build a narrative that links mercury to illnesses and claim this as proof that mercury is the cause.

One can download the first 46 pages of the book for free on iTunes, buy the book, wait for it to come to your library or used book story (don’t count on the used bookstore route. Last report I got was only about 600 books sold in the opening time for this book). Or, one could just not read it ever.

If you want just an idea of what the book is about you can read a short excerpt on the publisher’s website. It starts with this simple statement:

We believe that autism was newly discovered in the 1930s for the simple reason that it was new.

Why was it new? If I understand the logic, the idea is that a new mercury compound was invented and tested around that time: thimerosal. From a recent interview, here are Dan Olmsted’s words:

What we did really was try to trace the rise of autism and that led us to look at the first eleven families who had children diagnosed in the 1930’s .. in the famous paper. We were able to identify seven of those first eleven kids, who were only known by their first name and last initial. When we did, we found what we thought was significant exposure of the family to mercury, in particular a new kind of mercury that came on the market .. that was used in fungicides for agriculture and in vaccines. So, we think as that happened, the first cases appeared. Then it seemed reasonable to believe that when the vaccine schedule that included much more mercury exploded in the 1990’s and so did autism .. there’s probably a connection that has been missed here.

First eleven kids? First studied or first with autism? They seem to be asserting that these are, indeed, the first autistics ever.


Thimerosal was invented in 1927. What strikes me odd about the position of Mr. Blaxill and Mr. Olmsted is that ten years before the invention of thimerosal, someone was born who would later be diagnosed with autism and receive support from the California Department of Developmental Services (CDDS) under the label “autism”. I know this because the data are publicly available. The CDDS data have been used for years to promote the idea of a vaccine-induced autism epidemic. Of course Mr. Olmsted and Mr. Blaxill are aware of these datasets as their colleague David Kirby made use of them many times over the years in his promotion of autism as vaccine injury, starting with his book “Evidence of Harm, Mercury in Vaccines and the Autism Epidemic: A Medical Controversy.”

Here is a list of the birth year and the number of people for each birth year who were getting services from the CDDS (note that these data were from the 1990’s. Some or all of these autistics may have passed on):

Birth-year number of CDDS consumers under the autism label
1930 1
1929 2
1928 3
1924 1
1923 1
1922 3
1917 1

There were not a lot of autsitics born before 1930 and still alive receiving services in the 1990’s, this is true. But, the oldest person in that group was 78 at the time. That’s one year older than Donald T. is this year, for those following that story. .Be that as it may, there are a number of CDDS consumers who were born before thimerosal was invented. It would be unwise to assume that these are all the people born before 1930 who were diagnosed autistic. They are but an example.

From what I’ve read, Mr. Olmsted and Mr. Blaxill spent about five years looking for the origins of autism (the time since Mr. Olmsted’s original UPI series of articles). They traveled internationally and, from their description at least, appear to have left no stone unturned in their search.

I wonder, did they ever challenge their assumption that autism was new? Did they seek out autistics who predated thimerosal and/or those who weren’t research subjects of Dr. Kanner? Or did they merely rework and expand on Mr. Olmsted’s previous work on Kanner’s subjects?

In their statement attempting to distance themselves from anti-vaccine groups, Mr. Olmsted and Mr. Blaxill state:

We don’t want crops to wither, or houses to rot, or children to die of vaccine- preventable illnesses. We simply want to stop an autism epidemic whose origin we believe can be discerned from a careful examination of its environmental history.

“Careful” examination. I wonder.

Donald Triplett – Autism’s Patient Zero

27 Sep

Donald Triplett is (for he is still alive) Kanner’s Case 1. Recently the story in a lovely portrait in The Atlantic, Donald has also had the sad misfortune to slowly but inexorably become a poster child for the autism/anti-vaccine movement. As one of the leading autism/anti-vaccine proponents, Ginger Taylor, writes:

While Kanner’s other cases had poor outcomes, Donald did not. It turns out Donald received a medical treatment that Kanner never recorded when, as a boy, he fell victim to crippling juvenile arthritis. Donald was treated with gold salts and his brother reported that as a result, Donald not only recovered from the arthritis, but “the proclivity to excitability and extreme nervousness had all but cleared up.”

Donald began to recover from “autism.”

This is highly relevant to the autism debate because gold has an extreme affinity for mercury and pulls it from the body. It is also significant because arthritis links his “nervous disorder” to his autoimmune disorder. It is historical evidence that the claims that parents have been making, that their children with autism had regressed after their mercury-containing vaccines, and that treating them for their autoimmune symptoms makes their “autism” better.

Sigh. And so we see the same old merry-go-round that has engulfed Hannah Poling – a determination to see one end and one end only for causing autism – vaccines.

And yet…theres no evidence Donald Triplett was ever vaccinated with anything. Certainly not thiomersal. Indeed, those who ‘discovered’ that Donald was treated with gold salts – Messers Blaxill and Olmsted, had to find another method of Donald being exposed to mercury. They claim that Donald:

…lived in an area where a water-soluble form of mercury was first used in forestry.

Bit of a stretch much?

There are a few reasons I really think this is debatable at best.

1) Why was Donald Triplett the _only_ person in Forest, Mississippi to ‘get’ autism from pesticides used in Forestry?

2) The only person who has suggested Gold Salts could theoretically chelate mercury is one Boyd Haley. In fact as Prometheus said way back in 2005:

The gold used to treat Donald T’s RA was a salt – the gold was an ion and not able to amalgamate with metallic mercury. In addition, mercury in animal tissue is also either ionized or chemically bonded with organic groups (e.g. methyl, ethyl, phenyl…) and also not able to form an amalgam.

3) Lets say that the gold salts performed the impossible and chelated the mercury. Why didn’t Donald Triplett simply ‘get’ autism straight away since mercury continued to be used in the Forestry industry? Chelation is not a preventative.

So here is this young boy who’s exposure to water soluble mercury seems in extreme doubt to me, who’s vaccination record seems to be zero but who was also autistic.

I’m afraid that only points one way to me.

Age of Autism – the book – sales figures

20 Sep

Deep in the heart of the Big Pharma Wackosphere, shadowy figures, twisted into parodies of humanity by their greed, shuffled to and fro. They all carried the stain of Big Pharma – a tattoo of Darth Offit – on the back of their left hand so that they might know each other. The stink of corruption hung in the air like the stench of a festering wound. Not that the Wackosphere cared. Such was their corruption that they breathed deep of the foetid stench…and called it good.

Two figures, barely human broke off from the main rank and file and walked towards a small door. They glanced quickly at each other. Nobody entered this room lightly. Behind its plain brown door lay secrets the likes of which those – the sheeple – outside of the Big Pharma Wackosphere could not even imagine. Dark secrets of events that had the power to blast ones sight and scar one’s mind. Repeated visits rubbed away at a man’s conscience until all that was left was greed and the desire to do harm via blogging. This was…The Knowledge Room.

The two figures steeled themselves. Once they had been simple bloggers, sheeple themselves, but over the years they had first sipped at the Cup of Corruption and then swigged greedily from its poisoned chalice. Now all they wished for was to do as much harm as was possible, whilst getting paid for it in silky Big Pharma cheques.

The first figure, who called himself Kev but who’s real name has passed beyond knowledge, turned to the other who called himself Sullivan, a twisted joke on the name of a sheeple film where monsters are the good guys.

“Go on, then.”
“Its your turn”
“Are you sure?”
“I think so.”
Kev uttered an oath. “I still don’t like this,” he said gloomily.
“Think of the money.”
“True.”
Kev reached out a hand and pushed at the door. It was unlocked as always, inviting visitors into its cold heart.

The room was a small, plain, somewhat arid brown box with a chair in front of a TV. The TV, as always was on and showing the snow of an untuned station.

Kev went to sit in the chair, then stopped.

“Are you sure its my turn?”
“Pretty sure.”
“Damn.”

He sat down.

“Erm…hi…I was wondering if you could tell us how many copies of The Age of Autism had actually sold this week. Uh…Please.”

The room went dark. Sullivan stepped back from the chair. All he could see was the dull throbbing of the tattoo of Darth Offit on Kev’s left hand. He knew what Kev was going through now. Delivery of the answer was always a hideously painful process. The price one paid for having access to this room.

Slowly the room lightened, little by little Sullivan made out the figure of Kev. He had fallen to the floor and was panting like a boxer who was still floored after a big punch.

“Well? How many?” Much rested on the answer to this question. If the book was a success, Big Pharma would have to spend more of their resources refuting the book. That meant less money for Wackosphere bloggers.

Kev looked up from the floor. “Twenty-six.” he panted.

“Twenty six?” Sullivan laughed darkly…by the power of Wyeth! To the Blogging Chamber!!”

Mark Blaxill promotes bad science

8 Sep

[wags finger]…and don’t you ever forget it 😉

Basically, the story is that The Blax wrote a blog post in which he said:

Despite the relentless drumbeat of propaganda from the CDC, public health authorities and the thuggish on-line goons of the medical industry, there’s a funny thing going on. The evidence of a connection between mercury exposure and autism keeps growing.

It does? Really? Such as what science exactly?

Well The Blax has the answer to that in that he quotes from a study which according to The Blax:

They found that thimerosal at the same concentrations received in human infants had clearly measurable effects on opioid receptor development in the infant rats.

Huh. Well imagine my surprise when I read two blog posts, one from Emily in which she says:

Their starting dose is at least 3.2 times the relevant exposure of Hg. But they’re not finished. They don’t use that dose once. They use it four times, injecting the newborn rats on days 7, 9, 11, and 15 of life, each time with 3.2 times the actual relevant exposure of Hg, for a total of 48 mcg of Hg/kg in a little over a week. Indeed, even if 12 mcg were the relevant exposure, they’re dosing their animals with it four times within a week, give or take, giving us ~13 fold the relevant exposure.

and another from Orac in which _he_ says:

…the minimum dose received was 48 ?g Hg/kg, and the maximum dose received was a whopping 12,000 ?g Hg/kg, or 12 mg Hg/kg!

So when The Blax states that this paper is a like for like comparison between infant vaccines and their dosage, I think its clear to see that this is incorrect. What these researchers have in fact done, is massively overdose their test subjects.

And thats not the only problem with this paper that The Blax is so in love with. Geier, Haley, Bernard…recognise these names? Of course you do! They’re the names that this paper relies on to support its underlying ‘science’.

I think the only real question that needs answering here is – how in heck did this paper get past peer review??

Age of Autism – Amazon file wisely

8 Sep

We all know the new Age of Autism book is coming soon. Its stocked at Amazon for example where pre-orders for the book have placed the books ranking at the heady heights of the top 100,000.

However, whats most interesting is the cover art that Messers Blaxill and Olmsted have chosen for the Kindle edition of the book. In a refreshing turn of honesty, they selected the below (click for bigger) as the cover art.

You can also see it in situ at Amazon US store.

A brave and refreshingly intellectually honest move by Blaxill and Olmsted, I think you’ll agree.

Review of the Introduction of Age of Autism – the book.

23 Aug

So begins the Olmsted/Blaxill upcoming book ‘Age of Autism’.

…instead of taking Kanner’s word for it, [we decided] to learn about these previously anonymous families ourselves. We took clues from his extensive case descriptions and started uncovering the identities of the original families. Time and again, we connected the occupations of the parents to plausible toxic exposures and especially to a new mercury compound first used in the 1930s as a disinfectant for seeds, a treatment for lumber, and a preservative in vaccines. Yes, the parents’ professions were clues— but not to their obsessions or their marriages or their parenting or their genetic oddities; instead, they pointed to a strikingly consistent pattern of familial exposures to the same toxic substance.

(emphasis authors, inserts mine)

This is the paragraph that sets the authors hypothesis out. When we look at it carefully, we can see exactly what its purpose is – its purpose is to fit a set of preconceived ideas that revolve around one central disproven hypothesis – that mercury in vaccines (thiomersal/thimerosal) causes autism.

I haven’t yet read the rest of the book but I’m pretty sure what I’m going to find. To talk about that now would just be conjecture however, so lets stick to what we have here.

According to Olmsted and Blaxill, syphilis treatment, hysteria, mental illness and a variety of modern illnesses are all caused by mercury. I’m very much looking forward to reading this section too. Olmsted & Blaxill use Pink disease (a definite form of mercury poisoning which looks nothing like autism to ‘justify’ the inclusion of these illnesses in the Introduction.

Blaxill and Omsted detail how they went on to meet “Donald T.” one of Kanner’s original cases:

By any mea sure, he has fared astonishingly well. President of his college fraternity and later the Forest Kiwanis Club, a pillar of his Presbyterian church, he had a long career at the local bank, plays a competitive game of golf, and regularly travels the world. We learned how “Donald T.” went from being the first unmistakable case of autism to the first unmistakable case of recovery.

So on one hand we have the doom and gloom of Pink disease (a foreshadow of autism according to Blaxill & Olmsted) which killed hundreds and then actual autism which doesn’t seem that bad. I’ll be very interested to see how Blaxill & Olmsted narrate Donald T.’s ‘recovery’…or could it have been that Donald T. was in fact one of the first cases of autism who also either moved ‘off the spectrum’ (as a certain percentage of autistic people do) or…y’know…he simply progressed as he got older. My guess is that Blaxill & Olmsted will reveal that Donald T. had some kind of miraculous exposure to a chelating agent or multi vitamins or some form of extreme biomed. Lets see.

The whole Introduction is about 6,000 words long. I can’t possibly attempt to review the whole thing and I won’t attempt to review the whole book either. These are the sections of the Intro that caught my eye particularly. Maybe others who have access to the Intro will tackle more. One thing you can be sure of, LBRB will be here to catch and expose the errors.

We will support your foundations

23 Aug

I read a terrible, terrifying blog post post yesterday from Kim Stagliano on the Huffington Post. In it she describes how her daughter has suffered abuse at the hands of a support worker. The story is also coverered by the Connecticut Times.

Police said the girl’s parents were trying to figure out how their non-verbal daughter kept getting bruises and sprained fingers on her right hand when on May 19 they received a call from the nurse at Frenchtown Elementary School that their daughter had arrived at school that morning crying hysterically. The parents then demanded to see the video from their daughter’s school bus.

That video, which also had audio, showed Davila grabbing the girl’s hands and the girl then crying out in pain.

Police said they then obtained DVD copies of the bus videos for April 27, April 29 and May 19. On the 27th and the 19th the driver of the bus was Davila’s mother.

Police said the April 27 video shows Davila, during the bus ride from the school to the girl’s home, putting her hands in the area of the girl’s hands. With each movement the girl’s cries get louder, police said.

This is one of my darkest fears. That my non-verbal daughter or my step-daughter, both autistic, should suffer abuse and not have the language skills to communicate their ordeal. Or even if they did have language skills that they were too terrified to speak out.

On this issue we – the whole autism community can easily stand as one. Whats happened to Kim Stagliano’s daughter is beyond appalling. She writes on the HuffPo of shaking the foundations of those who have hurt, or allowed to hurt, her daughter. I fully agree with her statement and as the title of this blog post implies, I will support her foundations in whatever way I can.

FDA warns maker of OSR #1, dietary supplement for autistic children is a “toxic” “drug”

24 Jun

“OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious potential side effects, FDA warns”. So starts a recent article in the Chicago Tribune, FDA warns maker of product used as alternative autism treatment.

The article is by Trine Tsuderos who has previously reported on the the industrial chelator turned dietary supplement in Industrial chemical OSR#1 used as autism treatment.

According to the website for the product, “OSR#1® is a toxicity free, lipid soluble antioxidant dietary supplement that helps maintain a healthy glutathione level”. According to the story in the Tribune, the claim of “toxicity free” may not be accurate. According to the Tribune story:

The FDA letter lists side effects recorded during Haley’s animal studies: “soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas” and a rapid increase in normal cells contained in the lymph nodes.

Here is that section of the letter in full:

However, animal studies that you conducted found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia. Based on these animal studies and side effects known to be associated with chelating products that have a similar mechanism of action to OSR#1, we believe the use of your product has the potential to cause side effects, and the before-mentioned website statements falsely assert that the product does not have the potential to cause side effects.

Mr. Haley is not unused to criticism of his so-called supplement. After the previous story by the Tribune, Boyd Haley tweeted multiple times “Contrary to the Chicago Tribune implication, OSR1 has undergone extensive safety testing. The truth is at http://www.OSR1.com. Please retweet!” When I checked the OSR website, I could find no mention of these test results–the results Boyd Haley himself submitted to the FDA. Is that the “truth”?

The Tribune quotes Ellen Silbergeld, a John’s Hopkins researcher:

“It would be hard to imagine anything worse,” said Ellen Silbergeld, an expert in environmental health who is studying mercury and autism at Johns Hopkins University’s Bloomberg School of Public Health. “An industrial chemical known to be toxic — his own incomplete testing indicates it is toxic. It has no record of any therapeutic aspect of it, and it is being marketed for use in children.”

and

Silbergeld said the product represents a clear example of endangerment of public health and that the FDA should stop CTI Science from selling it immediately. She drew a comparison to a city’s drinking water system: If contamination is found, she said, “they turn off the pumps.”

“They don’t have to engage in a long discussion with you,” Silbergeld said. “It would be hard to imagine a more clear example of immediate endangerment of public health. Turn off the pump.”

Kim Stagliano, Managing Editor of the Age of Autism blog, has touted OSR #1 in the past. She was quoted in the Tribune article:

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.”

There doesn’t seem to be any mention of the fact that Prof. Haley appears to have withheld safety information from the autism community. She “trusts his science”, yet makes no mention of the fact that it is precisely “his science” that indicates that this chemical is toxic.

The warning letter from the FDA is quoted below:

WARNING LETTER CIN-10-107927-14

Boyd E. Haley, President
CTI Science, Inc.
2430 Palumbo Drive, Suite 140
Lexington, Kentucky 40509

Dear Mr. Haley:

This letter concerns your firm’s marketing of the product OSR#1 on your website, http://www.ctiscience.com.This product is marketed in violation of provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.

Your firm markets OSR#l as a dietary supplement; however, this product does not meet the definition of a dietary supplement in section 201(ff) of the Act, 21 U.S.C. § 321(ff). To be a dietary supplement, a product must, among other things, “bear[ ] or contain[ ] one or more … dietary ingredients” as defined in section 201(ff)(1) of the Act, 21 U.S.C.§ 321(ff)(1). Section 201 (ff)(1) of the Act defines “dietary ingredient” as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. The only substance listed as a dietary ingredient on the labeling of OSR#1 is N1,N3-bis(2-mercaptoethyl)isophthalamide. N1,N3-bis(2mercaptoethyl) isophthalamide is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, N1,N3-bis(2-mercaptoethyl)isophthalamide is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. Thus, because OSR#1 does not bear or contain a dietary ingredient as defined in section 201(ff)(1) of the Act, this product does not qualify as a dietary supplement under section 201(ff) of the Act.
Your website includes claims such as the following:

• “OSR#1® … helps maintain a healthy glutathione level.”

• “Both OSR#1® and glutathione scavenge free radicals, allowing the body to maintain its own natural detoxifying capacity.”

The claims listed above make clear that OSR#1 is intended to affect the structure or any function of the body of man or other animals. Accordingly, OSR#l is a drug under section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1). Disclaimers on your website, such as “OSR#l® is not a drug and no claim is made by CTI Science that OSR#1® can diagnose, treat or cure any illness or disease,” do not alter the fact that the above claims cause your product to be a drug.

Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of OSR#1 without an approved application violates these provisions of the Act.

Your website includes the following statements: “Thyroid conditions, hypertension, and diabetes: Because thyroid conditions, hypertension, and diabetes have been associated with low glutathione levels …” and “OSR#1® … helps maintain a healthy glutathione level.” These statements suggest that OSR#1 is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Because thyroid conditions, hypertension, and diabetes are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use it safely for its intended uses. Thus, OSR#1’s labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). OSR#1 is not exempt under 21 C.F.R. §§ 201.100(c)(2) and 201.115 from the requirement that its labeling bear adequate directions for use because OSR#1 lacks an approved application.

Additionally, under section 502(a) of the Act, 21 U.S.C. § 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the Act, 21 U.S.C. § 321(n), provides that, “in determining whether a drug’s labeling or advertising is misleading, there shall be taken into account (among other things) not only representations made or suggested … but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations ….” Your website states that” [s]ome reports of temporary diarrhea, constipation, minor headaches have been reported but these are rare and the actual causes are unknown,” as well as “OSR#1 is without detectable toxicity” and “OSR#1® … has not exhibited any detectable toxic effects even at exceptionally high exposure levels.” However, animal studies that you conducted found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia. Based on these animal studies and side effects known to be associated with chelating products that have a similar mechanism of action to OSR#1, we believe the use of your product has the potential to cause side effects, and the before-mentioned website statements falsely assert that the product does not have the potential to cause side effects. Therefore, these statements render your product’s labeling false or misleading. As such, OSR#1 is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a).

Because the labeling does not warn consumers of the above-mentioned potential for side effects, the product OSR#1 is also misbranded under section 502(f)(2) of the Act, 21 U.S.C. § 352(f)(2), in that the labeling lacks adequate warnings for the protection of users. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act, 21 U.S.C. §§ 331(a).

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. In this regard, please note that products are misbranded under section 502(j) of the Act, 21 U.S.C. § 352(j) if they are dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the products’ labeling.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action, without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed. Additionally, if another firm manufactures the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237, Attention: Stephen J. Rabe, Compliance Officer.

A description of the new drug approval process can be found on FDA’s internet website at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.

Sincerely,

/s/

Teresa C. Thompson
Cincinnati District

This story is being discussed at Countering Age of Autism as FDA Steps Up to the Plate on OSR#1.

Addenda:

CTI solicited charitable donations to help get started through the CTI Science Foundation, which includes “Katie Wright, Julie Obradovic, Dr. Jerry Kartzinel, Dr. Julie Buckley, Scott Barli and Kathryn Wachsman”

Kim Stagliano discussed previous Tribune stories and the question of toxicity of OSR in another piece

I was contacted by Ms. Tsouderos for an interview about her forthcoming article on a supplement called OSR from CTI Science. CTI’s Science’s FAQ page says OSR is less toxic than aspirin and Vitamin E. If the Tribune has its own toxicity testing, I’m sure readers will be interested in seeing the data. In light of the skewing of parental interviews in the past, I chose not to respond to her requests for an interview. Others, like the founder of CTI Science, Dr. Boyd Haley, graciously allowed the interview process to continue until such time as it became clear that the writer’s goal precluded gaining meaningful insight.

It appears to this reader that perhaps it was CTI Science and Boyd Haley who may have kept the readers from obtaining “meaningful insight”. If a reporter asks about toxicity and you have data showing hair loss, discolorations, and “abnormalities of the pancreas, and lymphoid hyperplasia” shouldn’t you produce that data?

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