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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?

Pity for the Rankins

26 Jan

Its no secret that Wade and I were once pretty good internet pals. We regularly communicated despite our staunch opposition to the others beliefs regarding vaccines role in autism. That changed however as Wade sunk deeper and deeper into the bad science surrounding autism.

Wade and his wife Sym have recently been the subject of a piece by the Chicagoist following Wade’s open letter to the Trib. The Chicagoist reporter (one Mr Carlson) had obviously read both the Trib articles and Wade’s open letter before writing his own piece.

And now Wade has been obligated into writing yet another blog piece as it seems the Chicagoist has taken a similar line to the Trib. Wade says:

Reading through Mr. Carlson’s brief post gave me the distinct impression that somehow the meaning of our letter had gotten lost,

A brief digression. Wade and his family used to live in the South and were affected very badly by Hurricane Katrina. Once the dust had settled they decided to resettle in Chicago. Once there I learned they had become aquainted with the infamous Erik Nanstiel and David Ayoub, both hardcore believers of the vaccine causes autism idea. Not long after that Wade’s own beliefs on the subject hardened and it wasn’t difficult to see where this hardening of beliefs was being hardened from. I found it increasingly difficult to accept the things Wade was saying. An intellegent man, his new beliefs can be summed up in his opinion of Lupron and OSR.

…we have not, as yet, utilized either the Lupron protocol or OSR #1, both of which were the subjects of Tribune smear pieces. That is not to say, however, that those interventions may not be appropriate treatments in particular circumstances. On the contrary, we know families that these interventions have helped…

The old Wade would not have ever considered using these snake oil treatments. The old Wade would not have described the Trib articles as ‘smear pieces’. The old Wade wouldn’t have described knowing families who did use them and would have been much less credulous about their effectiveness.

SO, back to Wade’s statement that he believed the meaning of his open letter had been lost. It was lost, he’s right. It was totally lost on Carlson, it was totally lost on the commenters to the site and its totally lost to people like me. Not that I’m singling myself out for any special praise – thats kind of the point. I’m just an ordinary person with no special agenda and yet Wade’s point is totally lost on me and I very much suspect the vast majority of people who read Carlson’s piece or either of Wade’s long pieces on the subject. (Its hard to say which of the two points of the Somerset Maugham quote Wade utilises for his blog ‘Have common sense and … stick to the point’ that Wade has more strongly abandoned).

I miss the old Wade very much – a strong, principled and funny man, Wade has become just another sad foot soldier in Jenny McCarthy’s Bimbo Brigade alongside his fellow Chicago hardcore believers. His child is 10 years old and I doubt very much that xe is anywhere even approaching the level of ‘cure’ or ‘recovery’ that Wade has been promised by the various DAN doctors and new friends I have no doubt xe has been worked through. Wade’s tone in both of his blog pieces is a sad, tired sort of bewilderment – a bewilderment that the world just can’t see what he can apparently see. Sadly – pitifully – the viewpoint that he has adopted only means he’s going to become more bewildered.

OSR#1: Industrial chemical or autism treatment?

26 Jan

The Chicago Tribune has added another chapter to their ongoing series posing difficult questions to the autism alternative medical community. OSR#1: Industrial chemical or autism treatment?, by Trine Tsouderos demonstrates the very low standards the alt-med community is willing to accept, at least when it comes to “supplements”.

OSR#1 is being marketed as a supplement by Boyd Haley, retired professor of Chemistry from the University of Kentucky. The chemical used is a powerful chelator, which will come as no surprise to those familiar with Dr. Haley’s history as a proponent of the mercury causation theory in autism. However, “chelation” is not mentioned in the marketing for OSR#1.

Trine Tsudorous has a style I like. She asks very tough questions, points the spotlight on questionable practices and backs up her stories with quotes from experts in the field.

One of the biggest questions raised about OSR#1 is whether the appropriate safety testing has been performed. The marketing doesn’t mention that the chemical used is a chelator.

The company that makes the supplement, CTI Science, describes it as an antioxidant. But pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical Biology at State University of New York at Stony Brook, said it is obvious from the product’s chemical structure that it is also a “powerful chelator,” a compound that binds to heavy metals such as mercury.

Note that CTI Science used to be called “Chelator Technologies, inc”. The chemical used in OSR#1 was invented (and patented) by a colleague of Dr. Haley’s at the University of Kentucky. According to the Tribune story, the original purpose of the chemical was to chelate “heavy metals from soil and acid mine drainage.”

Why would someone avoid calling a chelator a chelator? Especially in the autism alternative-medical community which has been led to believe that chelation is a valid treatment for autism? It appears that chelators are drugs and, as such, are subject to much more stringent and costly safety and efficacy testing than supplements. Dr. Haley is quoted as describing the chemical as “a food”. To my knowledge, this chemical is not found in nature and is not an extract from some food but, rather, a synthetic compound.

From the FAQ for OSR#1

Is OSR#1® a natural compound?

OSR#1® is a combination of two natural compounds that are non-toxic.

Perhaps I missed something–but either this is dodging the question or this is an admission that OSR is not a natural compound. However, either way the wording is carefully chosen.

Ms. Tsuderous brought in an expert on antioxidants for her story as w ell.

“I would worry a lot about giving anything to a small child that hasn’t been scrutinized for both safety and efficacy by the FDA,” said antioxidant expert Dr. L. Jackson Roberts, a pharmacologist at Vanderbilt University School of Medicine.

Which brings up the question, has the safety and efficacy been scrutinized by the FDA? From the Tribune story:

In January 2008 Haley changed the name of his company from Chelator Technologies Inc. to CTI Science Inc. Less than a month later, he notified the FDA he would be introducing the compound as a new dietary ingredient.

Federal law allows manufacturers of dietary supplements to market them without the rigorous testing for safety and efficacy the FDA requires of drugs. Developing, testing and bringing a drug to market can cost hundreds of millions of dollars, according to some studies.

But the law does require makers of supplements containing new dietary ingredients — such as OSR#1 — to establish that the product can be expected to be safe.

In June 2008, an FDA senior toxicologist sent a letter to Haley that questioned on what basis the product could be expected to be safe and could be considered a dietary ingredient. According to FDA spokeswoman Siobhan DeLancey, Haley has not responded to the request for more information.

DeLancey declined to discuss OSR#1 specifically, but she said the government prohibits companies from selling a product until the safety requirement is satisfied. Penalties can include warning letters, seizure of products or criminal prosecution. DeLancey said she did not know of any actions taken against Haley or his company.

Haley did not respond to questions from the Tribune about the FDA.

Well, Dr. Haley hasn’t responded to the request for more information. He could face…a warning letter. Sorry, that just summons up images of Michael Palin doing the “Spanish Inquisition” sketch from Monty Python. So far the FDA seems to have let this case slide for over a year, and should they focus attention on OSR#1 and find fault they might issue a “warning letter”? Has the FDA no teeth?

Some of the questions that arise in my mind reading this article are:

1) Is OSR#1 a chelator?
2) is it being marketed as an antioxidant/supplement to avoid the more costly and time consuming process of approving a drug?
3) is the level of safety testing OSR#1 has undergone appropriate?
4) are the customers for OSR#1 buying it as a chelator or as an antioxidant/supplement?

Let’s take a look at these questions

First, is OSR#1 a chelator? It appears the answer is a fairly clear Yes:

The company that makes the supplement, CTI Science, describes it as an antioxidant. But pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical Biology at State University of New York at Stony Brook, said it is obvious from the product’s chemical structure that it is also a “powerful chelator,” a compound that binds to heavy metals such as mercury.

Second, is OSR#1 being marketed as an antioxidant/supplement to avoid the more costly and time consuming process of approving a drug? I don’t think we can tell the motivations of Dr. Haley or his company. However, the Tribune story seems to ask the same question:

In January 2008 Haley changed the name of his company from Chelator Technologies Inc. to CTI Science Inc. Less than a month later, he notified the FDA he would be introducing the compound as a new dietary ingredient.

Federal law allows manufacturers of dietary supplements to market them without the rigorous testing for safety and efficacy the FDA requires of drugs. Developing, testing and bringing a drug to market can cost hundreds of millions of dollars, according to some studies.

Third, is the level of safety testing appropriate? Again, the Tribune brings up the question of whether the FDA has had all its questions answered, even for the lower standard of a supplement.

While not directly on point as to the safety testing, two quotes from the Tribune story stick in my mind when it comes to safety/efficacy:

Ellen Silbergeld, an expert in environmental health and a researcher funded by the National Institutes of Health studying mercury and autism at Johns Hopkins University Bloomberg School of Public Health, said she found the sale of the chemical as a supplement for children “appalling.”

and

“Treatment of autistic children with a potent chelator is potentially hazardous and offers no benefits,” Grollman said.

Lastly, I posed the question of whether the customers for OSR#1 are buying it as an “antioxidant/supplement” or as a chelator. Again, it is very difficult to ascribe motivations. However, I will point out that in over 400 comments to the Tribune piece, few (if any!) discuss OSR as an antioxidant. Instead there is much discussion of mercury. Rather odd discussion for something that is marketed “only as an antioxidant supplement”.

If you want more details than in the Tribune article, OSR was discussed by Kathleen Seidel of Neurodiversity.com in three articles:

A Fine White Powder

The Industrial Treatment

and

An Inquiry Emerges

Kathleen Seidel is the blogger with the most thoroughly researched articles I have ever seen.

One of the complaints about Ms. Tsudorous’ previous articles, posed by those promoting alternative medical treatments for autism, is that she didn’t seek out “balance”. First, Ms. Tsudorous did enough hard legwork to support her stories without having to rely on pitting parent/advocate opinion on an equal footing with medical experts. Second, Ms. Tsudorous attempted to get comments from a prominent parent/advocate who had publicly touted OSR#1. The parent declined to let her opinion be heard.

The bottom line for this autism parent? OSR#1 doesn’t come close to being something I would give to my child, no matter whether you call it a supplement or a drug. First I side with Dr. Grollman (“Treatment of autistic children with a potent chelator is potentially hazardous and offers no benefits”). Second, what I have seen of the safety studies doesn’t meet my standards. That’s putting it lightly.

edit to add: the Tribune has posted some of the communications between the FDA and the company selling OSR#1:

Click to access 51678955.pdf

The Tribune leads the way on autism coverage

19 Jan

The story sounds too lurid to be true – ignoring FDA regulations, a retired chemistry professor takes a chemical used to treat toxic waste,  and repackages it as a dietary supplement for disabled children. Welcome to the world of autism quackery.

The story in Sunday’s Chicago Tribune is the latest in a year-long investigation into America’s anti-vaccine movement, and its spin-off treatment industries. Last May the newspaper introduced us to <a href=”http://www.chicagotribune.com/health/chi-autism-lupron-geiers-may21,0,983359.story”>a Maryland physician</a> who purports to treat autism with Lupron, a powerful castration drug also used to treat sex offenders. In November, reporters Trine Tsouderos and Patricia Callahan showed how alternative practitioners <a href=”http://www.chicagotribune.com/health/chi-autism-science-nov23,0,6519404,full.story”>misrepresent legitimate science</a>, and <a href=”http://www.chicagotribune.com/health/chi-autism-treatments-nov22,0,7095563,full.story”>use phony lab results</a>, to push quack autism treatments. “There is a whole industry that preys on people’s fears of heavy metal poisoning,” said Dr. Carl R. Baum, director of the Center for Children’s Environmental Toxicology at Yale- New Haven Children’s Hospital, something that comes as no surprise to the nation’s 60,000 pediatricians.

The latest story introduces us to Prof. Boyd Haley, a retired former head of the Department of Chemistry at the University of Kentucky, and a micro-celebrity in the vaccine-rejection community. His wonder-drug, called OSR#1, was first formulated as an industrial chemical that separates heavy metals from polluted soil and mining drainage. Haley first repurposed the chemical as a chelating agent for treating autism, but when FDA approval was not forthcoming, he rebranded OSR as a nutritional supplement. Only one problem – the FDA says food supplements must be, uh, edible.

No wonder Haley runs from publicity he can’t control.

Federal law requires manufacturers to explain why a new dietary ingredient reasonably can be expected to be safe. The Food and Drug Administration told the Tribune that Haley had not submitted sufficient information.

In an interview, Haley said that the compound had been tested on rats and that a food safety study was conducted on 10 people. Asked to provide documentation of the studies, he stopped communicating with the Tribune.

Experts expressed dismay upon hearing children were consuming a chemical not evaluated in formal clinical trials for safety, as would be required for a drug prescribed by doctors.

Ellen Silbergeld, an expert in environmental health and a researcher funded by the National Institutes of Health studying mercury and autism at Johns Hopkins University Bloomberg School of Public Health, said she found the sale of the chemical as a supplement for children “appalling.”

“I would worry a lot about giving anything to a small child that hasn’t been scrutinized for both safety and efficacy by the FDA,” said antioxidant expert Dr. L. Jackson Roberts, a pharmacologist at Vanderbilt University School of Medicine.

The anti-vaccine movement has long relied on message control to convince parents that vaccines were more risky than the diseases they protect us against, and for too long credulous editors and reporters obliged with dutiful stenography and false balance. The Tribune’s coverage shows us that those days are numbered.

Cross-posted at AutismNewsBeat.com

Boyd Haley brings the weirdness

19 Nov

On 12th Novemeber, Vueweekly featured the second part of an interview with Boyd Haley during which Professor Haley contradicted so many of the basic tenets of the autism/vaccine hypothesis – and also of good ol’ common sense (remember her?) that I was left wondering if he was in fact an Evil Neurodiversity spy sent to make himself look like an asshat.

“What about the argument that autism rates haven’t declined since thimersoal has been removed from vaccines?” I pose. “It’s a total deception,” he says. “We don’t actually know the autism rate for the last officially thimerosal-vaccinated cohort. And according to parents who asked to look at vaccine inserts, thimerosal was still present in childhood vaccines as late as 2004 in many places. Then in 2004, the flu vaccine, which contains thimerosal, was recommended for six-month-old infants. I don’t know if we even have a thimerosal-free time frame.”

Uh….what? Whilst Haley is literally right he kind of misses points so large they’d fit perfectly on the head of a stag. He claims we don’t know the autism rate for the last officially thimerosal-vaccinated cohort, whereas it might be more accurate to state we don’t really *know* the rate for any autism cohort, ever. No one’s looked. The latest estimates in both the UK and US come in at around 1 in 100. And really, he has the question bass-ackwards. What we need to know is how much thiomersoal was in official use during the last few years as the autism estimates have been rising. The answer to that is, aside from the voluntary flu vaccine and a trace amount used in the manufacture of one brand of vaccine, none. Doesn’t need a professor to work this out…lets go through it Boyd, no thiomersal, rising autism estimates…hmmmm….

We don’t _need_ a thiomersal free time frame. We simply need to compare the autism estimates for when there was a lot of thiomersal in use to now, when there’s pretty much none.

Cherry picking another bemusing quote, we get:

Autistic infants are totally incapable of excreting mercury. They’d be fine if they weren’t exposed to thimerosal.

Hmmm, a Professor of chemistry who’s not aware that even Jill James doesn;t claim that autistic infants are *totally incapable* of excreting mercury. And a professor of chemistry who’s not aware that mercury occurs naturally in humans in greater amounts than vaccines.

Haley then brings on a strawman:

Whatever is causing autism must affect boys more than girls, as autism rates are higher among boys than girls. It is well-known and documented that testosterone accentuates the effects of mercury…

Firstly, it is now suspected (I’ll try hunt down the link) that autism affects females in a much greater number than previously suspected. It should also be noted that whilst testosterone does accentuate the effects of mercury, no valid research has ever been done to show that testosterone is working with thiomersal to heighten the effect of the mercury. Haley is just making a specious correlation.

More weirdness:

“We know autism isn’t genetic,” he says. “You can have a genetic susceptibility, which together with an environmental toxin is what I believe is causing it, but autism went epidemic in all 50 states at one time. This isn’t the behaviour of a genetically caused disease.

Actually, a goodly proportion of autism *is* assocated with genetic abnormalities. Rett syndrome – a form of autism – is _entirely_ genetic.

Haley is also in error when claims autism ‘went epidemic’. Nobody knows wether the rates of autism have ‘gone epidemic’ because we have no base measurement. Nobody can say how many autistic people there were five years ago, let alone 20. And Boyd, really, doesn;t the fact that – as you state – something happened ‘at one time’ lead you to look for explanations closer to reality? Something like…oh, say, a change in the DSM criteria which massively expanded the definition of autism? Something that _did_ happen 20 yeas ago?

The rest of Haley’s piece is a pointed reference to himself as a hero whos truth is being hidden from us all by the nasty pharma companies.

Weird. Just weird. Haley needds to catch up with the rest of the anti-vax loons who have cottoned on to the truth that the thiomersal boat is full of massive holes and pretty much lies waterlogged somewhere off the coast of Stupidville.