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Is Boyd Haley resurrecting OSR#1 as a chelator?

22 Jul

Boyd Haley was a professor of chemistry who was very active in the failed thimerosal-causes-autism movement. He earned extra notoriety for trying to coin the phrase “mad child disease” (yes, a variation of mad cow disease) for autistic children. He also found notoriety for marketing a synthetic chemical as a “nutritional supplement”, calling it OSR#1. Prof. Haley is certainly persistent. He’s working on a clinical trial.

How did this come to pass? Well, one of the professors in Prof. Haley’s department found that a certain compound could effectively treat mining waste, removing mercury. Given his own interests, Mr. Haley started a company with an investor with the intent to bring this chelator to the public. The chelators used in medicine today were developed for lead and have been expanded to also treat mercury. I.e. there is no mercury specific chelator and this new compound would fill that gap.

All well and good, but in his zeal to bring this product to market, Prof. Haley cut a few corners. Chelators are drugs. The compound he was working on was synthetic. But Prof. Haley chose to rush the product to market as a “nutritional supplement”. Instead of calling it a chelator, he called it OSR#1. OSR standing for “oxidative stress relief”. Mr. Haley skipped the process to prove that his drug was safe and effective. Supplements have a much lower standard for safety and efficacy testing.

The FDA was not fooled. Mr. Haley and his company were given a warning letter which pointed out that the compound is not a supplement, it is a drug:

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.

Also that the company was making claims that the drug could treat medical conditions and that the labeling was misleading in this regard. Further, that the toxicity was not adequately tested nor reported.

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).

That was in 2010. Prof. Haley and his company are now back, trying to get a clinical trial started on their compound. Essentially, they are trying to do what they should have done in the first place: get proper approval for a drug. An article in Chemical & Engineering News discusses this effort. Actually, it’s part of the cover story, “Building Pharma Molecules”

buildingpharma

The story on Mr. Haley’s Company, CTI Science, has contracted with another company, PCI Synthesis, to manufacture the new compound.

haley2

The article is, well, a bit of a sales pitch and gets a few facts wrong. There’s a bit of spin on the FDA warning letter, for example:

“The effort to develop the compound as a mercury poisoning therapy accelerated in 2010 when the company received notification from FDA that it couldn’t market NBMI as a nutritional supplement until it underwent the full drug approval process”.

As we’ve just seen above, the compound is not a nutritional supplement at all. It needs the drug approval process because it is a drug.

The CEO of PCI is quoted as stating:

“The main starting material is cysteamine hydrochloride, which is basically an amino acid and found naturally. So it has attributes that could qualify it as a natural product.”

Which was part of the sales pitch for the OSR#1 in the old days and, again, the FDA disagreed. Just because something is synthesized from a natural product, that doesn’t make it a natural product. Otherwise there would be no synthetic products at all. Everything at some level comes from a natural product.

The article discusses how to qualify for a clinical trial the product must meet current Good Manufacturing Practices (cGMP). The article states:

The primary challenge was the removal of impurities to a level that meets cGMP standards

Think about that a moment. Apparently OSR#1 was sold with more impurities than would meet this standard–a standard for food and dietary supplements.

The article notes that, yes, this compound was sold as a product at one time

Sales to date: $1.5 million, as a nutritional supplement

$1.5M in sales. And the only reason it wasn’t higher was because the FDA stepped in. It was only out for about a year, as I recall.

I found this statement interesting, from the Wikipedia page for the compound:

In animal experiments, the amount of mercury in brain tissue was not increased, but also not decreased

So, even if you believe in the failed mercury hypothesis. What exactly were you supposed to get from this compound? I somehow doubt that even the strong believers in the mercury hypothesis think that removing mercury from, say, your liver will cure autism.

It does seem that Mr. Haley and his company are doing some of the right things now. Show that this drug is safe and effective for its intended purpose: chelation. There are some problematical statements that they may market this not as a drug but as a nutritional supplement, which is a non-starter.


By Matt Carey

Autism an inside job: a webinar by 9/11 truthers and some names you might recognize.

8 Mar

For some reason autism and vaccines attract a certain fringe element. And for some reason certain segments of the autism communities are willing to join forces with this fringe. For example, consider years back when Andrew Wakefield spoke in Ireland with a new world order group at a rally called “The Masterplan: The Hidden Agenda for a Global Scientific Dictatorship”. Given this history I shouldn’t have been surprised when I ran across websites discussing a webinar held last year: “Autism 9.11 – An Inside Job: Vaccines – A Vicious Social Policy”. As you will see, the webinar includes some names that are familiar to those following the failed mercury/autism hypothesis.

Here’s the trailer for the webinar. It’s only three and a half minutes long and it’s annoyingly edited, but give it a watch.

“Born to be free. Vaccinated to be controlled”. Subtle, eh? OK, maybe in comparison to “The great culling had begun”.

In case you curious as to what the “inside job” is, and the 9.11 reference: to this team autism was an “inside job” just like 9/11 was an “inside job”. Yes, we are talking 9/11 truthers. Yes, people who think that the September 11 attacks in the U.S. were orchestrated by the government. Think this is too far out to be true? Think again:

“Is there anyone conscious who does not know that 9/11 was an inside job? Not anyone that I talk to. By now you also know that autism is an inside job as well. The crony corporatists (aka, “globalist elite”) expect to profit handsomely from the genomic disruption of our children.”

From that same page:

And what about the autistic children now becoming adults in the millions, the tragic victims of the Vaccine Big Lie? The Elite have plans for them, since they follow orders if their basic needs are met with predictable routine. They have been made into the perfect worker drones. Dr. Paul G. King told us that the vaccine schedule is being “fine tuned” to produce more “high functioning” autists for the new world order.

Yep. The rise in autism is not only real, but it is a government approved program to create a “Delta” (think Brave New World) class of workers. And, no, I’m not exaggerating.

In case you think you recognize the name in that paragraph, that would be Paul King of CoMeD. CoMeD is a group run by Mark and David Geier, major proponents of the failed idea that mercury in vaccines caused an autism epidemic. And apparently now Mr. King is telling is that “the vaccine schedule is being “fine tuned” to produce more “high functioning” autists for the new world order”.

Let’s take a look at the schedule for the “Inside Job” webinar:

SCHEDULE Autism: An Inside Job The England Hypothesis: Creating Delta Workers with Vaccines Tentative Webinar Schedule
[1] Introduction: Maj. Gen. Albert N. Stubblebine III (US Army, Ret.)
[2] Welcome: Rima E. Laibow, MD – We are all Vaccine Injured
[3] Focus: Ralph Fucetola, JD – Genomicidal Tech leads to GDS
[4] Thoughts on Individuality: General Stubblebine
[5] Viera Scheibner, PhD: The Fundamental Facts about Vaccination
[6] Christina England: Born to Be Free: Vaccinated to Be Controlled [7] Clint Richardson: Outsourcing our Children’s Minds, the CORE of the Problem
[8] Boyd Haley, PhD: Vaccine “Science” – Lies, Damned Lies and Shoddy Statistics
[9] Paul J. King, PhD: Mercury Murder
[10] Brian Hooker, PhD: Vaccine Lies to Build a New World Order

[11] Panel Round Table
[12] Q and A
[13] Conclusion: Genome Optimization Therapies: Think Globally; Restore Locally – Dr. Rima

I took the liberty of bolding the talks from people who may be best known to readers here. Boyd Haley is not heard from as much anymore, but he was very vocal during in the past decade promoting the idea that mercury in vaccines was responsible for the rise in diagnoses. He coined the phrase “Mad Child Disease” for autism. Nice, huh? Then there is Paul King with “Mercury Murder”. As I’ve noted, Mr. King is a member of CoMeD, an organization run with Mark and David Geier, the father-son team known for bad research, bad medicine and unethical behavior. Brian Hooker is an autism parent and long-time member of the “mercury militia” who appears to have splintered from the “mainstream” mercury groups and is possibly best known online for claiming that documents he has obtained through FOIA requests and other routes “prove” that the CDC and other orgs are covering up the claimed harm from vaccines.

The titles of those talks are a bit extreme, to be sure. And we have the webinar “trailer above” showing this to be a very fringe event. Of the talks, I can find only one online: Mr. Hooker’s talk is on YouTube. It’s long (about 40 minutes).

The first thing you may note that the title is different than the one in the schedule. Instead of “Vaccine Lies to Build a New World Order” we get “The CDC, Ground Zero for the decline of children in the United States.” Complete with mushroom cloud icon, just in case we didn’t get the meaning of “ground zero”. He pulls no punches, telling us that in his opinion there is a level of “voluntary manslaughter and murder” within the CDC. He calls the federal government “the hub of autism creation” with President Obama and the Gates Foundation exporting autism to other countries with mercury containing vaccines. He claims that every study showing vaccines don’t cause autism is statistically flawed. Except, of course, for those points he wants to cherry pick to support his argument. For those the statistics are valid. Instead of his toned down talk he prepared for the Committee on Congressional Oversight and Reform, here we hear all about how the CDC and the HHS are committing genocide.

There is a lot of discussion towards the end about how vaccines are being intentionally used to create a cheap workforce, what the promoters of the webinar call a “delta workers” (think Brave New World). It’s a favorite theme of the group hosting the webinar.

Autism-Inside-Job-Final[1]

With the subtitle “Depopulation, Delta Worker Drones and Autism Eugenicide”

At the end of the presentation we hear this exchange between Mr. Hooker and the host of the webinar:

Host: I’m thrilled to have you as a colleague and a fellow advocate for an end to vaccination.

Brian Hooker: Thank you and god bless you both, I really appreciate it.

Perhaps Mr. Hooker felt that it would be impolite to correct the host in her assertion that he is a “fellow advocate for an end to vaccination”. Perhaps not.

The webinar was made into an eBook. Boyd Haley’s talk changed to a “special message” entitled “CDC/NIH/IOM ABANDON SCIENCE!”. The title for Paul King’s contribution is “Mercury Madness” rather than “Mercury Murder”. And the title for Brian Hooker is “CDC: Ground Zero” rather than “Vaccine Lies to Build a New World Order”.

The “Educational Value” of the eBook is given as:

At the conclusion of this webinar, the participant will be able to discern whether vaccines are used because of the neurological damage they produce or in spite of it, leading to more informed vaccine choices for themselves and those they impact.

Yes, you’ve already heard this message. They think that vaccines are not only causing autism, but that this is an intentional effort by the government.

It would be easy to mock this webinar and the participants. It is very, very fringe. But it isn’t funny. It’s irresponsible.

I’d ask why the hell are Boyd Haley, Paul King and Brian Hooker lending their names to this irresponsible effort, but Mr. Hooker’s presentation makes it very clear. He’s not duped or fooled. He’s complicit[see below]. We can’t say for certain about Mr. Haley or Mr. King, but it’s not as though the message on that website is subtle or hidden.

No, this is no where near funny. For anyone who has read the damage these messages have caused within the autism communities knows: there’s zero humor in this nonsense.

Edit to add: Mr. Hooker has contacted me and informed me that he is not a 9/11 truther.

By Matt Carey

OSR pulled from the market….or is it?

3 Aug

Here on LeftBrainRightBrain we recently discussed a letter from Boyd Haley, Ph.D. announcing his decision to voluntarily remove his product, OSR #1 from the market. The letter from Mr. Haley stated (in part):

The product will not be available for sale after that date until new drug approval has been obtained. Please continue to access our website, http://www.ctiscience.com , for updates on OSR#1® in the future.

The CTI website is down, and has been for a few days. The message I get when try it is:

HTTP Status 404 -

type Status report

message

description The requested resource () is not available.

Two locations I checked are still selling OSR.

The Forrest Health site has the letter from Mr. Haley noting that he has pulled the product from the market. They not only let you buy it, but they require that you purchase 3 or more “Note: you must order at least 3 items”.

Living Well International has OSR on their site as well. In response to my email, they response to my email request, “Do you still have OSR#1 for sale?”, they responded “Yes we do. It is $60 for a box of 30″

I do wonder how long before someone decides to make his or her own batch of OSR. Mr. Haley has been quoted as stating it was not difficult. The published recipe for the chemical indicates a few potential concerns. First, the chemicals are themselves not without hazards.

Triethylamine

Liquid causes first degree burns on short exposure; [CHRIS] Corrosive to skin; [Quick CPC] Short-term exposure at high concentrations may cause pulmonary edema. [ICSC] A lachrymator; [CHEMINFO] Experimental animals exposed repeatedly to 100 ppm show evidence of liver, kidney, lung, and heart damage. [HSDB] A corrosive substance that can cause pulmonary edema; [ICSC]

Chloroform has relatively high LD50 values (the amount where 50% of exposed animals die). But the MSDS lists reproductive toxicity as:

Birth defects have been seen in rats and mice exposed by inhalation of chloroform at concentrations greater than 100 ppm in air. Ingestion of chloroform by pregnant laboratory animals has resulted in fetotoxicity but not birth defects, and only at levels causing severe maternal effects.

Isophthaloyl chloride is only listed as an eye/skin irritant. I won’t go down the list of all the chemicals. I think you get the idea. It is likely that a competent chemist with a reasonable laboratory (including a fume hood and access to nitrogen gas) could produce “bathtub OSR” reasonably safely. I frankly cringe at the thought of someone attempting this at home. I will add, the yield of the published process for producing this chemical is about 72% without optimization. This begs the question to me as to how clean the product is in this form.

OSR to be pulled from the market?

22 Jul

OSR #1, a chemical invented as a chelator and now marketed as a dietary supplement, will be pulled from the market in about 1 week’s time if the message below attributed to Boyd Haley is accurate:

On 18 June 2010, the FDA wrote to CTI Science questioning whether OSR#1® fit within the agency’s definition of a dietary supplement, indicating that instead it appeared to be a drug. Although we believe the product meets the legal definition of a “dietary supplement,” we have decided not to contest this point but to work with the agency. While achieving formal drug approval is lengthy and costly, CTI Science will in the course of it prove to FDA’s satisfaction the safety and efficacy of OSR#1® and ultimately be able to offer OSR#1® to the public with FDA-authorized therapeutic claims.

As a result of this decision, *CTI Science has voluntarily agreed to remove OSR#1® from the market effective Thursday, 29 July 2010*. The product will not be available for sale after that date until new drug approval has been obtained. Please continue to access our website, http://www.ctiscience.com , for updates on OSR#1® in the future.

On a personal note, I have met most of the medical professionals we deal with, and your passion and dedication to excellence are rarely seen these days. It has been an honor to work with you, and I am deeply appreciative of the support you have shown in the past. Please accept my best wishes for your continued success. I look forward to working with you in the future again with OSR#1®.

Boyd E. Haley, PhD

President
CTI Science-Color-EM
CTI Science, Inc.

The Twitter account for CTI science has the following message posted earlier today which would suggest the above message is accurate:

Registered Medical Professionals: Please review your email for an important message about the future availability of OSR#1®. http://www.OSR1.com

I will say that I welcome this move. I agree with the FDA that OSR #1 is not a dietary supplement and, as such, should undergo much more rigorous safety testing before being marketed.

OSR: The Littlest Consumers and other posts from Neurodiversity.com

14 Jul

There has been much discussion here and elsewhere on the net about OSR #1, the chelation chemical sold as “oxidative stress relief” supplement. The latest round of this was sparked by a story in the Chicago Tribune, FDA warns maker of product used as alternative autism treatment.

Much of the early investigation of OSR #1, it’s origins as an industrial chelator and so on, were done by Kathleen Seidel of Neurodiversity.com. Ms. Siedel is probably the most thorough blogger (or writer of any kind) I know of. Her posts are long and detailed and well referenced.

Her recent post, OSR: The Littlest Consumer, takes on the subject of internet reports of OSR being given to small children. The website for OSR (CTI Science) states, OSR#1TM is not recommended for children under 55 pounds or under 4 years of age.”

And, yet, OSR appears to be being given to small children. Also, if the internet reports are accurate, this occurs sometimes under the advice of DAN doctors.

People interested in a thorough discussion of OSR can reference previous articles by Ms. Seidel include:

Haley’s Chelator: For Cats Or For Kids? (April 26, 2008)
A Fine White Powder (August 1, 2008)
The Industrial Treatment (August 8, 2008)
An Inquiry Emerges (August 14, 2008)
FDA To Haley: OSR#1 A Misbranded, Mislabeled, Unsafe Drug (June 24, 2010)
OSR: Fuel For Thought (July 7, 2010)
OSR: A Bevy Of Adverse Events (July 12, 2010)

Boyd Haley discusses OSR #1 in the Lexington Harald-Leader

12 Jul

As noted here on LeftBrainRightBrain, OSR #1 is currently under scrutiny by the FDA. Our post followed a report by the Chicago Tribune, FDA warns maker of product used as alternative autism treatment.

OSR stands for Oxidative Stress Relief. It is a chemical invented at the University of Kentucky for chelating soil from mining operations. It was originally discussed at autism parent conferences as a chelator, but the focus has changed to “oxidative stress relief” over time. It has not been marketed, to my knowledge, by CTI Science for its chelator properties.

Today, Mr. Boyd Haley, who has been marketing OSR #1 through his company CTI Science, has made a public statement as an Op-Ed piece in his local newspaper, the Lexington Harold-Leader:

Dietary supplement safe for right use
chemical name might be confusing; toxic effects low

First, I note that previous statements have indicated that OSR is “totally” without toxicity. Now the statement is “toxic effects low”.

Mr. Haley starts his piece on the offensive:

This is just one of several Chicago Tribune articles focusing on criticism of doctors who treat autistic children, raising similar concerns to that of a fringe group called Neurodiversity, which thinks autism should be celebrated instead of treated.

He then defends his product:

It is critical to be noted that there has been no report of any significant adverse effect for OSR#1. Our legal representation has contacted the Food and Drug Administration and we are working with the agency to resolve its concerns.

Mr. Haley is apparently unaware of the potential adverse effects reported on internet forums for his product. Kathleen Seidel of neurodiversity.com has a piece up OSR: A Bevy Of Adverse Events today which may be enlightening.

Mr. Haley notes that his company has made no medical claims about the efficacy of OSR. He then offers a statement about the compound he is marketing:

The letter from the FDA might also have been caused by a naming misconception. The chemical name of OSR#1 is N1N3-bis-(2-mercaptoethyl)isophthalamide, which might imply a complex chemical with no natural components.

However, the structure of OSR#1 contains a benzoate group (found in cranberries) and two cystamines (a metabolite of cysteine and found in all meats).

The FDA description of a dietary supplement extracted from their warning letter is: “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.”

It is apparent that OSR#1 bears and contains one or more dietary ingredients and is why OSR#1 was submitted over two years ago to the FDA for consideration as a dietary supplement. It might be that the chemical name we placed on the label has confused this issue.

I don’t think it is the chemical name which has confused the issue. But maybe that is just me. When I read the patent that the University of Kentucky (Mr. Haley’s former institution) has licensed for use as OSR, I read this:

Multidentate sulfur-containing ligands
, patent 6,586,600

Which states that (a) the compound is “novel” and (b) it has the function of a chelator.

Novel sulfur-containing ligands for binding of heavy metals are disclosed. The ligands incorporate a central ring structure and pendant alkyl-thiol chains. The ligands are of the general structure: ##STR1##where n is an integer from 1-4, and X is selected from the group consisting of hydrogen, lithium, sodium, potassium, rubidium, cesium, and francium. The ligands of the present invention are suitable for binding any metal in or capable of being placed in a positive oxidation state, such as cadmium, lead, nickel, zinc, mercury, copper, and the like. Additionally, methods for removal of heavy metals from various substances are disclosed, comprising separating selected heavy metals from selected substances by contacting the substances with an effective amount of the novel sulfur-containing chelate ligands for a sufficient time to form stable, irreversible ligand-metal precipitates, and removing such precipitates.

In one of the Chicago Tribune pieces on OSR #1 a pharmacologist was quoted:

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.

I will await the FDA’s review of whether a “novel” compound “might imply a complex chemical with no natural components”. Also, I will await whether under the law one can state that because a chemical has subgroups found in foods, it is a “combination of dietary ingredients”. It strikes this reader as unlikely that the FDA will agree with Mr. Haley’s position, however.

Consider this–take vitamin C powder and Vitamin D powder. Mix them up in whatever ratio you want. Put it in a pill. This is a combination of vitamins C and D. However, the molecules in the mixture exist in original form and can be considered to act in the body in their expected manners. The pill will work as vitamin C and vitamin D.

Now consider OSR #1. Assume that the molecule can be described as segments of various chemicals found in foods. However, the resultant molecule is “novel”, i.e. not found or synthesized previously. The resulting molecule will act in the body in a different manner than the sub-units.

Another way to look at this–if a person were to eat cranberries and meats (which contain the subunits of OSR #1 according to Mr. Haley), would one get the same results in the body? Is OSR “supplementing” the benzoate groups (found in cranberries) and two cystamines one would get from one’s diet?

Is OSR #1 safe or toxic? I don’t think the data are available to answer that question. And that presents a big question here: has sufficient study been performed? Is it appropriate to market this compound as a “supplement”? That will go a long way towards determining whether there is sufficient safety data. The FDA warning letter claimed that OSR #1 is not a supplement but a drug.

Boyd Haley comments on the FDA warning letter.

30 Jun

Below is a communication attributed to Boyd Haley. He is the president of CTI Science which is marketing “OSR#1″. OSR#1 is a chemical which was originally invented to chelate wastewater from mining operations. Mr. Haley’s company markets it, not for its chelating properties, but as a source of “oxidative stress relief” (OSR). The FDA has recently sent him a warning letter noting that it is likely that OSR is (a) not a supplement and (b) is a drug.

Jaquelyn: Below is my response to the Chicago Trib article. We have also had our legal help contact the FDA and explain our position. They have extended our time to respond in detail until the end of July and implied that they are willing to work with us on this issue.

The article by the Chicago Tribune and the warning letter from the FDA are fueled by a misconception. The chemical name of OSR#1 is N1N3-bis-(2-mercaptoethyl)isophthalamide which makes it sound to many like an exceptionally complex chemical with no natural components. However, looking at the structure of OSR it is easily seen that it contains a benzoate group (found in cranberries) and two cystamines (a metabolite of cysteine and found in all mammalian cells and on the terminal end of Coenzyme-A). The coupling of cystamine to benzoate is through the same type of amide linkage found in connecting amino acids to produce protein.

The FDA description of a dietary supplement as extracted from their letter is: To be a dietary supplement, a product must, among other things, “bear [ ] or contain [ ] one or more…dietary ingredients” as defined in section 20 I (11)( I) of the Act, 21 U.S.c.§ 321 (ff)( I). Section 20 1(11)( 1) or 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. Using this description it is obvious to a biochemist that OSR#1 bears and contains two dietary ingredients. It appears as if the chemical name (which we had to place on the label) has confused this issue. Hopefully this can be cleared up.

Regarding the toxic effects the FDA and Chicago Tribune comment on. The diarrhea and pancreas problems reported occurred during an UP/DOWN study to determine the LD-50 of OSR, that is “what amount of OSR would cause 50% of the test animals to die?”. Problem was that during the experimentation, even to reach the 5 grams/kg body weight they finally achieved, the researchers had to give the OSR (dissolved in corn oil) at three different times during the day. Even then the test animals showed no weight loss or ataxia or other signs of toxicity except diarrhea and a pancreas abnormality. They were giving these animals massive doses (e.g. 1,000 to 5,000 times the recommended level for humans) trying to kill them. Almost all supplemental materials would cause some problems at these levels and the LD-50 of OSR (decided to be greater than 5 g/kg) is considerably above the LD-50 of some commonly used supplemental compounds used today.
For example, a 220 lb (100 kg) person would have to take 500 grams/day or 5,000 OSR capsules/day to reach the 5 g/kg body weight level. We recommend 1 capsule or 0.1 gram/day level usage (i.e. 100mg) which is 5,000 times below the 5 gram/kg level in this example. When the long term study was done and the maximum amount tested was 1 gram/kg body weight the diarrhea and pancreas issues disappeared. At 1 gram/kg a 220 lb person would have to take 1,000 capsules/day to reach a level where no toxic effects were noted. In it’s initial letter responding to our Premarket Notification the FDA did not mention these test animal toxicity studies as being of any concern. I don’t know what changed their minds to make them go back and review this, but their review and the comments in this recent letter do not reflect a concern I would agree with.

Also, OSR has never been promoted by CTI Science as a treatment for any specific disease and FDA disclaimers are on every package.

I would point out that the FDA warning letter was not based on any reported adverse effect. Since CTI Science has been selling OSR (about 2 years) we have not had one severe adverse effect reported to our FDA based adverse effect reporting system. We have had many very positive responses from physicians and parents regarding the use of OSR. However, the fact is that I have to obey the FDA directive or risk damage to my co-workers as well as myself, and/or spend the funds to legally counter the FDA decision. What to do is under study. But from the above, you can see why I strongly believe that OSR is a dietary supplement by FDA criteria and that it is without detectable toxicity at the levels recommended.

Boyd E. Haley, PhD
Professor Emeritus

University of Kentucky
Chemistry Department

Boyd E. Haley, PhD
President

CTI Science, Inc.

It appears to this reader that Mr. Haley’s defense hinges on the part of the law which defines a supplement as “…or combination of any dietary ingredient from the preceding categories”. In particular, he appears to be claiming that his compound, which is apparently in the same form in a food, is a “combination” of other ingredients.

Mr. Haley can point to the various constituents of the molecule he is producing and marketing and state, “that part is from a food”. But, is that a valid argument? Does the law really intend that “combination” means “mixture” as in, say, a multivitamin?

Here is the full section of the law defining a “supplement”

ff) The term “dietary supplement”—

(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);

(2) means a product that—

(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or

(ii) complies with section 411(c)(1)(B)(ii);

(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and

(C) is labeled as a dietary supplement; and

(3) does—

(A) include an article that is approved as a new drug under section 505 or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and

(B) not include—

(i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507 7, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or

(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act.

Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act.

I’m trying to find some sort of case-law that would help define the word “combination” here. But I feel that Mr. Haley’s interpretation is not likely to hold.

Mr Haley has in the past described OSR#1 as “totally without toxicity”. Now, “Even then the test animals showed no weight loss or ataxia or other signs of toxicity except diarrhea and a pancreas abnormality. ” Yes, those animals were given massive doses. But, once again, it comes down to definition of words. Is Mr. Haley using the word “totally” appropriately? Is OSR#1 “totally” without toxicity?

OSR#1

30 Jun

My own contribution is here, with less science and more snark:

Please leave your comments there or here, it doesn’t matter.

Another Hero Of The Anti-Vaccine Movement Bites The Dust

29 Jun

So says Steven Salzberg in a Forbes blog post, Another Hero Of The Anti-Vaccine Movement Bites The Dust. Prof. Salzberg is referring to the recent FDA warning letter sent to Mr. Haley about his product, OSR#1. The FDA has warned Mr. Haley that his “supplement” meets the criteria for a drug and the testing involved indicates that there may be serious side effects.

Prof. Salzberg introduces Mr. Haley as a “hero of the antivaccine movement” for his outspoken positions on mercury, especially on thimerosal and autism. Prof. Salzberg poses and answers his own question:

Is Haley simply a confused chemist who fails to understand epidemiological evidence? Or does he have another agenda?

Well, he does: money.

The rest of the piece does not go favorably for Mr. Haley.

Given that piece, I decided to check the website for OSR #1. Mr. Haley has apparently not responded to the FDA formally as of yet but has responded on his website:

Why did the FDA send CTI Science, Inc. a warning letter about OSR#1®?

The FDA sent CTI Science, Inc. a warning letter dated June 17, 2010. They state that OSR#1® is not a dietary supplement because N1, N3-bis(2-mercaptoethyl)isophthalamide is not a known dietary ingredient. However, N1, N3-bis(2-mercaptoethyl)isophthalamide is a combination of two dietary ingredients, benzoate and cystamine coupled together by an amide linkage which is naturally found in proteins coupling amino acids together. The FDA further states that CTI Science, Inc. makes drug claims on its packaging, website and promotional material. CTI Science, Inc. does not believe that the claims it previously made about OSR#1® were drug claims. However, all claims the FDA referenced in its letter were removed from the website. The FDA further states that there may be a safety issue with regard to OSR#1®, because diarrhea was experienced in animal subjects when fed OSR#1® dissolved in corn oil by gavage three times daily at a rate of 5g per kg body weight. This would be the equivalent of 500g for a 220lb person or 5,000 capsules plus a bolus of corn oil. CTI Science, Inc. does not believe this diarrhea is a toxic effect as the animals continued to gain weight like controls and did not develop any toxic effects like ataxia. Using this definition any food, like milk, would be toxic if taken at such a high level.

The Company is evaluating the FDA letter and preparing its response

Now I am not a former chemistry professor, but a few points in the above statement struck me as odd.

First, he notes that his product is the combination of two dietary ingredients. Well, if the resulting chemical isn’t found in foods, isn’t that the real definition of “dietary ingredient”? It doesn’t matter what the source materials are. Heck, can’t you have synthetic sources of “dietary ingredients”? It is the end product, not the source materials that count.

Second, he hasn’t addressed all the issues that the FDA brought up in the warning letter.

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

Hair loss, “abnormalities of the pancreas”, “lymphoid hyperplasia”. Those are not mentioned on the OSR website.

Third, ” Using this definition any food, like milk, would be toxic if taken at such a high level.”. Did Mr. Haley just make a “the dose makes the poison” argument in his defense? Many people promoting the idea that mercury causes autism have rejected the “dose makes the poison” idea, claiming that any amount of mercury is toxic.

Back to Prof. Salzberg’s post. One observation: Forbes magazine is taking on the alternative medical community and their “treatments” for autism, at least in this one case. But take a look at the tags attached to the piece: “antivaccinationist, Autism, Boyd Haley, chelation, mercury, pseudoscience, thimerosal, vaccines”. Ouch.

Supporters of OSR #1, “drug” given to autistic children, see FDA warning as no big deal

24 Jun

The story broke yesterday that Dr. Boyd Haley has been given a warning letter by the FDA about his chelating product, OSR #1. The FDA has warned Dr. Haley that his own safety tests indicate the possibility for adverse reactions and that since the substance is not found in any food or mineral, it is not a “supplement” as he markets it, but a drug. Drugs require much higher standards of proof of safety.

One could make an easy bet that the Age of Autism blog, which has helped tout the drug/supplement OSR, would come to Dr. Haley’s defense. The way they went about this is quite surprising to me. In Chicago Tribune Protecting Consumers Against Natural Supplement (Again), the Age of Autism writes:

CTI Science got a letter from the FDA about its ingredients. They will respond. Dr. Weil got a similar letter last year when he dared to offer an immune support formula in place of the H1N1 vaccine. Drug companies get the letters every day of the week for their advertising claims. You think 50,000 people in America even know what OSR is? They will now.

Yes–the letter from the FDA is no big deal. One of their favorite alternative medical practitioners got one last year, and the pharmaceutical companies get them too. While it isn’t mentioned in the AoA piece, Dr. Weil appears to have ignored the warning letter without any repercussions as no response has been recorded.

Yes, “you don’t have to respond to the FDA’s letters” appears to be a valid excuse to the Age of Autism.

There is a major difference between the warning letters sent to Dr. Haley and Dr. Weil. Dr. Haley’s letter shows that his own safety data, data not previously made public from what I can see, indicates the drug he is selling has the potential to cause adverse reactions. Dr. Weil appears to be only making claims of efficacy which he can’t back up. Only.

And, yes, big companies flout the FDA letters too. Merck, a giant pharmaceutical company, has one warning letter. One. That’s for Vioxx. Merck didn’t respond. That didn’t exactly go well for them, did it?

The full warning letter to Dr. Weil is quoted below.

TO XXXXXXXXX
http://www.drweil.com

FROM: The Food and Drug Administration and the Federal Trade Commission

RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus; and

Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure the H1N1 Virus

DATE: October 15, 2009

WARNING LETTER

This is to advise you that the United States Food and Drug Administration (“FDA”) and the United States Federal Trade Commission (“FTC”) reviewed your website at the Internet address http://www.drweil.com on October 13, 2009. The FDA has determined that your website offers a
product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.

This product is your Immune Support Formula. The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331, 351, 352. We request that you immediately cease marketing unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.

In addition, FTC staff reminds you that the FTC Act, 15 U.S.C. § 41 et seq., requires that claims that a dietary supplement can prevent, treat, or cure human infection with the H1N1 virus, must be supported by well-controlled human clinical studies at the time the claims are made. More generally, it is against the law to make or exaggerate health claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims. Violations of the FTC Act may result in legal action in the form of a Federal District Court injunction or Administrative Order. An order also may require that you pay back money to consumers.

Some examples of the claims on your website include:

On a webpage entitled, “The Swine Flu – H1N1 ,” with the subtitle “Swine Flu and You”:

“[D]uring the flu season, I suggest taking a daily antioxidant, multivitamin-mineral supplement, as well as astragalus, a well-known immune-boosting herb that can help ward off colds and flu. You might also consider. .. the Weil Immune Support Formula[,] which contains both astragalus and immune-supportive polypore mushrooms ….”

On a product webpage describing the Immune Support Formula:

“The Immune Support Formula contains astragalus. . . . Astragalus … is used traditionally to ward off colds and flu and has been well studied for its antiviral and immunity-enhancing properties.”

“Th[e] synergistic combination of immune modulators [found in the Immune Support Formula] is especially useful for those who tend to get every bug that goes around during the winter.”

On the same webpage, under “Supplement Facts,” describing the Astragalus supplement (which is one element of the Immune Support Formula):

“Astragalus … is … used traditionally to ward off colds and flu, and has demonstrated both antiviral and immune-boosting effects in scientific investigation.”

On the website’s home page, DrWeil.com:

“Worried About Flu? Dr. Weil’s Immune Support Formula can help maintain a strong defense against the flu. It contains astragalus, a traditional herb that boosts immunity. Buy it now in one click, and start protecting your immune system against flu this season.”

On the Dr. Weil Vitamins – Daily Vitamin Packs webpage:

“[L]earn more about Dr. Weil’s Immune Support Formula, which contains astragalus – an herb Dr. Weil recommends to help ward off colds and flu.”

The Secretary of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. § 247d, has determined that a public health emergency exists nationwide involving the H1N1 Flu Virus that affects or has the significant potential to affect national
security. Following this determination and in response to requests from the U.S. Centers for Disease Control and Prevention, FDA issued letters authorizing the emergency use of certain unapproved and uncleared products or unapproved or uncleared uses of approved or cleared products, provided certain criteria are met, under 21 U.S.C. § 360bbb-3. The marketing and sale of unapproved or uncleared H1N1 Flu Virus-related products that are not authorized by and used in accordance with the conditions of an Emergency Use Authorization, is a potentially significant threat to the public health. Therefore, FDA is taking urgent measures to protect consumers from products that, without approval or authorization by FDA, claim to diagnose, mitigate, prevent, treat or cure H1N1 Flu Virus in people.

You should take immediate action to ensure that your firm is .not marketing, and does not market in the future, products intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus that have not been approved, cleared, or authorized by the FDA. The above is not meant to be an all-inclusive list of violations. It is your responsibility to ensure that the products you market are in compliance with the FFDC Act and FDA’s implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that the claims you make for your products do not adulterate or misbrand the products in violation of the FFDC Act. 21 U.S.C. §§ 331, 351, 352. Within 48 hours, please send an email to FDAFLUTASKFORCECFSAN@fda.hhs.gov, describing the actions that you have taken or plan to take to address your firm’s violations. If your firm fails to take corrective action immediately, FDA may take enforcement action, such as seizure or injunction for violations of the FFDC Act without further notice. Firms that fail to take corrective action may also be referred to FDA’s Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws.

FDA is advising consumers not to purchase or use H1N1 Flu Virus-related products offered for sale that have not been approved, cleared, or authorized by FDA. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning marketing unapproved, uncleared and unauthorized H1N1 Flu Virus-related products in violation of the FFDC Act. This list can be found at http://www.accessdata.fda.gov/scripts/h1n1flu. Once the violative claims and/or products have been removed from your website, and these corrective actions have been confirmed by the FDA, the published list will be’ updated to indicate that your firm has taken appropriate corrective action.

If you are not located in the United States, please note that unapproved, uncleared, or unauthorized products intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus offered for importation into the United States are subject to detention and refusal of admission. We will advise the appropriate regulatory or law enforcement officials in the country from which you operate that FDA considers your product listed above to be an unapproved, uncleared, or unauthorized product that cannot be legally sold to consumers in the United States.

Please direct any inquiries to FDA at FDAFLUTASKFORCECFSAN@fda.hhs.gov or by contacting Kathleen Lewis at 301-436-2148.

It is also your responsibility to ensure that the products you market are in compliance with the FTC Act. FTC staff strongly urge you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. The FTC also asks that you notify it via electronic mail at flu@ftc.gov within 48 hours of the specific actions you have taken to address the agency’s concerns. If you have any questions regarding compliance with the FTC Act, please contact Karen Jagielski at 202-326-2509.

Very truly yours,

/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission

/S/
Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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