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.
Left Brain Right Brain 
On the Autism Speaks board I had the pleasure of witnessing Boyd claim to have tested OSR on his neighbour’s cat.
So little, says so much.
“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).”
This is like saying a car is a motorcycle because it has tires, a gas tank and a headlight. It is not just what something is made of that determines what it ultimately is, but also how those parts are put together. OSR#1 is no more a steak with cranberry compote than a car is a motorcycle.
I think all kinds of what most of us would think of as drugs are sold as dietary supplements. The FDA has much less authority to regulate dietary supplements. However, didn’t I see somewhere else that they started the process to get this approved as a new drug before they began to market it as a dietary supplement? If so, that seems like that could turn out to be their bigger problem….
“Pumping our kids full of an industrial chemical”. What a joke, look at the ingredients of most vaccines (ignoring thimerosol, which they “recommended” not be added anymore, but are still using up the millions of vials that were produced). Ammonium sulfate – used industrially as a soil fertilizer. Aluminum phosphate – used industrially as a dehydrating agent. Aluminum hydroxide – industrially to manufacture aluminum metal and as a fire retardant. Formaldehyde, MSG…the list goes on of the ingredients that have uses both in medicine and industry. Quite the double standard, these ingredients are ok in our vaccines, but not to help promote/restore health that is potentially lost due to the vaccines.
Lhs,
“fire retardant”?
If OSR #1 had a clinical trial for safety comparable to any vaccine, I would not be blogging this. How many thousands of children were tested for OSR #1? Answer: zero.
Giving it to goldfish and rats and claiming it is a “supplement” is circumventing the law, in my opinion. Can you describe how OSR is a supplement?
My twins have been on OSR for nearly 2 years. We were one of the first families to have the privilege to get it. My son spoke his first words after beginning OSR. My daughter stopped eating her own feces. We had NO side effects at all!!! NONE! Only benefits. I am a registered nurse and kept close watch on them. I do not take the accusations made toward Boyd Haley lightly as he was the only person that actually tried to help my children. He has taken so much crap for trying to help children. He did not charge an unreasonable amount of money for the OSR…he wasn’t out to get rich. He is a humble man. When my husband and I had tried so many other therapies in vain we found him and the OSR. He never once told us that it would cure our children but it came closer than anything so far. And now you label him a liar and criminal?? How dare you!!! Now our great government that injured my children is taking away the only supplement that has helped…way to go FDA….
Vicki,
I have to ask a few questions. 2 years ago, what safety studies did Mr. Haley present to you?
Could you tell me, what does OSR supplement, exactly? The body doesn’t produce nor does it ingest the chemical in OSR. Even Mr. Haley’s comments which claim higher levels of glutathione use the logic that those higher levels result from scavanging of free radicals which would deplete glutathione. Thus, it is not “supplementing” glutathione, even if the claims are correct.
Two years ago did he call it a chelator? If so, that is interesting in that his story changed over time. If not, why not? Why not inform you of what this chemical is designed to do? You appear to be interested in this chemical from its chelation potential (based on your comments about mercury).
That begs the question: why chelate for two years? Standard chelation protocols for real heavy metal poisoning is much shorter.
There are so many questions. I do hope you take the time to answer them.
Vicki, you are an insult to real nurses around the globe. Stop pretending, and present real science and not anecdotes.
Chris and Sullivan’s comments spoken like those who obviously dont have autistic children. And I find it very interesting that Nurse Practitioners all over the nation who have practices chelating special needs children, many of them recommending OSR with great results AND NO SIDE EFFECTS.
If all these parents and their kids would stand up and be counted, THERE WOULD BE YOUR STUDY
BACK OFF and SHUT UP.
I am so tired of people who think the FDA is still a benevolent institution. Is it something in the water?
I also have to laugh at the list of so-called side effects that are supposed to make OSR dangerous. As a veteran to many detoxing protocols, I would have to say that detox is not pretty, its not for the faint-hearted or those who say “Ew ish!” too easily.
Lots of urination? Lots of big BM’s? Rashes, itching? I have had all of these with other products. WHy arent they being scrutinized by the FDA?
One merely needs to back off the protocol slightly and increase methods to release toxins.
Sorry you had to take that abuse, VIcky.
“I also have to laugh at the list of so-called side effects that are supposed to make OSR dangerous. As a veteran to many detoxing protocols, I would have to say that detox is not pretty, its not for the faint-hearted or those who say “Ew ish!” too easily.”
I’m glad you can laugh at children suffering; do you visit children’s hospitals for your chuckle-fests? I think it’s funny that you’re shocked that parents of autistic children don’t want their children endangered by a fake cure.
“Chris and Sullivan’s comments spoken like those who obviously dont have autistic children.”
Because they care about their children, and don’t want to buy a product that some psycho tested on his neighbor’s cat? You have a real high opinion of parents.
“BACK OFF and SHUT UP” – there, there.
Rebecca – why do you assume that because people disagree with you, they can’t be a parent of an autistic child?
I am and I thoroughly disagree with you.
Rebecca Dudley ,
what are all the side effects of OSR, short term and long term?
The point is, you don’t know. No one does.
As with Kev, I am the parent of an autistic child. I disagree with you. I don’t think I will back off nor will I shut up while untested synthetic chemicals are passed off as “supplements”.
Ms. Dudley:
My son was never diagnosed with autism, it is true. That is because he did not meet the criteria when he went to the child neurologist in 1992 when he three years old. He was tested for Landau Kleffner Syndrome because he had a history of seizures and no speech. But while he may have damage to the frontal lobe, he does not have LKS.
His most severe seizure was while he was sick with a now vaccine preventable disease. As an adult, he is still disabled. He can now speak, but it is difficult sometimes to understand him.
Explain why you would want to exclude from any discussion the experience of a parent whose child was impacted by a real disease.
Vicki, It is tough being a nurse with open eyes, I know. I had taken OSR for 2 years… Never a bad anything. We have to keep the faith. I am sorry that some closed minds have to attack you..Let them chose chemo…We can have a choice!!!
Terri,
Were you part of a clinical trial so others could benefit from your experience? What assurances were you given for safety? Based on what data? Long term outcomes?
Had you suffered an adverse reaction, what recourse was being offered?
Is it ok for people to go outside the law to provide a synthetic compound as a “supplement”?
I’m closed minded. I expect suppliers of medicine to follow the law, provide real safety data and accurately label their products.
Wow, so people with autistic kids that has never tried the OSR has a reason attack the ones that have tried the OSR and reported good things about it. The only ones stating bad side effects is the FDA not the parents, not the patients. My mother used to take OSR for parkinsons desease. My nephew was using for autism, both of them were way better when the have access to OSR, ever since it was taken away, they have stopped progressing and nothing else has worked, none of that FDA approved crap have done anything for them. How can you fill your mouth with all this so called knowledge provided to you by goverment agencies and not take a minute to listen to the people that has an actual experience give them benefit of the doubt. What a bunch close minded people.
“Wow, so people with autistic kids that has never tried the OSR has a reason attack the ones that have tried the OSR”
Can you point me to a place where parents are “attacked”?
Yes, I disagree with the manufacturer, and those who have promoted this, for their methods.
Actually, we have no idea of what the side effects (or the beneficial effects) of OSR would be. Mr. Haley requested that users report adverse reactions to him, rather than to the appropriate government agency. So, we can’t tell what the side effects have been. Mr. Haley chose to market a clearly synthetic chemical as a “supplement”. This prevented the consumer from having access to safety and efficacy data that clinical trial would allow.
I don’t give people the “benefit of the doubt” when they are selling drugs without the appropriate safeguards.
Nelly:
Uh, huh. We will assume everything you posted was pulled out of thin air unless properly documented.
I just found out that as of 09/01/2011, OSR is available by precription. No longer a supplement, but not a danger to society either. Will see what happens next.
Nelly RAldiris,
perhaps you could point us to the clinical trials necessary for a prescription drug? Seems highly unlikely that OSR was approved in such a short time and with the small budget that Mr. Haley has at his disposal.
Note that the company which produced this product does not list it as currently being sold
http://www.ctiscience.com/
Repeat for emphasis: “questions about products the Company has sold in the past”
No mention of products currently being sold.
Chris: my post is based on experience, yours is based on stuff you read somewhere else. So you keep reading, no one is going to judge you for that.
Spoken like an addict, trying to move up to pusher.
Prove it. Using something like this.
Show where it was approved from this site.