Boyd Haley finally does the right thing, but is it for the wrong reasons?

“reasoning” that because it has a benzoate chemical group, which, as he points out, is found in cranberries, and two cystamine groups, which are found in meats it’s made up of two “natural food” elements?

The carbon atom is found in the natural and safe molecule DNA. The nitrogen atom is found in the natural and safe molecule DNA. Hence, if you add one carbon atom to one nitrogen atom, the result must be perfectly safe, right?

…

What, you’re telling me that cyanide is poisonous? Nonsense! It’s found in all natural apple seeds! It has to be healthy!!

For that matter, the amino acids cysteine and glycine are found in insulin – a vital hormone required for normal metabolism – and in alpha-conotoxin – a deadly snail toxin. The fact that the same 22 amino acids are used to make essential cellular components and deadly poisons gives the lie to Professor Haley’s glib “explanation”.

I suspect, too, that the FDA is not going to be any more convinced than I am. In fact, I think that Professor Haley may well come to wish he had shut down OSR sales immediately rather than trying to clear out remaining inventory through this “Fire Sale” notice.

He’s making it look like he doesn’t take the FDA seriously, and I don’t think they’ll take that very well.

Prometheus

From “Aqueous mercury precipitation with the synthetic dithiolate, BDTH2“, via Kathleen’s article “OSR: Fuel For Thought” (no links, don’t want to trip the spam filter):

BDTH2 [a.k.a. OSR #1] is also effective in the aqueous precipitation of other soft, divalent metals, such as copper, cadmium, lead, and the main group elements, arsenic and selenium.

Copper is a biologically essential metal. And calcium is a divalent metal, and is “soft”, if the “soft” in the quote above refers to physical hardness. Calcium is essential in the process of muscle contraction.

And since OSR has an affinity for cadmium, from Wikipedia’s article on cadmium:

Cadmium is a chemical element with the symbol Cd and atomic number 48. The soft, bluish-white metal is chemically similar to the two other metals in group 12, zinc and mercury. Similar to zinc it prefers oxidation state +2 in most of its compounds and similar to mercury it shows a low melting point compared to transition metals.

Given that it has affinity for cadmium and mercury, it sounds like it might also have affinity for zinc, another biologically essential metal.

Of course, a chelator having affinity for biologically essential metals doesn’t (necessarily) mean it should never be used, just that it should only be used under supervision by a qualified medical doctor, rather than be sold as a dietary supplement.

I am surprised he just doesn’t take what he has and label it OSR#2®.

OSR#2® – Now with enhanced gullibility for those who chelated their sense away with OSR#1®.

Woot! Orac’s back, and with great good news to boot! Strikes me that Haley might want to have a little caution with the hubris there – I mean, “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.” Seriously? Ah, well, I suppose he’s not worried about egg on his face when his little “supplement” fails miserably – he’ll just claim Big Pharma persecution, after all.

And, Orac, dear – from my “inflamed balloons full of snot” to yours, I feel for ya, buddy. Why, just today, I was thrilled by the milestone of having made it through a whole hour without needing to blow my nose. Summer colds (and/or summer allergies) suck mightily.

“In fact, I think that Professor Haley may well come to wish he had shut down OSR sales immediately rather than trying to clear out remaining inventory through this “Fire Sale” notice.”

He seems to be saying, “Well, they say it’s illegal to sell this stuff, and in the long run it would cost too much to fight them, so let’s just go ahead and sell it for another week, because in the short run, it would cost them too much to raid anyone over the sale of a few grams.”

Hey, these folks have gotten into the party spirit:

“ALERT: OSR is going off the market. We are stocking up as much as we can but supplies are going fast. We suggest you purchase large quantities if you want to assure availability.”

I don’t believe he will go through the expense and likely ultimate failure of winning drug approval. I’m betting he will offshore it under another name and brand. Probably several names and brands, making the FDA work that much harder and take that much longer to shut down each of those operations if they can.

With the amount of profit Orac estimates, the fanatical demand, and the buyer’s disregard for consequences or placing blame on him, Haley would be a fool not to find a way to bring this crap back. He would very likely be able to raise the price as a result of the increased offshoring costs. I bet six months at the outside.

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.

Only a crank would claim to know with certainty the results of a trial before the trial is even conducted.

@ Pareidolius: so I guess the product is useful for either miners in mercury-laden areas of California or women who wear make-up( see NaturalNews; 7/22/10).

$35 per GRAM?! Are you kidding me? That’s how much I used to pay for SEVEN grams of good weed. What a ripoff!

@Dan Weber

Here’s basically how drug regulation works. If you have a product and you want to be able to market it to cure, treat, mitigate or diagnose a disease or condition, you need to run Phase I-III clinical trials and apply for marketing approval to the FDA. Depending on the safety profile/existence of similar products, you may be able to get expedited review or exemption from some of the regulations. Once you get approval, you can market the product for the claims for which you gained approval. If you want to add an indication or significantly change the approved populations, dosage, administration or formulation, and market the new indication, etc., you need to go through FDA again.

Once a product is approved by the FDA, you can only actively market (which includes anyone from your company/organization promoting its use) for the approved indications/populations/dosage/form. Physicians, on the other hand, are under no such obligation to the FDA and can use the product however they see fit, though they should have reasonable scientific justification for using a product off-label (e.g., published journal articles supporting the off-label use). FDA does not regulate the “practice of medicine”.

So, what Mu says is a possibility. Haley does the studies to gain approval for it as a chelating agent for heavy metal toxicity and markets it as such, all the while his patron quacks physicians hawk it to their patients as the “dietary supplement” or “autism treatment”. Unless he specifically tests for and submits an application for approval of an autism treatment claim to the FDA, he would not be able to actively market those claims (which, remember, would include him or anyone from his company talking up its use as an autism treatment in an attempt to increase sales). There’s a fine line, too, between sales and informational presentations at conferences. Kind of a hazy area in the regulations.

@Parse

The FDA can only take action based on the products sold/claims made. He could set up under a different guise, but FDA would basically have to start from scratch in going after the new entity. At least, that’s the impression that I have. The FTC on the other hand might be better able to tie the different entities together and take legal action against Haley, to bar him selling or making fraudulent claims. We’d really need to see what happens. Other than what’s already taken place, there’s not a whole lot that can be done about future incarnations.

It was obvious from the content of the warning letter that Boyd Haley would have no choice but to stop shipping OSR#1. Failing to do so would have put Haley on a one-way track leading inexorably to crippling fines and some combination of

(a) a consent decree spelling the end of the company,

(b) having his doors chained shut, and

(c) time in prison.

That’s the way these things work. People do the right thing every day to avoid going to jail, but they don’t deserve special credit for it.

Nobody in their right mind sees them or follows them, and it makes no sense at all that marketing idiots fight so hard over their silly virtual billboards.

You’re overgeneralizing from yourself. Perhaps YOU don’t follow ads, but many other people DO. They’ve been found to be quite cost-effective, actually – far more so than most other forms of advertising.

“…my allergy or a bad cold has turned my sinuses into inflamed balloons full of snot. That makes me particularly ornery”
When facing a night of suffocation via inflammed sinuses, I take the Pliny the Elder remedy…a clove of fresh garlic with cold water. If eating a clove isn’t completely effective, I cut up one or two others and apply them with medical tape to the sinuses surrounding my eyes. Yes, it can burn the skin, but the effect is almost always effective in unplugging the sinuses.

They only need to get one therapeutic claim approved, at one “safe dosage”. Oh well, now it’s a safe chelator for acute heavy metal intoxication at 10 mg for 7 days. They can sell it in 1000 pill bottles, and its not their fault that people are using it to treat autism by feeding their kids 100 mg a day long term. That’s just “off-label” use of an FDA approved medication.

Didn’t Haley start calling it a “dietary supplement”, and stop referring to it as a chelator for heavy metals (indeed, refusing to refer to it as a chelator) to avoid having to do any testing of it as a heavy metal chelator? If he did do the testing to get it approved for that, wouldn’t he just drop the dietary supplement pretense?

Matthew Cline wrote:

Someone else (several someone elses?) noted that, for these types of people, what matters is the (perceived) motivation of those manufacturing/selling the drug. They perceive Haley as being motivated by helping autistic children, so he doesn’t need to prove to the world that OSR is safe. If his motive is to help autistic children, then he can simply be trusted to have done everything necessary to ensure that OSR is perfectly safe.

… Or something like that.

Is there a name for this sort of thinking? The pattern shows up so often in altmedland that’d it be nice to have a handy label (and a WP page to link to).

MC wrote Didn’t Haley start calling it a “dietary supplement”, and stop referring to it as a chelator for heavy metals (indeed, refusing to refer to it as a chelator) to avoid having to do any testing of it as a heavy metal chelator?
Yes, he did that to get around having to do any testing at all. Now that he’s forced into testing he needs to regroup. Part of the FDA approval is showing efficacy, and he can do that heavy metal chelation much easier than for autism. So, if he can show it works as a chelator, and it has a safe dosage, and he can make some form of claim it’s better/cheaper/safer than the existing products, he can get it approved, if only for a niche application. But that’s all it takes to get it on the market, and then people like the Geiers or Thoughtful House can legally approve years of study to test for efficacy with autism, giving semi-respectability to the DAN doctors who suggest it off-label (it’s in clinical trials for that after all).

We have used it with amazing results. Our kids’ glutathione levels have normalized and we can tell when we skip using the product. Boyd Haley is not only a man of tremendous compassion, but generous. He did not charge us anything for it. Many people invested a lot of money in his research which is not free. People have been on a witch hunt. It is unfortunate we cannot afford to buy more of the product. We are almost out. He gave us a year’s supply for all of our children who were in need. We are very, very grateful for his generosity, his hard work and dedication to children.

@Rockhopper:

We have used it with amazing results. Our kids’ glutathione levels have normalized and we can tell when we skip using the product.

OSR is a chelator, and is marketed as an anti-oxidant. As a chelator it would have no effect on glutathione, since glutathione contains no metal atoms. As an anti-oxidant, well, glutathione is also an anti-oxidant. (Or maybe you mean it’s normalized the ratio of reduced glutathione to oxidized glutathione?)

Anyways, if your kid needs an anti-oxidant, use one that isn’t a chelator. Seriously.

@Matthew Cline
The softness of metals referred to is according to the Hard Soft Acid Base theory (http://en.wikipedia.org/wiki/HSAB_theory). Sulphur is a soft electron-pair-donor (in this theory, electron-pair-donors are called bases), so it will bond to soft electron-pair-acceptors (acids) such as mercury and cadmium. Calcium is a hard acceptor, so it will prefer to bond to hard donors, typically oxygen-containing (which is why calcium oxalate precipitates). Zinc is borderline, and will bond to both hard and soft donors, so the OSR#1 will bond to it, but not as efficient as it does to mercury.

But, in general, chelators do nasty things amount of minerals available to the body, and should not be used without a doctor supervising the process, and not without a very good reason.

I keep waiting to see somebody advertising something like “concentrated rhubarb pills” to treat autism (since, technically, it contains a chelator, oxalic acid). At least in that case, it would actually be something generally recognized as both safe and, y’know, *food*.

andrew, the likely drive-by troll,
No one is going to take you seriously if you do not provide some evidence of your claims. Do you have some evidence to indicate the article is wrong in some way? What do you disagree with any why?

In fact if we look at the article and your posting, it seems you are more likely to be paid by someone, you pop onto a blog post about a product, you post something saying it is wonderful and should be on the market. But I guess you most likely do not want anyone to apply your standards to yourself.

Well you seem to be “jumping” to an evidence free statement?

Though I agree that Boyd Haley is very corrupt when he markets an unproven chemical to be given to children.

“Just stick with objective facts, name your sources, and cite the studies”

Very ironic advice given the citation free commentary you provided us.

By the way, chlorella is used for toxic waste clean up and is safe to ingest; so quit the baloney of using word descriptions/associations to conjure up all sorts of horrible images in people’s minds.

What, because one product used for toxic waste cleanup is theoretically edible (I’m not a big fan of eating algae, personally, though it could be an important element of future spaceflight), all of them must be?

The point of OSR 1 being tested only as an industrial chelator is not that industrial stuff is fundamentally bad. It’s that industrial standards are radically different than food or drug standards (industrial salt isn’t something you’d want to put on your food unless you like playing roulette with any contaminants that may be in it) and that having proven it will work as a chelator in the soil is a very different thing from proving it’ll work as a chelator in the human body. (And it has absolutely zip doodle to do with proving it to be safe to ingest at the recommended dose, which Haley has not done at all. Hell, he really hasn’t even established a recommended dose.)

Also, I could accept taking Haley to task over profiting excessively from the product if you did the same for the rest of the pharmaceutical industry.

You must be new here. Orac has written on that topic before.

Personally, my main beef is that so many people suffer under the delusion that fraud and greed are somehow peculiar to companies which make FDA-approved products, and that non-FDA approved products must be free of this sort of thing. In fact, all drug manufacturers (no matter what they call themselves) are prone to fraud, greed, and waste, which is why I don’t trust any of them. At least with the FDA-approved stuff, at least a minimum of due diligence has been performed. Can’t say the same for OSR 1.

I also find it interesting that you are willing to accept complaining about “profiting excessively” but evidently have a problem with complaining that the product has never been properly tested as a drug or food additive, and really has only been tested in industrial applications.

Actually, I wouldn’t be surprised if Barbara doesn’t have a franchise to sell OSR herself.

Drugs that are approved are fast tracked through the FDA approval process, only to be met with massive law suits for death and permanent harm. The FDA shut down Professor Haley, not because OSR did not work, but because there is a policy on the books that states that the FDA holds all rights to any product that is distributed as a cure for anything. Professor Haley holds the patent on OSR…OOPS!

Professor Haley holds the patent on OSR…OOPS!

Could you cough up the number on that one? Generously assuming that he didn’t whomp up “OSR#1®” in the basement, it seems likely that the University of Kentucky holds the patent.