Looks like Boyd Haley is pulling OSR#1 following FDA warnings

Antonio Perez, Chicago Tribune

You may recall a post or two about on this blog about an industrial chelator turned dietary supplement called OSR#1.  It has been used by some to treat autism in children, despite a lack of evidence that it would be safe or effective to do so.  Well after the FDA stepped in recently, CTI Science Inc. appears to be pulling the product until further notice.

Here's an update from Orac at Respectful Insolence which includes part of what appears to be an email from CTI Science president Boyd Haley.  According to that email:

...CTI Science has voluntarily agreed to remove OSR#1® from the market effective Thursday, 29 July 2010.

If you were wondering why they're going to wait until July 29, Orac offers up an answer:

My question is this: Why don't Haley and CTI Science simply shut down production and sales now? Why sell OSR#1 for another week? My guess is that the answer is that Haley wants to milk his cash cow for one more week. All the quacks who "prescribe" or recommend OSR#1 to their clients will rush out to buy a boatload of the stuff before Haley cuts off the supply. It's pure profit, because the stuff costs only $0.25 per gram to synthesize. I don't know what Haley sells OSR#1 for wholesale, but Kathleen Seidel points out that certain retailers sell it for $60 to $105 for 30-100 mg capsules of OSR#1. That's right: $20 to $35 a gram--seriously righteous bucks, a markup of up to 14,000%. Given that the Univesity of Kentucky bore the costs of development, and the packaging and filler can't cost all that much...

FDA Warns Maker of Chelation/Antioxidant Pills OSR#1

Antonio Perez, Chicago Tribune

Update:  See this post by Orac on Haley's response to the FDA warning.

I previously wrote a post about a chelating agent marketed as an antioxidant supplement called OSR#1, an unproven product that's been given to children to "treat" autism.  So far it's unclear whether these little pills have any therapeutic effect (seems doubtful) and whether or not they're safe (seems like they're not).

Well the FDA has been paying attention, and recently issued a warning to the maker: CTI Science (previously Chelation Technologies Inc.) run by president and CEO, Boyd Haley.  You can read the full letter from the FDA website.

(No worries - I'll pause here while you read the FDA's letter...)

Journalist Trine Tsouderos of The Chicago Tribune writes...

The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and hero to the autism recovery movement, details five violations of the Federal Food, Drug and Cosmetic Act related to his product, OSR#1. Failing to correct such violations can result in fines, seizure of products and even criminal prosecution.

The Tribune in January reported that the compound, sold as OSR#1, had been developed to treat mining wastewater, and that it had not undergone rigorous testing to ensure it is safe and effective. The report was part of an investigation into unproven autism therapies offered by health providers who say they can reverse the disorder.

Haley did not reply to repeated requests for an interview Wednesday. An FDA spokeswoman said the agency has not received any communication from Haley, who has 15 working days from the date of the letter to respond.
...

In the interview last year, Haley called the product "a food" that is "totally without toxicity." Haley said the compound had been tested on rats, and a food safety study was conducted on 10 people. Asked to provide documentation of the research, he stopped communicating with the Tribune.

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.

Continue reading at the Chicago Tribune...

Ouch!

Over at Boyd Haley's OSR1 twitter feed, there hasn't been much action since their last exposure in the Chicago Tribune. Here's the feed as of June 25...

My BS meter tends to go crazy when someone responds to criticism with something like "the truth is at [my website]". Also, that earlier Chicago Tribune article Haley is referring to is this one, also written by Trine Tsouderos.

For more details on Boyd Haley and the autism community, jump over to Respectful Insolence and read Orac's post, Pumping autistic children full  of an industrial chelator (revisited).

Michael Specter on the Dangers of Science Denial

Behold... the human brain!

"...one of science's final frontiers ... the human brain."

Tonight, while sharing a late night bowl of ice cream, my wife and I happened upon the fourth episode of the Brain Series by Charlie Rose. It pretty much poked all my science-dork buttons, so I of course had to run right over to the computer and put up a post telling you to watch the series - it's cool stuff!!

You can see all available episodes of the series here. The discussions cover some interesting and important topics. I'm already excited for next episode on brain development and child learning.

I haven't watched them all yet, but the series seems to touch on a variety of topics related to what our brains do and how they do it. The format is the usual scene: a table full of experts moderated by Charlie Rose. If anything, it's a great chance to hear a handful of experts discussing some of the latest insights into common brain disorders like autism/ASD, schizophrenia, and depression. There is also a fair bit of discussion related to brain development during the first few years of life, which should be of interest to parents.

For more info, check the links above and your local PBS listings.

A "Dietary Antioxidant" for kids, or an environmental chelator?

I had made a few posts related to autism a while back, and today came across this article (via Orac's post over at Respectful Insolence).  It's a nice example of bullshit truth in advertising by Kentucky company CTI Science, Inc. ran by Boyd Haley.

I first wondered if the product would be equally marketable were it more appropriately named "Chelator, with Titanium and Iron Rust" or maybe "N¹, N³-bis(2-mercaptoethyl)isophthalamide", instead of "OSR#1", and in the end I decided the answer was probably no.  Why?  So far it looks like a large portion of the intended consumers are parents and caretakers of autistic children...

Haley Autism One 2007 Powerpoint, p. 63 [Source]

More important than the name, I wondered about the truthfulness of the claims on the product website, particularly the scant evidence that the stuff is really safe for children, and of course the story behind this blurb on their FAQ page (as of 19 January 2010):

There is an internet rumor that OSR#1® is an Industrial Chelator. Is this true?

No. OSR#1® as produced by CTI Science is not now and has never been marketed or tested as an environmental or industrial chelator. Nor has OSR#1® been tested in humans as a chelator by CTI Science, and no claims of chelation treatment use are made by CTI Science.

Now, here it's worth noting that CTI Science website also states that OSR#1 was developed in conjunction with...

the University of Kentucky in Lexington which licenses the underlying patent rights to the Company.

(By the way, is it just me, or wouldn't you really like to know what that patent number is?)

According to the articles above, it seems that statement is indeed highly questionable, and the source of that mean ol' "internet rumor" appears to be (gasp!) a University of Kentucky patent -- presumably the very same one mentioned by the CTI Science website?

Reading into this great report and in particular this post (both from 2008), we find...

Prof. Boyd Haley’s new chelator N,N’-bis (2-mercaptoethyl)isophthalamide, or “CT-01” — represented to the FDA as a “new dietary ingredient,” and now marketed as an antioxidant for consumption by autistic children under the trade name “Oxidative Stress Relief” (OSR) — is substantially similar if not identical in its chemical structure to one member of a family of industrial chelators developed by his colleagues at the University of Kentucky, and for which U.S. and international patents were awarded in 2003.

U.S. Patent No. 6,586,600, Multidentate Sulfur-Containing Ligands (issued July 2, 2003) (.pdf) names as its inventors chemists David A. Atwood, Brock S. Howerton and Matthew Matlock of Lexington, Kentucky. David Atwood is a Professor of Chemistry at the University of Kentucky, and Mr. Howerton and Mr. Matlock are graduate students. The rights to the patent are assigned to the University of Kentucky Research Foundation.

More details on the patent issue were posted later here, but it's pretty clear from patent #6586600 mentioned above (presumable the patent licensed to CTI Science, Inc.) that these compounds were intended to be used as environmental chelators.

Looking back at the claim from the website, we see the beauty of good advertising: so far, it looks like CTI Science hasn't technically lied to their consumers here.  You see, while these chemicals were initially patented as environmental chelators, it's technically true that (bold added for emphasis)...

OSR#1® as produced by CTI Science is not now and has never been marketed or tested as an environmental or industrial chelator.

So what do you think? Are they being maybe just a little bit misleading as they try and dodge the association of their product with it's intended role as an environmental chelation agent?

Autism & Vaccines Revisted (... again)

Massimo Pigliucci's has a nice post on his blog Rationally Speaking, summarizing a recent eSkeptic article entitled "Vaccines & Autism: A Deadly Manufactroversy." It's a nice read for those unfamiliar with the history of the widespread fear that vaccines are the cause of autism, and the consequences of that belief.

In case you're wondering "Why all the fuss about the 'vaccines cause autism' scare?" I think the issue warrants attention for at least two reason: First, as countless individuals and organizations have made abundantly clear, we need vaccines to prevent the death and life-long suffering caused by preventable infectious diseases, particularly among children. Second, we need to focus on uncovering the real story behind autism so that we can more effectively treat and prevent autism spectrum disorders.


Quinn, a boy with autism, and the line of toys he made before falling asleep.
More about Quinn at: http://www.youtube.com/watch?v=G7kHSOgauhg


A boy with a rash indicative of rubella (German measles)
(click and search the CDC images for "10146" for details).
Rubella during pregnancy can cause severe birth defects.

Vaccination is to Autism as Tobacco is to Lung Cancer... Ummm, What?!

Continuing this thread on vaccination against childhood diseases, a friend of mine pointed out the article Vaccine Court: Autism Debate Continues from the Huffington Post, authored by Robert F. Kennedy Jr. and David Kirby. You might take a few minutes and give it a good read.

There are two big issues at play in this article - particularly within the context of vaccination legislation - that should really be presented more distinctly. These are (1) the extent to which vaccines contribute to the incidence of autism or autism spectrum disorders (ASD), and (2) the consequences of whether or not we vaccinate our population against these types of infections. What I realized in reading this article is that talking ad nauseum about the first issue without also addressing the second is, quite frankly irresponsible and dangerous.

Before I explain why, lets mention some important background information. First, I will distinguish here between the infection (i.e. simply hosting a viruses, say HIV) and the disease (i.e. the symptoms caused by that virus, which for HIV would be AIDS). This is important because not all infections lead to disease (i.e. injury or death).

We also need to understand the role of herd immunity as it relates to infections that transmit from person to person. In short, a certain percent of the population needs to be vaccinated (or otherwise resistant) to infection in order to prevent a few infections from becoming a big epidemic. If to few are vaccinated, epidemics can take off and spread through the unvaccinated portion of the population, which is bad.

Think of vaccinated and unvaccinated individuals and fire-proof and flammable wooden sticks, respectively. A population then would be analogous to a pile of such sticks. With enough fire-proof (vaccinated) sticks in the pile, a single match won't start much of a fire. On the other hand, too few fire-proof sticks (too few vaccinated individuals), and whoosh! The pile goes up in flames. In the case of infectious diseases, the proportion vaccinated needs to be relatively high in order to prevent outbreaks, usually upwards of 80-90% in a given community.

Back to our two main questions. Speaking as someone with a strong quantitative background (i.e. an applied mathematics graduate student) the first thing I want to know regarding issue (1) is what evidence exists that children receiving vaccines show a significantly higher rate of ASD relative to unvaccinated children (all else being equal), and how much higher is it?

This next bit is what they leave out of the article, and is of fundamental importance to the vaccine-autism/ASD controversy: how we evaluate the answers we receive to the first question depends enormously on what we learn from issue (2). In short, if we have to pick our poison we had better know which option is worse! If we compare a sufficiently vaccinated population and one with low or no vaccination (all else being equal), how do they compare on both childhood disease and autism?

The evidence I have seen and that the experts have summarized for the rest of us suggests that there is at worst a relatively small number of cases where vaccines caused significant harm to the people that they were intended to protect. This is true of most drugs, medical treatments, safety mechanisms in automobiles, and countless other things we make and provide one another - simply put, nothing is perfect though we can usually do a little bit better and a whole lot worse.

So lets revisit the common (and very flawed) argument against vaccines that goes something like this: "vaccines cause injury and death, therefore they are bad and we should stop pushing them on the public." Sounds reasonable, right? Well, it isn't. A more relevant statement to make would go something like "if vaccines cause injury and death, we should categorize them as bad if they caused more injury and death than the diseases which they prevent."

While this comparison seems like a no-brainer, it hardly ever gets as much thought as it deserves! This is in part because of the concern (and in many cases fear) many parents have over the perceived risk of vaccines, and also because there is more anecdotal evidence on the vaccine-ASD issue floating around out there than on the vaccinated-unvaccinated issue despite the often unnoticed historical figures. We also have more control over our own individual choices about vaccination compared to our contracting diphtheria, for example, which focuses attention there instead of on the larger issue of society doing the greatest for its people.

This my friends, is why so many public health professionals and concerned citizens push so strongly to fight all the anti-vaccination rhetoric and fear that pervades that ether of public information and knowledge. Vaccines may cause great harm to a very small few - each and every case meaning the world to someone, and each deserving the appropriate level of recognition and in some cases redress.

But without vaccines, and without enough vaccine coverage to ensure we stand above the herd immunity threshold, the cost in human lives and human suffering would be much greater. And that folks, just isn't an acceptable alternative.

I'll leave you to look back to the tobacco analogy drawn in the article above, and how irresponsible it is to compare the tobacco industry with the medical industry. Tobacco products don't do much good for society (as far as I know) - and they certainly don't protect little boys and girls from the wrath of so many truly horrible diseases that once plagued our population.

To vaccinate, or not to vaccinate... is that the question?

A friend of mine posted a link to this video today, which I thought deserved some critical commentary. Before I get into it, click below to watch the clip. Even better click here to watch it in another window - I'm sure you'll want to go back and forth and review some of the video segments as you read on.

Lets start with Katie Couric's opening line in the piece, the rest of which is done by CBS's Sharyl Attkisson (whose strengths are more in matters of money and not medicine):

For years now parents have wondered if vaccines are linked to conditions like autism and ADD. Government officials and some scientists say there is no connection, and they are often backed by independent experts. But just how independent are they?

The first sentence implies those rightfully concerned parents haven't found any good answers, which is hardly the case. Plenty of answers can be found through one's local medical community, on the web at places like the National Network for Immunization Information, the U.S. Centers for Disease Control and Prevention, and so on. The claim that vaccinations cause autism and ADD have been investigated repeatedly by the scientific community and all the evidence suggests that vaccination won't give someone autism, ADD or the like - which is good news!

Taking those findings more skeptically, they suggest that even if vaccines were capable of causing autism or ADD, the odds of it happening to any particular individual are vanishingly small. That is, you are much more likely to be killed in some kind of accident in the months after getting the shots - and much less likely to develop autism or ADD.

The second part of this opening line is the real reason this clip caught my attention. The rather harmless sounding sentence calls into question the validity of all the work that has been done to understand the safety and risks associated with vaccines - by literally thousands of skilled people trained in using state of the art tools and methods to answer these kinds of questions - all cast into doubt by whether or not some organizations and individuals truly making independent claims from what the drug companies might say.

To give you a more clearly dubious yet analogous statement, this is like saying that if you walked into a car dealership - having done your homework and concluded that a Honda Civic was the perfect car for you - you should suddenly become overwhelmed with doubt about your decision upon hearing the clearly biased salesmen tell you to go with the Civic. Whether or not some (in this case, 3) individuals and organizations have a bias in favor of an otherwise good idea does not invalidate all of the other evidence supporting the notion that it really is a good idea!

The clip then goes on to point out financial ties between drug companies and three entities that one would expect to be "independent" from the likes of Merck and Wyeth: The American Academy of Pediatrics, Every Child by Two, and outspoken pediatrician Dr. Paul Offit, M.D.

I must mention that Dr. Offit would otherwise be someone concerned parents would absolutely adore, were they made aware of his dedication to preventing childhood diseases, his work in doing just that, and his books to help inform the public on these matters. Instead, Sharyl Attkisson further vilifies him with remarks like "he has gone so far to say that babies can theoretically tolerate '... 10,000 vaccines at once.' " (This statement is a testament to the amazing capacity of the human immune system to fend of pathogens, by the way - not some expressed desire make pincushins of infants!)

So what of their examples? Questionable or not, the consequences of any bias are blown way out of proportion here - although clearly some of these associations are to be frowned upon. AAP received $342K from Wyeth ("for a community grant program"), $433K from Merck (the same year their HPV vaccine was introduced), and unnamed funds from "another top donor, sanofi aventis." Each Child by 2 admits taking money, claiming no conflict of interest. However, their former treasurers - and the word "former" was absent from the script, but shows up in the visuals - included an official from Wyeth and one "paid advisor to big pharmaceutical clients" (which might sound bad, but without knowing the nature of the advising its hard to pass a quick judgment).

We could go on and on, for example the statement that

Today's immunization schedule calls for kids to get 55 doses of vaccines by age 6. Ideally it makes for a healthier society.

"Ideally?" How about "clearly" or maybe "demonstrably"? Immunizations as part of overall improved health care do make for a healthier society than without them. If you need some evidence of this fact, consider the last time someone in your neighborhood died from or became paralyzed by polio. Even better evidence is readily available if you look for it, such as in this article, for example.

Overall, I hope you can see how a little bit of critical thought on this piece turns up a lot of other issues that are probably more worthwhile to think about than how much money Merck gave the APP for a community grant program. Before you go, watch the piece again and let me know what you think!

Finally, I'll end with a teaser for an upcoming post where I'll come back to this thread and discuss a few other question from this clip. These come from the way that Dr. Paul Offit was dubbed a "vaccine industry insider" (the implication here is of course, not positive) because his Merck-funded position at Children's Hospital, and the nature of his work in trying to prevent childhood diseases.

It begs the question: What role should industrial/commercial/any scientists play in promoting products or information that by all measures will benefit society (in this case, that save lives)? When does "independent" trump "expert"?