"AutismFreeBrain"? Selling supplements to cure autism

You might find this hard to believe, but sometimes I find the antivaccine crank blog Age of Autism to be useful. Obviously, I don’t find it useful in the same way that its editors think it is useful. Those paragons of the arrogance of ignorance and fetishism of hatred of science-based medicine don’t actually teach me anything about vaccines and autism. The torrents of pseudoscience, quackery, conspiracy mongering, and hostility do, however, serve their purpose. They keep my finger on the pulse of the “autism biomed” movement and what the latest “autism biomed” quackery du jour is. It looks like I just found out too, and I’m amazed. I thought that I had heard of every organization promoting autism quackery. The vast majority, but not all, of them are also rabidly antivaccine, but it’s not just antivaccinationism. Basically, if AoA likes something, the odds of its being based on good science are about as high as the odds of a single molecule of starting remedy being left in a 30C homeopathic solution. AoA is just that reliable when it comes to science.

This time around, AoA introduced me to something called AutismFreeBrain, whose tagline is “breakthrough science for a cure.” Now, whenever I see a phrase like “breakthrough science for a cure” applied to autism, it sets the skeptical antennae a’twitchin’ fast and furious, and there’s a lot on this site to set the frequency of this twitching to “vibrational frequencies” that would make a woo-meister envious. I guess I might as well start right at the beginning. See if you can see what I see in the way of red flags. It begins right on the main page:

Putting an End to Autism by Fighting Brain Immunity Storms™

AutismFreeBrain, Inc. was created to fund innovative research to develop a cure for Autism Spectrum Disorders (ASD). Our studies have identified inflammatory processes in the brain, we called Brain Immunity Storms, that are much like an allergic reaction, releasing surges of molecules that disrupt areas of the brain responsible for emotion and language.

First of all, whenever you see a website like this asserting that neuroinflammation is, in essence, the be-all and end-all of the pathogenesis of autism, you know that there’s likely to be some mighty fine woo there. There’s no doubt that there have been studies suggesting an association of markers of inflammation with autism, but the significance of these observations have not been worked out. Not that any of this deters antivaccinationists. As many of you quite correctly pointed out yesterday, the term “inflammation” is a term much beloved and abused by quacks of all stripes, and autism biomeddlers are no exception. This tendency to view autism as an inflammatory condition probably has a lot to do with the general antivaccine leanings of most such practitioners. Basically, inflammation is a convenient means for them to link their two greatest hatreds: vaccines and autism.

Once the “problem” (inflammation) has been identified, then the cure is obvious. Well, actually, no it isn’t, but that doesn’t stop autism biomed advocates from subjecting their children to all sorts of interventions that are claimed to be able to combat the inflammation that is supposedly at the heart of autism. They also make up terms that aren’t used in medicine, such as “brain immunity storm.” In fact, if you search for that term, bracketed in quotation marks to make sure that Google searches for only the exact term, the only hits you will get come from AutismFreeBrain and related sites. Amusingly (to me at least), an old Google site comes up as well. It isn’t nearly as slick as the current site, but it is, if you will excuse the wretched word choice, a damned sight more revealing, because the new website appears to have consciously toned down the antivaccine angle. On the new website, I couldn’t find a reference to vaccines anywhere.

On the old website, I find standard antivaccine talking points like this:

Brain immunity storms are an auto-immune chain reaction that leads to a storm of inflammatory and neurotoxic molecules in the brain and can lead to autism.

These storms may be started in many ways that are similar to those reported by parents and in studies including; heavy metals, chemicals, oxidative stress, fertilizers/pesticides, extreme prenatal stress, etc. Once started the immune system releases molecules that cause inflammation, disrupt intestinal function, cause allergies, and breakdown blood barriers, in other words the long list of medical conditions that is autism.

Do you think that AutismFreeBrain suddenly changed its mind about vaccines and “toxins” as a cause for these “brain immunity storms? Me, neither. However, the new website is really slick compared to the old one, and on it AFB claims to have had multiple scientific breakthroughs, and label these their “top five findings”:

1. Brain Immunity Storms damage behavior and language brain regions affected in ASD
2. A novel molecule, found to cause inflammation, will be targeted to inhibit Brain Immunity Storms
3. Two blood biomarkers can be used for early and objective ASD diagnosis
4. Laboratory experiments showed that Brain Immunity Storms can be prevented and reversed
5. Clinical trials show that a unique natural formulation benefits 75% of children with ASD

These would all be impressive research accomplishments, were they true. Are they? I have no idea. The articles included as part of AFB’s research library don’t seem to directly support the claims being made in the website. A suspiciously large number of them are published in a single journal, one I’ve heard of before and one I’ve been suspicious of before as well, the Journal of Neuroinflammation. A lot of the appear to be basic science studies being extrapolated to make clinical claims, and a lot of them on first glance don’t look to impressive. Perhaps if I’m feeling energetic (and particularly self-destructive) one night, maybe I’ll do some in-dept reading and deconstruction of a couple of these papers.

But who’s behind AFB? It appears to be primarily the work of Theoharis Theoharides, MS, PhD, MD. His profile on the AFB website sure sounds impressive:

Theoharis C. Theoharides, M.S., Ph.D., M.D., F.A.A.A.A.I. is the Director of the Molecular Immunopharmacology and Drug Discovery Laboratory, as well as a Professor of Pharmacology, Biochemistry and Internal Medicine and Associate Professor of Psychiatry at Tufts University School of Medicine, Boston, MA, USA. He has published over 350 research papers and 3 textbooks. He has been placed in the top 5% of authors most quoted in pharmacological and immunological journals.

And so he is. If you peruse Theoharides’s publications on PubMed, one thing you’ll notice is that the non-autism papers seem pretty reasonable. However, 18 of his papers mention autism, and they all see to promote the hypothesis that autism is due to neuroinflammation. More specifically, Theoharides links autism to the release of cytokines from mast cells. Now that in and of itself isn’t what makes me wonder about him. What makes me wonder about him is his involvement with a company called Algonot and the sale of a supplement solution called NeuroProtek®, complete with a quack Miranda warning. (“THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FDA. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE.”) Here’s what the Algonot website says about it:

NeuroProtek® is a unique all natural oral dietary supplement in a soft gel capsule. NeuroProtek® uses an exclusive combination of flavonoids, based on the scientific research of Dr. Theoharides M.D., PhD,. NeuroProtek® is formulated to maximize affects of flavonoids while also overcoming any absorption obstacles. NeuroProtek® contains the flavonoids: Luteolin, Quercetin, and Rutin. Unique to Algonot’s formulations is olive kernel oil, a powerful anti-oxidant that is instrumental in helping the body absorb and delivery the dry flavonoids found in each soft gel capsule.

Interestingly, there is no mention anywhere in the Algonot website of exactly what it is that Neuroprotek is supposed to treat or protect against, although Theoharides is not nearly as shy elsewhere, as you will see. Note that Luteolin is the compound listed on the AFB website as the treatment for autism that supposedly reverses it by reversing “brain immunity storms.” But based on what clinical evidence are these claims made? To find out, I decided to go to PubMed again. All I could find was a single case series by Theoharides. Is it a randomized, double-blind, placebo-controlled study? Silly boy! Of course not! It’s an open label, single-arm case series in 37 children with autism spectrum disorder. In other words, it’s damned near completely useless for determining whether Neuroprotek does anything whatsoever for children with ASDs. Big surprise, it found that eye contact and attention improved in 50%, social interaction improved in 25%, and speech improved in 10%. There was one other study out of Greece I could find for a formulation of luteolin and quercetin that sounds very similar to Neuroprotek. Guess what? It was an open label, single arm trial for 26 weeks. Not surprisingly, this trial showed benefit as well, this time in adaptive functioning as measured by using the VABS age-equivalent scores), as well as in overall behavior as indicated by the reduction in Aberrant Behavior Checklist subscale scores.

Then there is this video:

Yes, it’s an interview in which Theoharides is hawking a supplement. He uses all the buzzwords that the “autism biomed” movement likes, including “oxidative stress,” “autoimmunity,” food intolerances, and the like. It’s basically one big commercial for Neuroprotek. I will give Theo credit, though. The interviewer asks him if Neuroprotek is FDA approved, and he uses the same argument that supplement hawkers of all types use, namely that the ingredients don’t need FDA approval. I do, however, think that Theoharides is flirting with the very borders of the quack Miranda warning in that he does arguably appear to be making a claim to be able to treat a specific condition (autism). He also touts his preliminary clinical trial, while admitting that he hasn’t done a randomized clinical trial yet and is trying to get funding to support doing such a trial. In fact, I noticed on the AFB website that not only is Theoharides trying to get grant funding for his clinical trial, but he’s also hitting up the antivaccine faithful. Indeed, he’s trying to raise $1 million

Of course, my answer to such a defense of selling supplements is invariably this: You shouldn’t be selling this stuff if you don’t have solid clinical trial evidence that it does what you claim it does. Theoharides does not have the evidence, plain and simple, but he’s still selling the supplement. In fact, in light of these observations, it’s rather amusing to see Theoharides unable to answer most of the questions of the interviewer, such as, “What’s the dose?” or “When can one expect to see results?”

Oh, and it turns out that Neuroprotek isn’t Theoharides’ only foray into supplement sales. He also promotes a supplement known as Cystoprotek:

CystoProtek® is an all natural oral dietary supplement in a soft gel capsule. CystoProtek® uses an exclusive combination of the purist ingredients of flavonoids along with sodium hyaluronate. CystoProtek® contains glucosamine, quercetin and rutin as well as chondroitin sulfate and sodium hyaluronate. Unique to Algonot’s formulations is olive kernel oil, which is instrumental in helping the body absorb and delivery the dry ingredients found in each soft gel capsule. CystoProtek® is free from artificial colors or flavors, corn, milk products, preservatives, salt, starch, sugar, wheat or yeast. Our ingredients are not obtained from beef or beef by-products.

As is the case for Neuroprotek, there is no mention of what CystoProtek is actually supposed to treat (the quack Miranda warning, of course). However, Theoharides is much less shy in this video, as he is much less shy in the video above:

Oh, and if you don’t have interstitial cystitis, maybe you’re a middle-aged dude like me who’s entering the age range where benign prostatic hypertrophy becomes an issue. If so, then Algonot’s got you covered with Prostaprotek!

Of course, I now know why Algonot doesn’t say what its products are supposedly good for on its website and why the quack Miranda warning figures so prominently. There’s a little trick I’ve learned whenever I blog about something, and that’s to search the FDA website for it. Guess what I found here? Yes, indeed. It would appear that in 2011, Algonet got a major slapdown from the FDA in the form of one of those warning letters we all now know and love. The letter applied to pretty much all of Algonot’s products, including ProstaProtek, CystoProtek, and NeuroProtek. No wonder there’s no mention on the Algonot website of just what it is that each of these products is supposed to do, while, for NeuroProtek, at least, the promotion happens on the AFB website, in videos like the one above, and, of course, at autism biomed quackfests like Autism One.

Why am I not surprised? After all, AoA only promotes the finest woo. What’s sad about this one is to see the fall of a scientist who by all appearances started out not just respectable but prominent and well-published into selling supplements designed to treat not just autism but other conditions without any compelling clinical evidence in the form of randomized trials that it does what he claims it does.

ADDENDUM: Ack! How did I miss this? It’s been pointed out below that Dr. Theoharides gave a presentation this year at everybody’s favorite autism biomed quackfest, Autism One, just this May. This brings up what should be another blogging rule for me, just like the one that tells me to search the FDA website whenever I blog about a supplement. The rule? Whenever I come across “autism biomed” claims with which I’m not familiar or a new autism biomeddler whom I’ve never heard of, go to the Autism One quackfest website and search it to see if that person has ever presented at Autism One. Learn it, do it, love it, I will.