Monday, April 2, 2007

Discussion of financial interest

I have posted on my blog, a financial disclosure which states that I am actively researching and commercializing these bacteria to prevent and treat a number of disorders including ASDs, and that I have patents issued and applied for. I put the statement there in the interests of full disclosure. If any reader considers this bothersome or unacceptable, please don't read my blog.

There has been concern expressed that I am attempting to merely introduce "another" biological based "treatment" to "cure" ASDs, and that my motives and by implication my methods are no different than those of the quacks pushing their various "snake-oils".

My perception is that my motives and my methods are completely different than those of the quacks. I feel that I have nothing to hide, and that filing for patents is a normal, even a necessary part of commercialization of any product, including treatments for medical disorders. The only thing that patents provide is the ability to bar others from making, using or selling the patented thing. My control of this does prevent the quacks from using it once it becomes proven. Believe me, I will prevent them.

I have spent over 10,000 hours researching NO, ASDs, and other disorders associated with low NO. I have received no funding for this. I am starting a company to commercialize this (as I have to commercialize other products I have invented). I have invested my entire life-savings in this. If the company succeeds, so will I. If it doesn't, I will need to do something else. t should be noted, that on the AutismHub, there are "Autism Pro bloggers". These individuals make their living by providing services to ASD individuals. While I don't consider myself a "pro", no one begrudges them fair compensation for their labors.

I am extremely cognizant of the potential harm that unproven "treatments" or "experiments" can do. I am being extremely careful in my research, and in the claims I have made, and in how I am proceeding. I am on the spectrum myself. I started my NO research before I knew I was on the spectrum. The only reason that I started doing research on ASDs was because my Asperger's got better, a lot better.

I have been using this on myself for over 5 years now. I have been actively researching the connections to ASDs for 3 or 4 (since I realized I was on the spectrum). I haven't jumped to try and sell this, or lie to people about what I have, or what it will do for them. I am perfectly prepared to be wrong, but I don't think I am, because I have read an extremely large amount of the NO and ASD literature. I am not quite hyperlexic, but I can read (and understand) dozens of papers in an evening. As far as I can tell, everything in the literature is consistent with my hypothesis (after discarding the stuff that is wrong). My literature file has about 57,000 items in it, some of those are duplicates, and when a web page is stored there are multiple items from it. There are probably at least 20,000 papers in it that I have "read". No, I haven't read them all carefully, but because I read so fast, I don't need to, I can carry them with me on my laptop (it only takes up 16 GB) and refer to them when I need to. The senior researcher in the NO field thinks I am very likely the best read in the NO field. I think he is right. I read really fast, and I don't have to maintain a lab, a family, or a life like everyone else does.

This is why I am so convinced of my hypothesis. I am prepared to be wrong, but it will mean that much of what is in the literature is also wrong, and must be discarded. I consider the possibility that thousands of papers in the literature are all wrong in the direction that would erroneously suggest my hypothesis is correct to be very unlikely. It is somewhat "infuriating", when people suggest after listening to half an hour of explanation, that I am wrong because it "can't be that simple". Nothing about NO is simple; any system of thousands of coupled non-linear parameters cannot be "simple". Ferid Murad has stated that he thinks that we understand perhaps 15% of NO physiology. I think he is wrong by at least 3 or 4 orders of magnitude, perhaps more. If I am wrong, show me where.

I have been following the mercury/vaccine stuff very carefully, and have read virtually everything I could on it. There is no comparison between what I am doing and the fraud that is being committed by those quacks. My treatment is not "yet another “alternative” biomedical treatment to the appalling array already in existence." The "reason" there are so many "treatments" for ASDs, is because there is no effective treatment. I posted a blog about mercury, my mercury file has 450 items and is 93 MB. It is "enough" for something that has no relationship to ASDs. Things that are more important I have done more research on.

So far, the only ASD individual that has used this is me. I would like to get a clinical trial going, but I don't have a clinic or an IRB. I think the "risks" are near zero. But I only want a trial to go forward with everyone involved completely aware of every possible risk, even those that are extremely unlikely, or even impossible. I have done an extremely extensive safety review. There is not a single reported instance of these bacteria causing an "infection". It is likely than they cannot do so, even in immunocompromised individuals. These bacteria express no virulence factors, no toxins, no porters to excrete them; they are unable to grow on any media used to isolate pathogens. I understand that the word "bacteria" invokes fear and loathing. These bacteria are safer than the bacteria in yogurt, the daily consumption of many ounces of which is considered benign, even healthful. In contrast to the zero reported cases of infection from the type of bacteria I am using, there have been reports of liver abscesses from yogurt bacteria (in immunocompromised individuals (yes, plural)). The treatment modality I use is topical application to unbroken skin. What risk is there from the application of bacteria that are safer than yogurt to external unbroken skin? I think only risks that are quite small. What "therapeutic benefit" can justify the "risk" of applying bacteria that are safer than yogurt to unbroken skin? I think a relatively small benefit. I have experience benefits considerably greater than that.

I don't really consider this to be a medical "treatment" or "intervention" per se, any more than a nutritious diet, or moderate exercise, or sufficient rest is a medical "treatment" or "intervention". They are normal components of a healthy lifestyle. I think in time, it will be recognized that the proper surface biofilm of these bacteria is also a normal part of a healthy lifestyle.

What are the "risks" of a nutritious diet, moderate exercise and sufficient rest? There may be "side effects", but I don't think there are any "adverse side effects", or "risks". People may disagree on that. I would be happy to discuss that with an IRB.

I very much recognize that "cure" means different things to the ASD and to the NT communities. What I have has not made me "Asperger-free". I can still enjoy playing minesweeper for 10 hours straight. There is no way that I could "pass" for NT. But I am much less anxious, my mood is a lot better, I am more functional in many ways. I think that every ASD would "like" the changes that my stuff produces. I think that many parents would "like" the changes that my stuff would produce in their ASD children because it will make them happier, and lead richer, more fulfilling lives as the ASD individual sees it. I don't think that my "cure" should be imposed on anyone who doesn't "want" it.

I think that some NTs won't "like" what this does to ASDs, because it will make them less susceptible to bullying. I think that many NTs don't appreciate how important bullying is in their interactions with other NTs and with ASDs (think of John Best for example, his only way of interacting is via bullying. Were his bullying to be rendered ineffectual, he would be emasculated). I don't think the "curebie" parents will "like it" because it won't turn their children into the "Stepford children" that they want. What I think it will do is make ASDs more what the ASDs want to be.

As I understand it, having a biofilm of these bacteria was how our ancestors evolved, back 5, 10, 50, even 100 million years. Our physiology has come to need these bacteria, and it suffers when we don't have them. The loss of them mimics the effects of "stress", and invokes all the stress compensatory pathways, one of which I think is the ASD phenotype. I think all the other degenerative diseases of the developed world are also the consequences of overactive stress responses.

The mechanisms behind the "relaxation response" work because they cause the release of NO. Raising the level of NO with my bacteria rolls back the stress setpoint. It reduces the stress response to a given stressor. It does so without any "doping", or cognitive impairment.

One way to describe it is that it increases the effectiveness of rest. It does so by restoring the "natural" setpoint of the physiological processes that are activated during rest.

I am still working alone in ASDs. I have tried to interest clinicians, but they don't have the background to understand what I am saying, and in my ASD way, I can't explain it to them in the few minutes they have before they glaze over and think I am wacko and grandiose for thinking I can cure essentially every degenerative disease.

I have tried to publish, but keep being told I need a larger n. I can't get research grants because I don't have an institution that fits the profile, and I don't have any credentials and what I am proposing is too "high risk". What they "mean", is not that it is risky for patients, rather it is so "far out" that if it fails, the people who approved it will look foolish, something that NTs are extremely reluctant to even consider. Soil bacteria preventing disease? Who has heard of that? No one, because I discovered it.

I think it would stop meltdowns in a day or so. Depending on severity. How things proceed from there is hard to judge. I think that everyone can appreciate that a large reduction in meltdowns would have beneficial effects that would increase over time. I only have an n of 1 to work with, and my understanding of ASDs is limited.


Oscar said...

How do you propose that topical nitric oxide on the scalp can reach the brain?

Not to say that's impossible, since I have seen 1 paper describing a dose-dependent increase in the pig's brain when given NO via the airway.

You seem to be very well-versed, so I'd like to hear your description.


daedalus2u said...

There are several mechanisms. In humans, there are veins from the scalp that drain through the skull, called emissary veins. into the venous sinuses in the brain. While NO as NO probably couldn't make it, a number of NO species could, including nitrite, S-nitrosoalbumin, S-nitrosohemoglobin, nitrosyl heme, and perhaps others.

NO via airway is not a good way of delivering systemic NO because the oxygenated hemoglobin destroys it at essentially diffusion limited kinetics. The venous blood in the scalp has lower O2 tension, so NO is going to have a longer half life (but probably still too short to make it as NO).

When the venous blood leaves the major sinuses in the brain, it passes through retes where it passes counter current with arterial blood. There is some data that in pigs, some steroid hormones are transported from the venous blood to the arterial blood. If hormones could make it, perhaps NO or other NO species could make it too.

J said...

Daedalus -
I am commenting here because it was I who made the comments that prompted you to do this post. I was directly questioning your intentions, and I apologize for that. While I am sure you understand the basis of my skepticism, it does not excuse the way in which I made the comments. I commend you for your research, and look forward to the results.

daedalus2u said...

Steve, That is ok, I wasn't offended. Your question is an understandable one, considering the fraud and dishonesty that the quacks have put out there.

I appreciate that I am making what some would consider extraordinary claims. I don't feel that the claims are extraordinary. I think they quite logically follow from what is well known about NO, and the observations I have made on how NO has affected my Asperger's. I recognize that my subjective observations are not compelling evidence for anyone but myself (and people who knew me before, and so can see the obvious and otherwise inexplicable change that there has been).

J said...

Thanks. I just feel the need to apologize when I feel apologies are due. I have now seen many of your comments on other blogs, and realize how much I mistook your posts on Kev's blog.
I am opposed to harmful (or potentially harmful) treatments that are sold under the guise of "curing" autism.
On the other hand, I am all for safe treatments that can truly make lives of ASD folks easier or more enjoyable in any way.

daedalus2u said...

As I mention, the notion of a "cure" means different things to different people. There is no treatment that will change the neural structures that are laid down in utero. That part of ASDs isn't going to change.

The greatest dysfunction associated with ASDs (according to ASDs) is not due to the neural structures, it is due to the "melt-downs" that occur. Raising the threshold for a "melt-down" to occur is (I think) the major effect that most ASDs would observe on my stuff.

The biggest dysfunction of ASDs according to "curbie" parents is that their children are "unlovable". That is not a problem with the child, that is a problem with the adult.