Autism TSO Blog

Major TSO Allergy Study in Press

2009-09-23T16:10:00Z

A major double-blind, placebo controlled study of TSO therapy for allergic rhinitis is complete and about to be published in the Journal of Allergy and Clinical Immunology. Here is the citation: Bager P, Arnved J, Rønborg S, Wohlfahrt J, Poulsen LK, Westergaard T, Petersen HW, Kristensen B, Thamsborg S, Roepstorff A, Kapel C & Melbye M. Trichuris suis ova therapy for allergic rhinitis: A randomized double-blind placebo-controlled clinical trial. J Allergy Clin Immunol. 2009;In press:

It has not yet appeared in the journal and is not on the web-accessible portion of the journal’s website. Here are the links to J Allergy Clin Immunol and the in-press articles currently pending publication.

TSO To Be Studied At Seaver Center

2009-08-05T21:48:00Z

The Seaver Autism Center for Research and Treatment at Mount Sinai is interested in testing the hypothesis described in this site. Since my presentation in November 2007 there have been sufficient anecdotal reports of improvements in self-injurious and repetitive behaviors to warrant further study.

Two Years on TSO

2008-10-04T19:35:00Z

My son (about to turn 18) was on TSO (2500 bi-weekly) for two years, and during that time there was a complete elimination of aggression, agitation, tantrums, melt-downs, OCD, etc. (see the rest of this site for the full history). For the last 8 months or so he has been increasingly quiet, and developed small “absence” seizures lasting 30 seconds or so, where he would just stop what he was doing and stare, with one arm shaking, several times a day. He had some mildly abnormal EEG’s as a child and since a fairly significant percentage of autistic kids develop seizure disorder, especially as they enter adolescence, we had him worked up with in-hospital sleep studies and treated with anti-seizure meds. The extreme quietness continued, punctuated by days or weeks when he would talk normally, great eye contact, almost acting in many ways like a typical teenager. We were (and still are, when these times occur), completely blown away by it. But I was concerned that perhaps TSO was in some way contributing to the extreme quietness. Perhaps it was a dose issue, or perhaps he did not even need TSO anymore and its continued use was somehow dampening his immune response when it did not need to be, Perhaps the symptoms that we were seeing, which could be interpreted as depression (fatigue, malaise, quiet, lack of interest in things, etc) were somehow connected to the altered immune response. There is growing scientific interest in a possible connection between cytokines and psychiatric disorders, including depression. Meanwhile, the anti-seizure meds eliminated the mini-seizures and he was weaned off them.

In an effort to confirm if TSO was playing any part in this I decided to stop TSO for an extended period. We stopped for 10 weeks - no weaning period, we just stopped. What we saw was as follows: Just as before, the periods of extreme quiet and fatigue were still happening, punctuated by days of unbelievable relatedness, eye contact, full language, appropriate behavior, etc. There did not appear to be any change with respect to removal of TSO, with one huge exception. Starting at about 8 weeks we began to see the agitation and OCD return. For the first time in two years he started hitting himself again. His hypersensitivity to noise returned, as did the beginning of his OCD behaviors. Life began to return to pre-TSO status. He was headed towards becoming unable to go out anywhere in public because of his violent melt-downs. So, we started the TSO again, and he received 2500 ova last week. Since his original response to TSO seemed to take 8 weeks, and the beginnings of the full return of symptoms began at about 8 weeks off it, I am getting the sense that at least in my son, the immunoregulatory aspect of TSO takes about 8 weeks. I expect the next couple of months for us will not be any fun.

I will post again soon, hopefully to report that TSO is working again.

Video on Helminth Therapy

2008-05-25T03:43:00Z

The video below is an excellent 5 minute overview of helminth therapy produced and created by Asphelia Pharmaceuticals.

Collecting Data on People’s Results with TSO

2008-05-07T04:03:00Z

Since my presentation on my experience with TSO and my son last October at Mount Sinai, a number of people have connected with doctors and tried TSO for the treatment of certain symptoms of autism. Many of these people (but not all) have registered with this site and have informally shared their experience and results to date, either via Blog posts or by e-mailing me directly. The results range from very significant positive results to no changes. Some people report that it took significantly longer to see results than the 8-10 weeks I reported, some people saw changes very quickly. Some report no change after several months. I think it would be very helpful to collect this data so that we can learn from it; perhaps we may be able to include it as some type of pilot data in our application for funding clinical trials. To this end, everyone that has registered at this site will be receiving an e-mail from me with a link to a survey site, where you can provide information about the individual taking TSO, the dose and timing of TSO use, changes seen, etc. Anyone that would rather use e-mail to communicate will be able to get a copy of the survey form and just e-mail it back. No personal information will be shared with anyone, and any information submitted as part of a funding application will be aggregated or will have any specific personal information deleted prior to submission. Also, if anyone knows someone that is using TSO for autism that is not registered on this site, feel free to forward my e-mail to them.

Regards,
Stewart Johnson

AutismTSO site back up

2008-04-03T03:59:00Z

After a few weeks of down-time the site is now back up and functioning. Some userid’s had been inadvertently deactivated by me during maintenance. These id’s have now been reactivated. Sorry about any inconvenience.

FDA Approves IND Application

2008-01-16T13:33:00Z

Yesterday the IND (Investigational New Drug) application for the Multiple Sclerosis study with TSO at the University of Wisconsin was approved by the US FDA. “Helminth-induced immunomodulation therapy (HINT) in relapsing-remitting multiple sclerosis (RRMS)”, sponsored by the National Multiple Sclerosis Society and the National Institutes of Health (NIH) is now actively in preparation.

Dose Response

2007-12-30T02:49:00Z

After almost two years, in an act of either bravery or insanity (depending on how you look at it), I decided to see if Lawrence could be maintained on a lower dose of TSO. I reduced his last two doses by one third, to approximately 1600 ova. This is done by shaking the bottle and just removing one third. Since the ova are not in suspension this method is not accurate, but after consulting with experts in the topic I believe that it is accurate enough for my purposes. There was no change in the first week, then the following symptoms started to come back, in this chronological order:

1. Stimming (he had not had any stimming since he started TSO)
2. Hypersensitivity to noise and external stimuli (fingers in the ears all the time)
3. Agitation (mild, so self abusive behavior)

Obviously, my little experiment is over. After one month at the lower dose he’s going back to 2500 starting Monday. It is very interesting that there is such a clear dose response and that the first things to return were stimming and hyperacusis.

Misconceptions about my hypothesis

2007-12-19T05:03:00Z

Based on questions and comments I’ve gotten I’d like to clarify certain misconceptions about my hypothesis:

What my hypothesis is: First, you have to accept the Hygiene Hypothesis as fact, i.e. the absence of helminths in the human gut causes autoimmune response and allergies in genetically predisposed individuals. You also need to accept that the reintroduction of helminths (whether by TSO or other worms) re-regulates the immune response and eliminates the aberrant immuine response at its source. After accepting these premises, my hypothesis is simply that certain symptoms of autism are the result of an aberrant immune response, and as a result, can be reduced or eliminated by reintroduction of helminths.

Assertions or inferences that have nothing to do with my hypothesis:

Autism stems from gut problems. Fix the gut, fix the autism. Many believe this, and it may be true; it just has nothing whatsoever to do with my hypothesis. TSO may indeed fix the gut, but this is a sideshow, at least according to my theory. Some subset of autistic individuals have gut problems (my son did not). These may in fact be just another aberrant immune response, where the immune system is attacking the gut. By eliminating the aberrant immune response, the gut problems may in fact go away, and certain of the autism symptoms may go away, but not because the former is causing the latter, Rather, they are both symptoms of the same underlying problem.

TSO is providing an alternate immune target, distracting it from the autoimmune response. Possible, but I don’t think so. In fact, I think the “alternate target” theory is valid and supported by the improvements seen in fevers and, in the case of my son and others, chigger bites. Both are alternate targets and provide alleviation of symptoms. But why do allergies disappear in TSO treatment? Allergies are unaffected by fever or (at least in my son’s case) chigger bites. I think the TSO is achieving its result by a different mechanism. It is eliminating the autoimmune response right at its source.

TSO and secretin are both normally found in pigs. There is some unknown agent in the porcine environment that is providing these benefits. Anything is possible, but I don’t think so. If secretin provides any benefits it is doing so by a totally different mechanism than TSO. In fact, if my hypothesis is true, then hookworms, human whipworms (trichuris trichuria) and any number of other helminths not normally found in pigs would provide the same benefit as TSO in autism. That non-porcine helminths have a protective effect against autoimmune disorders in mice and humans has been well documented.

As I get further questions and comments that indicate a misunderstanding of my hypothesis I will attempt to clarify using this blog entry.

Mount Sinai Conference Video

2007-12-15T17:53:00Z

Here is video of my presentation at The Mount Sinai / Seaver Center Autism Research Conference on October 28, 2007:
PART 1

PART 2

PART 3

Kennedy Kreiger Study confirms Fever Effect

2007-12-14T06:47:00Z

A study by the Kennedy Kreiger Institute at Johns Hopkins confirms the existence of the widely reported “fever effect”, where autism symptoms improve when a child has a fever. My son’s fever effect was pronounced and was only matched when he was bitten by chiggers (see “Clues” section of this site). Fever is the result of an infection, which prompts an immune response. Chiggers also elicit a powerful immune response. Both the infection and the residual material left by the chiggers become legitimate targets for the immune system, which would otherwise be involved in overproduction of pro-inflammatory cytokines and an autoimmune response, possibly directed and the brain and nervous system. You can read about the study at www.npr.org.

IND Application filed with FDA

2007-12-04T03:12:00Z

An Investigational New Drug (IND) application has been filed with the FDA for TSO in connection with an upcoming Multiple Sclerosis study. The FDA should complete their review by the end of December. If the application is accepted, the Import Alert should be lifted.

FDA stopping shipments of TSO

2007-11-17T03:58:00Z

The FDA has issued an Import Alert (IA 57-21) for TSO, effectively stopping its importation into the U.S until an IND (Investigational New Drug) application is filed. The import alert is based on one article and a follow-up article that cite concerns about TSO, but which ignore the safety data from the Crohn’s and UC studies. The error in these articles are pointed out in a reply from the authors of the Crohn’s studies. In addition, the FDA cites concerns over the possible contamination of the agent or the accompanying solution, evidently not aware that the manufacturer of TSO (Ovamed GmbH) obtained a GMP (Good Manufacturing Process) designation from the national regulatory agencies in the European Union.

An IND is being put together for a planned upcoming trial of TSO in Multiple Sclerosis. The IND should be filed before the end of the year. Once the IND is filed and TSO has investigational new drug status the FDA should lift this Import Alert.

Ordering, Dosage, etc

2007-11-03T01:43:00Z

I’ve gotton a lot of questions about ordering, dosage, etc. I’ll try to answer them here, based on my own experience. TSO is made by Ovamed, GmbH in Germany and is approved by the Thai government for over the counter sale in Thailand. It can be ordered online from the distributor in Thailand at www.biomonde.co.th, and it will be shipped to you. Whether or not it is allowed past customs in your country depends on the country you live in. I can only speak for the US, where TSO has not yet been approved by the FDA. In order to get it through customs in the US you must apply for an import permission with your local FDA office. This involves supplying a letter from a licensed US medical doctor stating that the agent is for treatment of a serious medical condition for which no effective treatment currently exists, and that it will be given under the supervision of the doctor. I also supplied a written prescription indicating TSO, dose, frequency ,etc. With this documentation the FDA will release it. For details of the FDA process please see the FDA website. As far as protocol, there really is no protocol for autism yet. Only my son and two or three other patients with autism are taking it currently. My son tried 1000 ova every three weeks for 26 weeks, with minimal results, then 2500 ova every two weeks, which he has been taking for about a year and a half. My son was adult sized when he started so my dosage was based on a full adult dose - the same dose that generated results in the Crohn’s and UC trials. Dosage recommendations, import information, prices, etc are all on the FAQ section of www.ovamed.org. It is expensive, especially if you live in the US and are looking at an all time low of the Dollar versus the Euro.

As I say throughout this website, I strongly encourage anyone that is thinking of doing this to do it only under the supervision of a medical doctor. Although there have not been any reported side effects from TSO, given how far ahead of the scientific curve this all is it makes sense to be conservative.

I’ve also gotten questions regarding Crohn’s and UC, and the relationship of GI symptoms to this treatment. My son does not have, and has never had, any GI symptoms of any kind, either before or after the TSO. I am not a doctor and this is not a professional opinion, but my hypothesis is that the symptoms of autism that I describe in this site are an aberrant immune response. In essense I am saying that these symptoms are autoimmune in nature, and since Crohn’s and UC are both autoimmune disorders that are being effectively treated by TSO, I thought that TSO might also restore normal immune function in autism and thereby alleviate some of these symptoms. If the first trials of TSO had been on another autoimmune disorder instead of Crohn’s or UC, I still would have made the connection and tried it. The fact that TSO populates the human gut and the first autoimmune disorders to be treated with it are intestinal disorders is, as far as I know, happenstance. In fact there are trials of TSO starting soon on other autoimmune disorders, including asthma and MS.

Anyone wishing to understand more about TSO should read the information and published studies available on Ovamed’s website, or just do a Google search. Also, take a look at the work of Doctors Weinstock, Elliott, and Summers either on Google or via Medline or some other medical literature search facility.

Mount Sinai autism research conference

2007-10-30T02:47:00Z

On Sunday 10/28/07 I presented my hypothesis and the results with my son at the annual autism research conference sponsored by Mount Sinai School of Medicine and the Seaver and New York Autism Center of Excellence. There was a huge turnout for the conference; by lunchtime the auditorium was full. Given the tremendous audience response to my presentation it is clear that there is interest in this topic. It was great to meet people so interested in this and especially those that travelled to the conference on short notice just to hear about TSO. Thanks so much to everyone for your support and kind words.