How can we help accelerate Dr Naviaux's ME/CFS Suramin trial?

[dreampop]

I think that should be forwarded to Davis and Naviaux

Definitely leave them out of the ethical dilemma of people using research chemicals to experiment on a disease it's not approved for. There needs to be a healthy seperation between patients and researchers and notifying the OMF everytime you experiment with something is not good for either party an is and unhealthy weight to put on the researcher.

 

[Jesse2233]

Bayer refused to give suramin to dr. naviaux for the trial. Looks like no trial this year. So disappointed..

Also disappointed it didn' work for the few people who tried it.

There is no hope

Don’t forget about Cortene

 

[Daniel Tobin]

I am one of the persons @adamjfpickering mentioned. I took 2 x 1mg Suramin 3 weeks apart. The last one was a month ago. I haven't had any improvement. I didn't have any side effects either, other than a mild headache lasted a few days after the first injection.

I am the only one who used research version of suramin from this company, others got their suramin from other manufacturers.

Of course, this doesn't prove anything about its effectiveness for ME. We still need to see metabolomics studies before and after injections. Maybe the proposed dose is too low for ME patients.

My ME is slow onset type developed over 16 years. My PEM starts 48 hours after exertion. I have every single ME symptom in CCC other than tender lymph nodes.

ETA: I introduced myself as a researcher to be able to buy suramin. Research chemical companies don't sell products to patients.

Hi,

I'm wondering how you decided what dosage level to take. In naviaux's autism trial, from what I can understand, he used dosages of 50 mg followed by 20 mg. The technical details in his trial paper are a bit confusing for me so perhaps I'm misreading these numbers. I also think he administered it by drip over 3 minutes which could be significant as well. You might be correct that the dose was too low to have any impact. And since the autism trial showed that these higher levels were safe then maybe that's the way to go?

I say all this as a person suffering from this illness who wishes to try this treatment.

PS
If anyone can decipher the details for the levels of suramin dosage (pasted below) from naviaux's autism trial I would be very grateful. As I mentioned, I am not familiar with medical language so if anyone would be able to tell me what naviaux is saying regarding the dose he gave the patients I would be very thankful.

Suramin was provided as the hexasodium salt (MW 1429.2 g/mol) in 1 g lyophilized vials by Bayer Pharma AG (Leverkusen, Germany), under Dr. Naviaux's IND #118212. Lot #BXNOGW1, expiration date of 3 September 2018, was used in these studies. A 1 g vial was reconstituted in 10 mL of sterile water for infusion to prepare a 10% (100 mg/mL) solution. All infusions were conducted at the University of California, San Diego School of Medicine Clinical and Translational Research Institute (CTRI) in La Jolla, CA. Height and weight were recorded, vital signs and capillary oxygen saturation (pulse oximetry) measured, physical and neurological examinations were conducted, and urine and blood for safety monitoring, pharmacology, and metabolomics were collected before the infusion. Each child then received a 50 mg test dose (0.5 mL of a freshly reconstituted 10% solution) of suramin in 5 mL of saline, or 5 mL of saline only given by slow intravenous (IV) push over 3 min, followed by a 10-mL flush of saline. One hour after the test dose, vital signs were repeated and a single infusion of either suramin (20 mg/kg, minus the 50 mg test dose, in 50 mL, up to a maximum of 1 g) or saline (50 mL IV) was given over 30 min, followed by a 10-mL flush of saline. One hour after completion of the infusion, vital signs and the physical and neurological examinations were repeated, blood was collected for safety monitoring and pharmacology, and the family discharged to home. A typical infusion visit to the Clinical Translational Research Institute (CTRI) lasted about 4 h from start to finish.

 

[Daniel Tobin]

This is disappointing news. I was in the planning stages of also trying this. I have a few ideas in the pipeline. I have found a source for tocilizumab so will work on that as a project for a trial at home if I need to trial a new drug. I would like the OMF to at least consider tocilizumab for some lab tests.

What I have to say is fair play to you all for going ahead and trying this. There is no way we should just lie in our beds waiting for new treatments while our bodies are rotting away from the insides. So much respect to you all.

Hi,

I have a feeling that suramin may need to be administered in a specific way and specific dose to have any noticeable effect. As with all medications, the dose is key and in the autism trial the dose seemed to be higher than some people might have experimented with. Also the dose was administered by drip so these are the details that I think are very important to consider. I really want to give it a shot but I feel I need someone who really knows what they are doing to administer the drug for me in the correct dose and correct manner. The fact that his autism trial details the dosages (which I found difficult to fully understand) and proved their safety at these levels means I would tend to favour a doseage level somewhat similar to that. I believe Dr naviaux said that for ME/CFS he would use 1/5 the level of dosage as is used for sleeping sickness but I'm unclear on what that level is.

 

[Daniel Tobin]

I've heard of people going to mexico for suramin

Hi,

do u have any more info on this by any chance? Do u know whether they are going to mexico to get it administered there or are they just purchasing it? I am really eager to try it out and am seeking a willing expert to administer it to me as I don't think Id be able to do it effectively myself.

 

[melihtas]

Hi,

I'm wondering how you decided what dosage level to take. In naviaux's autism trial, from what I can understand, he used dosages of 50 mg followed by 20 mg. The technical details in his trial paper are a bit confusing for me so perhaps I'm misreading these numbers. I also think he administered it by drip over 3 minutes which could be significant as well. You might be correct that the dose was too low to have any impact. And since the autism trial showed that these higher levels were safe then maybe that's the way to go?

I say all this as a person suffering from this illness who wishes to try this treatment.

PS
If anyone can decipher the details for the levels of suramin dosage (pasted below) from naviaux's autism trial I would be very grateful. As I mentioned, I am not familiar with medical language so if anyone would be able to tell me what naviaux is saying regarding the dose he gave the patients I would be very thankful.

I took the same dose as in the autism trial. They used 1gr (1000mg) suramin but they reduced the dose for smaller kids according to their body weight. The 50mg injection was a test dose to see if the kids show a bad reaction to the drug. They waited one hour after the test dose and gave the rest of the whole dose.

I mixed 1gr suramin with 100ml isotonic water (sodium chloride 0.9%) and administered it as an infusion (drips) over 30 minutes.

Hi,

do u have any more info on this by any chance? Do u know whether they are going to mexico to get it administered there or are they just purchasing it? I am really eager to try it out and am seeking a willing expert to administer it to me as I don't think Id be able to do it effectively myself.

Someone on Reddit said he was planning to go to Mexico the get suramin but he never checked it is really available there. He just assumed he could buy any drug in Mexico without a prescription. He never went to Mexico.

https://www.reddit.com/r/autism/comments/6r5gnr/trying_out_suramin/

Suramin is only available as a research chemical.

 

[Daniel Tobin]

I took the same dose as in the autism trial. They used 1gr (1000mg) suramin but they reduced the dose for smaller kids according to their body weight. The 50mg injection was a test dose to see if the kids show a bad reaction to the drug. They waited one hour after the test dose and gave the rest of the whole dose.

I mixed 1gr suramin with 100ml isotonic water (sodium chloride 0.9%) and administered it as an infusion (drips) over 30 minutes.



Someone on Reddit said he was planning to go to Mexico the get suramin but he never checked it is really available there. He just assumed he could buy any drug in Mexico without a prescription. He never went to Mexico.

https://www.reddit.com/r/autism/comments/6r5gnr/trying_out_suramin/

Suramin is only available as a research chemical.

Thanks for getting back to me. That's disappointing that it didn't have any noticeable effect. Did u have assistance in the administration or you did it alone? I ask this because I wouldn't know where to start if I was to attempt to administer this.

 

[melihtas]

Thanks for getting back to me. That's disappointing that it didn't have any noticeable effect. Did u have assistance in the administration or you did it alone? I ask this because I wouldn't know where to start if I was to attempt to administer this.

I prepared the drug myself but someone started the IV for me.

I do NOT recommend you to experiment with research chemicals. When you inject it into your bloodstream directly, any substance can be dangerous if you do a mistake. I did a very thorough research for a few months. I read every paper ever published about suramin. I carefully calculated every step of the administration process and only then I took the risk. Your knowledge about drug administration is very limited and you can make a mistake which can lead to very bad consequences.

 

[Daniel Tobin]

Thanks again. I appreciate your advice. If I ever try this drug I will make sure that it is done with care.

 

[Sushi]

I am the only one who used research version of suramin from this company, others got their suramin from other manufacturers.

Sorry if you have mentioned this elsewhere, but is your source one that Dr. Davis mentioned in his presentation? I am writing from memory but I believe he said that the results using Bayer Suramin were different because other versions available were not a "pure?" As I remember, there were some failed studies using non-Bayer products and that there was speculation that the purity of the Suramin could have influenced this. Sorry I don't have the direct quotation.

 

[imitate-past-reign]

I prepared the drug myself but someone started the IV for me.

Thank you for sharing. You did not notice an infusion reaction, correct? That was the most glaring mistake in the trial.

 

[frozenborderline]

Hi,

do u have any more info on this by any chance? Do u know whether they are going to mexico to get it administered there or are they just purchasing it? I am really eager to try it out and am seeking a willing expert to administer it to me as I don't think Id be able to do it effectively myself.

I think that in general, it's easy to get packaged, pharmaceutical grade drugs in mexico from a pharmacy with little regulation. I've even heard of people buying opioids over the counter.

The person who mentioned this was on reddit/r/autism and I have PM-ed him. He was planning to cure his autism with suramin. Sorry I don't have any more information yet. I wouldn't try suramin if I were you unless you have a nurse or someone that can do an IV and monitor blood levels somehow. There are other anti-purinergic compounds found in plants, there's a thread on this. may be safer. like emodin and sytrinol

 

[melihtas]

Sorry if you have mentioned this elsewhere, but is your source one that Dr. Davis mentioned in his presentation? I am writing from memory but I believe he said that the results using Bayer Suramin were different because other versions available were not a "pure?" As I remember, there were some failed studies using non-Bayer products and that there was speculation that the purity of the Suramin could have influenced this. Sorry I don't have the direct quotation.

Ron Davis was just explaining where the scary side effects of suramin on Wikipedia page come from. He said CDC didn't use Bayer's suramin for cancer trials and contracted out for the suramin to be made. That suramin had impurities that may have caused the side effects. Then, they sold the leftover suramin for non-clinical use. He said
"So if you buy suramin on the market you are probably getting the old CDC suramin".

Any impurities can affect the outcome of a clinical trial. It is important to know if side effects are caused by the drug itself and not by impurities. So, it is pretty normal for researchers wanting the purest drug possible for the trials. I don't think it is important for personal use. I took the risk of having some extra side effects.

The suramin I bought was a fresh batch. Research chemical companies don't sell old products. However, the brand I bought was the cheapest product on the market with only ≥98% purity levels. I chose it because that was the only product I could afford. I know three other people bought more expensive suramin from other research chemical companies with ≥99% purity. They did not have any improvements either.

Here is the relevant part of the transcript of the video:

Ron: This comes from Robert K. Naviaux, MD, PhD, because he has done some exploring. If you look in the Wikipedia and do some searches on the web and look up side effects of Suramin and they are pretty scary. But Robert K. Naviaux, MD, PhD, knows that that is not really true. So there are two issues with this. One is that the amount of suramin that you use clinically for sleeping sickness is lower, the amount he uses is also lower. What is happening in the bulk of the literature is that the CDC (centers for disease control) did a big clinical trial of suramin for cancer. What I think, I am guessing on this, but I think what usually happens with cancer is that you try to use the highest dose (of the drug) that you can. I think anybody with cancer knows that the chemotherapy makes them sick. Well, partly, they are using as high a concentration as the patient will tolerate in the hopes that it will have a bigger effect. That’s what they did in the case of suramin I think is they used the highest dose that the patient could tolerate which basically has all sorts of side effects. And so those are the side effects that you see. That’s what’s reported now. That is what I thought was the answer. Then Robert K. Naviaux, MD, PhD, said actually no. There is something else going on, maybe. That is that when the CDC did that they did not get their suramin from Bayer, which is the main supplier of suramin for clinical use. I do not know why. It may have financial. It may have been that Bayer did not want to participate. They contracted out for the suramin to be made and Bob thinks it had a number of contaminants. He knows that from his mass spectrometry.

Ben: Yep! The tools of the trade.

Ron: The suramin from Bayer is very clean. The suramin probably that the CDC used is not. But, they made a large amount of it. He said that then is being sold off to suppliers for non-clinical use. So if you buy suramin on the market you are probably getting the old CDC suramin. It’s not necessarily newly synthesized. And so that suramin might have problems. We are concerned about that because we are trying to do tests in the lab. I want the clinical version, because if there are contaminants then we might see problems with those contaminants. That is what I have been struggling to get access to some clinical grade suramin.

Whole transcript:
https://docs.google.com/document/d/1QFtQsUo0mfg_xo-uNBhM2O7SYxXO90LB3uGXAj0BFME/edit

The video:
Suramin part starts at 49:50

Thank you for sharing. You did not notice an infusion reaction, correct? That was the most glaring mistake in the trial.

With a drug like suramin, any commercial contract is probably buying the API from a single manufacturer, so formulation discussion is likely irrelevant.

No, I did not have any infusion reaction. The only side effect was a mild headache lasted a few days after the first infusion.

 

[dreampop]

Well that's very dissappointing results but I respect @melihtas for going out there and trying to find something that works. I suspect they will go ahead w/ trials at the OMF. If the results are consistent, what does this tell us? Every failure is a lesson.

• 1mg is low but it's still not too far off the 4-5mg/kg used in African Sleeping Sickness.
• Suramin may not treat CFS, although it significantly (though not fully) resolves the impedance.
  
• Then it follows that drugs that resolve the impedance may not treat CFS.
  
• And therefore the metabolic situation may be adjacent rather than causative in the experience of symptoms.
• And the same may be true of the CDR.
  
• Also, if the results are consistent, excess eATP is unlikely to be the cause of the symptoms since, presumably, suramin would treat this.

To me this actually makes sense to me via a comment i made in another threa

But if you look on his original paper of metabolic features of CDR, the metabolic features of CFS are not the opposite of summer metabolism. Perhaps most importantly, it shows ATP being more intracellular.

And even more strangely, he recommends suramin for CDR, but also CFS, when he says they are opposites. I think his suggestion is that, "a postexposure adaptation or mitocellular hormesis" (whatever that is) gears the cells to the opposite of CDR response through the same CDR pathways, esp purinergic. Buy you can't just make every pathway do the opposite.Well, I really assume you can't.

And yet at the same time we have the OMF suggesting the hypometabolic results have been replicated. So if it's not the CDR, it's not the HPA axis (I've written my doubts about Cortene in that thread), where in heaven's name is producing our fatigue.

One other thought is that the CDR may not lead to the metabolic state seen in CFS, and that may be a bias from Naviaux's specific interest in CDR. Instead, some other factor may be triggering the hypometabolic state.

Any thought's @nandixon @necessary8 @Murph maybe I've gotten all this wrong again.

 

[Seven7]

Apparently you can request funds to pineapple fund, so maybe they can apply for funds to the manufacturer that will give the drug.

 

[necessary8]

I am one of the persons @adamjfpickering mentioned. I took 2 x 1mg Suramin 3 weeks apart. The last one was a month ago. I haven't had any improvement. I didn't have any side effects either, other than a mild headache lasted a few days after the first injection.

I am the only one who used research version of suramin from this company, others got their suramin from other manufacturers.

Of course, this doesn't prove anything about its effectiveness for ME. We still need to see metabolomics studies before and after injections. Maybe the proposed dose is too low for ME patients.

My ME is slow onset type developed over 16 years. My PEM starts 48 hours after exertion. I have every single ME symptom in CCC other than tender lymph nodes.

Oooh, this is interesting. Thanks for tagging me @dreampop

@melihtas, thank you so much for spending your money and risking your health to do this trial - as preliminary as it may be, this is a great information to have.

Now, you didnt fully follow Naviaux's autism protocol, you made one small change of using 100ml of saline instead of 50ml. This changes the concentration to be two times lower in your IV, but because both of those volumes are very small compared to the overall human blood volume, I dont think it matters. Let's see, assuming a blood volume of 4,5 liters, your change in protocol makes the difference between 0,02198% and 0,02174% blood concentration of suramin. So I dont think it matters, but I there might be some unknown to me reason why this simple calculation is not reflective of the actual change @Hip , what do you think? Am I missing something here?

Assuming that this change doesnt matter though, why didnt it work? Well... I dont know. There can lots of reasons.

Also, if the results are consistent, excess eATP is unlikely to be the cause of the symptoms since, presumably, suramin would treat this.

Maaaaybe. I'm like 60% willing to agree with this statement, 40% that something else is going on. There are a few very key uncertainties in this whole eATP/CDR/suramin shebang, that make me unable to make any real conclusions here. And I need to ask a few questions directly to Ron or Naviaux to solve those, but I havent been able to reach them so far. Until then, my hands are tied, and I cant make any solid predictions or hypotheses on this.

 

[Hip]

So I dont think it matters, but I there might be some unknown to me reason why this simple calculation is not reflective of the actual change @Hip , what do you think? Am I missing something here?

I don't think the IV fluid volume makes any difference, only the mg dose of suramin placed in the IV fluid.

 

[Butydoc]

I haven't read the entire thread so hopefully this isn't redundant. Suramin is sold in Tanzania, Uganda and Kenya under the name "Bayer205". It is classified as a class I drug in the USA. That is the same class that heroin is placed. The only way I can figure out how to obtain the Bayer made Suramin is for someone in the above three countries to send it to someone in the USA and hope it passes customs.

Relatives of mine in Israel can only obtain the drug for the indication of Trypanosomiasis.

 

[melihtas]

@dreampop, @necessary8

I have no idea why it didn't work. Maybe, CDR and metabolic changes are not the cause but the result of ME. Maybe, suramin might only work for a subgroup of ME patients like Rituximab does and I am not in that group. Even if it doesn't work for anybody, a clinical trial will produce very significant data to understand the disease.

@Butydoc

Before buying the research version of suramin, I contacted hundreds of chemists and doctors in all over Africa including the three countries you mentioned. None of the chemists was able to get Bayer's suramin. Bayer's suramin is also sold in South Africa but chemists can only get it if your prescription is approved by Medicine Control Council. I found a doctor in South Africa willing to give me a prescription for suramin but MCC approval was impossible.

 

[necessary8]

Before buying the research version of suramin, I contacted hundreds of chemists and doctors in all over Africa including the three countries you mentioned. None of the chemists was able to get Bayer's suramin. Bayer's suramin is also sold in South Africa but chemists can only get it if your prescription is approved by Medicine Control Council. I found a doctor in South Africa willing to give me a prescription for suramin but MCC approval was impossible.

Holy shit, thats a lot of regulation for a drug with absolutely no black market use. I wonder why its so strict.
Also, mad props to going to such lengths. You did a great job to explore all those options.