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New CFS clinical study offered by Dr. Jon Kaiser in San Francisco Bay Area

Discussion in 'Active Clinical Studies' started by richvank, Feb 9, 2012.

  1. richvank

    richvank Senior Member

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    Hi, all.

    I want to tell you about a new treatment study for chronic fatigue syndrome that is available to patients in the San Francisco Bay Area, or to those able to travel to this area. It was announced today.

    The study is being conducted by Dr. Jon D. Kaiser, M.D., who practices in Mill Valley, CA, and who is the CEO and Medical Director of K-PAX Pharmaceuticals, Inc. Dr. Kaiser has extensive past experience in the treatment of HIV/AIDS, and is currently specializing in chronic fatigue syndrome.

    In order to participate in this study, patients will need to be able to visit Dr. Kaisers office once. His office is located 30 minutes north of San Francisco. In the office visit, a patient will be screened to determine whether she/he satisfies the criteria for the diagnosis of chronic fatigue syndrome. Conditions that may exclude a person from this trial are significant fibromyalgia, a history of heart disease, uncontrolled high blood pressure, major depression, or ulcer disease.

    The treatment will last for one month. It will consist of a low dosage of a currently available medication with a potent nutrient-antioxidant cocktail that boosts immune function to provide CFS patients with a healthy and balanced increase in their energy level. Specifically, the treatment will consist of the commercially available K-PAX Immune Support Formula (see www.kpaxpharm.com) combined with a low dosage of Ritalin.

    According to Dr. Kaiser, the rationale for this combination is By pharmacologically boosting central nervous system signaling from the brain, plus concurrently enhancing mitochondrial energy production with potent micronutrients, it is possible to initiate a reintegration of the neuro-endocrine-immune axis, providing CFS patients with an improved quality of life and the potential for complete cure.

    The office visit and the nutritional supplement for the study will be provided free of charge. This will be an open-label clinical study with no placebo group, so everyone who is selected to participate will receive the actual treatment.

    Dr. Kaiser reports that this treatment has already shown promise in a significant number of CFS patients.

    There will be an opportunity to continue this treatment beyond one month if a patient experiences benefit and desires to continue.

    (I am not financially associated with Dr. Kaiser or with K-PAX Pharmaceuticals, Inc.) For more information or to enroll in the trial, please email Anne Lahaderne at a.lahaderne@mac.com or call her at (415) 381-7655.

    Best regards,

    Rich
  2. Snow Leopard

    Snow Leopard Senior Member

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    Since this is an open label study, I am really hoping the primary outcome will utilise objective measures - eg actigraphy. This study won't have much validity if the outcome is merely a few ticks on another questionnaire.
  3. richvank

    richvank Senior Member

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    Hi, Snow.

    I agree.

    According to Dr. Kaiser, this open label study is preliminary to a planned full-on study that will be carried out if the preliminary study continues to give promising results. I haven't seen the plan for the placebo-controlled study, but I think it will have objective measures.

    Best regards,

    Rich
  4. Andrew

    Andrew Senior Member

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    According to the website they are using a prescription version of K-PAX Energy, not K-PAX Immune Support Formula.

    Additionally, I got an email that says:

    It would be interesting to know which definition of CFS they are using. And fwiw, I use their immune formula.
  5. richvank

    richvank Senior Member

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    Hi, Andrew.

    Thanks for adding this information. I think that what is meant in the part you quoted from the website is that the prescription aspect of the treatment in this clinical study is the Ritalin, while the K-PAX Immune Support Formula will be used as the nutritional supplement. The "over-the-counter version" they are referring to is their other product, K-Pax Energy. In that product, caffeine is used as the stimulant, while in the clinical study, Ritalin will be used as the stimulant.

    Dr. Kaiser's hope is that if this preliminary study is successful, and if they are able to go on and carry out a placebo-controlled trial which is also successful, it might be possible to interest a pharmaceutical company in doing the expensive Phase III testing that it would take to get FDA approval for a treatment that would include nutritional supplements, together with a prescription drug. The role of the drug would be as a stimulant in the initial treatment. Over time, the hope is that patients will be able to take a maintenance dose of the nutritional supplements alone in order to prevent recurrence of the disorder.

    If this worked, it would be a breakthrough in terms of getting nutritional supplements into use by conventional physicians, who up to now have been trained to believe that they aren't very efficacious compared to drugs, "but they probably won't hurt you."

    I expect that people will have a variety of views about this. However, as we know, the pharmaceutical companies have not been very involved in trying to develop treatments for ME/CFS, and if there is no prescription treatment available, the majority of the conventional physicians will not use it, because they have been trained to use drug treatment, and the system in which they work pretty much dictates that they do that. The reality is that if someone is not able to make a profit from an approach to treatment, it simply will not be implemented by the medical establishment on a significant scale. We might not all like that, but it is the way the system works.

    Of course, if a pharmaceutical company spends the money to do this testing, they will make sure that the treatment has patent protection so that they will have a monopoly on it for some years, so that they can raise the price sufficiently to cover their costs of testing and promotion, and make a profit. That is the way the system works. This may result in insurance coverage for ME/CFS treatment that includes nutritional supplements, and if so, I think that many more people could be treated, and if that happens, I think it would be a good result overall.

    One concern I expressed to Dr. Kaiser is that if this happened, the FDA might make it difficult for people to obtain the nonprescription ingredients over-the-counter, if they wanted to do that, because not everyone has insurance or can get to a physician who might prescribe this combination. His response was that the FDA has done that only for single-ingredient patented drugs in the past (an example of this would be Kuvan, which is the synthetic form of tetrahydrobiopterin (BH4). BH4 used to be available over-the-counter from Switzerland, but no longer is available that way). He may be right that this would not be a problem. For example, PamLab produces prescription "medical foods" that contain methylfolate, but methylfolate is still sold over-the-counter in smaller dosages, and there are now two manufacturers of the basic 5L-methyl tetrahydrofolate, so there is competition. There are also knock-off racemic versions (both the useful type and the mirror-image molecule together) sold over-the-counter.

    In this preliminary clinical study, they are using the Fukuda definition. I suggested to Dr. Kaiser that if they go on to do the placebo-controlled trial, they should consider making post-exertional fatigue/malaise a requirement in the patient screening. He seemed receptive to this. He attended the Ottawa conference, and he is aware of the newer definitions.

    Best regards,

    Rich
  6. Andrew

    Andrew Senior Member

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    Thanks, for clearing that up. I sent them an email yesterday suggesting that they use whatever definition they are using (I assumed it would be Fukuda), but also track which subjects fit ICC. And then release information about both. But I do like your idea about a modified Fukuda.
  7. richvank

    richvank Senior Member

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    Hi, Andrew.

    I'm glad to hear that you suggested that to them. Dr. Kaiser told me that the patients who have been tested with this combination so far actually all did report postexertional malaise/fatigue, even though they were using the Fukuda definition, which doesn't require it to be present. So it sounds as though they have a valid group of patients in the study so far.

    Best regards,

    Rich
  8. madietodd

    madietodd Senior Member

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    What does this treatment look like? Do you go once and get a month's supply of pills and then return a month later? Or do you need to stay close-by for, eg, regular infusions?

    Andrew, do you think you're going to participate in the study?
  9. richvank

    richvank Senior Member

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    Hi, madie.

    Dr. Kaiser told me that participants in the study would only have to make one visit to his office, at the beginning. No infusions. The outcome evaluation will be done with visual analog scales and a questionnaire. If this small study shows good results, they are planning to do a more sophisticated clinical trial, but they need to get financial support to do this.

    Best regards,

    Rich
  10. richvank

    richvank Senior Member

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    Hi, all.

    For what it's worth, here are some more comments from Dr. Kaiser about the treatment he is testing:

    "I must tell you that the genesis of this treatment (K-PAX Immune Support Formula + Low-Dose Stimulant Medication) was the result of over 20 years of experience in treating people with severe CFS. Once I began giving CFS patients this combination, I was astounded at both the benefits and tolerability of the treatment. It has literally changed the lives of many of my patients with long-standing CFS within just a few months. It appears to provide just the right amount of stimulation to the brain and energy level which is balanced by the high potency nutrient and antioxidant support. Brain fog and concentration difficulties improve very quickly.

    "I continue to follow the patients who have completed the trial and over 90% of them have elected to continue taking the treatment. As their health improves over time, my goal is to gradually taper the stimulant medication so that can be maintained on the Immune Support nutrient formula alone.

    "As you may know, performing clinical trials is very expensive. While K-PAX Pharmaceuticals would like to conduct a six month, double-blinded, placebo-controlled trial using actigraphy, the cost of this trial is prohibitive at this time. We are currently looking for a pharmaceutical company partner that is interested in working together on the future development of this treatment so that it can become a well studied, FDA-approved therapy."

    Best regards,

    Rich
    sensing progress likes this.
  11. Andrew

    Andrew Senior Member

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    I can't, I'm not in the bay area. But if I were in that area I probably would. I'm already a customer.

    Even more difficult to get partners for CFS. With something like HIV it's much easier (http://www.kpaxpharm.com/studyresults.html)

    I wonder how I would try their over-the-counter version. I'm already taking their "professional strength" immune formula. Their energy formula is like a weaker version of that plus caffeine. To take the energy version, I'd have to reduce my overall vitamin intake.
  12. madietodd

    madietodd Senior Member

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    Hmmm.......has folic acid. That knocks me out of the running! Well, plus it's being across the country.
  13. Dreambirdie

    Dreambirdie work in progress

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    He also plans to use Ritalin. NO THANKS, I will pass on that!
  14. Snow Leopard

    Snow Leopard Senior Member

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    I'm also of the opinion that a no-Ritalin group is necessary so that the effects of Ritalin can separately be identified.
  15. Jmitchell

    Jmitchell

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    The last date to enroll in this clinical trial is 4/30/2012
  16. Helene

    Helene

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    Thanks for your continued work, Rich. In your view how would this treatment address the methylation block? Would it be addressed in some way?
  17. Helene

    Helene

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    The concern I have is that 'boosting' is not really curing, or keeping in remission. I took hormonal boosters for a couple of years and I could function better; but eventually I crashed so hard it took years to get out of that. The booster effect can gives a false sense of well-being.

    I just watched the video component on the website and Dr. Kaiser says the product will give a few hours of extra energy--it gives a boost. It is presently being recommended for shift workers and students who need to cram at night.

    The position that Dr. Kaiser takes is that this product and the ritalin will reverse the neuro-endocrine-immmune status of the CFS person.

    I have heard this approach before, from the approach taken by Dr. Teitelbaum. He too suggests Ritalin. Recall his book: From Fatigued to Fantastic. He is a talented physician--no doubt. But the promises have not worked.

    Please do not get me wrong, but I wish that this would be the pill to do the job. But I am worried that a fatigued person is not necessarily the same as a person with CFS/ME.

    I hope I am wrong, and I hope that this proves to be the thing.
    deirdre likes this.

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