In Part II, Judy and I talk moving forward after XMRV, repurposing drugs, taking a multidisciplinary approach, and how the ME/CFS community can make strides.
FULL TEXT TRANSCRIPT:
Dr. Craig: Welcome back to Spoonie Radio with your host Dr. Courtney Craig and my guest today Dr. Judy Mikovits. Now here in Part II in my talk with Judy I want to talk more about the future of chronic fatigue syndrome research, as well as what this community can take away from this story as detailed in her book Plague.
Now I remember when that XMRV study made major headlines and it was all over the news, it was everywhere. It instilled so much hope in this community, everyone was so excited, and finally people were recognizing our illness as real, which was a breath of fresh air. And yet it didn’t quite turn out that way. So even though we made headlines and we brought this issue back to the public, would you agree that it actually hurt this community more than it helped?
Judy: Oh, absolutely and that’s my biggest frustration, sadness is the way this whole XMRV thing was handled and spun as I mentioned earlier, was really deliberate to hurt this patient community. And in fact while they--the NIH, the FDA, anybody else, CDC--they put up smokescreens about, “Oh yeah, we’re going to do this research and we are going to get answers,” the fact is that it’s gotten worse.
Now we have the patients being relegated to the Institute of Medicine, the IOM, and the P2P. I guess it was March of last year the FDA released a drug guidance act where they are going to teach all of us how to start with square one, identify biomarkers, and they are going to teach us how to develop the drug. And all I could say, I gave this presentation at Sue Vogan’s Physician’s Roundtable in Tampa last March of 2014, and that talk is on our website MarConsutling.com but what I showed that in the beginning and I said, “Oh my God, I’m a drug developer.” I think the slide said, “WTF?!” but at any rate… I have been a drug developer for decades and we didn’t do that with HIV-AIDS.
We went to our stores, we went to our libraries, we went to drug companies and we recognized the severity and that these patients didn’t have that long to wait. So we took old drugs and we learned new things about them. So we learned that it could in fact help AIDS patients. We learned that it crossed blood-brain barrier, as we’ve gone 30 years beyond that and developed therapies, we don’t treat HTLV associated cancers or neurological diseases. In the beginning we don’t even test for the virus. If you have an antibody that Spleen Focus Forming Virus Antibody Envelope, to the envelope that I showed in at least 30% of this patient population and crossing over into the Lyme community, into the cancer communities and things like that--and in the autism communities.
So if you have that antibody, then you can start to say you are going to have the following immune defects and we can treat with this immune modulator, we can treat the immune system and we can do that with therapies available now, already on the shelf. So this talk at the Physician’s Roundtable was all about that. I showed data that Frank presented in 2010 from his work with HTLV-1 and the interaction with plasmacytoid dendritic cells (pDC’s).
There is a compound known as Imiquimod which is a toll-like receptor modulator (TLR). This is a therapy which is essentially non-toxic, which can just modulate that part of your immune response to stop the aberrant signaling and reset, if you will, the immune system in order to respond to whatever the various pathogens; or just reset it to a healthy response. So I went through in this maybe it was an hour and a half long talk and I showed examples from AIDS, to cancer, to HTLV-1 associated myelopathy, and leukemia to drugs that were out there.
What was fascinating is at the 2011 Retrovirology Conference in Leuven Belgium, we saw the results of a clinical trial where they were using ATL, adult T-cell leukemia, one of the most aggressive cancers known, caused by HTLV-1. That means HTLV-1 is in every single tumor cell sequences.
And with AZT, the old drug AZT, and alpha-interferon and Decitabine, the methylation modulator, they are now talking cures. Use them all low dose, use them a little bit differently, bounce them off each other, allow a rest, once you activate the virus from the reservoirs you hit it with the AZT, it kills the reservoir and it clears the bone marrow, the cells of the reservoir because it is a very small population. We thought of similar things in early HIV.
So again we don’t have to start from square one, there are 25 years of beautiful immunological studies of biomarkers, of immune deficits, where we can come right in and in a compassionate way, use therapies which are already on the market in other diseases which can impact this disease and give people a quality of life as we have done in HIV-AIDS and other things.
Dr. Craig: Right and as soon as you bring up the idea of using antiretroviral drugs for CFS, it’s like everybody says, “No way, don’t even mention it.” And you mentioned it in the book like you weren’t even allowed to say this in the paper. That was so amazing to me especially with the new research that’s out now where we are doing clinical trials with Rituximab. And as far as safety profiles it’s a no-brainer here, Rituximab is a very dangerous intervention to use and it doesn’t really look at root causes when compared to antiretroviral drugs. So what is your opinion on these new clinical trials with Rituximab?
Judy: Well as we published in our Nova book chapter, the various immune deficits that we saw and as I mentioned in our last segment about our meeting with Fluge & Mela, I think there is a way to use them differently. I think there is definitely a population that will benefit but if we don’t use diagnostic strategies that say yes, you have this B-cell deficit, you are making CD20, CD23 B-cells which we showed in in Frank Ruscetti’s talk back in 2011, and we developed these cell lines from people by doing nothing.
So clearly there is a process that’s driving a clonal derivation, which is the definition of a cancer of a population of B-cells and so those can be contributed to the cytokine dysregulation, as all the cells in the immune system talk to each other. So yes, I am in favor of these things but used differently, systemically, not if it is a cancer patient, use it as a pulse, very low dose, absolutely. And our Nova chapter details all our thoughts on this and shows the immune deficits from Deborah Goetz’s PhD thesis research.
Dr. Craig: Now some CFS clinicians have really stuck their neck out and prescribed antiretroviral drugs to patients. So you can talk a little bit about the results of that and the risk associated with physicians prescribing these drugs?
Judy: There is a level of risk to any chemical intervention. I know very well as I was working with those physicians and again, it’s the same as with Rituximab, you want evidence of expression of retroviruses. I like evidence that is broad-spectrum such as looking at reverse transcriptase, and other things and then targeting those things. I like multiple therapies, I like low-dose.
One of the things I talk about with Professor Kramer & Bieger in Germany last December we made a film where we discussed the Physician’s Roundtable talk and we discussed Rituximab, we discussed antiretrovirals, we discussed these very questions you are asking me so that YouTube video should be available in the next few weeks, maybe even sooner.
So you can see how Dr. Kramer & Dr. Bieger is approaching the problem, because antiretrovirals used in the appropriate patient population can be safe and effective. We have worked with doctors but they have patients who have, remission and it’s not a lifelong thing because it’s not HIV. So if you can shut down the expression of the viruses, regardless of who they are, get the methylation machinery back into control, and balance the immune system so that their immune system is strong.
Then of course they can fight their own disease, do things like the Wahl’s Diet and other diets that strengthen the cell membranes, strengthen the signaling pathways that lower the inflammation, because inflammation is part of the problem. By definition inflammation causes the aberrant expression of various genes and chronic methylation is the sixth hallmark of cancer leading to the very worst of the disease. We could cure the cancer if we can prevent both the immune suppression and the immune activation in conjunction with the treatment.
So I am very much in favor and I worked for the better part of a decade developing what I consider adjuvant; natural therapies that we can use in combination to lower the dose, lower the toxicity, lower the risk. Some patients do well, some patients don’t do well, and some patients don’t notice a difference. So designing clinical trials, selecting the appropriate patient population based on the molecular markers, the immune dysregulation, the things we put out there, which are all available to do right now it is not rocket science as I would say because it’s been done. It’s not like anybody else found evidence of retroviruses and some patients with strong immune systems keep them latent forever.
I use the example again of HTLV-1, only 5% of the people with HTLV-1 ever develop disease: 1% develop the cancer, about 4% develop the associated uveitis, an inflammatory disease of the eyes. There is an arthropathy, a myelopathy that puts them in wheelchairs, and they don’t treat those with antiretrovirals by and large, they treat them with immune suppression. They calm the inflammation and the people can get out of the wheelchairs and live a normal life.
So you silence the retrovirus or you silence whatever it is, you reestablish a normal functioning immune system. Many, many tests, easy tests to do to show which part of the immune system is wrong. But yes, when you see high levels of reverse transcriptase and other things, the benefit to this population far outweighs the risks. And because of all the work that has gone on in HIV/AIDS, we’ve developed some new therapies, some combination therapies in a single pill that are very, very low dose, very low risk.
You can do things if the gut is the primary source. You can do things like suppositories, you can do things like nasal sprays if the sinuses are the problem. Then you prevent systemic side effects. We can do a lot with drug delivery. We can do a lot with putting the microenvironment responsive to curing. We can do a lot with those things and that, as I said is your first question of the hour, that’s the disappointment because in this patient population, that’s not what’s happened. Because the patient population has been relegated back to, “Well let’s let the Institute of Medicine redefine this disease. Let’s go back to square one and develop drugs from square one.” Why the bias? Why the misogyny?
This patient population should be in the National Institute of Allergy and Infectious Disease where it should have been in the beginning when it was described as non-HIV/AIDS because it is. It has all the hallmarks of HIV, and the only thing that’s not there is HIV. But there are mycoplasma, there are retroviruses that Elaine Defreitas, Sidney Grossberg, and I all characterized in patients, in different populations with these diseases--with Paul Cheney with Tony Komaroff--with some of the earliest patients, with the brain inflammation, clear changes in SPECT scans, clear changes that say inflammation, that say aberrant immune responses. And so these should be given the same resources that HIV/AIDS and cancer are given and that’s not what happened – “We’re going to go back and redefine and start over.”
I was in Sweden talking to a group of doctors over the Christmas holidays, and one of the doctors, patient advocates parents of 3 affected children, 3 adult children with CFS in the family in Sweden. So the gentleman was talking to me and he said, “I didn’t even know about your book. I didn’t know what happened, I didn’t know anything. All I know is I could see a visible change.”
Like in the autism community, people being taken from their home and vaccinated without their parents’ permission, people Munchausen by proxy mothers being arrested, parents being arrested, children being put in sanitariums, insane asylums and everything else, it’s worse. He confirmed to me it’s worse and that’s why we wrote Plague because this can’t happen again.
We need to spread Plague throughout the world so that everybody understands what’s happening, how the spin on the media, how parents who want to protect their children from autoimmunity or other things; who want to vaccinate their children, but who want them to be old enough, have a healthy immune system, who want one at a time, who want a vaccine that has been demonstrated to work, and not one that has been mandated to give them with 3 antigens and in fact data that shows it does not work has come out, been covered up and scientists like me are bullied… Well we couldn’t be bullied, I just want to say any scientist like Thompson, like the Merck scientists, they are not whistleblowers to me, they are criminals. They covered up data and did so much damage that could have hurt so many people and to me that’s reprehensible and yet, to protect their own retirements.
Frank Ruscetti and I didn’t protect our economic status, or our status in a community, or even our ability to work. We did the right thing and that’s what as you said earlier: that’s what everybody needs to see. So yes, there are some promising avenues but they are not given near enough information, near enough funding and we keep seeing commercial after commercial.
We don’t see a word about this on CNN, but we see international CNN, “How exercise anxiety is the reason for CFS. So all patients have to do is be trained to get over their anxiety about exercise and they can recover. The mitochondria are protecting themselves because they are being robbed of their energy. If they overexert they have no energy at all and by definition you die.” What else do you need? It’s not only idiotic, it is criminal. You are so sick you can’t move. Absolutely criminal.
Dr. Craig: Absolutely criminal. You brought up some excellent things there. You talk about a lot of things that patients can DO! When all of this story kind of fell apart, misconstrued and everything, patients lost hope, this was like, “Oh, people are going to be interested. We will have research funded, we will have a “cure,” that four letter word again. That all fell apart and now I think a lot of patients, they are so sick, they are in dark rooms, they cannot be their own advocates because of the illness.
Yet there is still so much the patient can do whether it’s bolstering the immune system through things like diet, eliminating potential triggers in our environment. We talked about heavy metals and things in our first hour…even GMOs and gluten and all of these things which I talk about all the time on this show, there are things that patients could do so I really wanted to instill that there is still hope moving forward both in natural methods and as well as looking more into pharmaceutical methods.
Judy: Yeah, one of the things I want to say to that is yes, there is things patients can do but think about it…They can’t leave their house, what you just said. They are suffering in their beds, they can’t cook a meal. They can’t afford a healthy meal, they can’t afford non-GMO foods. They can’t get insurance coverage for high-quality supplements.
Sure I can recommend things and actually supply to patients--always have for decades in cancer and AIDs--I actually supply their expensive well researched no known contaminants supplements to help. These patients can’t get food, they can’t leave their house. They can’t get anything. No doctor will see them and treat them like anything more than a lunatic if they can even get to a doctor, and the doctors can’t come to them by and large in this country at least.
Dr. Craig: It’s very discriminatory.
Judy: Very discriminatory. The idea that patients can help themselves, “Pull yourselves up with your bootstrap and get over it, move on!” Ridiculous! That’s what this is about, that’s what the problem is. The patient community, the autism families, you wouldn’t believe just keeping economically above water, a mom can’t work, the whole family can’t work, the daughter can’t go to college because if she gets vaccinated with the mandatory MMR or HPV vaccines she goes into CFS, because she has and immune dysfunction like her brothers.
They have lost their home, they are in foreclosure, they can’t get through a day much less eat well, much less cook a meal. And most don’t have the resources to have somebody cook a healthy meal so sure all of these things can have them but not until we change the bias. That’s why Plague the book, that’s why we are going to change this from the top of the roof tops if we have to that everybody read this and that the laws are changed so that that high-quality supplements are covered under insurance, so that disability is paid so that the incomes that these patients earned before they had been forced to stop working so that they can function, so that they can have a life so that they can at least try to get better.
Sure, there are lots of things that we can do but it is not practical for the sickest of the sick in their beds and it is not practical until attitudes and laws are changed just like we did in HIV when that was about bias against homosexuals. It has to change and they can’t get out and fight for themselves, so the only people who can fight for them are people like you and me--the medical community, the doctors as you said.
Many doctors who care, they can’t give away their services, they can’t be forward all the time, they do a lot, but they can’t be worried about the government coming in there and shutting them down if they use a antiretroviral off-label. The whole system is broken and until we fix it and stop the special interests and the conflicts of interest of who owns what, it’s simply not going to change.
Dr. Craig: Do you see a way out of this? There are movements in the autism community but it is still rife with controversy. What can the CFS community do, all of our advocacy groups, to undo this whole movement?
Judy: I do see a way out of this and you just mentioned how. And as I wrote in the book that very smart member of Parliament MP over in Stormont Ireland in 2011 said, “Judy I don’t understand a word of what you just said. But you said autism, you said ALS, you said fibromyalgia, you said ME/CFS, you said cancers, and our antibody studies say between 10 and our protein studies say 10 in 20 million Americans are carriers or have some kind of acquired immune deficiency or susceptibility if you will. So that’s 20 million Americans! You vote. Throw them all out and start over and then say until you look at us as a community, don’t fight each other. Don’t fight the chronic Lyme community, because we all have different opportunistic infections or environmental stimuli or even microbiomes that are different and all contribute to our disease, but we are all one in that we are all denied our basic right of healthcare.
We are all denied our basic right of research and we are all humans too so when the communities fight together--and the best examples I can give on this is a group called oneintwo.org. So oneintwo.org is a combination between the Brighton Foundation of babies and an Alzheimer’s foundation. And they got together a few years ago and said, “If we do nothing, in 20 years 1 in 2 Americans will have a chronic debilitating disease. All the way from autism in babies and children, to Alzheimer’s disease,” which is also going up, up, up. So they got together to do something, to raise funds.
We can go out in the private sector and say everybody has a victim. We are just like in the early days when the National Cancer Institute was formed. Every family now knows somebody with cancer. More and more people in America have friends or family with these diseases, and if they are all considered on a spectrum of chronic debilitating disease, and they all get equal attention, we’ve got a lot of brilliant scientists unemployed!
Oh great, we can get in there and we can work to change this! And we can use the technologies I mentioned at the top of the show. All we have to do is put the people who very much want to work and to change this to work to help you. They are out there right now as I mentioned; Dr. Kramer, Dr. Gordon--Gordon Medical in Santa Rosa--everywhere, Dr. Cheney, Dr. Bell. They’d do anything to change things, they’ve pent their whole lives doing this and want to solve the problem.
And we have specialties, we have areas, Dr. Shoemaker with mold. Yes, mold contributes to a big part of this in an immune compromised individual. So then we can use Dr. Shoemaker’s decades of treatment, his VIP protocols, we can put the right protocol in the right people. We can work together with Frank Rice in New York in integrated tissue dynamics who has looked at pain as one of the world’s experts in different mechanisms of pain developing new paradigms to treat, treat fibromyalgia, work together as a network to share our insights and cross over patient populations to see common pathways involved.
And that’s what I’ve tried to show and that’s why we wrote the book--looking at the common pathways. Because that’s what we did in the beginning. That’s how I met Kent Heckenlively. We looked at families and we said, “Okay inflammatory bowel disease, psoriasis, cancer, autism, CFS, fibromyalgia, there they are. A little ALS too, throw that in.” You can start putting and looking at them as the same thing, you can start pulling out common pathways – mitochondrial deficiencies as Sarah Myhill’s worked on, that’s the expertise.
I don’t know that, I don’t know mold, I don’t know mycoplasma. But when we start putting everything together and stop thinking in the box and work as a community – And the physicians and the scientists, they want to do it but the system’s broken. You can’t write a grant like that, it will never get funded, “Oh, you’re too far out there, you are not focused.” Well you know I think I am focused but as I said, the system is broken.
And until the system changes…and I guess unfortunately financial incentive has to be put in there in order to change the system because right now the Journals are owned by the NIH, the Universities are owned by the NIH. The NIH was never supposed to fund an entire institution with indirect costs of 100%! That means turning on the lights, you get a million-dollar grant in places like Harvard, they get 100% indirect cost.
So the institution gets the grant and it’s funding the University. That’s not how it was intended! The institutions were supposed to pay the staff. And the grants were supposed to fund the research into areas that wouldn’t ordinarily be done. But over the past 30 years, it’s been corrupted to be an old boys network, and there are very few people at the top controlling the purse strings and we all know in this disease – Tony Fauci relegated it to the Office of Women’s Health. Ignored everybody with non-HIV-AIDS; nurses, doctors, patients and those are the very samples that Lo & Alter looked at when another virus was found.
They went back to the early 90s, made late 80s, and they went to a freezer of blood samples and said, “Maybe it’s this,” and of course it was, but they rode them until they were out of the thing by corrupting the science and corrupting the replication studies. The long hot confirmation summaries is the chapter of the book, of Plague you don’t want to miss.
Dr. Craig: Oh, absolutely! That’s where everything comes together.
Judy: We can change it but we’ve got to work together, and we’ve got to put that 20 million Americans together like oneintwo.org has done and start forming these foundations to have the CFS community say, “Were not going to fight the chronic Lyme, or the fibromyalgia, or the autism community for $2 million. We are going to get together and we are going to get $3,000 per patient just like we do for HIV/AIDS research, just like we do for some areas of cancer.
Dr. Craig: That was so wonderfully put and it’s so important I think that I want to kind of say it again. That’s one thing that I have been in this community for over 15 years now as a patient, and I am just amazed at the lack of community actually in this community.
There is so much argument over what we call it. I don’t have CFS, I have M.E. Well I don’t care what you call it, we are not helping each other, we’re not moving this whole neuro-immune community forward with infighting. I think it is so important that – it talks about Dr. Shoemaker, you mentioned Dr. Wahls, all of these different doctors with different areas of specialties that need to come together and create a holistic approach and a better way to look at this illness from outside of the box. That’s awesome.
Judy: Believe me; the doctors want to do it.
Dr. Craig: Absolutely! That’s why I do what I do. We have to be a team here and so far I have not seen a team effort in this community, and that’s the only way I think we can move forward from this.
Now not just this community moving forward, what about you? How are you moving forward? You’ve lost so much. What are you doing now through your consulting work and your different research projects?
Judy: Well I mean I never stopped, so moving forward is something that I always do. So you might kick me a bit, but I always move forward. So I haven’t changed one thing that I do. I keep working with the patients. We formed a company which we try to look at the data, put the samples, we know those investigators that I have named, and we are working with those investigators so we pretty well act as a bridge to doctors.
If the patient happens to be in Europe, we can try to pull it, we can say, “Okay, so let’s look at your records.” We can get a detailed look of your records, we can say which tests they might do, we can talk directly with their doctors. We are putting together from the literature talks like I gave at the Physician’s Roundtable.
And I applaud Sue Vogan and that organization who put that together because that was a community of people looking at Lyme disease, looking at autism, looking from the very beginning from the first time she started having these meetings. They are meeting with patients, they are meeting with doctors.
I remember one of the things that I was vilified for in 2010-11, was I actually talked to the patient’s – What’s that about? What scientist doesn’t… I can’t understand a disease unless I talked to the patients. That was the brilliance of Dan Peterson. Of course he didn’t have… That’s why our 67%, because for every thousand records that came to him, he had an eye for who the patient was that was the closest to minimize the diversity, to make it homogeneous, to make it as close to a single population.
Not all cancer is breast cancer. Not all cancer is leukemia. So he did that, and for instance when he saw pain he sent a patient to Lucinda Bateman. So those patients were never in our studies so it’s not surprising to us that those patients from Lucinda’s studies have no XMRV; or no evidence or less evidence or maybe only at the controlled evidence. Because that was the patient population we were looking at.
Dr. Craig: Right.
Judy: So when Dr. Shoemaker looks and he sees the mold, and Dr. Chia out here sees enteroviruses is one of the biggest problems, just brilliant work that we can put together. And so there are lots and lots of opportunities to do this. So our group, Mar Consulting, me..I am still talking.
I am moving forward and as I always have, I continue with my plans to live. Frank Ruscetti and Sandy Ruscetti and my husband and I have planned more than a decade, 15 years ago to retire in Carlsbad. So we went ahead when Frank retired last year and moved down here, we went ahead and moved down here also. Of course we were forced to, with the loss of our home and economically. But I mean I live a half block from the beach and we work everyday on that beach discussing ideas outside of the box.
So in my 35 years, nothing has changed. I am doing what I love to do, I am thinking about science with Frank Ruscetti and Sandy as well. For me, that’s my passion. I am helping people if it’s only one at a time.
Dr. Craig: Yeah, that’s great. We are out of time but I want to thank you on behalf of the whole community for carrying this torch. There is still hope alive and patients, and advocate, and the caregiver, everyone needs to read this book Plague. So Judy, if you could tell our listeners where we can find out more about you and your work, your websites and how to get the book.
Judy: Well you can get the book essentially anywhere. Amazon. You can go to Plague website. There’s a lot more information at www.plaguethebook.com. Our website is www.marconsultinginc.com. The book is wonderful, there is an audio version, there is a Kindle version, an e-book reader and hard copy, love the Audible version. Eric Martin who read it has a marvelous voice.
We wrote it in such a way that if people are put off by perhaps the complexity, every chapter essentially stands alone. So I don’t think linearly and the book isn’t written linearly so just dive in and whatever interests you. If you want to just read chapter 5 today, it can be done and or have it read it to you. You can slow down, Eric Martin’s reading in the Audible.
You can get the book essentially any way and we can almost always find me through our website or through plaguethebook.com. There is a supportdrJudy.com website where basically tells you what meetings I’m attending, things like that. They are opportunities so if I happen to be in your neighborhood, we can get together and meet as we did in Minneapolis a few weeks ago.
Dr. Craig: Great okay. Definitely check all of those things out, get a hold of the book, read chapter 5 first. Actually maybe read Hillary Johnson’s prologue first and then read chapter 5.
All right Judy I want to thank you so much. This has been so informative; you have such a mind, and so much information here in both of these episodes. So I wish you luck and for all our listeners, be sure to tune in next time on Spoonie Radio!