We Must Move Forward by Michael Snyderman, MD

Dear fellow patients, physicians and scientists:

The quest for identifying and treating retroviruses that are involved in the pathogenesis or CFS/ME, neuroimmune, autoimmune and neoplastic disorders will not end today despite the negative results of the XMRV, pMLV study. I have CFS/ME and cancer. My data supports the presence and importance of retroviruses in the pathogenesis of both disorders and the potential for anti-retroviral drugs to help us.

My data shows the presence of a clonal T-lymphocyte expansion which is probably CD8 cells. Having a clonal T-lymphocyte expansion is abnormal.  In addition, I have increased monocytes (monocytosis). I have looked at 56 of my patients with various types of cancer and half of them also have a detectable T-lymphocyte expansion and monocytosis. My point is that what I see in myself may be a common phenomenon and actually may be happening in millions of people. I haven’t looked in CFS/ME, because I limit my practice to Hematology-Oncology.

T-lymphocytes and monocytes are important because they are permissive of retroviral invasion and because they are pre-programmed to make cytokines. Presumably the increased numbers of these cells after infection has occurred would lead to increased amounts of cytokines that would dysregulate the immune system. In addition, monocytes give rise to the microglial cells which migrate to the brain and spinal cord and potentially could deposit abnormal amounts of cytokines in direct proximity to the neural elements.

Dr. Lipkin mentioned a polyclonal expansion of B-lymphocytes as important in our type of disorder and this could be a result of the increased amount of cytokines. In fact, in my patients who had a clonal T-lymphocyte expansion and/or monocytosis, 50% had autoimmune markers. What is reasonable to postulate is that we now have explained the known connection between inflammation and cancer and neurodegenerative disorders and it all goes back to the retroviruses.

I have previously shown response of my leukemia, monocytosis and clonal T-cells to AZT, raltegravir and after relapse a second response to the addition of tenofovir. I had hoped to demonstrate that a PI would be valuable treatment and waited to add this category of drug until relapse. My leukemia responded and relapsed in parallel with the monocytosis and clonal T-cell expansion but at a somewhat different rate.

The last graph shows that the clonal T-lymphocytes, CD8 lymphocytes and monocytes were increasing after relapse on AZT, raltegravir and tenofovir. Quest discontinued doing the quantitative TCRγ in 2011. As a favor to me, Quest put it up but with different reagents so that the results from the new assay are not superimposable over 2011’s. Please note that the clonal TCRγ values are a ratio rather than an absolute number of cells.

I didn’t have the new clonal T-cell assay available until later in the graph and didn’t think of looking for CD8 cells initially. After the relapse was clearly documented, I added the PI, lopinavir. The T-cell parameters and monocytes continued to trend up for the next 4-8 weeks before clearly trending down.

The only reasonable explanation for what has happened to me and what I have found in half of my cancer patients is that retroviruses participate in the pathogenesis of our illnesses. Please note that I do not claim that the retroviruses cause the illnesses but emphasize that the retroviruses participate in the pathogenesis. The likelihood is that genetic susceptibility and toxic exposure determines whether an infected person would develop disease and how it would be manifested.

It is clear to me from the data I have, that many people have susceptibility to develop disease after infection with retroviruses. It is now up to the scientists to identify the infection and the basis of genetic susceptibility. Once there are easy methods to identify who is infected and with what, treatment trials could be started. We must go forward.

Michael Snyderman, MD

 

Click figures to enlarge

 

WPI vs Mikovits: Kangaroo Court In Session

“This is a court of law, young man, not a court of justice.”
~ Oliver Wendell Holmes, Jr.

The WPI’s lawsuit against it’s former chief scientist continues to cut its swath of destruction through the heart of the ME/CFS community. Dr. Judy was forced to declare bankruptcy yesterday. She has already spent her retirement on lawyers and now she will lose one, if not both, of her two small condominiums, which one still to be determined by a bankruptcy trustee. And most importantly, she isn’t working on our behalf…

Here’s a letter posted this morning on the Messages of Support for Dr. Judy Mikovits FaceBook page (there are several such pages with hundreds of members):

Dear Judy,
It is beyond me that in this day and age this injustice is allowed. I am not a naive person but I had hoped that the 21st Century would bring a greater justice and compassion to the world.
How can these corrupt people be able to ruin, mentally, physically and personally an innocent and truly good individual?
I am deeply sad.

Me too. It is beyond crazy. A travesty of justice. A misuse of the system. The WPI, a non-profit, spent large amounts of money on lawyers to write hundreds of pages of legal documents, to destroy what was in fact their only resource. To what end? They knew there was nothing to get monetarily. An apology? What a joke. Even if they were right, which they aren’t, what would someone interested in the greater good have done when confronted with the problems that Annette Whittemore was confronted with?

In a nutshell, this is where the case stands. The first judge ruled against Dr. Mikovits in a default judgement because she wouldn’t give up her personal email which contained confidential information on many study participants. Then he recused himself to make sure there was no appearance of impropriety, since he had received significant campaign contributions from Harvey Whittemore, who is under indictment for making illegal political contributions and lying to the FBI, not to mention his other business problems: Ex-business partners: Whittemores owe more than $24M. Of course, Harvey claims to have nothing to do with the WPI. So a new judge was appointed. One would have thought that the opportunity would have been seized to right the wrong and run the case as it should have been run in the first place, but no, the judge decided to continue where the old judge left off, leaving the judgement in place, with a “prove up” hearing scheduled for today, to determine an amount, thus forcing the bankruptcy.

The WPI wants Dr. Mikovits to pay for their loss of donations compared to before she was fired. As if they didn’t cause it all with their own actions!! They didn’t have a fund raiser this year because who would be there? They want back her entire 5 years of salary, during which she was desperately trying to, and in fact did, help their daughter. Plus, they want the entire cost of the research program from inception. Oh, and the punitive multiplier for her “bad behavior” since she was fired! And they want their legal fees, so they don’t have to defraud the community and the NIH to pay their lawyers. Of course Dr. Mikovits has no money…

Meanwhile, back at the ranch, not a peep of anything worthwhile, not a paper, not even a kept up website: Research Studies and Clinical Trials. Just pleas for more money. Perhaps for the CEO’s upcoming defense? Although the piece by Casey Schwartz in the Daily Beast, How Research into Chronic Fatigue Syndrome Turned into an Ugly Fight, had the toned down feel of tight editorial control, it did state that Dr. Mikovits was fired after demanding the commercial lab, VIP Dx, stop selling an unreproducible test.

In July 2011 she told Harvey Whittemore of the potential contamination, she says, and expected that the VIP Dx lab would cease testing patients for the XMRV virus. “I just kept saying, stop it, stop it, stop it. We have to sort this out,” Mikovits says. According to Mikovits, the testing did not stop. And after a tense summer, she was fired in September.

Let’s not forget what this is really about, not some imaginary IP in some old notebooks, but the thousands of bogus tests that were sold, some after they knew they were bogus, some paid for by Medicare?

The fall out from it all? The WPI’s legacy, from an advocate of 20 years, posted to FaceBook last night and republished with permission.

My Opinion: We’ve been ized
~by John Herd

The Whittemores overly self-mesmerized
Their grandiosity so fantasized
Just because of money legitimized?
They expected to be idealized

Constructive input demonized
As sound advocates often minimalized
While many amongst us patronized
And those with differing views were ostracized

Obligations amortized
Stupid actions authorized
Moral integrity compromised
“For the sake of patients” bastardized

Sound PR strategies brutalized
With so much about WPI fictionalized
In fake news coverage televised
Fabrications on the Internet digitalized

Research assets cannibalized
Clinically unvalidated test commercialized
Protecting scientific data criminalized
While Judy Mikovits sat in jail demoralized

Judicial corruption legalized
Their lavish travel and living publicized
Questionable scientific integrity sanitized
As their research director was victimized

The whole view of CFS jeopardized
By the WPI saga being so scandalized
An insult to patients already traumatized
From misinformed views of the illness so hypothesized

All WPI’s books should be scrutinized
With all their records analyzed
If they’ve not yet been sterilized
And financial assets vaporized

From the CFS world they should be exorcised
Because they added to our being even more stigmatized
Let’s face it, we’ve been sodomized
But oh how nicely Annette is accessorized

 

Today’s song: Which Side Are You On? Performed by Natalie Merchant

And a modern version of this classic protest song by Ani Difranco

Integrity

In cancer science, many “discoveries” don’t hold up, by Sharon Begley, a disheartening story, published today. Without integrity, there can be no science. This is probably how we got sick in the first place, though in the early years, it was more likely scientists doing whatever popped into their heads willy nilly, like Victor Frankenstein, with no framework for evaluating the possible consequences. With statistics like the one presented in Ms. Begley’s report, it seems folly to expect “science” to save us now. The system is completely broken.

The same problem with integrity in reporting results extends to doctors. This problem is particularly rampant amongst LLMDs, who continue to make exorbitant amounts of money harming patients, extolling the virtues of “sophisticated” combinations of antibiotics for “seronegative Lyme”. Not that Lyme Disease isn’t real, but it can’t be eradicated in the way they are trying to do it. Problems with a generalized lack of scientific integrity aside, here is the first paper I’ve ever read that adds something to the clinical picture.

Persistence of Borrelia burgdorferi in Rhesus Macaques following Antibiotic Treatment of Disseminated Infection by Embers et al.

They infected monkeys with Bb and found that treated or untreated, the monkeys demonstrated persistence of the organism and inflammatory changes. Therefore trying to eradicate Lyme with endless courses of antibiotics is not the most sensible course of action, acknowledging the exception of a small subset who do relatively well on old fashioned acne treatment. Antibiotics are a double edged sword at best, particularly in the setting of preexisting dysbiosis.

My hat is off to these researchers for their fine study, sensible discussion and clear attempt to give physicians in practice something to work with. A marker!

In some cases, patients who have been treated for Lyme disease experience persistent symptoms. The assertion that further antibiotic treatment is warranted in these cases is a matter of contention and considerable debate [33,34,35,36]. Our results indicate that disseminated spirochetes of two different B. burgdorferi strains can persist in the primate host following high dose, or long- lasting antibiotic therapy. In terms of disease, only objective signs of disease post-therapy may be measurable in an animal model. While we did not find gross signs of disease postmortem, in Experiment 1 we did identify heart sections with inflammatory infiltrates in three of the treated animals. In addition, several animals, both treated and untreated showed sections of heart and meninges that were positive by immunofluorescence for B. burgdorferi. At the molecular level, B. burgdorferi DNA would indicate the presence of organisms, live or dead. The detection of RNA, however, should indicate that those present are metabolically active and thus alive. In Experiment 1, spirochetal DNA and RNA were detected in the tissues of a few animals, independent of treatment. This may reflect a low spirochetal burden, lack of flaB transcription [37], and/or seclusion in untested tissues.

And this:

The most pressing question in terms of human disease is whether or not spirochetes remain pathogenic after antimicrobial therapy. Similarly, do spirochetes persist long-term, or are they eventually cleared by the host? Clearly, the phenotype of persistent organisms needs to be elucidated. These studies support the use of the C6 test for diagnosis and measurement post-treatment; however, the absolute quantification of antibody levels may be essential in determining treatment efficacy for PTLDS patients, as low levels (yet above baseline) may indicate presence of residual spirochetes or antigen. Finally, the use of variable and pulse-dosing regimens of antibiotics may improve efficacy [43] and this warrants testing in an appropriate model.

That pretty much says it all I think. My daughter and I were an inappropriate model for a doctor testing various pulse-dosing regimens by trial and error on sick people, instead of monkeys. Saving a few isn’t an excuse for worsening the tenuous condition of the others, while claiming cure of a huge percentage, with no data, especially since the “treatment” takes years to evaluate. Treatment worse than the disease. Russian roulette. From my email yesterday:

I  want to very much thank you for steering me away from ILADS doctors! As I said, I went ahead and did a trial of antibiotics to “provoke” Igenex testing, just to settle the question for myself, and I ended up with acute pancreatitis (I do not drink alcohol; it was the antibiotics), and then an immune fatigued body so sick I was hospitalized twice with pneumonia after catching a flu (my husband says he was worried I was near death — I had pneumonia for six weeks).

After all this (and what would have been thousands of dollars in testing if I weren’t billed at the Medicare rate by Igenex and if the testing hadn’t been covered for me  by insurance), my labs for Lyme AND coinfections were flat negative (except for band 41 and mycoplasma). The ILADS doctor nonetheless encouraged me, based on this, to travel to another specialist and get a port, so we could provoke and continue treatment with even stronger drugs — and said I mostly certainly had “seronegative lyme” no matter what because of my symptoms of ME and tourette’s syndrome. I am glad my insurance and Medicare covered most of this. I am also lucky to not have died or had permanent effects (other than a collection of snake oil). Your words of warning were what kept me from damaging my body and taking the seductive and expensive hope.

The 5000 year old mummified corpse recently unthawed and autopsied had Lyme Disease. Iceman Autopsy. Although he was old enough to be developing atherosclerosis, he died of trauma. He had significant health problems, but at least he wasn’t infected with something created in a lab. They’ve sequenced the entire genome of a person dead 5000 years, not that that doesn’t have value, but when are they going to get around to us?

And hot off the presses from MedScape:

March 29, 2012 — The prevalence of autism spectrum disorders (ASDs) has increased by 78% since 2002, a new report from the Centers for Disease Control and Prevention (CDC) shows. However, the exact reason for this increase is unclear.

Overall, the report’s data, derived from the Autism and Developmental Disabilities Monitoring (ADDM) surveillance network, show that in 2008, 1 in 88 children aged 8 years — 1 in 54 boys and 1 in 252 girls — had an ASD diagnosis by age 8, a significant jump from the current estimate of 1 in 110.

Their conclusion? It must be because of better diagnosis, reporting and access to services! Oh that’s a relief. We can all relax now. In the meantime, our little team continues to make slow progress, with no paid help to complete an IRB approved Family Study. I don’t think Dr. Snyderman and I ever thanked everyone publicly for taking the time and energy to participate in the Informal Family Study last year. We learned a lot. The problem was the extremely labor intensive data entry, incomplete data sets, and no controls, but it made it clear that there is much to be learned. We are working slowly to bring it to reality. We are all in different parts of the country, with different primary responsibilities, but we will get it done. Stay tuned.

Much aloha.

Today’s song: Sounds of Silence by Simon and Garfunkle

Link if embedded video is not streaming well:

The Sound of Silence – Madison Square Garden, NYC – 2009