The Borrommean Property, ME/CFS and HGRV

"Borromean property: the three together are inseparable but no two are linked"

The Borrommean Property is exhibited in three entangled circles, in which, if any one is removed the other two are no longer entangled. A less complex, and less useful, way to imagine this is to think of a 3-legged stool that will fall over if one leg is removed.

To reiterate, it takes all three circles, or properties, to manifest the whole. Until the third property is added, the other two manifest nothing as an entity, although they may separately produce manifestations unique to themselves.

This property should not be confused with Torus Circles, which are another way of entangling three circles, but in which two circles remain entangled even if any one is removed.

How This Property Might Apply to ME/CFS

(and other neuroimmune diseases)

Suppose that one theoretical circle represents the class of retroviruses now being called Human Gamma Retroviruses (HGRVs), for lack of a better description. It is possible that other retroviruses, such as the spuma retrovirus, might fulfill the requisites of this circle.

Suppose that another theoretical circle represents a virus from the Herpes Viruses family, such as EBV, herpes simplex, or a half-dozen others, all of which are common infections that the healthy immune system clears, or at least keeps at bay. This family of viruses is also extremely destructive in the immune-compromised person. It is responsible for neuropathy and rare cancers in humans and animals with compromised immune systems.

Suppose that the third circle represents a much larger menu of possibilities. These might include spirochetes such as those thought to cause Lyme disease. It might include environmental toxins such as solvents, herbicides, insecticides, fungal toxins and other virus families. Stress from surgery, traumatic accidents or extremely stressful life events like war, rape or other physical brutality might be factors.

Some Possible Scenarios

1 – Suppose a person is born with an HGRV, forming circle one.

Then a herpes virus invades, subsides and then hides in the lymphatic system of those susceptible to the disease, for whatever reason, forming circle two.

Then something from the third list, say a spirochete infection or exposure to nerve-damaging herbicides such as those derived from Agent Orange (all nerve agents) occurs to link all three.

The last two insults link with the first to cause brain and CNS damage. Depending on the age of the brain and the strengths and weaknesses of the individual's constitution/genetics, several systems of the body are damaged.

Perhaps the HGRVs stop the body from repairing itself in normal time. The fact that they write themselves into human DNA near the stop-start codons might make it possible to slow down the metabolism and/or the speed of natural repairs. This would result in pain (tissues never get completely repaired) and exhaustion (mitochondrial myopathy, unrepaired tissues and disrupted metabolism). You develop classic ME/CFS.

2 - You are born with HGRV and as a baby you are exposed to viruses from list 2 and jabbed with several vaccinations that provoke an immune response. Your HGRV is stimulated to replicate fast and furiously, damaging your immature immune system and your brain. You are diagnosed with autism spectrum disorder.

3 – You have latent HGRV (from birth or from exposure during an outbreak) and latent EBV (or other herpes viruses). You are exposed to toxic mold, have surgery with an anesthetic that is inappropriate for your body or undergo extreme stress that damages your immune system further. You develop ME/CFS, GWS, MS, ALS or other neuroimmune disease.

4 – Same as number 3 but instead of toxins, surgery or stress as the third circle, you are infected with a spirochete from a tick bite. You develop treatment-resistant Lyme, which is actually neuroimmune disease.

Treatment Implications

Treating any one of these symptom-causing organisms may help the body function better and lighten the viral load. As one ME patient has said, it's like carrying around a backpack of rocks. If you treat one virus successfully, it's like tossing out one of the rocks. But lightening the load is not treating the whole disease complex. It does not remove the effect of that second circle; it simply makes it less.

Since we cannot go back in time and remove the latent viruses or remove the insult from the third circle/list, it follows that we need to focus on the first circle, the one that holds the whole entity together: HGRV.

We cannot remove HGRV from our bodies either, but treatment to stop replication and to stop attachment to cells and, possibly to lower the viral reservoirs, is the natural, logical next step in treating this disease.

Balancing the immune system would then help the patient to become more likely to fend off other insults in the future and keep latent viruses and retroviruses latent.

Borrommean Treatment Approach in Neuroimmune Disease

1 – Test for viruses such as the herpes viruses and the dozens of others that have been found at above normal rates in ME/CFS/Neuroimmune Disease. Treat with antiviral drugs. Develop strategies for patients with extreme sensitivity to drugs or their effectiveness. Starting low and raising dosage slowly might be required.

2 – Test and treat for immune abnormalities. Enhance immune function. Low Dose Naltrexone, Ampligen, Oxymatrine are possibilities.

3 - Test and treat for retroviruses. Ampligen, AZT, tenofovir and raltegravir are available now. Develop a protease inhibitor or retrieve from earlier HIV drug investigations.

Fragile patients might need to start with number 2, enhancing the immune system, before ever trying other drugs. Or they might be successful at starting with low doses and working up.

Stronger patients and those who haven't been sick for decades may be able to do all three legs of this three-legged stool at once. As in HIV/AIDS treatment, a drug “cocktail” may be just what the doctor needs to order.

All of these treatments are available now and there are hundreds of thousands of patients who would gladly become the subjects of treatment trials. The risk of injury or death from such treatments pales in comparison to the living death patients experience now.

My “Borrommean” Prayer

I pray that all the fighting factions, whether fighting from ego, greed, stubbornness and/or ignorance will have an attack of conscience, compassion and accountability and begin to think of all aspects of this disease as treatable now.

Blessings

Blessings on those who already have a well-developed conscience, compassion and a sense of accountability.

You know who you are!

This includes all those physicians who are already quietly doing this for patients who have the resources. Of course, it includes the WPI, which will open its translational medicine clinic for neuroimmune diseases on August 1, 2011, at the U of Nevada, Reno, truly an historical moment!

Borromean DNA

Nadrian Seeman has succeeded in making Borromean molecules. As part of his programme to develop techniques in nanotechnology, he makes DNA molecules with prescribed geometric or topological structures. The construction of known DNA knots and links provides useful objects on which to study the action of enzymes, topoisomerases, which change the topology (link type) of molecules. There are more details at the lab website.

100. Mao, W. Sun, N.C. Seeman, `Construction of Borromean Rings from DNA', Nature 386 (1997) pp137-138.

Are Singh and Bateman Afraid of Proof of Principle Studies? Why?

“Our findings do not support an association between CFS and MLV-related viruses including XMRV and off-label use of antiretrovirals for the treatment of CFS does not seem justified at present.^”

^{-Dr. Ila Singh et al}

^{http://jvi.asm.org/cgi/content/abstract/JVI.00693-11v1}

^{After yet another study purporting to look for HGRVs such as MLVs and XMRV in ME/CFS patients but not following the exacting protocols of the original Lombardi et al study published in Science in 2009, nor those of the Alter/Lo study, the scientific conclusions of this study were predictable. The question still unanswered: When will researchers actually replicate the original study they seek to refute? And how can they, in scientific honesty and in good conscience, keep claiming to refute the study they refuse to actually replicate?}

^{And why add the editorial and unscientific comment attempting to discourage proof of principle studies? Is it about your patent applications, Dr. Singh?  From April 7, 2011 publication of her patent application:}

Title:

COMPOSITIONS AND METHODS FOR TREATING MLV-INFECTION, AND PREVENTING AND TREATING MLV-INITIATED DISEASES

Abstract:

Compositions and methods for inhibiting infection by XMRV or other MLV are disclosed. Also disclosed are methods for treating cancers resulting from infection by XMRV or other MLV, and for preventing such cancers. The anti- XMRV/anti-MLV compounds are predominantly integrase inhibitors, such as globoidnan A, L-000870812, S/GSK1349572, S/GSK1265744, Raltegravir and Elvitegravir, and also reverse transcriptase inhibitors AZT, tenofovir, and tenofovir DF. The compounds are also useful for treating chronic fatigue syndrome or other diseases with neuroimmune symptoms resulting from an infection by XMRV or other MLV. The compositions can also include other therapeutic agents known for treating prostate cancer, breast cancer, lymphomas, and leukemias, such as anti-androgenic agents, radioisotopes, and conventional anti-cancer compounds.

^{What Is “Proof of Principle”?}

^{See my earlier post: http://biomedicalmecfs.blogspot.com/2011/01/xmrv-proof-of-principle-studies.html}

^{In short, proof of principle studies, in the case of ME/CFS, would treat a cohort of patients who have been diagnosed with the illness by competent physicians and, preferably, who have tested positive for XMRV and/or other MLVs/HGRVs, with antiretrviral drug “cocktails”, perhaps in combination with other antiviral drugs to treat some of the co-infections such as those found by Dr. Montoya at Stanford. Another possible combination might include Ampligen.}

^{Dr. Singh herself has already found that at least 3 of the ARVs considered safe enough for HIV/AIDS patients, are effective against XMRV in the lab. Is she afraid that ME/CFS patients will use this information to justify trying to save their own lives by trying those drugs? And if they come to harm, that they would blame her? That doesn't seem logical to me, but I'm trying to understand why she would come out against proof of principle trials and I can't think of any scientific reason. It has been obvious since the mid-1980s, from the brain scans of the Incline Village patients, that the disease is associated with a retrovirus and/or virus(es). Not knowing specifically which RV or virus is no excuse for not treating for them.}

^{She and her collaborators seem to have bought, or wish to promote, the establishment stereotype of ME/CFS patients as a bunch of uninformed fanatics, so desperate that they would harm themselves for no reasonable chance of improvement. Surely she is aware that any patient who tries “off-label” use of antiretroviral drugs to treat the retroviruses associated with ME/CFS are not getting these drugs without the support and assistance of their own physicians. Why accentuate the “risks”, which are acceptable for other patients with retrovirus-associated diseases such as AIDS, without acknowledging the potential benefits? The risks are well known and physicians are doing the tests and surveillance required, so they don't need to be cautioned by researchers. The cautions appended to this study create a murky atmosphere and lead to suspicions of ulterior motives by this group of researchers. At best, it only serves to support the CDC's mantra, there are no tests for ME/CFS, there are no treatments for ME/CFS. Chant three times for maximum inculcation.}

“...off-label use of antiretrovirals for the treatment of CFS does not seem justified at present.^”

^{-Dr. Ila Singh et al}

^Justified?

^{What a curious assessment and what an arrogant, giant leap of logic!}

^{Why should Dr. Singh, the Drs. Light and Bateman make this judgment for others who are equally, or better informed than they are on the subject?}

^{Does anyone actually think that Dr. Snyderman and Dr. Deckoff-Jones should have just accepted their “fate” while waiting for researchers to do the “science” in their own sweet time? See their takes on the subject on her blog: http://treatingxmrv.blogspot.com/}

^{Each of these physicians with personal knowledge of the disease, the research and the potential treatments and side effects came to the conclusion that intervention was and is “justified”. Each has experienced substantial improvement in quality of life. It may even be that Dr. Snyderman has saved his own life, or at least prolonged his survival.}

^{As a cancer researcher, Dr. Singh ought to be more cognizant than she appears to be of the association of all known retroviruses with immune dysfunction and rare cancers, which turn out to be not so rare in ME/CFS patients. This is just one of many similarities that ME/CFS shares with HIV/AIDS. Surely Dr. Singh is not so young or so uninformed that she does not know that early drug interventions were trialed in AIDS before all researchers were convinced that HIV was the cause.}

^{To tell ME/CFS patients like Dr. Snyderman and Deckoff-Jones, and all the rest of us, that we should keep experiencing disease progression, the deterioration in quality of life, the impoverishment, degradation and premature death that comes with having a debilitating illness that has not been dealt with in a scientific, ethical or pragmatic manner for so many decades is incomprehensible to me. It seems like an underhanded swipe at the translational medicine and research of those scientists and physicians at WPI and the University of Nevada, who are collaborating to save lives right now, not in some distant future when “consensus” has arrived.}

<sup>I have to wonder if she would have said the same thing to my mother when she was pressured by her doctor to trial tamoxifen, an unproven cancer drug that patients had to pay for themselves since it was deemed “experimental”. Why is it OK for AIDS patients and cancer patients to try “experimental” or “off-label” drugs when the alternatives can only offer an earlier death or further disease progression?

Why is Singh's co-author, Dr. Bateman, getting involved in the pay-for-treatment study of Ampligen which could be described, in part, as an antiretroviral drug? Who but ME/CFS patients will participate in this study? Hemispherx has said that those who test postive for XMRV have a higher success rate than those who don't.</sup>

^{The conclusions of this study might as well have been “...treatment of CFS does not seem justified at present.”}

^{The only “advancement” of science this study provided: more proof that no one will find the retroviruses WPI found unless and until they actually REPLICATE the study. Just going through the motions without actually REPLICATING the original study does nothing but waste money and, more importantly for me, time.}

^{The ethical, moral and scientific questions I pose to Dr. Singh and her collaborators are these: Why didn't you replicate the WPI study? Why do you engage in this double standard of attitude and treatment of ME/CFS patients vs. those with other diseases?}

"... cheaper than chimpanzees." Experimenting on mental patients & prisoners.

"In widely covered congressional hearings in 1973, pharmaceutical industry officials acknowledged they were using prisoners for testing because they were cheaper than chimpanzees." - AP story on Yahoo

"ATLANTA – Shocking as it may seem, U.S. government doctors once thought it was fine to experiment on disabled people and prison inmates. Such experiments included giving hepatitis to mental patients in Connecticut, squirting a pandemic flu virus up the noses of prisoners in Maryland, and injecting cancer cells into chronically ill people at a New York hospital." - Michael Stobbe

If you think the psychiatric industry's push to have ME/CFS categorized as "medically unexplained" and a "psychosomatic" illness has no meaning for you who have this neuroimmune disease or care about someone who has it, think again. Institutionalized mental patients are, for all intents and purposes, prisoners. They become prisoners of mental institutions without the due process of law that those who are accused of crimes are afforded under the law.

In some US states, psychologists and psychiatrists are advocating a change in laws that now require two doctors to sign legal papers authorizing the commitment "for observation" of those who might be "a danger to themselves or others". They want to be able to commit people on the signature of one doctor.

Imagine that you or your loved one goes to a physician who diagnoses the ME/CFS patient as depressed or as somatizing. Imagine the prescription for exercise, talk therapy, drugs. If the patient, knowing her own body and her own experience, refuses this "treatment", she could be committed to a mental institution to enforce "compliance", "for her own good". The death of Sophia Mirza is one of the results of this policy already in force in UK. The men in white coats came to her door, with her mother present and objecting, forced their way in and took her away against her will. It could happen in the US.

Mental hospitals do not have the capacity or the knowledge needed to treat a neuroimmune disease and the multisystem dysfunctions that result from it. To the person with a hammer, everything looks like a nail. ME/CFS patients committed to a mental institution can expect to be pounded into the perceived holes dreamed up for them by psychiatrists, psychologists and physicians who collude with them.

Once committed, patients no longer have the right to "refuse" treatment or even give consent to treatment. They can be, and are, injected with psychotropic drugs against their wishes. And if the psychiatric industry so declares it, the "treatment" for ME/CFS can be GET, CBT and antidepressant and antianxiety drugs. These drugs have generally proven unhelpful for those with ME/CFS. They can have side effects that are permanent. As for exercise as a "treatment", ME/CFS patients are already doing all they can physically, so urging them to increase physical activity is unnecessary and can be damaging.

And what if "resistant" mental illness "requires" ECT - electro-convulsive "therapy"? You thought that went out in the era of "One Flew Over the Cuckoo's Nest"? No, it comes back around in fashion every so often. It's the treatment of last resort in the minds of some psychiatrists, rather like sending the patients to a psychiatrist was in the first place, for the physician who couldn't correctly diagnose ME/CFS in the first place. For the ME/CFS patient already experiencing seizures, being convulsed by electricity as a "treatment" for a CNS that is already fragile could be the last shock it could not withstand.

Research by scientists and clinicians who actually treat biomedical ME/CFS, not the watered-down version invented by the CDC and the NHS in UK, but the Canadian Consensus definition of CFS, has shown that exercise and talk therapy are no more "treatments" for this neuroimmune disease than they would be for other diseases, such as HIV/AIDS, polio, MS, malaria or hepatitis C.

Of course, any sufferer of debilitating disease might benefit from counseling on how to cope, but coping strategies are not treatments for the disease itself.  Any researcher or clinician who acquiesces to this emotional and intellectual manipulation is colluding with the school of propaganda that seeks to inculcate the disinformation that "illness beliefs", present stress from previous childhood abuse, or any other thoughts cause or sustain this disease.

If you don't apply this standard to other neuroimmune diseases, you can't apply it to ME/CFS. Period.

The race is on. Will biomedical researchers be able to prove, create and market a reliable test for the biomarkers already found for ME/CFS before the psychiatric cabal can change the involuntary commitment law and the DSM to suit themselves?

This is why it is such a big deal when the likes of Kim McCleary, Suzanne Vernon and CJ do and say things that chip away at the real biomedical research and those researchers. Delaying and sabotaging biomedical research give the psychiatric lobby, supported by the disability insurance lobby, time to get their plans into place.

For a glimpse into how disability insurers such as Unum operate, read the case of a man disabled with CFS and how many years of harassment, appeals and fighting it took for him to win. Read the judge's list of 13 illegal tactics several insurers and reinsurers regularly use to avoid paying legitimate disability claims. Mr. Merrick was a millionaire and had the means to fight and to survive the fight, unlike the vast majority of those who have already been impoverished by the disease before they try to get disability benefits.

It would shortcut the process a great deal to just have those with ME/CFS labeled as mentally ill, to prescribe GET, CBT and cheap drugs and to then put them away if they don't or can't comply.

Sophia Mirza.....it could happen here. And Kim McCleary regrets that CBT and GET are "not available treatments" in the US, no thanks to her and her cronies.

My Letter to the SEP: Dr McClure's Appointment Is Inappropriate

Subtitle: Sending the Fox to Guard the Hen House.

I sent this letter:

To:

kathleen.sebelius@hhs.gov,francis.collins@nih.gov,dennis.mangan@nih.gov,toni.scarpa@nih.gov,hoshawb@csr.nih.gov,AskDrH@ostp.gov

Cc:

m.mcclure@imperial.ac.uk

I will post any responses I get.

******************************** 

 

My fellow Americans, Myra McClure, Ph.D. has been appointed to membership on the Center For Scientific Review, Special Emphasis Panel, ZRG1 CFSH80 2/22/2011-2/23/2011 meeting. This appointment is inappropriate for the following reasons: 　 1 - From the NIH Scientific Center For Review: How Scientists are Selected for Study Section Service : "Fairness and objectivity are the most important criteria for a reviewer." Dr. McClure, of UK, has demonstrated that she is neither fair nor objective when it comes to research on the neuroimmune disease "CFS", better known as ME/CFS.   She has personally denigrated the discoverers of XMRV, a novel retrovirus recently found in ME/CFS patients and she has declared she is "1000% sure there is no XMRV in UK". Other researchers have found it in abundance all over UK & Europe.   After she was criticized for poor specimen selection, poor cohort selection and poor laboratory procedures, she declared "I wash my hands of any further CFS research." And: "Nothing on God’s Earth could persuade me to do more research on CFS." 2 - She received her 14 year old lab specimens, in the one XMRV/CFS study she did, from a UK psychiatrist who has made a career out of promoting his idea that "CFS" is a mental disorder. Using pretzel-logic, he distorts every biomedical finding in this area of research into an "illness belief". 3 - She has since toured the world in a speaking campaign promoting the unsupported contention that all CFS reseach into XMRV, and the related MLVs that Drs. Alter & Lo of NIH/FDA and Dr. Komaroff of Harvard found in CFS patients, (concluding that their work supports the findings of the original work at WPI) - that all this work is merely "lab contamination". The WPI researchers are former NCI researchers with decades of experience in HIV and cancer research and are therefore knowledgable about lab contamination possibilities, so it is clear that this in nothing more than a "marketing" approach to squelch more research into the viral and retroviral cause(s) of ME/CFS. I contend that it is the mission of Dr. McClure to see to it that there is no more research into the viral/retroviral cause(s) of ME/CFS. More specifically, she will vote against funding any research by WPI and anyone else who wishes to research viral causes in CFS, unless they have her agenda - to disprove viral involvement. Background information: The Department of Works and Pensions in UK (equivalent to the SSA in the US) is under the influence of the giant disability insurance company, Unum (also called UnumProvident), the biggest seller of disability insurance in the US and the UK. This insurance company has a history of malfeasance in the denial of insureds' disability claims. Since about 2007, it has been advising DWP in UK on how to deny disability claims most effectively. It has targeted such diseases as ME/CFS, fibromyalgia, Gulf War Syndrome and MCS for claims denial. It has a "five year plan", ending in 2012, to "re-educate" those doctors who find in favor of the disabled, in UK.To that end, NHS has suspended or harassed doctors who treat ME/CFS biomedically. There, the National Health Services deny patients with CFS any biomedical testing or treatments, in favor of counceling and drugs for "mental health". In the US, Unum has an ongoing campaign to harass doctors who see and treat CFS patients so that doctors will drop those patients. See the judge's comments in this 2008 case of a CFS patient denied and harassed by Unum: http://scholar.google.com/scholar_case?case=3736254457285322723&hl=en&as_sdt=2&as_vis=1&oi=scholar The psychiatrist Dr. McClure got her "CFS" specimens from is deeply involved with the Unum effort and she has been unduly influenced by him. Together, they have their minds made up not to ever acknowledge the biomedical basis of ME/CFS and to deny funding of any research that would move the science forward. Again, I say, Dr. McClure is incapable of being either fair or objective when it comes to voting on ME/CFS research. I would also like to say, as an aside, that there are too many psychologists and dentists on this panel, as well. It appears to be stacked against funding any research that is actually relevant to the biomedical disease processes in ME/CFS. This idea is born out by the history of NOT funding the many biomedical studies that have passed through this panel's process and have NOT been funded. It's past time that that attitude is changed. Appointing professionals with better qualifications in virology, retrovirology and neuroimmune diseases would a step in the right direction. There are many American scientists who would be a better choice. Sincerely,

********************************************

Response from Sebelius:

Thank you for your email

 

While we will respond to the specific issues you raise as soon as we can, I wanted to let you know that your message has been received and that I appreciate your taking the time to write.

The mission of the Department of Health and Human Services (HHS) is to protect the nation’s health and provide essential human services, and, as part of that mission, we are at the forefront of the federal government’s efforts to address a wide range of critical issues and challenges.  I wanted to take this opportunity to update you on our work.

First, on March 23, after more than a year of extensive debate, the President signed into law health reform legislation that brings down health care costs for American families and small businesses, expands coverage to millions of Americans and ends the worst practices of insurance companies. As a result of the new law, Americans will begin to see significant benefits take effect this year, with other important reforms following shortly after.  In the weeks, months, and years ahead, our department will be responsible for implementing many of these reforms.  You can be assured that we are firmly committed to explaining these changes to the American people clearly, and to enacting them carefully and effectively.  For information about the new law, I would encourage you to visit www.healthcare.gov.

Meanwhile, thanks to the American Recovery and Reinvestment Act, we’ve made hundreds of millions of dollars available as part of a comprehensive prevention and wellness initiative, Communities Putting Prevention to Work.  This new initiative supports local efforts to reduce obesity, increase physical activity, improve nutrition, and decrease smoking – the four most important things we can to do to fight chronic diseases and improve public health.  And it’s right in line with the First Lady’s “Let’s Move” campaign, which calls on Americans to work together to solve childhood obesity in a generation.  You can learn more about these and other Recovery Act initiatives at www.hhs.gov/recovery.

In addition, it is a core responsibility of HHS, through the Food and Drug Administration (FDA), to ensure the food we eat is safe.  Toward that end, I am firmly committed to working with my colleagues at the Department of Agriculture to achieve the President’s goal of upgrading and strengthening our food safety system; restoring trust in the FDA as the leading science-based regulatory agency in the world; and fulfilling our obligation to the American people to ensure that the food they purchase and serve to their families is safe to eat.  For more information, please visit www.foodsafety.gov.

Finally, HHS plays a vital role in getting our children ready to learn and thrive in school, helping low-income working families struggling to make ends meet in this difficult economy, and meeting the basic needs of vulnerable populations, such as abused and neglected children, refugees, and individuals with disabilities.  As the Administration works to turn around our economy, we recognize that the economic downturn has had its greatest impact on the most vulnerable among us – low-income families with children.  Through child care, child support, energy assistance, and other efforts, the Department helps low-income parents and their communities weather this economic storm.  We will continue to work hard to improve these programs through evidence-based approaches that make a difference for these families and children.

Again, thank you for writing. [END]

*******************************

Perhaps we need to begin each communication with HHS/NIH, et al, with the statement that we are among the "vulnerable populations" of "individuals with disabilities", since it Ms. Sebelius's statement that they are "working hard" to improve those programs through "evidence-based" approaches.

Open Letter to Dr. Elizabeth Unger, new Chief of Chronic Viral Diseases Branch

January 21, 2011

Dr. Elizabeth Unger

Chief of Chronic Viral Diseases Branch

National Center for Emerging and Zoonotic Infectious Diseases

Division of High Consequence Pathogens and Pathology

Centers for Disease Control and Prevention

Dear Dr. Unger,

Congratulations on your appointment to your new position. I wish you great success. Your future performance in this position will have a huge effect on my future and the futures of millions of Americans and others around the planet.

The only way I could see your future performance as a success would be if you will take the Chronic and Viral Diseases Branch of the National Centers for Emerging and Zoonotic Infectious Diseases in the direction of research into the viral cause(s) of the infectious neuroimmune disease called myalgic encephalomyelitis by the World Health Organization and trivialized by the CDC by calling it “chronic fatigue syndrome” for the last 20 years.

The NIH symbolically extended its middle finger into the faces of “CFS” patients when it moved “CFS” research to the Office of Women's Health, which has no labs, no recognition and no power to do anything positive about this disease. After 8 years of making recommendations to the Secretary of Health, virtually none of those recommendations have been acted upon and for many years, those suggestions have not even been acknowledged. This disease disables children, men and women.

You have it in your power to change the direction of “CFS” research, away from the marketing and public relations attempt to morph it into a form of mental illness – a direction it should never have been forced into by your predecessors. You can get this research, and the taxpayers' investment, back on target, or you can continue the bad faith pseudo-research of those who preceded you. This pseudo-research has benefited only the disability insurance industry - because it enables them to deny disability payments to patients - and the psychiatrists who have captured the field in lieu of any biomedical treatments being sanctioned by CDC.

From the time of the 1984 epidemic outbreak of this disease in Incline Village NV, where the attending physicians had brain scans showing punctate lesions similar to patients with that other infamous, retrovirally caused disease – HIV/AIDS - through the ensuing 27 years, researchers have continued to pile up the evidence that this is a disease caused by one or more viruses. Hundreds of physicians and their patients have noticed for decades that this illness has many of the same symptoms and signs of other viral diseases, such as influenza, chronic Epstein-Barr, and HIV/AIDS.

Yet the CDC called it “mass hysteria” in the 1980's. That was nonsense then and it's still nonsense.

Dr. Harvey Alter of NIH has said recently, if “CFS” is not caused by the retrovirus XMRV and/or related MLVs, it is still obviously a serious biomedical disease with a viral cause and we need to do the research to find out which virus(es) are responsible.

You, Dr. Unger, have the chance to stand on the shoulders of giants like Drs. Alter, Lo and Komaroff, or to sink back into the 19^th Century's misogyny and misdiagnosis that views this disease as a mental illness. I fervently hope you will do right by American taxpayers, persons who have ME/CFS and those who care about them.

Sincerely,

Lilly Cooper – American citizen with ME/”CFS” for 29 years

********************************************************************************************

eunger@cdc.gov (Elizabeth Unger)bzb8@cdc.gov (Beth Bell)
txf2@cdc.gov (Tom Frieden)
kathleen.sebelius@hhs.gov
dennis.mangan@nih.gov
francis.collins@nih.gov
anthony.fauci@nih.gov

UNUM Is Still Doing It To the Disabled

UNUMProvident is the gigantic disability insurance company that operates in both the US and the UK.

In UK it advises the Work and Pensions department, a loose equivalent of the US Social Security Administration, on how to “limit liability” - a euphemism for “deny claims”.

According to ConsumerAffairs website on Nov. 13, 2002 UNUMProvident had 30% of the market for disability insurance, making it the largest provider in the US.

It has been rated as the second worst insurance company in the US. A survey of its policy holders found that 45% were either very dissatisfied (36%) or dissatisfied; 45% were “somewhat” (?) satisfied; 0% were very satisfied and 9% were satisfied. The 45% who were “somewhat” satisfied seem to be damning with faint praise. If you add them to the 45% who were dissatisfied you get 90% who were either neutral or negative vs the 9% who were either satisfied or very satisfied.

The above referenced rating included insurance companies that don't offer disability insurance, such as Allstate, the company that ranked worst. I speculate that if car and home owner insurance customers were eliminated from the survey, UNUMProvident would rank as the worst disability insurance provider.

In the last 8 years UNUMProvident has cleaned up its image but has it cleaned up its act?

In 2002 a class-action lawsuit was brought against them in NY. It alleged that UNUM was a “disability denial factory”. Documents provided by former employees disclosed that UNUM gave out a “Vulture Award” for the most claims denied. The lawsuit also alleged that the company used non-medical personnel to decide which claims to deny and then used its 100 on-staff doctors to create a paper trail to justify the decision.

It also came to light that prior to settling with insurance regulators in several states, they offered loans to their claims adjusters and then allowed them to pay off the loans with credits for money saved by denying claims. This ranks right up there with pimps getting hookers addicted to drugs and then controlling them by supplying the drugs, or Mafiosos loaning money and then coercing the borrower into their illegal activities in order to repay them.

Particularly fascinating, since in UK Works and Pensions has decreed that the neuroimmune disease ME/CFS is mental and not biological, is the case of the eye surgeon who developed a “phobia that caused his hands to shake” and couldn't do surgery anymore.

Dr. Randall Chapman had paid premiums for long term disability (LTD). UNUMProvident paid his claim for 3 months and then denied it, saying their doctors disagreed with that diagnosis.

A California jury awarded Dr. Chapman $31.7 million in damages in 2003. In Florida, Dr. John Tedesco, an ophthalmologist who developed Parkinson's disease won $36.7 million in federal court. UNUM then appealed and the cases were settled out of court for undisclosed amounts.

If this had happened in UK, would UNUM have offered these doctors GET (Guided Exercise Therapy), CBT (Cognitive Behavioural Therapy) and antidepressants for six months and told them to go back to work?

In 2007 the BBC aired at least two reports on UNUM and the job it was doing at Works and Pensions, calling it a “rogue” company. I viewed those reports on YouTube. They can no longer be found on YouTube, nor can they be found by searching the BBC website. It's as if they never existed, but there are references to those broadcasts all over the web, so I know my memory is not playing tricks on me. One of them on YouTube now has an announcement that the up loader has “closed their YouTube account”.

CBS's 60 Minutes program with Ed Bradley reported on UNUM in 2002. Read the transcript for chilling conversations with former employees, including doctors, who say they were pressured to meet monthly income goals by denying claims. One doctor was fired for not complying. California's insurance commissioner called UNUM an “outlaw company”.

See this 2009 article “Denying Disability May Be Just One of UNUM's Profitability Tricks” for one legal firm's take on UNUM as an investment risk. It ends with “...it probably wouldn’t be a bad idea for Unum to bank on honesty instead of smoke and mirrors for a change.” - referring to UNUM's investor relations.

Speaking of investors, I wish someone would ask Simon Wessely and the other ME/CFS denialists in UK whether they, their spouses, children or any other relatives own stock in UNUMProvident. Could this be why Myra McClure is "1000% sure" there is no XMRV in UK? Could this be why Wessely told the BMJ Podcast "The cause of CFS onset is irrelevant to management of the condition", and he would not treat viruses in CFS patients even if detected, because he is "in the business of rehabilitation". Commenting on a study that stated XMRV virus was found in two thirds of CFS patients, Wessely said this research "fails to model the role childhood abuse, psychological factors, and other infections may play in the illness".

Policyholders past and present allege that UNUMProvident claims to lose crucial documents from their doctors, their Congressional representatives and themselves. UNUM then denies claims, saying they didn't get the documents in the proper time frame or they didn't get them at all.

UNUM's strategy seems to be that losing in court is just a cost of doing business. It's like a license to steal from all those premium-paying, deniable little people in order to pay the disabled doctors and lawyers who can afford to take them to court, plus rewarding UNUM investors, and their CEO.

In 2009 UNUM's CEO Thomas Watjen received $8.79 million in compensation. Perhaps he deserves the biggest Vulture Award of all.

XMRV Deja Vu: Dr. Bell's Appeal to Fund WPI Is Still Pertinent, 8 Months Later

McHumor Cartoons

On May 1st, 2010, Dr. David Bell issued a call to patients and those who care about them to donate to WPI. His assessment of the situation was right on target then and it still is.

WPI's youtube videos: one has Dr. Deckoff-Jones speaking
                                                                              

David S. Bell MD, FAAP
Lyndonville, NY 14098

May 1, 2010

To my friends with ME/CFS,

I would like to put out a personal appeal for funds to be sent to the Whittemore Peterson
Institute (WPI) in order to speed up the progress of the current research. Here is my reading of a
very complex situation.

Medical authorities, educational institutions, governmental agencies, and most practicing
physicians have disrespected and minimized CFS in just about every way possible, from creating
an insulting name for the illness to advising extreme caution in treatment, except cognitive
behavioral treatments.

It is easy to dismiss my remarks to follow by saying that I am biased. And it is true, I am
very biased and for twenty five years I have quietly sat on the sidelines believing that science
will win out and true progress will be made. I am beginning to think this has been a great
mistake. The profession I love has failed miserably.

In 1985 an outbreak of CFS hit Lyndonville NY and affected 210 persons, 60 of whom
were children. The official response from the CDC and the New York Health Department was
that this was mass hysteria. No one talked with a single patient. In 1990 I worked with Dr. Elaine
DeFreitas and Dr. Paul Cheney and a retrovirus was found and the material published(1). A
second paper had been accepted by PNAS and contained a photograph of C-type retroviral
particles from a tissue culture of spinal fluid of one of the children in the Lyndonville outbreak.
This paper was suddenly pulled and not published after a couple of flawed negative papers. A
complete description of these troubled times is in Osler'sWeb by Hillary Johnson. The funding for
our studies was pulled and all work on this abruptly stopped.

I think the same tactics are being employed to hamper the current work on XMRV by the
WPI. The WPI is a private organization and, as I understand it, no federal grants or funding has
been forthcoming. There have been three negative PCR-only studies which have established only
that CFS can not to be superficially studied. At this time no study that has attempted to replicate
the WPI study has been heard from. Many CFS research organizations have declared publicly
that "XMRV is a dead issue."

Nothing is farther from the truth. I cannot predict the future, but my fear is that the
current political and scientific organizations who do not want to see retroviral involvement will
attempt to stifle studies on XMRV in CFS. Huge amounts of money are spent on studies on
cognitive therapy, and studies proving that CFS is heterogeneous (you can argue that polio is
heterogeneous).

We have not heard from the CDC, other than the inappropriate comment that this was not
likely to turn out to be anything, made right after the Science paper publication in October 2009.
We are now eight months later and not a peep. Maybe they are finding XMRV and want to be
very careful. Maybe they haven’t looked and are assuming that this heretical idea will blow
away. Eight months?

And the Band Played On.

It is possible that thirty other labs are finding XMRV in CFS or that no one else in the
world is even looking for it. Science requires that labs do not disclose their findings prior to
publication and I agree with this rule. But is the WPI going to be isolated by the scientific
community and wither away because of lack of funding? Is XMRV going to become more of the
compost of CFS research?

But there is an alternative. We cannot wait ten years for science to grind outs its
conclusions. Every person in the world who believes that CFS is important should send $10 to
the WPI. I plan to send $10 today. It may not be much, but it is a start. There may be 10 million
persons in the world with CFS. Lets see, that’s…I need a calculator. May 12 is our day. Lets do
this.

After 25 years of work in this field I do not have much. But I have my integrity. I feel
that WPI has made an important discovery and I feel they are an ethical organization, they are
not padding their pockets. But I also have my fears. And the greatest fear of all is that their
discovery may not be appropriately followed up.

For the 9,999,999 other people out there who think CFS is both real and important, send
$10 to: Whittemore Peterson Institute, 6600 N. Wingfield Parkway, Sparks, NV 89436.

Thank you.
David S. Bell MD, FAAP

1. DeFreitas E, Hilliard B, Cheney P, Bell D, Kiggundu E, Sankey D, et al. Retroviral sequences
related to T-­‐lymphotropic virus type II in patients with chronic fatigue immune dysfunction syndrome.
Proc Natl Acad Sci. 1991;88:2922-6.

                                                                     

XMRV Proof of Principle Studies = Clinical Trials Now

Are ME/CFS patients first and foremost lab animals or patients?

Apparently, it depends on your point of view.

With the news that XMRV, a newly discovered retrovirus may contribute to or be the cause of chronic fatigue syndrome, or myalgic encephalomyelitis, as it is called by the World Health Organization, some patients, doctors and researchers called for clinical trials of the drugs already developed for HIV/AIDS.

Courgnaud et al, Department of Medicine, University of Alberta, Edmonton, AB, Canada wrote, in a commentary on the Alter/Lo paper in PNAS:

"As we currently lack postulates to prove a causal association with a prevalent agent and a chronic disease with genetic predisposition, it would also be appropriate to conduct interventional studies. Indeed, the Helicobacter pylori hypothesis of peptic ulcer disease was only accepted after Barry Marshall showed that bacterial eradication with antibiotics cured peptic ulcer disease (21). Studies to gain proof of principle have been performed with antivirals in other chronic, idiopathic diseases linked to retroviral infection, such as primary biliary cirrhosis associated with mouse mammary tumor virus, another possible murine zoonosis (22). Trials using a combination of reverse transcriptase inhibitors led to significant improvements in clinical, histological, and biochemical outcomes in these patients, albeit with some evidence of viral resistance to therapy (23). Such studies are now feasible for CFS, because reverse-transcriptase inhibitors, such as
tenofovir and emtracitabine, and the integrase inhibitor raltegravir can inhibit XMRV (24). The caveats for conducting clinical trials in patients with CFS and MLV infection are that the potential benefits of treatment should outweigh the risks; also, studies should be conducted as randomized controlled trials with meaningful and feasible endpoints using robust therapies. At this juncture, studies to establish proof of principle are justified to determine whether safe antiviral regimens can impact on CFS and to determine whether xenotropic or polytropic MLV is causally associated with this debilitating disease."

On the other side of the argument Mary Kearney and Frank Maldarelli, HIV Drug Resistance Program, National Cancer Institute, National Institutes of Health, Bethesda, Maryland declared that :

“Such pressures are not justification for testing of therapies in an uncontrolled manner. Indeed, because they are of no help whatsoever to other patients, physicians, pharmaceutical companies, or regulatory agencies, such uncontrolled therapy works directly against the goal of providing effective therapy to the million or more individuals experiencing these serious conditions.”

OK, so some researchers, pharmaceutical companies and regulatory agencies have decided to wait and see. To them , the one million or more people who have CFS are to be the source of lab samples to be tested. Some researchers have predicted it will be at least ten years before treatment could become available. Others are still contesting whether XMRV is the cause of disease, or whether it is even a human pathogen.

In the meantime, physicians who have been trying to help CFS patients for decades look at this research and ask themselves and their patients, what have we got to lose?

Dr. Ila Singh has already found that three drugs developed for HIV/AIDS treatment are also effective in the lab against XMRV and the related MLVs that further research has found in CFS patients.

Physicians have been prescribing drugs “off label”, or for conditions the drug wasn’t developed or approved for, since forever.

When selecting a drug to prescribe for any ailment the physician never knows whether it will work for her/his patient until the patient tries it.

It wouldn’t be the first time a disease was proven to exist by its response to treatment. Barry Marshall, PhD, proved peptic ulcers were caused by bacteria, not stress, by infecting himself with that bacteria and then curing himself with antibiotics. He got a Nobel Prize in Medicine for it.

Physicians are ethically obligated to do the best they can for the individual before them. They tend to see patients as people who need treatment rather than potential contributors of lab samples. If they and the patient, after assessing the risks of the treatment and the risks of doing nothing, decide to try antiretroviral drugs, there is nothing unethical or zealous about it. They can do the same monitoring for these patients that they would do if the patient were HIV positive instead of XMRV positive. They can discontinue therapy if there are warning signals indicating they should.

A physician’s first responsibility is to the patient, not to research, regulatory agencies or pharmaceutical companies. To withhold reasonable treatment in an attempt to advance science would be unethical.

Haven't both medicine and research progressed past the "Tuskegee Mentality"?

From 1932 to 1972, when public outcry stopped the program, patients infected with syphilis were "observed" but not treated by the US Public Health Service in Tuskegee AL. At some point the CDC was created and took over the study.

From the CDC's account of the experiment:

[1969 CDC reaffirms need for study and gains local medical societies' support (AMA and NMA chapters officially support continuation of study).


1972 First news articles condemn studies.


1972 Study ends.


1973 Congress holds hearings and a class-action lawsuit is filed on behalf of the study participants.


1974 A $10 million out-of-court settlement is reached and the U.S. government promised to give lifetime medical benefits and burial services to all living participants. The Tuskegee Health Benefit Program (THBP) was established to provide these services.]

In 1947 penicillin was found to effectively treat syphilis, but it was not offered to the men in the study. Reminiscent of Nazi medical experiments, it was decided to observe the men until they died, do autopsies on them and pay for their burial.

From 1946-48 the US did the same thing in Guatemala except that it purposefully infected prisoners and mental patients with syphilis.

It bears repeating: A physician’s first responsibility is to the patient, not to research, regulatory agencies or pharmaceutical companies. To withhold reasonable treatment in an attempt to advance science, however misguided that attempt might be or however highly approved it might be by other researchers, would be unethical.

Prisoners and mental patients may lose their civil rights but they never lose their human rights, even as those rights are being abused. Persons with ME/CFS have long had their human rights abused and arguably, their civil rights as well. But more about that in another post.

Two Physicians Try Antiretroviral Drugs For ME/CFS

ME/CFS is a crippling neuroimmune disease that has ruined the lives of at least a million Americans.

After 20 years of searching for treatment, the parents of Andrea Whittemore, who has had it since she was 12, funded research into the illness. They started WPI, the Whittemore Peterson Institute.

This resulted in the finding in 2009 of a new retrovirus, tentatively named XMRV, in most ME/CFS patients. In 2010 virologists at the FDA, NIH and Harvard published a study supporting the 2009 findings of WPI.

Subsequently, Dr. Ila Singh researched whether any of the drugs developed for the well known retrovirus, HIV, might be effective against the new virus. She found 3 FDA approved drugs that were effective against XMRV in the lab: AZT, Viread and Insentress.

Patients and the doctors who treat them have suspected a virus or retrovirus was the culprit, all or in part, since AIDS-like lesions were found in brains scans of ME/CFS patients in the 1980’s. The relapsing-remitting pattern of the illness also mimics viral illnesses such as malaria or herpes. The profound, disabling exhaustion is reminiscent of infection with Epstein Barr virus. The flu-like symptoms many experienced at onset also infer a viral infection.

Not surprisingly, doctors may also get this disease.

Two who did get it, Dr. Jamie Deckoff-Jones and Dr. Michael Snyderman, in consultation with their own physicians, decided to try the treatments found by Dr. Singh to be effective against XMRV in the lab.

Dr. Snyderman is an oncologist, a cancer specialist, who himself developed a rare cancer that is not that uncommon in CFS patients. He started treatment with AZT and Isentress at HIV doses. He reported that he felt 25% better after 3 weeks. In the 6th month of treatment he added Viread, also at the HIV dosage. At a medical conference he presented a poster detailing his tests, treatment and outcome.

Thanks to Mindy Ketei at http://www.cfscentral.com/2010/10/dr-michael-snydermans-md-anderson.html for that link.

His poster indicates that he no longer tests positive for the XMRV retrovirus and the markers for his cancer have been reduced.

Dr. Deckoff-James was an emergency room surgeon before she became too disabled to work. Last March she began treatment with AZT and soon added Isentress. She and her daughter, who is also disabled with ME/CFS, have blogged about their experiences with the treatment. They added Viread in May. They have shared their ups and downs with their blog readers through the months of overall improvement.

Dr. Deckoff-Jones has said she has improved from approximately 50% functioning to about 80% in the 9 months they have been on these ARV drugs. This has allowed her to go back to work part time. She will be working with Dr. Judy Mikovits, one of the discoverers of XMRV, on a project to educate physicians on how to treat ME/CFS patients who have tested positive for the retrovirus.

Dr. Deckoff-Jones recently overdid it and experienced a "crash" - post-exertional malaise (PEM). She also regrets ever trying to calculate her progress using the KPS (Karnofsky Performance Scale) to estimate her level of functioning. Like many others with CFS, she has found it doesn't do justice to the differences between physical functioning and mental functioning. Many of the details simply do not correlate well to the kind of disabilities CFS patients experience.

Dr. Mikovits is scheduled to report on similar ARV drug treatments by other physicians on January 17, 2011. In a sneak peak at some information that will be shared in Santa Rosa CA on that date. Dr. Timothy Luckett, blogging about ME/CFS, says that "all CFS patients showed remarkable improvements after receiving antiretrovirals - the group that received Viread and Isentress faired out best."

Unfortunately for most ME/CFS patients, these drugs are too expensive. The CDC has declared all tests and treatments for CFS to be "experimental". That means that no insurance program, including Medicare, will pay for them. At a cost of $1200-1500/month plus the costs of seeing a physician who will prescribe them and the monitoring that must be done while taking them, this treatment is out of reach of most ME/CFS patients.

Cartoons by T. McCracken