Alter, Lo and Gill Live Webcast, February 22, 3pm CST: CFS: Is There a Virus?

Demystifying Medicine - Chronic Fatigue Syndrome: Is there a virus?

The NIH is airing a live webcast and the event can be viewed live at: http://videocast.nih.gov/

Air date:           Tuesday, February 22, 2011, 4:00:00 PM EST

Description:     This event will include the presentation of patients, pathology, diagnosis and therapy context of major disease problems and current research. The course is designed to help bridge the gap between advances in biology and their application to major human diseases. Each session includes clinical and basic science components presented by NIH staff and invitees. These seminar series are primarily directed toward PhD students, clinicians and program managers. All students, fellows and staff are welcome, as well.

For more information, visit http://www1.od.nih.gov/oir/DemystifyingMed

Author:            Shyh-Ching Lo (FDA), Fred Gill (NIDDK) and Harvey Alter (NIDDK)
Runtime:         120 minutes

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

Maybe this time we can get the straight talk without the interference and insinuations of smoke screeners and denialists like Dr. Stoye and others of his ilk we suffered at the Blood Products production.

Still no new info on this as of 2/15/2011.

Here's the NIH profile of Dr. Gill:

Biosketch
After receiving his medical degree from Northwestern University Medical School, Dr. Gill trained in internal medicine as an intern and resident at New York University-Bellevue Hospital followed by research training as a research associate of the National Institute of Allergy and Infectious Diseases (NIAID). He completed his clinical training as a medical resident and infectious disease fellow at Cornell-New York Hospital. Dr. Gill is an elected fellow of the American College of Physicians and the Infectious Diseases Society of America.
 

After many years of private practice in Bethesda, Maryland, Dr. Gill initiated the Internal Medicine Consultation Service for the Clinical Center in 1998. His practice in the Bethesda community combined primary care in internal medicine and consultation in infectious diseases. He served as chief of the Division of Infectious Diseases, Rheumatology and Allergy and chair of the Infection Control Committee at Suburban Hospital and as attending physician on the Consultant Service of NIAID’s Laboratory of Clinical Investigation. During this time, he participated as a co-investigator on research projects in the NIAID, the CC Clinical Pathology Department (now the Department of Laboratory Medicine), and the National Cancer Institute.

Dr. Gill led the development of the AIDS clinic for the Montgomery County Health Department and has chaired the AIDS Committee of the Medical and Chirugical Faculty of Maryland. He has served on many committees, including the Maryland Governor’s Advisory Council on AIDS, NIAID’s Advisory Council for Lyme Disease and Suburban Hospital’s Board of Trustees.

At NIH, besides heading the internal medicine consult service, Dr. Gill is chair of the CC Ethics Committee, principal coordinator for clinical education for the NIH Clinical Research Training Program, and an attending physician for NIAID’s Infectious Disease Consultation Clinic. He is a co-investigator on protocols of the National Human Genome Research Institute, National Eye Institute and NIAID. and served as the medical monitor for a National Human Genome Research Institute study. He is a member of data and safety monitoring boards for other institutes and of several CC and NIH committees.

And Dr Alter:

Biosketch
Dr. Harvey Alter earned his medical degree at the University of Rochester Medical School, and trained in internal medicine at Strong Memorial Hospital and at the University Hospitals of Seattle. In 1961, he came to the National Institutes of Health as a clinical associate. He then spent several years with Georgetown University, returning to NIH in 1969 to join the Clinical Center's Department of Transfusion Medicine as a senior investigator becoming Chief of the Clinical Studies and Associate Director of Research in the Department of Transfusion Medicine at the NIH Clinical Center.

Dr. Alter is also a clinical professor at Georgetown University.

Dr. Alter co-discovered the Australia antigen, a key to detecting hepatitis B virus. Later, Dr. Alter spearheaded a project at the Clinical Center that created a storehouse of blood samples used to uncover the causes and reduce the risk of transfusion-associated hepatitis. He was principal investigator on studies that identified non-A, non-B hepatitis, now called hepatitis C. His work was instrumental in providing the scientific basis for instituting blood donor screening programs that have decreased the incidence of transfusion-transmitted hepatitis to near zero.


In 2000, Dr. Alter was awarded the prestigious Clinical Lasker Award and in 2002, he became the first Clinical Center scientist elected to the National Academy of Sciences (NAS) and in that same year was elected to the Institute of Medicine. Only a small number of scientists nationally are elected to both these scientific societies.

FDA Assigns CFS Treatments to DPARP

DPARP stands for Division of Pulmonary, Allergy, and Rheumatology Products.

The first question that comes to mind: What do lung problems, allergies and rheumatology have to do with viral myalgic encephalomyelitis, morphed into chronic fatigue syndrome by the CDC, with NIH complicity? 

I have emailed them to inquire whether treatments for HIV/AIDS are also reviewed by DPARP, and if not, why not. I also asked whether antiretroviral drugs being used to treat XMRV and MLVs, and the drug Ampligen, will be reviewed by this division.


The announcement: (notice that the headline says "drugs" but the body of the article says "products".)

Assignment of Drugs Developed to Treat Chronic Fatigue Syndrome (CFS)

"The Office of New Drugs (OND) recently announced a jurisdiction decision for products to treat chronic fatigue syndrome (CFS).

Applications for products being developed to treat chronic fatigue syndrome had previously been assigned to at least six different review divisions within OND. Across these applications, a variety of different endpoints have been evaluated in assessing products for CFS. More recently there has been interest in the development of endpoints such as instruments that rely upon patient reported outcomes. Developing such tools may help facilitate development of new products to treat patients with CFS and allow for a better means for assessment of the benefits such products provide to patients.
The search for an underlying etiology or etiologies for CFS continues. Further research to understand the underlying etiology of CFS and the pathophysiology of the condition may also help in the development of new products.

In order to work effectively with internal and external stakeholders on developing clinical trial endpoints (e.g., PRO instruments designed for assessing patient symptoms and response in CFS) and clinical trial designs, OND leadership have agreed to assign all CFS applications to a single OND review division, the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP). This will allow for a coordinated and consistent process for review of products being developed for the treatment of CFS. In addition, consolidation to one division should allow for efficient and effective review, development of expertise within this area, and provide a single point of contact for CFS applications for stakeholders external to FDA.

Effective immediately, all new applications for drug and therapeutic biologic products for CFS, regardless of the proposed mechanism for the therapeutic product or primary endpoint, will be assigned to DPARP. Existing active applications (NDAs and INDs) will be transferred to DPARP in an orderly manner (timing to be mutually agreed between the DPARP and the currently assigned division)." [end of statement]

It could be good news: at least now FDA is admitting there may be drugs and "therapeutic biologic products" developed for the treatment of "CFS". Let's hope that won't include the latest antidepressant or antianxiety drugs, developed especially to treat the "personality disorders" and "depression" due to "childhood sexual abuse" that the CDC has been foisting off on a gullible public and compliant medical industry for decades. (I can't bear to call it a "profession" anymore although I readily admit there are still some professionals in the industry.)

The announcement says they will take into consideration patient reports of efficacy. This could be good news, too, if they should begin to listen to patients like Kelvin Lord and Mary Schweitzer on Ampligen.

The (possibly) bad news: Well, what do lung problems, allergies and rheumatology have to do with viral myalgic encephalomyelitis, morphed into chronic fatigue syndrome by the CDC?

I emailed them. You can, too. Their comment form:
http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm

This is their email address:
druginfo@fda.hhs.gov

Ancient Wisdom

* The person saying it cannot be done should not interrupt the person doing it. *
      (Are you listening Myra McClure? Dr. Stoye? Contamination papers?)

* Better a diamond with a flaw than a pebble without one. *
      (A comparison of Dr. Mikovits to CDC personnel?)

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

johnny foreigner: Now it's 'official'. The UNUM cat's out of the bag.

johnny foreigner: Now it's 'official'. The UNUM cat's out of the bag.

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

Hysteria As Misdiagnosis - Then and Now

Over 45 years ago Dr. Slater documented the frequent misdiagnosis of neurological diseases as “hysteria”. He published his findings in the British Medical Journal in 1965.

Following 85 patients admitted to a mental hospital, nine years later 50% were dead or disabled; 50% were living independently; 22% were symptom free.

The dead or disabled were found to have had vascular disease, epilepsy, vestibular lesions, angioma of the brain stem or neoplasms such as brain tumors.

At least 50% of those patients admitted to a mental hospital had physical diseases yet were diagnosed as “hysterical”, the old way of saying “It's all in the head.”

The idea that physical illnesses were manifestations of feelings and thoughts started with Charcot in the 1880's. His pupil, Freud, advanced that idea with a series of writings that have since been found to be largely fabricated.

For instance, a man knocked unconscious for 5 days by a carriage was unable to speak, walk or remember the accident when he regained consciousness. Charcot diagnosed him as being hysterical because of the psychological trauma of the event.

As Richard Webster says “Le Log - the classic example of a patient who supposedly suffered from traumatic hysteria, did not forget because he was frightened. He forgot because he was concussed. His various symptoms were not produced by an unconscious idea. They were the result of brain damage”

When a 14-year old patient of Freud's died of abdominal cancer two months after he diagnosed her with “unmistakeable hysteria” he claimed her hysteria had caused the tumor.

Webster explains how hysteria, renamed conversion disorder or somatoform disorder, became so popular:

“What made the resulting labyrinth of medical error all but inescapable was that practically every other physician had become lost within it. Over and over again, highly trained medical practitioners, confronted by some of the more subtle symptoms of epilepsy, head injury, cerebral tumours, multiple sclerosis, Parkinson’s disease, Tourette’s syndrome, autism, syphilis, encephalitis, torsion dystonia, viral hepatitis, reflux oesophagitis, hiatus hernia and hundreds of other common or uncommon conditions, would resolve their diagnostic uncertainty by enlarging the category of hysteria yet further. As a result medical misconceptions which sprang from one misdiagnosis would almost inevitably receive support, and apparent confirmation, from misdiagnoses made by other physicians.”

After brain scans of patients sufferering from chronic fatigue syndrome were shown to an expert scan reader in 1984, he said the punctate lesions he saw looked like the scans of AIDS patients. Months later the CDC issued its verdict. The town of Incline Village NV was suffering from mass hysteria.

Misdiagnosis of neurological disease in 1890 or even in 1965 is understandable.

It remains a mystery why the Centers For Disease Control (CDC) continues to place research on CFS in the Chronic Viral Diseases Branch of the National Center for Emerging and Zoonotic Infectious Diseases, yet has refused to research the viral associations with this illness and, instead, pursues mental illness as a diagnosis 27 years after those brain scans showed it to be a neurological disease.

"Somatoform disorder" is characterized by physical symptoms that suggest physical illness or injury - symptoms that cannot be explained fully by tests used by the attending physician. It is newspeak for "hysteria". In the tradition of Charcot and Freud, some doctors who cannot find the reasons for a patient's illness resort to the default diagnosis of somatoform disorder. That they stubbornly stick to this diagnosis even when physical signs and symptoms should alert them to change their diagnoses is a testament to the egos, culture and political considerations that get in the way of pure science.

To quote Slater:"The malady of the wandering womb began as a myth, and a
myth it yet survives. But, like all unwarranted beliefs which still attract credence, it is dangerous. The diagnosis of " hysteria " is a disguise for ignorance and a fertile source of clinical error. It is in fact not only a delusion but also a snare."

Cartoons by T. McCracken

For Your Amusement #2

The Faker

For Your Amusement

Judging Disabilities

Treatment NOW!

Dr. Timothy Luckett's sister has ME/CFS. He reports that small trials with Viread and Isentress have turned out well. Read his blog:
Initial findings from a yet-to-be publshed study

Dr. Jamie Deckoff-Jones and her daughter Ali both have ME/CFS. They blog about their treatment with antiretrovirals here:
The lessons of HIV and HAART

See my article on Yahoo! about Dr. Deckoff-Jones and another doctor being treated with ART, Dr. Michael Snyderman, oncologist:
Antiretroviral drugs or not? Two Doctors With CFS Decide

From Dr. Snyderman's poster:

Highly increased incidence of non-Hodgkin's lymphoma in ME/CFS

By Dr. Michael Snyderman, an oncologist with Chronic Lymphocytic Leukemia and ME/CFS:

XMRV has recently been identified in patients with prostatecancer and Chronic Fatigue Syndrome (CFS). CFS patients have an increased incidence of lymphoproliferative malignancy compared to the normal population.

While the incidence rate of non-Hodgkin's lymphoma is 0.02% in the United States, nearly 5% of CFS patients developed the disease.

A patient with CFS and CLL with adverse prognostic factors was shown to have XMRV in plasma and CLL cells. Within the first 100 days of treatment with AZT and raltegravir, he showed multiple benefits simultaneous with disappearance of infectious XMRV.

These findings suggest that XMRV is etiological for both the CLL and CFS and that virus-direct treatment was beneficial in this patient.

Further CLL patients should be studied especially as CLL has been statistically associated with an increased risk for other neoplasia.

Questions to be answered are what neoplasms are associated with XMRV, will existing antiretrovirals have antineoplastic activity in these neoplasms and what is the optimal combination of antiretroviral drugs.

Sometimes the corporate media gets it right

We know they have their own agenda; we don't know why they are now interested in telling the truth about ME/CFS - maybe there is money to made off our suffering as opposed to money being saved by the disability insurers who have made out like the bandits they are, for so many years.

In any case, it is good to have some balanced and fair news in the mainstream press once in a while. Here are the best:

Right click to go to: New York Times health blog: Well

It has at least 9 pages of comments, some of the most well-informed comments I have ever seen. Of course, the usual trolls and idiots have to chime in, like Skeptic and someone who claims to be a doctor, but probably isn't.

Another right click: Amy Dockser Marcus at the Wall Street Journal
She has been the best journalist by far, since Hillary Johnson, to cover ME/CFS fairly and accurately.

Not the corporate media:
Hillary Johnson's blog: Osler's Web from her book of the same title.
Right click to open in a new window. This book is a must read for anyone who wants to know the history of the politics behind ME/CFS and the CDC's attempt to disappear it.

Historical videos re: CFS on youtube

Crime of deception: XMRV epidemic the CDC calls 'CFS' (1 of 6)

Although this video is labeled with 'XMRV', that retrovirus is not mentioned in this video; XMRV and related MLVs have not yet been proven to cause ME/CFS. Nevertheless, "crime of deception" is still an adequate name for what the CDC has been doing since it was brought to their attention over 20 years ago that patients have lesions in their brains similar to those of HIV/AIDS patients, whom we know are infected with an infectious retrovirus.

As of 2011, the funding for research into the cause(s) of CFS is only $5 million, less than for hay fever or erectile disfunction. The possible reasons for this lack of an attempt to find the viral cause(s) and the attempt to divert biomedical attention from the disease are discussed in this series of 6 videos.

What the CDC and NIH Knew In 1984

1996 PRIMETIME LIVE Sick and Tired: Chronic Fatigue Syndrome

Right click for the youtube video where Dr. Philip Lee of NIH says CFS is probably caused by a virus or a retrovirus.

New Year’s Resolution: Contract AIDS/HIV

I wanted AIDS for Christmas but I was too sick to seek out someone who could give it to me.

I was too weak to look for unprotected sex. Who would admit to having it let alone be willing to give it to me? I shudder to think how many “exposures” it might take to, ah, “take”.

I've never liked needles, don't know any needle-using drug fiends. I didn't want to get mugged just cruising the kind of area such persons might inhabit.

As I lay in bed in pain and an exhausted stupor, I tried to think up my own Modest Proposal*. I thought about putting an ad in the newspaper, asking for someone with AIDS to come to me. I'd supply needles.

From there, the details get trickier. I would want someone with proof of AIDS. I would want the date of the test to be very recent.

I would also require that he swear he had not begun treatment. I guess I'd have to take his word for that. I would be counting on the fact that it takes a day or two after any test to get the prescription(s) and start taking them. It might even take a month or more for the drugs to have any effect. So maybe I could accept someone with a positive HIV test that was a month old.

Then I tried to think of what I might have to offer in return for the favor.
I'm living on less than $800 a month in disability insurance, so it wouldn't be money. I have codeine for pain. Maybe I could trade a month's worth of pain pills for a month's worth of needling.

I'm not sure just what to needle myself with or just how to do it. Maybe my “provider” will have suggestions. We could just scrape or scratch my skin until it bleeds and then drop a drop of the donor's blood onto my injury. We wouldn't need the needles at all.

Why would I want AIDS?

For the treatment. I would like to take AZT, Viread and Isentress asap. If I had AIDS Medicare would cover treatment and doctor visits. I've done my research and those drugs are pretty safe. Unfortunately, together they cost about $1500 a month.

Why do I want to take antiretroviral drugs? I have myalgic encephalomyelitis, erroneously renamed chronic fatigue syndrome. It has recently been proven to my satisfaction that it is caused by a retrovirus. A lab tested the drugs used to treat AIDS and found these three also treat the retroviruses found in ME/CFS.

The government calls all treatments for ME/CFS experimental, meaning no insurance pays for them. Yet those who can afford to pay for them have experienced great improvement in the few months they have taken them.

It's simple. If I had AIDS I could get treated for ME/CFS.

*1729 satire by Jonathan Swift, suggesting that the starving Irish eat their children

http://www.gutenberg.org/ebooks/1080

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0009948