At War with the United States Government

"Those who cannot remember the past are doomed to repeat it." George Santayana

Part of my job as Patient Advocate for my thirty-six year old daughter, housebound in St. Paul, MN, is to follow ME/CFS research and treatment developments. In this capacity, I read the internet, consult with doctors and researchers, and attend CFS/ME conferences. I try to share my observations and experiences on this blog - for better or worse.

Recently, unusual things are happening in CFS/ME research. I wrote about Kerr and Huber in London - two lingering "strangenesses". My observations are taken by some readers as "conspiracy theories". I can assure you that the Patient Advocate does not believe in conspiracy theories. He believes in reality - and in his own observations. In my role as a Patient Advocate I am essentially an "observer". I listen to CFS/ME associated individuals - patients, advocates, doctors and researchers - and I make my own observations. At times I talk to and communicate with CFS/ME patients and researchers. Most of the time I am on my own - coming to my own conclusions through connecting the dots. Coming to certain conclusions is not as difficult as it is made out to be. I am guided by an attitude developed over years of dealing with doctors, lawyers, politicians, artists, and academics.

For instance the situation that I related about Jonathan Kerr is not a fantasy. It is real. The only question that can be disputed in the exact manner in which he was given the big "squeeze". Huber's situation (along with her buddy Coffin) is even worse than I imagined.

For the moment I am worried about the FDA/NIH XMRV study. Dr. Alter gave a talk at the end of May (reported by journalists in the Netherlands), where he revealed an FDA/NIH study confirming the findings of the October 2009 Science study of the NCI, the Cleveland Clinic and the WPI. The FDA/NIH report reveals that 80% of the tested CFS patients were positive for XMRV and 7% of controls. In giving this talk in late May, Dr. Alter obviously felt that this study was just about to be published - otherwise he would have been crazy to put up slides about it. From this it can be deduced that the results were known over a month ago, probably much longer than that.

In the meantime, the CDC, using their own primers, have been unable to confirm the findings of the WPI, the NCI and the Cleveland Clinic. They found the elusive "zero" XMRV. What else is new? They play their part and even overplay it. These are the same people who tripped up on positive samples given to them by the WPI prior to October 2009. These people at the CDC are the kind of neighbors that you do not want. They are trouble makers - and they are venal. They insist on being in control, and always have. Why would they change now?

Presumably the CDC thinks that their primers are state of the art and the best available. Presumably they think the NIH/FDA study is flawed. The NIH and the CDC are parallel organizations existing under HHS. Obviously the CDC put pressure on someone above them to block the NIH study.

So what is happening here? The straight skinny is that CFS/ME is at war with the United States Government. The CDC wants to deep six the FDA/NIH study. At the moment both studies are "on hold".

At this very moment our loving and supportive government officials at HHS are trying to "reconcile" these two studies. I hate to think of what the term "reconcile" means to them - especially in light of the leaked story from Holland. One thing is certain: If this story had not been leaked. no one would have ever heard of the NIH study. It would have been "disappeared". (Imagine what Dr. Alter is thinking at the moment. He must be a little bummed out). But the story was leaked - and now things are "difficult" for the HHS. I suggest that we make it more difficult for them. It will take someone more skilled than I to organize resistance against the HHS. But if there ever was a time, it is now.

I imagine that the CDC is going to try to delay things by insisting that the NIH test their samples. This idea is fraught with peril -as who can imagine what they might have already done to these samples to not have them yield any positive XMRV. You can see their devilish logic, as this might very well unseat the NIH study if the NIH cannot get positive XMRV results from the CDC cohort.

All this is highly unusual and speaks to a more serious and complicated game being played. We have two studies here and there is no "reconciliation" possible. It is too late for reconciliation - and the CDC is not to be trusted. These two studies should be published as is.

Otherwise, things will muddle along.

Without clarity, the WPI and others will continue their poorly supported, but highly significant, research. With clarity, these obstructionist in our government can be held accountable.

What will the future hold? More than likely, the confirmation will have to come from outside of government organization. The government does a poor job at protecting the health of their citizenry and it is corrupt. There are various independent possibilities for confirmation studies, but they are months away. In the meantime, research grants are being put off and applications delayed. Time is being wasted and various labs are having to answer skeptical questions all day long. It is a fine tactic, expecially when used against researchers with limited resources. Again we can see the measly fingerprints of the CDC as various trials were stopped, months of time and momentum lost, and studies had to be restarted, all for no good reason.

"Ouch!" - losers lose

Late in the day on June 22, 2010 a preliminary news report was released regarding confirmation of the October 8, 2009 Science paper on the connection of XMRV and CFS/ME. The report indicates that both the FDA and the NIH have confirmed the association of XMRV with CFS/ME and the potential that this retrovirus is communicable. You can read about is here. This confirmation was a long time in coming, and a great deal of momentum was lost in the interval. However, the moment of truth has now arrived and, for those in the know, it is not surprising news.

The game that has been played for the last eight or nine months is over. The WPI, this small outfit now rising up very large from the beautiful northern Nevada desert, has won. Suddenly the losers have to get on a long uncomfortable train ride to nowhere and eat bad food. The real winners can now get down to business - and things can move forward.

With this very great bit of news, the WPI and their outreach friends can move on to testing, expanded research and treatment options for this nasty illness.

Here are comments of Hillary Johnson.

The Igniter: Annette Whittemore writes on the WPI.

This article appeared in Molecular Interventions June 2010. This is a long article but well worth the read, especially in light of all the crap floating around today regarding serious CFS/ME research. This article might get some readers to focus a bit more on what this very small institute is trying to do.

The Whittemore Peterson Institute
Building the bridges through private and public sector collaboration

Annette Whittemore

The Whittemore Peterson Institute’s (WPI) publication of its ground-breaking study on October 8, 2009, of the link between a cancer-related retrovirus, XMRV, and patients with myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”) brings a desperately needed legitimacy to a complex yet controversial and misunderstood disease (1). News of this significant association brought hope to millions around the world who have suffered in silence from its devastating effects. Perhaps, just as important, the discovery of XMRV infection in humans allows the medical world to construct a testable hypothesis of how XMRV may cause or contribute to illnesses across a wide spectrum of chronic inflammatory diseases and cancers and new paradigms of treatment and perhaps prevention.

That the discovery happened in just three years of a small research institute’s existence is almost as amazing as the extraordinary scientific work. This is the story of how and why the Whittemore Peterson Institute came to be. It is a story of multiple collaborations at every level, revealing a blueprint for other groups of dedicated scientists, doctors, and philanthropists to create greater progress through unique and selfless partnerships across nontraditional boundaries. Like other philanthropic endeavors, it began as an idea evidenced through personal suffering and acted upon after all other avenues had failed.

The personal decision to commit time and money to build an institute for patients with neuroimmune diseases came from a desperate need for medical solutions to a disease that had been destroying our daughter’s life for over twenty years. We were also faced with the reality that experienced physicians were retiring without passing on their knowledge of ME/CFS to new physicians . In addition, the existing medical establishment lacked both knowledge and medical tools to effectively treat patients who suffered the debilitating effects of this neurological disease. Around the world, those who suffer with ME/CFS have been told that their physical disorder is a manifestation of a psychiatric disease. Subsequently, these patients may then be denied medical support by their government-run health care programs.

Box 1. The Historical Description of Myalgic Encephalomyelitis Myalgic Encephalomyelitis was first described by Melvin Ramsey in the UK after an outbreak in the 1950s [(5–7), see also (8)]. He coined the term to describe the muscle pain and symptoms of brain and spinal-cord inflammation its sufferers experienced. In the early 1980s, an outbreak in the United States of a disease with the identical symptoms of ME was reported to the CDC. With little input from the physicians who first described the disease, a small group of scientists, doctors and psychiatrists renamed the disease from the earlier term, chronic Epstein-Barr virus, to simply “Chronic Fatigue Syndrome” (9). By emphasizing fatigue as a symptom, which is known to be associated with many chronic conditions, those with “CFS” quickly became confused with others who were simply “tired” or “burned out” from overwork. Unfortunately for those who were truly ill, and not merely tired, this misunderstanding has prejudiced scientists and doctors before they ever examined a patient with “CFS.”

Journey Through A Medical Wilderness
Our odyssey began in 1989, when my daughter, Andrea, became ill with a mononucleosis-like illness and then failed to return to normal health After many months of continuous relapsing and remitting flu-like symptoms, she was referred to a major medical institution for evaluation. She was given a cursory check up, then provided with a psychological explanation for her infectious symptoms of sore throat, severe head and nerve pain, swollen lymph glands, night sweats, tachycardia, and muscle aching fatigue. Even to a non-scientist that answer seemed ridiculous. The consulting physicians could offer no explanation for what was clearly a biological phenomenon.

I returned home with Andrea, determined to find a doctor who knew something about the outbreak of a disease that had occurred at Lake Tahoe, a favorite summer destination frequented by our family. A physician and next door neighbor, Reggie Davis, who had known Andrea as a healthy child and saw her frequently during her illness, was convinced that her symptoms were like those of individuals from that outbreak. He suggested that we see Raymond Scott, an internist in Reno, even though Andrea was only twelve. Before allowing her to see the doctor, I scheduled an interview with him to be sure he knew something about the disease: I was not going to allow her to be told that her symptoms were not real, as did the doctor who told her that she “most likely hated her parents, her friends, and her school.” Through it all, other physicians confirmed what I knew––that my daughter was ill with a very real disease. Fortunately, Dr. Scott had worked with other patients in the Incline Village, Lake Tahoe area and knew more about CFS than any other doctor in Reno. Although the treatments he offered provided only symptomatic relief, her life improved under his compassionate care. She continued this modest improvement until she decided to enroll at the University of Nevada–Reno. The admission policy required the measles, mumps, and rubella (MMR) vaccination prior to starting classes. Within five days of the MMR vaccination, Andrea had a severe relapse and never regained her previous level of health.

Reflections

As her health continued to deteriorate, Dr. Scott became more concerned. Soon we were on our way to another major medical institution in California, where rounds of tests and several physicians later, we ended the visit with a referral to another hospital’s pain clinic where she was told she should fill out a questionnaire everyday, then learn to live with her pain. Just eighteen years old, Andrea was facing a lifetime of pain that was so severe she required the use of a transcutaneous electrical nerve stimulation unit and injections to make it through the day.

Only after a visit to a local gastroenterologist, one year later, did we find that much of her pain arose from a diseased gallbladder. Within six months of her gallbladder surgery, she also had to have her appendix removed. We began to worry that a vital organ might soon be affected, so we followed her doctor’s advice and sought out internist Daniel Peterson of Incline Village. Months later, Andrea was accepted into his practice

Dr. Peterson has a passion for his work and his patients. He is one of a small number of well-respected CFS physicians and was one of two doctors who first alerted the Centers for Disease Control to a possible outbreak of a new disease, then dubbed chronic Epstein-Barr virus (EBV) (2). Dr. Peterson knew that something was making his patients sick and keeping them from getting well again. The CDC’s quick reply left Peterson with the impression that the CDC didn’t know what the cause was and that it did not think it warranted more attention. Without serious government-backed follow-up to validate those initial and unfortunate faulty conclusions, medical scientists were dissuaded from researching the cause of the new disease, while many more around the world became ill.

Patients who had what was now known as ME/CFS were left with modest victories to cheer and little medical hope. In 1993, Nevada became one of the first states to request that the President and Congress increase funding for research into CFS4. In addition, the Nevada legislature agreed to include the drug, Ampligen, which acts to stimulate the body’s antiviral defenses, in modest recovery models for Phase III trials. Treadmill VO2max (i.e., the volume of oxygen utilized during exercise of maximum exertion) was used as a guide to evaluate patient disability and response to treatment. When Andrea turned twenty-one, she enrolled in the phase III drug trial. Twice a week she was given an intravenous (iv) infusion that at first caused her to experience a worsening of her symptoms. Other days, she spent hours receiving nutrient iv fluids that supported her health. Finally, after one year of treatment, she began to improve with the drug and continued to take it, off and on, for eight years. Blood tests, developed in a laboratory in Belgium, helped determine some of the unique traits found in many CFS patients. After the bombing of the World Trade Center, however, transporting blood overseas was no longer an option. We and a few other patient advocates were approached by one of the owners of the Belgium lab and asked to support the establishment of a US lab that would perform the same tests. Because most of the American patients lacked the insurance to pay for the tests, my husband, Harvey, and I agreed to help and soon supported the lab in its entirety. We felt supporting this lab was critical to the ongoing work in developing and testing therapies for patients with CFS. As a result of supporting the lab, valuable RNase L studies and natural killer (NK) cell work were able to continue, which eventually led to the hypothesis that patients with CFS might be infected with xenotropic murine leukemia virus-related virus (XMRV). While taking Ampligen, Andrea improved to 75% of her previous levels of energy and stamina, but despite many of the positive outcomes, she continued to fall ill with opportunistic infections. For unknown reasons, Andrea began to develop reactions to Ampligen, making her too sick to continue. Once off the drug, she began a continuous decline. Today, without treatment she experiences daily seizures, nausea, vomiting, severe allergies, and painful lymph-node swelling. As a result, she requires nearly full-time help to care for herself and her home. Instead of answers and solutions, we were left with hopelessness.

CFS: Challenges To Overcome

The difference between the actual effects of this disease and that which is portrayed in the popular media could not be greater. The current CDC definition states that a patient must satisfy two criteria:

1. Have severe chronic fatigue of six months or longer duration, with other known medical conditions excluded by clinical diagnosis; and

2. Concurrently have four or more of the following symptoms: substantial impairment in short-term memory or concentration; sore throat; tender lymph nodes; muscle pain; multi-joint pain without swelling or redness; headaches of a new type, pattern or severity; unrefreshing sleep; and post-exertional malaise lasting more than twenty-four hours.

The symptoms must have persisted or recurred during six or more consecutive months of illness and must not have predated the fatigue. The CDC then recommends a series of common blood tests, but goes on to predict that:

“More than 90% of patients presenting with severe fatigue will test at normal levels for the series of laboratory tests listed above. Assuming that there is nothing in the physical examination or in the personal history of the patient that suggests a clear direction to the doctor, no further laboratory testing is recommended.”

With what other disease could government health officials suggest waiting six months for a diagnosis, using tests that will only tell you what it is not, and leave you with no answers as to what it is or how to treat it? The CDC concludes that because not every CFS patient has the same abnormalities in their immune systems or brain scans, further evaluation is not necessary. Thus, scientific answers become even harder to obtain.

Perhaps what is missing most from the public’s awareness is the description of the most severely ill patients, like Andrea, who, at times, was so ill and weak that she was unable to feed herself or walk unaided. As these patients’ immune systems weaken and various chronic infections take hold, they live their lives between doctor’s offices and their homes physically and emotionally isolated from their families, friends, and communities. Many go on to develop life-threatening complications. In a retrospective analysis, Leonard Jason found that those diagnosed with ME/CFS died of heart disease, cancer, or suicide at ages approximately twenty-five years younger than the normal population. Only detailed epidemiological studies will reveal the true complications of long term disease and mortality resulting from the complications of this disease.

The problems that patients experience when dealing with the healthcare system can be as difficult as the disease itself. Most doctors have difficulty diagnosing ME/CFS and when they do, are at a loss as to what to do for their patients. The lack of medical consensus is so great that most doctors disagree on the best treatment strategies or what, if any, biological treatments to consider. Doctors and patients are left to their own devices, experimenting with drug treatments that are unproven, toxic, or both. Scientific and educational information surrounding ME/CFS is conflicting and often consists of anecdotal observations from physicians. Additionally, many patients are told they suffer from “faulty thinking” about the illness and are then prescribed cognitive behavioral therapy and graded exercise therapy.

More Than A Foundation

It was evident to me, after working with another research foundation to study CFS, that engaging various scientists to do related research projects was only one part of the solution to the much bigger issues surrounding ME/CFS. This initial research program was narrowly focused on one virus and relied on individual researchers to apply for grants. Much like the extramural grants of the NIH, these projects are scattered among different unrelated researchers and not organized in a comprehensive and coordinated manner.

One thing that I admired about the foundation’s director was her ability to access researchers to do the work that she felt might reveal new information. After reading about the XMRV finding in prostate cancer, I tried to contact the group of researchers at UCSF that had made the extraordinary new discovery. I wanted to pay them to test CFS patient samples using their viral-chip technology. After several attempts, I gave up that effort and instead began to develop another plan of action. That plan was to create a research program within the structure of a medical research center.

Many advocacy organizations had expressed an interest in government support of Centers of Excellence for the treatment of patients with ME/CFS. In fact, to address the issues of CFS, a bench-to-bedside approach was needed, requiring nothing less than an expert institution, which would combine translational research with patient diagnostics, treatments, and medical training for new doctors. When it became apparent that no one else was willing to create such a center, with the strong encouragement of my husband, family, friends, and political leaders.

Reflections

I agreed to act. With a promise from medical doctors to support our efforts, I committed my time and my family’s resources to create and build such an institute. In early 2005, Dr. Peterson and I began working to describe this institute’s future clinical practice. Meanwhile, my husband discussed with John Lilley, then president of the University of Nevada–Reno, the School of Medicine’s desire for a new medical research building. Our Governor and good friend, Kenny Guinn, agreed to place this project in his state budget. Legislative leaders who understood the potential benefits to both patients and future medical education in this state also began to offer their support. This new research facility was to house three significant interest groups: researchers from the University of Nevada’s Medical School; the Nevada Cancer Institute; and the Center for Neuroimmune Disease (now called the WPI). That winter, I gathered scientific information for a presentation to the 2005 state legislature, arguing the need for such a medical center. University representatives and Nevada Cancer Institute scientists did the same. Passionate pleas were made by several patient advocates in addition to our testimony. By the end of the legislative session, ten million dollars has been allocated to support a new research and medical office building5 (Figure 2). The main portion of the building was built from bond money which was based on the indirect costs of the researchers’ grants. My husband and I committed to give or raise an additional $5 million towards WPI’s portion of the building, and soon the construction began, bringing reality to a dream.

The Real Work Begins

Judy Mikovits and I met at an HHV-6 Foundation conference in the spring of 2006. It was at that conference that Dr. Peterson presented patient data describing many longstanding CFS patients who had developed rare lymphomas. Dr. Mikovits was intrigued and, as a seasoned scientist with experiences in retrovirology, recognized a potential for discovering a new disease causing pathogen. Shortly thereafter, I asked Dr. Mikovits to serve as the Institute’s full-time Research Director. She immediately planned a comprehensive research program to answer questions that would support the development of diagnostics to help define those who had this illness. She began by building a repository of patient samples and organizing her studies to generate sufficient data to justify an NIH grant, which was submitted in June, 2007 and finally funded in October, 2009.

Having the support of University leadership––President Milton Glick and Ole Theinhaus, Dean of the Medical School––was also critical to our success. Experienced scientists such as Steven St. Jeor, a CMV researcher; Greg Pari, an expert in Kaposi’s sarcoma-associated herpesvirus (KSHV); and Ian Buxton, a pharmacologist, offered their assistance. Soon after moving to the University, we organized a small conference as a means to formally introduce ourselves. Researchers from the University, the National Cancer Institute, and the WPI came together with ME/CFS physicians, to discuss their areas of expertise. The following year Dr. Mikovits led the first meeting of the Institute’s new scientific advisory board. Today, the WPI Scientific Advisory Board engages scientists with expertise in cancer, infectious disease, autoimmune diseases, immunology, and virology.

WPI has had to use a combination of funding mechanisms to pay for the many different activities neccessary for the creation of a working institute. Like many medical research non-profits, WPI must rely on the talents of its researchers to receive grant support and the ability of its administrators to raise funds from the larger community. When a disease is not well understood and often maligned, it is an even more daunting task. For example, it took WPI three years to receive NIH funding for reasons unrelated to the quality of the proposal.

Donations to the Institute come in many forms. WPI has a yearly gala dinner which raises hundreds of thousands of dollars. We ask private foundations, companies, and individuals for their help in a variety of ways. We have also used yearend gift appeals and a new Facebook Cause page to raise money and awareness. The WPI Web site has been a source of donations, as well. The urgent need for a continuous source of income to support the clinical work of the Institute is now our greatest priority. Generous patients, hopeful for answers, make up a significant part of the funding in this disease. They must choose between several organizations who claim to be doing important research work. It is difficult for most laymen to decipher the kind of science they are funding or whether or not the scientists are qualified to do the work. Thus, private donations which are very competitive can be spent on research that does not provide significant results. Educating the public about the importance of our organization’s own research capabilities is time consuming and requires a full time effort, but is extremely necessary if one is to gain public support.

The Intramural NCI Program:
The Value Of Basic Research

The selection of Dr. Mikovits as the research director of the WPI was fortuitous in that she had worked for twenty years in the Intramural Program for the NCI as research technician, graduate student, postdoctoral fellow and finally as head of the NCI contractor’s lab of Antiviral Drug Mechanisms. The NCI’s tumor virus program of the late 1970s supported the identification of retroviral oncogenes in human tissue and of the tumor-causing human retrovirus, human T cell leukemialymphoma virus type I (HTLV-I) by Bernie Poiesz and Frank Ruscetti, in the laboratory of Bob Gallo. By 1984, NCI investigators were co-discoverers of a new retrovirus, HIV-1, which is the causative agent of AIDS. It was natural for Dr. Mikovits to enlist the help of her former NCI colleagues, Frank and Sandy Ruscetti, Mike Dean and Rachel Bagni, to look for an infectious agent. Thus, NCI’s investment in funding basic research in animal and human virology made the discovery process possible. Initially, the discovery process focused on the use of a viruschip assay similar to the one used to discover xenotropic murine leukemia virus-related virus (XMRV) in the tissue of men carrying RNase L mutations who had prostate cancer (4). After two and a half years of trying to make sense of the viral chip data, we narrowed our focus to XMRV, because many CFS patients also suffer from an RNase L defect, and initiated a collaboration with Bob Silverman, a co-discoverer of the virus, of the Cleveland Clinic. All patient material used in this study were subjected to four separate XMRV assays: DNA PCR from peripheral blood cells (PBMC); viral protein expression in PBMC; presence of antibodies in plasma; and the recovery of infectious virus from plasma transmitted to indicator permissive cell lines. After five months of a rigorous review process, the journal Science published our findings (1).

The Aftermath: Still Stuck
In Osler’s Web

By attempting to bring chronic fatigue syndrome (CFS research out of the shadows and squarely onto the nation’s health agenda, we knew that we would be the object of much criticism from both the medical establishment and those individuals invested in other theories of disease causation. Previous experiences had shown that some of these activities would parallel what happened during the early days after the discovery of HIV and AIDS.

CFS was belatedly recognized as a legitimate disease entity by the Centers for Disease Control in 1997 but is still denied recognition as an infectious immune disorder. The HHV6 foundation believes that HHV6 is the sole cause of CFS. A major CFS patient advocacy organization is on record, having concluded that a retrovirus has nothing to do with the pathophysiology of CFS. Much of the opposition outside of the CFS community firmly believes this disease and others that are similar arise from psychiatric disturbances. Within a week of the Science online publication, several scientists publicly announced that they would not be able to replicate the findings, negative findings were reported on blogs, and within a month, three negative papers had been written and submitted about the lack of XMRV in CFS.

Without directed research allocations from a Director of an NIH institute, it can take between three to five years before money can be allocated to study the role of XMRV in disease. Fortunately, Robert Wiltrout, Director of the National Cancer Institute’s Intramural Center for Cancer Research, has already requested that the scientists in the intramural program begin to develop reagents to determine the role of XMRV in the development of cancer and other chronic diseases. The other difficulties surrounding funding of governmental research grants are numerous, including the time it takes for the entire process to be completed. NCI has developed a mechanism to rapidly give new research funding to existing cancer centers. Unfortunately, when a new, non-traditional entity such as the WPI is created, it must often delay work until the funding is already in place. To solve these problems, we have found it beneficial to work with other institutions and experienced investigators who have offered to co-author grants in a mentoring relationship. But we have also learned a valuable lesson: a non-traditional entity may point out a new research direction, but it must be confirmed by traditional engrained mechanisms.

Reflections

Although the challenges have been significant, the personal rewards one receives by helping others through the work of this institute have been tremendous. We meet and talk often with hundreds of individuals who are thankful that the WPI is creating a scientific program of discovery that will improve their lives. They have spent too many years suffering in silence, often opting out of the medical world when they can’t find relief. Scientific efforts to solve the many questions surrounding neuroimmune diseases have brought a renewed interest in the field and hope to millions throughout the world. Below are just two of thousands of messages sent to our offices. “Canada cheered when we heard the news.” Another patient wrote, “I do not have words to thank you for the work you have done. It has now been 30 years since I fell ill and I truly never thought I would see the day this terrible knot was untied.” Therein lies the motivation, despite all obstacles, to continue this vital mission.

References
1. Lombardi VC, Ruscetti FW, Das Gupta J, Pfost MA, Hagen KS, Peterson DL, Ruscetti SK, Bagni RK, Petrow-Sadowski C, Gold B, et al. (2009) Detection of an infectious retrovirus, XMRV, in blood cells of patients with Chronic Fatigue Syndrome. Science 326:585-589.
2. Holmes GP, Kaplan JE, Stewart JA, Hunt B, Pinsky PF, and Schonberger LB (1987) A cluster of patients with a chronic mononucleosis-like syndrome. JAMA 257:2297–2302.
3. Jason LA, Corradi K, Gress S, Williams S, and Torres-Harding S (2006) Causes of death among patients with chronic fatigue syndrome. Health Care Women Int. 27:615–626.
4. Urisman A, Molinaro RJ, Fischer N, Plummer SJ, Casey G, Klein EA, Malathi K, Magi-Galluzzi C, Tubbs RR, Ganem D, et al. (2006) Identification of a novel gammaretrovirus in prostate tumors of patients homozygous for R462Q RNASEL variant. PLoS Pathogens 2:e25.
5. Ramsay AM and O’Sullivan E (1956) Encephalomyelitis simulating poliomyelitis. Lancet 270:761–764.
6. Ramsay AM (1957) Encephalomyelitis simulating poliomyelitis. Public Health 71:98–112. 7. Ramsay AM (1957) Encephalomyelitis in north west London; an endemic infection simulating poliomyelitis and hysteria. Lancet 273:1196–1200.
8. Ramsay AM (1986) Myalgic Encephalomyelitis: A baffling syndrome with a tragic aftermath. M.E. Association Journal 1986, UK.
9. Jason LA, Najar N, Porter N, and Reh C (2009) Evaluating the Centers for Disease Control’s empirical chronic fatigue syndrome case definition. J. Disability Policy Studies 20:93–100.

Swallowing the Poison Pill

Before I get back to more practical aspects of dealing with this disease there is one leftover from the London Conference about which I want to write. It links together with a few other behavioral and professional "strangenesses" and makes me wonder what is going on in the world of CFS research.

The CFS/ME world is a funny place. There was a time, years ago, when Dr. Jonathan Kerr, researcher, was seen as a hero. In 2005 he announced discoveries in genetic and CFS/ME that were seen as revolutionary.

An article in 2005 said this: “British researchers led by Dr Jonathan Kerr "believe they have pinpointed biological markers of chronic fatigue syndrome which could help develop a test and treatment for the condition.”

Around this time, I saw him in a television interview saying that there would be treatment for CFS/ME in a year and a marker in two years, tops. Researchers cannot restrain themselves. They say whatever comes to their heads, make shit up out of whole cloth and people believe them. I watched the interview several times. It was what everyone in the CFS/ME world wanted to hear, yet I remained skeptical. Nevertheless this was real CFS/ME research, and in the UK of all places. I have followed him closely since then, seeing him at conferences in FL, Reno, Baltimore and four times in London. I am a great admirer of Dr. Kerr.

Four years ago this was in a newspaper article: “"We've found that the genes in patients' white blood cells — a key part of the immune system — are switched on and off in an abnormal fashion," Kerr says. The hope is that a relatively old drug, called interferon beta, can help to restore the balance. A controlled trial is planned. What researchers such as Kerr find disheartening is that there seems to be little official support for this biological-based research (in CFS/ME) in Britain. The bulk of the funding has gone to the psychological approach.”

While the interferon beta trial was never funded, Kerr did soldier on and another important article was published in 2008: “In the UK, Kerr has demonstrated differential expression in 88 genes [85 up-regulated and 3 down-regulated] indicating hematological disease and function, immunological disease and function, cancer, cell death, and infection, all of which are seen in ME/CFS but not in states of psychiatric fatigue.” [J Infect Dis 2008:197(8): 1171-1184]

In 2008 Kerr gave every indication that he was on the top of his game, moving forward at his own pace and maintaining his independence. He presented at the 2008 London Invest in ME conference and my report is here: “Next up Jonathan Kerr gave his usual fine low-key and precise lecture. He is usually allotted a half-hour, which I suppose is all that he needs to present his important work. He presented his gene expression work in his soft-spoken voice, and there was nothing new here. He and his group have identified seven subtypes, each which has a potential treatment with existing drugs. They are working on a marker (or markers) in order to identify subtypes. No timeline for a marker, or markers, was given. Presumably and eventually, trials with specific existing drugs with subtypes could be done. Kerr did reveal that his application for a trial of Enteracept on a subgroup was turned down by the government - and that this trial is not going to happen. The most poignant moment came at the end of his lecture where he put up a picture of his “group”, the same photo he has shown in the past - six researchers. This group has now dwindled to three - as his funding has been cut, and he gets no funding from the UK government health ministries. Fortunately he is working in collaboration with a group of Americans, who have a deeper appreciation of his work.”

In 2009 and earlier it became apparent that Kerr was working closely with the folks at WPI – or visa versa. Together they were awarded a NIH grant, the first grant that the WPI received. It promised a bright future for genetic research and international cooperation, this latter idea being one of the hallmarks of the WPI. The WPI pledged from the beginning to reach out to researchers worldwide, to share information and to work collaboratively. The relationship with Jonathan Kerr seemed to be a good example of how “collaboration” might work. Small groups of people in different parts of the globe communicating instantly through the internet.

The expectation built throughout 2009 that something big was going to come out of the WPI. Sure enough we found out about XMRV in October. Since then, not much has been heard from Kerr. He has, for whatever reason, become the “forgotten man” of CFS/ME. His name did surface in March of 2010, tacked onto the end of a strangely negative validation study of XMRV. Everyone and his mother was surprised by his name being there - and wondered why and how this could be.

Jonathan Kerr was invited to update his research at the Invest in ME conference in May 2010. He was not in attendance as the conference began and came slinking in halfway through the morning. He gave a very short lecture where he turned away from the microphone towards the slides on the screen and talked in his usual inaudible voice. No one could hear anything that he was saying. A woman patient raised her hand and asked him to speak louder or into the microphone and Richard Simpson hustled up to the lectern to adjust the microphone so that it could be closer to Kerr. Kerr continued to speak turned completely away from the microphone, in a way now that seemed deliberate. He also showed slides that were entirely bleached out and it was totally impossible to see any of the distinctions that he was pointing out. The upshot was that the spectator had no idea what they were observing. At the end of this very short talk he put up a slide of the names of his research help including that it was funded by the ME Trust. Gone was the usual photograph of his young and pleasant looking researchers. What happened to these nice young optimistic researchers? Their picture, though dwindling in number, always gave us hope. What happened?

To this observer it was obvious that Dr. Kerr was embarrassed and did not want to be at this conference. His entire manner and presentation, or lack of presentation, spoke of him just wanting to disappear. He was noticeably not interacting as in the past. He seemed like dead weight, and psychologically half his size.

How did we get to this point? What has happened to our vaunted British colleague? What was with his name being placed on this bogus study, negative for XMRV? Here is my suggestion:

It had been obvious from the beginning that Dr. Kerr’s CFS/ME gene work did not win approval from his colleagues in the UK. His work, though dramatic, was not encouraged - evidenced by his diminished funding and the specific rejection of his Interecept trial (This was shocking.). The writing was on the wall and things obviously got hotter for him when he collaborated with this rogue agency in the US, this WPI place. And then XMRV hit the fan and that was enough for Dr. Kerr’s colleagues. They pulled the plug on him. In various countries, they put polonium 210 in the soup, in the UK they just give the “poison pill” (in a collegial manner).

I imagine that Kerr always expected that something bad was going to happen. So he must not have been surprised when the late night call came, or someone cornered him in the hallway of his tiny research facility - urging him to disassociate himself from “these people”. This friendly fellow or gal, a fully supportive, honest soul, must have said to him, “Jon, pull yourself together, just take this pill, just take this poison pill. Swallow it with a full glass of water.”

Kerr, not having many options, swallowed the pill. (Some people, in their eagerness, take two pills.) The “trusted” fellow, whomever or wherever, informed Kerr, in his smug self-satisfied way, that he could “keep his job” and the ME Trust would keep his pitifully funded efforts going. Otherwise, if he strayed, he would be “chucked”.

What I would like to know is what happens to the joint research project with the WPI now that Kerr has been “disappeared”? From the PR side of things, it looks like someone from the UK is trying to send a message. This tactic is a very effective way to “cut off research dollars”.

(Perhaps there are two sides to this story. I would like to hear it.)

Try to connect the dots here. This isn’t science, this is shit. It is tough to lose a fine CFS/ME researcher like this. There are not very many of them in CFS/ME. Kerr should suck it up and move to the United States.