Dr. Ian Lipkin and XMRV

The Patient Advocate was reading the NY Times Science section this morning when he noticed the front page article on Dr. Ian Lipkin. The PA had seen the online version yesterday but was pleased to see this in the real paper. The first question that came to the Patient Advocate's mind was - why this extensive profile of Dr. Lipkin and why now? It was only when the PA got to the last paragraph of the article that the PA understood what this article is about. Dr. Lipkin has been selected as our "big daddy" for the rough ride ahead. A few well-place telephone calls and Dr, Lipkin is given the highest exposure in the NYTimes. Someone has to do this job and Dr. Fauci of the NIH has selected Dr. Lipkin, who credentials are sky-high. It is going to be Dr. Lipkin's job to try to convince the rest of us that everything is "going to be alright" in this "virus thing" with XMRV and other MLV-related viruses and their association with ME/CFS, breast cancer, prostate cancer, etc. Dr. Lipkin will be the voice of calm reassurance. He will convince us that science will triumph, and that there is nothing about which to panic. We will be seeing Dr. Lipkin again very soon when the results of the blood working group phase II are made public. Then we will see him again when Dr. Ila Singh's research is published. We will be seeing alot of Dr. Lipkin. Get used to him.

Meanwhile Dr. Lipkin's real job will be to substantiate what has already been substantiated. Under normal circumstances (but for the CDC errant study) the Lo/Alter paper would have been accepted as a confirmation of the October Science study of Lombardi et al. But these are not normal circumstances. Because the CDC failed at their task, either diliberately or through magnificent incompetence, Dr. Lipkin's job will be to "reconcile the irreconciliable". So his tasks are two-fold - sustantiate the substantiated, and reconcile the irreconcilable. The first part will be easy. The second part less so. The Patient Advocate cannot imagine the explanation that will have to be invented for the second part - but one thing is certain - it will be a doozy.

Substantiating the Science paper will be easy. The Patient Advocate, or any semi-competant person, could do this job. It is a set up. Dr. Lipkin, using the right tests and having the blood of real ME/CFS patients (samples from Komaroff, Levine, Montoya, Bateman and Klimas and probably others) will find 80-90% of them positive for XMRV ( if not more). Dr. Lipkin will get another feather in his cap, and be a local hero - at least at Columbia.

Meanwhile, for the rest of us, the real heros will have been passed over, and the real scientific discovery neutralized. But for the hopeless failings of the CDC, the research into XMRV and it's association to neuro-immune illness would be sailing along. Instead the NIH is involved in the final solution for XMRV, which involves great delays which are not without consequences. This maneuver also allows a shift away from the real scientists in this XMRV association with ME/CFS - Dr. Vincent Lombardi and Dr. Judy Mikovits of the Whittemore Peterson Institute.

This entire situation is nauseating. (This has very little to do with Dr. Lipkin, who the Patient Advocate imagines is "top notch".) It characterizes the most lethal of academic prescriptions: create a tangle in some fashion, create uncertainty, create delay - and then bring in an outside high profile consultant - an expensive hired gun - to straighten everything out. This is obviously a desperate measure to "take control" of this issue. As with all "control issues", one thing lies in the background: venality and/or malice.

The Patient Advocate quickly fashioned a letter to the NYTimes this afternoon summarizing the situation:

"Thank you for your article on Dr.Ian Lipkin. Dr. Lipkin is obviously a remarkable researcher. It did not escape the attention of this reader that the gist of the article is left to the last paragraph. Dr. Lipkin has been hired by the government to straighten out the discordant research regarding the new human retrovirus XMRV in its association with ME/CFS. This is a set up. Dr, Lipkin has been put in charge of substantiating what has already been substantiated by the Lo/Alter paper of September 2010. This task, the outcome of which is entirely predictable, will be another feather in Dr. Lipkin’s cap. Meanwhile the NY Times has missed the main story. The article should have been written about Dr. Judy Mikovits and Dr. Vincent Lombardi of the Whittemore Peterson Institute who wrote the Lombardi et al in the October 2009 Science magazine. It was these scientists who did the original astonishing work in the association of the retrovirus XMRV with ME/CFS (and potentially other neuro-immune illnesses.) They are the real heroes of this unfolding disease drama."

The Patient Advocate wishes to point out the difference between overseeing a support study and doing original research. While running a confirmation trial takes some delicate skills, it is nothing like the intensity and creativity necessary to scope out a complex problem and go to the root of it. The former situation involves standing on the back of others, the latter involves standing alone. And yes there is a difference.

Challenge the CDC campaign email #2

The following is a very important announcement by an anonymous contributor. The Patient Advocate recommends that the reader respond to this request as quickly and as forcefully as possible as this is a matter of the utmost urgency.

We have heard nothing from the CDC about who will be appointed Chief, Chronic Viral Diseases Branch. The person in that position will be supervising the Chronic Fatigue Syndrome Translational Research Program at the CDC. Many emails were sent three to four weeks ago to Dr. Monroe expressing opposition to the appointment of Dr. Elizabeth Unger, who is the current Acting Chief. Dr. Monroe is making the decision about who will be appointed Chief. We pointed out that Dr. Unger has not communicated well with ME/CFS researchers and clinicians outside of the CDC. At the Chronic Fatigue Syndrome Advisory Committee (CFSAC, an advisory committee to the Secretary, Health and Human Services) she defended CDC research done using the “empirical” definition of CFS (Reeves, 2005). This definition has been shown to be too broad, including many people with other diagnoses. The CFSAC itself rejected the use of this definition at its meeting in October, 2009. Conclusions from research using this definition in the past year include: XMRV is not found in any “CFS” patients and “CFS” patients have a high incidence of personality disorders. In addition, during her term as Acting Chief, Dr. Unger has not improved the CDC website, which continues to have significant inaccuracies and omissions. She has not shown any willingness to alter the established policies that the CDC has followed for years in regard to ME/CFS. If she is appointed Chief, we can expect more of the same.

The decision about who fills this position is likely to occur soon, perhaps within the next few days. It’s time to restate our opposition to Dr. Unger. Please send a new email to Dr. Monroe, Dr. Frieden, Dr. Koh and Secretary Sebelius. A suggested text and all the contact information is listed below. If you want to reword it, add to it, send it to other people, please do. This is planned as a one-time email (again), but if you want to send several emails please do. If we hear nothing back again, we may send another email (or two) in December. If possible, please also send a copy to challengeCDCcampaign@gmail.com so we have some idea how many emails are sent. It doesn’t matter if you’ve already sent one or if you haven’t. We need to emphasize how we feel about Unger and the past actions of the CDC.

This is important. Thanks for helping all of us.


Suggested text:

Dear Dr. Monroe, Dr. Frieden, Dr. Koh and Secretary Sebelius,

I am writing to express my opposition to the appointment of Dr. Elizabeth Unger as Chief, Viral Diseases Branch at the Centers for Disease Control. In this position, Dr. Unger will be supervising the Chronic Fatigue Syndrome Translational Research Program at the CDC. Dr. Unger has served as Acting Chief, Viral Diseases Branch for several months. During that time she has shown no understanding of the importance of improving the accuracy of the CDC’s CFS website, which is referenced by physicians and patients all over the world. She has continued to allow research to be published using a definition of Chronic Fatigue Syndrome that was rejected by the Department of Health and Human Services’ own Chronic Fatigue Syndrome Advisory Committee (CFSAC) in October, 2009. She has failed to communicate or collaborate with CFS experts outside of the CDC. She has not established “progressive leadership at the CDC that can achieve efficient, meaningful progress in CFS research, clinical care, and education,” another CFSAC recommendation from October, 2009. She has not shown that she is qualified to be permanent Chief. I urge you to select another candidate to fill this important position.

Sincerely,

Name
Patient for years
City or Town, State or Country


Suggested recipient email addresses:

stephan.monroe@cdc.hhs.gov,txf2@cdc.gov,howard.koh@hhs.gov,kathleen.sebelius@hhs.gov

Please send a copy to: challengecdccampaign@gmail.com

Here is additional contact information if you want to call, fax or snail mail:

Stephan S. Monroe, PhD
Director, Division of Viral and Rickettsial Diseases
Room NCEZID
CLFT
Atlanta, GA 30329-4018
tel: 404-639-2391
fax: 404-639-3163
email: stephan.monroe@cdc.hhs.gov

Thomas Frieden, MD, MPH
Director, Centers for Disease Control and Prevention
CLFT Building
Room OCOO
Atlanta, Ga 30329-4018
tel: 404-639-7000
fax. 404-639-7111
email: txf2@cdc.gov

Howard Koh, MD, MPH
Assistant Secretary for Health, Department of Health and Human Services
Room 7-716G
200 Independence Ave., SW HHH B
Washington, DC
tel: 202-690-7794
email: howard.koh@hhs.gov

Kathleen Sebelius
Secretary, Department of Health and Human Services
Room 120F
Washington D.C.
200 Independence Ave. SW
tel: 1-877-696-6775
email: kathleen.sebelius@hhs.gov

Laura Hillenbrand and the WPI

With the publication of her remarkable book "Unbroken" Laura Hillenbrand has once more emerged out of the shadows of her illness. The PA is enthralled with this book, and he is in the middle of reading it. However this post is not about the book; instead it is about the author and her illness – and the research into and the advocacy of her illness. The Patient Advocate feels that he has license to speak of Ms. Hillenbrand’s illness, as she has been open in publicizing it.

Laura Hillenbrand became ill in 1987 and has been housebound or bed bound ever since. Her list of symptoms (no doubt incomplete) culled from the Internet is listed here:

extreme exhaustion
cognitive problems
daily flu-like symptoms
night sweats
light sensitivity
constant fevers
unrefreshing sleep
vertigo, a neurological abnormality
weight loss
consistently weak and dizzy (too weak to sit up or talk)
inability to stand (orthostatic intolerance)
inability to recover after exertion (post-exertional malaise)
“brain fog”
vision difficulties

This set of symptoms meets the 2003 Canadian Consensus Criteria of virally-induced sudden onset ME/CFS. This definition can be found here. This is a critically important document.

At the recent HHS so-called "Science Day", Dr. Joan Grobstein voiced her opinion that the above 2003 Canadian Consensus Criteria were sufficient for determining who has this illness (ME/CFS). It is her conviction that the government does not need to spend more money trying to define a disease outline - they already have one. Both my daughter and Laura Hillenbrand fall under the Canadian Consensus Criteria. (In the case of Laura Hillenbrand this is an educated guess on the part of the Patient Advocate. He has not seen her medical records and has no interest in seeing them - as he sees plenty with his own daughter.) They both have the same serious neuro-immune, neuro-endocrine illness. Many ill patients (between 67% and 84%) meeting the CCC guidelines are XMRV or MLV-related positive. They have a retrovirus of unknown pathogenesis.

Laura Hillenbrand is the public face of ME/CFS at this critical time, and has been for some time. Considering her illness state, Ms Hillenbrand has done valuable work as a ME/CFS advocate - appearing on talk shows (via tape) and radio interviews, as well as writing a wrenching account of her illness in the New Yorker in 2003. She has raised awareness of this illness nationally, perhaps more than any other individual. We owe her a great debt of gratitude.

And yet, in spite of all this, the Patient Advocate must strike a discordant note. In the last year, many things have changed in the world of ME/CFS; there has been a dynamic shift. These changes do not seem to be reflected in any of the reviews or interviews about Hillenbrand’s fantastic book.

To the Patient Advocate this seems like an opportunity missed. Here is a chance to bring two threads, two stories together – recent XMRV - ME/CFS research and the major ME/CFS figure with this illness. The public does not need to hear the old stories about CFS. They have digested Hillenbrand’s CFS and found it to be quaint. In the general public's assessment, this remarkable person has to "lounge around" while she writes her books. The public either has no idea or no interest that ME/CFS is a serious, devastating illness – and that there are answers in terms of diagnosis and treatment on the near horizon. This is not 2003. Today ME/CFS is most likely a retroviral-associated illness. We need to find well-known people to raise up this disease. This illness needs to be elevated in order to bring money and funding for research. Out there in the real world there have to be voices connected to this illness who could speak up and broadly focus the issue. We, the patients and advocates, have to find them.

The Patient Advocate would like to see Laura Hillenbrand connected in a real way to the Whittemore Peterson Institute. The WPI is the best bet to unlock her illness and bring her improvement.

Dr. Marcus Conant and Advocacy

In his quest to help his daughter get better, the Patient Advocate went to hear Dr. Marcus Conant at the recent ILADS conference. Dr. Conant was one of the courageous few that clinically engaged the AIDS epidemic in San Francisco in the early 1980's. Dr Conant did not flinch in the face of this terrible burden thrust upon him. Instead he treated these near dead and dying patients - and became a great advocate for them. He knows the business of disease advocacy, and when he speaks it makes sense to listen.

Recently Dr. Conant moved from S.F. to New York, where he is a consultant. Among other things, he has an interest in this XMRV retrovirus. Dr. Conant sees many parallels of the current situation with neuro-immune illness and the early years with AIDS. An astute Dr. Burrascano invited Dr. Conant to lecture. Dr. Conant gave his lecture without remuneration.

In his half-hour lecture entitled "Lessons learned from AIDS", Dr. Conant gave a stirring talk enumerating a number of key points. The Patient Advocate has read over his notes on this lecture and Dr. Conant's advice to us follows:

"What the AIDS patient learned to advocate for was not compassion from the public, was not sympathy from the public - what they learned to advocate for was research dollars, research funds."

"Focus energies on getting money for research. Find out the etiology of this disease." (in this case he was speaking of Lyme)

"Focus on research, not suffering."

"Don't trust the press." "The press is not your friend." - they are corrupt and have another agenda.

"Congress is your last resource, not your first." "The federal government is not your friend." You first have to prove that something is there.

"Dont blame your adversaries" "Bring them (your adversaries) in, don't cut them out." Otherwise you will have to wait until they are dead - and that could be a long time. (Dr. Conant was not talking about deadly enemies here. He expressed clearly that he would not waste any time on someone whose mind he could not change. In this above quote, he was emphasizing the notion of inclusion - and of not unnecessarily making enemies)

“Develop coordinated activism" How do we best get funds to study this disease?

A month later this presentation still reverberates in the mind and heart of the Patient Advocate. This talk could not have come at a better time.

With ME/CFS, we stand at a crossroads. At this moment the government is sitting on the HHS XMRV blood study group's phase II study. The government is worried about the blood supply. The government has the data and it is pretty convincing. What will they do and when?

Meanwhile NIH research money is not coming to the WPI. The WPI funding applications have been turned down at least four times. They are having trouble getting their current research published in legitimate journals. Why is this? Whatever limited funding they have is drying up. Whether this all is by design is anyone's guess.

Meanwhile other research into XMRV is going on around the country in both expected and unexpected places, fueled by discretionary funding or siphoned off from other projects. Researchers are drawn by natural interest to this new retrovirus. Here is one recent study. And here is another (from MN, no less). These ongoing research projects hold the key to the solution of this ME/CFS XMRV-related illness. Science is the answer. The WPI and their affiliates triggered this. They tripped the switch on all this research. This flashpoint Institute needs funding in order to come up with more answers. Research is the answer. We cannot wait any longer.

(The PA wrote about Dr. Conant before, but this needs repeating)

Laura Hillenbrand

Walking along Broadway in NYC, the Patient Advocate ducked into the Barnes and Noble looking for Laura Hillenbrand's new book "Unbroken". The PA had read book reviews in the WSJ here and here. The PA was informed that the book is actually not released until Tuesday. The Patient Advocate already knows a great deal about this remarkable author and looks forward to reading her new book. Laura Hillenbrand is a very resilient individual and those of us who are familiar with this ME/CFS illness stand in awe of her accomplishments. On Tuesday the Patient Advocate will buy his copy of her book.

Here is a quote from the review: "I'm attracted," she says, "to subjects who overcome tremendous suffering and learn to cope emotionally with it.

Maija Haavisto

Here is a video of Maija Haavisto speaking about her experience with Low Dose Naltrexone (LDN).

The Patient Advocate has wanted to write something about this amazing young woman for some time. Now, with this excellent and informative video, is a good time to do this. Maija Haavisto, a ME/CFS patient herself, has written an excellent book on drug and supplement treatments for ME/CFS. The book is called "Reviving the Broken Marionette" and it can be purchased on her blog site or on Amazon. This book is a must read for anyone dealing with this illness. The Patient Advocate, in his efforts to help his daughter, has consulted this book many, many times. If the PA were to recommend buying one book on ME/CFS, this would be it.

Maija is a self-starter who has done a tremendous amount of research on various drugs that can potentially be helpful in ME/CFS. This self-directed research evolves from her desire to cure herself of this illness. Maiji clearly believes that there are existing drugs and therapies that can bring relief or partial relief to this strange illness. While she is correct in this assessment, she is also open to suggestion. She is a particularly strong advocate of LDN as a ME/CFS therapy. Take a look at this video and admire the efforts of this young woman.

Blood Working Group

With the spate of recent conferences, the Patient Advocate has seen things moving along in the larger world of ME/CFS. Currently we are in a lull - although it is clear where things are going. In the near future, the HHS XMRV Blood working group will issue a report. Although their findings are unknown, the results are painfully obvious to anyone who has been paying attention. The government has seen now the data. The question is, what will they do with it? They have a problem here. How big is anyone’s guess. At the very least, ME/CFS patients in the USA will be banned from giving blood. Most likely the government will have to undertake fishing XMRV out of 4-7% of the blood supply. This will not be cheap or easy. At this point the federal government will be exposed and their resistance to the reality of this new retrovirus will partially collapse. In the meantime the Patient Advocate expects them to try to water down the findings - as they did with the Lo/Alter paper (unsuccessfully). They will try some type of bait and switch.

Various "groups" at Stanford, in Florida and in Reno are working to complete their work on meaningful cytokine/chemokine arrays for diagnosis and treatment of ME/CFS. A few patients and doctors will continue to test existing antiretroviral drugs against XMRV-related illnesses. Labs will be testing additional drugs against XMRV and PMRV. Small pilot treatment trials or individual experiments will be or have been started with a variety of drugs, whether they be antiretrovirals, GcMAF, peptide T, rituximab, stem cells or other drugs. Some will even involve existing therapies. It is worth remembering that existing therapies have brought betterment to many virally-compromised patients. Now these therapies will be able to be tested in a more refined manner - and it is hard to imagine a situation where existing therapies will not be rolled into future treatments. The window of observation and tracking treatment will broaden

It is worth reminding the reader that the consolidation of the research comes only in the wake of the October 2009 paper. Many other clinicians and researchers over the years have made significant contribution but the WPI has been the flashpoint and they lit the match.

The Patient Advocate started this blog to communicate his experience as a patient advocate - in hopes that it might benefit others in a similar position. Over time, the content has drifted into the ongoing struggles of advocacy, and the battle over research into ME/CFS.

The subject of the blog has become bifurcated - between practicality (the daily nitty-gritty) and abstractions (research and potential treatments surrounding the discovery of XMRV). These are two different worlds in which a Patient Advocate must live: the daily grind of particulars, and the more rarified abstractions involving "potentialities". The one is very real; the other is very theoretical.

Search for an I.D. doctor

Recently, the Patient Advocate has begun an effort to find an Infectious Disease doctor in the Twin Cities - someone who will take an interest in his daughter’s case. The Patient Advocate has systematically and slowly searched out and emailed 50 I.D. doctors in the Twin Cities. Each doctor gets a letter explaining the particulars of the PA's daughter's illness and a request for help and suggestions. The PA has received ten responses, some with very general advice that indicates that the recipient did not read the email very carefully. None of the responses made a specific suggestion. The Patient Advocate has no illusions here. This is not going to be easy. This might take some time. 

In the meantime the PA is going to learn the names of every I.D. doctor in the Twin Cities. Each one of these doctors is going to get the report of the HHS XMRV blood working group as soon as it is published, along with every other significant piece of information that emerges in this unfolding drama. It might take a few more years in order to get a doctor for my daughter.

This effort to find a compliant I.D. doctor conforms to the aspirations of the Whittemore Peterson Institute. The WPI is looking for or searching out I.D. doctors with whom to work. The WPI already has reached out to make a connection to Dr. Brewer, an infectious disease doctor in Kansas City, Dr. Montoya at Stanford, Dr. Burrascano in NY and Dr. Conant - all who have expressed interest or partial interest in collaborations.

Patients all over the country are looking for doctors who might be open-minded about the ME/CFS- XMRV connection. Patients and advocates ask what can they do to help? One specific thing that they can do is to try to find doctors who are willing to take on XMRV-related patients. In the Patient Advocate opinion HIV doctors are the best bet.

The enigmatic E. F. Ramos, M.D.

From his small perch in MN, the Patient Advocate looks out over the ME/CFS landscape. The PA has arrived once again in this frozen city to help his daughter. The Patient Advocate’s daughter has started a new blog here.

The internet is a funny place. Yesterday a message was left on the PA’s blog under an old post on Dr. Kenny de Meirleir. (The reader will remember that Dr. de Meirleir has said that XMRV “is not everything” in this ME/CFS illness.) The poster of yesterday’s message was a certain E.F. Ramos, M.D. The name is not known to the Patient Advocate, nor was the PA able to find out much about him from an internet search. So E. F. Ramos remains an enigma. Here is the message:

“With the help of De Meirleir and his team I’ve gone beyond them. Although he and his groups unveiled ONE fundamental pathophysiological mechanism in ME/CFS, he did not reach the ULTIMATE CAUSE of the disease. And it seems I did. So far I have tested as REAGENT 127 patients with his NEUROTOXIC METABOLITE test, and 82% became NEGATIVE after the therapy I’ve developed. Also most got real clinical improvement, or full remission. I’ll soon publish my data.”

On another blog, an October 19, 2010 message, also by a certain E. F. Ramos M.D., states:

“Hello folks, I have been studying ME/CFS for 11 years and I’m finishing a clinical research with already 148 patients, all tested with a miniaturized version of de Meirleir test. This test doesn’t detect the CAUSE, but rather a POWERFUL PATHOPHYSIOLOGICAL MECHANISM involved in ME/CFS. However, I’ve developed a unique treatment that leads to a NEGATIVE test in previously REAGENT patients, with impressive clinical improvements in most of them. Very important I have tested and treated 16 DOCTORS and NURSES with the disease but their skepticism faded with successful targeted treatment.

I’m not hunting patients, I do not intend to continue diagnosing and treating ME/CFS patients; and I am not involved with business related to ME/CFS. In fact de Meirleir just sent me the tests for evaluation; and he doesn’t even know my results. I just intend to discover how to cure the disease. Meanwhile I can only affirm the test is a good diagnostic tool, especially useful for those not acquainted with ME/CFS clinical coherence, something that takes time to achieve. Soon I will publish my results.”

Perhaps a reader can shed some light on this?