Friday, September 24, 2010

WGBH Program: PBS NewsHour

Click on title to view video.

The Patient Advocate stumbled upon this news feature on September 23, 2010 on the PBS newshour. The story seemed strangely familiar. The relevant part of the program starts at 33:15. It is a fascinating story involving real researchers in real universities.

The model presented in this video is the model that the Patient Advocate hopes can be followed in ME/CFS research. It is the public stance of the Whittemore Peterson Institute, a position that they have articulated from the very beginning. The essential bullet points involve collaborative research, shared data in real time, and patient (or treatment) oriented research. (bench to bedside to bench). These are not new ideas invented by the Whittemore Peterson Institute - as can be seen in this video. These forms of research are happening in a variety of areas - HIV, gioblastomas, MS, kidney disease - and more. The WPI is just applying them to ME/CFS research, so far with uncertain results.

Whether or not this model is realistic for the historical claptrap world of ME/CFS research will be seen in the future. Various circumstances of the last year reveal that the scientific force field in ME/CFS is more convoluted than in a disease like MS. (Is this possible?) Most of this can be related to the "disbelief factor" of ME/CFS. Perhaps with the reality that ME/CFS is crossing over (or has crossed over) into the Infectious Disease category will bring it more legitimacy. With an established disease legitimacy, more cooperation, more sharing of data (without stealing) perhaps can take place. The Whittemore Peterson Institute is certainly committed to this idea. They need our continued backing at this critical juncture. Without collaborative research, without the possibility of sharing data, any advances in ME/CFS research will take place very slowly or not at all.

The Patient Advocate has pointed out previously an article in the NYTimes on a similar collaborative, data sharing project in Alzheimer's - underwritten with hard cash from the NIH. Whether these projects are funded by the government or private donors, the essential element of trust has to be present. Older ideas of backbiting and backstabbing have to be temporarily put aside, in order to reach a higher level of operation. This means that data that is freely given or made public by one entity cannot end up in another researcher's grant proposal or published paper, presented as her own. This newer model also cannot work if there is not a give and take. The paradigm is inoperable in a situation were people only take. The WPI is taking their chances reaching out to some of these big-shot research centers, who might be guided by self-interest and venality. This is a two-way street - an idea of total commitment and collaboration. Individuals have to take a back seat to a larger effort. But is this possible in ME/CFS research? It is on this single issue that ME/CFS research will live or die.

Thursday, September 16, 2010

Catch-22

The Patient Advocate is not clear on the blog protocol or etiquette on promoting another blog site. Certainly the PA lists the blogs that he reads regularly, but how does one highlight something beyond that? The fact of the matter is that some ME/CFS blogs rivet one's attention on a regular basis.

One of these exceptionally special blogs is maintained by Kyal, entitled livingwithchronicafatiguesyndrome.wordpress.com. Recently Kyal has taken on the anti-CFS American and UK establishment from his home in Australia. His detailed reporting on these interchanges is significant and revealing, and he is up to the task of engagement. What is most surprising is that this all comes from a chronically ill young person. Having a front row seat as this fellow guns down bureaucratic shitheads a half a world away is a real privilege. Towards the end of his recent blog post "The CDC Responds", quoting from Joseph Heller's Catch-22, Kyal shows that he deeply understands the mechanisms and mindset of the "poisonalities" at the CDC. Through polite deliberation and finely detailed argumentation, Kyal engages them -allowing them to hoist themselves on their own petard. They are no match for him and his persistent, sharp, articulate arguments. Of course, they don't have the "time" (or the brains) to properly answer his questions as they are Gogolian "important" people. This blog of Kyal's makes for very exciting reading - and it reveals, in a perverted and controlled way, the heart of the problem with the CDC (and others). For those who do not read Kyal's blog, the Patient Advocate suggests that you start now and give it a try. It might be to your taste. For the PA, it is the very best.

Friday, September 10, 2010

The Rescued and the Rescuers

On Friday September 10th, the Whittemore Peterson Institute had their 6th annual fundraiser in Reno, Nevada. A three part video was presented at this event, profiling the rescued and the rescuers. The video examines several XMRV-associated illnesses. This set of videos was conceived by the WPI and filmed and edited by Peter Cairns. The music is by the Polish composer Maciej Zurawski, who lives in Edinburgh and who has recovered from ME/CFS.




Thursday, September 9, 2010

Hire this guy.

Dr. Michael Snyderman

Yesterday's question and answer session was a grinding bore. The tone was set by an incredibly irritating moderator from the UK. Who was this guy? Where do they find these people? He was like a bad English actor, a bit drunk, a bit incoherent. The session quickly evolved into a series of incredibly stupid questions. Each questioner, deeply ignorant of the subject, felt the need to say whatever came into their heads. And then there was the obligatory researcher griping by a woman who needed to have the door closed on her publicly. These guys and gals have no shame. They have no ability to restrain themselves, and this inability allows the situation to fall apart very quickly. Towards the end, an oncologist from Buffalo, pictured above, asked the only good question of the day. His question got some of the members of the panel to focus on what is at hand. This fellow's name is Dr. Michael Snyderman. Hire this guy - he is great.

Hopefully there were other people at this conference like Dr. Snyderman - men and women who can identify the problem and focus their minds on it. Make no mistake, in spite of the circus idiocy of this conference, the WPI is building allies, accumulating collaborators. It is obviously slow going, but it is happening. The WPI is holding all the cards. They just need to keep doing what they are doing, picking up the smart folks and forgetting about the rest. Seeing Dr. Snyderman in this sea of crap gave me hope - and no, the Patient Advocate had no idea about him previously.

(On September 28th Jamie Deckoff-Jones published a very important post on Dr. Snyderman's poster paper at the XMRV conference. Later the same week Mindy Kitei wrote a post on Dr. Snyderman and promised more to come in the form of a longer interview. These are two of the key bloggers on XMRV or MLV-related viruses.)

Wednesday, September 8, 2010

The REAL second most important day in ME/CFS research

Yesterday, events forced the Patient Advocate to move the vaunted Dr. Alter's confirmation paper to third on the list of "the most important days in ME/CFS research". Sorry, Dr. Alter.

Yesterday morning the Patient Advocate received a call from his son Peter, asking if he had heard the news on the BBC world news about the study that came from the University of Dundee in Scotland? (My wife also heard it on the news on the way to work.) I immediately went looking for it and found very little online. Later the contents of the study were released here.

This study came out of the blue. Very few people knew about it, or knew that it was coming. This study is a very big deal. While it does not mention XMRV, it does establish an association between white blood cell dysfunction and ME/CFS.

ME/CFS patients' systems give clear indication of fighting viruses, along with the attendant inflammatory issues. Coming hard on the heels of the long and unnecessarily delayed confirmation of the NCI/WPI October study, the study release gives us the REAL "second most important day in ME/CFS research".

In Bethesda today, the NIH conference is continuing. At this point, we are supposed to be thankful to these people. The NIH has had two weeks to respond in a positive way to the Alter study by freeing up discretionary money for research. Instead they have done nothing. Believe me, money is a five minute cell phone call away. Instead the NIH wants to run another confirmation trial, to revolve the discrepancies of the prior negative studies. Good luck! This is the usual "money well spent" - money used to elevate and justify one's own incompetence. Do we need this? No, we do not need this.

Somehow we are supposed to trust and believe in the very institutions that have participated in a not so subtle contortion of reality for 25 years. The Patient Advocate does not trust any government scientist. The PA has no reason to trust them.

The NIH obviously now wants to "get in on the action". This long summer of unease at the NIH/HHS occurred for a reason. The reason for the delay of Alter's paper was not because further study was warranted. Dr. Alter was not telling the complete truth on this one. The three month delay was designed to strategize what to do with the discovers of this XMRV connection with ME/CFS - and to figure out how to neutralize or degrade the NCI/WPI/Cleveland clinic position. It is currently going on. The NIH is interested in wresting control or partially wresting control of this illness connection away from the discoverers of it.

What can the NIH really do to help? They can immediately give money to the people who have gotten us here. (The Patient Advocate can supply them with a list.) They can immediately fund treatment trials. They can even do their little confirmation trial if it makes them feel happy. The time is now to move. Until the NIH comes up with a load of dough, this organization will be without any credibility.

So this conference goes on into its second day. Andrea Whittemore states that, "things will finally be put to rest during Dr. Ruschetti's talk on CFS". Having seen Dr. Ruschetti in action, the PA believes what Andrea says. Mikovits will give her talk and then, during the question period, smack NIH questions out of the ballpark. The Patient Advocate has seen it.

At the end of the day, the question will be, did the NIH learn anything? For the past two days, 200 new-fangled scientists have been sitting in a conference room trying to get up to speed. Did anything happen? Will they be able to get on board, or are they going to continue to dawdle?. Things are now moving at exponential speed. The NIH needs to wake up. It is not too late. If it didn't happen today, it will never happen.

The NIH added this CFS section at near to the last minute. Input was invited from those who know the most about this illness - the WPI, Dr. Brewer, Dr. Cheney, Dr. Bell, Dr. Peterson, and Dr. de Meirleir. A consortium needs to be funded around these clinicians, and NIH funded treatment trials begun. The framework is there. This is going to happen, either with or without the NIH. It's their choice - but please - if you don't want to help - get out of the way.

(All I can say after watching this supposed panel discussions taking questions from a partially differentiated, partially "semi-intelligent" group of scientists, is - thank God for the WPI. Over the years, the Patient Advocate has seen some pathetic question and answer sections, at conferences and in academia. This was the worst. There was one sharp question (from an oncologist). The general level of ignorance of these folks was astonishing. (ME/CFS questioners are excluded from this criticism.)


Tuesday, September 7, 2010

CFS Patients meet with NIH

SUMMARY OF SEPT 7, 2010, MEETING WITH NIH OFFICIALS AND CFS PATIENTS AND FAMILIES

By Rivka Solomon, with help from Robert Miller

Contact: Robert Miller

On September 7, 2010, at 11 a.m., at the NIH campus in Bethesda, MD, a group of 9 CFS patients and their families met with high-up NIH officials. To my knowledge, this is the first meeting of its kind in the 27 years since I was first struck down with this illness in 1983.

The meeting was organized by long-time CFS patient Robert Miller. The meeting's CFS participants (patients and family) included: Charlotte, Linda, Sherry, Scott, Marielle, Bobbi, Rivka, Robert and Megan. A wonderful surprise addition to the meeting was Dr. Dan Peterson, of Incline Village, NV, champion doctor of CFS patients and co-founder of the Whittemore Peterson Institute in Reno, NV.

The meeting was held just prior to the start of the 1st International XMRV Conference sponsored by the NIH. The NIH officials present included:

Michael Gottesman, M.D.

Chief of NCI's Laboratory of Cell Biology

and Director of the NIH Office of Intramural Research

http://www.nih.gov/about/almanac/historical/deputy_directors.htm#gottesman

Paul H Plotz, M.D.

Chief, Arthritis and Rheumatism Branch (NIH)

http://www.niams.nih.gov/Research/Ongoing_Research/Branch_Lab/report_individual.asp?id=569&Branch_LabID=25&email=plotzp@mail.nih.gov%20&includefile=RAG

Roland Owens, Ph.D

Assistant Director of the NIH Office of Intramural Research and Chief of the Molecular Biology Section in the Laboratory of Molecular and Cellular Biology in the National Institute of Diabetes and Digestive and Kidney Diseases at NIH.

http://jgh.hunter.cuny.edu/index.php/component/content/article/6-biographies/95-owens-roland-a-phd.html?directory=18

These are my impressions of the meeting. Any and all mistakes, such as misrepresenting someone's words or sentiments, are all mine. And I welcome any corrections from others.

The agenda that Robert Miller originally set for us went smoothly. It was for a half hour meeting, but in the end we were given a full hour. First, Robert had the patients go around the large table and introduce ourselves, stating how long we have been, or our family member has been, ill. Then he read a statement which included points and issues he felt needed stressing. They focused on, but were not limited to, these two key points:

1. The need for trust building

In the past, our government offices (NIH, CDC) have acted in ways that has eroded our trust in them, from the (rather amorphous) decades of neglect to, most recently, the highly concret fact that Judy Mikovits, the scientist who found the link between XMRV and CFS, was excluded from the XMRV Conference line up until patients loudly complained. Robert said that we now need our government to act in a way that engenders our trust in them.

2. The need for funding

Funding is needed for ME/CFS research, clinical trials, and Centers of Excellence (including WPI).

(For the full text of Robert's statement, see below.)

After Robert made his very salient, well-written points, Dr. Peterson made a statement, and then three additional patients made theirs, each lasting about 2 minutes. (My statement is included below.) Honestly, embaressingly, I can't recall any of them. Though I do recall feeling very proud to be on the same side as Dr. Peterson. And I do recall feeling very moved by the patients' statements. One woman, the mother of a long-time patient, made a strong plea for attention to pediatric CFS issues.

After Dr. Peterson and the patients' spoke, it was Dr. Michael Gottesman's turn. He told us that he had talked to Dr. Francis Collins just that morning, and that the NIH Director wanted us to know that positive things were going to happen. "We are on track. Things will happen." He did mention that NIAID is currently setting up multicentered clinical trials.

After he talked, we patients started with questions. It was a 1 hr meeting, so there were many topics and I cannot recall all of them. They included (not necessarily in this order):

- What power and purse strings Gottesman has as Deputy Director of Intramural Research. He was pointedly asked, Can you make a commitment to us right now for clinical trials? Answer: Gottesman explained that his department, Intramural Research, means research done within the NIH, not outside the NIH. Intramural Research is only 10% of the NIH budget. Intramural Research is where "higher risk" research can be done (I am not sure why he brought up that point, i.e. if it relates to us or not.) My impression was that he felt he did not have a lot of say in deciding on clinical trials. My impression was that he was at this meeting because Collins wanted someone high up to meet with us, but that Collins did not have the time (or inclination? Or knowledge of our needs?) to match the person we would meet with what our actual needs were. Others may have a different impression of the situation. Gottesman did say, in so many words, that the meeting was hastily arranged, and for the short time they had to arrange it, it was pretty good to get someone as high up as he. In terms of funding, he did say, "There will be more funding, and more publications."

- Patients pointedly asked why has this illness been ignored for 2+ decades. When Gottesman said it was due to a lack of concrete scientific, clinical and medical findings and published papers, patients countered that there are 5000 scientific and medical studies on CFS already published.

- When Gottesman said that Alter's paper was the first evidence of something concrete (i.e. a virus) for CFS, patients reminded him about Elaine DeFreitus and how her viral findings were ignored and even discredited by the CDC 19 yrs ago.

- Strangely, at least to us patients, Gottesman praised the former CFS point person Dr. Strauss, saying that both the NIH and CFS patients lost a good fighter for our cause when we lost Strauss. No patients nodded their heads in agreement. Gottesman also seemed not to know about the disappointment patients feel towards NIAID Director Fauci. So we told him we did not feel warm and fuzzy towards him for having ghettoized us to the Office of research for women's health (I don't recall their official name), which has no money.

- Gottesman noted how dangerous it is to take antiretrovirals when we have not done clinical trials. And before clinical trials they need to test the meds in vitro. We patients responded with the fact that there are already two published studies on antiretrovirals that work to hinder XMRV in vitro. (We sent these two studies to Gottesman via email after the meeting.) I think it was Dr. Peterson who talked about how patients are already doing antiretrovirals. That that is how desperate we are.

- We talked about how if XMRV or related viruses are a deadend (i.e. not a cause of CFS, and not a cause of anything hurtful to the body), we hope their interest in CFS does not reach a deadend, too.

- Patients discussed the pathetic name our illness was given, Chronic Fatigue Syndrome, and how that very name has contributed to families abandoning their sick family members because of a disbelief that they are really sick.

- Gottesman talked about how respected Dr. Alter is and how Alter's interest in our illness and his published study will change everything for our illness. Alter, and his paper, carry a lot of weight.

- When the NIH team (Dr. Owens) said more people were needed to go into the field of CFS research, Dr. Peterson said there are many good doctors who are already working on this, but not getting funding. And patients stated that the lack of funding in general, for CFS, turns off potential researchers.

- Patients talked very concretely about how funding for CFS projects and research are selected and allocated, and how the team who approves CFS research grants is flawed (noting the dentists and psychologists who are included in the team, as opposed to more immunologists and CFS experts).

- Gottesman said that for our specific concrete greivences, we need to write a letter stating those grievances and concerns and send that to the Director Collins's office. He promised us that it will be addressed and forwarded to the right person within the Director's office. (If patients are willing to send emails to Director Collins, we ask you to select something from the list of points Bob raised in his statement, found below. Pick the one or two points that you feel most effects or moves you.)

- Most importantly, Gottesman said he'd meet with us again. And I think 3 months time was suggested. We said we'd like others involved in that meeting, perhaps others from the NIH who we might suggest, due to our specific needs.

Any mistakes in this assessment of our meeting are all mine. There is a good chance there are many mistakes, as it was all taken in through exhaustion, brainfog and a poor memory.

Thanks to Robert Miller for organizing this meeting, to Dan Peterson for adding the weight of his years of experience and expertice. Thanks also to the amazing patients and family members who shared difficult stories of years lost to CFS, and to the NIH officials who took the time to meet with us and will hopefully meet with us again in the near future.

-- Summary by Rivka Solomon, with help from Robert Miller

_______

Robert Miller's testimony at the NIH meeting, September 7, 2010

My name is Robert Miller. I want to thank you for meeting with us today. We are particularly grateful for your work Dr. Lo and for Dr. Alters as well, and the PNAS publication.

I have had CFS for all of the 25 years that it took the NIH to get to this point. And still, we are only at the beginning of understanding a retroviral role in my illness.

I’d like each person with me to introduce themselves to you briefly and then I have 5 points that I want to make on behalf of patients here and the 1-4 million others suffering throughout the U.S.

INTROS

  1. Trust Building: The PNAS paper was critical in confirming the Science study last fall which identified a retroviral association with CFS. But the fact that it almost wasn’t published, that it took an outcry from patients and scientists, and that the NIH almost let the CDC prevail after 25 years of failed CDC studies, is frightening to us patients.

    1. Even with the first XMRV conference sponsored by NIH, starting today, the researchers that found the XMRV association in CFS were not going to be invited to speak until patients protested.

    1. So, we present this petition, even though the study was published, because the 1016 patients who signed this petition, and many more will be watching the NIH’s commitment to scientific progress in CFS very closely, and you have some trust to build as our federal health agency in this patient population.

    1. We are also delivering this second petition from P.A.N.D.O.R.A. (PATIENT ALLIANCE FOR NEUROENDOCRINEIMMUNE DISORDERS ORGANIZATION FOR RESEARCH AND ADVOCACY) with nearly 1600 signatures requesting a meeting with Secretary Sebelius to address the lack of funding for CFS/ME, and related illnesses.

  1. Funding. NIH’s record of funding CFS research is near zero. Less than $2 per CFS patient per year. So patients are demanding that the NIH allocate at least $100 million dollars over the next two years to researching CFS, especially the family of retroviruses that you have now identified.

    1. I’ve heard years of excuses at the CFSAC meetings from NIH representatives that not enough fundable proposals make it through your process. We know that right now you have a stimulus budget. We Say “Build it and They will come”. You have a huge opportunity right now to attract hundreds maybe thousands of proposals on this illness, and you need to be aggressive about it. That means changing the process, expediting the way proposals get reviewed and studies get funded, like you did with AIDS.

    1. There are many lessons from the AIDS epidemic that you published yourselves. [shown in the report]. One lesson is that funding early saves money in the future and certainly could prevent the spread of a debilitating virus. The book that gives an account of the politics behind HIV in America "And the Band Played On" describes Dr. Don Francis then at the CDC, was turned down for $30 million in funding when he was desperately trying to prevent the spread of AIDS in 1985. That lack of early funding for HIV prevention cost the U.S. government $$$ Billions of Dollars later while addressing the HIV/AIDS epidemic, which we are still fighting.

  1. We would not be here if the privately funded Whittemore Peterson Institute had not identified the connection between XMRV in cancer and the immune problems (RNASE L defect) in CFS patients. They had to know CFS patient histories to figure that out. That is why it is Key to have doctors like Dr. Daniel Peterson, Dr. Nancy Klimas, Dr. Antony Komaroff and others working with NIH researchers. We need CFS Centers of Excellence funded by NIH – as recommended by the CFSAC advisory committee for years. The WPI should be funded as the first one, and you need to make others happen.

4. NIH and FDA need to drive a clinical trial process for treatments with the end goal of making safe and accessible treatments available as soon as possible. We are already experiencing the AIDS-effect of patients self-medicating with very serious medications, such as antivirals and antiretrovirals, because many of us are desperately sick and there are no alternatives for CFS patients - none.

a. I have participated in the only clinical trial approved by the FDA for CFS, the Ampligen (AMP-516 and AMP-511) study. I was on it 10 years ago, And I improved, the data showed efficacy, but still the FDA denied approval. After living in the DC area for 5 years, I had to up-root and move my 10-year old twin sons back to Reno, so that I could access Ampligen again, but yet To This day, I am still one of only a few patients with access to Ampligen. There is no excuse that there is only one trial in one city in the whole country to access the only treatment available. NIH needs to seed this process quickly, so patients have faith that FDA trials will bring them relief. The alternative is chaos like the early days of AIDS.

5. Lastly, children with CFS is a very troubling issue. Many recommendations have been made by CFSAC to address the obstacles to real pediatric care and coordination with educators and law enforcement. Children with CFS have to be part of the science. Your PNAS study also compels us to worry about passing this living torture to our children and spouses, and to worry whether every childhood cold will trigger what I have. What would you do if it were your child?

While I am angry that it has taken decades to get here, I Still have Hope, Because, We are sitting here today, just prior to the First XMRV Conference and because the NIH has confirmed a breakthrough. Your speed and commitment will give us our lives back.

Thank you for allowing me to speak here today.

-- Robert Miller

________

Rivka Solomon's testimony at the NIH meeting, September 7, 2010:

In 1983, I was 21 when I got mono and never fully recovered.

So one day I'm a straight A student leader, a mountain hiker, a global traveler, climbing the career ladder in int'l relations -- the next day I didn't have the strength to brush my teeth.

Two decades later, I'm still bedridden and homebound much of the time. Two decades -- because my gov't and the medical community refused to believe my illness was real. Instead of taking me seriously, my illness was labled "fatigue." The NIH ignored us, which was devastating. But the CDC did worse; They published studies saying CFS was an inability to handle stress, was due to childhood abuse or was an emotional imbalance. (Their most recent study saying this came out just last month.)

Last wk, 26 yrs after I got sick, my blood was tested and, yes, I have the human gamma retrovirus XMRV. My next step is to take dangerous anti-retroviral meds, even though, unfortunately, clinical trials have not been conducted.

I'm still bedridden much of the time; it will take me weeks to recover from the energy required for this meeting. But I am so glad to be here.

I am here to ask each of you, personally -- you (point or look at each NIH rep) -- to help me and the 1-4 million Americans with CFS that I represent today.

- We want you to fund fast-track clinical trials for treatments, medications.

- We want you to fund Centers of Excellence just for this illness, starting with the WPI in Reno, the folks who discovered this link between XMRV and CFS.

We have spent the last few decades abandoned by our gov't. Abandoned. Please do what is right and help us. Now. Finally.

Lastly, I want to publicly thank Dr. Dan Peterson for believing us and for dedicating his life to us.

And I want to thank my mother, who has stood by through the last 2 decades. (She was present at the meeting.)

-- Rivka Solomon

_______

Closing Note: In a post-meeting email exchange between Deputy Director Gottesman and CFS participant Rivka Solomon, Dr. Gottesman said he would be forwarding Rivka's "Dear Secretary Sebelius, Dear Director Collins" singing video to NIH Director Francis Collins. (Video found here: http://www.youtube.com/watch?v=8t1Xqp1LDxM )