On September 7, 2010, at 11 am, at the NIH campus in Bethesda, MD, a group of 9 ME/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, MD
Chief of NCI's Laboratory of Cell Biology
and Director of the NIH Office of Intramural Research
Paul H Plotz, MD
Chief, Arthritis and Rheumatism Branch (NIH)
Roland Owens, PhD
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.
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 have eroded our trust in them, from the (rather amorphous) decades of neglect to, most recently, the highly concrete fact that Dr. 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 Attachment #1 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 Attachment #2 below.) Honestly, embarassingly, 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 NIH Director Dr. Francis Collins just that morning, and that the 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 multi-centered clinical trials.
After he talked, we patients started with questions. It was a 1 hour meeting, so there were many topics and I cannot recall all of them. They included (not necessarily in this order):
Question: What power and purse strings does Gottesman have as Deputy Director of Intramural Research? He was pointedly asked, “Can you make a commitment to us right now for clinical trials?”
Response: 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?) for the meeting.
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."
Question: 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 5,000 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 researcher Elaine DeFreitas and how her viral findings as a Wistar Institute virologist were ignored and even discredited by the CDC 19 years ago.
• Strangely, at least to us patients, Gottesman praised the former CFS point person Dr. Steven 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 regarding NIAID Director Anthony Fauci (appointed in 1984). So we told him we did not feel warm and fuzzy toward Fauci for having ghettoized us to the NIH Office of Research on Women's Health, 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.
Other Topics Covered
• We talked about how if XMRV or related viruses turn out to be a dead end (i.e., not a cause of CFS, and not a cause of anything hurtful to the body), we hope their interest in CFS will not reach a dead end, 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 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 grievances, 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 affect or move you.)
• Most importantly, Gottesman said he will 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 whom we might suggest, due to our specific needs.
(Note: 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 expertise. 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.
Robert Miller's testimony at the NIH meeting, September 7, 2010
[including presentation of patient petitions to the NIH]
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. Alter’s work as well, and for 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 to 4 million others suffering throughout the U.S. [Pause for introductions.]
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.
a. 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.
b. So, we present this petition [demanding publication of the Alter/Lo/Komaroff paper], even though the study was published, because the 1,016 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.
c. We are also delivering this second petition from P.A.N.D.O.R.A. (Patient Alliance for NeuroEndocrineImmune Disorders Organization for Resarch and Advocacy) with nearly 1,600 signatures requesting a meeting with Secretary Sebelius to address the lack of funding for CFS/ME, and related illnesses.
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 over the next two years to researching CFS, especially the family of retroviruses that you have now identified.
a. I’ve heard years of excuses at the CFS Advisory Committee 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.
b. 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 how 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 in addressing the HIV/AIDS epidemic, which we are still fighting.
3. Centers of Excellence
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 has been recommended by the CFS Advisory Committee for years. The WPI should be funded as the first one, and you need to make others happen.
4. Treatment Trial Process
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.
b. 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 can have faith that FDA trials will bring them relief. The alternative is chaos, like the early days of AIDS.
5. Attention to Pediatric CFS
Lastly, children with CFS is a very troubling issue. Many recommendations have been made by the CFS Advisory Committee 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 about 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 International 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 (firstname.lastname@example.org)
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 international relations, and 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 government and the medical community refused to believe my illness was real. Instead of being taken seriously, my illness was labeled "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 week, 26 years after I got sick, my blood was tested and, yes, I have the human gamma retrovirus XMRV. My next step is to take potentially 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 (I pointed and looked at each NIH rep) – to help me and the 1 to 4 million Americans with CFS whom 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 government. 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 is here in this meeting and has stood by through the last two decades.
– 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 )
Note: ProHealth has reproduced this material here with the generous permission of the authors, and humbly thanks them and all who used precious energy today to stand in for millions more – in the US and all around the world.