Saturday, June 25, 2011
Friday, June 17, 2011
Tuesday, June 14, 2011
Principal Deputy Assistant Secretary for Health
Designated Federal Official--Chronic Fatigue Syndrome Advisory Committee
US Department of Health and Human Services
200 Independence Ave. SW, Room 716G
Washington, DC 20201
Phone (main) 202 690 7694
Phone 202 260 4432
Fax 202 690 6960
"Mobilizing leadership in science and prevention for a healthier nation"
Monday, June 13, 2011
A number of weeks ago I posted a letter from Dr. Joan Grobstein to Wanda Jones in which Dr. Grobstein addressed a number of "shortcomings" at the recent ME/CFSAC meeting.
Generally people in the position of Wanda Jones will do one of two things. They will either reply immediately - or not at all. Let's give credit to Wanda Jones for her speedy reply. Her letter follows here:
"First of all, Dr. Grobstein, I assure you these circumstances were NOT at my direction. Indeed, registration is not required for a public meeting, but we are limited by capacities set by fire codes. We have little history of having more than 50 people in attendance at a CFSAC session, and we had no reason to think we would have more demand than we could accommodate this time.
As soon as I heard that people were being turned away, I went to the lobby to find out what was going on. There was a miscount of people signed in, and staff thought we were at the fire limits for the room that second morning. Only people who had already signed in and were returning were able to enter; we straightened out the counts, and in fact added 8 more chairs. To my knowledge folks who came after things were clarified were allowed entry, at numbers up to the room capacity. We had very few, if any, empty seats the morning of day 2. We also looked for several people who had not returned for day 2, so that further enabled attendance by others. I am not aware of the guards turning people away, but we will ensure that the procedures for managing building entry are clear for future meetings.
Rules governing Federal Advisory Committees require that all materials provided to the Committee as part of the proceedings must be distributed through the Designated Federal Officer or designated staff. Individual leafleting or leaving materials (including testimony) on a table in the back of the room is not permitted, the goal being that ALL materials provided are part of the public record. (We have discontinued providing copies of everything because of the cost; when we analyzed what was left over, we found ourselves recycling over 80% of the copies, not a good use of taxpayer funds. All the material provided as part of the meeting is posted on the CFSAC website, and is in a notebook at the back of the room for viewing during the meeting.) We did distribute copies of Megan’s testimony to the members, and it will be posted on the website, as is all material submitted. Materials at the back of the room are to be placed there solely by the DFO and staff, not by audience members. We monitor the tables for new additions and remove those items as we find them. This is how CFSAC has been managed since its first meeting in 2003, and this policy is consistent with the regulations governing Advisory Committees.
I was not aware that everyone was removed from the meeting room during lunch. That has never been our policy, as we recognize that some people bring their own food and others simply need the quiet, as you have expressed. That room is engaged by us for the whole day, and again, going forward, we will ensure that a staff member remains in the room. We have been admonished ourselves by HHS Security, for failing to observe the requirement that we accompany visitors whenever they leave the meeting space. I’m sorry this seems obtrusive, but as you know the configuration of the meeting area and the nearby restroom is only minimally acceptable for a large meeting. You’re right that no one should be shouted at, and so, we’ll address these issues with the folks who are providing onsite support for future meetings.
Finally, your suggestion of recapping the recommendations at the end of the meeting is a good one. This meeting, unlike others, generated recommendations as it progressed, rather than in the flurry of the last hour or so of the scheduled time. It would have been good to restate all the recommendations at one time. Three recommendations endorsed by the Committee will be submitted to the Secretary by the end of May. She has 30 days to review them before we post them. Again, this is a standard procedure for advisory committees run by HHS.
Thank you for taking time to point out some of the logistical and other concerns with the May 10-11 CFSAC meeting. As the responsibilities for managing the Committee had already begun their transition, resulting in many new people assisting with various aspects of the meeting, there were bound to be some miscommunications and problems. We are committed to providing a fully accessible meeting, and your feedback is helpful in attending to the onsite issues. "
The problem with rapid responses is that they are rapid. Too much comes out in misdirected fashion. A more measured, reflective response might have served Wanda Jones better in this situation - a situation, incidentally, that she created herself.
Nevertheless we will leave it to Dr. Joan Grobstein to point out the deficiencies in Wanda Jones response. Dr. Grobstein's letter follows:
Dear Dr. Jones,
Thank you for your very quick reply. I wish I was capable of replying as quickly.
I have some concerns about your reply.
First, the literature distribution policy has not been consistent since 2003. At the first meeting I attended in October, 2009, I brought copies of my oral testimony and handed them to a staff member who placed them at the back of the room. There were many other copies of testimony on the table. Audience members were free to take these copies. I understand that the government may not want to pay to make copies if few are actually read. However, it does not seem reasonable to prohibit the public from bringing their own copies, handing them to a designated staff member who can save a copy to incorporate into the public record and then make them available to whoever wants to take one. We are all willing to follow rules, but the rules must honor our right to free speech and assembly, which is not suspended when we enter a room where a Federal Advisory Committee is meeting. Also, the rules should be clear and consistent from meeting to meeting. Any changes should be announced in advance, and all rules should honor basic constitutional rights.
Second, you have not explained why CFSAC staff was not permitted to distribute Charlotte von Salis' copies of the Overview of the Canadian Consensus Definition to Committee members. She referred to this document in her testimony, so it was already part of the public record. She also was not permitted to have CFSAC staff distribute copies of a petition, signed by over 550 members of the patient community, stating that they do not recognize the CFIDS Association of America as their representative agency (http://www.change.org/petitions/petition-to-disassociate-from-cfids-association-of-america-as-our-advocacy-representative). This was also part of her testimony and was also already part of the public record. No member of your staff volunteered to distribute these documents, as occurred for other people who submitted written material. It appears that rules for distribution of written material were not the same for all audience members. Ms. von Salis has written to you about this matter and other difficulties she experienced at the meeting. Meghan Shannon has also documented her experience. I have appended Ms. Shannon's documentation at her request. It is important that the rules not only be consistent over time, but that they be applied consistently to audience members with differing points of view.
Third, you have not explained why Ms. von Salis could not give copies of these documents to a fellow audience member when asked to do so. This is not "leafletting". This is free speech between two private citizens. It is odd that one's normal rights are suspended when entering a public meeting.
Fourth, you have not addressed the reality that people were told this meeting was not a public meeting and were turned away. You state that you did not direct the "circumstances" that led to people being turned away. However, somebody did. Somebody told the guards at the front of the building that this was not a public meeting. Somebody needs to take responsibility for this misinformation to ensure that it does not happen again. People travel a long distance at considerable personal expense to attend this meeting. No one should be turned away. We need to know who to contact if this situation arises again. It may have been a mistake, but it is a violation of civil rights to deny access to a public meeting. The people who were prevented from entering also are protected under the American Disabilities Act.
Fifth, you have not indicated what the solution to possible overcrowding in the meeting room will be in the future. The threat of not being admitted to the meeting because of overcrowding is a significant deterrent to attendance by this disabled community. A plan for accommodation must be in place.
Sixth, it is extremely important that your staff be aware of the physical limitations of this patient population. I was told by a staff member that I was not allowed to eat in the meeting room. Your response indicates that eating in the meeting room is permissible. Patients should have been allowed to remain in the meeting room. The rules regarding use of the room need to be clear to both staff and attendees. If a larger room is used for the next meeting arrangements for eating need to be clear. This patient population is not highly mobile. Most patients require regular nourishment, including snacks. Also, many patients have orthostatic intolerance. Prolonged standing should be avoided. It would be very helpful to have footstools available in the meeting room. Accommodation for these needs is necessary.
Thank you for addressing the need for courtesy by all staff members. I look forward to substantive plans to address the above six concerns.
Finally, thank you for addressing the important need to review all recommendations at the end of the meeting to make sure that everyone understands them.
Joan Grobstein, M.D.
Monday, June 6, 2011
Back in the day, when students read books, things were different. A typical college student in the fifties or sixties would walk around carrying a book, or having one in their back pocket. Often the book had nothing to do with what was assigned in class, and would have arrived in the purview of the students’ focus through any number of oblique avenues - but never from “the Professor”.
One of these touchstone books was Rainer Maria Rilke’s “Letters to a Young Poet” This small book was a set of eight exquisite letters written from the 28-year-old poet Rilke to a 19-year-old would be poet, a fellow named Franz Kappus. This set of letters gave “advice” and “reflection” to the younger aspiring poet about love, life, resignation, solitude and a host of other feelings and experiences. The book is still in print but seldom read by college students - who have other things on their mind these days.
Please consider the following from the perspective of Rilke’s Letters. These two letters, part of an ongoing series, are written as “guidance” to a contemporary and hypothetical young researcher. They are the contribution of one of my alter-egos.
Let's start with reading a published paper describing scientific research. Unless it is directly in a field vital to your continued existence, you can pretty well ignore the title. It will be inscrutable at best, with many omissions and obscurities. Reading the abstract may possibly tell you what the title was intended to mean, but this only takes you to another level of obscurity.
The important information comes from the names of authors and their current affiliations. Do you recognize any 'invisible colleges' worth joining? Has the balance of power shifted?
Real meat is hidden in acknowledgments of grants. Which funding did they use, and how much? What does this tell you about alliances between organizations? It is vital to discover what went into this research. The output is far less important, you hold it in your hands.
Next, scan the paper for useful information. Hard data which can't be reinterpreted can generally be ignored. Nobody needs your support for facts. Opinions are another matter entirely. Does this tell you how to slant your next grant proposal? If the authors were nobodies, you wouldn't even bother. If they are 800-lb. gorillas, the dominant silverbacks of the field, you have to pay careful attention to their slightest quirks.
I cannot emphasize enough the importance of recognizing the final arbiter of scientific truth early in your career -- the ability to obtain funding.
Dear “Hypothetical future important person”,
Your idealism is commendable in the abstract, but an absolute disaster in concrete career terms. You have this notion that scientists move ahead by solving problems of great importance to society. The truth is that they move forward by working on such problems, not solving them.
Let us consider the clear example of the Apollo program, in which scientists were curious about the composition of the Moon, and engineers were employed with the mission of landing a man on the Moon, and returning him safely to Earth, before the decade was out. Here was a mission stated clearly at the highest levels of government. Thousands worked on this, and solved the problem ahead of the stated deadline.
What happened? Thousands of them were laid off, starting even before the first Moon landing. Many lost their homes, some lost the automobiles they planned to use in search of their next job; the federal credit union which had loaned them the money to buy these even kept their last paycheck on the reasonable assumption that such jobs were going to be few and far between once the program ended, leading to defaults on loans.
A better paradigm is exhibited by the War on Cancer, launched during this same period. Has cancer been vanquished? Do patients still tremble when given these diagnoses? Has the cost of treating cancer fallen or risen? Do scientists working on cancer research still have jobs?
I should think the important career lessons are blindingly obvious.
Sunday, June 5, 2011
Friday, June 3, 2011
In January 2007, I was in the men’s room of the conference facility in Fort Lauderdale, FL washing my hands when Dr. Byron Hyde walked in. He started to complain to me, a stranger, about CFS and the conference sponsors, saying that this illness was 30 separate diseases wrapped in one, and that he could only help 15% of his patients. He was perplexed and angered by the vagaries of this conference, and its inability to focus on the problems. At that time, I had to inform him that he was saying this shit to the wrong fellow, as I was only interested in getting answers to my daughter’s illness. Since then I have come to understand more of the cesspool world of ME/CFS that Dr. Hyde was describing.
A few years later Dr Hyde was very quick to dismiss the possibility of an XMRV association with ME/CFS. He has his own ideas and they can be viewed here. In the past few years, Dr. Hyde has disappeared off the larger ME illness stage, presumably to continue his practice that yields so little success.
Time moves on, and Dr. Hyde is now joined by a host of people who have set aside the possibility of the association of a retrovirus with ME/CFS illness. Today we are told that the editors of Science magazine have asked the WPI and Judy Mikovits and Vincent Lombardi and the other co-authors to withdraw their October 2009 paper of the association of retroviruses XMRV with ME/CFS. What are we to make of this?
For starters, this request, to the initiated, should come as no surprise. There has been a feeling of inevitability to the dismantling of the retroviral (or viral) involvement in this illness since the publication of the October 2009 paper. Someone does not want this to happen – and it has nothing to do with science.
(Recently I saw an old acquaintance, a woman who was friends with Elaine de Freitas in the early nineties (their children were friends). The acquaintance got a “close up” view of the dismantling of Dr. de Freitas by the CDC, and it was not pretty picture – nor was it subtle.)
The only surprise is that the Science editors did not have the courage to withdraw this paper themselves. If they have made a mistake in publishing this paper, where is their courage in withdrawing it? How is it possible that the greatest “Science” research magazine in the world has made a mistake of this magnitude? When was the last time that something like this happened? Are these Science editors the Bernie Madoff investors of the science world? Perhaps there are other answers, answers to which we are not privy?
Why has it taken so long to knock out this paper - the weak association of a retrovirus with the innocuous fatigue syndrome knows as CFS? At the moment, we are to believe that the paper was lousy science; next we are to believe that the editors of Science were somehow duped. And all this took over a year and a half to supposedly disprove. What is with this? Is this how high-level science occurs? Remind me why I couldn’t get any of my three very smart kids to take any science classes in college. To them, one look was sufficient.
I stand with Dr. Mikovits and the WPI. This remarkable woman and this remarkable institute have brought so much to the field of ME/CFS research. I admire Dr. Mikovits tremendously for what she is doing for my daughter and for thousands of others. Please count Annette Whittemore and Vincent Lombardi in this group - and all the other researchers at WPI, all those who are driven to find a solution to ME/CFS. Please also include all those who are allied with and inspired by the Whittemore Peterson Institute.
People argue that the XMRV phenomenon has been a distraction, that it has taken attention away from other serious research in ME/CFS. Of course this is a fantastic joke. Please show me the serious research; the consolidated research that was happening that has been neglected. I, and the WPI, would be very interested in what has been dislodged. The WPI, even before XMRV, has elevated the level of research to the very top and - forgive me, for revealing this - they will continue to do so in the future. This institute, their researchers and clinicians, are committed to seeing an end to this illness. They will do whatever is necessary to get to that point. The interest spawned over the last few years linked to XMRV and other WPI research has propelled ME/CFS onto the world stage. Many people – important people – are now aware that this illness is a serious disease and needs attention. Researchers like Ian Lipkin, Harvey Alter, and even John Coffin are on record to find out more about this illness, its cause and treatment.
Of course there are other heroes in this field – too many to name. Not all of them line up directly with the WPI - but they have the spirit, the drive to look for solutions. Some are clinicians, some are researchers, and some are both.
Foremost among them is Dr. John Chia. Dr. Chia, an individualistic clinician/researcher, has gone perhaps farther than anyone to nail down a significant aspect of this illness He has revived a forgotten triggering aspect of the illness - Enterovirus (Echo and Coxsackie B viruses). His research has found real virus in real tissue. His current treatment (with oxymatrine) has modest success with 52% of patients. Dr. Chia believes that other treatment possiblities are in the pipeline with Roche Pharmaceuticals, perhaps available in the next two years. Dr. Chia, devotedly supported in his work by his wife and his son Andrew, is living proof that one person can make a difference. In this discombobulated, confused world of ME/CFS this is often forgotten and discounted. Dr. Chia is a very smart and dedicated man. Incidentally Dr.Chia does not spend any time denigrating others who are seriously working in the field of ME/CFS research. Instead he maintains his independent stance while admiring the work of others, including that of Dr. Judy Mikovits.
And then there are clinician/researchers like Dr Joseph Brewer, Dr. Jose Montoya, Dr Kenny deMeirleir, Dr. Patricia Salvato, Dr. Derek Enlander, Dr. Susan Levine, Dr. Sarah Myhill, Dr. Nancy Klimas, Dr. David Bell and Dr. Paul Cheney, all working to put together the pieces of this illness. All of these people have great interest in serious scientific pursuit. I can’t imagine that any one of them agrees with this Science magazine withdrawal request. All of them believe something significant is behind this illness, and all have wrestled with it for years.
And then there are the more confusing aspects of ME/CFS illness - aspects that are very difficult to decipher. In Reno Nevada in 2009, I stood three feet away from Dr. Dan Peterson, who was being honored by his patients. In a deeply emotional scene, Dr. Peterson, overwrought, was barely able to respond. It was a profound moment and I was glad to be there. At that point Dr. Peterson was in on the beginning research of the WPI. Shortly thereafter he resigned his Medical Directorship at the WPI – for unknown reasons. Later, I sat in front of Dr. Peterson at the InvestinME conference at the moment of Judy Mikovits’ presentation directly following the sandbag lecture of Dr. Huber. Dr. Peterson leaned forward to me and said that he hoped Judy “could control herself”. (She did). His comment struck me as signifying something. At this same conference he expressed to me his belief that XMRV was part of the problem - but not at the percentages presented in the Science paper. Since then Dr Peterson’s attachment to XMRV has wilted. Why? We need to know. Does he believe HHV6 is the primary culprit in the illness - and where is his study to prove this? HHV6 has been a suspect for 20 years without any proven diagnosis or treatment. HHV6 is our greatest hope? We might as well all go home. What went wrong here between the WPI and Peterson? Is this the stage we are at - where personality disputes control our lives, our health? What is the problem?
In the last year the retreat from an XMRV association to ME/CFS has gathered strength in a controlled and measured fashion, with various people switching sides, Stoye, Coffin, Singh, Peterson – a steady drumbeat of defection, unfolding as if choreographed by Merce Cunningham. Why have all these former advocates jumped ship?
Many others are still committed to the idea that something is seriously wrong with these patients, and they continue to try to figure it out - treating it as less of an “Abstraction” (an intellectual game), and more as a real illness with devastating, life-altering or life-destroying consequences.
What forces are at work here? There is great evidence of a power struggle – but over what? And who are the real losers? This last question is easy to answer – the patients get the short straw.
There is much strangeness to this situation. A single patient advocate, pinned down with disease problems of his daughter, can only catch a few glimpses in passing. But by stringing them together, one is left to wonder.
It is known that Jonathan Kerr’s samples from Dr. Enlander “disappeared” in a UK study and are unaccounted for. In the process, Jonathan Kerr himself has “been disappeared” for his fine research efforts in ME/CFS - and is now packing groceries at Sainsbury’s. All of Kerr’s efforts went down the drain. His alliance with the WPI was ground into paste. What is the consequence for the rest of us?
Dr. Bridgette Huber, a protégé of John Coffin, pledged the night before her lecture at the 2010 InvestinME conference that she would not present the results of her negative XMRV study. Something happened later that evening and Huber changed her mind. Most likely she got a late evening call from “Boston” telling or urging her to drop the bomb. It was evident at this time that something big was at stake. There was great eagerness on someone’s part to take advantage of the situation, despite it being the wrong forum in which to present this flawed data.
And then there was the delay in the Alter study. Please explain this to me? Along the way, perhaps you can explain it to Dr. Alter?
It is known that a researcher at the NCI was approached by a colleague early on in the XMRV discussion and told to “distance himself” from the WPI because “they were going to be taken out”. What does this mean in the world of “science”? I suppose this could have been some kind of joke, but subsequent events indicate otherwise.
In this entire sorry affair of trying to dismantle a retroviral association with ME/CFS, Dr. Coffin has played an important role. Dr. Coffin first took center stage at the CFSAC meeting in October 2009 as the resident "retroviral expert”. Relatively quickly he changed sides, devoting great efforts to dislodge any retroviral association with this illness - presumably forever. In the attempt, Dr. Coffin is doing a great disservice to continuing research into this illness. Whether he knows it or not, he is helping put the brakes on any continuing serious research, retroviral or not. His public preening and grandstanding include his misstep at the NIH State of Knowledge meeting where he impulsively recommended “moving on” – and then immediately started backing up. I imagine that Dr. Coffin might have something to do with the Science withdrawal request. There is some larger issue here.
Repeatedly the long suffering patients with this illness are accused of showing “bias” or hysteria in their interest in a potential solution - as though it were a crime to have aspirations for betterment, and their own sense of knowledge about what concerns them the most.
Clinicians are criticized - by nonentities - for treating very sick patients with antiretroviral drugs. These drugs are deemed to be “dangerous” and “with side effects” - even though these same drugs are being given out like candy in Africa as a prophylactic against HIV. ME/CFS itself has “side effects” - a crippling set of symptoms that delivers a “living death” to many patients. Why this great interest in prematurely closing the door on a potential treatment? Why do these “warning” come from “researchers”? What do they know? What is their real interest in this disease? Why do they feel compelled to practice medicine?
I advance these instances because I have stumbled upon them in my effort to aid my daughter. What I present is a partial picture of what I have observed. These instances disturb me, and make me wonder what has become of the world of science that I grew up in? Today’s world of “science” seems more a world of bad human drama, where there are no rules or restraints. Anything goes, and anything is possible. Who gets trampled on in the process makes little difference.
In the last year and a half we have witnessed a withering set of attacks on XMRV - the only consolidated serious shot of real science applied to this ME/CFS in many years. What has provoked this attack? Are we to believe that there is serious fault with the science – and that it is some big mistake? How come the resistance comes from so many different directions - some of it half-assed, some of it more serious - and yet, collectively, unable in over a year and a half to knock out XMRV? Science is said to be slow, but this is a bit thick. It is worth mentioning that resources for this dismantling have been “available” (from where?). A great deal of funding is working on the discrediting side of the equation, very little on the advancement side. Why is this?
The larger question, the most important question, remains unanswered. Where is the ongoing and future interest in this illness? Where are the larger research ideas and platforms? Where is the data? How come the WPI sponsored association of XMRV has not generated an ounce of further positive research at the NIH - perhaps outside of XMRV, perhaps looking to other causal factors? How come so few advance an interest in research into the fundamentals of this illness - even if XMRV is wide of the mark? There is a larger, more deadly association here - and it is to finish off all serious research into this particular illness. Why?
My contention, my belief, is that this illness generates disregard, disbelief and distaste. The patients are ignored, mistreated, and abused; those who have the courage to contend with the disease are ostracized and ridiculed; and those who research it are quickly sunk. One can speculate where the disregard comes from - what particular shape it takes - but all the evidence is there for those who want to look.
In this polluted environment, the WPI and Dr. Judy Mikovits and Vincent Lombardi are trying to make headway against neuroimmune illnesses. In spite of the very stiff resistance, momentum is on their side. Their aspirations are noble, and their cause is just. The WPI remain undeterred and are moving forward.
Us poor little suckers suffering from this illness are supposed to believe that both pure science and perfidy can exist side by side. This is a big lie. They overlap and are intertwined. Today, it is difficult for the average to above average intellect to figure out what is going on. It is very difficult to regard any efforts surrounding this illness to be moving towards a larger field of betterment. Everything is tangled to an infinite degree, and much of it is very negative - hostile even.
This illness has never enjoyed any sense of anything - just a lonely gloom, and the feelings of misdirection, hopelessness and unnecessary rip-off. What is it about this disease that frightens people and puts them off? Can someone explain to me the unexplainable?
I come back to the essentials. I love the WPI and Judy Mikovits - because they exist. Once they are gone, once they too are “disappeared”, we are going to notice the difference. In a perfect world the WPI would have spawned, as was their hope, other groups working hard at a solution. Perhaps the perfect world is still to come?
It becomes clear that ongoing research is going to have to come from private funding. The government is committed to hanging these patients with ME/CFS out to dry. Efforts will need to be made to secure private research funding. Research must continue into this disease, and those committed to it must not be put out of business. If not XMRV, then what? This is the question that researchers should be asking – and answering. There is no excuse for not pursuing the cause or causes of this serious illness. We need answers and we need treatments.