Thursday, December 30, 2010

Amy Dockser Marcus cited for XMRV coverage.

Amy Dockser Marcus was cited for her Health Blog on XMRV. This gal is a real old-fashioned journalist. She is one of a few who are keeping the tradition alive. Amy Marcus was on this XMRV story early and has kept after it. She has outstripped her competitors - such that they exist. Amy has an "attachment to the subject", the principle ingredient necessary, along with guts, for profound journalistic writing. While her interest is natural and springs from her instinctual gifts, this reportage is going to pay off big-time for her in the long run - and also for the rest of us. With all the delays built into the recognition of this pathogen, her telling the story to the end or the near-end is going to secure her another Pulitzer Prize. In the meantime it will be exciting to follow her journals. It is marvelous to see a person with real empathy get the attention that she richly deserves. Increasing amounts of people are tuned into her reporting of this unfolding disease drama. Single-handedly Amy Marcus is getting WSJ readers aware of and interested in this story. She is the real deal. Congratulations to her!

Saturday, December 25, 2010

Repost of Laurel's video

Here is an exquisite Holiday gift from Laurel. Take a look at this video. It is the one of the best that the Patient Advocate has seen on ME/CFS - perhaps the very best. Yes, it is the very best. It was made by Laurel of dreamsatstake.blogspot.com
Her blog is one of the premier blogs on this illness. The Patient Advocate only posts this video here in order to direct you to her blogsite.
The Patient Advocate recommends going to Laurel's site to look at this video - as she has a commentary on the making of it. This is a remarkably poignent and powerful video made my a remarkable woman. What a fine effort!

Thursday, December 23, 2010

InvestinME statement- Push Back

Today InvestinME joins forces with other like-minded people in pushing back on these recent "contamination" papers. Their statement can be found here. InvestinME sponsors the best conference on ME/CFS. This year's one-day conference will be held in London on May 20th.

IACFS should try to learn something from InvestinME, but, of course, this will not happen. IACFS is a larger feeding trough for so-called research, some of it very good, most not - the organization could benefit from paring down, and focussing.

This year's InvestinME conference will focus on treatment possibility for ME/CFS. It will present the leading researchers and clinicians willing to move forward in this illness with immediate treatment. InvestinME has understood since their beginning that research is the only answer to this nasty and serious illness. The organizers of this conference include Richard and Pia Simpson, and, incidentally, this excellent conference is privately funded. These InvestinME people are not waiting around for a government that will never show up.

Wednesday, December 22, 2010

The Sucker Punch - no Knockdown

Vincent Racaniello is among the scientists taking another look at the complex issue of the "contamination issue" in the retroviral association with ME/CFS. His further analysis is here. Various other scientists will be doing the same re-figuring as the dust from this "pollution" settles. Various tempered responses have been released that sharply differ in tone and substance from what has been published by a knee-jerk press - and disseminated worldwide. This is not an argument with the studies themselves, just with the circumstance of their release. The studies can be dissected on their own and will be dismembered, piece by piece, but the disturbance to the large "force field" of serious research is going to be very difficult to reverse.

It is important to register that there has been no knockout punch of XMRV. The X-people are still standing (or reclining, as the case may be). In the last two days, many ME/CFS patients have been damaged by this disproportionately negative spin on this so-called news - and for what?

The situation and motive surrounding the "set-up" of these Monday morning press releases is highly questionable. These collectively released sucker punches have done a great, great disservice to trying to figure out the complex potential association of MLV-related viruses and ME/CFS. Someone engineered this release for maximum damage - and they have been very successful. Who did this? Is it willful malice? In no way is this an innocent coincidence. The scientists and/or editors responsible for this should be fired - the whole pack of them. As Caligula said, "If only all of Rome had one neck to wring."

Monday, December 20, 2010

The Mouse that Roared*

Many of the participants of the Blood Study group advisory committee meandered off to have a little dinner and feel good about themselves. Their self-assessment mirrors a comment overheard recently in a NYC coffee shop: "I feel good about myself and I think I do a good job." The rest of us go back to our life of illness or illness support. It is a grim life, made more difficult by having to go back to confront illness reality after a day with these FDA losers. It is this disconnect that is really irritating - the disrespect for this illness that individuals like Coffin and Stoye display publicly. They are playing their little games, disguised as science - and their successes in their careers come at the expense of patients. They do not give a shit. This is what I dislike. It is the contempt and the disregard and the ignorance of the consequences of their actions. It is in this way that they are modern people - self-pleasurers.

On this December 20th, a story from November 2009 has taken center stage and has become a "realization". A year ago a well-known cancer virologist was approached in the halls of the NCI by another virologist and advised to "distance himself from the WPI" - that "they (unknown elements) were going to take out the WPI". Today this story resounds more convincingly - and gives some credibility to the lies that have been circulating over the last few months.

The news today was not good for ME/CFS patients - not good for their health. For the moment the largest exposure (what is most suspicious) of these "smoke 'em out" retro-virology papers is the timing. These scientists chose to have their XMRV contamination studies released five days before Christmas, a time when ME/CFS patients are under the greatest stress of the year. ME/CFS or XMRV-related illness is a stress-related disorder of the first magnitude, and many patients, like my daughter, go down for the count during this time, and take weeks to recover. It is a very sad and painful time for ME/CFS families and friends. ME/CFS is a very nasty illness with a great fragility and unpredictability to it. These virologists, in their little ivory towers, can only think of these patients, as "complainers", resenting the "harassment" email activity of these desperate patients, now desperate for twenty-five years and counting.

It was quite noticeable in the conversation with Dr. Stoye the other afternoon that he has zero idea of the outlines or the seriousness of this illness - and no desire to find out, preferring to splutter and grimace instead. (Can one imagine that being true with Salk and polio patients?) Complete disregard can also be placed at the feet of the stuff shirt Dr. Coffin and the haughty and diffident Dr. Huber, neither of whom show the slightest knowledge or interest in the reality or character of this patient group. They are too busy talking about themselves, preening and mincing about.

In the unlikely event that these studies knock out the association with XMRV, we have a larger moral issues here - a moral issue parading in the name of science. These scientists in their "need to know" and "to win" are perfectly happy, in their deep ignorance, to trample on the feelings and spirit of this patient group. At the very core, they are an unfeeling, heartless bunch of bastards. Is this what science has become?

This disregard is only the most obvious example of the evil that is taking place now. It was obvious at the Blood Study Group Advisory meeting that there are larger, even unknown, issues here that various sides are contesting furiously - with the gloves off. At times it is difficult to determine if this is normal academic infighting, where scientists fight to the death over limited or non-existent stakes. Or whether, on the other hand, there are much larger issues here - issues of proprietary rights, influence, credit, power and, of course, money. For a long time now it has seemed that an aggregate grinding sound of anxiety and exacerbation has filled the hallways of university labs in the US and the UK over the WPI discovery. This has been written about before on this blog. Now comes the serious push to discredit ME/CFS.

This effort to discredit has been going on since October 2009 - and probably before. The first manifestation of "difference" - in hastily organized papers in the late winter of 2010 - was to knock out the Science paper. A number of people went down for the count in this exchange, including our friend Jonathan Kerr. These highly publicized negative worthless papers were dragged out over the summer. Finally the Lo/Alter paper was released and at this point things began to get serious.

Something big is at stake here and the struggle for control is not a friendly one. The opponents of the association of MLV-related viruses are intent on doing one of two things. The first possibility is to completely knock out and bury the association that a retrovirus could be attached to this illness and other unknown illnesses. The second is that they want to blunt the XMRV connection, bury it, and wrest control of the entire issue for themselves. From a scientific point of view the first option doesn't make a whole lot of sense. The ferocity of the fighting indicates that the second possibility is more probable. Large powerful elements want to wrestle this retroviral connection to neuro-immune and other illness from the WPI and their collaborators. The negative consequence of this for the patients of ME/CFS is not calculated in their bargains.

For the last few months, and longer, every step has been taken to isolate the WPI and starve them to death. All funding requests have been turned down based on the idea that the XMRV association is experimental. (Unfunded studies have to be completed to apply for funded studies.)

The release of these papers and its immediate uptake by the UK and soon the US press (think of our vaunted NY Times and of these "riled up" CFS people) indicates that the time was calculated for greatest exposure and to neutralize the level of the response. It was a good trick and one has to admire it for its connivance/deviance. These contamination studies made it very quickly into the major news media, especially in the UK. Someone was waiting for them - it was a set up.This was the hard take-out that has been expected for some time now. This is just another chapter.

The WPI has always been weak on the communications/public relations front. They are understaffed and poorly funded, particularly after opening their marvelous new building - an act that only further needled their enemies. At the moment the WPI is unprepared to strike back on this recent take-out, but things are going to change. As they gather forces and consolidate the means of aggressively pushing their agenda, the roll back will happen.

Let us imagine for a moment that the worst has occurred (the doomsday scenario) - that the XMRV association with ME/CFS has been broken and smashed. Let us imagine the unimaginable, that the UK whatshername and Coffin and Stoye have bested the valiant Dr. Mikovits. Is this the end?

We have to remember that it was the WPI that got us here. With all due respect for Klimas and Natelson and others, the WPI has gone farther and faster in their research - and without much institutional research money. Try to remember what it was like before the Reno conference in March 2009. At this point, a direction was set - entirely by the WPI and their then Medical Director Dan Peterson, and it has been a fast ride since then. Can anyone imagine that this will change? The XMRV was an unexpected gift - and it is a gift that is going to keep on giving. If it hadn't been for the October 2009 paper none of this additional broad-based research - Singh, Hansen, Bell, Cheney, Klimas, Montoya, de Meirleir - would have occurred. Whatever else happens the Whittemore Peterson Institute got the ball rolling, and now it is impossible to put the genii back in the bottle. As Dr. Alter said, if it is not XMRV, we have to find what it is. And then there are all the immune panels and cytokine studies. Soon it will be on to treatment trials.

Word comes late in the day of a comment on these five studies from the researcher/clinician Dr. Kenny de Meirleir (published on Merutt.wordpress):

“The contamination by mouse material was excluded in our study, that of Lo and that of Lombardi et al. We are not using PCR as a basis of the test but human prostate cancer cells that do not express RNase L so the virus from patient’s blood can grow in it. We also sequence the virus and I can assure you it is not mouse material. Governments and insurance companies are horrified by the idea that there is a new retrovirus out there that has infected 10 times more people than HIV up to date. My preliminary data show that the virus does not grow in culture anymore after Nexavir + GcMAF although the procedure was identical to the pretreatment culture. In the next months more will come from our side. A study with healthy blood donors, ME patients who got ill immediately after blood transfusion and ME patients who gave blood after they got ill will be published in the first half of 2011.

What these 5 are doing to the patients is a crime against humanity.

Kenny De Meirleir”

*a 1957 UK film starring Peter Sellers, where an impoverished backward nation declares a war on the USA hoping to lose, but things don't go according to plan.

Friday, December 17, 2010

Amy Marcus - WSJ versus NY Times

On Wednesday the Patient Advocate read both the WSJ and the NY Times - as is his usual habit. The PA noticed that on page 2 of the print edition of the WSJ there was an article by Amy Dockser Marcus on the recent FDA advisory committee recommendation to restrict ME/CFS patients from donating blood. The journalist Amy Marcus continues to report on this story, on every step of this unfolding disease drama. She (as well as the Patient Advocate) has a sense, an instinctual feeling, of where this is all going. In the meantime, she, along with her editors, is willing to take a chance and cover this story in a journalistic fashion, believing that there is still an audience at large out there who will follow this story - and a belief that the audience will grow in time, as the real-world situation develops and the coverage expands.

As far as the Patient Advocate can discern, Amy Marcus of the WSJ has attended all the major XMRV ME/CFS events -including the August XMRV one-day conference at the Whittemore Peterson Institute in Reno, the CFSAC meeting in DC and the recent FDA Blood study advisory group in Gaithersburg, MD. Amy Marcus' background orients her towards science and its application to disease. Why she has this "inclination" is anyone's guess. This inclination of hers - this instinct to commit to a fascinating story with fascinating people - is going to greatly benefit ME/CFS patients. Amy Marcus is doing the most of any person in the journalist world to promote both an awareness and a serious discussion of these important disease issues.

All this is going to assure one thing: Amy Marcus is going to win another Pulitzer prize for her coverage of XMRV and XMRV-related illness. Because the government has put the kabash on research into this illness, progress is slower than it should be. For her storyline to take hold, the research must advance to the point where she will be able to characterize the illness with patient, advocate and clinician interviews. Once that occurs, and it is not going to be in the far distant future, she will have the human element that she needs to elevate this story - the human suffering, emotional toll, salvation, and redemption. Reporting on absurd scientific squabbles has only so much human interest quality. It is the patient' and their suffering that are of interest, and her story line needs to get there for her efforts to reach the level of profundity - and win her another Pulitzer. Let's wish her well.

Meanwhile the Patient Advocate also reads the NY Times. Recently, in the last ten years, this habit has begun to flag. The NY Times is hardly the newpaper it used to be, hardly a newspaper at all in that it has descended into rank partisanship, is poorly written and provides shallow coverage. All those elements that are strong in the WSJ - arts, music, theater, book, architecture, human interest - have gone completely in the tank with the NY Times. Their coverage of the association of XMRV and disease has been abysmal. They have treated it, as best, as a news story and reported the news - without actually following or developing the story. There is a difference between news reporting, and journalist coverage, and it is well illustrated in the great divergence in these two newspapers.

The one larger ME/CFS "coverage: in the NY Times coverage was on the virus-hunter (lame term) Ian Lipkin - and it was just a set-up. In response to this article the Patient Advocate sent a letter to the NY Times. It follows here:

"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 than 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 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 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 CFS/ME (and potentially other neuro-immune illnesses.) They are the real heroes of this unfolding disease drama."

This letter went unpublished.

In response the Patient Advocate received this email (with attachments).

Dear Professor Cairns:

Many thanks for writing. I've shared your letter with our writer, Carl Zimmer, and we plan to stay on top of the XMRV story as it unfolds.

Best,

David Corcoran / Science Times

This letter had the following attachments (in reverse order, email addresses deleted by the PA, for protection of the innocent)

Hi david--

This chronic fatigue stuff gets people all riled up. Some people think there's enough proof to start taking retovirals but most experts don't. The writer doesn't seem to get that the two studies he cites found two different viruses so they can't be supporting each other. And Lipkin is not in fact just confirming the september study.

Let me know if you need any more help on this.

Carl

Hey Carl, I need to reply to this reader ... can you give me any guidance? Thanks, David

The Patient Advocate first question was to wonder if this "science" writer thought two retroviruses in these patients was less frightening than one. Noting the difference in bias, literacy and tone from the WSJ, the PA started to write a post on this, but his daughter and son prevailed on him to try to use the "opening" to get their attention. So the PA wrote the following:

Dear David Corcoran,

Thank you for your response. I’m very gratified to hear that The Times intends to stay on top of the XMRV story. It is a complex and compelling one, with ramifications for many.

ME/CFS is a severe, debilitating illness that is estimated to affect at least a million people in the United States, so it is not surprising that people get “riled up” about it, as your colleague rather flippantly puts it. It appears to be increasingly likely that it is caused by one or more retroviruses, that it is contagious and that it is in the blood supply.

The impatience for treatment options on the part of those with ME/CFS is akin to that reported in today’s Times Week in Review article about delays in identifying the efficacy of Truvada as a prophylactic treatment for AIDS. There is concern that once again the delays in substantiating studies and approving treatment will be caused by “a combination of scientific caution and fiery politics.” Like AIDS, ME/CFS is surrounded by longstanding prejudices directed towards those afflicted - and there is currently no approved treatment.

Those who follow XMRV research closely know that two variants in the same virus family were found in humans in these two studies. Whether you call it XMRV or PMLV it is still a gamma retrovirus closely related to MLV propagating in humans. Dr. Harvey Alter himself stated that the Lo/Alter paper supports the Lombardi results – and XMRV has been now found in all of Alters’ own samples (by Ruschetti).

The Wall Street Journal has been covering the XMRV development regularly over the summer and fall. Their most recent article is here. It might be useful to compare your coverage.
http://online.wsj.com/article/SB10001424052748704243904575630700111729446.html

The viewpoint that I expressed in my original letter furthers the discussion of these issues, and should be published. The NY Times - known for its journalistic even-handedness – should avoid the appearance of bias in a matter of such importance.

Sincerely,
Christopher Cairns

This effort did not reach a form of "realization". It was what they call "a waste of time". The NY Times has displayed once again why it is going down the tubes.


Wednesday, December 15, 2010

"XRMV and CSF" - FDA Blood Study Advisory meeting

The Patient Advocate went with his son Nicholas to the FDA Blood Study Advisory meeting in Gaithersburg MD on December 14, 2010. This committee meets every six months to consider issues regarding the blood supply in the United States. They operate as an advisory committee, hear issues and vote on specific questions that are then passed on to the FDA itself. In most cases the FDA accepts the recommendations of the advisory committee.

In early December the Patient Advocate wrote an account of what was going to happen at this committee meeting, and this description foretells quite accurately what occurred on Dec 14th – with one major exception. With this particular committee there seemed to be no one in charge, no one running the show. Certainly it was not the appointed head of the committee - Dr. Blaine Hollinger - but surprisingly it was no one else either. In the PA’s experience this is unusual. This fact, this shortcoming, heightened the unmoored and discombobulated sense of the day’s presentations, and particularly the vote on one question – a very significant question – at the end.

In no sense did this committee, with a few exceptions, project the sense that they had ever heard anything about XMRV, or CFS before - even though there had been at least one earlier meeting on this subject - and maybe two. A number of the committee members invented their own illness acronym - CSF and XRMV - and used them repeatedly. The bottom line was that at the end of the day – after listening (or not listening) to the days’ presentation - the committee, during their discussion, seemed totally unmoored, unable to recognize what they were voting for, what the implications were, or even, most absurdly, what a yes or no vote actually meant. The discussion was stunning in its absurdity, the greatest sense of unreality that the PA has ever seen – and this is really saying something. The Patient Advocate was certain that he knew what was going to happen, but, for a few moments, the PA panicked with the realization that this group of “experts” was so lost and so self-absorbed that the issue could not be clarified and that the committee would not be able to do the task at hand.

So it was with some trepidation that the Patient Advocate watched the unfolding of the committee vote. The PA himself had been confused by the committee chair as to what the vote was actually about, what the main issue actually was - although the PA had not previously suffered from this “not knowing”. The 13 members voted with their little silent push buttons and suddenly the audience could see the result on the screen. The vote was 9-4 with the committee voting to restrict the participation of CFS patients in giving blood. Or that was the Patient Advocate thought after the committee confusions and this was shortly confirmed by reality - although Dr. Ruschetti also was unsure what the committee had voted for. It is the PA’s belief that some members voted no meaning to vote yes and some members voted yes meaning to vote no. Fortunately it worked out in the end - and this is how great victories are achieved in this modern world of ours.

The misdirection and confusion of this committee was stunning and took away, at least momentarily, the profound importance of their vote. This was a great day for ME/CFS patients - as the government recognized for the first time in history that ME/CFS was an infectious disease, and that it should be kept out of the blood supply. The Patient Advocate had a sense that the committee had no idea of the implications of their vote, either now or will in the future. Without their knowing, or seemingly even caring, this committee’s vote confirmed for the first time ever that the federal government is complicit in the neglect and abuse of ME/CFS patients. At a minimum it sets a date where the government is on record as acknowledging that they have some awareness –something to lose - that a new retrovirus or two or three are loose in the blood supply, and that it might have consequences. Hence the clock has been started for future liabilities for blood transfusions. The government had been wanting to push this date back forever, but events have descended upon them.

This was a very important day for ME/CFS.

From the beginning to the end it was a day of great strangeness.

The Patient Advocate will not enumerate the specific presentations of the day, preferring as usual, to give his “take” on the day (highlights and lowlights) and to try to project the general weirdness of it all.

Two new voting members were attached to this committee. They were Dr. Nancy Klimas and Dr. John Coffin. Late in the day, as the committee lurched uncertainly sideways, about to pitch themselves headfirst into the ditch, two presentations saved the day. One was more unexpected than the other. The first was that Dr. Klimas, at a critical moment, articulated the problem of patients with this illness and the danger to the blood supply - something that many could do, including the PA – but it was Dr. Klimas who was there at crunch time - and this needs to be noted. Dr. Klimas was great. Thank heavens that Dr. Klimas had been placed on this committee for this day, and that she was able to stroll in with her little rolling bag and do her thing. Otherwise the day would have been sunk.

The second surprising moment occurred when Dr. Harvey Alter, in no official role, stepped to the microphone and in a very short presentation articulated the main issues regarding the science of XMRV, set aside the notion of contaminations and basically framed what the committee needed to do. He also presented a spirited defense of the WPI research and Dr. Mikovits in particular.

The following is the near verbatim transcription of Alter’s short statement transcribed by Valerie in real time. The PA borrowed it from the ME/CFS forums. The Patient Advocate was sitting next to Valerie and he watched in disbelief as she rattled along typing up these lectures. How she does this the PA does not know, but the rest of us owe her a great sense of gratitude.

“When a group finds a new agent, become biased that it’s real. When it’s not found by another group, they become even more biased it’s unreal. Our goal should be to find the truth. The truth will out over the next year. I concur we have no evidence for causality, especially when we’re at the LoD and assay performance is so critical

But I still want to counter by saying that the current evidence for disease association is very strong that XMRV or MLV is strongly associated with CFS. In those labs who do find the agent, it's very reproducible. Year after year, same patients test positive. Confirmed by sequencing, reproducible over time. Dr. Hanson has demonstrated how critical the assays are. When tweaked assays, the findings are identical to Lo lab.

Diversity of XMRV/MLV being confirmed in WPI lab, so XMRV is the not only agent being confirmed there. In hundreds of negative controls in same lab (Lo’s) all results were negative, Lo has done what Coffin recommended to test for contamination, Always negative for contamination. It isn't logical to suggest otherwise. Stoye used single-case anecdotal information to try to make a case. Simply because it has happened in the past isn't valid to negate reproducible data from 4 different laboratories.

I'm not a CFS Dr, but have learned alot in last 6 months. Absolutely convinced when you define this by proper criteria, it's a very serious, medical disease. Characteristics of a viral disease. If it's NOT XMRV, we must continue the research to find out what is''.

Meanwhile, during this final discussion leading to a vote (and actually for the entire day), the other newcomer to the committee, Dr. John Coffin was doing his very best to confuse the issues. This behavior involved his usual obnoxious grandstanding and self-preening - trying to display his superior intellect in parsing these issues. Dr. John Coffin is immediately recognizable to the Patient Advocate as a person of the PA’s generation and the PA is embarrassed that he shares this man's culture. Dr. Coffin is a leading light of “The Stupidest Generation” (in the history of the world). This self-pleasuring has been evident since the Patient Advocate first saw this fellow at the CFSAC meeting in October 2009 . Dr. Coffin is a slippery adversary, and should not be trusted in any situation.

The Patient Advocate watches this old dilapidated codger (Coffin) and the others of my generation on the committee, and the PA wonders what they think of Dr. Judy Mikovits? The PA wonders if they see in her the extraordinary qualities that the PA sees? The PA would have to say – no, no, these fellows don’t see it. They are true to their generation, eaten up by their fear of being unseated by younger women who are much smarter than they are – and they are unable to get their minds around this and it coagulates them into a malleable jelly-like substance without any spine.

The day was a triumph for ME/CFS research. It is clear to the Patient Advocate that in spite of actually being able to execute the vote, the committee and the federal government that they represent is no longer in control of this issue. This was best highlighted by the presentation and comments of Judy Mikovits. While Dr. Mikovits presented nothing new, her acuity and intellect are so much more elevated than the others in the room that it is almost painful to watch. While she took her usual bashing, there was a sense in the room that she and other scientists are now in control of ME/CFS issue. The government is in the way and must move aside. Dr. Ian Lipkin should be given another job.

The presentation of Dr. Stoye was a curious one. For some reason Dr. Stoye, a UK virologist, was given a prominent place in this discussion - and he took full advantage of it. His assignment was to give an “overview” of the current research into retroviruses and ME/CFS. Why he was chosen for this task is hard to understand. Dr. Stoye, whatever his virtues are, has demonstrated that he does not do well on the open field. Dr. Stoye failed miserably at this overview task, instead giving a magnificent “underview” and quickly descending into a haphazard, lackadaisical, offhand, slipshod set of opinions and anecdotal assessments that bordered on the unprofessional. Dr. Stoye tried his best to reenter the contamination issue but, by the end of the day, this had been buried (at least for this day), primarily through the aforementioned summary of Dr. Alter. In other ways Dr. Stoye tried to shift the momentum against the validity of any association of MLV-related viruses with ME/CFS. As the committee vote revealed, Dr. Stoye’s contribution was ignored and did not take hold.

Despite the asinine aspect of this committee meeting and the ensuing confusion, this was a banner day for science and research relating to ME/CFS. The government will continue in its silly ineffectual way, but now they are strapped to the serious science being done at the WPI and other places and we are better for this. The good guys won the vote and the bad guys took a beating. Now it is time to move on.

Tuesday, December 14, 2010

Amy Marcus on FDA BPAC meeting

Amy Dockser Marcus delivers the news on FDA meeting here. The Patient Advocate was at this meeting with his son Nicholas.

Thursday, December 9, 2010

Minnesota Days - Real life in Room #316


Part 1

The Patient Advocate took his monthly trip to Minneapolis in October. This blog post will be long - and is not for everyone. I will split it in three parts as some readers might find this tedious and boring – and will want to skip over it.

The PA flies to Minneapolis from Philadelphia for one week every month. His daughter is housebound in St. Paul, now for over five years (sick for eight). The PA rents a studio apartment (Room #316) near Loring Park in Minneapolis. The building is a former hotel reputed to have had Liz Taylor and Jackie Gleason as residents. Can this be true? These days this rental building is full of young and elderly oddballs, almost all of them dog owners. The PA is not a dog person so this makes for interesting confrontations in the elevator. Young women with Doberman pinchers invite the PA to share the small elevator, but the PA politely declines, preferring at that point to take the stairs.

It is a strange, uprooted and disjointed life that the PA lives in Minneapolis. It is full of constant daily pressures. The PA chooses to live in Minneapolis, eight miles away from his daughter, as he wants ”his own life”. The Patient Advocate prefers not to live in his “daughter’s town”. She needs her space. This has proven to be a very wise decision.

Fighting ME/CFS takes money - and lots of it. Through long-ago “good fortune” (those were the days), the Patient Advocate owns a small apartment in lower Manhattan. The PA short-term rents this apartment for cash, traveling on an almost weekly basis to NY from his home outside of Philadelphia. The Patient Advocate cleans the apartment, does the laundry and greets the visitors – mostly folks from Europe or Australia. The PA has become very adept at cleaning and doing the laundry. The PA is especially good at cleaning bathrooms. All money received goes directly towards his daughter’s support and treatment. The Patient Advocate and his wife have completely rearranged their lives, financially and otherwise, to give priority to the betterment of their daughter. .

On a Thursday night in late September, the PA spent five hours at JFK waiting in weather-related delays for his Sun Country flight to MSP. He finally arrived in Minneapolis at 3 in the morning. The PA slept a few hours, and then started his tasks.

First up was an appointment with one his daughter’s doctors. This particular doctor – a gal - visits my daughter in her home once a year – an unheard of situation in this Progressive state. Generally doctors do not make house calls in Minnesota, a state with heavily regulated medical care. The PA's daughter has not been able to get to this doctor’s office for five years.

The Patient Advocate makes contact with his daughter’s doctors every three to six months. These consultations allow the PA to update a particular doctor about current treatment plans and future possibilities. It is a form of “checking in”. These doctors are sympathetic - even though the might not know much about ME/CFS. Most importantly, they are willing to write prescriptions, or to order routine (or experimental) tests. The Patient Advocate has assembled a cadre of physicians from all over the world who are contributing to the recovery of his daughter.

This particular physician has gained a growing respect for ME/CFS. She has “come around” from initially thinking the Patient Advocate's daughter’s illness with psychological. This physician is one of a handful in the Twin Cities with whom you can have a conversation about ME/CFS. This bastion of perfection - these Twin Cities, this wonderfully balanced community - is a backwater for ME/CFS. Ignorance prevails in Minnesota and most medical practitioners think this illness is a psychological disease. Bless their little hearts.

On this particular Friday morning, the Patient Advocate tells the physician about XMRV and about the current breakthrough research. Much of the conversation is one-sided – a bit of a lecture - with the PA talking about XMRV, the WPI, the NIH, and the crossover of ME/CFS into the infectious disease category. Along the way, the PA asks for suggestions on Infectious Disease doctors in the Twin Cities. It is the Patient Advocate’s opinion, based on unfolding events, that his daughter’s “illness” definition has moved into an Infectious Disease category. This has been obvious to the PA – a sculptor - since the very beginning of her illness - but now the evidence is piling up.

The PA is intent on getting his daughter an Infectious Disease doctor in the Twin cities, someone who will put his or her mind to real treatment or maintenance possibilities. (Incidentally this does not mean that the PA is looking for someone to dish out antiretrovirals. The need is much broader than that.) The Patient Advocate’s daughter has been without a real doctor for her entire illness. She does not have an attending physician, someone who can admit her to a hospital if necessary. This is a disgusting and shameful fact. One negative aspect is that it puts the PA himself in the position of being a quasi-doctor, and of making medical decisions. This is the reality of ME/CFS. It does not take much imagination to understand that this is a highly unwelcome position to be in - and a source of a certain amount of irritation and anxiety on the part of the Patient Advocate.

This particular doctor feels that most if not all the I.D. doctors in the Twin Cities will be resistant to engaging a patient like my daughter. However this doctor does identify the HIV clinics in the city - and she makes one quite specific suggestion, which was very helpful (This didn’t pan out). She also offers to send along a query to the HIV clinic in her own hospital, and asks the PA to write up a concise short paragraph on his daughter’s situation.

Part 2

It is October and a beautiful month in Minnesota, particularly for biking (Soon it will be ice and snow and cold biting wind, and this the Patient Advocate cannot get out of his mind.) One of the positives about the Twin Cities is that it is a very bike-friendly city. The Patient Advocate brought his bike when he first rented an apartment in Minneapolis. Almost immediately it was stolen. The PA found a bike shop and bought a used one - and he has been able to hang onto this one. Moving around the cities on a bike slows things down - but it is a great stress relief. Yes, the Patient Advocate too has stress! And biking has other compensations - as you can get close to nature. The irony does not escape the PA that while he exhausts himself biking around the cities, his daughter is confined to her room, exhausted.

During his visits to Minnesota the PA has various major and minor tasks that keep him busy. The days are long and hard. Each trip presents its special problems. On this occasion one of the PA’s tasks is to establish an “Oasis area” - embracing the rooms in which his daughter spends her time. Recently the PA did the ERMI mold test with Mycometrics. Surprisingly it came back with mold at the 92% level (of the national average). Whether this test is reliable is not clear - nor is it a simple matter to interpret the results. However this elevated mold test in combination with several elevated Shoemaker tests (c4a and MMP-9) indicate that mold might be a player in his daughter’s situation. Since it is impractical to consider moving, the prudent thing to do is to get rid of (or neutralize) the existing mold in living and sleeping areas. The Patient Advocate is aware that this is a complex problem, far beyond his powers to decipher. But the PA must do what he can do.

The washing of these rooms takes place in stages over the next several days. It entails washing the floors, walls and ceiling with a non-allergenic soap, followed by vinegar and water. Vinegar is reputed to inhibit mold. The PA is good at washing although it a boring job. All excess paper products are removed from the rooms and placed elsewhere in the apartment. In this way this set of rooms are made free of mold on existing surfaces. With the arrival of a second Aireox hepa air filter (from Needs), the area is made an “oasis”. Maintenance washing will have to be done.

During these week-long visits the PA tries to retain his own personality. The Patient Advocate does things to maintain his sanity –foremost amongst these is going to the orchestra. Minnesota has one of the finest orchestras in the world, although judging by attendance, there seems to be little local recognition of this fact. The director Osmo Vanska (personalized locally as “Osmo”} is a compelling conductor and has whipped this orchestra in shape. The Patient Advocate has heard the Minnesota Orchestra in Carnegie Hall in NY, where, because it is center stage, they play out of their heads. This weekend they played Brahms' stupendous 2nd symphony. The orchestra and biking, along with an occasional play, are the outlets that the Patient Advocate allows himself from his “tasking”.

Early Monday the Patient Advocate biked six miles out to St. Louis Park to see another of his daughter’s doctors. The bike ride was quite fine and it was a beautiful early morning. The PA had the illusion of biking into the country even though St. Louis Park is only a suburb of Minneapolis. The PA’s daughter has not seen this doctor in five years. This doctor is willing to talk about his daughter’s situation. His help is greatly appreciated, although it is recognized that this is not a good way to do medicine. He is the principle go-to guy in the Twin Cities for CFS.

This visit is roughly a repeat of the Friday doctor consult. The Patient Advocate wants to keep this doctor informed of what is going on in the larger world of CFS. This very compassionate and independent doctor is pinned down trying to help his many patients. He struggles for acceptance in the Twin Cities; and the PA is always a bit worried that this doctor will not be there the next time the PA wants to see him. These managed health care environments seem to have a way of “disappearing” independent doctors.

In addition to talking about XMRV, the WPI, and research into ME/CFS, we discuss thyroid regulation. Some of the hormonal problems of ME/CFS, like Hashimoto’s, have to be managed by the patient (and her advocate). Outside professional help is useful in that it can confirm the direction taken. Thyroid regulation is complex and elusive. Having more than one opinion is necessary in order to make a knowledgeable decision.

These doctor consults are difficult for the Patient Advocate - as the doctors never drop their “professionalism”. The PA surmises that most doctors do not like to talk to patient advocates. The normal doctor patient relationship becomes too skewed. While the Patient Advocate always remains polite and appreciative, the PA can never tell what these doctors think of him - whether they think the PA is desperate or on a hopeless mission or just full of shit. Most certainly they feel that the balance of control is not right and something is out of kilter. The Patient Advocate remains undeterred in and pushes forward.

The Patient Advocate mentions XMRV and the doctor says that he follows it a little. The doctor is surprised that the PA had been able to find out where to get the test done, and that has actually had it done. The PA is surprised that the doctor is surprised. After all, the PA has handed this doctor all sorts of sophisticated tests from obscure labs all over the world. The PA urges the doctor to look at Peter Cairns’ videos on the WPI. Clearly this doctor could use some more information than he is getting, and the PA tries to provide it. The PA gets the sense that none of this “adds up” for this doctor - and it is a very long way from the daily grind of dealing with his patient population. Who knows how to bridge this divide?

During the course of any particular day there are daily tasks – endless small errands, shopping for food and treats (coconut juice, homemade flaxseed crackers or wild rice organic chicken soup, for example), going to the FedEx to copy test results or to fax letters, writing in his journal, cleaning his daughter’s apartment, picking up pharmacy prescriptions – all attendant to picking up the slack of an invisible life. In addition the Patient Advocate does his regular several daily hours of research and communication on the internet – including the writing of this blog.

Lest the reader think everything moves in a certain pre-ordained direction, the Patent Advocate can disabuse them of this. Any sense of any success or of things going in the right direction is shaky at best and comes in the smallest of doses. Most of the effort is expended to maintain the status quo or to keep things from back-sliding. Finally there are the interactions and circumstances that bring with them the sense that things are not going in the right direction, that realization that the situation is becoming further tangled. In other words, there is a great sense of defeat, both small and large. One example follows.

Part 3

This trip includes a particular irritation. For no particular reason, the overzealous local township has taken it upon itself to make sure the apartment in which his daughter lives is up to code. We are supposed to believe that these people are “just trying to help”. They are unaware of and indifferent to the fact that they are directly threatening my daughter’s health. The inspector is a young fellow who feels that he needs to be extra vigilant, especially since there is nothing particularly wrong with the two-apartment house. Having the constant threat of inspectors and carpenters lounging around and dropping in as they see fit, is a great source of stress for my daughter. These “inspections” and their follow-up “cures” have precipitated a number of crashes for the PA’s daughter.

The Patient Advocate spent a great deal of time trying to protect his daughter from this insult. How does the PA tell a bunch of Minnesota dolts that their existence and presence is bad for his daughter’s health? Of course the first thing that they wanted to do was take out the stair lift - installed with great care to code requirements several years ago (by the PA himself). This stair lift is the lifeline of my daughter, and allows her to occasionally get down on the porch or out into the yard for a few minutes. With zero information about stair lifts in his brain, this neophyte inspector sees danger. The Patient Advocate has to appeal to State regulators and local stair lift inspector records to try to fend off this inspectors’ zeal to prove that this stair lift was unsafe.

Many very minor problems were cited in my daughter’s apartment. For instance there was a non-structural crack in the ceiling of the kitchen that allowed for a few very small flakes of paint to appear. Despite the fact that this is entirely a cosmetic situation the local “enforcers” required that the entire kitchen ceiling be scraped and repainted. In order to keep painters out of my daughter’s kitchen for the two or three days necessary to do this job, the Patient Advocate took it upon himself to do it. Of all the situations in the 67 years of the PA’s life this was one of the most absurd.

Tuesday is the day that the PA's daughter gets IV treatment. This also often involves doing a blood test at the same time. The Patient Advocate arranges all the ordering of test kits, along with the paperwork and the shipping. He is handed the blood by the IV nurse and then he goes into action mode. While much of this testing procedure has become routine, obstacles are always arising - as there is a slender thread connecting the home-bound ME/CFS patient to the real world. In this instance an underling at the FedEx refused to ship the package - as it contained a “liquid” and she claimed that she was prohibited sending liquids from her shop – this in spite of having checked it out with the manager that very same morning. Multiple trips to FedEx are always necessary to make things happen. Making sure of every detail is part of the PA’s job. The PA had a sharp exchange with this gal, threatening her for her impertinence - and the blood sample eventually was shipped out in time.

One of the things that the Patient Advocate likes to share with his daughter is juicing – vegetable juicing. Several years back the PA latched onto this idea, and it has developed over time. The PA enjoys going to the Whole Foods, lugging, slicing and juicing the vegetables. Vegetable juice is like gold. The PA and his daughter make a load of juice with her Omega 400 juicer. The juice is made from lettuce, tomatoes, carrots, beets, cucumbers, red peppers, celery, garlic, and ginger. The PA’s daughter believes that juicing is good for her. How could it not be?

The Patient Advocate had a phone consultation with a third MN doctor on Tuesday. The PA and this doctor talked about the methylation protocol and the PA's daughter’s improved reduced glutathione status on the recent Vitamin Diagnostics test. We talked a bit about mold, and the doctor gave me some suggestions. We discussed thyroid regulation.

This doctor is very hip to XMRV - 8 of 10 of her lyme patients have tested positive for XMRV. She will be going to the ILADS conference in Jersey City. The Patient Advocate alerted her to the talks of Montoya, Marcus Conant and Brewer and she was appreciative of the heads-up. She made a suggestion of an Infectious Disease doctor at the UM. The PA wrote this doctor (along with 60 other I.D. doctors in the Twin Cites), but of course the PA did not get a reply.

The PA writes up a summary of every doctor consultation. Everything needs to be written down and communicated to other members of the family - so that they are clued in on what is happening (in case the PA drops dead on his bike). Years of detailed note taking pays off in various ways.

Wednesday morning the Patient Advocate finally figures out how to put his bike on the front rack of the buses - so that he can move around town faster. The morning also involves sending test results, mailing stuff at the post office, emailing with a lab, going to the medical supply company to discuss the alleged “problems’ with the stair lift, calling to get the specs on the stair lift and buying replacement batteries, buying artichokes (The PA’s daughter likes artichokes), and going to the hardware store for paint supplies.

Tuesday the PA climbed up on his ladder and sanded the ceiling of his daughter’ kitchen. It is difficult for a 67 year old to do this, but the PA has done this many times in the past. The PA has to do this job as it is preferable to a situation where workers come into my daughter’s apartment and make her sicker. The local code enforcer has zero interest in the particulars on the subject, even after a long conversation with the Patient Advocate. The threats to a ME/CFS patient come from every conceivable direction, and it is the job of the Patient Advocate to try to protect his patient. Sometimes the PA is successful in this enterprise, sometimes things do not work out - and the jerks of the world accomplish what they want.

The time in MN is not leisure time. From the rise from bed at 6 until the retirement at midnight the day is full of one consternation or squabble or uncertainty after another. For instance in a routine matter of a blood draw there can be massive complications. The system is not built for home draws, and very few people understand what it takes to do these tests out of the home. All sorts of people tell me that they would do the same if their own child was sick. The Patient Advocate know that this is not true. Most people, most healthy people, are not equipped to do this job. .

Thursday was mostly sucked up with dealing with apartment doings. The Patient Advocate met with the safety inspection person and went over the specs of the stair lift. This Bruno stair lift is one of the best, most reliable and most expensive in the business. For the moment let’s forget about the PA's acquisition of this stair lift through Craig’s list - at a bargain basement price. For every patient advocate looking for a stair lift, there is someone else desperately looking to unload one. The Patient Advocate hopes that he was able to convince this particular inspections fellow that this was not a flyby installation, and that it had been maintained by one of the best medical supply companies in the Twin Cities. It seems that the inspector will insist on a few minor changes, but that the stair lift, the lifeline of the PA’s daughter, will be able to stay. The entire situation was bizarre and ate up a great deal of time and concern on the part of the Patient Advocate - to say nothing of the effect on his daughter. ME/CFS is a stress related disorder and this kind of stress is pure murder.

Lastly, the PA painted a final coat of paint on the ceiling of his daughter’s kitchen. The Patient Advocate used paint that was VOC free and this went fine, except for the paint that dripped all over his face and arms. It is difficult to paint a ceiling.

The PA buys some flowers for his daughter, kisses her goodbye and gets on a plane back to Philadelphia and begins preparing to come back the next month. And so it goes, month after month after month.

Thursday, December 2, 2010

Crunch Time - FDA Blood Advisory Committee, December 14, 2010


It has been a long three months since the 1st XMRV conference and there has been very little information released by the Federal Government regarding what they plan to do about a number of XMRV-related subjects - most importantly what they plan to do about XMRV and the blood supply

This is about to change. The FDA is trapped by their own agenda, and they will have to say something on December 14th. On that day, the FDA is seeking advice from the Blood Products Advisory Committee in an afternoon meeting in Gaithersburg MD. Background information, discussion and summary of this meeting is provided here.

The FDA Blood Products Advisory Committee meets every six months to discuss various issues related to the blood supply. The committee's charge is here. More information is provided here. The December 14th agenda is provided here, and the presentation regarding XMRV takes place in the afternoon from 1-5:30.

An assessment of the current research into XMRV and its association with illness will be given by Jonathan Stoye. We last saw Dr. Stoye doing a haplessly weak job refereering at the Q&A of the 1st annual XMRV conference. This fellow morphs together in the Patient Advocate's mind with that other fellow, what's his name, whom the PA saw also give an XMRV research assessment at the CFSAC meeting in October. Do not expect much, except misdirection and inept sandbagging, from this UK virologist.

Following this, short presentations will be given by Shyh-Ching Lo, co-author of the FDA/NIH paper, Maureen Hanson, co-author of the 10-10-10 study (with David Bell), and Judy Mikovits.

An XMRV blood working group update will be given by Graham Simpson of Blood System Research Institute (SSRI). Dr. Simpson's name was on the CDC XMRV paper. The XMRV blood working group was formed by the HHS in 2009 to investigate XMRV presence in the blood supply. (The PA sees it as a sub-committee of the Blood Study Advisory Committee.) Their plan is to study XMRV and the blood supply problem in four phases. A report of the first stage is given here. The second phase is to determine a diagnostic protocol for XMRV testing that will allow for broader examination of the blood supply. The report of the second stage was scheduled to be released in early November, but this release has been delayed without explanation. The PA imagines that something concrete will be presented at the December 14th meeting.

Indira Hewlett, Francois Villinger, Micheal Busch and Rachel Bagni will also give presentations.

Following the presentations there will be both an open public hearing and an open committee discussion. As usual it is here where things are apt to get interesting.

The Patient Advocate has attended a number of these FDA advice or recommendation panels - mostly regarding diagnostic tools for diabetes. These panels are composed of various government scientists along with a healthy dose of academics. The dynamics of the public forum are always the same. Very articulate but powerless patients or advocates stand up and in a very compressed time period argue their points to indifferent and ignorant functionaries. Many of the panel members, half asleep, are hearing the information for the first time, and nod off under the pressure of their ignorance. They will be called upon to cast their votes at the end of the day. Often these committees are in the grips of two or three "important people" whose guiding principle is "answers first, questions later". This process leads to one recommendation absurdity after another in an endless array.

The "discrepancies" between the advocates and the committee members couldn't be greater. For the objective observer, the situation challenges any known form of reality, and one is apt to become unmoored by the absurdity of it all. It has always been the PA's opinion that these two groups should trade places - allowing for real change.

The open committee meeting is even worse. With an exception or two, each panel member tries to position themselves, with a mixture of confidence and imbecility, with the majority - or with what they perceive to be the majority. This "territory" can be shifting and dangerous at times. Often there are palpable and anxious vibes of members desperately trying to figure which way the wind is blowing while at the same time trying to cover their asses. These folks are real professionals with a capital P- and are to be deeply admired for their detachment.

The stated purpose of this meeting is thus: the FDA is seeking advice. In this case the Patient Advocate thinks that they will get it. What they do with the advice is another matter. One thing is clear. The FDA will ban CFS patients from giving blood in the US. (ME/CFS patients blood donations have already been banned in the UK, Canada, NZ, and Australia.)

While taking this step the FDA will reassure the public that all is well (in spite of the fact that at least two new retroviruses are in the blood supply and maybe as many as four), that this is just a prudent and precautionary step, necessary to protect ME/CFS patients from themselves. Later the full extent on the presence of these viruses will be determined, but the FDA and HHS will try to take their time with this. The pertinent question is whether the government can really get on top of this situation at the moment - or whether their fatal errors of the past condemn them to always being behind in managing the situation. The Patient Advocate would put his money on the latter.

The good news is that circumstances, i.e. reality, has taken over and the situation is driving itself. The only question is how to speed it up.


Tuesday, November 23, 2010

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.

Monday, November 22, 2010

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

Sunday, November 21, 2010

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.

Saturday, November 20, 2010

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)

Sunday, November 14, 2010

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.

Saturday, November 13, 2010

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.


Friday, November 5, 2010

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?


Friday, October 29, 2010

Judy Mikovits is our Frederick Banting

Between traveling to Minnesota to help his daughter, attending conferences on ME/CFS, writing posts on his blog, cleaning a small apartment (toilet too) in NY for short term rental money (cash for research and treatment), the Patient Advocate has a few moments where he tries to retrieve a little of his former life, much of which has evaporated (the PA is not complaining).

This week in NYC, the PA went to a fascinating show on the history of insulin at the New York Historical Society. The Patient Advocate has a long-time interest in diabetes as a close family member has type 1 diabetes. So the Patient Advocate knows something about this illness also.

The story of insulin is a fascinating one and the show itself was quite amazing, with many original and fascimile documents. The Patient Advocate bought a book called "Breakthrough" - authored by Thea Cooper and Arthur Ainsberg. The book tells the story of the discovery of Insulin and the last minute "resurrection' of Elizabeth Hughes (and others). Elizabeth was the daughter of the Secretary of State, Charles Evans Hughes. While the story line is riveting, the book suffers from various shortcomings, not the least is that it was written by two people - a fatal formula. Ultimately the book is a "poor read", as it suffers from unnecessary and misleading modern "flourishes". In other words the authors make shit up, they "dramatize" situtions that never happened. In this sense it is very "modern" and idiotic. This almost gets in the way of the essential narrative of this powerful story - and ultimately led the PA to go to the local public library and get out an older book on Frederick Banting, the Canadian inventor of insulin.

While reading "Breakthrough", the Patient Advocate had drumming through his head repeatedly - "Judy Mikovits is our Frederick Banting, Judy Mikovits is our Frederick Banting".

Frederick Banting has always been a favorite of the Patient Advocate - and it is no secret that Dr. Judy Mikovits is also a favorite of the PA, and has been for some time.

The idea of the cure for diabetes came to Banting late at night after he read a recent article on the illness. He knew almost nothing about diabetes and had no access to a lab. Circumstances unfolded, mostly of his own doing, allowing him to do research over the summer of 1921.

Later he had this to say about scientific discovery:

"We do not know whence ideas come, but the importance of the idea in medical research cannot be overestimated. From the nature of things ideas do not come from prosperity, affluence, and contentment, but rather from the blackness of despair, not in the bright light of day, nor the footlights' glare but rather in the quiet, undisturbed hours of midnight, or early morning, where one can be alone to think. These are the grandest hour of all, when the progress of research, when the hewn stones of scientific fact are turned over and over and fitted in so that the mosaic figure of truth, designed by Mother Nature, long go, be formed from the chaos."

In the middle of that night Banting had an insight and wrote down 25 words outlining his idea. Where to look occurred to him in a flash - and to only him. A similar situation arose in 2007 when Mikovits attended a meeting in Barcelona. Through happenstance, and upon further reflection (Mikovits too had no clue about ME/CFS.), Mikovits too had a flash of insight: "It's a retrovirus." Like Banting, Mikovits went looking, and with a little necessary luck (which also accompanies "special people") she stumbled on XMRV. And the world turned. In both cases there had been prior suspicion or identification of the "culprit", but no one had been able to substantiate it. In both cases it took the arrival of a "special person" to unlock the key.

Upon the discovery and production of insulin by Banting, immediate efforts were taken by others to marginalize him - to "take him out". The PA is reminded of the story of a government figure (CDC, NIH?) approaching a very well known scientific colleague of Mikovits and warning him to "distance himself from the WPI". This functionary stated that "the WPI is going to be taken out"

The idea of an unknown (hick) person, Banting, making the insulin discovery was intolerable to the academics around him -although Banting (like Mikovits) did have some close allies. The worst part of the insulin story involves a particular fellow named Macloed, who, for no good reason except self-aggrandizement, ended up sharing the Nobel Prize with Banting. Through the early years, Banting had to keep his head in order to hold onto his invention. Continuous efforts were made to take him out of the equation and substitute others. Eventually, through doggedness, Banting was able to get the recognition that he deserved. He resolved not to be pushed aside and fought back. Banting had guts.

Banting came from modest circumstances and had no larger aspirations beyond solving this specific problem. He had what is known as "intellectual curiosity". He wanted an answer and in no way was prepared for what lay in store for him. The negative assaults that he had to endure altered his view of the world - at the very same time that hundreds of patients were being saved. It is a convoluted and sad, yet exhilerating, story. People are really strange and the Patient Advocate does not want to speculate on what they are really "after".

Banting had a little trouble moderating his anger towards those who wanted to take him out. These were unsettled waters for Banting to negotiate and he was forced to rely on more primitve instincts that he learned in his upbringing on a farm. Some of his lab partners were afraid of him - afraid of being physically assaulted. Our own favorite, Judy Mikovits, gives the impression of wanting to also "punch out" a few people. The Patient Advocate speculates that he was sitting right behind two very good targets at the recent CFSAC Science Day.

For his entire life, Banting had a deep personal attachment to his patients, in spite of his own somewhat rough personality. He liked the idea of saving children (and adults). He was personally invested in his practice and kept up a lifelong interest and exchange with his patients. In other words he had empathy, a quality that is increasingly absent in the world in which we live. Judy Mikovits too has this empathy with patients - witness the recent NJCFS meeting.

As a result of the insulin discovery, there was a great amount of room for additional people to get involved in this positive effort. In the ME/CFS world we are now seeing this on a daily basis. It occurred in the 1920's - there were other heroic collaborators in the unfolding drama of insulin - and it is happening now, right now in ME/CFS.

All this sounds vaguely familiar doesn't it?

Conclusion? Seeing this exhibit (reading this book) cemented the idea in the Patient Advocate's mind that Judy Mikovits is our own Frederick Banting.