April 28, 2009
Tags:
CDC Seeks Input
Five More years?
The Centers for Disease Control intends to stay in the “CFS” business for another five years in case anyone was wondering.
Yesterday afternoon, on Monday, April 27, the agency held a four-hour group therapy session for people who have suffered so in the Reeves Era.
The agency has created a five year strategic plan. Yup. Using the Internet, agency staff put out the word: they sought “input” on this plan from citizens. The notice came suddenly last week. People wanted more time to prepare for the event. The agency was accommodating, extending its deadline to send in comments until May 1, or Friday. But, swine flu or no swine flu, they stuck to their guns on the matter of holding the public meeting in Atlanta yesterday.
As it turned out, the all-afternoon call-in fest was remarkable in myriad ways. I hadn’t expected to be so profoundly affected by it.
In my long memory, it was the first time I have seen agency staff leave themselves quite so vulnerable. There was no filter between government staff and the public, some members of whom arrived in person to participate in the four hour session in Auditorium B2 of the CDC’s Global Communications Center. One couple flew all the way from Texas to make their brief comments, for instance; the wife, ill, the husband, healthy.
The agency provided a freebie telephone line for everyone else to dial up. Thus, one had the option of listening to the proceedings in the comfort of home while, say, scanning the front page of the New York Times, or to actually participate and hear one’s voice piped into the auditorium. It was all very high tech and nicely worked out.
The sole ground rule in this entire affair had to do with the number of minutes people were given to go full tilt at the agency: five. Due to what may have been an unexpected short-fall in the number of people who chose to participate—thirty-two by my count--and the generous four-hour time allowance, however, organizers allowed that rule to fall by the wayside. Numerous people managed to pop back into the proceedings a second time in order to continue their original train of thought or make additional points. The afternoon unfolded into a luxurious expanse of time, in fact, and left the battered agency asking, at the end, rather masochistically—“Anyone else?” And in the brief moment of silence that followed, one sensed a collective feeling of peace, perhaps the first in a quarter century. Everyone who wanted to speak their mind had been accommodated, whether it was to simply “bring home the hurt” caused by CDC policies, as one man said, or to plead for the involvement of outside scientists, or to demand that Bill Reeves be removed ASAP.
The language coming from the floor and the common phone line was often riveting, always thoughtful and, for the ensuing four hours, it never really let up.
CDC staff arranged for a very sweet lady named Becky to moderate, no doubt to defang any vitriolic detractors. Becky had a lovely “thank you” for everyone who called, no matter their disposition or rank, no matter how irate their statements.
I had planned to merely listen, but eventually talk of decades of life lost and minds wasted got my blood pounding, and I found myself pushing the star key on my phone. Presto-magic, I was in the queue and then quickly on the line. Given its monstrous history in this disease, I said, “The CDC needs to make a formal apology to every American citizen with this disease, and recuse itself from the further study of this disease.” I heard a tiny smattering of applause and imagined more than a few rolling their eyes.
“Thank you,” Becky said, sounding a little sad. To the tender-hearted Becky, I say, “And thank you!”
Acting CDC director Richard Besser was busy with swine flu on Monday so the agency sent the head of the National Center for Zoonotic, Vector-Borne & Enteric Diseases, Lonnie King, in his stead. King is a veterinarian and, more interestingly, the boss of Bill Reeves. Also present was Stephen Monroe, who heads the division of viral and rickettsial diseases. For those of a sentimental bent, Monroe’s division was the long-ago workplace of Gary Holmes--of the famous “Holmes” criteria of ‘88. It was also the workplace of Keiji Fukuda--of the famous “Fukuda” criteria of ‘94.
Fukuda is now the deputy general director of the World Health Organization. Who says “CFS” ruins careers?
The afternoon began with a rather superfluous if breathless update on the state of the swine flu outbreak. CDC staff have been preparing quite literally for years for such a flu pandemic and should cases in the U.S. become either more virulent or common, it’s one public health crisis where the agency might actually score a win, something it badly needs in these days of unruly U.S. senators making inquiries into the CDC’s spending sprees and slamming even its ability to prevent and control disease.
Apparently, I wasn’t the only one who found irony in the flu update.
“You have declared swine flu a public health emergency. With four million cases of CFS, what does it take to have it declared a public emergency?” was Kim McCleary’s surprising zinger. Go Kim!
Lonnie King began his welcome patter by noting that two years ago, a CDC staffer had written an account of her “CFS” for an in-house publication, an account that he seemed to have found heart wrenching.
“One of our CDC employees came forward,” King began somberly.
He certainly got the diction right, since we all know admitting to having “CFS” is analogous to coming out of the closet, and many who care about their reputations and their livelihoods, if they are lucky enough to have either, will prefer to stay in. As a patient in the auditorium noted eventually, “Having CFS is like having AIDS in the 1980s. You don’t want to tell anyone. There’s an immediate response that you’re psychologically unbalanced.”
And what federal agency, far, far away from the Capitol and way down in Atlanta, Georgia may have played a role in that phenomenon?
At King’s mention of a CDC staffer—one of their own!—spelling out in black and white the nature of her suffering for agency scientists to read, I was reminded of my one of my visits to the CDC in the late 1980s. I discovered then that approximately one-hundred letters from people with “CFS” were pouring into the agency by the day. These letters collected in boxes in corridors like so much trash before they were thrown out. Some of them were ten or more pages long, handwritten on legal pads. They read like small novels.
And, by 1990, the letters were complemented by frantic, terrified phone calls from patients that came in ‘round the clock. I met a secretary that year at the agency whose job description included wrangling a telephone answering machine that collected these phone calls. I was incredulous, but she insisted that at least two to three-hundred or more calls came in during the day in response to a hot-line the agency had set up for "CFS." She added that the message tape was filled to capacity with calls that came in during the wee hours—every night. “These people stay up late,” she added.
That same year, Newsweek devoted a cover story to "CFS." The agency received over 15,000 calls "in the space of a few days," according to a staff person at the agency. In 1991, the agency hired a second full-time staffer to help log calls from "CFS" sufferers. Now, two people were working full-time simply logging the name and address of every caller or correspondent. Division head Brian Mahy frequently asked his staff for a tally of the "CFS" calls.
All this--during a period the agency was diverting millions of Congressionally mandated "CFS" research dollars to researchers' pet projects and staff travel--and lying about their progress in the disease to Congressional oversight committees.
So, Dr. King, I say, Cry your crocodile tears of sympathy. Unless you somehow discovered a mere two years ago that this disease is a nightmare, I remain unconvinced that you or anyone else at the agency could possibly have been so innocent of the depth and breadth of this disaster. Did it really take just one letter from one patient in 2006 to impress you?
Very quickly, agency honchos sat down to listen and the real business of the afternoon began.
Immunologist Nancy Klimas complained about the fuzzy strategic plan, which had exactly four points—things like “laboratory research” and “Educational Intervention Research.”
If there were themes during the afternoon, this was one of them: zero details.
“Three of these [four] don’t look like research goals,” said McClearly, who seems to have morphed into Robocop in the last few months. I like the new vibe.
“Your outline—it’s so devoid of specifics,” added Jennifer Spotila, a colleague of McCleary’s. “What is the priority order? What funding has been identified? What are the milestones for performance? How will you engage extramural researchers? How exactly do you propose to develop an international consensus on CFS? I could go on—your outline could have been written two years ago—or ten.”
And to that, I’ll add twenty.
Marly Silverman of Pandora offered one of the most jam-packed and specific counters to the agency’s de minimus five year plan, proposing that the SSA develop a mechanism to track denial and approval rates for “CFS” claims, for instance, and that the CDC “enhance the program of medical providers [doctors, for the rest of us] to include specialists in neurology, endocrinology, dentistry, mitochondrial disease,” and more. “We see flaws in studies of defined populations,” Silverman hammered away. “[Create] provider-based patient registries, with online patient self-reporting. Cross reference it with patient medical providers…Send CDC teams to patient providers. We also suggest visiting these patients at home. The most difficult cases of CFS—these patients are bedbound and homebound…”
Ahh—great suggestions--even if Pandora may be too generously crediting CDC staff with the ability to diagnose a case. But, while floating in the Blue Sky reality offered by the Centers for Disease Control, why not ask for the moon? Go for it. (On a personal note, if I knew in advance anyone from the CDC was coming to my house, I would arrange for a restraining order.)
Another theme, no surprise, was suffering.
“I’ve already lost my twenties—I don’t want to lose my thirties,” said the young woman from Texas.
Said her husband, “You will be saving marriages”--if agency scientists could find a cure.
Another woman took up the cry: “There is an urgency to this matter. I have lost my thirties, my forties and my fifties—I don’t want to lose my sixties…My daughter has this disease. If my seven year old grandson gets this, my heart will break into a thousand pieces…There are many people out there holding on day by day.”
To which one can only say, Amen, sister.
“In the past, CDC has ignored us, lied to us—I just want to really bring home the hurt,” said one caller who spoke in a halting, choked voice. “I remember a couple of years into it. I was in my car, writing a suicide note. I only didn’t do it because I thought about my kids.” After which, there was silence while he composed himself. “I want you to think long and hard…” he added.
“Thank you,” Becky said after waiting a decent interval.
Not surprisingly, over the course of the afternoon the tone moved from sophisticated criticsm, to hurt and, eventually, to barely suppressed rage. If CDC had any motives other than to solicit “input” on their slap-dash five year plan, then allowing the steam to rush out of the pressure cooker must have been among them, and that is what happened.
From the even-tempered, watchful Craig Maupin, who misses nothing: “Reeves has worked diligently with the military on stress research. His passion for stress research is commendable. He should follow his passion.”
And this from a veteran of the disease: “For twenty years I have had chronic EBV, chronic mycoplasma, and chronic HHV6. CDC has consistently failed to find HHV6 in CFS. Meanwhile, the CDC has recognized the swine flu outbreak and is working on it in a matter of days.
“CFS is an infectious illness," the speaker contined. "The CDC has watered down the definition so that it bears no relationship to the disease. The agency should model its research after the Whittemore-Peterson Institute in Nevada. [Instead] it’s calling people in Georgia twenty years later to ask them if they’re tired. You are wasting taxpayer dollars. Adopt the Canadian definition, adopt the WPI methods, including viral research, and stop characterizing CFS as a psychological disorder.”
And another old-timer: “We have been terrorized by this illness, but no one seems to care that much. We’ve experienced foreclosures way before the normal population has. We can’t work, we can’t play. We’ve lost our identities—it’s devastated every area of our lives. We need our doctors, our neighbors, to know we’re not lazy or crazy. Maybe until the CDC can find solutions, they can at least educate.”
If only!
And from seemingly out of nowhere emerged Dr. Fred Volinksy on dial up, an authoritative person with an exhilarating attitude who called in once, and then again, the second time demanding the firing of Reeves.
“We want new leadership for this program!” he said. “Twenty years without any progress! You have at least one to two million patients with CFS—and no money!..I’ll be absolutely disgusted if we have the same leadership here,” Volinsky continued. “I need to know which senate committee has oversight over the CDC.”
Becky was put off her stride. “Are you through Mr. Volinksy?” she asked after a minute in her honey-toned voice.
“No! I’ll never be through!” Volinksy replied. “This is an example of the whistle blower law being used in a very unethical way,” he said in a reference to Reeves’ invocation of the Federal Whistle Blower Act.
You'll recall that after the news was everywhere and about to break in the Washington Post in 1998, Reeves stepped forward and began spilling his guts about the CFS slush fund. That was almost two years after I broke the same story in Osler’s Web, but who’s counting? The point of the Act is to encourage ethical conduct in government. Volinsky was implying the obvious: Reeves used the Act to hang on to his job.
For the record, the Senate and House subcommittees that have oversight over CDC are the subcommittees that appropriate money to the Department of Health and Human Services. History shows they are easily deceived by, and frequently in awe of, government scientists.
Patricia Blankenship was another whose heartfelt, thoughtful remarks kept the bar high for these proceedings: “I’ve been in this fight for years,” she said. “I’ve testified for years—the things we’ve been asking for all those years—there are no treatments, no medical markers, the physician education is a joke, there is no outreach to medical schools. Doctors should not have to learn what is going on from paper we’ve printed out from the internet that we bring to them.
“I have very little confidence that CDC is going to make new breakthroughs or help the patient community, because the same people are at the plow.”
Scott Royal, who is the current project director for Abt Associates, the contractor that was first hired by the agency in 1988 to conduct surveillance and has made ungodly amounts of money from the agency’s “CFS” boondoggle ever since, was the jolliest of those who spoke. “Participation in our Macon (County) clinics is very positive (for patients) and provides validation to them that their experience is real...The mere fact that CDC is funding this research,” he said, sounding a little choked up himself, empowers patients because it makes them aware that their disease must be important.
Another superfluous piece of flotsam from an agency employee/conractor. Royal describes himself as a "social and behavoiral epidemiologist" on his resume and has a masters in public health. He is credited on the Abt website for being "instrumental in designing and implementing a strategy that has significantly built the Abt Associates porfolio of work at the CDC." In fact, Abt Associates opened an office in Atlanta in July of 2008, an office that I'm guessing was built with a lot of "CFS" research money.
To Royal, I would simply say, I don’t believe patients are looking for empowerment from the CDC, the very folks who helped disempower them, nor are they looking for validation that what they are experiencing is "real." Only a CDC pod person could infer, in 2009, that patients are in a state of uncertainty over the reality of what has happened to them.
In my experience, patients are looking for rational, competent, scientific research. And if the agency didn't hear that this afternoon, it never will.
So, in addition to my sentiments expressed above, I think the CDC should get out of the empowerment business.
And to those who braved the wear and tear of this remarkable afternoon, I would like to say, “Group hug, anyone?"
Please scroll down to read comments:
Comments
Rich Van Konynenburg wrote an informal summary of the meeting which can be read at:
http://tinyurl.com/richcdc
i.e.
http://www.prohealth.com/me-cfs/blog/boardDetail.cfm?id=1346564
My testimony is also part of the discussion
Great coverage but I was a bit shocked to learn you told CAA's Kim McClery -- Go Kim!
When she recently spoke up regarding the CDC I said, "why all of a sudden now." And, I'm still wondering...
The CDC and CAA with Wm Reeves at the helm have drug each other down and out and not just in Atlanta.
Sincerely,
Diana Saba
Disabled Retired Nurse
Well done! You wrote a great piece describing the highlights of the CDC CFS meeting on April 27. I look forward to other pieces in the future.
I will be publishing my entire remarks today or tomorrow and will leave you a link. I had so much more to say; I could have plowed into them for the entire 4 hours. How to choose what to say to sum up 19 years - 1/3 or my life - living in the hell that CDC has only made worse.
And thanks for your summary here. Slowly with several people Tweeting and blogging what they recall, we will build up a full picture of the debacle that is their "5 Year Strategic Plan." I laugh in their faces, and I cry with my brothers and sisters!
And this from a veteran of the disease: "For twenty
years I have had chronic EBV, chronic mycoplasma,
and chronic HHV6. CDC has consistently failed to find
HHV6 in CFS. Meanwhile, the CDC has recognized the
swine flu outbreak and is working on it in a matter of
days.
"CFS is an infectious illness," the speaker contined.
"The CDC has watered down the definition so that it
bears no relationship to the disease. The agency
should model its research after the
Whittemore-Peterson Institute in Nevada. "[Instead]
it's calling people in Georgia twenty years later to
ask them if they're tired. You are wasting taxpayer
dollars. Adopt the Canadian definition, adopt the
WPI methods, including viral research, and stop
characterizing CFS as a psychological disorder."
WHY IS NO ONE MENTIONING THE TERRIBLE SIMILARITIES BETWEEN TICK BORNE PATHOGENS AND CFS? HOW ABOUT PUSHING THE CDC TO DEVELOP ACCURATE TESTS FOR BORRELIA, BABESIA AND BARTONELLA FOR STARTERS.
Paula Carnes
Patient Advocate since 1997 diagnosed with cfs in 1995 and Lyme disease in 2003.
>
> Dr. Nancy Klimas remarked that CDC studies of
> psychiatric stressors were "way behind the times"
> and that the "emperor has no clothes" when CDC's
> long-term studies of patients don't produce any data
> about the long-term risks associated with CFS.
Such as 19 OUT OF 59 MEMBERS OF THE ORIGINAL 1985 INCLINE VILLAGE
CFS COHORT GETTING LYMPHOMA?
-Erik Johnson
1985 Incline Village "Tahoe Flu" survivor
International Conference on HHV-6 & 7 in Baltimore, Maryland, USA
Day 4 - June 23, 2008.
> > -Daniel Peterson (Clinician Forum Session)
> > "Antiviral treatment of patients with HHV-6, EBV & Enterovirus:
case reports"
> > http://www.scivee.tv/node/7030
____________________________________
And I'm sorry to be skeptical about the former Kim Kenney of CFIDS ASS. Marc Iverson, the founder of the Association, knew that the current leaders of CFIDS ASS did not have the best interests of the patients at heart and are only there to go along to get along with the government and Reeves. Otherwise they would call him out years and years ago. I'm sorry, but I don't believe Kim. She just wants people to subscribe to the Chronicle and keep her salaried position. They are not effective in the least.
Many of us believe that there is money at the bottom of this issue and that too needs to be figured out. WHY is the CDC so not interested in us? Money. Did the insurance companies get to the CDC and tell them that validating CFIDS would cause financial collapse for them and other parties?
Personally, I just send the CDC nasty emails attacking them for doing nothing for us. No, not true. They have kept us back 30 years and caused us more damage than had they just stayed out of CFIDS research. I expect nothing from them and at this point, 30 years after the first outbreaks, I think it may be best that the CDC stay out of the CFIDs business since they only seem to hurt us further.
Thank you for your hard work on CFIDS. Because of you and your book, background information on CFIDS and how it is handled has been super critical. Actually, your book is THE MOST CRITICAL document on CFIDS and its history.
I read your book many years ago and have loaned it to so many as "the chronology" of this shameful piece of medical history. I thank you for that.
Nearing my 70th birthday, I look back and see many lost opportunities and now find myself as caretaker for a husband with cancer. Fortunately, I have a PCP who cares and believes. I didn't always.
Challenged cognitively, I try to share with our local support group so my next newsletter will have a link to this report.
Thank you for this report. We need to hear from the perspective of someone who will be frank. It is so satisfying... but sad at the same time.
I just read the report of Ryan Baldwin, Asheville, NC who was taken from his loving parents and put into foster care because it was believe he really wasn't ill. A report of that is in today's Co-cure postings.
Again...THANK YOU!
Anyway, I've testified for my five minutes at the CFSCC and CFSAC since 1996, and I've felt under pressure because these days maybe 5 patients show up, and if I screw it up like I feel I did, I've screwed it up for everybody.
But so many people spoke up - the dam was overflowing. It was frustrating to be shoved aside by yet another disease, but I think it may have been the straw that broke the camel's back, and got everybody speaking the truth. You spoke out so firmly, and so many people talked about what they've been through, that what I said didn't even matter - the message was so overwhelming. I hope someone was listening, but to everyone who spoke - wow - you really made my day - we were a community. Some of the testimony broke my heart, but it was honest.
I'm glad Kim was honest in her testimony, but I'm really worried that she doesn't seem to understand how dangerous to us that Wichita two-day hospital stay was, where they "found" 43 patients with "CFS" using their questionnaires - but only 10 could be diagnosed with CFS using Fukuda, and the other 33 really had depression. They need to send those questionnaires to a toxic waste dump.
You'd think they couldn't do us more harm, but the Reeves "international empirical" definition and questionnaires will, if allowed. This definition, reduced to questionnaires, drops the most serious patients and substitutes a lot of people who mainly have primary depression. CDC has become the U.S. Mouthpiece of the British psychiatrists. There were so many British "biopsychosocial" buzz words in those "5-year" goals.
I was happy to hear so many people repeat over and over again that we need to define subgroups with biomarkers and find treatments - I think the community has come to a consensus on this, and I bet this was the first time anybody new to CDC and CFS heard about it.
It was insulting to be shoved aside by yet another disease, and the CDC so ignorant they don't know that if swine flu is for real, we're a high-risk group. Are we going to be able to get Tamaflu?
If they had paid attention to ongoing research on this, they'd know that swine flu plus EBV or something else, maybe left alone, is going to create another set of people like us. Will they then get ignored, just like us?
I'm really happy that you are going to speak in London at the InvestinME conference. They need to hear what you have to say, and you will learn a lot of what we are in for if CDC is allowed to continue with this dangerous and immoral plan.
Yes, group hug everyone, and thanks Hilary.
Why has there never been a class action lawsuit to bring them to justice, or to "heel", at least, rabid dogs that they have been to the cause of understanding CFS?
Of course there were only a few patients attending in Alanta; we are sick, sick, sick...but, oh, those of you who called in were wonderful, magnificient, and I am so proud of you for fighting this war on our behalf.
After 27 years of CFS, with 3 mycoplasmas, chronic EBV, and whatever else I've never been tested for because my doctors "don't believe" in CFS; after being a support group leader for 2 wonderful, fulfilling years and then burning out from the hundreds of phone calls from people desperately seeking doctors and we could recommend none; after getting myasthenia gravis diagnosed last year, and finally, after deciding I could no longer fight back and I could only live day by day, I found myself energized by the callers who participated in the teleconference and once again awed by the breadth and depth of their knowledge. I have made Osler's Web my bible, along with "The Clinicial and Scientific Basis of M.E./CFS, the incredibly visionary and medically correct compilation of studies the CDC let fall by their careless wayside.
My only grandaughter "caught" CFS from me, as I carried her in my arms the first 5 weeks of her life, during the very first 6 months of my own illness. She is 21, and has no life, no health insurance, one friend and here family 1600 miles away. My heart breaks for her. Her mother has many small signs of developing CFS, also.
My only grandson lives 45 miles from me; so far, he seems well, but there are little things I have noticed; a brilliant mind, but little "tic" in brain and facial expressions that worry me.
I have to stop now, my emotions are getting the better of me, and I have worked so hard to keep them under control because they can put me in bed for days. Again, thank you all for your honorable recitations on our behalves.
Dr. Fred Volinsky http://www.epiphanybio.com/about/team.html
Hi - If anyone wants to read my full comments, which I had to cut WAY short due to the difficulty of thinking while on the phine, I posted them at
http://www.patblankenship.net/cfs/final_cdc_submission_4_27_09.html
Pat
I started to try to summarise it but it's a bit hard for me and I'm a bit short for time. So I think it's easier if I just post it - people don't have to read it. It may not be word-for-word what I said but the second part in particular is pretty close]
I should first apologise and say that I didn't think I was going to be speaking today so I don't have anything prepared.
I have been ill for 20 years since the age of 16. I got 1460 in my SATs, top percentile in both of the subjects so had a promising future ahead of me, but I have now been housebound for over a decade[it is actually nearly 15 years - August 1994].
- I have read the CDC's research plan and am concerned that Graded Exercise Therapy and CBT based on Graded Exercise Therapy are going to be recommended. I am concerned that the CDC has been taken in by the hype of these treatments. Lots of people have been made worse by these treatments.
Unfortunately, because they are not drugs, there is no easy way for patients or doctors to report adverse reactions the way there is with drug treatments. So no one is recording that many people are being made worse by these treatments.
About the only place this shows up is in patient surveys: patient survey after patient survey shows a high percentage of people have been made worse by Graded Exercise Therapy and CBT based on Graded Exercise Therapy.
- Lots of patient surveys by patient surveys have found high rates of adverse reactions to that Graded Exercise
Therapy and CBT based on Graded Exercise Therapy. However the reporting system for adverse reactions to treatments in countries is generally designed for pharmaceutical treatments, not non-pharmaceutical interventions like Graded Exercise Therapy and CBT based on Graded Exercise Therapy. So these adverse effects tend not to be noted anyway.
- The draft plan uses the word "evidence based" three times. I think it is premature to use this term. There have only been a relatively small number of Randomised Controlled Trials and Controlled trials in the area. I fear
what it means is that the CDC is going to be supporting and recommending GET and CBT based on GET.
- The draft plan refers to arriving at an "international consensus on management". But again, I think it is premature to be talking about an "international consensus". There are lots of views. I fear that what the
CDC is referring to is GET and CBT based on GET especially after the publication of the NICE Guidelines.
- I am concerned by the phrase "prevention of CFS". This phrase isn't used much. One prominent person [I was referring to Prof. Peter White] believes that one can prevent CFS by getting people moving and exercise soon after an infection. Many other people would think this is dangerous and what people actually need to do is rest. I am
concerned that what the CDC is referring to is getting people to exercise after an infection which could be risky.
- When the CDC refers "intervention studies" I fear what the CDC is referring to is GET and CBT and GET. In other countries, these strategies have gobbled up a lot of the governmental money. Another study just gives these
treatments an unfair advantage - other treatments have barely been tested at all.
- The whole idea of GET and CBT based on GET is to get people to do more. But where is the evidence that it actually achieves this? There is none. There is no actometer data. All they have is questionnaire data which could be due to factors such as placebo or time spent with a therapist. It isn't solid evidence. Indeed one CBT study by Friedberg[1] this year reported that people
improved on the SF-36 physical functioning scale and on a fatigue scale but actually were doing less as measured by actometer data. This intervention involved encouraging patients to go out walking. And yet at the end people weren't walking more. So there's a lot of hype about GET and CBT based on GET but the evidence isn't there.
- I think the empirical definition is flawed. It selects 2.54% of the population or 1 in 40 of the population[2]. I don't think they all have what is commonly understood to be CFS. Who knows what some of the people have. A study found that 38% of those who had major depression but didn't have CFS satisfied the empirical definition[3]. This definition messes everything up.
- The thresholds for the empirical definition such as the 25th percentile for the SF-36 subscales weren't picked statistically, they were picked out of the air[4]. There is no particular reason why that should be the threshold. The role emotional subscale isn't a suitable way to pick way to find people who are functionally impaired on its own - Leonard Jason and lots of others also don't think it is suitable[5,6]. It shouldn't be used to decide that people are functionally impaired (and hence satisfy the impairment criteria in the Fukuda definition).
- At this time, when we don't know who might be harmed by GET and CBT based on GET, I think it is dangerous to be recommending them.
Thank you.
=========Second contribution on the phone===================
I just thought I'd add something as my first piece wasn't pre-planned and I left some information out.
- The draft plan refers to "international consensus on management", "intervention studies" and "evidence based .. management of CFS". I fear that these will not include strategies such as pacing and the "envelope theory".
Leonard Jason in 2007 published a study, "non- pharmaceutical interventions for CFS"[1], from money from an NIH Grant. It found that pacing came out better than CBT, an exercise program and a relaxation intervention.
There is also some evidence that a similar strategy, the "envelope theory", is useful.
These strategies have excellent safety records.
These strategies involve listening to your body. This is very different from the rationale of Graded Exercise Therapy and CBT based on Graded Exercise Therapy.
So I am not sure how there can be any consensus at this time. It is premature to have consensus at this time. However I fear what is being talked about is to recommend Graded Exercise Therapy and CBT based on Graded Exercise Therapy.
- There is a lot of hype about GET and CBT based on GET. I fear that the CDC may have been taken in by this hype. Often the words "evidence based" and "effective" for example are used with regard to these treatments. However, reviews of the treatments do not show them to be that effective.
Malouff in 2008 published a meta-analysis of cognitive behavioural therapy Trials[2] (this included some studies on Graded Exercise Therapy). They calculated a Cohen's d effect size to be an average of 0.48 for the outcome
measures. For those who don't know, an effect size is a measure of how effective a treatment is - some treatments can help a little, some treatments can help a lot. 0.48 is below the threshold for a treatment to be seen as having a moderate effect size.
So the hype of cognitive behavioural therapeutic interventions isn't justified.
A Cochrane Review of CBT studies[3] found that at the end of treatment, 40% of people in the CBT group showed clinical improvement in contrst to only 26% in the control group (usual care) but at follow-up, 1-7 months after the treatment end, when drop-outs were included, there was no difference.
In Belgium[4], they set up five rehabilitation clinics that used GET and CBT. If you look at the questionnaire data, yes, it looks like the patients were helped like with other published literature. However, on the exercise studies, there was no difference. And on the hours worked, patients were actually working less hours than before they did the CBT and GET.
So as I say, many questions remain about GET and CBT based on GET.
- With regard to the empirical definition, I forgot to say in my first submission that I set up a petition on the issue on the 15th of April. Already 250* people have signed it. It calls for the CDC to stop using the empirical definition, also called the Reeves definition, for its research. It's on ipetitions.com [5] - if people go there they can see the many points people have made on the issue
[I am copying it below. I did not get a chance to say that other people also added comments but for some reason they did not show up]
- I forgot to say that I have a personal reason that I am so concerned about exercise programs. My own health was ruined by an exercise program. Before I did the exercise program I was only mildly affected but now I have been
housebound for over a decade.
- A final point is to say that there are many problems with the philosophy surrounding GET and CBT based on GET. Many of the proponents say patients with CFS shouldn't be entitled to disabiliy benefits. They also say that people shouldn't get home help as this can get in the way of the
rehabilitation. Also that family and relatives should not be helpful for the same reason. They can also recommend against people getting disability aids and parking badges.
And this is for an illness where at the very least we don't know what is causing it. But there is plenty of evidence to suggest it's "physical". As one person said to me once, the attitude (of those promoting the CBT/GET model) is medieval.
Thank you for saying it as it is.
I suffer ME and I’m tired. Tired to the very core.
I am tired of seeing psychiatrists and psychologists listed as speakers at ME conferences.
I am tired of the the oh-be-joyful brigade and the reports they write after such events; and with each passing decade, I become more and more tired of their claims that “exciting progress” has been made in the ME field as indeed, I have become increasingly tired of their typical reaction -- smiles that turn rapidly to snarls when one asks them to be specific.
I am tired of ignorant people wearing and abusing the mantle of authority.
I am tired of the liars, the cheats and the criminals who benefit financially while we die.
Yes....i guess it could be said: i am tired!
Thank you, Hillary for allowing sick patients world wide to voice their opinions!
There are only four words concerning our CDC that come to my mind and they are violation of public trust!
When the National CFIDS Foundation's web link from the CDC's web site was linked to a porn site for a year or longer regardless of how many pleas from the NCF I called the CDC and made an official complaint and it was only then the CDC's web master addressed the matter and removed the porn link and inserted the proper link to our NCF.
I then contacted The Center for Public Intergrity
http://www.publicintegrity.org/
and various other sources about the situation.
If you scroll to: Great Lakes Danger Zones there is a report the top officials of the CDC thought was too hot for the public to handle.
I spent my toddler years living near Oak Ridge Tn then Lake Michigan and Lake Huron and have lived within 30 miles of a nuclear plant in Arkansas, less than 100 miles in Virgina and less than 200 miles from the nuclear reactor in Pennsylvainia which Beyond Nuclear has just released information May 1, 2009 that the Containment Steel Liner Eaten Through in PA Reactor found during a recent inspection.
www.beyondnuclear.org
In memory or those remembered
http://www.ncf-net.org/memorial.htm
Sincere soft hugs & prayers,
Reading through the comments, they were inspiring and reflected a real grasp
of issues.
Best wishes,
Jill
It is my experience that what cures there are, other than symptomatic relief, lie within, in our ability to self-heal, in our drive and faith, having a goal in life, and carefully monitoring our activity. I still collapse when I overdo it and panic, but I know now that it is a reaction and it will pass with rest and healing. I wish more people could get MariEl training, which has been the most effective healing for me, along with prayer. It always restores my resources.
I worry that too many people become perpetually victimized by this illness, and the lack of treatment, and that it creates a self-perpetuating state of existence.
I have clearly not suffered as much as others, but have had this for 17 years, not counting childhood and adolescence. Having had mononucleosis and a mother with polio, I see the likelihood of connections to ebv-type viruses and genetic vulnerability. My adult onset was after a flu shot, so I believe that it was imported from China in the vaccine of 1992, I believe it was the last one to use live viruses.
One strategy for handling the CDC is to ignore them except to issue statements utterly devaluing all their work as it is published.
I think our biggest obstacles are getting insurance to cover the expensive treatments that work, and to have proper training taught in medical and nursing schools.
My biggest problems now are more mental than physical: the brain fog that comes after hard thinking, and the psychology that I don't dare to do so much because of what might happen. I've been invited to teach in Brazil and Singapore, but I am afraid to travel so far. I do and don't know my limits.
I do think that healing is not a given, it must be sought after and cultivated, internally and externally. We must find and use the force of our souls to persevere. We must know ourselves as well, our true selves, not what we think we are.
Want to point out that H1N1 (swine flu) is affecting young, healthy people, not immuno-compromised, so I DON'T feel at risk for that & I think we need to be wary, but not to panic over H1N1 right now. Also, those of us converted to TH2 (or TH17 as they are now saying) seem to be able to stay away from viruses. That's why I was much more worried about the Anthrax scare. I have had CFS since 1987, so I'm one of the "nearly originals" and have not had a virus since 1993 when I used to get sick at least once per year.
Anyway, perhaps with this new Obama-era-transparency-in-gov. we can hold CDC to task now!!
Given the importance of the issues involving the CDC and pediatrics for the
upcoming CFS Advisory Committee (CFSAC) meeting this week, and in particular,
the external review of Dr. Reeves and his work at the CDC, there was important
and relevant dialogue and discussions in selective portions of the minutes that are on the
HHS CFSAC site:
http://www.hhs.gov/advcomcfs/meetings/index.html
The discussions below show some interesting interactions and obvious inconsistencies
between different parties that have occurred over the past few years. I added some information
for clarification or explanation in brackets or parentheses and included portions of relevant
recommendations made by the committee, which are also posted on the CFSAC
website:
http://www.hhs.gov/advcomcfs/recommendations/index.html.
In Nov 2006, Kim McCleary expressed no concerns about the CDC and discussions
seemed more about how well things were going, and in general about
getting more money.
In May 2007, the CFSAC was pressing for information on use of CDC funds
and budget.
In Nov 2007, the committee continued to press for budget information from CDC.
May 2008, Dr. Reeves issued a scathing indictment against the CFIDS
Association, that the CFIDS Association's contract work had dismal
results and basically failed. He then opined that ending the contract
was good and would save money that could be used to put to better use.
Oct 2008, Kim McLeary lambasted the CDC for lack of leadership, lack of
direction and lack of outcomes.
Yet patients have been saying these things about the CDC for years, which was
clearly and concisely documented in Hillary Johnson's book Osler's Web, while the
CFIDS Association was working closely with CDC and were heavily involved
with them, participating in CDC meetings and workshops etc. and giving
them glowing remarks. So why all of a sudden the change of position?
May 08, Dr. Jason brought up the name change. Dr. Reeves said to prove that patients
want a name change or that patients think that the name is demeaning, which
may be a matter of opinion.
The CFSAC has been pressing for answers and have made solid recommendations.
We need to know that they are received and will be considered.
It is time that the patient community take careful consideration of these
issues.
Jill McLaughlin
========================================================================
Selected Minutes from the CFS Advisory meeting of November 20-21, 2006
Reeves (Director of the CDC CFS Program) “We have updated and revised the
HHS/CDC/CFS booklet. It’s available to all members of the public. It took a year
to get it updated, approved, and printed-it’s obviously also available online.
Most of what we are doing in education is through contract with the CFIDS
Association of America…
The contract with CFIDS illustrates the value of the government working with a
patient advocacy group to increase recognition and diagnosis of CFS.”
McCleary (President/CEO of the CFIDS Association) “ We’re using what is called
in social marketing a push-pull strategy with health care professionals in the
CDC national awareness campaign.”
McCleary “We’re actually doing some of that through the National Center for
Health Marketing. We have some of the partners who have already signed on to the
campaign printed on the back of the toolkit.
[Dr. Reeves suggested that Ms. McCleary might want to explore further the use of
these partnerships to increase provider awareness.]”
In the notes concerning the CFIDS Association’s work: “The November 3 launch of
the CDC national CFS awareness campaign was its most intense phase. Paid
advertising will roll out in December and last for about three months. After
that, the campaign will consist basically of earned media and publicity
generated by the traveling CFS photography exhibit. The target market is women
aged 40-60, because that group exhibits the highest prevalence of CFS. To make
the campaign longer and more intense and to reach a greater variety of people,
more funding is needed.”
--------------
CFSAC Recommendations to the Assistant Secretary of Health and the Office of the
Secretary:
The Committee recommends that the FY08 and 09 budgets of the CDC for research be
restored to or increased beyond the FY05 level in order to sustain the CDC's
remarkable momentum including the ability to finish the Georgia Study
(especially the longitudinal portions).
=============================================================================
Selected Minutes from the CFS Advisory meeting of May 16-17, 2007
Reeves: “Our current allocation in 2007 is $4.3 million to the CFS program.”
Reeves: “This is the last year of the provider education contract. We will be
competing and advertising a new contract and we have the funding to pay for at
least one year of it.”
McCleary: “Through the public awareness campaign, we have targeted medical
media as well as lay media.”
Jason (Chair of the Research Sub-Committee): “I am still trying to get the big
picture about where the money in this large system is going for different
things. I don't know how as a committee we get access to that data in a way that
we can summarize it so that we can see the big picture. Unless it is in front of
us, it's difficult to make the kind of recommendations that are strategic and
focused.”
Parekh (In charge of the CFSAC): “If there is interest by the committee to find
published, transparent information about where dollars are being allocated to
CFS, what's the best way?”
Reeves: “Put in an official request from the Executive Secretary to the Director
of the CDC to provide you with a breakdown of the budget. I'm not sure how it's
going to help the committee in any way.”
Jason introduced a third research-related motion to have a letter drafted by
the chair to the CDC asking them to specify to CFSAC their current funding and
where it goes, plus projected funding for next fiscal year, and specifically
what programs will not be funded under a budget deficit. That level of
specificity would be extremely helpful, he said.
===========================================================================
Selected Minutes from the CFS Advisory meeting of Nov 28-29, 2007
Reeves: “CFIDS has elected not to bid on the next phase…”
McCleary: (Audience) “We were concerned about the type of information that was
being provided through the contract and the requirements that would be imposed
for the continuation of the contract. The feedback we received and our evaluation
measures pointed to the need for more clinically-based information rather than
research and epidemiologically-based information. We felt that we would be
freer to pursue those initiatives independent of CDC funding.”
Klimas (President of IACFS/ME and committee member): “At the CDC you work
through both contracts and collaborations. Is there any way that we can get some
feedback on what work is going on through CDC’s contracts and collaborations?”
Reeves: “The money that CDC allocates to CFS goes to contracts and cooperative
agreements. We do not do grants. Everything we do has to fit into the research
strategy of trying to control the illness.”
Jason: (Report from the Research Sub-Committee). We continue to be most
interested in looking at the big picture trying to understand how different
sources of funds are being generated and used in different agencies,
particularly NIH and CDC. We also hope to have more funding information from NIH
and CDC. We have asked Drs. Reeves and Hanna to work with us on this.
--------------
Recommendations to the Assistant Secretary of Health and the Office of the
Secretary:
It is recommended that the CDC effort on CFS be restructured to reflect a
broader expertise on the multifaceted capabilities required to execute a
comprehensive program that incorporates the following elements:
1. an extramural effort directed by the Office of the Director;
2. sufficient funds for a program for which the authority and accountability is
housed at the level of a coordinating center director;
3. a lab-based component that maintains the current search for biomarkers and
pathophysiology;
4. the recommendations of the external CDC Blue Ribbon panel, including
developing, analyzing, and evaluating new interventions and continuing support
for longitudinal studies; and
5. an expanded patient, healthcare provider, and family caregiver education
effort that is managed by staff with appropriate expertise in clinical and
public education strategies.
===========================================================================
Selected Minutes from the CFS Advisory meeting of May 5-6, 2008
Miller (At the CDC, oversees office where Dr. Reeves works) “The target CDC
appropriation for work specifically related to CFS is $4.8 million annually for
FY 2006-2008. The actual appropriation has been somewhat less. In Dr. Reeves's
group, this supports 13 full time equivalents (FTEs), 17 contractors, and all
program research and activities…The $4.8 million funding target does not cover
all the funding that is made available at CDC for CFS. Some $5.5 million was
added for FY 06-09 for the CFS Public Awareness Campaign in the Marketing and
Communication Strategy Branch. This includes funding allocated to the CFIDS
Association of America for its public awareness campaign.”
CDC plans to conduct an external peer-review of the CFS program in late
summer/early fall 2008. This review will be conducted by a panel composed of
national and international experts that is to include representatives from the
Coordinating Center for Infectious Diseases Board of Scientific Counselors and
CFSAC. CDC is requesting that CFSAC members recommend names of experts with no
conflict of interest (direct funding from CDC) who could sit on a panel to:1.
Review program goals and objectives. This will include a candid and open
review of the direction of research.
Reeves: “CDC has been involved in a provider education program since 2001. The
2001-2007 period was largely exploratory with diffuse outreach and material
development to determine how to build a provider education program. It cost
about $3.8 million over that time period to support the contract. Education
accounted for 11 percent of our total research allocation.
Provider education had four components: Train-the-trainer – Efforts consisted of
setting up exhibits at professional conferences, offering free Continuing
Medical Education (CME) courses, conducting grand rounds, and marketing these
opportunities. The train-the-trainer program was discontinued in 2004 due to:
lack of sustained interest by the core trainers, low rate of core trainers
conducting follow-on training, expense of train-the-trainer workshops, effort
required to maintain the program.
Professional conferences – CFIDS had booths at 55 conferences from 2003-2007
that resulted in: 12,000 booth visits, 24 conference presentations with about
1,300 attendees, Distribution of 32,000 copies of printed materials. Seventy-two
percent of these were a popular laminated resource guide, Distribution of 4,240
print CMEs, with only 5 percent completed—a "dismal" rate, Distribution of 870
video CMEs with only 2 percent completed.
Marketing expenses were about $500,000 over that time period. One has to begin
to question whether 12,000 booth visitors and a very low CME rate are worth that
expense.
Grand rounds – CDC and CFIDS tried to interdict CFS into medical school
curricula by: Giving 29 presentations at 10 venues from 2005-2007, Reaching
about 1,370 attendees, Attempting to obtain KAB, with a "dismal" response rate.
Developing CME Curriculum – CDC worked with CFIDS to produce: 3,000 CME web hits
between 2003 and 2007, a 42 percent certificate award rate. When compared with
conference statistics, this percentage demonstrates that CMEs are important and
really need to be done over the Web.
The contract with CFIDS lapsed at the end of 2007."
Reeves: “In my opinion, the impact of ending the CFIDS contract is that we have
saved a substantial amount of money that will help us look for biomarkers rather
than go to meetings and hand out brochures.”
Fridinger (Works at the CDC and oversees The CFS Public Awareness Campaign).
Timeline started with the media launch in November 2006 and will continue
through September 2009. There is about $900,000 remaining until September 2009…
CDC is discussing strategy with CFIDS to reinvigorate some of the activities
that are currently part of the awareness campaign
Jason: “I am the chair of the CFSAC research subcommittee. I and members of my
subcommittee have been most interested in understanding how funds have been
allocated at NIH and CDC over the last number of years. There has been
information that has been provided. However, in my efforts to get information on
specific funding and how the funding occurred—particularly at the CDC—when I
have asked Dr. Reeves this for the record several times, he has suggested that
if I want that information I should issue a Freedom of Information Act request.
I have not done that. That's not something I intend on doing. So I was
appreciative of the fact that you (Dr. Miller) mentioned that information about
funding at the CDC for the last few years could be made available to our
subcommittee. I just want to make sure that this is accurate and that we will be
provided this information.”
Reeves: “I advised that CFSAC must request this information from the Director of
CDC, not that Dr. Jason should file a Freedom of Information Act request. This
is an official committee. If this committee requests that information through the
appropriate channels at CDC, CDC will provide that information. That is not a
Freedom of Information Act request, that is also not Dr. Jason specifically
requesting it, it is this combined committee requesting that information from
the Center for Disease Control and Prevention.”
Miller: “I want to make one more comment on the budget issues. You now have a
direct communication link for budget items. Please make a request to our Center
through Sarah and we can get that information for you from our financial
management office at the high levels where that money is tracked.”
Jason: “I think that you can understand why it's important for us to have this
information. If we are the committee that's trying to make recommendations to
the Secretary of HHS, we need to really have information concerning how funds
are being used by the Federal government, particularly CDC and NIH.”
[In the minutes, the committee was informed at this meeting that in FY 2007
budget material provided by CDC to CFSAC names the five funded areas of the
scientific research program. These categories could help CFSAC ponder which
areas the CDC should be emphasizing: Surveillance and epidemiology - $600,000;
Clinical assessment and evaluation (Emory inpatient study) - $1.2 million;
Objective diagnosis and pathophysiology, laboratory studies, meetings,
workshops, computational models - $2.1 million; Treatment and intervention
(meetings and consultations) - $121,000; Provider education - $300,000]
Jason: “If over 90 percent of patients affected by this illness want the name
changed, how would you respond to the fact that there's not effort being made to
change the name in your office?”
Reeves: “I would want to be shown that 90 percent of patients in fact thought
that, and not 90 percent of a particular organization. It's very easy to say
that every person with CFS feels that the name is demeaning. This may or may not
be true, or may be reflecting one's own opinion.”
==========================================================================
Selected Minutes from the CFS Advisory meeting of October 28-29, 2008
Miller: “…Sarah and I both have been very concerned about being open and
transparent with every penny that we can show, and we’ve tried to do that as
best we can.”
McCleary: “Based on information that we have received directly from CDC
officials—and I do have to thank Mike and Sara and Steve for the improved
transparency over the last five months… the “boom” of CDC research that occurred
during the post “payback” years from 1999-2005 has eroded into what I believe is
a “bust” of shameful scientific leadership, zero accountability, invisible
outcomes, and millions and millions of dollars stuck in suspended animation, if
not wasted…send another vote of strong no-confidence in leadership of this
program based on these spending irregularities, the waste of the funds that have
been allocated to these projects that have not been spent, and the lack of
productivity of the dollars that have been spent.”
McCleary: “It’s not a lack of resources at CDC, it’s a lack of leadership, and
that’s really what it boils down to. Hearing the concerns of this committee over
the last year has reinforced that. We felt that it was important to bring that
discussion to all of you this afternoon.” “there has been no strategic direction
coming from the top over the past several years. That’s evidenced by the lack of
outcomes and the way that the dollars have gone out and not produced much in
terms of product for this committee or the patient community or us as a nation.”
Klimas: Four years ago I was funded by the DOD to do study comparing Gulf War
Syndrome compared CFS in collaboration with the CDC. In this study we collected
samples from 105 people. We put them through an exercise stressor and we were
trying to map out the mediators of relapse. The total budget was $450,000. We
collected all the samples and did all of the expensive immunology. The CDC could
not finish its portion of this study—the gene expression analysis for Gulf War
Syndrome. I was struck when I looked at that GCRC budget because they’re
basically doing the same thing, and they have $2 million this year. I have in
the freezer everything completed except for the genomics part of my study. I
have an appointment with the genomics team at the University of Miami next week
and I think that they’re going to help me out. I don’t want to go back and
collaborate with CDC because it’s the second time I had the plug pulled on this
study in the last year. It’s embarrassing and it’s also a missed opportunity.
There’s something wrong. I understand that budgets and priorities shift, but to
not run the CFS samples seemed rather odd to me. I find that to be the most
disturbing of the symptoms of what is happening at CDC.
------------------
Recommendations to the Assistant Secretary of Health and the Office of the
Secretary:
It is recommended that CDC’s external review process evaluate CDC’s use of third
party contracts for provision of logistical support for research projects.
-------------------
.
Quick thoughts: If objective, one might identify a number of problems in the psychosocial intervention studies from the CBT school, notably questions re theoretical underpinnings of CBT for CFS, e.g. model is based on reductionistic, out-dated assumptions; no room for individual differences (e.g. the model implies a universal response of avoidance, misinterpretation of symptoms and inability to deal with stress), lack of flexibility to deal with high functioning patients and complexities such as infections, MCS, etc; limited measures e.g. somatic symptoms; reliance on flawed fatigue measure (with low ceiling); lack of objective measures for activity post CBT/GET; lack of detailed info about manuals used to enable replication, e.g. Nijmegen's protocol differs from the one described by King's; lack of acknowledgement of modest effect sizes etc.
Solution: promote the ideas of the best psychologists, who are able to deal with the theoretical and research issues eloquently and effectively. More Jason etc. We can balance the debate. It's like operant conditioning. Or as Dr. Phil puts it, do what works.
Science has the answers to limit the psychologisation. Just make sure everyone knows it. Inform, educate etc.
Can't wait to see the CBT study funded by the CDC. We need more ecological validity for CBT. Suspect they won't be into that. Few have been.
Really?