Tuesday, October 8, 2013

Stop the IOM; Team Up with Gulf War Veterans

Patient advocate Wildaisy has started a petition to stop the Institute of Medicine (IOM) contract to redefine ME. If the IOM contract goes forward, chances are good that ME will go the way of Gulf War Syndrome, which was pathetically redefined at the beginning of the year as chronic multisymptom illness (CMI).  The recommended treatments included cognitive behavioral therapy, graded exercise and antidepressants--the same recommendations CDC gives ME patients now.

CFIDS Association Suzanne Vernon is supposed to be appointed to the IOM committee to study ME. On September 28, I wrote to Suzanne Vernon for a comment. She did not respond. 

Bona fide ME experts have already signed an earlier petition to halt the IOM and adopt the Canadian Consensus Criteria to define ME. Despite the impressive effort, there has been no response from HHS Secretary Kathleen Sebelius. 

If you want to join the effort to stop IOM, here is what the new petition says and the link to it:

"We, the undersigned people suffering from Myalgic Encephalomyelitis, along with our families, carers and friends hereby ask Secretary Kathleen Sebelius to cancel the contract HHS signed with the Institute of Medicine (IOM) to develop “clinical diagnostic criteria” for ME/CFS. We further urge Secretary Sebelius to respect the consensus reached by a group of experts supporting the adoption of the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS."


Many Gulf War veterans have been enraged by the IOM's redefinition of their disease.  If ME patients could team up with Gulf War veterans, perhaps their combined voices will be heard.

Tuesday, September 24, 2013

CDC's Two-Day Exercise Test: Not Negotiable


Center for Disease Control's head of CFS research Dr. Beth Unger is slated to do a problematic one-day ME exercise study called the Cardiopulmonary-Exercise Testing, instead of the two-day test favored by most patients and ME-educated researchers. What’s wrong with Unger's study? 

The problem is that studies show that defects in ME patients' exercise capacity aren't evident until the second day of testing. With one-day testing, ME patients resemble deconditioned controls, a fancy phrase for couch potatoes. 

In a letter discussing her reasons for favoring the one-day study, Unger says two days would be an “unnecessary burden” for patients. Would most patients prefer a difficult one-day study that makes ME sufferers out to be indolent grumblers or a grueling two-day study that shows just how sick ME patients are? Do I really have to answer that question? Besides, the very sick patients who can't handle the second-day exercise test provide helpful data for researchers. The fact that they can't do a second day would become part of the study's findings.

Could Unger just not know about second-day crashing in ME patients?  Dr. Chris Snell, an expert in the field of exercise testing for ME patients and a proponent of two-day testing, served as president of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). Unger attends its meetings, so she's aware of his work.

In citing other reasons for her decision to go ahead with one-day testing, Unger said more patients could be tested in a one-day study. To which I say: Quality, Dr. Unger. Not quantity. 

Exercise Not Negotiable 
When the one-day study shows most ME patient to be just deconditioned—not sick—the phony prescription will be, of course, exercise. Patient advocate Mary Schweitzer, in a terrific post on Unger's proposed study, calls it a set-up; I call it rigged.  

Unger believes in graded exercise for ME patients the way Republicans believe in the late Ronald Reagan. In fact, Mary Schweitzer makes this trenchant point about Unger:  

"The only time I ever saw Dr. Unger get angry in a CFSAC meeting was when we were all calling for a change in the CDC's recommendation of graded exercise. We asked not only that they quit recommending it, but also that they openly WARN physicians about the dangers. She was furious. She said that the emphasis on graded exercise was supported by scientists and was 'not negotiable.' Those very words. 'Not negotiable.' "

Patients need a CDC researcher who understands how dangerous exercise can be. How does Beth Unger get off telling patients that she knows best, that graded exercise is good for them, when it's the patients—not she—who understand this disease, who've been suffering for years if not decades? 

Patient advocate Cort Johnson has also written an in-depth piece arguing for a two-day exercise study. He points out that instead of enlisting the experts in the field to conduct the study—Snell and Stevens—CDC is calling upon Connie Sol, who, he writes, has done only one study.

Chris Snell's Studies
The way I see it, it's clear to most patients, advocates and ME-educated researchers that a two-day exercise test is necessary. In a letter, Unger explained that she had consulted Snell on which he thought was the better approach—one-day or two-day exercise testing. Snell said two-day testing. 

When asked to comment on Unger's proposed study, Snell wrote in an email to CFS Central: "
Unfortunately I do not feel able to comment on the proposed CDC study at this point. I am not involved in the study and do not know much about the design, measures, or any hypotheses they intend to test. My views on exercise testing for ME/CFS are well-documented, including a number of presentations available on the WWW. The most recent is the FDA ME/CFS drug development workshop earlier this year. Please feel free to cite any of our work or public comments."

Snell and Steven's most recent study, published in June, found that two-day testing is vital in ME patients, with emphasis added:

"The objectives for this study was to determine the discriminative validity of objective measurements obtained during CPET to distinguish individuals with CFS from non-disabled sedentary individuals. Methods Gas exchange data, workloads and related physiological parameters were compared between 51 individuals with CFS and 10 control subjects, all females, for two maximal exercise tests separated by 24 hours.  Results  Multivariate analysis showed no significant differences between controls and CFS for Test 1.  However, for Test 2 the individuals with CFS achieved significantly lower values for oxygen consumption and workload at peak exercise and at the ventilatory/anaerobic threshold. Follow-up classification analysis differentiated between groups with an overall accuracy of 95.1%. Conclusions The lack of any significant differences between groups for the first exercise test would appear to support a deconditioning hypothesis for CFS symptoms. However, results from the second test indicate the presence of a CFS related post-exertional fatigue. It might be concluded that a single exercise test is insufficient to reliably demonstrate functional impairment in individuals with CFS. A second test may be necessary to document the atypical recovery response and protracted fatigue possibly unique to CFS, which can severely limit productivity in the home and workplace."

In other words, according to Snell's study, it takes two days of testing to see the poor recovery responsepost-exertional malaisein patients. 

Which brings me back to Unger's study. I believe the study must be changed. The data from a big CDC two-day study would be a game-changer. The data from a big one-day study will inevitably show patients are lazy and need exercise.

IOM
We have seen the government ignore hundreds of letters from patients and ME-literate researchers and clinicians and sign the Institute of Medicine (IOM) contract anyway. That way, in a crazy-making move, researchers who know absolutely nothing about ME will redefine the disease to the tune of one million dollars when we already have a good working definition of the ME with the Canadian Consensus Criteria. Researchers, clinicians and advocates fired back yesterday in a letter to Kathleen Sebelius, the secretary of Health and Human Services (HHS) explaining just that.

Now, I believe we need to do the same thing with Unger and her bosses (see their emails below this post). We need patients to explain to HHS and CDC that a one-day test is not acceptable. 

If CDC won't change the test to two days, and/or if HHS is unable to see the wisdom of the CCC for diagnosing ME, then the next step is to take the long and sordid, heavily documented history of disregard for patients' well being and good research and approach Congress, asking for a subcommittee to look into these abuses.

Tom Hennessy
On another note, Tom Hennessy, a ME patient I’ve know for 19 years who lived with debilitating pain, committed suicide on September 9th. If Beth Unger, CDC and HHS spent more time doing legitimate research and stopped spewing out crap, perhaps patients like Tom wouldn’t feel the need to end their lives.  

Patients can't let Beth Unger and CDC screw things up yet again with this shortsighted exercise study. 
If Unger remains resistant to a two-day test, she needs to be put where she belongs:  on the unemployment line.

Don't feel sorry for her. Unger's collecting a good salary, fabulous health-care benefits and amassing a pension—and doing research that's damaging to patients. Meanwhile, patients like Tom Hennessy die or commit suicide after years of illness and pain.

Who can endure another 20 years of this bullshit?

                                                                   ***
Kathleen.Sebelius@hhs.gov
howard.koh@hhs.gov
txf2@cdc.gov [Thomas Frieden]
Tomfrieden@cdc.gov
cfsac@hhs.gov
eunger@cdc.gov [Elizabeth Unger]

SAMPLE LETTER
Email subject:  two-day exercise test (feel free to change subject name; it helps avoid screening of your email)

Dear Dr. Unger:

We need CDC to do a two-day exercise test in CDC's Cardiopulmonary-Exercise Testing, not a one-day exercise test.

Previous studies, including those by Dr. Chris Snell, have shown that the fatigue ME/CFS patients experience is not felt immediately upon exercise; it develops 24 to 48 hours after exercise. If you test patients for only one day, your results will not be accurate and patients will appear to be deconditioned. If you test patients for two consecutive days, their PEM will be measurable.

That is why CDC must do a two-day study.

If patients are too ill to complete the second day of exercise, then the test can be stopped.  If the test has to be stopped, that will also give CDC valuable information about ME/CFS.

We need to know in a timely fashion that CDC is willing to do the study correctly with a two-day test. If the CDC continues to ignore patients, we will escalate this matter to your superiors, the press and Congress.

Sincerely,

(your name, how long you have had M.E.) 



Monday, August 26, 2013

What’s the Matter with Meghan?

It appears that Meghan O’Rourke may have ME, but The New Yorker writer doesn’t know it. 


In the current edition of The New Yorker, writer and poet Meghan O’Rourke pens in the readable piece "What's Wrong with Me?" that she's been sick for years with an autoimmune disorder that no one can identify, but the illness has the classic symptoms of ME.

Her early blood work showed recent exposure to Epstein Barr, cytomegalovirus and parvovirus. Her lymph nodes "ache," she’s developed Hashimoto’s thyroiditis, she forgets words, transposes words and can’t think. She’s been plagued with neuropathy, migraines, terrible fatigue, hives, low blood pressure, dizziness, bruises, fevers. These are textbook ME complaints. But it's not just the litany of symptoms that is so familiar. It's the way she describes them, from her brain being "enveloped in a thick gray fog" to this description of an evening out: “Sitting upright at my father’s birthday dinner required a huge act of will."

O’Rourke also has a family history of several autoimmune illnesses, including rheumatoid arthritis, ulcerative colitis and thyroid disease. She has two cousins who, like her, are “inexplicably debilitated.”  

Her illness has doctors baffled. One theorizes that, in addition to her Hashimoto's, she has an autoimmune disease attacking her hypothalamus. And while she's improved on a gluten-free, specific carbohydrate diet, her symptoms persist.

As O'Rourke has vacationed in New England, where she enjoyed walking under the “tall New England sugar maples," she should also consider the new culture test for Lyme disease as well. Some cases of Lyme masquerade as ME.

My advice to O'Rourke would be to first read reporter Hillary Johnson's seminal work on ME, Osler's Web. My bet is O'Rourke will see herself reflected in the stories of these patients.

If you believe that O'Rourke may have ME, why not let her and The New Yorker editors know with a letter to the editor? The issue is available for free with an android device, and for 99 cents with most Kindles (except the Kindle Fire, which will cost you $5.99 for the issue).


Sunday, July 7, 2013

Interview with Ryan Prior
and Nicole Castillo
of The Blue Ribbon

Journalist Ryan Prior and filmmaker Nicole Castillo didn’t have an aha moment that prompted them to make the documentary, The Blue Ribbon, about ME. Their interest, which marinated over a period of months, began when Prior, who’s had ME since October 2006, wrote his first piece on the subject for the USA Today College blog in October 2012, “two weeks after Ian Lipkin’s nail-in-the-coffin study on XMRV,” he recalls. The response to Prior’s piece was overwhelming: The average USA Today college story generates 30 Facebook likes; this one got 500. 

“I had touched such an untapped reservoir of pain,” Prior, 23, says evenly. Some of the patients who weighed in, he says, had contemplated suicide, and Prior realized that more needed to be done about ME. Advocates started contacting Prior, and he began his immersion into the disease.

Social Justice
For her part, 23-year-old Nicole Castillo, who doesn’t have ME, has worked on feature films and in television. Currently, she serves as a TV computer graphics technician and floor director. But her passion is social justice. After volunteering at a men's homeless shelter, a daycare center, a nursing home and even spending her spring break senior year living at a convent, she knew she wanted to make medical and social-justice documentaries and was itching to start. She just needed the right subject. And she found her inspiration closer than she could have imagined, in Prior, who is also her boyfriend.

“Seeing Ryan’s hardships with ME/CFS was heartbreaking,” Castillo says. “It made me feel so helpless myself. With little understanding of the bouts of brain fog, exhaustion and inability to speak, it was devastating to not be able to help him.” At the time, Prior and Castillo were students at the University of Georgia, and Prior was having trouble keeping up because of ME. In fact, he was about to drop a class he needed to graduate to complete a dual degree. “Because he has such a supportive family, adaptations in his schedule and lifestyle and a lucky bout of timing, he prevailed,” Castillo says. Prior graduated with his dual majorswith honors.  “Unfortunately," says Castillo, "this is not the norm for so many patients.

“After experiencing a loved one go through all of that, I refuse to stand still when I have an opportunity to be a voice for the ME/CFS community,” she says. “I will do my very best to make a documentary to do justice to those in despair, and demonstrate a pain that is far too unknown to the mainstream. I want to make a documentary for the public, politicians, journalists, researchers and doctors to display the grand need for support.” 

Castillo is overseeing production, audio, camera and editing of the film. “I want to capture the spirit of what Ryan is trying to get across,” she says. 

West Coast/East Coast Filming
Prior admits that he’s had a lot to learn about ME—and his education from the patient community has been swift.  Even though he’s lived with the disease for nearly seven years, he, like many patients, used to accept the Centers for Disease Control’s (CDC) definition. At only 23, he hadn't been aware of the long, sordid history of the disease until he began writing about it.  "But I did realize a much more national discussion needed to take place," Prior says. "The goal of the film is to bring more awareness to this disease.” 

Prior and Castillo want their 90-minute film to resonate with the entire patient community—and at the same time to resonate with the public at large.  The two will spend 10 days conducting interviews on the West Coast, and then move on to the East Coast.  Among others, they hope to interview Dr. Andy Kogelnik at the Open Medicine Institute, Gunnar Gottschalk and Dr. Daniel Peterson at Simmaron Research, Staci Stevens and Dr. Chris Snell at the University of the Pacific, Dr. Judy Mikovits, Dr. Nancy Klimas, Dr. Ian Lipkin and perhaps government officials. “There are no plans to interview the Whittemores yet,” he says.

They also plan to meet with a few patients in the 25 percent—the sickest, bedbound patients.  Both Prior and Castillo are concerned, however, that the interviews and the technology they’re bringing in their homes will be problematic for the patients, and they want to minimize their distress.

Medical Fellowships
In addition to making the film, Prior and Castillo hope to raise $50,000 for 10 medical students to do eight-week fellowships with ME experts. “We hope they will help train the next Daniel Peterson or David Bell,” Prior says.

Following Dr. Jacob Teitelbaum’s ME protocol, Prior is highly functional now.  That wasn’t the case when Prior, a serious soccer player and runner, first got sick and had to drop out of high school. Now, Prior can even exercise—every other day.  When he tries to exercise daily, however, he crashes. 

Raising Money
If Prior and Castillo raise enough money, the duo may continue filming in the U.K. and/or Hawaii, where the film Unbroken, based on ME patient Laura Hillenbrand’s book of the same name, is being directed by Angelina Jolie.

Where they go is up to the public—and funding. After the Kickstarter fundraiser for the film ends July 10, Prior and Castillo will ask patients to vote on where they should go next. “Aristotle said democracy was mob rule, but we feel that the patients have bigger and better ideas than anything Nicole or I can come up with,” Prior says.

If you’d like to contribute to The Blue Ribbon, go to Kickstarter by July 10, or donate to the film’s PayPal account after the 10th.