Wednesday, July 25, 2007

CFS on M&J yesterday

For those who didn't get a chance to see the show ....

They only gave it about 10 minutes. Started with the Yuppie Flu/Shirker Syndrome accusations, but then admitted that CDC has now acknowledged how devestating it can be, with theories of genetic pre-disposition and toxic origin. A telephone survey showed 1-in-40 adults may have CFS.

The guests were Shanley Crutchfield, a 21 y/o girl; Brian Bernard, a 13 y/o boy, and his mom Dr. Donnica Moore; and Dr. Mark Siegel of NYU Medical School.

The girl described it as "utter exhaustion". The boy asked his mother "do I have cancer or AIDS?" because he thought he was going to die. Dr. Siegel says (as I do) that it's both under- and over-diagnosed (i.e., people who have it get misdiagnoses of something else, and people who have something else get misdiagnosed as CFS), and stressed that early intervention makes a difference. Unfortunately -- like CDC's website -- he didn't say what intervention. (The only early intervention I was offered was anti-depressants, which are known to be totally useless.)

It worked out that in the audience was Kathy Rabin, who was a lawyer at Massachusetts General Hospital when she was struck in 1990; as a result she had access to top specialists. Juliet observes "You went to Harvard and Yale; you're not lazy."

Being a doctor herself, Dr. Moore had access to all 3 of the top CFS specialists for her son. The only one she mentioned by name was David Bell. As she was asking him the question, the answer dawned on her, that the reason this is most diagnosed in overachievers is that "only overachievers have the credibility" to be taken seriously that they are not lazy.  (Though this requires the doctor to either know the patient previously or believe she's an overachiever -- most doctors didn't inquire into my history, just assumed that I don't like to work because the stereotypical woman gets married to be a housewife and I don't want to exercise because women don't like to get sweaty.) 

Dr. Siegel did bring up the problem of symptom overlap with depression, as well as depression caused by the limitations imposed.

I think we all need to go to the MandJShow website and thank them for making the point that it's real and not just an excuse. [email protected]

Next: we inundate Oprah and Dr. Phil's websites with requests for a full-hour show with Bell, Peterson, Cheney, Klimas, Jason and Komaroff talking about the science behind it.

Tuesday, July 24, 2007

More on the NYT Article & Ampligen

A letter from CFS patient Nancy Kaiser to the author of the NYT article (which was also published elsewhere) suggests reviewing the website of The National CFIDS Foundation, click on Medical Discoveries.

Nancy also quotes extensively from "Osler's Web" which she calls "my story of the battle with this illness. I was sort of the poster girl for being as sick as you can get with this disease(I still am)" "My story was also the lead story in the Newsweek article from November 12, 1990 -- plus then carried a few months later in Reader's Digest." Nancy was one of the first patients to receive Ampligen in clinical trials.

(The entirety of Nancy’s extremely lengthy response is available on It is much too long for the size limit on blog posts here, so I feature only excerpts.)

* The loss of Stat1 in patients with this disease has been confirmed by three independent research groups [DeMeirleir; Suhadolnik; Knox and Carrigan]. Loss of Stat1 constitutes a serious illness that may ultimately be fatal due to the fact that this leaves the patient unable to fight bacterial and viral infections thereby resulting in severe immune deficiency [Dupuis; Durbin]. Patients are frequently seen with multiple secondary opportunistic infections with researchers labelling this disease as a form of AIDS [Klimas].

* Immune disruptions have been frequently documented in these patients as evidenced by abnormal changes in CD4/CD8 ratio, absolute changes in lymphocyte or T-cell counts (typically lymphopenic); changes in CD19 B-cell counts either diminished (Common Variable Immune Deficiency/CVID) or increased (Leukemia). [Uckun; Johnson; Hilgers].

* Dramatic alterations to circulating blood volume have added to further restrict patient daily activities [Streeten] with exercise capacity and performance directly related to immune dysfunction [Snell; Nijs; DeBecker]. Abnormal changes in heart rate and blood pressure are frequently present [Streeten].

[ The following are excerpts from the book "Osler's Web: Inside the Labyrinth of the Chronic Fatigue Syndrome Epidemic" by Hillary Johnson, Crown Publishers, Inc., 1996. ] All text ©1996 by Hillary Johnson

p. 254 (1988) Since the local epidemic, Peterson had been an avid reader of the AIDS medical literature, scouring journals for studies about the better-studied immune disorder in hope of finding therapies for his own patients. ... Aside from Ampligen's apparent clinical safety, Peterson noted that the test subjects who fared best were those who had yet to advance to full-blown AIDS -- the AIDS-related complex sufferers -- whose clinical symptoms were virtually indistinguishable from those of chronic fatigue syndrome sufferers.

p. 355 (1989) Additional testing revealed that those patients who responded well to Ampligen had a deficit in the body's natural antiviral defense system. David Strayer had found the same deficit in AIDS sufferers who responded well to Ampligen. Peterson and Strayer suspected this defect might eventually become the diagnostic hallmark that had been sorely lacking in CFS.

p. 506 (1991) Few placebo recipients demonstrated improvement; in fact, several deteriorated during the six months of the trial.

*Their deterioration may have been due to the fact that they were required to stop taking all other medications in order to participate in the trial. In addition, simply getting to and from the infusion site two or three times a week [frequency was determined by dose; not all patients received identical dosages] amounted to tremendous exertion for CFS patients and may have exacerbated their disease. The forty-five people who received Ampligen were demonstrably better. The outcome was so dramatic, in fact, that HEM decided to end the trial after just twenty-four weeks rather than the forty-eight weeks it had first planned. For instance, there had emerged strong evidence that interleukin-1, a substance manufactured by the immune system in response to viral infection, might be a marker of disease severity. Patients who received Ampligen experienced a reduction in interleukin-1 as well as a reduction in symptoms. In addition, in 1994, Temple University School of Medicine biochemist Robert Suhadolnik and other clinicians and scientists who collaborated on the trial published a study reporting that the drug ameliorated a defective antiviral pathway common to CFS patients.

*Robert J. Suhadolnik et al., "Changes in the 2-5A Synthetase/Rnase-L Antiviral Pathway in a Controlled Clinical Trial with Poly(I)-Poly(C12U) in Chronic Fatigue Syndrome," In Vivo 8 (1994): 599-604.

"Poly(I)-Poly(C12U) is the molecular name for Ampligen. Before treatment with Ampligen, the molecular indicators for damage to this pathway were "significantly elevated" compared to those of controls. (This finding was yet another link between CFS and AIDS; victims of AIDS suffered an identical defect.) After treatment, these molecular indicators were vastly improved in CFS sufferers, as they had been in AIDS patients after Ampligen treatment, and Suhadolnik and his co-authors noted that they corresponded with "clinical and neuropsychological improvements."

none had been restored to a degree of health that had allowed them to return to their jobs. Even more problematically, among those who were taken off the drug temporarily, for whatever reason, the disease had become significantly worse, suggesting that to derive benefit patients needed to be maintained on Ampligen indefinitely and that withdrawal from the drug could actually exacerbate symptoms. By the third and fourth week off the drug, patient who had been confined to wheelchairs before they entered the trial were returned to their wheelchairs; almost everyone was again housebound.

p. 520 (1991) Few involved in the struggle to bring Ampligen into the marketplace failed to appreciate the larger political issue that had emerged along with the promising results of the clinical trial. One arm of the nation's federal health establishment, the Food and Drug Administration, was being asked to rule on the use of a potent antiviral drug for a disease the Centers for Disease Control and the National Institutes of Health had dismissed for years as a psychiatric condition. The ramifications of the FDA's decision were hardly lost on patient advocacy groups. "If Ampligen is approved for treatment of CFIDS," the CFIDS Association in Charlotte had told its 25,000 members in a special mailing that summer, "this will be a monumental step toward gaining credibility and focusing more attention and research on CFIDS." At the same time, Paul Cheney noted, "The FDA is really in a bind. If the agency approves the treatment IND application, they will, in one swoop, destroy the credibility of two government agencies."

p. 534 (1991) Anthony Komaroff told the reporter, "This isn't a medicine that acts on the psyche. It acts on the body." On the eve of the FDA's response to HEM, Paul Cheney and Dan Peterson, independent of one another, were gloomy about the drug's prospects. "There's not a chance the Food and Drug Administration is going to approve this drug," Peterson said over dinner the night of Carter's presentation. "How can they approve a drug for a disease the NIH says doesn't exist?" Cheney predicted the agency would "probably delay approval pending toxicity issues, but it's just a way to delay. They don't have the guts to kill it, because the patients will kill them. But they don't have the guts to approve it, because Straus will kill them." "To approve Ampligen would be the single most powerful blow for the credibility of this disease," said Marc Iverson, the CFIDS Association's president. "This was not a decision based on science. It was politics." In a newsletter published later that fall, the CFIDS Association's executive director, Kim Kenney, wrote, "We suspect that this is a delay tactic employed by the FDA to prevent the approval of an antiviral drug by one governmental agency for an illness that another, namely the NIH, still considers to be simply depression by another name."

p. 647 (1994) "It's a miracle drug. I know AIDS patients who were being maintained on this drug and died immediately when they took them off. Here was a massive, million-dollar investment with good results," Suhadolnik added in reference to the four-city CFS trial. "Why didn't it meet FDA approval? It's just plain crazy." After a moment he added, "The biggest problem that drug has is that it works."

This page is maintained by Roger Burns of Washington, D.C. E-mail: [email protected]

* * * *

For 18 years, FDA has been telling us Ampligen is "18 months from approval". At least they’re consistent. But that’s an additional 18 years that patients have continued to suffer while the government plays games.

Dr. Jose Montoya of Stanford has come up with an alternative – an anti-viral that’s already FDA approved, which has produced remarkable results that Dr. Montoya deemed a "cure".

As Dr. Komaroff observed, these are not drugs that work on the psyche – these are drugs that treat the viral infection that patients report triggered their problems, and that many doctors refuse to accept as being connected to the symptoms. This is not depression by another name. This is a disease that was once referred to as "AIDS Lite" because of its many similarities to AIDS, which appeared on the scene just a few years before the Incline Village epidemic.

But, in fact, "AIDS Lite" is – according to experts who treat both – more disabling than AIDS. Dr. Mark Loveless, an infectious disease specialist and head of the CFS and AIDS Clinic at Oregon Health Sciences University, proclaimed that a CFIDS patient "feels every day significantly the same as an AIDS patient feels two months before death."

AIDS got respect only when patients began dying; before that, it was written off to patients simply being depressed because they were gay. When I was diagnosed with CFS, I was given the good news that CFS wouldn’t kill me ... every patient who had died "of CFS" had committed suicide. Now, 20+ years out, we have CFS patients beginning to die of heart failure, cancer, opportunistic infections (which is the same thing that kills most AIDS patients). How many deaths will it take to wake people up that this is a serious disease that requires serious drugs?

Anti-depressants have repeatedly been proven to work only on patients who have concomitant depression. They relieve the depression enough to sort out how much of the symptoms is caused by depression and how much by CFS. In some cases, the depression overlay was what was preventing the patient from working, because the CFS symptoms were comparatively mild.

However, only 60% of CFS patients also have depression. The other 40% show no benefit at all from psychiatric drugs, because their problem is purely physical. Anti-depressants do nothing at all for me, other than making me sicker, and repeated psych evaluations have confirmed that I am not depressed: they have unanimously pointed out that the "symptoms of depression" noted by MDs (most notably fatigue) are also symptoms of the flu – the emotional symptoms (low self-esteem, loss of interest/enjoyment, suicidal ideation, etc.) are entirely missing in my psych profile. I’m still interested in doing the things I love, I just, physically, cannot do them; I start projects but lack the stamina to finish. Those are not typical of depression, where the initiative to start is missing.

I enjoy life as much as possible, but when you’re mostly confined to bed and the few things you do are chores, there’s not a lot of Quality of Life to be enjoyed. For someone who used to love to dance, play baseball and volleyball, go biking, and take long walks, there’s not much Quality of Life to be had in watching bad TV 20 hours a day because you can’t even focus on a magazine article, and watching life pass you by while waiting for someone to do something to make you well. But saying "I hate watching TV" is not the same thing as being depressed.  It means that I still have the initiative (if not the physical ability) to want to dance.