Thursday, February 28, 2013

Hillary Johnson's “Chasing the Shadow Virus” – A Review

Article first published as "Hillary Johnson's 'Chasing the Shadow'" on Blogcritics.

Recent events surrounding the FDA's failure to approve Ampligen (yet again) for treating ME/CFS have pushed aside what was left of the media storm precipitated by the discovery, dismissal and ultimate disavowal of XMRV. The disappearance of the retrovirus from the scientific scene does not mean that XMRV is dead. It lives on, regenerated by Hillary Johnson.

The March issue of Discover magazine includes a tour de force of journalism, Hillary Johnson's stunning article on XMRV, the retrovirus that was claimed to cause not just ME/CFS (aka myalgic encephalomyelitis or, as it is known in the US, chronic fatigue syndrome), but some forms of prostate cancer as well. Ultimately, XMRV was exposed as a lab artifact, but not before creating a sensation, which Johnson vividly captures in her article.

In “Chasing the Shadow Virus,” Johnson leads us through the dramatic twists and turns of the XMRV debate, from the original elation at the discovery of the cause of ME/CFS, to the CDC's panic at the horrible prospect of a contaminated blood supply, to the “cottage industry” of researchers who were unable to find XMRV in ME/CFS patients, and finally to the humiliation and public disgrace of the research director of the Whittemore Peterson Institute, Judy Mikovits. Those who followed the XMRV debacle with bated breath already know the story. But do we know its implications?

Midway through her tale, Johnson puts her finger on the true significance of the XMRV scandal:
“After novelistic plot twists that included a police raid, an arrest, and a public tarring and feathering of the outspoken Mikovits, the scientific community is now convinced that XMRV was a false lead. Yet the expenditure of time and money to reach that conclusion was hardly an exercise in futility. The 2009 meeting in Bethesda marked the beginning of a change in the CFS cosmos, with a slew of prestigious scientists entering the field and government officials taking a more serious view of this formerly neglected disease. Moreover, the XMRV saga opened a rare window into the way scientists and government officials respond to findings that not only challenge the status quo but have profound implications for public health.”
Those final words are an echo of what Johnson wrote in Osler's Web, her exposé of the CDC's mishandling of the ME/CFS epidemic during the 1980s. The “window into the way scientists and government officials respond” is the same window that was opened seventeen years ago in Osler's Web, and in its even older predecessor, And the Band Played On. It is a window that reveals a glimpse of a murky and disorganized public health system whose job it is to ignore threats to its own complacency, to squelch any dissent from the ranks of upstart epidemics, and to starve researchers who are bold enough to investigate their causes. This has been the fate of ME/CFS for the last thirty years.

Johnson ends her article on a positive note. Ian Lipkin, the world-renowned virologist who proved that XMRV was not, indeed, the cause of ME/CFS (or anything else), credited Mikovits with “opening Pandora's box.”

“Right or wrong about this particular virus,” he says, “she deserved credit for awakening interest in CFS.”

Johnson's final words reflect that sentiment. “For a disease that has languished in a kind of political never-never land for at least one human generation, leaving millions profoundly disabled,” she writes, “that is significant progress.”

Whether this awakened interest is sufficient to spur concrete actions – the generation of NIH funding for research into the disease, changing the CDC's dismissive name, and convincing doctors that patients who suffer from its crippling effects are not just overworked, neurotic women who should have stayed home rather than enter the work force – remains to be seen.

Wednesday, February 20, 2013

ME/CFS: From Infectious Disease to Autoimmune Disorder

Dr. Kenny De Meirleir spoke at the Whittemore Peterson Institute on January 28, 2013. The following summary of his talk was posted on January 30 on WPI's blog, Wings of Hope. 

Dr. Vincent Lombardi, WPI Research Director, introduced Dr. De Meirleir as one of the world's foremost experts in ME and primary research collaborator on WPI’s current RO1 federal grant. He also stated that Dr. De Meirleir has authored hundreds of publications and several books on ME/CFS and other medical research topics. Dr. Daniel Peterson, who was in the audience, was also recognized for his outstanding contributions to this field of medicine.

Dr. De Meirleir's talk included years of significant research which is very technical and complicated. Therefore, this review is not meant to be a summary of the underlying science but rather a summary of the practical application of this work. However, we will place a recording of this talk on the WPI website:, as soon as possible for those who are interested in the actual research data.

Dr. De Meirleir presented a comprehensive lecture on the many factors that appear to play a role in the pathophysiology of ME.  In support of his conclusions, he drew information from other well-known researchers in the field including Drs. Chia, Klimas, Peterson, Mella and Fluge, as well as his more recent clinical studies of patients from Belgium and Norway. After the one hour and fifteen minute presentation, interested patients, researchers, doctors, nurses, and medical students were given a chance to ask questions.

Dr. De Meirleir uses a number of diagnostic tests to diagnose his patients’ underlying biological abnormalities and to guide his successful treatment protocols. Biomarkers include abnormally low NK cell number and function, cytokines indicating a shift in the balance of Th1 and Th2 immune responses, up regulation of Th17 immune cells, and abnormal levels of nagalase and elastase activity. He also tests for various active infectious agents including Borrelia, Bartonella, Brucella, mycoplasma, parasites, and various herpes viruses. He stated that environmental and genetic factors contribute to aberrant protein conformation in some patients.  Other diagnostic tests include fecal analysis and tests for levels of LPS or soluble CD14 as an indicator of gut inflammation.

Basic to Dr. De Meirleir’s treatment protocol is a plan that addresses specific dietary restrictions. He reported that many patients are fructose, lactose, casein and/or gluten intolerant. His patients often begin feeling better after eating a diet free of these substances, as they are most likely to cause an inflammatory response. In addition, he includes a fecal microbial analysis to determine whether or not to begin treatment with pulsed antibiotics. Based on the fecal analysis, which indicates whether or not his patients are suffering from a compromised intestinal barrier, he also prescribes specific probiotics, prebiotics such as lactoferrin, and digestive enzymes. When viruses or other pathogens become chronic Dr. De Meirleir prescribes antiviral therapies and/or additional antibiotic treatments.

It is generally accepted knowledge that ME patients have difficulty controlling various herpes viruses and other pathogens, in addition to exhibiting abnormal natural killer cell function. Subsequent searches for immune modulating drugs have included trials of several different products. Gc-MAF is a macrophage stimulating substance that has recently shown great promise.  Dr. De Meirleir highly recommends that patients address any leaky gut issues before beginning treatment with Gc-MAF.  He also mentioned risks that can be associated with this type of treatment.  Risks include a shift to autoimmunity and an immune reconstitution reaction known as IRIS although  none of his patients have developed autoimmune disease as a result of Gc-MAF treatments and less than 20% have experienced IRIS. Dr. De Meirleir routinely monitors his patients for IRIS cytokines after starting them on very low doses of Gc-MAF, as a method of prevention. Other immune supportive therapies include the use of Kutapression/Hepapressin complex (Nexavir), which has been reported to inhibit EBV and HHV-6, and Isoprinosine for those with low serum uric acid levels. Finally, Rituximab, a B-cell depletion immune therapy, has been used successfully in a small trial of patients with ME by oncologists Fluge and Mella. Because of the delayed therapeutic response of two to seven months, the authors of this study remarked that there is a possibility that ME has an autoimmune component. (Note: These two physicians are now looking for collaborative research sites and additional funding to engage in a much larger clinical trial due to their 67% rate of success.)

Dr. De Meirleir concluded his talk with a detailed slide describing the various pathways that are disrupted in ME and several other autoimmune diseases. He spoke about a continuum of autoimmune diseases including ME, lupus, RA, type 1 diabetes, and remitting MS that involve a dysregulation of two important immunological pathways, 2’-5’OA synthetase and Th1/Th2 immunity.

It was evident from his lecture that the key to Dr. De Meirleir’s success with patients is his recognition of the serious infectious and immunological issues facing those with ME. His research provides strong evidence for the support of biological testing and treatment.

WPI is thankful to Dr. De Meirleir for his outstanding commitment to this patient population. We feel fortunate to be able to provide his lecture as part of our mission to support outreach and education. We look forward to sharing more good news with you in the future.

Sunday, February 17, 2013

Many Hands Make the Load Lighter

Yesterday, there were 6,292 free downloads of Chronic Fatigue Syndrome: A Treatment Guide, 2nd Edition.

I can't begin to describe how I felt when I saw that number this morning. I had hoped to reach a total of 5,000 this month. But as of today, the total number of free downloads has reached 9,602. We are fast approaching the 10,000 mark.

From the bottom of my heart, I want to thank all the people who made this possible – those who “liked” the Facebook post, those who put the free day on their own Facebook pages, websites, and blogs. Those who announced it on boards, who wrote reviews, who sent encouraging emails to their friends and support groups.

Yesterday represented the culmination of a spectacular joint effort. It proves that we can all pull together for the good of the community. I certainly could never have achieved this wonderful success on my own.

I sincerely hope that Chronic Fatigue Syndrome: A Treatment Guide will help many people along the road to recovery. I know that while we may be frail as individuals, together we can – and will – continue the heart-lifting labor of bringing us all closer to what we most desire: a return to health.

Yours in health,
Erica Verrillo

Friday, February 8, 2013

ME/CFS Treatment Guide Free on February 16th

Please help me spread the word! So far, I've given away over 3,000 copies. I'd like to reach 5,000 this month.

On February 16th, will be giving away free copies of Chronic Fatigue Syndrome: A Treatment Guide, 2nd Edition. Dr. Charles Lapp, director of the Hunter-Hopkins Clinic, calls this “the book every patient should have.” 

The book includes over 100 effective treatments, spanning the full range of pharmaceutical and complementary modalities, an in-depth discussion of symptoms with cross-referencing to appropriate treatments, the latest research into the causes and mechanisms of the illness, doctors' protocols, coping techniques, special sections for managing chemical sensitivities, dietary restrictions and the special needs of children, as well as extensive appendices covering resources, locations of doctors and clinics, local, national and international organizations, and internet ordering information. The book also features over 2600 useful links to further reading, research articles, and patient reviews.

A Kindle is not needed to read this book! Amazon provides free apps that allow eBooks to be read on computers, iPads, phones and other devices.

For more information go to:

Tuesday, February 5, 2013


You can stop hitting me now...

What follows is the full text of Hemispherx Biopharma's press release. Anyone who has been following the long, long history of Ampligen vs. The World, won't be surprised that, yet again, HB has been trounced. To be fair, the odds were slightly tilted in favor of the FDA and the multi-billion dollar industry it represents. (FYI: I have italicized the touching section in which HB expresses "concern" for our health. Apparently, Bob Miller got their attention. Good job, Bob! Next time, I'll join you.)

PHILADELPHIA, Feb 04, 2013 (GLOBE NEWSWIRE via COMTEX) -- Hemispherx Biopharma, Inc. (nyse mkt:HEB) (the "Company" or "Hemispherx"), announced that it received a Complete Response Letter from the US Food and Drug Administration ("FDA") declining to approve its new drug application ("NDA") for Ampligen for Chronic Fatigue Syndrome ("CFS"). The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.
In its Complete Response Letter ("CRL"), the FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues. The Agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data.
In the two pivotal clinical studies that form the basis of approval for Ampligen, Hemispherx believes that the primary efficacy endpoints were met and that they showed a statistically significant improvement (i.e., with a p-value of 0.05 or less). The FDA and Hemispherx do agree that in clinical study AMP-502, the primary endpoint was met (p=0.02). In clinical study AMP-516, the FDA's analysis resulted in a p-value of 0.10, while Hemispherx's calculation resulted in a p-value of <0.05, and yet both analyses indicate that those patients on Ampligen improved over those on placebo. With regard to safety, Hemispherx has provided data from the 845 subjects who have received Ampligen, including 589 subjects suffering from severe CFS and over 200 CFS patients who have received Ampligen for at least one year or longer. The Company believes that these data are sufficient to determine the safety profile of Ampligen. At the December 20, 2012 FDA Advisory Committee meeting, 8 of the 13 Advisory Committee members voted yes on the question of "Is the safety profile of Ampligen adequate for approval for the treatment of CFS?"
Hemispherx plans to request an end-of-review conference with the FDA as a precursor to submitting a formal appeal to the Office of New Drugs in the FDA's Center for Drug Evaluation and Research regarding the Agency's decision. The purpose of the conference is to review all of the issues raised in the Agency's CRL as well as to discuss the corroborating data and experiences of clinicians and patients who have seen the benefits of Ampligen therapy.
Hemispherx has become aware that a prominent CFS advocate and long-time CFS sufferer, who has been on Ampligen since 1999 through a treatment IND, began a hunger strike on January 30, 2013 to seek FDA approval of Ampligen. Hemispherx understands the frustration that there is still no FDA-approved treatment for CFS and the concern that patients may lose access to Ampligen therapy. Out of concern for the health of the CFS community, Hemispherx has asked any hunger strikes be discontinued and that patients join in a collaborative effort between the FDA, Hemispherx, CFS clinicians and patient advocates to find a solution to this significant unmet medical need.
In the past, the FDA has shown great willingness to work with stakeholders to find solutions for serious and life-threatening illnesses. Dr. Margaret Hamburg, Commissioner of the FDA has previously stated that, "FDA has an important role to play in shaping the future of medical breakthroughs by bringing stakeholders together to identify and overcome challenges." Hemispherx hopes that the FDA will view the Ampligen end-of-review conference as an opportunity to involve patient advocacy, clinicians and researchers in a concentrated effort to do something for these patients over the near-term, including further evaluation of how new legislation, such as the recently enacted "FDASIA" statute, may have a role in finding a solution. The views of one internationally recognized researcher/clinician, Dr. Nancy Klimas, who has over 20 years' experience evaluating and treating CFS patients, can be found at
DISCLOSURE NOTICE: The information in this press release and the article referenced therein includes certain "forward-looking" statements (explained below), including statements about the remaining steps, including the aforementioned end-of-review conference and appeals process, which the FDA may require and Hemispherx may take in further seeking FDA approval of the Ampligen NDA for the treatment of Chronic Fatigue Syndrome. The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the Ampligen NDA. Any failure to satisfy the FDA's requirements could significantly delay, or preclude outright, approval of the Ampligen NDA.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen and Alferon LDO. Because both Ampligen and Alferon LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. Ampligen is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit .
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "believes," "plans," "anticipates," and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations and represent the Company's judgment as of the date of this release. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved, including its intent to pursue the end-of-review conference and appeals process. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K and Hemispherx's beliefs that the Ampligen NDA may be covered by the new provisions of the FDASIA statute, which are subject to FDA interpretation and implementation, or that such provisions, if applicable, will be helpful with regard to obtaining FDA approval of the Ampligen NDA. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof.

Sunday, February 3, 2013

OUTPACED: The Empire Strikes Back

It can't be mere coincidence that the day before the FDA was scheduled to make its decision on Ampligen, the PACE group published the results of its lengthy study on treatments for CFS.

The study, published in 
Psychological Medicine on February 1 2013,  compared the effectiveness of four different types of treatment: 1) adding cognitive behavior therapy (CBT) to specialist medical care, 2) adding graded exercise therapy (GET) to specialist medical care, 3) adding adaptive pacing therapy to specialized medican care, and 4) specialized medical care alone. It should not have come as a surprise that the study confirmed "that recovery from CFS is possible, and that CBT and GET are the therapies most likely to lead to recovery."

The PACE study, of course, proved nothing of the kind. Even a quick perusal of the methods used to determine the cohort, the absurdity of the statistical analysis, and the complete lack of a viable definition of "recovery" should undermine any conclusions that this study purported to make.

Unfortunately, the mere existence of a study with even a whiff of bogus science (and institutional backing) is enough to provide fodder for those who will do anything, say anything, and invent anything, to prevent CFS and ME from being considered organic illnesses. The reason for this is clear. If Ampligen is approved, then all arguments about whether CFS and ME are psychological or physical will cease.

As far as insurance companies are concerned, that is a terrifying prospect. This is a complex illness, perhaps the most complex the world has ever seen. The costs of actually treating CFS and ME, as opposed to having its victims take a daily stroll, or chat with a counselor about their misguided "illness beliefs," would be staggering. There can be no doubt that the possibility of bankrupting insurance companies is what is foremost in the minds of the FDA committee as they weigh the "safety" of Ampligen.

Standing up against the machinery of what we call our "health care" system is what Bob Miller is currently attempting. I only hope that the tanks don't roll over him ... and all the rest of us as well.

Saturday, February 2, 2013

CFS patient starts hunger strike for FDA approval of Ampligen

Bob Miller

Bob Miller on Hunger Strike: Send This 1-Minute Email to Get FDA Approval for Ampligen

February 1, 2013, Phoenix Rising
by Sasha

Bob Miller has started a hunger strike to push for FDA approval of Ampligen. He and his wife, Courtney Alexander, who are well-known for drawing President Obama’s attention to the plight of people with ME/CFS, urge us not to do the same.

Instead, they’d like us to send the email below, alerting key decision-makers to his strike, to add pressure to approve Ampligen as a therapy for ME/CFS.

The FDA is expected to announced its decision sometime around  2nd February – this Saturday – so there’s no time to lose.

Wherever you are in the world, please use Bob’s template to email, and do it right now. It takes less than a minute: I’ve already sent mine.

Bob’s message

Yesterday January 29th, I began a hunger strike seeking FDA approval of Ampligen, the only medication in FDA-approved clinical trials for Chronic Fatigue Syndrome, (ME/CFS).

The FDA Advisory Committee voted Ampligen is safe given the serious nature of CFS and the critical unmet need of patients.

Please support access to Ampligen for ALL ME/CFS PATIENTS by sending a note like the one below to the Secretary of Health Kathleen Sebelius, Assistant Secretary of Health Dr Howard Koh, FDA Commissioner Dr Margaret Hamburg, and FDA CDER Director Dr Janet Woodcock and Deputy Director Dr Sandra Kweder.

You can just copy and paste the email below.

Please also email or call your Congressional Representatives and Senators (look them up here and just click on your state) and ask them to investigate why the FDA refuses to approve the ONLY medication for CFS despite safe testing for 20 years. This is a health crisis!

The email

Subject: CFS patient starts hunger strike for FDA approval of Ampligen

“Long-time ME/CFS patient Robert Miller from Reno, Nevada began a hunger strike in advance of the FDA’s Feb. 2nd deadline to decide on Ampligen, the ONLY medication in clinical trials for my illness. I support Mr. Miller because my life has been stolen by ME/CFS and I need real treatment options. We have waited 20 years, and we can’t wait any longer. The FDA Advisory Committee voted Ampligen is safe enough to market because CFS is so serious and there are NO medications to treat patients. Please don’t let the FDA reject the only medication CFS patients can hope for any time soon.”

Your Full Name Here:
Address Here:
Years ill:

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