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

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 16^th, Amazon.com will be giving away free copies of Chronic Fatigue Syndrome: A Treatment Guide, 2^nd 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: http://www.cfstreatmentguide.com

DOWN FOR THE COUNT

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 http://www.sciencedaily.com/releases/2013/01/130124183448.htm

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 www.hemispherx.net .

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.

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.

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

http://phoenixrising.me/archives/15415

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  2^nd 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

To: kathleen.sebelius@hhs.gov, margaret.hamburg@fda.hhs.gov, janet.woodcock@fda.hhs.gov,

sandra.kweder@fda.hhs.gov, howard.koh@hhs.gov, ash@hhs.gov,

bobmiller42@gmail.com

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:

A Biomarker for CFS/ME?

The study referred to in this news report was published in 2011. (See below for a link.) The researchers compared cerebrospinal fluid from 10 healthy controls with the fluid from people with CFS (using the Fukuda case definition) and with Neurologic Post Treatment Lyme disease syndrome (nPTLS), two conditions  that share common symptoms of fatigue and cognitive dysfunction. The rationale for the study was that "despite extensive research,  CFS and nPTLS remain medically unexplained. There are no biological markers to distinguish these syndromes, creating diagnostic dilemmas and impeding research into understanding each individual syndrome."

After examining the cerebrospinal fluid samples, the research team discovered distinct sets of proteins which could accurately distinguish between the two illnesses and differentiated them from healthy controls. The study identified 738 proteins that were found in CFS, but not in either healthy normal controls or nPTLS; 2) 1,582 proteins that were not identified in CFS, but were in either nPTLS disease or healthy normal controls; 3) 692 proteins that were identified in the nPTLS patients, but not in healthy normal controls or CFS; and 4) 1,597 proteins that were not identified in nPTLS, but were identified in either healthy normal controls or CFS. (Of further interest the researchers noted that the CDK5 pathway, was "significantly enriched" for proteins found exclusively in the CFS fluid. The researchers pointed out that this signaling pathway has been linked to Parkinson's and Alzheimer's, two neurological diseases.)

The significance of this study is that the analysis of proteins in cerebrospinal fluid could serve as a biomarker for CFS.

Reference:
Schutzer, Steven E., Thomas E. Angel, Tao Liu, Athena A. Schepmoes, Therese R. Clauss, Joshua N. Adkins, David G. Camp II, Bart K. Holland, Jonas Bergquist, Patricia K. Coyle, Richard D. Smith, Brian A. Fallon, Benjamin H. Natelson. “Distinct Cerebrospinal Fluid Proteomes Differentiate Post-Treatment Lyme Disease from Chronic Fatigue Syndrome.” PLoS ONE 6(2): e17287. (2011) http://www.plosone.org/article/info:doi%2F10.1371%2Fjournal.pone.0017287

"We are not crumbs..."

Mindy Kitei speaking before the CFSAC

Mindy Kitei is a science reporter who has been covering CFS/ME for more than 20 years. Her commitment to people with CFS/ME has been unflagging, and her barbed criticism of the CDC's mishandling of the CFS/ME epidemic has been continual over the course of her career. On May 12, 2011, she delivered this fiery public comment at the CFS Advisory Committee (CFSAC) meeting.

" To the CDC and NIH scientists who have been ... sweeping a world-wide human catastrophe of 17 million people under the carpet, I say to you, 'Have you no sense of decency?'"

Full Text:

My name is Mindy Kitei.  I’m a science reporter who’s covered ME/CFS for twenty years.  Last June, I began my blog, CFS Central, in honor of my friend Nancy Kaiser.

I met Nancy in 1994, while working on an investigative piece for Philadelphia magazine called “The AIDS Drug No One Can Have” about the experimental HIV and ME drug, Ampligen.

Nancy had a severe case of ME. She had multiple seizures every day. When she tried to sit or stand, her blood pressure plummeted; she often crawled instead. She tried many experimental treatments to get well.

Nancy died on June 15, 2008.  I naively thought she’d never succumb to the illness, as if by sheer will she’d keep herself alive.

Three other ME patients whom I interviewed in 1994 have also died of the disease.

Despite its gravity, despite ample evidence that ME is an infectious disease, the government treats it like a joke. The CDC and parts of the NIH have been playing a shell game:  studying patients with simple fatigue or chronic fatigue or depression—but labeling them CFS patients. 

Even when the CDC conducted its XMRV study, it studied the wrong cohort and refused to do an actual replication of the Science study.  It’s just a different kind of shell game from the bogus psychological CFS studies that are the agency’s trademark.

To the CDC and NIH scientists who’ve been doing this ludicrous research for three decades and sweeping a worldwide human catastrophe of 17 million people under the carpet, I say to you:  Have you no sense of decency at long last?

ME patients are suffering from a serious infection— most likely a retrovirus—but are told by charlatans to exercise and have a positive attitude. 

Researchers in government and at universities, as well as the CFIDS Association, admonish desperate patients that taking anti-retroviral drugs is medically indefensible.  When the healthy reprove the sick that they’re impatient and reckless and foolish and need to wait for treatment, I say there is no treatment, and where are the drug trials?  Thirty years and not one approved drug and none in the offing.

ME patients should have the same freedom to try medications that AIDS patients had in the early days.  The AIDS patients became their own advocates because there was no one advocating for them.  The same holds true for ME patients now. Patients are gravely ill, and they have the right to treatment.  To say that they don’t—that’s what is medically indefensible.

The U.S. government conducted the Tuskegee Syphilis Experiment from 1932 to 1972.  The study tracked the progression of untreated syphilis among poor African American men but didn’t tell them they had syphilis. The men got sicker and many died.

In 1997, President Clinton apologized to the remaining Tuskegee men.  Clinton said:  “What was done cannot be undone. But we can end the silence. We can look at you in the eye and finally say on behalf of the American people, what the United States government did was shameful, and I am sorry.”

The United States government has watched ME patients suffer and die for 30 years, and has done nothing, and that is shameful.

In less than a year, more than 125 thousand patients from 108 countries and territories have found my blog, CFS Central.  Patients write to me asking for help every day.  Toward that end, I request a meeting with Kathleen Sebelius, Howard Koh, Francis Collins, Tony Fauci and Thomas Frieden to discuss how to turn this situation around, by funding good studies and finding effective medications.

About funding ME, Dr. Dennis Mangan said during this meeting:  “We’ll use one dollar and try to make two.”   I’m sure Dr. Mangan means well, but it isn’t enough.  As AIDS activist Larry Kramer said years ago about HIV patients:  “We are not crumbs.” After thirty years of neglect, ME needs research parity with HIV. We also need a czar who will oversee ME and report directly to President Obama. 

Finally, we need to enact the ME/CFS Care Act.  Much like the Ryan White Care Act for HIV patients, the ME/CFS Care Act will provide health coverage to needy patients.

In closing, I ask you, Dr. Wanda Jones, to ensure that this meeting occurs.  Dr. Jones, will you help me? 

Visit Mindy Kitei at: http://www.cfscentral.com/