Thursday, October 31, 2013

CFSAC Nomination:
Jeannette Burmeister


Wouldn't it be great to have patient advocate Jeannette Burmeister on the Chronic Fatigue Syndrome Advisory Committee?  On her blog, she's been a fierce advocate and takes no prisoners when it comes to the government's mishandling of ME.  She's been nominated already by patient advocates John Herd and Eileen Holderman. Holderman fought the good fight on CFSAC; her tenure expires in the spring. 

Now patients could certainly use another strong patient advocate.  If you'd like to shower Burmeister with the support she's earned, email CFSAC@HHS.gov and tell the agency.


Tuesday, October 22, 2013

New ME Film:
Canary in a Coal Mine


Jennifer Brea and Kiran Chitanvis have just launched their Kickstarter campaign to raise $50,000 to make Canary in a Coal Mine, their documentary about ME. Brea, a journalist, came down with ME three years ago. An interview with Brea will follow shortly on this blog. You can share their campaign with others and view two terrific clips from their film here. When you click to get to the film clips, you'll see where you can donate to Kickstarter. 

Saturday, October 12, 2013

Don't Let Petition Fatigue Set In:
Contact Congress to Stop the IOM Contract and Adopt CCC



Patient advocates, including Mary Dimmock and Patricia Carter, sent this call to petition Congress to stop the IOM contract and adopt the Canadian Consensus Criteria. Patients no doubt are experiencing petition fatigue, but the signatures of 34 key ME researchers and clinicians on the petition to HHS Secretary Kathleen Sebelius to stop the IOM contract have been one of the most important advocacy moves of the past 30 years. Congress, unlike HHS and CDC, is much more likely to listen to the patients and these experts--and that's why advocates have drafted this petition to Congress.

Given the situation, despair is understandable, but despair won't change anything. This is usually the time that patients fold and let the government have its way--and patients get shafted yet again. This is usually the time when patients say maybe it will be different this time and try to work within the system, but so far that hasn't worked. This is usually the time when patients let the CFIDS Association, HHS, CDC and their minions say soothing things--but walk all over them. But this time can and should be different: This time patients have 34 experts supporting their cause, and that should make Congress take notice.

Here's step-by-step directions to contact Congress:

For U.S. residents only
Please contact your congressional leaders as soon as possible within the next two weeks and ask them to tell HHS to adopt the CCC and cancel the IOM contract. Please ask your family and network to do the same.

Instructions and a sample letter are below. Note that while the government is still shutdown, the web contact forms still work and the messages from constituents will be recorded. Sending in messages now will ensure that they are logged and available for staff members.

For U.S. and international members of the community
If you have not done so, please sign the two attached petitions calling on HHS to adopt the CCC and cancel the IOM contract. Ask your family and friends to do the same.

1. October 7, 2013 petition calling on HHS to stop the HHS/IOM contract and accept the CCC definition.

2. June 2013 petition calling on HHS to adopt the CCC and stop using the name ‘chronic fatigue
syndrome.’

General background can be found here. Additional facts about the HHS/IOM contract for ME/CFS can be found here.

Instructions to email or call your congressional leader (U.S. only) 
1. Senators and members of the House of Representatives need to hear directly from their constituents. You can get the contact information for your congressional leaders at this website.

Type your zip code into the form and click on “Submit It.” The website will return the names of your two senators and one representative along with their phone numbers and a link to their contact form.

2. Click on the link to the web contact form for your senators and representative. This will bring up the web contact form for that legislative leader.

a. If you are using the sample letter, copy it into the box provided for your message.

b. Use “Stop the IOM Contract to Redefine ME/CFS" as the subject.

c. If the online form indicates that you need to choose the nature of the issue, select a choice dealing with healthcare.                                             

Sample message 
To be copied into the web contact form:

I am asking you to contact the Department of Health & Human Service (HHS) today and tell them to follow the lead of Myalgic Encephalomyeltis/Chronic Fatigue Syndrome (ME/CFS) disease experts. Tell HHS to adopt the Canadian Consensus Criteria and cancel its contract with the Institute of Medicine (IOM) to redefine ME/CFS.

On September 23, thirty-five of the leading ME/CFS researchers and clinicians wrote to Health and Human Services Secretary Kathleen Sebelius calling for the Canadian Consensus Criteria (CCC) to be used as the sole case definition for ME/CFS. These experts also urged HHS to abandon its plans to contract with the Institute of Medicine (IOM) to use non-experts to create its own definition. On the same day, despite an outpouring of patient opposition, HHS announced that it was going forward with the IOM contract to develop its own clinical diagnostic criteria for ME/CFS, instead of adopting the 2003 Canadian Consensus Criteria (CCC) created and endorsed by ME/CFS experts.

Regarding the IOM contract, the thirty-five experts stated,“[S]ince the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort (the IOM study) is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

The use of non-experts is especially concerning because, thanks to the bad definitions that HHS has promoted, the disease is so poorly understood that the medical community at large believes the disease is either not real or is a form of depression or deconditioning. ME/CFS is not deconditioning or depression. It is a devastating disease that causes neurological and immunological dysfunction and leaves patients bedridden, housebound and unable to work. ME/CFS costs the U.S. economy an estimated $17-$23 billion dollars a year in lost productivity and direct medical costs.

Given the overwhelming opposition to HHS’ plans by both patients and experts, I am asking you to contact HHS today and tell them to follow the lead of ME/CFS disease experts. Tell HHS to cancel the contract with IOM. Tell HHS to adopt the Canadian Consensus Criteria.

For more information, see the following links or send an email to meactnow@yahoo.com.
– Link to Sept 23 announcement from HHS on the IOM contract.
– Link to Sept 23 letter to Secretary Sebelius from the 35 ME/CFS experts.
– Link to additional background.

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. 

Thursday, June 6, 2013

Ampligen Up for Approval--
in Argentina


Hemispherx, the company that makes the experimental ME drug Ampligen, applied for approval in Argentina in July of 2012.  ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica), Argentina’s version of the FDA, generally renders decisions in one year. The company already received approval for a form of interferon called Alferon in Latin American countries (it's approved in the U.S. for genital warts). And ANMAT broadened Alferon's approval this year to include other diseases, including hepatitis C.

Hemispherx's stock price, which had plummeted from $1.10 to 18 cents a share following FDA's refusal to approve the drug for ME at the close of 2012, recently has been edging up, hitting a high of 29 cents today.

Sunday, April 28, 2013

WELL, AT LEAST THE FOOD WAS GOOD



My Thursday-night dinner at the FDA meeting—grilled salmon and broccolini—was terrific for hotel food.  Earlier, the cocktail hour of mostly vegetarian appetizers, arranged by advocate Denise Lopez-Majano, whose two sons are sick with ME, was equally good.  

That being said, why any of us bothers to attend these government dog-and-pony shows is anyone’s guess.  I suppose hope springs eternal and all that.  This meeting, at FDA, seemed to hold more promise, at least, than the Chronic Fatigue Syndrome Advisory Committee meetings at CDC.  Then again, the bar couldn’t get much lower.  While patients had only two minutes to talk, FDA officials waxed lyrical about the lovely baby grand piano in the hallway, should any patient care to play.

Dr. Daniel Peterson’s talk was more interesting than the FDA meeting.  Dissed by the FDA and not given a place on any of the panels, Peterson talked in his meeting across the hall about his success with Vistide when used on patients with active infections by PCR with HHV-6, Epstein Barr or CMV—meaning the virus is actively replicating—as opposed to just the high antibody numbers to these herpes viruses that many with ME sport.  Probenecid, Peterson explained, potentiates Vistide’s effects.  He found that VO2 max—one’s aerobic threshold—improves on Vistide/Probenecid, and natural killer cells increase.  Peterson asked: Why should getting rid of the virus result in VO2 max shooting up?  His theory: The virus is messing with mitochondria.  One of Peterson’s patients on Vistide checked out of a nursing home and went back to work.  Of the 27 patients on Vistide, 18 didn’t relapse off the drug. 

More later. 

Wednesday, April 24, 2013

GONE TO THE FDA



I'm going to the FDA tomorrow and Friday.  If Internet connections and my Kindle cooperate, I'll try to post on Twitter in real or semi-real time.  If not, I'll post when I return.


Monday, February 4, 2013

Ampligen: It's a NO


From the GlobeNewswire:

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 .="" nbsp="" p="">
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'sCenter 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 athttp://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 visitwww.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.