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Saturday, March 30, 2013

5 Tough Choices You Face When Chronically Ill or in Pain


Originally Published in Psychology Today January 28, 2013 

By Toni Bernhard, J.D.

Suffering from chronic pain or illness—or, as is often the case, both—can feel like a full-time job. One reason for this is that we must constantly assess and evaluate if we’re managing our health and our relationships as skillfully as possible. This ongoing decision making makes up a major part of the workload in this full-time job—a position we certainly never applied for!

Here are five tough choices we continually face. There aren’t easy answers to the issues they raise: that’s why they’re tough choices.

1. Do we talk openly about our health problems or do we keep them private?
This is an ongoing tough choice we face whenever we communicate with friends and family, whether it be in person, by phone, by email or even text. If we talk about our health problems, some of them may respond judgmentally or even turn away from us. And even those who don’t turn away may change the way they relate to us. We want to be treated as whole people and as adults, but if we share our health struggles with others, we risk being treated like a shadow of our former self or, even worse, as dependent children.
On the other hand, if we keep quiet about our health issues—perhaps even acting “fake healthy” as I’ve been known to do— we risk leading others to misunderstand what we can and cannot do. In addition, by keeping quiet, we’re passing up the possibility of receiving much needed support—both emotional and practical.

If you’re like me, it can be exhausting, both physically and mentally, to continually assess and decide what you will and what you will not share with others about your health.

2. Do we ignore a new symptom or have it checked out by a doctor?
On the one hand, it’s not good for us emotionally to be overly focused on every little ache and pain in our body. In addition, we may be concerned that if we raise a new symptom, our doctor will think we’re being oversensitive or even a hypochondriac—either of which could affect the quality of care we receive.

But consider this. I read in one of my chronic illness books about a woman who ignored a new symptom because she decided it was best to assume it was related to her chronic illness. She also said that she waited so long to see her doctor because she “didn’t want to bother him.” The new symptom turned out to be stomach cancer.

What to do when a new symptom appears necessitates making another tough choice: wait or act immediately? We have to listen carefully to our body and decide for ourselves. It isn’t easy, that’s for sure.

3. Do we follow our doctor’s treatment plan or do we try alternative and unconventional therapies?
There’s no right or wrong course of action here, but it’s a choice that, for me, has been costly, both to my pocketbook and, at times, to my health. I used to spend hours and hours, utterly exhausting myself, combing the Internet for cures. As I wrote about in my piece “Finding the Health Information You Need on the Internet,” anyone can create a website, set up a payment plan, and ask for your credit card number. Anyone. Treatments-for-sale can be packaged to sound very seductive. People spend thousands of dollars on false cures. I know because I've done it.

On the other hand, I’ve also read about people who’ve been helped by alternative or unconventional treatments, so it may not be wise to decide to disregard them entirely. These tough choices—what to take, what not to take, how to assess the monetary costs, what to tell our doctor about what we’re taking or not taking—also make up a major part of the workload for those of us with chronic health problems.

4. Do we push our body to the limit or do we always play it safe?
Sometimes, the desire to be like healthy people is so strong that we can talk ourselves into pushing our body to do what it cannot reasonably do. About two years ago, my granddaughter Camden was visiting. I was so frustrated by always feeling sick when she was here that I decided to “act healthy.” We have a park next door to our house. I took her there for over an hour, helping her with the slides, pushing her on the swings. I was in a defiant mood: “I’m tired of being sick. I’m just going to act as if I’m healthy.” What I got for my effort was a week of payback with exacerbated symptoms.

On the other hand, I find that if I always play it safe, my body gets so used to the strict regime I put it on that I lose my ability to be flexible at all. For example, if I always nap at noon sharp, then if I’m fifteen minutes late one day, I feel like I’m going to collapse on the spot. So I purposefully mix up the exact time I nap so that my body doesn’t become conditioned to following a rigid schedule. That said, my ability to be flexible has its limits: I don’t have the luxury to just skip the nap.

If it’s possible for you, I recommend a middle path of gently challenging your body now and then so that you don’t fall into a fixed pattern of behavior that underestimates what you might be able to do. But, as with the other tough choices, I find this constant assessing and adjusting, assessing and adjusting to be exhausting in itself, both mentally and physically.

5. Should we aggressively fight to regain our health or should we accept our fate?
Constantly fighting to regain our health is also exhausting, physically and mentally. But the alternative of passively accepting that this is the way we’re going to be for the rest of our lives doesn’t feel like a wise choice either. Again, I recommend a middle path. It took me a while to realize that I could acknowledge and accept my health as it is right now, while at the same time continuing to try to regain the health I had before I got sick. These two courses of action aren’t contradictory.

It wasn’t until I began to accept—without aversion—however I happened to feel on any given day, that I was able to begin looking for ways to enjoy my life again. But an integral part of that life is keeping an eye out for new treatments. And, working to gracefully accept how I feel at the moment, while at the same time continuing to be proactive about my health is…you guessed it—exhausting.

I see that I’ve used the word “exhausting” five times in this piece (not counting its presence in this very sentence!). It’s no surprise that mental and physical exhaustion are the consequences of having to continually assess, evaluate, and choose a course of action while already sick or in pain. My wish for you is that you be as kind to yourself as you possibly can as you struggle with these tough choices.

Toni Bernhard is the author of the award-winning How to Be Sick: A Buddhist-Inspired Guide for the Chronically Ill and their Caregivers. Her new book, How to Wake Up: A Buddhist-Inspired Guide to Navigating Joy and Sorrow, is available for pre-order and will be released in September. Until forced to retire due to illness, Toni was a law professor at the University of California—Davis, serving six years as the dean of students. Her blog, “Turning Straw Into Gold” is hosted on the website of Psychology Today. She can be found online at www.tonibernhard.com.

Monday, March 25, 2013

The National ME/FM Action Network needs your vote!

This is it! Today is the last day to vote for The National ME/FM Action Network! This worthy charity is still 1000 votes short of making it into third place. Third place will get them $5000. Fourth place gets them nothing. We need more  votes!!

If every person reading this post votes on the link below, and then passes the link on to just one other person, we can get 1000 votes in one day!

Vote here: http://www.sharethebounty.ca/charities.php

Instructions: Scroll over to the "N" on the alphabet bar and click. Then click on National ME/FM Action Network. (You'll have to give them your email address. Don't worry - you won't get ads unless you click on the box to receive them.)

Here's what The National ME/FM Action Network does (from their website):

The NATIONAL ME/FM ACTION NETWORK became a Canadian charitable organization on June 18, 1993 dedicated to Myalgic Encephalomyelitis, also known as Chronic Fatigue Syndrome (ME/CFS) and Fibromyalgia (FM) through support, advocacy, education and research. Since its founding, the organization has been an ACTION Network. Some of our accomplishments are:
  • Providing knowledge and empowerment to the people who need information and help
  • Establishing relationships with both the provincial and Canadian governments in Canada to better the lives of people ill with ME/CFS and FM
  • Developing contacts with medical and legal professionals
  • Working with National and International Support Groups
  • Publishing a quarterly newsletter keeping people informed about the progress in research and related matters
  • Spearheading the development of the Consensus Documents, known as the Canadian Definitions
  • Resource guides for disability matters
  • TEACH-ME guide for Teachers and Parents of children and youth with ME/CFS and FM

The NATIONAL ME/FM ACTION NETWORK hosted the 10th International IACFS/ME research and clinical conference for ME/CFS and FM and related illnesses in Ottawa from September 22nd to 25th, 2011 consisting of professional workshops and meetings as well as a one-day meeting for the general public.

Our Motto: People Helping People Helping Themselves

Friday, March 22, 2013

Norwegian Group Begins Ambitious Fundraiser for ME/CFS Treatment, Rituximab

The Norwegian group, MEandYou, has begun fundraising for an ambitious study on the cancer drug, rituximab (trade name: Rituxan), for patients with ME/CFS.  Their goal is to raise 7 million kroner, or 1.2 million US dollars in three months to support a study headed by professor Olav Mella and Dr. Øystein Fluge at Haukeland University Hospital, Norway. A total of 140 patients will be involved. Rituximab made headlines when Mella and Fluge reported that several ME/CFS patients who had been treated for cancer using rituximab experienced a remission of ME/CFS. (For an excellent summary of the rituximab studies, read Cort Johnson’s article “A Drug For ME/CFS? The Rituximab Story.”)

Below is the full statement and call to action taken from MEandYou’s website.

This is MEandYou

Do you want to be a part of making a medical breakthrough? Do you want your families and friends to have an opportunity to be a part? Invite them.

Millions of people suffer from the disease ME, but today there are no medications to treat them. Scientists at Haukeland Hospital in Bergen have found that a drug might make more of them healthy. It was so startling that it made ​​international headlines in BBC, Der Spiegel, and ABC News. If the findings verified, thousands of patients worldwide have a healthier life.

Scientists at Haukeland need only one study to be able to find out if this is the breakthrough you have been waiting for. 140 ME sufferers have to try out the medication in a research project. It cost 7 million. However, the public authorities have refused to grant money.

We are fundraising the cost for 140 ME-sufferers to Haukeland Hospital, cancer ward, to be a part of a clinical trial on Rituxan. The cost is 1,2 million USD,  55 000 Norwegian kroner each. We are going to do it in 90 days.

The Rituxan study at Haukeland Hospital, presented in PlosOne autumn 2011, showed the most promising results worldwide for ME/CFS-sufferers. 2/3 had good or moderate effect. The bigger RCT-study has not had sufficient economical support from the official health care system to continue their research.

ME/CFS is a poorly understood, but debilitating, neuroimmunological illness with none or little treatment, that affects hundreds of thousands of people world wide. Have you ever thought about how much society would save just by getting a few of those sufferers back to work and as participants of the community?

What if it turns out that the research that you, as an individual, support will be a breakthrough in the medical field? What if you are one of those people who in few years can say that, yes, I was a part of it! This might be your chance. The patients, the families, the friends pass those well-established channels and contribute funds directly to the research projects we want to support, so that they become a reality. Do you want to be a part of it?

We can do it. MEandYou.

Sunday, March 17, 2013

Omega-3 Fatty Acids Could Prevent And Treat Nerve Damage, Research Suggests

Research from Queen Mary, University of London suggests that omega-3 fatty acids, which are found in fish oil, have the potential to protect nerves from injury and help them to regenerate.

When nerves are damaged because of an accident or injury, patients experience pain, weakness and muscle paralysis which can leave them disabled, and recovery rates are poor.

The study, published in January, 2012 in the Journal of Neuroscience, suggests that omega-3 fatty acids could play a significant role in speeding recovery from nerve injury.

The study focused on peripheral nerve cells. Peripheral nerves are the nerves which transmit signals between the brain and spinal cord, and the rest of the body.

These nerves have the ability to regenerate but, despite advances in surgical techniques, patients usually only have good recovery when their injury is minor.

Omega-3 fatty acids are vital for the body’s normal growth and development and have been widely researched for their health benefits. Because the body cannot manufacture omega-3 fatty acids, they have to be consumed in foods such as oily fish.

In the new study, researchers first looked at isolated mouse nerve cells. They simulated the type of damage caused by accident or injury, by either stretching the cells or starving them of oxygen. Both types of damage killed a significant number of nerve cells but enrichment with omega-3 fatty acids in cells gave them significant protection and decreased cell death.

Next the researchers studied the sciatic nerves of mice. They found that a high level of omega-3 fatty acids helped mice to recover from sciatic nerve injury more quickly and more fully, and that their muscles were less likely to waste following nerve damage.

The research was carried out by a group led by Adina Michael-Titus, Professor of Neuroscience at Barts and The London Medical School and lead of the Neurotrauma and Neurodegeneration group in the Centre for Neuroscience and Trauma, Queen Mary, University of London.

She explained: “Our previous research has shown that these fatty acids could have beneficial effects in a number of neurological conditions. This new study suggests that they could also have a role in treating peripheral nerve injuries.

“More work is needed but our research indicates that omega-3 fatty acids can protect damaged nerve cells, which is a critical first step in a successful neurological recovery.”

Reprinted with the kind permission of Queen Mary, University of London

Monday, March 11, 2013

Bee Propolis: Nature’s Wonder Food

Those busy little bees really know what they're doing.

"Health Benefits of Bee Propolis"
By C.L. Davis, Herbal Wisdom Blog

The benefits of bee propolis have been well-known for a long time but, as with many natural remedies, some of this knowledge has been obscured in recent times.

Using natural substances to cure various ailments is something that our ancestors did with much success. Many people are now re-discovering the benefits of using natural remedies, such as propolis.

About Bee Propolis

Honeybees collect more than just pollen when they are buzzing around the yard. Resins are collected from various plants and trees, mixed with beeswax and amino acids and used to form structures within the hive, similar to the way that we use cement. Bees need to protect themselves from disease just like we do and propolis is their solution. As the bees travel through the hive, they rub against the propolis and receive the benefits of the natural antibiotic, anti-inflammatory, antifungal and antiviral properties from their building materials.

Active Ingredients & Uses

Immune Boost
Propolis has antibiotic and anti-microbial properties. Because propolis is high in the vitamin B complex vitamins, has significant amounts of vitamin C, and contains vitamin E, it naturally boosts the immune system. High levels of antioxidants are also found in propolis and these also give our natural immune system functions a boost, as well as doing the same for the bees! Because of its ability to enhance the function of the immune system, Propolis is a great treatment for cold and flu symptoms and even food poisioning. It can be taken in the form of capsules or as a tincture and is easy to obtain.

Wound Healing
Bee propolis also promotes wound healing, making it very useful in topical treatments such as ointments and creams. It is easy for burns, abrasions and lacerations to become infected, but when treated with a strong antibacterial agent the body has a chance to heal quickly and with less chance of scarring. Studies conducted in several different countries show that bee propolis has strong antibacterial and anti-microbial properties. As an anti-inflammatory, bee propolis has been shown to be very effective. This is another way in which propolis can be useful as a topical treatment for wounds.

Anti-Inflammatory
Taken internally, it can also reduce the damaging effects of inflammation in the body. Inflammation is the cause of many diseases, including heart disease, inflammatory bowel disease, some bone diseases, pelvic inflammatory disease and arthritis. Autoimmune diseases such as endometriosis have also been shown to respond well to treatments that include the use of propolis.

Anti-Viral
The anti-viral property of bee propolis is another one of its well-known benefits. Viruses such as herpes can cause painful and embarrassing canker sores but relief has been found by using bee propolis. It can be taken internally to inhibit the action of the virus and used topically to treat blisters and canker sores. The antiviral properties of bee propolis are also what make it so effective in treating colds and the flu. Warts, which are thought to be caused by viruses or deficiencies in the immune system, have also been treated successfully with propolis.

Allergy Relief
Rats were shown to produce less histamine when given propolis, indicating that it has the potential to be effective in providing allergy relief.

Anti-Fungal
Propolis’ antifungal property is another one of its benefits. Common fungal infections include yeast infections of the mouth and vagina, foot fungus and jock-itch. Propolis has been shown to be an effective antifungal agent in a variety of studies. It can be used in the form of a topical treatment, as a tincture or in capsule form. Its effectiveness is due in part to enhancement of the immune system, and in part to its natural antifungal properties.

Cancer & Chemotherapy Relief
In some studies, propolis has also been shown to be effective against cancer cells. Propolis was applied as a tincture to cancerous prostate and colon cells, among others and caused significant rates of cancer cell death. Healthy cells were not destroyed, which is what happens in chemotherapy. Studies of the benefits of propolis in treating cancer are ongoing, but show that there is a possibility that some of the devastating effects of chemotherapy could be reduced by making use of bee propolis.

How To Use
Bee propolis is available in a number of forms, such as ointments, lotions, tinctures and capsules. It can be used to heal burns and other wounds, clear up infections, reduce the impact of inflammatory diseases and fight viruses. Some studies have even indicated that bee propolis can be used to treat cancer. Its antibiotic, anti-inflammatory, antifungal and antiviral properties have been known to humankind for ages and proven effective in numerous scientific studies the world over.

Thursday, March 7, 2013

Who Took the “ID” Out of CFIDS?


Et tu, Brute?
First published on Blogcritics as "Chronic Fatigue and Immune Dysfunction: Who Took the “ID” Out of CFIDS?"

Does anyone remember CFIDS, aka Chronic Fatigue and Immune Dysfunction Syndrome? Back in the 1990s this was the accepted term for what is now called CFS, or, if you are so inclined, CFS/ME. The ID was quietly dropped by researchers and doctors about 10 years ago in favor of Steven Straus’s infamous legacy: chronic fatigue syndrome. Everyone agrees that CFS is a confusing, misleading and utterly dismissive name for the illness. Not only does it harm people who have CFS, it harms people who don’t.

In a recent study of patients newly diagnosed with MS, nearly one-third had been diagnosed with CFS (or with the even more vague, “fatigue”) for one to two years prior to being diagnosed with MS. Imagine how many other patients with incipient cancer, heart disease, liver disease, diabetes (to name a few “fatiguing” illnesses) have had the catch-all diagnosis of CFS slapped on them simply because they were tired. The term CFS has been just as much a curse to those patients, whose correct diagnoses and treatments have been delayed by years, as it has been to patients with CFIDS.

Who did this? Who managed to drop the all-important feature of immune dysfunction from the name? After all, it is obvious that people with CFIDS have an immune dysfunction. Chronicity is, in fact, the product of an altered immune system. With a fully functioning immune system, the host recovers. Immune dysfunction is not just a feature of chronic disease, it is its definition.

What’s more, the furor over what to call the “Disease of a Thousand Names” has only intensified since the ID dropped about. Prior to the deletion of the ID, people who had been diagnosed with ME (on one side of the Atlantic) and CFIDS (on the other) maintained a cordial relationship. Since the change, they are at each other’s throats. People with ME do not want to be diagnosed with an illness that not only reduces all their symptoms to the “f” word, but is doggedly lumped into some ill-defined category of mental illness.

Who did this? Who managed to divide what was once a unified community into squabbling sororities? The CFIDS community could, and did, accomplish so much when it spoke with one voice: national organizations, political lobbies, well-subscribed magazines. Now, it is factionalized, torn apart by the desire to achieve maximum distance from the stigma of "fatigue."

An even more disturbing consequence of dropping the ID is that supposed friends, clinicians who once championed the cause, have not only slipped into using the term CFS, but are adding insult to injury by dropping the S part and referring to this illness, which not only destroys lives, but can eradicate them, simply as “chronic fatigue.” It’s bad enough that the patients call their illness “chronic fatigue,” but Nancy Klimas, head of the Neuro Immune Institute and world-renowned CFIDS specialist, should know better.

Who did this? Who trivialized this illness among formerly committed researchers and clinicians? Who robbed CFIDS patients of their defenders?

Benjamin Natelson.

In 2002, Benjamin Natelson, noted CFIDS researcher, was given a grant by the NIH to do a meta-analysis of immune studies in CFIDS patients. Meta-analyses are not research studies, they are simply analyses of studies that have been performed in the past. Because meta-analyses basically serve as Cliffs Notes for researchers who are too pressed for time to read the original work, their ultimate value to the research community has been questioned. Natelson’s meta-analysis, entitled “Evidence for the Presence of Immune Dysfunction in Chronic Fatigue Syndrome,” examined 79 studies of immune function in CFIDS patients. Natelson found that that there was no consistent immune dysfunction. Some studies indicated that there were increased pro-inflammatory cytokines, others found increased anti-inflammatory cytokines.

Given the fact that one of the hallmarks of CFIDS is waxing and waning symptoms, this "inconsistency" should not have come as a surprise. The immune dysfunction that characterizes CFIDS is that it both under- and over-responds. Immune, as well as neuro-endocrine, swings are the inevitable outcome of the loss of homeostasis that lies at the heart of the illness.

Natelson ignored this aspect of immune dysfunction, just as he ignored the one consistent piece of data he found across these studies – low natural killer (NK) cell function. He concluded that, “the available evidence does not support chronic fatigue syndrome as being due to any consistent immunological dysfunction … we believe that the term “chronic fatigue syndrome” is preferable to the older “chronic fatigue and immune dysfunction syndrome.”

Aside from the damaging consequences of this conclusion, it turns out that Natelson was wrong.

In 2012, a group of Australian researchers headed by Ekua Brenu completed the first longitudinal study of immune function in patients with CFS/ME (CFIDS). This was the first time researchers had examined immune function over a long period of time, in this case, 12 months. The value of longitudinal studies to measure immune function is that the immune system is a moving target. It responds instantly to environmental input. Even the best short-term study of the immune system can’t give researchers more than a snapshot.

The Brenu study found that patients with CFIDS do indeed have an immune system dysfunction. It is the same immune dysfunction that most other studies have found over the past two decades: low NK function. The natural killer cells of CFIDS patients ignore invaders, tumor cells among them (which is perhaps why so many people diagnosed with CFIDS in the 1980s went on to develop lymphomas). The authors concluded that because cytotoxic activity was consistently decreased during the course of the 12-month study it “may be a suitable biomarker for diagnosing CFS/ME.”

Notwithstanding the tantalizing possibility that a biomarker may have finally been found, the real clincher came at the end of the discussion section, where the authors explained why previous short-term studies had been equivocal:

“Cytokine release in CFS/ME patients undergoes shifts during the course of the disease where patients may present with either an amplified or depressed anti-inflammatory or pro-inflammatory cytokine profile. These alterations in cytokine secretion may occur during the course of the disease and at different times causing either a shift towards a predominant Th1 or Th2 immune response in CFS/ME This makes it difficult to establish a unique CFS/ME-like inflammatory cytokine profile. The observed pattern of cytokine distribution among our CFS/ME patients is consistent with equivocal findings in the literature. In adolescents with CFS/ME, cytokine secretions have been observed to be correlated with seasonal variations. Therefore, CFS/ME may be associated with oscillations in pro and anti-inflammatory cytokines, supporting the heterogeneity and multifactorial nature of the disease and the diversity in symptom presentations.”

That paragraph alone should have heralded a new age in CFIDS research. It should have stimulated a lively discussion. It should have prompted a retraction of Natelson’s damning conclusion. It should have reinserted the ID.

But instead of doing any of those things, it was ignored, not just by the broader scientific community, but by CFIDS researchers, clinicians and, saddest of all, by those who would have benefitted the most - the patients. We are now lying in the bed that has been made for us.

And it is a hard one.


References:

Berger JR, Pocoski J, Preblick R, Boklage S. “Fatigue Heralding Multiple Sclerosis,” Mult Scler. 2013 Feb 25. [Epub ahead of print]. http://www.ncbi.nlm.nih.gov/pubmed/23439577

Natelson, Benjamin H., Mohammad H. Haghighi, and Nicholas M. Ponzio. "Evidence for the Presence of Immune Dysfunction in Chronic Fatigue Syndrome." Clin Diagn Lab Immunol. 2002 July; 9(4): 747–752. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC120010/

Ekua W Brenu, Mieke L van Driel, Donald R Staines, Kevin J Ashton, Sharni L Hardcastle, James Keane, Lotti Tajouri, Daniel Peterson, Sandra B Ramos, and Sonya M Marshall-Gradisnik. “Longitudinal investigation of natural killer cells and cytokines in chronic fatigue syndrome/myalgic encephalomyelitis.” J Transl Med 2012; 10: 88 doi: 10.1186/1479-5876-10-88.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3464733/


Sunday, March 3, 2013

The FDA's Response Letter Re: Ampligen


Below is the FDA's response to my email encouraging the FDA to approve Ampligen. Their response is a PR masterpiece. If the FDA, NIH, and CDC spent as much money on researching ME/CFS as they do on their Public Relations efforts, we would have a cure by now. 

Dear Erica Verrillo,

Thank you for sharing your personal testimony as well as your desire for the U.S. Food and Drug Administration (FDA) to approve Ampligen. Please accept this response on behalf of FDA’s leadership, who forwarded your email to the Division of Drug Information for direct reply.

As evidenced by the hundreds of letters, emails, and testimonies submitted to FDA, Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS) is a devastating disease with a serious impact on quality of life. We are acutely aware of the seriousness of this disease, that no FDA approved treatments are available, and of the community’s strong desire to see rintatolimod injection (Ampligen) approved.

For many years FDA has worked with Hemispherx Biopharma, Inc. (Hemispherx) on an approval pathway for Ampligen. Since the time of the original New Drug Application (NDA) submitted by Hemispherx for the use of Ampligen to treat CFS in 2007, FDA’s review division has provided many specific recommendations on how best to address deficiencies in the application. In 2009, the review division asked Hemispherx to conduct at least one additional controlled clinical study showing a convincing effect in the CFS population. No new trials were conducted. Hemispherx conducted additional analyses of their existing data, which FDA agreed to review in a resubmitted NDA.

A public meeting of FDA’s Arthritis Advisory Committee (AC) on December 20, 2012, was held to provide FDA with independent scientific and clinical expertise regarding the Ampligen NDA. At the meeting, both Hemispherx and FDA reviewers presented assessments and analyses of the NDA data to the experts, including physicians with expertise in CFS, a CFS patient representative, and an industry representative. The majority of AC members were concerned about the lack of consistency within the clinical trial results, as well as the limited size of the database available to evaluate Ampligen. The members shared FDA’s concerns, as well, about how the studies had been conducted, including multiple discrepancies and gaps in the safety data. At the end of a full day of discussion AC members voted 8-5 against the approval of Ampligen for the treatment of patients with CFS because of insufficient safety and efficacy data.

On Monday, February 4, 2013, Hemispherx announced the receipt of a Complete Response (CR) letter from the FDA for Ampligen. FDA issues a CR letter to convey that our review of an application is complete and we cannot approve the application in its present form. A CR letter describes all of the specific deficiencies that the Agency has identified in an application, allowing the company an opportunity to correct those clearly defined deficiencies in a re-submission. FDA’s decision regarding Ampligen encompassed many factors, including the safety and efficacy data and the advice of the AC. We understand the frustration and pain of ME/CFS patients and their caregivers, and how important it is that we continue to work toward development of treatments.

We want to emphasize that the CR letter issued for Ampligen is entirely separate and distinct from FDA’s support of drug development pathways for CFS – these initiatives remain unaffected and fully supported. ME/CFS is a serious disease and treatments for it represent an important area of unmet need. We will continue to encourage the pharmaceutical industry to develop new treatments in this area. To assist companies with their development, FDA is sponsoring a workshop in spring 2013 focused specifically on ME/CFS drug development.

We express our gratitude to you and the ME/CFS community for your unwavering support of the research and care of those with ME/CFS. We join you in this commitment, and we look forward to exploring how best to facilitate and expedite the development of safe and effective drug therapies for the signs and symptoms of this debilitating disease.

Best regards,

Mary Kremzner, PharmD
Director, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at http://twitter.com/FDA_Drug_Info

This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.