Saturday, December 22, 2012
Chronic fatigue syndrome is little understood, and Ampligen's approval would give patients some standing with their insurers, Klimas said.
"Even a single approved therapy, even if it were one I choose not to use, would be very helpful when I am arguing with insurance companies to legitimize the condition and that it is serious enough to require an intervention," Klimas said.
* * *
Even if Ampligen isn't approved, at least stories about it are getting the word out that CFS is a legitimate disease.
Friday, December 21, 2012
magazine, on Dec. 14, 2012. (Google English translation below)
A Magazine Dec. 14, 2012
Original text (in Norwegian)-
Hopes on a miracle
Desperate Norwegians travel to California for treatment-with same
cancer medicine looks to cure CFS patients in Bergen.
Maria Gjerpe is 44 years and has had ME since she was 16. For just
over a half ago she lay under the covers 21.5 hours a day. Now she
sits full of pep at Haukeland University'cancer ward. In the hand, she
has a cannula in face a wide smile and eyes that glows. Beside her
stands chief Øystein Fluge and oncology nurse Helle Øvrebø. Rarely do
they see so striking transformations in patients.
- When you came here for the first time in April, it was as far as we
got up from the wheelchair to the bed. You were shaky, unwell and very
difficult to talk with, recalls Øvrebø.
- I hardly remember it. All that concerned was to survive, replies Gjerpe.
This is the fourth time she's in Bergen to be given the cancer drug
Rituximab. Earbud and the dark sunglasses she wore on her first,
exhausting journey from Oslo, she long since put away.
- How's it going? ask Fluge
- I must exert myself for not only a grin: I am perfectly well!
- How is your activity level?
- I go for walks in nine miles, without break and without getting
tired. I read, lectures and writes feature articles, reply Gjerpe
proud. In better times she has been able to train as a doctor, but it
took her 12 years.
- There is no longer any doubt: You approaching complete response to
medicine, concludes Fluge, while Nurse Øvrebø almost feel honored.
- I did not like this was possible. It's incredibly nice to be with
when people get their lives back. I had no idea that so many suffered
so terribly with ME, she says.
STUMBLED INTO. It had no powers over Øystein Fluge and his colleague
Professor Olav Mella either, until they observed something surprising
in 2004: A woman with ME had lymphoma and was treated with four
different chemotherapy regimens. Six or seven weeks out of one of
them, she was suddenly temporarily relieved by ME symptoms.
Doctors analyzed cell poisons she had received and decided that it was
probably a drug that affects B-cells (a type of white blood cell),
which had had the unexpected effect of ME disease. After she recovered
from cancer, why they chose to give her the cancer drug Rituximab,
which targeted reducing the number of B-cells.
Mella and Fluge knew that Rituximab also be applied to autoimmune
diseases such as rheumatoid arthritis and lupus. Could it be that the
"mysterious disease" ME belonged to the same category?
Having seen the response in another two pilot patients, implementing
the a small, double-blind study. 15 ME patients received within 14
days two infusions of Rituximab, as many received only saline
(placebo), and neither the doctors nor the subjects knew who got what.
The results of the study were published in the medical journal PLoS
One last fall and attracted attention world over 10 of the 15 who had
received Rituximab, were significantly better. But jubilation over the
breakthrough was not unanimous.
SHOCK. Ignite a peppery, roll in a minefield and pour gasoline on the
fire. About as explosive, the Norwegian ME debate.
In one corner: those who believe ME / CFS is a psychosomatic illness
that can be cured with cognitive techniques such as Lightning Process
(LP) or mindfulness. In the other: those who argue that ME is a
clearly defined physical diagnosis that will be cured as researchers
find biomarker and forensic medicine.
Duellantene lashed out swing punches to beat counterpart knockout.
With the imminent danger to frame even those who have inadvertently
ended up somewhere in the middle.
People like Mella and Fluge.
- Our field is cancer. We had no idea how inflamed ME discussion is.
Fasten a ME conference in London sat patients and hollering and
whistling at debate panel. That aggression is not exactly accustomed
to cancer conferences. But there also experiencing the patients to a
greater degree to be taken seriously, says Mella.
- I stay away from all the noise on the Internet, avoid google ME and
chronic fatigue syndrome.
War of words is just distracting. I understand why we are taken to the
income a purely biological view, but that is to underestimate us. The
psychic and the physical hangs course together, says Fluge.
CALIFORNIA DREAMIN '. After their study became known last year, Fluge
Mella and received over 500 inquiries, many of them utterly
heartbreaking, from ME sufferers who desperately want to try
- I am almost sick when I read. It is lidelseshistoríe by
lidelseshistoríe, but it gives inspiration to work on this, says
Some medicine he can not offer those who contacts. It can, however,
the American physician Andreas Kogelnik at the Open Medicine Institute
outside San Francisco. He has begun to accept Norwegian CFS patients
for examination and treatment.
- We have been contacted by over a dozen Norwegian patients, and a set
of them are now participating in our studies, says he to A magazine.
One of them is "Maya". She lives in Oslo Area, is 28 years old, has
had ME since she was 16, and the last four years the disease has taken
over her life. She is partially disabled, has at times been in need of
care, and she knows that for every helpless today as yesterday, be
more dreams in ruins.
She believes that medicine made her a little better, but that the
effect slackening journey is so insanely exhausting. In January, she
travels back in the wheelchair and companion, for another infusion.
- I have to pay for this with loans all sides, which puts me in a
future financial difficulty. I no guarantee that the treatment going
to work, and it is therefore an immense physical strain to travel so
far. Yet I have not really been in doubt. I think no one in my
situation would have been.
For not only is life put on pause; she also fear being regarded with
suspicion at all levels, that many believe she only makes itself. It
is not to endure.
- I can not let this stand untested. For the chance to get myself and
my life back, I am willing to sacrifice everything.
FRUSTRATED. In Mid-Norway live "Unni" another of Kogelnik's Norwegian
patients. When Fluge and Meller study published last fall, was
23-year-olds hope. That soon was turned to frustration.
- To know that there was a medicine that might help me, but I at best
to wait for several years to make, was cruel. I want the to live a
At Christmas last year, she started and family to probe the
possibility of â Rituximab get outside Norway. They knew it would cost
enormously, both of money, time and effort, but decided to let it rip.
- For me it would have been luxury to take the mail without any
problems. At times I have to lie down and recuperate for â grab a
glass of water. Travel to California seemed impossible. In addition
did we that I could end with no response or with serious side effects.
Yet I decided to try.
So far she has been three times in Kogelnik. Without getting better.
The last month is she on the contrary become much worse.
- It's awful tough. I do not know about deterioration due to
medication. But I try to keep up hope.
The next visit is scheduled for January. The family has already spent
over 200,000 dollars on travel and treatment. Unni knows she is lucky.
- There will be a class distinction between ME patients either alone
or with family's assistance may buy assistance and those who can not
afford. I think it is incredibly unfair.
NOT MYSTERIOUS. Since the first study of its fame in October, have the
verbose enthusiastic Bergenser Fluge and Mella, which carry serenity
of his home district Kongsvinger deep forests, conducted a open-label
study of 28 patients who know that they receive Rituximab.
The results are not yet published, but at conferences, there have been
shows that also in this study, approximately two of the three
participants significantly response. Kogelnik report corresponding
payout on their patients, and says that he is now of organizing a
double-blind and placebo-controlled Rituximab study at six or eight
international research centers.
- I will get back to coordinate with Fluge and Mella, he assures.
Meanwhile, only two of the ten recovered in Fluge and Mella's first
study avoided relapse. Much suggests therefore, the medication must be
taken over a long time, as it is used by people with arthritis.
- If the ME is an immunological disease, so we believe it will be the
rule, says Mella.
But this is also a disease that can be cured with mental coping
techniques? Mella and Fluge invalidates no experience of ME sufferers
who after three days of Lightning Process Course gets up from the bed
and declares healthy, but tries to balance them against their own
Their theory is that CFS symptoms not always directly caused by the
- We know that especially in the frontal lobe brain through very
active thinking can affect and suppress the involuntary nervous
system. That's probably a major reason for the LP and other extreme
forms of cognitive treatment can provide as rapid effect. For some
lasting effect, and then probably the underlying disease state "Burned
out." In others effect of such techniques are at best transient. When
we believe that the underlying cause, the disease state, probably
still present, explain Mella.
NOT EXPERTS. Many other question remains: Why respond some of
Rituximab after six weeks, others for six months? And what about those
who do not have known effect at all, neither in the first or second
Plays possibly immune system T-cells a larger role than B-cells with them?
- We try not to appear to be experts on ME. Both our studies has clear
weaknesses: The first was small, the other is open and without the
placebo group. But we are quite confident that we have fallen into
something that is true, says Mella.
- A mysterious illness is not. When their mechanisms underlying
available, we think, of course, that's it! For we know that Rituximab
works, what remains is to find definitive answer as to why, adds
COLLECTION. That's why searched the Research Council for nine million
to implement a large, double-blinded and randomized national study in
140 ME patients next year.
Last week came the answer: 34 projects of more than 400 applicants in
health, medicine and biology were awarded a total of 234 million.
Mella and Fluge were not among them.
The reactions were not long in coming. Patients and families
desperately, Ema Solberg called the decision sad, both Maria Gjerpe
and ME Association announced that it would start rolling penny, a
upset Laila Dâvøy (KrF) rushed right the Parliament's rostrum and
demanded that the government immediately allocate 9 million, and
Health Minister Jonas Gahr Støre expressed surprise the Research
Council's decision, however, without giving binding promises.
The only ones who seemed to make the decision calmly, was Mella and Fluge.
- It actually came as no big surprise. There were many very strong
candidates, and we had under 10 percent chance of getting a yes. But
we continue to plan our study. I'm sure there will be funds
eventually. There is appropriated two million both this year and next
year budget, and with time we will have accumulated enough money. For
Fluge and me this is not a tragedy. But it's a pity for the patients,
said Mella. oIa.firstname.lastname@example.org
Lene Loe (39)
Married, two children
I've had ME since 2007. When I got the offer to participate in the
first study to Mella and Fluge, I lay in my room, full of anxiety,
despair swell. They could offered anything.
I had nothing to lose.
As month after month passed without any thing happened, I was sure I
had received placebo. But then. After about six months, it began to
It lasted not. One year after infusion, I was almost back where I
started. Fortunately I got Rituximab again from the autumn of 2010,
and experienced exactly the same: After six to seven months I was
better. I, who had not been in town for years, endured the sudden both
light and sounds.
Now I have received infusions of between three and six month
intervals, the last in February, and shape improvement has been
remarkable. I am back at work as a teacher, zumba dancing and going to
yoga. I have nearly repressed how sick I was.
Up and down and up and down and up
Mariann Ripel (41)
Married, three daughters
- I was one of those who received Rituximab in Mella and fly first
study in 2008. The effect came after just seven weeks. I got better
and better. Started to go for walks and socialize. It lasted approx.
Then it turned.
In 2009, I join the second their study. The same thing happened this
time, but now I got multiple doses, and progress only continued. In
January 2011, I received the last dose. Then I had ten months without
recurrence. So said the pang.
Within two months I was back in the bottom.
In January this year, I luckily be the pilot for the next trial, and
history has repeated itself. It is just not possible to say that this
is a coincidence. Now I work 40 percent as a nurse and has begun to
further study to be a nurse.
The way it looks now, I can not continue on the medication forever. I
hope that the disease burns out, and try not to think that I can get a
new relapse. No one knows what the future holds, I can in a car
accident tomorrow, and I refuse to take your sorrows in advance. I
have one infusion again. After that I have at least ten good months to
look forward to. Those I enjoy.
When I was in the first study, I slept up to 20 hours a day, was dizzy
and nauseous. I had a huge hope that medication would help, but knew
that it was 50 per cent chance that I was given medicine without
substance. Then after a year I was informed that I had received
placebo, I was so happy. Then I knew you it was still likely that the
medicine would work on me.
I got to be involved in the maintenance study in 2010. Mella and Fluge
said it probably would not take long before I noticed any response, so
I was not really waiting, but after infusions in October and November,
I knew that something was happening in the body. Suddenly, I was
refreshed after sleeping. After a few weeks I asked my husband if we
were to walk, and so it has continued.
I will say that I'm 100 percent healthy. I have finished Master degree
gave-my friend and is working full time, but I have not told about the
disease to my bosses. I fear that it will cleave to me if I seek new
jobs. Therefore, I will remain anonymous in A magazine well. There are
many prejudices ME. Many people think that it is really just to pull
I can only imagine how painful it is to read about people like me, for
those who do not get medicine. I've got my life back and hope that
everyone gets this chance. I seems certain newly saved, but it's so
wonderful to live and work normally. Now I've been healthy for two
years. I am no longer afraid of relapse. This is going to hold.
December 20, 2012, 6:52 p.m. ET
Panel Rejects Drug for Chronic Fatigue Syndrome
By JENNIFER CORBETT DOOREN A federal advisory panel on Thursday said a
proposed medicine from Hemispherx Biopharma Inc. HEB -5.26% to treat
chronic fatigue syndrome isn't ready for approval, dealing another
setback to the drug maker.
Hemispherx Biopharma is seeking approval from the U.S. Food and Drug
Administration for the drug, Ampligen. The product, which been in
development for more than two decades, was reviewed Thursday by the
agency's arthritis-drugs advisory panel, which is made up of non-FDA
medical experts. In an 8-to-5 vote, the panel said the company didn't
provide sufficient data to support the approval of Ampligen. The vote
amounts to a recommendation that FDA not approve the drug.
Several panel members said they struggled with their decisions because
it appears the drug works in certain patients even if it wasn't
strongly shown in the clinical data presented to the panel.
"I think the advisory panel in general hopes there will be an
effective drug and hopes this might be the drug" for chronic fatigue
syndrome, said Lenore Buckley, the panel's chairwoman and a professor
at Yale School of Medicine. "We are interested in seeing more data." A
decision by the FDA on whether to approve Ampligen is expected by
Almost three dozen patients or family members testified in person or
via video before panel, urging them to approve Ampligen. Anita Kathryn
Patton, who's had chronic fatigue syndrome for more than 20 years, was
first given Ampligen in 1997.
"It was like rising from the dead," Ms. Patton said of her disease
improvement. She and some other patients are receiving Ampligen
through a special access program at a cost of about $25,000 a year.
At issue is whether Ampligen, which is the drug's proposed brand name,
is effective and safe. The FDA said there was missing data in clinical
studies that made it hard to tell whether the drug is safe. Potential
safety concerns include infections and liver problems. FDA medical
reviewers questioned whether the data meet drug-approval requirements
demonstrating "substantial evidence" of safety and efficacy, or
Theresa Michele, an FDA team leader, said the agency believes that
chronic fatigue syndrome is a serious disease that needs treatments,
but said clinical studies submitted in support of products have to
meet federal drug approval standards showing "substantial" safety and
effectiveness. "We have to be certain a drug works and we clearly know
what the risks are," Dr. Michele said.
The FDA and the company differed on whether one of the main clinical
studies reached a goal showing a statistically significant test
showing patients receiving the drug were able to walk on a treadmill
for a longer period than patients receiving placebo injections.
The company said on average there was an improvement of about one
minute while the FDA said the difference appeared to be about 20
"Regardless of the [measurement] approach there's a consistent pattern
of benefit in the data, which favor Ampligen," said William Carter,
Hemispherx chief executive. At a minimum, Dr. Carter said, the drug
"prevents further disease progression." After the meeting, Dr. Carter
said he had no comment.
Chronic fatigue syndrome, also known as myalgic encephalomyelitis, is
believed to affect more than one million Americans, according to the
Centers for Disease Control and Prevention. The condition is marked by
severe fatigue, muscle pain and memory and concentration problems. It
isn't known what causes the condition and there are currently no
Ampligen, an injectable drug, is believed to boost the body's immune
system and fight viruses.
Write to Jennifer Corbett Dooren at email@example.com
Thursday, December 20, 2012
fibromyalgia technically they are separate disorders which can co-occur
with any disease. They may be a normal response to chronic pain. As
always, a common caveat with medical populations is that symptoms that
commonly occur with disease, including fatigue or loss of energy, changes
in sleep patterns and changes in appetite, may be misinterpreted by
healthcare providers, researchers or patients as mood-related particularly
when specificity and severity are lacking
Men with fibromyalgia often go undiagnosed, Mayo Clinic study suggests
December 19, 2012 in Arthritis & Rheumatism
Fibromyalgia is a complex illness to diagnose and to treat. There is not
yet a diagnostic test to establish that someone has it, there is no cure
and many fibromyalgia symptoms—pain, fatigue, problems sleeping and memory
and mood issues—can overlap with or get mistaken for other conditions.
A new Mayo Clinic study suggests that many people who have fibromyalgia,
especially men, are going undiagnosed. The findings appear in the online
edition of the journal Arthritis Care & Research. More research is needed,
particularly on why men who reported fibromyalgia symptoms were less likely
than women to receive a fibromyalgia diagnosis, says lead author Ann
Vincent, M.D., medical director of Mayo Clinic's Fibromyalgia and Chronic
"Health care providers may not think of this diagnosis when face to face
with a male patient with musculoskeletal pain and fatigue," Dr. Vincent
says. "These findings need to be explored further."
Researchers focused on Olmsted County, Minn., home to a comprehensive
medical records pool known as the Rochester Epidemiology Project, and used
multiple methods to try to get at the number of people over age 21 with
fibromyalgia. They used the epidemiology project to identify just over
3,000 patients who looked like they might have fibromyalgia:
Roughly a third had a documented fibromyalgia diagnosis. That amounted to
1.1 percent of the county's population 21 and older. In the second method,
researchers randomly surveyed Olmsted County adults using the American
College of Rheumatology's fibromyalgia research survey criteria. The
criteria include the hallmarks of fibromyalgia: widespread pain and
tenderness, fatigue, feeling unrested after waking, problems with memory or
thinking clearly and depression or anxiety, among other symptoms.
Of the 830 who responded to the survey, 44, or 5.3 percent, met those
criteria, but only a dozen had been diagnosed with fibromyalgia. Based on
the study's findings, the researchers estimate that 6.4 percent of people
21 and older in Olmsted County have fibromyalgia—far more than have been
officially diagnosed with it. Fibromyalgia is more common in women, but men
can get it too.
The discrepancy between the number of people reporting fibromyalgia
symptoms and the number actually diagnosed with the condition was greatest
among men, the study found. Twenty times more men appeared to have
fibromyalgia based on their survey response than had been diagnosed, while
three times more women reported fibromyalgia symptoms than were diagnosed.
"It is important to diagnose fibromyalgia because we have effective
treatments for the disorder," says co-author Daniel Clauw, M.D., director
of the University of Michigan Health System Chronic Pain & Fatigue Research
Center. Studies also show that properly diagnosing people with fibromyalgia
reduces health care costs, because they often need far less diagnostic
testing and fewer referrals looking for the cause of their pain, Dr. Clauw
Read more at:
Wednesday, December 19, 2012
report? We'll see tomorrow..Check out the latest here:
Monday, December 17, 2012
Our editorial in the most recent Breakthrough magazine (Autumn 2012) seems to have stuck a chord, so the text is now available on our website http://bit.ly/RmOw5M
The key point – that many people referred from primary care with a diagnosis of ME/CFS are found to have another, treatable condition when assessed at a specialist clinic – might not surprise patients themselves, since many have already questioned their own diagnosis and/or have had difficulties with the "patient-GP encounter" (for the patient view see http://bit.ly/TqoM61 and for the GP view http://bit.ly/V5myQ9 ). Yet, the accumulating evidence of misdiagnosis on such a scale should be astonishing to healthcare professionals, and ought to greatly concern the NHS as an institution. Something is far wrong, and it needs to be fixed.
Sunday, December 16, 2012
to develop an accurate "blood test" for pain making it difficult to
objectively measure pain and thus pain relief. And no one drug (or other
treatment) is a miracle for every single person who tries it regardless of
the condition or disease but particularly in areas where there is
diagnostic confusion and overlap.
Cochrane Database Syst Rev. 2012 Dec 12;12:CD008242. doi:
Amitriptyline for neuropathic pain and fibromyalgia in adults.
Moore RA, Derry S, Aldington D, Cole P, Wiffen PJ.
Pain Research and Nuffield Department of Clinical Neurosciences, University
of Oxford, Pain Research Unit, Churchill Hospital, Oxford, Oxfordshire, UK,
Amitriptyline is a tricyclic antidepressant that is widely used to treat
chronic neuropathic pain (pain due to nerve damage) and fibromyalgia, and
is recommended in many guidelines. These types of pain can be treated with
antidepressant drugs in doses below those at which the drugs act as
To assess the analgesic efficacy of amitriptyline for chronic neuropathic
pain and fibromyalgia.To assess the adverse events associated with the
clinical use of amitriptyline for chronic neuropathic pain and fibromyalgia.
We searched CENTRAL, MEDLINE, and EMBASE to September 2012, together with
reference lists of retrieved papers, previous systematic reviews, and other
reviews; we also used our own handsearched database for older studies.
We included randomised, double-blind studies of at least four weeks'
duration comparing amitriptyline with placebo or another active treatment
in chronic neuropathic pain or fibromyalgia.
DATA COLLECTION AND ANALYSIS:
We extracted efficacy and adverse event data, and two study authors
examined issues of study quality independently. We performed analysis using
two tiers of evidence. The first tier used data meeting current best
standards, where studies reported the outcome of at least 50% pain
intensity reduction over baseline (or its equivalent), without the use of
last observation carried forward (LOCF) or other imputation method for
dropouts, reported an intention-to-treat (ITT) analysis, lasted 8 to 12
weeks or longer, had a parallel-group design, and where there were at least
200 participants in the comparison. The second tier used data that failed
to meet this standard and were therefore subject to potential bias.
Twenty-one studies (1437 participants) were included; they individually
involved between 15 and 235 participants, only four involved over 100
participants, and the median study size was 44 participants. The median
duration was six weeks. Ten studies had a cross-over design.
Doses of amitriptyline were generally between 25 mg and 125 mg, and dose
escalation was common.
There was no top-tier evidence for amitriptyline in treating neuropathic
pain or fibromyalgia.
Second-tier evidence indicated no evidence of effect in cancer-related
neuropathic pain or HIV-related neuropathic pain, but some evidence of
effect in painful diabetic neuropathy (PDN), mixed neuropathic pain, and
Combining the classic neuropathic pain conditions of PDN, postherpetic
neuralgia (PHN) and post-stroke pain with fibromyalgia for second-tier
evidence, in eight studies and 687 participants, there was a statistically
significant benefit (risk ratio (RR) 2.3, 95% confidence interval (CI) 1.8
to 3.1) with a number needed to treat (NNT) of 4.6 (3.6 to 6.6).
The analysis showed that even using this potentially biased data, only
about 38% of participants benefited with amitriptyline and 16% with
placebo; most participants did not get adequate pain relief.
Potential benefits of amitriptyline were supported by a lower rate of lack
of efficacy withdrawals; 8/153 (5%) withdrew because of lack of efficacy
with amitriptyline and 14/119 (12%) with placebo.More participants
experienced at least one adverse event; 64% of participants taking
amitriptyline and 40% taking placebo.
The RR was 1.5 (95% CI 1.4 to 1.7) and the number needed to treat to harm
was 4.1 (95% CI 3.2 to 5.7). Adverse event and all-cause withdrawals were
Amitriptyline has been a first-line treatment for neuropathic pain for many
years. The fact that there is no supportive unbiased evidence for a
beneficial effect is disappointing, but has to be balanced against decades
of successful treatment in many patients with neuropathic pain or
There is no good evidence of a lack of effect; rather our concern should be
of overestimation of treatment effect. Amitriptyline should continue to be
used as part of the treatment of neuropathic pain or fibromyalgia, but only
a minority of patients will achieve satisfactory pain relief.
Limited information suggests that failure with one antidepressant does not
mean failure with all.It is unlikely that any large randomised trials of
amitriptyline will be conducted in specific neuropathic pain conditions or
in fibromyalgia to prove efficacy.
FDA to rule on 'Lazarus' drug
Published 4:41 pm, Saturday, December 15, 2012
WASHINGTON --For about a million Americans, Thursday will be a seminal
day. That's when some of them come before the Food and Drug
Administration to petition for approval of a potent and controversial
drug, a so-called Lazarus drug.
The drug, first synthesized by Hemispherx Biopharma, Inc., of
Philadelphia, in the 1970s, is Rintatolimod (tradename Ampligen),
which is used to treat chronic fatigue sSyndrome, also known as
myalgic encephalomyelitis. It is a grim but little-understood disease
of the immune system, resulting in collapse, pain, confusion and
sensitivity to light and noise.
Patients and their doctors want the drug, but there is concern that
the FDA will fault -- as it has in the past -- the scope of the
clinical trials and the documentation of collateral effects.
The FDA is expected to rule early next year.
The sickest of the sufferers, mostly bedridden and some so sick they
have to lie in dark rooms for 18 hours a day, are pinning their hopes
on a drug that will allow them to rise from their sick beds, thus the
Dr. Andreas Kogelnik, who runs the Open Medicine Institute in Mountain
View, Calif., puts the chances of FDA approval for Ampligen at just 50
percent. Although he is rooting for the drug to be approved, he says
the FDA may require more data on collateral effects. This has happened
in the past and the FDA has not been satisfied with previous
Dr. Daniel Peterson, who has been treating CFS since 1984 in Incline
Village, Nev., said recently that he thinks fewer than 100 people at
any one time, either through trials or compassionate waivers, are on
Ampligen. The drug is only available in a few states, most prominently
New York and Nevada. It is very expensive (about $25,000 for a course
of treatment) and has to be administered through intravenous infusion
-- a long, slow process, at regular intervals.
According to Kogelnik, some patients react poorly right off the bat,
while others show substantial improvement almost immediately.
Mary Schweitzer, a CFS sufferer, said that she can only walk when she
is getting Ampligen. She travels regularly from her home in Delaware
to New York, where Dr. Derek Enlander, who specializes in CFS, is a
major proponent of Ampligen therapy.
Even devout proponents of Ampligen do not tout it as a cure but as a
therapy that helps them move about and approach a kind of normalcy.
Anita Patton, who lives in Nevada, said in prepared testimony for the
FDA: "Ampligen increased my ability to eradicate viruses. I previously
had not been able to walk up the stairs to then being able to exercise
for 19 minutes on the treadmill.
"The joy that even a small improvement can give a person, to be able
to do household tasks or get out of the house and use my body to take
walks, is something that many patients do not have. The quality of
life of a patient with this horrible illness is so difficult not to
care for yourself and have to endure severe pain in muscles and
nerves, being too exhausted to even take a shower or lift my arms to
fix my hair.
"The suffering is immense. Many patients have to lie in bed for 18
hours a day, as I did before Ampligen, needing care and not having a
life of their own. Many patients have lost all friends and family."
When patient activists face the government in various hearings, it is
painfully asymmetrical, it seems to me. The sick tell sad stories of
suffering, loss of love as well as health, while the government people
talk abstractly about patient loads, international disease
definitions, allocation of resources and appear self-important rather
than appalled at the suffering that passes before them.
The patients turn to the government for recognition, but the
government turns them into a statistic.
(Llewellyn King is executive producer and host of "White House
Chronicle" on PBS. Email: lking(at)kingpublishing.com.)
I keep this link bookmarked and reference it often.
I think you will find it useful too.
For example, I love how our tax money funded the flu $272 MILLION, whereas patients suffering & dying of "CFS" received $6 MILLION.
ah, the inequities of life.
We must write to our representatives regularly demanding funding. If you don't think you are 'competing' for funding, you would be wrong.
U.S. reps can be found here:
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