Charlotte CFS/ME/FM Support Group Newsletter

for March 18, 2013

 

Hi Friends,

Dr. Myra Preston will be our guest speaker. We are very happy to have her speak to our group as it as been a long time since her last visit.  If you want to know the particulars of her treatment, just refer to her web site at

 http://www.siberimaging.com/about.html .

Our meetings are always the 3rd Thursday of the month, which means this Thursday, February 21, at 7:00 PM -- 8:30/9:00 PM.

I am awaiting news of what our April meeting will offer. This will be announced in an interim newsletter at the beginning of April.

 

**************** About our Meetings *************** 

As always, our meetings start at 7:00 PM and wind up around 8:30-9:00 PM at Sharon Presbyterian Church, located 0.8 miles south of SouthPark Mall on Sharon Road. Use the entrance closest to the mall if you can. There is a second entrance but you'll have to weave around in order to find the parking lot to the left of the sanctuary building (left as you would be facing the building).

We meet in the Charles Little Activity Building (or CLAB), which is the brick building at the rear of the parking lot. As you come into the building you should see a sign for the meeting, then after you get inside - go into the first door on your right - the Parlor - where our group meets.

And if you need further directions or have questions, you can call me at 704-563-0657.  Remember no perfumes so as not to make those with MCS ill and "please" no smoking anywhere on the church grounds.

 

NOTE: We are always looking for new volunteers so if you are interested in helping in your area of interest or expertise, please see any of the members as listed at the bottom of this newsletter.

****************************************************************************************************

Topics in this Newsletter

- FDA Adds Ampligen Experts to Roster for CFS Workshop
- FDA not inviting Dr. Peterson to Ampligen Conference

- Chronic Fatigue Syndrome and Fibromyalgia Current and Anticipated Treatments

- Offensive Movie Regarding Fibromyalgia

- Cort Johnson provides us with diet info for ME/CFS/FM Patients

- Dr Myhill on Fibromyalgia and Mitochondrial Dysfunction

 

From Co-Cure:

Date:    Fri, 15 Mar 2013 18:21:06 -0500
From:    Tate Mitchell <tatemitchell@gmail.com>
Subject: NOT: FDA Adds Ampligen Experts to Roster for CFS Workshop
 
https://www.bioworld.com/content/fda-adds-ampligen-experts-roster-cfs-workshop-0
 
FDA Adds Ampligen Experts to Roster for CFS Workshop
By Randy Osborne
Staff Writer
 
The FDA published a notice in the Federal Register about the public
workshop called "Drug Development for Chronic Fatigue Syndrome [CFS]
and Myalgic Encephalomyelitis [ME]," slated for April 25-26 in
Bethesda, Md.
 
It's the first such workshop held as part of the Patient-Focused Drug
Development initiative, mandated in the authorization of the
Prescription Drug User Fee Act, and a prime topic, given the uproar
over the agency's refusal to approve Ampligen (rintatolimod) after a
negative advisory panel meeting in December. (See BioWorld Today, Dec.
21, 2012.)
 
Ampligen was the only potential therapy on the horizon for CFS, long
derided as "not a real disease," and many patients protested the FDA's
inaction, especially those who had been benefiting from Ampligen by
way of clinical trials conducted by its sponsor, Philadelphia-based
Hemispherx Bioscience Inc. One activist patient, Robert Miller, went
on a hunger strike to call attention to the issue. (See BioWorld
Today, Feb. 6, 2013.)
 
Over the weekend, Miller wrote to the Health and Human Services' (HHS)
secretary, Kathleen Sebelius, and to Margaret Hamburg, commissioner of
the FDA, as well as others, calling the advisory panel meeting that
turned thumbs-down on Ampligen "a pony show," and asking that he, as
well as Daniel Peterson, who headed Hemispherx's trials and
collaborated on others, be invited to the workshop.
 
"Did we not learn anything from HIV/AIDS?" asked Miller, who has been
a CFS patient for 30 years and gained results with Ampligen. "Yes,
[patients] know you are doing more, but after 30 years of nearly
nothing, a Band-Aid appears huge. Every year, there are excuses they
[HHS and its agencies] cannot do more."
 
In the Federal Register posting Monday, the FDA requested that anyone
who wants to register to attend and/or take part in discussions submit
their requests to the agency by April 8. The workshop will take up two
main topics: disease symptoms and daily impacts that matter most to
patients, and patients' perspectives on current approaches to treating
CFS and ME.
 
Meanwhile, although the full roster of those invited to the workshop
has not been made public, Kimberly McCleary, president and CEO of the
Chronic Fatigue and Immune Dysfunction Syndrome Association of
America, said she has seen a partial list.
 
"It's an interesting blend of CFS experts, so I think that will make
[Miller] and others happy to see that, including two people who have
been involved in the Ampligen studies," she told BioWorld Today.
"They're both very capable spokespeople for what it's like to live
with this. One is a physician herself who had to retire after she
became ill. The core group [of those who formally present at the
workshop] will be very compelling."
 
Peterson is not on the roster McCleary has seen. "One person contacted
me independently and told me that he was going to be on the list," she
added.
 
That's Bernard Munos, a consultant formerly with Eli Lilly and Co., of
Indianapolis.
 
A CFS expert "who has looked at other treatments and done some pilot
studies using other drugs and drug combinations" is included in the
lineup, too, McCleary said.
 
The post in the Federal Register said the FDA "will try to accommodate
all participants who wish to speak on [the first day, which is an
afternoon session only], either through the panel discussions,
audience participation, or the open public comment period," but warned
that "the duration of comments may be limited by time constraints,"
probably anticipating a flood.
 
McCleary said "the bulk of the time, I would imagine, is going to be
spent with the people the FDA has asked to attend," and each of those
has been asked to stay for both days of the workshop, "so that they
can then have a dialogue about the meeting in its entirety."
 
Hemispherx, which got its complete response letter from the FDA in
February, said its hoped-for end-of-review conference with the agency
will serve a precursor to submitting a formal appeal to the Office of
New Drugs in the FDA's Center for Drug Evaluation and Research.
 
Ampligen, a Toll-like receptor 3 modulator, once was slated to undergo
a Phase III trial to follow the AMP516 study, but the strategy later
became to submit a new analysis of existing data from the 516, which
used saline as its placebo control. But the decision to use saline was
made in the early 1990s, before researchers began to use saline as a
therapy for orthostatic and blood-volume problems in CFS. This meant
the results may have been confounded by using a comparator with
clinical efficacy, McCleary noted. (See BioWorld Today, Feb. 11,
2013.)

 

(This was published before the article above)

From Co-Cure:  Subject: ACTION NEEDED / FDA Not Inviting Expert ME/CFS Clinician Daniel Peterson

 

ME/CFS Patients, Loved ones and Friends Your Action Needed:

The FDA has now told ME/CFS patients who have called them, that they have not invited Dr. Daniel Peterson, because they state he only uses Ampligen to treat ME/CFS patients.

"To Be Clear This Information is Wrong". Dr.Peterson uses several treatments for ME/CFS. He treats the individual patient based on each patients symptoms and their individual Lab tests. Some of the treatments used under his clinical expertise are: Vistide, Valcyte, Anti-virals, Amino Acids, iv fluids as needed, Ampligen and other secondary treatments he has found to be of benefit over a 30 year period of treating ME/CFS. It is why he has such a high success rate with ME/CFS patients.

As a world renowned ME/CFS specialist, here in the U.S. FDA should have contacted Dr. Peterson in advance for an accurate understanding of the breath of his experience with treatments. 

It is imperative that all ME/CFS patients have access to Dr. Peterson's knowledge at the First ME/CFS FDA Scientific Stakeholder Workshop. This will only happen if Patients, Loved ones and Friends "ACT NOW" by making Phone Calls to FDA's Mary Gross at (301)-796-3519 and by Doing Daily emails (see my Facebook Event page)

Link Here: http://www.facebook.com/events/538335312878071/

Explain to MaryGross that FDA has it wrong, that Dr. Peterson uses the treatments listed above and this ME/CFS FDA Workshop needs his attendance to be comprehensive.


FDA has been polite when calling them, so please be polite as well.


FDA is supposed to be about facts and science, they have missed both here.  Amd please send a reply email to ampligenteam@gmail.com when you call FDA.,To allow us to keep count of the calls.  Just copy and paste "I just called Mary Gross" at FDA.

Thank you,

Robert Miller & Ampligen Team

 

 

"Chronic Fatigue Syndrome and Fibromyalgia Current and Anticipated Treatments"

Hope you'll join us on March 22, 7:00 pm, as we welcome Paul Cheney, Md, PhD for this presentation.

Forsyth Medical Center Maya Angelou Center for Women's Health and Wellness, Conference Center, 3333 Silas Creek Pkwy, Winston Salem, NC 27103

Call 336-718-7000 to register. This event is Free and open to the public. See Attached flyer.

Dr. Cheney has pioneered clinical research into the mechanisms and possible treatments of CFS and is an internationally recognized authority on the subject. Since 1990 Dr. Cheney has headed the Cheney Clinic here in NC, and has evaluated more than 8,000 patients from 48 states and 24 foreign countries.

Hope to see you on the 22nd!

 

Teresa Simmons

Winston Salem Chronic Fatigue Syndrome, Fibromyalgia, Lyme Disease Support Group

www.cfsfms.org Visit our New website for Calendar of Events!

336-784-4338

 

 

Offensive Movie Regarding Fibromyalgia

It was brought to my attention about a movie by the name of "Identity Theft", is really down- playing and bashing Fibromyalgia. Apparently the character that plays Molly on the show ” Mike and Molly” has Fibromyalgia in the movie and they are really making fun of that diagnosis.

Perhaps some will want to boycott the movie or if some do attend, realize that the message conveyed there is wrong and sad and may be offensive. The diagnosis of FM has come so far, that things like this discredit the diagnosis.

NOTE From Nancy:  I personally would like to know others who have seen this movie and found it offensive. I was planning on seeing when it comes out on DVD via Netflix but this is giving me second thoughts.


 

Cort Johnson Provides us with the Correct Diet for ME/CFS Patients

What could a bunch of overweight, cigarette smoking, high blood pressured or diabetic Spanish people tell about a diet for chronic fatigue syndrome? Perhaps a lot.

No one diet will be right for everyone with ME/CFS but a very large recent Spanish dietary study that was called a ‘watershed moment in the field of nutrition’ suggests that diet can make a difference, a large difference, in a person’s cardiovascular risk.

The study suggested that no less than 30 percent of heart attacks, strokes and deaths from heart disease could be prevented in individuals that are at high risk of cardiovascular events (stroke, heart problems) if they switched to a Mediterranean diet featuring olive oil, nuts, white meat, fish, beans, fruits and vegetables

Why does this matter to people with chronic fatigue syndrome? Because the nature of their disorder may very well put them into the high cardiovascular risk category. First let’s take a look at the study.  Click on or go to the link below:


http://www.cortjohnson.org/blog/2013/03/04/the-best-diet-for-chronic-fatigue-syndrome-mecfs/

 

Dr Myhill on Fibromyalgia and Mitochondrial Dysfunction

By Sarah Myhill, MD* • ProHealth.com • December 21, 2011

Dr. Sarah Myhill is a UK-based physician with a special interest in fatigue and nutrition. Her pioneering research (“Chronic Fatigue Syndrome and Mitochondrial Dysfunction”) suggests the cells’ energy generating mitochondria are dysfunctional in ME/CFS – a situation that can produce various symptom clusters, including: a) blood flow/vascular abnormalities such as orthostatic intolerance, b) the widespread pain and sensitization most typical of fibromyalgia syndrome, and c) fatigue, exhaustion & brain fog. This information is excerpted with kind permission from (DrMyhill.co.uk).*


Fibromyalgia – Possible Causes and Implications for Treatment

The word ‘fibromyalgia’ just refers to a symptom - it means pain in the muscles. It occurs very commonly with chronic fatigue syndrome [ME/CFS] because I suspect the underlying causes are similar.

To read this article,

http://www.prohealth.com/fibromyalgia/library/showArticle.cfm?libid=16720&B1=EM031313F&utm_source=EM031313F&utm_medium=em&utm_campaign=FM&slvor=11063.1090639.0.1.0.86766&eid=nmhenson@aol.com

 

 

Our Support Group Leader and Board Members:

 

- Our Support Group Leader is Kebbie Cannon at kebbie1@windstream.net or Asst. Support Group Leader, Maggie Reed at Maggie_Reed@comporium.net

- Medical Advisor Dr. Charles Lapp, Hunter Hopkins Clinic in Charlotte. You can visit Dr. Lapp's Web Sites at www.drlapp.com where there is ample info about his clinic and making an appointment if you need. Another site, which is primarily directed toward helping your doctors treat these disorders, is: http://www.cfstreatment.info/

Also, there is the site primarily directed toward helping your primary care doctors or any other doctors who need to know this information that treat you on a regular basis. It is http://www.cfstreatment.info/

- Treasurer is Leslie Vann at llvann@usa.net

- Publicity Chairman is Howard Honeycutt at honeycutt2194@carolina.rr.com

- Newsletter Editor is Nancy Henson at nmhenson@aol.com

- Visit our web site at www.CharlotteCFS.org