Archive for December, 2012

Early/pediatric onset list reminder

People within our community have many different perspectives, and yet those differences pale in comparison to our commitment to move things forward.

We are learning a lot from each other as we engage in interesting and informative discussions. We have many common goals.

As we look forward to 2013 we hope that our community continues to build on our strengths so we can make even greater strides for the benefit everyone affected by ME(CFS).

 

PLEASE SPREAD THE WORD:

Speak Up About ME maintains a list of early/pediatric onset ME/CFS.

If you came down with ME/CFS before age 23, please add your name and illness info to the list*!

Provide

name (let us know if we should use your full name, first name only or a nickname that you provide),

age at onset,

age at diagnosis,

current age,

location (country is sufficient).

Encourage others with early (pediatric) onset ME/CFS to get their onset information listed also.

Send your onset info to: speakupaboutme at gmail dot com.

FDA Arthritis Advisory Committee Meeting to review Ampligen – December 20, 2012

 

The meeting will be webcast.

It starts at 8am (eastern time) and will continue until 5pm.

Watch the meeting, take a breather when necessary, watch some more if you can.

The link is: https://collaboration.fda.gov/aac122012/    

Sign in as a guest. No password is required.

Further details are here:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM332510.pdf

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM332510.pdf

 

Agenda, committee roster and more for 20 Dec 2012 FDA meeting

We all need to stay positive.
Encouragement for everyone is needed….
We WILL move forward and this meeting may be a big step for us…

Here are links to the agenda, rosters, the questions the panel will vote on, etc as well as to the information that will be discussed:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM332504.pdf

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM332505.pdf

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM332507.pdf

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM332508.pdf

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM332510.pdf

and if you want the nitty-gritty:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM332514.pdf

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM332515.pdf

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM332517.pdf

 

If you can be at the meeting, please attend.

For those who can’t be there, the meeting will be webcast and the link is: https://collaboration.fda.gov/aac122012/    

Sign in as a guest. No password is required.

Further details are here:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM332510.pdf

 

“FDA to rule on ‘Lazarus’ drug” Llewellyn King

http://www.stamfordadvocate.com/local/article/FDA-to-rule-on-Lazarus-drug-4121250.php
“FDA to rule on ‘Lazarus’ drug Llewellyn King 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 Syndrome, 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 patients turn to the government for recognition, but the government turns them into a statistic.

We are PEOPLE, not statistics.

Please do everything possible to be at the meeting on Dec. 20th, 2012 so that FDA sees people (not statistics)..

.

 

The full article can be found here http://www.stamfordadvocate.com/local/article/FDA-to-rule-on-Lazarus-drug-4121250.php

PLEASE Encourage attendance! SPREAD THE WORD! SPREAD THE WORD! SPREAD THE WORD!

 

(Per Robert Miller)
ME/CFS Patients – Let the FDA Know you Exist!!!
SPREAD THE WORD! SPREAD THE WORD! SPREAD THE WORD!
PLEASE Encourage attendance!


This is one of the most important meetings for CFS/ME Patients – Thursday December 20th, is a public meeting for the FDA review for approval (hoped for) of the first ever treatment for Chronic Fatigue Syndrome.


It is important to be seen – FDA is used to seeing people attend these meetings. Other disease organizations/patients make sure the FDA knows they exist by getting patients and loved ones in front of FDA every chance they get.


If patients do not attend, FDA will think we are not interested. Please attend!


For yourself and all those suffering, we need you and your loved ones to come! You do not need to be there all day, but
please attend the Public Comment Session that is from (about) Noon to 2:30 pm. Please keep in mind that this meeting could be a driving force to change the course of this illness.


We know it’s a struggle, as patients, we also know it is hard physically & mentally. We have patients coming from across the U.S. at great cost to themselves. (Giving up time with family & friends during this Holiday Season) We know the timing is BAD, but since when have our disabilities to attend meetings been taken into account?


An approved treatment for CFS will legitimize our illness in the medical community and other drug companies will see a new opportunity, which means Research.


Here’s where to go and when:


December 20, 2012


8AM-5PM (with patients giving public comment around 1:00 pm based on meeting progress, Enter by Noon)


FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room, (room 1503)
(Sign in at Building 1, BRING PHOTO ID )
Silver Spring, MD 20993-0002

No need to register; just bring ID. Enter the meeting by Noon. There is parking at FDA. You can bring food or there is a food stand there. For more information go to:
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm324972.htm


Meeting Room Details:
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm

 

 


 


 

SPREAD THE WORD! Encourage attendance ME/CFS Patients Let the FDA Know you Exist!!

This is one of the most important meetings – December 20th is a public meeting for the review of the first ever treatment for Chronic Fatigue Syndrome. 

 

It is important to be seen – other disease organizations/patients make sure the FDA knows they exist and get in front of them every chance they get. So FDA is used to seeing people there and would think we are disinterested if we aren’t there in numbers! 

 

We know it’s a struggle, we know it is hard on you physically & mentally. Please keep in mind that this meeting could change the course of this illness.

 

Here’s where to go and when:

December 20, 2012

8AM-5PM (with patients giving public comment beginning around 1pm)

 

FDA White Oak Campus

10903 New Hampshire Avenue

Building 31 Conference Center

The Great Room, (room 1503)

(Sign in Building 1)

Silver Spring, MD 20993-0002

 

No need to register; just bring ID.  Enter the meeting anytime. There is parking at FDA.  You can bring food and, there is a food stand there too.  For more information go to: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm

Your seat on the bus Your public comment

 

Simmaron Research

To ME/CFS Patients Living in NJ, NY, PA and surrounding area

A bus is being sponsored by Simmaron (http://simmaronresearch.com/ ) to take patients, family and friends to the FDA Advisory Meeting on Dec. 20th on Ampligen.

This will be the first drug ever reviewed by an advisory committee for the treatment of ME/CFS. Your presence at this meeting is invaluable. Show the committee and the FDA that we need treatments and that this disease is serious.

The bus (free ride) will be leaving from 783 Jersey Avenue, New Brunswick, NJ (parking is safe and available for the full day – no cost). There are 28 seats available. Drinks & snacks, comfortable seating and restroom facilities on board.

Boarding Location: 783 Jersey Avenue, New Brunswick, NJ

Time: Thursday, December 20, 7:00 AM BOARDING – 7:30 AM DEPARTURE

Time: The bus will board at 7 AM; depart by 7:30 AM and head to the meeting in Silver Spring, MD. The bus will re-board at end of meeting at 5:30 PM and head back to NJ.

If you are interested in going – you must email or phone Nancy by Thursday, Dec. 13th at 1 PM. Email: nancyimc2@aol.com or call her at 610-952-2595.

FDA meeting link: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm324972.htm

CDER

December 20, 2012

8:00 a.m. to 5:00 p.m.

FDA White Oak Campus
Building 31
Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue Silver Spring, Maryland

 

 

If you were unable to submit your public comment for the 20 December 2012 FDA meeting about Ampligen, Bob Miller (511bobmiller42@gmail.com)has offered to hand carry your public comment to the meeting.  He cannot guarantee that they will be read but they will be seen!

Tell the advisory committee what it is like to have ME/CFS and tell them that treatment is needed NOW.

Feel free to use this template:

“Subject line:  Treatment for Chronic Fatigue Syndrome- Ampligen

To The Advisory Committee Reviewing Ampligen:

My name is ___________________…. .

I have had CFS for more than ___ years.

Before I became ill, I ______________________…….

My life because of CFS _______________________________________________……..

The reality is that CFS is a horribly devastating illness that effects every moment of my life.

CFS patients need treatments.

We have seen patients do well on Ampligen. We have seen patients’ quality of life improve as a result of Ampligen.

Help us have access to treatments.

Please give the CFS community hope of getting our lives back.

Sincerely,