P.A.N.D.O.R.A. received today a letter from HemisphereRX, the maker of Ampligen, a drug which has been shown to help individuals with CFS-ME. I thought you would like to read it too. I have cut and paste the entire letter for you. Please share with other members of our community.
HEMISPHERE RX LOGO
To: The CFS Patients, Advocacy Community and Healthcare Practitioners
From: Dr. David Strayer
Medical Director of Hemispherx Biopharma
Re: FDA Response on Ampligen®
Hemispherx has received a “complete” response from the FDA in which the FDA requires one additional clinical study to show a convincing effect of Ampligen in the treatment of CFS and confirm the safety in the target population. The on-going open-label study (AMP 511) and the patients enrolled will continue under the current protocol.
The FDA has provided Hemispherx with a clearly articulated set of recommendations to go forward. I would like to share with you the process we plan to go through with the agency in order to identify the most expeditious path to satisfy the requirements for the approval of the Ampligen NDA.
We plan to schedule a meeting with the agency as quickly as possible in order to obtain additional guidance and clarification concerning a number of matters, including the design of this clinical trial. This will be an ongoing process with the agency.
As part of this dialogue, we plan to evaluate the utility of a special protocol assessment from the agency in order to clearly delineate the clinical trial end points, the statistical methods to be utilized, and to obtain agreement with the agency on the results necessary for approval.
Four factors will support the sufficient execution of this clinical trial. First, the CDC's awareness program has increased public knowledge of the disease. Second, the recent identification of a potential etiologic agent, namely a novel retrovirus, should help accelerate patient identification.
Third, the company plans to utilize longstanding relationships with a group of internationally renowned clinical investigators to accelerate patient enrollment.
Lastly, the company plans to expand recently entered contractual relationships with two of the largest clinical research organizations in the world to accelerate its clinical monitoring and data collection capacity.
Finally, the company has adequate finances and resources to address and respond to all of these FDA recommendations. We have been and will continue to be committed to those suffering from Chronic Fatigue Syndrome. Additional information can be found at www.hemispherx.net. (12/17/09)
Showing posts with label me. Show all posts
Showing posts with label me. Show all posts
Thursday, December 17, 2009
Tuesday, May 6, 2008
CFSAC Meeting - Washington DC, May 6,2008 - Day 2, Part I
Great items to report. The Empty Chair project went well. I was pleased to see that the room was not empty as usually and I had a less amount of chairs available for placement of caregivers/family pictures and of CFS individuals. The feedback we received from Dr.Anand was really encouraging. He is looking at all venues of communication with the patient population by using available technology that we advocacy orgs can post on our web sites and in the case of P.A.N.D.O.R.A., on our non profit page of YouTube.com.
In the meantime, we patients need to click on their web site at http://www.hhs.gov/advcomcfs/pastmeetings.html to read the Nov 28, 2007 meeting minutes to get a feel and an update for what the CFSAC is doing. I want to acknowledge here everyone who sent us an e-mail and ask for your understanding if we did not get back to you in time for this meeting. We received 100s e-mails and letters and our volunteer office staff was overwhelmed with the response. But we will keep your letters, pictures and will contact you to finalize it as we are considering making the Empty Chair project a "travelling exhibition". We will let you know if it will be possible.
The CFSAC is up for renewal this September and although the renewal of this committee is not in jeopardy as I was told by DHHS staff, the CFIDS Association does not want us to take any chances and it has issued an action alert asking CFS patients to write to Secretary Leavitt to ensure the committee remains fully funded. I actually would like to see its budget increased considerably. So make sure to say it if you write to Secretary Leavitt on the issue to raise its future funding.
Today as I was told, (and as I witnessed yesterday) was a heart wrenching public testimony period, as the CFS patients made their presentations in person. Every personal story makes your heart cringe and your eyes watery. As much as I am a veteran,seasoned patient advocate, the emotion I hear, see and feel emanating from these patients are difficult to handle. And I today did not get to witness them in person due to a morning visit to Capitol Hill to visit House Representatives Ileana Ros-Lehtinen whom I had the opportunity to meet again in person, and with Rep. Robert Wexler'staff as well with Rep. Ron Klein. These morning meetings were quite productive as our appropriations requests are in place and moving along the long tedious process. They will require a bit of tweaking regarding the language we used, and P.A.N.D.O.R.A. will work it out in the coming months, but before we tackle the next step of this project I will have to rest aggressively and recoup from this trip.
It is gratifying to see that Rep. Ros-Lehtinen understands that without a Center of Excellence and without statutory language with specific funding for the CFS/Neuroendocrineimmune Centers of Excellence, their establishment will not be realized. I say she gets it! And so do Reps Wexler and Klein (my own congressman who represents the district where I live in Florida!)
I am extremely grateful that two of their staff members: Eva Dominguez (Wexler) and Virgina Neale (Klein) came to the CFSAC meeting in the afternoon and were educated and appreciated for their interest in coming to such an important meeting for our community. I have been coming to Capitol Hill for the past 4 and half-years if not longer and this is the first time congressional staffers attended a CFSAC meeting. I am excited, grateful and elated to say the least!
A long list of recommendations are being sent to Secretary Leavitt by the CFSAC and it is incumbent on us to advise Secretary Leavitt of the importance of these recommendations to our Quality of Life. There is a huge momentum here and we need to grab it!
And to finish my report on the last day of this two-day meeting, with some exciting notes: The presentation by Dr. Kenneth Friedman, our Secretary & Chairman of Public Policy for P.A.N.D.O.R.A. provided a great insight on the New Jersey CFS Association and on their medical student scholarship, which is creating the much needed awareness of the plight of CFS patients to physicians-in-training, and affording our community a greater potential that the next wave of physicians will be well trained in neuroendocrineimmune disorders and in particular CFS. He proudly announced our own scholarships and we are elated that one of them we are naming it after him for his accomplishments, hard work and collaborative efforts in uniting our community. It has been a pleasure for me to personally collaborate and see the results of our joint efforts. It is extremely gratifying!
We are hoping that other organizations follow and apply these initiatives in their own regional areas. Our community grants are made to work as seed money/change to encourage this type of collaboration and additional initiatives.
I am also amazed at one of the most professional patient representations I have seen in the CFSAC since I have attended these meetings by Rebecca Artman,our Public Policy and Community Advisor, who valiantly, smartly and persistently is fighting for patient's issues. Her work has been diligent, to the point, and on target! I take great pride to say that she is a true representative of what P.A.N.D.O.R.A. means to our community.
I also want to invite you all to join P.A.N.D.O.R.A.'s efforts on May 12 2008-Awareness Day. During the month of MAY, series of proclamation day letters for May 12as P.A.N.D.O.R.A.'s Neuroendocrineimmune Disorders Day in the cities of Pompano Beach,Pembroke Pines, Lighthouse Point, Deerfield Beach, Delray Beach, Boca Raton, all in the state of Florida and in the city of Murphy, North Carolina are being issued by their respective mayors. If you live in any one this cities, please send your mayor a note of thanks!
I want to thank Cort Johnson, Pat & Bruce Fero, Dr. Sharon Ostalecki, Claudia Wendlandt and Rik Carlson whose organizations signed up on the letter we sent to Congressional Members of the Health Committees (appropriations) as well as their own congressmen inviting their staff to attend at least the public testimony portion of the CFSAC meeting followed by a short list of priorities that only funding will address.
I also want to thank patient advocates Mary Schweitzer, Megan and many of the brave patients, parents and caregivers who presented their testimonies during these two day-meeting. It goes further to show, that ONE VOICE, ONE CAUSE, ONE COMMUNITY, United can make a difference and I ask you who is reading this post today, to Join US and become an Agent for Change too!
ADVOCACY WORKS!
In the meantime, we patients need to click on their web site at http://www.hhs.gov/advcomcfs/pastmeetings.html to read the Nov 28, 2007 meeting minutes to get a feel and an update for what the CFSAC is doing. I want to acknowledge here everyone who sent us an e-mail and ask for your understanding if we did not get back to you in time for this meeting. We received 100s e-mails and letters and our volunteer office staff was overwhelmed with the response. But we will keep your letters, pictures and will contact you to finalize it as we are considering making the Empty Chair project a "travelling exhibition". We will let you know if it will be possible.
The CFSAC is up for renewal this September and although the renewal of this committee is not in jeopardy as I was told by DHHS staff, the CFIDS Association does not want us to take any chances and it has issued an action alert asking CFS patients to write to Secretary Leavitt to ensure the committee remains fully funded. I actually would like to see its budget increased considerably. So make sure to say it if you write to Secretary Leavitt on the issue to raise its future funding.
Today as I was told, (and as I witnessed yesterday) was a heart wrenching public testimony period, as the CFS patients made their presentations in person. Every personal story makes your heart cringe and your eyes watery. As much as I am a veteran,seasoned patient advocate, the emotion I hear, see and feel emanating from these patients are difficult to handle. And I today did not get to witness them in person due to a morning visit to Capitol Hill to visit House Representatives Ileana Ros-Lehtinen whom I had the opportunity to meet again in person, and with Rep. Robert Wexler'staff as well with Rep. Ron Klein. These morning meetings were quite productive as our appropriations requests are in place and moving along the long tedious process. They will require a bit of tweaking regarding the language we used, and P.A.N.D.O.R.A. will work it out in the coming months, but before we tackle the next step of this project I will have to rest aggressively and recoup from this trip.
It is gratifying to see that Rep. Ros-Lehtinen understands that without a Center of Excellence and without statutory language with specific funding for the CFS/Neuroendocrineimmune Centers of Excellence, their establishment will not be realized. I say she gets it! And so do Reps Wexler and Klein (my own congressman who represents the district where I live in Florida!)
I am extremely grateful that two of their staff members: Eva Dominguez (Wexler) and Virgina Neale (Klein) came to the CFSAC meeting in the afternoon and were educated and appreciated for their interest in coming to such an important meeting for our community. I have been coming to Capitol Hill for the past 4 and half-years if not longer and this is the first time congressional staffers attended a CFSAC meeting. I am excited, grateful and elated to say the least!
A long list of recommendations are being sent to Secretary Leavitt by the CFSAC and it is incumbent on us to advise Secretary Leavitt of the importance of these recommendations to our Quality of Life. There is a huge momentum here and we need to grab it!
And to finish my report on the last day of this two-day meeting, with some exciting notes: The presentation by Dr. Kenneth Friedman, our Secretary & Chairman of Public Policy for P.A.N.D.O.R.A. provided a great insight on the New Jersey CFS Association and on their medical student scholarship, which is creating the much needed awareness of the plight of CFS patients to physicians-in-training, and affording our community a greater potential that the next wave of physicians will be well trained in neuroendocrineimmune disorders and in particular CFS. He proudly announced our own scholarships and we are elated that one of them we are naming it after him for his accomplishments, hard work and collaborative efforts in uniting our community. It has been a pleasure for me to personally collaborate and see the results of our joint efforts. It is extremely gratifying!
We are hoping that other organizations follow and apply these initiatives in their own regional areas. Our community grants are made to work as seed money/change to encourage this type of collaboration and additional initiatives.
I am also amazed at one of the most professional patient representations I have seen in the CFSAC since I have attended these meetings by Rebecca Artman,our Public Policy and Community Advisor, who valiantly, smartly and persistently is fighting for patient's issues. Her work has been diligent, to the point, and on target! I take great pride to say that she is a true representative of what P.A.N.D.O.R.A. means to our community.
I also want to invite you all to join P.A.N.D.O.R.A.'s efforts on May 12 2008-Awareness Day. During the month of MAY, series of proclamation day letters for May 12as P.A.N.D.O.R.A.'s Neuroendocrineimmune Disorders Day in the cities of Pompano Beach,Pembroke Pines, Lighthouse Point, Deerfield Beach, Delray Beach, Boca Raton, all in the state of Florida and in the city of Murphy, North Carolina are being issued by their respective mayors. If you live in any one this cities, please send your mayor a note of thanks!
I want to thank Cort Johnson, Pat & Bruce Fero, Dr. Sharon Ostalecki, Claudia Wendlandt and Rik Carlson whose organizations signed up on the letter we sent to Congressional Members of the Health Committees (appropriations) as well as their own congressmen inviting their staff to attend at least the public testimony portion of the CFSAC meeting followed by a short list of priorities that only funding will address.
I also want to thank patient advocates Mary Schweitzer, Megan and many of the brave patients, parents and caregivers who presented their testimonies during these two day-meeting. It goes further to show, that ONE VOICE, ONE CAUSE, ONE COMMUNITY, United can make a difference and I ask you who is reading this post today, to Join US and become an Agent for Change too!
ADVOCACY WORKS!
Monday, May 5, 2008
CFSAC Meeting - Washington DC, May 5, 2008
I am here in Washington DC on my way to attend the May5-6, 2008 CFS Advisory Committee meeting at the DHHS. I am excited as I heard that several patient advocates are flying in from different parts of the country to submit their testimonies. This indicates to me that I may not have as many empty chairs for our advocacy project which is exactly the results that we like to see.
I have letters from CFS patients from several states and their pictures as well to place in the empty chairs. I am meeting with some congressional staffers tomorrow. Dr. Kenneth Friedman, our Secretary and Chairman of our Public Policy committee will make a presentation at this meeting regarding initiative or methods to get medical students to learn about CFS-ME. We are excited about his presentation because the methods he spearheaded at the NJCFS Association is something that other organizations can follow. P.A.N.D.O.R.A. has expanded their original initiative and we have established community grants which will be disbursed in the coming months. The first community grant from P.A.N.D.O.R.A. was given to DePaul University for the Chronic Ill Student Patient program. The second one was an advocacy grant given to the CFIDS Association of America, Inc. Complete details on these grants and about our entire community grant initiative will be going out soon. Please check our web site on May 12, 2008 - Our International Awareness Day - One special gift that Tom Hennessy Jr. gave us when he worked valiantly for the rights of CFS and Neuroendocrineimmune Disorders Patients worldwide.
I will provide you with some pertinent information as the meeting progresses and when I am able to log on the net.
As May 12 approaches, the cities of Murhpy-North Carolina, as well as the cities in Florida of Delray Beach, Pembroke Pines,Lighthouse Point and Boca Raton have issued letter proclaming May 12, 2008 - PANDORA's Neuroendocrineimmune Disorders Awareness Day in their cities. More to come soon...
Life is Good!
Marla Silverman
I have letters from CFS patients from several states and their pictures as well to place in the empty chairs. I am meeting with some congressional staffers tomorrow. Dr. Kenneth Friedman, our Secretary and Chairman of our Public Policy committee will make a presentation at this meeting regarding initiative or methods to get medical students to learn about CFS-ME. We are excited about his presentation because the methods he spearheaded at the NJCFS Association is something that other organizations can follow. P.A.N.D.O.R.A. has expanded their original initiative and we have established community grants which will be disbursed in the coming months. The first community grant from P.A.N.D.O.R.A. was given to DePaul University for the Chronic Ill Student Patient program. The second one was an advocacy grant given to the CFIDS Association of America, Inc. Complete details on these grants and about our entire community grant initiative will be going out soon. Please check our web site on May 12, 2008 - Our International Awareness Day - One special gift that Tom Hennessy Jr. gave us when he worked valiantly for the rights of CFS and Neuroendocrineimmune Disorders Patients worldwide.
I will provide you with some pertinent information as the meeting progresses and when I am able to log on the net.
As May 12 approaches, the cities of Murhpy-North Carolina, as well as the cities in Florida of Delray Beach, Pembroke Pines,Lighthouse Point and Boca Raton have issued letter proclaming May 12, 2008 - PANDORA's Neuroendocrineimmune Disorders Awareness Day in their cities. More to come soon...
Life is Good!
Marla Silverman
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