ProHealth me-cfs Vitamin and Natural Supplement Store and Health
Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help

|
|

Trending News

Interview: Jennifer Brea Talks About Obstacles, Adjustments, and Inspiration

Fatigue & Fibro Fog: Could You Have a B-12 Deficiency?

Post-Exertional Debility is an Important Symptom during Myalgic Encephalomyelitis

Burmeister Wins Lawsuit: Court Rules Government Must Produce IOM Documents

Traditional Chinese medicine for chronic fatigue syndrome: A systematic review of randomized clinica...

Is the physical examination normal in CFS?

Symptoms of autonomic dysfunction in chronic fatigue syndrome

Irritable bowel syndrome and chronic fatigue six years after Giardia infection: a controlled prospec...

False Allegations of Child Abuse in Cases of Childhood Myalgic Encephalomyelitis (ME)

Your Rights When a Disability Claim is Terminated

 
Print Page
Email Article

A Call to Action! Bob Miller Urges FDA to Include ME/CFS Clinicians and Patients

  [ 2 votes ]   [ Discuss This Article ]
By Bob Miller • www.ProHealth.com • March 10, 2013


Dear Patients, Patients' Loved Ones and Friends,

Since I ended my hunger strike, I have learned that the FDA has sent invitations for the ME/CFS scientific stakeholder workshop scheduled for April 25-26th. The FDA hasn’t disclosed who it is inviting, and did not solicit input from patients. You, the patients, made this FDA stakeholder meeting happen, and we believe patients need to be involved in setting the agenda and ensuring that the most valuable clinical expertise is represented at the meeting. 

Therefore, Ampligen patients and I are asking you to email the FDA and Secretary of Health to urge them to invite the most experienced ME/CFS clinicians who use the most sophisticated treatments available and to host an Ampligen Roundtable in conjunction with the FDA scientific and stakeholder workshop.  The lessons that are being learned from the Ampligen trials will benefit every ME/CFS patient.

During my hunger strike, the FDA and Secretary Sebelius’s office were inundated with emails and phone calls, and congress people heard from their constituents. I humbly thank you for all your work during those days; our coming together raised the attention of our federal agencies on our health crisis. Once again we need to ACT together by emailing and phoning the FDA to have our voices heard. There is a template email/letter below. For those wishing to use it, just copy and paste for ease. The Cc is to me allowing me to calculate the number of emails sent.

For the health of Our ME/CFS community,

Kindly,

Robert Miller &The Ampligen Team

Email To

Secretary of Health Kathleen Sebelius, FDA Commisioner Dr. Margaret Hamburg, CDER Deputy Director Sandra Kweder, David Banks in FDA Office of Special Health Issues

Phone contacts: Please call in to make a personal request if you can:

  • FDA Commisioner, Dr. Margaret Hamburg (301) 796-5000 
  • Mr. David Banks, Office of Special Health Issues (301)-796-8459

See Email Template Below:

Email To: kathleen.sebelius@hhs.gov, margaret.hamburg@fda.hhs.gov, Sandra.Kweder@fda.hhs.gov, david.banks@fda.hhs.gov,  ME-CFS-Meeting@fda.hhs.gov

Cc: ampligenteam@gmail.com

Subject: ME/CFS FDA Scientific Stakeholder Workshop

Dear Secretary Sebelius, FDA Commissioner Hamburg, Dr. Kweder and Mr. Banks,

FDA states that the upcoming FDA scientific workshop and stakeholder meeting on ME/CFS is the right place to address the path forward for treatments, including but not limited to Ampligen. There is a serious unmet need in the patient community for medical treatment, and Ampligen is the only medicine that has been tested in clinical trials for ME/CFS in the last 20 years. However, we understand that the few clinicians with extensive experience using Ampligen have not been invited to the workshop to share their understanding of clinical endpoints related to this debilitating illness.

As a patient with ME/CFS, I am strongly urging FDA to do three things regarding the ME/CFS science and stakeholder workshop:

  1. The FDA should invite Dr. Daniel Peterson, who has undeniably the most experience treating patients with Ampligen and has among the most sophisticated understandings of clinical endpoints, enabling him to identify likely responders by subgrouping patients for various treatments, not limited to Ampligen. In his role as Scientific Advisor to Simmaron Research Foundation, he is collaborating in scientific studies into the immunological abnormalities of ME/CFS, including the NIH and CFI multi-site studies.  His clinic has the highest response rate to Ampligen. That, along with his 30-year clinical experience, necessitates his input into future treatment pathways
  2. FDA should hold an Ampligen roundtable with the most experienced Ampligen clinicians, patients, the sponsor and the FDA, CDC and NIH representatives, in conjunction with the FDA workshop. No other medication is, or is about to be, in advance studies for treating ME/CFS or has shown such promise. The experts need to collaborate on a path toward approval for Ampligen, so current Ampligen patients can continue to have access to the drug and many other patients and their doctors can decide if Ampligen might work for them. The benefit of clinical knowledge gained from identifying those who respond to Ampligen is imperative. After FDA denied the application for Ampligen’s approval in February, it posted a statement, saying “To assist companies with their development, FDA is sponsoring a workshop in spring 2013 focused specifically on ME/CFS drug development.” And Dr. Hamburg has stated, “We are committed to continuing our dialogue with companies, innovators, patients, and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation.” This is the time to learn from Ampligen, as well as other experts.
  3. I also urge FDA to invite Robert Miller as a patient representative. Mr. Miller has taken the lead among patients in urging federal health agencies to pursue smart science and effective treatments for more than 10 years. He played a large part in getting the FDA stakeholder meeting scheduled. His longtime experience in the Ampligen clinical trial gives him a perspective that is necessary to represent patients who participate in the only clinical trial available, as distinct from any of the patients who have been invited thus far. He is a leader among ME/CFS patients generally.

Our understanding is that this stakeholder meeting is designed to identify endpoints for measuring efficacy, so that more clinical trials can be set up and a path to approved treatments and drugs will be established and clarified. 

As an ME/CFS patient my voice should be represented at this critically important meeting.

Your Name Here___________

Years ill ______________

City and State ______________



Please Discuss This Article:   Post a Comment 



[ Be the first to comment on this article ]




 
Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Our FREE
Newsletter
Subscribe Now!
Receive up-to-date ME/CFS & Fibromyalgia treatment and research news
 Privacy Guaranteed  |  View Archives

Save on Vitamin B-12

Featured Products

MitoQ® MitoQ®
Powerful Antioxidant Support to Mitochondria
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth

Natural Remedies

VIDEO: Healthy Eating and Fibromyalgia VIDEO: Healthy Eating and Fibromyalgia
More Weight Loss than Any Other Discovery in Supplement History More Weight Loss than Any Other Discovery in Supplement History
The Brain Boosting and Fatigue Fighting B-12 The Brain Boosting and Fatigue Fighting B-12
Itching to Find Dry Skin Relief? Itching to Find Dry Skin Relief?
Dreaming of a Good Night's Sleep? Dreaming of a Good Night's Sleep?

FIBROMYALGIA RESOURCES
What is Fibromyalgia?
Fibromyalgia 101
Fibromyalgia Symptoms
Fibromyalgia Treatments
| CFS RESOURCES
What is CFS?
ME/CFS 101
ME/CFS Symptoms
ME/CFS Treatments
| FORUMS
Fibromyalgia
ME/CFS
ADVANCED MEDICAL LABS
WHOLESALE  |  AFFILIATES
GUARANTEE
CONTACT US
PRIVACY
RSS
SITE MAP
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing