Activate Now
ProHealth fibromyalgia Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Chronic Fatigue Syndrome, Fibromyalgia and Mitchondrial Disorders: A Comparison Plus the MitoQ Trial...

Aromatherapy Diffusers For Fibromyalgia Support

Dr. Teitelbaum's 3 Steps to Fibromyalgia Pain Relief - Part 1: Understanding Fibromyalgia Pain

An Interview with Ken McKim: Educating the public about chronic illness

Repair Damaged Mitochondria and Reduce Fatigue Up to 45%

Are All the "Feel-Good" Pathways Blocked in Fibromyalgia and Chronic Fatigue Syndrome?

5 Things I've Learned About Chronic Illness Through Mindfulness

Cellular Havoc: Zeroing In On The Sleep Problems in Fibromyalgia?

Solving the mysteries of fibromyalgia could help patients break free

Staying healthy from fibromyalgia is ongoing hard work

Print Page
Email Article

FDA Pronounces ME/CFS ‘Serious and Life Threatening Disease’ in Sep 13 Meet

  [ 142 votes ]   [ 1 Comment ] • September 14, 2012

Following is a note circulated Sep 14 by ‘Rivka’ – a well-known patient activist and one of a group of ME/CFS patients and advocates who teleconferenced on Sep 13 with FDA officials, drug companies, and others. The large meeting was part of the FDA’s planned series of activities focused on drug development to treat the symptoms of ME/CFS.* Thank you Rivka and all!


FDA Meeting with ME/CFS Community

Dear Friends,

In an exciting turn of events, the FDA seems to be taking ME/CFS seriously.

We had a very successful 1.5 hr phone meeting yesterday with the FDA, led by Sandy Kweder (FDA/CDER’s Office of New Drugs, Deputy Director).

• Her superior, Dr. Janet Woodcock, joined for a short time.

• The meeting included 50 people: FDA officials, patients, advocates, drug companies and unidentified others. I expect the CDC had reps there, too.

• A transcript of the meeting and a participant list will be available shortly.

At yesterday's meeting, the FDA pronounced ME/CFS a "serious and life threatening disease with no meds currently available" (or some lingo like that), which opens the door for new drugs for our illness to be considered for "Accelerated Approval."

• Many meds were mentioned by patients (including Rapid Lab's mDAPTA, by me).

• The FDA also said there are currently 8 open INDs [investigational new drug applications] for ME/CFS.

More FDA meetings will follow, including an Ampligen meeting in December and a larger ME/CFS-FDA Stakeholder meeting this spring. Info will be posted on this website:

Yesterday's FDA meeting comes just weeks after Obama raised the priority of ME/CFS and assigned a key health care policy point person to watch over it and just days before
the Sept 18th NIH-funded Lipkin/XMRV study release and press conference in which ME/CFS will be taken very seriously by the scientific research community.

After decades in the dark, perhaps the tide is turning on the government's response to this illness.

- Rivka


* Drug Development for Myalgic Encephalomyelitis & Chronic Fatigue Syndrome (ME/CFS)

[This is the page on ME/CFS drug development activities. It lists the Sep 13 phone meeting, will post the meeting transcript, and will list further activities when they are announced. Please go to this link - - for links to the referenced PDFs and additional resources.]

FDA will be planning a series of activities focused on drug development to treat the symptoms of Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS) in order to explore:

• The burden of disease that impacts the quality of life for ME/CFS patients;

• The quantitative outcome measures or endpoints that determine if disease symptoms improve with intervention; and

• How drug efficacy should be clinically tested based on these endpoints or measurements.

Please send correspondence regarding ME and CFS to

Please Note: The list of activities will be updated as each activity is announced.

Teleconference between FDA and Patients/Patient Advocates – September 13, 2012 [completed]

• Background Information (PDF - 20KB)

• Docket for questions/comments that are not addressed on the teleconference (Docket Number: FDA-2012-N-0962)

• Response Letter to Questions and E-mails Regarding Teleconference Invitation (PDF - 22KB)

Additional Resources:
How FDA Evaluates Regulated Products: Drugs

Post a Comment

Featured Products From the ProHealth Store
B-12 Extreme™ Optimized Curcumin Longvida® Hydroxocobalamin Extreme™

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products

Article Comments Post a Comment

Mycoplasma/retrovirus envelope
Posted by: Dr.Al
Sep 19, 2012
I suggest doing an internet search on the following: Special Virus Cancer Program + Boyd Graves; Special Virus Cancer Program + Robert Gallo; Tetrasilver Tetroxide Patent + cure for AIDS; The Journal of Degenerative Diseases Volume 5 Number 3 + AIDS Made in America. You will find that the real culprit is a synthetic biological agent bio weapons designed and deployed for the purpose of depopulation and financial gain. One to kill (AIDS); and one to disable (ME/CFS). It’s a mycoplasma/ retrovirus combination. The scientists who have stumbled upon the truth are quickly shut down and threatened in order to prevent them from doing anything with the information. Funding goes to people who are willing to “play ball” and lead the research away from the truth while providing additional money for pharmaceutical drugs that do little to help and in many cases do real harm. There is a cure and they know it! In addition to Tetrasil which was not allowed to be made available, electro-magnetic devices such as those recommended by the late Dr. Bob Beck (Sota) to electrocute the pathogens, and others are effective far beyond any drugs being pushed by the pharmaceutical patsies.
Reply Reply
Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Subscribe Now!
Receive up-to-date ME/CFS, Fibromyalgia & Lyme Disease treatment and research news
 Privacy Guaranteed  |  View Archives

Repair Damaged Mitochondria and Reduce Fatigue Up to 45%

Featured Products

Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 your brain needs for detox & sharpness
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Guaifenesin FA™ Guaifenesin FA™
Helps the Body Eliminate Excess Calcium and Phosphates
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Fibro Freedom™ Fibro Freedom™
Soothes, strengthens & revitalizes

Natural Remedies

The Most Powerful Natural Antioxidant Discovered to Date - Hydroxytyrosol The Most Powerful Natural Antioxidant Discovered to Date - Hydroxytyrosol
SAD? Coping with Seasonal Affective Disorder
Breaking Through the Mental Fog Breaking Through the Mental Fog
Sunshine Vitamin Has D-lightful Health Benefits Sunshine Vitamin Has D-lightful Health Benefits
The Big Blue Fish that Helps Chase the Blues Away The Big Blue Fish that Helps Chase the Blues Away

What is Fibromyalgia?
Fibromyalgia Diagnosis
Fibromyalgia Symptoms
Fibromyalgia Causes
Fibromyalgia Treatments
Fibromyalgia Diet
Fibromyalgia Medications
M.E. & CFS
What is M.E./CFS?
M.E./CFS Diagnosis
M.E./CFS Symptoms
M.E./CFS Causes
M.E./CFS Treatments
M.E./CFS Diet
M.E./CFS Medications
What is Lyme Disease?
Lyme Disease Diagnosis
Lyme Disease Symptoms
Lyme Disease Causes
Lyme Disease Treatments
Lyme Disease Diet
Lyme Disease Medications
M.E. & CFS
Lyme Disease
General Health
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing