Mail de FDA en teken de petitie om goedkeuring Ampligen

[spring]

Graag nog een mailtje versturen mensen. Vandaag. Zo gedaan. Laat ze weten dat de hele wereld mee kijkt!



Hi folks: ME/CFS activist Bob Miller has started a hunger strike. Let's support it to leverage as much attention as possible, and to shame the HHS and FDA into action. Please send this below notice to everyone (email, facebook, listservs, etc), so we can get the attention of the HHS & FDA-powers-that-be. Post widely.
_______


... FORWARD WIDELY ...

WHAT
Supporting ME/CFS Patient on Hunger Strike: Send this email to HHS, FDA

WHEN
Right now! Sunday and Monday, Feb 3rd and 4th, 2013

SEND TO
Please send this email to the US Dept of Health and Human Services and the FDA:
kathleen.sebelius@hhs.gov, sandra.kweder@fda.hhs.gov, margaret.hamburg@fda.hhs.gov, janet.woodcock@fda.hhs.gov, howard.koh@hhs.gov

SUBJECT LINE:
Urgent: Well-Known Journalist & AIDS Activist Support Patient Hunger Strike

Dear Secretary Sebelius, Sandra Kweder, Margaret Hamburg, Janet Woodcock, Howard Koh:

Shame on you for ignoring the needs of one million disabled ME/CFS patients, many of whom are bedridden and homebound, suffering for decades with little help from the US government. You and the NIH dedicate only $6 million dollars each year for ME/CFS research -- a pittance.

Robert Miller's hunger strike continues -- and is gaining attention -- as we all wait for the FDA's decision, due Monday, Feb 4, 2013, on whether or not to approve Ampligen, the first medication ever considered by the FDA for ME/CFS.

There are two developments regarding this:

Well-known HIV/AIDS activist, Cleve Jones, founder of the AIDS quilt project, came out in support of ME/CFS patient Robert Miller's hunger strike. Mr. Jones writes: “My friend is on a hunger strike to get the first medicine approved for his severe case of chronic fatigue syndrome. FDA is likely to deny the drug this weekend. We know we wouldn’t be where we are today if some of us hadn’t protested inaction by federal agencies on AIDS treatments. Email: kathleen.sebelius@hhs.gov Urge FDA to approve Ampligen, so all CFS patients can have just one treatment option. CFS patients suffer without any treatments, and I can remember those days in my life. I urge Secretary Sebelius to approve Ampligen for CFS and apply what we learned with HIV about getting treatments to patients like every minute counts.”

Additionally, long-time Washington DC journalist, Llewellyn King, commented on ME/CFS sufferer Robert Miller's hunger strike on his PBS television program, "White House Chronicle." It is airing this weekend on PBS stations in Washington --Sunday, Feb. 3 at 9 a.m. on WETA, Channel 26; Sunday at 11:30 a.m. and 6:30 p.m. on WHUT, Channel 32. It will air throughout the week on some 200 PBS and public, educational and governmental cable TV stations and worldwide on Voice of America Television. An audio version of the episode will air Saturday, Feb. 2 at 9:30 a.m., 3:30 p.m. and 9:30 p.m. on Sirius XM Radio's POTUS (Politics of the United States) Channel 124. The episode will be posted on the "White House Chronicle" Web site, whchronicle.com, on Monday, Feb. 4.

One million disabled Americans have been ignored for over 2 decades. This can not continue. We desperately need your help.

Best,

Your name
Location
Years sick (or state your relationship to patient)

[annemoontje]

dank je spring voor het plaatsen, deze had ik nog niet gezien, natuurlijk ook gemaild, net als alle andere mails. laten we hopen dat het iets oplevert..

[lulu]

als je naar

http://phoenixrising.me/archives/15415

gaat, zie je onder "the email" click here staan. op klikken en alleen nog naam en woonplaats invullen en klaar -> send.

[josje15]

fijn dat jullie het hier weer plaatsen....

[annemoontje]

als je naar

http://phoenixrising.me/archives/15415

gaat, zie je onder "the email" click here staan. op klikken en alleen nog naam en woonplaats invullen en klaar -> send.

voor de duidelijkheid: dat is weer een andere mail dan die van Spring, dus als je die al had gestuurd, deze ook alsnog aub (voor zover nog niet gedaan). alle mails sturen, 't is nu of nooit!

[annemoontje]

ik begrijp van het blog van CFS-Central (Mindi Kitei) het Ampligen niet goedgekeurd is..
http://www.cfscentral.com/2013/02/ampli ... o.html?m=1

en de bron van de feitelijke press release door Hemispherx:
http://globenewswire.com/news-release/2 ... drome.html

PHILADELPHIA, Feb. 4, 2013 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced that it received a Complete Response Letter from the US Food and Drug Administration ("FDA") declining to approve its new drug application ("NDA") for Ampligen® for Chronic Fatigue Syndrome ("CFS"). The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.
[...]
Hemispherx has become aware that a prominent CFS advocate and long-time CFS sufferer, who has been on Ampligen® since 1999 through a treatment IND, began a hunger strike on January 30, 2013 to seek FDA approval of Ampligen®. Hemispherx understands the frustration that there is still no FDA-approved treatment for CFS and the concern that patients may lose access to Ampligen® therapy. Out of concern for the health of the CFS community, Hemispherx has asked any hunger strikes be discontinued and that patients join in a collaborative effort between the FDA, Hemispherx, CFS clinicians and patient advocates to find a solution to this significant unmet medical need.

In the past, the FDA has shown great willingness to work with stakeholders to find solutions for serious and life-threatening illnesses.

laten we hopen dat de FDA samen met Hemispherx etc. een oplossing kan vinden zodat mensen als Bob Miller iig ampligen kan gebruiken en hopelijk ook dat er mogelijkheden (lees: fondsen) komen voor de aanvullende zaken die Hemispherx moet doen.

[kik]

Hebben jullie ook een mail gekregen van Division of Drug Information van de FDA?
Ik vind het best een bijzondere brief. Hier staat de brief online http://www.fda.gov/Drugs/NewsEvents/ucm337750.htm

Ze willen ons in ieder geval moed inspreken......

We want to emphasize that the CR letter issued for Ampligen is entirely separate and distinct from FDA's support of drug development pathways for CFS - these initiatives remain unaffected and fully supported. ME/CFS is a serious disease and treatments for it represent an important area of unmet need.

[annemoontje]

ja, inderdaad, had ik ook, zullen ze iedereen hebben gestuurd die gemaild heeft. idd hoopgevend, zeker omdat ze inmiddels hebben aangegeven dat ze in gesprek gaan met div. instanties en natuurlijk de geplande stakeholders meeting wat niet meer gedaan is sinds Aids in de jaren 80/90...

EN:
" https://www.facebook.com/permalink.php? ... 4801179671

Hunger strike is over. [Edit: He is fine.]"

"Robert Miller feels he has accomplished some good objectives and has for this reason chose to end his action. He asks that the mass emails stop now and that we engage through the FDA Stakeholders’ Meeting. Says the Secretary’s office [SoH, I think] will engage with us there. Sounds promising."

http://phoenixrising.me/archives/15722#comments (comments Alex and Willow, 8 febr.)

[asje]

Best hoopgevend ...