Fighting For a Stake! FDA Cold Shoulder = More Action On Treatments For ME/CFS

May 19, 2012

Posted by Cort Johnson

(This was never going to be easy….ME/CFS has been ignored by every federal agency for over 2 decades and its going to take time and work to break down those walls.  Let’s send a message that we are no longer willing stand for being ignored…Thanks to Mary Dimmock, Bob Miller and others for standing up for  the possibility of equal treatment for ME/CFS and producing this. )

CALL FOR THE FDA TO HOLD A STAKEHOLDER MEETING – SECOND LETTER!

May 14, 2012

To All who took ACTION requesting THE FDA TO HOLD A STAKEHOLDERS MEETING for ME/CFS

THANK YOU!!

We have not yet heard from the FDA re: The ME/CFS Stakeholders Meeting. Therefore, we ask everyone to send in a follow up letter. This letter is directed to Dr. Woodcock and is requesting that the stakeholder meeting be held and that we are responded to by June 1. We are urging Dr. Woodcock to preside over this critical meeting.

PLEASE SEND IN YOUR LETTER BY MAY 25 and urge your relatives and friends to do the same.  A sample template letter and email addresses are included below. Just Copy and Paste

YOUR LETTERS COUNT. Remember – INTENSE LOBBYING & ADVOCACY is how AIDS/HIV got $3 BILLION a year for research, CFS gets $6 million. AIDS/HIV sufferers now have multiple drugs to fight the disease. We have NONE.

WE MUST STAND UP FOR OURSELVES, and ask family and friends to do the same, We Must Change Our Situation. We must insist that those who work for our benefit listen to us and Act!

For reference, the original sample letter that was sent in late April can be found at these links on Co-Cure and Phoenix Rising.

Thank you everyone for taking ACTION!

Copy & Paste email addresses

To:  Kathleen.Sebelius@hhs.gov ,  margaret.hamburg@fda.hhs.gov,  janet.woodcock@fda.hhs.gov,howard.koh@hhs.gov , brian_ahlberg@harkin.senate.govMichael_Barnard@menendez.senate.govAlex_Stern@mikulski.senate.gov ,  jeff.carroll@mail.house.gov ,  monica.volante@mail.house.gov ,  Annie_Walden-Newman@murray.senate.gov , mecfsaction@yahoo.com

_____________________________________________________________________________________________________

Sample Letter to Dr. Woodcock

From: Your Name                                                                                May 25, 2012

To: Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research

cc: Secretary Kathleen Sebelius, Department of Health and Human Services; Dr. Margaret Hamburg, Commissioner, FDA, Dr. Howard Koh, Assistant Secretary of Health; Chairman Tom Harkin, Health, Education, Labor, and Pensions, Senator

Barbara Mikulski (D-MD), Senator Menendez (D-NJ), Senator Patty Murray (D-WA), Congressman Frank Pallone (D-NJ), Congressman Joseph Pitts (R-PA)

Subject: Request for FDA Stakeholder Meeting on Chronic Fatigue Syndrome

Dear Dr. Woodcock:

We urge you to preside over a stakeholder meeting of the clinicians, researchers, manufacturers, advocacy groups, and patients to engage in a rigorous dialogue to accelerate treatment for ME/CFS.  We ask you to set a date for this meeting by June 1st.

As declared by Dr. Hamburg “FDA has an important role to play in shaping the future of medical breakthroughs by bringing stakeholders together to identify and overcome challenges.” It’s time for the FDA to live up to their role.

As you yourself have stated, “It should be noted that FDA assess the benefit-risk of new drugs on case-by-case basis, considering the degree of the unmet medical need and the severity and morbidity of the condition the drug is intended to treat.”

As one of the millions of people suffering from ME/CFS, I cannot even dream about a better quality of life because there is simply no avenue to get there. I live every day with a disease that the CDC has said is as disabling as multiple sclerosis, heart disease, end-stage renal disease and similar chronic conditions; AND YET THERE ARE ZERO TREATMENTS TODAY. As this falls within your responsibility to address this “unmet medical need” please Act Now.

Your Name

Address

City, State  -  Zip code

 

 

 

 

11 comments

{ 11 comments… read them below or add one }

K2 for Hope May 19, 2012 at 12:26 pm

Just to confirm, I copied the email addresses and put all into the cc: section of my email letter except I pulled the one for Dr Janet Woodcock out and put it into the to: section (janet.woodcock@fda.hhs.gov,).

I then copied the Subject "Request for FDA Stakeholder Meeting on Chronic Fatigue Syndrome" and pasted into subject line of email.

I then copied the rest of the letter from "Dear Dr. Woodcock:" to the last paragraph.

I then signed with my name and address, city, state and zip code per sample.

Thanks for the notification. We MUST continue to advocate for our cause.

karmajinpa May 19, 2012 at 3:20 pm

Don't know how or why, but all the addresses, with the exception of Dr. Woodcock's would not go through as they were copied and pasted. I re-checked with the originals and couldn't see the problem. Did anyone else experience this and, if so, what are the correct emails?

ggingues May 19, 2012 at 5:28 pm

Is this a one time deal or is it supposed to be daily?

GG

PS I thought this similar action was supposed to be daily.

Sing May 19, 2012 at 6:07 pm

I will write and cite as an example of a drug which could be very useful to us, the still not FDA-approved "Northera" from Chelsea Therapeutics. The FDA would not approve this drug, although it has been used for years with success in Japan and Europe, because of the risk of supine hypertension. Well, any drug which increases blood pressure is apt to do that too. Midodrine, which has been approved for years, does that, though it is considered a less effective drug for NMH.

See this link http://www.fiercebiotech.com/press-…complete-response-letter-food-and-drug-admini

Grape Funk May 19, 2012 at 8:47 pm

how many letters did we send in last time around and from how many different email addresses? I am curious to see how many people are sending emails and participating. Main Organizers should know as we attached the me action email address.

medfeb May 20, 2012 at 4:21 am
K2 for Hope

Just to confirm, I copied the email addresses and put all into the cc: section of my email letter except I pulled the one for Dr Janet Woodcock out and put it into the to: section (janet.woodcock@fda.hhs.gov,).

I then copied the Subject "Request for FDA Stakeholder Meeting on Chronic Fatigue Syndrome" and pasted into subject line of email.

I then copied the rest of the letter from "Dear Dr. Woodcock:" to the last paragraph.

I then signed with my name and address, city, state and zip code per sample.

Thanks for the notification. We MUST continue to advocate for our cause.

That's fine, K2. You can also just copy all the addresses into the 'To' box

medfeb May 20, 2012 at 4:32 am
karmajinpa

Don't know how or why, but all the addresses, with the exception of Dr. Woodcock's would not go through as they were copied and pasted. I re-checked with the originals and couldn't see the problem. Did anyone else experience this and, if so, what are the correct emails?

I just tried it and all of the addresses did work – at least I didn't get any 'no delivery' emails

If you still can't get it to work, can you copy from this message?

To: Kathleen.Sebelius@hhs.gov , margaret.hamburg@fda.hhs.gov, janet.woodcock@fda.hhs.gov, howard.koh@hhs.gov , brian_ahlberg@harkin.senate.gov, Michael_Barnard@menendez.senate.gov, Alex_Stern@mikulski.senate.gov , jeff.carroll@mail.house.gov , monica.volante@mail.house.gov , Annie_Walden-Newman@murray.senate.gov , mecfsaction@yahoo.com

medfeb May 20, 2012 at 4:37 am
Grape Funk

how many letters did we send in last time around and from how many different email addresses? I am curious to see how many people are sending emails and participating. Main Organizers should know as we attached the me action email address.

Grape Funk
A few hundred emails were sent to the MECFS Action address but some organizations used a different tracking address and some removed the address. So the total was more than that.
Mary

karmajinpa May 20, 2012 at 9:30 am
medfeb

I just tried it and all of the addresses did work – at least I didn't get any 'no delivery' emails

If you still can't get it to work, can you copy from this message?

To: Kathleen.Sebelius@hhs.gov , margaret.hamburg@fda.hhs.gov, janet.woodcock@fda.hhs.gov, howard.koh@hhs.gov , brian_ahlberg@harkin.senate.gov, Michael_Barnard@menendez.senate.gov, Alex_Stern@mikulski.senate.gov , jeff.carroll@mail.house.gov , monica.volante@mail.house.gov , Annie_Walden-Newman@murray.senate.gov , mecfsaction@yahoo.com

That did it! Thanks so very much. :)

ggingues May 20, 2012 at 6:42 pm
ggingues

Is this a one time deal or is it supposed to be daily?

GG

PS I thought this similar action was supposed to be daily.

Any one know the answer to this?

GG

Sing May 21, 2012 at 6:29 am
Sing

I will write and cite as an example of a drug which could be very useful to us, the still not FDA-approved "Northera" from Chelsea Therapeutics. The FDA would not approve this drug, although it has been used for years with success in Japan and Europe, because of the risk of supine hypertension. Well, any drug which increases blood pressure is apt to do that too. Midodrine, which has been approved for years, does that, though it is considered a less effective drug for NMH.

See this link http://www.fiercebiotech.com/press-…complete-response-letter-food-and-drug-admini

APOLOGY: I forgot to say the most important thing which is that "Northera" is a drug for NMH, Neurally Mediated Hypotension, Orthostatic Intolerance.

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