Sunday, July 7, 2013

Send a message to Congress: We can't wait any longer!

The Bob Miller team is once again springing into action. This letter (see below) is a call for the FDA to hold a follow-up meeting to expand upon the FDA meetings of April 25-26.  (You can read a summary of Day One of the FDA meeting here. You can read summaries of the Day Two morning sessions here, and Day Two afternoon sessions here.)

Why is this necessary? 
The FDA meetings opened the door for people in government, and in industry, to start thinking about ME/CFS treatments. Although it's nice that they are beginning to think, the epidemic that marked the beginning of agency concern about ME/CFS happened nearly 30 years ago. We can't wait another 30 years. 

By Bob Miller

We, the “FDA Team*,” are asking you to send the message below to the FDA and to listed members of Congress.

The recent patient-focused drug development meeting held by the FDA was a start – but only a start. The FDA stated that their goal was to support treatments for the chronically ill, particularly where there is a drug deficit, yet the meeting fell short of meeting that goal.

The original goal of the FDA Stakeholders was to provide a clear regulatory pathway that would support faster drug development for ME/CFS. That obviously did not happen.

Now Bob Miller and others on our team are continuing communication at the top level, including with Dr. Janet Woodcock, Director of the Center for Drug Development and Research at the FDA. We have informed her that your messages will be sent to one of her staff members, David Banks PhD, of Special Health Issues.

We want them to hear from you, family and friends. This keeps critical channels of communication open.


AIDS patients demanded one thing: Treatment. And they got it! We must demand the same.
Please email the following to David Banks and myself, Bob Miller. (I am monitoring how many emails are sent along with other FDA team members.) Also, we ask you to CC others in the Department of Health and Human Services and congressional staff members so they can influence the FDA.

Just copy and paste, please add your name and address or email information at the end. (As always, this is just a suggested template for your convenience):


Subject: ME/CFS Treatments

Dear Dr. Woodcock:
Over 1 million Americans and their families continue to suffer with ME/CFS. Patients have no treatment options as there are no FDA-approved treatments. One drug has been stuck in the pipeline for two decades (Ampligen), and there are no others likely to be reviewed for years to come. The recent patient-focused drug development meeting fell short of meeting the needs of ME/CFS patients. By the end of this year, FDA must convene a follow-up meeting to engage pharmaceutical and biotech companies to assist the FDA in establishing a regulatory pathway for drug approval.

The stakeholder meeting held on April 25th and 26th opened the FDA’s eyes to the severity of our condition and the enormous Unmet Medical Need. FDA has the power and the authority to waive traditional regulations when healthcare demands, particularly when the disease is serious/life-threatening, as ME/CFS clearly is. We need access to treatments NOW. Please act now for us! Don’t stop the progress; let’s keep it going. We cannot wait another decade for relief. People are suffering and dying.

Thank you,

“Place Your Name Here”:
“Place Address and/or Email Here”

- – - End of your email message – - -

*The FDA Team includes:
Cort Johnson, patient and principal of Health Rising
Robert Miller, ME/CFS patient /activist and (Courtney Miller, patient wife FDA Team support)
Lori Chapo Kroger, patient and president of PANDORA Org.
Pat LaRosa, patient / patient advocate
Billie Moore, parent of patient lost to ME/CFS & patient advocate

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