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Call for Congressional Hearing on Treatment for ME/CFS

Posted Jun 12 2014 3:20pm
Picture The following announcement comes from the FDA Treatment Team, a group of people dedicated to securing FDA approval for Ampligen. 

The team has drafted a letter requesting a congressional hearing on Ampligen. You can support their effort by sending your own letter (see template below).

The team has provided email addresses on their template letter. In addition, I recommend you send the letter to your own representatives as well via their web forms. Representatives always pay attention to letters sent by their constituents. You can find your representatives  HERE  simply by typing in your zip code.
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New Opportunities to Create FDA Action on ME/CFS Treatments

Currently, Congressmen Fred Upton (R-MI) and Diana DeGette (D-CO) have spearheaded a bipartisan initiative called " 21st Century Cures " to increase the pace of medical breakthroughs. This initiative gives us fertile ground to press Congress and the FDA to provide an environment that attracts drug companies to ME/CFS research and for the FDA to give conditional approval of Ampligen. Remember, if we get one drug across the line, many more will follow.

We are asking you to help us continue to push the FDA to foster and approve treatments for ME/CFS. It is important that ME/CFS stay high on the FDA's agenda. Please cut and paste the following message and send it to the email addresses below.

~From The FDA Treatment Team

Cort Johnson, Bob Miller, Billie Moore, Pat LaRosa, Dr. Janet Smith, Anita Patton, and Lori Chapo-Kroger
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Email to
margaret.hamburg@fda.hhs.gov; janet.woodcock@fda.hhs.gov; janet.maynard@fda.hhs.gov; howard.koh@hhs.gov

Cc
mark.ratner@mail.house.gov; monica.volante@mail.house.gov; rachel.stauffer@mail.house.gov; robb.walton@mail.house.gov; catie.fulton@mail.house.gov; christopher.stewart@mail.house.gov; kathryn.allen@mail.house.gov; mitchell.vakerics@mail.house.gov; heidi.ross@mail.house.gov

Subject line
FDA fails to approve drug for ME/CFS - Time for a congressional hearing

In the body of the email
Recently, Congressmen Fred Upton (R-MI) and Diana DeGette (D-CO) spearheaded a bipartisan initiative called "21st Century Cures" to increase the pace of medical breakthroughs. This initiative provides opportunities to help speed approval for treatments that affect underserved populations - such as those who are severely ill with ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome).

To date, the FDA has failed to approve a drug considered safe for ME/CFS, leaving chronically ill patients to take untested, off-label medications. ME/CFS costs the United States economy approximately $20 billion annually and affects one million Americans. It has left many families in ruins.

The FDA says it will approve drugs with serious adverse side effects that they believe are effective for ME/CFS, but they won't approve Ampligen, a drug that they acknowledge is safe.

Where is the data on efficacy and safety of the drugs currently being used off-label to treat ME/CFS?

ME/CFS Expert Dr. Charles Lapp, who has treated thousands of ME/CFS patients and has used Ampligen for more than 25 years, said, "Even if Ampligen doesn't improve a patient, it does no harm."

The experts have said it works, and the FDA Advisory Committee has said it's clear that patients are experiencing benefit. More than 700 patients provided testimony at the FDA Advisory Meeting in December 2012 requesting approval of Ampligen, and more than 4,000 signed a petition after FDA denied the approval in February 2013.

In April of 2013 - four months after the FDA denied approval for Ampligen - the FDA admitted they did not have a complete understanding of ME/CFS. We believe that if the FDA had understood the unique needs of ME/CFS patients prior to the Ampligen approval hearing, the drug would have received conditional approval, leading to a functional improvement in many severely ill patients.

The FDA is to be commended for acknowledging the seriousness of ME/CFS. However, more needs to be done. The FDA needs to recognize the special circumstances and desperation of the ME/CFS community and act accordingly by assisting drug companies in bringing their products to market.

A group of patient advocates has demanded a congressional hearing, and I agree. A congressional hearing is needed. The FDA must live up to its commitment and help those with chronic illnesses. We have a right to treatment; our voices and our experts need to be heard.

[your name]

[your city and state]

[years you have been sick]
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