How can you help: Please submit your comments to the FDA.
For ME/CFS, this is an excellent opportunity to help the FDA better understand how ME/CFS affects the patients. Your support is essential to ensure that ME/CFS is one of the 20 selected diseases. A sample letter has been provided in case you want to pull from it to develop your own. As you write your own letter, make points that reflect how ME/CFS meets the criteria below.
Please send your comments in by November 1, 2012, to ensure that the FDA understands why ME/CFS should be selected as one of the 20 diseases.You can submit your letter electronically or mail it.
Further information on the patient focused drug development initiative and the list of 39 diseases initially nominated can be found here: https://www.federalregister.gov/articles/2012/09/24/2012-23454/prescription-drug-user-fee-act-patient-focused-drug-development-public-meeting-and-request-for
To: FDA Patient Focused Drug Development Initiative
I am writing to request that chronic fatigue syndrome (also called myalgic encephalomyelitis or ME/CFS) be included as one of the 20 diseases in the patient focused drug development initiative.
ME/CFS is a complex, neuroimmune disease that affects one million Americans. It affects people of all ages, races and income levels. Patients can be sick for decades, with 25% house, bed or wheelchair bound, struggling to take care of themselves, let alone take care of their families or work. According to the CDC, ME/CFS can be as debilitating as Multiple Sclerosis (MS), end-stage renal disease, chronic obstructive pulmonary disease (COPD) and similar chronic conditions. One study suggests patients can die prematurely from cancer, heart disease and suicide.
What is tragic is that almost thirty years after the outbreaks that brought ME/CFS to national attention, there have been almost no clinical trials for drugs to treat ME/CFS and there are still NO approved treatments and NO biomarkers or outcome measures have been agreed upon.
By ensuring a thorough understanding of the severity of ME/CFS from a patient perspective, especially given the lack of any viable treatments to change the course of the disease, the patient focused drug development initiative could make a tremendous difference in the lives of one million Americans.
The listing that follows is intended to help you as you are writing your letter by providing additional information about how ME/CFS meets the FDA criteria for selection of disease areas. Try to include points in your letter that hit on these key criteria.
FDA Criteria, and
Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living
Disease areas that reflect a range of severity
Disease areas for which aspects of the disease are not formally captured in clinical trials
Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly)
Disease areas that represent a broad range in terms of size of the affected population
Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives
Stigma and confusion about nature of disease