share: Can you help me and my fellow leukemia patients?
There's an important issue impacting my health, and I would appreciate your help. As many of you know, I have a rare form of leukemia, known as chronic myelogenous leukemia, or CML. The National CML Society of the United States, as well as the CML Society of Canada, have identified a serious concern that affects some of my fellow survivors. It involves the Food and Drug Administration review for a drug called Omacetaxine which is a lifeline for those who are dealing with a specific mutation that can affect those with CML.
In most drug reviews the responsible committee members vote on the clinical efficacy of the drug, but in this case they chose to vote on the lack of a standardized test to determine
the presence of the mutation. This is rather odd as none of the other tests currently used to diagnose or track our treatments are standardized at this time.
While the patient support organizations commend the work of the FDA in reviewing Omacetaxine, and indeed all of the drugs currently used to treat this disease, they are dismayed by the sudden change of policy and have developed a petition asking the FDA to re-visit their recommendation and allow Omacetaxine to come to market while the drug manufacturer (ChemGenex) works with labs to standardize mutation testing.
This is critical to patients who harbor these mutations. We don't know what causes this mutation and can't predict who will develop it, so this could be the fate of any CML patient, including me. Not having a treatment available could be life-threatening.
Please visit the US and Canadian websites and visit the petition page to read more about this
important situation and consider providing support by signing the petition. I would also be happy to discuss this with you through a direct message through the EmpowHER site.
Thank you!
United States http://www.nationalcmlsociety.org/
Canada http://www.cmlsociety.org/
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Add a Comment2 Comments
Pat, I'm signing the petition and sharing with my network. I know what it means to discover treatments that could help these catastrophic illnesses, only to find that they're stuck in the approval process. I hope the best for you and others coping with CML. Thank you for informing us. Annette
May 25, 2010 - 9:55pmThis Comment
Pat, I'll be happy to sign the petition and I thank you for your post here. Seems like an odd change midstream for the FDA, especially since standardization in other tests/medications hasn't happened yet. Thanks so much.
May 27, 2010 - 8:31am