To Whom It May Concern,
This letter comes to you with great concern of the FDA’s Dec. 16, 2010 decision to stop the approval of the drug “Avastin” as a line of targeted therapy for stage four breast cancer women. The FDA continues to stand on their grounds saying that “cost” was not a factor in their decision and giving them the benefit of the doubt, I can appreciate that this was not a deciding factor. However, the FDA does go on to say that their decision was based on the fact that the studies did not show a long enough survival time in the women taking Avastin to justify the risk involved. The FDA stated that they were looking at targeted results of women surviving an extra 5 to 11 months on the treatment, but the results came in with the results of 2 weeks to 5 months of extended life.
My concern is the following: Does an expansion of any time in ones life not hold great value, especially given the fact that the drug “Avastin” provides women with a quality of life during a horrid and grim diagnosis? Who should be given the opportunity to decide how long a person must live to justify administering a particular drug to them? Shouldn’t this remain in the hands of the doctors and patients to decide? Women fighting stage four breast cancer understand that all of their weapons to fight the disease have life threatening side effects that come along with treatment. The patient and the doctor are responsible to make this decision for themselves and to monitor the progress and any side effects that may arise due to the treatment. The truth is, when someone is faced with stage four cancer, side effects aren’t at the top of their list of concerns.
Please look into this decision that the FDA has made. The FDA is in the process of deciding to allow the appeal of Genetech to plead their case. The FDA’s decision to stop allowing Avastin to be used as a line of therapy for stage four breast cancer is a huge step backwards in cancer research. Please take into consideration that this should remain in the hands of the doctors and patients individualized care, not government. Many lives are depending on this drug. Hundreds, if not thousands of women, have been LIVING with stage four cancer for two years now because of a miracle drug called “Avastin.” Please don’t take this drug from their lives.
As far as the side effects, yes, Avastin does have some serious side effects. But lets be honest here and look at all chemotherapy drugs. They all hold the potential of deadly side effects. Once again, this is the job of the Doctors to decide what would be the best drug for the patient.
Please let our concerns be heard.
Sincerely,
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