YouTube plea helps patient get breast cancer drug early


As of this posting, nearly 40,000 people have viewed Darlene Gant's plea to the FDA on Youtube. Gant has metastatic breast cancer that has spread to her liver. She is asking for the release of the investigational drug pertuzumab to her on a compassionate use basis.She writes:"I am stage 4 breast cancer and am in final stages. I have a beautiful son, Cameron age 11 that is watching me die little by little each day, as well as my husband. It is tearing us up and so many other families are going through this too. The most unfortunate part is that there is a very promising drug for me, Pertuzumab that the FDA is just sitting on since December and does not plan on releasing it until June 2012. I am not expected to make it to June, my liver is engulfed with tumors and I am wasting away. In this video, which we did not plan, I am reading cards that I have filled out for my son from age 12-25 for birthdays, graduation, wedding et.... I am trying to leave him pieces of me to comfort him and let him know how much I love him - he is my world. I can handle dying but not leaving my son. You see I want to finish my mission here and raise my baby to manhood. For years I have watched other women die waiting on the FDA to release a drug that has concluded all their trials and data and they would not give the drug for compassionate use then either. I do NOT qualify for any trials as my disease has progressed to much. We must stand together and not let anyone else die WAITING. Please help by passing on this video link and writing to your local congressman or senator. Support the NBCC, National Breast Cancer Coalition as they are fighting for us and with us to make compassionate use a standard. It may be too late for me but there are so many others waiting and yet to come. Blessings."Pertuzumab, which is expected to be approved by the FDA this summer, has been shown to delay disease progression in women with HER2-positive breast cancer, but it's not known if it will work for Gant's cancer. However, after weeks of public pleas, most likely generated by her video, Genentech, the drug's manufacturer, has allowed Gant to receive it before final FDA approval. (The FDA also approved the compassionate use of the drug.)There are a lot of questions raised by Gant's case: Why does the FDA wait on approval decisions when it is apparent some drugs are better than what's available (pertuzumab was given priority review, which means it was reviewed much faster than the traditional route)? Is the use of social media appropriate in asking for compassionate use (when typically it is the patient's physician who works with the pharmaceutical company to get access)? And can anyone fault a patient for trying each and every way to cure their disease? What would you do?

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