The Food and Drug Administration plays an important role in the world of medicine, specifically in drug approvals with credibility being like a vital organ. The FDA is constantly being challenged by advocacy groups, doctors, patients and caregivers demanding answers. One of these groups is CareToLive, a non-profit organization that came into existence as a patient advocacy group. They filed suit against the FDA over the lack of the approval of Provenge, a cancer vaccine manufactured by Dendreon to help fight prostate cancer.
CareToLive spokesman Mike Kearney discusses recent controversy over disapproval of Provenge. He also comments on how terminally ill patients access immunotherapies. Prostate cancer patients, Ted Girgus and Eduardo Garcia, share their stories in hopes of helping all of us understand why they both desperately seek FDA approval of Provenge. Ultimately, the goal is to rebuild the immune system to fight cancer; the current method of treatment is chemotherapy, which kills bad cells but also the good cells.
Andrew leads the discussion with an emphasis on obstacles that delay approval for drugs that seem to help patients substantially, but contrary to that might be getting approved too easily.
A critical point is the suggested evidence from previous clinical trials that Provenge works, which is why CareToLive is fighting the FDA for approval of this drug. CareToLive is made up of a myriad of people, patients, their families, doctors, lawyers, scientists, investors, and people who care to fight cancer. The underlying goal of this program is to give hope to patients and assist in getting safe and effective immunotherapy to patients who have no other options.
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