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Prostate Cancer: Fighting the FDA for your Life

PROGRAM DETAILS:

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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EXPERTS & GUESTS:
Mike Kearney,
Spokesperson
Mike Kearney comes from a family of 12. Cancer touched his life personally when over 40 years ago, at the age of 8, his brother, nicknamed Butch, lost a painful battle with leukemia. Mike's brother died at the age of 15. Mike knew then that he wanted to do something to help avert the suffering that cancer causes but he... more >

Ted Girgus,
Prostate Cancer Patient
Ted is married and has 5 beautiful grown children 4 sons and 1 daughter. Ted has a strong faith based belief in God and is a medically retired VP of Admissions & Marketing from a private college in Santa Barbara California. He also served 8 years in the Air Force from 1961-69. Ted was diagnosed with prostate cancer on Feb.... more >

Eduardo Garcia,
Prostate Cancer Patient
Eduardo received Provenge and has expressed that it changed his life! He flew to Washington, D.C. with his grandsons, George Giacomo and Eddie Garcia Jr., to testify before the FDA Advisory Panel this past March in hopes of the approval of Provenge. more >

TRANSCRIPT:

  1. Introduction
  2. Care to Live Objectives
  3. Is the FDA Approving Drugs Too Easily?
  4. Eduardo Shares How Dendreon has Benefited Him
  5. Ted Girgus Shares His Story
  6. Decision Making by the FDA
  7. How to Participate
  8. Challenging the FDA
  9. What Can We Do to Make Progress?

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