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Patient Advocates Take On the FDA
FAMEDS & Genentech Fight for Avastin

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A conversation with Terrence Kalley (see bio), founder of Freedom of Access to Medicines (FAMEDS), regarding patient advocacy and his organization's fight against FDA's plans to remove the metastatic breast cancer indication for Avastin, a biologic drug produced and marketed by Genentech/Roche.

Aired LIVE on: Thursday, May 5, 2011

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Background

FAMEDS was founded by Terrence Kalley in order to fight for the right of all women to have access to the drug Avastin in their fight with the incurable disease, metastatic breast cancer. Mr. Kalley's wife, Arlene has been an Avastin patient for more than two years and her medical team ascribes her longevity and quality of life to Avastin. When the FDA announced that it was withdrawing approval for Avastin after granting it previously on an accelerated basis, he was outraged. "Denying Avastin to these woman is akin to denying someone food and water. It is inhumane and uncivilized. It's completely un-American. A woman's right to choose with her physician the best medical options for her went out the window. The most fundamental of rights, the right to one's own life, was dismissed with contempt by the FDA. What happened to inalienable rights to Life, Liberty and the Pursuit of Happiness? "

His outrage only grew when the FDA announced a hearing for Avastin on June 28th and 29th, 2011 where Avastin's manufacturer, Genentech, will challenge the FDA in what is essentially the Avastin women's last chance before their death sentence. Amazingly, the FDA appointed the same panel to hear the appeal that had ruled against Avastin originally. To add to the indignity, no Avastin patient will have the right to address the hearing.

When he heard this, he knew that he had to act. Although others had been active in various arenas, he could not find any organization or website focused on helping the Avastin woman. So he established FAMEDS to fill this void.

Questions/Topics To Be Discussed

  • Please fill us in on FDA's plans to drop the metastatic breast cancer (MBC) indcatioon for Avastin. Why does it want to do this?
  • Tell us a little more about FAMEDS, where it gets its donations, and any relationship the organization has with the drug industry.
  • What is FAMEDS doing to "Take on" the FDA regarding this issue? Are there other patient advocates for Avastin that you know of? Does FAMEDS plan to be at the upcoming FDA hearing in June? Will FAMEDS and other patient advocacy groups be allowed to speak at that hearing?
  • What qualifies patient advocates and organizations like yours to question the scientific evidence FDA uses to approve or removal approval of drugs?
  • Tell us more about FAMEDS online campaign that includes a website, Tweeting, Facebook activities, LinkedIn networking, YouTube videos and blogging.


Guest Bio

Terrence Kalley Terrence Kalley is the founder of Freedom of Access to Medicines and President at Bright Solutions International LLC. See his LinkedIn profile for more information.


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