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Presentation to FDA Hearing on Avastin, June 28, 2011

Presentation to FDA Hearing on Avastin, June 28, 2011. Presenter: Terrence D. Kalley Husband of Arlene Kalley, Avastin patient Founder, Freedom of Access to Medicines, the only organization dedicated to advocating for the Avastin women. Arlene Kalley My wife is not a statistic!.

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Presentation to FDA Hearing on Avastin, June 28, 2011

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  1. Presentation to FDA Hearing on Avastin, June 28, 2011 Presenter: Terrence D. Kalley • Husband of Arlene Kalley, Avastin patient • Founder, Freedom of Access to Medicines, the only organization dedicated to advocating for the Avastin women

  2. Arlene KalleyMy wife is not a statistic!

  3. . Unless you have witnessed a loved one battle metastatic breast cancer, you cannot know the pain and anguish of these Avastin women …

  4. FDA’S Process is Inhumane • Undignified • Beyond the norms of a civilized society • Cruel & unnecessary

  5. Utter FDA & CMS Indifference To Patient Needs The Past 11 Months • Total government silence: • Fate of current Avastin patients regarding their medication (FDA) • Medicare coverage after the FDA decision (CMS)

  6. A precious moment with our daughter Leila, thanks to Avastin – Go Gators!

  7. FDA Policy is Trumping Humanity • The FDA’s crushing of Avastin to signal the elimination of accelerated approval ignores 17,500 American lives

  8. Super Responders Exist • Most likely explanation: Avastin works exceptionally for one or more subpopulations of women with metastatic breast cancer

  9. Study the Super Responders = Good Science • Good science looks at all evidence, giving a lesser weight to anecdotal evidence but not excluding it

  10. THE SUPER-RESPONDERS CANNOT BE SEEN IN THE AGGREGATE DATA USED BY THE FDA – THEIR EXISTENCE IS HIDDEN

  11. WHEN ALL DATA POINTS FOR INDIVIDUAL PATIENTS ARE SHOWN (IN ADDITION TO THE MEDIAN), SUPER-RESPONDERS ARE NO LONGER HIDDEN & THEIR EXISTENCE IS READILY EXPLAINED

  12. Lack of Proof • Good scientists know that the absence of evidence is not the evidence of absence • Simply because biomarkers for super-responders have yet to be identified, does not mean that they do not exist

  13. Right to Choose & Right to Life Threatened • Deprive women of their right to choose their life-saving medication today, what’s next tomorrow?

  14. Trip to California - $1500, Day at the Park - $150. The benefits of Avastin - priceless

  15. The Loss of Avastin Coverage is Real & The Biggest Threat • Only the wealthy will have access to Avastin • *December, 2010 - Palmetto cuts off Medicare coverage for Avastin • Insurance companies waiting to cut coverage for Avastin based on the outcome of this hearing • *Reversed later

  16. Freedom of Information Act Request of FDA Unanswered on Key Issues • What is the FDA hiding and why? • www.fameds.org

  17. Battle to Continue if FDA Takes Avastin Off Label • Avastin advocacy to continue until all current Avastin patients keep Avastin & their current insurance coverage • CMS & insurance companies next in advocacy campaign, if necessary

  18. 26th Wedding Anniversary– thanks to Avastin

  19. “The greatest risk to my health from Avastin is its unavailability” – Arlene Kalley

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