Navigation Links
Breast Cancer Patients and Families Decry FDA Panel Vote to Remove Life Saving Drug From Approved List
Date:6/29/2011

SILVER SPRING, Md., June 29, 2011 /PRNewswire-USNewswire/ -- Breast cancer patients and their families expressed extreme disappointment at today's Food and Drug Administration (FDA) decision to remove the anti-cancer drug Avastin from the approved medication list for treatment of late stage breast cancer.

Terry Kalley, founder of the Freedom of Access to Medicines (FAMEDS), condemned the decision, saying, "While this vote is disappointing, it wasn't unexpected, because of the six voting members on today's panel, five of them are already on record as opposing the continued use of Avastin for treatment of breast cancer."

Kalley, whose wife has late stage breast cancer and has been immensely helped by Avastin, criticized the FDA panel's makeup as lacking expertise in the area of breast cancer.

"This panel that has passed judgment on a life or death matter with breast cancer should have been made up of breast cancer specialists and oncologists, but it had zero breast cancer specialists or oncologists on it.  But we had breast cancer oncologists testifying on our behalf yesterday to keep patient access to Avastin," Kalley said.  "Additionally, this panel was handpicked by FDA Director of the Office of Oncology Products, despite rules that the panel must be independent of him.  Nothing in this panel's process seems impartial or fair."

Kalley pointed out that the FDA dismissed anecdotal evidence when listening to super-responding patients give their stories of survival, but then later used anecdotal evidence to help make its case against using Avastin for breast cancer patients.  He asked FDA Commissioner Margaret Hamburg, who will make the final decision on Avastin, to continue allowing breast cancer patient use of the medication.

"We appeal to FDA Commissioner Margaret Hamburg to correct this grave injustice and do the right thing by extending the label for Avastin to provide continued coverage for metastatic breast cancer," Kalley said.

For more information on FAMEDS and the stories of breast cancer Avastin patients, go to www.fameds.org.

CONTACT: Terry Kalley

248-761-8215


'/>"/>
SOURCE Freedom of Access to Medicines
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Breast Cancer Patients and Families Stand Up To FDA
2. Ventana Medical Systems, Inc. Receives FDA Approval for the First Fully Automated Diagnostic Assay for HER2 Gene Status Determination in Breast Cancer Patients
3. FDA Approves New Test To Help Determine if Breast Cancer Patients Are Candidates for Herceptin Treatment
4. Data from Clinical Studies of bioTheranostics CancerTYPE ID® and Breast Cancer Index(SM) Molecular Diagnostic Tests Presented at ASCO 2011 Annual Meeting
5. Precision Therapeutics Demonstrates Utility of Multi-Gene Predictors in Predicting Chemotherapy Response for Breast Cancer Patients
6. NKTR-102 Demonstrates Sustained Clinical Benefit in 46% of Patients with Metastatic Breast Cancer in Data Presented at 2011 American Society of Clinical Oncology Annual Meeting
7. Genomic Health Presents Ten New Studies in Breast, Colon and Prostate Cancers at the American Society of Clinical Oncology (ASCO) Annual Meeting
8. MD Anderson and Biocept Scientists to Present Poster at ASCO on Disseminated Tumor Cells (DTCs) in Bone Marrow and Circulating Tumor Cells (CTCs) in Blood in Early Stage Breast Cancer Patients
9. The World Leader in Molecular Breast Imaging to Premiere Largest Detector in the Industry
10. Tigris Pharmaceuticals Initiates Randomized Phase 2 Study of AFP-464 in ER-Positive Breast Cancer Patients
11. Nexavar in Combination with Chemotherapy Improves Progression-Free Survival in Patients with Advanced Breast Cancer in Phase 2 Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2017)... Sept. 19, 2017   ZirMed Inc ., a recognized ... announced that it has been ranked #1 by its users ... Rankings 2017 User Survey. ZirMed was recognized as the ... hospitals and medical centers over 200 beds and holds one ... technology user survey history. ...
(Date:9/18/2017)... 18, 2017 EpiVax, Inc. ("EpiVax") ... and immune engineering, today announced a new ... (H7N9) vaccine. ... influenza and presents a challenge for traditional ... to be effective. Using state-of-the-art bioinformatics and molecular ...
(Date:9/12/2017)... YORK , Sept. 12, 2017   EcoVadis , the leading ... has published the first annual edition of its Global CSR Risk and ... companies evaluated by EcoVadis, based on Scorecard Ratings that analyzed nearly 800,000 ... ... Index ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ProVest ... the greater Dallas, Miami, and Raleigh regions, is organizing an extended charity drive ... rare and deadly chromosome abnormality. , After struggling since birth with several health ...
(Date:10/13/2017)... ... , ... While it’s often important to take certain medications during the night, ... has identified a solution. , She developed a prototype for MOTION LIGHT-UP PILL BOX ... eliminates the need to turn on a light when taking medication during the night, ...
(Date:10/13/2017)... ... ... PurhealthRX , a leading Health and Nutrition Company, is announcing the ... spectrum CBD oil will revolutionize the rapidly growing CBD market by reducing the amount ... into liquid products, while reducing costs to end users. , The team of researchers ...
(Date:10/13/2017)... CT (PRWEB) , ... October 13, 2017 , ... ... long-term care services, staged a mock evacuation of the facility as part of a ... Shelton Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Ellevate Network, ... in business to advocate for action towards gender equality at their inaugural Summit in ... around the globe, and reached a social audience of over 3 million. To watch ...
Breaking Medicine News(10 mins):