Local couple fighting FDA over cancer drug Avastin
6:39 PM, May 26, 2011
9:41 PM, May 26, 2011
TROY, Mich. (WXYZ) - Arlene Kalley of Troy has been fighting breast cancer for more than 30 years.
Three years ago it became stage 4, spreading to her stomach and lungs.
The one medication that's helped to reverse some of the cancer, according to her husband Terry, is the drug Avastin.
"We believe it's kept her alive," Terry Kalley told Action News.
The U.S. Food and Drug Administration is in the process of removing its approval of Avastin for metastatic breast cancer. The FDA says the risks outweigh the benefits, and the drug has not been shown to be safe and effective based on its conclusions of four clinical studies. In fact, the FDA says the drug can lead to life-threatening side effects.
"I think the FDA is making a horrible mistake here," Kalley says.
Terry Kalley has made it his mission to fight the government's decision. He has established a website and he's started a non profit called Freedom of Access to Medicines.
A hearing is scheduled in June. Kalley hopes to make a personal appeal and will hold a protest outside.
Kalley worries that if the government moves forward with its decision, insurance companies will no longer cover Avastin for patients with metastatic breast cancer. And the cost could put the drug out of reach for the majority of those who use it.