Anne C. Boudwin, cancer survivor treated with Avastin
In a sign of things to come, members of the Food and Drug Administration’s Oncologic Drugs Advisory Committee voted Wednesday to reject an appeal of its December 2010 recommendation that the FDA withdraw its sanction of Avastin for treatment of breast cancer.
The day before, in what now seems futile, advocates for the drug rallied at the FDA headquarters in Silver Spring, Md., with signs, chants and a folk singer.
Blocked by a team of Homeland Security police officers in combat uniforms, the nearly 100 pink-shirted protesters massed in front of the entrance to the agency’s campus demanding it continue to approve Avastin for metastasized breast cancer.
Standing face-to-face with the on-site commander of the police contingent, which included deputies, keeping the protesters from marching toward the looming edifice 100 yards away, Terrence Kalley, the leader of the protest, said into his bullhorn, “We will continue to obey the law.”
Because Kalley, whose wife, Arlene, is battling metastasized breast cancer, was a scheduled witness to speak to the FDA’s Oncologic Drugs Advisory Committee hearing on Avastin, he was allowed to proceed to the building, after he put down his bullhorn and sign.
Kalley said his mission is to convince the panel to recommend that the FDA continue to sanction the drug bevacizumab, the technical name of Avastin, for the treatment of breast cancer.
If the FDA withdraws this approval, which is also called “unlabeling,” government agencies and insurance companies no longer have the obligation to cover the cost of dosages, which approach $90,000 per treatment-year.
The businessman left the company he built and led for 30 years to fight for the continued labeled used of the drug, he said. “I am coming to beg for them to let my wife live. Nobody should have to beg their government to live.” His organization, Freedom of Access to Medicines, is dedicated to advocating for women using Avastin.
Among the protesters were many women battling breast cancer and members of their families, such as Tracy Galvin. Galvin said she drove with her husband, Martin Galvin, and their two children, Fiona, 5, and 18-month-old Tommy to join the protest and to take part in the Capitol Hill office visits afterward.
“Avastin worked for me. After nine months on Avastin, I am stable,” she said.
The Westlake, Ohio, housewife, said, “I am terrified that I might not have access to this drug and it will be taken away from the 17,500 metastatic breast cancer patients currently benefiting from it.”
Anne Boudwin said she drove from Pennsylvania with her children, Sarah, 13, and 12-year-old Rob to attend the rally and make her case on Capitol Hill.
Riding on the bus chartered by Kalley’s group, Boudwin said she grew up in Dorchester, Mass., and moved her family from Kingston, Mass., to the Keystone State because doctors at both Boston’s Massachusetts General and Beth Israel hospitals refused to treat her with Avastin.
“They gave me a death sentence,” she said.
“In the spring of 2008, I met in Boston with the top breast cancer oncologist in the world, who told me I had 18 months to live because of the aggressive path and nature of my cancer,” she said.
“Yet, here I am—alive and thriving with no evidence of disease. So yes, Avastin, without question, has substantially extended my survival,” she said.
At the Capitol, Boudwin told her story to congressional aides in more than 10 offices—the House is in recess—and left behind an information packet that included a petition with more than 3,000 signatures of Avastin-treated women.
At one office, she said, she found herself pulled around the corner to a private hallway by an aide who lost her own sister to breast cancer. Together the two women cried as they shared the spirit of a battle lost, and a battle still undecided.
Notwithstanding the recommendation to withdraw the Avastin sanction by the FDA’s Center for Drug Evaluation and Research, along with Wednesday’s ruling, the final decision rests with FDA Commissioner Margaret Hamburg. No date has been set.