Avastin ruling evokes support, dismay

The FDA's decision to revoke Avastin's approval for advanced breast cancer treatment dismayed some local advocates but served as a reminder to others how the regulatory process weeds out medications that don't work for everyone.

Ushered into cancer therapy on a wave of promise seven years ago because it chokes off a tumor's blood supply, Avastin has been embroiled in controversy because it works in some patients, but not in others.

"I am devastated by this decision. No one heard us," said Patricia Howard, who retired last year to Florida after 21 years as a Smithtown teacher. She said that she has been taking Avastin for advanced breast cancer since 2008 and has thrived on it.

Howard testified before an FDA committee last year, asking panelists to keep the drug on the market.

Hillary Rutter, director of the Adelphi NY Statewide Breast Cancer Hotline and Support Program in Garden City, said scientific studies conclusively showed Avastin doesn't extend lives and is also capable of causing harm.

Stony Brook University studies in recent years have demonstrated Avastin can lead to hemorrhaging, intestinal perforation and kidney damage in some patients.

"I know there will be women who are devastated by this decision, but you have to go with the science," Rutter said. "This is very similar to what happened with bone marrow transplants in the 1990s."

Two decades ago, anecdotal data suggested bone marrow transplants extended lives of patients with advanced breast cancer, but randomized clinical trials showed the opposite.

In Manhattan, advocate Musa Mayer, director of AdvancedBC.org, an online community of 1,500 women with metastatic breast cancer, is also pleased with FDA Commissioner Margaret Hamburg's decision Friday.

"It makes me feel really good that such a thoughtful person is FDA commissioner," Mayer said. "This is really good news.

"You cannot leave drugs on the market that only benefit a few people when the scientific evidence does not show a benefit for everybody."

Still, revoking Avastin's breast cancer approval only deepened the divide in the advocacy community.

"It ticks me off," said Lorraine Pace, co-president of Breast Cancer Help in Bay Shore. "I know a lot of women with metastatic disease, but unfortunately they're not with us anymore. If there's a medication that's out there, people should have access to it."

Great Neck breast cancer specialist Dr. Frank Arena was saddened by the decision. "This drug is not a perfect home run," he said. "But one has to question how the European Union could approve it based on the same clinical trial."