Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, December 16, 2010
FDA made the right decision in starting the process to remove the breast cancer indication for Avastin. We commend the FDA for carefully considering the concerns of patients currently on Avastin who believe that Avastin has helped them, but ultimately, FDA’s decision needs to be based on science. Scientific research results are clear: Avastin doesn’t prolong survival — the data show it often reduces survival. And, Avastin has potentially terrible side effects that harm patients’ quality of life. Painful and potentially deadly perforations in the nose, stomach, and elsewhere are clearly a result of the Avastin, for example.
We hope that the FDA will move quickly to ensure that breast cancer patients are not harmed by Avastin. We urge the agency to stick to the science and not be intimidated by the company or by those who don’t understand the need for scientific decision-making. The company has made a lot of money selling Avastin to breast cancer patients, and they will fight the FDA’s decision with well-paid lobbyists and multi-million dollar public relations efforts. Breast cancer advocates need to see through those lobbying and PR efforts, and help the FDA finalize their decision and thus safeguard patients’ lives and the quality of their lives.
We agree with the FDA that research is needed to figure out if there are breast cancer patients who can be identified as most likely to benefit from the drug. If Genentech can identify a subgroup of patients who have a high likelihood of success and low risk of harm, FDA can consider an approval decision just for those types of patients.