Statement of Diana Zuckerman, Ph.D. President, National Research Center for Women & Families Presented by Paul Brown, Government Relations Manager At the FDA’s Oncologic Drugs Advisory Committee meeting on Avastin

July 20, 2010

I am Paul Brown, and I am glad to present the testimony of Dr. Diana Zuckerman, president of the National Research Center for Women & Families and our Cancer Prevention and Treatment Fund.

Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research.  We do not accept contributions from companies that make medical products, so we have no conflicts of interest.

Dr. Zuckerman is also a fellow at the University of Pennsylvania Center for Bioethics.  Her perspective is as a researcher who was previously on the faculty at Yale and Vassar, was trained in epidemiology at Yale Medical School; conducted research at Harvard, and worked on health issues in Congress, at the Institute of Medicine, and for nonprofit organizations.

We had hoped that new research would support the FDA’s decision to give Avastin accelerated approval for first line breast cancer treatment in 2008.  The drug showed promise in an open-label trial, in terms of progression free survival but not overall survival.

As you can see in FDA’s summary, these two new placebo controlled trials indicate that the drug has a much more modest effect on progression free survival than was claimed in 2007, and no improvement in overall survival.  In fact, the placebo patients tend to do better in overall survival.

Simply put, the patients are dying of other causes related to serious adverse reactions such as heart attacks, strokes, and gastro-intestinal perforation.  Even when these are not fatal, it has a terrible impact on the cancer patient’s quality of life.

Metastatic breast cancer is not curable and most people live less than 2 years, so if treatment can’t prolong survival then the focus on treating these stage 4 breast cancer patients needs to be quality of life.

Avastin does not improve either the quantity or quality of life of breast cancer patients, according to these two studies.  It may shorten survival and it certainly harms the quality of life.

In 2007, this Advisory Committee recommended against approval for Avastin but FDA approved it anyway.

We urge you to set the record straight - send the FDA a clear message that this Committee is putting public health first. It is clear that the benefits do not outweigh the risks and that the indication for treatment of metastic breast cancer should be REMOVED from the Avastin label.