New at BCA

• December BCA Source Now Online
• New Issue of Saber es Poder: Nueva Edición de Saber es Poder 
• Reports from the San Antonio Breast Cancer Symposium
• New Face at BCA

In the News

• Two New Anemia Drug Studies Indicate Tumor Growth and Patient Death
• Sears and Kmart to Phase out PVC

Take Action

• Tell FDA Commissioner to Deny Avastin for Breast Cancer

Save the Date

• Annual Conference for Young Women Affected by Breast Cancer, February 22-23, Jacksonville, FL
• Reclaiming Our Healthy Future: 26th National Pesticide Forum, March 14-16, Berkeley, CA

FAQ of the Month

• What is the FDA's process for cancer drug approval?

Hot Off the Virtual Presses: December BCA Source Now Online 

The December 2007 issue of the BCA Source is now online and includes coverage of the 2007 ASCO Breast Cancer Symposium, an article by noted writer Barbara Ehrenreich, a profile of BCA's program associate, a news clip on MRIs for breast cancer detection, and an article about the use of acupuncture for the relief of chemotherapy side effects.

New Issue of Saber es Poder: Nueva Edición de Saber es Poder

BCA just produced its newest issue of the Spanish language newsletter, Saber es Poder. This issue features stories on environmental health, including a healthy food choices guide, recipes for home cleaning products, and an interview with a Latina-owned and operated housekeeping cooperative that cleans with safer supplies. You can read it online or contact Pauli Ojea at pojea@bcaction.org to request a copy by mail.

BCA acaba de producir la nueva edición del boletín en español, Saber es Poder. Esta edición trata de la salud ambiental, e incluye una guía para comidas saludables, recetas para preparar productos de limpieza en la casa, y una entrevista con una cooperativa de limpieza, dirigida por Latinas, que limpian con productos más saludables. Puedes leerlo en nuestra página de web o contacte con Pauli Ojea al pojea@bcaction.org para recibir una copia por correo.

Reports from the San Antonio Breast Cancer Symposium

BCA staff and volunteers recently attended the 30th Annual San Antonio Breast Cancer Symposium. Staff's reflections from the meeting are available online.
The March issue of the BCA Source will also feature more detailed conference coverage.

New Face at BCA: Amy Harris, Development Director

Hello, I'm Amy Harris, BCA's new development director. I bring to BCA more than eight years of fundraising experience from nonprofit organizations serving the Bay Area and the Greater Boston Area. I joined BCA because I was struck by the unique and vital way that information about breast cancer is organized, analyzed, and distributed. I feel empowered and honored to be working alongside such talented and passionate volunteers, advocates, and staff members who are striving to end the breast cancer epidemic. I invite you to contact me at aharris@bcaction.org or 415-243-9301 x15.

Two New Anemia Drug Studies Indicate Tumor Growth and Patient Death

The Food and Drug Administration (FDA) announced last week that it is reviewing two new studies that provide further evidence that the anemia drugs known as erythropoiesis-stimulating agents (ESAs) could be dangerous to breast cancer patients who receive them for treatment of chemotherapy-induced anemia.

The FDA says the studies show that patients with breast or advanced cervical cancers who received Aranesp, Epogen, or Procrit died sooner or had more rapid tumor growth than similar patients who did not receive the anemia drugs.

These new studies come on the heels of six other studies--which had similar outcomes--that prompted the FDA in November to order stronger label warnings about the use of ESAs in cancer patients.

The FDA's Oncologic Drugs Advisory Committee will meet in March to review the new data and assess the risks of using ESAs.

Sears and Kmart to Phase out PVC

Sears Holding, Inc. (parent company of Sears and Kmart) announced last month that it plans to phase out the use of polyvinyl chloride (PVC) in its packaging and merchandise, citing the "potential health and environmental risks tied to the manufacture, use and disposal of PVC."

The new policy, posted on the company's web site, also calls on vendors to reduce or eliminate their use of PVC, promises to identify products that are PVC-free, and sets a long-term goal of "sourcing bio-based polymers that are sustainably sourced, have higher recycled content, and can be reused, recycled, or composted."

Learn more about the problem with PVC.

Tell FDA Commissioner to Deny Avastin in Breast Cancer Treatment

FDA Commissioner Andrew von Eschenbach is scheduled to decide next month whether to allow biotech company Genentech to market its drug Avastin (bevacizumab) as a treatment for metastatic breast cancer.

The FDA's Oncologic Drugs Advisory Committee (ODAC) voted last month to deny the application of Avastin for breast cancer. BCA urged ODAC to deny the application, arguing that there is no evidence that Avastin prolongs survival or improves quality of life. BCA also pointed out that the data did not show that the benefits of the drug outweighed the toxic side effects.

Now is the time to urge Commissioner von Eschenbach to follow ODAC's recommendation. Below is a sample letter you can adapt and send to the commissioner and to the head of the Division of Oncologic Drugs, Dr. Richard Pazdur. Please send a copy of your letter to pojea@bcaction.org so we know how many people have taken action.

Contact information:
andrew.voneschenbach@fda.hhs.gov
richard.pazdur@fda.hhs.gov

Dr. Andrew von Eschenbach
Commissioner
Food and Drug Administration
Bldg. PKLN, Mail Stop HF-1
Rockville, MD 20857

Dr. Richard Pazdur
Director, Division of Oncologic Drugs
Food and Drug Administration, HFD-150
5600 Fishers Lane
Rockville, MD 20852

Dear Commissioner von Eschenbach:

I urge you to follow ODAC's recent recommendation to deny Genentech's application to market Avastin as a treatment for metastatic breast cancer.

Genentech should be required to demonstrate that the benefits of Avastin--which should include either improved overall survival of patients, improved quality of life for patients, or both--outweigh the risks from its toxic side effects. Avastin did not appear to do either of these; therefore, it should not be approved as a breast cancer drug.

I hope you will put the needs of patients first, and deny approval of Avastin for breast cancer.

Sincerely,

YOUR NAME

Annual Conference for Young Women Affected by Breast Cancer, February 22-23, Jacksonville, FL

The Young Survival Coalition and Living Beyond Breast Cancer's Annual Conference for Young Women Affected by Breast Cancer is the only international event focused on the unique needs and issues faced by young women who are diagnosed with breast cancer. Created by young women for young women and their caregivers, the conference has grown to one of the largest meetings in the world for women with a history of breast cancer. This one-of-a-kind event features educational programming focused on every phase of a young woman's breast cancer journey: from recent diagnosis, to treatment, to living with advanced breast cancer, to post-treatment and years beyond. Learn more and register online.

BCA will be exhibiting at this conference. If you'd like to help BCA staff our table, please contact Pauli Ojea at pojea@bcaction.org. We have one free pass available for a volunteer.

Reclaiming Our Healthy Future: the 26th National Pesticide Forum, March 14-16, Berkeley, CA

Reclaiming Our Healthy Future: Political change to protect the next generation, the 26th National Pesticide Forum, will include sessions on children's health, farmworker justice, fair and healthy food, skills training workshops, and much more. The conference is convened by Beyond Pesticides, Californians for Pesticide Reform (CPR) and Pesticide Action Network North America (PANNA). Learn more and register online. 

What is the FDA's process for cancer drug approval?

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, effectiveness, and security of pharmaceutical drugs. Andrew C. von Eschenbach is commisioner of the FDA as appointed by President Bush.

The approval of cancer drugs falls under the FDA's Center for Drug Evaluation and Research (CDER). Richard Pazdur is the director of the Office of Oncology Drug Products within CDER. The FDA also has an advisory committee called the Oncologic Drugs Advisory Committee (ODAC), whose members include scientific experts, consumers, industry representatives, and patients.

When a pharmaceutical company wants to market a drug for a certain type of cancer, they submit an application to the FDA. The FDA staff reviews the application and does its own analysis of the drug's safety and effectiveness. The FDA commissioner can then decide to approve or deny the drug based on the drug company's application and the FDA staff analysis, or he/she may solicit input from ODAC before making a decision.

If ODAC reviews the application and the FDA analysis, its recommendation then goes to the commissioner, who makes the final decision. The commissioner does not have to follow ODAC's recommendation.

Members of the public can submit comments to ODAC and to the commissioner regarding the approval of drugs. A schedule of the cancer drug applications that are coming before ODAC can be found on the FDA web site. Individuals can also request regular updates from the Office of Special Health Issues Cancer Liaison Program by emailing jminor@oc.fda.gov.

Learn more about the FDA's mission and function.

 -- YOUR INPUT WANTED: Is there a question you want answered, or an issue that you want BCA's opinion on? Send it to info@bcaction.org and we'll try to answer it personally or feature it in a future e-alert!