Strategic Priority: Advocate for more effective and less toxic breast cancer treatments by shifting the balance of power in the Food and Drug Administration’s drug approval process away from the pharmaceutical industry and toward the public interest.

by Lisa Wanzor, Associate Director

Since Breast Cancer Action’s first days, the organization has been on the forefront of applying a critical analysis to current and emerging treatments and medical devices used in breast cancer. BCA’s founders honed their skills on the science of breast cancer, sharpened their critical analysis of clinical trial data, and raised advocates’ voices at federal government agencies where cancer policy was being made. These efforts drove the mission of BCA then as it does now.

One of BCA’s new strategic priorities is a fine-tuning of our founders’ vision. Only one of our founders is alive today, but we are pleased to honor the vision they set forth nearly two decades ago. Continuing our watchdog role, BCA will advocate for more effective and less toxic breast cancer treatments by shifting the balance of power at the FDA away from the pharmaceutical industry and toward the public interest. The FDA must act with integrity and without conflicts of interest to be the strong and effective agency that patients need it to be. BCA’s independence from pharmaceutical company funding puts us in a unique position in the breast cancer movement to advance this ambitious goal. BCA has always put the needs of women with breast cancer first, and we will continue to work to assure that the FDA does the same.

And there is clearly work to be done. In early 2008, the FDA allowed fast-track approval of Avastin as a breast cancer treatment. At that time, the drug was already approved as a lung cancer treatment and was being prescribed off-label for breast cancer patients. Even though the FDA found that no survival data were available and that data showing improvement in quality of life were not sufficient, Avastin was granted fast-track approval by the FDA. Fast-track approval means that its manufacturer, Genentech, will need to provide additional supporting data in the future. Studies have indicated that Avastin might be helpful for women with metastatic breast cancer, but the data do not show this yet. BCA believes that drugs should be approved only if they improve overall survival or quality of life, or if they cost less and are as effective and safe as current treatments. The current data available for Avastin do not show this, but with fast-track approval of the drug, Genentech’s stock price soared.

Erythropoiesis-stimulating agents (ESAs), on the other hand, had long been approved for anemia in cancer patients undergoing chemotherapy. New data in 2007 indicated dangerous side effects for some cancer patients. The data also produced some debate about whether the drugs were harming or helping cancer patients. BCA applauded the very complicated ruling issued by the FDA restricting the marketing of ESAs for certain cancers, including breast cancer. ESA manufacturer Amgen’s stock prices plummeted.

Hormone therapy (HT) had long been questioned by BCA as increasing breast cancer risk, though prescribed by many doctors for women entering menopause. Finally in 2002, the news hit the headlines that HT was increasing the risk of breast cancer. Wyeth, the HT manufacturer, was forced by the FDA to add a warning label, and HT sales stopped in their tracks. Some researchers have attributed the recent dip in breast cancer incidence rates to the reduction of HT taken by older women since these data were released.

Clearly, the FDA’s decisions have major implications for drug companies and for patients as well. With this in mind, BCA and many others have grave concerns about the independent functioning of the FDA when it is heavily funded by the companies that it regulates. For these reasons, much work remains to be done as we strive for more effective and less toxic treatments for breast cancer patients. BCA will remain a respected voice offering a crucial public health and patient perspective to counter the hype of pharmaceutical press releases and attention-grabbing news headlines. BCA will continue to work toward a future when all patients have access to and receive the gold standard of breast cancer treatment no matter their income, insurance status, ethnicity, or any other factor. In the meantime, BCA renews its efforts to free the FDA from pharmaceutical interests, enabling the FDA to fulfill one of its most important obligations—protecting patients. BCA’s plan is to educate its members about the FDA while identifying the opportunities where public pressure can compel change. In our role as a watchdog, BCA will continue to provide analysis and comment when drug and device applications are being reviewed. We will expose decisions, structures, and policies that seem more aligned with the interests of the pharmaceutical industry than the interests of patients and work to change them. We will also build alliances with organizations sharing these common goals. Increasing BCA’s presence in Washington, D.C., we will be better poised to advocate for public health-centered policies. With allies and a growing membership our voice will be stronger. The future of breast cancer treatment is in your hands. Together, we can affect positive change at the FDA.

Please join us.

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