FDA Says it is Harmful, Breast Cancer Advocates Say it saves Lives

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By US Daily Review Staff.

Breast cancer patients, their families and advocates expressed extreme “disappointment” at the recent Food and Drug Administration (FDA) decision to remove the anti-cancer drug Avastin from the approved medication list for treatment of late stage breast cancer.

Terry Kalley, founder of the Freedom of Access to Medicines (FAMEDS), condemned the decision, saying, “While this vote is highly disappointing, it wasn’t unexpected, given the FDA’s continued, closed-minded opposition to the continued use of Avastin for treatment of metastatic breast cancer.”

Kalley, whose wife has late stage breast cancer and has been immensely helped by Avastin, criticized the FDA Commissioner for lacking the resolve to override her career staff. “The Commissioner lacked the courage to make a decision for the benefit of American women. Instead she caved in to the internal pressure within the FDA. It is impossible to see how the health care of Americans is improved by limiting their choices.”

Kalley pointed out that women in Japan and the European Union will have access to the life-saving drug, while American women will be denied this drug, invented in the U.S. “Is this the new America where the critically ill are denied care and coverage to pay for the other excesses of government?”

“The wealthy will find ways to obtain Avastin, while the rest will be rationed according to their health insurance coverage,” Kalley continued. “As a consequence of this decision, women will die because this option has been denied patients and their physicians.”

The FDA commissioner, Dr. Margaret A. Hamburg, said that clinical trials had shown that the drug was not helping breast cancer patients to live longer or to meaningfully control their tumors, but did expose them to potentially serious side effects like severe high blood pressure and hemorrhaging.

The United States has the most stringent drug approval laws in the world. The upside to such is that many potentially harmful drugs (or ineffective ones) from reaching the market. The downside is that many of these drugs are proving successful in other parts of the world. For example, Avastin is well received in Europe and Asia. For those who are terminally ill, there is an ethical concern about preventing such patients any opportunity to try and recover.