Anyone who has been diagnosed with cancer knows the importance of having an arsenal of therapeutic weaponry. So why are federal officials asking patients with advanced breast cancer to unilaterally disarm?
The weapon in jeopardy is Avastin, a biologic drug that cuts off the blood supply to tumors. Clinical studies prove that for women with stage 4 breast cancer, Avastin buys them weeks or months in which the cancer doesn't spread.
But the Food and Drug Administration isn't satisfied this time is “enough,” and will decide by Dec. 17 whether to revoke its approval of Avastin as a treatment for breast cancer.
Patients and their doctors have proclaimed they should decide what constitutes “enough.” Cancer treatment can't be one-size-fits-all. Some research has found, on average, Avastin doesn't prolong life. But scientists universally agree that it does prolong the quality of life. One study demonstrated that Avastin plus chemotherapy delayed tumor growth a median of about 11 months — five months longer than chemo alone.
Focusing only on averages ignores patients that are “super-responders.” Erin Howarth, was 31 when she learned her stage 4 breast cancer had spread to her spine, skull, pelvis and right leg.
“I got the impression that it was just like, ‘Well, you're going to come here for chemo every week . kind of until you die,'” Howarth told a newspaper.
But she sought out other doctors who put her on Avastin. Within seven months, her cancer was in remission. Labeling herself the poster child for Avastin, she concluded “it worked really well for me.”
Susan G. Komen for the Cure and Ovarian Cancer National Alliance wrote to the FDA urging them to preserve Avastin. They contended that removing it from the FDA's list of approved drugs for breast cancer could discourage future drug development.
Since the FDA fast-tracked approval of Avastin two years ago, it has been prescribed to about 17,500 patients a year with metastatic breast cancer.
This summer, a 13-member FDA advisory panel — with only two breast cancer oncologists — recommended that the FDA withdraw its approval of Avastin for breast cancer patients.
Doctors could still prescribe Avastin without FDA approval by going “off label.” But if the FDA revokes its breast cancer seal of approval for Avastin — insurance companies, Medicaid and Medicare are also likely to deny coverage.
The latest vote of confidence in Avastin comes from the National Comprehensive Cancer Network — a not-for-profit alliance of nearly two dozen of the world's top cancer centers. Last month, they announced it had reviewed and affirmed its guidelines for using Avastin to treat metastatic breast cancer.
The FDA should listen to these experts, and to patients. Avastin may well be the best weapon they've got to fight cancer — and the government shouldn't take it out of their hands.
