Washington, DCThe recent decision by the US Food and Drug Administration (FDA) to withdraw the approval of the anti-cancer drug Avastin for breast cancer due to Avastin side effects has its critics. Senator David Vitter and Representative Rodney Alexander, both of Louisiana, have likened the decision to rationing and the FDA to a "death panel" that decides who lives and who dies.
However, a study released February 2 in the Journal of the American Medical Association (JAMA) found that 2.5 percent of patients taking Avastin and undergoing chemo died, compared with 1.7 percent of those taking chemotherapy alone, an increased risk of 47 percent.
Nearly a quarter of patient deaths involving Avastin and chemo were due to severe bleeding, the analysis found. Another 12.2 percent died because their treatment destroyed infection-fighting white blood cells.
USA Today reported in January that Avastin won fast-track approval in 2008 to treat advanced breast cancer in combination with the chemotherapy drug Taxol. This, in spite of an FDA advisory panel voting 5-4 against approval a year earlier. Nonetheless, the FDA based its approval on a study that showed bevacizumab Avastin slowed tumor growth for longer periods than simply using chemotherapy alone.
However the approval was based on the requirement that Avastin manufacturer Genentech demonstrate that survival rates could improve through the use of Avastin, over and above the use of Taxol alone.
Three subsequent studies concluded that while Avastin did, indeed, slow tumor growth, the drug did not necessarily improve survival.
And then there are the Avastin side effects: heart attack, stroke, severe high blood pressure, holes in the intestines, blood clots, brain swelling, headaches and confusion. In two studies, Avastin users exhibited higher risk of dying from treatment side effects than other participants.
Dr. Shenhong Wu and colleagues studied 16 clinical trials involving more than 10,000 patients who received an Avastin/chemo combination. "We initially thought this drug was less toxic," said Wu, in comments published February 2 in Newsday. Dr. Wu still prescribes Avastin for some patients and noted that treatment-related toxicity is a problem with more conventional cancer drugs.
Even so, the FDA began the process in December to remove the approval of Avastin. Genentech has appealed the decision.
Christie Bowen is a breast cancer patient who was prescribed Avastin and Taxol. USA Today tells the story of how Bowen seemed to be doing fine on the drug until the morning she awoke to an incapacity to dress herself or even walk. Bowen suffered seizures as her husband got her to the car for the drive to hospital. The fear was that her breast cancer had spread to her brain.
But it wasn't that at all. Bowen was diagnosed with a rare, albeit serious neurological condition linked to Avastin.
For now, Avastin injection is still approved and remains viable until the approval is withdrawn. "If somebody's on the drug and they seem to be stable, it shouldn't be withheld from them now," says Mark Pegram, director of the University of Miami's Braman Family Breast Cancer Institute, in comments published in USA Today January 5. But Pegram says the research findings have dissuaded him from starting patients on the drug. He had a cancer patient die from a perforated ulcer while taking Avastin.
Any forthcoming Avastin lawsuit may be double-edged: allegations that the drug caused harm through Avastin side effects, coupled with the approval of a drug in spite of the recommendation of an FDA advisory panel against approval, only to withdraw the drug after (some) patients had come to depend on it. To this end, forthcoming Avastin news could be varied.
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