Tomorrow, the Food and Drug Administration could inflict a gross injustice on American patients. The agency is expected announce it is revoking approval of the biopharmaceutical Avastin for the treatment of late-stage breast cancer.
In the two years since the FDA initially approved Avastin, the drug has been prescribed to about 17,500 breast cancer patients annually. In August, though, an FDA advisory panel recommended the agency "de-list" Avastin for breast cancer, arguing that the drug doesn't grant "enough" extra time for the average breast cancer patient.
Patient and doctor groups across the country, including the Susan G. Komen Foundation and the Ovarian Cancer National Alliance, protested the recommendation. Those pleas appear to have fallen on deaf ears. The FDA has until tomorrow to make the panel's recommendations official. And all signs indicate agency officials have been persuaded that Avastin should be de-listed, primarily because of the severity of the drug's side effects and the limits of its improvements on patient lifespan.
Every year, about 40,000 women die from breast cancer. Avastin, which fights cancer by cutting off the blood supply to tumors, has been shown to delay the advance of cancer for weeks, months, and sometimes even years.
In fact, one of the very studies on which the advisory panel based its recommendation found that the average Avastin breast cancer patient has about three extra "progression-free" months, compared to those without the drug.
Another study found that Avastin, in combination with chemotherapy, holds off tumor growth for about 11 months for the average patient -- or about five months longer than chemo alone. And a survey of about 500 breast cancer patients between the ages of 40 and 64 found that Avastin provided nearly six months of additional life.
There's also a select set of "super responders" who receive abnormally large benefits from Avastin. As Eric Winer, the director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston, has put it: "There is almost certainly a group of women who get a big benefit" from the drug.
One such super responder is Florida native Erin Howarth. Ms. Howarth was just 31 when she was diagnosed with stage IV breast cancer. "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,' " she told a Florida newspaper.
But she found a doctor to prescribe her Avastin. Within seven months, her cancer was in remission.
For super responders like Ms. Howard, alternative medications to Avastin likely won't be as effective. A denial from the FDA could literally rob them of years of life.
Medical decisions need to be left to patients and their doctors. They're the ones with access to crucial information needed to make the right decision about treatment options. Conceiving of medicine as one-size-fits-all, as the FDA Avastin ruling could do, is simply dangerous and ignores the individual biological nuances inherent in the U.S. patient population.
Of course, doctors could still provide Avastin for breast cancer treatment by prescribing it "off label." But an FDA denial means that public insurance programs like Medicaid and Medicare could refuse pay for the drug. Private plans would almost certainly follow suit.
In fact, evidence suggests that insurance companies are rooting for the FDA to de-list Avastin for advanced breast cancer. Already, the Regence Group, a regional health insurer in the Pacific Northwest, has published a policy listing Avastin for breast cancer as "medically unnecessary." And this policy was applied retroactively!
Without insurance coverage, patients would have to bear the full brunt of Avastin's price tag, which typically runs about $8,000 a month. Technically, women would still have access to this life-saving medication. But the only ones who will actually get to use it are the very slim minority with great financial means.
Worse still, revoking Avastin's approval would stifle medical innovation. Virtually every oncologist believes that the future of cancer treatment lies in complex, biologic drugs like Avastin. These kinds of drugs differ from traditional treatments in that they can be hypercustomized to meet the specific medical needs of individual patients. They also tend to be more effective.
By revoking Avastin's approval, the FDA would effectively eradicate the financial incentive for drug companies to develop advanced treatments like it. We'd lose out on an entire generation of cures.
Avastin has given life and hope to tens of thousands of American women. It shouldn't be on the chopping block.