Medical Community Stands Against The FDA On Avastin
The FDA decided in December to revoke approval of the miracle drug Avastin for the treatment of late-stage breast cancer. NCCN has just thrown down, announcing that the organization is standing 100 percent behind its endorsement of Avastin as a breast cancer treatment.
Avastin fights tumors by choking off their blood flow. Combined with the chemotherapy agent Taxol, it has proven to radically slow or even reverse the growth of cancer cells. In 2010, roughly 17,500 breast cancer patients got prescribed Avastin. For a select group of "super responders," the drug has extended their lives as long as multiple years.
The NCCN research team looked at much of the same data FDA officials did but came to a very different conclusion: While Avastin doesn't radically improve the lifespan of all breast cancer patients, it does significantly hold off progression of the disease for many and can significantly improve quality and length of life for some.
So what justifies the FDA switching sides on Avastin? An arbitrary change in the standard for approval. When the FDA granted the drug accelerated approval for metastatic breast cancer treatment in 2007. officials applied a "progression free survival" measurement testing how long Avastin holds off tumor growth in the average patient. For the reversal, however, it instead applied "overall median survival," which essentially measures how much additional life the drug gives the average patient.
Avastin fares well on the first, but poorly on the second. The bulk of its benefits fall on these super responders for whom Avastin is nothing short of a miracle.
The FDA ignored this nuance, moved the goalposts, and ruled that Avastin doesn't "provide a sufficient benefit in slowing disease progression."
The agency's real motive for revocation sends a confusing message. The FDA is getting pressure to get companies to follow the effects of drugs like Avastin that receive accelerated approval. Yet most patients already avoid enrolling in studies after a drug is approved because of fear they won't get the treatment right for them. But by switching the measure of efficacy after a study was conducted, the FDA has engendered mistrust among patients and their doctors.
Moreover, the FDA has broken its pledge to use the science of personalized medicine to evaluate products once in the marketplace. NCCN -- which has no financial stake in the outcome of the assessment -- did apply such insights in its evaluation of Avastin .
The FDA's use of a new goal unfortunately moves cancer treatment away from personalized medicine to one-size fits all care. It's a well know fact that you can bury important differences in response to a product by looking at the average effect on the average patient. It's the best way to show no effect at all. That's what the FDA did, and that is how new technologies and new uses of medicines will be evaluated under Obamacare, when government decides whether to pay for something or not.
At roughly $90,000 for an annual regimen, Avastin isn't cheap. The government stands to reap huge savings if it no longer has to pay for the drug for breast cancer patients through public insurance programs. The FDA's revocation of approval can provide a justification for insurers to refuse to cover the drug - giants Medicare and Medicaid first of all. Private insurers could swiftly follow suit; indeed, Blue Cross Blue Shield's Excellus has already reworked its payment policy to eliminate Avastin coverage for new late-term breast cancer patients.
Because Avastin retains its approval for the treatment of other diseases, physicians will still have the option of prescribing it "off label" to breast cancer patients. But, in this case, the women receiving it will have to bear the drug's entire cost. Most simply can't afford to do that. In effect, Avastin will only remain a treatment option for the most affluent of breast cancer patients.
Ultimately, the Avastin ruling robs thousands of dying breast cancer patients of their last chance at survival.
To its credit, the FDA is revisiting it's decision. The NCCN's evaluation is in response to that action. Unfortunately, the FDA's reconsideration will take time. That's something many women with advanced breast cancer do not have.
Dr. Robert Goldberg is vice president of the Center for Medicine in the Public Interest. He is also author of "Tabloid Medicine: How the Internet is Being Used To Hijack Medical Science For Fear and Profit" (Kaplan, December 2010).
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