Will the FDA give women a reason to celebrate?

The FDA’s wishes are clear. A review committee voted 12-1 in December to nix the drug for breast cancer. The drug’s makers have appealed the decision, but they’ll be facing tough odds. The June hearing will be held in front of the same FDA committee, and the FDA officer in charge of the hearing has refused to add any additional cancer experts to the panel. So much for the government’s scientific expertise, or fairness.

If the FDA revokes its approval, doctors will still be able to prescribe the drug “off-label.” But it’s likely that Medicare and many insurers won’t cover it. With yearly treatment costs running close to $90,000 per year, the drug will be out of reach for most women.

The FDA denies that cost is a factor. But it’s easy to be skeptical of the official line—especially when one of the agency officials who voted against approving the drug explicitly mentioned cost during an FDA hearing.

Already Palmetto GBA, one of the companies that determines regional drug coverage for Medicare, announced it would not cover the drug. Under pressure, Palmetto quickly reversed its decision. But it’s suggestive of the heavy political pressures the drug faces.
 
For the government’s drug bureaucrats, that may be business as usual. But for thousands of women with breast cancer across the country, it’s the potential loss of a chance at a longer, healthier life.

Worldwide, breast cancer is the most common form of cancer among women. In the U.S., 207,000 women were diagnosed with it last year alone: 40,000 died from it.

In 2010, doctors prescribed Avastin to 17,500 breast cancer patients in the U.S. Those women didn’t have many options: In the past decade, the FDA has approved just two first-line metastatic cancer treatments.

Avastin isn’t a cure, but it can prolong a woman’s life. Clinical trials show that on average, the drug slows the progress of breast cancer by about four months. One study showed that among a subgroup of 496 patients between 40 and 64, the average survival benefit was about 5.7 months—with some individuals gaining years extra.

This was evidence enough for regulators in Europe. Last month, an investigation by the European Commission confirmed that Avastin, in combination with chemotherapy, kept breast cancer patients healthier for longer than if they’d gone without treatment.

And it helped convince the National Comprehensive Cancer Network, a group of oncologists that produces treatment standards recognized in more than 100 countries, to continue supporting use of the drug against breast cancer.

But the FDA, despite its prior approval, isn’t satisfied. The agency says Avastin does not provide “a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.” But whose job is it to determine whether a treatment’s benefits are really “sufficient”—the government’s? Or a woman, her doctor, and her family?

Most women can probably answer that question easily. It’s a shame the FDA is having such a hard time.

Time—more of it—is what this decision is all about. Let’s make sure that as we celebrate National Women’s History Month, we don’t somehow forget to ensure that thousands of American women also have a future.

Holly Pitt Young is the senior vice president of public affairs at Aristotle and is an expert on the crossroads between policy and political engagement.