The Fatal Move From The FDA

On Dec. 17 the Food and Drug Administration is expected to take the radical step of revoking approval for an advanced drug in the treatment of one of the country’s most deadly diseases.

Avastin, an advanced treatment for late-stage breast cancer, made it through the FDA approval process back in 2008. But over the summer, an advisory commission at the agency determined that the drug wasn’t providing sufficient benefits to patients and recommended that the full FDA board retroactively rescind that stamp of approval.

The FDA has until Dec. 17 to make that recommendation official. If it does, the effects on breast cancer patients will be devastating. Some 17,500 American women are prescribed Avastin every year. Many will face shorter, more painful lives because of the FDA’s decisions.

Despite all evidence to the contrary, the advisory committee claims its recommendation had nothing to do with Avastin’s cost. The FDA’s top brass will doubtlessly take the same line and claim that its decision to ratify that recommendation was based solely on the drug’s medical efficiency.

The truth is that Avastin is expensive. A year-long supply for breast cancer treatment costs upwards of $80,000.

However, many American women are getting something priceless in return for those dollars: life and vitality. In one clinical trial, nearly 50% of patients receiving Avastin witnessed their tumors shrink. Another study found that patients receiving the drug in conjunction with chemotherapy lived “progression-free” twice as long as patients without it.

What’s more, for a select group of “super responders,” Avastin can improve life span by years. That can mean years of extra time for, say, a mother to attend her son’s soccer games, for a daughter to vacation with her husband, or for a grandmother to watch her grandchildren grow up.

However, if the FDA revokes Avastin’s approval, public insurance programs like Medicaid and Medicare could decide to refuse coverage of the treatment. Many private insurers would likely do the same. Indeed, several major insurance companies–including Regence and HSCS–have already reacted to the FDA Avastin debate by restricting coverage for the drug in the treatment of breast cancer.

Of course, doctors would still be able to prescribe the drug “off label.” But because patients wouldn’t have coverage, the only ones that could still use Avastin would be the small minority that can afford

to pay its full price out-of-pocket.

Both the Susan G. Komen Foundation and the Ovarian Cancer National Alliance have sent letters to the FDA urging it not to revoke approval. They rightly believe that treatment decisions should remain exclusively in the hands of individual patients and their doctors. After all, those are the people best positioned to weigh costs and benefits and decide which course of treatment is best.

Government drug rationing isn’t going to stop at Avastin. The Obama administration hasn’t been shy about expressing its affections for the practice. None other than the head of the Centers for Medicare and Medicaid Services, Dr. Donald Berwick, has said that “it’s not a question of whether we will ration health care,” but “whether we will ration with our eyes open.”

Every year about 40,000 American women die from breast cancer. Avastin is the last hope for many not to meet that fate. While the drug is costly, it often provides immense benefits to patients. The FDA shouldn’t revoke the drug’s approval.

Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

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