YOUNG: Will the FDA let women die?
'Access denied' isn't the message Obama should deliver
On Friday, the Food and Drug Administration (FDA) will face a choice: It can continue to stand by a breast cancer drug that it approved two years ago and on which thousands of women across the country rely. Or, the FDA can revoke approval for the drug, called Avastin. In so doing, it can let tens of thousands of American women face a terminal illness without access to one the most promising treatments available today.
It's a choice between supporting vulnerable women or saying "access denied." Signals suggest the FDA will let women go it alone and revoke approval for Avastin.
Over the summer, an FDA advisory committee voted to remove breast cancer from its list of officially approved uses for Avastin. Although it is rare for the agency to pull its approval for a treatment, it also tends to follow the advisory committee's advice.
If its approval does get revoked, Avastin would still be legal, but Medicare, Medicaid and private insurers could decide to stop reimbursing patients for the drug. Few women will be able to pay for an Avastin regimen, at $90,000 a year, on their own.
Thus, the message from the FDA would be clear: Sorry, breast cancer patients, but your life just isn't worth it.
Officially, the FDA advisory panel denies that cost influenced its recommendation. Instead, it says the drug's effects weren't "clinically meaningful."
But anyone who thinks cost isn't a factor is fooling himself. The fact that cost played a role in the recommendation was all but confirmed when Jean Grem, a member of the FDA committee, slipped up and admitted that "we aren't supposed to talk about cost."
No cure exists for cancer. But in large clinical tests, almost half of those who were treated with Avastin saw their tumors reduced in size. More than half saw their lives extended by months. A drug need not be a cure to be a blessing. I've certainly seen its benefits in my own family.
When my mother was diagnosed with stage IV colon cancer, I was floored. That diagnosis, for all practical purposes, was a death sentence. How long, I wondered, would I have left with her? A year? A month? A week?
After the diagnosis, she underwent surgery and started chemotherapy. She also started taking Avastin. Two years later, she's still here. That's two more birthdays. Two more Christmases. Two more years of watching her three grandchildren grow up. For her, and for those of us in her family, those years have been priceless.
Yet the government seems all too ready to put a price on those years - and then to take that extra time away from thousands of women and their families.
And the story of the government putting price over people doesn't stop at Avastin. When President Obama made the case for his health care law, he promised that it would not lead to rationing. Yet, earlier this year, he appointed Dr. Donald Berwick to run Medicare and Medicaid.
Dr. Berwick has declared "[It'] not a question of whether we will ration health care," but "whether we will ration with our eyes open." He has been leading the charge to start denying public coverage to several expensive - but, often times, uniquely effective - medical treatments.
Thanks to my mother, my eyesare open. At this point, it would hard to see a decision to revoke Avastin's approved status as anything but a decision to ration care.
The Susan G. Komen Foundation and the Ovarian Cancer National Alliance have both urged the FDA not to rule against Avastin. These groups rightly want to leave treatment decisions in the hands of women and their doctors.
When the FDA makes its Avastin decision this month, I hope it rules in favor of empowering patients and continues to give thousands of women access to the same drug that gave my mother hope and life.
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