Will the FDA Stand With Women — or Rationing?

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By Holly Pitt Young

“All we can do at this point is manage your cancer.”

Those were the words my mother heard two years ago when she was diagnosed with stage IV colon cancer. Once cancer has progressed that far, it’s treatable — but no longer curable. My mom had been given a death sentence.

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When I heard the news, I collapsed. She had always been extremely active — a vivacious woman, she raised me all alone as a single mother. I was her only child.

I was crushed by her diagnosis. It felt like a death sentence for me and the time I would have left with her. I prayed for just one more month. I desperately wanted more time. I knew my children wanted more time with their grandma, as well.

She had surgery to remove her cancerous tumors. And in conjunction with chemotherapy, she started taking a breakthrough drug called “Avastin” that had recently been approved for colon cancer. Her pain, thankfully, became manageable.

Her life was different, of course. She was much more tired. But she could take part in just about all life’s normal activities. Little things like waking up, getting dressed, brushing her teeth, and eating breakfast were no longer taken for granted. They became reminders of life. Every day was cherished.

One month passed. Then two. Then a year. Thanks to Avastin, we were able to celebrate another Christmas. She was able to watch her three grandchildren search for Easter eggs and celebrate their birthdays.

And she’s still with us. Today, my mom wants just two things: less pain and more time. Avastin has helped her with both those wishes.

Avastin doesn’t just help those with colon cancer. Doctors have used the medicine to treat patients with colon, lung, brain, kidney, and breast cancer, as well.

It’s not a cure, of course. But it is a miracle drug. Every additional day with my mom is a blessing. For cancer patients and their loved ones, Avastin is invaluable.

But shockingly, the government may soon take this medicine away from women with breast cancer.

In July, an FDA advisory panel urged the government to withdraw Avastin for the treatment of stage IV breast cancer. Dr. Richard Pazdur, who heads the FDAs cancer division, doesn’t think the drug helps patients in a “clinically meaningful” way. Between now and December, the FDA is expected to pull this medicine from the market.

It would still be legal, but only as an “off label” prescription. In other words, insurance companies and Medicare would likely refuse to pay for the drug, so women would have to pay for it out of their own pockets — to the tune of $8,000 per month.

Avastin has already met government standards for safety and efficacy with other cancers, so the only logical conclusion one can draw is that when it comes to breast cancer, the government just doesn’t think that treatment is worth the price. This is outrageous.

If the FDA decides to withdraw Avastin for breast cancer, I hope the that Dr. Pazdur announces the decision on the National Mall during the annual Susan G. Komen’s Race for the Cure. If he has to stand before that crowd and say “It’s just not worth it, ladies. The benefits aren’t ‘clinically meaningful,’” he better be a fast runner.

Many predicted that President Obama’s health overhaul would lead to rationing. I never believed that we’d see such a thing in America, though.

My mom is a true American success story. The odds were stacked against her — she never went to college — but she thrived. She raised me on her own, had a good job, and paid her taxes. Until her diagnosis, she was full of life.

Countless other women have defied the odds just like her. And many, every day, are diagnosed with breast cancer. Yet now the government is poised to ration one of their only hopes. This despite the fact that the median breast-cancer patient on Avastin lives nearly six months longer than she otherwise would.

What is six months, with less pain, worth to you — or your sister, your mother, or your wife? That’s a very individual decision. But it’s one that should be made by a patient and her doctor, not by a bureaucrat in Washington.

Holly Pitt Young is Senior Vice President of Public Affairs at Aristotle, Inc.


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