Health care debates often focus on budget numbers or policy goals. Seldom do we hear how policy changes will affect actual patients. Take what the Food and Drug Administration (FDA) is doing with the late-stage cancer drug Avastin.
To many women with breast cancer, Avastin is a miracle. More than 17,000 use the drug to restrict the flow of blood to tumors, slowing their growth and, in some instances, eliminating them. Each patient reacts differently, but in each case, the drug offers a last chance for life.
The FDA, however, is in the process of changing Avastin’s designation as a breast-cancer drug. The decision would allow it to stay on the market but require patients to pay for it themselves.
Unfortunately, Avastin isn’t cheap. And in an era where the president has mandated that we “reduce the cost of health care,” breast-cancer patients are the first victims of a rationing trend spreading throughout our health care system.
How will women with breast cancer be affected? In an op-ed for San Diego’s Mission Times Courier, Flori Hendron wrote:
Getting my cancer diagnosis 15 years ago, at only 38-years-old, was shocking and heartbreaking. While most friends enjoyed their late-30s with few health concerns, I endured painful radiation burns and slowly lost my hair, my breasts, and even my range of motion. What was also disheartening was the bureaucratic nightmare brought on by my insurance company -- and, as of last year, the FDA.
Avastin gave me my first stable, progression-free scan in years. Today, almost three years since I began the regiment, I'm not only still here, I'm enjoying life to the fullest with my family and friends.
Last month, the FDA moved to strip Avastin of its approval for breast cancer. Ignoring clinical studies and patient testimonials -- mine included, which I sent to the FDA's headquarters -- this step is the first in cutting off Avastin to all breast cancer patients. Without an FDA approval, especially for a pricey drug like Avastin, insurance carriers and Medicare almost always drop coverage.
Whether Avastin keeps a breast cancer patient alive an extra three months or an extra three years is a silly debate. Life doesn't have a price. Maybe someone needs to remind the FDA of that fact.
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There’s also Christi Turnage of Madison, Miss. In an op-ed for the San Francisco Chronicle, her son Josh wrote:
[T]he doctor encouraged us to try out a new, experimental drug called Avastin that had just been approved by the FDA for cancer treatment. The drug attacks cancer by choking off the blood supply to tumors, and was already in use in the treatment of kidney, colon, lung and brain cancers. After just four months of Avastin treatment in combination with chemo, the cancer effectively disappeared from my mother's body. In January 2009, my mom got to go off traditional chemotherapy and exclusively use Avastin. Nearly two years later, she's still cancer free.
Yet, the FDA may revoke Avastin's approval for treating breast cancer. The reason? This summer, an internal agency panel of 13 experts -- only two of whom are breast cancer oncologists -- determined that Avastin didn't have sufficiently large benefits for breast cancer, and advised the general body to rescind the drug's approval for treating the disease. Yet many studies have found that Avastin can offer a better quality of life and vitality to breast cancer patients.
Then there’s the wife of Michigan’s Terrence Kalley. In a piece for National Review Online, he wrote:
Can it get any worse than this? First you find out you have an incurable disease. Bad news. Then you find out there is a drug that may not cure you but at least keeps you alive. Great news. You take the drug and miraculously your disease is held in check. Miraculous news. Then the FDA tells you that despite your positive results, the drug does not work and they are pulling it off label. Nightmarish news.
However, as the drug is available for other diseases, you can still get the drug off label. Good news. But the drug costs between $56,000 and $96,000 per annum, and Medicare and private insurance companies often deny coverage for off-label prescription. Tough news. Maybe the drug company will make the drug available for free on a compassionate use basis. Hopeful news. But they can’t because they are afraid of corporate and personal liability. Sad news.
Then the drug company applies to the FDA for a hearing to review their earlier decision. Positive news. The FDA announces that a hearing will be held June 28–29 in Washington, D.C., at the FDA headquarters. Encouraging news. But no patients will be allowed to speak. Insulting news.
If the FDA succeeds, it will be like handing a death sentence to many women with breast cancer. There is still time to prevent this disaster, but we have to act now.
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