FDA Musn't Restrict Freedom to Use Avastin to Fight Breast Cancer

The FDA is deciding whether or not to remove Avastin from its list of drugs approved for breast cancer treatment.

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The health debate in America is more about saving money than it is about saving lives. And, in case you were wondering, this is not a good thing.

There are a lot of people to blame for this—including politicians, trial layers, so-called “community” organizers and pressure groups, the media, and everyone who focuses on making healthcare "more affordable" rather than making it better—which is not always the same thing.

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Part of the problem is the way that people—patients—have been taken out of the equation, almost out of necessity, by insurance companies, hospital corporations and sometimes even physicians who find themselves caught between satisfying the needs of the people they care for and the people who are in a position to affect the cost and quantity of the treatment provided—and by the federal government.

One man who knows this all too well is Terry Kalley, whose wife suffers from an advanced form of breast cancer.

Kalley’s wife has been receiving a drug known as Avastin as part of her care, which the U.S. Food and Drug Administration may be about to de-list as an approved drug for breast cancer treatment.

Admittedly, Avastin does not work in all patients and can have dangerous side effects.  But in the case of many other patients, including Kalley’s wife, Avastin seems to be working, prolonging their lives. 

“Knowing that death will come early from an incurable disease is devastating. But the FDA has compounded this anguish by its complete indifference to current Avastin patients,” Kalley said recently. “This is a regulatory machine on autopilot and a bureaucracy unencumbered by any ethical controls. It’s callous indifference is terrifying.”

Kalley wants the federal government to stay out of their medical lives. They, and others, understand the risks associated with Avastin and know the side effects can be serious. But Kalley believes that, without Avastin, his wife will die sooner than she might otherwise.

A rational policy would allow patients like Kalley’s wife to continue to use Avastin provided they are informed of all risks involved, sign a waiver to continue using the drug, and make the decision to do so in concert with her medical team. For the federal government to step in and pull the rug out from under by de-listing Avastin denies them this choice. [Read more stories about healthcare.]

If the FDA removes Avastin from the approved list for breast cancer treatment, then the Kalleys and every other patient current on the drug will have to pay the full cost, out of their own pockets. 

“Insurance will no longer cover the drug, and patients will be responsible for paying close to $100,000 year, so by the FDA taking this action, they are effectively removing this drug from patients with metastatic breast cancer,” Kalley said.

Kalley has put his life on hold to start a nonprofit organization to defend his wife and all the others with breast cancer who are taking Avastin called Freedom of Access to Medicines. He has visited members of Congress, written countless letters, contacted media outlets, and organized as many Avastin patients he can find (which federal medical privacy laws makes difficult).

On Tuesday, June 28, Kalley will be leading a protest at the FDA’s headquarters. It is the day the FDA is expected to decide whether Avastin will continue to be on the list of drugs approved for treating breast cancer. 

For those patients currently using Avastin, this impending FDA action looks a lot like issues that we heard about during the presidential campaign and debates over government healthcare, like a death panel rationing care, as well as the issue of low- and middle-income women being denied access to healthcare and life-saving medications.

“Today, it’s Avastin for metastatic breast cancer, tomorrow it could be the drug that your loved one needs to stay alive,” Kalley said.

He’s right. People should be free to choose the medicines they want, especially if there is no viable alternative available, regardless of what the federal government says, as long as they are willing, along with their doctors, to make an informed choice. When death is the alternative, the FDA and its long approval process and bureaucratic instincts should not be able to stand in the way.

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