The FDA considers revoking its approval for breast cancer drug for cost reasons


Sarah Palin coined the term “death panels” when she wrote about the rationing that would inevitably occur with ObamaCare. She was immediately slammed by ObamaCare supporters for fear mongering, but the term stuck because people understood what she meant: people’s lives hang in the balance as bureaucrats sit in government offices deny coverage and treatment in an effort to reduce costs.

We didn’t even have to wait until 2014 for ObamaCare to be fully implemented to see these death panels. Already the FDA is considering revoking its approval for Avastin as a treatment for women with advanced breast cancer because of issues with the drug’s cost. Determining whether a drug is or is not too expensive isn’t in the FDA’s purview. It’s job is to make sure the drugs are safe and effective. With ObamaCare, it’s hard to shake the words death panel.

The Food and Drug Administration is reviewing the recommendation of influential scientific advisers to revoke authorization of the drug to treat metastatic breast cancer. Contrary to initial research, new studies indicate that the benefits of the drug, which costs $8,000 a month, do not outweigh its risks, the advisory panel concluded.

Citing a dearth of evidence of the drug’s effectiveness, its potential toxic side effects and its high cost, many cancer experts, patient advocates and others are welcoming the prospect that Avastin’s authorization for breast cancer might be repealed. But the possibility is alarming other cancer specialists, women taking the drug, some members of Congress and advocates for giving patients as much access to as many treatments as possible.

The FDA is not supposed to consider costs in its decisions, but if the agency were to rescind approval, insurers are likely to stop paying for treatment.

“It’s hard to talk about Avastin without talking about costs,” said Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston. “For better or worse, Avastin has become in many ways the poster child of high-priced anti-cancer drugs.”
I can’t help but think of the Ford Pinto. Just like Ford’s bean counters, the FDA is making decisions based solely upon cost rather than on saving lives.  If the FDA decides to rescind its approval, it will affect all breast cancer patients, not just Medicare or Medicaid patients because health insurance companies will stop paying for it. But what about those who have the money to pay for it on their own? If it is no longer FDA approved, doctors probably won’t even prescribe it. So, every person who is suffering from metastasized breast cancer will die sooner.

The Susan G. Komen Foundation has responded:

In a joint letter sent to the FDA and key Congressional lawmakers Thursday, Komen for the Cure and the OCNA wrote, “We are particularly concerned about patients who are presently receiving bevacizumab and the message that this decision sends about drug development for women with advanced breast cancer.”

“We recognize the benefits of Avastin overall are modest for women with metastaticbreast cancer,” said Ambassador Nancy G. Brinker, Komen’s founder and CEO, in the joint letter to the FDA. “However, we do know that for some women, Avastin offers a greater than modest benefit. We hope that this decision will not restrict access toAvastin to all patients.”
The sentence about drug development is very important. All new life saving drugs are expensive for a while, but as pharmaceutical companies make additional advancements, the prices will come down. However, with the FDA beginning to make decisions about a drug’s approval based upon cost considerations, pharmaceutical companies will be less likely to spend up front the millions of dollars that are required to discover each new drug.

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