Medicine: The FDA has reversed its approval of a widely used cancer drug approved in Europe to treat breast cancer on the grounds it doesn't provide a "sufficient" benefit. Let the terminally ill and their doctors decide.
One of the blessings of blocking the omnibus spending bill was that it included $1 billion for the implementation of ObamaCare.
Yet the first effects are still being felt, the latest being the Food and Drug Administration's revoking of regulatory approval of Avastin to treat late-stage breast cancer.
The reason given by the FDA was that the drug does not provide "a sufficient benefit in slowing disease progression to outweigh the significant risk to patients." What risk? These women are dying.
The drug buys them precious time, and the only risk they face is from an FDA saying "pull the plug."
On the same day the FDA channeled Dr. Kevorkian, its European counterpart, the European Medicines Agency, issued a statement approving Avastin for metastatic breast cancer.
Benefits of the drug, it said, "continue to outweigh the risks, because the available data have overwhelmingly shown to prolong progression-free survival of breast cancer patients without a negative effect on the overall survival."
So what say you, FDA? An agency overseeing the cost-conscious, government-run health care systems in the European Union says Avastin does provide sufficient benefit at little risk to the patient.
The annual cost, however, is a staggering $88,000 annually, and under ObamaCare cost trumps medical care. A prime decision is whether extending your life is worth the cost.
Consider that every year some 17,500 American women are prescribed Avastin by their practicing oncologists to treat their condition and prolong their life. Last October, the U.S. National Comprehensive Cancer Network, a group of 21 leading cancer centers that issues evidence-based medical guidelines, reaffirmed Avastin's efficacy in certain cases.
Avastin, the marketing name for the drug bevacizumab, is the world's best-selling cancer drug. Used primarily to treat colon cancer, it was first approved by the FDA in 2008 for treating breast cancer after it was found that by cutting the blood flow to tumors it slowed the progression of the disease. In some cases it has been shown to extend life as long as 20 months.
In a joint letter to the FDA and key lawmakers, two organizations — Susan G. Komen for the Cure and the Ovarian Cancer National Alliance— urge that Avastin continue to be approved for metastatic breast cancer patients and warn of the message this "decision sends about drug development for women with advanced breast cancer."