Last week, the Food and Drug Administration (FDA) revoked its regulatory approval of the drug Avastin to treat late stage, metastatic breast cancer. Late stage breast cancer is defined as when the cancer has become invasive and has spread to other areas of the body, such as the lungs, liver, etc. At this point, without effective treatment, death is imminent.
Avastin has been proved to not only shrink tumors in late stage cancer patients but in some patients, albeit rare cases, they actually disappear. The FDA explained it was revoking approval of the drug for that use because it decided the drug does not provide "a sufficient benefit in slowing disease progression to outweigh the significant risk to patients." Huh?
So let’s see if I have this right… women with late stage breast cancer are facing certain death without aggressive and innovative treatment. There is clear, clinical evidence that tumors shrink, and sometimes even disappear in at least half the patients who have been treated with Avastin. But the FDA has decided they will no longer approve Avastin for use in breast cancer treatment because the risk to the patient is greater than the benefits to these dying women.
Only in America can the government make, and justify, such a stupid decision. The Susan G. Komen Foundation, the Ovarian Cancer National Alliance, a cancer patients' advocacy organization, and the U.S. National Comprehensive Cancer Network all want Avastin treatment to remain available for breast cancer. In Europe, where health care rationing is prevalent, the European Medicines Agency, the equivalent of the FDA for the European Union, ruled last week that Avastin would continue to be available for breast cancer treatment there.
The Obama administration and the Democrats in Washington, along with a select few “Republicans in Name Only” pushed the health care bill through and got it signed into law, against the will of the majority of Americans, all the while denying there would be “death panels” making decisions on medical care for Americans. People on the left called us crazy for uttering those two words and Sarah Palin was vilified for it (and other things, of course.) Yet this decision by the FDA was determined by an internal agency panel of 13 “experts”, only two of whom were breast cancer oncologists, and none of whom were breast cancer patients. And while they didn’t come right out and say it, there is no doubt that the cost of treatment was a part of the decision.
Avastin treatment currently costs about $88,000 per year. The FDA's decision means that Medicare and Medicaid will likely refuse to pay for the drug to treat breast cancer. These government programs do not pay for costly medicines that do not have FDA approval. This in turn provides the legal foundation for private insurance companies to now refuse payment for the treatment as well. They are not legally obligated to pay for costly therapies denied FDA approval and rejected by Medicare and Medicaid. Of course you can bet those on the left will vilify the insurance companies for refusing to pay for it but why would they pay for it if the government run health programs won’t? Curiously, Avastin is still approved to treat other forms of cancer. So why is the government killing women with breast cancer?This is only the beginning. In September, the FDA and Medicare proposed a "parallel review" process that will allow the two agencies to coordinate market and reimbursement approval. Medicare is also increasingly opening "national coverage determination" reviews that allow a government board to decide if a therapy is "reasonable and necessary." Death panels? Call them what you want but when government panels decide what medical treatment people can and cannot have, what’s in a name?
The bottom line is Avastin saves or extends the lives of many women with late stage breast cancer. The alternative is death. Shouldn’t it be up to those women whether or not the benefits are worth the risk? They are, after all, the ones who are facing death. Now the government has made that decision for them. During the health care bill debate Congressman Alan Grayson once made a spectacle of himself on the House floor by saying “Republicans health care plan – die early.” But it’s not a Republican administration that has decided to deny women this life saving drug, is it?