The political logic of socialized medicine becomes colder and crueler in its display.
Last week, the Food and Drug Administration (FDA) revoked its regulatory approval of the drug Avastin to treat late stage, metastatic breast cancer. Each year, the practicing oncologists chosen by 17,500 American women to save them from their life-threatening, heavily progressed cancer prescribe Avastin to treat them.
The FDA explained that it was revoking approval of the drug for that use because it decided that the drug does not provide “a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.” Risk? The drug is prescribed for women who are otherwise going to die from cancer unless the drug saves them at least for a time. The far greater risk to these women is from the FDA, not the drug.
As The Wall Street Journal said last Friday in response to the FDA’s explanation:
Ponder that [word] “sufficient.” The agency is substituting its own judgment about clinical meaningfulness for those of practicing oncologists and terminally ill cancer patients.
That FDA judgment was determined last summer by an internal agency panel of 13 experts, only two of whom were breast cancer oncologists, and none of whom were breast cancer patients.
Death Sentence for Mrs. Turnage?
Contrast the FDA’s elitist, authoritarian, Ruling Class explanation for its bureaucratic dictat with the real world experience of Mrs. Turnage, whose story was told in a New York Post commentary on December 15 entitled “Don’t Kill the Drug That Saved My Mom,” by her son Josh Turnage. Josh explained:
In June 2006, my mom was diagnosed with Stage II breast cancer. She underwent a double mastectomy, reconstruction and six months of chemo…. Then just 44, she had “triple negative breast cancer,” a rare and particularly lethal form of the disease.
As Josh observed, traditional therapies typically do not work against the disease that threatened to kill his mother at that early age. As a result,
A year after the initial diagnosis, the doctor told our family that the cancer had gone metastatic, or Stage IV, and had spread to her right lung. Such news is typically a death sentence.
But her doctor urged her to try a new experimental drug called Avastin, just approved by the FDA for breast cancer. Josh explained the results:
We got a miracle. After four months of Avastin treatment in combination with chemo, the cancer effectively vanished — the doctors literally couldn’t find any trace of the disease in her body.
In January, 2009, Mrs. Turnage’s chosen doctors decided she could terminate her chemotherapy treatments and just continue with exclusive use of Avastin. Today, nearly two years later, she’s still cancer-free.
Mrs. Turnage is a “super responder” to Avastin, one of a minority of patients receiving the treatment for whom the drug is powerfully effective. Tumors shrink for about half of patients receiving Avastin. On average, patients taking the drug with chemotherapy experience twice as many days or months with no progression of their tumors as those not taking the drug. That means they live longer, on average a few months longer, with their families and friends. Whether that and the chance for much greater success as for Mrs. Turnage is worth it is for patients to decide, with the advice of their doctors, not government bureaucrats.
As Josh rightly says, “We’re talking about Stage IV cancer; the FDA should let patients and doctors decide if a medicine’s benefits are worth the risks.” That has been the tradition of freedom in America.