FDA withdraws approval of Avastin for use in treatment of breast cancer

Early on in the health care bill debate Sarah Palin was ridiculed for calling a provision in the health care bill “death panels”.  Mrs. Palin’s comments came after she reviewed an original version of the bill that called for mandatory end of life discussions every five years for those patients on Medicare, i.e. the elderly.  In its present form the law calls for “voluntary” end of life discussions every year as part of an annual physical examination. Voluntary yes, but also incentivized to the physician who provides this additional service.

Once this practice becomes “incentivized” by the government, however, the game changes a bit. Starting January 1, 2013, a monolithic unknown bureaucracy inserts itself between you and your physician. Is your physician looking out for your best medical treatment at this point or is he trying to “make quota”?  There are harsh penalties if your doctor does not comply with the course of treatment directed by the bureaucrat at the other end of the phone or computer.

The head of the Centers for Medicare and Medicaid Services (CMS), Dr. Donald Berwick, has been very clear in his statements regarding rationing of health care services and his love of the British National Health Service program.  It should not be lost on us that this man was appointed by the Obama Administration in recess so as to not be subjected to Senate questioning and scrutiny.

We are now seeing the first example of health care rationing.  The FDA has decided to discontinue the use of Avastin for the treatment of breast cancer.  Avastin works by choking off the blood flow to tumors that allows them to grow. It was originally used in the treatment of kidney, colorectal and lung cancers with good results.  In February of 2008 the FDA granted accelerated approval for Avastin in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer.  The approval was based on an improvement in progression-free survival (PFS).  In other words – it delays for a short period the time when the tumors start to look worse on a CT scan. The results are mixed with breast cancer patients – some experience a few months of extended quality of life, others have had drastic, even deadly, side effects.

I have a very personal connection to this, as my mother was given Avastin as a final course of treatment for her breast cancer, which had metastasized to her liver.  She was diagnosed with breast cancer in 2001 and went through mastectomy, chemotherapy and radiation.  She was cancer free for nearly five years.  In 2005 an x-ray revealed tumors in her liver.  She sought out information on the internet and participated in experimental treatments at two different institutions.  The treatments were effective in killing existing tumors and repeated as new tumors appeared. Her final option was Avastin infusion along with 5FU, a standard drug used in chemotherapy. With all of these treatments she survived more than ten years.

To put this in perspective; during my mother’s battle with cancer she was able to be there for the birth of her fourth granddaughter, two granddaughters’ weddings and the birth of two great-grandchildren (who at six and four when she passed will have memories of their great-grandmother), along with the wedding of her long single daughter (me) who married after having been a divorced single mother for 27 years. Those extra years we had with mom have been priceless.  She was a strong woman with a strong will to survive, no matter what it required of her.  She was willing to participate in these various studies with the hope of extending her life, but also wishing to advance medicine’s understanding and treatment of cancer.

Faced with your own mortality, would you want to have the option of choosing such a treatment if it might promise a little more time?  Even if it did not benefit you, your contribution to the study may help researchers in the ongoing quest for a cure.

This debate revolves around who decides.  Do we want our medical care to remain a personal decision between ourselves and our physicians?  Or do we want some government bureaucrat with no medical training make this decision for us based on cost, actuarial tables for Quality Adjusted Life Years (QALY), and our worth to the collective?