December 16, 2010 will forever be the day that changed my life. I had just received a news flash across my monitor that the FDA had confirmed its advisory panel’s decision to ”de-label” the drug Avastin for breast cancer patients. The practical implication of this was that my wife Arlene was now at mortal risk.
My wife has stage IV or metastatic breast cancer. This is an incurable disease that claims the life of a woman every 14 minutes. A reported 17,500 women take Avastin for metastatic breast cancer and my wife is one of them. As Avastin is a unique drug that works by cutting off blood flow to tumors, we believe that the drug is saving my wife’s life and taking Avastin away is tantamount to a death sentence.
I picked up the phone to call my wife and tell her the news. When she answered, I was too choked-up to speak. The next five minutes were some of the worst moments of my life as I told my wife that bureaucrats in Washington were deciding to take away a drug that was keeping her alive.
I read a mountain of reports about the FDA’s Avastin decision and it become clear that it was corrupted with procedural problems (the Wall St. Journal referred to it as “rigged”), rendered almost meaningless by poor science and tainted by the bad faith of the FDA, which had moved the goalposts for approval of Avastin, almost after the game had been played.
The drug’s manufacturer, Genentech, said that it would file an appeal and the FDA granted a hearing for June 28 and 29 in Silver Spring, Maryland.
But something more had to be done but it just wasn’t clear what. I thought of our 24-year-old daughter, Leila, and what message I would be sending her if I sat idly by while her mother’s life was in peril.
I run a small supplier to the automotive industry, a company I had founded about 19 years previously and recently sold. But my first obligation is to my wife and her well-being. This was a full time project. So, I arranged to leave my company and set up my own organization to fight the FDA.
Over the next 90 days I set up an organization, Freedom of Access to Medicines, joint ventured with another nonprofit, found a top constitutional lawyer who would help challenge the FDA, started a website, www.fameds.org, created a couple of cartoon movies, walked the halls of Congress for a week trying to ignite support and anything else I could think of to fight for my wife.
Although this is a very personal story of a man trying to do what he believes is right out of love and respect for his wife, it is also a story with national policy implications. There are also fundamental human rights issues, which hit closer to home. Should a panel of 13 individuals make life and death decisions for 17,500 women or should those decisions best be left to doctors and patients? Are the FDA’s decisions motivated by cost and in fact a form of health care rationing?
In a few short months I have gone from interested but disengaged to fully active in a new world. While the odds continue to be stacked against our success, I continue daily to push the message in the hope that if enough Americans become informed in time about this Avastin sage, we can still save a huge number of precious lives.
On Tuesday, June 28 my family and I will be joining with other cancer patients, their families and concerned activists to mount a protest at the FDA hearing in Silver Spring, Maryland.
Whether or not you know an Avastin patient personally, we all have a stake in this fight. If this form of back door rationing at the FDA is not stopped now, it will become the norm in our system. Today, it’s breast cancer patients but tomorrow it may be the drug that keeps you or your loved one alive.
It literally means life or death to more than 17,500 people.
Terry Kalley is the founder of Freedom of Access to Medicines. His wife has metastatic breast cancer and currently receives Avastin treatments.