http://www.thedailylight.com/articles/2011/01/06/opinion/doc4d24a3a80e8df440468148.txtSad day for public health
Published: Wednesday, January 5, 2011 11:07 AM CST
Peter Pitts
Center For Medicine in the Public Interest
In late December, officials at the Food and Drug Administration announced plans to revoke approval of Avastin for the treatment of late-stage breast cancer. This move shocked much of the medical community — as it represents a huge step backwards in this fight against cancer.
Avastin works by cutting off the blood supply that cancerous tumors need to grow. Clinical studies proved that for women with stage IV breast cancer, Avastin bought them more time -- weeks or months in which the cancer wasn’t able to gain ground or spread.
That’s why it had earned a key endorsement from the National Comprehensive Cancer Network. This not-for-profit alliance of nearly two dozen of the world’s top cancer centers — including Stanford Comprehensive Cancer Center, Memorial Sloan-Kettering Cancer Center in New York, and the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — reviewed the studies on Avastin and affirmed its guidelines for using Avastin along with the chemotherapy agent Taxol to treat metastatic breast cancer.
Other prominent cancer groups — including the Susan G. Komen for the Cure and Ovarian Cancer National Alliance — also spoke out in support of Avastin as an option for breast cancer treatment.
So why is the FDA repealing the drug’s approval for this use? Agency officials argue that the drug doesn’t grant “enough” extra time for the average metastatic breast cancer patient to be worth it.
In response to the prospect of a withdrawal, scores of patients and their families launched heart-wrenching personal campaigns, begging the FDA to recognize that the extra weeks, months and in some cases even years Avastin may provide is absolutely “worth it” to them.
These patients know that every day in which their cancer doesn’t progress means more opportunities to do the things that make their lives uniquely worthwhile: to celebrate one more birthday, to witness their children graduating from high school and college, to complete career projects that could revolutionize their fields, or simply to watch one more spectacular sunset holding the hands of those they love.
While research thus far hasn’t proven that, on average, Avastin prolongs life, it has provided clear evidence that the drug can slow the spread of cancer while improving quality of life. One study of patients taking Avastin with chemotherapy found that such treatment delayed tumor growth a median of about 11 months — five months longer than chemo alone. Another study reported more modest but still significant delays in tumor growth.
And for scores of patients known as “super responders,” Avastin literally gives months or years of additional life.
One such super responder is Florida native Erin Howarth. Ms. Howarth was just 31 when she was diagnosed with stage IV breast cancer. “I got the impression that it was just like, ‘Well, you’re going to come here for chemo every week ... kind of until you die,’ “ she told a Florida newspaper.
But she found a doctor to prescribe her Avastin. Within seven months, her cancer was in remission.
For super responders like Ms. Howard, alternative medications to Avastin likely won’t be as effective. A denial from the FDA could literally rob them of years of life.
Avastin was being prescribed to about 17,500 breast cancer patients each year.
Theoretically, now that the FDA is pulling approval of Avastin for breast cancer patients, doctors could continue to prescribe it “off label,” as it’s approved to treat a number of other cancers. But for most patients, the gesture would be meaningless: government and private health insurance companies would likely stop covering it, and few patients could afford to pay for it themselves, as treatment costs about $8,000 a month.
Nearly 1 in 8 American women will develop invasive breast cancer in their lifetimes, and the disease claimed 40,000 lives last year. Metastatic breast cancer patients respond to Avastin in dramatically different ways — and some of those patients and their doctors insist it is their best hope for better days.
These patients are running out of options. And the FDA is on track to take one of those options away.
Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.