From today's edition of Reuters' "Great Debate" series:
Let cancer patients have this pill
By: Peter J. Pitts
One more day — or week, or month, or perhaps even a year. It may not seem like much time, but patients with incurable cancer know better. For Christi Turnage of Mississippi, who lives with stage IV breast cancer, it means seeing her daughter start kindergarten, celebrating her 27th wedding anniversary, and watching her sons graduate from college.
Her family and her oncologist credit her quality of life for the past two years to the drug Avastin, a biologic that combats cancer by cutting off the blood supply to tumors. But advanced breast cancer patients like Turnage have been forced to spend precious time battling something else: the possibility that federal regulators will vote today to remove approval of Avastin for their treatment.
If officials with the U.S. Food and Drug Administration are wise, they will overrule the agency’s cancer-drug advisory panel, which voted 12-to-1 last month to recommend denying a valuable clinical option to advanced breast cancer patients. According to the Department of Health and Human Services, an estimated 40,000 women die from breast cancer each year.
The panel concluded that the costly drug doesn’t eke out enough extra lifetime among breast cancer patients to justify its use and risks. This ignores all the “super responders” — the patients who reap significant benefits from Avastin. Scientists have no way of identifying these people in advance, and they could be devastated if they are denied the medicine.
“This is not a worthless drug by any means,” Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston. “There is almost certainly a group of women who get a big benefit.”
Indeed, the Susan G. Komen for the Cure and Ovarian Cancer National Alliance – recently sent a joint letter to the FDA urging the government to keep it as a choice best made by a woman and her doctor.
The groups also warned that if the FDA de-lists Avastin for breast cancer, it would only discourage future drug development.
Two years ago, the FDA fast-tracked approval of Avastin for metastatic breast cancer two years ago, and since then it has been prescribed to about 17,500 women a year with the disease. The drug, which earned FDA approval for the treatment of colon, lung, kidney and brain cancer, is the world’s best-selling cancer drug.
A clinical trial that took place from December 2001 and May 2004 found that Avastin boosted the amount of time that breast cancer patients lived without the disease spreading or worsening. The drug in combination with chemotherapy delayed tumor growth for about 11 months, which was more than five months longer than chemo alone. Follow-up studies indicated a less robust response, yet still found an average delay in tumor growth to between one and three months.
But even if Avastin does not, “on average,” extend life for breast cancer patients, that “average” is composed of patients who respond in dramatically different ways –including some like Christi Turnage who gain years.
Another is retired California art teacher Patricia Howard, who reports that infusions of Avastin every three weeks over the past two years have shrunk tumors in the lining of her lung and eliminated fluid that hampered her breathing. Now she enjoys shopping and golf, and describes her life as “beyond fabulous.”
Serving as a patient representative at the FDA’s last session, Howard recalled, “One doctor got up during the meeting and said ‘This drug gets women only to first base and we want a home run.’ I felt like jumping up and saying I don’t mind just being in the ballgame.”
If the FDA does remove approval of Avastin for breast cancer, doctors conceivably could write prescriptions for it anyway, going “off label.” But it’s likely that Medicare and private insurers would not cover the cost of what is one of the world’s most expensive drugs. Patients could continue Avastin only if they could afford $8,000 a month out of pocket.
Avastin is a better alternative than the status quo for breast cancer patients, and can be truly transformative for some. No wonder Avastin-users are desperately writing letters, circulating petitions and, like Turnage’s 19-year-old son Josh, posting videos on YouTube pleading their case.
Avastin is their last hope. The FDA should make sure it is not their lost hope.
