Peter J. Pitts is president of the Center for Medicine in the Public Interest, a nonprofit research group that receives partial funding from the pharmaceutical industry, and a former FDA associate commissioner.
Anyone who has been diagnosed with cancer knows the importance of having an entire arsenal of therapeutic weaponry. What might be ineffective for one patient could work wonders for another.
So why are federal officials asking patients with advanced breast cancer to enter this battle without one of their most effective and relied upon weapons?
The treatment in jeopardy is Avastin, a biologic drug that works by cutting off the blood supply that tumors need to grow. Clinical studies have shown that for women with stage IV breast cancer, Avastin buys more time - weeks or months in which the cancer isn't able to gain ground or spread.
But the Food and Drug Administration isn't satisfied that this extra time is "enough," and will decide by Dec. 17 whether to revoke its approval of Avastin as a treatment for breast cancer (the drug already is an approved and effective treatment for a number of other cancers).
In recent months, a chorus of patients and their doctors have proclaimed that they should decide what constitutes "enough" - and that the decision should be theirs, not made for them by a government bureaucracy. Originally, the FDA was to have made a final ruling on Avastin back in September, but the panel agreed to extend its review of the drug by three months - an unorthodox decision almost certainly the result of the aforementioned pro-Avastin movement.
Long Islanders must take note, as the Island has had one of the highest rates of breast cancer in the country.
Cancer treatment should never be a one-size-fits-all solution. Some studies have concluded that Avastin doesn't prolong life for those with breast cancer. Another demonstrated that adding it to chemotherapy delayed tumor growth a median of about 11 months - five months longer than chemo alone. A follow-up reported more modest but nonetheless significant delays in tumor growth.
But scientists universally agree that it does prolong the quality of life. This means that women who would otherwise be too weak or sick to participate in their final months will, because of Avastin, be actively involved in one more holiday, birthday or child's graduation.
And it's important to remember that focusing only on averages masks the reality that some patients are "super-responders" who report dramatic improvement. One of those is Patricia Howard of Long Beach, who served as a patient representative at the FDA's last session and reports that infusions of the drug have shrunk tumors in the lining of her lung and eliminated fluid that hampered her breathing.
Patients and their families have pleaded their cases in testimony to the FDA, websites and petitions. One signer of the largest petition - with nearly 10,000 signatures - was Myra Feeney of Greenlawn. "Being that there is no substitute," she wrote, "giving patients the option of taking Avastin seems fair."
Two influential activist groups - Susan G. Komen for the Cure and Ovarian Cancer National Alliance - have further contended that removing Avastin from the FDA's list of approved drugs for breast cancer could have the devastating effect of discouraging future drug development. "Unless we are willing to accept modest degrees of efficacy as a first signal," says Dr. Gabriel Hortobagyi, chairman of the Breast Medical Oncology department at the University of Texas MD Anderson Cancer Center, "we're going to kill some perfectly good drugs that might have been helpful if we had given them enough time."
It's true that if the FDA withdraws its approval of Avastin for breast cancer patients doctors could still go off label to prescribe it. But insurance companies, Medicaid and Medicare would be likely to deny coverage for breast cancer patients - leaving individuals on the hook for out-of-pocket expenses of up to $8,000 a month.
The FDA should listen to experts and patients who want to wage the most effective fight they can against cancer. Avastin may well be one of the best weapons they've got, and the government shouldn't take it out of their hands.