At the Food and Drug Administration (FDA) these days, the little ladies are to be seen and barely heard. As if "Mad Men" were a documentary rather than a televised slice of 1960s life, a major medical decision looms and the women it affects most directly will be given only a superficial moment to share their substantive views. What do a bunch of gals have to tell the federal government, anyway?
Well, a lot, it turns out.
Each year, about 40,000 women die from metastatic breast cancer (MBC). About 17,500 women with breast cancer are prescribed a drug called Avastin. While it does not reverse MBC, Avastin slows it and in some cases freezes it in place. The result? Women who are expected to die of breast cancer are extending their lives by anywhere from a few months to several years.
My wife is a so-called superresponder who thanks Avastin for the extra two years of life - and counting - that we are enjoying together.
The FDA, unfortunately, cannot leave miracles alone. Instead, the FDA's Oncologic Drug Advisory Committee (ODAC) rescinded Avastin's approval as a treatment. Never mind that just two of the 13 members are practicing oncologists. This panel brilliantly decided that Avastin does not offer "sufficient" benefits relative to its risks, and thus it lost its anti-MBC status. According to FDA-think, the universal risk of dying from MBC shrinks when compared to a greater danger that Avastin might fail some patients and keep others alive for just a few months - perhaps long enough to enjoy one last Christmas with loved ones or watch a beloved grandchild graduate from kindergarten. Who needs that when one can follow the FDA right to the graveyard?
The FDA plans a June 28-29 hearing on all of this. In an obvious move of desperation to appease an unhappy public, the agency announced yesterday that it will offer anyone with a stake in Avastin a chance to speak during the hearing - but only during a two-hour time block.
Considering that 17,500 patients are taking the drug and tens of thousands of family members recognize its value, this hardly seems like enough time. Even if the FDA limits comments to patients, each woman would have less than half a second to tell her story. To paraphrase Helen Reddy's 1971 feminist anthem, "I am woman, hear me meow."
Those who are aware of the forum and would like to speak must first submit a request to the FDA - giving the agency the ability to determine exactly what message will be heard in this short time. Should anti-Avastin messages dominate the hearing, the FDA gets to walk away saying it opened the forum to the public and the public - that the FDA selects - opposes the drug. With the FDA in charge of who speaks, the hearing is hardly a true public forum.
The topic could not be more serious. Avastin remains "on-label" for fighting colon cancer and other ailments. Some doctors still will use it "off-label" for MBC. However, others will be reluctant to do this.
More important, Medicare and private insurance companies often refuse to reimburse for off-label drugs. Because Avastin can cost between $56,000 and $96,000 annually, this is life-and-death stuff for many MBC sufferers. While wealthy patients will keep buying their Avastin, the FDA's message to those who can't afford a country-club membership is "Drop dead." This maddening position also is ironic, given the Obama administration's putative commitment to fighting for the poor and middle class, rather than defending the rich.
To its credit, Avastin's manufacturer, Genentech, helps truly needy patients by donating Avastin to them for free. But rather than applaud such corporate compassion, the FDA has adopted new policies that open drug companies and their employees to liability if they contribute drugs for off-label uses. Naturally, Genentech's attorneys worry about subsequent lawsuits. Thus, MBC patients of modest means may become unable to acquire this wonder drug - even for free.
Believe it or not, the FDA is dangling a costly drug beyond the reach of lower-and middle-income MBC patients while making it harder - not easier - to secure Avastin through compassionate donations. The FDA has become Robin Hood in reverse - and with dead women as the endgame.
No wonder FDA medicrats want most women with MBC to keep their pretty lips buttoned up.
To correct its vile blend of paternalism, sexism and stupidity, the FDA should simply reconfirm Avastin as an anti-MBC therapy. The FDA should respect each woman's right to choose whether or not to use Avastin. She and her doctor should make this informed choice, not 11 non-oncologists in Washington. She, her banker and her insurer should decide how to purchase this drug. And Genentech should receive a medal and endless encouragement to lower its prices or even give away Avastin if that would help financially needy women obtain this life-enhancing drug.
To yank Avastin from women with advanced breast cancer would be a literal death sentence. While a criminal defendant can appeal his conviction, a woman with MBC has few options for avoiding medical-grade capital punishment.
Terrence D. Kalley is founder of Freedom of Access to Medicines (fameds.org), established to fight the FDA's Avastin decision.
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