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Politics & The Nation


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FRIDAY, DECEMBER 17, 2010 FDAmoves against drug’s use for breast cancer


Hearing is expected on decision to revoke Avastin’s approval


BY ROB STEIN Federal regulators took the un-


usual step Thursday ofmoving to revoke approval of a drug that womenwithadvancedbreast can- cer turn to in a last-ditch effort to save their lives. The decision intensifies a polit-


ically charged debate over costly cancer drugs that appear to pro- ducemodest benefits—if any. The Food and Drug Adminis-


tration concluded that four stud- ies indicate that the blockbuster drugAvastin, theworld’sbest-sell- ing cancer drug and among the most expensive, does not help pa- tients withmetastatic breast can- cer live longer or provide other benefits that outweigh its poten- tially life-threatening risks. “Today’sdecisionwasadifficult


one for the agency,” said FDA offi- cialJanetWoodcock,whostressed that the decision was made by officials with experience treating cancer patients, including some who had been “personally


touched by the disease.” Woodcock added: “FDA is re-


sponsible for ensuring the prod- ucts we approve for patients both effective and safe.” The FDA gave Genentech,


which makes Avastin, 15 days to seek a hearing to review the deci- sion, and the company immedi- ately said it would make the re- quest. That would mark the first time a company has challenged the FDA on such a decision. Ge- nentech maintains that Avastin does help some patients, noting that the European Medicines Agency had affirmed the drug’s benefits the same day. FDA Commissioner Margaret


A.Hamburgmust decidewhether to grant the company’s request or proceedwith thewithdrawal.Un- til the finalFDAdecision,Avastin, which is prescribed to about 17,500 breast cancer patients a year, remains approved for breast cancer. The FDA’s step, which was rec-


ommended July 20 by an agency advisory committee,wasbasedon newstudies that officials conclud- ed had not shown that the drug extends life andindicatedthat the drug slowed tumor growth for perhapsas littleasamonth.At the same time,Avastincancause seri-


ous, potentially life-threatening side effects, including very high blood pressure, hemorrhages, heart attacks and heart failure. Avastin was the first drug de-


signed to fight cancer by blocking blood flowto tumors.But it is also one of the costliest of anewgener- ation of anti-cancer medications that appear to eke out only a few extra months of life. It has global sales of $5.8 billion, and it is the top-selling product for Roche, whose Genentech unit makes it. Its use to treat breast cancer brings in about $855 million a year in revenue in the United States. Even if the agency follows


through with the revocation, the drugwill remainavailable to treat cancer of the brain, colon, kidney and lung, and doctors could con- tinue to prescribe it for breast cancer as an“off-label” use. But the lossofFDAapproval for


breast cancer would probably prompt insurers tostoppayingfor Avastin formetastatic breast can- cer. Avastin costs about $8,000 a month. Medicare was awaiting the outcome of the FDA process before making a decision on whether to continue paying for Avastin,Woodcock said. Breast cancer patients also


would lose eligibility for a pro- graminwhichGenentechcapsthe annual cost of the drug at about $57,000 for women making less than$100,000 a year. The FDA is not supposed to


consider cost in drug approvals, andWoodcocksaidpricewasnota factor.But thedebateoverAvastin hasbecomeentangledinthepolit- ically sensitive struggle overmed- ical spending and effectiveness that flared during the battle to overhaul the health-care system. “With this disappointing deci-


sion, the FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug,” said Sen.Da- vid Vitter (R-La.), one of several lawmakers who questioned the action. “We can’t allow this gov- ernment takeoverofhealthcareto continue any further.” Eric P. Winer, chief scientific


adviser for thebreast canceradvo- cacy group Susan G. Komen for the Cure, also expressed concern that costmay have influenced the agency. “Though the FDA is not focus-


ing on cost, I think it’s hard, par- ticularly in 2010, not to pay atten- tion to the fact that this is a very expensive drug,” said Winer, di- rectorof theBreastOncologyCen-


ter at the Dana-Farber Cancer In- stitute inBoston. The decision comes as Medi-


care is conducting an unusual re- viewto determinewhether to pay for the first vaccine approved to treat cancer formenwithprostate cancer. The vaccine, called Provenge,costsabout$93,000per patient. ThepossibilityofAvastinlosing


authorization for breast cancer prompted anguish among some breast cancer advocates, doctors and patients, including somewho started petition drives to per- suade the FDAto retainthe drug’s authorization. “This is horrific,” said PatHow-


ard, 65, of Summerfield, Fla.,who has been taking Avastin for five years and credits the drug with putting her cancer in remission. “This is like saying, ‘We don’t val- ueyour life.’ I’mshocked. I’mtotal- ly shocked. Without Avastin, I’m going to die.” Internet chat rooms forwomen


withbreast cancer lightedupwith similar expressions of alarm. Several experts and advocates


argued that a some breast cancer patients clearly do benefit from Avastin, andtheyurgedinsurance companies to continue paying for the drug.


But other experts and consum-


er and patient advocates wel- comed the announcement, saying the weight of the evidence was that Avastin was not beneficial and potentially harmful. “We know how difficult it is to


dealwithbreastcancer.Weunder- stand how painful it is that we do not know how to cure metastatic disease,” said Fran Visco of the National Breast Cancer Coalition. “We need to focus advocacy, pub- lic policy and resources on saving lives and doing more good than harm.” The FDA approved Avastin for


advanced breast cancer in 2008 despite divided opinion about its usefulness for that purpose. Only one studyhadfoundthat thedrug appeared to slowthe growth of an advanced breast tumor, produc- ingadelayof about fivemonths. It remained unclear whether pa- tients lived longer or experienced animproved quality of life. The FDA authorized Avastin


under a special programdesigned tomake newtreatments available as quickly as possible, with the understanding that pharmaceuti- cal companieswould conduct fol- low-up studies validating the ef- fectiveness of the drugs. steinr@washpost.com


A filmmaker knows what he loves: Washington hornaday from A1


diverse as the WhiteHouse Corre- spondents’ Association dinner and a suburban Sunday brunch, the Jefferson Memorial wasn’t a totemic backdrop for thoughtful speeches on the Constitution or ruminations on the Bill of Rights. It was the backdrop for Holly Hunter and William Hurt’s first kiss. The give-and-take between


Washington and Hollywood has been well documented. (Alto- gether now: “Politics is show business for ugly people.” We’ve heard it.) To paraphrase the fa- mous observation about Fred Astaire and GingerRogers, just as she gave him sex and he gave her class, Washington confers intel- lectual heft and policy-wonk seri- ousness to the celebrities who come here to lobby and advocate, just as they sprinkle otherwise drab bureaucrats and politicians with a little stardust and bor- rowed glamour. Most movies approach Wash-


ington with the stock stiffness of “The Day the Earth Stood Still,” when a flying saucer passed all the familiar landmarks (Wash- ington Monument? Check. Capi- tol? Check. Smithsonian? Check.) before landing on the Ellipse. But once in a while, filmmakers es- cape the edifice complex and de- liver textured portraits of Wash- ington as a living, breathing city. William Friedkin did it in “The Exorcist,” where even in a story of wildly imagined horror, he cap- tured the feeling of walkingdown aGeorgetown street and wonder- ing what really lies behind its well-tended doorsteps.


A real sense of place Billy Ray did it twice, in “Shat-


tered Glass” and then again in “Breach,” about FBI mole Robert Hanssen, in which Ray depicted life in the bureau not as endless feats of derring-do and dead drops, but in all its linoleum-tiled, windowless banality.More recent- ly, Doug Liman captured both the messy home life of a typical two- careerWashington couple and the faceless institutions theyroutinely navigate in “Fair Game,” which toggles between Joe Wilson and Valerie PlameWilson’s cozilywell- appointed Palisades home and scenes where the White House loomsmenacingly,asilent, impen- etrable fortress of monolithic power.


“Broadcast News” and “How


Do You Know” deserve pride of place on the (short) list of films that mineWashington not for its majesty or monumental iconog- raphy, but as a lived-in place. In Brooks’s case, these oblique mo- ments glow with the added en- chantment of his own relation- ship to the city. Where some see monotony and blandness, when Mr. Brooks comes toWashington, he sees broad, inviting streets. Where some see Deep Throat in every parking garage, he sees a verdant mix of city and suburb, stately built environments and rolling parks. What some deride as entrenched bureaucracy, Brooks extols for its sense of stability and permanence other cities don’t have. With “How Do You Know,”


which takes place primarily in Logan Circle, AdamsMorgan and the Bowen Building downtown, Brooks once again infuses Wash- ington with his distinctive brand


KEVIN WINTER/GETTY IMAGES Writer-director James L. Brooks, left, with “How Do You Know” cast member Jack Nicholson at the film’s premiere earlier this week in Los Angeles.


of romance. And again, he avoids the most predictable tropes and themes of OfficialWashington to nibble at its edges, in this case the world of professional sports and investment banking. Rather than predictable shots


of theWashington Monument or the Capitol, Brooks pays gratify- ing attention to the details of the city’s street life, from the security badges the extras wear to a brief shot ofcommutersonSegways. In Brooks’s enchantedD.C., even the city bus becomes an improbably lyrical deus ex machina.


Today’s Everyman If the legacy of “Broadcast


News” was a new brand of hero- ine who personified the tough choices of 1980s feminism, “How Do You Know” presents us with an equally resonant leading man. As the new film opens, Rudd’s character, financial services exec- utiveGeorgeMadison, is indicted for securities fraud. George makes a recognizable Washing- ton figure, someone who may not inhabit the city’s most visible corridors of power but whose life is vitally connected to them.As he somberly quotes recent legisla- tion and fends off a loyal assis- tant’s efforts to sneak him inside information, George makes an unlikely but meaningful hero, ut- terly of his timeandplace: the last honest man inWashington. Although “How Do You Know” never explicitly invokes the finan-


ward, consists of characters giving each othernotes onhowto deliver amarriage proposal. The scene is pure Hollywood


artifice but disarmingly authen- tic because it’s so crazy. For Brooks, “How Do You Know” is about “men and women . . . just crawling toward each other through the fog. With what we’re getting battered with, it’s just such a rough time.” Here’s a theory: What keeps


Brooks coming back toWashing- ton, finally, isn’t its intricate grid or stately environment, but the fact that it so ably serves a con- cern with personal ethics that has animated his work from “Terms of Endearment” and “Broadcast News” through “I’ll Do Anything” and “Spanglish.” His recurring question is not How Do You Know? as much as How Do We Live?


Brooks’s Washingtonians may DAVID JAMES/COLUMBIA PICTURES VIA ASSOCIATED PRESS


In “How Do You Know,” with Reese Witherspoon and PaulRudd, James L. Brooks infusesWashington with his distinctive brand of romance. avoiding the most predictableD.C. tropes and images.


cial meltdown, institutional fail- ures and personal scandals of recent years, the upright, moral- to-a-faultGeorge stands as both a victim and a rebuke to the very worst that the city has come to represent.He’s a straight arrow in the world’s most crooked quiver. In “Broadcast News,” Albert


Brooks’s virtuous if self-righteous schlub called Hurt’s shallow, ag- gressively telegenic newsreader “theDevil.” (The scene of theDevil manufacturing a tear on cue dur- ing aninterviewsignaledthe com- ing soft-news apocalypse.) There are no devils in “How Do You Know” asmuch as flawed individ-


uals trying to heed their better angels. As they find their way through their own private Wash- ington, they constantly question themselves and each other, sec- ond-guessing motives and decla- rations; even the screwball climax of “How Do You Know,” set in a crowded room in a maternity


not indulge in oratories about history and politics, but they struggle with governing princi- ples all the same. Where better than Washington for Brooks to deliver yet another lesson in the civics of romance, where being a good citizen in love is as impor- tant as beingagoodcitizen in life? hornadaya@washpost.com


6


ONWASHINGTONPOST.COM What movies do you think


capture the realWashington? Add your opinion and see what others think at washingtonpost.com/style.


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