Fight to Live: Film Review

Convincing doc lambasts U.S. drug regulators.

Barbara Kopple finds tragic ironies in the FDA's drug approval process.

NEW YORK — While Congress is busy grilling Food and Drug Administration officials over doing too little to protect Americans from compounding pharmacies, filmmaker Barbara Kopple argues there are many ways in which the agency is doing too much. Her doc Fight to Live focuses on the approval process for new drugs, introducing us to those who are dying slowly, desperate to try experimental treatments the government has yet to allow. Widespread exposure on TV could make Fight a useful balance to what the doc might characterize as hysteria over prescription-drug side effects.

This is a country, after all, where thrill-seekers can legally strap on a parachute and jump off bridges. Why, one interviewee asks, is it so paternalistic when it comes to the decisions a well informed patient and doctor can make in coping with life-threatening diseases like ALS (Lou Gehrig's disease) and cancer?

We meet many of those patients here, like a former athlete now so immobilized he must use his nose to control a voice-synthesizing computer. He, and others with ALS, are fighting for permission to use the drug IPLEX -- already approved for treatment of a growth disorder in children -- which they believe will retard the disease's effects.

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Elsewhere, we observe efforts to shepherd a possible cancer vaccine through an approval process requiring hundreds of millions of dollars. We see a terminal prostate cancer patient engage in trials, knowing that he may be getting a placebo while others receive a drug that will save them. We meet a young doctor, who survived osteosarcoma thanks to an experimental drug, beg regulators to let him use that drug -- whose trials weren't designed to the FDA's liking -- on pre-teen patients who will likely die without it.

Kopple acknowledges cases, like that of the birth defect-causing Thalidomide, in which safety crusaders averted disaster. But she argues that journalists and lawmakers have, in outrages over drugs like Vioxx, created a hysteria that ensures regulators have far more reasons to say no than to say yes. At one point, she fills the screen with names of "breakthrough" treatments for assorted illnesses that are stuck in FDA limbo.

FDA scientists get a chance to defend themselves here, explaining the ways in which testing-protocol rules have snowballed to their current state. Kopple, like the doctors she interviews whose pioneering therapies wouldn't be able to clear today's hurdles, acknowledges that these regulators are intelligent, dedicated professionals. But the agency they inhabit, the film says, is protecting many Americans into an early grave.

Production Company: Cabin Creek Films

Director: Barbara Kopple

Producers: Hilary Birmingham, Barbara Kopple, Carla Woods

Executive producer: Glenn Rigberg

Director of photography: John Hazard

Editor: William Davis

No rating, 81 minutes