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A NEW CANCER DRUG'S BIRTH AND NEAR-DEATH
HER-2 Herceptin, approved by the Food & Drug Administration in September, proved in clinical trials to slow dramatically and, in some cases, reverse the spread of breast cancer in women who were dying of the disease. Dr. Larry Norton of Memorial Sloan-Kettering Hospital in New York, one of the nation's most esteemed oncologists, said it was ''the biggest difference I've ever seen in a trial of advanced breast cancer patients.'' The warriors had finally won a major battle against cancer. And it almost never happened. In HER-2: The Making of Herceptin, a Revolutionary Treatment for Breast Cancer, Robert Bazell, the chief science correspondent at NBC News, tells a complex tale of how very difficult it is to get just one radically new drug from concept to market. As HER-2 demonstrates, there are professional reputations, huge egos, and enormous sums of money involved in the development of any drug--so much so that the desperately ill patients a drug is meant to treat often seem mere bystanders in the drama. The focus of Bazell's book is a maverick oncologist, Dr. Dennis J. Slamon, director of women's cancer research at the University of California at Los Angeles, and his struggle to persuade biotech powerhouse Genentech to develop a drug far afield from its areas of expertise. Slamon and ex-Genentech researcher Alex Ullrich first discovered in 1986, almost by sheer luck, that 25% to 30% of all breast cancer victims overproduce a protein generated by a gene called HER-2/neu, which causes tumors to grow and spread rapidly. Slamon reasoned that if an antibody could be developed that would stop the action of the HER-2/neu gene, tumor growth could be slowed and even reversed. Getting Genentech to develop such a drug was no easy task, however. The company had already decided not to pursue cancer treatments, and one that would only work for a quarter of breast cancer victims seemed a particularly bad business risk. Besides, so-called monoclonal antibodies, designed to attack cancer cells without harming surrounding tissue, had been tested for 20 years and were usually rejected by the immune system before they could work. A new technique for developing monoclonal antibodies that are compatible With humans had been developed in the early '90s, however, making a HER-2/neu drug possible. Intense lobbying of Genentech honchos by Slamon got the company to commit money to the research. But in 1990, Hoffman-LaRoche Inc. bought a 60% stake in Genentech and the company went through a major shakeup, making the road from discovery to clinical trials a tortured one. Then there was the battle of egos among Genentech, Slamon--backed by a huge endowment from Revlon Inc.--and other top oncologists involved in the clinical trials. In addition to the palace intrigue, breast cancer activists, borrowing a page from the AIDS movement, were becoming increasingly militant in their demands for access to the experimental treatment, whether or not patients fit Genentech's research protocols. Woven through the Byzantine history of all these warring factions are the often heartbreaking stories of dying breast cancer victims who volunteered to test a highly experimental drug. There are sad endings, such as that of Marti Nelson, a California doctor who died at 40, unable to obtain Herceptin despite testing positive for the HER-2/neu gene. And there are success stories such as that of Anne McNamara, who has beaten the odds by living with breast cancer since 1978. She has been on weekly infusions of Herceptin for more than two years. The women's stories give the book a human face, but HER-2 is more corporate tale than breast cancer journal. It's a well-written and heavily researched window into the world of drug development. Genentech execs were remarkably candid with Bazell, given that their decisions often seemed callous. But Bazell's bias detracts from the reporting--he is clearly on the side of Slamon, who ends up feeling bitter that Genentech has taken much of the credit for developing Herceptin. HER-2, though, ultimately disappoints for another reason: its failure to place Herceptin's success in the context of the larger story of cancer research. Bazell never goes into what the drug's success means for other treatments in development. He doesn't mention a single other monoclonal antibody, although several are in clinical trials for cancer and garnering promising results. It is useful to remember that Herceptin is not an isolated victory in the war on cancer--scientists' egos and corporate intrigue aside, it is also the first of a new class of drugs that could revolutionize treatment.
BY CATHERINE ARNST RELATED ITEMS
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Updated Oct. 15, 1998 by bwwebmaster
Copyright 1998, Bloomberg L.P.
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