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To China For a U.S. Cancer Drug?
Deborah Weatherby-Falk of Vancouver is treated by a Chinese nurse. "I understand the criticisms," Weatherby-Falk said. "I came despite them." At right, Richard Weissenborn checks a clear PET scan from January, after treatment in Beijing with the drug Gendicine; later, his cancer returned.
(Photos By Ariana Eunjung Cha -- The Washington Post)
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"In the West, there are still people who are suspicious about this first gene-therapy product and have doubts about its origins and clinical practices. But after 50 years of fighting cancer, humans haven't had any obvious advancement in treatment other than this," Peng said.
"It is absolutely untrue that our drugs are the same," Peng added. "There's a huge difference -- the only thing that is the same is the name" of the cancer-related gene the two companies target with their therapies.
Meanwhile, the drug is beginning to transform the way cancer patients are treated in China, offering an alternative to traditional treatments with harsh side effects, such as surgery and chemotherapy. As of last month, more than 5,000 patients had been treated with the drug.
Weissenborn, 64, has traveled to Beijing three times to receive the Chinese gene-therapy treatment. He's a believer in the drug and is angry it is not available in the United States.
"If I died today, I have already prolonged my life and have a quality of life that I could not have with any other cancer treatment," he said.
Outside China, gene therapy is considered a provocative and important theory, but efforts to develop treatments using it have been troubled.
Many diseases, cancer included, arise when genes develop mutations that warp their normal function. Perhaps half of all cancers include abnormal copies of a crucial gene known as p53, the body's "guardian gene." It plays a central role in detecting abnormal growth and ordering cells undergoing it to commit suicide. When p53 itself becomes disabled by mutations, though, cells can more easily turn cancerous.
Various approaches are being developed to exploit this knowledge to battle cancer. One is to use gene therapy to insert normal copies of the p53 gene into cancer cells.
But it has turned out to be difficult, in practice, to get functioning genes into cells from outside the body. Research in the United States slowed down temporarily in 1999 when a teenage patient at the University of Pennsylvania died in a poorly run gene-therapy trial and then again when three children in France were stricken with a leukemia-like condition after receiving experimental treatments.
Jack A. Roth, head of thoracic and cardiovascular surgery at the M.D. Anderson Cancer Center at the University of Texas at Houston, helped pioneer the technology that both Introgen and SiBiono use. He said the Food and Drug Administration has been reviewing this type of gene therapy for more than seven years.
"The approval process is a frustrating business. It's not only very slow but unpredictable," said Roth, who helped found Introgen.
Introgen's Nance said the company may apply for FDA approval to market a gene-therapy cancer treatment as early as the end of this year. Like Peng, he cautioned against too much optimism about the drug.
