China, Unhampered by Rules, Races Ahead in Gene-Editing Trials
- U.S. scientists helped devise the Crispr biotechnology tool.
- First to test it in humans are Chinese doctors
HANGZHOU, China—In a hospital west of Shanghai, Wu Shixiu since March has been trying to treat cancer patients using a promising new gene-editing tool.
U.S. scientists helped devise the tool, known as Crispr-Cas9, which has captured global attention since a 2012 report said it can be used to edit DNA. Doctors haven’t been allowed to use it in human trials in America. That isn’t the case for Dr. Wu and others in China.
In a quirk of the globalized technology arena, Dr. Wu can forge ahead with the tool because he faces few regulatory hurdles to testing it on humans. His hospital’s review board took just an afternoon to sign off on his trial. He didn’t need national regulators’ approval and has few reporting requirements.
Dr. Wu’s team at Hangzhou Cancer Hospital has been drawing blood from esophageal-cancer patients, shipping it by high-speed rail to a lab that modifies disease-fighting cells using Crispr-Cas9 by deleting a gene that interferes with the immune system’s ability to fight cancer. His team then infuses the cells back into the patients, hoping the reprogrammed DNA will destroy the disease.
In contrast, what’s expected to be the first human Crispr trial outside China has yet to begin. The University of Pennsylvania has spent nearly two years addressing federal and other requirements, including numerous safety checks designed to minimize risks to patients. While Penn hasn’t received final federal clearance to proceed, “we hope to get clearance soon,” a Penn spokeswoman said.
“China shouldn’t have been the first one to do it,” says Dr. Wu, 53, an oncologist and president of Hangzhou Cancer Hospital. “But there are fewer restrictions.” In traditional drug development, too, human-trial rules can differ among countries. But China’s foray into human Crispr trials has some Western scientists concerned about the unintended consequences of using the wholly new tool—such as harm to patients—which could set back the field for everyone.
Western scientists the Journal interviewed didn’t suggest America’s stringent requirements should be weakened. Instead, many advocate an international consensus on ethical issues around a science that makes fundamental changes to human DNA yet still isn’t completely understood.“How do we make sure everyone is under the same tent?” says Jeffrey Kahn, director of the Berman Institute of Bioethics at Johns Hopkins University. With Crispr science still uncertain, “we need to be talking to each other internationally.”
There is little doubt China was first out of the block testing Crispr on humans. Nine trials in China are listed in a U.S. National Library of Medicine database. The Wall Street Journal found at least two other hospital trials, including one beginning in 2015—a year earlier than previously reported. Journal reporting found at least 86 Chinese patients have had their genes edited.
The trials align with China’s industrial policy. As part of its drive to place China on the global stage in a multitude of industries, Beijing in a 2016 five-year plan highlighted gene editing. Many of the Crispr trials emerged after that call-to-arms.
Carl June, lead scientist for the Crispr research team at Penn, says China could beat the U.S. to apply medical technologies such as Crispr pioneered in the West. “We are at a dangerous point in losing our lead in biomedicine,” he says. There is a “regulatory asymmetry” between America and China, Dr. June says, but Crispr science is so new “it is hard to know what the ideal is between moving quickly and making sure patients are safe.”In Europe, too, trials haven’t started. Crispr Therapeutics AG , whose founders include a scientist associated with the tool, announced in December it had filed with the European version of the U.S. Food and Drug Administration to open a clinical trial in Europe. Regulators are reviewing the application, and the company plans to start this year, a spokeswoman says.