Ahead of the whole planet
China, unfettered by the rules, is pushing ahead and is already trying out genome editing methods
Translation: Inopressa
Chinese physician Wu Shixiu has been trying to treat cancer with a promising new genome editing tool since March last year. "American scientists took part in the development of this tool, known as Crispr-Cas9 and attracting worldwide attention after an article from 2012 reported that it could be used to "correct" DNA."
In America, doctors are not allowed to use this tool in human trials, but in China, Dr. Wu can move forward. "It took only a few hours for the supervisory board of his hospital to allow him to be tested. He did not need the permission of national regulators, he has little to report on," the article says.
"Dr. Wu's research team at Hangzhou Cancer Hospital takes blood from patients suffering from esophageal cancer and sends it by high-speed rail to a laboratory that modifies cells fighting the disease: namely, Crispr-Cas9 is used to remove a gene that prevents the immune system from fighting cancer. Then doctors pour altered blood cells into patients, hoping that the reprogrammed DNA will prevail over the disease," the authors of the article explain.
The first human trials of Crispr outside of China are scheduled, but have not yet begun. The publication clarifies: "The University of Pennsylvania has spent almost two years meeting the requirements of federal and other authorities, including numerous safety checks that are designed to minimize the risk to patients." According to the representative of the university, he hopes to receive a final permit from federal agencies soon.
Some Western scientists are worried about the unintended consequences that the use of a completely new tool may have.
The authors note: "Western scientists interviewed by our newspaper did not offer to soften the strict requirements of the US authorities. On the contrary, many are calling for a consensus of different countries on the ethical aspects of science, which makes fundamental changes in human DNA, but is not yet completely clear to us."
"There is almost no doubt that China was the first to test Crispr on humans. The database of the US National Library of Medicine records 9 clinical trials in China. The Wall Street Journal found at least two more cases of trials in hospitals, including one trial that began in 2015 (a year earlier than previously reported). There was information in journal articles that gene editing was done to at least 86 patients in China," the article says.
The publication comments: "In order to bring China to the world stage in numerous industries, Beijing, in the five-year plan of 2016, paid special attention, among other things, to genome editing. After he "called to arms," many Crispr trials began."
Carl Jun, the head of a group that researches Crispr at the University of Pennsylvania, says that China can outpace the United States in the application of medical technologies originally developed in the West. "We are at a dangerous point where we can lose our leading positions in biomedicine," he said. According to Jun, there is an "asymmetry in regulation" between America and China, but the scientific method of Crispr is so innovative that "it is difficult to find the perfect balance between rapid progress and ensuring patient safety."
In Europe, the tests have not yet begun either, it goes on. In December, Crispr Therapeutics AG announced that it had submitted an application to the EU authorities to start clinical trials in Europe. A representative of the company said that the work is planned to begin this year.
Crispr-Cas9 works as a "molecular scissors" for cutting or repairing DNA, the newspaper writes. This method of genome editing is simpler and cheaper than others.
At the same time, there are risks, the publication admits. "Crispr may be making unintentional irreversible changes that may manifest in humans only after many years. A new Stanford University study suggests that many people already have immunity to Cas9 proteins and some Crispr therapies may not work or cause a dangerous immune reaction," the article says.
Wu calls Crispr a "double-edged sword." Some "see potential harm – we see potential benefit," he says. According to him, speed is the main thing, as his patients are on the verge of death. "If we don't try, we'll never know what will come out," the Chinese doctor notes.
The newspaper reports: "The results of the tests conducted in China have not been published. Wu and other doctors say that the condition of some patients has improved, but at least 15 of the 86 patients known to have died. The doctors who are conducting the tests claim that the cause of death was diseases that these patients already suffered from."
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