| 送交者: 手术刀[☆★声望品衔7★☆] 于 2018-11-30 20:59 已读 1792 次 | 手术刀的个人频道 |
Born CRISPR’d – can it happen here?
6park.comExperts say it’s time to seek international consensus over tool that changes human’s genetic blueprint 6park.comOct. 10, 2018: He Jiankui speaks during an interview at a laboratory in Shenzhen in southern China’s Guangdong province. (AP Photo/Mark Schiefelbein) 6park.comBy Lisa M. Krieger | lkrieger@bayareanewsgroup.com | Bay Area News Group 6park.comPUBLISHED: November 30, 2018 at 1:35 pm | UPDATED: November 30, 2018 at 5:08 pm 6park.comIn news that rocked the scientific community this week, a rogue Chinese scientist violated a scientific taboo by altering the DNA of twin girls, raising the question: What keeps American scientists from following in his footsteps? 6park.com
Answer: A one-sentence amendment to a critical 878-page funding budget. 6park.com
There was immediate international condemnation that scientist He Jiankui acted unsafely and unethically in his use of CRISPR/Cas 9, a UC Berkeley-conceived tool that gives us unprecedented power to create permanent changes to future people’s genomes. 6park.com But the news also confronts us with this unsettling reality: Nations vary widely in their oversight of this powerful and potentially beneficial technology — and there is no international set of enforceable ethical guidelines or moral norms to manage it. Experts predict CRISPR’s use likely will proceed at wildly different rates among different countries, cultures and regulatory systems. 6park.com
“We don’t have a good way of talking about what we owe future generations,” said Josephine Johnston, director of research for the Hastings Center, a bioethics institute. 6park.com
The U.S. doesn’t explicitly ban gene editing of embryos. But scientists are not allowed to use federal money to do it. And even if the work is privately funded, American scientists can’t get federal approval needed to offer the technology to patients. That’s because there’s a provision in the Consolidated Appropriation Act of 2016, renewed annually, that says that no federal money can be used to review an application in which an embryo was modified. 6park.com
The American, British and Hong Kong organizers of this week’s summit on human genome editing, where He announced his work, said the technology should not now be used on humans because the risks and benefits remain poorly understood. 6park.com
But they rejected calls for a blanket moratorium, saying the approach has future potential. 6park.com
In an analysis of relevant legislation and guidelines in 39 countries, bioethicist Tetsuya Ishii of Hokkaido University in Sapporo, Japan, found that 29 have rules that could be interpreted as restricting genome editing for clinical use, but rules vary widely elsewhere. 6park.com
6park.com 6park.com if ( "undefined" !== typeof googletag ) { 6park.com googletag.cmd.push( function() { googletag.display("div-gpt-ad-Cube_Article"); } ); 6park.com } 6park.com 6park.com 6park.comIn Germany, where the abuses of World War II still loom large in the collective memory, any embryo experimentation is a criminal offense. Other countries, such as China, Japan, India and Russia, merely rely on nonbinding recommendations or have “bans” that are not legally binding. 6park.com
America’s prohibition is not as nuanced, flexible and transparent as the United Kingdom’s, for example, which has spent decades building a regulatory apparatus. 6park.com
“It’s weird way to regulate,” said Johnston. “But these are the tools that our federal government has.” 6park.com
Stanford bioethicist and law professor Hank Greely, director of the Stanford Center for Law and the Biosciences, is confident that it wouldn’t happen here. 6park.com
“There is no reason to panic in the U.S.,” he said, because the FDA asserts its authority over a genetically modified human embryo as a “drug” or “biological product” — a claim likely to be upheld by courts. Violations can lead to civil penalties and possible federal criminal charges of misdemeanors with one year of prison and up to $100,000 fine, per count. 6park.com
Additionally, it would not be allowed under hospitals’ review board system. Because In Vitro Fertilization clinics that create embryos are subject to FDA and hospital rules if they take federal funding, they also would resist, he said. 6park.com
“Human embryos — it is hard to get ahold of them,” said Greely. 6park.com
But while that’s enough to dissuade most U.S. scientists, the implied-rather-than-explicit prohibition might not stop everyone, said Stuart Newman, professor of cell biology and anatomy at New York Medical College. “Of course it can happen here. There are all sort of things that go on in private clinics.” 6park.com
Newman worries about rogue actors. Scientists can avoid hospitals’ review system if they used no federal money, don’t do the work through a university or hospital and don’t plan to file for FDA approval. 6park.com
“Our restrictions — those are the restrictions that responsible actors abide by,” he said. “You have these scientists who see themselves as heroes then try it to provide it to people who don’t know it is wrong. 6park.com
“People do all sort of corner cutting,” said Newman, “and then just let the public and culture deal with it.” 6park.com
And even if the U.S. government bans such tinkering, experts agreed, it’s hard to control the introduction of “fixed” genes in a world where medical tourism is thriving. New York City’s Dr. John Zhang recently performed a banned procedure, called mitochondrial transfer, in Mexico for a U.S. couple. 6park.com
With the current pace of advances in the use of gene-editing technology, many say the Chinese news was inevitable. But because CRISPR is not now safe, it’s been assumed that no respected scientist would try it. 6park.com
“Everyone has been standing around looking at this weapon; He Jiankui is just the guy who walked up and pulled the trigger before anyone was quite clear where the thing was aimed,” wrote researcher Derek Lowe in the journal Science. 6park.com
To be sure, genetic mutations are a normal part of evolution. But now we can create them. Chinese scientist He edited the gene for a receptor of the immune system, called CCR5. If the girls become parents, this mutation will become part of the global human gene pool. 6park.com
The Chinese experiment rocked the scientific world due to its lack of transparency, poor experimental design, apparent disregard of safety and dubious informed consent, said Lowe. 6park.com
There’s still a lot we don’t know about CRISPR: What if the wrong genes are altered? What if an essential gene is damaged? What if a diseased gene is also beneficial? And what if parents seek to “improve” their offspring by making them smarter, more athletic, more attractive or longer-lived? 6park.com
“What do we do with those people?” asked Newman, who asserts such research violates the international Nuremberg Code and Declaration of Helsinki. 6park.com
A global prohibition is unlikely, experts agree. And it may be unwise; CRISPR could someday offer benefit to carriers of lethal disease. 6park.com
6park.com
Related Articles
6park.com 6park.com 6park.com Northern California man unveils new smile after face transplant 6park.com 6park.com 6park.com 6park.com 6park.com Opinion: Supervisor reflects on long fight against AIDS 6park.com 6park.com 6park.com 6park.com 6park.com Report: Life expectancy continues to fall in the US 6park.com 6park.com 6park.com 6park.com 6park.com Opinion: How California can become a model for mental health care 6park.com 6park.com 6park.com 6park.com 6park.com Appeals court overturns challenge to California’s right-to-die law 6park.com 6park.comBut a general international agreement — marking ethical boundaries — could help guide national lawmakers, experts agree.6park.com
“No laws work perfectly. And international agreements work less perfectly than other laws,” said Greely. “But they’re helpful, even if they don’t work perfectly.”
请点这里投票，“赞”助支持！