Do you remember President-elect Trump holding forth on the campaign trail about “China beating us at our own game”? Well, it’s true, as long as the game in question is editing human DNA using Crispr/Cas9. China is now using Crispr-edited cells in living, breathing human beings.

Last month, Chinese scientists at Sichuan University injected cancer-fighting, Crispr-modified white blood cells into a patient suffering from metastatic lung cancer. It was just the latest in a line of recent firsts for the People’s Republic of China, following on the heels of the first Crispr-edited monkeys in early 2014, and the first Crispr-edited human embryos last May. So there it is, Mr. President-elect: Are you going to let China win the race to edit humans?

Researchers and bioethicists worry that Trump’s political posturing could lead to a dangerous loosening of safety standards for patients. Right now, using Crispr–or any other gene-editing technique–is totally legal in the US, and subject to the same rigorous regulatory framework as other gene therapy treatments. There are even a handful of clinical trials in progress which use gene-editing, and more, including some that will use Crispr, are planned for next year.

Where it gets sticky is when you start talking about heritable changes to the human genome–what’s known as germline editing. Last December a broad coalition of leading biologists agreed to a moratorium on that until the discipline could learn more about the risks. It’s non-legally binding and anyone could buck that agreement, the problem is finding funding to do so. So what the US gene-editing community really wants to know is if Trump is going to make it possible for prospective human gene hackers to apply for big time federal grants.

Power of the purse

“There are two different and opposite things that are likely to happen,” says Hank Greely, a Stanford University lawyer and bioethicist. “The first has to do with Crispr and germline editing. Anything that looks like an embryo or sounds like an embryo will probably come under attack in the new administration.” That’s more or less the situation researchers face now. Last year’s omnibus spending bill contains a ban on all federal research dollars involving genetic manipulation of embryos, including via Crispr.

That spending bill expires December 9, though Capitol Hill Republicans plan to continue current government funding through March 31 (a short-term patch is aimed at giving the Trump administration a say in 2017 funding priorities). But don’t be surprised if embryonic editing stays taboo. The right wing’s history of opposing anything that seems like playing god goes all the way back to George W. Bush’s 2001 ban on federal funding for embryonic stem cell research.

At least one gene-editing pioneer sees that as short-sighted. “Germline editing is going to happen and to think otherwise is naive,” says University of Utah’s Dana Carroll. “And as to research on human embryos, whether or not it’s happening in the US anytime soon, elsewhere in the world it’s already started. If we want to know how to do it safely, research is going to have to provide those answers.” That may be true, but it won’t be happening on the government dollar, at least for now.

More likely is those Republican legislators will take another look at editing adult human cells–somatic cell therapies. This is the category of editing that the Chinese scientists just accomplished. The team at Sichuan University in Chengdu removed immune cells from a lung cancer patient and disabled their PD-1 gene, a brake pedal for the immune system which cancers exploit in order to proliferate. The researchers then inserted the re-engineered cells back into the patient as part of the first clinical trial to test Crispr’s safety in gene therapy applications.

The Yankee Clippers

In the US, two pieces of legislation currently in front of Congress could make it easier (and cheaper) for researchers to push similar treatments through the approval process. First is the Regrow Act, introduced in March, which would allow the FDA to bring drugs to the market for five years without Phase 3 trials (the phase where you figure out whether or not treatments actually work).

Then there’s the 21st Century Cures Act, which passed the House last year and is still waiting for a Senate vote. Actually a chimera of 19 separate bills, the proposed law would make substantial changes to the way the FDA approves drugs and devices, including streamlining of the clinical trial process. “Some provisions in there are aimed at making it easier for companies to get on the market. And while the main political thrust is stem cells, Crispr would certainly benefit as well,” says Greely.

Despite China’s head start, the international milestone still surprised some scientists–many expected the first human use of Crispr to come from a trial planned to begin next year at the University of Pennsylvania.

Whether or not you see that as a good thing depends on your politics, and what you have to gain from weaker oversight. The last few years has seen an increase in biotech lobbyists partnering with patient advocacy groups to make gene therapy and stem cell therapy treatments available to the public faster.

The Sichuan University trial received ethical approval from a hospital review board in July, after only six months of review. “To get the same thing approved in the US would take dramatically longer,” says Paul Knoepfler, a stem cell researcher at UC Davis. While study leader Lu You declined to comment for this article, others have noticed China’s reputation for moving quickly through the regulation process.

And Knoepfler says he can see how that would create a sense of urgency here in the US. “If the Trump administration buys into the idea of needing to be more competitive on gene editing, then all of a sudden there’s this pressure to allow things to move forward based on less data,” he says. “Speaking as a scientist though, we don’t tend to think along nationalist terms. None of us want to be scooped, but if it happens, we don’t care what country that person is from.”

Open the gates

The FDA, for better and for worse, is a historically cautious gatekeeper, unconcerned with international spitting contests. Clinical trials cost millions, and last for years. But George Church, Harvard University geneticist and co-founder of Editas Medicine believes it’s a necessary step to ensure new technologies like Crispr-based gene therapies really work. Even when they hold you up from making history. (Editas had been an early pick to cross the CRISPR clinical trial finish line first, in their efforts to treat a rare genetic eye disease.) “The FDA is commonly viewed as a roadblock,” he says. “But if your treatment is safe and effective it will fly through the approval process. It has nothing to do with novelty and everything to do with safety and efficacy.”

Patients are looking for answers. Biotech is looking for big bucks. Both oppose regulation. And both are at odds with scientists who think the current frameworks is appropriately judicious. “There is a real philosophical difference of opinion in Washington about whether competent adults should be able to take big risks, and whether desperate people should be offered false hope,” says Greely. He’s concerned about politicians playing up the threat of international competition to drum up support for deregulation. “That will allow trials to go forward without good data behind them. And I hope not too many people die as a result,” he says. “Elections have consequences.”

Yes they do. The consequences of this most recent one will be made clear soon enough.

25 Comments

  1. Jeramiah Johnson

    @ frankblank LMFAO yeah laughing at you 🙂 later sweetie pie

  2. You said too much. You suggested that your either a racist or a race baiting liar; you clearly don’t understand politics or anything else; and you are far too stupid to correct anything.

    ‘resurrects racism’ He ‘resurrected’ it by agitating racists like you, who immediately began spewing puke from their eyes, ears, mouths and fingers.

    There. Your incredible, cretinous ignorance has been replaced with a tiny bit of self knowledge.

  3. We’re so addicted to our cheap goods from China that we refuse to see them for the threat they are. We should be opposing them like we did the Soviet Union and forcing them towards an economic collapse like what happened to the USSR, but instead we are powering their growth. When it came to space with Sputnik and putting a man on the moon, we took on the Soviet Union as a challenge, an imperative that we show our way of life is superior. Now they are going to be topping American accomplishments from building a better canal than our Panama canal, building the fastest supercomputers, and advancing robotics and biotechnology faster than us. Why is it we had a problems with USSR and Cuba because they were COMMUNIST nations, but we empower China a communist sleeping dragon who will turn aggressive once they no longer have to worry about our opposition.

  4. eric Soulliage

    lol with a creationist evangelist as vice president this is JUST a start , better go take an immersion class at a quaker center or move out of the country

  5. Corporate Serf

    Except it not a religious issue, it’s cultural. The Bible contains no direct language against gene editing (or abortion for that matter). It’s American Christian’s cultural interpretation and The Catholic Church’s teachings, not the actual doctrine of Christianity. Religious people are all backward is a favorite saw of atheists, but historically a lot of scientific progress was made by religious people.

  6. Dwight Gilbert Jones

    What’s yet to be discerned is that editing DNA edits the Self, as our genotype is our Genity – the master molecule. Our bodies (phenotype) are just one possible printout of of our genetic identity, our personal current footprint in this infinite universe.

    This is the proper study of philosophers -identity – provided they have a B.Sc. not from Trump U. and aren’t limited to linguistic analysis. Find stewardship for your Genity, as a species we can blockchain with our own kind forever.

  7. SouthOhioGipper

    That’s an absolute falsehood. We can “cure” a few, very specific cancers like Hodgekins Lymphoma, some skin cancers, etc. But I promise you no one has a cure to Pancreatic Cancer, or Ovarian Cancer or Juvenile Leukemia or lung cancer or liver cancer. There is no “cancer” each one is unique.

    Cancer is your own cells going bad. It’s very difficult to target them safely without killing healthy cells.

  8. SouthOhioGipper

    Because it takes 10 years and over a billion dollars to work past FDR regs. We actually care about what Americans put into their bodies.

  9. The US just voted to kick 20 million people off of health care, and that will kill many thousands of them.
    If you’re from the US you have no room for criticizing the Chinese.

  10. BreadFish64

    Went to christian schools for 15 years. Pretty sure none of the commandments are “thou shalt not edit genes.” Now if we’re talking human cloning… things could get a little hairy.

  11. testing new cancer treatment on cancer patient, you think US doesn’t do this? US does this all the time for your information.

  12. right lives are cheap, that’s why they are using this technology to treat cancer while in the US they just let patients die with no other resort, talk about cheap.

  13. The bible was written over about 1600 years, from about 1500bc to about 100 ad. High technology at that time was the feather pen, and the crossbow… so yah, gene editing isn’t addressed…
    That said, I think this is less a religious issue, and more a cultural issue. Too many monster movies, and movie supervillans that use gene editing as the plotline, and too many science illiterate people that don’t know any better.

  14. carpefishus

    The atheists are ahead a bit over 60,000,000 dead in China than the “Religious Nations”

  15. Not only CRISPR, but so many advanced cancer therapies; Gendicine, Oncorin (H101), Endostar, Kanglaite, Boron-Neutron-Captured Therapy (NBCT), cryoablation, and many more. Many “high-tech” cancer treatments are available in China —no the U.S.

  16. Adebayo Bikila

    Will we one day have genetically modified humans with “Made in China” on their back sides ????

  17. William Donelson

    In the new super-double-standard world of Trump-Putin, anything can happen….
    ….
    FOR MONEY.

  18. deleted

  19. wproudchinese

    Fake moral.

  20. wproudchinese

    Ah…They do worshiping many many l one of the most important ” God: or :Divine” is ” Money God” !do you know the Red Enveloped?Google it, you and your kid love that too.

  21. If anything, I hope Trump is not that type of a Republican. I heard he does not go to church except occasionally for political or financial gains, so that’s a good sign.

  22. Jeramiah Johnson

    frankblank the alt has made a grievous mistake: “Ignorance now has its very own President.”

    Corrected; “Ignorance has had its very own President, for the last 8 years. The king of ignorance that divides people, that resurrects racism, that removes the rights of the people, that undermines the Office Of the President Of the United States, when he loses, the kind that attempts to load SCOTUS with judges that think the way wants them to, to speak the words he wants them to, to vote the way he wants them to, the kind that tell the House House of Representatives they do not need to know what they are doing, they only need to know they will vote the way he tells them to”.

    There now your mistake is corrected.

  23. Jeramiah Johnson

    Correction, there are many religions but then your comments show you are inherently ignorant of the very subject you are attempting to ridicule.

    Proof you have no clue what this is Tao.

  24. Big business actually can cure cancer, and has been done for long time already. Unfortunately, someone or some group decided to hold back giving to the world to create a demand and make money from it. Sad world we live in. Hopefully Trump will solve the problem of lobbyists in the Government. But I am not going to hold my breath.

  25. 1 million dead and 2 million families displaced in Iraq, over a lie, over a lie over WMD, just to get an oil pipeline. Shame on Americans and her allies!

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