Researchers fear 400 scientific studies used organs illegally harvested from Chinese prisoners

If a scientific study was conducted unethically, should publishers retract it?

protest of illegal organ harvesting in China
Up to three hundred supporters of the practice of Falun Dafa march through the city center of Vienna, Austria on October 1, 2018 to protest against the importing of human organs from China to Austria. (Photo by JOE KLAMAR/AFP/Getty Images)
  • A new study suggests hundreds of published scientific papers involving organ transplants in China violated ethical standards.
  • International professional standards say studies involving organ transplants shouldn't be published if the organs came from executed prisoners, or donors don't provide consent.
  • China has long been accused of facilitating a shady network of organ harvesting and trafficking, though it's been difficult to prove.

Hundreds of studies involving research on organ transplant recipients in China might have violated ethics standards, according to a new study that's called for the retraction of more than 400 published scientific papers.

Published in the journal BMJ Open, the study suggests that thousands of organs used for transplants in China likely came from condemned prisoners, and that past research has largely failed to investigate this possibility. As study authors Wendy Rogers and Matthew Robertson wrote in an article published by Newsweek, this violates international professional standards that say journals shouldn't publish research that:

  • involves any biological material from executed prisoners
  • lacks human research ethics committee approval
  • lacks consent of donors.

However, studies that fail to meet these criteria still get published. The study examined 445 papers, which detailed more than 85,000 organ transplants, published in peer-reviewed English-language journals between 2000 and 2017, finding that:

  • 92.5 percent of the publications didn't say whether the transplanted organs came from executed prisoners.
  • 99 percent didn't say whether organ donors gave consent.
  • 73 percent of papers received approval from an institutional ethics committee for their research.

​Organ harvesting in China

The Communist Party of China has persecuted Falun Gong since 1999. Hundreds of thousands of Falun Gong members have been unlawfully imprisoned, subject to torture, psychological abuse, and forced labor. They are thought to be a source of China's illegal organ harvesting trade.

Photo by JIM WATSON/AFP/Getty Images

The Chinese government says about 10,000 organ transplants occur in the nation each year, and that these come from the "largest voluntary organ donation system in Asia." But there doesn't seem to be any evidence that such a large-scale voluntary donation program exists (for example, in 2010 China's official number of voluntary donors was 34), and a 2016 report suggested the real number of annual donations is somewhere between 60,000 and 100,000.

What explains the discrepancy? The authors of the recent study suggest China has been harvesting organs from condemned prisoners and prisoners of conscience, which may include Falun Gong members, Uighur Muslims, Tibetan Buddhists and some Christians.

China has long been accused of facilitating a network of organ harvesting and trafficking, a claim that's supported by eyewitness testimony, shady government data and the relative ease with which recipients can buy organs in the country, while in most developed nations patients wait months. In 2015, China promised not to harvest organs from executed prisoners, though there's been no new laws or regulations passed that suggest the practice isn't taking place.

In December, the Independent Tribunal into Forced Organ Harvesting from Prisoners of Conscience in China released a report saying: "The tribunal's members are all certain – unanimously, and sure beyond reasonable doubt – that in China forced organ harvesting from prisoners of conscience has been practiced for a substantial period of time involving a very substantial number of victims."

​Scientists should be held responsible, too

The authors of the recent study argue that researchers and publishers should strictly adhere to ethical standards when conducting research involving organ transplants, and they've called for the mass retraction of all published work that fails to meet ethical standards.

"When a paper is published without identifying the source of the transplanted organs, it risks sending the message that ethical standards may be ignored or breached," the researchers wrote for Newsweek. "This undermines the incentive to comply with these standards in the future."

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Credit: National Cancer Institute via Unsplash
Technology & Innovation

This article was originally published by our sister site, Freethink.

For the first time, researchers appear to have effectively treated a genetic disorder by directly injecting a CRISPR therapy into patients' bloodstreams — overcoming one of the biggest hurdles to curing diseases with the gene editing technology.

The therapy appears to be astonishingly effective, editing nearly every cell in the liver to stop a disease-causing mutation.

The challenge: CRISPR gives us the ability to correct genetic mutations, and given that such mutations are responsible for more than 6,000 human diseases, the tech has the potential to dramatically improve human health.

One way to use CRISPR to treat diseases is to remove affected cells from a patient, edit out the mutation in the lab, and place the cells back in the body to replicate — that's how one team functionally cured people with the blood disorder sickle cell anemia, editing and then infusing bone marrow cells.

Bone marrow is a special case, though, and many mutations cause disease in organs that are harder to fix.

Another option is to insert the CRISPR system itself into the body so that it can make edits directly in the affected organs (that's only been attempted once, in an ongoing study in which people had a CRISPR therapy injected into their eyes to treat a rare vision disorder).

Injecting a CRISPR therapy right into the bloodstream has been a problem, though, because the therapy has to find the right cells to edit. An inherited mutation will be in the DNA of every cell of your body, but if it only causes disease in the liver, you don't want your therapy being used up in the pancreas or kidneys.

A new CRISPR therapy: Now, researchers from Intellia Therapeutics and Regeneron Pharmaceuticals have demonstrated for the first time that a CRISPR therapy delivered into the bloodstream can travel to desired tissues to make edits.

We can overcome one of the biggest challenges with applying CRISPR clinically.

—JENNIFER DOUDNA

"This is a major milestone for patients," Jennifer Doudna, co-developer of CRISPR, who wasn't involved in the trial, told NPR.

"While these are early data, they show us that we can overcome one of the biggest challenges with applying CRISPR clinically so far, which is being able to deliver it systemically and get it to the right place," she continued.

What they did: During a phase 1 clinical trial, Intellia researchers injected a CRISPR therapy dubbed NTLA-2001 into the bloodstreams of six people with a rare, potentially fatal genetic disorder called transthyretin amyloidosis.

The livers of people with transthyretin amyloidosis produce a destructive protein, and the CRISPR therapy was designed to target the gene that makes the protein and halt its production. After just one injection of NTLA-2001, the three patients given a higher dose saw their levels of the protein drop by 80% to 96%.

A better option: The CRISPR therapy produced only mild adverse effects and did lower the protein levels, but we don't know yet if the effect will be permanent. It'll also be a few months before we know if the therapy can alleviate the symptoms of transthyretin amyloidosis.

This is a wonderful day for the future of gene-editing as a medicine.

—FYODOR URNOV

If everything goes as hoped, though, NTLA-2001 could one day offer a better treatment option for transthyretin amyloidosis than a currently approved medication, patisiran, which only reduces toxic protein levels by 81% and must be injected regularly.

Looking ahead: Even more exciting than NTLA-2001's potential impact on transthyretin amyloidosis, though, is the knowledge that we may be able to use CRISPR injections to treat other genetic disorders that are difficult to target directly, such as heart or brain diseases.

"This is a wonderful day for the future of gene-editing as a medicine," Fyodor Urnov, a UC Berkeley professor of genetics, who wasn't involved in the trial, told NPR. "We as a species are watching this remarkable new show called: our gene-edited future."

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