Hong Kong – A Chinese researcher says he has helped create the world's best genetically modified children: two twins whose DNA has been modified to try to help them resist future viral infection with the human immunodeficiency virus (HIV).
If that were true, it would be a profound leap in science and ethics.
A US scientist said he had participated in Chinese works, but this type of gene editing is forbidden in his country, because DNA changes can be passed on to future generations and can damage other genes.
Many conventional scientists think it is too dangerous to try, so some have denounced the fact that the Chinese report is human experimentation.
The researcher, He Jiankui, from Shenzhen, said he modified the embryos of seven couples during fertility treatments and has so far resulted in a pregnancy. He reported that his goal was not to cure or prevent hereditary illness but to try to provide a feature that few people naturally have: the ability to withstand a possible future HIV infection, the virus that causes Immune Deficiency Syndrome.
He added that the parents involved refused to be identified or interviewed and did not say where they lived or where the work was done.
There is no independent confirmation of his claim and was not published in a journal where other experts could examine him. The announcement was revealed on Monday in Hong Kong, one of the organizers of an international conference on genetic publishing, which will begin Tuesday and before in an exclusive interview with The Associated Press.
"I feel a great responsibility that it's not just about making a premium, but also being an example," he said. "Society will decide what to do next" in allowing or prohibiting such sciences.
Some scientists were surprised to hear the request and strongly condemned this.
It's "inconceivable … an experiment with people who are not morally or ethically defensible," said Dr. Kiran Musunuru, an expert in genetic publishing at the University of Pennsylvania and editor of a journal of genetics.
This is too early, said Dr. Eric Topol, who runs the Scripps Research Institute of California. "We are dealing with the operational instructions of a human being, it is a big problem."
However, a famous geneticist, George Church at Harvard University, has defended the genetic editing attempt for HIV, which he described as "a greater and greater threat to public health."
"I think this is justified," the Church said.
In recent years, scientists have discovered a relatively easy way to edit genes, the DNA components that govern the body. The tool, called CRISPR-cas9, makes it possible to run with DNA to provide the necessary gene or disable one that causes problems.
Only recently has been attempted in adults to treat deadly diseases, and the changes are limited to that person. The issue of sperm, eggs or embryos is different, changes can be inherited. In the US, it is not allowed, except laboratory research. China prohibits human cloning, but does not specify gene editing.
El Jiankui (HEH JEE & # 39; -an-qway), who talks about JK, studied at the Rice and Stanford universities in the US. Prior to returning to his native country, he opened a laboratory at the South China University of Science and Technology in Shenzhen, where he holds two genetics companies.
An American scientist who worked with him on this project after his return to China was Physics and Bioengineering Professor Michael Deem, who was his counselor at Rice in Houston. We also have what he called "a small participation" and is part of the scientific advice of two companies.
The Chinese researcher said he practiced seven years of meeting of mice, monkeys and human embryos and sought patents for his methods.
He said he chose to test the embryonic gene for HIV because these infections are a major problem in China. He tried to disable a gene called CCR5 that forms a protein gate that allows the HIV virus that causes AIDS to enter a cell.
All men in the project had HIV and all women did not, but gene editing does not aim to prevent the low risk of transmission, he said. Parents have profoundly suppressed infections by standard anti-HIV drugs, and there are simple ways to prevent them from infecting children that do not alter genes.
Instead, the call was to give HIV-affected couples the opportunity to have a child who might be protected by a similar fate.
He recruited couples through a Beijing AIDS advocacy group called Baihualin. Its leader, known as the "Bai Hua" pseudonym, told AP that it is not uncommon for people with HIV to lose their jobs or if they have problems getting health care if their infections are revealed.
Thus the work was done:
The gene's release took place during IVF, or the fertilization of the laboratory plate. First, sperm was "washed" to separate it from semen, the fluid in which HIV can be hidden. A single sperm was placed in one egg to create an embryo. Then added the gene editing tool.
When the embryos were 3 to 5 days old, some cells were removed and their editing was verified. Couples can choose whether or not to use edited embryos for pregnancy trials. In total, 16 of the 22 embryos were published and 11 embryos were used in six implant trials before the twin pregnancy was performed, he said.
The evidence suggests that only one gemist had both copies of the gene of interest modified, and the other twin was altered without any evidence of damage to other genes, he said. People with a copy of the gene can still get HIV, although some very limited research suggests that their health may decrease more slowly once they did.
Several scientists have analyzed the materials provided to the PA and said the tests so far are not enough to say that the edition worked or to exclude the damage.
They also noticed evidence that the edition was incomplete and that at least one twin appears to be a mosaic of cells with several changes.
"It's almost like nothing will be edited" if only some of the cells have been modified because HIV infection can still occur, the Church said.
The Church and Musunuru have questioned the decision to allow one of the embryos to be used in an attempt to remain grave, as Chinese researchers have said they know in advance that both copies of the desired gene have not been altered.
"In that child, there was nothing to gain from protection against HIV and yet expose her child to all the unknown security risks," Musunuru said.
The use of this embryo suggests that the primary focus of the researchers was "to test the problem instead of avoiding this disease," the Church said.
Even though editing has worked perfectly, people without CCR5 normal genes face greater risks of contracting other viruses, such as West Nile, and die of influenza. According to Musunuru, there are many ways to prevent HIV infection and is very treatable if it appears, those other medical risks are a concern.
There are also questions about how he said he did. He gave an official note about his work a long time after he said he started on November 8th in a Chinese clinical trial registry.
It is not clear whether the participants have fully understood the purpose and possible risks and benefits. For example, consent forms have called the "AIDS Vaccine Development" project.
Rice researcher Deem said he was present in China when potential participants gave their consent and that "absolutely" believes they could understand the risks.
We say he worked with him on Rice vaccine research and believes that the gene edition is similar to a vaccine.
"This may be the way a layman describes it," he said.
Both men are physicians with no experience in clinical trials in humans.
The Chinese researcher, He, said he personally made the goals and informed the participants that they had never tried before editing the embryonic gene and taking risks. He added that he will also provide insurance coverage for any child conceived by the project and plans a medical follow up until the children are 18 or older if they agree once they are adults.
Other attempts during pregnancy are pending until the safety of this is being analyzed and experts in the field do, but participants have not been told beforehand that they may not be able to prove what they were enrolled once the first "task," he admitted. Free fertility treatment was part of the treatment that was given to them.
He requested and received the approval of his project at the Shenzhen Harmonicare Hospital for Women and Children, which is not one of the four hospitals he said he provided embryos for his research or attempts to be pregnant.
Some of the staff of some of the other hospitals have remained in the dark about the nature of the investigation, which, according to Deem, was made to prevent the disclosure of HIV infection to some of the participants.
"We believe this is ethical," said Lin Zhitong, director of Harmonicare, who runs the ethics panel.
Any member of the medical staff who handled the samples that could contain the HIV virus was aware, he said. An embryologist in Hei's laboratory, Qin Jinzhou, confirmed the AP had done the sperm scrubbing and injected the gene editing tool in some pregnancy attempts.
Study participants are not ethical, he said, but "there are so many authorities about what is right as what is wrong because it is their life on the line."
"I think this will help their families and their children," he said. If it causes side effects or unwanted damage, "I would feel the same pain as they are and it will be my responsibility."