Chinese scientist's risky experiment with gene-editing babies

It's China's biological Sputnik, launched by a rogue scientist. ...

Posted: Nov 29, 2018 8:26 AM
Updated: Nov 29, 2018 8:26 AM

It's China's biological Sputnik, launched by a rogue scientist. A Chinese scientist has claimed he has succeeded in editing the genes of twin girls, Lulu and Nana, in a medical first that is shocking -- for its secrecy, its needlessness and what it suggests about the culture of medical research in China.

Since the debut of the biotechnology CRISPR-cas9 in 2012, this day seemed inevitable -- despite endless warnings from bioethicists and a wide variety of scientific bodies. Hours after the announcement that the twins were born "a few weeks ago" with modified DNA, the technique's co-creator Feng Zhang called for an immediate halt to such trials.

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CRISPR is a kind of search-and-destroy or search-and-replace for the human genome. Normally, RNA molecules, spawned through DNA transcription, serve as the blueprint for proteins. But by pairing RNA with the aid of a DNA cutting enzyme called cas9, the CRISPR technique can snip out a particular DNA sequence, turning off genes or replacing them with other DNA.

And since scientists can easily generate an RNA pair for any sequence of DNA (the underlying biological code in each human cell), CRISPR has the potential to cure countless genetic diseases.

But the CRISPR technique isn't perfect, and in every few hundred cases, in what is referred to as "off-target events," it can edit the wrong portion of DNA, potentially creating unwanted mutations.

Less controversial trials are already underway involving humans after birth. This kind of gene editing revises somatic cells, the kind that are not passed on to our offspring.

But when a scientist edits the genes in an embryo prior to implantation into the womb, the germ line is altered. That means the laboratory edits could be passed along to all subsequent generations springing forth from this individual.

Germline editing is highly controversial but has been theoretically condoned under a range of strict criteria and regulations -- all of which include complete transparency within the experimental trial. (The one exception being the details of identification for the participants, which may be kept secret.)

Which is to say, no one wanted this kind of trial done in secret. But secrecy is exactly what the Chinese scientist appears to have chosen. He did not publicly announce his plans to conduct the trial or allow for the scientific community to debate its merits before announcing his findings this week.

And, in that secrecy, Dr. He Jiankui of Shenzen's Southern University of Science and Technology went forward with an ethically flawed research plan, choosing to edit the gene CCR5, so that it was no longer functional. People without working CCR5 genes are more resistant to HIV infection. The researchers targeted couples in which one partner has HIV, offering the hope they can give birth to an HIV-free and HIV-resistant child.

In the case of the former, it's already possible to prevent HIV transmission via sperm washing and assisted fertilization. And, in the case of the latter, while gene editing might be effective in providing some degree of long-term HIV immunity, this has not been proven in humans yet.

Furthermore, HIV vulnerability isn't a disease state -- it's our normal condition; we're all HIV vulnerable unless we happen to be one of the rare people with a naturally occurring CCR5 mutation. And, frankly, there are simple proven ways to prevent the vast majority of HIV transmission events: safe sex and avoidance of contaminated needles.

Most disturbing, CCR5 makes the children He has edited more prone to dying from the far more common influenza virus.

In a troubling twist, the Associated Press reports that American scientist Michael Deem, a professor of bioengineering at Rice University, appears to have participated in the work. Deem told the Associated Press he was in China when the study's participants consented and that they seemed aware of the risks involved. CNN reached out to Deem for comment, but he did not reply.

American research universities typically demand some level of oversight and awareness of their researchers' activities -- regardless of where in the world they are working. Rice University is now investigating Deem's alleged involvement. Rice's spokesperson told me in an email that "this work as described in press reports, violates scientific conduct guidelines and is inconsistent with ethical norms of the scientific community and Rice University."

An American Institutional Review Board, the kind of local body of clinicians, scientists, ethicists, and community members responsible for ensuring human subjects research is sufficiently safe and balances interests of the patient and community, would not have approved this study.

Though the Chinese university has denied knowledge of the study and said it violates their standards and the Chinese government has ordered an investigation into the study, that the work was done in China is hardly surprising (and not only because He himself is Chinese.) Last fall, according to ClinicalTrials.gov, 9 out of the 10 CRISPR trials listed were taking place in China.

Why? It's likely because China has a much more lax regulatory structure than in Europe or the United States, allowing relatively informal hospital ethics committees to approve novel genetic research. In Europe and the United States, multiple layers of national regulators provide checks and balance to highly formalized medical trials -- slowing the research process.

But this lax structure has gotten China into trouble before. In 2015, two of the world's top scientific journals, Nature and Science, both cited ethical objections in rejecting the first paper reporting on genetic editing of a human embryo -- work that took place in China. Protein and Cell, the journal that did publish the study, did so, it claimed, only to "sound an alarm" on the scientists who had carried out the study.

It is also dismaying to think an American research professor could have assisted in the project in any capacity.

In a YouTube video, He says that the birth of the world's first IVF child 40 years ago was greeted with a storm of controversy, but that the procedure is now routine, and he expects his announcement to be no different. In truth, there is no parallel. Fertilization of an egg outside the human body carries with it no change to the body of the subsequent child and has no impact on future generations.

But we don't need to imagine future transgressions in order to condemn this action. What kind of human rights violation is it called when ambitious scientists secretly make decisions that alter the human race? Will the Chinese government work to strengthen their regulatory framework to prevent future ethically questionable studies -- rather than just condemning the work of He in this particular incident?

He and Deem should not be rewarded for merely first doing what many others could have done, were it not for their own scruples. Without condemnation, we are giving a license to a gene race, which is far riskier than a space race ever was.

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