China, Unhampered by Rules, Races Ahead in Gene-Editing Trials (wsj.com)

U.S. scientists helped devise the Crispr biotechnology tool. First to test it in humans are Chinese doctors (Editor's note: the link may be paywalled; alternative link). WSJ reports: In a hospital west of Shanghai, Wu Shixiu since March has been trying to treat cancer patients using a promising new gene-editing tool. U.S. scientists helped devise the tool, known as Crispr-Cas9, which has captured global attention since a 2012 report said it can be used to edit DNA. Doctors haven't been allowed to use it in human trials in America. That isn't the case for Dr. Wu and others in China. In a quirk of the globalized technology arena, Dr. Wu can forge ahead with the tool because he faces few regulatory hurdles to testing it on humans. [...] There is little doubt China was first out of the block testing Crispr on humans. Nine trials in China are listed in a U.S. National Library of Medicine database. The Wall Street Journal found at least two other hospital trials, including one beginning in 2015 -- a year earlier than previously reported. Journal reporting found at least 86 Chinese patients have had their genes edited.

Comments

More government regulations holding us back

[Anonymous Coward]

America doesn't win anymore

China's curing cancer, and we can't even keep our government in operation

Re:China China China

[Immerman]

Natural gene transfer with viruses is hardly unheard of - something like 8% of the human genome is viral in origin, and it can reasonably be expected that the reverse happens as well. After all, they do hijack our own DNA replication equipment in the course of their normal reproduction. It may be spectacularly unlikely that any given gene will be incorporated (much less have a related effect), but the sheer number of viruses involved in a single infection improve those odds considerably.

There's also the question of how the CRISPR molecules are introduced to the nucleus of the cells - a viral "carrier" is one technique, in which case you may now be infected with modified viruses with the potential to pass on the changes to other people as well. I recall one study where modified viruses were used to introduce photoreceptor-producing genes to specific kinds of brain cells - and the researchers were quick to point out that their chosen virus was harmless, rarely even causing noticeable symptoms. What they failed to address was that it WAS harmless, but now caused brain cells to grow photoreceptors - with unknown long term consequences, not to mention the potential developmental consequences if it infected a developing embryo.

Plus, there's environmental factors as well - alter the ecosystem (body), you alter its inhabitants. The bigger point is that we're just barely getting a grasp on the immediate consequences of gene editing (i.e., managing to make the functional changes we desire), and have yet to even seriously consider the second-order and further consequences that may ripple out from those changes. That would be fine so long as potential repercussions stopped with the patient, but become societies concern when we haven't even begun to ask the question of what can go wrong.

And before you dismiss that out of hand, consider that with all the years of Cas9/CRISPR research that has been done, as of last year there had been only *one* study done involving full gene-sequencing of the subjects to look for "off-target" modifications, and they found lots of them. Now, there were some serious shortcomings in the study that call it's results into question, but it still stands as the *only* serious study into immediate unintended modifications. In that kind of reckless environment, we need outside regulations to help limit the potential damage being done.