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FDA Approves First Gene Therapy in US to Treat Leukemia

In a groundbreaking announcement, the U.S. Food and Drug Administration has approved the first treatment that uses genetic engineering of human cells to fight a disease, CBS News reports. Scientists hope to fight childhood leukemia with the new process, which uses patients’ own blood cells to “turbocharge” T cells, which zero in on, and fight, the cancer. Doctors said the first child treated with the therapy was near death five years ago, but is now cancer-free.

While this T cell treatment is an apparent gene-therapy success, I’m still concerned about a different type of gene tinkering known as CRISPR. Short for Clustered Regularly Interspaced Short Palindromic Repeat, CRISPR allows scientists to alter your actual DNA, and essentially cut and paste it at specified places.

But unlike the reported success of the T cell therapy for leukemia, a recent study in gene-edited mice showed that CRISPR can lead to hundreds of unexpected mutations, including more than 100 additional deletions and insertions and more than 1,500 single-nucleotide mutations. While scientists claim this isn’t anything they can’t fix, it’s worth noting that each mutation has the potential to lead to serious unintended and unexpected consequences.

With CRISPR gene-editing capabilities, three categories of DNA alterations become possible, including manipulating embryonic DNA (to eliminate inheritable diseases); alteration of genes in hopes of preventing a future disease of any type; and genetic “enhancement,” in which genes are installed or modified to change a person's physical or mental potential — all of which could become an ethical problem of enormous proportions if just one unexpected and wrong mutation were to occur.

You may be surprised to learn that CRISPR and other gene-editing tools are also being used in the food industry. Gene-edited crops, in which DNA is tweaked or snipped out at a precise location, have already been created — and eaten. Unlike genetically engineered (GE) foods, which may have genes from other species inserted, these foods aren’t even subject to regulation by the USDA or other regulatory agencies — which is something that should concern us all.
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