Chinese scientists have allegedly lost track of patients who participated in a trial of a gene therapy for cancer.
Losing track of these patients means that the researchers are now unable to monitor their condition, and that the effects of that gene therapy cannot be known. There is also concern that the backlash may have consequences for the broader biomedical research field.
'Since we do not fully understand the human genome and are still developing knowledge of [CRISPR/Cas9 and related technologies], we need to monitor the intended and unintended consequences over the lifespan of patients,' said Professor Jennifer Doudna of the University of California, Berkeley, and co-creator of CRISPR technology, the Wall Street Journal reported.
The participants in the clinical trial were late-stage cancer patients that had their DNA modified with CRISPR-Cas9. For trials involving gene therapies, experts such as Doudna insist that regular follow-up examinations are a crucial part of any experiment, as altering the DNA could have many unintended consequences.
These reports of missing patients are come at a time when the field of genome editing in China is already under scrutiny for questionable research practices. In November, Dr He Jiankui, an associate professor at the Southern University of Science and Technology, claimed that he created the first human beings born with altered genomes. The news generated international outcry and lead to calls for investigation and a suspension of Dr He's research activities.
Doudna stated that she is concerned 'about reckless applications of genome editing that put the safety of patients at risk, damages the public's acceptance of CRISPR technology, and could trigger a range of negative but permanent unintended consequences.'
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