Genome editing: WHO banks on whistleblowers

WHO Scientific Director Soumya Swaminathan is leading the work on genome editing. (Credit: WHO)

The World Health Organization (WHO) released on 12 July two reports on genome editing, in other words, the ability to modify the DNA sequence of a living organism, facilitated by the emergence of tools such CRISPR's molecular scissors. 

Unsurprisingly, these reports propose a global governance of these gene therapies and put forward recommendations in matters of safety, efficacy but also equality of access and bioethics – in particular with regard to the modification of transmissible genetic traits.

WHO has created a registry of voluntary reports of clinical trials of genome-editing therapies. The organisation is now calling for a mechanism to be put in place to allow whistleblowers to denounce potential abuses.

Why it matters. In December 2018, WHO established an advisory committee of international experts on the development of global standards for governance and oversight of human genome editing, in response to the scandal of the birth of two babies in China, whose genomes had been modified with the CRISPR molecular scissors. 

Two years later, these 18 experts deliver recommendations that do not only address the most obvious abuses of this technology but also call for all genome-editing clinical trials to be declared in a register created by the organisation.

Technology. The use of genetic tools is still far from perfect, in particular, because of the risk that the intervention does not affect only the target in the DNA. However, it is progressing rapidly with the first demonstration earlier this month of an in vivo intervention (without extracting the cells) in patients.

Although not exhaustive, the WHO Genome Editing Clinical Trials Register lists 126 gene editing trials, half of which started in the past two years.

Scenarios. WHO experts have developed seven scenarios for the potential abuse of this technology. Some are still hypothetical, such as the advertising of clinics for unproven gene therapies or the genetic augmentation of athletes. Robin Lovell-Badge of the Francis Crick Institute, one of the experts on the committee, cited several instances where scientists in Russia, Ukraine and Turkey, who were planning controversial gene-editing experiments, have come under pressure of their peers to abandon them.

Other scenarios are more realistic. For example, WHO experts have considered the possibility that a clinical trial of somatic human genome modification (to cure an inherited genetic disease that affects red blood cells and causes anemia, called sickle cell anemia) is taking place. in West Africa where the disease is widespread. The risk here would be that the populations of West Africa would then be excluded from these therapies because of their high prices.

The solutions. Faced with this situation, WHO experts call for more international collaboration even if they doubt an alignment of legislation. They mainly make two proposals:

  • Mandatory reporting of human clinical trials and even preclinical genome editing work, in a dedicated register.

  • An institutional mechanism for whistleblowers in this area.