The study, appearing in PLOS One, was funded by Tonix, a New York-based pharmaceutical company, and carried out by virologist David Evans at the University of Alberta in Canada, and his research associate Ryan S. Noyce. They synthesized the horsepox virus, which is in the same family as smallpox but is not known to infect humans. The goal was to see if the synthesized virus could be useful in making a safer smallpox vaccine. The experiment was relatively difficult because pox viruses are complex and have large genomes compared to other viruses. The scientists purchased genetic material from a company in Germany, stitched it together and demonstrated that live horsepox-virus particles could be grown in suitable cells. The effort, according to a World Health Organization briefing paper, took six months and cost $100,000.
The danger is that someone with malevolent intent could do the same for smallpox. The disease killed hundreds of millions of people in the 20th century alone. After eradication, routine immunization ceased, and today populations lack immunity. (Two remaining repositories of the virus are kept under lock and key in the United States and Russia.) The Canadian researchers did not violate regulations, but their work fell into a sort of gray area where regulations hardly reach. The U.S. government has restrictions on dual-use biomedical research, but they apply only to federally funded projects, not those privately funded. Horsepox is not on the U.S. list of select agents subject to restrictions for dual-use research. The WHO has recommended, and many nations have adopted, rules that prohibit laboratory reconstruction of more than 20 percent of the variola genome, but not horsepox. The researchers submitted their findings to two prestigious journals, which refused to publish on grounds that the risks outweighed the benefits, according to Kai Kupferschmidt of Science. But then PLOS One said it found the benefits outweighed the risks.
The life sciences revolution has produced huge gains for mankind, and it must be nurtured and supported. But a study such as this comes as a jolt. It was not necessary. A vaccine against smallpox already exists. The research was carried out unilaterally, without a broader discussion of the merits beforehand. There are apparently few oversight mechanisms when experiments are done with private funding. The restrictions that now cover dual-use research funded by U.S. government — which include an independent review process, and a weighing of the risks and benefits, as well as the ethics — should be expanded to private-sector research. The WHO should be given a stronger oversight role, too. There is no way to change biology's dual-use character, but there are ways to strengthen the chances that it serves only the betterment of man.
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