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Risks involved in experiments that create potential pandemic pathogens are too great

“Gain-of-function” experiments involving the creation and manipulation of potential pandemic pathogens are too risky to justify, and safer, more effective experimental alternatives exist, according to a Policy Forum article published in PLOS Medicine. The article, written by Marc Lipsitch from the Harvard School of Public Health, USA and Alison Galvani from Yale School of Public Health, USA, argues that a rigorous, quantitative, impartial risk-benefit assessment should proceed further novel potential pandemic pathogen experimentation.

Proponents of potential pandemic pathogen experimentation argue the experiments will improve the interpretation of surveillance data to detect dangerous viruses and facilitate vaccine development against future natural pathogens. However, the authors argue that there are strong ethical reasons why such experiments should not be done, because the risks of laboratory-associated infections are not negligible and the outcome of such an escape could be catastrophic. Using influenza as an example the authors argue that safer and more effective scientific approaches make the creation of potential pandemic pathogens unnecessary.

The authors say, “potential pandemic pathogen experimentation poses a significant risk to public health, arguably unique among biomedical research. Such experiments should be assessed on the basis of their marginal benefits, compared to those of safer approaches. In the case of influenza, given the higher throughput and lower cost of alternatives, we believe the benefits of alternative approaches will be greater than those of novel-potential pandemic pathogen experimentation, yet without the risks.”

The authors conclude, “funders and regulators should evaluate the balance of these risks and benefits before further novel-potential pandemic pathogen experiments are undertaken.”

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This work was supported by awards from the National Institute of General Medical Sciences, number 5U54GM088558 to ML and U01 GM087719 to AG. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of General Medical Sciences or the National Institutes of Health. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

ML reports consulting income or honoraria from the following sources within the past five years: Novartis, Pfizer (pharmaceutical companies); AIR Worldwide, i3 Innovus, and Outcome Sciences (risk assessment and consulting companies). None of these relationships is ongoing. He has research grants with Pfizer (active) and PATH Vaccine Solutions (pending). AG reports consulting income from Vitality (a health insurer) and AIR Worldwide (a risk assessment company). ML is a member of the Editorial Board of PLOS Medicine.

Ethical Alternatives to Experiments with Novel Potential Pandemic Pathogens, Lipsitch M, Galvani AP, PLoS Med, DOI:10.1371/journal.pmed.1001646, published 20 May 2014.