One small step for science, a giant risk for mankind � Prof. Simon Wain-Hobson � Institut Pasteur � Paris � � � Chair � Foundation for Vaccine Research � Washington DC �
What is influenza virus gain-of-function research? � Gain-of-function (GOF) research means deliberately transforming avian influenza viruses that are not transmissible between humans into viruses capable of efficient transmission from mammals to mammals � Avian influenza A H5N1 � � � � � ongoing � Avian influenza A H7N9 � � � � � ongoing � � Human SARS coronavirus � � � � � supposedly ongoing �
The controversy – summer 2011 to present � The pro-GOF group says that it will help prepare for a � pandemic while the risks can be mitigated and contained � � Useful for: � � • Vaccine production � � • Drug design � � • Pandemic preparedness � � • Interpreting naturally arising mutations in the field �
The controversy – summer 2011 to present � The anti-GOF group says there is nothing in the research � � to help a Health Minister make robust decisions � � • Vaccines � � No way � � � � � � Adel Mahmoud former President of Merck Vaccines � � • Drug design � Can get data by other means �� � � � � � Drug development is too long compared to a pandemic � � • Pandemic preparedness � � � � � � Nothing specific. Stockpiling of drugs, but obvious � � • Interpreting mutations in the field � � � � � � The data can be obtained by other means �
Poor science � • The potential of these avian influenza GOF viruses can never � � be assessed because the crucial experiment – infecting � � humans – is unethical � � • The pro-GOF group can never prove their case � � • Predicting which virus will go pandemic is next to impossible � � • Our track record at anticipating nature in any domain � � is very poor � � � • Meanwhile these GOF viruses are potential biological bombs �
No comment � If work goes unchecked the virologists � � WILL have phenomenally dangerous � � highly transmissible influenza viruses � � within TWO years �
GOF risk – unusually high stakes � • Can mitigate the risks but no system is perfect � � • Some risk factors � � Human error � � Disgruntled scientist � � Curious but irresponsible individual or garage scientist � � Earthquake, tornado � � • One slip, but of gigantic proportions � � � - a man made flu pandemic � � • No risk analysis has been published! �
WORLD VIEW A personal take on events My own opinion – Nature March 2013 � H5N1 viral-engineering dangers will not go away Governments, funders and regulatory authorities must urgently address the risks posed by gain-of-function research, says Simon Wain-Hobson . B arely two months after a small group of influenza virologists are chosen, a transmissible virus of low virulence would ultimately lifted a moratorium on work to make the H5N1 avian flu virus as emerge. Whether nature will take any of these courses is unknown. transmissible between humans as seasonal flu, researchers are at Take dog breeding. Ruthless selection of alleles over a short period has it again. Earlier this month, a Dutch scientist proposed similar experi- produced phenomenal phenotypic variation — dachshunds, salukis, ments with other avian flu viruses, as well as the SARS coronavirus. And whippets and setters. Would nature have come up with the dachshund? a fortnight ago, scientists in Germany and Switzerland reported how Second, infectious-disease researchers are fond of saying that they had tweaked canine distemper virus to make it grow in human cells. microbes do not respect barriers. So who makes the rules and provides The logic behind these kinds of experiments, collectively called oversight? Barely a sound has emerged at the international level. The gain-of-function (GOF) research, is to identify combinations of muta- World Health Organization has held essentially closed-door meetings tions that could allow an animal virus to jump to unprepared humans. and has failed singularly to widen the debate. By knowing the mutations, the thinking goes, we can better prepare Third, what if these groups generate a highly pathogenic and trans- and marshal our scientific defences against a possible threat. missible virus — which I suspect, within two years, they will? Then GOF research on avian flu provoked heated controversy, much of it what? Should the virus be shared? Should research on this novel virus covered by this journal. That controversy did not strain of catastrophic potential be highly restricted? go away with the lifting of the moratorium. On the Fourth, what if there were a leak or a small contrary, it continues to fester. Officials in Wash- INFLUENZA outbreak? Crippling lawsuits would follow. Are ington DC are putting the finishing touches to new the academic institutions sufficiently covered guidelines for the review, regulation and oversight in terms of insurance? Are university regents or VIROLOGISTS ARE of this kind of research. The chill winds that we can chancellors even aware of the power, and dangers, GOING DOWN A anticipate blowing from policy-makers as a result of the modern molecular biology going on in their could affect all of us who research viruses and their labs? Again, not a word has emerged. BLIND ALLEY pathology. To avoid this, researchers in this field Fifth, the world has never been more densely need to learn lessons from the past. populated. Is it appropriate for civilian scientists AND THE POWERS Rather than use the avian flu moratorium to to make microbes more dangerous? Is creating a THAT BE ARE BLINDLY seek advice, listen and foster debate, many influ- novel human virus antisocial? Was there a failure enza scientists engaged in an academic exercise of duty on the part of funders and regulators? What LETTING THEM GO of self-justification. There was a single large open is the ethical position on such work? Here there has meeting, at the Royal Society in London, which DOWN THAT ALLEY. been a start, but as yet there is no consensus.
Other recent opinions worthy of note � We have no plans to pursue such H7N9 GOF studies. � � Chen Hualan, Director of China's National Avian Influenza Reference Laboratory in Harbin � Science August 8, 2013 � I think such [avian influenza GOF] experiments should � never be repeated. Existing samples should be destroyed. � � Zeng Guang, Chief epidemiologist � Chinese Centre for Disease Control � Handelsblatt August 8, 2013 �
No consensus as to the benefits � • There is no consensus as to the merits of the science � � • Hence the benefits are not presently quantifiable � � • There is tremendous tension among virologists � � • There has NOT been adequate discussion and debate � � between stakeholders � � • Learned societies, regulators and some governments � � have FAILED to show leadership � � • Despite this avian influenza GOF work is proceeding �
Pragmatic suggestions � • FREEZE � � • Need an international conference with all the stakeholders � � � Virologists, infectious disease clinicians, epidemiologists, � � biosafety and biosecurity experts, lawyers, ethicists, � � government officials, university presidents, insurers, � � military, intelligence services, diplomats, press � �� • Need an independent risk & liability analysis � � • Need a considered moral opinion �
BWC, we have a problem � Prof. Simon Wain-Hobson � � simon.wain-hobson@pasteur.fr �
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