Senior scientists have criticised an American university for allowing controversial research on enhancing a pandemic strain of flu virus to be undertaken in a laboratory with a relatively low level of biosecurity.
The University of Wisconsin-Madison was labelled irresponsible and negligent for allowing one of its scientists, Professor Yoshihiro Kawaoka, to genetically manipulate pandemic H1N1 flu virus in a laboratory categorised as biosafety level-2 (BSL-2).
Other experts believe that the research, which involved the creation of a strain of pandemic flu that has "escaped" from the control of the human immune system, should have been done at least at BSL-3 or even BSL-4, the most secure level of biosafety reserved for the most dangerous pathogens.
When pandemic H1N1 emerged in 2009 it killed between 151,000 and 540,000 people in the first year of the outbreak. Since then, most people have acquired a level of antibody immunity to the virus, which is now classified as "seasonal flu".
The Independent revealed yesterday that Professor Kawaoka has for the past four years been working on ways of mutating the 2009 pandemic strain of H1N1 flu so that it is no longer neutralised by the antibodies that provide immunity for the wider population.
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Rebecca Moritz, who is responsible for overseeing the work on "select agents" at Wisconsin said that it is normal for such work on flu viruses to be done at BSL-2, which covers work on viruses and bacteria that cause only mild disease in humans or are difficult to pass on through airborne transmission.
"The 2009 pandemic strain of influenza is studied in many laboratories across the world. It is easily isolated from anyone who gets sick with influenza virus during the flu season. The appropriate biosafety level for this virus is BSL-2," Ms Moritz said.
However, leading experts in infectious diseases were amazed to discover that this work was carried out in a BSL-2 laboratory with only relatively minor precautions against accidental releases compared to the two highest levels of biosafety.
"That would be incredible if true because a modified virus that evades available protective immunity clearly mandates much greater biosafety," said Professor David Relman of Stanford University in California, a member of the US's National Science Advisory Board for Biosecurity.
Photo / Warren Buckland
"If real, this work is irresponsible, and unduly places humanity at risk of death and illness. The apparent lack of common sense and insensitivity to our responsibility as scientists to do no harm, is striking. It would seem that this area of research is now an unregulated free for all," Professor Relman said.
Professor Richard Ebright, a molecular biologist at Rutgers University in New Jersey, said that the research threatens to undermine efforts to control influenza rather than to help to curb future flu pandemics.
"If the reports are correct, Kawaoka, single-handedly, has rendered useless the billions of dollars and millions of person-hours expended in mass vaccination against the 2009 pandemic influenza virus and, single-handedly, has placed millions of lives at risk," Professor Ebright said.
"Incredibly, the 'research' is reported to have been performed at biosafety level 2, the same biosafety level as a physician's or dentists's office: no required biosafety protections beyond an open cabinet, gown, and gloves," he said.
The H1N1 flu virus from 2009 The H1N1 flu virus from 2009
Professor Sir Andrew McMichael, a vaccine expert at Oxford University, said that there are mounting concerns about this kind of work and there needs to be a wider debate between flu scientists, funding bodies and biosafety experts.
"It's very disturbing and poses real risks that do not seem to be appreciated fully by those involved. Is it really being done at BSL-2? That seems unbelievable," Sir Michael said.
However, Professor Wendy Barclay, a flu researcher at Imperial College said there was nothing wrong with Professor Kawaoka carrying out his research in a BSL-2 lab. "In nature there is no containment. He's only doing what happens in nature every day," Professor Barclay said.
Professor Simon Wain-Hobson, a virologist at the Pasteur Institute in Paris, said that the work has a dual function because it is about enhancing the genetic make-up of a human infectious agent, and the research should therefore only be done, if it is done at all, at the highest biosafety levels.
"If it escaped it would be equivalent to a new pandemic virus. It seems there was a tremendous lack of oversight in the funding and execution of this research at Wisconsin," Professor Wain-Hobson said.
- Pandemic flu questions and answers -
Why is this experiment different from what has been done before?
This is the first time that someone has taken a strain of influenza virus, called H1N1, known to have caused a global epidemic, in other words a "pandemic", and deliberately mutated it many times over. It can then evade the neutralising antibodies of the human immune system, which have protected much of the human population since the virus first emerged in 2009.
What has been done previously in this laboratory?
Professor Yoshihiro Kawaoka of the University of Wisconsin-Madison attempted to increase the transmissibility of the H5N1 bird flu strain by genetic manipulation and repeated infection in laboratory ferrets, an animal model of human influenza. H5N1 is highly lethal when it infects people, but in the wild it is very difficult to transmit from one person to another and is usually caught by direct contact with infected poultry.
The H1N1 flu virus from 2009 The H1N1 flu virus from 2009
Professor Kawaoka's most recent published research was on reconstructing the 1918 flu virus, the genetic structure which was known from samples retrieved from the frozen corpses of its victims buried in the Arctic, from wild strains of bird flu isolated from ducks. He managed to do this, but the study was widely criticised as "stupid" and "irresponsible".
Why does he want to do this work?
The aim is to understand what is known as "gain of function". What does it take, genetically, for a virus to become more infectious or more lethal? If we could understand this process then we would be in a better position to develop drugs, vaccines and other measures to protect ourselves from a sudden emergence of a new and deadly flu strain, or so Professor Kawaoka has argued.
Does he have the support of other scientists?
There is a big split within the scientific community over this kind of work. Some flu specialists support it, provided it is done under strictly regulated and controlled conditions. Others, mostly experts in infectious diseases outside the flu community, are passionately opposed to the work, claiming that the risks of an accidental (or even deliberate) release that will cause a devastating pandemic are too great to justify any practical benefits that may come out of the work.
Have there been any accidental releases from labs in the past?
Some experts cite the unexpected emergence of a new H1N1 strain of flu in 1977, which spread globally over three decades, as an early example of a flu virus being accidentally released from a lab. Genetic evidence points to it having escaped from a lab in China or the Soviet Union.
There are many examples of other infectious agents escaping from labs. Smallpox virus escaped from Birmingham Medical School in 1978 and killed a medical photographer, Janet Parker, the last person to die of smallpox. Foot and mouth virus escaped in 2007 from a veterinary lab in Surrey and in 2004 the SARS virus escaped from a high-containment lab in Beijing, infecting nine people before it was stopped.
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- UK Independent