Gain-of-function research is risky, but has a high reward if done correctly wwing/iStock

Anthrax, bird flu, smallpox, MERS and SARS. These are the deadly diseases that researchers had been using in their investigations, until they were banned in 2014.

Some scientists believe the best way to find a cure for a disease is to investigate a live sample of the pathogen, and genetically alter them to try and find a weakness. A 'keep your friends close but your enemies closer' type of scenario.

However, after a series of accidents in the US, the Obama Administration forced a moratorium of this research in October 2014, which the UK has adopted too. That meant the research method – known as gain-of-function research – was banned until further notice for all National Institutes of Health projects.

That 'further notice' may be sooner than some scientists were anticipating, as academics from across the country debated how to proceed with the research on 10-11 March 2016. The symposium, run by the National Academies of Sciences, Engineering, and Medicine, hosted representatives from the World Health Organisation (WHO), and several US government departments, including Homeland Security, and Health and Human Services.

"This is the final opportunity for public input," Filippa Lentzos told IBTimes UK, biosecurity expert and academic researcher at the Department of Social Science, Health and Medicine, King's College London. "Following this meeting, a final set of recommendations will be drawn up for the US government on how to proceed."

Why use gain-of-function?

The 'high-risk/high-reward' research has a number of uses to scientists. "Gain-of-function is a technique used in basic research to understand how pathogens spread and cause disease, how they evolve, and how new disease might emerge,' said Lentzos. "It is related to public health, but also to national security — new and emerging infectious disease, like pandemic flu, is considered one of the biggest threats to our nationals security."

The H5N1 virus, commonly known as bird flu, spread rapidly across parts of East Asia from 2008 onwards. Stacey Schultz-Cherry, a scientist from St. Jude Children's Research Hospital, carried out Gain-of-Function research on the virus, and discovered that it could become even more transmissible among humans. It was this discovery that led the WHO to actively work on finding a vaccine.

Scientist Paul Duprex, from the University of Boston, told The Guardian that the risks had been "blown out of proportion."

"People have worked with dangerous viruses for a very, very long time and risk is something we manage," he said. "The reality is that the people who are most at risk are the ones working with these viruses. And self-preservation is very powerful. Whether I'm sitting in front of an Ebola virus or a measles virus, I don't want to die."


Gain-of-Function could return, allowing scientists to experiment on deadly pathogens Michael7070/Flickr

Some people argue that you are almost asking for trouble when you meddle with potentially catastrophic pathogens. It is this risk which has caused some scientists to back the ban on the research.

With regard to the H5N1 virus, there is a little more to the story. Whilst ultimately the research forced the WHO into producing a vaccine, the method by which they did it brought huge scrutiny from the scientific community.

The scientists genetically altered the virus, and made it airborne. The research from 2011 managed to transmit the virus in the air, from one ferret to another.

"The mutated virus was highly virulent, killing more than 50% of those infected, and it was as efficiently transmitted as the seasonal flu," said Lentzos. Describing reactions to the news, she said: "The experiment was met with substantial alarm within the scientific community, and in the media.

"Concerned about information falling into the wrong hands, the National Science Advisory Board on Biosecurity initially restricted the publication of the experiment, saying the scientists could go ahead and publish their conclusions, but not the methods section."

Anthrax threat

Another pathogen which has scientists concerned is Baccilus anthracis – or anthrax. Just months before the moratorium was announced, the US Centres for Disease Control and Prevention became aware of a lab that was performing experiments on the anthrax bacterium without following proper protocols.

This laboratory had not known to make the bacterium 'inactive' before beginning their investigation. An inactive bacterium cannot cause the disease in humans, but as the anthrax was very much operational, the researchers were exposed to the lethal pathogen.

The lab, at the CDC's Roybal Campus in Atlanta, Georgia, was subsequently found to have carried out similar research on four other separate occasions within the previous decade.

UK accidents

The US is not the only culprit. In the UK, reports have suggested that there have been more than 100 cases of 'accidents or near-misses'. An investigation by The Guardian found reports from the Health and Safety Execustive (HSE) describing 116 incidents since April 2010. For example, a lab in Surrey meant to send dead anthrax bacteria to York and Belfast in the post, but the test tubes got mixed up and they accidentally sent live anthrax instead.

"In addition to concerns about accidental releases of super-pathogens created in the lab, there is also a risk of deliberate misuse to cause a man-made pandemic," said Lentzos. "While there certainly is a risk of crude bioterrorism attacks, what I worry more about is the potential for state or state-sponsored support of biological weapons.

"While the norm against biological weapons is strong, and the potential for state use is low, we cannot rely on biological weapons not being used in the future. This is coupled with an erosion of technological barriers to acquire and use bioweapons. Scientific advances could be used as a means to create and deploy new and sophisticated biological weapons for new types of warfare."

Lentzos refers to an FBI case which saw a disgruntled US government scientist send letters to two senators and several news offices. These letters were riddled with anthrax spores he was working with, and five people were killed with another 17 becoming infected.

The Decision

We do not know when the US government will make a decision on the gain-of-function technique. The symposium is a chance for experts to make recommendations to put forward.

That said, some researchers – including Filippa Lentzos – think the meeting is a turning point in a year-and-a-half long policy process on how to best regulate research that enhances pathogens. "The risks of this research are broader than just technical safety concerns," she said. "We need to incorporate wider social, ethical, environmental and security concerns into the risk/benefit assessments."