A series of security failures in US disease-control labs handling lethal bugs such as anthrax, smallpox and bird flu has raised questions about the dangers of research into deadly pathogens
For the danger they posed, the lapses were appalling. They put lives at risk, that much is clear. But they were shocking, too, due to where they happened. The US government’s high-security disease-control laboratories – which house samples of the most harmful germs in the world – cannot afford to screw up.
First came news of a single incident. Staff working on deadly bioterrorism agents at the Centres for Disease Control and Prevention (CDC) in Atlanta followed the wrong procedure to “inactivate” batches of Bacillus anthracis, the bacterium that causes anthrax. Though potentially still lethal, the bugs were sent to another CDC lab where staff were not equipped to handle live spores. A report into the lapse published last week revealed a worrying pattern of staff failures, and found that dozens were potentially exposed. The CDC doled out antibiotics and anthrax vaccine. Affected rooms were sterilised. They were lucky: no one got the disease. But that is hardly the point.
It was not an isolated event. As CDC investigators finalised their report into June’s anthrax scare they unearthed a more alarming incident that had gone unreported. In March, lab staff sent samples of a fairly harmless strain of bird flu to scientists at the US Department of Agriculture. To the agricultural team’s alarm, every chicken they infected with the virus died. It was only after 21 birds had succumbed that they discovered why: the CDC samples had been contaminated with a strain of highly lethal H5N1 bird flu. Natural outbreaks of the virus have killed hundreds of people in Asia.
The director of the CDC, Tom Frieden, took swift action. He closed the CDC’s anthrax and influenza labs and imposed a ban on the shipment of biological material in or out of the CDC’s highest-security labs while safety procedures are revamped. At a press conference last week, Frieden said the behaviour of some staff had been “totally unacceptable … Frankly, I’m angry about it.” On Wednesday, Frieden was called before a US House oversight committee to explain himself. The chairman, Tim Murphy, did not hold back. The incident was “troubling”, “completely unacceptable”, the CDC’s reputation “tarnished”. Frieden, he said, had called the anthrax scare a “wake-up call”. But that was a “dangerous understatement”, Murphy warned. “It was a potentially very dangerous failure,” he said.
The incidents cast a long shadow over the organisation charged with protecting the US public. But a third incident points to a broader failure in US biosecurity. In early July, six vials of smallpox were discovered in a storage room at an unguarded FDA lab in Maryland that once belonged to the US National Institutes of Health. After the eradication of smallpox, a horrific disease that kills 30% of people it infects, official stocks are kept only at the CDC in Atlanta and at the Russian Vector lab in Novosibirsk. The samples found in the NIH lab probably date back to the 1950s, but tests at the CDC found that despite their age, smallpox in two of the six vials was still alive and dangerous. (The last fatal case of smallpox in the UK happened in 1978, when the virus escaped from a laboratory at the University of Birmingham.) The bad news did not end there. On Wednesday, federal investigators reported more dangerous material from the same room. In all, they found 12 boxes containing 327 vials labelled with various unpleasant pathogens, from influenza and dengue fever to rickettsia and Q fever.
It was the NIH’s turn to apologise. Its director, Francis Collins, said that “overlooking such a sample collection for years is clearly unacceptable”. He ordered a full search of all fridges, freezers, cold rooms, storage shelves and cabinets, as well as offices linked to laboratories, in case other dangerous agents had gone missing. To the outside world, the most trusted keepers of lethal germs had shown themselves to be dangerously incompetent.
The failings will have direct consequences at the CDC and NIH, but the fallout from the lapses will be felt far beyond the US. There are major lessons to be learned about human error that even the most vigilant high-security labs in Europe, Asia and elsewhere must heed. But for some scientists, the incidents call for more drastic action. Some want the number of laboratories holding lethal bugs to be slashed, to minimise the risk of a catastrophic accident. Others want the highest-risk experiments curtailed, arguing that the fresh understanding they bring is not worth the real danger of an accidental outbreak.
“This is not just being seen as something across the Atlantic. There will be knock-on considerations, there have to be,” said John McCauley, director of the WHO influenza centre at the National Institute for Medical Research in London. “These incidents remind us that accidents, although extremely rare, can happen, and we need to be aware of how they occurred so we can minimise or even eliminate that kind of accident happening elsewhere.”
Eight labs in the UK are allowed to work with the most dangerous pathogens, and aside from two animal vaccine manufacturers, all are government-sponsored. Some, including the military labs at Porton Down, are world class, but others, such as the Institute for Animal health at Pirbright are reportedly more run-down. The 2007 outbreak of foot-and-mouth disease almost certainly came from the Pirbright lab, according to a Commons science committee report.
At Wednesday’s US hearing on the CDC anthrax scare, Richard Ebright, a biosafety expert at Rutgers University, called for a dramatic reduction in the number of labs permitted to work on the bugs, from 1,500 or so in the US to nearer 50, in order to minimise the risk of a serious accident. He urged the government to set up an independent federal agency to regulate the work, one with real powers to shut down labs that operated dangerously.
The US government is unlikely to embrace Ebright’s plan. On Sunday evening, the NIH sacked half of its biosafety panel by email. The move ousted 11 of the government’s original advisers, who in the past had raised concerns about experiments to create dangerous new pathogens. Critics are now waiting to see who will replace the fired advisers. One told the Guardian the replacements would be “yes men”.
Ron Fouchier, a virologist at Erasmus medical centre in Rotterdam, said slashing the number of labs working with dangerous pathogens would be a huge mistake. “The reason so many labs are doing pathogen research is because there is so much to be investigated, in the interest of public and animal health,” he said. The number of organisms that need high-security labs is rising. There are ongoing outbreaks of anthrax, various strains of bird flu, Ebola, and Middle East Respiratory Syndrome (MERS), which has killed hundreds in the Middle East, and a handful more in Africa, Asia, Britain, France and Germany. “I find it hard to believe theat Dr Frieden or Dr Ebright might think that some of the work is not needed and can be thus be reduced,” Fouchier told the Guardian. He said his lab already used dangerous pathogens only when there was no alterative. Working in high-security labs “is not fun, and is very expensive”.
But the breaches in the US have fuelled concerns about some of the more extreme studies that scientists do. When the CDC declared its anthrax incident, Marc Lipsitch, professor of epidemiology at the Harvard School of Public Health, said we should be glad it was only anthrax. He fears that scientists, Fouchier included, pose far greater risks to the public byintentionally creating dangerous pathogens. In 2011, Fouchier announced that he had mutated bird flu to make it spread easily in animals through coughs and sneezes. Advocates for these experiments, known as gain-of-function studies, say they give scientists crucial insights into the kinds of viruses to fear in nature. To Lipsitch and many others, the irony is all too clear. In trying to prevent the next pandemic, they say Fouchier and his colleagues make a disastrous outbreak more likely.
Earlier this week, Lipsitch convened more than a dozen researchers who shared his concerns. The result of their meeting was the Cambridge Working Group consensus statement calling on the US government to “curtail” experiments that create potentially pandemic pathogens, until proper risk assessments have been done. While Fouchier and others explain that they have already been through numerous risk assessments, and operate under extremely tight security, their critics are not reassured.
One of the signatories of the Cambridge Working Group statement is Sir Richard Roberts, a British scientist and Nobel prize winner, who now works at New England Biolabs in Massachusetts. Roberts hasn’t seen the risk assessments for Fouchier’s experiments, but notes that even the CDC labs, “which were generally considered to be the safest labs out there”, had had problems. “How can you trust anybody? Humans are human. People make mistakes.”
Lipsitch’s group wants to convene a meeting that brings together scientists and other experts to debate the potential risks of making dangerous pathogens, and to draw up binding guidelines to ensure that future experiments are safe. The plan mirrors the landmark Asilomar conference in California in 1975, which was largely driven by younger scientists who had concerns over the unknown risks of swapping genes in and out of different organisms. The meeting set important ground rules – including the introduction of biosafety containment levels around the world – for genetic studies to this day.
Vincent Racaniello, a virologist at Columbia University in New York, said the Cambridge Working Group was “infuriating” because it misled people into believing that viruses made in laboratories were a serious threat to the public. But because the experiments are done in ferrets, he argues, it is impossible to know if the bugs would spread in people, and how dangerous they might be. He added that deciding which experiments went ahead on the basis of a risk-benefit analysis was “absurd”, because it was often impossible to know the benefits of an experiment beforehand.
McCauley largely supports the experiments at the centre of the controversy, arguing that they reveal how viruses in the wild transform from harmless strains to more dangerous forms. “I need to be able to advise people,” he said. “And it makes me feel a whole lot happier knowing more.”
Roberts, though, is having none of it. “The risks are enormous and the benefits, to my mind, are non-existent,” he said. “If I suggested that you try to make the most virulent and dangerous virus that we can imagine, something that could kill a quarter of the world’s population if it got out, does that seem a sensible thing to do? That strikes me as being absolutely ridiculous.”
guardian.co.uk © Guardian News and Media 2014