The FDA just approved a drug to treat smallpox in case of a bioterrorism attack — here’s why that scenario is so scary

  • The FDA just approved a drug that could be used to treat smallpox.
  • The disease was officially eradicated in 1980, but experts are concerned that people could re-create smallpox and use it as a biological weapon.
  • Infectious disease researchers and bioterror experts say the world is unprepared for the emergence or release of a pandemic disease.


On any list of the most devastating diseases humanity has ever had to contend with, smallpox comes in near the top.

The contagious and potentially fatal disease is caused by the variola virus. It killed approximately 300 million people before mass vaccination campaigns made smallpox the first infectious disease to be eradicated from the wild in 1980.

But that doesn't mean it's gone for good.

The Food and Drug Administration (FDA) announced on July 13 that it had for the first time approved a drug that could treat smallpox if it were ever released as a weapon in a terrorist attack. The medication is called TPOXX (tecovirimat). 

"To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons," FDA Commissioner Scott Gottlieb said in a statement. "Today's approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon."

The potential release of smallpox as a weapon is an extremely concerning scenario; many experts think that a weaponized form of disease is one of the biggest risks humanity faces.

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Bioterrorism attacks
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Bioterrorism attacks
SALISBURY, ENGLAND - JULY 06: Emergency workers in protective suits search around John Baker House Sanctuary Supported Living after a major incident was declared when a man and woman were exposed to the Novichok nerve agent on July 6, 2018 in Salisbury, England. The couple, named locally as Dawn Sturgess 44, and Charlie Rowley, 45 were taken to Salisbury District Hospital on Saturday and remain there in a critical condition. In March, Russian former spy Sergei Skripal and his 33-year-old daughter Yulia were poisoned with the Russian-made Novichok in the town of Salisbury. British Prime Minister Theresa May has accused Russia of being behind the attack on the former spy and his daughter, expelling 23 Russian diplomats in retaliation.(Photo by Jack Taylor/Getty Images)
DAMASCUS, SYRIA - APRIL 08: An affected Syrian kid receives medical treatment after Assad regime forces allegedly conducted poisonous gas attack to Duma town of Eastern Ghouta in Damascus, Syria on April 08, 2018. At least 78 civilians dead, including women and children, according to the initial findings. (Photo by Mouneb Taim/Anadolu Agency/Getty Images)
Sierra Leonean doctor Donald Samuel Grant (R), accompanied by U.S. medical student Vanessa Raabe, attends to a patient in the Lassa fever isolation ward at Kenema Goverment Hospital in southeastern Sierra Leone, February 7, 2011. Lassa fever, named after the Nigerian town where it was first identified in 1969, is among a U.S. list of "category A" diseases - deemed to have the potential for major public health impact - alongside anthrax and botulism. The disease is carried by a species of rodent, Mastomys Natalensis, found across sub-Saharan Africa and often eaten as a source of protein. It infects an estimated 300,000-500,000 people each year, and kills about 5,000. Picture taken February 7, 2011. To match Reuters-Feature BIOTERROR-AFRICA/ REUTERS/Simon Akam (SIERRA LEONE - Tags: HEALTH SOCIETY)
Personel swab railings near a bench covered in a protective tent at The Maltings shopping centre in Salisbury, southern England, on March 16, 2018, as investigations and operations continue in connection with the major incident sparked after a man and a woman were apparently poisoned in a nerve agent attack in Salisbury on March 4. NATO Secretary General Jens Stoltenberg said March 16, the alliance did not want a return to Cold War hostilities with Russia while expressing support for Britain's strong stance on the nerve agent attack. / AFP PHOTO / Ben STANSALL (Photo credit should read BEN STANSALL/AFP/Getty Images)
TOPSHOT - Picture taken on June 12, 2018 shows police officers of a special unit wearing protective clothes and respiratory masks during an operation in Cologne's Chorweiler district, western Germany, where police found toxic substances after storming a flat. - A Tunisian man arrested in Germany is suspected of trying to build a biological weapon using the deadly poison ricin, prosecutors said on June 14, 2018, stressing however there was no indication of any 'concrete attack plans'. (Photo by David Young / dpa / AFP) / Germany OUT (Photo credit should read DAVID YOUNG/AFP/Getty Images)
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The world isn't ready for that possibility, nor is it primed to respond to a pandemic disease that occurs naturally. That means it's plausible that some sort of deadly pathogen — likely a virus — could spread around the globe.

As Bill Gates said in a recent talk, world governments are ill prepared for these sorts of scenarios.

"In the case of biological threats, that sense of urgency is lacking," Gates said. "The world needs to prepare for pandemics in the same serious way it prepares for war."

 

The return of smallpox

There are good reasons to be concerned about a potential smallpox release.

In theory, only two labs in the world are authorized to possess the variola virus: the CDC in Atlanta, and the State Research Center of Virology and Biotechnology in Russia.

But more samples of the virus may be out there. In 2014, vials containing smallpox were found in a cold storage room of an FDA lab at the National Institutes of Health's campus in Bethesda, Maryland. The possibility of an accidental release from that kind of forgotten sample is remote but real.

More concerning is the fact that researchers think it wouldn't be difficult for an ill-intentioned actor to create a version of the smallpox virus — even a more dangerous one — in a lab.

Now that smallpox has been "eradicated," most people no longer receive a vaccine, meaning the vast majority of the world would be vulnerable to an outbreak.

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History of smallpox
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History of smallpox
(Original Caption) 1941: Capillary tubes of smallpox vaccine are being sealed by flame here. Sterile needles in glass tubes accompany each vaccination outfit. Smallpox is now happily rare in the United States - largely thanks to prevention and to the work of the arsenals of health. By-Line Pictures, for release 7/27/41
(Original Caption) Ali Maow Maalin, of Merka, Somalia, who has the world's last recorded case of endemic smallpox.
(Original Caption) The colossal task facing India. At the end of 1962, India launched the world's largest national smallpox eradication campaign. Enormous quantities of freeze-dried smallpox vaccine, the most stable vaccine under tropical conditions, are required for the mass campaign. Countries producing this vaccine are assisting India with supplies of it but local production had to be started to to meet national requirements. At the King Institute of Preventative Medicine in Madras, with the assistance of WHO and UNICEF, freeze-dried smallpox vaccine is prepared from a virus grown on the skin of calves. This photo shows a child struck down by smallpox at the Infectious Diseases Hospital in Madras.
(Original Caption) 10/1/1939- Visalia, CA: Dr, F.H. Redwell and Mrs. Clarise Tucker, nurse both of the state department of public health, immunizing a squatter family for small-pox and typhoid fever. Back of station wagon serves as shelf for medical equipment.
A boy's face is scarred from the pockmarks of smallpox. Afghanistan, ca. 1970. (Photo by Paul Almasy/Corbis/VCG via Getty Images)
Smallpox Outbreak Birmingham 1978. Janet Parker a British medical photographer became the last person to die from smallpox. She was accidentally exposed to a strain that was grown in a research laboratory on the floor below at the University of Birmingham Medical School. Pictured. Doctor John Makuena (Spelling TBC) vaccinates to members of public including Bill Clayton (pictured) at Public Health Department clinic immunisation department in Congreve Street, Birmingham, 25th August 1978. (Photo by Birmingham Post and Mail Archive/Mirrorpix/Getty Images)
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The Department of Defense recently commissioned a report on defense against biological weapons from the National Academy of Sciences, Engineering, and Medicine. The report, published in June, said that the re-creation of known pathogenic viruses like smallpox using the techniques of synthetic biology should be of the "highest concern" for the US.

"The U.S. government should pay close attention to this rapidly progressing field, just as it did to advances in chemistry and physics during the Cold War era," Michael Imperiale, a professor of Microbiology and Immunology at the University of Michigan and the chair of the committee that wrote the report, said in a statement.

Last year, a Canadian researcher studying synthetic biology demonstrated that it was possible to create pox viruses related to smallpox from scratch using genetic material purchased through the mail.

Doing that cost the researcher $100,000 and "did not require exceptional biochemical knowledge or skills, significant funds, or significant time," according to a World Health Organization report. 

 

Other dangerous diseases

Weaponized variola is far from the only disease that researchers think could lead to a pandemic.

Experts think that if a flu like the 1918 version were to emerge again, it could kill 30 million people within six months. Even scarier flus are possible, too: In ongoing studies in 2014 that were resumed in the past year, scientists demonstrated how the flu virus can be made more deadly. The also showed that deadlier viruses can be engineered to become more contagious.

Experts at the CDC and World Health Organization keep lists of the diseases that are most likely to cause a deadly pandemic. Those lists include a number of naturally occurring pathogens, including some that might be turned into biological weapons, like Ebola, Marburg, SARS, anthrax, botulism, plague, tularemia, and smallpox.

Experts have also run simulations to see how the world would respond to the intentional release of a pandemic disease. The general consensus has been that humanity would not fare well.

In May, the Johns Hopkins Center for Health Security ran a simulation demonstrating what might happen if a fringe group were to release a modified disease related to the Nipah virus. An outbreak of the little-known Nipah virus in India in May sickened at least 18 and killed 17 of those infected.

In the Johns Hopkins simulation, the modified virus killed more than 150 million people within a year.

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SEE ALSO: Bill Gates thinks a coming disease could kill 30 million people within 6 months — and says we should prepare for it as we do for war

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