The Silent Monkey Victims Of The War On Terror
They are the unsung heroes of the war on terror — or its hidden innocent victims, depending on your point of view.
They have been deliberately infected with deadly bacteria and viruses, including plague, anthrax, Ebola, and smallpox. Some have been dosed with nerve agents. Others have been lethally irradiated. Many died during these experiments, or had to be euthanized after becoming severely ill — some found collapsed in their cages, others suffering from seizures or hemorrhaging into their guts.
They are research primates — mostly rhesus macaques, long-tailed macaques, and African green monkeys — acting as our surrogates in experiments designed to develop and test new drugs and vaccines against biological, chemical, and radiological weapons.
FBI / Getty Images
In 2001, starting just a week after 9/11, two senators and several journalists received letters containing deadly anthrax spores. Five people died from the exposure, and 17 were sickened. Since then, the U.S. government has poured billions of dollars into developing drugs and vaccines to fill the Strategic National Stockpile — an enormous medicine cabinet that will be opened in the event of mass exposure to biological or chemical weapons or the detonation of a nuclear device or “dirty” bomb.
This massive research investment, which is unique to the United States, has been steeped in controversy. Government scientific advisers have criticized it for slow and erratic progress. And earlier this year, a USA Today investigation revealed a series of embarrassing incidents in which deadly pathogens were accidentally released from secure containment, putting scientists — and in some cases, the public — at risk.
The U.S. government’s push in biodefense has also taken a heavy toll on research monkeys — a cost that has not been publicly tallied until now.
BuzzFeed News has calculated the number of primates used each year for what the USDA calls “Column E” experiments, in which animals experience pain or distress that is not fully alleviated with painkillers, tranquilizers, or other drugs. Because monkeys are emotionally complex creatures that are thought to experience suffering similarly to how we do, such experiments are especially controversial.
The number of primates used in these ethically fraught experiments has more than doubled since 2002, averaging more than 1,400 per year since 2009, according to a BuzzFeed News analysis of a USDA database called the Animal Care Information System.
According to federal regulations, research involving animals must be reviewed by an institution’s animal care committee. Scientists aren’t supposed to withhold drugs that could ease animal suffering unless this would interfere with the results of the research. And any research institution running Column E experiments must provide justification for the work in an annual report sent to the USDA.
BuzzFeed News has reviewed around 100 justification reports from more than two dozen labs, as well as scientific publications from labs using large numbers of Column E primates. These documents clearly show that the increase in monkey experiments involving pain or distress has been driven by the effort to develop countermeasures against biological, chemical, and radiological weapons.
Number of Primates Used in “Column E” Experiments
Peter Aldhous for BuzzFeed News / Via acissearch.aphis.usda.gov
If not for this boom in biodefense research, the number of primate experiments would almost certainly have been in decline.
In 2001, half a dozen multinational drug companies — which have mostly remained on the sidelines of biodefense research — accounted for just over half of the 649 primates used in Column E experiments. But by 2014, big pharma’s reported tally of Column E primates was down to just 29 animals.
These companies declined to discuss the details of their primate research, but industry observers note that the reduction may have been achieved, in part, by shifting monkey experiments to other countries, including China.
The BuzzFeed News analysis surprised several experts — even those who knew that the federal government’s programs in biological, chemical, and radiological defense had required the approval of ethically controversial experiments.
“Wow, that’s a lot of monkeys,” said Joanne Zurlo of the Johns Hopkins Bloomberg School of Public Health, who studies alternatives to animal experimentation. “It’s quite disturbing.”
Rhesus macaque
Ed Jones/AFP / Getty Images
Is the suffering of all these monkeys justified? Some experts consulted by BuzzFeed News argued that the research is necessary if we want to have drugs and vaccines to protect against a devastating terrorist attack. But monkeys are not always the best model for whether a drug or vaccine will work in people. Even when they are, some researchers have deep misgivings about the large numbers of monkeys that have been used in studies that condemn many to severe illness and death.
At the heart of this debate is the “Animal Rule,” a regulation adopted by the FDA in 2002 to provide a mechanism for approving drugs that could protect against biological, chemical, and radiological weapons — where running studies that expose people to the actual threat would clearly be unethical.
The rule states that animal experiments can be accepted as evidence that a drug works if the results are “clearly related to the desired benefit in humans, generally the enhancement of survival or prevention of major morbidity.”
This wording, with its focus on death and severe illness, has inevitably promoted experiments that involve animal suffering. But some experts question whether such experiments are giving the best scientific results.
Drugs Approved Under the Animal Rule
Scroll table to see more / Peter Aldhous for BuzzFeed News / Via fda.gov
“Rather than consuming an entire animal or using an animal as a crude screen, a more educated and targeted approach may yield better data,” Steven Niemi, director of the Office of Animal Resources at Harvard University, told BuzzFeed News. For example, he would like to see more studies in which monkeys and other animals are used to obtain detailed information on how a drug or vaccine works, rather than just recording whether they get sick or die.
Most research into biodefense drugs and vaccines is funded by the Department of Health and Human Services — through the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) – and the Department of Defense.
While these agencies have poured money into labs across the country — many of them at major universities — three institutes have dominated the most ethically contentious primate experiments: the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick, Maryland, the Lovelace Respiratory Research Institute in Albuquerque, New Mexico, and the Battelle Memorial Institute in Columbus, Ohio.
Since 2002, these three institutions have collectively used more than 6,400 Column E primates. In 2014, they accounted for almost two-thirds of the monkeys used in these experiments.
Institutions That Perform “Column E” Primate Experiments
Scroll table to see more / Peter Aldhous for BuzzFeed News / Via acissearch.aphis.usda.gov
USAMRIID was once the center of the U.S. military’s offensive bioweapons program. After that was shuttered in 1969, the institute became been the nation’s leading biodefense lab, and today works on a variety of threats including Ebola and anthrax. (USAMRIID was also the workplace of Bruce Ivins, the anthrax researcher who was the FBI’s prime suspect for the 2001 attacks, and who killed himself in 2008 as the feds closed in.)
Battelle manages laboratories for the U.S. government and conducts contract research, mostly related to defense. In recent years, its primate experiments have included tests of treatments for anthrax and exposure to cyclosarin nerve gas.
Lovelace evolved from a lab that studied the effects of inhaling radioactive materials and toxic chemicals — and also ran medical tests used to help select the first U.S. astronauts. Its Column E monkey experiments have included tests of drugs to treat plague and exposure to high doses of radiation.
The big three labs all declined to respond to specific questions about their primate research.
Greg Mathieson/Mai/Mai/The LIFE Images Collection / Getty Images
USAMRIID referred queries to the Pentagon. “The Department of Defense complies with federal laws and regulations regarding the use of animals,” DOD spokesperson Eric Badger told BuzzFeed News by email.
Lovelace responded with a statement issued through a public relations firm, which similarly stressed the lab’s regulatory compliance. It also said that “Lovelace Respiratory Research Institute has spent the last decade answering the nation’s and the world’s needs to combat and treat catastrophic health threats.”
Battelle refused interviews with its scientists, and spokesperson Katy Delaney declined to discuss the details of individual experiments.
“We’re not comfortable having that debate in the media,” Delaney told BuzzFeed News. “We have talented people, veterinarians, who care about the animals,” she added. “And they do their best to alleviate pain and discomfort.”
But Column E experiments, by definition, involve pain or discomfort. In studies to develop a system to test drugs for anthrax, for instance, Battelle scientists got long-tailed macaques to inhale lethal doses of the bacterium and then recorded symptoms including difficulty breathing, vomiting, and diarrhea. Most of the monkeys in the untreated control group died.
Facilities running research on monkeys are inspected at least once a year by the USDA to check that they comply with federal regulations and are following protocols for each experiment agreed upon with local animal use committees. Federal labs such as USAMRIID are exempt from these inspections, however.
After a routine inspection in March, Lovelace was cited for failing to provide monkeys with the care that was supposed to be delivered — including intravenous fluids, Tylenol for fever, and antidiarrheal drugs.
Whether monkeys provide the best guide to how a drug or vaccine will work in people depends on the condition in question.
For certain diseases, notably Ebola, they are clearly the best option. Although it is possible to infect various species of rodents with the Ebola virus, only monkeys show the full range of symptoms seen in people — including the excessive internal and external bleeding that frequently leads to death.
Developing drugs and vaccines against Ebola, which is on the U.S. government’s list of potential bioweapons, has been a top priority for USAMRIID. As Ebola raged in West Africa earlier this year, a vaccine that had recently been tested on long-tailed macaques at USAMRIID was one of two candidates rushed into human clinical trials in the affected countries. Supporters of the Animal Rule point to this as a vindication of primate experiments conducted in the name of biodefense.
“The next time there is an Ebola outbreak, hopefully there is going to be a vaccine,” Olaf Schneewind, a microbiologist at the University of Chicago who studies plague and anthrax, told BuzzFeed News.
Schneewind, meanwhile, has been involved with rodent and monkey tests of experimental vaccines against pneumonic plague, a virulent form of the disease caused by inhaling droplets containing Yersinia pestis bacteria. This is the major threat from weaponized plague, and if untreated can quickly kill.
The problem with using rodents, Schneewind explained, is that it’s fairly easy to protect them from the disease — which means that a vaccine that works in rodents might not work in people. It is much harder to protect monkeys from pneumonic plague, Schneewind said. So he believes the FDA should set a high bar and demand evidence from primate experiments that a plague vaccine can prevent fatal disease, before approving it for human use.
But monkeys don’t always provide the most reliable data. This lesson was learned with alarming consequences in 2006, in safety tests of an immune system protein called TGN1412, intended as a treatment for rheumatoid arthritis. No problems had emerged in tests on long-tailed macaques. But when TGN1412 was given to six healthy men at a hospital in London, it triggered a life-threatening inflammatory reaction. The men suffered damage to multiple organs, and one was held in intensive care for several months.
There have been no similar safety scares in biodefense research. Still, for some potential bioweapons, scientists disagree on whether monkeys are the best animals in which to test whether a drug a vaccine will work. The most prominent split is between two companies developing drugs to treat smallpox: Chimerix of Durham, North Carolina, and SIGA Technologies of New York.
Stocks of smallpox virus are known to be held at only two labs, the CDC in Atlanta and the Russian State Research Center of Virology and Biotechnology in Koltsovo, Siberia. So for practical reasons, SIGA and Chimerix began to study macaques infected with a related virus, monkeypox.
Smallpox virus
BSIP/UIG via Getty Images
But there was still a problem. For both smallpox and monkeypox, a very high dose of virus, usually delivered directly into a vein, is needed to establish a reliably lethal infection in monkeys. And the disease then looks rather different than human smallpox, lacking a lengthy incubation period in which the virus spreads slowly through the body.
Monkeys with this unnatural infection are a poor choice for testing human smallpox drugs, virologist Mark Buller of Saint Louis University told BuzzFeed News. He holds stock in Chimerix and has worked with both companies, testing their drugs in mice with mousepox, a related disease caused by the ectromelia virus.
Chimerix had further problems using monkeys because its smallpox drug, brincidofovir, is broken down too quickly in macaques. So the company abandoned primate experiments, and now hopes to convince the FDA to approve the drug based on tests in rabbits with rabbitpox and mice infected with the ectromelia virus. SIGA, however, continued testing its smallpox drug, tecovirimat, in macaques infected with monkeypox or smallpox.
Neither drug has yet been approved by the FDA, but that isn’t necessary for them to enter the Strategic National Stockpile — even unapproved drugs can be administered under an “emergency use authorization” in the event of a bioterrorist attack. Indeed, SIGA has already delivered hundreds of thousands of treatment courses of tecovirimat to the stockpile.
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