Monkey Shortage Threatens Germwar Vaccine Testing, Some Researchers Warn
by Zack Phillips
CQ HOMELAND SECURITY – TECHNOLOGY
The effort to develop countermeasures to biological terrorism, many scientists say, faces a looming problem on the horizon: a critical shortage of monkeys needed for testing.
Three years after the anthrax attacks that killed five people and injured dozens of others, many involved in biodefense research say the country does not have a large enough supply of non-human primates for the kind of massive research effort that would be needed in the aftermath of another bioterrorist attack.
“Today it is an area of concern,” said Michael J. Hopmeier, a special adviser to the U.S. Surgeon General, the Pentagon’s Defense Advanced Research Projects Agency (DARPA) and other government agencies. “In the near future, it’s going to be a significant problem.”
Testing vaccines to defend against bio-terror agents — such as anthrax, smallpox and even monkeypox — is too dangerous for human subjects. DARPA, long a leader in over-the-horizon scientific projects, is working to construct synthetic systems to duplicate human organs and immunology for such tests, but they are still far from producing results needed now, researchers say.
Thus the development of countermeasures to biological agents, many scientists say, rests largely on the shoulders of the monkey, the animal whose biology most closely resembles that of humans.
A rule developed by the Food and Drug Administration (FDA) in 2002 allows the approval of new drugs and products based solely on animal studies, in cases where clinical trials in humans are unethical or unsafe.
Biodefense researchers say they have enough monkeys for current projects. But many say no contingency stock is available to supply the kind of immediate and unexpected push for a new inoculation necessary in the wake of a bioterrorist attack.
“To me, we don’t have any surge capacity,” said C.J. Peters, director for biodefense at the University of Texas Medical Branch Center for Biodefense and Emerging Infectious Diseases.
Supply and Demand
The price of monkeys has risen with the drop in supply and a consistent and growing demand, Peters noted.
In the late 1980s, individual rhesus macaque monkeys cost several hundred dollars each. Now, Peters said, the price is $3,000 per monkey. Other researchers priced each monkey even higher.
The National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH) that supports biomedical research, has three breeding colonies with about 350 rhesus macaques available for testing in fiscal 2005.
But director Judith Vaitukaitis said all of those monkeys are dedicated to AIDS research.
Other government agencies contacted for this story were unable to furnish a comprehensive accounting of the nation’s supply of non-human primates for biodefense research.
That, many researchers say, is exactly the problem.
Government funds — primarily NIH grants — pay only for the monkeys required for specific, ongoing research projects. To date, no macro analysis has been conducted to determine how many non-human primates are currently available across the country and how many would be needed for vaccine development in response to a bioterrorist attack.
“In general, I do not believe the administration or the general research community as a whole really understands or has a clue just how important this is,” said Hopmeier.
“It’s not as fun as having a new vaccine. . . . But it’s absolutely vital to everything we do. In general, there just isn’t enough attention paid to this,” he added.
Existing research facilities lack the room to house the likely number of monkeys required, Hopmeier and others agreed. Two National Biodefense Laboratories currently under construction will become the first workspaces dedicated exclusively to researching emerging threats in biodefense.
Although these facilities may house more monkeys, organizations also suffer from a shortage of qualified personnel to perform high-level biodefense research, researchers say.
China Syndrome
Hopmeier and others involved in biodefense research say the post-9/11 demand for such animals comes at a time when circumstances have limited the supply of monkeys.
The number of imported animals, they say, has decreased, particularly after the severe acute respiratory syndrome epidemic in China, a major exporter of rhesus macaques. Meanwhile, the majority of Indian-born rhesus monkeys have been earmarked for AIDS research. And efforts to generate more monkeys are limited by the fact that the animals are not prolific breeders.
NCRR’s Vaitukaitis acknowledged a limited supply of available rhesus macaques but strongly denied a looming biodefense shortage, saying researchers can use other species of monkeys, which are more readily available.
But Peters, of the University of Texas, said the rhesus macaque is the preferred monkey because scientists know the most about it. Others agreed with his assessment that the looming shortage is real.
“The shortage of animals is, as of this moment, not holding back biodefense, but as you move down the line it will be a big issue,” said Andrew Lackner, director of the Tulane National Primate Research Center.
“To build up the animal facilities and animal resources is also going to take years. If everyone sits around and waits until [the laboratories] open their doors, [the shortage of] non-human primates is going to become a major roadblock.”
Officials from NIH, the FDA, the Department of Defense and other agencies should meet to quantify the national need and start fulfilling it, Peters said.
“We should put that breeding into place so we have a floor under the needs,” he said. “I don’t like to work with rhesus. . . . But I’d much prefer to work with them than [with] woman and children.”
CQ HOMELAND SECURITY – TECHNOLOGY
The effort to develop countermeasures to biological terrorism, many scientists say, faces a looming problem on the horizon: a critical shortage of monkeys needed for testing.
Three years after the anthrax attacks that killed five people and injured dozens of others, many involved in biodefense research say the country does not have a large enough supply of non-human primates for the kind of massive research effort that would be needed in the aftermath of another bioterrorist attack.
“Today it is an area of concern,” said Michael J. Hopmeier, a special adviser to the U.S. Surgeon General, the Pentagon’s Defense Advanced Research Projects Agency (DARPA) and other government agencies. “In the near future, it’s going to be a significant problem.”
Testing vaccines to defend against bio-terror agents — such as anthrax, smallpox and even monkeypox — is too dangerous for human subjects. DARPA, long a leader in over-the-horizon scientific projects, is working to construct synthetic systems to duplicate human organs and immunology for such tests, but they are still far from producing results needed now, researchers say.
Thus the development of countermeasures to biological agents, many scientists say, rests largely on the shoulders of the monkey, the animal whose biology most closely resembles that of humans.
A rule developed by the Food and Drug Administration (FDA) in 2002 allows the approval of new drugs and products based solely on animal studies, in cases where clinical trials in humans are unethical or unsafe.
Biodefense researchers say they have enough monkeys for current projects. But many say no contingency stock is available to supply the kind of immediate and unexpected push for a new inoculation necessary in the wake of a bioterrorist attack.
“To me, we don’t have any surge capacity,” said C.J. Peters, director for biodefense at the University of Texas Medical Branch Center for Biodefense and Emerging Infectious Diseases.
Supply and Demand
The price of monkeys has risen with the drop in supply and a consistent and growing demand, Peters noted.
In the late 1980s, individual rhesus macaque monkeys cost several hundred dollars each. Now, Peters said, the price is $3,000 per monkey. Other researchers priced each monkey even higher.
The National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH) that supports biomedical research, has three breeding colonies with about 350 rhesus macaques available for testing in fiscal 2005.
But director Judith Vaitukaitis said all of those monkeys are dedicated to AIDS research.
Other government agencies contacted for this story were unable to furnish a comprehensive accounting of the nation’s supply of non-human primates for biodefense research.
That, many researchers say, is exactly the problem.
Government funds — primarily NIH grants — pay only for the monkeys required for specific, ongoing research projects. To date, no macro analysis has been conducted to determine how many non-human primates are currently available across the country and how many would be needed for vaccine development in response to a bioterrorist attack.
“In general, I do not believe the administration or the general research community as a whole really understands or has a clue just how important this is,” said Hopmeier.
“It’s not as fun as having a new vaccine. . . . But it’s absolutely vital to everything we do. In general, there just isn’t enough attention paid to this,” he added.
Existing research facilities lack the room to house the likely number of monkeys required, Hopmeier and others agreed. Two National Biodefense Laboratories currently under construction will become the first workspaces dedicated exclusively to researching emerging threats in biodefense.
Although these facilities may house more monkeys, organizations also suffer from a shortage of qualified personnel to perform high-level biodefense research, researchers say.
China Syndrome
Hopmeier and others involved in biodefense research say the post-9/11 demand for such animals comes at a time when circumstances have limited the supply of monkeys.
The number of imported animals, they say, has decreased, particularly after the severe acute respiratory syndrome epidemic in China, a major exporter of rhesus macaques. Meanwhile, the majority of Indian-born rhesus monkeys have been earmarked for AIDS research. And efforts to generate more monkeys are limited by the fact that the animals are not prolific breeders.
NCRR’s Vaitukaitis acknowledged a limited supply of available rhesus macaques but strongly denied a looming biodefense shortage, saying researchers can use other species of monkeys, which are more readily available.
But Peters, of the University of Texas, said the rhesus macaque is the preferred monkey because scientists know the most about it. Others agreed with his assessment that the looming shortage is real.
“The shortage of animals is, as of this moment, not holding back biodefense, but as you move down the line it will be a big issue,” said Andrew Lackner, director of the Tulane National Primate Research Center.
“To build up the animal facilities and animal resources is also going to take years. If everyone sits around and waits until [the laboratories] open their doors, [the shortage of] non-human primates is going to become a major roadblock.”
Officials from NIH, the FDA, the Department of Defense and other agencies should meet to quantify the national need and start fulfilling it, Peters said.
“We should put that breeding into place so we have a floor under the needs,” he said. “I don’t like to work with rhesus. . . . But I’d much prefer to work with them than [with] woman and children.”
