YEMASSEE -- When a prestigious research team from Boston wanted to test a vaccine for the highly infectious Zika virus, they brought the project to a South Carolina monkey farm that has been steadily growing business at a secretive laboratory inside its boundaries.
The team also has used Alpha Genesis for studies on vaccines for the potentially deadly viruses that cause COVID and HIV. It reported that all of its projects won approval from an internal ethics committee at Alpha Genesis that is required by law to guard public safety and humane animal care.
Little is known about the operations of the Alpha Genesis lab or its small Institutional Care and Use Committee. The committee's work is so closely held that some members' names are redacted in reports it must file with a federal agency. None of its checks on the progress of experiments are made public. Company CEO and President Greg Westergaard did not respond to requests to name or interview its members.
But scientific journals offer details that raise questions about public accountability in a system heavily reliant on self regulation. State and federal public agencies do not give advance review to experiments OK'd by the committee. The only public input comes from a single member of the committee appointed by Westergaard to serve as what he called an "outside set of eyes."
The Zika study came to Alpha Genesis after the virus infected an estimated 1.5 million people in Brazil beginning in 2015, spreading to Puerto Rico and the Caribbean. Most people recovered, with about 50 recorded deaths in the Americas. But Zika's lethality caused global alarm because of the high rate of birth defects found among babies of infected pregnant women.
The virus is most commonly spread by bites from the Aedes mosquito, a type common in South Carolina's warm Lowcountry, but it can also be spread by sexual contact. Experiments involving animals would have to be carefully designed and rigorously monitored to avoid lab accidents that could cause it to spread, according to biosafety research guidelines.
Beaufort County News SC monkey farm president confirms monkey deaths that occurred over Thanksgiving holiday By Mitchell Black and Marilyn Thompson [email protected] [email protected]
"A unique aspect of Zika is that it's not just mosquito transmitted, it's sexually transmitted. When we think about the real concern for pregnancies and fetuses, and any unborn children. It's not just eliminating the mosquito exposure," said Melissa Nolan, director of the University of South Carolina Institute of Infectious Disease. "When you think about families that are trying to conceive, if one of them got infected, it could be transmitted to their partner."
Using animals to test new drugs is another source of a fierce global debate that has encircled Alpha Genesis after 43 monkeys tapped for federal research escaped in November. Federal regulators are now reviewing the incident, along with a complaint about another alleged accident that may have killed as many as 18 monkeys around Thanksgiving.
Westergaard on Dec. 20 acknowledged to The Post and Courier that some monkeys died in an incident around that time. He did not say how many or provide other details, other than to say the deaths were from carbon monoxide poisoning.
The company has also come under criticism from its congresswoman, U.S. Rep. Nancy Mace, who represents part of Beaufort County where a portion of the massive research center is located. She's part of a congressional animal rights caucus which objects to using taxpayer funds for animal research, an argument that could gain traction as anti-vaccine advocates move into key positions in the Trump administration.
"We are concerned about the potential risks associated with the research conducted at Alpha Genesis," Mace said in a statement, adding that she is collaborating with federal agencies on regulatory compliance and oversight. "It is essential Alpha Genesis adheres to all legal and safety standards, and we are committed to ensuring proper measures are in place for the responsible conduct of research."
Westergaard said in an email that the company has recently had inquiries from pharmaceutical companies about testing vaccines under development for bird flu, the latest virus to cause global pandemic fears. He said some studies of viral agents involve transporting infected monkeys off the property to another laboratory, but he declined to identify specific projects because of client confidentiality.
An internal committee with limited oversight
Westergaard has repeatedly said that three federal agencies oversee various aspects of his company's operation. The U.S Department of Agriculture "routinely reviews our IACUC practices and protocols as part of their oversight regimen" when animal inspectors visit the site, he said.
Known by the clunky acronym IACUC, internal committees have been required by federal law since 1985 at any company or institution that receives federal research money. The system has been repeatedly criticized by the inspector general for the U.S. Department of Agriculture, which regulates animal facilities, in reports dating back to 2005.
The inspector general and outside critics have flagged issues with potential conflicts of interest in how members are chosen and lack of oversight. Researchers have shown that 98 percent of projects are approved by IACUCs, including those at companies that earn revenue from the work.
"The IACUCs are a sham, purely for show to assuage a public that would never approve of what the vivisectors (researchers) were doing if they knew about the horror," said Dr. Lawrence A. Hansen, a neurology and pathology professor at the University of California San Diego School of Medicine. Hansen and others studied IACUCs at 25 major research institutions.
David Favre, a professor at Michigan State University College of Law who specializes in animal regulation, said federal agencies allow research centers to withhold names to protect members from harassment.
"The idea of the committee is a major step forward," he said. "However, political compromise being what it is, there is no enforcement mechanism. It's a good faith argument. You can go public and make a fuss and you can write letters to people, but the law isn't going to help you."
Beaufort County News SC monkey farm internal documents describe escapes, incompetent staff and sloppy practices By Marilyn W. Thompson and Mitchell Black [email protected] [email protected]
These committees are appointed by the company's CEO and report to an institutional official who is typically a senior administrator. That administrator must send an annual report to the National Institutes of Health. They must also immediately flag certain serious issues.
The animal rights group People for the Ethical Treatment of Animals has pushed for more disclosure and recently won a ruling by the 9th Circuit U.S. Court of Appeals in California that could force a research lab at the University of Washington to disclose names of its IACUC members. This came after members of the university's IACUC sued in 2022 to keep their names confidential, claiming that protesters could target their homes.
Federal documents show the Alpha Genesis committee is chaired by the company's sales director, Melissa Ferguson, and includes one staff veterinarian. Ferguson, a former restaurant owner who lists no scientific training on her LinkedIn page, plays a key role in managing research projects and gets credit in some scientific papers for helping with primate care.
PETA recently released emails and documents detailing alleged problems with animal care at Alpha Genesis, including concerns raised by employees that staff members were not properly trained to care for and treat the monkeys. The documents indicated that monkeys consistently broke free from, or became entangled with, their cages.
The Post and Courier spoke recently to a former employee who has raised concerns about animal treatment at the farm. The worker agreed to speak with reporters anonymously out of fear of retribution.
The ex-employee said that not addressing concerns, like the dangerous cages, allowed Alpha Genesis to "continue to run the facility on a very minimal budget, including unqualified staff."
In an interview soon after the monkey escape, Westergaard cited the internal committee as an important safeguard. He would not name the one community representative on the panel, but said that person has "no vested interest in the company at all."
He insisted the nature of his laboratory, which is a biosafety lab with moderate risk, makes it unlikely to cause any public health concerns.
"If there is an infectious agent, it's a very low level one, basically impossible to cause any bad, crazy outbreak," he said.
Zika comes to Yemassee
The Alpha Genesis laboratory has grown as demand for new drugs and vaccines exploded in the wake of bioterror incidents and a global pandemic. The company manages as many as 10,000 primates at three Lowcountry locations -- primate centers in Beaufort and Hampton County, and a free-roaming breeding colony on Morgan Island, known as "Monkey Island."
It ships truckloads of monkeys each year to private, university and government labs, including those run by NIH, which contracts with Alpha Genesis for 250 to 500 research monkeys annually. Monkeys are generally brought from Morgan Island to acclimate to humans at the two primate centers before they are sent away, according to press reports.
Other research is conducted on the Beaufort County property, with monkeys under study, sometimes for lengthy periods, while researchers log their reactions to novel drugs or treatments. According to federal reports, the on-site lab had 572 monkeys in experiments in 2021, up 45 percent from the previous year. In 2023, it reported 449 involved in research projects.
Westergaard said in November the monkeys are bred to be free of pathogens and are regularly screened for germs that could interfere with scientific experiments.
"Let's say they're developing a compound in mice, and they want to get some preliminary information on how that compound would work in a monkey. Then they might do the study here because their facility would not necessarily have monkeys at all," Westergaard said, describing his typical pharmaceutical client.
Beaufort County Out in the cold: Fugitive monkeys are still on the lam as Lowcountry winter approaches By Marilyn W. Thompson and Mitchell Black [email protected] [email protected]
He and other company supporters are proud that Alpha Genesis played a role in developing a COVID vaccine, which is credited with saving lives during the pandemic.
The research team that studied eight rhesus monkeys included Harvard Medical School professor Dan Barouch, whose team at the Beth Israel Deaconess Medical Center for Virology and Vaccine Research has conducted research on global pathogens including tuberculosis, HIV and Zika. Barouch did not respond to emails.
PETA recently wrote a letter to the Harvard Medical School to protest Barouch's involvement with Alpha Genesis.
The Zika project was funded by Janssen Pharmaceuticals, now part of Johnson & Johnson Innovation, and it received some support from a federal program, according to the paper published in August. The team notes that its protocol was approved by the Alpha Genesis IACUC, and it credits Ferguson and long-time Alpha Genesis scientist William Rinaldi as contributors.
The paper details how 14 pregnant rhesus monkeys received the experimental vaccine, then returned to their social groups while it took effect. Some were injected with Zika, which had been cultured in the laboratory. The paper does not detail any movement of the monkeys off the Alpha Genesis property. Experts say standard protocol is to confine them in cages inside the lab to avoid exposure. The author of the paper, Amanda Martinot, did not respond to emails from The Post and Courier.
Two weeks before their due dates, the pregnant monkeys underwent C sections. Researchers euthanized their fetuses to study their brains. They found several brain abnormalities consistent with defects researchers had found in infected human babies.
The researchers concluded from the study that the new vaccine effectively protects monkeys from the virus, a step in bringing the drug to human trials.
None of the Zika research thus far has yielded a marketable vaccine. The virus is still a problem in many parts of the world, and the federal Centers for Disease Control and Prevention warns international travelers to be careful in countries where Zika is present, though no cases have been acquired in U.S. states since 2017.
The former employee said that the areas designated for animal research were slightly more secure than the breeding colonies from which the monkeys escaped. Cockroaches, palmetto bugs and large rodents wriggled into the building holding these tested primates and could find their way out, the ex-employee said.
Westergaard has declined requests for reporters to tour the facility.