Project leader Thomas W. Geisberg was 2014 TIME Person-of-theYear
GALVESTON, Texas––A recent investigation of a disease in the Ebola family done at the University of Texas Medical Branch at Galveston involved alleged “critical, major, and minor” violations of animal welfare protocols, according to an audit by the National Institute of Allergy & Infectious Diseases.
The NIAIA audit report, summarizing findings by an investigative team on January 26-29, 2015, was edited “by agreement” of the University of Texas Medical Branch at Galveston and NIAIA personnel in more than 145 places to remove the names of almost everyone involved in the alleged violations before it was released to Stop Animal Exploitation Now cofounder Michael A. Budkie.
Tipped off to the existence of the NIAIA audit report by a University of Texas Medical Branch insider, Budkie obtained a copy of it through the Freedom of Information Act.
Among the names left legible in the report, occurring in at least three places, was that of Thomas Geisbert, long the biggest name in Ebola research, who was identified as project leader for the study Infectivity and Lethality of Marburg Virus Angola in Non-Human Primates Following Intramuscular Challenge.
But the intensive redaction to remove names left Geisbert’s role in connection with the alleged “critical, major, and minor” violations unclear.
Geisbert himself did not respond to an ANIMALS 24-7 request for comment.
“The project which was the subject of the audit was not one in which Geisbert was the principal investigator,” opined Budkie. “So, he isn’t particularly relevant to the audit,” a perspective apparently contradicted by Geisbert’s position as project leader.
Par for the course?
“However, the primary animal issue of the audit––allowing monkeys to die without receiving euthanasia, is par for the course at the Galveston National Lab, according to our source,” Budkie said.
“Also, to me,” Budkie continued, “the most striking issue of the NIAID audit isn’t really the animal issue as much as the sheer number and severity of the deficiencies listed there. Also, from what I am told, the University of Texas Medical Branch administration was engaging in something of a cover-up regarding the report. Both the Institutional Animal Care & Use Committee and the attending veterinarian were denied access to the report, which would be illegal in and of itself,” Budkie charged.
“So, once I had the report, I e-mailed it to the entire animal care staff, etc. Thought they should see it,” Budkie said.
“A matter of utmost importance”
Wrote Budkie to University of Texas system chancellor Bill McRaven on August 14, 2015, “I am contacting you about a matter of the utmost importance, research integrity within the University of Texas system. I was contacted by a whistleblower who has/had a connection to the University of Texas, Medical Branch/Galveston National Laboratory. This person provided me with information concerning the existence of a National Institutes of Allergies and Infectious Diseases site visit report that was highly critical of several research projects at UTMB/GNL. I have since obtained a copy of the report, which is attached to this communication, via the Freedom of Information Act.
The report, Budkie explained to McRaven, “reveals conditions that clearly had a serious and deleterious impact on the health and well-being of animals within UTMB/GNL laboratories. I have already provided this report to the USDA Animal & Plant Health Inspection Service,” Budkie said, which according to Budkie had already done “an inspection to specifically address issues relevant to SAEN’s complaint.”
Monkey deaths called “Loss of Data”
Budkie called McRaven’s attention to a section of the NIAIA report headed “Loss of Data.” Said the report of the non-human primates who had been exposed to the Marburg variant of Ebola virus, “Most animals (8 of 12) were found dead between Days 8 and 10. Since approximately 12-18 hours had elapsed between the last observations, when the animals were still alive, and when the animals were found dead the next morning, it is unknown how long these animals might have suffered before dying. This is an animal welfare issue despite the fact that the protocol states that ‘animals will be observed at minimum twice daily . . . . observations will increase in number as clinical signs warrant.”
Continued the NIAIA report, “It is unacceptable to leave animals that are expected to die unattended during the time frame that death is expected (Days 7-10 for Marburg virus). Even more of a concern, is the fact that collectively, data were available for all of these animals showing evidence of Marburg virus disease during the expected time of death.”
90 Critical, Major, & Minor deficiencies
Altogether, Budkie summarized to McRaven, “This report lists approximately 90 Critical, Major and Minor deficiencies discovered by NIAID during their site visit. The extremely high number of deficiencies must raise serious questions as to the conduct of these specific research projects, as well as the overall integrity of experimentation at the University of Texas Medical Branch/Galveston National Laboratory.
“In brief,” Budkie wrote, “the report states that a significant number (75%) of primates who were infected with Marburg virus were denied adequate veterinary care, (i.e. were not adequately observed or euthanized in a timely manner) and as a result were allowed to suffer an extremely painful death unnecessarily since death was not an endpoint of the studies in question. Additionally, this report reveals serious issues relevant to: failure to follow Standard Operating Procedures (SOPs); inaccurate, incomplete, & faulty documentation; seriously compromised experimental data, etc.
“Eleven of these citations were ‘Critical,’” Budkie pointed out, meaning that according to the NIAIA report itself, they “would affect the validity or integrity of a study and/or the acceptability of a Contract Research Organization (CRO). Regulatory Authority action is probable.”
Asked for investigation
Another 59 alleged violations were ‘Major,’ Budkie added, which according to the NIAIA report mean a procedural deficiency that “may jeopardize the acceptability” of the findings of an experiment, and that “Regulatory Authority action is possible.”
Budkie asked McRaven to “immediately institute an independent investigation of the experiments connected to this site visit, as well as all use of primates at University of Texas Medical Branch/Galveston National Laboratory relevant to compliance with the federal Animal Welfare Act, University of Texas Standard Operating Procedures (SOPs), Good Laboratory Practices (GLPs) and NIAID policies. As you can see from the attached report,” Budkie warned, “UTMB/GNL’s status as a Contract Research Organization for the NIAID is apparently in danger.”
Responding at McRaven’s request, University of Texas system vice chancellor for health affairs Raymond S. Greenberg on August 24, 2015 wrote to Budkie that he had received “all of the relevant documentation related to the NAIAD report, as well as subsequent communication between UTMB and NIAD, and information about an independent review conducted by USDA (orally presented but not yet received in writing.) Dr. Patricia Hurn, vice chancellor for research & innovation, has reviewed all of the written documentation,” Greenberg said, “and has been in daily contact with Dr. David Neisel, the vice president for research at UTMB.
“Dr. Hurn and I share the opinion that UTMB has responded in a timely, thorough, honest, and concerned manner to the issues that were initially raised by NIAID,” Greenberg said. “Virtually all of the issues raised by NIAID have been addressed. With two federal agencies already engaged in reviewing this matter, we believe that a third independent review by the University of Texas system would be unlikely to add useful information not already covered by the ongoing reviews.”
Budkie took case to feds
Budkie, however, had on August 19, 2015 sent another request for investigation to Axel Wolff, director of compliance oversight for the National Institutes of Health Office of Laboratory Animal Welfare National Institutes of Health.
“A source connected to the University of Texas Medical Branch informed Stop Animal Exploitation Now of an NIAID site visit report that raises many serious issues relevant to animal welfare,” Budkie opened. “Chief among these is that primates with Marburg virus are not being euthanized when they reach a humane endpoint, and are simply dying overnight.
“However, the handling of this NIAID report within UTMB is a major concern,” Budkie emphasized. “Our source has told us that this report was withheld from both the attending veterinarian and the Institutional Animal Care & Use Committee, preventing them from performing an investigation as is required whenever a credible source (such as the NIAID site visit team) raises a question regarding animal welfare issues.
“Also,” Budkie wrote, “we have been told that the bio-containment veterinarian has not been informing the IACUC of primate deaths within the Galveston National Laboratory, so they have not been able to address potential animal care issues.
“Additionally,” Budkie finished, “the attending veterinarian for this facility was recently terminated. On the day before termination, this veterinarian filed a 13-point complaint about animal care issues with the IACUC. It is unclear if this complaint was ever investigated.”
Responded Wolff overnight, “The Division of Compliance Oversight will open an investigation into these allegations and provide you with an assessment upon completion.”
Study funded coincidental with West African outbreak
According to the NIAID Quality Audit Report, “The conduct and reporting for audit of Study Number STDY-13-0005-TG, entitled Infectivity and Lethality of Marburg Virus Angola in Non-Human Primates Following Intramuscular Challenge was scheduled for evaluation for data completeness and integrity by Dr. Lynda Lanning, Dr. E1izabeth Glaze, Dr. William Dowling and Ms. Kathleen Andrews.”
The study was apparently funded in March 2014, coinciding with the outbreak of an Ebola virus pandemic now raging in six African nations for 17 months, killing more than 12,000 people. Another 28,000 have fallen ill. Altogether, more than five times as many people have died from the present Ebola outbreak as from all previous Ebola outbreaks combined since the disease was first discovered in 1976.
But the outbreak had barely begun when the National Institutes of Health allocated more than $26 million to a team led by Geisbert “to advance treatments of the highly lethal hemorrhagic fever viruses known as Ebola and Marburg,” summarized Rick Cousins for the Houston Business Journal.
The funding was awarded, Cousins continued, because “Ebola and Marburg are considered to have the most potential to be used in a deadly bioterrorism attack. There are currently no treatments, vaccines or antidotes for these dangerous pathogens.”
Geisbert and the University of Texas Medical Branch, Cousins wrote, “will use the grant over a five-year period in collaboration with the Maryland company Profectus Biosciences Inc., the British Columbia company Tekmira Pharmaceuticals, and the Vanderbilt University Medical Center in Nashville, Tennessee.
Said Geisbert then, “This research impacts public health in areas where the viruses are endemic, but also presents opportunities in the biotechnology sector to develop treatments for people that visit these areas, such as tourists, or soldiers. The approaches we are using are applicable to combating other infectious diseases, especially deadly emerging infectious diseases, for which countermeasures do not yet exist.”
Concluded Cousins, “The [University of Texas medical branch] will conduct three interdependent research projects, supported by the Galveston National Laboratory at UTMB, a facility with the highest level containment required to safely work with deadly viruses, biosafety level four (BSL-4). UTMB has the only operational BSL-4 laboratory on a university campus in the United States.”
“Save the world!”
The West African Ebola pandemic elevated the status of the Geisberg-led study from “only” that of a major biomedical research project to that of research that might help save the world from one of the most lethal and ugliest diseases known to pass from animals to humans.
The native hosts of Ebola viruses are believed to be fruit bats. Explained an October 2014 World Organization for Animal Health (OIE) media release, “When bats and other vertebrate species were experimentally inoculated, only bats became infected and shed virus in feces without showing any clinical signs. Monkeys are not considered as natural hosts because of their high sensitivity to the virus and their high mortality rate when infected,” but monkeys and great apes are frequently susceptible in the wild.
“Ebola is a disease transmitted from wild animals to humans most likely through hunting and collection of sick or dead wild animals and handling or consumption of uncooked bush meat,” the OIE release continued. “Although the source of infection for non-human primates often remains unclear, most evidence indicates direct infection from one or more natural hosts,” namely contact with fruit bats.
“Human to human transmission occurs through contact with body fluids of an infected person. It is thought that the current epidemics throughout West Africa originated from a single animal-human transmission event that occurred in the forest at the border between Guinea, Sierra Leone and Liberia,” the OIE said.
Thomas W. Geisbert
Geisbert, 53, had already been the biggest name in Ebola research for more than 20 years.
“Ebola has fascinated Geisbert since he first looked at the tiny particle through an electron microscope, noting its spaghetti-like shape with the characteristic shepherd’s crook on the end,” recounted Washington Post staff writer Nelson Hernandez on October 2, 2005, shortly after Geisbert developed the first vaccine for Ebola.
“Not long after,” Hernandez continued, Geisbert “co-discovered a strain that had broken out among research monkeys in Reston(Virginia), a tale that made its way into Richard Preston’s 1994 bestseller The Hot Zone and made Geisbert a celebrity in the science world.”
By the end of 2014 Geisbert was a rock star to the rest of the world, too.
“Time Magazine‘s 2014 Person of the Year is not one but many –– the Ebola Fighters,” editorialized Time on December 10, 2014. “Among those spotlighted is Thomas Geisbert, professor of microbiology and immunology, who is currently testing potential vaccines and treatments at the Galveston National Laboratory.”
What the audit report says
The major mentions of Geisbert in the NIAIA audit report are in an appendix that describe his participation in a meeting held on January 29, 2015 at which University of Texas Medical Branch at Galveston senior personnel discussed the audit report findings with the NIAIA investigators.
“The date and time of the meeting were changed,” the appendix states, “to accommodate Dr. Geisbert’s schedule.”
Three pages later, the appendix summarizes, “Dr. Geisbert asked for clarification regarding the use of the human pathologist to read the slides” of infected non-human primate tissues. “He asked if the issue was that an amendment should have been issued or if it was an issue with the fact that a veterinary pathologist was not used. Dr. [Lynda] Lanning [of NIAIA] indicated that both were issues. The change should have been captured in a Protocol Amendment and the pathologist evaluating the microscopic slides should have been familiar with the species of animal from which the tissues originated.”
A page later, “Dr. Geisbert asked if the audit team was looking at DVMAX [data tracking software] printouts when finding issues in the data across forms. Dr. Lanning stated that it was one of the types of documentation that did not match across other originally collected data. Dr. Geisbert said that could be the problem. Dr. Lanning reiterated that it is all raw data and that the laboratory cannot pick and choose what raw data to include in the study file and provide for review.”
“Geisbert was deeply involved in the research studies,” a well-informed source in virology told ANIMALS 24-7. “Tom Geisbert is a very meticulous guy and honorable guy,” the source continued. “I’d swear by him. I doubt he was careless but it doesn’t take much to overlook a necessary detail. Nobody’s perfect, although that is essential” when dealing with virus as deadly as Ebola-Marburg.