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contracts was signed by both Butler and a - university official and specified a fee to be ‘ars MOGUALSCIENCE sent to the university. The other, signed only by Butler, specified a second, identical fee that was sent directly to Butler. Together, the split fees added up to the company’s usual payment, about $6000 per patient. Pence testified that she was stunned to learn of the arrangement and that it violated health center rules requiring all trial funds to go through the university. Pugh also “felt retty stupid,” she admitted, because it ex- plained an oddity she had not understood in one of Butler’s previous contracts. In that case, she noticed that Pharmacia was paying Butler only half of what it was sending to another health center researcher involved in the same trial. “I became a little angered with Pharmacia,” she testified. “I thought they were trying to take advantage of Dr. Butler.” But when the administrators con- -tacted Butler and suggested that they might be able to double his fee, he told them “to butt out of it,” said Pence. ‘When the split contracts came to light, it all made sense, Pence testified. She im- mediately turned the matter over to univer- sity investigators. Into Africa Within the small world’of plague science, however, few scientists knew of Butler’s trou- bles at Texas Tech. They saw only a re- searcher on a roll—and returning to his roots. Butler’s first brush with plague came in 1969 in South Vietnam, where the disease was common. After completing his Navy service, he returned several times as a civil- ian researcher at Johns Hopkins University in Baltimore, Maryland. But the work ended when Saigon fell to Ho Chi Minh’s forces in 1975—Butler, in fact, was on one of the last planes carrying Americans out of the city. His last close encounters with plague came in Brazil in the late 1970s. However, Butler kept up with the liter- ature and published several book chapters and reviews—enough to retain his stand- ing as an expert. That reputation pro- pelled him back into the field in the late 1990s, when the threat of bioterrorism again made plague a hot topic. Experts had begun sounding the alarm after Ken- neth Alibek, a former Soviet bioweapons researcher, revealed that the former su- perpower had mass-produced the mi- crobe, which can kill in days when in- haled. Concerns deepened in 1995 when the U.S. government arrested microbiolo- gist Larry Wayne Harris, who had links to extremist groups, for ordering plague mi- crobes from a culture library under false pretenses. (The incident triggered Con- gress’s 1996 creation of the first stringent wwwsciencemag.org SCIENCE VOL 302 E TRIALS :OF THOMAS BUTLER Butler's Plague Itinerary - @ 4aprit 2002. Flies with samples fram Tanzania to London. Stays overnight and restocks dry ice. @ 1April 2002. Flies from London to Dallas, then to Lubbock, Texas. @ 23 June 2002. Drives from Lubbock to CDC lab in Fort Collins, Colorado. @® 9 September 2002. Sends plague cultures to Dar es Salaam by FedEx. © 1 October 2002. Flies from Lubbock to Weshington, D.C., then drives to U.S. Army lab in Fort Detrick, Marylond, 3 rules for transferring dangerous microbes, which Butler allegedly violated.) In 1999, Butler gladly accepted an invi- tation from the U.S. Army Medical Re- search Institute of Infectious Diseases (USAMRIID) in Fort Detrick, Maryland, to help produce a training video on how to rec- ognize and treat a plague attack. As Butler and a group of experts huddled over a simu- lated victim, they began debating the best treatment; he recalled. A variety of anti- biotics had been used to treat plague, but no- body knew which worked best or had the fewest side effects. A trial in humans would be the ideal way to answer the questions. But the logistical and ethical obstacles were daunting, Exposing healthy people to plague was out of the question, and most cases of the disease occur in the developing world. There are fewer than a dozen plague cases a year in the United States. . But Butler wasn’t deterred. After study- ing several options, he rejected a return to communist Vietnam and decided that French researchers had the inside track in Madagas-. car. So Butler contacted researchers in Tan- zania, and “they burst forth with enthusi- asm,” he said. * In 2001, Butler took a yearlong leave from Texas Tech to lay the groundwork for a ‘Tanzanian trial, which he jump-started with his own funds. Early that year, he arrived in Dar es Salaam laden with medications, sy- ringes, and cotton balls—a goodwill gesture to his collaborators—and met with Eligius Lyamuya, a well-known investigator at the Muhimbili Medical Center. Butler traveled to the mountainous Tanga region in north- eastern Tanzania, where plague is endemic. There, using a spartan clinic as a base, he 19 DECEMBER 2003 and his Tanzanian partners arranged for a side-by-side comparison of two antibiotics, doxycycline and gentamicin. The team members agreed that the study would inchidé drawing fluid samples from the “bubo3,” of-hideously swollen lymph nodes, of the patients to confirm the pres- ence of Yersinia pestis, the plague bac- terium. Butler would then isolate the microbes—and share his cultures with the Tanzanians. The Tanzanian government had approved the study, whereas the Texas Tech IRB had exempted it from its review be- cause Butler said he was just a consultant to the Tanzanian principal investigators (see sidebar, p. 2056). After a long delay, the clinical trial fi- nally began in early 2002. In Lubbock, Butler received word that his principal Tanzanian collaborator, William Mwengee, had enrolled the first of what would even- tually become more than 60 patients. By then, the 11 September terrorist at- tacks and October anthrax letters had moved bioterrorism to the top of the politi- cal agenda. Butler smelled new opportuni- ties: “Idea in AM. Go after bioterrorism moneys for grant to work on plague,” he wrote in one of his notebooks not long af- ter 9/11. Indeed, scientists at three govern- ment agencies were eager to work with him; the uncertainty about plague antibi- otics suddenly loomed large as a gap in na- tional security, FDA soon decided to fund his work by “buying” data from the Tanzanian trial, which one agency official at the time called a “truly unique asset.” Plague researchers at the Centers for Disease Control and Pre- vention (CDC), meanwhile, agreed to con- 2057