Since September 11, 2001, the threat of bioterrorism has caused Congress and the President to dramatically increase research funding for countermeasures, including funding for new biosecurity laboratories. The new kind of war against non-state actors who use terror to intimidate populations has also made the creation of new ethical and legal rules for researchers seem critical. New laws have been passed, and there have been proposals for new codes of ethics for bioterrorism-related research. Almost five years after September 11, however, the outcome of the development of new research rules remains uncertain.
Ethical guidelines for life sciences research that could be related to bioterrorism are critical, and the scientific community should be actively engaged in setting the standards for such research.1, 2 As the National Research Council of the National Academy of Sciences has stated, “biological scientists have an affirmative moral duty to avoid contributing to the advancement of biowarfare or bioterrorism.”1 It is reasonable for society to expect that scientists will adopt the equivalent of the physician’s “do no harm” principle.1 Arguing for such an oath well before September 11, literary scholar Roger Shattuck noted that it could “help scientists scrutinize the proliferation of research in dubious areas” as well as “renew the confidence of ordinary citizens” in what is a potentially revolutionary endeavor.3
As the debate about the role of ethical standards proceeds, some legal standards have already been adopted. Even with their new legal powers, the Federal Bureau of Investigation (FBI) and Central Intelligence Agency (CIA) have been unable to discover the source of the anthrax attacks. The FBI investigations have, however, focused on two other biosafety cases that have become infamous. Neither of these cases involves bioterrorism, but both illustrate how—in a post–September 11 world—the federal government and the public can be expected to react and even overreact if new biosafety rules are broken in ways that may create a biohazard or public health problem.
The Case of Thomas Butler
Dr. Thomas Butler was the first and so far the only physician-scientist to stand trial in the United States on a bioterrorism-related charge after September 11. On January 2, 2006, Butler completed a two-year sentence that was imposed after a jury trial and upheld by a U.S. Circuit Court of Appeals.4 The bioterrorism-related facts no longer seem to be in serious dispute.
According to his colleagues in the field of infectious disease, Butler has had a long and successful career dating from completion of medical school and residency at Johns Hopkins University at the end of the 1960s and his service in Vietnam in the Naval Medical Research Unit. He was a faculty member at Johns Hopkins University Medical Center and Case Western Reserve University before becoming chief of infectious diseases at Texas Tech University Health Sciences Center in 1987, a post he held until his trial. His work on plague (Yersinia pestis) dates from his experiences treating civilians in the Vietnam War. Most recently, this work involved research in Tanzania, where he and a colleague there compared the efficacy of gentamicin with that of doxycycline in treating patients with plague infection.5 The results of this research were published soon after Butler was released from prison.6
Butler traveled to Tanzania to help set up the study in 2001, and he returned in 2002 to collect samples of Y. pestis taken from the subjects. He returned to the United States with these samples without the required transport permits. In June, he drove to the laboratory of the Centers for Disease Control and Prevention (CDC) in Fort Collins, Colorado, to have the samples tested, again without the required government transport permits.
In September 2002, he sent a set of plague isolates back to Tanzania in a Federal Express box labeled “laboratory materials” without the required export permits, and in October, he flew from Lubbock, Texas, to Washington, D.C. (to the Army Medical Research Institute of Infectious Diseases), with plague samples without the required permit.
In November 2002, after a series of confrontations over timely documentation of complications and death among subjects in a study of antibiotics for the biotechnology company Chiron, Butler’s local institutional review board prohibited him from performing research on human subjects. On January 9, 2003, the board, dissatisfied by his lack of cooperation, reiterated the suspension in an e-mail.7 On January 10, he was notified by letter of a formal inquiry into his activities. On January 11, a Saturday morning, Butler noticed that a set of 30 tubes of Y. pestis cultures was missing, and he noted in his journal, “Set 5 missing!” The next day, he wrote, “Can’t explain other than intentional removal, suspect theft.”8 On Monday, January 13, 2003, he reported to the biosafety officer at the health center that 30 vials of Y. pestis were missing from his laboratory. The next day, senior officials at the health center met and decided to notify the local police and the health department. The police notified the FBI, and more than 60 FBI agents and local police officers conducted an immediate investigation.
Butler was questioned by the FBI, and he waived his right to counsel (this waiver is almost always a mistake). He first insisted that he did not know what happened to the samples. However, after failing a lie-detector test (the failure was not admitted in court) and, he says, being told by an FBI agent that if he signed a statement that he had accidentally destroyed the samples (to reassure the public that there was no danger), that would be the end of the matter, he signed a statement to this effect.4, 9 However, this statement was not the end of the matter. Butler was arrested, spent six days in jail, and then was placed under house arrest. In April 2003, a grand jury returned a 15-count indictment charging him with various crimes relating to his transport of Y. pestis, making false statements to the FBI, and tax evasion. Texas Tech also turned against Butler and helped the prosecution reframe the university’s contract disputes with him as crimes. In August 2003, after Butler refused to plead guilty in exchange for a six-month sentence, he was charged with 54 additional criminal counts; these included mail fraud, wire fraud, and embezzlement arising from Butler’s research for two companies (Chiron and Pharmacia-Upjohn—now Pfizer) and concealment of two contracts with the Food and Drug Administration (FDA) from the university.4
As part of Butler’s pay structure, a percentage of his income was provided by the state of Texas and the remainder came from the university’s Medical Practice Income Plan, which included money earned from seeing patients, research grants, and clinical trials. All monies from these sources, with the exception of consulting contracts, were to be remitted to the Health Sciences Center. Butler entered into contracts with both Pharmacia and Chiron in which his fee per subject would be split between the Health Sciences Center and himself. These contracts, the first of which commenced in 1998, continued until August 2001, and they did not come to the attention of the Health Sciences Center until July 2002.4
Butler voluntarily gave up his medical license before the trial. After the three-week trial, which included testimony from 40 witnesses, a jury found Butler not guilty on almost all the plague-related charges (which included lying to the FBI) and not guilty of tax evasion. It did, however, find him guilty on most of the charges related to his split-fee contract arrangements (44 of the 54 fraud counts) and on 3 of the 18 charges relating to the transport of plague samples.4 He was sentenced to 24 months in prison and 3 years of supervised release and was charged $15,000 in fines and $38,675 restitution to the university. He appealed.
Five issues were raised on appeal. The two most important of these issues dealt with the possibly prejudicial effect of combining the “plague counts” with the contract counts and whether there was sufficient evidence of criminal intent relative to the failure to file the required shipping forms for plague samples. Regarding the first issue, the appeals court ruled without much discussion (and arguably without much understanding of how medical research is conducted) that all these counts could be combined because they all had to do with Butler’s “research efforts”: “Butler’s handling of plague bacteria as part of his research efforts was ultimately related to his scheme to defraud the Health Sciences Center by concealing both his contracts with the FDA and the split contracts Butler maintained with the two pharmaceutical companies.”4 If the Supreme Court agrees to hear his appeal, the possibly prejudicial effect of combining these counts is Butler’s strongest argument.