Even worse, bioterrorism “preparedness” programs now under way include the development of a number of new secret research facilities that will store and handle dangerous materials, thus increasing the risk of accidental release or purposeful diversion. Reports of accidental leaks and improper disposal of hazardous wastes at the US Army facility at Fort Detrick serve as future warnings, as do revelations of mishandling of biological agents at the Plum Island, New York, facility that studies potential bioweapons that affect animals.
Most important, the proposed development of “biodefense” programs at sites, such as national nuclear weapons laboratories, that are traditionally secretive in their operations also provides an impetus for a potential global “biodefense race” that would likely spur proliferation of offensive biowarfare capabilities. Accidents or purposeful diversions from these facilities seem at least as likely as terrorist events, and perhaps more so, since the deadly materials are already present. The Patriot Act has greatly expanded the clock of secrecy that shields these facilities from public awareness and oversight.
In short, bioterrorism preparedness programs have been a disaster for public health. Instead of leading to more resources for dealing with natural disease as had been promised, there are now fewer such resources. Worse, in response to bioterrorism preparedness, public health institutions and procedures are being reorganized along a military or police model that subverts the relationships between public health providers and the communities they serve.
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U.S. v. BUTLER
429 F.3d 140 (5th Cir. 2005), cert. denied 126 S. Ct. 2049 (2006)
Before Wiener, DeMoss, and Prado, Circuit Judges.
Appellant Dr. Thomas Butler was convicted on 47 of 69 counts of various criminal activity relating to work he performed as a medical researcher at the Texas Tech University Health Sciences Center ("HSC"). Of these 47 counts, Butler was convicted of 44 counts of contract-related crimes, including theft, fraud, embezzlement, mail fraud, and wire fraud, (collectively, the "Contract Counts"). Butler was also convicted of three counts relating to the transportation of human plague bacteria ("Yersinia pestis" or "YP"), including the illegal exportation of YP to Tanzania, the illegal transportation of hazardous materials, and making a false statement on the waybill accompanying the YP vials shipped to Tanzania, (collectively, the "Plague Counts"). The district court sentenced Butler to 24 months' imprisonment followed by 3 years' supervised release, a $ 15,000 fine, and ordered him to pay restitution to HSC in the amount of $ 38,675. Butler timely filed the instant appeal. For the reasons discussed below, we affirm.
Butler was a professor and Chief of Infectious Diseases in HSC's Internal Medicine Department since 1987. As part of Butler's pay structure, a percentage of his income was provided by the State of Texas while the remainder came from the Medical Practice Income Plan ("MPIP"). Under MPIP, a doctor earned money by seeing patients, receiving research grants, or conducting clinical studies under the auspices of HSC. The monies received from the patients a doctor treated and the funds paid out for the research/studies was remitted to HSC. Part of these monies paid for HSC's overhead costs and other expenses while another part was paid out as the non-state portion of the doctor's income. Any remaining funds from a clinical study was transferred to a developmental account for the researcher's department or division. The money in this account was earmarked for expenses such as professional dues and business travel, none of which was related to any particular project.
When a researcher at HSC was in a position to obtain a research grant or conduct a clinical study, it was required that the accompanying documentation be submitted to the institution for approval. Moreover, any monies paid out as a result of the research grant or clinical study were required to be paid directly to the institution. Consulting contracts, however, received different treatment from research grants or clinical studies. Specifically, a consulting contract was viewed by HSC as a means for a doctor to sell his or her expertise or advice directly to a third party, such as in designing a drug study. The consulting would not involve patient care or patient safety issues, and the consultant would not be using HSC's resources such as labs and personnel. Because of these considerations, consulting contracts were permissible without HSC's financial involvement or approval, unlike contracts covering clinical studies.
Between 1998 and 2001, Butler entered into several clinical study contracts with two different pharmaceutical companies, Pharmacia and Chiron. The first contract entered into with Pharmacia occurred in March 1998. Under this contract, Pharmacia agreed to pay HSC $ 2,400 for each patient enrolled in the clinical study. Apparently unbeknownst to HSC, however, Pharmacia and Butler entered into another "shadow" or "split" contract that provided Butler with an additional $ 2,400 per patient enrolled in the same study. A similar contract was entered into between Pharmacia and Butler in the spring of 2000 and again in the fall of 2000.
With respect to the contract in the fall of 2000, there was another HSC researcher, Dr. Casner, who was working on the same study as Butler. Dr. Casner's contract with Pharmacia was not split, and therefore it appeared that he had a budget twice the size of Butler's. A representative with HSC who was aware of Dr. Casner's contract, contacted Butler to inform him that she could get Butler a bigger budget. Butler allegedly refused the offer and informed the HSC representative that he would remain in charge of negotiating his own contracts. Butler had also negotiated two similar contracts with Chiron (another pharmaceutical company), using the contracts with Pharmacia as a template. The contracts with Chiron involved drug studies that were conducted in February 1999 and March 2000. Butler received payments under the contracts with Pharmacia and Chiron until August 2001.
The existence of the shadow contracts first came to the attention of HSC in July 2002, when an HSC representative learned from a Pharmacia representative that Butler was getting one-half of the money from the Pharmacia studies, while HSC received the other half. HSC initiated a preliminary investigation into the split contracts that continued until January 9, 2003, when HSC informed Butler by letter that an additional investigation by authorities charged with compliance issues was to begin. In the letter, HSC sought a response from Butler by no later than January 21, 2003. For the reasons discussed below, HSC never received the requested response.
In addition to his work at HSC in Texas, Butler conducted plague research in Tanzania in 2001.1 Then, in April 2002, Butler returned to Tanzania where, for approximately 10 days, he worked on research of plague in human patients at clinics there. Part of his research involved personally culturing and subculturing specimens that he planned to bring back to the United States for additional studies.
Having returned to the United States with the Yersinia pestis cultures, Butler continued his research. Then, on January 13, 2003, four days after receiving the letter from HSC auditors warning of the impending investigation into the alleged shadow contracts, Butler reported that 30 vials of the Yersinia pestis were missing from his HSC laboratory in Lubbock. The FBI was immediately notified and within hours descended upon Lubbock, where Butler was questioned. Eventually, Butler revealed that the Yersinia pestis was not actually missing, but that he had destroyed the vials accidentally.
In April 2003, a grand jury returned a 15-count indictment charging Butler with various crimes relating to his transporting of Yersinia pestis, the providing of false statements to FBI agents regarding Yersinia pestis, and a tax crime. A superceding indictment was returned by the grand jury in August 2003, in which Butler was charged with 54 additional criminal counts, including mail fraud, wire fraud, and embezzlement that arose out of Butler's agreements with the pharmaceutical companies and the Food and Drug Administration (the "FDA"). Butler filed a motion seeking to sever the Contract and Plague Counts, which the district court denied. After a three-week trial in November 2003, the jury returned a mixed-verdict against Butler, finding him guilty on most of the Contract Counts and not guilty on most of the Plague Counts and the tax count. On March 10, 2004, the district court sentenced Butler to 24 months' imprisonment, three years' supervised release, $ 15,000 in fines, and a $ 4,700 special assessment. Butler was also ordered to pay HSC restitution in the amount of $ 38,675. Butler timely filed the instant appeal.
I. Whether the district court erred by not severing the Contract Counts and the Plague Counts.
On appeal, Butler argues the Federal Rules of Criminal Procedure and this Circuit's case law prohibit the joinder of unrelated criminal categories charged; here, the Contract Counts and the Plague Counts. Butler contends that trying all the counts together caused him prejudice. Conversely, the Government maintains that joinder was proper because the charges in the superceding indictment were linked as transactions within a common scheme or plan.
The indictment specifically outlines Butler's research into non-plague-related diseases for Pharmacia and Chiron and his plague-related research for the FDA. The indictment's description of Butler's scheme to defraud explained how he failed to disclose material facts to HSC regarding not only the Pharmacia and Chiron contracts, but also the plague-related contracts with the FDA.
The introduction to the superseding indictment details how the FDA offered research opportunities to medical professionals regarding "the development and review of medications for the prevention and treatment of illness that could be caused by terrorists using biological agents." The FDA subsequently purchased Butler's professional service, and specifically, according to the indictment, "for the results of experimental research regarding the post-antibiotic effect of drugs on the microorganism Yersinia pestis," and later "to provide experimental results from [Butler]'s laboratory about the] post-antibiotic effect of drugs on various strains of Yersinia pestis isolated from plague patients in Tanzania."
Meanwhile, the actual FDA fraud counts charged Butler with attempting to conceal the existence of his FDA contracts from HSC's administrative review and approval process. Butler was alleged to have subsequently obtained payments from the FDA without distributing any monies therefrom to HSC in accordance with HSC's relevant policies for doing so.
The superceding indictment clearly sets forth an alleged common scheme that connects both Butler's plague research and the Pharmacia/Chiron pharmaceutical contracts to the FDA fraud counts. In doing so, the superseding indictment, on its face, creates an overlap that logically intertwines the Contract Counts with the Plague Counts.
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V. Whether the Government presented sufficient evidence as to the Contract and Plague Counts.
. . . Butler maintains there was insufficient evidence to support the jury's finding that he willfully: (1) exported Yersinia pestis to Tanzania without a license; (2) described in a misleading manner the Yersinia pestis as "laboratory materials" on the FedEx waybill; and (3) violated federal hazardous material regulations when he shipped the Yersinia pestis to Tanzania.
As to the first sub-issue, the Government points this panel to evidence introduced at trial that Butler certified on the FedEx waybill that the samples were being "exported . . . in accordance with Export Administration Regulations," when in fact they were not. The Government notes that Butler had in his office a document downloaded from the Center for Disease Control website that clearly indicated a Department of Commerce permit was required to export Yersinia pestis. As further evidence of Butler's knowledge of export requirements, the Government observes that Butler previously signed four waybills shipping hazardous materials to Canada and checked the box indicating a Shipper's Export Declaration was not needed (which it is not in those circumstances). Moreover, the Government introduced evidence that during the 1990s, Butler properly shipped infectious substances and other dangerous goods more than 30 times. Based on this evidence, Butler's argument here must fail.
With regard to Butler's conviction for making a false statement by labeling the Yersinia pestis as "laboratory materials," he contends that because he did not intend to deceive anyone, he cannot be found to have acted willfully. The Government responds by noting that Butler also certified on that same label that he was not shipping dangerous goods. According to the Government, a reasonable person certainly could conclude that an accomplished researcher, who was the Chief of Infectious Diseases at HSC and had spent considerable time studying plague abroad, would have known that plague was a dangerous good requiring the proper identification thereof. Accordingly, Butler's sufficiency of the evidence argument on this sub-issue is also without merit.
Finally, Butler contends his conviction for violating hazardous material regulations required the Government to prove that his infraction could not have been due to a good faith mistake or misunderstanding of the law. The Government responds with an argument identical to its reason why there was sufficient evidence establishing Butler's unlawful export of Yersinia pestis to Tanzania without a license: Butler had successfully and legally shipped hazardous materials at least 30 times before making this particular shipment. Importantly, Butler comes forward with no specific evidence of his own on appeal refuting the Government's evidence, or establishing what about his actions warranted a finding that he made a good faith mistake or misunderstood the law. Without more, a reasonable trier of fact could have found that the evidence established guilt beyond a reasonable doubt.
Having carefully reviewed the entire record of this case, and having fully considered the parties' respective briefing and arguments, we conclude the district court did not commit reversible error by refusing to sever the Contract Counts from the Plague Counts. Moreover, the district court made appropriate discovery and evidentiary rulings. Also, there was sufficient evidence supporting Butler's convictions under the Contract Counts and the Plague Counts…. Accordingly, we AFFIRM Butler's conviction and sentence.
Notes and Questions
On January 2, 2006, Butler completed his two-year sentence and was released. A scientific article detailing his plague research in Tanzania, completed while he was in prison, was published shortly thereafter. See William Mwengee, Thomas Butler, et al., Treatment of Plague with Gentamicin or Doxycycline in a Randomized Clinical Trial in Tanzania, 40 Clinical Infectious Disease 614 (2006).
2. The case of physician-researcher Thomas Butler has been the subject of many commentaries—most arguing that his prosecution represents a gross overreaction on the part of federal authorities. Nonetheless, in an article in Science, Margaret A. Somerville and Ronald M. Atlas argued that Butler’s prosecution “sent a clear signal to the research community, especially scientists and university researchers, that all ethical and legal requirements must be respected when undertaking research.” The continued, “Biosafety regulations are not merely legal technicalities. They constitute some of the terms of the pact between science and the public that establishes public trust.” Ethics: A Weapon to Counter Bioterrorism, 307 Science 1881 (2005).
Ethical guidelines for life sciences research that could be related to bioterrorism do seem critical, and the scientific community should be actively engaged in setting the standards for such research. As the National Research Council of the National Academy of Sciences has states, “biological scientists have an affirmative moral duty to avoid contributing to the advancement of biowarfare or bioterrorism.” It is reasonable for society to expect that scientists will adopt the equivalent of the physician’s “do no harm” principle. 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. (Forbidden Knowledge, New York: St. Martin’s Press, 1996 at 224)
But can an ethical code be effective? What should it say? Who should write it? Consider, for example, the National Research Council’s seven classes of microbial experiments that should require special review:
The experiments would:
Demonstrate how to render a vaccine ineffective;
Confer resistance to therapeutically useful antibiotics or antiviral agents;
Enhance the virulence of a pathogen or render a nonpathogen virulent
Increase transmissibility of a pathogen;
Alter the host range of a pathogen;
Enable the evasion of diagnostic and detection methods;
Enable the weaponization of a biologic agent or toxin.
3. The major approach the administration has taken toward potential bioterrorism since 9/11 has been to categorize biological agents according to their risks of being used as a terrorist weapon. The current scheme has three categories, and the fact that plague is in category A goes a long way to explaining why the FBI acted so strongly against Butler.
Anthrax, botulism, plague, smallpox, tularemia, viral hemorrhagic fevers.
Brucellosis, food safety threats, glanders, melioidosis, psittacosis, Q fever, ricin toxin, staphyloccococcal enterotoxin B, typhus fever, viral encephalitis, water safety threats.
Category A, or “high priority agents…pose a risk to national security because they can be easily disseminated or transmitted from person to person; result in high mortality rates and have the potential for major
public healthy impact; might cause public panic and social disruption; and, require special action for public health preparedness.
Category B agents “include those that are moderately easy to disseminate; result in moderate morbidity rates and low mortality rates; and require specific enhancements of CDC’s diagnostic capacity and enhanced disease surveillance.
There is also a Category C for those agents “that could be engineered for mass dissemination in the future because of availability; ease of production and dissemination; and potential for high morbidity and mortality rates and major health impact.” CDC, Bioterrorism Agents/Diseases, available at (http://www.bt.ced.gov/agent/agentlist-category.asp)
An Institute of Medicine committee has suggested that making such lists is not a useful way to counter bioterrorism because it takes no account of the future of science. In the Committee’s words:
First, the future is now. Even in the short time since the
creation of the committee, we have seen the phenomenon of RNA
Interference capture the collective consciousness of the life
sciences community, providing entirely new insights into how
human genes are normally regulated and how this regulation might be disrupted for malevolent purposes by those intent on doing harm.
Similarly, ‘synthetic biology,’ an approach embraced and discussed
by few at the time the Committee was formed, has now been redefined and promoted on the cover of one of the most widely read scientific
journals. Neither of these developments could have been foretold ever
a few years back, pointing to the futility of trying to predict with
accuracy what will come in the next few years [the committee concluded, among other things, that we need a new threat reduction paradigm for the biological sciences].
Institute of Medicine, Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare Threats: Globalization, Biosecurity, and the Future of the Life Sciences viii (2006). On the risks to public health from concentrating too much on preparedness see Terrorism and Public Health: A Balanced Approach to Strengthening Systems and Protecting People (Barry S. Levy & Victor W. Sidel, eds. 2003)
4. There are other examples of an arguably overly aggressive FBI that seems to see bioterrorism in activities, including art, that it would not have seen them pre-9/11, and wastes time, effort, and resources that could almost certainly be better spent in trying to identify real bioterrorist threats:
Shortly after Butler’s trial, in another part of the country—Buffalo, New York—FBI agents were called in to investigate a suspected act of bioterrorism in the home of Steve Kurtz, a professor and artist at the State University of New York at Buffalo. Kurtz awoke on May 11, 2004, to find his wife dead beside him. Kurtz and his wife previously had cofounded the Critical Art Ensemble, an artists’ collective “dedicated to exploring the intersections between art, technology, radical politics and critical theory.” Kurtz liked to distinguish what he did from the emerging field of “bioart,” which is perhaps best known to the public because of the notoriety of Alba, a rabbit that glowed green because of the insertion of a jellyfish gene. Kurtz thinks of bioart as consisting of stunts and his own art as an exploration of “the political economy of biotechnology.” He had previously argued against the introduction of genetically modified food, and he had encouraged activists to oppose it by means of “fuzzy biological sabotage”—for instance, by releasing genetically mutated and deformed flies at restaurants to stir up paranoia.
The day after his wife’s death, the FBI raided his home in full biohazard gear. Kurtz had been studying the history of germ warfare for a new project. In connection with this project, he was growing bacterial cultures that he was planning to use to simulate attacks with anthrax and plague. He had obtained the bacteria samples (Serratia marcescens and Bacillus atrophaeus) from a colleague, Professor Robert Ferrell, a geneticist at the University of Pittsburgh Medical Center, who had ordered them for him from the American Type Culture Collection. Kurtz and Ferrell were suspected almost immediately of being involved in a bioterror ring and were thoroughly investigated. Once the New York department of Health determined that the bacteria were harmless and that Kurtz’s wife had died of natural causes, the bioterrorism investigation was dropped. The Justice Department nonetheless charged both Ferrell and Kurtz with four counts of wire fraud and mail fraud. The allegation was that Ferrell, at Kurtz’s request, defrauded the University of Pittsburgh and the American Type Culture Collection by representing that the bacteria samples he ordered would be used in his University of Pittsburgh laboratoy. [As of September 2006]neither case has yet gone to trial.
Exactly what Kurtz was planning to do with the bacteria is unclear, but serratia, which is known for its ability to form bright red colonies, has been used in biowarfare simulations in the past. Perhaps its most well-known use was a 1950 simulation in which an offshore naval vessel blanketed a 50-square-mile section of San Francisco with an aerosol spray containing serratia to determine what dose could be delivered effectively to the population. Whether using a similar technique as an art exhibit would constitute bioart, biotechnology, or biohazard (or even bioterrorism) may be in the eye of the beholder even more than in the eye of the artist or scientist.
Bioart is not bioterrorism, but the two are related politically. As bioart curator and commentator Jens Hauser has staid, bioart aims “at the heart of our fears” and is meant to “disturb.” He notes, “these artists expose the gulf between the apologetic official discourse about technoscience on the one hand, and paranoia on the other.” Like defensive and offensive bioweapons research, bioart and biotechnology may be impossible to distinguish by anything other than the researcher’s or creator’s intent. Thus, Alba, the bunny with the inserted jellyfish gene, is considered to be and is accepted as a creation of bioart, at least in the contemporary art community; whereas ANDi, the monkey with the inserted jellyfish gene, is considered to be a creation of science, at least in the biotechnology community. Hauser was referring to paranoia in the face of the “rapid acceleration of technical prowess.” On the basis of the reaction of federal law enforcement to the actions of Thomas Butler and Steve Kurtz, however, although the advances of biotechnology that have potential applications to bioterrorism and biowarfare are scary, even scarier are the responses—in the name of preventing bioterrorism—of law-enforcement agencies to legitimate scientists and artists whose actions pose no threat to the public.
Butler’s arrest came about one year after a simulated bioterrorism event in Lubbock, Texas; this simulation involved the use of aerosolized plague at a civic center. Simulations have been a centerpiece of efforts to prepare for acts of bioterrorism. As we should have learned from our obsession with building bomb shelters during the cold war, however, simulations promote fear of worst-case scenarios and make them look much more likely. Bioterrorism simulations such as Dark Winter (smallpox) and Top Officials (TOPOFF) involve more art than science and are likely to provoke a response based more on fear than logic. They should probably be classified as bioart in the sense of performance art, and they should have their most socially useful outlet not in federal law-enforcement agencies or biosafety laboratories but in television dramas like 24.
George J. Annas, Bioterror and “Bioart” – A Plague o’ Both Your Houses, 354 New Eng. J. Med. 25 (2006).
Do you agree? Are law enforcement agencies overreacting or underreacting to the threat of bioterrorism?
One reasonable response to the dispute between Butler and the Justice Department and the dispute between Kurtz and the Justice Department could be Mercutio’s retort in Romeo and Juliet: “A plague o’ both your houses.” This is because the public is currently more victim and bystander than participant and seems much more likely to be harmed than helped by much of the research. Members of the public recognize this probability, and their skepticism of federal authorities, of the effectiveness of countermeasures, of the existence of weapons of mass destruction in Iraq, and of the entire bioterrorism scare is well illustrated by the few people who took drugs to treat anthrax that were offered after the anthrax attacks. This same skepticism, combined with the lack of evidence of stockpiles of smallpox in Iraq and the certainty of side effects from the drugs, also explains the small number of health professionals who volunteered to take the smallpox vaccine immediately before and shortly after the commencement of the war in Iraq. Id. at 2719.
5. At least some over-reactions can be traced to books highlighting the dangers of a bioterrorist attack. President Bill Clinton, for example, said he first became focused on this risk when he read Richard Preston’s novel, The Cobra Event (1997) in 1997. Preston later wrote a nonfiction book on the dangers of a smallpox attack, The Demon in the Freezer: A True Story (2002). Perhaps more frightening to public health officials were the books by the former Soviet head of bioweapons development, Ken Alibek (Biohazard: The Chilling True Story of the Largest Covert Biologicaal Weapons Program in the World—Told from Inside by the Man who Ran It (1999), and by Minnesota epidemiologist Michael Osterholm (with John Schwartz), Living Terrors: What Americans Needs to Know to Survive the Coming Bioterrorist Catastrophe (2000). All of these books portray what might be described as worse case scenarios, and the value of concentrating on worse cases (instead of likely cases) is debatable. Of course the nuclear arms race provided the background for over-reaction, complete with its “mutually assured destruction” scenarios, home fallout shelters, and “duck and cover” grade school exercises. See, e.g., Herman Kahn, On Thermonuclear War (2d ed, 1961), and Sharon Ghamari-Tabizi, The Worlds of Herman Kahn: The Intuitive Science of Thermonuclear War (2005).
“Worst case scenarios” are not only popular in emergency preparedness training exercises, but also in more mundane public health problems such as deciding if a particular site for a new post-9/11 research laboratory is safe for the public. Controversy continues, for example, over Boston University’s plan to build a post-9/11 BSL-4 laboratory on the Boston Medical Center campus in the city of Boston. The following is from a Superior Court decision examining the adequacy of an environmental impact report prepared for the laboratory. The report was required by the Massachusetts Environmental Policy Act (G.L. c. 30, secs.61-62H).