WITH BIOTERROR FEARS RISING, AN EXPERT WINDS UP ON TRIAL
14 Apr 2003
Source: Wall Street Journal, April 14, 2003
With Bioterror Fears Rising, An Expert Winds Up on Trial
When Dr. Butler Said He Lost 30 Samples Of the Plague, It Triggered a Federal Case
By RUSSELL GOLD, Staff Reporter of THE WALL STREET JOURNAL
Dr. Thomas Butler has devoted much of his 30-year career to research on the plague, a fast-spreading infectious disease that kills its victims within days.
He earned a tenured position in infectious diseases at Texas Tech University and published dozens of papers in prestigious journals. As the threat of terrorism escalated in recent years, the Army and the U.S. Centers for Disease Control expressed interest in collaborating with him on studies of how best to treat outbreaks of the plague.
Then, on Jan. 11, he arrived at his office and made an entry in his research log that would change his life and stun his colleagues. He wrote that 30 vials of plague bacteria were missing and possibly stolen from his laboratory.
Campus police notified the Federal Bureau of Investigation. The news traveled quickly to Washington, where Homeland Security Secretary Tom Ridge personally ordered his staff to put crisis plans into action. By 3 a.m. on Jan. 15, 60 FBI and local law-enforcement agents were searching Dr. Butler's home and knocking on doors across Lubbock.
If a terrorist released samples of the plague bacteria -- known as yersinia pestis, or YP -- over a city using an aerosol bomb, thousands of people could arrive at emergency rooms with what appeared to be rapidly progressing pneumonia. Without proper treatment, patients would almost certainly die from respiratory failure.
Investigators descending on Lubbock discovered that Dr. Butler had traveled to Tanzania, a suspected haven for terrorists and site of a 1998 U.S. embassy bombing. Their suspicions only grew when federal officials learned the scientist had carried vials of YP on commercial flights from Tanzania to Texas without proper import licenses.
That afternoon, the 61-year-old Dr. Butler was led into court in leg irons and handcuffs. The missing vials were the top story on national cable news channels for hours on the morning of his arrest.
Before Sept. 11, 2001, the case probably wouldn't have aroused the attention of anyone beyond his immediate supervisors. Now, however, Dr. Butler faces 14 felony charges and, if convicted, up to 74 years in jail. Last week a grand jury handed up an indictment charging him with lying to federal agents and illegally transporting undeclared vials of YP on commercial airplanes and in Federal Express packages. No trial date has been set. Dr. Butler's lawyer says he will plead not guilty.
The FBI has concluded that Dr. Butler had no connection to terrorist activities. But why he would destroy the vials and lie about it, as the investigators allege, remains a mystery. Assistant U.S. Attorney Dick Baker describes Dr. Butler as a potential threat to the "safety of the community." Dr. Butler didn't respond to requests for interviews.
Until recently, Dr. Butler appeared to be on the forefront of the fight against terrorism. Now, he is under house arrest, wearing an electronic monitoring bracelet. His research has been halted. He is barred from any contact with colleagues at the Centers for Disease Control or the U.S. Army's Institute of Infectious Diseases.
Dr. Butler's case is an example of the difficulties involved in assessing potential threats in the wake of the Sept. 11 terrorist attacks. In a world where the public and law-enforcement officials alike are inclined to endorse hair-trigger responses, some people may be caught in the crossfire.
Aversion to Paperwork
Colleagues believe Dr. Butler is a diligent researcher with a blase attitude about paperwork. Federal officials, however, see him as a serious threat. Dr. Butler declined to comment for this article. His lawyer says he is a victim of the nation's "state of war" on terrorism. For now, it's impossible to know. Still, extensive interviews with others involved in this case and a review through open-records filings of hundreds of pages of documents show Dr. Butler's rapid transformation from respected researcher to accused felon.
Dr. Butler looks like Hollywood's image of a trustworthy physician: tall, thin and white-haired, with a gentle smile. When he wasn't teaching or treating patients, he worked in a windowless office on the fourth floor of the Health Sciences building at Texas Tech. The only personal touch in his lab was a coffee maker, colleagues said. Everything else was books and beakers.
He was a naval officer stationed in Vietnam in 1969, when he first witnessed the stunning brutality of the plague. "We were humbled by the swift progression of this disease which carried healthy individuals to death within three days," he wrote. He encountered the bubonic variety of the plague, which is spread by infected fleas and launched the pandemic responsible for wiping out a third of Europe's population in the 14th century. Officials worry that terrorists may deploy a different form of the same disease: the pneumonic plague, which can be spread by a human coughing -- or a terrorist's aerosol bomb.
Since 1999 his research focused on a seemingly simple question. Which antibiotic is better to treat the disease: streptomycin or gentamicin?
The Food and Drug Administration prefers streptomycin. But the drug isn't manufactured regularly anymore in part because it can cause hearing loss. Not being able to get enough antibiotics quickly would be catastrophic in the event of an outbreak. "Pneumonic plague is invariably fatal if antibiotic therapy is delayed more than one day," says the U.S. Army's handbook on responding to bioterrorism.
That's why the Army prefers the widely available gentamicin, even though it has never been approved by the FDA for use treating the pneumonic plague. Even before the Sept. 11 terrorist assaults, and the anthrax attacks that followed, interest in Dr. Butler's work was growing.
"I am very much interested in doing some collaborative plague work and would relish participating in some field trials," Col. Ted Cieslak of the Army's Institute of Infectious Diseases at Fort Detrick, Md., wrote to Dr. Butler in a 1999 letter obtained in an open-records request to Texas Tech.
Focus on Plague
In 2001, Texas Tech granted Dr. Butler a one-year sabbatical so he could focus exclusively on plague research. Three times over the next 12 months he traveled to Tanzania. There, he worked with William Mwengee, a medical officer for the Ministry of Health stationed in the rural northeast corner of the country, where the plague is endemic. With approval from the Tanzanian government, Dr. Mwengee began to recruit patients for his study.
At the same time, back in Lubbock, an academic spat with significant consequences was brewing. In 1999, Dr. Butler had received the first of two grants for a total of $179,000 from Chiron Corp., a biotech company in Emeryville, Calif., to enroll patients in a large study to determine whether an experimental drug improved their chances of surviving severe sepsis, an often-fatal blood infection.
Most patients with severe sepsis die quickly. The mortality rate can be as high as 50%. The number of patients dying in Dr. Butler's study attracted the attention of the university's Institutional Review Board, which oversees human research to protect patients. When the IRB asked questions, Dr. Butler was slow to provide requested documents, according to Lorenz Lutherer, a physiology professor who mediated a dispute between Dr. Butler and university administrators over how the incident was handled in its early stages. Texas Tech shut down the trial in May 2001, and then restarted it a month later when he provided documents showing that other hospitals involved in the drug trial had similar mortality rates.
"It was a paperwork issue," says Dr. Lutherer. The situation left Dr. Butler feeling as if his credibility had been unjustly attacked, according to Dr. Lutherer. While the academic spat was resolved, the IRB's investigation slowly proceeded.
As the dispute heated up, Dr. Butler was getting more deeply involved in his Tanzania project. In April 2002, on his final trip to Africa, he brought back YP samples in vials. The containers were stowed in his luggage aboard the commercial flights. According to the indictment, he failed to declare his cargo on customs forms, as the CDC required.
The next month, the FDA announced that it would award three grants with a combined value of $2.1 million to develop clinical studies of gentamicin, the Army's preferred plague fighter. In his Lubbock laboratory, Dr. Butler was already growing cultures of the YP strain he brought back from Tanzania. He began testing various antibiotics on the cultures. He appeared to be a leading candidate to receive one of the FDA grants.
In June 2002, he led a two-day seminar at the CDC's infectious-disease laboratory in Fort Collins, Colo., driving there from Texas with the plague samples in his car. Although preliminary, the results of his clinical trials on patients in Tanzania suggested that gentamicin was the better drug. The data were "quite promising," says David Dennis, a retired epidemiologist who oversaw the plague program for the CDC.
Seeking a Grant
Upon returning from Colorado, Dr. Butler went to work applying for one of the FDA's $700,000 grants. He submitted a 24-page proposal. For his work in Tanzania, he proposed to purchase a freezer, a centrifuge, $16,000 of antibiotics and a $30,000 four-wheel-drive vehicle. He detailed his contacts with Dr. Mwengee and explained that the Tanzanian government had given permission to test gentamicin on plague patients. For his Lubbock lab, he sought a $20,000 autoclave, which is used to sterilize lab equipment, and funding to pay a full-time research assistant an annual salary of $26,500.
Dr. Mwengee couldn't be reached to comment.
Dr. Butler failed, however, to file a two-page application known as Form 1571. Gentamicin isn't approved for plague patients, so the form was required before the drug could be tested on humans. In the application, Dr. Butler said he intended to test first, then file the form "if the clinical performance of gentamicin is good." Such "off label" use of prescription drugs by doctors is common, but clinical researchers are required to adhere to rigorous procedures to make sure patients in a drug trial are informed of the potential risks.
In August, the FDA says it rejected his application because he failed to file Form 1571. A university aide who helped Dr. Butler put together the application reminded him of the requirement to fill out the form three times, according to a university official. To date, only one of the three FDA grants has been awarded.
In September, Mike Jones, a Texas Tech biosafety officer, received a fax from the Army scientists at Fort Detrick requesting some of Dr. Butler's plague samples for study. When the biosafety officer asked Dr. Butler if he had plague samples in his laboratory, Dr. Butler said he didn't, according to an affidavit taken by university police. The federal indictment alleges that a couple of days earlier, Dr. Butler had packed YP samples into a Federal Express package and sent them to Tanzania.
About a month later, Dr. Butler learned that the university's Internal Review Board was shutting down all his human research. The IRB said the decision was based on a review of the work he did on the Chiron sepsis drug. The specific reason was blacked out on a document acquired through an open-records request.
A week after his suspension, university officials learned that Dr. Butler not only had YP samples in his lab but had given some of them to Army researchers at Fort Detrick. According to the indictment, Dr. Butler carried them on an American Airlines flight from Lubbock to Ronald Reagan Washington National Airport. Once again, he hadn't done the proper paperwork, according to the indictment.
On Jan. 10, Dr. Butler was hand-delivered a letter telling him the university was proceeding with an inquiry into his activities. The letter was obtained in a Freedom of Information Act request, but most of its contents were blacked out. It is unclear whether the focus of the investigation was the Chiron drug trial, Dr. Butler's plague research, both, or something else entirely. University officials confirmed they are investigating but declined to provide details.
The next day, a Saturday, Dr. Butler went to his lab to work on the plague samples. He wrote in his laboratory log that 30 vials of YP were missing.
On Tuesday afternoon, Dr. Butler met with the chairman of his department, Dr. Donald Wesson, and repeated that the vials were missing.
"I was flabbergasted," Dr. Wesson stated in an affidavit. Reached at his home Sunday, Dr. Wesson said, "I don't know why he did what he did," but declined to comment further.
Dr. Butler told his superiors he didn't see any reason to notify campus police. He suggested a departmental investigation. But the dean of the medical school disagreed and called the police.
A little more than a year earlier, Lubbock had been the site of a mock bioterrorism drill staged by the Justice Department. The scenario was eerily prescient: Terrorists use an aerosol bomb to spread YP at a concert in the Buddy Holly Civic Center.
When Dr. Butler reported the vials missing, campus police applied the lessons learned during the drill. That set off a chain reaction that tested many of the new systems established in the wake of the Sept. 11 attacks. Lubbock and Washington swung into action.
Dr. Butler's attorney, Floyd Holder, says local and federal officials overreacted. "Academic freedom," says Mr. Holder, "is inconsistent with us being in a state of war."
He says his client accidentally sterilized the tubes in an autoclave, then forgot he had done so. He notes that Dr. Butler had nearly 200 vials with YP in his laboratory and that losing track of 30 of them is not as difficult as it might sound.
In simpler times, a report of missing vials probably would have drawn little attention. Even Dr. Butler's decision to carry vials of the plague in his suitcase would have aroused scant concern. The practice is so common that CDC officials have a nickname for it: "VIP," for "vial in pocket."
But terrorist threats have changed that. After five people died from exposure to anthrax, Congress passed laws to expand federal oversight of laboratories working with dangerous toxins. The federal government wants to maintain an up-to-date national inventory of the toxins. Some of Dr. Butler's colleagues say his arrest could have a chilling effect on their work.
"The image of a professor in shackles was very upsetting to many of us," says Anthony Way, a preventive-medicine professor at Texas Tech. "Nobody, particularly a professor, deserves that treatment."
The CDC estimates that about 800 labs nationwide work with so-called select agents, the 49 toxins on the government's bioterrorism list. Federal officials acknowledge that policing these labs won't be easy.
Starting this spring, labs must submit a list of all the select agents they contain and notify the federal government when any of them are destroyed. In addition, the Justice Department will run background checks on scientists working with toxins. Failure to comply is a felony punishable by up to five years in prison.
The new laws also say that anyone convicted of a felony can no longer work with the 49 select agents. That means that if Dr. Butler is convicted, his career would effectively be finished.
-- Gary Fields contributed to this article.