Researchers at UT Southwestern Medical Center in Dallas have spent years and millions of dollars building vaccines and cancer treatments with ricin, a toxin so lethal that an amount the size of a grain of salt can kill a person.
But as federal oversight of deadly agents has increased dramatically since the 9/11 attacks, so have concerns about the university’s research program. For nearly five years, and as recently as August, some safety inspectors and law enforcement officials have worried that the ricin stockpile isn’t secure enough.
And internal e-mails and safety records depict a research program caught in the struggle between science and security — where some of the nation’s most prominent scientists have chafed at new safety demands and the inspectors who reviewed their labs.
“They sound like a bunch of Bushie Grunts to me,” decorated cancer and vaccine researcher Ellen Vitetta wrote in a 2004 e-mail, after a colleague’s meeting with safety inspectors. “Just carry on and hopefully they will soon leave us alone.”
Among the demands that researchers have expressed frustration about: requests to provide running logs of their ricin inventory, participate in annual safety drills, and install extra layers of security hardware on doors, closets and refrigerators. UT Southwestern has never had a security breach in its ricin program.
“What a headache, especially considering 1) you were using this stuff for years with absolutely NO oversight and 2) if any of us really wanted to cheat, we could do it easily and they’d never know!” ricin researcher Joan Smallshaw wrote in a 2006 e-mail to Dr. Vitetta, after biosafety officers asked for a new inventory of the stockpile. “Why torture us!?”
It’s a culture clash emblematic of debates in university research programs across the country, where these days, there’s almost as much demand for biosafety and risk management officers as there is for scientists.
Dr. Vitetta and her colleagues have broken major ground in the hunt for a ricin vaccine and new cancer therapies. But bidding for lucrative federal grants is a double-edged sword, they and other longtime researchers say, because the money and prestige come with significant red tape.
University officials say that the program has complied with every security measure inspectors have suggested. National security rules prevent them from describing these safety measures in detail or from disclosing how much ricin is stored at the university.
And Alfred Gilman, the medical school’s provost, dean and executive vice president for academic affairs, said the ricin researchers are entitled to the occasional eruption. Since 2001, Dr. Gilman said, they and other university researchers have been overwhelmed by federal reporting requirements.
“The number of issues we must track very, very carefully, we must educate everybody on, we must report back on and swear to the Lord on — it’s getting to be quite dramatic,” he said. “Is it frustrating? Yeah, it’s frustrating. But frustration doesn’t lead you to do something stupid and kill yourself.”
Among the security concerns was a 2001 incident in which two men approached a researcher with a pitch to partner on a ricin-related project. The men were turned away, but at least one police officer felt compelled to alert the FBI, according to a law enforcement official.
Two years later, campus officials were concerned enough about the safety of the ricin stockpile that they considered moving it off campus to a CDC-protected facility. They decided not to because transporting the materials back and forth to conduct research would be too risky.
And records indicate that the researchers have had to scramble to comply with federal regulations in the days and weeks before their inspections.
“If you have EVER used ricin for an experiment, check to see if you still have a tube of it tucked away in the fridge somewhere. … Everyone ELSE who has some MUST get rid of it,” Dr. Smallshaw wrote in an e-mail to staff in 2004, a week before a scheduled inspection. “And finally, the labs are now strictly off limits to anyone without FBI security clearance (you know who you are!)”
Safety conscious
Campus researchers say any suggestion that they are cavalier with ricin is ridiculous; after all, their own lives are on the line. Every lab in the country checks itself in the days before an inspection by the Centers for Disease Control and Prevention, they say. And they argue that the frustration they express to each other privately is a natural side effect of an ever-growing list of federal demands — inspections, meetings and reporting requirements that make them feel more like paper pushers than scientists.
“Anything that takes us away from doing our research, from moving ahead with projects we consider important, we consider frustrating,” said Dr. Vitetta, who directs the university’s Cancer Immunobiology Center.
Dr. Smallshaw added: “We are the first people who would suffer if we got careless. I’m not willing to subject myself to that kind of danger.”
Biodefense watchdog Edward Hammond, whose Austin-based Sunshine Project advocates against biological warfare, sees it another way:
“The biologists don’t think twice about enthusiastically lapping up federal defense money,” said Mr. Hammond, who uncovered one illness and several infections at a Texas A&M University lab last year. “But they don’t want to accept the safety consequences that come with it.”
Ricin vaccine
UT Southwestern’s research with ricin, a poison extracted from castor beans when they are processed to make oil, began in the 1970s, when Dr. Vitetta started using a portion of the toxic molecule to target cancer cells. For the next 20 years, she oversaw experiments on these “immunotoxins” — research that catapulted her into the national spotlight and won her entry to the National Academy of Sciences and the Texas Women’s Hall of Fame. Unlike traditional chemotherapy, Dr. Vitetta’s ricin treatments were intended to attack cancer cells while leaving healthy cells alone.
“She was really one of the first people in this field to develop a drug that … caused partial and even complete remission in patients with life-threatening cancers that were resistant to chemotherapy,” said Dr. Robert Kreitman, chief of immunotherapy research in the National Cancer Institute’s molecular biology division. Dr. Kreitman has run clinical trials with immunotoxins since the mid-1990s. “She is very widely known and very highly regarded in the field.”
By the late 1990s, Dr. Vitetta knew so much about ricin that she had developed an experimental vaccine, something the U.S. Department of Defense had been trying to do for years. She said that after the Sept. 11 terrorist attacks, “when it became obvious these things could be used in a fashion that was threatening to the public,” biodefense grants were plentiful, and she and her staff were awarded millions of federal dollars for vaccine research.
Dr. Vitetta’s ricin vaccine, which is still being tested, is the first to have been tried in humans, a step that comes with even more stringent federal reporting requirements. But she said that she has “been following very strict rules since before there even were rules” — and that security has always been paramount.
“We have a great responsibility, and we recognize that and take it very seriously,” said John Roan, the medical center’s executive vice president for business affairs. “We do believe this research is safe, and we do believe we have the appropriate and adequate security.”
Campus watchdogs, including one law enforcement official, paint a far different picture. They say that over the years, top university executives have treated the ricin experiments like sacred cows because of the funding and prestige they produced, siding with researchers and effectively ignoring police and biosafety officers’ requests for tighter security.
“We were a necessary evil,” the law enforcement official said. “They didn’t want us around and didn’t take us seriously.”
They point to alarm records as evidence of lax safety. Reports obtained by The News indicate the door to the ricin lab was either propped open or failed to close properly 140 times over a recent 14-month period, triggering an alarm each time. In one March incident, a newly installed lab door was found to operate backward, e-mails show; the door remained unlocked most of the time and locked only when someone used a swipe card to try to enter. That door was immediately fixed.
Interim campus Police Chief Bob Newton called the alarm records misleading. None of the door incidents involved criminal activity, he said: The alarms sounded even when a door didn’t latch perfectly, or when someone was standing in the doorway to finish a conversation. Each time, he said, an officer was dispatched to the lab.
An incident that prompted even more concern occurred the summer before the Sept. 11 attacks in 2001. The law enforcement official said police learned that two men had come to campus trying to consult with the university on a project involving ricin. The men never followed up on their pitch. Researchers later reported the incident to police; the law enforcement official said that after campus police conducted routine interviews, they were told to stand down.
“No one in the department had any clue until that point how much [ricin] they had in there,” said the law enforcement official, who said officers eventually passed the incident on to the FBI. “Everyone was saying, ‘Isn’t this something that needs better oversight?’ “
Chief Newton said he knows of no bad blood between researchers and law enforcement officials. In his entire career with the department, which dates to 1980, he has never once felt pushback over a security recommendation, he said.
“I’ve never been a part of any conversation that in any way expressed frustration with getting the necessary security implemented in that area,” Chief Newton said. “We’ve received full support.”
Push for oversight
For a time, university officials appeared to think more oversight of the ricin supply was necessary. In January 2003, e-mails show, publicity over ricin research led to unspecified threats against the program — and prompted the campus police to step up lab patrols. University officials declined to elaborate on the threats, except to say that the ricin supply has never been endangered.
And records and e-mails from March of that year indicate university President Kern Wildenthal wanted the ricin moved to a “Fort Dietrich”-like facility, one where the CDC would monitor the stockpile’s safety. In e-mails Dr. Vitetta sent at the time, she agreed it was “a wise idea to move our material off campus and put it under someone else’s control” — as long as she would have access to the agent whenever she wanted.
“Please realize that the loss of this material would do irreparable damage to my research program and would waste many millions of dollars of already-spent grant and private monies,” Dr. Vitetta wrote. “On the other hand, I fully understand all the security issues.”
The idea was eventually rejected, after officials determined that the risks associated with transporting the agent to and from UT Southwestern were too high. (The law enforcement official said until this decision was reached, campus police were planning an armed convoy to escort the ricin.)
By that point, the CDC had installed new rules to guide researchers using deadly agents, requirements that included frequent federal safety inspections.
Reports from these inspections, obtained by The News, don’t highlight any serious security breaches — like illness or infection — in the ricin lab. But in both 2003 and 2007, federal investigators cited the university for “deficiencies”: not having adequate records of its ricin inventory, not keeping complete logs of researchers entering and leaving lab areas, and not having security plans “commensurate with the risk posed by maintaining such a significant quantity of ricin.”
Under the CDC’s select-agent guidelines, labs must keep “accurate, current inventory for each select agent,” including information on where the agent is stored, how much is available, who last had access to it, and whether any of it has been destroyed.
After meeting with CDC inspectors in June, Dr. Smallshaw wrote in an e-mail that they “ARE worried about the security of the stockpile and recommend more [security] — I knew they would.”
Two months later, CDC officials initiated a conference call with the university to resolve lingering ricin issues, including a discussion over who could access the stockpile.
“I think they have concerns about the amount of ricin,” Julien Farland, then the university’s assistant director of environmental health and safety, wrote in an e-mail to Dr. Vitetta. “In particular they feel that the large amount of semi-purified castor beans are a risk and should be evaluated for increased security.”
During two separate interviews, university officials referred to the CDC inspection reports as “observations,””suggestions” and “clarifications,” and said UT Southwestern always satisfied the agency’s requests.
“Everything we have done, from an environmental health and safety standpoint, in checking and securing these labs, they have been satisfied,” Mr. Roan said. “We’ve had very good cooperation by the faculty, certainly from this lab in particular.”
Lab watchdogs say that’s hardly the case. In internal office e-mails spanning four years, researchers have complained about heightened scrutiny, called biosafety officers “paranoid,” and said federal inspectors make their “lives miserable.”
‘Comic relief’
In 2006, when campus law enforcement insisted on new doors and locks for the ricin stockpile, Dr. Smallshaw again voiced frustration with inspectors’ requests.
“They are not happy with the security of the ricin stash, so they are INSISTING that we install yet another … lock on the outer door,” she wrote to Dr. Vitetta. “I told them they can go CRAZY and install whatever they like so long as they understand … that we are not coughing up one red cent toward this.”
“If they want to hire James Bond, that is also fine with me,” Dr. Vitetta responded, “as long as we don’t foot the bill.”
Dr. Vitetta described the e-mails as “humans talking to humans” and said they’re a way for the researchers to find “comic relief” in the midst of ever-increasing federal mandates.
In every instance where researchers complained about the new safety measures, records and e-mails indicate they still complied with them, and sought ways — through new doors or security cameras — to make inspectors comfortable with their ricin supply.
In an e-mail to Dr. Vitetta after a June meeting with CDC inspectors, Dr. Smallshaw wrote: “Other than updates on some of our paperwork, they’re happy and grateful that we were so receptive and hospitable (which they tell us is not always the case).”
Dr. Vitetta said that there is no lab inspection on a university campus where “you don’t get ready a few days ahead of time.”
“If you know [the inspectors] are coming on Friday, you make sure all the books are up to date by Wednesday. … And sometimes you find small things you really need to get up to speed,” she said.
“Things can get lax in less important areas,” added Dr. Gilman, a Nobel laureate. “But when you’re dealing with a dangerous virus, or a highly toxic agent, people aren’t fools.”
ALL ABOUT RICIN
What is it?
Ricin is a poison produced when castor beans are processed to make oil. It can exist in powder, mist or pellet form, and it dissolves in water. If ingested or injected, a dose the size of a grain of salt is deadly.
How does it work?
Ricin attacks the body’s cells by preventing them from making proteins they need, and generally kills within three days. If inhaled, ricin causes fluid to build up in the lungs, and induces cough and fever. If ingested, it causes vomiting, seizures and hallucinations. Both lead to respiratory and organ failure.
How dangerous is it?
Ricin is a stable substance — it doesn’t break down easily. Unless a person inhales it, swallows it or is injected with it, he will probably not report symptoms. Accidental exposure is highly unlikely; illnesses are generally deliberate. There is no antidote, and vaccines are still in development.
Ricin incidents:
–In 1978, an assassin linked to the Soviet KGB used an umbrella loaded with a ricin pellet to kill Bulgarian dissident Georgi Markov in London.
–In 2003, the Secret Service intercepted an envelope filled with ricin headed for the White House. Ricin was detected on a similar envelope in a South Carolina mail facility.
–In 2004, ricin was detected in the mailroom of a Senate office building in Washington.
–Recent federal intelligence reports have linked ricin production to villages in Afghanistan and groups allied to al-Qaeda in northern Iraq.
SOURCE: Dallas Morning News research
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