• Sunday, May 27, 2012
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Scientist, Banned From Lab, Blames U. of Wisconsin for Biosafety Lapse

University of Wisconsin officials suspended a professor's laboratory privileges over unapproved tests involving an infectious disease, and said they've sent a strong message about accountability for hazardous materials.

Nevertheless, the message may be already getting muddled.

The researcher on the Madison campus, Gary A. Splitter, says there was also a misconduct finding by federal officials against the university, and it points out deep flaws in how his institution handles biological agents, some of which may be sought by terrorists. The university was fined $40,000 by the National Institutes of Health. And Dr. Splitter notes the university's penalty against him, reported last week by the Wisconsin State Journal, won't necessarily ruin his career.

The five-year ban on hands-on lab work "does not restrict other people from submitting grants; it doesn't restrict me from being an investigator on a grant; it doesn't restrict me from working with others on grants or on science," Dr. Splitter, a tenured professor of pathobiological sciences and a veterinarian, told The Chronicle.

The case, which dates back to a routine inspection of Dr. Splitter's lab by federal officials nearly three years ago, has garnered national attention in the past week as an example of concerns that the government may not be doing enough to guard against accidental or intentional spreads of pandemic disease.

In the case of Dr. Splitter, the work involved the pursuit of a vaccine for brucellosis, a disease that humans contract from farm animals. Its effects are usually limited to chronic flu-like symptoms, though complications make it fatal in about 3 percent of cases. The disease infects about 500,000 people a year, mostly in developing countries, where the months-long process of treatment with antibiotics can be prohibitive.

Lack of Approvals

In their search for a vaccine, Dr. Splitter and his graduate students have been testing various antibiotic-resistant genes of Brucella, a genus of bacteria that causes the disease. The use of Brucella is federally regulated, however, and the 2007 inspection by officials from the Centers for Disease Control and Prevention found that Dr. Splitter's lab did not have approval for all of the antibiotic-resistant genes it was testing.

Ensuing investigations, which involved interviews of Dr. Splitter's graduate students by federal inspectors and a nine-month closure of his lab, led to an agreement with federal officials last October in which the university paid the $40,000 fine. The university disclosed this month its decision to suspend Dr. Splitter's laboratory privileges for a five-year period, ending in 2013. (He has not been allowed in his lab since 2008 because of the investigation, so the university is counting those years as part of his suspension.)

One of Dr. Splitter's lab workers contracted brucellosis, the Wisconsin State Journal reported. The person recovered and it wasn't clear if the strain was related to the unauthorized experiments, the newspaper said.

William S. Mellon, associate dean for research policy at the University of Wisconsin at Madison Graduate School, said the university acted to penalize Dr. Splitter after concluding that Dr. Splitter was aware that new federal rules imposed after the September 11, 2001, attacks on the United States required him to seek specific government approval for his work with antibiotic-resistant genes.

It appears, Mr. Mellon said, that Dr. Splitter—who has spent 32 years at the University of Wisconsin and is one of only about five experts worldwide working on a vaccine for brucellosis—simply never accepted the new requirements imposed on researchers. "Those are hard transitions to make—I understand that," Mr. Mellon said.

Dr. Splitter, however, said that the university was ultimately responsible for telling the government exactly what antibiotic-resistant genes it was using and that the university allowed its biosafety operation to become so understaffed that it couldn't keep up with the workload.

Investigations, both by federal officials and by outside analysts hired by the university, found the campus's Institutional Biosafety Committee "was an organization in disarray," Dr. Splitter said.

There appears to be evidence supporting both the university's and Dr. Splitter's points of view. Dr. Splitter said the university required his lab only to give it broad "categorical descriptions" of the antibiotic-resistant genes it was using, even though the investigation has made clear that federal officials wanted more specific details.

The fact that federal officials chose to fine only the university, not him, is further evidence that the university is the only culpable party, Dr. Splitter said.

Heightened Safety Precautions

Mr. Mellon said he recognized that the case highlighted some shortcomings in the university's operations and that the university has responded, hiring five new biological-safety officers and a new director for the operation. He said it's "silly," however, for Dr. Splitter to deny his own responsibility.

The federal government had considered fining Dr. Splitter, Mr. Mellon said, but the university recommended during negotiations on the penalty that only the institution pay. Federal officials may have concurred in part because fining Dr. Splitter would have also meant fining his graduate students, Mr. Mellon said.

One of the graduate students, discussing the case with The Chronicle on the condition he not be identified, said the case pointed out the confusion over regulations and the hassles that await him if he decides to continue working with hazardous agents.

The university's penalty against Dr. Splitter became public the same week the Proceedings of the National Academy of Sciences published an analysis suggesting that the more restrictive biosafety laws imposed after the 2001 attacks had led to far fewer published studies in the field and accelerated the rate of researchers turning to other fields of study.

The lead author of that report, Elizabeth A. Casman, an associate research professor in the department of engineering and public policy at Carnegie Mellon University, said she doesn't feel the action against Dr. Splitter "has made us any safer."

"And the cost to the U.S.," Ms. Casman said, "was the scientific contribution of a trained and distinguished scientist for a minimum of five years, and perhaps much longer."

Comments

1. honore - May 20, 2010 at 09:26 am

more wisonsin politically correct window dressing and nothing really resolved by highly paid officials charged with overseeing this very possibility...pathetic

2. kymac - May 22, 2010 at 01:31 pm

I am so absolutely sure the college bucked up and offered to take the entire fine....

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