Questions Arise Over UW-Madison Germs Research

Jan 30, 07:12 PM

Jan. 30--Ebola virus. Bird flu. Botulinum toxin. The monkey version of AIDS. Bacteria that cause tuberculosis, a lung infection, and listeriosis, a food-borne disease.

UW-Madison scientists, like those at most major universities, study dozens of dangerous germs. A biosafety office and a faculty committee review the research to make sure it is safe, but discrepancies can lead some to question the oversight.

Critics cried foul after the National Institutes of Health said some of Yoshihiro Kawaoka's Ebola research must be done in a lab with the highest biosafety standards, overruling the campus committee's approval of a lower-level lab.

Now Kawaoka is carrying out different Ebola work in a lab with an even lower classification, and the university hasn't consulted the NIH.

"It's clearly an indication that something is amiss," said Ed Hammond, director of the Austin, Texas-based Sunshine Project, a biomedical research watchdog group.

Not true, said Jan Klein, UW-Madison's biosafety officer. She said Kawaoka's research, like that of all 500 scientists on campus who store or work with potentially problematic bugs, was carefully reviewed.

The six-person Office of Biological Safety and the 18-member Institutional Biosafety Committee make sure researchers use the appropriate labs and equipment to protect themselves and the public, Klein said.

"On rare occasions there are contentious issues," she said. "But the people doing the work on this campus live in this community, and their children attend schools here. They have a strong interest in assuring that things are done appropriately."

Ebola virus lab

The issue of biosafety oversight came up last week, when Kawaoka reported that he had removed a gene from the deadly Ebola virus to create a version he and others say is safe to use in most labs.

Kawaoka developed the altered live virus in Canada in a lab classified as Biosafety Level 4, or BSL-4. It is the highest level, in which workers use self-contained breathing devices.

Kawaoka has been working with the altered virus for a year at UW-Madison in a BLS-2 lab, which has less stringent precautions.

In 2006, Kawaoka was conducting other Ebola work on campus in a BSL-3 lab. He asked Klein if he could switch to BSL-2. She asked the NIH, which said the work should be done in BSL-4, which the university doesn't have. Klein made Kawaoka stop that work.

UW-Madison's biosafety committee approved Kawaoka's plans to eventually use the altered virus in BSL-2 before the NIH ruling on the other work, said Dr. Jon Woods, chairman of the committee.

The committee did not consult with the NIH about the altered virus work, Woods said. That is allowed under NIH guidelines, he said.

NIH spokesman Don Ralbovsky agreed. Ralbovsky, when asked if BSL-2 is appropriate for the new research, said he couldn't comment because the agency hasn't analyzed the situation.

The other Ebola work involves genetic components of the entire virus. The components are not infectious, but they also are not the "irreversibly defective fraction" of the virus required for work in labs other than BSL-4, the NIH ruled. That means the components theoretically could become a problem.

Kawaoka has pointed out that the Centers for Disease Control and Prevention in Atlanta has worked with the genetic components of Ebola in BSL-2, which CDC spokesman Von Roebuck confirmed. The NIH's Ralbovsky said he couldn't explain why the CDC can do this but UW-Madison can't.

"A catastrophic mess"

Hammond, of the Sunshine Project, in September made public the NIH's decision overruling UW-Madison's stance on the research involving genetic components of Ebola. He said the campus committee's approval of the altered virus work in BSL-2 could be further proof of oversight problems.

Hammond has requested the university's accident reports at BSL-2 and BSL-3 labs. UW-Madison attorney Ben Griffiths denied the request, calling it "unduly burdensome."

Hammond's record requests at Texas A&M University revealed that a scientist had been infected with Brucella bacteria. That finding led the CDC last year to ban Texas A&M from conducting research involving "select agents," germs considered bioterrorism threats.

The biosafety system is "a catastrophic mess across the country," Hammond said.

Dawn Kubly, of the Madison-based group Alliance for Animals, said she's concerned because deadly germs can escape from labs. That could be especially problematic, she said, if the bugs are being tested in animals, which could foster mutations.

"This is a huge public safety issue," Kubly said.

An outbreak of foot-and-mouth among cattle in England last year likely came from nearby research labs, British officials have said.

"Pretty good track record"

Klein, the UW-Madison biosafety officer, said a student researcher on campus became ill from the bacterium E.coli at a lab a few years ago.

Klein said she wouldn't discuss a "similar case" and other incidents in which lab workers may have been exposed to potentially dangerous germs.

"It's not even one such incident a year," said Klein, who noted that most of the 500 scientists working with pathogens on campus have several people in their labs, so thousands of researchers are involved. "It's a pretty good track record."

Each scientist who wants to work with potentially dangerous germs must apply to the biosafety office, Klein said. She and her staff review and approve roughly three-quarters of the requests, mostly those involving germs deemed suitable for BSL-1 because they are not threats to human health or the environment.

The other requests go before the committee, composed mostly of science faculty. It generally meets once a month.

The committee sometimes makes scientists add details to their plans, such as sterilizing lab equipment for 20 minutes instead of an open-ended period, said Woods, the committee chairman. On rare occasions, Woods said, the committee requires researchers to use higher-level labs than proposed.

Possible penalties

Klein's office can withhold research grants if scientists don't comply with the requirements, she said, and lock down labs if the the labs unsafe, "an ace I've never had to use."

A few researchers are "cavalier in their attitudes about safety," Klein said. Some question why they have to take certain precautions with germs that have never made them ill, she said.

Klein reminds them that some bugs -- such as the bacterium that causes the food-borne listeriosis -- can be especially troublesome to pregnant women or people with cancer or HIV, and lead scientists can't expect lab workers to reveal such risk factors.

Woods, in addition to being biosafety committee chairman, is one of a dozen researchers on campus who work in BSL-3 labs. He studies a fungus that can cause lung disease.

His work, like that of Kawaoka and most scientists, aims to make such germs less dangerous to people through the development of drugs and vaccines, he said.

"You try not to be medieval in denying current research that is leading to really exciting findings that can combat agents like Ebola," Woods said.

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