OJ Simpson is back in the news, following hard on the heels of other celebrities in legal entanglements: Paris Hilton, Britney Spears, Martha Stewart, etc., etc. Yawn. Were they treated more harshly beacuse they were celebrities? Yawn. The other side of the coin, of course, is the privilege of the famous and powerful. We know they often get off when lesser mortals wouldn't. So what does that have to do with what we usually talk about here, public health, infectious disease, bird flu, research? This.
Yesterday we brought you the latest in an ongoing series of posts about accidents in biodefense laboratories (see here, here, here, here, here, here, here). A major issue is the cavalier and often arrogant attitudes of researchers for safety regulations. We also talk a lot about research on avian influenza here. Sometimes the two subjects come together in odd ways. Yoshiro Kawaoka at the University of Wisconsin is a major figure in influenza research, an academic star. But his laboratory is involved in researching other dangerous agents as well. The availability of research dollars for bioddefense makes this area an attractive subject for high powered and ambitious investigators whose large laboratories, staffed with junior faculty, post doctoral fellows, graduate students and technicians, are hungry mouths that require constant feeding. Now we learn, from the indomitable folks at The Sunshine Project, that Kawaoka's lab at UW was playing it a mite too casually with Ebola virus:
In 2005 and into the summer of 2006, researchers at the University of Wisconsin at Madison (UW) made and manipulated copies of the entire Ebola virus genome without proper safety precautions. Although federal safety rules required a maximum protection Biosafety Level Four (BSL-4) lab for the research, UW allowed it to proceed at the much less safe and secure BSL-3 level.
The rules that UW broke are intended to ensure that extremely dangerous agents that are easily transmissible and usually incurable don't escape maximum containment. They prohibit working at BSL-3 with Ebola (and similarly dangerous) virus material that has not been rendered irreversibly incapable of reproducing. UW does not have a BSL-4 lab suitable for handling Ebola virus, which is one of the most dangerous pathogens in the world.
Despite the contrary provisions of the NIH Guidelines for Research Involving Recombinant DNA Molecules, permission for UW scientist Yoshihiro Kawaoka to perform the Ebola genome work at BSL-3 was granted by the University of Wisconsin Institutional Biosafety Committee (IBC). This significant violation of NIH Guidelines was not detected in a timely manner by the National Institutes of Health (NIH) or, apparently, by the CDC Select Agent Program staff that inspect the Kawaoka lab. (Press Release, The Sunshine Project)
The Sunshine Project's Director, Ed Hammond, asks exactly the right questions about this. In particular Hammond raises the question whether Kawaoka's celebrity status led UW to give him a pass:
The Kawaoka Lab is known for work on the bleeding edge of virology. It is a world of dangerous experiments with dangerous diseases, such as infecting monkeys with deadly agents. Daring lab workers frequently deal with diseases like 1918 influenza and - by protocol - preemptively pop Tamiflu like it was breath mint. Engineering controls clearly don't seem to themselves inspire complete confidence. It is doubtful that many other virologists would gain institutional approval for some of the lab's practices or, for that matter, would be willing to routinely subject themselves to some of the lab's risks.
The lab is well funded with biodefense grants and is at once admired and controversial. In late 2004, UW and the University of Pittsburgh got into an unseemly bidding war over the scientist, offering up tens of millions of dollars in salaries, labs, people, and other public resources in packages more reminiscent of a MTV pop music star's concert rider than a college professor's salary contract.
"Pecking order means a lot in biology, in Madison and elsewhere, and Kawaoka is a big bird," says Hammond. The Sunshine Project would like to know if celebrity status caused UW to disregard the NIH Guidelines and lower safety and security standards: "If it had wanted to, was the IBC even realistically able to veto Kawaoka's research plans after the University had spent millions to keep him, blowing cash and political capital all the way to the governor's office? That these imbalanced situations exist at all is one good reason to make IBC compliance a matter of law instead of guideline."
The Sunshine Project is now reporting other examples. There is an indication that Tulane University (New Orleans) has also handled the complete geneomes of BSL4-level agents, not only Ebola but Lassa Fever. The cases so far, therefore, may be only the tip of the ugly biodefense laboratory iceberg.
Which of these icebergs is in the direct path of some unsuspecting community, sailing along like the Titanic, believing itself unsinkable at the hands of its own government and its policies?
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There is a controversy here about a proposed biodefense lab to be built in Durham NC.
Maybe a virologist could weigh in on this, but "the complete genome" is not quite the same thing as live, infectious virus. I'm a little wary of the Sunshine Project's agenda here. We certainly need more than two BSL-4 labs in the country, in order to handle and study these kinds of agents safely.
That these imbalanced situations exist at all is one good reason to make IBC compliance a matter of law instead of guideline
for a frightening example of how IRB does not hold up in court, read Steve Wing's article Social responsibility and research ethics in community-driven studies of industrialized hog production.
Andy: They make note of this in their presser. However when you are a reverse genetics lab they aren't so far apart. The Ebola genome isn't sufficient in itself, as The Sunshine Project's own press release notes (I urge you to read the complete thing at the link) as it addresses your comment and may make you feel better about them. Yes, they have an agenda, as do the researchers and NIH.
Revere-While I agree with you about most of this there was/is a peer review by UWisc and they gave permission. Its kind of like Iraq, GWB did go to Congress and without declaring a war they signed on for it albeit from the wrong information.
A NIH guideline is not a rule nor is it the law. Each school /lab is approved by the USGovt. to perform some sort of research. As for detection the process is NOT something they just pick up the phone and send it down to CDC. Its part of their process to go before the committee. The assertion is that they did something wrong. I have researched it a bit and I can find nothing in the CDC's procedures that absolutely require that they perform such work in BSL-4. The process that this work was being done in required if I understand it to be in BSL-3 with some safeguards.
Now I agree wholeheartedly that there are a lot of gomers out there working with stuff that if released or bug dish to human, or test subject to human and then into the population would be bad. Well not even bad, devastating in fact. But is it that you are against the labs being biodefense, the fact that they are messing with the demon seeds, or the whole process.
Have you ever had a lab accident in a BSL-4 facility or even a 3 where you are? I cant mention obviously where you are but you and I know that just down the road and not far is a facility that has a pretty shitty record too. I am not confused by this anti defense posture which is really biowarfare with another name attached to it, but good things do come out of them as part of their research. The classified stuff we never see obviously. As I said, I am not confused just not clear what your itch is with it.
I pushed HARD for the Tennessee bid to become the new research facility NOT to happen. I do think I had an impact on that because our reception went from great idea to lukewarm. But others would do anything to employ. Kind of like a munitions factory on an Amish farm.
Enlighten me a bit more about what your position is on the above. I cant see that they broke a law, the bent a guideline and by your own admission its not the law. Are you concerned because there arent enough safeguards?
Randy; What "peer review" are you referring to? The government does certify labs to handle slect agents under certain conditions, which were arguably violated by Kawaoka's lab. The university has halted it, so that tells you something. Infectious Ebola is a mandatory BSL4 (as is Lassa). Full length cDNA Ebola can produce virus and we don't know what he was doing. This was typical of an arrogant and casual principal investigator who knows better than everyone else and snubs the guidelines. There is also no law that entitles him to our tax money and it can be taken from him as easily as it is given to him if he doesn't adhere to the guidelines. It's not a criminal offense but it can lead to loss of funding. It's not a question of law, it's a question of NIH and CDC policy. There are no BSL4s where we are and BSL3s are very uncommon. But lab accidents happen all the time, including in BSL3s and BSL2s. I was on several biosafety committees and have had big labs under my responsibility. I am not naive about what goes on in them. So that's where I'm coming from. If you work (unnecessarily) with dangerous organisms the consequences are worse than if the organisms are not so dangerous, it's as simple as that. And there is no public health rationale for most of this work.
Randy,
Read The Hot Zone and learn something about how little you and I know about these break outs. I live in the neighborhood of Ft. Detrick and litteraly down the street from the BSL-4 lab that had the 1989 Reston outbreak and, yeah, I sweat this stuff.
thank yuuu