Saturday, March 7, 2009

Baxter bird flu botch

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Baxter bird flu botch
Category: Big PharmaBird fluVaccinesPosted on: February 28, 2009 7:04 AM, by revere
In a post the other day on some kind of flu vaccine mishap in Austria we called it a colossal screw-up. It turns out we may have understated the case. Maybe. Because while more details are leaking out, the company responsible for it, Baxter International, isn't saying exactly what happened on the grounds that it is confidential business information. You almost have to admire that kind of arrogance. Almost. Meanwhile Helen Branswell brings us more details:
The company that released contaminated flu virus material from a plant in Austria confirmed Friday that the experimental product contained live H5N1 avian flu viruses.
And an official of the World Health Organization’s European operation said the body is closely monitoring the investigation into the events that took place at Baxter International’s research facility in Orth-Donau, Austria.
The contaminated product, a mix of H3N2 seasonal flu viruses and unlabelled H5N1 viruses, was supplied to an Austrian research company. The Austrian firm, Avir Green Hills Biotechnology, then sent portions of it to sub-contractors in the Czech Republic, Slovenia and Germany. (Helen Branswell, Canadian Press, via The Sun)
One of the big fears is that people or animals co-infected with a seasonal flu virus of humans and a virulent avian flu virus like H5N1 will act as a mixing vessel. Flu viruses each have eight genetic packages within them and when co-infecting a cell they can mix and match (reassortment), thus producing new hybrid bird-human viruses. Baxter put both viruses in the same vial, presumably for use as a vaccine. Baxter is calling the mixture an "experimental virus material," whatever that is. All we know is that a nasty live virus cocktail of human and bird influenza virus was made (Baxter says accidentally). Exactly to whom it was given, if anyone, is not being publicly divulged. We have a news report from an Austrian paper dated February 11, a Wednesday, that tells of 19 people being seen as outpatients at a Vienna hospital the previous Monday (February 9) because of exposure to "bird flu virus." The article said no one was sick, there was no evidence of infection, and the females were prophylaxed with antivirals (presumably Tamiflu).
WHO's European regional office in Copenhagen is saying they are confident there is no public or occupational health risk "at present," but they also acknowledge they don't know exactly what happened. They also say they do not any evidence that any reassortment occurred. I'm not sure exactly what evidence they looked at or have available, so I don't know how to interpret this absence of evidence. I'm certainly not reassured that unlabeled live H5N1 virus was released, even if just to another lab. There are people and animals in laboratories that were exposed and could have resulted in the virus getting into the general community in a major city with many international links.
Baxter's not saying much. Branswell quotes a company spokesperson as saying the incident happened through a combination of “just the process itself, (and) technical and human error in this procedure.” This doesn't sound very reassuring, either, because it sounds like there is a process that is error prone ("technical" and human). If Baxter's name sounds familiar it may be because almost exactly a year ago they were in the news over a series of fatal allergic reactions among dialysis patients who used the blood thinner heparin they manufactured. It turned out their heparin came from China and contained an adulterant, oversulfated chondroitin sulfate. Patients in six countries and over a dozen states in the US had serious adverse reactions and more than 80 deaths. At the time, Baxter said on their website that they "will not sell another vial of heparin until the company has helped to create a system in which the quality and safety of heparin is secured." (Medpage Today)
They weren't saying anything about the safety of their bird flu products, then. And not much now, either.

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