Tuesday, March 17, 2009

A Few More Details On The Baxter Mishap

 

 

# 2903

 

 

 

Baxter Pharmaceuticals has done a singularly poor job over the past month in explaining exactly what transpired last January when samples of the highly lethal H5N1 virus were accidentally sent to a lab in the Czech Republic.  

 

That lab appears to have sent samples on to labs in Slovenia and Germany as well.  

 

The mistake was discovered when ferrets, exposed to what was supposed to be the non-lethal H3N2 virus, began to die.

 

The earliest reporting (Feb. 17th) from DPA indicated that an experimental vaccine had been contaminated with the H5N1 virus. A subsequent report in late February by Helen Branswell of the Canadian Press, brought us news that it was an `experimental virus materialnot a vaccine – that was contaminated.

 

That explanation, quite frankly, made more sense than a contaminated vaccine.  

 

But since then, Baxter has remained infuriatingly silent on this incident.

 

In the absence of clear and comprehensive information about what really happened we’ve seen a good many highly speculative (some might say outlandish) stories  emerge in newspapers, and across the Internet, that are not only damaging to Baxter, but to the vaccine manufacturing industry as a whole.

 

Baxter’s ongoing silence has only served to fuel this rumor mill.

 

Today the Financial Times has the first mainstream report I’ve seen in more than two weeks.  The details provided here appear consistent with the story brought to us last month by Helen Branswell.

 

A hat tip to Crof at Crofsblog for this link.

 

First some excerpts, then a short discussion about how these `experimental virus materials’ might be used.

 

 

 

WHO mulls stricter transport of bio products

By Andrew Jack

Published: March 16 2009 22:10 | Last updated: March 16 2009 22:10

 

Public health officials are studying the need for tighter controls on the transport of biological products after Baxter, the US pharmaceutical company, inadvertently supplied samples of the H5N1 bird flu virus to a series of European laboratories.

 

Specialists from the World Health Organisation and the European Centre for Disease Prevention and Control are monitoring the case at a time of growing concern that existing international rules to minimise the risks of the spread of pathogens are too weak.

 

Their scrutiny follows an incident that recently came to light when samples of H5N1 from Baxter’s Austrian labs contaminated batches of the less harmful H3N2 seasonal flu virus that it was supplying under a commercial contract to a customer, Avir Greenhills Biotechnology.

 

<snip>

 

It somehow mixed with H3N2 before distribution last December to Avir, and the more potent virus was detected by a subcontractor in the Czech republic last month after it rapidly killed ferrets exposed to the viruses. Avir had also sent samples to Slovenia and Germany.

 

(Continue . . . )

 

 

 

Based on the reporting I’ve seen to date, the following is my current (and possibly flawed) understanding of what happened.  

 

 

In order to test the effectiveness of a vaccine, researchers must vaccinate lab animals (in this case ferrets) and then after a suitable period of time, expose them to a live flu virus.  

 

This is what is known as a challenge experiment.

 

The virus in this challenge test was supposed to be the relatively benign H3N2 seasonal flu virus.

 

Somehow (and here the story gets vague) the `experimental virus material’ provided by Baxter to the lab in the Czech Republic for these challenge studies was accidentally contaminated with the H5N1 virus.

 

When the ferrets were exposed to this `experimental vaccine material’, they began to die, which immediately set off alarm bells among the researchers.

 

While the H5N1 virus was contained, and no one was infected, this could have led to the infection of lab personnel, or worse, the accidental release of the virus outside of the lab.  

 

Obviously this was a colossal (and potentially dangerous) screw up, but it would seem a far cry from what some `alternative’ press sites are reporting. 

 

Reports to the contrary aside, this does not appear to have been a contaminated vaccine, nor does this`experimental virus material’ appear to have been ever intended for human use.

 

 

If I’ve got any of this wrong, hopefully someone at Baxter will email me and let me know.  I’d be more than happy to give them column space to explain this better.