Effect Measure

Baxter bird flu botch

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.

[snip]

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.

Comments

  1. #1 humorix
    February 28, 2009

    As for the virus of the mad cow or the AIDS, reports(connections) state (here) of ” germs escaped ” from laboratories.
    What of better for a laboratory than to spread a virus and to propose after an antivirus (!?) .*

    * As there is on internet (virus / antivirus).

  2. #2 Racter
    February 28, 2009

    If this had been the plot for a movie, I’d have been rolling my eyeballs, squirming in my seat, and exhibiting other symptoms of a guy struggling to suspend his disbelief. Come to think of it, I guess that’s happening anyway. Perhaps someone at Baxter aspires to the notoriety of becoming the world’s most infamous prankster. Any bets on whether this story goes viral in the antivax blogosphere?

  3. #3 Monotreme
    February 28, 2009

    Some further speculations/comments based on the available information:

    1. The H3N2 sent to the Czechs was to be used in challenge experiments. Either they had already been sent a vaccine and the shipment spiked with H5N1 contained unattenuated H3N2 to test the vaccination of the ferrets or the H3N2 was attenuated and intended to serve as a vaccine (like FluMist). The latter possibility would explain the ambiguity as to whether the H3N2 was a live virus or a vaccine – it was both.

    2. As some of the experts quoted in the Branswell article indicate, this should not have happened. No system can prevent human error. However, procedures can be designed such that certain outcomes are highly unlikely, even assuming human error. Such procedures are required in the US when handling pathogens as dangerous as H5N1. If Austria has laws requiring similar procedures, it is possible that these laws were broken by employees at Baxter. This would explain the stonewalling on exactly what happened. Their claim that they are withholding information for proprietary reasons is not credible, imo.

    3. Given Baxter’s disastrous quality control record with respect to both approved human treatments (heparin) and preclinical studies (H5N1 and H3N2), shouldn’t the FDA and other regulatory agencies consider halting clinical trials with reagents that Baxter has handled until they have disclosed all information on the current incident? As bad as the known situation is, it is conceivable that some of the same errors could lead to infection of subjects in clinical trials. For example, this one:

    http://clinicaltrials.gov/ct2/show/NCT00741806

  4. #4 Lora
    February 28, 2009

    I suppose what astounds me is that there are still people who assert that having pet chickens in a backyard is a major risk for bird flu, yet the professionals who are supposed to know their asses from their elbows come up with this kind of shit.

    I hereby declare that Baxter is NOT representative of all Big Pharmas in this regard–if I want to ship any type of anything, even plain DNA & water, so much as to the same company’s other building 200 feet down the road, I have to get three individual sign-offs that the contents of the box are properly labeled, appropriately double-wrapped and packed with ice, that the recipient has both the legal standing/expertise to receive the shipment and that our legal agreement is current, and voice confirmation that the recipient will be waiting for the delivery truck with open arms. One of those sign-offs is done by a lawyer, another by a shipping specialist, another by my boss. No matter how high up your title, you need those three signatures.

    We also keep all infectious diseases in separate labs according to type, so our buildings have about a zillion little closet-size rooms. Within the infectious disease unit, everyone works on only one bug at a time for years on end, and it’s a separate department of health & safety who comes in and does the sanitizing and cleaning between bug change-overs. It’s not like you’re going to accidentally forget and leave something contaminated, the health & safety guys pretty much gut your incubators and autoclave the contents, then dispose of everything not made of stainless steel, autoclave and disinfect anything that’s still visible, and hose down the walls and floors with disinfectant.

    I swear, we’re not all that stupid. On the plus side, looks like Baxter is going to be giving out pink slips soon, so if anyone needed a job…

    Lesson for Big Pharma: Don’t send your research to contractors. Precisely because you can’t stand over their shoulders and yell, “you’re doing it wrong!” Of course, it seems like Baxter management hasn’t been standing over anyone’s shoulder to yell “you’re doing it wrong” for a long, long time…

  5. #5 Monotreme
    February 28, 2009

    Lora, in this case Baxter was the contractor for a much smaller company, Avir Green Hills Biotechnology. Whether Baxter relied yet another contractor for any relevant reagents, we don’t yet know.

  6. #6 paiwan
    February 28, 2009

    “know their asses from their elbows come up with this kind of shit”
    “I hereby declare that….”
    “I swear, we’re not all that stupid”

    You do not know how ignorant you are. It is the most terrible tone that I have ever heard from science people.

  7. #7 Paul
    February 28, 2009

    Assuming the story is true, the tone reflects justifiable outrage. The better solution, if available, would appear to be to bring criminal negligence prosecutions against people who engage in reckless conduct that endangers the public health. And while the authorities are at it, they should be bringing criminal prosecutions against those whose gross recklessness and fraud has savaged the world’s financial systems.

  8. #8 paiwan
    March 1, 2009

    Lethal viral lab is not less dangerous than nuclear power plant. Now we stop building new nuclear power plant. No, it is not a matter of big or small Pharmas. 2007, England had FMD virus accident from Lab and had caused damages to cow, not to human beings in that time.

    We would rather have no human lethal virus Lab nearby. It should have strict scrutiny and highest bio-security and in very remote area. And forgive me, it is no way under commercial entity.

  9. #9 Lora
    March 1, 2009

    Well, paiwan, I am glad that you can stay calm and cool and collegial towards your abysmally idiotic colleagues when they execute a massive screw-up that could have killed people. Me, personally, I would rather not stay too chummy with the morons who apparently are so sloppy in their work that they could kill me by accident. I would rather that such gross negligence and bad habits were banished from all of science-based jobs and blacklisted. I would rather demonstrate what good lab practices are and show that SOME of us know how to perform them with diligence and skill, so as to make the general public hate pharmaceutical companies slightly less than they already do.

    I am not a close ranks kind of person, the main reason being that if you don’t police your own then you are not going to have the public’s trust. If you don’t have the public’s trust when it comes to making, say, flu vaccines, then you are not going to get many people lining up for vaccination. If you don’t have the public’s trust, then you will be put out of business–either by regulation OR by the market. If that tone offends Baxter executives, well, they can go cry in their pillows at night, but their bad management and lack of communications in this respect is endangering public health and since I am one of the public too, I kind of care about that stuff, you know?

    If this is the most terrible thing you have heard from a science person, then seriously, paiwan buddy, you need to get out more often. The science world, it is not full of hugs and kittens and rainbows.

  10. #10 Paul (The Troll)
    March 1, 2009

    Aside from the scandal of what happened, (this is perhaps, a naive and uninformed question), but is it possible the reason for Baxter’s “proprietary” secrecy is that they’re working on a vaccine purposely combining H5N1 with the more easily transmittable (within humans) H3N2 to create an attenuated, effective vaccine, whether attenuating it directly, or through successive passage through generations of a mammalian species – such as ferrets, once they got the calibration or mutations such that the animals weren’t killed outright, as happened (accidentally?) in this first generation? The Japanese are working on the same idea, using a combination with smallpox.

    (By the way, that Brit, today, really was funny!)

  11. #11 revere
    March 1, 2009

    Paul: I doubt it very much. That would be an incredibly dangerous vaccine that no one would approve.

  12. #12 Bob
    March 1, 2009

    Many times researchers do not play by the rules. As one who has sold and serviced the Life Science Industry, and who has be thoroughly trained in laboratory safety. What I have seen in this field would amaze you. People are human.
    One virologist who will remain anonymous was going to work with deadly viruses did not want to invest in Biologial Safety Hoods. His labs should have been at BSL 3 minimum. He arrogantly informed me that he worked with the polio virus before there were Biohoods. Arrogance and stupidity he personified.
    In one case a government lab was working on dangerous pathogens with no BSL notice on the door and not biohood in the room.
    In other cases samples of dangerous pathogens were transferred from one PI to another. When one of the PIs lab was certified for the use, and the other was not.
    It does not surprise me that this happened.
    My question is is there a sick person at Baxter? I hope not.

  13. #13 Paul
    March 1, 2009

    Revere, I understand that it would be a dangerous vaccine in the beginning. But a good defense is often an offense. Humans have been fearfully awaiting this exact reassortment eventually happening in a wild, random setting of chickens, pigs, humans, etc. Given the chance it may very well occur, but at the whim of chance and in a situation well before our knowledge, despite all our pre-pandemic planning, and most likely breaking out despite everyone’s attempts at monitoring and culling.

    If the process were handled with proper safeguards, why couldn’t scientists preemptively (and under our control) create the very monster combination we’ve been fearing in order to produce the exact antigenic vaccine that will prepare us for what we’ve all been hoping (against hope) will not happen. If we leave it to chance and allow the wild virus to develop on its own, it’s still going to kill millions of people before we can create the very vaccine we might have created on our terms and on our turf.

  14. #14 paiwan
    March 2, 2009

    Lora:

    When you furiously kick out the fox, we are all grateful. What concerns me most is you then are going to invite the tigers.

    In this world, there are lots things can be privatized, but not all. Viruses relating to pandemics research are not of them. No, we are not ready for relinguishing to commercial operations. I have followed the trend of this blog that no patent no IP should be given to individuals or private sectors in this regard. Moreover, the research and test relating to this category should be under extremely public scrutiny and confident protocol. Unfortunately, we are not ready for this-call me buddy.

    People may say that the train of commercial Pharmas have moved for a while- it was a mistake and a bad decision due to non-transparent international Public Health administration in the past.

    And we have to change this habit. It seems that not only politicians but science persons also need the shakeup nowadays.

  15. #15 daedalus2u
    March 2, 2009

    I see only two possibilities. Either the two viruses were grown separately and then mixed together, or they were mixed together and then grown together.

    The first possibility is very bad, the second possibility is many orders of magnitude worse.

    They transported the virus across national boundaries. That makes it an international incident, one where bioterrorism statutes can be invoked.

    If Baxter is not being 100% completely open and 100% completely transparent with the relevant health authorities, allowing them full 100% complete access to their facility and records, then those health authorities should shut Baxter down, take the Baxter employees into custody, seal off the plant and investigate until they do find out what happened.

    If the health authorities are unwilling to do this, then if CIA was still doing black operations, they should kidnap the Baxter officials and find out what happened. This is the kind of thing that could kill tens of millions of people. If ever there was a justification for extreme rendition and torture to find out what is going on, this is it.

  16. #16 CDS
    March 2, 2009

    I agree with daedalus2u. This sounds like a serious error on their part and immediate action needs to be taken. Shut down Baxter and do not allow them to operate any longer. This is plain stupidity and a snot nose kid with an IQ of 100 could have executed these simple task perfectly. This sounds like a conspiracy to unleash this flu to the world.

  17. #17 paiwan
    March 3, 2009

    Folks and Revere:

    I don’t like to be sounded very cynical towards Pharmas’ research programs.

    But dealing with virus like Baxter’s case have alerted us all to be extremely prudent and sobering to how the issue would be tackled in the future.

    We can not accept that in the name of solving hunger and let the big corporate to conduct GMO program and damage our ecosystem. In the same token, we can not accept that in the name of health and let the Pharmas to conduct dangerous virus programs.

    Let me say one thing, if lethal virus can travel on airplane (artificial allocation) here and there without discrete control; UK had FMD( Foot and Mouth disease) outbreak, soon or later virus leakage like the lesson Three Miles nuclear plant’s will happen in our neighborhood.

  18. #18 g336
    March 4, 2009

    No, Daedalus2u, this is NOT a case that justifies torture.

    First of all, professional military interrogators all the way back (at least) to the US Marine Corps Interrogator/Translator Teams in WW2 will tell you, torture
    does
    not
    work.
    People under torture say whatever they think their torturer wants to hear in order to stop the pain.

    Now are you going to tell me that you know better than the entire United States military in the entire WW2 and Cold War and post-Soviet period? Or do you think that our Marines are wimps? Let’s hear it, this oughta’ be amusing…

    Second, taking that step smashes the foundation of civilization and replaces it with barbarianism: as per the Fascists, the Communists, and lately the Taliban. Are you sure you want to go there…? If so, hop on a plane for the border zone between Afghanistan and Pakistan where the Taliban hold power, and try living under a barbarian system for a year, or even a month.

    Third, what if you get bad information and act on it? Millions of deaths due to barking up the wrong tree. You want that on your conscience? Are you sure…?

    The way to deal with Baxter is to throw the full weight of civilized law enforcement at them. Get the warrants, make the arrests, lock down the lab for a thorough search, get the judge to deny bail, and then let the pros do the interrogating in ways that will stand up in a court of law. That’s how to get the goods to secure convictions and prison terms.

    As a famous maker of computers says, “It just works.”

  19. #19 Paiwan
    March 4, 2009

    Then, we need to pass an international law of Virus Non-Proliferation Treaty covering all these protocols.

  20. #20 voice of reason
    March 5, 2009

    Go to infowars.com This is part of a larger agenda.
    Anybody say New World Order population reduction plan?

  21. #21 anti nwo
    March 6, 2009

    agreed voice of reason this was done intentionally
    it is almost impossible for this to happen accidentally
    lets not forget the factor eight contaminated with hiv
    that was KNOWN to be contaminated yet it was allowed by the US government to be sold to europe and the far east
    resulting in thousands of deaths to innocent hemophiliacs

    wake up sheeple the elite want you all dead you need to see
    end game blueprint for global enslavement
    it can be found on google video youtube and higher quality but subscrition needed on prisonplanet.tv

  22. #22 Metro
    March 6, 2009

    @anti nwo:

    Up your meds.

    @daedalus2u
    “If ever there was a justification for extreme rendition and torture to find out what is going on, this is it.”

    And if ever there was a statement that summed up why torture should and must be banned in every decent nation, explicitly and forever, that was it.

    Because first it was about “the ticking atom bomb” scenario, now you’re applying it to sloppy researchers. Who next? People who shove into the queue in front of you?

    Mind you, if any situation required a good dose of torture, that would be it …

  23. #23 rudya
    March 6, 2009

    While this “accident” is bad enough, what is even more scary is the fact the US media seems to be keeping the story from us.

    I always thought we had a corporate controlled media, but it sure looks like the corporates have far more control than I imagined possible. I actually found one site that had this story posted on FEB 25! ow can they keep it quiet that long?
    http://www.google.com/hostednews/canadianpress/article/ALeqM5jJ4CmDnp1pP1ZqHShBeayzTuzsEA

  24. #24 Andreas
    March 7, 2009

    There is no story in the german medias. Only a few blogger reporting on the “accident”.
    There is one story in the blog from http://www.freitag.de about it.

  25. #25 Borg Doofus
    March 7, 2009

    This was not a mistake. This was a purposeful attempt of the new world order elites to kill millions of people. This is mind boggling, but if you get your hands on every available fact and add two plus two, this conclusion is inescapable. The globalists are beginning to implement their plans to kill 95% of the earth population. Yes, this is unfreakingbelievable to normal people who cannot imagine evil of this magnitude. I understand completely, but the facts are the facts, and hyper-evil people do exist.

  26. #26 Dirk
    March 8, 2009

    This was purely intentional. There is no amount of human error that would cause this to happen when it comes to infectious diseases.

    I am guessing that main stream medias refusal to report this combined with Baxter Inc’s lame excuse is a result of their knowing this is sabotage.

  27. #27 revere
    March 8, 2009

    Dirk: Do you have evidence for your assertion that human error is implausible or is this just another way of asserting your opinion? If you have ever worked in a lab I doubt you would say this. The extraordinary clam that this was intentional (for what purpose? to sell vaccines?) requires extraordinary evidence. Let’s see it.

  28. #28 Dawn
    March 10, 2009

    Thank you for writing about this. Finally! A sane piece of writing on this website!

  29. #29 paiwan
    March 10, 2009

    Dawn:

    You are right in the first half. A good instructor is always asking right questions.

    Nevertheless, the art of blog has her beauty. It is like evolution, full randomization, and dynamic and reciprocating dialogues.

    Paul Krugman now even praises that the solutions coming from blogs in relating to economy plan are much advanced than the experts in Wasington DC. Believe it?

  30. #30 M. Randolph Kruger
    March 12, 2009

    g336 Sheik Khalid gave it up in just the first 30 minutes of interrogation and prevented at least 5 planned attacks. Hey anyone hear that one of the released Gitmo detainees is now the head of terror ops in Afghanistan. Good one guys.

    Remember, they got rights. Wouldnt want to screw up anyones Chi.

    But, about that flub with Baxter. It was a lot closer than anyone will ever know.

    Paiwan, if you havent noted it the NYT is about to take a header and very likely Krugman who you seem to adore is going to go with it. No one who is outside of the beltway and/or Boston, New York cares too terribly much what he has to say. There will be a few that disagree of course… Like in the socialist states of the EU.

    He got a Nobel. So did Al Gore for GW “Awareness”. Hey, can I get one for laughing at them when they were standing in a foot of snow and 20 degrees at the last glowball awareness gig on the Capitol steps? Hey, didnt Carter get one too?

    If thats the case then so should Clinton for calling the Dems about Freddie and Fannie, then federal regulators , then McCain, Bush, McCain again. Then we had a global meltdown in economics…Where was this guy? He missed an opportunity to get another check and the Oscar for helping to set the policies in place that got the entire world into a near depression now. So I for one dont put any credence in what he is saying except for the last two days….Kind of like economics of the wild. They eat their young and this time he is going after Obama and his economic policies.

    The US national debt-In 50 days he has spent MORE than the three last administrations front to back combined and he is going to spend MORE. Revere is going to love him for it. Of course no one will be able to pay their taxes,they wont have a job, nor will it do anything but create a false bottom. So adulations to Krugman are falling on stone deaf ears. You might have noticed also as a big reader apparently that the stock market isnt buying his and previously adulated Obama’s policies at all. 14800 at the start, then 8800 or so until inaugaration day. Then Obama opened his mouth and sent it south another 2000 points. Krugman was loving him for a whole 25 days then he got hungry… So Krugman will be available real soon for speaking engagements as the NYT fades into history and his day job will be gone.

    But back to the Baxter.

    Revere, we need D. Hammond to do his thing about this virus screw up. He is good at this and IMO if you have an email for him then tell him to start at the beginning…. the very beginning and move from there. He will be AMAZED if he creates a timeline with events….hint. If you have noticed I have been stone silent on it.

  31. #31 revere
    March 12, 2009

    Randy: I heard both those Gitmo stories are bullshit. Good one, though.

  32. #32 paiwan
    March 13, 2009

    Randy:

    We can talk about Krugman, Roger Cohen, Nytimes whole day and whole night, there is no problem to me. But there is one matter that you have to clear here. Say we love someone who has happened to be hated by you. Are you going to spot his/her residence like what you were doing to Revere?

    Revere has owed us one thing that he has not chastened your misconduct here so far, maybe he has not read Talmud or Mitzvot 613 long enough and let loose and shown a kind of appeasement to you.

    It is not good for you and the commenter here. Maybe you just boasted and joked by yourself. But I don’t entertain this behavior. Look at 17 years old killer of German boy, he joked to fry someone. The tragedy was he actually did it.

    Randy, say something here. We are all reasonable people and willing to respond to you decently.

    Respectfully

  33. #33 Charlotte Creamer
    March 15, 2009

    If this were merely a mistake, the American mainstream media would have been all over it. As it were, only a few outlets in Canada have picked it up. Google “Baxter bird flu” and see for yourself. The only listings are for Canadian newspapers and magazines and a few scientific blogs (plus, of course, the Alex Jones rant). The American media’s silence on this is deafening. That, to me, is evidence enough of a plan gone wrong (for the planners, not for us). Someone’s head must be rolling for this. Wonder how many months it set them back on their world domination quest. Interestingly, when you google “Baxter bird flu”, the only American listings on the first 10 pages are related to press releases: “European agency endorses Baxter’s bird flu vaccine”, “New Human H5N1 Bird Flu Vaccine From Baxter Shows Promise In Trial”, “Indonesia, Baxter sign MOU on bird flu vaccine”, except for a single listing from Chicago’s Daily Herald, at the bottom of google’s page 10. Mark my words, folks — sending the live virus was no mistake. Poor ferrets. Lucky (for now) us.

  34. #34 marcus
    March 28, 2009

    has anyone noticed some of the articles quoted have been removed or are no longer available either by google or the canadian press