Let them eat anthrax vaccine

Bioterrorism defense dollars seem to be devoted mainly to procurement. This follows President Bush's prescription for how all Americans could defeat the terrorists after September 11: go shopping. Practicing what they preach, the federal government has gone on another buying spree for something we don't need: anthrax vaccine:

The federal government has awarded a $400 million contract to Emergent BioSolutions for another 18.75 million doses of anthrax vaccine, with a bonus to be paid if the company wins approval for extending the vaccine's shelf life.

The 3-year contract for BioThrax vaccine, also known as Anthrax Vaccine Adsorbed (AVA), is worth up to $448 million, according to the US Department of Health and Human Services (HHS). The vaccine will go into the Strategic National Stockpile of drugs and medical supplies for civilian use.

Besides the shelf-life bonus, the contract also provides for bonuses if the company makes progress toward winning regulatory approval for using the vaccine to help protect people after possible exposure to anthrax (postexposure prophylaxis, or PEP). The vaccine is currently approved only for preexposure use.

Emergent BioSolutions, based in Gaithersburg, Md., previously sold a total of 10 million doses of AVA to HHS under contracts awarded in May 2005 and May 2006, according to a company news release. (CIDRAP News)

Anthrax is not a contagious disease. It is also extremely difficult to weaponize. To make someone sick one would have to make it into a form that is extremely easily dispersed and then disperse it in a way that millions of people are exposed to it. It is hard (impossible?) to imagine a scenario where ten million people would be exposed, and if they were, this vaccine has not been shown to work after exposure and would have to be adminsistered in a few days by health care personnel. Not likely, given we have only a rudimentary public health system for this purpose. In the highly unlikely event of where we know an anthrax attack has occurred prior to anyone getting sick, we already have a prophylactic agent, the antibiotic cipro, which can be self-administered. The US strategic stockpilehas enough cipro to treat 40 million people. We aren't going to immunize a civilian population before an attack because we don't know where an attack will occur and immunizing the whole population would be a disaster since this vaccine, like all vaccines, has side effects and the likelihood that any particular individual would be the object of such an attack is close to zero.

This procurement is being done under the successor to the failed Bioshield program. Under Bioshield a $877 million anthrax vaccine contract was awarded to a company that had never made a successful vaccine. It failed even before it reached phase 2 trials. The child health program now threatened by a Bush veto is a $6 billion program. The successor program to Bioshield, Biomedical Advanced Research and Development Authority within HHS, is funded to the tune of $5.6 billion. Here we see it used to take money that could be better used elsewhere and dump it down the crapper.

It seems inescapable that public health policy is in the hands of incompetents, ideologues or rogues, probably all three. A disgrace.

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Revere I must respectully disagree with your assertion that its a bad idea to buy the vaccine. Streaming anthrax from an ordinary plane is actually very easy and especially easy from a crop duster. Saddam had a squadron of jets that were specifically designed for bio and chemical dispersion. Not more than 20 lbs would be needed to do say Chicago or New York in a solution form. But you could do it from a Cessna with a ram air tube feeding an ordinary garden sprayer with an inlet into it and hang the handle out the window shooting the spray into the slipstream.

http://www.globalsecurity.org/wmd/library/report/2000/davis.htm

From the above info from Global Security the numbers are upped from what I was taught as late as 1998 from 40% to 50% now for gastrointestinal anthrax which you can get from tainting a water supply and that above all is so easy that a couple of kids could do. And from 85% to 100% if its inhalation. Upped but not much. Inhalation is and would be my way to go if I were doing it.

In addition the ease with which something can be smuggled into the country isnt in question. Its whether its already been or being done. We dont have sniffers for bio as a rule and this could come in via a load of peat moss or something equally bulky. Disguised phosphates?

Here is something on the use of Cipro. The quantities do not exist or a delivery system to the people if we get a city wide attack. By the time we realized it was underway, probably 1/4th would be too far gone for Cipro or heading for the hearse door. It also likely I read that it would be ineffective at that stage, even if it were ground up and injected instead of the vaccine. The vaccine using pneumatic guns might just be able to deliver a city worth in under 48 hours if they have it ready to go. It could be into any country in the US in under four hours or less, with addtionals inside of 8. Thats a lot of time in a CBW attack.

http://www.fda.gov/cder/drug/infopage/cipro/cipro_message.htm

Its all about your arsenal Revere, cant just have one thing in it. Cipro is one, vaccine is another and has anyone got anything else? It may never be used. But who would they beat up if they didnt have it? A CBW attack would be absolutely devastating. There are 8 million stories in the Naked City. Lets hope they all dont end in the same way.

OTOH, I WOULDNNT I marry up the two issues and the veto of extending coverage to 200% of the poverty line children. Its not the same issue. Congress votes bills, the President either approves or disapproves. This one simply doenst go to socialized medicine or UHC. Its part of a war.

The Congress has authorized this purchase and not some agency. Thats a Democrat controlled Congress at that and the Republican President agrees with them.

http://www.whitehouse.gov/omb/memoranda/fy2007/m07-25.pdf

By M. Randolph Kruger (not verified) on 30 Sep 2007 #permalink

jim: LOL. Unfortunately you probably alerted them to a whole new set of dangers.

Randy: I don't care whose dumb idea it was. Contrary to what you say, it is actually quite difficult to weaponize this material and expose large numbers of people, but let's assume you could do this. What would you use a vaccine for? You aren't goig to i9mmunize the US population on speculation this might happen. You don't have time to give injections to a whole city, assuming you even knew the attack had happened. And you already have 40 million doses of cipro in the stockpile and we know that cipro works for post exposure prophylaxis. So it isn't a matter of whether an attack could happen. While I don't think it's plausible we'd expose more than a few hundred to a few thousand but it's irrelevant; even if it were 10 million the vaccine wouldn't be of any use. They took my money, involuntarily, and gave it to a foreign biotech company (to put it in terms you can understand). I'd rather have government health insurance. I'd be safer.

I doubt you would be safer from anthrax though Revere. You might just have a room to die in, that is instead of on the street. Pretty gnarly way to go....

Hey go call Nancy and Harry and tell them of your disgust. Cant make anthrax vaccine in the US because of the liabilities. Liabilities are the reason we dont make our own stuff now. Thats because the Dems have jacked torts for years and one mistake and doctor cant afford to be a doctor anymore, or a company make a vaccine. At least we might have demanded that it be made here huh?

Congress, and that is a Democrat Congress are the ones who along with the Republicans wholeheartedly signed on for this one Revere.

We are both shit out of luck and now money for a four year shelf life vaccine as you say that may never be used. I hope to heck we never do have to worry about using it. BTW, a five pound charge with three overlapped layers of ordinary screen mesh in a five gallon pail will drive right thru five pounds of anthrax powder (uncut lightly wetted ball) like a million little knives. Saw a drawing of a weapon doing just that.

When it goes off the mesh tears into the ball and most of it shears the stuff away at the precise micron level to weaponize it. Some of course gets stuck in the mesh but mostly. Of course the higher the better but you have a WMD. Wet spray though is better as it applies more evenly.

Its a lot of money Revere, I'll give you that. The Cipro you speak of exists but there is no way to deliver that in time even by jet and dedicated truck. The bulk alone would make it ineffective. Wouldnt want it in the targeted city anyway. Contamination.

BTW-Iran has just started supplying Nicaragua with cheap oil. Hmmmmm............

See you at the bar. I am buying.

By M. Randolph Kruger (not verified) on 01 Oct 2007 #permalink

Randy: Liability is NOT the reason we don't have it. We don't have it because there was no demand or need. The cipro is distributed into regional lots. It is a lot easier to administer (leave it in a mailbox) than a vaccine. The vaccine is a boondoggle, pure and simple.

Dear Revere,
Please consider that the vaccine may be for postal workers and first responders, government workers, etc.
I had occasion recently to have breakfast with a postal service worker from D.C. She was working there on 9-11 and was scared out of her wits. You remember that several postal workers died. I related to her that I remembered that 4 or 5 anthrax letters were mailed that day. She said, "That's just the ones the media found out about." I asked her how many she knew about and she said there were 12 letters.
She retired recently just to get away from the anxiety of it all. I'm sure the postal workers would welcome a vaccine.
As an aside, Ramsey Yousef, the planner of 9-11, originally wanted to bring down 12 planes. He only succeeded in bringing down four planes and killing a Japanese national aboard a fifth plane. And now, twelve anthrax letters. There seems to be something significant for Yousef in the number twelve. Twelve tribes of Israel? Twelve apostles?
Love,
Library Lady

By Library Lady (not verified) on 01 Oct 2007 #permalink

LL: No, they are for the public, at least that's what is being said. Moreover they couldn't vaccinate every postal worker and government worker. They can't even get the military to take it under orders. The postal workers, unlike the congressional staff, weren't given prophylactic cipro, which is the only feasible and plausible way to protect against an anthrax attack. Ten million doses of anthrax vaccine is both a waste of time and monumentally stupid. We have 40 million doses of cipro in the stockpile which can be distributed quickly and self administered, unlike an untested anthrax vaccine. Stupid. Very, very stupid.

Liabilities are the reason we dont make our own stuff now. Thats because the Dems have jacked torts for years and one mistake and doctor cant afford to be a doctor anymore, or a company make a vaccine.

Randy: Liability is NOT the reason we don't have it. We don't have it because there was no demand or need. The cipro is distributed into regional lots. It is a lot easier to administer (leave it in a mailbox) than a vaccine. The vaccine is a boondoggle, pure and simple.

Hmm.

If memory and my sources have served me, the anthrax vaccine we presently have turned out to be neither safe nor effective.

Randy, one of my former bosses was in the service himself. BTW, he is at least as conservative as you are. And he was willing to flat out resign before they gave him the anthrax vaccine. The service ended up folding it's hand, which, as you know, almost never happens. Unless they're standing on quicksand and know it.

You see, he had done his homework prior .... Always a good idea if your specialty is forensics, not so?

As for weaponization .... Revere, correct me if I am wrong, OK? But I think I can cite this from memory.

In order to pass muster as an effectively weaponized agent for aerosol delivery (best way, Randy, you're right about that), an agent needs three physical properties.

1) The particle size needs to be in the 1 to 5 micron range. The short end of that scale is better.

This size is optimal for sticking to the inside of the lungs once inhaled.

Too big and you also get the particles falling out of suspension earlier than you would prefer.

2) The particles need to be protected against oxygen and sunlight. With anthrax spores, this is a given, but with other organisms, this can be very, very tricky indeed.

3) The particles need to be electrostatically treated so that they repel each other. And they have to stay that way. Otherwise, they clump together, and your agent violates condition (1) on it's ownsome.

Getting all these three physical attributes right, simultaneously, and doing it dependably, is the tough part. You do not just scatter your anthrax spores like evil pixie dust. Not even out of a crop-duster. That'll give you a nasty biohazard incident, a few score sick, and a few dozen dead for your pains. It isn't going to get you three megadeaths per hundred pounds of deployed agent, which is the classical figure if your bioweaponeers know what they're doing.

Bottom line: No, it is NOT easy to pull this off. Not kitchen chemistry by any means.

Randy, there was a REASON why the Soviets established Biopreparat at a nominal 60,000 staff and put in 15 years hard work before they really reached payoff time.

By Charles Roten (not verified) on 01 Oct 2007 #permalink

Charles.... I can only say that the screen effectively turnes into the equivalent of knives and cuts this stuff up like no tommorow. Its slightly wet so the blast doesnt burn it up and the aluminum in the wire acts as a heat sink but not a blast sink. But you are right about the micron level and about the military deciding after so many got sick from the vaccine not to give it any longer. But, thats the military. You can order people to take it and if they dont, you Article 15 at a minimum the enlisted and court martial the others. If a declared emergency or martial law was in effect those officers and enlisted would be changing their minds.

I took it and it made me feel dizzy, nauseated, feverish and it took me out for a day. Many had long term effects, but I can account for like only two deaths from memory.

As for one, not if its liquid spray or high air burst over a population. Or so I understand. Would many get sick? Yup. If they inhaled it then we would all be lining up for the shots or Cipro or something else. Doesnt matter, the whole idea behind this is to create chaos. That would surely follow.

Me, like I said before I wouldnt be using this stuff because of the inherent problems. I would be looking for something REALLY sexy such as that VX that the Syrians werent fitting onto the missiles in the S. of Syria last week. You know, the stuff along with the dirty nuke stuff that that the Israelis didnt get samples of.

3 atoms of that inhaled and you are at the very least down and hard. If you are lucky.

The whole point is though that the same types who beat the administration up for Katrina preparedness, bio-defense etc. would be screaming that we didnt do enough, didnt think it thru, didnt have Halliburton involved. The usual drivel when something happens.

Anyway, since 1962 there has apparently been a vaccine and there has been extensive use of it. Multiple papers say its effective and safe. I guess you would get to say you were right if someone popped a cap and soldiers started falling like flies.

http://www.anthrax.osd.mil/whatsnew/ATXupdate.asp

By M. Randolph Kruger (not verified) on 01 Oct 2007 #permalink

I would be looking for something REALLY sexy such as that VX that the Syrians werent fitting onto the missiles in the S. of Syria last week. You know, the stuff along with the dirty nuke stuff that that the Israelis didnt get samples of.

3 atoms of that inhaled and you are at the very least down and hard. If you are lucky.

Here is the definition of a 'mole'. Note that the bottom line goes thusly: One molecular weight's worth of grams of any given chemical equals "Avogadro's number" worth of molecules ~ 6.022 x 10^23 molecules.

Here is the Material Safety Data Sheet on VX. When we calculate the molecular weight from the given chemical structure, we find that the molecular weight of VX is approximately 267.37. If you like, I will give you the URLs of several molecular weight calculators available on the web.

So 267.37 grams of VX contains 6.022 x 10^23 molecules.

So 0.0267.37 grams, or 27 milligrams, of VX contains 6.022 x 10^19 molecules. This calculation is an easy decimal place shift.

Now, that same Material Safety Data Sheet gives the median lethal dose as 30 mg-min/m^3. "m^3" means meter cubed.

It also gives the permissible airborne exposure concentration for VX for an 8-hour workday of a 40-hour work week as an 8-hour time weighted average (TWA) of 0.00001 mg/m^3.

Now assume a "tidal volume" of 500 milliliters/breath (if you want references, I can supply you with a few), which converts to (5/10^4) m^3/breath. Multiply by a nominal 20 breaths per minute and you get a volume of 1/100 m^3/min of air through the lungs.

Multiply by the median lethal dose and you get a total median lethal dose of 0.3 milligrams of VX. This is around 6 x 10^17 molecules.

Multiply by the permissible airborne exposure concentration and you get an admissible dose of 10^(-7) grams. Divide by the molecular weight and, again, by Avogadro's number, and you get an admissible dose of about 2.25 x 10^14, or 225 trillion molecules.

Note that both of these numbers are considerably larger than 3 molecules, let alone "3 atoms".

I think an intelligent person will take away a lesson from this, that has nothing to do with toxicology or mathematics, and has a lot to do with the wisdom of making wildly inflated claims in a public forum without first checking your facts.

By Charles Roten (not verified) on 02 Oct 2007 #permalink

Well Charles, now you've done it. You have proven that your calculator works. I am sure you know all about airborne inhalation agents such as VX, Tabun, Sarin, Anthrax.

I am also so sure you know about FM 3-50, FM 3-60 and this particular one AMedP-6(B).

Here is the suggested human fatality limit below. Not much success in determining it, but I am sure you can whiz wheel it out. Thats about the limit of the ability to measure it. But hey, a smart guy like you knows all about it having been in the military, been the NBCW officer for your unit and attended all sorts of training, completed all sorts of written exam and above all worn your CBW suit for days at a time.

INGREDIENTS FORMULA PERCENTAGE AIRBORNE
NAME BY WEIGHT EXPOSURE LIMIT

VX C11H26N02PS 100 .00001 mg/m3

I am also sure that you know that the suggested exposure for VX is based only on primates and guinea pigs and that using the word intelligent is fatuous of you and your supposition that there is a limit.

The money being spent on anthrax is I hope never necessary, but VX is lethal in the blood stream as stated before, at least in the test subjects. It was never tested against humans, even Saddam didnt try it that we are aware of. So I tell you what Charles. Tip on down to the Army and let them know you have some theories about the dispersion and effective lethal limits of the VX molecules. You can volunteer your services.

I will also tell you this Charles. What you can put on the end of a pointed end of a pin will kill you dead in a very short time, depending on the thickness of your skin. If you get the same amount into your eyes, the reaction is almost instantaneous. So if you want to do more math and try to say that there is a safe limit of exposure, there isnt. Everything ever tested died within minutes, hours or days. There is no safe limit and the OSHA sheets say exactly that.

So if you are trying to make a point then fine, I'll accept your fine analysis of something you know nothing about and how well you do your math. Else if your bent is an attempt to impugn me then mathematically you are correct, but that is what we are taught. If you doubt it, then go and have them test it on you, please. I wont say you are wrong in your math, only that the outcome was never in doubt after an exposure of any kind. For instance one film I saw where pigs (big ones) were exposed in a room with a concentration of only 1 ppb made them nuts, then muscle spasms set in, then they died in under
a couple of hours. Inhalation type. We were told they never were able to put that into a syringe or drop it onto an animal in that low of a concentration. Therefore the amount was inordinately higher by definition to have a skin contact or into the blood in that amount. How to measure it so you know what you have?

We really would like to know because measurability has always been the biggest problem with these things as I was instructed in 1979, 83, 89, 94, 96. To clear an area for occupation you have to be able to determine safety limits and so far, with persistent agents nothing has ever worked. There was always something still able to cause harm to humans or the environment in it. The military is taught and this is the no shit level 3 atoms of VX. That was hammered into us about how lethal it was. Thats it. There is no exposure that doesnt produce a reaction of some kind in primates, short or long term. You have about 3 minutes if you are contaminated to get it off your skin and administer the treatment. If its inside your lungs you are done.

By M. Randolph Kruger (not verified) on 02 Oct 2007 #permalink

This is a classic example of the opportunity costs in public helath that this administration doesn't seem to understand. As was pointed out in Revere's original post, the resources going into this behemoth of a program could better serve public health needs elsewhere. As for the military, I can tell you on pretty good athority that the mandatory anthrax vaccine program is alive and well and with its complex administration (dosing on day 0, 14, 30, at 6 months, 12 months, 18 months and then annual boosters), it has distracted an already over-taxed military health system. It will be too bad for the troops who get GI or respiratory illness (like TB or Typhoid) because somebody was too focused on administering the anthrax program and one of the other, more important programs dropped.

Contrary to what one other poster said, this vaccine was found to be effective in protecting against inhalational anthrax, and the military did not fold up and walk away. There was a federal court injunction that stayed the military's mandatory anthrax program. The conditions of that have been met (FDA had to study efficacy for inhalational anthrax), and the mandatory program is back on.

Randy, you are correct that this stuff can be weaponized and delivered. I just think a portion of that 6 bn should have gone into a real risk assessment and the rest saved when the administration found out that no one REALLY has the capability to manufacture and deliver it (speculation there just like the speculation above that someone could manufacture and deliver it). But then we know what happens when this administration tries to do a chem/bio risk assessment!

Anthrax vaccine is a sad distraction from REAL public health, and another example of the military industrial complex wagging the national dog (isn't the compay owned by a bunch of retired military officers?).

Just like with the "Duck and Cover" campaigns of the 60's, we've distracted our public health system again with the anthrax bogeyman when there are real health threats out there that need to be worked on (MDR-XDR TB, HIV/AIDS, childhood immunization rates, disease surveillance that works...I could go on and on).

E3