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Advisory Panel Urges U.S. to Conduct Controversial Anthrax Vaccine Trial in Children
ScienceInsider ^ | 28 October 2011 | Jennifer Couzin-Frankel

Posted on 10/31/2011 8:29:24 PM PDT by neverdem

An advisory board to the U.S. Department of Health and Human Services this afternoon urged the U.S. government to launch a controversial trial of the anthrax vaccine in children. The 12-1 vote backs a September recommendation from a working group that spent about 3 months weighing the pros and cons of such a study and came out in favor of it.

Today's recommendation, by the National Biodefense Science Board (NBSB), isn't binding, and even if a study goes forward it will have to jump through many hoops before it can get up and running. That's because a trial like this one is almost without precedent in modern medical research: It involves giving children a vaccine that is almost certain not to benefit them, and that might harm them, all to protect other children from an unlikely scenario—a large-scale anthrax attack.

That said, "the science is clear that we need to do this," says Daniel Fagbuyi, the medical director of disaster preparedness and emergency management at Children's National Medical Center in Washington, D.C. Fagbuyi chaired the NBSB Anthrax Vaccine Working Group with seven voting members, all of whom are also part of the NBSB. The lone dissenter on the vote was Patricia Quinlisk, state epidemiologist and medical director of the Iowa Department of Public Health. Quinlisk chairs the NBSB and also sat on the working group, but said without elaborating that she could not support the recommendation.

The working group began considering a pediatric anthrax trial back in the spring at the government's request. The concern was that researchers have tested other vaccines given to children beforehand, to ensure that they're both safe and effective, but the anthrax vaccine never has been given to children. In a real disaster, medical personnel would be making decisions on the fly, uncertain whether children would react as adults do to the vaccine dose. For some vaccines, like tetanus, "the same dose is given to a 2-month-old infant and an NFL football player," says John Grabenstein, senior medical director for adult vaccines at Merck, who also sat on the working group and voted in favor of the recommendation this afternoon. Other vaccines, like hepatitis B and flu, are dosed differently in kids.

"For me, this decision comes down to, would I rather the first exposures [in children] occur before mass exposures or not, and I would," said Grabenstein during a conference call this afternoon prior to the vote. "I'd rather know what the response to the vaccine is before offering it to many, many, many thousands of children."

In adults, studies have suggested that the anthrax vaccine is quite safe; it's made with inactivated protein from the anthrax bacteria, much like vaccines that protect against diptheria and tetanus. Generally, however, studies in children must meet a higher standard than adult trials in protecting children from risk, particularly if the treatment has little chance of providing benefit. And that's where some worry that the proposed anthrax trial fails to meet ethical standards.

"I don't see how you can ethically do a study on a child where there is no chance the child benefits from that study," says Paul Offit, an infectious disease specialist at the Children's Hospital of Philadelphia in Pennsylvania, who often speaks out in favor of childhood vaccination. Offit attended one of the meetings of the working group and spoke out against a study. "I didn't prevail," he says.

Another big question is who would enroll their children in a clinical trial like this one. Fagbuyi, who served in Iraq as a U.S. Army Major and received the anthrax vaccine himself, says that some military members, first responders, and scientists working with anthrax—many of whom get the vaccine now—have expressed interest in having their children vaccinated, too. They may be comfortable volunteering them for an anthrax study, if it gets off the ground.



TOPICS: Culture/Society; Government; News/Current Events; Testing
KEYWORDS: anthrax; anthraxvaccine; vaccine
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1 posted on 10/31/2011 8:29:28 PM PDT by neverdem
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To: neverdem

I wouldn’t allow my child 3,000 yards of that “vaccine”.
Obama does hate children dont he.


2 posted on 10/31/2011 8:35:23 PM PDT by GreatRoad (O < 0)
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To: neverdem

Hoo boy. I am in favor of vaccinations for communicable diseases, but I don’t agree with this.

I say we make sure it is as safe for adults as we can make it, and if we have to give it to kids due to a real anthrax emergency, we unhesitatingly do it.

But I don’t like the suggestion to do this when not under duress.


3 posted on 10/31/2011 8:36:44 PM PDT by rlmorel (The Rats won't be satisfied until every industry in the USA is in ruins and ripe for nationalization)
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To: neverdem

Over my dead body will they do that to my daughter. I’m the ex wife of a Desert Storm vet who came home sick. I won’t let it happen.


4 posted on 10/31/2011 8:37:07 PM PDT by Edyie
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To: neverdem

Is this one of the idiotic study groups set up by Obamacare?


5 posted on 10/31/2011 8:41:30 PM PDT by Ingtar
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To: Mother Abigail; EBH; vetvetdoug; Smokin' Joe; Global2010; Battle Axe; null and void; ...
micro/immunology ping

Possible study of anthrax vaccine’s effectiveness in children stirs debate

6 posted on 10/31/2011 8:50:59 PM PDT by neverdem (Xin loi minh oi)
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To: neverdem
"That said, "the science is clear that we need to do this," says Daniel Fagbuyi..."

Fine.

As the lead scientist making the recommendation, Dr. Fagbuyi must then certainly see the necessity of putting his own "skin in the game" by volunteering his own children (or grandchildren, as the case may be) to be the first test subjects for the new experimental vaccine.

I'm sure the other 7 scientists on the board that voted for it will feel exactly the same and will gladly offer up their descendants as well.

What's that familiar sound I hear ???? << crickets >>
7 posted on 10/31/2011 8:51:18 PM PDT by Captain Rhino (“Si vis pacem, para bellum” - If you want peace, prepare for war.)
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To: neverdem

Not until it’s tested on politicians first!!!


8 posted on 10/31/2011 9:01:34 PM PDT by FlingWingFlyer (Stop Government Greed Now!!!!)
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To: neverdem

Here we go...more UNaccountable totalitarian bureaucrats deciding what is right for us. It’s like a Freddy Krueger movie on Halloween.


9 posted on 10/31/2011 9:06:33 PM PDT by PGalt
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To: GreatRoad

Not as a test, I wouldn’t either. However, the intended use of the vaccine is post exposure to an anthrax attack where it would be coupled with an antibiotic. It would not be given to the general population as preventative.


10 posted on 10/31/2011 9:09:28 PM PDT by Cold Heart
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To: neverdem
We can start with the children and grandchildren of the members of this board. I'd say that’d be a sufficient pool to get the initial data. I'll also accept immediate termination of parental rights and transfer of these children to others for any child that objects to their parents or grandparents volunteering them for this experimentation.
11 posted on 10/31/2011 9:13:17 PM PDT by kingu (Everything starts with slashing the size and scope of the federal government.)
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To: kingu
Thesis: Congress is a bunch of grasping suck-ass incompetents.

Proof:

We can just volunteer *Congress* for it: after all, if they're so much more important than us, then surely they need the protection most of all, right?

And it's perfectly safe, since our government would NEVER use anyone as guinea pigs, right?

Corollary: Hey! What is that black helicopter hovering over my...? HEY! HEY! (scuffle, door slams)

*Q.E.D.*

Cheers!

12 posted on 10/31/2011 9:17:24 PM PDT by grey_whiskers (The opinions are solely those of the author and are subject to change without notice.)
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13 posted on 10/31/2011 9:20:50 PM PDT by RedMDer (Forward With Confidence!)
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Comment #14 Removed by Moderator

To: neverdem

As long as the first kids to get it are the children and grandchildren of those that think its great and any polician that likes the idea, their kids and grandkids. Then lets see if it works...They can be the guinea pigs.


15 posted on 10/31/2011 9:36:36 PM PDT by goat granny
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To: 2ndreconmarine; Fitzcarraldo; Covenantor; Mother Abigail; EBH; Dog Gone; ...

Ping! (Thanks, neverdem!)


16 posted on 10/31/2011 10:02:30 PM PDT by Smokin' Joe (How often God must weep at humans' folly. Stand fast. God knows what He is doing)
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To: Smokin' Joe

Thanks for the ping!


17 posted on 10/31/2011 10:03:51 PM PDT by Alamo-Girl
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To: Alamo-Girl

You’re Welcome, Alamo-Girl!


18 posted on 10/31/2011 10:07:58 PM PDT by Smokin' Joe (How often God must weep at humans' folly. Stand fast. God knows what He is doing)
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To: Smokin' Joe

No way, no how would they be running this clinical trial on my kid. I hope they give informed consent to the parents! Otherwise, they are breaking the law. But Obammy and our government thinks they are above the law. Parents really need to be careful these days. The elite don’t care much for human life and dignity and kids are easy to pick off.


19 posted on 10/31/2011 10:10:25 PM PDT by SaraJohnson
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To: Yehuda
We can start with the children and grandchildren of the members of this board, AS WELL AS THE OBAMA CHILDREN

Sure, sure, and they'd televise the injection of all these folks with normal saline...just like a certain politician getting a 'Swine Flu vaccine' a few decades ago.

20 posted on 10/31/2011 10:11:17 PM PDT by Smokin' Joe (How often God must weep at humans' folly. Stand fast. God knows what He is doing)
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