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I don't pretend to know what the repercussions of such testing would be for children. But I do know that for me, regardless of the chances of a possible threat from Anthrax spores in the future; I draw the line at ANY children being treated as guinea pigs in ANY test for ANY vaccine without full knowledge beyond the shadow of a doubt of ANY possible side effects whether they're short-or-long-term. There's got to be another way of testing this product.

Children are off limits for me. Full stop. End of freakin' story.

The National Vaccine Information Center has the deeply disturbing story:

The U.S. Department of Health and Human Services (DHHS) and the nation’s sole manufacturer of anthrax vaccine, Emergent BioSolutions, are making plans to go forward with an experimental clinical trial testing anthrax vaccine on American infants and children. Last month, the Alliance for Human Research Protection (AHRP) issued a strongly worded, evidence-based letter to the Presidential Commission for the Study of Bioethical Issues protesting pediatric trials using BioThrax® anthrax vaccine for the purpose of proving the vaccine is safe and effective to give to infants and children.
Description of the ["strongly worded, evidence-based"] letter sent to the commission is here:

The report released by the Presidential Commission for the Study of Bioethical Issues (created by Executive Order #13521 (PDF) on November 24, 2009) says the program would still have hurdles to surmount before the initiation of any vaccine testing on children. In fact, now that the report has been released, the next step is that any final decision to go forward with the program and take the steps recommended by the commission lies with Secretary of Health and Human Services Kathleen Sebelius

Here's more from the National Vaccine Information Center:
 

Along with AHRP, the National Vaccine Information Center (NVIC) is also on public record since 2011 as opposing proposed anthrax vaccine experiments on children. The 2013 letter to the Presidential Commission, written by AHRP President Vera Sharav and Board Member Meryl Nass, MD, states that the anthrax vaccine’s “effectiveness after exposure to inhalation anthrax is unknown, and the lack of a reliable animal model makes any calculation of effectiveness and dosing impossible. What is known is that BioThrax is a dangerous vaccine. The FDA-approved 2002 label states: 5% to 35% of adults who were vaccinated suffered adverse events.”

The AHRP letter comes after several years of meetings in which federal officials and consultants debated the risks and ethics of enrolling infants and children in experimental trials and injecting them with the controversial vaccine. BioThrax anthrax vaccine was first associated with hundreds of cases of chronic brain and immune system damage and death suffered by soldiers in the Gulf War, who received a series of anthrax shots along with many other vaccines.

Reuters is reporting a sales report of the vaccine by Emergent BioSolutions:

The company reported $215.9 million in sales of BioThrax, its only licensed product, in 2012.
The following description of the product in question is from the blog @ Scientific American: (written in May 2012)
... the package insert on Biothrax (AVA) says:

Serious allergic reactions, including anaphylaxis, have been observed, and notes that birth defects were slightly more common in first trimester-exposed infants (odds ratio = 1.18). There was a >10 % incidence of significant arm pain after injection, with limited range of motion. All adverse events were more common in women.

In 2011, a bioterrorism preparedness exercise, “Dark Zephyr,” was conducted. (This was a coy symbolic name, as Zephyr means “A soft gentle breeze,” and reminded me of spies and intrigue.) The Dark Zephyr exercise found a notable lack of data about the safety or immunogenicity of AVA in those <18 or >65 years old.

And here's a webpage describing the program, "Dark Zephyr" which led us to where we are now. The report's from the Global Security Newswire. The program ensures distribution of vaccines for first responders in various cities. Participants in the program would follow specific regiments in dosing at "pilot sites":
A standard vaccination regimen would involve five shots over 18 months and yearly boosters to confer and sustain immunity. The trial is expected to hew roughly to the duration of the initial 18-month "priming series."
It's unclear if any testing on children or infants would follow regiments different from
the ones prescribed for adults.

Here's more from Scientific American:

Historically, dosing for children has been extrapolated from that for adults. The NBSB argues that, during an emergency, the planned dosage of vaccine would have to be the same as in adults and that they would not be able to do sequential studies. So the question is whether the limited likelihood and risk of an attack warrants testing a vaccine with significant side effects on healthy children—especially since it is not known whether any antibodies formed would actually be protective, and boosters have to be given annually. (Note: for example, the dose of diptheria and tetanus proteins in vaccines are higher for infants than for adults.) And it is known that antibiotics and post-exposure vaccination are effective for preventing anthrax infection if necessary.
Here's a very informative article on the history of Anthrax vaccines in the DoD from the Homeland Security Affairs Blog @ The Journal of the Naval Postgraduate School Center for Homeland Defense and Security written shorty before the 2009 Executive Order was issued:
Past problems with the Department of Defense anthrax vaccine currently impact national emergency response plans approved by the Department of Homeland Security and Department of Health and Human Services. Following the 2001 anthrax letter attacks, those departments diverged from long established protocols advocating limited use of the old anthrax vaccine, also known as BioThrax®. The Executive departments procured mass quantities of the product for the Strategic National Stockpile as a prophylaxis for citizens under emergency contingencies. The departments share oversight responsibilities for the emergency stockpile’s composition of vaccines and drugs based on Presidential Directives. 1 Yet a review of past oversight efforts reveals regulatory problems, ethical controversies and dubious threat assessments underlying use of the vaccine. Based on the historic controversy, and studies suggesting the majority of U.S. service members continue to object to the vaccine’s use, 2 the government should resurvey the vaccine’s suitability for American citizens. A thorough review may find that widespread use of a known antiquated product of disputed safety and efficacy in treating a non-communicable threat provides an imprudent illusion of protection for our citizens.
Corporate profit margins for products deemed compulsory for American citizens gives me an uneasy feeling in my gut. I know it takes money to test and produce these products but corporations have been known to take shortcuts in the past as far as testing goes, and I don't want to see any children harmed while being subjected to these tests whether it's by side effects in the present or by side effects... unexpectedly discovered in the future.

I'll end this with another disturbing little detail reported by Reuters:

Under a 2005 law, children in an anthrax-vaccine study would be prohibited from seeking damages through the legal system. The presidential commission, said Gutmann, "strongly recommended that a plan be in place to compensate any children" who are harmed.
Carte Blanche?

Call me paranoid... but not my grandchildren.

Not now. Not ever. No way. No how.

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Comment Preferences

  •  I'd like to know why they can't find a suitable... (4+ / 0-)

    animal model for testing. As much as I abhor it, it's still better than testing this on children.

    "That men do not learn very much from the lessons of history is the most important of all the lessons of history." ~ Aldous Huxley

    by markthshark on Wed Mar 20, 2013 at 06:02:08 AM PDT

  •  Unbelievable! (3+ / 0-)
    Recommended by:
    markthshark, worldlotus, Joieau

    I wonder whose children they're going to test it on. Rich, upper class kids? Yeah, probably.

    •  Not in this world, OPOL... (2+ / 0-)

      Apparently, our children and grandchildren are expendable.

      Only the children of the plutocrats are worthy of legacy.

      "That men do not learn very much from the lessons of history is the most important of all the lessons of history." ~ Aldous Huxley

      by markthshark on Wed Mar 20, 2013 at 06:17:26 AM PDT

      [ Parent ]

    •  Children are the property of their parents. (3+ / 0-)

      Parents can sign a release and offer their children as subjects for experimentation.
      This is more evidence that property rights trump human rights.

      Also, under the new rubric of informed consent, abuse is not abuse, if it's agreed to. That's why the all-volunteer military is such a boon. Individuals who have agreed to give up their lives, if so ordered, are presumed to have surrendered all other rights in a sort of lesser, included sacrifice -- a variant of the lesser, included offense that is often used in criminal charges, to get a perp in case the big charges don't stick.

      The argument that the rule of law is being lost misses the point. The rule of law marches on unimpeded. What is being lost is justice. For the law is being used to subjugate and subordinate, but, instead of targeting some few populations (blacks, women, recent immigrants, children), the principle of equality demands that all be targeted equally. So, everyone can be equally deprived of rights.
      There's a reason why the Cons are keen on the rule of law. It lets them wash their hands, just like Pontius Pilate did two thousand years ago. People shirking responsibility has a long tradition.

      We organize governments to deliver services and prevent abuse.

      by hannah on Wed Mar 20, 2013 at 07:14:39 AM PDT

      [ Parent ]

      •  All in the name of profit... (1+ / 0-)
        Recommended by:
        One Pissed Off Liberal
        People shirking responsibility has a long tradition.

        "That men do not learn very much from the lessons of history is the most important of all the lessons of history." ~ Aldous Huxley

        by markthshark on Wed Mar 20, 2013 at 07:23:05 AM PDT

        [ Parent ]

        •  Only if you equate profit with exploitation. (1+ / 0-)
          Recommended by:
          One Pissed Off Liberal

          Money actually lets us track it and identify it more accurately.

          Consider, for comparison's sake, the rape and abuse perpetrated by parents and family members where no money changes hands. For that matter, the exploitation of girl friends and spouses is many times greater than the abuse of sex workers.

          Some humans exploit their own kind, regardless of whether they get any monetary benefit. Money is not the prompt. The prompt is a predatory instinct that's not controlled.

          We organize governments to deliver services and prevent abuse.

          by hannah on Wed Mar 20, 2013 at 08:24:02 AM PDT

          [ Parent ]

      •  People shirking responsibility (2+ / 0-)

        goes back MUCH farther than Pontias Pilate, if you're going to use a religious example. Don't forget that Adam blamed Eve for the apple, and Eve blamed a snake. If I recall correctly, the owner of that apple tree didn't buy either excuse.

        •  The snake lied. (1+ / 0-)
          Recommended by:
          Joieau

          On the other hand, the fruit of the tree didn't make humans smart, either.
          The story does convey that the cuture of obedience is well-rooted.
          Are lies and excuses a response to the culture of obedience or its justification. Coerced obedience, extracted under the threat of punishment, is essentially abusive. If humans have free will, then they must be free to make mistakes. Denying responsibility is trying to have it both ways.
          It is possible that some humans shirk responsibility because they "know not (are not aware of) what they do." Our mistake is in letting such people, who are incapable of thinking ahead and anticipating consequence they need to avoid, make decisions for other people. The incompetent should not be in charge--of anything.

          We organize governments to deliver services and prevent abuse.

          by hannah on Wed Mar 20, 2013 at 09:45:01 AM PDT

          [ Parent ]

  •  Can I get a source other than (3+ / 0-)

    an anti-vax group like the NVIC?

    I don't have time to waste with press releases or 'strongly worded letters' from groups that are straight up anti-science.

    Look, I tried to be reasonable...

    by campionrules on Wed Mar 20, 2013 at 06:21:21 AM PDT

  •  The way you write this (3+ / 0-)
    Recommended by:
    campionrules, sturunner, gramofsam1

    makes it sound like families would have no choice. Participation in any clinical trial is voluntary and requires parental approval for children. Anthrax vaccine has been used in adults for a while now, it's not like they are starting the very first tests by using children. They have, I guarantee, been tested in animal models as well before the vaccine went to human adults. Children come last in the testing stages.

    Some trials don't work out. The rotavirus vaccine unfortunately did not. But the only way to find out the safety and efficacy ultimately is by doing a trial. I don't know their population of interest, but it might be useful for families who live on farms since anthrax lives in soil.

    •  No, the testing is not compulsory... (0+ / 0-)

      but, it might be in a practical situation.

      In this economy, parents will be tempted to enroll their children in the program for the money. And the 2005 law leaves no avenue for recourse if something happens to the test subject during the process. And they're not even dead certain on the dosage.

      Have any suggestions for who should volunteer?

      I've got one. How about the children of the vaccine's developers?

      (actually, I don't want to see anybody's kids tested like that)

      "That men do not learn very much from the lessons of history is the most important of all the lessons of history." ~ Aldous Huxley

      by markthshark on Wed Mar 20, 2013 at 06:52:57 AM PDT

      [ Parent ]

      •  Well (1+ / 0-)
        Recommended by:
        gramofsam1

        I would be curious how much the compensation would be. I believe it is against federal law to offer compensation for a trial that is high enough to be coercive. I work on a survey and the IRB won't let incentives go above about $20 for participation.

        As for who should volunteer, I would imagine they would look at kids where there is a nonzero risk of exposure, because that is the key. You can't show it worked if no one was exposed. So it might be kids who live in areas with soil exposure, maybe kids of lab workers who work with it? I don't know.

        •  Here are the (1+ / 0-)
          Recommended by:
          gramofsam1

          HHS guidelines to researchers and IRBs about compensation of research subjects -
          http://answers.hhs.gov/...

        •  I just worry about the crap they push on us... (1+ / 0-)

          that hasn't been adequately tested. Hell, they don't even have a consensus on vaccinating adults with this product.

          As far as I can tell they'll be testing different age groups at different sites in a finite time period.

          In this age of mega-capitalism where everything is profit-driven, corporations have every incentive to take shortcuts whenever possible -- damn the consequences.

          Children are not guinea pigs.

          They're our future.

          "That men do not learn very much from the lessons of history is the most important of all the lessons of history." ~ Aldous Huxley

          by markthshark on Wed Mar 20, 2013 at 07:11:19 AM PDT

          [ Parent ]

          •  I agree (2+ / 0-)
            Recommended by:
            markthshark, gramofsam1

            It should be thought about a lot and if done, done very carefully.

            We have a lot of regulations and guidelines now that are a reaction to terrible decisions in the past, like the Tuskeegee experiment. I do think it is pretty well safeguarded at this point and the government and independent panels like IRBs oversee a lot of how things are done.

            •  I wish I could be as certain as you... (0+ / 0-)

              especially where children are concerned.

              (btw, I couldn't get the CBS link to work. I get more or less a content-free page)

              "That men do not learn very much from the lessons of history is the most important of all the lessons of history." ~ Aldous Huxley

              by markthshark on Wed Mar 20, 2013 at 07:28:25 AM PDT

              [ Parent ]

              •  Sorry (0+ / 0-)

                Using my phone. I will try to find it on the computer later and update.

              •  Here it is (2+ / 0-)
                Recommended by:
                gramofsam1, markthshark

                http://www.cbsnews.com/...

                a presidential commission says the government would have to take multiple steps -- including more safety research in young adults -- before it would be ethical to consider tests in children.
                Worried about how to handle an emergency, a government advisory group recommended studying the anthrax vaccine in children if independent ethics experts agreed it could be done appropriately. The Obama administration put that question to the panel.

                Tuesday's answer: Children don't gain any benefit from pre-attack research with the anthrax vaccine or other countermeasures. So the panel said such studies would be ethical only if they presented no more than minimal risk to participants -- like the risk from a routine medical check-up. Determining that would require, among other things, more testing in adults, the panel added. Something that proved safe in 18-year-olds, for example, might be a candidate to study next in 16- and 17-year-olds.

                However, the government should plan now for how it would study children who receive those treatments in the event of an attack, the panel said.

                Seems like they had a different take on the panel's recommendations.

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