USG-Proposed anthrax vaccine trial in children

May 7, 2011

From: Meryl Nass <mnass@...>

I'd go to the blog for the links and the formatting.--Meryl

http://anthraxvaccine.blogspot.com/2011/05/lets-test-anthrax-vaccine-in-children.html

Let's Test Anthrax Vaccine in Children/ Bio Prep Watch

Yesterday it was announced that the government would be purchasing 3.42

million doses of anthrax vaccine to add to the civilian anthrax vaccine

stockpile. This is on top of the military stockpile, and comes out

of DHHS funds. The purchase adds up to $101 million to the total

contract for DHHS' anthrax stockpile, now worth about $500 million.

Stockpile cost could climb to over $2 billion if the government purchases

the 75 million doses it said it needed.

Emergent Biosolutions, the vaccine's manufacturer, also secured a $186.6

million contract for a recombinant protein antigen to combat anthrax and

a $28.7 million contract for a third-generation vaccine. Not too

shabby for a 12 year old company purchased for about $20 million from the

state of Michigan, selling the federal government a vaccine developed by

the US Army. Emergent's Board (2007 and 2011) is made up of

national political operatives with little anthrax experience but

impressive connections.

Vaccine vials expire after 3-4 years, requiring continuous

replenishment. What a marvelous business model! And what a

way to throw taxpayer money into a black hole, according to the Center

for American Progress.

But the gaping yaw of Emergent Biosolutions wasn't satisfied.

Emergent's courtiers in Washington decided only one thing would appease

it: the sacrifice of virgins on the anthrax vaccine altar.

Children would have to become test subjects to " prove " the

vaccine's " safety " . Later, children everywhere would be

able to receive anthrax vaccine, were the government to declare an

anthrax emergency. At present, the vaccine has never been tested in

children, and it is not FDA-approved for their use.

Yet this vaccine is neither safe nor effective. After the

anthrax attacks, CNN reported that Bill Frist, M.D., bioterrorism expert

and Senate Majority Leader pointed out:

" The vaccine is a dated vaccine, it's an old

vaccine. There are very real and potentially serious side effects from

the vaccine and anyone who elects to receive the vaccine needs to be made

aware of that. I do not recommend widespread inoculation for people

with the vaccine in the Hart Building. There are too many side

effects and if there is limited chance of exposure the side effects would

far outweigh any potential advantage. "

According to a 2007 report by the Congressional watchdog agency, the

Government Accountability Office (GAO):

" Officials from the VHC [DoD's Vaccine Healthcare

Centers] Network and CDC estimate that between 1 and 2 percent of

immunized individuals may experience severe adverse events, which could

result in disability or death. "

Yet these facts are being ignored, according to BioPrepWatch:

" Lurie, the assistant secretary for

preparedness and response at the U.S. Department of Health and Human

Services, last week asked the National Biodefense Science Board to

investigate the safety concerns of collecting data on the effects of

anthrax vaccine in children.

Lurie_3

Dr. Lurie

There is currently no safety, immunogenicity or

efficacy data in pediatric and special populations that would allow the

U.S. Food and Drug Administration to evaluate the drug for its

utilization under an Emergency Use Authorization. In the case of an

emergency, adults could receive the countermeasures under the less

stringent EUA status, while an investigational protocol would still need

to be developed for its use in children and special populations. This

would present an array of logistical, clinical and communication

challenges during a public health crisis. " (emphasis added)

There are several ways to read this. The first is, YES: giving

anthrax vaccine to children would present an array of challenges, since

an anthrax vaccine trial fails to meet the normal legal standard with

respect to clinical trials in children. These must entail no more

than minimal risk if a child does not have a condition that would benefit

from the intervention being studied (45 CFR 46, subpart D). There

is one rarely used exception for " not otherwise approvable "

research in children, and it requires assent of an advisory panel,

" sound ethical principles " and consent of both children and

parents. DHHS will probably try to squeeze the proposed research

through under this exception, 45 CFR 46.407.

Another way to interpret these challenges is that the federal government

cannot justify using the vaccine in children, let alone adults, in an

emergency, given the following facts. But then how would it

explain the large vaccine stockpile? On the other hand, if DHHS

could generate scientific evidence to support vaccine use, it might

circumvent those challenges:

a) LOGISTICAL: The vaccine takes 5+ weeks and 2 doses

before it provides significant immunity.

CLINICAL: Antibiotics (and monoclonal antibodies)

are effective immediately, so there is probably no meaningful role for a

vaccine whose benefit only starts 5-6 weeks after exposure.

* Remember, antibiotics were 100% effective at

preventing anthrax after the letters attack, while at best, this vaccine

is no more than 90% effective, and may be much less effective.

* Remember, we are talking about preventing and

treating a fatal disease. No matter what the government says,

doctors cannot in good conscience switch from a highly effective drug

treatment to a less effective vaccine, sacrificing some patients to a

theory of vaccine benefit.

* Be aware there exist no human efficacy data to

support the use of the current anthrax vaccine after exposure to inhaled

anthrax.

c) COMMUNICATION: Government spokespersons would look

like morons trying to justify use of the vaccine in children, when the

media present both sides of the story... as they already have. In

2001, 32,000 people who were possibly exposed to anthrax took antibiotics

and were offered additional vaccine; only 198 (less than 1%) accepted

anthrax vaccinations, the rest having watched the news.

* The vaccine has caused thousands of serious

illnesses in soldiers.

* Vaccine effectiveness in animals varies widely,

depending on the strain of anthrax used and the amount of spores

inhaled.

* In humans, antibody levels vary widely depending on

HLA type. So depending on your genes, you may not develop immunity

even after multiple vaccinations.

* According to the Washington Post, Army tests in

vaccinated monkeys revealed many got sick from anthrax despite

vaccination, though most survived.

Current law does allow FDA to issue an Emergency Use Authorization (EUA)

for drugs that have not been tested for safety in humans, during

emergencies. (So the proposed child research is not, strictly speaking,

necessary.)

FDA issued an EUA in 2005 for use of anthrax vaccine in military

servicemembers. The EUA allowed the military to continue to

use the vaccine, after a federal judge revoked its license due to lack of

proof of efficacy. FDA knows about the vaccine's dangers; it has

collected thousands of reports of illnesses related to anthrax

vaccine. Perhaps FDA did not want to sign off on an Emergency Use

Authorization (EUA) for children, given the known facts about the

vaccine.

Or perhaps DHHS decided the Department would be in a stronger legal

position if evidence of anthrax vaccine " safety " in

children were generated before widespread use. This is because

DHHS, not the manufacturer, is on the hook for damages if the vaccine

causes injuries, as a result of the 2005 Public Readiness and Emergency

Preparedness Act.

Did Lurie, M.D. want an honest, independent review of anthrax

vaccine and research in children? If so, she took her concerns to

the wrong place. Who are the members of the National Biodefense

Science Board, an entity created by Dr. Lurie, in part, to provide

support for controversial decisions?

One member is retired Colonel Grabenstein, Ph.D., who led the

military anthrax vaccine program from 1999 through 2006, supervised

multiple poorly conducted studies of anthrax vaccine safety, then moved

to Merck Vaccine as a VP. (I have critiqued the research projects

here, here, here and elsewhere. FDA noted serious methodological

issues with the studies in its 2002 package insert.)

A second member is retired Major General , M.D., a former

Commander at Fort Detrick, where anthrax vaccine was developed and has

been researched for over 60 years. He has been a strong anthrax

vaccine proponent, and is currently a vice president of SAIC, which

happens to be in the military vaccines business. No one else in

Lurie's advisory group is an anthrax vaccine expert. Since only the

military has used the vaccine, the other members will likely defer to the

two experts on the panel, whose reputations rely on the vaccine being

safe and effective.

The panel will issue its recommendation in the fall. Whose children

will then be used in the name of Biodefense Preparedness? Will they

belong to Emergent's officers or Board? To DHHS officials? To

retired military officers? Or will they be recruited from an inner

city medical center with a high minority population? What exactly

will the consent form disclose about the vaccine's risks?

Posted by Meryl Nass, M.D. at 10:09 PM

Meryl Nass, MD

Mount Desert Island Hospital

Bar Harbor, Maine 04609

W 207 288-5081 ext. 1220

C 207 522-5229

H 207 244-9165

pager 207 818-0708

http://anthraxvaccine.blogspot.com

Sheri Nakken, former R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

http://vaccinationdangers.wordpress.com/ Homeopathy

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May 7, 2011