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 one product, a vaccine developed by the US Army. According to the Wall Street Journal, between 2000 and 2010 Emergent received government contracts valued at about $1.4 billion.  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:

"Nicole 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.

 Dr. Nicole 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.

b)   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 Nicole Lurie, M.D. want an honest, independent review of anthrax vaccine 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 John 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 John Parker, 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?

UPDATE:   Eight years ago, a similar trial of smallpox vaccine in children was proposed.  Professors Paul Offit and Robert M. Nelson of the University of Pennsylvania wrote a detailed analysis of why the proposed trial would not be conducted ethically (or legally) under federal regulations that still guide the conduct of human subject research. 

It was pointed out by Professor William Bicknell of Boston University that "THE CONSENT FORM (of the smallpox trial) NEVER STATES THE CHILD IS AT RISK OF DEATH OR SERIOUS DISABILITY FOR WHICH THERE IS NO KNOWN TREATMENT."  Presumably the same would be true of the consent form for anthrax vaccine, as there is no known way to reverse anthrax vaccine-related illnesses, and were the 1-2% risk of potential disability or death to be disclosed, there would be no willing subjects.

UPDATE:  Here is the letter Dr. Lurie sent to her National Defense Science Board asking for their help in getting the pediatric anthrax vaccine trial going (despite the fact it violates federal regulations, which she failed to mention).

UPDATE:  According to the May 26, 2011 Wall Street Journal:

"Emergent BioSolutions Inc.'s (EBS, $25.33, +$3.89, +18.14%) shares hit their highest point since 2009, as the company is expected to receive a five-year contract potentially worth more than $1 billion from the U.S. government for its anthrax vaccine BioThrax. The U.S. government surprised observers by sending a request for proposal seeking more anthrax vaccine. Because Emergent is the only registered Anthrax vaccine maker, it's essentially guaranteed the contract, Wedbush said. The firm, which values the pact at more than $1 billion based on the vaccine's price, said "five-year visibility into sales is exceptional in any business." Emergent said any contract will likely be finalized during the third quarter."

Apparently the contract is a done deal, as Bioport's rep in Congress, Mike Rogers (who authored the legislation creating BARDA in 2006) praised the decision to award Emergent the contract.http://bioprepwatch.com/news/248321-rep-mike-rogers-praises-biothrax-contract