ALLIANCE FOR HUMAN RESEARCH PROTECTION        

June 27, 2011

Kathleen Sibelius
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, DC 20201

 Dear Secretary Sibelius,

 The Alliance for Human Research Protection (AHRP) is contacting you today with serious concerns about several issues related to anthrax vaccine:

 a)    DHHS has submitted a proposal to conduct a trial to test the anthrax vaccine in children;
http://bioprepwatch.com/news/243663-expert-calls-for-research-into-safety-of-anthrax-vaccine-in-children

 b) The FDA has given a fast-track designation for a new anthrax vaccine that includes a novel adjuvant never before used in a licensed vaccine the US or, as best we are aware, in any other licensed vaccine in the world;
http://www.businesswire.com/news/home/20110609006611/en/Emergent-BioSolutions%E2%80%99-Investigational-Anthrax-Vaccine-NuThrax-Granted

c) DHHS has proposed to purchase 44.75 million additional doses of anthrax vaccine for the National Strategic Stockpile.
http://bioprepwatch.com/news/248321-rep-mike-rogers-praises-biothrax-contract

The AHRP believes that each of these three initiatives by your Department constitutes a radical departure from responsible public health policy which must be grounded in careful risk / benefit analysis, ensuring that the benefits outweigh the risks for individual citizens as well as for the public. To date, the available evidence about the safety and efficacy of the anthrax vaccine is resoundingly negative. Thus, the DHHS anthrax vaccine initiatives represent a reckless deviation from the precautionary principle of medical ethics and fiscal responsibility.  

We cite the following reasons:

 1.  There is little or no threat

•       No evidence has been put forward to show that US citizens are at risk of anthrax. 

•         Anthrax has never been used on any battlefield in world history or in any terrorist attack by foreigner.

•      The FBI closed the anthrax letters case--which was the only anthrax attack on US citizens ever-- concluding that a sole US scientist in the military sent anthrax by mail.  So who is the enemy that threatens us with anthrax?

 2.  Because the threat of exposure to anthrax is insignificant, the vaccine is of little to no value as protection against anthrax.

• The anticipated risks of exposure to the vaccine for children--who are legally incapable of consenting to research participation--are substantial, as indicated by points #3 to #9 that follow.

•  Accepted public health practice balances risks and benefits to ensure that benefits outweigh the risks.  In this case, healthy children, who would derive no benefit from the trial, would be exposed to a controversial vaccine whose anticipated risks of morbidity and mortality are substantial. The proposed DHHS pediatric anthrax vaccine trial would  sacrifice children's welfare, much as canaries sent into the coal mines were sacrificed.

3.  There is no scientific evidence that supports the use of the anthrax vaccine after an exposure.

• Od 30,000 people exposed to anthrax who were offered anthrax vaccine in addition to antibiotics, only 198 accepted.  Both groups--those on antibiotics alone, and those on antibiotics and vaccinated--were completely protected from developing anthrax.  The addition of the vaccine did not improve outcomes.

• The Anthrax vaccine takes at least 35 days and at least 2-3 doses to stimulate antibody levels that might provide protection

• The only benefit of vaccinating is to shorten the 60 day duration of antibiotics use, while the risk is death from anthrax if the vaccine does not perform as well as antibiotics. Additionally, there is a risk of developing illnesses due to the anthrax vaccine.

• Even assuming (for argument's sake, but with no substantiating evidence) that the vaccine provides some protection, it will never be as much protection as antibiotics, because even the most effective vaccines are never 100% protective.

• Physicians could not, in good conscience, switch patients from a proven, 100% effective therapy (antibiotics) to a less effective therapy (vaccine). Some patients switched to vaccine would almost certainly die as a result.

•   After the anthrax attacks, CNN reported that Bill Frist, M.D., bioterrorism expert and (then) 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."
  http://archives.cnn.com/2001/US/12/18/anthrax/index.html
  
  
• The GAO noted, in a 2007 report:

"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." http://www.gao.gov/new.items/d07787r.pdf

•  The CDC conducted a Congressionally-mandated clinical trial of anthrax vaccine in 1,564 US volunteer subjects between 2002 and 2007.  This is the largest prospective, randomized, controlled trial on anthrax vaccine to have ever been done.  There were 229 reports of serious adverse events in these subjects that were submitted to the Vaccine Adverse Event Reporting System (VAERS) between 2002 and 2007. They were discussed in conference presentations but no report of the completed trial has ever been published. 

• CDC's failure to publish the completed trial data and analysis raises serious concerns about the safety of the vaccine, and the credibility of  CDC pronouncements.  The public has virtually no verifiable information about the nature of the adverse events in the CDC trial and how they may be related to vaccination.

• It is important to note that in 2002, the FDA required a revision of the AVA product label to include approximately 40 serious adverse events. As the product label for AVA now reads, "Approximately 6% of the reported events were listed as serious. Serious adverse events include those that result in death, hospitalization, permanent disability or are life-threatening."
  Further, the FDA raised the rate of systemic reactions by up to 175 times over what had been listed on the previous 1999 product label, from 0.2% to 5-35%.

 5. Under US law, clinical trials in children must not entail 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 (45 CFR 46.407) for "not otherwise approvable" research in children, which requires that:
  "the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children."

• Inasmuch as there is absolutely NO EVIDENCE to support a claim that anthrax poses "a serious problem affecting the health or welfare of children," and the anthrax vaccine provides no prospect of direct benefit for children, what ethical principles can possibly justify  exposing children--much like canaries in the mines--to the serious risks involved in an anthrax vaccine trial? 

• A similarly ill-conceived anthrax vaccine trial was to include 100 healthy children: it was withdrawn by the National Institute of Health in 2005 following a complaint by Senator Jeff  Bingaman to the Secretary of Health and Human Services. NIH retracted the trial stating  "The Web announcement ... was in error. It has since been corrected." No children would be used.
  http://www.ahrp.org/cms/images/stories/anthraxkidsbingamanleavitt07-01-05.pdf
  http://articles.courant.com/2005-07-12/news/0507120138_1_anthrax-vaccine-bioport-s-vaccine-vaccine-test-trials

• AHRP asserts that the proposed pediatric vaccine trial is unethical and legally not approvable under the law.

•  This waives virtually all manufacturer liability for injuries from the vaccine.  It makes DHHS responsible to determine what injuries, if any, are due to the vaccine, and to compensate injured recipients from DHHS funds.
  http://www.hrsa.gov/gethealthcare/conditions/countermeasurescomp/cicp_admin_final_rule.pdf

•  What efforts has DHHS made to determine which injuries are caused by anthrax vaccine?

• How much money is designated for DHHS to compensate injured vaccine recipients?

 7.  Purchase of 44.75 million additional doses of anthrax vaccine for over $1,000,000,000 (billion) is unnecessary, is a waste of taxpayer money, and is entirely unacceptable given the state of the US economy.

• The Center for American Progress issued a report in 2010 about anthrax vaccine procurement by the federal government titled, “Getting Rich on Uncle Sucker:  Should the Federal Government Strengthen Efforts to Fight Profiteering?”  The report concluded that the vaccine’s manufacturer made excessively high profits (on the order of 300% or more) and that such profits had the corrosive effect of “generating large political contributions and heavy duty lobbying.”
  http://www.americanprogress.org/issues/2010/10/pdf/unclesucker.pdf

 8.  Since there is no good reason to use anthrax vaccine in anyone, there is absolutely no justification to test it in children, for whom no benefit is expected but who may incur significant harm.

• The Institute of Medicine's report "Ethical Conduct of Clinical Research Involving Children" (2004), reaffirms the duty to protect children from risks associated with experimental medical research, affirming federally mandated protection for children:  "Meeting the special ethical and legal standards for protecting infants, children and adolescents who participate in research demands additional resources and attention beyond that required for protecting adults...In some cases, the special ethical and regulatory protections for children may preclude potentially important clinical studies that would be approved for adult participation."
  http://www.nap.edu/openbook.php?isbn=0309091810

9.  In order to improve on the current anthrax vaccine, a similar vaccine with an added novel adjuvant, made by the same manufacturer, has been given fast-track approval by the FDA.

• The new vaccine is therefore likely to be licensed in 6 months, with only rudimentary data regarding safety and efficacy, given that only Phase 1b trials have been conducted so far.

• Novel adjuvants are substances used to boost the strength of a vaccine.

• They are generally believed to induce more autoimmune adverse effects than a vaccine without a novel adjuvant will do.

• Indeed, FDA’s director of the Office of Vaccines Research and Review, Norman Baylor, pointed out in Science magazine that novel adjuvants could increase the supply of vaccine by using less antigen, but may be more dangerous for the individual.  “…Antigen-sparing strategies benefit populations, not individuals. ’You have to think about those trade-offs,’" Baylor said.
  http://www.sciencemag.org/cgi/content/short/324/5934/1496
  
  

• The adjuvant used in the new vaccine is an immunostimulatory oligodeoxynucleotide compound, CPG 7909.  This is a piece of DNA, which might insert into one’s genes, with unknown effects.

• This adjuvant has never been used in any licensed vaccines in the US, and therefore fast-track status is inappropriate and dangerous, since it is an entirely new class of drug additive, which has never been used outside small clinical trials.

 AHRP asks that you call an immediate halt to the proposed pediatric anthrax vaccine trial--as it fails to comply with ethical and legal standards.

 We further ask that you re-examine the justification for spending more than $1,000,000,000 (billion) of scarce taxpayer funds--desperately needed for medical treatment-- to purchase additional anthrax vaccine that will likely never be needed.

 We further ask that FDA not minimize the approval process by fast-tracking a new anthrax vaccine whose adjuvant components, the FDA acknowledges, "may be more dangerous for individuals" than the antigen itself.

 Finally, it is imperative that data from the CDC clinical trial be made publicly available, to facilitate independent review of anthrax vaccine safety and efficacy data before any new purchase commitments are made.

Sincerely yours,   

 Vera Hassner Sharav,  President and Meryl Nass, MD

on behalf of The Alliance for Human Research Protection