The National Biodefense Science Board,convened a two day meeting of the Anthrax Vaccine Working Group at the request of the Department of Health and Human Services. The July 7 meeting was open to the public, followed by a closed meeting on July 8.
Below are the written two-minute allotted public comments submitted by AHRP board members, Meryl Nass, MD and Vera Hassner Sharav. VHS attended the July 7 meeting and will have a follow-up post.
Below these comments is an excerpt from the FDA-approved Anthrax Vaccine Adsorbed (Biothrax) label warning .
Meryl Nass, MD
Board Certified in Internal Medicine
Mount Desert Island Hospital
10 Wayman Lane
Bar Harbor, Maine 04609
207 288-5082, ext. 1220
July 7, 2011
Dear NBSB members:
Performing experiments in non-consenting children, especially when they do not have a condition the experiment is designed to address, is carefully regulated. Thus, according to Protection of Human Subjects in the Code of Federal Regulations (Part 46.407) a federal advisory committee must review the proposed research, and opportunity for public comment is required.
My fear is that the work you and I are expending on this question may be merely to meet the letter of the law, and not the spirit.
The intent of this federal law is to protect vulnerable child subjects from abuse by a research enterprise. The bottom line on anthrax vaccine is that we do not have any idea how well it will work in humans. Vaccinated monkeys and rabbits appear to do well after challenge… except that many vaccinated monkeys in Art Friedlander and Bruce Ivins’ tests 20 years ago did develop cases of anthrax, though they eventually survived. Other species of animals do less well with the vaccine when challenged.
The vaccine is unsafe, due to a small percentage of severe illnesses that do not resolve. These often resemble Gulf War Syndrome, characterized by fatigue, chronic pain and other symptoms. Don’t believe me: ask Renata Engler, whose Vaccine Healthcare Centers staff have documented chronic illnesses in several thousand young anthrax vaccinees. Ask why CDC officials told the GAO that 1-2% of vaccinees may develop illnesses resulting in disability or death. Ask why CDC has failed to publish the final results of its clinical trial of 1564 subjects, though data collection ended in 2007.
Yes, the Defense Department has managed to produce plentiful literature supporting the excellent safety and efficacy profile of this vaccine. DOD’s job is to fulfill its missions, not to win prizes for scientific accuracy or honesty.
The claims in the Q and A provided for parents of potential subjects are misleading or worse, and once children become ill those claims may come back to bite this committee and any others who signed off on the trial.
Meryl Nass, M.D.
The Alliance for Human Research Protection asserts that the proposed anthrax vaccine experiment in children is unethical and legally unapprovable.
1. To date, the available evidence about the safety and efficacy of the anthrax vaccine is resoundingly negative, notwithstanding CDC and FDA unsubstantiated claims.
Accepted public health practice balances risks and benefits to assure that benefits outweigh the risks–in this case, the benefits of anthrax vaccination are negligible compared to the anticipated substantial risks of morbidity and mortality for children exposed to the vaccine.
Therefore, the proposed trial in children represents a deviation from the precautionary principle of medical ethics.
2. US law prohibits exposure of children to greater than minimal risk if they don’t have a condition that would benefit from the intervention being studied.
The only exception under US law, is if the research furthers "understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children."
3. No evidence has been presented to show that anthrax is a "serious problem affecting children’s health or welfare."
- Anthrax has never been used in any foreign terrorist attack or on any battlefield in world history.
- The FBI concluded that the anthrax letters–the only instance of an anthrax threat to US citizens–was committed by a sole US army scientist who is dead. So who threatens American children with anthrax?
- There is no evidence of an anthrax threat. Just as there was no threat of "Iraqi weapons of mass destruction."
4. However, the documented risks of exposure to the vaccine for children are substantial.
- The FDA label states: "6% of reported adverse events were serious. These include events that result in death, hospitalization, permanent disability or are life-threatening."
- In 2007, a GAO report stated:
"the Vaccine Healthcare 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
- Between 2002 and 2007, CDC conducted a large, randomized, controlled anthrax vaccine trial in 1,564 US volunteers. But CDC never published a report about the completed trial. WHY?
- Failure to disclose the results raises serious concerns about the safety of the vaccine and the credibility of CDC claims.
5. Antibiotics were 100% effective at preventing anthrax in thirty thousand people who may have been exposed to spores from the anthrax letters and used them. No one who was treated after exposure, if they were not already ill, developed anthrax-related illness. Although 198 people received some vaccine after exposure to the anthrax letters, none appear to have benefited, as the unvaccinated population was entirely protected by 60 days or less of antibiotics.
Given that the scenario of an anthrax risk is entirely speculative, exposing children to the documented serious risks of the vaccine, is unethical. Such an experiment would exploit children’s vulnerability and legal incapacity to protect themselves from research that may harm them by refusing to consent.
The proposed anthrax vaccine trial would sacrifice children’s welfare, much as canaries sent into the coal mines were sacrificed.
The question is, WHOSE CHILDREN WOULD BE SACRIFICED?
Vera Hassner Sharav
Alliance for Human Research Protection
31 JAN 2002 FDA-Approved Label Warning
"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. The serious adverse events most frequently reported were in the following body system categories: general disorders and administration site conditions, nervous system disorders, skin and subcutaneous tissue disorders, and musculoskeletal, connective tissue and bone disorders. Anaphylaxis and/or other generalized hypersensitivity reactions, as well as serious local reactions, were reported to occur occasionally following administration of BioThrax. None of these hypersensitivity reactions have been fatal.
Other infrequently reported serious adverse events that have occurred in persons who have received BioThrax have included: cellulitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema and other hypersensitivity reactions, asthma, aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis, Guillain-Barré Syndrome, immune deficiency, seizure, mental status changes, psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy, hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis, cardiomyopathy, atrial fibrillation, syncope, glomerulonephritis, renal failure, spontaneous abortion and liver abscess. Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, musculoskeletal system.
Reports of fatalities included sudden cardiac arrest (2), myocardial infarction with polyarteritis nodosa (1), aplastic anemia (1), suicide (1) and central nervous system (CNS) lymphoma (1).