Presentation to the Presidential Commission for the Study of Bioethical Issues, Amy Gutmann, PhD, Chair
Re: Ethical Issues Associated with Countermeasures for Children
By the Alliance for Human Research Protection
This Presidential Commission spent 4 meetings and the greater part of a year deliberating about the ethics of testing the anthrax vaccine on children, but somehow ignored the most basic information about the vaccine: its 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 label1 states: 5% to 35% of adults who were vaccinated suffered adverse events. Those adverse events encompass local adverse reactions—such as, bruising, inflammation, swelling, pain, and fever; systemic reactions—such as, muscle aches, joint aches, headaches, malaise, rashes, chills, fever, nausea. The FDA-approved 2012 label2 states:
“acute allergic reactions, including anaphylaxis…Stevens Johnson syndrome have occurred with BioThrax… [and] BioThrax can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while ta king this drug, the patient should be apprised of the potential hazard to a fetus.”
A “pivotal safety / immunogenicity trial” conducted by the Centers for Disease Control reported in the Journal of the American Medical Association (JAMA, 2008)3 that 12% of the adult subjects suffered “serious adverse events” (SAE) during the 43 month trial. SAEs are defined as
“death, life-threatening events, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability or incapacity…”
The following presentation is made on behalf of The Alliance for Human Research Protection (AHRP), a national 501-C3 human rights organization dedicated to advancing responsible and ethical medical research practices. We will make the case that the proposed pediatric anthrax vaccine trial and broader non-specific “countermeasures research” in children, involving greater than minimal risk is unethical and unapprovable in the absence of a clear and present danger to children.
At the close of the Commission’s May 17, 2012 meeting, you pinpointed4 precisely the two most important factors for the Commission to consider when developing its recommendations. First, it needed to consider the relevant scientific facts and the state of knowledge relating to the issues involved in pediatric “countermeasures research”:
“To say that research on one vaccine should go forward really requires having facts, not just the framework…. I would definitely agree you can’t come to a decision in this matter without having the facts… I would request that all of you who work in the domain of the facts get us the relevant facts — all of the relevant facts that are known or any that are unknown– that would need to be gotten… that would have to be known before a final decision should be made on specifically a vaccine, an Anthrax vaccine for children… it’s really important for us to know what is the state of knowledge of the facts in this matter…”
You also pinpointed the most important ethical consideration which is tacitly overlooked by many IRBs: whose children would be the subjects of countermeasures research?
“…if the people who are in favor of this would feel that it was the right thing to do to volunteer their children, that would send a very strong signal about the confidence in the rightness of doing this.”
Unfortunately none of the invited presenters at the Commission’s subsequent public meetings provided “the facts.” No one even referred to the disclosures contained in the FDA-approved vaccine label which explicitly states: “The safety and efficacy of BioThrax in a post-exposure setting have not been established.”5 And no one ever mentioned volunteering their own children for such a study.