Human subject research is rife with potential ethical peril. That is why, beginning with the Nuremberg Code — which led to the USA’s Common Rule and international legal agreements, such as the Helsinki Accords — great efforts are made to ensure that human experimentation protocols protect participants’ safety, most particularly that of the most vulnerable, such as children.
With so much going on, self-monitoring is often the rule. And with protocols complicated and often arcane, it can be very difficult for to keep an eye on what is going on. That is why I so admire the the Alliance for Human Research Protection (AHRP) — an organization that endeavors to cast the public’s eye on dubious or unethical research practices.
The AHRP is currently campaigning to protect healthy children from being used as research subjects in an anthrax vaccine study — which could expose them to potential health risks. Despite the fact that the experiments are non-therapeutic as to the children who would participate, as I reported in March, President Obama’s bioethics council okayed the experiments moving forward, at least in theory.
Now, the AHRP has issued a public letter to Obama urging him to shut the process down. From the letter:
Inasmuch as there is no evidence that American children are at risk of a bioterrorist attack, such medical experiments are explicitly prohibited by Federal statutes. Accordingly, children may not be exposed to more than a “minor increase over minimal risk” in research unless: “The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition.” [45 CFR46.406]
Well, a bioterrorist attack with anthrax is certainly a possibility, given the times in which we live. But, it seems to me that a vaccine’s experiment on children that could harm them is not of “vital importance” for understanding or ameliorating a risk that is mostly theoretical, and if it occurs, very likely to be a localized threat.
Moreover, according to the AHRP, adult studies have apparently not demonstrated efficacy:
The planned anthrax vaccine experiment was initiated on the basis of a simulated exercise — called “Dark Zephyr” — not on the basis of real evidence of risk. After decades of testing, the effectiveness of the anthrax vaccine (BioThrax) following an attack has never been proven, and its safety problems are of considerable concern. Indeed, the FDA-approved label states: “The safety and efficacy of BioThrax in a post-exposure setting have not been established.”
Children exposed to this controversial vaccine will be put at significant risk of harm — not to mention severe pain — with no benefit for them. Furthermore, given the vaccine’s failure, after decades of testing in adults, to demonstrate its effectiveness, a pediatric trial is unlikely to succeed. Therefore, the trial will have no clinical or scientific value, much less be “of vital importance.”
I can’t imagine any parent allowing their child to be exposed to potential illness in an anthrax study, which even Obama’s commission admitted carries more than “minimal risk.”
It is so hard to follow these things. Thanks to the AHRP for keeping a sharp eye.