Singulair Human Radiation Experiments, Risk Phase, Nuremberg Code, Achre, Research Protocols

We believe the following are among the most important shortfalls in the conduct of research involving infants, children and adolescents:

Failure to examine alternative methods of obtaining needed information so that research involving risk for children is minimized. The goal should be to limit the exposure of children to trials that seek vital information that is "unprocurable by other means" - as mandated under the Nuremberg Code and as stipulated in current federal regulations - 45 CFR 46 Subpart D - which restrict the exposure of children to greater than minimal risk. Indeed, until the FDA adopted the "Pediatric Rule"[4] in 1998, high risk, phase I trials in children "had been primarily limited to life threatening diseases and children who had the disease for which the new drug was being proposed." It is difficult to justify a shift in policy that will increase children's exposure to pain and risks of harm.
Inadequate review: failure to evaluate risks relative to existing empirical evidence of harm.
Failure to minimize risks, including psychological risks, or to justify them from the perspective of the child.
Absence of evidence-based guidelines for classifying research protocols "minimal risk," "minor increase over minimal risk," or "greater than minor increase over minimal risk."
There is a pressing need to examine cases that resulted in harm to children - and to draw policy recommendations on the basis of that evidence - so that we can avoid causing harm in the future. Such an analysis was carried out by the Advisory Commission of Human Radiation Experiments (ACHRE), and for that reason ACHRE stands apart from all subsequent ethics advisory committees whose recommendations were unsupported by evidence.
Absence of boundaries to limit the level of risk and pain to which a child may legitimately be exposed.
Pervasive conflict of interests of all involved - including, and especially, institutional review boards that have been shown to rubber stamp approval of harm producing trials.
Absence of an independent child subject's advocate to monitor his/her well-being.
Lack of accountability or enforcement of federal safeguards.
Lack of penalties for those who violate ethical standards.
................................................................................................................................................................................................................................i found this on the best for childrens pharma act websight,it was a letter of worry from several doctors