Vital information symptoms and conditions

I am relaying the story of the granddaughter of my boss. She was 15 when she got the first shot of Gardisil in May of 2007. Within hours of the shot, she collapsed and an ambulance was called because she had distressed breathing. She was taken to a hospital and was in intensive care for 2 weeks in and out of consciousness. In the meantime, her mother tried to get the shot records from the doctor's office that gave the shot. They did everything in their power to:
A.Dismiss the correlation between the shot and the girl's collapse, despite the girl being in good health before the shot.
and
B.Keep the parents from getting hold of the vaccination records.
It was like pulling teeth to even get the vaccination batch numbers, and finally the office told the parents that somehow, the girl's health records went "missing". Luckily, the parents still had copies of most of the doctor visits, plus the "aftercare" paper following the shot with vital information on it.

When the girl finally began to be able to sit up again and eat on her own, she experienced mental fuzziness, memory problems, and speech problems. She had perpetual tingling and jolts of pain on the arm that had gotten the shot, in her side and abdomen and down both legs. Three weeks after the shot, she tried to get up out of bed and found she could not walk. She was diagnosed tentatively with Guillain-Barre Syndrome, also with nerve damage. It took her three full months to walk again without help, and even now, a year and a half later when she comes into the office she still has a bit of a limp. She lost over 25 pounds, which is pretty sad as she was not overweight or anything. She now looks very skinny and sickly. She had to quit school and started being home schooled because of the physical and memory problems and depression. I feel so sorry for her and her parents, who thought they were doing the right thing.

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" 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