Government-funded medical experiments on babies

Government-funded medical experiments on babies risked blindness and death, over 23 prestigious universities involved


(NaturalNews) In a sick experiment on humans that eerily resembles the
horrors of the infamous Tuskegee syphilis study, which involved
deliberately infecting hundreds of black men with sexually-transmitted
diseases between 1932 and 1972, a cohort of researchers from at least 23
prestigious American universities is the center of a new controversy
involving medical experimentation on premature babies. According to The New York Times
(NYT), parents who allowed their children to participate in a recent
oxygen study were not properly informed about the serious risks
involved.

These risks included blindness and death, both of which
are common particularly among premature babies when the oxygen levels
they breathe are either too low or too high. But the orchestrators of
taxpayer-funded research involving both the deprivation and
over-administration of oxygen to premature babies failed to disclose the
severity of these risks to the babies' parents, which ended up coming
as a surprise in the form of eye disease and early mortality. And a
prominent government agency whose purpose it is to protect research
participants from harm agrees.

"[T]here is significant evidence
from past research indicating that the oxygen provided to an infant can
have an important effect on many outcomes including whether the infant
becomes blind, develops a serious brain injury or even possibly whether
the infant dies," explains the U.S. Office for Human Research Protections
(OHRP) in a recent letter. The risks associated with participating in
the trial, the agency adds, "were not the same as those receiving
standard care."

Stanford, Duke, Yale and many others appear to have violated federal informed consent laws

The
study in question took place between 2004 and 2009, and involved 1,300
infant participants, all of whom were born early at a time between 24
and 27 weeks of gestation. These high-risk participants were assigned to
either high- or low-oxygen treatment groups, and were subjected to said
treatments for observation purposes. The results of the study were
published in the New England Journal of Medicine (NEJM) in 2010.

But after hundreds of babies
died or developed eye disease, parents and others decided to take a
closer look at the consent forms issued in conjunction with the study.
It was determined, upon investigation, that the consent forms failed to
mention either blindness
or death as a possible outcome for infant participants, and instead
only mentioned very minor risks such as abrasion to infants' skin that
may occur as a result of being hooked up to an oxygen monitoring device.
Worse, the same consent forms actually alleged that infant participants
could derive health benefits from the treatments, including a lowered
risk of needing eye surgery in the future.

"t [is] well
recognized that changing a premature infant's amount of exposure to
oxygen could have an impact on a number of important health outcomes,
including the development of severe eye disease (and possibly
blindness); reduced neurologic[al] development, including brain damage;
chronic lung disease; and could even lead to death," adds the OHRP
letter, noting that none of these risks were plainly disclosed in the
study's consent forms.

You can read the complete OHRP letter here:
http://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf

As
pointed out by many commenters on the NYT article, OHRP's active
response to this blatant violation of federal informed consent
requirements contrasts with its complacency in addressing the nationwide
experiment involving electronic medical records. Such devices are now
being widely used despite having never received approval by the U.S. [i]Food and Drug Administration (FDA), which means they are in clear violation of the Federal Food, Drug, and Cosmetic Act (FD&C).

Source:-
http://www.naturalnews.com/040057_medical_experiments_infants_universities.html