EPA To Allow Pesticide Testing On Orphans & Mentally Handicapped Children

The rule allows for government and industry scientists to treat children as human guinea pigs in chemical experiments in the following situations:

1. Children who "cannot be reasonably consulted," such as those that are mentally handicapped or orphaned newborns may be tested on. With permission from the institution or guardian in charge of the individual, the child may be exposed to chemicals for the sake of research.
2. Parental consent forms are not necessary for testing on children who have been neglected or abused.
3. Chemical studies on any children outside of the U.S. are acceptable.

• EPA believes its goal is to ensure, to the extent
possible, that all people who participate as subjects of human research
are treated ethically, are fully informed of the potential risks, and
experience no harm from their participation. We hope--through our
rules, policies, procedures, and regulatory actions--to discourage or
prevent the conduct of human studies that do not meet rigorous ethical
and scientific standards. (A scientifically inadequate human study is
inherently unethical, because it fails to provide new information
reliable enough to justify subjecting volunteers to any risks by
participating in the study.)
• EPA believes the federal government should use all of its
authorities to make clear that certain kinds of human research can
never be acceptable. In particular, we regard as unethical and would
never conduct, support, require, or approve any study involving
intentional exposure of pregnant women, infants, or children to a
pesticide.

1. Children who "cannot be reasonably consulted," such as those that are mentally handicapped or orphaned newborns may be tested on. With permission from the institution or guardian in charge of the individual, the child may be exposed to chemicals for the sake of research.
2. Parental consent forms are not necessary for testing on children who have been neglected or abused.
3. Chemical studies on any children outside of the U.S. are acceptable.


Moreover, they assert that while
the Agency cannot undo what has already happened, EPA can clearly
express its disapproval of past unethical conduct. They note that to
replicate scientifically sound but ethically flawed human studies may
not be ethical, no matter how carefully such replicate research might
be conducted, since any increment of risk to potential subjects would
not be justified by anticipated new generalizable knowledge. Holders of
this view also stress the importance of strengthening protections for
volunteers who participate in future studies, while taking advantage of
all that can be learned from past research to benefit society.
EPA finds compelling many of the points made by both sides, and
agrees with those who say that the possibility of conducting and using
human studies in regulatory decision-making must be approached with the
utmost caution. Each side bases its arguments on important societal
values. Our mission is to make the best possible regulatory decisions
to protect public health and the environment in this country, and to
support similar efforts around the world. We do not want to ignore
potentially important information that might benefit our decision-
making. At the same time, we agree that our conduct should encourage
high ethical standards in research with human subjects and strongly
discourage unethical research.

Submission of these studies following FQPA elicited a strong
expression of public concern. In response, EPA convened an advisory
committee under the joint auspices of the EPA Science Advisory Board
(SAB) and the FIFRA Scientific Advisory Panel (SAP) to address issues
of the scientific and ethical acceptability of such research. This
advisory committee, known as the Data from Testing of Human Subjects
Subcommittee (DTHSS), met in December 1998 and November 1999, and
completed its report in September 2000. Their report is available in
the docket for this proposed rulemaking, and on the web at:
www.epa.gov...
The DTHSS advisory committee heard many comments at their two
public meetings, and further comments have been submitted in response
to their published report. The committee agreed unanimously on several
broad principles, including the following:
• Any policy adopted should reflect the highest standards,
and special concern for the interests of vulnerable populations.
• The threshold of justification for intentional exposure of
human subjects to toxic substances should be very high.
• The justification cannot be to facilitate commercial
interests, but only to safeguard public health.
• Not only the nature and magnitude of risks and benefits
but their distribution must be considered in assessing research protocols.
• Bad science is always unethical.
Yet no clear consensus emerged from the advisory committee on many
other points, among them both the scientific merit and the ethical
acceptability of studies to identify or measure toxic effects of
pesticides in human subjects. A vigorous public debate continued about
the extent to which EPA should

www.democracynow.org.../12/22/151230&mode=thread&tid=25

A new BBC documentary exposes how the city of New York has been forcing HIV positive children under its supervision to be used as human guinea pigs in tests for experimental AIDS drug trials.
All of the children in the program were under the legal guidance of the city's child welfare department, the Administration for Children's Services. Most live in foster care or independent homes run on behalf of the local authorities and almost all the children are believed to be African-American or Latino.

The BBC identified pharmaceutical giant GlaxoSmithKline as one of the companies that provided the experimental drugs for the tests. In an email to Democracy Now! GlaxoSmithKline stated "pharmaceutical companies are not directly involved in the recruitment, enrolment or participation of patients in such trials." GSK went on to say "the FDA encourages studies in pediatric patients. Clinical trials involving children and orphans are therefore legal and not unusual."

www.democracynow.org.../05/02/1348210&mode=thread&tid=25

VERA SHARAV: These children were in foster care under the ACS, as well as Catholic charities. Many of the homes were run by them.

AMY GOODMAN: HIV+?

VERA SHARAV: HIV+. Now there’s even an issue about some of the trials, some of the protocols say that the children are, and I quote, “presumed to be HIV+.” Now, what kind of – what kind of society are we that children who are only presumed, and by whom are they presumed – what criteria makes them presumed to be HIV, that those children then get exposed to as many as seven highly toxic experimental drugs? These children were not in treatment, and ACS can’t fudge that. Research and treatment are two very different things. Our first question when we filed our federal complaint to the FDA and the Office of Human Protection a year ago – and those investigations, by the way, are still ongoing – we asked, why were those children denied the best treatment that was available, that was known already to be as effective as whatever it was?