Circare   (Paul Gelsinger, Adil Shamoo Ph. D, Michael Susko)

Subject: LACK OF INFORMED CONSENT IN CASE OF DANIELLA ROGERS
Date: Sat, 01 Mar 2003 13:16:27 -0500
From: CIRCARE

REGARDING: THE LACK OF INFORMED CONSENT IN THE CASE OF DANIELLA ROGERS
The case of Daniella Rogers, for which a determination letter by the Office of Human Research Protection has recently been issued, raises serious concerns, as layers of protection broke down leading to a lack of informed consent and an avoidable death.

1.The parents of Daniella were not informed of the real risks of chemotherapy, in this case standard treatment for a type of smooth muscle tumor. Liver damage was listed, but not liver failure with a risk of death. In similar previous (IRSG-COG) studies, there had already been two previous deaths from liver failure.
2. Daniella was in a "control" group and her parents told she would be given the "standard treatment" which had a high success rate. The parents were not informed, however, that dosing was two times the normal rate and that it would be given as one dose rather than pulsed over a five day period - in effect becoming a type of experimental treatment itself. The attending physician, Dr. Wilson, commented in his notes that live failure was the direct result of "high dose cytoxan."
Human beings are not simple material for novel protocols, and experimenters should risk accurately informing their subjects of possible harms, so that true informed consent can be obtained.
CIRCARE believes that great care and caution should be exercised in all human subject studies, especially with vulnerable children.

Michael A. Susko
President of CIRCARE
410-435-4895
msusko@mindspring.com

For more information on this story see the web site http://www.daniellarogers.org

Additional Media contact:
Adil E. Shamoo, Ph.D.
Co-founder, CIRCARE
Department of Biochemistry and Mol. Bio.
108 N. Greene Street
Baltimore, Maryland 21201
Tel#: 410-706-3327
Fax#: 410-706-3189
http://www.umaryland.edu/bmb/shamoo.htm

New Officer for CIRCARE
Friends, Colleagues, and Media Professionals:

CIRCARE announces that Paul Gelsinger has been elected Vice President of Citizens for Responsible Care and Research. Paul is active, in his own right, as a national advocate for protections of human subjects, particularly in the area of genetic research. Paul would like to add a few comments below on his decision to join CIRCARE and his hopes for the future.

Three years ago, being an active part of the research environment was the farthest thing from my mind. In September 1999 my son, Jesse, died as a direct result of a gene therapy clinical trial, a safety and efficacy study that offered him no long term benefit. Investigations into the reasons for his death uncovered areas of great concern for me. While the doctors and institution involved made serious ethical errors, I discovered that what happened was not that unusual. Non-reporting of serious adverse side effects in most of gene transfer research was widespread. I was and remain deeply disturbed by the financial influences exerted on researchers and our government. Belonging to CIRCARE has brought me a greater knowledge regarding the problems inherent to the human research endeavor, especially in the areas of informed consent, conflict of interest, and government oversight. I appreciate the opportunity given to me as vice-president, a position that should enable me to offer a stronger voice for the average person wishing to participate in research.

Paul Gelsinger Vice President of Circare

Michael A. Susko
President of CIRCARE
410-435-4895
msusko@mindspring.com

Additional Media contact:
Adil E. Shamoo, Ph.D.
Co-founder, CIRCARE
Department of Biochemistry and Mol. Bio.
108 N. Greene Street
Baltimore, Maryland 21201
Tel#: 410-706-3327
Fax#: 410-706-3189
http://www.umaryland.edu/bmb/shamoo.htm

Subject: Infomail regarding death at St. Louis Children's Hospital
Tue, 28 May 2002 18:01:57-0400
From: "CIRCARE" <msusko@mindspring.com>
To:<msusko@mindspring.com>
To Friends, Colleagues and the Press:

CIRCARE has concerns regarding a recent death (May 3) of an 18 month old child, Daniella Rogers, at St. Louis Children’s Hospital in human subject research.

1. The appropriateness of using 18 month year old children in a research protocol, rather than engaging in standard treatment. In this case, the subject was in the group given the standard treatment, but another group was given a novel treatment.
2. The risks of the research were not properly identified - most importantly a side effect of the treatment - veno-occlusive disease, which was reported at least in two cases prior to Daniella's death, in which one resulted in a fatality and one a serious adverse event.
3. According to the father, the child was not properly monitored during research protocol, so that symptoms a couple days previous, early warning signs of veno-occlusive disease, were missed.
4. The fact that alternative treatments were not identified.

Currently the Office of Human Research Protection is looking into this case, and the parents of Daniella hope that reform can be initiated so that future deaths and the tragedy they have endured will not be repeated.

Michael A. Susko
President of CIRCARE
Visit CIRCARE on the internet: http://www.circare.org

Media contacts:
Adil E. Shamoo, Ph.D.
Co-founder, CIRCARE
Department of Biochemistry and Mol. Bio.
108 N. Greene Street
Baltimore, Maryland 21201 Tel#: 410-706-3327
Fax#: 410-706-3189
http://www.umaryland.edu/bmb/shamoo.htm
Michael A. Susko, 410-499-4895, msusko@mindspring.com

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