ALLIANCE FOR HUMAN RESEARCH PROTECTION
(AHRP)
http://www.ahrp.org
Contact: Vera Hassner Sharav
212-595-8974
e-mail: veracare@ahrp.org
FYI
Eighteen month old, Daniella Rogers, died on May
3, 2002, two months after
undergoing a clinical trial of chemotherapy treatments
at St. Louis
Children's Hospital.
When her parents, John and Oksana Rogers, learned
that their baby daughter,
Daniella, had cancer, they knew she might die.
But they hardly expected that
the medicine that was supposed to save her would
instead take her life.
"It wasn't the cancer that killed her. It was
the treatment," Oksana Rogers
said
The St. Louis Post Dispatch reports: "The chemotherapy
drugs Daniella
received [ ] as part of a clinical trial caused
the blood in the small
vessels of her liver to clot like curdled milk.
Three other children died of
the same side effect before the study's sponsor,
Children's Oncology Group
of Arcadia, Calif., and the National Cancer Institute
temporarily suspended
the trial last year."
The federal Office of Human Research Protections
(OHRP)has ruled that the
University of St. Louis
medical school had not
spelled out the risk of veno-occlusive disease of
the liver, a rare but well-known reaction to commonly
used, toxic,
cancer-fighting drugs. [See
http://ohrp.osophs.dhhs.gov/detrm_letrs/YR03/jan03a.pdf
]
In this trial, the treatment-induced disease occurred
in about 1 out of 20
patients.
Four of the 360 children enrolled died of it.
However, an investigation by the FDA found "no
significant deviations."
The disagreement between the inspectors of two
federal agencies about what
constitutes
ethical / legal violations of informed consent
illustrates a lack of
consistent standards--even between two federal
oversight agencies.
"Daniella's case is one of the latest to raise
questions about the massive
clinical research industry, and to provoke debate
about how far researchers
must go to make sure subjects understand the risks."
The parents say they
were not told about the risks or the other deaths.
The circumstances of Daniella's death highlight
once again, disturbing
questions:
How safe is it to enroll a child in clinical research?
What constitutes informed consent?
Where can a family turn for help?
What compensation is there if research subjects
are harmed?
Who is accountable if ethical standards are violated
and death results?
The Post Dispatch correctly reports that OHRP's
finding "carries no
sanctions or fines."
The parents' public complaints led Washington
University to change its
informed consent for the remaining participants
in the cancer trial to
better reflect the actual risks.
The Post-Dispatch reports that "Washington University
wouldn't allow
[reporters] to interview its doctors about Daniella's
case because the
Rogers family has threatened to sue. However,
the university released
several statements and documents that defend its
actions."
According to the Post-Dispatch, FDA's chief of
human subject protection
division, Dr. David Lepay, credited the research
enterprise claiming that
his agency's inspectors "find far fewer problems
now than they did 25 years
ago, when perhaps 20 percent of trials failed
to meet key regulations. Now,
the number of violators is around 2 percent."
Given the risks in clinical trials are often involve
matters of life or
death, it is hard to understand FDA's disregard
for violations of federal
disclosure requirements which are necessary for
valid, informed consent.
If
the agency dismisses violations of informed consent
as "not significant
deviations," it is difficult to know what violations
FDA's inspectors do
consider "significant." Dr. Lepay's optimistic
calculation --2 percent
violations--is at best pulled out of a hat.
Full article with pictures of Daniella [whose
age was incorrectly stated in
the article]
and her parents are online at:
Death prompts scrutiny of research risks
By Sara Shipley Of the Post-Dispatch
02/15/2003 12:39 PM
________________________________________________________________________
Thu, 14 Nov 2002
Dying for a Cure: Pediatric Cancer Trial Undisclosed
facts - NBC, Chicago
How can parents protect their children from harmful medical
experiments if the facts are withheld from them? So far, Congress
has enacted no law to protect children from experiments that
disregard their life-safety in clinical trials.
An investigative news report aired last night by WMAQ-TV,
an NBC owned station in Chicago, focused on a government sponsored
pediatric cancer trial-- COG D9803. The station's investigative
team (unit 5) uncovered documents revealing previously undisclosed
deaths of 4 children, and 16 cases of a life-threatening side
effect of the drugs used to treat the cancer-- veno-occlusive
disease or VOD, (liver failure).
In
all, 300 children had been enrolled in the trial at 250 locations
in the US and abroad. See list:
http://www.nbc5.com/news/1781498/detail.html
NBC Unit-t reported that physicians received a $2,000
per case reimbursement for enrolling children in the trial,
COG D9803.
On July 22, 2002, the Station filed a Freedom of Information
request with the National Institutes of Health asking for
information on the federally-funded study, specifics of adverse-event
reports, and the number of deaths related to VOD. Less than
a month later, the trial was suspended and the Office for
Human Research Protections said it was beginning its own investigation.
Among
those interviewed were the parents of two child casualties:
twenty month old, Daniella Rogers, who died of VOD on On May
3, 2002, http://www.daniellarogers.org/ and the parents of
three and a half year old Travis Whitman, who died October
21, 2001. http://www.traviswhitman.com/
The parents claim
they were never warned about VOD--even though it is a life-threatening
risk. Nor, they claim, were they told that children enrolled
earlier had died in the trial.
John
and Oksana Rogers
contact@daniellarogers.org
More
Links To Daniella on the Web.
Research
Subjects News MSN
Childhood
Cancer Resources
Child
Organizations
/ Mental
Pediatric
Cancer - Rhabdomyosarcoma
WEB
DIRECTORY SITES - ABOUT Chemotherapy
Daniella's
Hometown AOL page.
Daniella's
MSN Site. (Rhabdo
Kids)
Johnny
& Janie Rogers Press Release (Daniella's Grandparents)
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