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BIO + MED by VIVEK ATHALYE

Stanford RAMPART Quelling electrical


storms of the mind

Seizure Study without active


consent
A mother holds her child’s across the country are on schedule to launch
shoulder helplessly as he shakes the study in the beginning of 2009, and the
uncontrollably on the grass. The public declaration is necessary because of a
child is in Status Epilepticus—his brain’s prickly point. The patients who participate in
neurons are generating a storm of electrical the study will not be conscious to give their
signals, causing a prolonged seizure that informed consent, or to object.
will not stop without medical intervention.
The ambulance arrives, and the paramedics This type of research is under the category
administer medicine that quells the seizure. EFIC, a medical equivalent of Code Red to
Although long-lasting seizures are often denote emergency medicine research in the
fatal, this child’s life is saved. extreme cases of life-threatening situations:
Exception from Informed Consent. This
Seizures arise from disturbances to the is Stanford’s first EFIC study. What this
electrical connectivity or activity of the means, then, is that Stanford exhibits public
brain, which arise from a variety of factors discussions of research so that the subject
including epilepsy, drugs, tumors, stroke, community understands the study, and
and injury. Regardless of the cause, the perhaps more importantly, is given the
shorter a seizure lasts, the better a person’s opportunity to refuse to participate.
chances for recovery. “You want to stop
a seizure as soon as you can,” says James The Facts
Quinn, MD, Associate Professor and With funding from the National Institute
Research Director in Emergency Medicine of Health, or NIH, the study will be part of
at Stanford Medical School. “Paramedics the Neurological Emergencies Treatment
now stop them with medications in the Trial Network, or NETT, which consists
field, but there’s a big variation in practice of seventeen academic medical centers,
about what medications to use.” including Stanford and UCSF. As William G.
Barsan, MD, of University of Michigan said
The scene of the mother and child in the online video for the RAMPART study,
plays on a video on a Stanford “Research in an ambulance or in the ER is
Medical School seizure hard to do, so as a result, we often don’t
treatment research website. The know the best ways to treat patients during
three-year seizure treatment the first few critical minutes and hours after
study— RAMPART, or Rapid an emergency. “ In the particular case of
Anticonvulsant Medication seizure treatment, paramedics have the right
Prior to Arrival Trial—seeks to medicines. What they do not know is the
determine whether injection best way of administering them.
or an IV line is a more
effective means There are two primary methods, both
Credit: sxc.hu

of administering of which are used by paramedics in the


medication to stop field, and doctors in the hospital. The
seizures. What is first administers Lorezepam directly into
interesting is the video a vein through an IV. The mechanics of
is an advertisement for medicine flow in the blood stream enable
the study, which will take fast absorption and a quick response, but
place in seventeen academic starting an IV in a person who is seizing
medical centers including is difficult. The medic must hold the
Stanford. Quinn and colleagues seizing patient steady while he applies a

12 www.stanfordscientific.org
BIO + MED

tourniquet, a compressing device such as a


rubber band, to engorge veins and identify
Community Discussion
one suitable for injection. He must then
of the Study Lorezepam is directly
The controversial point of the study is injected into the blood
carefully insert the IV needle into the vein
that by the EFIC procedure, any patient stream to fight seizures.
while the patient’s body, and all this while
in status epilepticus within one of the The downside, is that
the patient’s body convulses violently.
medical centers performing the study is the drug must be
This necessary set up time often delays
automatically registered for the study. In injected while the
treatment.
other words, for the sake of science, consent person is moving
is implied. erratically.
The second method is to give Midazolam as
a shot into a muscle using an auto-injector,
Before sci-fi visions of maniacal doctors
similar to the Epi-pen used for patients with
flash before you, rest assured that many
severe allergies. While this administration
steps were taken to ensure a study like this
method is faster, the medicine’s entry
is well understood by the community. First,
point prevents it from stopping the seizure
Stanford formed community focus groups
quickly, as the medicine does not directly
in which the study was discussed and
enter the bloodstream.
responses measured. According to Dr. Quinn, it: sx
c.hu
Cr e d
87-89% of people strongly agreed with the
In the study, half the patients will receive
basis of the study, which allowed the study
Lorezepam through an IV and a placebo
to proceed to larger scale promotion.
shot, and the converse—Midazolam
trough the shot and a placebo IV—will be
While this reaction is very favorable, the
true for the other half of patients. It will
fundamental controversy of the consent
be a double-blind experiment, and thus
is that people must actively decline
neither the patients nor the paramedics
to be in the study, rather than actively
will know which source provides the actual
provide consent. Opposed members of
medicine, eliminating a potential source of
the community must contact Stanford
psychological interference.
Medical Center to receive a medic alert tag
specifically declining participation in the
An important point is that both Lorezepam
study. In order to spread awareness of the
and Midazolam are used by paramedics as
study, public discussion of the study was
standard procedures for treating patients in
broadcast on Stanford TV and news shows
status epilepticus. Both administrations have
as well as the Dr. Dean Edell radio program.
equivalent risks—since seizure medications
The Stanford community has been strongly
are designed to reduce hyper mental
activity, common side effects include
favorable to the study, and so the study is Humans are very
set for trials at the start of 2009.
sedation and shortened breathing.
unlike lab equipment
Ultimately, the study will determine not only The Ethics of the Study and testing modules.
which method stops seizures fastest, but While the science of the double-blind test
also which yields less serious side effects. is sound, the heart of the matter lies with
the ethics: is it right that patients be pulled
A doctor simply does
Today, the better procedure for treating a
prolonged seizure is unknown, and after the into the study without explicit consent? Why not experiment with a
study, it will not be—a fact with significant must the patients be active about refusing
implications for the standardization of the study, rather than active about being in life.
medicine practice and for countless lives. it?

volume VIII 13
BIO + MED

One may take a step back and look upon carcasses behind him as he pushes forward
medicine with a larger scale perspective on his path to greater knowledge. While the
u to find an answer. When a patient arrives scientist must be a cool, objective observer
c.h
sx unconscious in the ER, doctors act on who watches as his inserted chemical brings
it:
ed
Cr the assumption that the patients want poisonous death to the bacteria strain or as
the doctors to do their best to save the the over-amplified signal causes black smoke
patients’ lives. They treat them as best to emanate from a circuit board—the doctor
they can though do not have consent. But looks upon a patient with understanding of
as a doctor says on the RAMPART video, both the mechanics and biology of the body
“Sometimes we don’t know for sure what and the emotion of his being.
is best. Some treatments are truly tested,
and some are used because they might The human condition complicates the

Credit: sxc.hu
be good.” Subtle and silent is the fact that scientific method, as a doctor from the
doctors do not always know what will work RAMPART website points out, “It is difficult to
well. Their actions, grounded in concern do research in emergency medicine because
and compassion for the patient’s life, stem of the conditions. Because of that, doctors
from underlying science, which requires don’t have scientific backing for emergency
experiments—experiments that are not procedures enacted in the crucial minutes
easy to do when it comes to human lives. immediately after an accident.”
Humans are very unlike lab equipment and
testing modules. A doctor simply does not However, there is no denying that the power
experiment with a life. of medicine is the power of science. For a
relevant illustration, before 2001, paramedics
The RAMPART study functions as EFIC were not even allowed to administer drugs
because it does not present any additional to seizing patients. The monumental PHTSE
risk to the patient, and, as Dr Quinn said, study of the late 90’s, also EFIC, determined
“there’s just no other way to do this kind of that administration of anticonvulsant
research.” He concedes, “This sort of study is medication was an effective and safe
obviously a huge burden for ethical reasons. treatment for seizing patients. Because of
As a doctor, there’s nothing more important that EFIC study, many lives have been saved.
than the health and rights of the patient.”
The RAMPART study will change the way all
Medicine is at an interesting intersection of future seizing patients will be treated. That
science and more compassionate service. is what patients are giving with their implied
Humans are very In the perspective of science, the body is consent. What the seizure study presents
a dynamic experiment in action—provide is an example of how science and human
unlike lab equipment an input, measure an output. From the compassion can work together to change

and testing modules. perspective of a doctor helping a fellow


human being, the body is the seat of the
lives.

A doctor simply does person’s soul, and no life can be treated


as an expendable test subject. The doctor To Learn More
For more information, including a video
not experiment with a is unlike the scientist who cracks open
the body of a system to understand how
and a survey, please visit www.med.
stanford.edu/survey/rampart
life. it works and leaves a trail of these test

14 www.stanfordscientific.org