A mother holds her child’sshoulder helplessly as he shakesuncontrollably on the grass.
Thechild is in Status Epilepticus—his brain’sneurons are generating a storm of electricalsignals, causing a prolonged seizure thatwill not stop without medical intervention. The ambulance arrives, and the paramedicsadminister medicine that quells the seizure.Although long-lasting seizures are oftenfatal, this child’s life is saved.Seizures arise from disturbances to theelectrical connectivity or activity of thebrain, which arise from a variety of factorsincluding epilepsy, drugs, tumors, stroke,and injury. Regardless of the cause, theshorter a seizure lasts, the better a person’schances for recovery. “You want to stopa seizure as soon as you can,” says JamesQuinn, MD, Associate Professor andResearch Director in Emergency Medicineat Stanford Medical School. “Paramedicsnow stop them with medications in thefield, but there’s a big variation in practiceabout what medications to use.” The scene of the mother and childplays on a video on a StanfordMedical School seizuretreatment research website. Thethree-year seizure treatmentstudy— RAMPART, or RapidAnticonvulsant MedicationPrior to Arrival Trial—seeks todetermine whether injectionor an IV line is a moreeffective meansof administeringmedication to stopseizures. What isinteresting is the videois an advertisement forthe study, which will takeplace in seventeen academicmedical centers includingStanford. Quinn and colleaguesacross the country are on schedule to launchthe study in the beginning of 2009, and thepublic declaration is necessary because of aprickly point. The patients who participate inthe study will not be conscious to give theirinformed consent, or to object. This type of research is under the categoryEFIC, a medical equivalent of Code Red todenote emergency medicine research in theextreme cases of life-threatening situations:Exception from Informed Consent. Thisis Stanford’s first EFIC study. What thismeans, then, is that Stanford exhibits publicdiscussions of research so that the subjectcommunity understands the study, andperhaps more importantly, is given theopportunity to refuse to participate.
The Facts
With funding from the National Instituteof Health, or NIH, the study will be part of the Neurological Emergencies Treatment Trial Network, or NETT, which consistsof seventeen academic medical centers,including Stanford and UCSF. As William G.Barsan, MD, of University of Michigan saidin the online video for the RAMPART study,“Research in an ambulance or in the ER ishard to do, so as a result, we often don’tknow the best ways to treat patients duringthe first few critical minutes and hours afteran emergency. “ In the particular case of seizure treatment, paramedics have the rightmedicines. What they do not know is thebest way of administering them. There are two primary methods, bothof which are used by paramedics in thefield, and doctors in the hospital. Thefirst administers Lorezepam directly intoa vein through an IV. The mechanics of medicine flow in the blood stream enablefast absorption and a quick response, butstarting an IV in a person who is seizingis difficult. The medic must hold theseizing patient steady while he applies a
Stanord RAMPARTSeizure Study
Quelling electricalstorms of the mindwithout activeconsent
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tourniquet, a compressing device such as arubber band, to engorge veins and identifyone suitable for injection. He must thencarefully insert the IV needle into the veinwhile the patient’s body, and all this whilethe patient’s body convulses violently. This necessary set up time often delaystreatment. The second method is to give Midazolam asa shot into a muscle using an auto-injector,similar to the Epi-pen used for patients withsevere allergies. While this administrationmethod is faster, the medicine’s entrypoint prevents it from stopping the seizurequickly, as the medicine does not directlyenter the bloodstream.In the study, half the patients will receiveLorezepam through an IV and a placeboshot, and the converse—Midazolamtrough the shot and a placebo IV—will betrue for the other half of patients. It willbe a double-blind experiment, and thusneither the patients nor the paramedicswill know which source provides the actualmedicine, eliminating a potential source of psychological interference.An important point is that both Lorezepamand Midazolam are used by paramedics asstandard procedures for treating patients instatus epilepticus. Both administrations haveequivalent risks—since seizure medicationsare designed to reduce hyper mentalactivity, common side effects includesedation and shortened breathing.Ultimately, the study will determine not onlywhich method stops seizures fastest, butalso which yields less serious side effects. Today, the better procedure for treating aprolonged seizure is unknown, and after thestudy, it will not be—a fact with significantimplications for the standardization of medicine practice and for countless lives.
Community Discussionof the Study
The controversial point of the study isthat by the EFIC procedure, any patientin status epilepticus within one of themedical centers performing the study isautomatically registered for the study. Inother words, for the sake of science, consentis implied.Before sci-fi visions of maniacal doctorsflash before you, rest assured that manysteps were taken to ensure a study like thisis well understood by the community. First,Stanford formed community focus groupsin which the study was discussed andresponses measured. According to Dr. Quinn,87-89% of people strongly agreed with thebasis of the study, which allowed the studyto proceed to larger scale promotion.While this reaction is very favorable, thefundamental controversy of the consentis that people must actively declineto be in the study, rather than activelyprovide consent. Opposed members of the community must contact StanfordMedical Center to receive a medic alert tagspecifically declining participation in thestudy. In order to spread awareness of thestudy, public discussion of the study wasbroadcast on Stanford TV and news showsas well as the Dr. Dean Edell radio program. The Stanford community has been stronglyfavorable to the study, and so the study isset for trials at the start of 2009.
The Ethics of the Study
While the science of the double-blind testis sound, the heart of the matter lies withthe ethics: is it right that patients be pulledinto the study without explicit consent? Whymust the patients be active about refusingthe study, rather than active about being init?
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Lorezepam is directlyinjected into the bloodstream to fight seizures.The downside, is thatthe drug must beinjected while theperson is movingerratically.
Humans are veryunlike lab equipmentand testing modules.A doctor simply doesnot experiment with alife.
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