What is the Pediatric Seizure Study?
The Pediatric Seizure Study, a double blind study, will enroll children without parental consent, from 3 months to 18 years of age, who will be admitted into 11 hospitals with status epilepticus, defined as continuous, unrelenting seizures, in an effort to determine which of the two drugs, diazepam or lorazepam, is the most effective and best for treating children. At present, lorazepam is not approved by the Food and Drug Administration (FDA) for use in children.
The National Institute of Child Health and Human Development (NICHD), which sponsors research on development before and after birth, concerning maternal, child and family health, as well as reproductive biology and population issues and medical rehabilitation will be the branch of the National Institutes of Health (NIH) sponsoring the Pediatric Seizure Study.
The NIH News release, at the NICHD website, asks and answers the question:
Who is at risk for status epilepticus?
Status epilepticus may occur in anyone who has seizure disorder, which is often called epilepsy. The condition often results from failure to take medications that are used to prevent seizures. It may also occur in response to such conditions as meningitis (infection of the fluid around the brain), brain tumor, head injury, extremely high fever or low blood pressure.
It is also stated that children with no apparent risk factors may experience status epilepticus. The urgency in treating this condition, which according to the NIH results in death in 4 percent of its cases, allows for possible inclusion of children without their parents' consent or input in deciding which of the drugs may be used.
The hospital and universities which will be participating in the Pediatric Seizure Study, provided by the NICHD at its website, will be:
Children's National Medical Center, Washington DC
University of Maryland for Children, Baltimore, MD
Children's Hospital Boston, Boston, MA
Children's Hospital of Philadelphia, Philadelphia, PA
Children's Hospital of Wisconsin, Milwaukee, WI
Primary Children's Medical Center, Salt Lake City, UT
Women and Children's Hospital of Buffalo, Buffalo, NY
University of Rochester Medical Center, Rochester, NY
Children's Hospital of Michigan, Detroit, MI
University of Michigan Health System, Ann Arbor, MI
The article, No Parental Consent for Pediatric Seizure Study, discusses in detail concerns I have raised pertaining to this experiment that denies parental involvement in possibly life threatening decisions to be made regarding their children.
The news release found at the NICHD website, in addition to listing the locations participating in this study, also provides more details regarding the experiment and restates some of the same facts that are outlined in the National Institutes of Health (NIH) announcement at NIH News of the same date, May 23, 2007.
In October 1996, the FDA created new regulations and guidelines that allow for researchers to enlist individuals into study experiments without informed consent after it has been determined that certain criteria are met. These criteria can be found in the article, Who Will Speak for the Voiceless.
The news release posted at the National Institute of Child Health and Human Development (NICHD) also asks and answers this question with two options:
What if parents do not want their child to participate?
Parents/guardians may decline to have their child take part in the study, either before the child experiences status epilepticus or even during an episode of status epilepticus when they are present with their child in the emergency department.
Families will be given every opportunity to decline to participate before a medical emergency arises. If a child resides in a study area and his or her parents do not want the child to participate, the parents may contact the center in their area to make their wishes known. (Participating centers are listed at the end of this document.) Children who decline to participate in the study will still receive the best medical care for their seizure.
The first option, parental involvement at the scene in the emergency room, is an already established practice. The second option, contacting the hospital or university participating in the study in the area where the family lives, prior to the need for emergency services, does not address the possibility of the child's inclusion in the study if the need for emergency treatment arises, for instance, while the child is out of the area and they are treated at another hospital involved in the study.
The second option, which is an inadequate option, will only provide total parental involvement for declining participation in the study if parents or guardians of every child in every city where the study will be conducted, contact all of the hospitals in the study, those in and outside of the areas where they live, since status epilepticus may occur in children as a result of other factors or conditions as stated above, other than in children with a diagnosed history of epilepsy, such as meningitis, brain tumor, head injury, extremely high fever, low blood pressure, as well as children with no apparent risk factors.
In answering the question, How would children be enrolled in the study? , it is explained, due to time factors, if parents weren't allowed to give informed consent, they will be notified as soon as possible when the child is stable and given the option to withdraw from the study. It also states:
The study will be stopped as soon as researchers know which medication offers the best treatment.
No additional time frame for how long this experiment will be conducted is given nor is an estimate given for how many children may be involved in this study. Some participating study sites will begin "within a few weeks" states the release, with others not expected to begin for several months.
In the NIH News release, linked at No Parental Consent for the Pediatric Seizure Study, it states:
Status epilepticus affects between 50,000 to 60,000 children and adults in the United States each year, explained the study’s principal investigator, James Chamberlain, M.D., Division Chief of Emergency Medicine at Children's National Medical Center in Washington, D.C. He added that four to eight children per every 1,000 will experience status epilepticus before age 15. Status epilepticus may occur in patients with epilepsy or in patients without epilepsy who experience a seizure due to a high fever, low blood sugar, an infection of the central nervous system, or a head injury. Children who have no apparent risk factors may also develop status epilepticus.
What percentage of these annual estimated 50,000 to 60,000 persons will be children? What percentage of these children will be seen by the 11 hospitals conducting this study? All of the planned community outreach, regarding this experiment, or any experiments, meant to let everyone know that there will be an experiment, still deprives individuals, and in this specific case, parents and guardians of children the right of informed consent, a fact that is not negated because the community was informed that the study would be occurring and this reality is unacceptable.
As I stated previously in Research Versus Freedom of Choice:
A possible solution to eliminate short circuiting individual choice (of informed consent) would be some form of prior consent to be devised, to be kept on file, where a patient would state, much like in the case of organ donation, that they choose or do not choose to participate in experiments if they are unable to speak for themselves and time prevents family or representation for the patient to be contacted for informed consent.
In the case of individuals who do not have adequate health care, or no health care at all, as a great many do not have in the U.S., whenever these individuals are seen, usually on an emergency basis, they may be asked to complete the form. Current technology provides for the option of an on line declaration of one's choice to be involved in or not involved in an experiment as well. Some form of outreach should be devised to attempt to address this crucial issue.
Freedom of choice to not be experimented upon must not be given away simply because it may be difficult or impossible to acquire consent from an incapacitated patient or the unfortunate factor of time stands between an experimenter and distraught family members or representatives needing to be included in decisions regarding the injured patient, who is in need of the best medical services that can be provided to them.
The Pediatric Seizure Study , with a link at www.dcchildrens.com, identifies its research network as the Pediatric Emergency Care Applied Research Network (PECARN) , "....the first federally funded, multi-institutional network for research in pediatric emergency medicine."
At the Pediatric Seizure Study site, maintained by the Children's National Medical Center in Washington, D.C. , a Participant Refusal Form is available for opting out of the experiment, to be faxed to a Washington, D.C. area number. The form includes this instruction to parents or guardians:
In order to assure that your child will not be enrolled, we may send a bracelet that your child must wear at all times so that if you come to the Emergency Department the doctors will know right away that you have chosen not to participate.
Click here for a list of some ongoing PECARN studies.