A Mother's Thoughts on the Pediatric Seizure Study

Photos

A Mother's Thoughts on the Pediatric Seizure Study

see larger image

uploaded by Karen Hatter

Anyone who may have read either of my articles, What is the Pediatric Seizure Study or The Research Network of the Pediatric Seizure Study, possibly both, (Thanks, by the way!) may have glimpsed my feelings regarding this study that will enroll children, 3 months to 18 years of age, without parental consent and in a state of status epilepticus, into a study to determine which of two drugs, diazepam, also known as Valium or lorazepam, also known as Ativan, will be most effective and best for use in children. Only one of these two drugs, diazepam, has been approved by the Food and Drug Administration (FDA) for use in children.

Click here for a refusal form, available at the Pediatric Seizure Study web site, hosted by the Children's National Medical Center in Washington, D.C. A link to this form can be found under Your Feedback at the site. This form informs parents or guardians that, " .... we (the hospital) may send you 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 you have chosen not to participate."

A NIH News release, at the National Institute of Child Health and Human Development (NICHD) website, asks and answers this question about the condition status epilepticus:

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.

I state, for the record, I am a mother of two teen aged daughters. I am also the grandmother of two grandsons under the age of twelve. Why am I so riled about this study? Well, for one thing, it just so happens that I live not too far from one of the hospitals in this study.

It is also a fact that, rather frequently, my family and I spend time in another of the cities that has been identified as having a hospital conducting this study. Remember, this study deals with emergency circumstances, which could occur at any time, anywhere. My daughter recently joined her class on a field trip to that other city!

Secondly, it is my opinion, after reading all of the rationales given at the various sites promoting this study, that the main reason for initiating this and all of these studies during emergency circumstances is to circumvent the rights of patients and their families, guardians or representatives.

Who can expect that any parent, guardian or representative, charged with representing their loved one or dependent, in this instance, a child in need of emergency treatment, when asked if their loved one could be included in a study where the loved one may or may not receive specific treatment, since the study is a double blind, would say, " Yes, most definitely, please experiment on them!"?

In my opinion, citing chaotic surroundings as a basis for overriding parental authority, has resulted in a shameful attempt to quasi dismiss the parent, guardian or representative's ability to assess or understand information in order to make an informed decision and is stated at the Pediatric Seizure Study site under Exceptions from Informed Consent:

Patients with seizures are frequently transported via ambulance in an environment that is very noisy and chaotic, preventing the opportunity to present a research study in a calm, systematic manner

I agree that this characterization of what may be happening on the scene is, for the most part, a true statement of fact. However, because, I, as a parent, may be emotionally involved in my child's welfare, does not impair my judgment regarding whether or not I want my child to be experimented upon nor should my child be experimented upon without receiving my permission prior to an experiment being conducted!

Because circumstances prevent or hamper the researchers' ability to present the study, ".... in a calm, systematic manner....", does not translate into a situation where the researcher should now decide, for me, that my loved one should be used in that manner!

Emergency treatment often requires medications be given or strategies used and performed, without the informed consent of the patient, loved one, guardian or representative. However, being treated during emergency circumstances and being experimented upon during emergency circumstances are not the same thing!

If it is determined that the window of inclusion of subjects into studies is narrow and time will not permit seeking informed consent, when the study is a double blind study, the choices and decisions to be made by the physician and medical team are also overridden by the guidelines of that particular study, possibly resulting in the medical professional's inability to give their best service, since their input or choice is not being exercised.

I am well aware that all of these studies have been approved of and passed with the acceptance of most ethics boards within the medical community, who may have been called upon to review these strategies and guidelines.

This flagrant disregard and disconnect between incapacitated patients and their loved ones or representatives exercising the right of informed consent for those in need of emergency medical treatment and procedures does not lay solely at the feet of the research medical community. This must be laid at the feet of the United States government, through it's agency, the Food and Drug Administration (FDA).

I want to know WHY every household in the U.S. was not informed, in 1996, that children and adults could very well be enrolled in studies without their consent! My articles, Ignoring Patient and Family Rights and Who Will Speak for the Voiceless, detail the experiments being conducted by the Resuscitation Outcomes Consortium to be carried out on unconscious, adult patients.

Given specific circumstances and opportunities, if anyone of us may have the unfortunate luck to have to be seen in an emergency room that may be part of a network, similar to the Pediatric Emergency Care Applied Research Network (PECARN) or the Resuscitation Outcomes Consortium (ROC), we may be used in an experiment, without our consent, provided certain aspects of patient conditions fit those desired by the researchers.

I am unsure how this situation can be turned around. You can't unring the bell but, I think the first thing anyone who finds this situation several levels above unacceptable may want to do is canvass their neighborhood hospitals to determine what may be the likelihood that anyone in their family or themselves may be enrolled in a study without their consent, especially identified teaching hospitals.

The next step may be, after weighing personal convictions, to devise a strategy for notifying hospitals in the area of wishes NOT to be enrolled nor to enroll children of the family, if that is one's personal choice.

If there aren't any feelings one way or the other regarding this issue or you wish to be included in any of these current, ongoing studies or any future studies, nothing need be done, aside from inquiring of facilities in your area and outside of your area of your desire to participate.

In the overall scenario, if circumstances arise for use of persons in a study, within a hospital where treatment being sought is enrolled as a participating hospital, under the Exceptions From Informed Consent provisions established by the FDA, persons may possibly be enrolled anyway.

Letters or e mails to elected officials may serve some use. Most of these actions, like this authorization to do research without informed consent, have come into being as the result of legislation passed, calling for some form of action to be taken by one governmental branch or agency, which in turn passed it on. Someone then wrote legislation, enacting a law(s) and, EUREEKA!, we now have these situations legally sanctioned!

Maybe through the legislature, some sort of roll back or rescinding of this practice of enrolling people in emergency settings into studies without their consent could be sought.

I want the ability to seek the best medical care that can be offered to myself and my family and I support the general spirit of medical research. Yet, I do not feel that citizens, as individuals, parents and guardians, should have their freedom to choose what can be done to their bodies or persons or that of their loved ones taken away, at what may be some of the most crucial times our freedom of choice would be required, during what may also be some of the most critical times we may encounter in our lives.