Drugs tested on unsuspecting epileptic patients at area hospitals
When we think of clinical research, what comes to mind is the important advancement of medicine and the search for cures for health conditions that plagues us. Through a series of tests and studies, that may often take years to determine results, pharmaceutical companies and hospitals utilize controlled human studies. These studies are done with the consent and agreement of participants, who willingly engage in the trials to determine the effectiveness of new and promising medicines.
However, for Blacks, the history of medical studies on people of color without their knowledge or consent has been an indelible stain. Many refuse to participate in medical studies of anything, regardless of the need. When considering the honesty of the medical community, many Blacks point to the Tuskegee experiment and the histories behind the “advancement” in gynecology procedures, cervical cancer treatment, as well as other instances of ethical abuses as they question the value of taking the COVID-19 vaccination. Many are steadfast in their refusal to take the vaccine that could prevent them and their families from getting a virus that has already claimed over a half a million people in this country alone. Yes, medical studies and trials have come a long way since the Tuskegee study, with regulations being put in place to ensure that history does not repeat itself. However, some suggest that these rules and regulations need to be reviewed as recent news of a study that was being done without the consent of those in the study has come to light.
Yes, the metro Atlanta community is shocked to learn about the treatment of epileptic patients that entered the emergency rooms at Grady Memorial Hospital and Children’s Healthcare of Atlanta at Egleston. Patients who came to these facilities for help, as they were suffering from epileptic seizures, were being placed into a medical study without their knowledge or consent. From 2015 to 2018, patients with life-threatening epileptic seizures were unsuspecting lab rats for these medical institutions in Atlanta and 56 others nationwide.
With the goal of learning which medication was best, patients, ages 2 to 94 were randomly assigned, one of three approved anticonvulsant drugs after the patients failed to respond to initial treatment. Doing it without patients’ consent was legal under Exception from Informed Consent (EFIC), a federal rule. In 1996, the US Food and Drug Administration (FDA) created the EFIC pathway to allow some emergency trials to enroll patients without informed consent. Designed to provide for better study of emergency medicine, the law permits researchers to enroll patients without obtaining consent.
Public Citizen, a watchdog advocacy group based in Washington, D.C., is accusing the researchers and the regulators who approved the study of potentially endangering some patients’ health to let the research proceed. In a letter to federal regulators, Public Citizen is calling for review of the system that made it possible, alleging multiple flaws in the study’s design which resulted in hospitals under-dosing some patients, denying some patients the right drug at the right time, and failing to disclose those factors in consent forms presented to patients or their parents after the treatment was done. Furthermore, the letter says, even though researchers had an obligation to ensure an equitable population in the study group, the patients enrolled in the study were more likely to be African American than the population of patients historically hospitalized for the condition, called status epilepticus.
Compared to other hospitals in the nation conducting the study, Grady and CHOA provided a higher number of patients. Both Grady and CHOA are staffed by Emory University, who also conducts research at the hospitals. “This is among the most concerning trials I’ve seen in my experience,” said Dr. Michael Carome, director of the health research group at Public Citizen. Previously, Carome worked at the U.S. Health and Human Services Department’s Office for Human Research Protections.
Under normal circumstances, the first-line treatment is to give the patient a benzodiazepine drug. If the patient did not respond, the process was for patient’s doctor to decide what type of second-line treatment to offer, which would be one of three approved drugs levetiracetam, fosphenytoin, and valproate, to try to break the seizure.
In this study, treatment was changed from the normal next steps as the patient’s doctor was removed from making that decision and instead, the study randomly assigned one of those drugs. The doctor would then administer to the patient whatever that was. Only after the crisis was over were the patients or parents of the epileptic children informed about their enrollment in the study. The concern over this practice is because epilepticus has a significant mortality rate, the faster the seizure is stopped, the better for the patient. Enrolment in this study did not permit that and may have prolonged it in many cases. According to the watchdog’s analysis, among 462 patients enrolled, 12 died.
The National Institutes of Health, which funded the study, said in a statement that the study was important for the very reason that doctors need to choose the right drug and pushed back at Public Citizen’s charges about underdosing, saying the dose amounts followed national single-dose guidelines and did not result in adverse effects. As to the racial makeup of the patients, NIH said that was simply a factor of the hospitals chosen for the study. Grady, which is a level 2 hospital is known for serving a higher number of people of color versus the other medical facilities in town.
In a joint statement to the AJC, Emory Healthcare, Grady and CHOA pointed to the study being accepted in two elite medical journals: the New England Journal of Medicine and The Lancet in Great Britain. None of the three health systems involved in the study responded directly to Carome’s allegations. Instead, they said, “Additionally, peer review of the studies has proven positive, and follow-up responses from participants and family members of study participants showed 90 percent were glad they/their family member participated in the ESETT study.” The hospitals referred further questions to the study leaders, but media sources say they did not respond to inquiries.
Critics of EFIC say abuses against patients have piled up under it, because the leaders involved in designing, approving and publishing studies are also usually researchers and people sympathetic to researchers. Their mindset inevitably tips over from care from the individual patients in the study to the public gains that might be made, said George Annas, director of the Center for Health Law, Ethics & Human Rights at Boston University. Annas is in favor of reforming the Exception from Informed Consent.
A medical ethicist and lecturer at Columbia University, Harriet Washington, wants it repealed. She has written on race and medical research consent, saying that the disproportionately large share of African Americans in the study “violates social justice” because the risks of the study fell disproportionately on them. Washington is also the author of Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present.