Clinical Trials are one of those research fields where human participation is very much important to bring life-saving drugs into the market and save the lives of millions of other human beings. Errors, accidents, and tragedies are part of the research. Sometimes we have to face incidents that cost human life during research. It is very heart-wrenching to see someone die due to a human mistake. Such cases have happened in many clinical trials in the past. One such case is New York’s Lidocaine Case in which a 19-year-old student, Nicole (Hoiyan) Wan, lost her life in 1996.
What was this trial about?
In 1996, The University of Rochester was offering $150 to participants for their participation in the study which was designed to be a minimal-risk study. It was focused on the mechanism by which the lungs fight against infections and pollutants. Ms. Nicole, a student of the same university, took part in that trial just for $150 because she wanted to visit her parents living in Queens. Her parents were unaware of this. Many college students participate in such clinical studies because they get attracted by the money offered for participation. Nicole was one of them.
This trial required a bronchoscopy of participants to retrieve a sample of lung cells. For this, a topical anesthetic drug named ‘Lidocaine’ needs to be applied inside the throat to suppress the gag reflex caused by the procedure, in which a bronchoscope (flexible optic fiber) is used to obtain biopsies from tissues in the lower lobe of the lungs.
What happened to Ms. Nicole?
Ms. Nicole Wan, a nursing student, underwent a bronchoscopy on 29 March 1996. During this procedure, at the hands of an inexperienced intern, Ms. Wan received 9 mg per ml of Lidocaine which was higher than the original one i.e. 5 mg per ml mentioned in a protocol. Then she remained under observation for about 90 minutes. She was discharged after that despite feeling weak and experiencing severe pain. About a half-hour later, Ms. Wan's condition worsened and she was then taken to the hospital. She died two days later i.e. on 31 March 1996 due to a heart attack.
What happened after the tragic death of Ms. Nicole Wan?
Four-month investigation revealed that The University of Rochester had violated its own guidelines by increasing the dose of Lidocaine for Ms. Nicole. In her case, doctors wanted to retrieve more cell samples and hence they used more anesthetic than that mentioned in the original protocol.
This incident raised the following ethical questions regarding the conduct of clinical trials which are still valid:
Should invasive procedures in clinical trials have more strict age criteria?
Should trials involving vulnerable subjects need a more strict consent process?
Is it ethical to advertise such compensation-based clinical studies among college students between the ages of 18-21 years considering their financial condition?
Are those conducting the trial procedure provided with proper training?
Are the researchers’ training being monitored and updated regularly?
A major contributing factor in this tragedy was that the study protocol wasn’t followed properly and an overdose of an anesthetic drug was given to the participant by an inexperienced person. This obviously led to the emergence of new stringent guidelines in clinical research.
Clinical trials are very important for the progression of human health. It needs the participation of brave volunteers like Ms. Nicole Wan. It is the duty of every stakeholder in a clinical trial to provide necessary safety to the volunteers. After all one of the ICH GCP principles says that, “The rights, safety, and wellbeing of research participants are most important and should prevail over the interest of science and society.”
(HN)
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