TWIL: Clinical trials gone wrong

I am now officially finished with the Supernova monoclonal antibodies clinical trial. I suppose I blind myself to bad news about trials because the next thing I did was ask ChatGPT about clinical trials gone wrong. (I feel the need to disclose that AI helped with this post.)

I knew about some trials: the Guatemalan and Tuskegee syphilis trials, and the Vioxx trial. Others required more research.

So, this week I learned about these trials.

Jesse Gelsinger Gene Therapy Trial (1999, University of Pennsylvania)

Jesse Gelsinger was participating in a trial he should have been disqualified from because he had high levels of ammonia in his blood chemistry. The gene therapy trial was targeted at people with a genetic liver disease called ornithine transcarbamylase deficiency (OTCD). He died four days after getting the drug from a severe immune reaction that led to multiple organ failure and brain death.

Illegal Trovafloxacin Trial (2004, Pfizer)

This was an illegal clinical trial Pfizer conducted in Nigeria. They gave the antibiotic Trovafloxacin (not the standard antibiotic) to children suffering from meningitis. Eleven children died (probably of liver damage) and many others suffered severe side effects, including paralysis, brain damage, and blindness.

BIA 10-2474 Trial (2016, Bia-Portela)

This trial involved an experimental painkiller intended to treat, among other things, chronic pain from multiple sclerosis. Well into the Phase I trial they upped the dosage, and one participant died. Four others were hospitalized with severe neurological damage. It seems like they stopped all the trials related to this or any drug like it.

Theralizumab Trial (2006, Parexel)

This was a Phase 1 trial of a monoclonal antibody designed to treat autoimmune diseases and leukemia by stimulating the immune system. Within minutes, all six participants experienced a severe “cytokine storm” (a massive immune system response). Some of them were left with permanent damage, and one participant was in a coma for weeks.

My favorite quote was from the Theralizumab trial fallout. “You don’t need to be a rocket scientist to work out what will happen if you non-specifically activate every T cell in the body.”

So, what I get from this is: don’t participate in Phase I trials, illegal trials, trials you are disqualified from, or trials where they jack up your T cells.