Medical trials on volunteers are one of the most important phases in the drug development procedure. People who volunteer for these causes either participate with the hope of getting cured or to do something good for science and society. Generally, most of the trials go well by following scientific research ethics. However, sometimes, because of unusual causes, and human errors, things can turn really bad. Below, we have listed 10 medical trials that went terribly wrong for people who volunteered.
1. Thalidomide was a mild sedative drug that in 1961 led to deformities, infant deaths, and birth malformations worldwide after its use by pregnant women to minimize morning sickness symptoms. After growing pressures and allegations, it was banned for sale in 1962.
Thalidomide was supposed to be a “wonder drug” made by the German company Chemie Grünenthal in the 1950s. It was advertised around the globe in 46 countries as a sleeping pill and labeled as safe for everybody, including pregnant mothers and their kids. The demand was so high at one point that it was giving competition to aspirin in terms of sale.
The mild sedative drug became quite popular among pregnant women after Dr. William McBride from Australia found out that the drug is effective against morning sickness issues during pregnancy. Soon after its wide distribution, numerous reports of infant deaths and startling birth malformations were emerging worldwide.
These incidents put several question marks on the use of thalidomide by expectant mothers and its connection with deformities in newborn babies. However, the German company denied all such allegations.
It was not until 1961 that McBride noticed the link between the so-called safe compound with horrendous birth defects in the babies he delivered, such as phocomelia, causing shortened or absent forelimbs. Growing pressure from the media forced the company to stop its sale within Germany. Finally, in 1962, all other countries who were selling it followed Germany and banned the drug. (1, 2)
2. Hoi Yan Wan, a healthy 19-year-old university student, died of a heart attack in 1996 after she was administered a heavy dose of lidocaine during a medical study she volunteered for to get some pocket money.
In 1996, Hoi Yan Wan, a healthy 19-year-old University of Rochester student was desperate for some pocket money. So, without informing her parents, she volunteered for a medical study focusing on the effect of airborne chemicals on lung cells, which promised to pay her $150.
During a process known as “bronchoscopy,” doctors inserted a flexible long tube down her throat to collect lung cells for further investigation. But the medical team violated the FDA rules by giving her four times the recommended dose of lidocaine, an anesthetic sprayed on the throat.
Ms. Wan, also known as Nicole, was in tremendous pain and was feeling weak after she was discharged, and two hours later she suffered a heart attack. On March 31st, she died due to another heart attack. Her autopsy confirmed that the lethal dose of anesthetic caused her sudden heart attack. (source)
3. Ellen Roche died on June 2, 2001, a month after she volunteered for a medical trial pertaining to asthma research at Johns Hopkins Hospital due to a dose of hexamethonium, a compound that wasn’t approved by the FDA.
Ellen Roche, a young lab technician at Johns Hopkins Hospital, decided to volunteer to participate in an asthma trial for healthy individuals. The objective of the study was to decipher the mechanism that protects healthy people from symptoms of asthma.
The doctors tried to trigger a mild asthmatic reaction and then treated it with hexamethonium, a chemical that wasn’t approved by FDA for use. In the beginning, she had a bit of a cough after inhaling the medicine. But as time passed by, her health deteriorated and she was put on a ventilator.
She was experiencing a potentially fatal reaction. Because of the drug, her lung tissue broke down and her kidneys began to fail. Ms. Roche died on June 2, 2001, a month after the trial. The medical team of the study admitted that hexamethonium played a major role in her illness. Later, it was revealed that the hexamethonium was administered with a more powerful spray mechanism than used on previous volunteers to shorten the procedure. (1, 2)
4. A medical trial, nicknamed “The Elephant Man Trial,” of the leukemia drug TGN1412 at a northwest London Hospital became a nightmare for six healthy young men who volunteered for it. While some of them collapsed and suffered head swelling, excruciating pain, and vomiting. Others lost their fingers and toes.
The most horrific medical trial, The Elephant Man Trial, happened in 2006. Eight healthy young men took part in an experimental trial of the leukemia drug TGN1412 at northwest London’s Northwick Park Hospital when everything went wrong. In less than an hour after receiving the drug, which had never before been tested on humans, six of the volunteers were rushed to the intensive care unit where they were fighting hard to stay alive.
The volunteers were feeling cold, experiencing excruciating pain in their heads, and started vomiting. It was chaos all around, and the medical team was panicking as the patients were collapsing due to the drug’s effect. The gruesome incident caused the loss of fingers and toes of one of the patients, and another participant had to have his foot partially amputated.
The participants shared their experience of the catastrophic day in a 2006 BBC documentary. One of the volunteers, Rob Oldfield, said to the BBC, “I remember being sick into a biohazard bag, and all of us being very ill. But the worrying point for me was when one guy, they drew the curtains around him, then these guys with gowns came up, like from an operating theatre.”
The investigation team didn’t find any flaw in the medical protocol, but in the final report, they mentioned that the dose used in the trial was not safe for humans. Even to this day, six of the volunteers suffer from weak immune systems and other health complications. (source)
5. Jesse Gelsinger from Arizona died four days after a gene therapy trial to cure his metabolic disorder, OTCD, on September 17, 1999, which had been conducted by a University of Pennsylvania research team.
Jesse Gelsinger, from Arizona, was suffering from a rare metabolic disorder called “ornithine transcarbamylase deficiency syndrome,” or OTCD, in which ammonia concentration reaches dangerous levels in the blood.
In 1999, he took part as a volunteer for a potential OTCD treatment trial program through gene therapy. Researchers at the University of Pennsylvania tested the gene therapy on 17 people before Jesse without any severe complications. However, contrary to the other cases, his symptoms were extremely worrisome.
Within a day of taking the dose, he became disoriented and developed other fatal symptoms like jaundice, a blood-clotting disorder, and multiorgan failure. Four days later on September 17, 1999, Jesse was declared brain dead and taken off life support. When the FDA investigated his case, they revealed some irresponsible actions taken by the research team.
First, the group continued the trial despite severe adverse reactions being shown by patients before him. The second action was even more shocking. The ammonia concentration was so high in Mr. Gelsinger’s blood that the medical team should have disqualified him from the study in the first place. (source)