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Clinical trials are a critical phase in the FDA's drug approval process, ensuring the safety and effectiveness of new medications. While most trials proceed smoothly, leading to the approval of safe drugs, there are rare instances where things go terribly awry. Discover 10 infamous cases that pharmaceutical companies would rather keep under wraps.
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10. The Seroquel Experiment at the University of Minnesota
“Nearly five years ago, my son Dan passed away during a clinical trial at the University of Minnesota. He had no diagnosis to justify his participation, and despite my efforts over five months, I couldn’t get him out of the study.” Since her son’s tragic death, Mary Weiss has been tirelessly sharing her story to raise awareness.
In 2003, Dan Markingson, who was suffering from delusions, was diagnosed with schizophrenia and admitted to the University of Minnesota Medical Center in Fairview. Soon after, he was enrolled in a clinical trial evaluating three schizophrenia medications: Seroquel, Risperdal, and Zyprexa. His condition deteriorated rapidly as the daily 800mg doses of Seroquel intensified his delusions.
Desperate to help her son, his mother sent numerous letters, emails, and made countless calls to the study coordinators, pleading for his removal from the trial. However, the administration refused, even threatening to institutionalize Dan if he attempted to withdraw. Weiss was horrified, especially after discovering that the university stood to gain $15,000 from her son’s participation.
Trapped in the trial, Markingson’s mental state worsened until he tragically took his own life by stabbing himself in the shower. His suicide note chillingly stated, “I went through this experience smiling!” Heartbroken, his mother filed a lawsuit against the university, which denied any wrongdoing. Markingson was among five trial participants who attempted suicide, with two, including him, succeeding.
9. The Biotrial Disaster in France
In January 2016, Biotrial, a French company, conducted a clinical trial involving 128 healthy volunteers to test a new drug aimed at alleviating anxiety in cancer and Parkinson’s patients. Initial low doses showed no adverse effects, but as the dosage increased after the first week, severe issues emerged. Six participants fell critically ill and were rushed to the emergency room.
A healthy man in his late 20s, one of the trial participants, was declared brain dead just one week after hospitalization and two weeks into the trial. The remaining five patients, though stable, are expected to face permanent brain damage and cognitive impairments.
Despite being the first human trial for the drug, administrators were aware of its serious risks. A French news outlet revealed that a pre-trial on dogs had resulted in fatalities and brain damage among the animals. Despite these alarming findings, the trial proceeded on humans, leading to catastrophic outcomes.
8. The Thalidomide Disaster
Originally developed in Germany to treat respiratory infections, Thalidomide is now infamous for its devastating impact on pregnancy. During the 1960s, over 10,000 children were born with severe birth defects, including limb deformities and cleft palates, due to this drug.
What makes the Thalidomide trial uniquely unsettling is that it initially appeared successful. During testing, researchers focused on animals but overlooked the effects on their offspring. Since the drug was non-lethal even in high doses, it was deemed safe and released to the public in 1956.
The connection between Thalidomide and birth defects was only uncovered in 1961 by Australian physician William McBride. Prior to this discovery, all clinical trials had erroneously concluded that Thalidomide was a safe over-the-counter medication, a mistake that cost 10,000 people dearly.
7. The Gene Therapy Trial Tragedy
At 18, Jesse Gelsinger joined a study aimed at evaluating the safety of gene therapy for children with severe liver-related genetic disorders. Born with OTC, a condition impairing his liver’s ability to process ammonia, he was injected with a cold virus as part of the treatment. However, a high dose of the experimental drug proved fatal. On September 17, 1999, his health rapidly declined from jaundice to organ failure and ultimately brain death.
The FDA’s investigation into Gelsinger’s death revealed alarming negligence. Earlier groups in the trial had already experienced severe adverse reactions, yet the study proceeded. Additionally, Gelsinger’s ammonia levels were dangerously high, making him ineligible for participation. He was initially an alternate but was rushed into the trial after another participant withdrew.
6. Anil Potti’s Controversial Cancer Treatment
In the 2000s, Anil Potti was hailed as a rising star in the medical field, claiming his cancer treatments had an 80% success rate and could save 10,000 lives annually. However, in 2015, his career collapsed when he was exposed for including false data in a manuscript, nine research papers, and a grant application, rendering his study results invalid.
Joyce Shoffner, patient No. 1 in Potti’s July 2008 trial, was deeply impacted by this deception. Enticed by the promise of an 80% cure rate for cancer, she enrolled in the study to treat her breast cancer. She endured a painful biopsy, where tissue samples were extracted using a needle from her arm to her neck, followed by a grueling Adriamycin-Cytoxan (AC) chemotherapy regimen. Two years later, she learned the study was invalid due to Potti’s misconduct. While Shoffner is now cancer-free, she suffers from blood clots, diabetes caused by the AC treatment, and PTSD from the traumatic experience.
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5. The Stem Cell Vision Therapy Disaster
In January 2017, three women, aged 72 to 88, participated in a stem cell therapy trial for macular degeneration, an age-related eye condition. Each paid $5,000 for the experimental treatment, which ophthalmology experts later deemed “atypical and unsafe.” Tragically, they lost their vision entirely as a result of the procedure.
Shortly after the procedure, all three women experienced severe complications, such as bleeding and retinal detachment. One patient lost her vision completely, while the other two suffered significant vision loss. Recovery is not expected for any of them. Experts had identified red flags early on, including the requirement for patients to pay for the treatment—a clear indicator of illegitimate research. Furthermore, attempts have been made to obscure the trial’s history; government records misleadingly state the study was “withdrawn prior to enrollment,” contradicting the actual events.
4. The CAR-T Leukemia Trial Tragedy
In July 2016, three leukemia patients died during a trial of Juno Therapeutics’ cellular therapy, CAR-T. This innovative treatment aimed to target and eliminate cancerous cells, earning it the title of the “fifth pillar” of cancer therapy. However, the 2016 trial results shattered these high hopes.
The patients’ deaths were attributed to cerebral edema, or brain swelling. Juno Therapeutics acknowledged that brain swelling is a known risk of CAR-T therapy, alongside immune system reactions and heightened neurological toxicity.
Following the announcement of the deaths, Juno’s stock plummeted by 27%. The FDA is now scrutinizing their practices, and it remains uncertain whether they will be permitted to proceed with further research.
3. The Elephant Man Trial Disaster
The infamous Elephant Man Trial occurred in London in 2006, testing a new cancer drug called TGN1412. The eight participants were told the worst side effects would be mild, such as headaches and nausea, but the reality was far more severe.
Shortly after receiving the drug, all participants experienced extreme reactions, including intense pain and vomiting. One man lost fingers and toes, while another required partial amputation of his foot. The trial’s nickname arose when one participant’s head swelled dramatically, leading his girlfriend to compare him to an elephant.
The exact cause of the disaster remains unclear, but theories abound. One participant believes the rapid six-minute injection into humans, compared to the 90-minute process used on animals, played a role. Another theory points to flawed animal testing, as researchers used macaques (94% DNA match to humans) instead of bonobos (98% match) to save costs. The long-term impact on the participants’ lives remains uncertain.
2. The Johns Hopkins Asthma Study Tragedy
Ellen Roche, a technician at Johns Hopkins Hospital, participated in an asthma study designed to understand why healthy individuals do not develop asthma symptoms. Researchers triggered a mild asthmatic response and treated it with hexamethonium.
Initially, the treatment caused Roche to develop a cough. However, her condition worsened, leading to lung tissue damage and kidney failure. She was placed on a ventilator and passed away on June 2, 2001. Trial officials acknowledged that hexamethonium was either the primary cause or a significant factor in her illness. It was later revealed that hexamethonium was not FDA-approved, a fact omitted from the consent form, leaving Johns Hopkins fully accountable for her death.
1. The New York Lidocaine Catastrophe
In 1996, Hoi Yan “Nicole” Wan, a University of Rochester sophomore seeking extra cash, enrolled in a clinical trial offering $150 without her parents’ knowledge. The study involved a bronchoscopy, where a tube was inserted into her lungs to examine the effects of pollution on her respiratory system.
Nicole was unaware that the researchers collected significantly more cell samples than the study proposal allowed. As they extracted additional samples from her lungs, they administered Lidocaine at doses far exceeding FDA-approved limits. After being released, she experienced extreme weakness and severe pain. Two days later, she was found dead. An autopsy confirmed that the excessive Lidocaine, resulting from the study’s negligence, caused her heart to stop and led to total organ failure.
