New drugs are supposed to save lives but some of them end lives even before they are used to treat anything. The world needs new drugs all the time and the only way to get them on the shelves is through a clinical trial. The problem, however, is that most people do not like being used as the trial and error subjects for these new drugs and the fear is quite justified. Despite the safety regulations required by authorities, the manufacturers often fail to consider the subjects leading to fatal cases, lucky subjects may end up with life-long defects. To bypass the stigma, some pharmaceutical companies are forced to lie to the subjects which make any complications even worse. Here is a look at 10 clinical trials that went really wrong.
The Thalidomide Drug Trials
By the late 1950s, Thalidomide was almost as popular as Aspirin today. It had been developed in post-war Germany as the best sedative and later the best treatment for nausea and morning sickness in expectant mothers. This drug was marketed as totally safe as the lab claimed they could not find “a dose large enough to kill a rat.” When it hit the US market in the 60s, Frances Kelsey, the FDA inspector refused to approve it because she felt there was insufficient information on the safety of the drug.
Her fears were confirmed a year later by Dr. Arthur McBride from Australia as he noticed that the drug inhibited limb development in unborn children and caused defects. Most of them were born with flipped limbs or just no limbs at all. More cases were confirmed across Europe with numbers rising to over 10,000. This disastrous impact raised fear causing the drug to banned across the world. I was however accepted as a reliable remedy for leprosy.
The Pfizer Clinical Trial
In 1996, Nigeria was hit by what is regarded as the worst outbreak of Meningitis in African history. Pfizer, one of the largest pharmaceutical companies in the world, offered to help. They brought in two trial dugs and gave them to hundreds of children. They, however, didn’t tell the parents that their children were being used as tests for these drugs. The parents were assured that the drugs had been used before and proven to be safe.
Their trial became more dangerous when they decided to use lower doses than recommended on some children resulting in slurred speech and even brain damage. 11 of the children died prompting the State of Kano where most of the tests were conducted to sue Pfizer. The company initially claimed that the children had died from Meningitis but later admitted wrongdoing and paid $175,000 to each affected family.
The Elephant Man Trial
TGN1412 was a magical cure initially believed by many scientists to be able to treat leukemia, arthritis and other autoimmune diseases. PAREXEL an American company organized the first phase of human trials assuring the volunteers that the worst side effects of the drug would be a headache, just a headache! The £2000 prize was a welcome bonus too for the 8 young men who signed up for a clinical test in London hospital. The government had said the drug was safe when used on monkeys, so nothing could go wrong, or so they thought.
Within minutes of being injected with the drug, the volunteers started wailing in agony and projectile vomiting. The drug caused multiple organ failure as their immune systems overreacted. Their bodies were swollen like “elephant men” as the victims and the clinical officers later described the effects. Most of them were left with lifelong defects including amputated limbs and breathing difficulties. It was confirmed that the drug had been administered 10 times faster on the subjects than it had been on the monkeys. They sued the company and were paid off in out of court settlements.
The Leukemia CAR-T Trial
Cancer is the major focus for many clinical trials today but none ever turned as fatal as this trial. The CAR-T treatment was one of the most promising ones in 2016 sponsored by Juno Therapeutics, a startup valued at $4.3 billion at the time. The treatment was focused on inducing the development of T-cells in the body which helps to fight tumors in cancer. The trial was testing whether the drug could be used for adult Lymphoma, a rare form of blood cancer. The first patient treated with the drug got worse within a few weeks and died even after the doctors stopped the treatment and resumed chemotherapy. Two more patients in the sample of 20 died within the same period forcing the FDA to shut down the experiments. The company lost over 25% of its stock value and the drug was put under review.
The Eye Stem Cell Transfer Trial
Most clinical trials pay the test subjects to participate but not this one. In 2015, the US government website for clinical trials (clinicaltrials.gov) advertised a stem cell treatment for old patients suffering from poor vision. Despite the risk of blindness from the procedure, the three women paid $5000 for a stem cell treatment in their eyes to restore their full sight. All the patients were over 70 years of age when they decided to participate. The government had approved stem-cell transfer aimed at replacing cells lost in Age-related Muscular Degradation, a condition common for old people.
At the time of treatment, the patients had partial vision loss but after the procedure, all the three went totally blind. They suffered from severe bleeding and total retinal detachment, a state that left them permanently blind. Researches conducted after the procedure confirmed that proper safety measures were not included in the treatment and that it should not have been done on both eyes simultaneously.
The Gene Therapy Clinical Trial
Gene therapy has been around for decades with lots of criticism. When this technique of treating genetic disorders picked pace in the late 20th century, tragedy struck. Jesse Geisinger, an 18-year-old high school graduate from Arizona signed up for an experimental treatment for OTC deficiency. He actually knew that the treatment would not heal his condition but it was not supposed to kill him either. He only signed up so the results could help other patients. The experiment was testing the possibility of gene therapy treating acute cases of OTC deficiency in infants.
His desire to save the future generation, however, turned fatal for him as he became the first person to die from gene therapy trials. The study was conducted at the The University of Pennsylvania which had received FDA approval although the authorities were skeptical about the treatment. The actual cause of his death was not established but other complications were reported among other patients receiving similar treatment earlier. The administrators had not disclosed the other adverse cases and so safety measures were not included in his trial.
The University of Minnesota Antipsychotic Drug Trial
In 2003 Dan Markingson was diagnosed with psychosis and a federal judge gave him two choices, be confined at a state mental facility or accept treatment from the university hospital. Bot options were for his safety and the latter seemed like the best option when it was actually a death sentence. After enrolling for the study, his condition worsened as his actions became more erratic and suicidal prompting his mother to advise the university to stop. The administration, however, kept him on the medication which later led to his suicide.
He left his mother a suicide note before stabbing himself with a knife in the bathroom. The university immediately downplayed the effects of their actions and denied responsibility for 11 years. Public outcry forced them to accept an external auditor to review the study in 2015. He later confirmed that their conduct of the trial was unethical and contributed to Markingson’s suicide. The university had used coercion and forced treatment to administer the drugs even after the patient became worse. The university was forced to shut down the research.
The John Hopkins Asthma Trial
Ellen Roche was an employee at the John Hopkins University hospital when she signed up as a volunteer for the cancer study in 2001. The experiment aimed at finding the exact cause of Asthma. She was told the worst side effects would be slight shortness of breath. It involved inhaling one drug that temporarily constricted the breathing tract and a second one that prevented the nerves in the lungs from reacting normally. Roche was the third volunteer in the research, the second subject had used the drugs, got sick then recovered making the doctors more confident.
She was however very unlucky as her lungs started failing immediately leading to her admission to the ICU. He condition deteriorated quickly leading to multiple organ failure. Her family finally decided to put her off life support a few days later as her condition was only getting worse. A review of the drugs identified the second drug, hexamethonium, as dangerous and not approved by the FDA. The doctors just said she gave her life for an important study.
The Biotrial Anti-anxiety Clinical Trial
Biotrial is a French Pharmaceutical company which launched
The University of Rochester Bronchoscopy Tragedy
Bronchoscopy is a popular procedure used to draw samples from the lungs by inserting a tube through the mouth. The University of Rochester hospital was doing research on how respiratory cells react to pollutants. In its 15th year in 1996, they advertised for a volunteer to offer cell samples from their lungs. The prize was $150 and Nicole Wan and her boyfriend signed up for some pocket money except for her, it was a death sentence. After the process, she felt weak but the hospital still discharged her. Two days later, her heart stopped and she died. The biopsy confirmed that the researchers had used way too much anesthetic in the process and taken too much sample from her which proved fatal. The university had even exceeded their own regulations stated before the sturdy and caused the death of the student.