How much is your health worth? The horror of clinical trials gone wrong
Would you risk your health for £1000? What about for £10,000? Well, here's something my mum doesn't know - throughout university I took part in psychology trials and studies for a little extra cash. Mine didn’t exactly pay well, but I was confident they wouldn’t be harmful and, let’s be honest, on a student budget the extra income goes a long way.
But in recent years, a number of high profile clinical trials gone wrong have highlighted how risky these tests can be, particularly the first time that drugs are trialled on humans. Nonetheless, in 2016-2017, over 665,000 people in the UK alone took part in some form of clinical research trial, according to the National Institute for Health Research. But is it worth the risk? These are some cases that might make you think twice.
The Elephant Men
In 2006, six healthy British men entered into a study organised by life-sciences firm Parexel to test an experimental new leukaemia drug and known as TGN1412. Within an hour, they were fighting for their lives. The drug, which was supposed to work by controlling the body’s white blood cells, had already been tested successfully on monkeys. However, despite the dose given to these men being 500x less strong, almost as soon as the drug was injected, volunteers began experiencing vomiting, soaring temperatures, failing organs and swelling heads - to the extent that newspapers, ever sympathetic, dubbed them the “Elephant Men”. The trial ultimately resulted in many of the test subjects undergoing amputations and suffering prolonged psychological side-effects. An official report, produced in May 2006, ascertained that the “unpredicted biological action of the drug in humans” was to blame for the failure of the trial.
The French Biotrial Tragedy
In January 2016, 128 volunteers took part in a study to test the side effects of a new drug to combat mood disorders such as anxiety, with each receiving varying doses and some a placebo. While patients that received lower doses reported no side effects, one patient, who had taken a higher dose, was admitted to hospital experiencing severe headaches and “stroke like symptoms” believed to be caused by the drug. Yet, the very next morning five more volunteers were given the highest dose possible. Within three to five days those same individuals had begun experiencing symptoms and were also admitted to hospital. The trial ultimately led to one man’s death and resulted in longterm neurological damage in four other participants. The trial had been approved by French regulators and the drug itself had already been tested on chimpanzees and two dogs, although disturbingly, the dogs had died. In an interview with French newspaper Le Maine Libre, survivor Stéphane Schubhan criticised the lack of transparency in the trial: "If I’d known the dogs were dead, I wouldn’t have risked my life for €1,900. I wouldn’t have signed up. I’m not crazy.”
Stem Cell Sight Therapy
Macular degeneration, which causes the loss of central vision in both eyes, is the biggest cause of sight loss in the elderly and a condition for which there is no cure. So it makes sense that if you’re already experiencing it and there is a chance to be cured, you’d take it, right? That’s what three women in Florida did - with disastrous consequences. They entered into a stem cell test as part of which all three had cells injected directly into their eyes. As a result, one was left totally blind and the others legally blind. Each had actually paid $5000 to take part in the trial; in the US many stem cell trials aren’t subject to regulation by the Food and Drug Administration (FDA) meaning so called “for-profit” trials can take place freely.
John Hopkins Asthma Trial
In May 2001, a perfectly healthy 24-year-old named Ellen Roche, who worked as a technician for John Hopkins University’s asthma and allergy centre, inhaled an experimental drug that was designed to shed light on why some individuals suffer from asthma when others are immune. The drug taken by Ellen was intended to induce a mild allergic reaction, then scientists would combat it using hexamethonium, which is not approved by the FDA and was withdrawn from use in humans in the 1970s. In the days following the trial, Ellen developed a cough, before her lungs gradually began to fail and she was admitted to intensive care. She passed away just under a month later, having spent her final days on a life support machine. In the aftermath of her death, her family set up a scholarship to support other aspiring scientists.
The Anti-psychotic Trial
In 2004, Dan Markingson was living in a secure psychiatric unit in Minnesota, having been involuntarily committed six months earlier after displaying symptoms of psychosis. Under the remit of the University of Minnesota, doctors asked Dan to enrol on a trial testing the effectiveness of three antipsychotic medications; he agreed, despite objections from his family about his vulnerability. During the course of the trial, Dan was discharged into a residential facility, but was told that if he should fail to keep to the trial obligations he could be returned to involuntary confinement. The medical trial continued for five months, even though his mental health was deteriorating and despite his mother’s pleading with doctors for the drugs to be stopped. He took his own life in May 2004. Dan Markingson's death provoked a storm of debate about the ethics surrounding bio-medical trials, and the university was blasted by the Legislative Auditor's office for both their handling of and response to the situation.
In many ways, the failure of clinical trials only serves to show just how important medical testing is to science and to protecting people in the long run. But one thing is clear: this has to be done in a responsible and controlled fashion. If all of this hasn’t put you off the idea of taking part in a medical trial, the reassuring news is that pre-trial regulations are, slowly, becoming more stringent. The European Medicines Agency (EMA) issued new guidelines for “first time in human studies”, which should hopefully make the clinical process more watertight. The rules, which take effect from February 2018, particularly focus on dosage and the responsibility to define uncertainties ahead of time. Let's hope they have an impact.
Featured illustration by Egarcigu