Recently a clinical test of a new medication resulted in the death of one patient and the hospitalization of five others, with a high chance that the survivors have suffered irreversible brain damage. This was a phase one clinical trial in which healthy patients were given a new drug to determine how the human body would respond. The company, BioTrial, which administered the tests has been carrying out clinical trials of new medications since 1989 without complications of this sort.
The drug in question was meant to inhibit FAAH, an enzyme that breaks down anandamide, a fatty acid identified in the ‘90s which stimulates the bodies cannabinoid receptors, believed to play a role in mood stabilization, including feeding behavior and receptivity to pleasure. Inhibiting FAAH leads to higher levels of these fatty acids, such FAAH inhibitors have been sold as designer drugs in the past, with no reported cases of brain hemorrhaging and death as occurred in this recent trial.
These tests are an inescapable part of developing new medicines, before a drug can be given to those it was designed for, it is important to ensure that no adverse effects are seen in healthy patients. Prior to that, animal testing is also necessary, and in this case such tests had been carried out on dogs, rats and chimps – though notably not pigs, which have been proven time and time again to be an invaluable species for testing medicine and procedures that later would be used on humans.
There are those who object to testing drugs on animals, but without first seeing that other living creatures can survive administration of a new medicine, subjecting humans to such risk is totally unacceptable. Then the question of the reserved folk becomes “Why develop new drugs at all?” and the answer is that modern medicine is thriving, but we are far from understanding everything about the human body, there are always new disorders and new solutions to be found.
Unfortunately animal testing isn’t a perfect substitution for healthy humans, even those so genetically close to us as pigs, but carrying out animal tests to their fullest extent with as many species as possible could greatly lower the risk to human test subjects in later trials.
What is remarkable is the willingness of healthy patients to subject themselves to such risk. They are paid, but no amount of money makes up for a bad case of Swiss-cheesed brain. Much of modern medical knowledge came about in World War 2, where people far from willing were subjected to unspeakable horror at the hands of the axis. Nowadays these patients are sourced from volunteers, mercenaries of medicine willing to put their lives on the line for money, and surely in some cases a genuine desire to see the new medication succeed and go on to help those in need.
I certainly am not interested in subjecting my body to the unknown, but I can understand the temptation. It’s a simple task – eat this pill, see how you feel – and that’s the deal. I imagine the dangers are made clear, but at the same time plenty of people automatically trust smiling folk in scrubs with a nametag touting their qualifications.
I ask, why source test subjects from the general public? Perhaps prisoners could be given the opportunity to shorten their sentences or make money at a rate that dwarfs the jobs available to them. Many are already in prison for drug abuse, they could enjoy some indiscriminate drug use while locked up, and at the same time further the goals of massive pharmaceutical companies. In the U.S. especially, it seems only logical to pair our private medical industry with the private prison system.