Should a Failed Clinical Trial Continue?

Bipolar Disorder. ADHD. Obsessive Compulsive Disorder. Schizophrenia. Autism. Post Traumatic Stress Disorder. Anxiety. Depression. What do these all share in common?

These are all incredibly common mental disorders and illnesses, affecting a person’s cognition, behavior, thinking, and mood. And these are the very things that Doctor Helen Mayberg ― Professor of Psychiatry, Neurology and Radiology at Emory School of Medicine ― is trying to find a treatment for.

Beginning in 2003, Dr. Mayberg had been organizing a clinical experiment with her colleagues to treat chronic depression. Mayberg implanted several metal electrodes within the brain in a specific area called Area 25, with the intention of finding a possible treatment for depression when all other medicines and forms of treatment fail. According to The Lancet, 90 participants had been going through the 12-month study, ultimately finding no statistically significant results between the control and the test group in 2012.

 

On the image above, the region of Area 25 is indicated by the blue dot. (CNN/Helen Mayberg)
On the image above, the region of Area 25 is indicated by the blue dot. (CNN/Helen Mayberg)

 

However, despite the study’s failure and the majority of patients terminating further treatment, 44 patients were still followed for an additional 24 months with the intention of disproving the experiment’s failure. All the leaders of this clinical experiment still, collectively, went on with their study, despite the fact that they were supposed to discontinue it, as ordered by the medical board.

But this kind of behavior brings about another question, on the ethical side of the experiment. If the organizers of these conducted experiments are given this kind of power to go over the heads of their superiors, possibly wasting significant materials and resources on a failed experiment even after it has been declared as closed, what does this mean for our scientific community as a whole?

“ I think[s] the experimental procedures should be reviewed by a board of safety or medical professionals just to ensure that it’s safe for the actual participants,” said MVHS junior Priya Gundavajhala when asked about the protocol regarding experimental failures.

But again, what happens when a board of safety, such as the National Institute of Health, one of America’s medical research agencies that mainly focuses on developing research, labels the experiment as unfit to continue? What happens when these doctors, who had their entire life’s work on the line with this experiment — such as Mayberg, herself — are forced to reluctantly retire the experiment?

Experiments such as Mayberg’s, however, are more common than previously thought. In an article written by Maryam Zaringhalam and published in the Scientific American, she questions, “If we’re destined to fail and fail often, why not also fail openly and fail together?”. Failure is extremely common in scientific studies so maybe it is important to embrace this aspect, as well as the successful studies.

But then again, regardless of whether or not a patient has consented to this radical treatment, the doctor has the ultimate say and the patient should not be able to change this. An experiment that has already failed to find a result after several years and that has been terminated due to its non-existent results should not be given the luxury or materials to keep going.

For starters, who is responsible for paying for these additional materials? Would this responsibility lie with the patients who requested it in the first place?

The clinical trial isn’t technically supposed to be continuing the experiment, so the risk of the treatment negatively affecting the patient’s health is much too large to be able to continue to navigate between the lines, but still not cross it entirely.

In respect to participating in the already failing experiment, Gundavajhala said, “if there’s any kind of risk, I wouldn’t want to partake in the experiment at all, but if these volunteers were okay with it, then I mean, that’s their choice”.

In other words, if it’s the patients’ choice to continue to volunteer for the experiment although it potentially would not work to treat their chronic depression, then should they be allowed to? This could just be wasting their time and the patients might end up lacking the opportunity to actually get alternate relevant treatments that may result in significant breakthroughs.

Mayberg, referring to the clinical experiment stated that “despite encouraging results in small studies, industry trials have not gone as well”.

Doesn’t this tell us something? After years and years of attempting a trial, fixing it, gathering patients and redoing the process all over again, the experiment has not been significantly worthwhile or valuable and most likely never will be. In that case, what’s the point in spending extra time and resources on a most expectedly fruitless experiment?

We need to consider these issues because one day we might be put in a situation where we are conducting one of these trials or we are participating in one of these trials.

Additionally, anyone who has ever used medicine knows how much it can affect them, both physically and mentally, such as in the case of depression medication. If your treatment has been conducted improperly or your medication has been mishandled, then the only person who will be affected by this will be you and only you. Therefore, as a patient, you need to determine where you stand on this. We cannot put doctors in the position of having to reject our request for extra treatment time, nor can we bypass our ethical code of medicine and completely disregard our respect for rules.

 

Sources:

http://www.sciencemag.org/news/2017/10/researchers-grapple-ethics-testing-brain-implants

http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(17)30371-1/abstract