art by Camille Sturdivant
Protecting the Vulnerable: Ethics of Medical Research
by Jennifer Cortes
When we hear about the latest advancements in medical research, the prospect of new knowledge and breakthroughs can be quite exciting. However, embroiled in our exhilaration, we may not consider the ethics around the research and subsequent distribution as well as availability of the new medication or medical device. A sliver of possibility to improve the quality of life of so many patients tends to obscure these other often-underscored yet crucial questions.
History has given us innumerable examples that illustrate specific instances of ethical conundrums in scientific research. However, the present offers us with a notably fresh and multifaceted issue that has the potential to impact us for many more years to come.
Advancements in neuromodulation represent a new realm of possibilities. Deep Brain Stimulation (DBS), with its long track record of dedicated research and broad range of applications, serves as an excellent example of the ethical considerations that must be discussed in order to ensure that the well being of patients is not marginalized—both during clinical trials and after the implementation of treatment standards.
Although electrical stimulation of the brain has been studied since the early 19th century, DBS implants did not emerge until the 1970s. In many ways, DBS technology resembles a heart pacemaker in structure and function, containing a neurostimulator connected to electrodes that are surgically targeted and placed into the interior of the brain. Electrical stimulations are delivered from the battery pack, which contains the neurostimulator, via the electrodes to areas of the brain such as the thalamus and globus pallidus. DBS therapy has been shown to successfully ameliorate the motor symptoms of Parkinson’s disease (PD), with research now expanding its potential use for treating obesity, addiction disorders, Alzheimer’s diseases, severe intractable depression and a host of other conditions.
Beyond the major observable components of the diseases targeted by DBS, the ailments often have a psychiatric component. As an example, patients with PD can suffer from depression, impulse control disorders or anxiety. On the other hand, conditions such as depression and addiction disorders tend to be primarily psychiatric in nature. One of the main concerns with research involving patients with mental health disorders is the impaired ability of these individuals to give consent or hold certain misconceptions about the research.
Interestingly, however, a study conducted by Columbia University researchers evaluated the effect of DBS for treatment-resistant depression, finding that patients with psychiatric disorders do not have significantly impaired capacities to consent to research. In fact, it was found that subjects who were more depressed held fewer misconceptions about the research study. The authors suggest that concerns about the ability of people with psychiatric disorders to consent “might instead be a reflection of the widespread stigma and prejudice against psychiatric disorders,” which is an important issue in ensuring appropriate research practices.
In terms of post-implantation, one potential side effect of DBS is its ability to induce a hypomanic state in patients, which can complicate the issue of consent. Hypomania is characterized by an unusual cheerfulness, racing thoughts and exaggerated confidence that can impair a patient’s competency to carefully evaluate decision-making consequences. Cases have been reported where subjects have been unaware of their manic state and refused to have their neurostimulator settings adjusted. As a result, these patients were more likely to inflict harm onto themselves due to their compromised faculties. Since all subjects have the right to leave research studies at any time and for any reason, hypomania jeopardizes this autonomy due to patients’ inability to be critical judges of making the right decision.
Patient situation is yet another factor to consider. In a more general sense, simply being ill renders patients vulnerable, making them more willing to participate in highly invasive research studies such as DBS since they may consider themselves to be out of options. Whereas clinicians are primarily concerned with what is in a patient’s best interest, a researcher’s primary focus may rest in the generation of data.
Even assuming acceptable research practices, a subject might enlist in a study with high hopes of reaping benefits from an experimental treatment and fail to recognize that they can become a control subject that does not receive the therapy. Patients’ overall unrealistic expectations of the possible outcomes of research treatment they receive might further complicate matters. For instance, addressing treatment-resistant depression by DBS has been described in the media as a successful way to “‘reset’ the brain’s mood switch from sad to normal . . . [with] ‘striking’ improvements.” In reality, there is still an insufficient amount of research to state that DBS is effective for treating depression and other psychiatric disorders.
However, now that most insurance companies cover DBS for the treatment of PD, there appears to be a disparity in its use. A study was conducted by researchers at the University of Pennsylvania Perelman School of Medicine and Washington University School of Medicine that analyzed data from more than 665,000 Medicare beneficiaries with PD. From the patients whose PD was being treated by DBS, 94.9 percent were white and 59.3 percent were male. The study went on to conclude that black and Asian Medicare beneficiaries were less likely to receive DBS therapy for their PD than were white beneficiaries, with women Medicare beneficiaries being less likely to receive therapy than men. Furthermore, DBS was more frequently provided to beneficiaries from neighborhoods with the highest median income and educational achievement. Considering that Medicare patients receiving DBS must still pay $2,200 out-of-pocket yearly, the cost might discourage patients who are socioeconomically disadvantaged.
There is no quick fix to the ethical problems around DBS. Since this therapy is just one of many emerging biotechnologies, the importance of discussing the ethics on research and treatment is wide-reaching and essential for reliable and valid future research that serves to help rather than inadvertently harm. Increasing awareness of the complex nature of this issue can potentially lead to renewed efforts towards protecting research subjects and improving access.
However, this is only the first step. The struggle to achieve greater consideration will take substantial effort from us all.