temp_copy

The issue of whether or not a sham brain surgery is necessary for the research of Parkinson’s disease is complicated. Following several decades, different treatments for Parkinson’s disease have been developed, such as cell implantation, fetal nerve-cell transplantation or gene therapy. There was some common point that the radical or significant effect on the improvements of motor disability or balance control was found during the phase I trial; however, during the phase II trial, the treatment effect did not precede that in the sham-surgery control group. In an ethical point of view, is it ethical to easily and immaturely shift studies failed in the phase II trial without regard to the potential values to patients? Besides, due to the shortage of funding resource, fewer and fewer research groups could afford the expensive sham-surgery which is also too risky to find enough subjects of the control group to compare with the experimental group. Therefore, increasing numbers of scientists...

A control group seems to be an undisputed cornerstone to a strong study. So what happens when people say the control group is muddling the conclusions? This is the opinion dividing researchers who develop surgical treatments for Parkinson’s disease. In the last decade, several interventions that appeared promising in Phase I trials failed to have a significant impact in Phase II (sham-controlled) trials and subsequently were abandoned [1,2,3,4]. Many patients who benefited from the early trials say that the sham controls are obscuring the efficacy of the much-needed treatments. Meanwhile, proponents of the sham controls claim that the controls are necessary to demonstrate the efficacy of a treatment, especially in light of the robust placebo effect in the Parkinson’s population. Katsnelson’s article “Why Fake It?: How ‘Sham’ Brain Surgery Could Be Killing Off Valuable Therapies for Parkinson’s Disease,” presents an interesting discussion of this issue [5]. The ethical concerns of the t...

The article Why Fake It? How ‘Sham’ brain surgery could be killing off valuable therapies for Parkinson’s disease brought up differing viewpoints on sham surgery. Proponents of sham surgery claim that they are critical about discovering whether new treatments actually work or if the positive outcomes are based solely on placebo. While opponents of sham surgery argue that the sham surgeries are unnecessary and detrimental to advancing therapies. From a researchers perspective a well-designed study includes several components, the most important being controls. Some people believe that controls should undergo the same treatment regimen the individuals actually receiving the therapy undergo except for the actual treatment because this is the best way to compare to see whether the treatment itself was useful. Others believe that controls should be individuals at a similar disease state who do not receive the treatment. The need for controls in a good research design is important and I bel...

There is an ethical dilemma in neurosurgical trials regarding the use of sham surgeries as placebo controls. There have been countless instances of treatments that showed promise during preliminary trials, but failed to move past phase II clinical trials when the treatments proved ineffective compared to sham controls (Freed et al., 2001 & Olanow et al., 2003). The article “Why Fake It? How ‘Sham’ brain surgery could be killing off valuable therapies for Parkinson’s disease” discusses the issues regarding using shams in neurosurgical studies particularly in Parkinson’s disease. There is one group that encourages the use of shams as the only true way to statistically prove that a treatment is effective. Without proper double blind, control studies, how can you move a drug past clinical trials and not be worried it won’t actually help anyone? The other group discourages the use of shams arguing that they are expensive, yield abundant false negatives, and can potentially cause detrime...

I am on my way to become a scientist. In this phase of my life I am finding out how to, as one of our ethics professors puts it, “tease apart the fabric of the universe!” It is an interesting journey! The pursuit of science has taught us much through the millennia: how to build great monuments to the sky, how to heal our sick, what lies beyond the stars, what lies within our minds, etc. Scientists before me have expanded the scope of that which is accomplishable today. More so, they have shifted the views of our selves, of each other, and of the space in which we live. With such an impactful pursuit, it is incumbent upon any who would practice science to perpetually consider the effects of each contribution. Likewise, the public must be mindful of their role in guiding the arm of research—through public opinion, financial support, and the law—and develop thoughtful stances on the topics of the day. Let’s consider this topic: sham human neurosurgery in the study of treatments for Parkin...