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Drilling for Answers (Sep-08)

Find out about some experimental treatments for Parkinson's Disease. And then decide how you'd respond if you had a chance to participate in this research. In this interactive decision, we’re going to ask you about some experimental treatments for Parkinson’s Disease.

What is Parkinson’s Disease?

Up to 1 million Americans are currently diagnosed with Parkinson’s Disease, a brain disease that gradually worsens over many years and causes tremors, stiffness, slowness of movement, and balance problems. Some people with Parkinson’s Disease also experience changes in memory, concentration, and mood.

The average age at onset of symptoms is 65, but 5% to 10% have onset before the age of 45. The symptoms are caused by the death of cells in the brain that make a chemical called dopamine. Medications that are available to treat Parkinson’s Disease provide more dopamine to the brain or mimic the action of dopamine in the brain. In early stages of Parkinson’s Disease, symptoms generally respond well to medications. Over time, the medications become less effective and may cause more side effects.

What treatments are researchers developing?

One experimental procedure to treat moderate to advanced Parkinson’s Disease is gene transfer, which involves neurosurgery to insert a gene into the brain, to lower the side effects of medications and to increase the effectiveness of medications. Note that no stem cells or fetal cells are used. The patient is sedated but remains awake. The scalp is numbed by injections of local anesthetics (like Novocaine), so the patient should not feel discomfort. The surgeon drills two small holes into the skull and injects a liquid containing the gene on each side of the brain into areas known to be affected in Parkinson’s Disease.

How would gene transfer surgery be tested?

To see if the gene transfer surgery is truly effective, investigators need to compare a group that receives the gene transfer surgery with a group that does not. People would be randomly assigned (e.g., by flipping a coin) to one of the two groups. This kind of study could be done in two ways.

  • An open study could be done, where everyone knows who has and who has not received the gene transfer. One half of the patients would receive their usual medications only. The other half would receive their usual medications plus the gene transfer surgery.

  • A blinded study could be done, where neither the patient nor the evaluating researcher knows who has and who has not received the gene transfer. One half of the patients would receive their usual medications plus gene transfer surgery. The other half of the patients would receive their usual medications plus “sham surgery.” Patients receiving sham surgery have the two small holes drilled into the skull. But the protective coverings in the brain are not disturbed, and there is no insertion of any material into the brain.

    In a blinded study, only the surgeon would know who has received the gene transfer surgery and who has received sham surgery. If the gene transfer surgery is found to be both safe and effective, those in the sham surgery group would have the option of receiving the gene transfer at a later date without cost, using the holes drilled during the sham surgery.

What are the risks of these studies?

For surgery patients in both an open study and a blinded study, the surgery poses potential risks. There is a 1% to 4% risk of bleeding into the brain (usually minor, but there is a less than 1% chance that it could result in death or substantial disability). There is also a 1% to 5% risk of infection developing in the skin or brain, which would be treated with antibiotics. Overall, the risk of bleeding and infection is smaller for sham surgery than for actual gene transfer surgery.

Those subjects receiving the gene transfer surgery would face additional risks, including the possibility of brain tumors, inflammation of the brain, and a worsening of the Parkinson’s Disease. Patients in pilot studies have been followed for only one year, so longer-term effects are not known.

What are the pros and cons of the two kinds of studies?

When deciding whether or not to adopt a new procedure, it’s important to get accurate, unbiased evidence. If we adopt a new procedure that is unsafe or ineffective, people will end up receiving unnecessary surgeries. If we fail to adopt an effective procedure, we miss the opportunity to offer people a treatment that could benefit them.

Most, but not all, researchers in the field believe that the blinded study, using sham surgery, would provide better quality data than the open study. These researchers worry that if people know which procedure they receive, the results of the study may be difficult to interpret because expectations of both the patient and the evaluating researcher can unintentionally bias the results.

However, some people, including some researchers, worry that a study using sham surgery may not be worth the risks and burdens. The patients with Parkinson’s Disease who get the sham surgery undergo a neurosurgical procedure that provides no benefit to them, while being exposed to the risks and burdens of the procedure. There is also the worry that people with moderate to advanced Parkinson’s Disease are vulnerable to exploitation because having a serious, incurable illness may put them in a desperate situation.

Now, you decide!

Imagine that you have moderate to advanced Parkinson’s Disease. You can do most things independently, but involuntary movements interfere with your routine activities. Daily chores take twice as long compared to people without Parkinson’s Disease. For some parts of the day, your movement is extremely slow and you need help with daily activities.

You are asked to participate in either an open study or a blinded (sham surgery) study. Which study would you choose to participate in?
  • Blinded study (sham surgery)
  • Open study
  • Would not participate

Researchers have found that only about 35% of the general population would choose, as you did, to participate in the blinded study. As reported in a 2008 article in the journal Movement Disorders, about 55% of the general population would choose the open study, and the remaining 10% said they would not participate.

When these same questions were posed to people who actually have Parkinson’s Disease, the response was quite different: 24.5% picked the blinded study, 41.5% picked the open study, and 34% said they would not participate. The researchers observe that patients with chronic illness adapt to their disabilities; the people with Parkinson’s Disease might have felt that they had less to gain or more to lose from the benefits and risks associated with a trial involving surgery. Alternatively, people without Parkinson’s Disease may have over-estimated the impact that disability might have on them or underestimated their ability to function.

In this study, people were also asked to imagine that they were members of an ethics review committee deciding whether to allow certain studies. About 81% of respondents said that they would definitely or probably allow the open study for gene transfer. 55% said that they would definitely or probably allow the blinded (sham surgery) study. These results were the same for both the general population and people with Parkinson’s Disease. In other words, a very large majority of both Parkinson’s patients and non-Parkinson’s patients endorsed the open study as ethically acceptable. A majority endorsed sham surgery as an ethically acceptable control condition.

In analyzing these results and reading the written remarks added by the respondents, the researchers comment, “Education seems to play a strong role in people’s willingness to take a more societal perspective and balance the burdens to participants with the overall scientific and societal benefit. . . Those opposed to sham surgery appeared to have an intrinsic objection to blinding, and to focus on the invasive nature of the sham surgery per se . . .Given the complexity of the topic, it may be that laypersons, especially those with less education, may need more opportunity to learn and deliberate on the issues.”

Interestingly, scientists researching Parkinson’s Disease were presented with these same questions in a related study (Kim SY, Frank S, Holloway R, Zimmerman C, Wilson R, Kieburtz K. Science and ethics of sham surgery: A survey of Parkinson disease clinical researchers. Arch Neurol 2005;62:1357-1360.) Only 50% of these clinical researchers would allow open studies, and 94% would support controlled studies using sham surgery.

In conclusion, “Future research needs to determine whether eliciting more considered judgments of laypersons would reveal different levels of support for sham surgery.”

For a complete discussion of this research, see Frank S, Wilson R, Holloway R, Zimmerman C, Peterson A, Kieburtz K, Kim SY. Ethics of sham surgery: Perspective of patients. Movement Disorders 2008;23(1):63-68. The senior author, Scott Y. Kim, MD, PhD, is a faculty member at the Center for Behavioral and Decision Sciences at the University of Michigan.

Read the article:

Ethics of sham surgery: Perspective of patients.
Frank S, Wilson R, Holloway RG, Zimmerman C, Peterson DR, Kieburtz K, Kim SY. Movement Disorders 2008;23:63-8.

The August 2016 issue of AMA Journal of Ethics features commentaries by Christian Vercler, Lauren Smith, and Andrew Shuman.

"Is Consent to Autopsy Necessary? Cartesian Dualism in Medicine and Its Limitations"
Commentary by Megan Lane and Christian J. Vercler

"I Might Have Some Bad News: Disclosing Preliminary Pathology Results"
Commentary by Michael H. Roh and Andrew G. Shuman

"Requests for VIP Treatment in Pathology: Implications for Social Justice and Systems-Based Practice"
Commentary by Virginia Sheffield and Lauren B. Smith

Research Topics: 

Dr. Andrew Barnosky stepped down from his role as Adult Ethics Committee chair, which is a position he has served for the last 16 years. CBSSM Faculty member Dr. Andrew G. Shuman will be the new committee chair. Dr. Barnosky will continue as a member of the faculty and a member of the Committee. The UMHS press release can be found here.

Megan Knaus, MPH

Research Associate

Megan joined CBSSM in 2014 and has worked on multiple grant funded research projects related to health communication, patient-provider decision making, and health interventions driven by behavioral economics. She currently works with Dr. Brian Zikmund-Fisher on a National Science Foundation grant testing infectious disease communication strategies.

Last Name: 

CBSSM is co-sponsoring the MICHR Research Education Symposium: Life at the Interface of Genomics and Clinical Care. This event will be held March 15th, 8-1 pm. Keynote speaker is Dr. Ellen Wright Clayton, JD, MD, Rosalind E. Franklin Professor of Genetics and Health Policy; Craig-Weaver Professor of Pediatrics; Professor of Law; and Director, Center for Biomedical Ethics and Society, at Vanderbilt University. Dr. Wright Clayton’s topic will be “Addressing Biomedical Ethics.”

Thu, April 04, 2013

Babies cry and spit up … and too often those common symptoms are labeled as disease, according to a new study conducted by U-M researchers. Frequent use of the GERD label can lead to overuse of medication. The study was published online today in the journal Pediatrics.

Stories have already been published by Reuters,  Yahoo News!MedPage TodayNPRMSN Healthy Living,  CBS News, and the Chicago Tribune, among others. Laura Scherer, PHD, Brian Zikmund-Fisher, PhD, Angela Fagerlin, PhD and Beth Tarini, MD are authors on this study.

Mon, January 06, 2014

Dr. Reshma Jagsi worked on a study detailing the decline of US research spending versus the increase in spending in Japan and China. In the UMHS article, she says, "The United States has long been a world leader in driving research and development in the biomedical science. It's important to maintain that leadership role because biomedical research has a number of long term downstream economic benefits, especially around job creation," 

Research Topics: 
Sat, February 23, 2013

Susan Goold was quoted in a recent Associated Press article: Some Patients Won't See Nurses of Different Race."
"In general, I don't think honoring prejudicial preferences ... is morally justifiable" for a health care organization, said Dr. Susan Goold, a University of Michigan professor of internal medicine and public health. "That said, you can't cure bigotry ... There may be times when grudgingly acceding to a patient's strongly held preferences is morally OK."

Dr. Jason Karlawish, Professor of Medicine and Medical Ethics at the University of Pennsylvania, will discuss his forthcoming novel, "Open Wound: The Tragic Obsession of Dr. William Beaumont" on Thursday, October 20, 3-5 pm, at the Biomedical Research Science Building (BSRB), Room 1130.  "Open Wound" is a fictional account of true events along the early 19th century American frontier, tracing the relationship between Dr. William Beaumont and his illiterate French Canadian patient.  The young trapper sustains an injury that never heals, leaving a hole in his stomach that the curious doctor uses as a window both to understand the mysteries of digestion and to advance his career.  A reception will follow the talk, and books will be available for purchase on site from Nicola's Books.  The event is co-sponsored by the Center for Bioethics and Social Sciences in Medicine, the Center for the History of Medicine, and the University of Michigan Press.  Click here for more information about the book. 

CBSSM Seminar: Rana Awdish, MD

Thu, February 15, 2018, 3:00pm
NCRC, Building 16, Room 266C

Dr. Rana Awdish is the author of In Shock, a memoir based on her own critical illness. She is also Director of the Pulmonary Hypertension Program at Henry Ford Hospital in Detroit and a practicing Critical Care Physician. She lectures to physicians, health care leaders and medical schools across the country on the necessity of compassionate care. She was recently named Medical Director of Care Experience for the Health System.

In Shock will describe Dr. Awdish's personal transformation from critical care physician to critically ill patient and describe how the events surrounding her near death changed her understanding of the culture of medicine and lead her to alter the course of her institution. Focusing on Physician communication training, narrative medicine and visual thinking strategies, and a culture of caring, she will illuminate the path towards creating a more resilient culture for everyone involved in health care.


1. Describe the ecosystem of medical training and practice and the way it compromises empathy and compassion.

2. Illustrate how medical humanities and a purpose driven culture can be used to promote a culture of resilience.

3. Recognize the barriers to implementing institutional change and empowering individuals.

4. Identify practices that will engage providers and leaders in promoting development of resilient systems.

Rana Awdish, MD
Director, Pulmonary Hypertension Program, Henry Ford Hospital, and Medical Director, Care Experience, Henry Ford Health System, Detroit, MI

Dr. Rana Awdish is the Director of the Pulmonary Hypertension Program at Henry Ford Hospital in Detroit and a Critical Care Physician. She also serves as Medical Director of Care Experience for the Henry Ford Health System. Dr. Awdish’s mandate as well as her passion is to improve the patient experience across the system. 

After suffering a sudden critical illness herself in 2008, she has become a tireless activist, refocusing her fellow providers on the patient experience and improving empathy through connection and communication. She lectures to physicians, hospital leadership and medical schools around the country. Her book, In Shock: My Journey from Death to Recovery and the Redemptive Power of Hope, has been featured in the Washington Post, NPR, The Today Show, The Times Literary Supplement, and is now an LA Times Bestseller.

Dr. Awdish received the Schwartz Center’s National Compassionate Caregiver of the Year Award in 2017. She was named Physician of the Year by Press Ganey in 2017 for her work on improving communication, and received the Critical Care Teaching Award in 2016. She, along with three others, began the CLEAR Conversations Project at Henry Ford, using improvisational actors to train physicians in patient-centered empathic communication. 

Prior to coming to Henry Ford, Dr. Awdish completed her training at Mount Sinai Beth Israel in Manhattan. She attended Wayne State University Medical School, and completed her undergraduate degree at the University of Michigan in Ann Arbor. She is board-certified in Internal Medicine, Pulmonary and Critical Care Medicine.