Jean Burns, Parkinson’s, and The Risk of Undertaking A Clinical Trial

JeanBurns-NIHPressenterJean Burns of Phoenix, Arizona, is a long time friend of The Parkinson Alliance.  She is a strong advocate to provide a safety net to protect participants in research who may be harmed as a result of a clinical trial.  Jean’s story started in 2003 when she was diagnosed with Parkinson’s. Being a former web developer, she immediately took to the web to learn what she could about the disease, including various trials that she could participate in.  “I joined my first clinical trial in 2003, five months after my diagnosis.”

Because she kept close tabs on the research world, and did her homework, Jean became the third person to be accepted into a National Institutes of Health clinical trial on GDNF gene therapy, a therapy that might slow the progression of the disease. This was no small undertaking.  As part of her five year commitment, she has thus far had MRI-guided brain surgery, 9 MRIs, 3 PET scans, and three lumber procedures.

The surgery, however, almost didn’t happen when Jean read about all of the things that could go wrong.  Even though only a remote possibility, some of the complications included a stroke, seizure, brain hemorrhage, even being left in a vegetative state. Because Jean is the child of a parent who had a stroke and needed long term care, she knew first hand the difficulties and expense such a complication could create.  She naively thought that if she were harmed, she would get all needed medical care from the NIH.  Then, while reading the 21-page consent form, on the last page she found her answer. “I learned I could stay at the NIH hospital for a month. After that I had the right to sue the US federal government. What a surprise! There was no long term care.”

Jean then had a decision to make.  Her health was rapidly declining, and she was afraid for her future. Although she was concerned about the possible complications, she also felt she had no other choice but to participate in the trial. She signed the content, and on March 7, 2014, she had 11 hour brain surgery to inject the experimental treatment into four areas of her brain.  She recognized that every precaution was taken and she had what she called “superb care” (although it will be years before the trial results are in).  While Jean does not regret her decision to participate in the trial, she continued to question why there is no safety net in place for trial participants. When she talked to the department about her concerns, she learned the policy has nothing to do with her doctor or his team.  Jean appealed to the ethics experts at the NIH Clinical Center where her surgery took place.  She made such a strong case and good impression that the NIH ethicists invited her to became the first ever patient-participant presenter to tell her story before the NIH Grand Rounds held in Bethesda, Maryland.  The purpose of the NIH Grand Rounds it to present an issue that raises what is believed to be important ethical issues to discuss.

On February 4, 2015, NIH ethicist David Wendel presided over the Grand Rounds topic “Should There be a National System to Compensate Subjects for Research Related Injuries?” You can watch the presentation here.  He began by stating that the issue of compensation in various situations for research related injuries has been around for a long time.  He mentioned countries, such as Uganda, Brazil, India, the Ukraine, and most of Europe has such a program in place. He stated that in 1979 the Presidential Commission for the Protection of Human Subjects of Biomedical and Behavioral Research ruled that it was a matter of justice to have some kind of compensation to protect participants of clinical trials.  “There should be the development of national pilot programs to see how we could implement, on a national level, compensation for research related injuries in the U.S.” Some 20 years later a national program was again called for, as it was in 2006, and again in 2011.  He also read what is in the policy of one institution. “We will provide acute care that you need for any medical injuries that result from this research, and we will bill you and or your insurance company for that care. University sponsors do not provide any other symptoms of compensation for research released injuries.” Today, there still is no national policy on this issue. Next he introduced Jean who was interviewed by Scott Kim, and Jean told her compelling story.

The next speaker was Ken Feinberg, an attorney and the administrator of major compensation funds, such as the September 11 Victim Compensation Fund of 2001, One Fund Boston (the compensation program following the Boston Marathon Bombings), the BP Deepwater Horizon disaster, and several others. He stated that such a fund is a “very complicated provocative topic” and that “determining eligibility for compensation is a very sophisticated difficult assignment.”  He posed many questions as way to break down the issues. Do the policy makers want such a fund? Where is the money coming from? How much money is there?  Who is eligible to receive such compensation? Is it a tort based system? A worker’s comp based system? What are the proof requirements that a victim demonstrates that the injury is a consequence of the research? How do you prove it? Is it 100% the cause? 50% the cause? 10% the cause? What are the consequences of taking the compensation? What are the due process requirements? Who is administering the program? You signed a consent form. Is a public policy encouraging these consents?    He stated, “There has to be a public policy basis, an end game, an objective when you compensation research victims.”

Jean countered Mr. Feinberg’s list of questions, believing they were a bit off topic. “I think we can all acknowledge, if I undergo brain surgery and have a stroke on the table, that was research related. If I have a hemorrhage on the table, that was research related.” Jean is looking for some type of insurance policy, a safety net. Regarding signing the consent form, she countered, “You have to acknowledge that you may be dealing with patients who are desperate for better treatments or a cure. And so sometimes this is our only recourse.” In Jean’s final point, she asked, “Do our researchers want to continue to run clinical trials and studies? Do they want to continue to have patients volunteer? Because if we’re not treated well, we may dry up.” Mr. Feinberg noted that her questions could answer public policy objectives.

Another person from the audience suggested a principled basis for compensation in the form of needed healthcare. “One could be gratitude and the other would be justice in a specific sense of making a person whole.” He gave an analogy to military service. “We can think of participants … as putting their bodies on the line. We can have a compensation that consisted in healthcare services that were needed to make them as whole as possible.”  Like with veterans, “We could do the same for those who put their bodies and sometimes their psyches on the line in serving as human research participants.”

Steve Sternberg reported on this issue last month in an article entitled, “Undertake a Clinical Trial at Your Own Risk,”  in USA News.  In it, Elizabeth Pollard, Executive Director of the World Parkinson Coalition, stated that “Without research volunteers, test of new drugs will stall. Their volunteering is a currency. They are as valuable as the investors who are financially backing the studies.”

Jean states, “The NIH actively looks for volunteers for its clinical trials and calls them “heroes.” She doesn’t understand why people are not as appalled as she is.  “It does require courage to undergo experimental brain surgery without a safety net. And while at that time I felt I had no other options and took a leap of faith, I am now taking a step back and will no longer recommend that other human beings participate in high risk clinical trials.”

We thank Jean for all that she does to bring attention to this matter. But, we want to hear from you. What do you suggest we in the Parkinson’s community do to bring about a national policy to protect research participants in clinical trials?

— Margaret Tuchman, President of The Parkinson Alliance, and her blogging partner Gloria Hansen

 

 

 

 

Mindfulness and Parkinson’s Disease

Mindfulness-1

Becoming “mindful” has entered the American mainstream as evidenced by the countless books and articles devoted to the topic.  At its most basic, being mindful is being consciously aware of something in the present moment and accepting that awareness without judging it.  Many claim that being mindful results in a variety of benefits.  It apparently is good for our bodies, possibly boosting our immune system, and good for our mind, by helping to reduce stress and depression, and it can even tune out distractions and help us better focus.  But can mindfulness possibly play a role in helping to treat  Parkinson’s?  In trying to answer this question, we came across a clinical study written by Barbara Picket, MD, M.P.H. and researchers at the University of Amtwerp in Belgium called Mindfulness Training among Individuals with Parkinson’s Disease: Neurobehavioral Effects.

For this study, persons with Parkinson’s took part in a study in which half of the group were assigned to a mindfulness-based group and the other half to a usual care group.  Those involved in the mindfulness group had weekly sessions that included things like yoga and sitting medication.  They were also instructed how to practice mindfulness at home.  At the start of the study, all participants had a MRI of their brain.  At the end of the study, each had another MRI to see if the MRI recorded any changes in their brains. Interestingly, for the individuals in the mindfulness group, there were changes that included an increase in grey matter density in the left and right hippocampus and other areas of the brain that was not seen in the participants in the other group.

The study concluded that “Even with advances in symptomatic treatment, there is a need for adjunct person-centered therapeutic approaches to help improve the well-being of people who are faced by this disease in daily life. … Mindfulness training, as taught by qualified and experienced teachers, may offer a more participatory medicine, empowering the individual by engagement to learn how to strengthen internal resources to help cope with chronic disease. Mindfulness training may help to restore some degree of self-determination in the experience of living with PD. This is in line with person-centered research that employs scientific methods that are holistic, integrated, and transdisciplinary.”

It is also noted that caution must be used in interpreting their results because of acknowledged limitations of the study.  Even so, the study may demonstrate that a program of mindfulness training for people living with Parkinson’s can be beneficial. The study is available under the Creative Commons Attribution License.  You can read it at Parkinson’s Disease, a peer-reviewed, open access journal, at http://dx.doi.org/10.1155/2015/816404.

If you’d like to try adding mindfulness to your day, there are several resources that will help get you started.  Mindful.org has an article called 11 Steps Toward Daily Mindfulness .  Its goal is to help you avoid going down the “same old mental ruts” and to instead become aware of where your attention is and “deliberately changing the focus of attention.”

In this Ted Talk, mindfulness expert Andy Puddicombe describes the power of refreshing your mid for 10 minutes a day.

 

In this TED talk, Pico Iyer talks about the insight that comes with taking the time for stillness.

 

Do you have Parkinson’s and practice mindfulness?  Please let us hear how it is working for you!

– Margaret Tuchman and Gloria Hansen, The Parkinson Alliance

Goodbye Parkinson’s, Hello Life!

Recently we came across an article entitled, Israeli healer treats Parkinson’s through talk and danceIt’s the story of how Michael Wiese, a publisher who was diagnosed with Parkinson’s, came to meet Alex Kerten, the founder and director of the Gyro-Kinetics Center in Herzliya, Israel. Wiese was so impressed with how Kerten helped him (along with thousands of others with Parkinson’s) that he told Kerten he would like to publish a book describing his technique.  Wiese introduced Kerten to David Brinn, the managing editor of The Jerusalem Post, who became the book’s co-author, and Goodbye Parkinson’s, Hello Life was born.

GoodbyeGoodbye Parkinson’s, Hello Life is a 203 page book with the goal of reducing Parkinson’s symptoms by lowering anxiety through mindfulness and creating motion in the body through music, movement, and rhythm.  Kerten explains that anxiety is often rooted long before a diagnose of Parkinson’s, and he addresses how to recognize it and change the negative scripts that might be playing in your mind.  “Our biochemistry and our psychology start to change as we learn to control our way of thinking.” Movement is through a series of exercises that focus on breathing, movement, self-massage, conducting, and improvised dancing.  By synchronizing your thoughts and actions, you can become a “Parkinson’s warrior” —  a person who is unafraid to change their story and feel good again.

Yes, it takes work to both incorporate mindfulness and exercise into your day. Yet the benefits are clearly there.  And as he points out, the book is not a replacement to your movement disorder specialist or medications.  Instead it is a complement to them. Kerten recognizes that people with Parkinson’s have good days and bad days.  He suggests that you use the book as a guide or to “take from it whatever you need to help you cope and overcome whatever difficulties you are facing on a particular day.” He concludes with “Believe in your commitment, visualize it, dream it, expect it, and bring more and more of what you want into your life.”  Become a Parkinson’s warrior.

– Margaret Tuchman and Gloria Hansen, The Parkinson Alliance

 

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