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One of the major issues that I’ve dealt with as an advocate has been getting people interested and getting involved in Parkinson’s Disease-related clinical trials. During this time other issues have subsequently come to light, thus the reason for sharing my and others’ experiences with the clinical trial process. Perhaps this post will give a bit more insight as to the passion I have to change the system that has remained in place, and until there is equal access for any and all interested in getting involved in the clinical trial process, regardless of the ability to afford to take part, very little or nothing will change. Researchers will remain on one side of the fence and people living with Parkinson’s Disease will remain on the other. Researchers asking why people aren’t willing to give of their time and funds for such an important cause, while people with Parkinson’s Disease asking why don’t they understand that I’m willing to help but if I can hardly afford my medications, how do you expect me to get to where you need me? My case in point—

I was given the phone number to the patient care coordinator at the Parkinson’s Disease clinic at the National Institutes of Health and asked to call to get involved in their trials. I called and visited about my background, diagnosis, etc. and was told that there was an appointment available on a certain date. The lady went on to say that she would send me the airline reservations, the hotel information, and the ground transportation instructions by mail, and oh, by the way, “I just want you to know that the funds being used are not just funds that are given away. These are your taxpayer funds at work. We appreciate you giving of yourself for us to study this disease.” Wow! I kept thinking, you’re thanking me for doing this?!?

My wife and I left Midland, Texas, and went on our way to Bethesda, Maryland, (a distance of 3,300 miles round-trip) for an appointment with a researcher that would take three hours to learn all that there was about me, my situation, my diagnosis, along with a complete physical exam and various blood tests, and the usual finger tapping, heel tapping, and everything else that goes along with the neurological exam. The time spent at the National Institutes of Health (NIH), which houses 23 (at that time) medical centers on their huge campus, devoted to research of all types was well worth the time and effort to get involved. The experience was an incredible one because of the care, the compassion, the respect, and the appreciation shown to me/us as they work on developing better treatments, and ultimately a cure. I asked my wife a question on the way out of the medical center, “If you had not been here with me and I had tried to explain what an incredibly positive experience I had just gone through, would my words have done it any justice?” Her response was that they would not.

I return to my part of the world and immediately start making arrangements to visit with individuals, groups, organizations, and anyone else that would listen about my experience with the NIH and the need for them to get involved. People start checking into trials that they may qualify for and make plans to volunteer. This is where it gets complicated and I don’t have an answer for any of the people who started asking me questions. I want to do my part but I can’t afford to get to the study site. What can you do to help me? I thought you told me that the NIH trials would pay for the costs associated with participating? Now it gets interesting and the dichotomy comes into play—

The National Institutes of Health has intramural research (based on their campus in Bethesda, Maryland) and extramural research that takes place in any area other than at the site in Bethesda.

As part of their funding on the intramural side, the costs for bringing in people, regardless of what part of the country they live in, is included in their budget. How can they get more studies completed and cutting-edge research accomplished? In my opinion, the answer lies in not having the worry about people being able to afford to get to their research site and those willing to get involved not having to worry about being able to afford to get there.

The extramural side of the NIH research, which comprises the bulk of their funding, takes place in all other areas of the country. These are the highly sought grants that are awarded to leading researchers across the country. The problem with these grants is that they do not include funds to cover the costs associated with participating on the patient side. Through what has amounted to many hours of seeking an answer as to why this is so, the best answer that I can be given is that extramural research grant applicants can ask for funds to cover these costs but the majority of them don’t.

It doesn’t make sense to me to have the best research organization in the world having a set up in funding sources such as this. Should the funding be set up to where anyone that qualifies for a trial only has to concern themselves with providing the time and effort to get involved? Would funding of this sort, made as a part of any NIH grant that involves patients, be made a requirement?

We keep hearing about trials that have never been able to start because of no one willing to volunteer, other trials are extended because of delays in being able to get people to participate, and yet others that get canceled because they just plain give up on finding volunteers. Unfortunately through all of this, it is the patient community that keeps getting the blame, the research community asks for more funds to keep the trial going beyond its projected end time, which in turn leads to research funding that we fight so hard to get into the hands of the researchers being wasted because they can’t get volunteers and the cycle goes on and on and on..

Again, this only covers issues that we are dealing with in the United States. As one man from Scotland asked me a couple of years ago, “Why is it that the richest country in the world has people living with Parkinson’s Disease and are having to do without?”

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2 thoughts on “Case in Point – The National Institutes of Health: An Interesting Dichotomy

  1. Thank you Israel for your blogs on clinical trial participation. I also participated in NINDS studies and I agree they did whatever was needed to enroll participantsi They seemed to understand the roadblocks faced by many PWP
    I’m not sure when the NIH began covering travel expenses, but around 2005, the pipeliners began advocating for private companies to provide their trial participants with funding for plane fare, food, taxis, caregiver expenses, etc.. We identified other economic barriers like lost wages, child care expenses and possible medical costs, if problems developed.
    In the past, the stipends often didn’t cover everything and people had to pay travel expenses upfront and then apply to the drug companies for reimbursement, which sometimes took months. Sometimes expenses were not approved (after the fact) Some patients believed that accepting money from Pharma was unethical. I guess that has to be balanced against the ethics of many more pwp having equal access to clinical trials, and the scientific benefits of a wide based and diverse group of clinical trial participants.

    Over the years as more patients started requesting travel expenses, opinions and then policies have evolved, and it is more common for drug companies to provide the stipends. I like your idea of including funding for patient expenses with the grant.
    But it is still difficult for some to travel to the trials. Another way of increasing participation might be to bring the trials to the people. This was discussed a few years ago, but never took off. Maybe it should be reexamined. There could be a network of community doctors, trained by the sponsors to monitor the trials, and also aid with recruiting. Participants would be working with medical staffs they know and trust, and it would open up access to trials to those outside of the big cities. Eventually, travel stipends will be a thing of the past, as evaluations and ratings will be measured and transmitted electronically – that is if you have a computer.

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    • Thank you for the insightful comments Linda. If I have been in any way successful in raising awareness as an advocate, it is because of you, Perry, Peggy, Paula, and others in the Parkinson Pipeline Project whom have worked tirelessly through the years, setting the foundation and the example of what it means to be an effective advocate. If “standing on the shoulders of giants” has ever applied, it would be the case with the pipeliners. The next wave of people living with Parkinson’s Disease who have taken an interest in advocating to raise awareness, educate, and push for changes that make the quality of life more bearable for all living with PD owe you a debt of gratitute for allowing us to “stand on your shoulders”. I am so thankful for your leadership. I often think of you and the rest of the group when I speak or write on anything PD-related. I send along my best wishes-

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