Interview with Stephen Mikita
Stephen Mikita, J.D., is a Participant Representative on the Steering Committee for All of Us, a National Institutes of Health research study that aims to gather health data from 1 million Americans in order to advance precision medicine. An assistant attorney general for the state of Utah, Mikita makes time to participate in the Steering Committee in order to represent the unique concerns of those with disabilities. He took time to chat recently about his role with the project and his hopes for its ultimate impact.
How do you feel about being included in this historic project and what are your objectives in participating in this effort to build a more inclusive picture of Americans’ health?
I am one of four Participant Representative on the All of Us Steering Committee. This committee oversees all aspects of the program and helps give direction to it. I was selected from among a lot of applicants to be one of the first two—there are now a total of six Participant Representatives on the Steering Committee. I think it speaks well of the All of Us mission and commitment to include diverse Americans, and particularly those of us with disabilities, on the committee. Participants in the All of Us Research Program are treated as true partners. The focus is on capturing data and information to achieve the ambitious goals of precision medicine. One size doesn't fit all.
The director of All of Us, Eric Dishman, has survived cancer, so he is an individual who has benefited from precision medicine and that is why he is such a great champion and leader for this program. I would invite you to watch his video blog, called "The Dish." He has also given TedTalks and he is extremely sensitive and informed about those of us with disabilities.
The first time I went to a Steering Committee meeting in Bethesda in June 2017, I went into this big conference room where I was one of the first people to arrive. Eric is sitting working on his laptop and he immediately gets up, starts moving chairs out of the way, asks me where I would like to sit and visits with me and could not have been more sensitive to my needs. That illustrates in a very anecdotal way what this program's commitment is to accommodating and including individuals with disabilities. I was not only welcomed but my presence was embraced and my voice was valued.
I was one of the featured speakers at the All of Us national launch on May 6 of this year. That took place at seven sites throughout America and in my remarks I talked about how, being a person with a disability, a lot of my life has been spent not being invited to the party, whether it was Christmas or Halloween or kids' birthday parties. And what attracted me to this program is the fact that everyone is invited to this party—no one is excluded, no one is ignored. It aims really for "quadruple diversity," by that I mean four elements...it represents the diversity of the American population in terms of types of people, geography, health status, and data types.
Like every party you go to, you can't just sit in the corner—if you agree to participate, you are going to provide your answers to questionnaires, access to your electronic health records, contribute some baseline physical evaluation metrics, and donate your urine and blood samples. Throughout the life of the program, you may be asked to provide more information in terms of surveys about your overall health, access to healthcare, how often you use healthcare providers, and the barriers you have confronted previously in terms of healthcare utilization, lifestyle, and environmental exposure.
In what way have people with disabilities helped make the All of Us protocols sensitive to the concerns and needs of people with disabilities?
There were working groups before I came onboard and there is also going to be a Disability Task Force assembled to focus on questions and appropriate surveys for individuals who identify as having a disability. I have spoken extensively on these topics and been heard by the program and others. It's important to speak up and lean in for those of us with disabilities, since we consist of one-sixth of the US population. In terms of coming to the physical evaluation appointments, the program has heard my concerns about the ability to park, access to the healthcare provider, the need for signage, so that individuals with disabilities will not confront any architectural, access, or parking barriers in getting to their respective appointments. I'm the co-chair of the Special Populations Committee now. One of those special populations is individuals who have impaired decision-making capacity. We have not yet begun working on that particular population but that is another example of this program's commitment to including diverse populations.
What about children's participation in All of Us?
Under that Special Populations Committee, the Program will continue to develop the protocol for child enrollment.
How do you hope precision medicine can help Americans with disabilities?
I think that the key to precision medicine over time is to accumulate a rich database of individuals, including individuals with disabilities. The more information provided to researchers for their projects, the better the outcomes will be. The data will be reviewed by the program for a host of security issues to ensure that people are not stigmatized and information will not be used in any sort of unethical or illegal way by prospective researchers. I think that individuals with disabilities and their loved ones will benefit greatly from precision medicine. Just because you provide a parking space or ramp, doesn't mean that you are meeting the research needs of those with disabilities.
People with disabilities have been excluded oftentimes on the basis of health criteria from participating in research. Now their info and data will go a long way toward promoting and encouraging researchers to take a deeper dive into more extensive analysis of their data so they can help develop treatments for their conditions. It's not a panacea, for those of us with rare diseases, but it certainly goes a long way in identifying individuals who have certain health conditions that deserve more research.
What excites you most about All of Us?
What excites me most is the fact that there really, truly is a commitment to developing a rich and diverse database that reaches out to include those who heretofore have been excluded from research, and especially underrepresented in biomedical research. It's not just, "Let's reach out to healthy volunteers and let's try to understand a health condition by submitting healthy volunteers to this research project." Precision medicine is not one size fits all— if we want to deliver the right medicine in the right way in the right dosage, then we have got to involve the right populations and the more populations and more diversity the better, so we can develop treatments that will benefit all Americans.
What are the most important ways in which being left out of medical research is hurting Americans with disabilities?
With respect to my particular disease, spinal muscular atrophy, for the first 50 years of my life there were no treatments. Now, due to the commitment of precision medicine, children with my disease can be partnered with researchers. There are pharmaceutical companies who have developed and are developing drugs to treat SMA—and I never thought that would be possible in my lifetime! There are actually babies who were dying before the age of two who are now reaching normal infant developmental milestones, which is really breathtaking. These babies were dying and now they are living, because of a medication [Spinraza] that came out of family members advocating for researchers to commit to finding treatments for this progressive terminal disease—that's staggering! We need more research like that and that's the promise of precision medicine.
The more researchers see successes from one group of people with disabilities the more those researchers are going to be encouraged to dive in with both feet and find solutions for others. So that's what excites me. There's never been a research program like this, recruiting 1 million people. We are already over 100K people.
People with disabilities worry about their health and their family's health and their neighbors' health just as much as those individuals who have traditionally been asked to volunteer their medical and physical information to advance research. Now this is a national focus, to include everyone. All of Us goes down to each individual American and says, "We are interested in you. We want to know why you are healthy or why you don't feel well. We want to understand more about you." The focus is on the individuals rather than certain categories of individuals who have traditionally been enlisted to volunteer. This taps into a national grassroots movement that everyone can get behind because everyone wants their loved ones to have the best, most precise treatments possible to help them live longer and better lives.