By Atiba Madyun
“Twenty-first century businesses will rely on American science and technology, research and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine — one that delivers the right treatment at the right time.” President Barack Obama 2015 State of the Union
Personalized medicine is changing the way medicine and treatment therapies are administered. Unfortunately, minorities or sub-group American populations are not fully benefitting from the changing science, because they are not fully integrated as clinical trial participants. “Research shows that if patients are asked, they will participate.” Dr. Valerie Montgomery-Rice, President and Dean of Morehouse School of Medicine said during a Congressional briefing, convened by the Congressional Hispanic Leadership Institute (CHLI) last week on Capitol Hill.
Some attribute a lack of minority participation to the Tuskegee syphilis experiment. An infamous study conducted from 1932 to 1972. During that study, the US Public Health Service told black male participants they were treating them, but they were not. Men died, 40 women contracted the disease and 19 were born with congenital syphilis.
The effect it has had on minorities participating in clinical trials has and will be debated for years. Nevertheless, forty years later, medical discoveries are opening new pathways to treat serious illnesses like diabetes and cancer, that disproportionately impact communities of color.
Michael Fitzhugh in Negotiating a Place for Race in Age of Personalized Medicine writes, “Fewer than 5 percent of participants in trials registered with ClinicalTrials.gov are non-Caucasian, University of California-Davis, researchers recently found. In cancer, one of the most heavily researched fields in medicine, the picture is even worse, with fewer than 2 percent of clinical studies focusing on non-Caucasian ethnic or racial groups, the researchers found.[i]”
CHLI’s briefing “How Personal is Your Medicine? How to Improve Clinical Trials and Better Latino Health” addressed this and more. Panelists from a university, advocacy organization, corporation and government offered their insight on present challenges and how to create more inclusion.
“As President of one of three historically black medical schools, one would think that we don’t have diversity issues. Many would be surprised to see how many unconscious cultural biases exist there. For instance, an Asian doctor may only have Asians around them. While on another floor, a doctor from Africa may only have Africans working with them.” Dr. Montgomery-Rice explained, “Often, at meetings with my peers, I am the only female sitting at the table among medical school Presidents.”
Her description highlights the harsh reality and need for more practitioners and researchers of color in the medical field, but more importantly the need to get them working together and learning from one another. “We have to start in 9th grade to get students interested in STEM and on track to medical schools. When we are talking about research, we are talking not just about discovery. We are talking about the real engagement on the street, which is clinical trials.” Dr. Montgomery-Rice said.
PhRMA companies need access to data to provide timely research and process the data. Yet when looking at past incidents like the Tuskegee study, we note and recognize that there is mistrust, but there also is not enough inclusion, some of it is systemic and some self imposed.
“It is about having more access to data.” Dr. Elena Rios, President of the National Hispanic Medical Associaition said. “When contractors get contracts from PhRMA companies, they should have to have 30% of those working on the trials be members of subgroups and minority communities. We cannot continue to say and believe that if something works in one community, that it will work in another.”
For many years, terms like health disparities, health inequity, cultural competence, social determinants of health, and language barriers have been used to define inequalities in healthcare access. Companies have been told they needed more diversity in their workforce and clinical trial participation. But what do you do when minorities aren’t asked to participate? What about when practitioners don’t communicate in a trusting way to patients due to lack of cultural competence? Think of the data that is lost because of language barriers and cultural challenges? As Dr. Rios said, “access to data is important.” Everyone today seems to have a cell phone. What if information can be gathered simply by a patient communicating to researchers through text or email what symptoms they are incurring. Isn’t that data useful?
Recognizing that one treatment therapy works better for one group compared to another is a significant achievement. It is important to recognize that one size does not always fit all.
As Dr. Montgomery-Rice explained, “If you gave three kids standing at a fence trying to watch a baseball game the same sized box to see over a fence. What if one is short, another of medium height and the third is tall? The short one may stand on the box and still not be able to see over the fence. The second may stand and his head make it just to the top. The tallest might see well over the fence. This is how we have to look at health equity. We have to know what they need, so that we can provide them with what they need.” Dr. Montgomery Rice said.
Pfizer’s Karen Brooks began her comments with a quote from their Chief Medical Officer, Dr. Freda Lewis-Hall. “If it was an easy problem it would have been solved 20 years ago. We are trying to solve Star Wars problems with Flintstone solutions.”
So how do we address the changing world recognizing that there are language and cultural barriers? Are there other barriers? A clinical trial may be once a week or month. What about patients who don’t have paid leave? Will taking off work be an issue? The reality is that “some participants may go to their doctor once a year. Participating in a clinical trial is totally different,” Brooks said. “Clinical trial participants are our medical heroes. They are the voice to our science!”
To move toward personalized medicine, “companies need access to more big data.” Dr. Rios shared. “There are 50,000 Hispanic doctors in our database. We have to empower our physicians who mainly take care of Hispanic patients.”
Recognizing that their respective communities can be better served with greater participation in clinical trials, last year, both the National Hispanic Caucus of State Legislators (NHCSL) and the National Black Caucus of State Legislators (NBCSL) passed policy resolutions to address clinical trial participation.[ii] Both resolutions emphasize the need to better engage their communities by increasing awareness of the importance of participating in clinical trials.
This will not happen without greater involvement, participation and trust. It also requires more people of color pursuing career pathways in research, development and practice. The science proves we are on the right path to cure some of our worst diseases. Cures cannot happen without data, research and the best minds to find effective ways to treat diseases and communicate with broader audiences. This means, as was emphasized by all the panelists, more diversity in the workforce and younger students being exposed to STEM programs.
As the President highlighted to much fanfare in the medical community during his 2015 State of the Union address, “In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable. So tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information, we need to keep ourselves and our families healthier. We can do this.”
[i] Negotiating a Place for Race in Age of Personalized Medicine, by Michael Fitzhugh – http://www.bioworld.com/content/negotiating-place-race-age-personalized-medicine-0
[ii] National Black Caucus of State Legislators, Increasing Clinical Trial Participation 15-35, http://www.nbcsl.org/public-policy/resolutions/item/1359-health-and-human-services-resolution-hhs-15-35.html
National Hispanic Caucus of State Legislators, A Resolution to Increase Public Awareness & Education on Participating in Clinical Trials 2014-8, http://www.nhcsl.org/106/resolution/a-resolution-to-increase-public-awareness-&-education-on-participating-in-clinical-trials/
Atiba Madyun is the President of The Madyun Group (TMG), a Public Affairs firm based in Washington, D.C. and creator of Cognitive Relevance (CR) and Party Politics (PP). Follow on Twitter @atibamadyun or Like Atiba Madyun on Facebook.