It's no surprise to anyone that the healthcare field in general and laboratory medicine in particular are deeply in crisis as we face a shortage of laboratory and healthcare professionals. We've also witnessed equities in the delivery of quality healthcare, particularly among disadvantaged communities. This challenge is our opportunity. Now is the time to step forward and lead in the areas of diversity, equity, inclusion, and access. I am pleased and thrilled that our scientific general session speaker today is renowned for her leadership in oncology and her experience in promoting diversity, equity, and inclusion in this major area. General Mitchell is an oncologist and a retired brigadier general of the U.S. Air Force, currently serving as clinical professor of medicine and medical oncology at Jefferson in Philadelphia. During her childhood, Dr. Mitchell's family did not have access to quality medical care because of segregation, and she's made a difference. She first earned her bachelor's degree from Tennessee State University, then joined the U.S. Air Force while attending Virginia Commonwealth University School of Medicine, where she was the only black female student. And backstage, she and Dr. Sanford remarked that they have shared some of the same mentors at VCU. Dr. Mitchell then completed her internship and residency in internal medicine at Meharry in Nashville and became a hematologist at Andrews Air Force Base. She also led a team of microbiologists to help provide safe drinking water and administer hepatitis vaccines to underserved communities in the Midwest. And following that work was appointed Missouri Surgeon General, where she initiated a military women's health program and took part in establishing national guidelines for transporting wounded soldiers in military aircraft. In 2001, Dr. Mitchell became the first African-American woman to be promoted in the Missouri Air National Guard, and I believe in the United States, to brigadier general. Please put your hands together for that. That singular accomplishment, after retiring from the Air Force, she joined the faculty of medicine and medical oncology at Thomas Jefferson, where she conducts research into pancreatic cancer. In 2009, she was presented the American Cancer Society's Cancer Control Award for her research in pancreatic and colorectal cancer. And she is the first black woman to receive the PHL Life Sciences Ultimate Solution Award. It is our pleasure, please, to welcome Dr. Edith Mitchell, General Mitchell, to the podium. Thank you so much, Dr. Rinder, for that introduction. My mother would be so proud. And thank you to the audience and members of ASCP to invite me here to speak today. I am most appreciative, deeply humbled, and just so thankful to be here with you today. As an oncologist, I have worked with pathologists for so many years. And as cancer treatment, cancer diagnosis has improved in this country for so many years, it's really a close collaboration between the pathologists, laboratory medicine, and others, because the patients depend on us. And I work with the pathologists so that not only are we evaluating the pathology of the malignancy, but also the follow-up laboratory information, because that allows us to determine the best time and the best treatment for patients. And treatment of patients, giving the patients the best care at the right time, the right treatment, based on laboratory medicine, is so important. So I thank you so much for the opportunity to be here today. And I'd like for you to join me in this effort that we are planning the future with precision medicine, but we still need to think about planning the future with precision medicine, but assessing the past through the rearview mirror. So I'd like for everybody to think about, don't forget what is behind us, because that can help us determine future directions and what we need to do in our careers, in our work, in our laboratory medicine, in our clinical medicine, so we can offer the best medicine to the American population, but also, as we are leaders in the world, it is for everybody. And Dr. Rinder, thank you for mentioning the things that I did in my military career that allowed us to take care of those individuals who are giving their lives to take care of us. So thank you for mentioning my military work. I have no disclosures for what I will discuss today, and these are my efforts and the information that we will discuss. And why do I say the rearview mirror? The poet James Baldwin said, and he's one of my favorites, know from whence you came. If you know whence you came, there are absolutely no limitations to where you can go. And I think that's a good effort for us in medicine today. Remember where we were. And where we were, when the slaves first came to the American colonies more than 400 years ago, they arrived sick with many diseases and were given very poor care at that time. And here we are now, more than 400 years later, and still we are talking about disparities and poor care in the American population. So it's up to us to think about, to do, and to make sure that all of our patients in this country have equity to health care, health care medicine, health care delivery, and therefore important for the country to move forward. And we cannot move forward in health care unless we all have the access and opportunities. So join with me. Dr. Penn mentioned the National Medical Association, and I will do the same. The National Medical Association is one of the efforts for health care equity in this country. It was established in 1895 when black doctors were denied membership in most of the societal organizations, were not allowed to have privileges at hospitals, and therefore the NMA, 12 black doctors got together in Atlanta, Georgia, formed the National Medical Association to therefore represent the initiatives of black doctors and the patients that they cared for. Noting that in 1895, most black doctors only were allowed to take care of black patients. I am very thankful to follow Dr. Vivian Penn, who was a president of the National Medical Association, and I was the 115th president of the National Medical Association. The NMA is still the largest organization of black doctors in this country, as well as the world, who work on the initiatives of not only black patients, but other individuals in this country who are members of groups that are disenfranchised. And that includes not only black patients, but also other racial and ethnic minorities, rural individuals, poor individuals, inner city individuals, and those individuals who have a lack of access to care. And I encourage all individuals in this audience to work with the NMA, therefore bringing equity to all individuals in this country. It is interesting also that the largest medical organization in this country apologized to black doctors not in 1800s, but 2008. Black doctors received an apology from the largest medical organization in this country for excluding them in 1895. So the National Medical Association, still working hard to promote and provide health care equity in this country. Another area that we don't think about as contributing to disparities in this country, and that was the 1910 Flexner Report. And of course we all know of the Flexner Report as contributing to health care and medical education in this country, was a landmark study. It forced all but two black medical schools in this country to close. So five medical schools for blacks were closed. And what this allowed for was no place for students interested in medicine to attend. Only Howard University School of Medicine, Meharry Medical College being the two that were left. And therefore the Flexner Report is partially responsible for the lack of black doctors in the country today because the number has not increased for black doctors in this country since that time. But one thing that is not promoted or talked about was a content area of the Flexner Report that said blacks should be trained in hygiene rather than surgery and specialty and should mainly serve as sanitarians whose purpose was protecting whites from diseases like tuberculosis and other infectious agents. So can you imagine Dr. Penn and me being only sanitarians? But this contributed to disparities because there was a lack of doctors in neighborhoods. The National Cancer Act of December 23, 1971 was an important act signed by then former President Nixon, but it established and expanded the efforts of the National Cancer Institute, established the National Cancer Advisory Board, the National Cancer Centers Program, which includes training and research programs. There are now 71 National Cancer Institute designated cancer centers in this country. So therefore expanding our cancer and research programs and offering opportunities. The Cooperative Group Program was established, the Cancer Control Program, and the Surveillance Epidemiology and End Results Program, the SEER program, that collects the data and allows us to do research based on the data related to cancer in this country. So a very important act, and it was just December 23, 2021, when 50 years of the National Cancer Act and therefore the research by the National Cancer Institute. Another area is recognition of Dr. Jane Cook Wright. Dr. Wright was a clinician, researcher, and she was the first to say that if you want to understand taking care of patients with cancer, you've got to study those tumors in the laboratory. So she was the first to bring together clinical medicine and laboratory medicine, and that is really the hallmark of what we do today. She was also one of the seven founders of the American Society of Clinical Oncology, ASCO, and very, very active. So when we talk about the merging of clinical medicine with laboratory medicine, we must remember Dr. Jane Cook Wright. I was very fortunate to meet Dr. Wright as a member of ASCO. And here we have on the screen to your right, the Lifetime Legacy Award presented to Dr. Wright as a combination of ASCO and the National Medical Association. So we must remember Dr. Jane Cook Wright, and actually her father was very, who was also a surgeon and influenced his daughter in medicine, and they were both active in health activities in the community, politics and others, and were residents who worked with former President Roosevelt on the Hill-Burton Act and the stopping of building the black hospitals such as Homer G. Phillips in St. Louis, the Tuskegee Hospital, and the Tuskegee Veterans Hospital, and he influenced former President Roosevelt to stop building those separate and unequal hospitals. So we have the rights, both Dr. Jane Cook Wright and her father, to thank for integrating many of the systems for clinical medicine. Another area that we don't think about, and that is the Medicare Act, signed in 1965 by then former President Johnson. And former President Johnson, rather than sign that bill passed by the Congress in the Oval Office, as we hear a lot about, he flew to Kansas City, Missouri, and he signed the bill in the Truman Library, recognizing former President Truman as the first president to request funds from the Congress for, it was labeled elderly then, but it was for those over 65. Note, I don't say elderly so much now. But you ask, what did Medicare have to do with health care in this country, and especially since I'm talking about disparities in diversity? So it was signed, as I said, in 1965. And even when you read through the fine print of that document, there was no mention of the Civil Rights Act that had been passed in 1964, one year prior. And the Civil Rights Act said that no organization could receive federal funds unless they adhered to the Civil Rights Bill. So that resulted as a major force for racial desegregation of health care facilities in this country. Consequently, all of the institutions that had signs saying colored on one end and whites only in another entrance are on the floors, whites only, colored. Therefore, this reduced the number of hospitals and health care institutions that had segregated facilities, and therefore, common waiting rooms. And therefore, this was an opportunity for patients. But not only did it integrate the institutions, it allowed for black doctors and other minority physicians to have memberships on the medical staffs, to have pathologists heading those laboratories and others. So it really allowed for integration of health care facilities for our patients and for employees. But this resulted in disparities in the number of individuals who had access to care, who could therefore provide care. And that allowed for greater opportunities. And the gaps between those admissions to hospitals between blacks and whites, collected by Sear and others to close the gaps. And therefore, more access to care, not only for patients, but also for employees. Now one of the areas that I've been interested in is racial differences in cancer in this country. And my colleague and I wrote this premise on racial differences in cancer. While I won't talk about the whole publication, what was noted and a surprise to us was the differences in the cost of cancer care and how individual groups had differences. This slide represents those age 40 to 64. And note that Medicaid covered for whites only about 3.5%. And private insurance covering more than 72% of the cost of cancer care. Whereas for blacks, Medicaid covered 21% of the cost of cancer care. And private insurance only 62%. Now the next slide shows the cost of care for those over 65, which we defined as the Medicare eligible population. That on the right, Medicare covered 68% of the cost of individuals for cancer, with Medicaid only covering 0.1% of the cost of cancer care. Note on the left for blacks, Medicare only covered 51%. So a difference of 68 and 51%. And Medicaid still covering 15% of the cost of care for blacks. And many thought that everybody had access to Medicare. But remember, for Social Security and other benefits, one must have paid into the system. And consequently, many blacks having jobs and other procedures for their lifetime support in career fields where they were paid either cash or some other way of care. So Medicare not being actually equal at that time of this publication for all. Dr. Harold Freeman said, and provided me this slide, that while we know that genetic influences on the gene environment and others very important, but genetics only covers part of the deal. There is the influence of social injustice, poverty, low socioeconomic status, culture, and other that can affect the gene environment, and thus the expression of these genes. And therefore, if we are to attack cancer rates, we must start with prevention and go all the way through diagnosis, treatment, and the overall support of the patient. And that includes survival and mortality rates. The AAMC has also discussed the area and saying that we must devise medical education according to the population. And the population of the United States is changing with individuals over 18 years old being 68% Caucasian at the time of the publication. And yet for evaluating the same individuals, but those over 18 years, 56%. So a decline in the population that is Caucasian with an increase in minority groups. And therefore, we must address medical education according to our population. The Accreditation Council for Graduate Medical Education has made some substantial recommendations regarding diversity and equity in this country. And what they have said is that the physician numbers in minority populations are small, and we've got to address that. The population of black and Hispanic physicians hasn't changed significantly over several decades and accounts for approximately 5%. And in some years, less than 5% of the practicing physicians in this country. And therefore, it's up to us to address this. The goal of the workforce diversity really can influence health equity and incidence and mortality rates of groups. Inclusion is the tool that we need to use, and health equity is the means of achieving that. ACGME has thus devised the DEI plan. And with it, it says that as a group, we've got to acknowledge that this is a problem. We've got to accept and own the issue. We've got to act. We've got lots of smart people in many different areas. And we, therefore, must devise the methods and then be accountable with evaluation and expanding the needs and recognize that equity matters. We must also be innovative in the processes. We've got many great institutions in this country, many good residency programs and others. And therefore, we've got to use our talents, devise methods, and continue the implementation process until we actually have justice in the system. And with justice, yes, we can add tools that allow for improving implementation of inequality. We can give added efforts and call it equality. But notice in this cartoon representation that the tree is bent. And therefore, that allows for disparities and opportunities for groups. And note that in the first three pictures, the side of the tree has no sunlight and therefore bearing no fruit. But what we really have to do is fix the system, straighten up this tree so that all individuals have equal opportunities to the programs that we have in the country. So equity. I'll go back to the National Cancer Act now. National Cancer Act of 1971, therefore, allowed for collecting data. And the first data was reported as the example here in 1975, where only data between blacks and whites was collected at the time. And note that African Americans had worse cancer mortality rates and outcomes than whites. In the late 90s, there was collection of data from many other racial and ethnic groups with reporting beginning in about 2000. And note still, African Americans throughout all of these reports had the worst mortality rates of any group in the country. And therefore, very important that we know our communities and can therefore influence data collection. Note that African American men have the worst incidence and mortality rates of any one group in the country, whereas for women, whites have higher incidence rates perhaps because of the method of recording, but higher mortality rates and consequently very important. Note that there has been a continuous decline in cancer death rates as well as incidence rates in the country since we started collecting data as a result of 1971 Cancer Act. And yet, we note that there are differences. So I'll discuss just a few of the cancers. First of all, for breast cancer. Breast cancer has a higher burden in African Americans, higher mortality rates, more advanced stage at the time of diagnosis, younger age distribution, increased frequency of adverse tumor features, a larger number of poorly differentiated triple negative tumors. There's also a higher incidence of male breast cancer. And these rates are all influenced by socioeconomic disparities, delivery of care, lifestyle, diet and nutrition, and others. I've mentioned triple negative breast cancer. And note for the group on your left, with the highest best rates of survival, those tumors that are hormone receptor positive and ERB B2 negative are in whites, whereas the highest number of triple negative breast cancers occur in African American women. There is also the note that many organizations are recommending screening of breast cancer to start at age 50 and mammograms starting at age 50 and none for those over age 75. Note that whether black women develop breast cancer, whether at age less than 40 or over 75, triple negative breast cancer is the most commonly noted cancer. And if we delay mammography screening until age 50, note that because triple negative breast cancer occurs in both white and black women under age 40, that these women will not have had access to screening. So therefore, if there is any influence, let's make sure that women have the opportunities for early screening of mammograms. And as our population ages, that we have screening for mammograms in, I won't say the elderly population, but those over age 75. And as our age groups increase in the country, therefore, again, giving equity of cancer care and cancer prevention to all. So I'm frequently asked, what do you mean by triple negative breast cancer? Well, there is no expression of estrogen, progesterone, or ERB2 receptors in the cancers. Accounts for about 15% of all breast cancers. More aggressive chemotherapy is our currently main treatment. And therefore, many of the hormone receptor positive targets not acceptable for this group of women and because of lack of effect. They're more common in young women, African-Americans, Hispanics, and in the BRCA1 group. So breast cancer being very important and very important with the laboratory as we devise other targets and other methods of measuring these targets. The next group I'll talk about is multiple myeloma. And multiple myeloma is a group, it is actually the most disparate of all cancers, small numbers, but note that African Americans in terms of incidence rates, more than double that of other racial groups, and the same thing is true for the mortality rate. Now much of our effort is directed toward trying to find out why. It is well recognized that the pre-existing disposal or risk of multiple myeloma is due to monoclonal gammopathy of unknown significance, or MGUS, which is higher in blacks than in other racial groups, and not all individuals with MGUS will develop myeloma. So trying to define what are the factors that predispose to progression from MGUS to frank myeloma in patients. Another group after myeloma is that of the gastrointestinal cancers, and I'll only mention colorectal cancer, which has a higher incidence rate in African Americans, about 20% higher, and about a 40% higher mortality rate in blacks than in whites, and black patients are more likely to be diagnosed at an earlier age, have more advanced tumors and advanced stages at the time of diagnosis, as well as more aggressive disease as manifest by the poorly differentiated colorectal cancers. And over the years, there's been a decline in death rates from colon cancer, but still the gap exists between whites and blacks, with African Americans having a higher rate. One of the interesting changes in recent years is the increase in the rate of development of colon cancers in young individuals, and over the last two decades, there has been a 53% increase in colon cancer in young individuals. In fact, my youngest patient, 15 years old, young girl, who had told her parents and pediatricians about some bleeding, and they told her, well, you're at that age, but it turns out she was seen in an emergency room with a perforation of the rectal cancer, and it was stage four at that time. So colorectal cancers in younger individuals, and that continues to increase, with a lot of research ongoing to try to determine the reasons and etiology of this change in young individuals. Now, with COVID-19, there was a decrease in screening, both for colorectal cancer and breast cancer, and with modeling, data modeling, the National Cancer Institute has predicted that in about three years, we're going to see increases in these cancers in individuals because of the failure of screening during the pandemic. So more to come on that. What we have is, if we're going to focus on these groups of patients, the younger patients, those with myeloma, breast cancer, colorectal cancer, as well as other cancers, we've got to engage the populations, the communities, to try and bring individuals into clinical trials, clinical studies, so that we've got evaluation. We also must get rid of our biases in seeing patients, so that we eliminate unconscious bias in communities and in the care of patients. We've got to make sure there's community engagement. We are inviting individuals in the community, whatever the community is, to participate in clinical trials and get the information. What we know is that individuals in Hispanic communities and in African American communities, as well as inner city and rural communities, do not receive the laboratory studies that I've described, as well as others, to understand the disease processes. African Americans have only about a 20% participation in clinical trials that evaluate laboratory processes that allow us to evaluate risk and determine treatment. So very important. And we ask, why participate? Well, the data from SEER shows that for clinical trials presented to the FDA, African Americans' participation is 1.6%. Hispanic, 2.7%. Native Hawaiian and other Pacific Islanders, about 6%. And overall, 1% of the trials approved by the FDA have a total of about 1% of disparate populations. So therefore, we've got to address these. Racial disparities in healthcare is very important. And it's not just the genetic processes, but low numbers of professionals, minorities. And that's not only clinicians, but laboratory scientists and others. There's lower rates of comprehensive insurance. The out-of-pocket costs are higher. And others, so consequently many individuals, are not a part of and don't receive the great procedures that you are doing in the laboratories giving us more information on cancers and the differences in populations. So for healthcare policy, for the ACA and cancer disparities, there are studies that have recognized that in states where there is Medicaid expansion, that individuals who are poor or who are members of the minorities have access to care that is reached faster than those states without Medicaid expansion. And consequently, Medicaid expansion has allowed for greater treatment opportunities and earlier treatment to patients with access to diagnostic testing and the diagnostic procedures that we all in this audience know about, are developing, are continuing with research, and therefore developing more opportunities. So Medicaid expansion, an opportunity for patients. For the Sydney Chemo Cancer Center at Jefferson, we have devised this method to increase our accrual to clinical trials. And with the clinical trials, the diagnostic tools that are a part of these trials, therefore offered to everybody. So working with the community, developing partnerships, making sure we have access to basic science, clinical science, our data collection science, and all of this focused on increasing accrual to our clinical trials and therefore offering opportunities to all. Another area of research is that of the All of Us program. It is the largest clinical trial that ever NIH has conducted. And we don't even call the members patients, they are participants. And with this, there is an idea for those individuals who are not sick, who have no evidence of disease, to have access to the laboratory studies that you have developed and therefore be able to predict what disease processes an individual might be at risk for. The study was opened in May of 2018, and now there are over 400,000 participants. And what that means is that it was planned for 10 years, but already in the five years of operation, we're nearly at half point collecting. So All of Us, there is information on the website of NIH for access to All of Us program. Another area, President Biden said he was reigniting the Moonshot program, which was started during the Obama administration when former President Obama said for the Moonshot program, he was putting Joe in charge. And as the vice president then, he ignited that. I had the privilege of working on the first Moonshot, and therefore this was very important. And President Biden reigniting the Moonshot. And he said he wanted to decrease cancer death rates in this country by 50% in 25 years. So these are things that are ongoing. I am currently finishing up my term on the president's cancer panel. And this panel, on the day that President Biden gave his speech to the country on reigniting the efforts for cancer, our panel gave this report to the president, that we needed to improve and align communications. One hospital can't talk to another, give a report that can be picked up by the other hospital, facilitate equity and access to all, strengthen the workforce collaborations, and create effective health IT. So that program is ongoing with the president's cancer panel on gaps in cancer in this country. So I'd like to summarize now to say that the Precision Medicine Initiative, which was launched in January of 2015, is ongoing and has been reignited by the president, that cancer death rates and mortality continue to decline in the country, that understand disparities in cancer incidence and mortality rates, and the impact of social determinants of health are major areas of research and focus, combined with collaboration of clinicians with laboratory science, and therefore putting the two together to try and understand the influence of social determinants of health on genetics, but also on expression of receptors and expression of genomic profiles, but the influence on drugs and other therapeutic modalities on these. It's important to remember historical contributions to the decline of cancer death rates, and therefore we need to include all of these in our research studies. Cancer health disparities happen when there are higher rates of new diagnoses and cancer death rates among certain individuals, racial, ethnic, rural populations having lack of access as well as the clinicians in these disparate areas having a lack of access of the laboratory diagnostic procedures for their patients. There is newer therapeutic and research interventions, clinical trials that offer opportunities for all of us as cancer researchers, whether your research area is in the laboratory, in the pathology laboratory, in the clinical understanding and treatment of individuals. All of these are important, and we must figure out how we can develop collaborative methodology to allow us to incorporate all of these into our treatment intervention plans. The All of Us program is a precision medicine approach to understanding and preventing disease. The information is actually given back to the participant, so you will know whether you're at risk for certain disease processes from genetic or other precision medicine treatment approaches. It will also allow for understanding disease processes in communities where there might be factories or other influences on health care. And lastly, that the Medicaid expansion has offered greater opportunities for individuals and the president's plan for reigniting the cancer moonshot, and therefore more research available for your laboratories, as well as clinical procedures. And the president's cancer panel to increase cancer screening, and this report now is being utilized throughout the nation, and therefore you may see that in your institutions and in your laboratories, those tests related to increasing cancer screening. And with that, I'd like to conclude. I thank you for the opportunity, allowing me to speak today, and I hope all will use our science to understand and to provide it to all of our communities so that we can use all of our processes, all of our information, and all of the things that we have developed to be combined in a collaborative manner so that we are approaching disease. And not only cancer, you could say the same thing for other diseases, so lupus and others. So thank you so much for the opportunity to speak today. Thank you.

healthcare inequities

laboratory medicine

Dr. Edith Mitchell

oncology

diversity and equity

racial disparities

community engagement

clinical trials