Mr. Chair, I have an amendment at the desk. Mr. Chair, just a few weeks ago, I had a roundtable discussion with health professionals and those who are suffering from diabetes. I heard the stories of…
Mr. Chair, I have an amendment at the desk.
Mr. Chair, just a few weeks ago, I had a roundtable discussion with health professionals and those who are suffering from diabetes. I heard the stories of how much insulin costs and how difficult it was to be able to access healthcare, in many instances. This discussion was held at the University of Houston medical school.
The Jackson Lee amendment makes a good bill even better by providing $10 million more to help ensure that the national goals of finding and bringing
more and better treatments for diabetes is aided by an expanded pool of diverse and talented medical researchers and clinical trial participants.
Many racial health disparities, including diabetes, stem from a lack of access to quality healthcare and proper health awareness. Unfortunately, this means that the incidence of kidney disease has not always matched trial populations. African Americans represent 12 percent of the U.S. population but only 5 percent of clinical trial participants.
Hispanics make up 16 percent, but only 1 percent of clinical trial participants.
Sex distribution in cardiovascular device trials is 67 percent male.
Other significant barriers to diversified clinical trials, which are key to sound medical research and the foundation for medical cures and breakthroughs, as reported by investigators and coordinators, are insurance status, patient inconvenience, cost, availability of transportation, distance to the study site, and patient and family concerns about risk.
My amendment, in particular, focuses on ensuring the outreach for researchers and, as well, those who would be participants in clinical trials. Physicians are the gateway to the patient as well, and the lack of access to physicians also diminishes the rights or the ability for people to be in trials.
My amendment is intended to aid in the necessary effort to diversify the pool of doctors and medical researchers conducting clinical trials and, thereby, helping to diversify the participants in the clinical trials.
I would ask my colleagues to support this amendment.
Mr. Chairman, it is important to take note of this particular chart; proportion of volunteers in clinical research by race and ethnicity. And you will see, as it relates to minorities, at every step of the way, dealing with total U.S. population, only 33 percent participate. NIH-funded clinical research only 36 percent participate; and industry- funded clinical trials, a paltry 16.7 percent.
It indicates as well, and I include in the Record ``Clinical Trials Shed Light on Minority Health.''
[From FDA Consumer Health Information]
Clinical Trials Shed Light on Minority Health
The Food and Drug Administration (FDA) is working to
increase the participation of people in racial, ethnic and
other minority groups in the clinical trials that test new
medical products.
The Food and Drug Administration (FDA) is working to
increase the participation of people in racial, ethnic and
other minority groups in the clinical trials that test new
medical products.
Why is this important?
Ensuring meaningful representation of minorities in
clinical trials for regulated medical products is fundamental
to FDA's regulatory mission and public health, says Jonca
Bull, M.D., director of the agency's Office of Minority
Health (OMH). Racial and ethnic minorities include African
American, American Indian, Alaska Native, Asian American,
Hispanic American, Native Hawaiian and Pacific Islander
communities.
OMH project manager Christine Merenda, M.P.H., R.N.
explains that clinical trials are the proving ground for new
drugs, vaccines and devices. They provide the data that will
determine whether FDA approves a manufacturer's application
for marketing approval.
``Potential racial, ethnic and other differences in
response to drugs are important to FDA's efforts to help
ensure that the safety and effectiveness of drugs are studied
in all people who will use the products once they are
approved,'' she says.
Considering Genetic Differences
Bull explains that there are biological differences in how
people process drugs. For example, variations in genetic
coding can make a cancer treatment more toxic in one ethnic
group than it would be in another. These variations can make
also make drugs like antidepressants and blood-pressure
medications less effective in one group than another.
Getting more data on these differences is essential for FDA
to truly know that a medical product will truly work and be
safe for all patients, Bull says.
Members of minority groups may be more vulnerable to
certain diseases. ``We know, for example, that African-
Americans and Hispanics have higher rates of diabetes, HIV/
AIDS, obesity and cardiovascular disease,'' says Bull. Native
Americans and Asians have been shown to have higher rates of
hepatitis, while Hispanics are disproportionately affected by
diabetes.
But historically, both women and minorities have been
under-represented in clinical trails. For example, according
to a 2011 report from the conference ``Dialogues on
Diversifying Clinical Trails,'' sponsored by FDA's Office of
Women's Health and the Society for Women's Health Research
and supported by OMH:
African Americans represent 12% of the U.S.
population but only 5% of clinical trial participants;
Hispanics make up 16% of the population but only
1% of clinical trial participants; and
``Men make up more than two-thirds of the
participants in clinical tests of cardiovascular (heart and
blood vessel) devices?''
At the conference, more than 200 representatives from
government and industry came together with patient advocates
and the scientific community to discuss strategies for
increasing the participation of women and minorities in
clinical trials.
Why the Disparity?
Bull says there are different reasons why minorities have
been under-represented in clinical trials.
One reason may be a lack of trust because of past abuses,
Bull says. One notorious example was the Tuskegee Syphilis
Study, experiments conducted between 1932 and 1972 by the
U.S. Public Health Service. Health officials recruited poor
black share-croppers in Alabama to study the natural progress
of syphilis. However, while the study was in progress,
penicillin was discovered to treat syphilis. The study was
not stopped and the men were not treated with penicillin that
could have cured them.
According to a recent university study, however, this
attitude seems to be changing. The study was designed to
learn the health concerns and research perceptions among
under-represented groups. When asked about their over-all
interest in medical research, 91 percent of African-Americans
expressed interest in participating.
Nonetheless, recruiting people to participate in clinical
trials--no matter what race or ethnicity--is difficult in
general, Bull notes. FDA works to protect participants in
clinical trials and to ensure that people have reliable
information as they decide whether to join a clinical trial.
There are many benefits to minority participation for
researchers that extend, in larger sense, to society.
Minority participation helps researchers find better
treatments and better ways to fight such diseases as cancer,
diabetes, heart disease and HIV/ AIDS. In addition, it
uncovers differences by gender, race, and ethnicity that may
be important for safe and effective use of therapies.
Safeguards and Resources
Safeguards for clinical trial participants include
oversight by institutional review boards (IRBs), composed of
at least five members, including scientists, doctors, and lay
people. IRBs ensure that appropriate steps are taken to
protect the rights and welfare of participants as subjects of
research.
Though it's too soon to tell, Bull says that the FDA Safety
and Innovation Act (FDASIA) signed into law by President
Obama in July 2012 could have a helpful effect in supporting
efforts to enhance minority participation in clinical trials.
FDASIA requires that FDA report to Congress by July 9, 2013
on the diversity of participants in clinical trials and the
extent to which safety and effectiveness data based on such
factors as sex, age, race and ethnicity are included in
applications submitted to FDA.
Based on these findings, FDA and others involved in
clinical research will be able to identify needs and
opportunties to increase minority representation, says Bull.
In the meantime, Bull encourages consumers to take a more
proactive approach. If you're undergoing treatment and your
condition is not improving, she says, you may want to talk to
your health care professional about the availability of
clinical trials that address our condition.
FDA also has information at fda.gov (http://www.fda.gov)
with information about participating in clinical trials
(http://www.fda.gov/ForConsumers/ByAudience/ ForPatientAdvocates/ParticipatinginClinicalTrials/ default.htm) and links to an array of resources. And
clinicaltrails.gov (http://www.clinicaltrials.gov) is another
resource from the National Insitiutes of Health.
Mr. Chairman, the Food and Drug Administration is working to increase the participation of people in racial, ethnic, and other minority groups in the clinical trials that test new medical products.
So I would indicate that this particular amendment is to give greater focus to ensure that we have access to these individuals. Again, diabetes in minority communities is surging. The difficulty of getting access to insulin is also a conspicuous medical concern. But certain medical illnesses have been known to have a higher prevalence in certain demographic groups, including Type 2 diabetes, lupus, sickle cell anemia, and triple-negative breast cancer.
This particular amendment is, of course, helping to end, or to work on improving the access at this time.
Mr. Chairman, I yield 1 minute to the gentlewoman from Connecticut (Ms. DeLauro).
Mr. Chairman, I urge support of this amendment.
Mr. Chair, I wish to thank Chairman McGovern and Ranking Member Cole of the Rules Committee for making this Jackson Lee Amendment in order.
I thank Chairwoman DeLauro and Ranking Member Cole for their hard work in bringing Division A, the Labor-HHS portion of this omnibus appropriations legislative package, to the floor.
I thank them all for this opportunity to explain the Jackson Lee Amendment, which makes a good bill even better by providing $10 million more to help ensure that the national goals of finding and bringing more and better treatments for diabetes is aided by an expanding pool of diverse and talented medical researchers and clinical trial participants.
Many racial health disparities, including diabetes, stem from lack of access to quality healthcare and proper health awareness.
Unfortunately, this means that incidence of kidney disease does not always match trial populations.
For example, consider that:
1. African-Americans represent 12 percent of the U.S. population but only 5 percent of clinical trial participants.
2. Hispanics make up 16 percent of the population but only 1 percent of clinical trial participants.
3. Sex distribution in cardiovascular device trials is 67 percent male.
Other significant barriers to diversified clinical trials, which are the key to sound medical research and the foundation for medical cures and breakthroughs, as reported by investigators and coordinators are insurance status, patient inconvenience costs, availability of transportation, distance to the study site, and patient and family concerns about risk.
But the most significant barriers limiting clinical participation are race, age, and sex of participants:
1. Women and minority patients are more difficult to recruit.
2. Women and minority physicians have less experience and are relatively costlier to engage.
3. Minority patients with limited English proficiency can require costly translation services.
The first step in engaging women and minorities in clinical trials is finding them.
Research has shown that minority patients seek physicians of their own race, so bringing these doctors into trials is critical.
Physicians are the gateway to the patient.
There are disturbing statistics on the number of African Americans, Hispanics and Native Americans pursuing academic qualification and participating in scientific research.
Many barriers exist that account for the low rate of participation among diverse communities, including patient fear of experimentation and lack of understanding or education with regard to the importance of clinical trials in creating new treatments and cures.
The Jackson Lee Amendment is intended to aid in the necessary effort to diversify the pool of doctors and medical researchers conducting clinical trials, and thereby helping to diversify the participants in the clinical trials.
In short, the Jackson Lee Amendment seeks to open the ``physician gateway'' to the patient.
The Journal on STEM Education reported in 2011 that only 8.34 percent of the STEM doctorates awarded in 2006 were given to underrepresented minorities (URMs), despite making up approximately 28 percent of the U.S. population.
Additionally, GAO found that while the percentage of underrepresented minorities nationwide increased from 13 percent to 19 percent from 1994 to 2003, the total number of STEM doctorates awarded to the same group dropped during this period from 8,335 to 7,310.
In response, the National Institute of General Medical Sciences (NIGMS) created the Minority Opportunities in Research (MORE) Division and similar academic intervention programs.
The MORE programs are comprised of four primary components: research experience, mentoring and advisement, supplemental instruction and workshops, and financial support.
This includes the Minority Biomedical Research Support-Research Initiative for Scientific Enhancement (MBRS-RISE) program, the Minority Access to Research Careers (MARC), Post-baccalaureate Research Education Program (PREP), and the Bridges to the Baccalaureate and Bridges to the Ph.D. programs.
The amount of funds dedicated to these programs reflects the commitment by the science and research community to the goals of the MORE Division in addressing this problem.
Certain medical illnesses have been known to have higher prevalence in certain demographic groups, including type II diabetes, lupus, sickle cell anemia, and Triple Negative Breast Cancer for which African Americans are more than twice as likely to be diagnosed on average.
Race and ethnicity have also been shown to affect the effectiveness of and response to certain drugs, such as antihypertensive therapies in the treatment of hypertension in African Americans and anti-depressants in Hispanics.
Increased diversity in research trials could help researchers find better, more precise ways to fight diseases that disproportionately impact certain populations and may be important for the safe and effective use of new therapies.
But before we can engage more women and minorities to participate in clinical trials, we must be able to find them.
And the key to finding minority patients is find more physicians from their racial and ethnic groups because research has shown that physicians are the gateway to the patient.
The Jackson Lee Amendment opens that gateway.
I urge support for the Jackson Lee Amendment.
Mr. Chairman, I yield back the balance of my time.
Mr. Chairman, I have an amendment at the desk.
Mr. Chairman, let me take this opportunity to thank Congresswoman DeLauro and her leadership as the chairwoman of this subcommittee, and her ranking member, Mr. Cole. I had the privilege of appearing before them in making my request, and so I want to thank them for many of the requests. I don't want to be too celebratory and say all of my requests, but I am very pleased that the investment in healthcare, education, many of the issues that I was concerned about, are well-invested, and it will be the kind of announcements that I will be able to make in my district for the great needs that are needed.
My amendment is to emphasize the importance of a program that, when I went to graduations, I saw students wearing banners, if you will, that said the word ``TRIO;'' that they were graduating with the help of TRIO. They were going on to college with the help of TRIO. And I was very excited about
the opportunity of seeing, in living proof, the proud symbols of those who had had a greater opportunity.
My amendment makes, again, a good bill even better by providing $10 million more to help ensure that TRIO students at the greatest risk of not completing their degree program get additional assistance to finish their education. I was excited when these students walked across the stage going on to college with TRIO support.
TRIO is a set of seven federally-funded education opportunity outreach programs that help low-income, first-generation students, and students with disabilities, to pursue higher education.
There are many opportunities for individuals to go into the trades and other disciplines, but many want to go to college.
The Upward Bound Program, the first Federal TRIO Program, was created in 1964. Later, Talent Search was created. The TRIO name itself was born four years later, when the Higher Education Act of 1965 was amended to include Special Services for Disadvantaged Students.
So today, there are nine TRIO programs that I am excited about; and my emphasis is to ensure that these programs are well-funded.
Even in my own community, I can tell you that TRIO is well-needed and well-utilized.
Mr. Chairman, I ask my colleagues to support the Jackson Lee amendment.
Mr. Chairman, could you tell me how much time is remaining?
Mr. Chairman, I yield 1 minute to the distinguished gentlewoman from Connecticut (Ms. DeLauro).
Mr. Chairman, I am excited that, in 1986, we added the Ronald E. McNair Postbaccalaureate Achievement Program--we all remember him as a great astronaut who died in a horrific astronaut calamity--to foster doctoral degree attainment by students from underrepresented segments of society.
But, Mr. Chair, a young man went to the Upward Bound program at the historically Black Texas Southern University. He graduated from Sterling High School, but he grew up in extreme poverty, stricken with food insecurities and difficult living conditions.
Poverty is not only a state of being, but a state of mind.
However, with the help of TRIO, he went on to acquire life skills, strategies, and the support he needed to follow the dream of attending the University of Texas at San Antonio, majoring in Construction Science Management.
Not only did he graduate from UTSA, but he graduated with honors, and he plans to attend graduate school in the fall. He is one of many students that are impacted; and the more we focus on the at-risk students, the more America continues to ascend to her greatest level.
We helped Terrance, who is a 40-year-old student that began working on his GED at Houston Community College in 2005. He ultimately achieved it 5 years later.
My amendment, again, is to emphasize the doors of opportunity, from Ronald E. McNair, Student Support Services, Talent Search, the Training Program for Federal TRIO Programs, Upward Bound, Upward Bound Math and Science, and Veterans Upward Bound. It is encompassing of many aspects of young people and those returning to school.
I ask my colleagues to support the Jackson Lee amendment, which focuses on those at risk, and turns that at risk into success.
Mr. Chair, I wish to thank Chairman McGovern and Ranking Member Cole of the Rules Committee for making this Jackson Lee Amendment in order.
I thank Chairwoman DeLauro and Ranking Member Cole for their hard work in bringing Division A, the Labor-HHS portion of this omnibus appropriations legislative package, to the floor.
I thank them all for this opportunity to explain the Jackson Lee Amendment, which makes a good bill even better by providing $10 million more to help ensure that TRIO students at the greatest risk of not completing their degree program get additional assistance to finish their education.
TRIO is a set of seven federally-funded educational opportunity outreach programs that help low-income, first-generation students and students with disabilities to pursue higher education.
The Upward Bound Program, the first Federal TRIO Program, was created under the authority of the Economic Opportunity Act of 1964, as amended.
A year later, Talent Search was created as part of the Higher Education Act of 1965 to assist students applying for newly authorized federal financial aid for postsecondary education.
The TRIO name itself was born four years later when the Higher Education Act of 1965 was amended in 1968 to include the Special Services for Disadvantaged Students program--what is now called Student Support Services (SSS).
Since 1968, TRIO programs have been expanded to provide a wider range of services.
Today, nine TRIO programs are included under the TRIO umbrella, seven of which provide direct services to students.
The 1972 amendments to the Higher Education Act created Educational Opportunity Centers (EOCs) to help adults select a postsecondary education program and obtain financial aid.
Veterans Upward Bound (VUB) was also initiated in the 1972 as part of the Upward Bound program to serve returning Vietnam veterans.
Amendments in 1986 added the Ronald E. McNair Postbaccalaureate Achievement Program (McNair) to foster doctoral degree attainment by students from underrepresented segments of society.
In 1990 the Upward Bound Math and Science (UBMS) program was initiated as part of the Upward Bound program to address the need for specific instruction in the fields of mathematics and science.
TRIO also includes a training program for project directors and other staff of TRIO projects (Training Program for Federal TRIO Programs, which was authorized in 1976).
The TRIO programs are administered by the Student Service area of the Department's Office of Postsecondary Education.
TRIO includes: Educational Opportunity Centers; Ronald E. McNair Postbaccalaureate Achievement; Student Support Services; Talent Search; Training Program for Federal TRIO Programs Staff; Upward Bound; Upward Bound Math-Science; and Veterans Upward Bound.
Currently serving nearly 790,000 students across America, TRIO provides academic tutoring, personal counseling, mentoring, financial guidance, and other supports necessary for educational access and retention.
TRIO programs serve students from middle school and high school (Talent Search, Upward Bound, Upward Bound Math-Science) to college and postgraduate study (Student Support Services, Ronald E. McNair Postbaccalaureate Achievement).
TRIO also provides services to adult learners (Educational Opportunity Centers, Veterans Upward Bound).
Jackson Lee Amendment No. 15, adds $10 million in funding to assist students at the greatest risk of not completing their degree program.
TRIO students can include teens to older adults trying make a career move or complete a life goal of a GED or college degree.
I ask my colleagues to support this Jackson Lee Amendment.
LiTroy
TRIO/Upward Bound program at Texas Southern University
Story: Litroy Lambert graduated from Sterling High School in Houston Texas in 2014.
He grew up in extreme poverty stricken with food insecurities and difficult living conditions.
Poverty is not only a state of being it can too often become a state of mind where dreams fester and die.
However, with the help of the TRIO/Upward Bound program at Texas Southern University LiTroy was able to acquire the life skills, strategies and the support he needed to follow his dreams of attending the University of Texas at San Antonio (UTSA) majoring in Construction Science Management.
Not only did LiTroy attend UTSA, but he also graduated with honors and plans to attend graduate school in the fall.
LiTroy is one of many students whose lives have been dramatically changed by the efforts of TRIO/Upward Bound programming and staff.
Stories from Houston Community College's (HCC) TRIO Educational Opportunity Center:
Terrance, age 40
Terrance is a 40-year-old student that began working on his GED at Houston Community College in 2005.
Upon meeting Terrance in his GED class, he explained that he had been working on his GED off and on and was unsuccessful at completing his GED because of the cost of the exam and his inability to pass certain portions of the exam.
He is a father and has also worked odd jobs while attempting to complete his GED.
TRIO offered Terrance an alternative to the GED exam, the HiSet, which is an approved high school equivalency certification recognized by the Texas Education Agency.
In addition to offering him an alternative exam, HCC provided him with vouchers to cover the cost of the exam and within his first attempt of taking the HiSet exam, he successfully earned his high school equivalent certificate.
We assisted Terrance with applying for college and financial aid and he is currently enrolled at and set to begin college classes this fall to earn a Communications degree.
Stories from Houston Community College's TRIO Educational Opportunity Center.
Eric, age 44
Eric is a 44-year-old student that began working on his GED in 1995, stopped attending and then returned to complete his GED in 2017 when he was unable to receive a promotion on his job because he did not have a high school diploma.
After several attempts at the GED, Eric was unable to pass portions of the GED exam because of his work schedule that prevented him from attending class regularly.
Eric struggled with portions of the exam and TRIO offered him tutorial services and the alternative HiSet exam.
Eric successfully passed the HiSet exam and earned his High School Equivalent certificate.
TRIO also assisted Eric with applying for financial aid and college admissions.
Eric will begin working on his pre-nursing courses in the fall so that he can eventually apply to nursing school and receive a promotion at his job.
Christina, age 65
Christina is a 65-year-old disabled student that contacted TRIO because she had problems finding a program that would lead to a job.
She wants to get off disability and work in an office job so that she can take care of herself without the limited income that disability provides.
TRIO was able to advocate for Christina to get financial aid reinstated because she was on probation when she attended previously, due to the demands on her time because of having to care of her sick husband, who died when she was in school.
The TRIO Educational Opportunity Center was also able to connect her with free tuition that is offered by Houston Community College so that she can maximize her financial aid.
We assisted Christina with finding a program that will give her the technology/computer skills she needs that will lead to a job.
Christina is currently enrolled in summer classes and pursuing a degree in Business Technology.
Mr. Chairman, I yield back the balance of my time.