[Congressional Record Volume 161, Number 108 (Monday, July 13, 2015)]
[Extensions of Remarks]
[Pages E1047-E1049]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                         21ST CENTURY CURES ACT

                                 ______
                                 

                               speech of

                        HON. SHEILA JACKSON LEE

                                of texas

                    in the house of representatives

                         Thursday, July 9, 2015

       The House in Committee of the Whole House on the state of 
     the Union had under consideration the bill (H.R. 6) to 
     accelerate the discovery, development, and delivery of 21st 
     century cures, and for other purposes:

  Ms. JACKSON LEE. Mr. Chair, I rise in support of H.R. 6, the 21st 
Century Cures Act, a bipartisan piece of legislation that is vital to 
the future and health of our Nation's citizens and ecosystem.
  This thoughtful legislation is the culmination of the hard work of my 
dedicated colleagues who have sought out and engaged in public 
conversations with patients, innovators, providers, regulators and 
researchers about how to move advances in science and medicine into new 
therapies.
  This outreach has garnered the critical input and support of more 
than 370 patient and physician groups, state and local organizations, 
cancer centers, and research and life sciences.
  I'm proud to be one of the cosponsors of H.R. 6, which represents a 
new national effort to find treatment and cures for thousands of 
unknown and rare diseases.
  Looking to the various policies this legislation aims to address, it 
is important to highlight the commendable objectives and that will not 
only accelerate the discovery, development and delivery of new 
treatments and cures for thousands of serious and rare diseases, but it 
will also open the doors of innovation and the growth of health care 
system by enhancing and enriching the medical field for all Americans.
  The most ambitious action calls for $10 billion in mandatory funding 
to be delivered over the next five years to the National Institutes of 
Health (NIH).
  NIH is part of our nation's top ranked educational research 
institutions in the world.
  In order to maintain our global competitiveness in the biomedical 
field, we must invest in the industries that guarantee economic 
prosperity for our current and future economies.
  It has been estimated that every $1 of NIH funding generates about 
$2.21 in local economic growth, and, in 2012, NIH funded research 
supported an estimated 402,000 jobs all across the U.S.
  The bill's funding for NIH would provide for an annual 3% increases 
in the NIH budget, which has been stagnant for the past few years and 
which desperately needs more funding to capitalize on emerging 
scientific insights.
  This increased funding not only aims to continue the sustainability 
of our economy but it also supports our President's initiative to 
provide more resources to the biomedical field.
  The 21st Century Cure Act supports the President's Precision Medicine 
Initiative, which would advance a new model of participant-centered 
research to accelerate biomedical discoveries and provide clinicians 
with new tools and therapies tailored to individual patients' needs.
  The Obama Administration believes they can build on their progress in 
improving the drug development and approval process by: incorporating 
patients' voices into the Food and Drug Administration (FDA) decision-
making; encouraging the development and qualification of reliable 
biomarkers to accelerate work on important new therapies; and reducing 
barriers to initiating medical device trials.
  In furtherance of this initiative, H.R. 6 allows for the creation of 
an ``Innovation Fund'' through the National Institute of Health.

[[Page E1048]]

  This ``Innovation Fund'' is a welcome effort because it promotes the 
maintenance of the best biomedical workforce in the world and help to 
increase the diversity of the biomedical workforce.
  In particular, the $2 billion provided for the Innovation Fund, will 
not only increase the number of the research projects it supports but 
it also increases the cap for NIH's loan repayment programs.
  This would include a repayment program for clinical scientists who do 
research in health disparities and for clinical scientist from 
disadvantaged backgrounds, from $35,000 per year to $50,000 per year 
plus a yearly inflation for adjustment.
  With the support of H.R. 6, underrepresented communities and those 
with disadvantaged backgrounds from across the country can undoubtedly 
provide the future researchers and workers of the biomedical workforce.
  The Journal on STEM Education reported in 2011 that only 8.34% of the 
STEM doctorates awarded in 2006 were given to underrepresented 
minorities, despite making up approximately 28% of the U.S. population.
  Furthermore, GAO noted that while the percentage of underrepresented 
minorities nationwide increased from 13% to 19% 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.
  In 2007, NIGMS' annual budget was $1.9 billion, of which nearly $126 
million was spent on its MORE programs.
  This amount 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 PhD 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.
  Increased funding set forth in H.R. 6 will only strengthen NIH's 
focus on diversifying the biomedical workforce by requiring NIH to 
focus on ensuring participation from scientists from underrepresented 
communities.
  In addition to addressing the needs of underrepresented communities, 
H.R. 6 also calls for specific action to increase representation of 
racial minorities.
  The 21st Century Cures Act acknowledges that there are disturbing 
statistics on the low numbers of African Americans, Hispanics and 
Native Americans pursuing academic qualification and participating in 
scientific research.
  Under H.R. 6, the National Institute on Minority Health and Health 
Disparities will necessarily include strategies for increasing 
representation of minority communities in its strategic plan.
  I am proud to say that H.R. 6 includes the Jackson Lee Amendment, 
which makes a good bill even better by ensuring that the national goals 
of finding and bringing more cures and treatments to patients and 
strengthening the biomedical innovation ecosystem in the United States 
is aided by an expanding pool of diverse and talented medical 
researchers.
  Specifically, the Jackson Lee Amendment provides: The Secretary of 
Health and Human Services shall conduct outreach to historically Black 
colleges and universities, Hispanic-serving institutions, Native 
American colleges, and rural colleges to ensure that health 
professionals from underrepresented populations are aware of research 
opportunities under this Act.
  Many racial health disparities stem from lack of access to effective 
test, treatments and cures for illnesses that have devastating 
consequences for African American, Hispanic and Native American 
populations.
  For example:
  1. African-Americans represent 12% of the U.S. population but only 5% 
of clinical trial participants.
  2. Hispanics make up 16% of the population but only 1% of clinical 
trial participants.
  3. Women are under-represented in cardiovascular device trials, which 
have 67% male participation.
  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 more costly to engage.
  3. Minority patients with limited English proficiency can require 
costly translation services.
   Physicians are the gateway to the patient.
  Increasing diversity of those conducting research will have 
implications on the types of conditions that are researched and the 
participants in clinical trials that are seeking answers to illnesses 
like lupus, triple negative breast cancer, and sickle cell disease that 
can be difficult to detect, treat and cure.
  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.
  Lupus, triple negative breast cancer and sickle cell disease are of 
particular concern because they are often difficult to diagnose and 
disproportionately impact persons of color and especially women.
  In particular, Lupus is a chronic, complex and prevalent autoimmune 
disease that affects more than 1.5 million Americans. Yet, Lupus is one 
of America's least recognized major diseases.
  More than 90% of lupus sufferers are women, mostly young women 
between the ages of 15 to 44, and women of color are two to three times 
more at risk for lupus than Caucasians.
  Triple negative breast cancer also disproportionately impacts younger 
women, African American women, Hispanic/Latina women, and women with a 
``BRCA1 genetic mutation, which is prevalent in Jewish 
women.
  More than 30% of all breast cancer diagnoses in African American are 
of the triple negative variety, and African American women are far more 
susceptible to this dangerous subtype than white or Hispanic women.
   Additionally, there are about 2 million people that carry the sickle 
cell trait and with about 100,000 having the disease.
  According to the Centers for Disease Control and Prevention, sickle 
cell trait is common among African Americans and occurs in about 1 in 
12, and sickle cell disease occurs in about 1 out of every 500 African-
American births, compared to about 1 out of every 36,000 Hispanic-
American births.
  Treatments for Lupus, triple negative breast cancer and sickle cell 
disease are not progressing as quickly as desired by patients, 
researchers, and policy makers.
  We must support the advancement of legislation that will allow for 
the remediation and end of health care disparities and the promotion of 
research parity for diseases such as lupus, triple negative breast 
cancer, sickle cell disease, and countless other rare and serious 
diseases.
  Race and ethnicity have also been shown to affect the effectiveness 
of and response to certain drugs, such as anti-hypertensive 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.
  As one of the most diverse cities in the country, Houston is the 4th 
largest city in the United States and the 5th most populated 
metropolitan area in the nation.
  Houston is home to the largest medical complex in the world--the 
Texas Medical Center, which provides clinical health care, research and 
education at its 54 institutions.
  The University of Houston, ranked number three out of all other 
colleges and universities in Texas, is an example of a premier 
institution that can produce students with advanced STEM degrees who 
would be able to join a progressing biomedical field.
  Another important requirement of H.R. 6 is that it would require the 
National Institutes of Health to publically report the number of 
children by race and gender who participate in NIH funded clinical 
trials.
  This legislation would help ensure that children of all races are 
adequately represented in clinical trials and that we can determine the 
safety and effectiveness of drugs on children of all demographic 
backgrounds.
  With 10,000 known diseases, 7,000 of which are rare, and treatments 
for only 500 of them--clear there is much work to do.
  Medical research saves lives and improves the quality of life for 
millions of Americans because the government provides a steady and 
reliable commitment to basic research into cures for debilitating and 
deadly diseases.
  Given the array of commendable initiatives, H.R. 6 is a necessary 
piece of legislation that will accelerate the discovery, development, 
and delivery of promising new treatments and cures for all patients 
while investing in our nation's ability to maintain the best and most 
diverse biomedical workforce in the world.
  Mr. Chair, I call for the support of all of my colleagues in ensuring 
the passage of the important legislation.

[[Page E1049]]



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