[Congressional Record Volume 166, Number 208 (Wednesday, December 9, 2020)]
[House]
[Pages H7086-H7088]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




         HENRIETTA LACKS ENHANCING CANCER RESEARCH ACT OF 2019

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 1966) to direct the Comptroller General of the United States 
to complete a study on barriers to participation in federally funded 
cancer clinical trials by populations that have been traditionally 
underrepresented in such trials, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 1966

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Henrietta Lacks Enhancing 
     Cancer Research Act of 2019''.

     SEC. 2. FINDINGS.

       Congress finds as follows:
       (1) Only a small percent of patients participate in cancer 
     clinical trials, even though most express an interest in 
     clinical research. There are several obstacles that restrict 
     individuals from participating including lack of available 
     local trials, restrictive eligibility criteria, 
     transportation to trial sites, taking time off from work, and 
     potentially increased medical and nonmedical costs. 
     Ultimately, about 1 in 5 cancer clinical trials fail because 
     of lack of patient enrollment.
       (2) Groups that are generally underrepresented in clinical 
     trials include racial and ethnic minorities and older, rural, 
     and lower-income individuals.
       (3) Henrietta Lacks, an African-American woman, was 
     diagnosed with cervical cancer at the age of 31, and despite 
     receiving painful radium treatments, passed away on October 
     4, 1951.
       (4) Medical researchers took samples of Henrietta Lacks' 
     tumor during her treatment and the HeLa cell line from her 
     tumor proved remarkably resilient.
       (5) HeLa cells were the first immortal line of human cells. 
     Henrietta Lacks' cells were unique, growing by the millions, 
     commercialized and distributed worldwide to researchers, 
     resulting in advances in medicine.
       (6) Henrietta Lacks' prolific cells continue to grow and 
     contribute to remarkable advances in medicine, including the 
     development of the polio vaccine, as well as drugs for 
     treating the effects of cancer, HIV/AIDS, hemophilia, 
     leukemia, and Parkinson's disease. These cells have been used 
     in research that has contributed to our understanding of the 
     effects of radiation and zero gravity on human cells. These 
     immortal cells have informed research on chromosomal 
     conditions, cancer, gene mapping, and precision medicine.
       (7) Henrietta Lacks and her immortal cells have made a 
     significant contribution to global health, scientific 
     research, quality of life, and patient rights.
       (8) For more than 20 years, the advances made possible by 
     Henrietta Lacks' cells were without her or her family's 
     consent, and the revenues they generated were not known to or 
     shared with her family.
       (9) Henrietta Lacks and her family's experience is 
     fundamental to modern and future bioethics policies and 
     informed consent laws that benefit patients nationwide by 
     building patient trust; promoting ethical research that 
     benefits all individuals, including traditionally 
     underrepresented populations; and protecting research 
     participants.

     SEC. 3. GAO STUDY ON BARRIERS TO PARTICIPATION IN FEDERALLY 
                   FUNDED CANCER CLINICAL TRIALS BY POPULATIONS 
                   THAT HAVE BEEN TRADITIONALLY UNDERREPRESENTED 
                   IN SUCH TRIALS.

       (a) In General.--Not later than 2 years after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall--
       (1) complete a study that--
       (A) reviews what actions Federal agencies have taken to 
     help to address barriers to participation in federally funded 
     cancer clinical trials by populations that have been 
     traditionally underrepresented in such trials, and identifies 
     challenges, if any, in implementing such actions; and
       (B) identifies additional actions that can be taken by 
     Federal agencies to address barriers to participation in 
     federally funded cancer clinical trials by populations that 
     have been traditionally underrepresented in such trials; and
       (2) submit a report to the Congress on the results of such 
     study, including recommendations on potential changes in 
     practices and policies to improve participation in such 
     trials by such populations.
       (b) Inclusion of Clinical Trials.--The study under 
     subsection (a)(1) shall include review of cancer clinical 
     trials that are largely funded by Federal agencies.
  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Oregon (Mr. Walden) each 
will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material on H.R. 1966.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield the balance of my time to the 
gentleman from Maryland (Mr. Mfume).
  The SPEAKER pro tempore. Without objection, the gentleman from 
Maryland will control the balance of the time of the majority.
  There was no objection.
  Mr. MFUME. Mr. Speaker, I thank the chair of the Energy and Commerce 
Committee, Mr. Pallone of New Jersey. I appreciate his oversight of 
this bill and the way his committee has moved us to where we are today.
  Mr. Pallone and I go way back. When I left this body some time ago, I 
didn't know I would come back and he would be chair of the committee, 
but I couldn't think of a better person.
  I also say to Mr. Walden, the ranking member from Oregon, that the 
body obviously will miss you. And as you heard on both sides of the 
aisle with the comments that have been made, people have respected your 
leadership and the leadership that you have brought to that committee 
both as ranking member and as chair. By the way, let me tell you, there 
is life after Congress. I went out and found 24 years of it before 
coming back. So best of everything to you, sir.
  Members of the body, if I might, let me just talk a bit about a 
distinguished, in my opinion, woman whose picture is here beside me. 
Her name was Henrietta Lacks. She was born 100 years ago in Roanoke, 
Virginia.
  Mrs. Lacks and her husband and her family later moved to Baltimore 
County in 1941, seeking, as a lot of people did, what they thought were 
jobs that were available the further north you moved. They moved to an 
area near what was known as the old Bethlehem Steel Plant. Henrietta 
and her family lived not far from me and my family in a segregated 
Black enclave known as Turner Station.
  Ironically, Mrs. Lacks got ill. In 1951, as a young mother, she went 
to the hospital complaining of vaginal bleeding. She went to Johns 
Hopkins at the time, which was one of the few hospitals that African 
Americans could go to and be treated.
  Upon examination, gynecologists discovered a large, malignant tumor 
in her cervix. During her treatment there, two cell samples were taken 
from Mrs. Lacks and from her cervix without her permission and without 
her knowledge. One sample was healthy tissue, the other sample was 
cancerous tissue. And these samples were given to a physician and a 
cancer researcher at Hopkins to study.
  What this researcher would soon discover was that Mrs. Lacks' cells 
were unlike any others he had ever seen. Where other cells would die, 
Mrs. Lacks' cells doubled every 20 to 24 hours.

                              {time}  1500

  This continued after her death.
  The cells from the cancerous sample became known eventually as the 
HeLa immortal cell line.
  The HeLa immortal cell line is the oldest and the most commonly used 
human cell line in scientific research anywhere in the world. The cell 
line was found to be remarkably durable and prolific, which allows its 
use extensively in scientific study. This was the first human cell line 
to prove to be successful in in vitro studies, which was a scientific 
achievement with profound implications on the future and profound 
benefits to medical research.
  HeLa cells can divide an unlimited number of times in a laboratory 
cell culture plate as long as fundamental cell survival conditions are 
met and sustained. There are, as we have come to know over time, many 
strains of HeLa cells as they continue to mutate in other cell 
cultures, but all HeLa cells are descended from the same tumor cells 
once removed from Mrs. Lacks. The total number of HeLa cells that have 
been propagated in cell culture far exceeds the number of cells that 
were in her body.

[[Page H7087]]

  Today, these incredible cells are used to study the effects of 
toxins, drugs, hormones, and viruses on the growth of cancer cells 
without having to experiment on humans while that is being done. They 
have been used to test the effects of a number of different things: 
radiations, poisons, to study the human genome, and to learn more about 
how all viruses ultimately work, and they have played a crucial role in 
the development of the polio vaccine.
  When Jonas Salk was so close to getting to what he thought was an 
effective vaccine, Dr. Salk tested the vaccine against the cells, and 
the cells directed him to make the vaccine even more potent.
  The NIH analyzed and evaluated scientific literature over the course 
of time involving HeLa cells and found that over 110,000 publications 
cited the use of those cells from 1953 to 2018. So this analysis, I 
think, further highlights the persistent impact of HeLa cells in 
science and in medicine, proving that they have been a consistent and 
essential tool that has allowed researchers to expand their knowledge 
base in fields such as cancer biology, infectious disease, and many, 
many other areas.
  There is so much to be said about Ms. Lacks, who died in that same 
Black, poor enclave many, many years ago, but to her credit and to the 
credit of all science, her living clearly was not in vain, and her 
death has proven something that nobody ever anticipated at the time: 
that there could even be such a cell that would continue to develop and 
mutate long beyond the donor's ability to live.
  Mr. Speaker, I reserve the balance of my time.
  Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I thank the gentleman from Maryland (Mr. Mfume) for 
bringing us this legislation and for his very kind comments about my 
service and the future that lies ahead of me, perhaps. I appreciate his 
leadership and his kind words.
  I, too, rise today to speak on H.R. 1966, the Henrietta Lacks 
Enhancing Cancer Research Act of 2019, which was sponsored by the late, 
great Representative Elijah Cummings originally.
  This bill is named after Henrietta Lacks, a woman of color who 
donated her cells, without her knowledge and consent, to Johns Hopkins 
in 1951, beginning what was the first human cell line able to reproduce 
indefinitely.
  Her cells have been used in biomedical research around the world.
  H.R. 1966 requires the Government Accountability Office, or the GAO, 
to study how Federal agencies have addressed barriers to participation 
in cancer clinical trials by individuals from underrepresented 
populations and to provide recommendations for addressing such 
barriers.
  The intent of the bill is laudable, as racial and ethnic minorities 
are currently underrepresented in clinical trials.
  I know that has been an issue even in the COVID trials. I have talked 
to the people who have developed these vaccines, and this is a real 
issue they face, trying to get the right mix to reflect the community 
and make sure that everyone who takes the various drugs and vaccines 
are represented in these trials.
  It is a concern, because people of different ages, different races, 
different ethnicities, they simply may react differently to medical 
treatments. So we have to get this right.
  Mr. Speaker, I appreciate my friends from Maryland for bringing this 
legislation to the floor, and I, of course, pay homage to 
Representative Cummings for his initial leadership on this as well.
  Mr. Speaker, I reserve the balance of my time.
  Mr. MFUME. Mr. Speaker, I yield 5 minutes to the gentleman from 
Maryland (Mr. Ruppersberger) of the Committee on Appropriations.
  Mr. RUPPERSBERGER. Mr. Speaker, I rise in support of H.R. 1966, and I 
thank the gentleman for yielding.
  I proudly co-led this bill when it was first introduced by our late 
friend, Elijah Cummings, in honor of the extraordinary life and legacy 
of a Baltimore native, Henrietta Lacks.
  Although Congressman Cummings has passed on and remains deeply 
missed, I am proud and grateful that Congressman Mfume has picked up 
the mantle on this important legislation.
  Without her knowledge or permission, doctors used Henrietta Lacks' 
cells for medical research that eventually led to some of medicine's 
most critical breakthroughs, including development of the polio 
vaccine, along with treatments for cancer, HIV/AIDS, leukemia, and 
Parkinson's.
  I can think of only a handful of Marylanders or even Americans who 
have contributed more to modern medicine than Henrietta Lacks. Her 
lifesaving contributions will continue to advance cures for 
debilitating diseases for generations to come.
  Yet more than 70 years after Henrietta Lacks' death, many communities 
still face glaring health disparities. For example, while cancer 
incidence rates are highest among non-Hispanic White females, non-
Hispanic Black females have the highest rate of death.
  Clinical trials are a key component to advancing cancer research and 
treatment, but 20 percent of cancer clinical trials fail because of a 
lack of patient enrollment, with racial and ethnic minorities and 
older, rural, and lower-income Americans generally underrepresented in 
such trials.
  This bill examines access to government-funded cancer clinical trials 
for traditionally underrepresented groups, but it is also about much 
more.
  It is about giving credit where credit has been long overdue, it is 
about ensuring all Americans get the medical treatments they deserve, 
and it is about ensuring clinical trials succeed because they are 
inclusive.
  Mr. Speaker, I urge all of my colleagues to support this bill.
  Mr. WALDEN. Mr. Speaker, I yield such time as he may consume to the 
gentleman from Oklahoma (Mr. Kevin Hern).
  Mr. KEVIN HERN of Oklahoma. Mr. Speaker, I thank the gentleman from 
Oregon (Mr. Walden) for yielding.
  I rise in support of H.R. 1966.
  This legislation was first brought to my attention by my constituent, 
Carla Prothro, who is fighting cancer. We talked about the way clinical 
trials impact the treatments available for cancer patients. The trials 
very rarely reflect the population of cancer patients.
  When women and minorities are underrepresented in clinical trials, it 
negatively impacts the results. About one in five cancer trials fail 
because of a lack of participation.
  This bill addresses that by studying the barriers to participation 
for underrepresented groups. We need to find ways to reduce those 
barriers and enroll more patients from diverse backgrounds.
  My niece, Juniper, is 3 years old and fighting stage 4 neuroblastoma. 
She is just a little kid, but her short life has already had so much 
pain. She has spent a third of her life in the hospital.
  Juniper is a fighter, though, and she has so many people who love her 
and are praying for her.
  Bills like this help Juniper and Carla and millions of cancer 
patients around the world. Every step forward in cancer research is 
important. Every bit of progress gets us closer to a better world.
  Mr. Speaker, I urge my colleagues to vote in support of H.R. 1966 
today.
  Mr. MFUME. Mr. Speaker, I reserve the balance of my time.
  Mr. WALDEN. Mr. Speaker, I don't have any other speakers on my side. 
I encourage Members to support this really important legislation, and I 
yield back the balance of my time.
  Mr. MFUME. Mr. Speaker, I would inquire how much time remains on my 
side.
  The SPEAKER pro tempore. The gentleman from Maryland (Mr. Mfume) has 
10\1/2\ minutes.
  Mr. MFUME. Mr. Speaker, I yield myself such time as I may consume.
  My thanks, again, to the gentleman from Oregon (Mr. Walden) and the 
others who have spoken on behalf of this, including Congressman 
Ruppersberger, who has been, as he indicated, a part of this effort for 
a while.
  And that while goes all the way back to the other reason that I am 
here today, and that is my friend of 42 years and a Member of this body 
for 23 years, the late Elijah Cummings, who originally introduced this 
bill before his death, and a commitment that I made to he and to others 
long ago that, working outside of the Congress, I would be supportive 
of him.
  But now that I am inside, I wanted to make sure that I got unanimous 
consent from this body, as I did a month

[[Page H7088]]

or so back, to be able to assume the leadership of this bill, its 
sponsorship, and to move it forward, and we have been doing all that we 
could to get to this point.
  Again, Mr. Speaker, I would be remiss if I did not thank Mr. Pallone 
and Mr. Walden for their efforts.
  Let me, if I might, just say a couple of things, Mr. Speaker. It has 
been long recognized that the burden of cancer is not equal and not 
equivalent among different racial and ethnic groups in our society. In 
fact, there is a fourfold increase, or disparity, in the number of 
Black people diagnosed with cancer in this country as compared with the 
proportion of Black people participating in clinical trials.
  The gentleman from Oregon (Mr. Walden) mentioned how sensitive this 
is right now as we are trying to work with drug companies to come up 
with a number of vaccines. And whether it was the Pfizer trial or the 
Moderna trial, one thing is clear: there has never seemed to be enough 
persons of ethnic backgrounds, particularly African Americans and 
Latinos, who are participating in these trials.

  To underscore this more, let me remind you that 20 percent of 
Alzheimer's patients in this country are African American, but only 3 
to 10 percent are the trial participants in clinical trials.
  As I said, COVID is a disease with a roughly twofold higher rate of 
diagnosis and mortality between African Americans and other 
populations.
  So all of that, in the aggregate, really stresses the need for a more 
diverse research participatory effort in order to fully understand, 
comprehensively deal with, and cure these diseases.
  Clinical trials are an essential step in advancing potential new 
cancer treatments. We know that. Patient participation in those trials 
is absolutely crucial to their success.
  Now, many patients will express a willingness to participate in 
clinical research, yet only a small fraction of those persons do 
actually do that.
  In terms of the larger African-American community, some of the 
barriers that have existed continue to exist. People can't take time 
off from their job to participate and be studied in a clinical trial, 
or, more importantly, there is this level of distrust.
  The distrust, particularly among African Americans, goes back to 
1932, when our government, through the United States Public Health 
Service, oversaw and gave authorization for what was to become known as 
the infamous Tuskegee Study, where 600 Black men, without their 
knowledge, without their approval or consent, were injected with 
syphilis and told that they were being treated for something altogether 
different.
  Those 600 men lived and watched their bodies change. Many of them may 
had reinfected others. They suffered a great deal of pain. And nowhere 
during that time did the government step in and say, ``Stop it.''

                              {time}  1515

  That Tuskegee study, which many of us grew up hearing about, is 
something that lurks in the minds of a lot of African Americans about 
why you can't trust the government on research when it comes to your 
body. The shame that went with that ought to be a collective shame that 
all of us in this country feel.
  We are beyond 1932. People are still getting ill. There are all sorts 
of infectious diseases. We need vaccines, and we have to find a way now 
to participate in that process and to find a way to get beyond the 
things that hold us back.
  But in this instance, I just thought it was important to mention why 
that reluctance tends to exist.
  Racial and ethnic groups, and older Americans, rural Americans, and 
poor Americans, are all the groups that still remain underrepresented 
in cancer clinical trials. Without action, these groups will continue 
to face barriers in terms of enrollment in cancer and other clinical 
trials, which then deprive many Americans from access to effective 
treatments and effective interventions.
  Mr. Speaker, I close by reminding us how we began, and that is with 
the story, the life, and the lesson of Henrietta Lacks, who died at an 
early age, a mother of five who came north seeking employment, who 
developed an illness, who got treated, and who, without her knowledge 
or consent, had cells taken out of her body that were not cancerous--in 
addition to the cancerous cells--only to miraculously find that there 
was something very, very special about Ms. Lacks and her biological 
makeup: a cell that continued to mutate and to mutate and to double 
long after it was taken from her body, long after her death, and even 
now has created 110,000 studies about this miraculous cell, which we 
call HeLa, that has been the basis of research, Nobel award-winning 
research, in the years that followed.
  My thanks to all of you for participating and for understanding the 
passion that drove Elijah on this, that drives me on this.
  I want to thank the Lacks family, the Henrietta Lacks Foundation.
  I want to thank the American Cancer Society, the National Institute 
of Minority Health and Health Disparities, Research America, and all 
the other organizations that continue to fight to bring about some sort 
of balance and equity in the whole issue of research and clinical 
trials.
  Mr. Speaker, I yield back the balance of my time.
  Ms. ESHOO. Mr. Speaker, I rise in support of H.R. 1966, the Henrietta 
Lacks Enhancing Cancer Research Act. I urge my colleagues to support 
this bill in honor of two Baltimoreans who changed the world--Henrietta 
Lacks and Representative Elijah Cummings.
  Representative Cummings introduced this legislation to help address 
the barriers facing minority, low-income, and underrepresented groups 
when it comes to enrolling in federally-funded clinical cancer trials. 
He named it after Henrietta Lacks to honor the role she and her tumor 
samples played in breakthroughs for cancer, HIV/AIDS, leukemia, polio, 
and Parkinson's disease. Henrietta Lacks' tumor samples were used 
without her or her family's knowledge or consent and her contribution 
has been overlooked for decades. This legislation will begin to correct 
that wrong, while also improving access to medical research for African 
Americans and other underrepresented groups.
  Representative Cummings dedicated his Congressional career to 
ensuring underrepresented groups had access to health care. He 
championed policies to improve health equity by lowering drug prices 
and improving maternal care for African American women. I'm pleased 
that this bill will be added to his legacy and I thank Representative 
Mfume for ensuring the advancement of this bill.
  I urge my colleagues to support this legislation.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, H.R. 1966, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

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