[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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