[Congressional Record Volume 160, Number 128 (Tuesday, September 9, 2014)]
[House]
[Pages H7344-H7347]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
TICK-BORNE DISEASE RESEARCH ACCOUNTABILITY AND TRANSPARENCY ACT OF 2014
Mr. BURGESS. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 4701) to provide for scientific frameworks with respect to
vector-borne diseases, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 4701
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 ``Tick-Borne Disease Research
Accountability and Transparency Act of 2014''.
SEC. 2. LYME DISEASE AND OTHER TICK-BORNE DISEASES.
Title III of the Public Health Service Act (42 U.S.C. 241
et seq.) is amended by adding at the end the following new
part:
``PART W--LYME DISEASE AND OTHER TICK-BORNE DISEASES
``SEC. 399OO. RESEARCH.
``(a) In General.--The Secretary shall conduct or support
epidemiological, basic, translational, and clinical research
regarding Lyme disease and other tick-borne diseases.
``(b) Biennial Reports.--The Secretary shall ensure that
each biennial report under section 403 includes information
on actions undertaken by the National Institutes of Health to
carry out subsection (a) with respect to Lyme disease and
other tick-borne diseases, including an assessment of the
progress made in improving the outcomes of Lyme disease and
such other tick-borne diseases.
``SEC. 399OO-1. WORKING GROUP.
``(a) Establishment.--The Secretary shall establish a
permanent working group, to be known as the Interagency Lyme
and Tick-Borne Disease Working Group (in this section and
section 399OO-2 referred to as the `Working Group'), to
review all efforts within the Department of Health and Human
Services concerning Lyme disease and other tick-borne
diseases to ensure interagency coordination, minimize
overlap, and examine research priorities.
``(b) Responsibilities.--The Working Group shall--
``(1) not later than 24 months after the date of enactment
of this part, and every 24 months thereafter, develop or
update a summary of--
``(A) ongoing Lyme disease and other tick-borne disease
research related to causes, prevention, treatment,
surveillance, diagnosis, diagnostics, duration of illness,
intervention, and access to services and supports for
individuals with Lyme disease or other tick-borne diseases;
``(B) advances made pursuant to such research;
``(C) the engagement of the Department of Health and Human
Services with persons that participate at the public meetings
required by paragraph (5); and
``(D) the comments received by the Working Group at such
public meetings and the Secretary's response to such
comments;
``(2) ensure that a broad spectrum of scientific viewpoints
is represented in each such summary;
``(3) monitor Federal activities with respect to Lyme
disease and other tick-borne diseases;
``(4) make recommendations to the Secretary regarding any
appropriate changes to such activities; and
``(5) ensure public input by holding annual public meetings
that address scientific advances, research questions,
surveillance activities, and emerging strains in species of
pathogenic organisms.
``(c) Membership.--
``(1) In general.--The Working Group shall be composed of a
total of 14 members as follows:
``(A) Federal members.--Seven Federal members, consisting
of one or more representatives of each of--
``(i) the Office of the Assistant Secretary for Health;
``(ii) the Food and Drug Administration;
``(iii) the Centers for Disease Control and Prevention;
``(iv) the National Institutes of Health; and
``(v) such other agencies and offices of the Department of
Health and Human Services as the Secretary determines
appropriate.
``(B) Non-federal public members.--Seven non-Federal public
members, consisting of representatives of the following
categories:
``(i) Physicians and other medical providers with
experience in diagnosing and treating Lyme disease and other
tick-borne diseases.
``(ii) Scientists or researchers with expertise.
``(iii) Patients and their family members.
``(iv) Nonprofit organizations that advocate for patients
with respect to Lyme disease and other tick-borne diseases.
``(v) Other individuals whose expertise is determined by
the Secretary to be beneficial to the functioning of the
Working Group.
``(2) Appointment.--The members of the Working Group shall
be appointed by the Secretary, except that of the non-Federal
public members under paragraph (1)(B)--
``(A) one shall be appointed by the Speaker of the House of
Representatives; and
``(B) one shall be appointed by the Majority Leader of the
Senate.
``(3) Diversity of scientific perspectives.--In making
appointments under paragraph (2), the Secretary, the Speaker
of the House of Representatives, and the Majority Leader of
the Senate shall ensure that the non-Federal public members
of the Working
[[Page H7345]]
Group represent a diversity of scientific perspectives.
``(4) Terms.--The non-Federal public members of the Working
Group shall each be appointed to serve a 4-year term and may
be reappointed at the end of such term.
``(d) Meetings.--The Working Group shall meet as often as
necessary, as determined by the Secretary, but not less than
twice each year.
``(e) Applicability of FACA.--The Working Group shall be
treated as an advisory committee subject to the Federal
Advisory Committee Act.
``(f) Reporting.--Not later than 24 months after the date
of enactment of this part, and every 24 months thereafter,
the Working Group--
``(1) shall submit a report on its activities, including an
up-to-date summary under subsection (b)(1) and any
recommendations under subsection (b)(4), to the Secretary,
the Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education,
Labor and Pensions of the Senate;
``(2) shall make each such report publicly available on the
website of the Department of Health and Human Services; and
``(3) shall allow any member of the Working Group to
include in any such report minority views.
``SEC. 399OO-2. STRATEGIC PLAN.
``Not later than 3 years after the date of enactment of
this section, and every 5 years thereafter, the Secretary
shall submit to the Congress a strategic plan, informed by
the most recent summary under section 399OO-1(b)(1), for the
conduct and support of Lyme disease and tick-borne disease
research, including--
``(1) proposed budgetary requirements;
``(2) a plan for improving outcomes of Lyme disease and
other tick-borne diseases, including progress related to
chronic or persistent symptoms and chronic or persistent
infection and co-infections;
``(3) a plan for improving diagnosis, treatment, and
prevention;
``(4) appropriate benchmarks to measure progress on
achieving the improvements described in paragraphs (2) and
(3); and
``(5) a plan to disseminate each summary under section
399OO-1(b)(1) and other relevant information developed by the
Working Group to the public, including health care providers,
public health departments, and other relevant medical
groups.''.
SEC. 3. NO ADDITIONAL AUTHORIZATION OF APPROPRIATIONS.
No additional funds are authorized to be appropriated to
carry out this Act and the amendment made by this Act, and
this Act and such amendment shall be carried out using
amounts otherwise available for such purpose.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Texas (Mr. Burgess) and the gentleman from New Jersey (Mr. Pallone)
each will control 20 minutes.
The Chair recognizes the gentleman from Texas.
General Leave
Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and to insert extraneous materials into the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Texas?
There was no objection.
Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of H.R. 4701, the Tick-Borne
Disease Research Accountability and Transparency Act of 2014,
introduced by Chris Gibson of New York.
Lyme disease is the most commonly reported vector-borne illness in
the United States. Prior to 2012, the Centers for Disease Control and
Prevention reported about 30,000 new cases each year in the United
States, with 95 percent of those cases in 13 States concentrated in the
Northeast and upper Midwest.
The Centers for Disease Control now estimates that around 300,000
people in the United States are diagnosed each year with Lyme disease,
making it a substantial public health problem.
H.R. 4701 is an important bill that addresses the growing threat of
Lyme disease in the United States, it prioritizes Federal research
online, and related diseases, and gives patients a seat at the table.
The bill would establish a working group at the Department of Health
and Human Services that would prepare a report summarizing Federal
activities related to Lyme disease, identifying the latest scientific
advances and making recommendations to the Secretary and to Congress.
It also ensures that the Federal Government consults with patients
and physicians in their work on the disease.
I would like to thank Mr. Gibson for his hard work and dedication on
this issue.
I urge my colleagues to support H.R. 4701, and I reserve the balance
of my time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I think we can all agree that Lyme disease is a
concerning public health issue. The CDC estimates there are
approximately 300,000 Lyme disease cases each year in the United
States.
H.R. 4701, the Tick-Borne Disease Research Accountability and
Transparency Act of 2014, creates a new working group to develop a
summary of research in advances related to Lyme disease and other tick-
borne diseases, monitor Federal activities, and make recommendations to
the Secretary of HHS and hold annual public meetings.
I support ensuring that research in the area of Lyme disease is
productive and significant. However, there are still a number of other
changes that need to be made to this bill, particularly regarding
appointments to and responsibilities of the working group.
{time} 1800
Additionally, we do not want the resources needed to maintain this
working group to take away from the already strained budgets of current
Federal research and surveillance efforts related to Lyme disease.
At the full committee markup of H.R. 4701 in July, Chairman Upton
committed to continue to work with myself and other Members to address
these concerns before bringing the bill to the floor, and I am
disappointed to say that that commitment wasn't honored. While I have
reservations about H.R. 4701 in its current form, I would not object to
considering it on suspension and advancing the bill here today, but I
will continue to advocate for resolving these issues in the bill as it
moves forward.
I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield 4 minutes to the gentleman from New
York (Mr. Gibson).
Mr. GIBSON. Mr. Speaker, I rise today on behalf of thousands of
Americans who have been impacted by Lyme disease and tick-borne
illnesses each year, including in my district in upstate New York,
where this is a public health scourge.
This legislation is truly constituent-driven and represents a
significant step forward in what has been an extensive process. For the
past few years, I have worked with physicians, patient advocates,
professional researchers, and patients and their families throughout
New York and the United States on a bill that focuses on solutions.
I am proud to be joined by two of my colleagues who have been
national leaders on this issue: Chris Smith of New Jersey is our
leader, who has, for several decades, been a tireless advocate for our
sufferers, and Frank Wolf of Virginia, who has added his significant
voice to this issue and has also made incredibly meaningful
contributions to this bill and the cause. I thank them both.
Likewise, I thank Dr. Richard Horowitz, Pat Smith, David Roth, Jill
and Ira Auerbach, Holly Ahern, Chris Fiske, and other Lyme advocate
leaders from Pennsylvania and from across the Nation for their
significant and persuasive engagement and unyielding commitment to
change the direction of U.S. policy to bring solutions and relief for
our chronic Lyme sufferers.
Mr. Speaker, I would also like to thank Chairman Upton, Chairman
Pitts, their ranking members, and their dedicated committee staffs.
Thank you all for your great work.
In August of 2013, the Centers for Disease Control and Prevention
estimated that the number of Americans diagnosed with Lyme disease each
year is now over 300,000, while other researchers, such as Holly Ahern,
have shown that we are significantly underestimating the cases in the
U.S. It is clear that the increase of Lyme disease and other tick-borne
diseases is rapidly becoming a public health crisis in the United
States. While the CDC, NIH, and other Federal agencies have recognized
this threat to public health, regrettably, we have made far too little
progress in improving prevention, diagnosis, and treatment.
This legislation before us seeks to make a positive difference,
prioritizing and coordinating Federal tick-borne
[[Page H7346]]
disease research through an interagency working group made up of
relevant Federal agencies as well as non-Federal partners, such as
experienced physicians, researchers, patient advocates, and chronic
Lyme disease patients themselves.
The working group is tasked with ensuring interagency coordination,
accountability, and transparency, minimizing overlap, examining
research priorities, and ultimately making policy recommendations. The
working group is required to reflect a broad spectrum of scientific
viewpoints and ensure patients and their advocates have a seat at the
table.
The bill increases oversight and accountability over tick-borne
research throughout the relevant Federal agencies, ensuring all
stakeholders are situationally aware of all existing research before
making policy recommendations.
Importantly, this bill also requires the Secretary of Health and
Human Services, informed by the working group report, to submit a
strategic plan to Congress to improve patient outcomes to cure our
chronic Lyme sufferers. This plan will include benchmarks to measure
progress, ultimately ensuring we spend the taxpayer dollars wisely and
find solutions and cures that are long overdue.
Finally, this bill is dedicated to those chronic Lyme sufferers out
there who have been ill for years, at times seemingly without hope,
wondering if anyone in Washington was listening or cared. We hear you.
We do care. Today we pass this legislation to help you get better.
I urge my colleagues to support the bill.
Mr. PALLONE. Mr. Speaker, I yield such time as he may consume to the
gentleman from New York (Mr. Sean Patrick Maloney), one of the sponsors
of the bill.
Mr. SEAN PATRICK MALONEY of New York. Mr. Speaker, I am proud to be
one of the sponsors of this bill. I thank the gentleman from New
Jersey.
I want to thank my colleague, Chris Gibson from New York. Here we are
again. Just a month ago, my colleague Mr. Gibson and I were working
across the aisle to lower energy prices in the Hudson Valley, and here
we are working again on an issue of tremendous importance to our
region. I support the Tick-Borne Disease Research Accountability and
Transparency Act, along with so many others, and I want to acknowledge
Mr. Gibson's leadership on this issue.
I am proud we are working across the aisle, because Lyme disease is
an epidemic in the Hudson Valley, and it is hurting our kids, our
friends, and our families. It is happening everywhere--on our
playgrounds, in our backyards, at parks, picnics, and on trails in the
woods. It is the invisible, silent disease that so many find themselves
developing--and far too many find out too late. It is now one of the
most common and fastest growing infectious diseases in our country.
Every year, there are hundreds of thousands of cases nationwide, with
96 percent of those cases in only 13 States.
In New York, thousands of my neighbors in the Hudson Valley are
suffering from Lyme disease every day. Four counties in the Hudson
Valley, including Dutchess and Putnam Counties, have reported the
highest rates of Lyme disease in the entire country. I hear about it
everywhere I go.
A man named Alex from Washingtonville told me he has been suffering
from Lyme disease for over 35 years. I spoke with a man who has a tree-
cutting business in Garrison, New York. He said he has got about 12
guys working for him. I said, How many have got Lyme disease? He said,
Every single one. All of my guys have Lyme disease, he said.
A member of my own staff spent a month this summer injecting himself
with heavy-duty antibiotics through a catheter that was put into his
heart. A member of my own staff had to sit on a couch every day and
inject antibiotics into his heart because of this disease. Thank God he
caught it in time and will make a full recovery.
I met a woman at an event in Poughkeepsie who came up to me with a
cane. She couldn't be more than 30 years old. She was with her husband.
She said:
Our whole lives have been ruined by this disease. My
husband and I were just starting our life together. We were
going to have a family. We had big plans, and now all we do
is deal with this chronic Lyme disease that I have, and I
can't get better.
There is a woman named Valerie from Westchester County who wrote to
me and says:
No one listens. I hope you will listen.
Well, we are listening today, Valerie, and I urge my colleagues to
listen and pass this critical bill.
This bipartisan legislation makes a landmark investment in Lyme
disease and other tick-borne illnesses so that our friends and families
in the Hudson Valley no longer have to suffer in silence. When folks
are suffering, I guarantee you they aren't thinking, Mr. Speaker, about
partisan politics.
There is no Republican or Democratic Lyme disease, and Americans
expect us to work together. That is why I am proud we are doing so
today. We can stand up. We can stand shoulder-to-shoulder and say the
health of our communities is too important to wait. For neighbors like
Alex, Valerie, the others I mentioned, and for so many others I have
never met, I want you to know we are listening.
I urge my colleagues to support H.R. 4701 because our constituents
deserve a government that is working for them and that steps up to the
plate when they need it most.
Mr. PALLONE. Mr. Speaker, I have no further speakers at this time,
and I yield back the balance of my time.
Mr. BURGESS. Mr. Speaker, at this time, I yield the balance of my
time to the gentleman from New Jersey (Mr. Smith), who will provide our
closing.
Mr. SMITH of New Jersey. Mr. Speaker, I thank my good friend from
Texas, the distinguished subcommittee leader, chair, and doctor.
Mr. Speaker, I rise in very strong support today of the Tick-Borne
Disease Research Accountability and Transparency Act of 2014, an
historic bill offered by my good friend and distinguished colleague,
Chris Gibson.
From all those who suffer from this hideous disease, thank you,
Chris.
I would also like to extend my very special thanks to Chairmen Fred
Upton and Joe Pitts, as well as their staff, for their tireless efforts
to ensure the final bill brought before the floor today establishes a
means to address huge gaps that exist and the great unmet need in the
Lyme community.
Mr. Speaker, in 1992 I met with the two top medical officials at the
National Institutes of Health and the Centers for Disease Control
working on Lyme and an extraordinary woman named Pat Smith. We laid out
a case. She did most of the talking. They listened. They were
responsive. However, 22 years later, far too little has been
accomplished.
I raised, as did she, the apparent ineffectiveness of a month-long
antibiotic treatment for a sizable percentage of people. The CDC says
between 15 to 20 percent of the people suffering from this disease
don't seem to get better. We call it chronic Lyme.
Dr. Richard Horowitz notes in his bestselling book, ``Why Can't I Get
Better?'':
A patient's journey typically begins with a primary care
physician or a family doctor. A maximum of 30 days of
antibiotics is the accepted standard of care for Lyme
disease. If patients report back that they are not getting
better, they are likely diagnosed as having ``post-Lyme
syndrome,'' chronic fatigue syndrome, or fibromyalgia.
He then described how children are treated for other diseases or
disorders, and continues:
This may help some of the symptoms yet fail to address the
root problem.
Unfortunately, without better information on chronic Lyme and how to
treat it, we will continue to ``fail to address the root of the
problem'' and, in so doing, fail to assist patients in need.
Mr. Speaker, I fully understand that there are concerns about the
prolonged use of antibiotics. I chair the Global Health Committee and
have chaired numerous hearings on multidrug-resistant tuberculosis and
many other diseases that increasingly are being treated with
antibiotics with less effectiveness. Yet the ISDA, in their final
report of the Lyme Disease Review Panel, found:
There has yet to be a study that demonstrates comparable
benefits to prolonged antibiotic therapy beyond 1 month.
There have been far too few studies. There is an engraved invitation.
I say to my colleagues, there needs to be those studies. You can fit on
half a
[[Page H7347]]
page the number of studies that have been done over these many years.
However, in that same report, they went on to say:
This conclusion was reached despite the large volumes of
case reports, case series, anecdotes, and patient
testimonials reviewed that attest to perceived clinical
improvement during antibiotic therapy.
Large volumes are just dismissed and laid aside as if they were
trivial. It was dismissed and didn't make it into the final report,
except for that sentence.
Dr. Horowitz has said that:
In fact, increasing the dose of antibiotics and/or
extending the length of treatment clearly did help a certain
percentage of my patients. Their fatigue, headaches, joint
and muscle pain, and cognitive symptoms improved.
Among clinicians--and I have met with dozens of them--Dr. Horowitz is
not alone at all in those findings.
So, Mr. Speaker, we need scientifically-based answers and a
comprehensive probe that goes wherever the data suggests. And this is
especially important for my own constituents. In New Jersey, over the
last 15 years, about 55,000 people have had cases of Lyme.
This bill before us accelerates the process of helping Lyme patients
by establishing an interagency working group on Lyme disease with
diverse opinions--which is very important--in a transparent and open
manner and creates a strategic plan to guide existing Federal Lyme
disease research and treatment programs.
Of particular significance, the House bill that we will vote on today
for the first time identifies and seeks to address chronic Lyme
disease.
Mr. Speaker, the CDC says:
Approximately 10 to 20 percent of patients treated for Lyme
disease with a recommended 2-4 week course of antibiotics
will have lingering symptoms of fatigue, pain, or join and
muscle aches.
I would respectfully submit that they are symptoms of something that
has a root cause.
The CDC refers to chronic Lyme as ``Post-treatment Lyme Disease
Syndrome,'' and many people have been dismissed and told, Oh, you are a
hypochondriac. And yet there are so many cases, it can't be dismissed.
This bill is a great step forward for chronic Lyme patients,
especially those who have suffered for decades with this debilitating
disease, again, only to be told that their illness does not exist.
Again, I want to thank my good friend, Chris Gibson, for his
leadership and for the leadership of our House Republicans and our
friends on the other side of the aisle. This is a bipartisan bill, and
I do hope Members will support it robustly.
Mr. BURGESS. Mr. Speaker, I yield back the balance of my time.
Mr. WAXMAN. Mr. Speaker, I would like to offer my thoughts on H.R.
4701, the Tick-Borne Disease Research Accountability and Transparency
Act of 2014.
H.R. 4701 would create a new working group to review efforts on Lyme
disease and other tick-borne diseases within the Department of Health
and Human Services. I support efforts to advance research and public
input in this area, but I remain concerned that today's legislation is
not the best way to advance these goals. Specifically, I have concerns
that H.R. 4701 could unnecessarily politicize federal activities on
Lyme disease and potentially result in recommendations that are not
supported by a strong, scientific evidence base.
I hope that my colleagues in the Senate will take a careful look at
H.R. 4701 and make changes to address these concerns before considering
it further.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Texas (Mr. Burgess) that the House suspend the rules and
pass the bill, H.R. 4701, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
The title was amended so as to read: ``A bill to provide for research
with respect to Lyme disease and other tick-borne diseases, and for
other purposes.''
A motion to reconsider was laid on the table.
____________________