[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.

                          ____________________