[Congressional Record Volume 144, Number 54 (Tuesday, May 5, 1998)]
[Senate]
[Pages S4361-S4363]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DODD:
  S. 2034. A bill to establish a program to provide for a reduction in 
the incidence and prevalence of Lyme disease; to the Committee on Labor 
and Human Resources.


                the lyme disease initiative act of 1998

  Mr. DODD. Mr. President, I am pleased to introduce the Lyme Disease 
Initiative Act of 1998, companion legislation to a bill being 
introduced today by Representative Christopher H. Smith of New Jersey. 
The objective of this bill is to put us on the path toward eradicating 
Lyme disease--a disease that is unfamiliar to some Americans, but one 
that those of us from Connecticut and the Northeast know all too well.
  Almost everyone in my state, including myself, has seen the 
devastating impact that this disease can have on its victims. Lyme 
disease can cause serious health problems, both physical and 
psychiatric, and can ruin a family's life. Some damage due to the 
disease, especially memory loss and other brain damage, is permanent.
  And we have also seen that, in many ways, efforts to educate people 
about this disease and to find a cure have come up short.
  The number of cases reported to the CDC increased from 500 cases in 
1982 to 16,000 cases in 1996. And some reports suggest that these cases 
only represent the tip of the iceberg--that there are in fact tens of 
thousands more cases that have gone unreported or undiagnosed, due in 
part to the lack of a standardized diagnostic test.
  Studies indicate that long term treatment of infected individuals 
often exceeds $100,000 per person--a phenomenal cost to society. 
Because Lyme disease mimics other health conditions, patients often 
must visit multiple doctors before a proper diagnosis is made. This 
results in prolonged pain and suffering, unnecessary tests, and costly 
and futile treatments. But an even greater price is paid by the victims 
and their families--we can put no price tag on the emotional costs 
associated with this disease.
  But there is hope. We are close to the approval of vaccines to 
prevent this disease--perhaps as soon as next spring. And combined with 
a strong commitment to public education, we can hope that the numbers 
of new families affected by this terrible disease will finally begin to 
diminish.

[[Page S4362]]

  But we can't let down our guard. We can't let the promise of a 
vaccine to prevent Lyme disease distract us from seeking more effective 
ways to diagnose an treat those individuals who are already infected.
  The Lyme Disease Initiative is a $100 million federal initiative 
which will, for the first time, establish prominent, coordinated, 
federal role in Lyme disease research, treatment, and education. 
Various agencies within the federal government have made a good start 
in addressing Lyme disease concerns. These efforts have been hampered, 
however, by a lack of interagency coordination, inconsistent funding, 
and limited agency staff attention. The Lyme Disease Initiative will 
correct these problems.
  First, my bill calls for a 5 year plan to be established by the 
Secretary of Health and Human and Services, in coordination with the 
Secretary of Defense and outside experts, to advance the treatment of 
and a cure for Lyme disease. This legislation also sets out four 
critical public health goals for advancing Lyme disease research 
efforts which include: the development of standardized diagnostic 
tests; a review of current systems for reporting cases; a study on how 
to improve the accuracy of diagnoses; and a campaign to educate 
physicians how to properly diagnose and treat Lyme disease.
  Other major provisions of the bill include establishing a Lyme 
Disease Taskforce to provide advice and expertise to Congress and 
federal agencies on all areas of Lyme disease policy; requiring that 
annual reports be submitted to Congress on the progress of NIH, CDC, 
and DoD with respect to the goals and programs funded in this bill; an 
authorization of $100 million over five years to ensure sufficient 
resources for critical, scientific research; and a request to the FDA 
rapidly and thoroughly review pending Lyme disease vaccine 
applications.
  Summer is just around the corner. My hope is that the Lyme Disease 
Initiative Act of 1998 will help to ensure a future where children and 
their families can engage in outdoor activities without the fear of 
contracting this dreaded disease.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2034

       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 ``Lyme Disease Initiative Act 
     of 1998''.

     SEC. 2. FINDINGS.

       The Congress finds as follows:
       (1) The incidence of Lyme disease in the United States is 
     increasing more rapidly than most other diseases. The Centers 
     for Disease Control and Prevention has determined that, since 
     1982, there has been a 32-fold increase in reported cases.
       (2) For 1996, such Centers determined that 16,455 cases of 
     the disease were reported.
       (3) There is no reliable standardized diagnostic test for 
     Lyme disease, and it is therefore likely that the disease is 
     severely underreported. The disease is often misdiagnosed 
     because the symptoms of the disease mimic other health 
     conditions.
       (3) Lyme disease costs our Nation at least $60,000,000 a 
     year in direct medical costs for early, acute cases. The 
     costs of chronic cases of the disease, as well as the costs 
     of lost wages and productivity, are many times higher.
       (4) Many health care providers lack the necessary knowledge 
     and expertise--particularly in non-endemic areas--to 
     accurately diagnose Lyme disease. As a result, patients often 
     visit multiple doctors before obtaining a diagnosis of the 
     disease, resulting in prolonged pain and suffering, 
     unnecessary tests, and costly and futile treatments.

     SEC. 3. PUBLIC HEALTH GOALS; FIVE-YEAR PLAN.

       (a) In General.--The Secretary of Health and Human Services 
     (acting as appropriate through the Director of the Centers 
     for Disease Control and Prevention and the Director of the 
     National Institutes of Health) and the Secretary of Defense 
     shall collaborate to carry out the following:
       (1) The Secretaries shall establish the goals described in 
     subsections (c) through (f) (relating to activities to 
     provide for a reduction in the incidence and prevalence of 
     Lyme disease).
       (2) The Secretaries shall carry out activities toward 
     achieving the goals, which may include activities carried out 
     directly by the Secretaries and activities carried out 
     through awards of grants or contracts to public or nonprofit 
     private entities.
       (3) In carrying out paragraph (2), the Secretaries shall 
     give priority--
       (A) first, to achieving the goal under subsection (c);
       (B) second, to achieving the goal under subsection (d);
       (C) third, to achieving the goal under subsection (e); and
       (D) fourth, to achieving the goal under subsection (f).
       (b) Five-Year Plan.--In carrying out subsection (a), the 
     Secretaries shall establish a plan that, for the 5 fiscal 
     years following the date of the enactment of this Act, 
     provides for the activities to be carried out during such 
     fiscal years toward achieving the goals under subsections (c) 
     through section (f). The plan shall, as appropriate to such 
     goals, provide for the coordination of programs and 
     activities regarding Lyme disease that are conducted or 
     supported by the Federal Government.
       (c) First Goal: Detection Test.--
       (1) In general.--For purposes of subsection (a), the goal 
     described in this subsection is the development, by the 
     expiration of the 18-year period beginning on the date of the 
     enactment of this Act, of--
       (A) a test for accurately determining whether an individual 
     who has been bitten by a tick has Lyme disease; and
       (B) a test for accurately determining whether a patient 
     with such disease has been cured of the disease.
       (d) Second Goal: Improved Surveillance and Reporting 
     System.--For purposes of subsection (a), the goal described 
     in this subsection is to review the system in the United 
     States for surveillance and reporting with respect to Lyme 
     disease and to determine whether and in what manner the 
     system can be improved (relative to the date of the enactment 
     of this Act). In carrying out activities toward such goal, 
     the Secretaries shall--
       (1) consult with the States, units of local government, 
     physicians, patients with Lyme disease, and organizations 
     representing such patients;
       (2) consider whether uniform formats should be developed 
     for the reporting by physicians of cases of Lyme disease to 
     public health officials; and
       (3) with respect to health conditions that are reported by 
     physicians as cases of Lyme disease but do not meet the 
     criteria established by the Director of the Centers for 
     Disease Control and Prevention to be counted as such cases, 
     consider whether data on such health conditions should be 
     maintained and analyzed to assist in understanding the 
     circumstances in which Lyme disease is being diagnosed and 
     the manner in which it is being treated.
       (e) Third Goal: Indicator Regarding Accurate Diagnosis.--
     For purposes of subsection (a), the goal described in this 
     subsection is to determine the average number of visits to 
     physicians that are made by patients with Lyme disease before 
     a diagnosis of such disease is made. In carrying out 
     activities toward such goal, the Secretaries shall conduct a 
     study of patients and physicians in 2 or more geographic 
     areas in which there is a significant incidence or prevalence 
     of cases of Lyme disease.
       (f) Fourth Goal: Physician Knowledge.--For purposes of 
     subsection (a), the goals described in this subsection are to 
     make a significant increase in the number of physicians who 
     have an appropriate level of knowledge regarding Lyme 
     disease, and to develop and apply an objective method of 
     determining the number of physicians who have such knowledge.

     SEC. 4. LYME DISEASE TASK FORCE.

       (a) In General.--Not later than 120 days after the date of 
     enactment of this Act, there shall be established in 
     accordance with this section an advisory committee to be 
     known as the Lyme Disease Task Force (in this section 
     referred to as the Task Force).
       (b) Duties.--The Task Force shall provide advice to the 
     Secretaries with respect to achieving the goals under section 
     3, including advice on the plan under subsection (b) of such 
     section.
       (c) Composition.--The Task Force shall be composed of 9 
     members with appropriate knowledge or experience regarding 
     Lyme disease. Of such members--
       (1) 2 shall be appointed by the Secretary of Health and 
     Human Services, after consultation with the Director of the 
     Centers for Disease Control and Prevention;
       (2) 2 shall be appointed by the Secretary of Health and 
     Human Services, after consultation with the Director of the 
     National Institutes of Health;
       (3) 1 shall be appointed by the Secretary of Defense;
       (4) 2 shall be appointed by the Speaker of the House of 
     Representatives, after consultation with the Minority Leader 
     of the House; and
       (5) 2 shall be appointed by the President Pro Tempore of 
     the Senate, after consultation with the Minority Leader of 
     the Senate.
       (d) Chair.--The Task Force shall, from among the members of 
     the Task Force, designate an individual to serve as the chair 
     of the Task Force.
       (e) Meetings.--The Task Force shall meet at the call of the 
     Chair or a majority of the members.
       (f) Term of Service.--The term of service of a member of 
     the Task Force is the duration of the Task Force.
       (g) Vacancies.--Any vacancy in the membership of the Task 
     Force shall be filled in the manner in which the original 
     appointment was made and shall not affect the power of the 
     remaining members to carry out the duties of the Task Force.

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       (h) Compensation; Reimbursement of Expenses.--Members of 
     the Task Force may not receive compensation for service on 
     the Task Force. Such members may, in accordance with chapter 
     57 of title 5, United States Code, be reimbursed for travel, 
     subsistence, and other necessary expenses incurred in 
     carrying out the duties of the Task Force.
       (i) Staff; Administrative Support.--The Secretary of Health 
     and Human Services shall, on a reimbursable basis, provide to 
     the Task Force such staff, administrative support, and other 
     assistance as may be necessary for the Task Force to 
     effectively carry out the duties under subsection (b).
       (j) Termination.--The Task Force shall terminate on the 
     date that is 90 days after the end of the fifth fiscal year 
     that begins after the date of the enactment of this Act.

     SEC. 5. ANNUAL REPORTS.

       The Secretaries shall submit to the Congress periodic 
     reports on the activities carried out under this Act and the 
     extent of progress being made toward the goals established 
     under section 3. The first such report shall be submitted not 
     later than 18 months after the date of the enactment of this 
     Act, and subsequent reports shall be submitted annually 
     thereafter until the goals are met.

     SEC. 6. DEFINITION.

       For purposes of this Act, the term ``Secretaries'' means--
       (1) the Secretary of Health and Human Services, acting as 
     appropriate through the Director of the Centers for Disease 
     Control and Prevention and the Director of the National 
     Institutes of Health; and
       (2) the Secretary of Defense.

     SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

       (a) National Institutes of Health.--In addition to other 
     authorizations of appropriations that are available for 
     carrying out the purposes described in this Act and that are 
     established for the National Institutes of Health, there are 
     authorized to be appropriated to the Director of such 
     Institutes for such purposes $9,000,000 for each of the 
     fiscal years 1999 through 2003.
       (b) Centers for Disease Control and Prevention.--In 
     addition to other authorizations of appropriations that are 
     available for carrying out the purposes described in this Act 
     and that are established for the Centers for Disease Control 
     and Prevention, there are authorized to be appropriated to 
     the Director of such Centers for such purposes $8,000,000 for 
     each of the fiscal years 1999 through 2003.
       (c) Department of Defense.--In addition to other 
     authorizations of appropriations that are available for 
     carrying out the purposes described in this Act and that are 
     established for the Department of Defense, there are 
     authorized to be appropriated to the Secretary of Defense for 
     such purposes $3,000,000 for each of the fiscal years 1999 
     through 2003.

     SEC. 8. SENSE OF THE CONGRESS.

       It is the sense of the Congress that the Food and Drug 
     Administration should--
       (1) conduct a rapid and thorough review of new drug 
     applications for drugs to immunize individuals against Lyme 
     disease; and
       (2) ensure that the labeling approved for such drugs 
     specifically indicate the particular strains of Lyme disease 
     for which the drugs provide immunization, the duration of the 
     period of immunization, and the reliability rate of the 
     drugs.
                                 ______