This past summer, freshman Senator Richard Blumenthal (D-CT) introduced the Lyme and Tick-Borne Disease Prevention, Education and Research Act of 2011 (S. 1381). The Legislation was introduced along with Senators Jack Reed (D-RI), Kristen Gillibrand (D-NY), Sheldon Whitehouse (D-RI), Joseph Lieberman (I-CT), and Al Franken (D-MN).
Senators Susan Collins (R-ME), Frank Lautenberg (D-NJ), and Charles Schumer (D-NY) later co-sponsored the legislation. The bill was referred to the Committee on Health, Education, Labor, and Pensions (HELP). No hearings on this legislation have been scheduled as of today’s date.
Lyme disease is caused by bacteria called Borrelia burgdorferi (B. burgdorferi). Blacklegged ticks carry these bacteria. The ticks pick up the bacteria when they bite mice or deer that are infected with Lyme disease. You can get the disease if you are bitten by an infected tick.
Lyme disease was first reported in the United States in the town of Old Lyme, Connecticut, in 1975. In the United States, most Lyme disease infections occur in the following areas:
- Northeastern states, from Virginia to Maine
- North-central states, mostly in Wisconsin and Minnesota
- West Coast, particularly northern California
The purpose of the legislation is to “provide for the expansion of Federal efforts concerning the prevention, education, treatment, and research activities related to Lyme and other tick-borne diseases, including the establishment of a Tick-Borne Diseases Advisory Committee.” At the beginning of the legislation, the bill sets forth a number of findings related to Lyme disease, including:
- If Lyme disease does not receive treatment, such individuals can develop severe heart, neurological, eye, and joint problems
- Ticks that spread Lyme disease also spread other diseases, such as anaplasmosis, babesiosis, and tularemia, and carry Bartonella and other strains of Borrelia.
- The Centers for Disease Control and Prevention (CDC) reported more than 38,000 confirmed and probable Lyme disease cases in 2009. Over the past decade, the incidence of Lyme disease has increased by 84 percent.
Establishment of a Tick-Born Disease Advisory Committee
The legislation would instruct the Secretary of Health and Human Services (HHS) to create within the Office of the Secretary, a Tick-Borne Diseases Advisory Committee (“Committee”). The HHS Secretary is responsible for appointing members of the Committee who in general must be individuals who are not officers or employees of the Federal Government. Voting members would include the following:
- Not less than 4 members within the scientific community related to Lyme and other tick-borne diseases.
- Not less than 2 representatives of tick-borne disease voluntary organizations.
- Not less than 2 health care providers, including not less than 1 full-time practicing physician, with relevant experience providing care for individuals with a broad range of acute and chronic tick-borne diseases.
- Not less than 2 patient representatives who are individuals who have been diagnosed with a tick-borne disease or who have had an immediate family member diagnosed with such a disease.
- At least 2 representatives of State and local health departments and national organizations that represent State and local health professionals.
The Secretary will also designate, as nonvoting, ex officio members of the Committee, representatives overseeing tick-borne disease activities from each of the following Federal agencies:
- The Centers for Disease Control and Prevention (CDC)
- The National Institutes of Health (NIH)
- The Agency for Healthcare Research and Quality (AHRQ)
- The Food and Drug Administration (FDA)
- The Office of the Assistant Secretary for Health.
- Such additional Federal agencies as the Secretary determines to be appropriate.
Notably, it does not appear that there will be any industry representatives present on the Committee. Additionally, it is unclear whether individuals, who have worked developing, researching or consulting about drugs, treatments, or devices related to Tick-Borne diseases, will be able to serve on the Committee. Presumably, all members will have to meet the federal requirements for conflicts of interest for advisory committees, which will likely mean that many qualified experts in Tick-Borne diseases will be excluded from service. These rules however, are currently under scrutiny, particularly at the FDA, where the requirement of “fair balance” has been raised.
The Committee will be Co-Chaired by the Assistant Secretary of Health as well as a Co-Chair selected by the appointed members of the Committee. Members of the committee are appointed for four (4) year terms. Additionally, the Committee would be responsible for advising the Secretary and the Assistant Secretary for Health regarding the manner in which such officials can:
- Ensure interagency coordination and communication and minimize overlap regarding efforts to address tick-borne diseases;
- Identify opportunities to coordinate efforts with other Federal agencies and private organizations addressing such diseases;
- Ensure interagency coordination and communication with constituency groups;
- Ensure that a broad spectrum of scientific viewpoints are represented in public health policy decisions and that information disseminated to the public and physicians is balanced; and
- Advise relevant Federal agencies on priorities related to Lyme and other tick-borne diseases; and
The Committee would also be responsible, in coordination with relevant agencies within HHS, to regularly review published public and private treatment guidelines and evaluate such guidelines for effective representation of a wide diversity of views.
Meetings, Report, and Appropriations
The Committee will hold public meetings and must meet at least twice a year with additional meetings subject to the call of the co-chairpersons. Agenda items with respect to such meetings may be added at the request of the members of the Committee, including the co-chairpersons.
No later than 1 year after the bill is enacted, and annually thereafter, the Committee, acting through the members representing the CDC and NIH, must submit a report to the Secretary. Each such report must contain, at a minimum:
- A description of the Committee’s functions;
- A list of the Committee’s members and their affiliations; and
- A summary of the Committee’s activities and recommendations from the previous year.
No set amount of money is set out in the bill to carry out this legislation. It only states, “such sums a may be necessary for each of the fiscal years 2012 through 2016.” The legislation does note that expenses and per diem costs incurred by the Committee must be in accordance with the Federal Advisory Committee Act except that no voting member of the Committee will be a permanent salaried employee.
Diagnosis, Surveillance, Prevention and Research
The HHS Secretary, in coordination with the other federal health agencies, will provide for certain activities and the coordination of all Federal programs and activities related to Lyme disease and other tick-borne diseases. Activities will include:
The development of diagnostic tests including
- The development of sensitive and more accurate diagnostic tools and tests, including a direct detection test for Lyme disease capable of distinguishing active infection from past infection;
- Improving utilization of diagnostic testing currently available; and
- Providing timely evaluation of promising emerging diagnostic methods.
Surveillance and Reporting, including:
- Accurately determining prevalence of Lyme and other tick-borne diseases;
- To evaluate the feasibility of developing a reporting system for the collection of data on physician-diagnosed cases of Lyme disease that do not meet the CDC surveillance criteria; and
- To evaluate the feasibility of creating a national uniform reporting system including required reporting by laboratories in each State.
Prevention
- The provision and promotion of access to a comprehensive, up-to-date clearinghouse of peer-reviewed information on tick-borne diseases;
- Increased public education related to Lyme and other tick-borne diseases through the expansion of the Community Based Education Programs of CDC to include expansion of information access points to the public;
- The creation of a physician education program that includes the full spectrum of scientific research related to Lyme and other tick-borne diseases, and, in coordination with the Advisory Committee, the publication of an annual report that evaluates published guidelines and current research available on Lyme disease, in order to best educate health professionals on the latest research and diversity of treatment options for Lyme disease; and
- The sponsoring of scientific conferences on Lyme and other tick-borne diseases, including reporting and consideration of the full spectrum of clinically based knowledge, with the first of such conferences to be held not later than 24 months after the date of enactment of this Act.
– Clinical Outcomes Research
- The establishment of epidemiological research objectives to determine the long-term course of illness for Lyme disease; and
- Determination of the effectiveness of different treatment modalities by establishing treatment outcome objectives.
The Secretary must submit to Congress no later than 18 months after the legislation is enacted, a report on the activities, including:
- Significant activities or developments related to the surveillance, diagnosis, treatment, education, or prevention of Lyme or other tick-borne diseases, including suggestions for further research and education;
- A scientifically qualified assessment of Lyme and other tick-borne diseases, as well as published peer reviewed data, that must include recommendations for addressing research gaps in diagnosis and treatment of Lyme and other tick-borne diseases and an evaluation of treatment guidelines and their utilization;
- Progress in the development of accurate diagnostic tools that are more useful in the clinical setting for both acute and chronic disease;
- The promotion of public awareness and physician education initiatives to improve the knowledge of health care providers and the public regarding clinical and surveillance practices for Lyme disease and other tick-borne diseases; and
- A copy of the most recent annual report issued by the Tick-Borne Diseases Advisory Committee and an assessment of progress in achieving the recommendations included in the Committee’s report.