TB Notes Newsletter
No. 1, 2013
One of the most important annual events for people working in TB control is World TB Day. On that day, March 24, and the days leading up to it, CDC and many others take advantage of the attention and press coverage to speak out about successes in TB prevention and control, as well as to speak of the challenges that hinder our progress. I hope all of you had a chance to plan or take part in your own World TB Day activities. Staff of CDC’s Division of Tuberculosis Elimination (DTBE) organized a number of events; please read about them in this issue.
In December 2012, DTBE first reported on a shortage of isoniazid (INH) in the Morbidity and Mortality Weekly Report (MMWR): www.cdc.gov/mmwr/preview/mmwrhtml/mm6150a4.htm). Unfortunately, shortages of INH are continuing and there will likely be a limited supply of INH for several months. CDC and the National TB Controllers Association (NTCA) have been working closely with the Food and Drug Administration (FDA) and drug manufacturers to assess the INH supply and determine how to ensure that the highest-risk patients receive this medication.
CDC published a health advisory via the Health Alert Notification (HAN) on January 28, 2013 (http://emergency.cdc.gov/HAN/han00340.asp) which suggests the following priorities for allocation of INH:
- Patients being treated for active TB disease
- Patients being treated for latent TB infection if they belong to any of the following categories:
a) Were diagnosed during a contact tracing of a patient with contagious TB,
b) Are immunocompromised (e.g., persons with HIV infection, or receiving immunomodulating medications), or
c) Are less than 5 years of age.
There is also a temporary supply interruption for Tubersol. Please see the CDC Health Alert, "Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice," for information about the shortage: http://emergency.cdc.gov/HAN/han00345.asp
FDA continues to update its website with the most recent information (www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm). DTBE will continue to provide updates on the status of the drug shortage as new information becomes available. DTBE Program Consultants will be checking in with TB programs regularly to assess drug needs. Please be prepared to update your area's Program Consultant on stock levels, as this will help inform additional steps that DTBE can take.
In other news, after serving as the Director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) for 7 years, Dr. Kevin Fenton has returned to the United Kingdom to serve as Director for Health Improvement and Population Health for Public Health England. Kevin’s dedication to the health and welfare of the populations served by the divisions in our Center has been exemplary and inspirational, and his friendly and gracious demeanor will be missed by all. We wish him much success in his new position. In the interim, as his replacement is sought, Rima Khabbaz, MD, CDC’s Director of the Office of Infectious Diseases, has been serving as Acting Director of our Center.
On December 4–5, 2012, the Advisory Council for the Elimination of Tuberculosis (ACET) met in Atlanta; I will touch on a few of the numerous updates provided at the meeting. In my report, I related that five TB Regional Training and Medical Consultation Centers (RTMCCs) were selected for 2013–2018. In addition to the current four centers (Curry International TB Center in San Francisco, Heartland National TB Center in San Antonio, New Jersey Medical School Global TB Institute in Newark, and Southeastern National TB Center in Gainesville), the group now includes the Mayo Center for TB in Rochester. I also reported that the new TB Epidemiologic Studies Consortium, which focuses on latent TB infection, conducted a pilot study of its Task Order 1 during July–September 2012. Based on the results, the protocol for the task order was amended, and active recruitment for the task order started in fall 2012. In the clinical research arena, I shared that Study 33 (3HP self-administered vs. DOT) is enrolling participants, as is Study 34 (study of Gene Xpert in the United States).
Ms. Ann Cronin reported that the Food and Drug Administration (FDA) approved bedaquiline for treatment of multidrug-resistant (MDR) TB; CDC is working with other agencies to develop a plan for use of bedaquiline in this country (please see the article in this issue about the subsequent expert consultation convened by CDC in January 2013). Also, as described above, shortages of TB drugs are being reported in several states. As one potential solution, DTBE has submitted for IRB approval an Investigational New Drug (IND) protocol for clofazimine, which has a history of safe and effective use for leprosy and MDR TB. The protocol would provide access to clofazimine for patients who have limited other options, i.e., persons with MDR TB, persons with XDR TB, and persons who have had adverse events with other medications. CDC will be responsible for the institutional review board approved IND protocol that programs can rely on, but TB programs will still need to submit a single IND form for each patient to the FDA. TB controllers may contact their Program Consultant for more information on this topic.
The second ACET meeting of 2013 was held March 5, and was conducted as a brief webinar that focused primarily on ACET’s report to the Secretary of Health and Human Services. The webinar consisted of three discussion topics: 1) the ACET Chair’s report to the Secretary, which entailed a wide-ranging discussion of recommendations, 2) the roles and responsibilities of Federal advisory committees, and 3) topics for the next ACET meeting. The next ACET meeting will be held in Atlanta June 4–5, 2013, and will be conducted as a regular meeting.
The 2013 National TB Conference will be held June 11–13, 2013, at the Crowne Plaza Atlanta Perimeter at Ravinia Hotel. The theme for the 2013 conference is “TB at the Crossroads: Reasons for Optimism.” This important meeting brings together state, local, territorial, and other TB control professionals with colleagues from CDC to discuss a wide array of TB issues. DTBE considers this to be the most important meeting of the year and requires representatives from all 68 TB Cooperative Agreement recipient sites to attend. As in the past, the conference will be preceded with special meetings on Monday, June 10, and there will be post meetings on Thursday, June 13 and Friday, June 14. I look forward to seeing you there!
Kenneth G. Castro, MD
Assistant Surgeon General, USPHS, & Commanding Flag Officer
CDC/ATSDR Commissioned Corps
Director, Division of Tuberculosis Elimination
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention