IDSA News - December 2014
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CDC Warns of Drifted Influenza A H3N2 Viruses
As influenza season gets underway, the Centers for Disease Control and Prevention (CDC) issued an advisory regarding the potential for circulation of drifted influenza A viruses. The advisory was issued to re-emphasize the importance of the use of neuraminidase inhibitor antiviral medications when indicated for treatment and prevention of influenza, as an adjunct to vaccination.
IDSA offers two email services to help members stay informed of new drug approvals and similar updates from the Food and Drug Administration and CDC. Content includes a range of topics, including drug warnings, recalls, and outbreak investigations. Recent alerts have included:
Multistate Outbreak of Listeria Monocytogenes Infections Linked to Caramel Apples
FDA Approves Gardasil 9 for Prevention of HPV
Dietary Supplements Containing Live Bacteria or Yeast in Immunocompromised Persons: Warning - Risk of Invasive Fungal Disease
Fungal Contamination of Probiotic
IDSA members can sign up for these services online. (To subscribe, check the appropriate boxes to receive CDC’s Health Alert Network [HAN] messages and/or alerts from FDA, and provide your email address and name where indicated.)
Is Your Facility Experiencing Antibiotic Shortages?
IDSA members are urged to report drug shortages directly to FDA and to copy IDSA staff at email@example.com.
The Future of Telemedicine in ID
A recent cover story of Infectious Disease News focused on the use of telemedicine in infectious disease. Telemedicine is an area of great interest for many IDSA members and the Society is interested in building resources that will aid members in better understanding and appropriately adopting this technology into their practice.
IDSA is asking those members who have experience in telemedicine and have an interest in participating in a work group to please email Andrés Rodríguez, IDSA’s director of Practice and Payment Policy, at firstname.lastname@example.org with their contact information.
Fiscal Year 2015 Brings Stagnant Funding for ID, HIV
Details of a final House and Senate appropriations package for Fiscal Year 2015 were released earlier this month showing a spending agreement that largely flat-funds federal agencies of interest to the infectious diseases community. The final package sent to President Obama will include:
One notable exclusion in the bill was funding for the new CDC Detect and Protect Against Antibiotic Resistance Initiative. The CDC proposal was pushed by many stakeholder groups and fully supported at $30 million by the Senate Subcommittee on Labor-HHS Appropriations over the summer. However, the final bill failed to fund the new program.
- National Institutes of Health funding increased by $150 million (0.5%) to $30.08 billion, including National Institute of Allergy and Infectious Diseases level-funded at $4.36 million.
- Centers for Disease Control and Prevention (CDC) funding went up $22 million (0.3%) to $6.93 billion, including an Emerging and Zoonotic Infectious Diseases (EZID) increase of $15 million (3.8%) to $405 million, and flat funding at $18 million for the National Healthcare Safety Network. HIV prevention is funded at $787 million, a slight decrease from 2014. Funding for Hepatitis Prevention at the CDC remains flat at approximately $31 million, and funding for domestic tuberculosis activities, including the Tuberculosis Trials Consortium remains at $142 million.
- The Health Resources and Services Administration (HRSA)/HIV/AIDS Bureau Ryan White Program is flat funded at the same levels provided in FY 2014 across all of the Parts.
- Food and Drug Administration funding increased by $22 million (1.1%) to $2.59 billion.
- Biomedical Advanced Research and Development Authority funding held flat at $415 million.
- In a win on the global health front, the bill increases or maintains almost all areas of global health spending for fiscal year 2015. This includes a $300 million increase for the President’s Emergency Plan for AIDS Relief (PEPFAR), restoring half of the $600 million in cuts the PEPFAR program has seen since 2011. The Global Fund to Fight AIDS, Tuberculosis and Malaria is fully funded at $1.35 billion. USAID’s global tuberculosis program is funded at $236 million, the same level as FY 14 but a significant increase over the President’s requested $192 million.
Unfortunately, the bill also continues the ban on federal funding for syringe exchange programs and continues support for prevention focused on abstinence-only until marriage programs.
The omnibus spending bill did include some bright spots such as $5.4 billion of President Obama’s $6.2 billion emergency supplemental spending request to support preparedness and response efforts for Ebola and future outbreaks. The bill also continues support for the CDC Advanced Molecular Detection & Response to Infectious Disease Outbreaks program, now in its second year. Appropriators reversed a decision by the administration to cut nearly 10% from the Section 317 Immunizations program, opting instead to provide the full FY 2014 level of $611 million. These line-items were also pushed by health and public health groups and their grassroots advocates.
The health and public health advocacy communities now look towards the FY 2016 appropriations process, which will begin with the release of the President’s Budget Request, likely in early February. President Obama is expected to call on Congress to provide significant new funding for his national strategy to combat antibiotic resistance. The advocacy efforts of stakeholder groups – including IDSA and HIVMA – will continue to play a pivotal role in bolstering federal efforts on antibiotic resistance and the many other important ID and HIV policy issues.
New Law to Incentivize Ebola Drug Development
and Senate both passed the IDSA-supported legislation that will add Ebola to
the FDA Priority Review Voucher program, to help incentivize development of new
drugs to treat Ebola. The bill is headed
to the President for his signature.
Science Speaks, the blog of the Center for Global Health Policy, covered global health developments to be thankful for over the holidays, with:
IDSA In-Training Exam is a Good Predicator of Performance on ID Certification Exam
According to a study recently published in Clinical Infectious Diseases (CID), there is a significant relationship between scores on the IDSA In-Training Examination (IDSA ITE) and performance on the Infectious Disease Certification Examination.
The IDSA ITE is a feedback tool that allows fellows to track their educational progress during fellowship training. The CID study, led by Irina Grabovsky, PhD, with the National Board of Medical Examiners, compared scores on the IDSA ITE with those from other knowledge assessments in their ability to predict performance on the American Board of Internal Medicine (ABIM) Infectious Disease Certification Examination.
The study included 1,021 second-year fellows who took the IDSA ITE and ABIM Infectious Disease Certification Exam from 2008 to 2012 and found that the IDSA ITE scores were the strongest predictor of ABIM ID Certification Exam scored, followed by prior ABIM Internal Medicine Certification Exam scores, United States Medical Licensing Exam (USMLE) Step I scores, and fellowship directors’ medical knowledge ratings. IDSA ITE scores were also a significant predictor of passing the ID certification exam.
For more information on the IDSA ITE, visit http://www.idsociety.org/FITE/.
IDSA Offers New MOC Modules on General ID and Infection Control
IDSA introduced two new Maintenance of Certification Modules at IDWeek 2014: General ID 2014 and Infection Control. The Infection Control Module is one of the few that satisfies the new American Board of Internal Medicine (ABIM) Patient Safety Requirement.
Visit http://idsa.knowledgedirectweb.com/ to access the modules and see what other learning activities are available from IDSA.
Additional CME opportunities from IDSA can be found at http://www.idsociety.org/CME/.
Atabani, Sowsan, MBBS, MSc, PhD
Bodner, Corey, MSc
Bonilla, Maria-Fernanda, MD
Budhwani, Henna, PhD
Cope, Jennifer, MD, MPH
El Hefnawy, Moustafa, MD
Eranki, Ambika, MD
Lloyd, Ann, PharmD
Marx, Melissa, MPH, PhD
McGinty, Tanner, PA-C
Phillips, Doak, MD
Pizarro, Glenn, MD
Sarubbi, Christina, PharmD
Thal, Gary, MD
Wrenn, Rebekah, PharmD
Colgrove, Robert, MD
Gardy, Jennifer, PhD
Henderson, Jeffrey, MD, PhD
Lyons, Jennifer, MD
Rajagopalan, Govindarajan, PhD
Ramachandran, Veena, MD
Roth, Prerana, MD, MPH
Tonelli, Melinda, MD
Tulara, Neeraj, MD
Vaughan, Leroy, MD
Abodunde, Oladapo, MD
Aburjania, Nana, MD
Castillo, Caroline, MD
Cataldi, Jessica, MD
Chandranesan, Andrew, MD
Collins, Jennifer, MD
Dwilow, Rachel, MD
El Chebib, Hassan, MD
Fine, Antonella, MD
Ford, Gavin, MD
Gundacker, Nathan, MD
Hill, Emilie, MD, MPH
Magro, Francis, MD
Merrick, Maria, DO
Norton, Laura, MD
Parr, Jonathan, MD, MPH
Penafiel, Julio, MD
Poole, Nicole, MD, MPH
Popiel, Kristin, MD
Robinson, Makeda, MD
Roukens, Anna, MD, MSc, PhD
Seales, Maxine, MD
Skar, Gwenn, MD
Tagashira, Yasuaki, MD
Thompson, Amelia, MD, MPH
Vazquez, Gabriela, MD
Chiu, Edwin, MD
Enriquez, Matthew, MD
Giles, Sarah, MD
Martin, William, MD
Nizami, Sobia, MD
St. Louis, Joshua, MD
Acosta Marinez, Dionisio, MD
Beavers, Josh, PharmD
Duffey, Megan, MD
Korndorf, Therese, MD
Miroballi, Yolanda, MD, MPH
Skoog, Kehly, PharmD
Stachulski, Theodre, PharmD
Wesemann Reoyo, Charles, MD
From the President: My Membership in IDSA is Part of My Identity as an ID Physician
IDSA is the professional society that best represents my subspecialty of medicine, its core values and the broad range of interests encompassed in that specialty, from research and education to clinical practice to ensuring that the profession many of us consider a calling, continues to thrive. Membership in IDSA is part of my identity as an Infectious Disease physician. Take the time today to renew your IDSA membership and encourage your colleagues, particularly those just beginning their career in ID, to join.
I have been a member of IDSA for 35 years and wanted to use this opportunity, as the Society begins its membership renewal and enrollment campaign, to reflect on why being a member of this Society has been so important to me. IDSA is the professional society that best represents my subspecialty of medicine, its core values and the broad range of interests encompassed in that specialty, from research and education to clinical practice to ensuring that the profession many of us consider a calling, continues to thrive. Membership in IDSA is part of my identity as an Infectious Disease physician.
The Society provides many important activities that have contributed directly to my own professional career development, as well as those of the young people drawn to our specialty. These include outstanding educational opportunities including the annual meeting (now IDWeek), unmatched career and advocacy support, and countless ways to connect, network and consult with ID professionals. In addition, IDSA provides invaluable materials including a set of robust practice guidelines that help with guiding effective patient care every day; a growing portfolio of resources to assist members in communicating the value of ID within their networks; access to three outstanding journals (including Clinical Infectious Diseases, The Journal of Infectious Diseases and the new, innovative open access Open Forum Infectious Diseases); and a number of very helpful Member Services such as career opportunity postings, daily news summaries, the Emerging Infections Network (EIN), CDC alerts and many others.
IDSA represents more than 10,000 members and the size and diversity of its membership allows it to effectively advocate at the national, state and local levels for issues important to the practice of Infectious Disease, for funding and furthering important research priorities, and for improving public health and infectious disease prevention.
The Society has focused a lot on attracting the best and brightest young people into this specialty, certainly a key issue given the recent declines in the match results, as well as providing opportunities for these people to learn our specialty through outstanding fellowship training programs, hosting annual fellows meetings on careers in clinical ID and research, providing a large number of travel grants to IDWeek each year, and funding research grants for young investigators.
I also support the IDSA Education and Research Foundation, the charitable, non-profit foundation of IDSA, and I hope you also will consider supporting this generously this coming year when you renew your membership. The Foundation focuses on career development of medical students, fellows, and young faculty, promoting important research, and disseminating knowledge about infectious disease and public health. Infectious Diseases has been a wonderful specialty for me and my career, and IDSA has been a major part of that.
I urge you to lend your voice, expertise, and time. Volunteer on committees that will further the cause of ID. Join advocacy efforts that support federal funding for medical research and public health. Pay it forward through IDSA's mentorship programs. Donate to the IDSA Education and Research Foundation and its pledge to promote research and develop careers of young people, so vital to attracting people to our specialty. Take the time today to renew your IDSA membership and encourage your colleagues, particularly those just beginning their career in ID, to join.
Progress Continues on Several Antimicrobial Resistance Advocacy Fronts
Senate introduces important legislation that would establish a Limited Population Antibacterial Drug (LPAD) approval mechanism for drugs to treat serious or life-threatening infections where there is an unmet medical need. IDSA and S-FAR advocate for Stewardship as a Condition of Participation in Medicare.
Senate Introduces PATH ActIDSA’s 10-year effort to spur the development of new antibiotics took another step forward this month when Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act in the U.S. Senate. The bill would establish the Limited Population Antibacterial Drug (LPAD) approval mechanism for drugs to treat serious or life-threatening infections where there is an unmet medical need. IDSA supports this important bill, as well companion legislation in the House. Many IDSA members have been extremely helpful to the Society over the years in developing and advocating for the LPAD concept.
IDSA Leads Stakeholders In Support of Stewardship as a Condition of Participation in Medicare
In a letter to the Centers for Medicare & Medicaid Services (CMS), IDSA’s U.S. Stakeholder Forum on Antimicrobial Resistance (S-FAR), and other organizations advocated that hospitals and long-term care facilities be required to implement an antibiotic stewardship program as a condition of participation in Medicare and Medicaid. CMS is known to be actively considering the proposal. The recommendation was also made by the President's Council of Advisors on Science and Technology (PCAST) in their recent report on combatting antibiotic-resistant bacteria.
IDSA Participates in Two-Day FDA Meeting on Antibiotics
The U.S. Food and Drug Administration (FDA) recently held a two-day meeting of the Anti-Infective Drugs Advisory Committee (AIDAC) to discuss streamlined clinical trial designs for anti-bacterial products meeting an unmet medical need and to consider recommending approval of ceftazidime-avibactam for the indication of complicated intra-abdominal infections and complicated urinary tract infections.
Jason Newland, MD, member of the IDSA Antimicrobial Resistance Committee (ARC) presented to the committee on behalf of IDSA and PIDS. His presentation outlined IDSA priorities for antibacterial product development policies and included his own patient stories. The committee also considered a series of questions posed by FDA relating to streamlined trial designs. The committee’s input will be used to inform finalization of the FDA’s draft guidance on streamlined development programs and clinical trial designs, including for pathogen-specific antibacterials. In general, the panel supported the concept of streamlined trials for these drugs and understood the reasons why trials for multi-drug resistance organism (MDRO) indications are a particular challenge. Panel members stressed, however, that the FDA must retain significant flexibility to tailor trial requirements based on the severity of medical need.
IDSA staff Amanda Jezek presented to the committee during the December 5 open public comment section on the urgent need for new antibiotics. The committee subsequently voted in favor of two indications for ceftazidime-avibactam; for complicated intra-abdominal infections (CIAI, 11-1) and for complicated urinary tract infections (CUTI, 9-3). However, the committee rejected the idea of approving the drug for other indications (including hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia and bacteremia) when limited or no alternative treatments are available, citing the fact that the drug sponsor Cerexa did not submit human data for these indications. The committee also raised concerns about labeling, particularly for patients with renal impairment.
IDSA Ebola Grants Still Available
IDSA’s Center for Global Health Policy is offering service grants for IDSA members volunteering in West Africa to contain the spread of the Ebola outbreak. Since the November announcement of the availability of the grants, 26 IDSA members have applied for an Ebola service grant, and 10 have met all eligibility requirements for receiving a grant, leaving 30 grants still available.
IDSA’s Center for Global Health Policy is offering service grants for IDSA members volunteering in West Africa to contain the spread of the Ebola outbreak.
Each grant of $2,500 is meant to offset some of the costs volunteers incur by attending the Centers for Disease Control and Prevention (CDC) training course or traveling to West Africa, as well as providing a small amount toward income lost while volunteering.
Applicants must provide verification of attendance at the CDC training and of affiliation with a governmental or non-governmental organization (NGO) coordinating the volunteer effort such as USAID, Médecins Sans Frontières (Doctors Without Borders) or Partners in Health.
Since the November announcement of the availability of the grants, 10 have met all eligibility requirements for receiving a grant, leaving 30 grants available. Additional applicants are in the process of applying to volunteering programs in West Africa.
Medical Scholars Program Applications Accepted Now Through February 2
The IDSA Education and Research Foundation offers scholarships to medical students in U.S. medical schools with mentorship by an IDSA member or fellow. IDSA members and fellows are encouraged to identify and solicit interested students. Each scholarship recipient receives $2,000. Applications will be accepted through February 2.
An important part of IDSA’s mission is to promote the subspecialty of infectious diseases by attracting the best and brightest medical students to the field. To further this goal, the IDSA Education and Research Foundation offers scholarships to medical students in U.S. medical schools with mentorship by an IDSA member or fellow. IDSA members and fellows are encouraged to identify and solicit interested students.
Each scholarship recipient will receive $2,000: $1,500 to be disbursed in the spring, with the remaining $500 awarded at the conclusion of the project and submission of a final report to IDSA. All applications for 2015 scholarships must be submitted by close of business (5 pm) Monday, February 2, 2015. For more information, see http://www.idsociety.org/Medical_Scholars_Program/.The Medical Scholars Program is supported by member donations to the IDSA Education and Research Foundation. Donate today to help support this valuable program.