IDSA News - May 1, 2008
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FDA Lowers Vancomycin Breakpoints for Staph Infections

The Food and Drug Administration (FDA) has lowered the breakpoints for vancomycin in the treatment of Staphylococcus aureus to reflect growing rates of resistance, and in response to urging from IDSA and others. 

The Food and Drug Administration (FDA) has lowered the breakpoints for vancomycin in the treatment of Staphylococcus aureus to reflect growing rates of resistance, and in response to urging from IDSA and others. 

According to a recently updated package insert for Baxter Healthcare Corporation’s vancomycin injection in GALAXY plastic containers, the susceptibility test interpretive criteria for S. aureus have been changed as follows:

 

Minimum Inhibitory Concentration (MIC) (µg/mL)

 

Susceptible (S)

Intermediate (I)

Resistant (R)

Updated

≤2

4-8

≥16

Previous

≤4

8-16

≥32

The breakpoints for other infections remain unchanged. 

(Note: see "High-Dose Vancomycin May Lead to Nephrotoxicity" in this issue's IDSA Literature Review.)

Clinicians are encouraged to make sure that clinical microbiology laboratories with which they are associated are using the revised vancomycin susceptibility breakpoints for S. aureus.  

The change follows mounting evidence that patients infected with S. aureus strains with MIC of 4 µg/mL were failing therapy.  Robert C. Moellering, Jr., MD, FIDSA, past president of IDSA, and Fred C. Tenover, PhD, FIDSA, published a “Viewpoints” article in the May 1, 2007 issue of Clinical Infectious Diseases detailing the rationale for lowering the breakpoints. The article was based on data Dr. Tenover had collected and presented to the Clinical and Laboratory Standards Institute (CLSI), which updated its breakpoints last year and submitted a “Citizens’ Petition” to FDA advising the agency to do the same. 

For years, IDSA has been urging FDA to update breakpoints for key antimicrobials and backed legislation passed last fall requiring the agency to do so. This is the second time in recent months that FDA has updated breakpoints for a major antibiotic and suggests a new willingness on the part of the agency to modify these important benchmarks. 

In related news, see the article in this issue of IDSA News on the recent FDA meeting to hear testimony on other key antimicrobial issues.

WHO Reports Progress on Dracunculiasis Eradication

The end is in sight for the global campaign to eradicate dracunculiasis (guinea-worm disease), but daunting challenges still remain in endemic areas of Mali and Sudan, according to the World Health Organization. 

The end is in sight for the global campaign to eradicate dracunculiasis (guinea-worm disease), but daunting challenges still remain in endemic areas of Mali and Sudan, according to the World Health Organization. 

During 2007, the campaign was successful in reducing the number of overall cases by 62 percent—from 25,217 in 2006 to 9,585 in 2007. Transmission of the disease was halted in four of the nine countries where it remains endemic (Burkina Faso, Cote d’Ivoire, Ethiopia, and Togo), with all four countries reporting 0 indigenous cases throughout 2007.

The 2007 figures represent a 99 percent reduction in cases since 1989, when 892,055 cases were reported. That was the year that most endemic countries began to report monthly from village-based surveillance systems. The number of villages reporting endemic transmission dropped from a peak of 23,735 in 1991 to 2,016 in 2007—a 92 percent reduction.

Insecurity in Mali and Sudan poses a challenge to eradication. In addition, both countries are remote, poor, and devoid of infrastructure. Residents are nomadic, moving seasonally with their cattle in pursuit of water and pasture, making it difficult to determine where and when transmission is occurring. The peak transmission season coincides with the rainy season, which impedes travel by health workers.

An analysis of the epidemiological situation is featured in WHO’s Weekly Epidemiological Record, No. 18, 2 May 2008.

IDSA Literature Review - April 2008

In this new feature, a panel of IDSA members identifies and critiques important new infectious diseases studies in the current literature that have a significant impact on the practice of infectious diseases medicine.

In this new feature, a panel of IDSA members identifies and critiques important new infectious diseases studies in the current literature that have a significant impact on the practice of infectious diseases medicine.

For more from Clinical Infectious Diseases and The Journal of Infectious Diseases, see the "In the IDSA Journals" section of IDSA News.



High-Dose Vancomycin May Lead to Nephrotoxicity 

Sara E. Cosgrove, MD, MS

High doses of vancomycin may be associated with increased risk of nephrotoxicity, according to a study in the April issue of Antimicrobial Agents and Chemotherapy.  

Lodise et al. compared 26 adults who received  4 grams of vancomycin or more daily to 220 who received less than 4 grams and to 45 who received linezolid.  Vancomycin dose  of 4 grams per day or more was an independent predictor of time to nephrotoxicity. Total body weight of 101.4 kg or more, estimated creatinine clearance of  86.6 mL/min or less, and ICU admission also predicted nephrotoxicity. 

This was a retrospective, non-randomized study in which bias may be introduced by patient factors that lead clinicians to choose higher doses of vancomycin that may also be associated with increased risk of nephrotoxicity. Nevertheless, the results suggest that clinicians should monitor patients carefully when using high doses of vancomycin, particularly patients with risk factors for renal dysfunction or on concomitant nephrotoxic agents. (Lodise et al., Antimicrob Agents Chemother. 2008;52:1330-6.)

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Antibiotics May Prevent Catheter-related Bloodstream Infections—But Use Caution 

Sara E. Cosgrove, MD, MS 

Both topical and intraluminal antibiotics helped prevent catheter-related bloodstream infection (CR-BSI) among hemodialysis patients in a meta-analysis published in the April 15 issue of Annals of Internal Medicine, but it may be too soon to consider changing practice. 

Mupirocin or polysporin triple-antibiotic ointment at the catheter insertion site decreased CR-BSI, Staphylococcus aureus bacteremia, and exit site infections compared to no ointment in three pooled studies.  Use of intraluminal antibiotics (or “antibiotic lock therapy”), in which antibiotic solutions are placed in the lumen of the catheter between dialysis sessions, decreased CR-BSI but not S. aureus bacteremia or exit site infections compared to no antibiotics in 11 pooled studies; gentamicin was the most commonly studied agent. 

However, some additional factors should be considered before changing practice in this area.  First, several of the studies included in the meta-analysis were small and unblinded, and use of meta-analysis cannot compensate for flaws in individual studies.  Second, rates of emergence of resistance—always a serious concern—were not evaluated.  Non-antimicrobial alternatives are available, such as povidone-iodine antiseptic at exit sites, which is recommended in the current IDSA guidelines for prevention of catheter-related infections.  At this point, use of topical and intraluminal antibiotics should likely be reserved for patients with recurrent CR-BSIs who have limited options for vascular access.  (James et al., Ann Intern Med. 2008;148:596-605.)

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Resistant Pneumococci Decline with Reduced Antibiotic Use 

Melinda M. Pettigrew, PhD

Rapid seasonal declines in otitis media caused by antibiotic-resistant Streptococcus pneumoniae occurred concomitant with seasonal reductions in antibiotic prescriptions among Jewish children in southern Israel in a study in the April 15 issue of The Journal of Infectious Diseases. Authors Dagan et al. did not observe the same seasonal decline in resistant strep among Bedouin children in the same region, among whom antibiotic prescription patterns are less seasonal. 

Several studies have linked high levels of antibiotic use with high levels of antibiotic resistance. This study is particularly noteworthy because few have demonstrated that reductions in antibiotic prescriptions rapidly result in lower levels of antibiotic resistance in the community. 

It may be that prescriptions to the Jewish children were reduced to a critical threshold needed to achieve a significant reduction in resistance. Further studies are needed to define this threshold. More research is also needed to evaluate whether these data are generalizable to populations outside of Israel and whether reductions in antibiotic prescriptions will similarly impact resistance in other bacteria species. (Dagan et al., J Infect Dis. 2008;197:1094-1102.)

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Meta-analysis Confirms Need for Droplet Precautions until Influenza Symptoms Resolve 

Khalil G. Ghanem, MD

A new meta-analysis of duration of influenza virus shedding and symptoms confirms conventional wisdom and has implications for infection control. The study of 56 influenza virus challenge studies in 1,280 healthy human volunteers is published in the April 1 issue of the American Journal of Epidemiology.

Overall, virus shedding was detected one day after inoculation and persisted for a total of 4.8 days. Shedding was found to be lower among persons infected with influenza B as compared to influenza A. Approximately 70 percent of volunteers developed symptoms: 58.8 percent developed upper respiratory symptoms, 21 percent developed lower respiratory symptoms, and 34.9 percent developed a fever. Symptoms peaked by day two or three, and returned to baseline by day 10. Viral shedding began approximately 10 to 12 hours before the onset of symptoms and decreased in parallel to the symptom scores. 

This study confirms prior opinion on the duration of viral shedding and the frequency of symptoms in influenza infection. It also highlights the importance of using droplet precautions until symptoms abate in hospitalized patients suspected or diagnosed with influenza infection. 

There are several limitations to note. Viral dynamics may be different in more debilitated hosts. Viruses used in these experiments may have been less pathogenic than wild-type viruses. Also, most of the volunteers had low pre-existing immunity to these viruses. (Carrat et al., Am J Epidemiol. 2008;167:775-85.)

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Brazil Has Large Dengue Fever Outbreak

Brazil is experiencing a large outbreak of dengue fever this year. As of March 28, health authorities have reported at least 120,570 cases, including 647 cases of dengue hemorrhagic fever (DHF) and 48 deaths. As of April 10, Rio de Janeiro has had 75,399 cases of dengue fever, including 80 confirmed deaths. The Ministry of Health is working with the state government and armed forces in a crisis office. The U.S. Centers for Disease Control and Prevention is advising travelers to Brazil to take appropriate precautions to protect themselves from mosquito bites.  See http://wwwn.cdc.gov/travel/contentDengueTropicalSubTropical.aspx.

For information on reporting dengue cases and shipping specimens, see http://www.cdc.gov/ncidod/dvbid/dengue/dengue-hcp.htm.

Malaria Reported in Bahamas

The U.S. Centers for Disease Control and Prevention (CDC) has received a report of a confirmed case of malaria in a person who traveled to Great Exuma, Bahamas, in March. The person had not recently traveled to any other country. Great Exuma had two recent prior outbreaks of chloroquine-sensitive Plasmodium falciparum malaria occurring in travelers, one in May 2006 and another in August 2007. There is currently no known risk of malaria on the other islands of the Bahamas. CDC is recommending that travelers to Great Exuma take chloroquine prophylaxis and use other measures to prevent mosquito bites. See http://wwwn.cdc.gov/travel/contentMalariaBahamas07.aspx.

Polio Eradication Update: Cases Down Overall, But Type 3 Cases Up

The total number of polio cases worldwide declined by 34 percent last year, from 1,997 cases in 2006 to 1,310 in 2007, according to the May 9 Morbidity and Mortality Weekly Report. The international eradication program’s focus on the more-virulent type 1 virus (WPV) has paid off, but type 3 (WPV3) experienced a significant upsurge. 

India had the most total cases in 2007, with 870. Increased use of monovalent type 1 vaccine led to a dramatic 87 percent decline in WPV1 cases, from 646 in 2006 to 83 in 2007. Transmission of this strain may be interrupted in 2008. On the other hand, an outbreak of WPV3 drove the number of WPV3 cases up from just 28 in 2006 to 787 last year. 

Nigeria cut its total case count from 1122 in 2006 to 285 last year. WPV1 cases were down 86 percent and WPV3 cases were down 39 percent. However, there has been a worrying increase in WPV1 cases so far this year. Problems with the quality of vaccination campaigns have been reported, and large numbers of children still go unvaccinated.

Cases in the other two endemic countries, Pakistan and Afghanistan, also declined slightly last year, as reported in last month’s IDSA News.

Polio cases continued to crop up in six of the 13 formerly polio-free countries that had imported WPV cases in 2006. In addition, Burma (11 cases) and Sudan (one case) had their first outbreaks in several years.  

Widespread use of monovalent type 1 vaccine will continue, and efforts to improve campaign quality are ongoing.

Rift Valley Fever Outbreak in Madagascar

Madagascar has reported an outbreak of Rift Valley Fever, with 418 suspected cases as of mid-April, including 17 deaths (for a case-fatality rate of 4 percent). The cases come from the regions of Alaotra Mangoro, Analamanga, Anosy, Itasy, and Vakinakaratra. According to the Pasteur Institute in Madagascar and the World Health Organization, there have been 59 laboratory-confirmed human cases. Animal cases have also been reported. Control measures have included case management, surveillance, social mobilization, providing medicines, prevention, and strengthening measures to control nosocomial infection. Information on Rift Valley fever—including clinical features, diagnosis, treatment, prevention, and control—is available at http://www.who.int/mediacentre/factsheets/fs207/en/.

Vietnam Reports Cholera Outbreak

Vietnam reported nearly 2,500 cases of severe acute watery diarrhea between March 5 and April 22, including 377 cases positive for Vibrio cholerae, the bacterium that causes cholera. The serotype has been identified as 01 Ogawa. There have been no reported deaths, which the World Health Organization says indicates good case management. The outbreak has affected 20 Vietnamese provinces and municipalities, particularly Hanoi. The predominant route of infection appears to be contaminated food; bacteria have not been found in drinking water but have been found in some surface water. Additional investigations are underway, as is a public health education campaign. Neither WHO nor the U.S. Centers for Disease Control and Prevention recommends restrictions on travel. A WHO fact sheet on cholera is available at http://www.who.int/mediacentre/factsheets/fs107/en/index.html. Information for travelers is available at http://www.who.int/topics/cholera/faq/en/index.html.

Yellow Fever Reported in Liberia, Argentina

Two confirmed cases of yellow fever, including one death, have been reported in Liberia as of April 25. Both cases were in Zuotuo, in Tappita district. Liberia, with technical assistance from WHO, has initiated a reactive mass vaccination campaign in Tappita that it plans to extend to neighboring districts. 

Argentina has reported five confirmed human cases and one monkey case of yellow fever in 2008, including one human death, as of March 26. The cases were all in the Misiones Province, which borders Brazil and Paraguay. Health officials in Argentina are increasing vaccination in surrounding areas and specific risk areas. Since late 2007, emerging yellow fever has been reported in monkeys and humans from many South American countries. 

The Centers for Disease Control and Prevention recommends yellow fever vaccination for travelers older than 9 months who are going to Liberia, affected parts of Argentina, and other countries. See http://wwwn.cdc.gov/travel/default.aspx.

Cefixime Available Again in the United States

Cefixime 400 mg tablets, currently the only oral treatment for uncomplicated urogenital or rectal Neissesria gonorrhoea recommended by the Centers for Disease Control and Prevention (CDC), is again available in the United States, from Lupin Pharmaceuticals. Information about obtaining cefixime tablets is available by calling Lupin at (866) 587-4617.  Special pricing is available for qualifying public health centers.

The drug was previously manufactured by Wyeth Pharmaceuticals. Production was discontinued in July 2002.

Another cephalosporin, ceftriaxone, available in injection form only, is the CDC recommended treatment for all types of gonorrhea infections.  Treatment guidelines and additional information can be found at http://www.cdc.gov/std/treatment.

Drug Approvals, Recalls, Adverse Events Update

IDSA offers two e-mail services to help members stay informed of updates from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Recent alerts have included:

IDSA members can sign up for this service online. (You must be logged in to have access to this link.)

In the IDSA Journals

New Studies on When to Start ART Suggest Earlier is Better 

Two new studies in the April 15 issue of The Journal of Infectious Diseases provide new insights on the risk-benefit calculation of when to start antiretroviral therapy (ART). In one study, patients who initiated or restarted ART below 250 CD4+ cells/mL were more than four times as likely to die or experience opportunistic diseases or serious non-AIDS events than those who started at or above 350 cells/mL. (The Strategies for Management of Antiretroviral Therapy (SMART) Study Group, J Infect Dis. 2008;197:1133-1144; editorial commentary by Hughes and Ribaudo, J Infect Dis. 2008;197:1084-1086.)

An accompanying study by the same group showed that the risks of opportunistic disease and death were higher the longer virus replication went unchecked, even among those with higher CD4+ cell counts. (SMART Study Group, J Infect Dis 2008;197:1145–1155.) The authors said their new results should be verified in a larger randomized trial on when to start therapy.

Varicella Vaccination May Require Second Dose 

Outbreaks of chickenpox among vaccinated children may be the result of lower-than-expected vaccine effectiveness. Of 148 healthy children receiving one dose of varicella vaccine at a median age of 12.5 months, one in four had no detectable antibodies an average of four months later. This is significantly lower than the 86 percent to 96 percent seroconversion rate reported in other studies. These results support the recent recommendation by the Centers for Disease Control that a second dose of varicella vaccine be routinely given to all children.. (Michalik et al., J Infect Dis. 2008;197:944-949; editorial commentary by Shapiro, J Infect Dis. 2008;197:935-937.)

Pneumococcal vaccine in the elderly population

The authors of this study compared the immunogenicity and safety of 7-valent conjugate vaccine (7vPnC) with that of the polysaccharide vaccine (PPV) in elderly adults who had not been previously vaccinated. One year after the initial vaccination, 7vPnC recipients received a booster dose of either PPV or 7vPnC, whereas PPV recipients received a booster dose of 7vPnC. An initial dose of 7vPnC was found to elicit higher and potentially more effective levels of antibodies, compared with an initial dose of PPV, and antibody titers were maintained through subsequent administration of either 7vPnC or PPV. (de Roux et al., Clin Infect Dis. 2008;46:1015-1023.) 

Clarithromycin for the therapy of ventilator-associated pneumonia (VAP) and sepsis  

Patients with sepsis and VAP were given clarithromycin (1 g) or placebo daily for 3 days, and their outcomes were compared in a randomized trial. The median time required for resolution of VAP was 10 days for clarithromycin-treated patients and 15.5 days for placebo-treated patients, whereas the median time required for weaning from mechanical ventilation was 16 and 22.5 days, respectively. Among the patients who died due to sepsis, time to death was significantly prolonged in clarithromycin-treated subjects. These results suggest a benefit associated with the adjunctive use of clarithromycin for patients with VAP and sepsis. (Giamarellos-Bourboulis et al., Clin Infect Dis. 2008;46:1157-1164.)

Outcome of prosthetic joint infection

The extent of adherence to recently recommended treatment modalities for prosthetic joint infection was analyzed in a group of 68 patients at a Swiss hospital. The chosen surgical strategy was in agreement with the recommendations in 88% of the cases, and the antimicrobial regimen was in agreement with the recommendations in 84%. The risk of treatment failure was significantly higher for patients in whom the surgical strategy or antibiotic treatment did not correspond with the recommendations. (Betsch et al., Clin Infect Dis. 2008;46:1221-1226.)

More from the literature…

Don’t miss a new feature to help you stay up to date on the infectious diseases literature: Each month, IDSA News will feature brief summaries of key infectious diseases studies in the previous month’s major journals chosen by the new IDSA Literature Review Panel. [[LINK]]

In addition, the “In This Issue” section of each issue of Clinical Infectious Diseases highlights several important studies from that journal. (Click for May 1 or May 15.)

For a review of other recent research in the infectious diseases literature, see “In the Literature,” by Stanley Deresinski, MD, in each issue of Clinical Infectious Diseases.

May 1

  • Syphilis: Old and New World
  • The Risk of Stroke Decreases Rapidly after the Initiation of Effective Antibiotic Therapy for Endocarditis
  • High-Dose Isoniazid (INH) for Multidrug-Resistant Tuberculosis (MDR-TB)
  • The Genetic Basis of Job's Syndrome  

May 15

  • Is It Time for Vancomycin in Surgical Prophylaxis?
  • Do Serum Concentrations of Antituberculous Drugs Matter?
  • Tuberculosis in the United States: Down, but Definitely Not Out

From the President

Moving On After the Lyme Investigation

The IDSA leadership, staff, and I are extremely grateful for the words of encouragement members sent us following the announcement of our agreement with the Connecticut state attorney general regarding our Lyme disease guidelines. The most important reason why IDSA entered the agreement ending the antitrust investigation is that we believe it is in the best interest of our patients, the Society, and evidence-based medicine to ensure that the proper treatment of Lyme disease remains a medical issue and not a legal one. The support from members has been heartening. (For more information on the agreement, our press release is online.) 

We have always found puzzling the attorney general’s charges that the guidelines panel had conflicts of interest, because no infectious diseases physician had anything to gain from recommending against long-term antibiotic therapy—the central issue in this controversy. The guidelines recommend against this treatment because it provides no demonstrated benefit yet carries significant risks. However, we write our guidelines to advise clinicians, not to dictate to them. Nothing substitutes for a clinician’s judgment. The real issue for proponents of this unproven treatment is that many insurance companies will not cover it. What the insurance companies will cover is up to them, not us.

The attorney general also claimed that the panel excluded competing viewpoints, but this simply is not the case. The panel considered evidence presented by proponents of “chronic” Lyme disease and long-term antibiotic therapy and weighed it alongside all the other evidence. We have complete confidence in the panel’s conclusions. We hope that the additional review of the guidelines set forth in the agreement will demonstrate to our critics that our recommendations are sound.

I would like to extend my sincere thanks to the panel members for their steadfast dedication throughout the investigation, and especially to panel chair Gary Wormser, MD, FIDSA, and Eugene Shaprio, MD, FIDSA, who as IDSA’s leading experts on Lyme disease have borne the brunt from very early on. Thanks also to Standards and Practice Guidelines Committee Chair Thomas File, MD, FIDSA, for his wise counsel during the negotiation of the agreement.

The next step will be to convene the review panel. IDSA will be looking for open-minded individuals versed in evidence-based medicine to examine the data and recommend whether any changes to the guidelines are necessary. Your participation will be crucial. A request for panel applicants will be arriving by e-mail soon.

The distractions of the Lyme disease investigation have not kept IDSA from moving forward on issues of the utmost importance to our members and our patients. We continue developing guidelines that provide clinicians with the best recommendations that medical science has to offer their patients. This year, the Society took the reins of the Seasonal and Pandemic Influenza meeting after two years as co-sponsor. This forum brought together the world’s top leadership in research, clinical care, industry, and government for an update and to exchange ideas. And our “Bad Bugs, No Drugs” advocacy campaign continues, highlighting the rising threat of antimicrobial resistance and the shortage of new drugs.

In a major development on this front, we are pleased to report that, following years of steady prodding from the Society and its members, the Food and Drug Administration (FDA) is at last updating breakpoints for some clinically important antibiotics. This month, FDA lowered the breakpoints for vancomycin for use against Staphylococcus aureus, an increasingly resistant organism. Last month, FDA raised the breakpoints for penicillin for use against pneumonia caused by Streptococcus pneumoniae, which in this setting still responds well to this safe and effective drug.

In another encouraging sign, FDA held a meeting last month to hear testimony on how to move forward with other key issues in antimicrobial resistance. The agency has been stalled on these issues for years. IDSA was a leading voice at the meeting and submitted a comprehensive plan of action.

After spending nearly two years and nearly half a million dollars responding to the Lyme disease guidelines investigation, IDSA is happy to be closing this chapter and moving on. We thank you again for your support and look forward to your input on the review panel. And we pledge to continue to serve as leaders across the entire field of infectious diseases.

IDSA Endorses Two Vaccine Financing Bills

IDSA recently endorsed two critical bills addressing vaccine financing sponsored by a leading legislator on health issues

The Vaccines for Children Access Act of 2008 (H.R. 4990) would expand the category of children and adolescents who are eligible for the Vaccines for Children (VFC) program to include the under-insured who are vaccinated at any public health clinic.  The VFC program is federally funded and provides vaccines to all eligible children, through the age of 18, who might not otherwise be able to afford them.

The Vaccines for the Uninsured Adult Act of 2008 (H.R. 4993) would establish a Vaccines for Uninsured Adults Program (VFUA), providing routinely recommended vaccines to eligible adults, and would be modeled on the successful VFC program. 

On a related front, at a recent meeting of the National Vaccine Advisory Committee (NVAC), IDSA urged the Committee to recommend expanding VFC eligibility and also to support adding an administration fee so that health care providers are adequately reimbursed for vaccinating children and adolescents. 
NVAC provides recommendations for vaccine policy to the Department of Health and Human Services.

Both pieces of legislation were sponsored by Rep. Henry Waxman (D-CA).   IDSA’s letter of support to Rep. Waxman is available online.

IDSA Urges FDA to Dedicate Resources to Antimicrobial Resistance

IDSA presented testimony to a US Food and Drug Administration (FDA) panel on April 28 to address the increasingly troublesome issue of antimicrobial resistance.  FDA’s hearing is a promising sign that the agency is moving forward to address antimicrobial policy issues after years of delays.

In their testimony, John G. Bartlett, MD, FIDSA, chair of IDSA’s Antimicrobial Availability Task Force, Neil Fishman, MD, chair of the Society’s Antimicrobial Resistance Work Group, and Robert Guidos, IDSA’s director of public policy and government relations, warned of a potential impending health crisis due to decreases in research and development, impediments and uncertainty in FDA’s antibacterial drug review process, and the lack of federal funding and attention paid to this important medical/public health problem.  They set forth numerous recommendations aimed at reducing the impact of antimicrobial resistance on the public and galvanizing the development of new products to address the increase in antibacterial resistant infections.

The Society called for reestablishing consistency, predictability, and timeliness in FDA’s antibacterial drug review process while providing economic and other incentives to spur the development of new antibacterial products.  IDSA called upon FDA to commission a study to determine which incentives might work best. 

IDSA also supports the creation of a strategic research plan for antimicrobial resistance to establish priorities and strengthen collaborations between FDA, the National Institutes of Health, the Centers for Disease Control and Prevention, the Departments of Agriculture, Veteran Affairs, and Defense, and the Environmental Protection Administration. IDSA also proposes improving data collection on clinical, veterinary, and human antibacterial use.

Improving surveillance efforts to detect and monitor the emergence of resistance is especially crucial given the diminishing numbers of antibacterial drugs, IDSA leaders said.

Other solutions proposed by the Society include educating physicians and patients about the appropriate use of antibacterial drugs and preventing antibiotics of critical consequence to human health from being used in agriculture, as well as developing better options for antibacterial drug use in animals and agriculture. 

In December 2000, FDA’s Task Force on Antimicrobial Resistance issued a report containing priority recommendations the agency was to implement to address the antimicrobial resistance and pipeline problems.  Few of these recommendations have been implemented to date.  Such past inaction on FDA’s part has raised questions about the agency’s commitment to address the brewing antimicrobial resistance crisis—a problem that infectious diseases physicians believe should be a significant priority of the U.S. government.

"IDSA leaders hope that the hearing signals a turning point in FDA’s level of commitment and a demonstration of agency leaders’ desire to tackle these critical patient safety and public health problems," Guidos said.  "To confirm this, FDA should act immediately to dedicate the resources and staff time necessary to implement the recommendations of its own task force as well as the recommendations that IDSA has proposed."

Members on the Move

Larry J. Martinelli, MD, FIDSA, was selected in April to serve a two-year term on the American Medical Association’s (AMA) Relative Value Update Committee (RUC) after several years of participating in the RUC process including the Five-Year Review of evaluation and management codes. The RUC is an expert panel which develops relative value recommendations to the Centers for Medicare and Medicaid Services (CMS).  Dr. Martinelli is currently chair of IDSA’s Clinical Affairs Committee and an ID practitioner in Lubbock, Texas.

Welcome, New IDSA Members!

Members

Baiden, Frank, MD
Burkholder, Greer, MD
Burnett , Mark, MD
Castillo-Londono, Juan, MD
Corales, Roberto, DO
Girgenti, Douglas, MD
Gomez Quintero, Carlos, MD
Gurtman, Alejandra, MD
Herbener, Amy, MD
Hoyos, Alvaro, MD
Leal, Aura, MD
Linas, Benjamin, MD
Marino , Ana, MD
Mendoza Ramirez, Henry, MD
Namias, Nicholas, MD, MBA
Onate, Jose, MD
Osorio-Pinton, Johanna, MD
Raper, James, PhD, NP
Sharma, Tanvi, MD

Associate

Andes, Rebecca, FNP
Bagarazzi, Mark, MD
Cruz-Lopez, Sydia, MD
De Oliveira Misiara, Antonio Carlos, MD
Devi, Uma, MD
Hasan, Syed, MD
Jarvis, Michael 
Keruly, Jeanne , MS
Khasawneh, Faisal, RPh
Kile, Jarrod 
McCoy, Nicoe, PharmD
Rice, Dennis, PharmD
Rivard, Mimi, NP, MSN
Rooney, Erin 
Shiloh, Micheal, MD, PhD
Sousa, Ana, MD, PhD

Members-In-Training

Bonilla, Luis, MD
Gomez Rincon, Julio, MD
Narvaez, Alvaro, MD
Jenh, Alice, PharmD
Kim, Young, MD
Naba, Mazen, MD
Ornstein, Bradley, MD
Bar, Katharine, MD
Tapia Zegarra, Gino, MD
Daniel, Santhosh, MD
Khan, Raymond, DO
Raygada, Jose, MD
Tilley, Drake, MD
Odero, Randy, MD
Kirk, Jason, MD
Buchupalli, Deepika, MD
Santana-Lopez, Carmelo, MD
Qamar, Farah, DCh
Ketsela, Gizatchew, MD
Rodriguez, Marcela, MD