In a new article appearing in the forthcoming issuue of the Journal of Medical Entomology called “What Do We Need to Know About Disease Ecology to Prevent Lyme Disease in the Northeastern United States?” authors from Colorado State University and the Centers for Disease Control assess the potential reasons for the continued lack of success in prevention and control of Lyme disease in the northeastern United States, and they identify conceptual areas where additional knowledge could be used to improve Lyme disease prevention and control strategies.

Some of these areas include: 1) identifying critical host infestation rates required to maintain enzootic transmission of B. burgdorferi, 2) understanding how habitat diversity and forest fragmentation impacts acarological risk of exposure to B. burgdorferi and the ability of interventions to reduce risk, 3) quantifying the epidemiological outcomes of interventions focusing on ticks or vertebrate reservoirs, and 4) refining knowledge of how human behavior influences Lyme disease risk and identifying barriers to the adoption of personal protective measures and environmental tick management.

The article briefly summarizes existing prevention and control strategies and tools aimed at reducing human exposure to vector ticks and B. burgdorferi, and highlights conceptual areas where additional studies on the enzootic transmission cycle or the human-tick interface are needed to fill in the knowledge gaps preventing the development of novel, more effective Lyme disease prevention strategies and tools or the implementation of existing ones.

Because the likelihood of human exposure to the tick and the pathogen both can be influenced by human behavior, the authors focus not only on the density of infected ticks, which represents the fundamental (or acarological) risk of human exposure to B. burgdorferi, but they also provide an overview of studies that identify behavioral risk factors and explore areas where additional information in this field are needed.

FDA’s action will provide surgeons with a minimally-invasive option for repair of aortic endografts (endovascular grafts) that are not properly positioned. Aortic aneurysms can, over time, become weak and result in a life-threatening rupture. The endograft is placed inside the aorta to seal off the aneurysm and direct blood away from it.

The Aptus EndoStapling System is a cassette of nickel-cobalt corkscrew-shaped staples that is loaded into a long, thin, tube-like delivery catheter. The catheter is inserted into an artery in the leg and directed through the arteries to the failed endograft. Using a controller on the handle of the catheter, the surgeon applies one staple at a time around the top edge of the endograft to anchor the device and repair the endograft-artery seal.

“Leakage between the top end of the endograft and the aorta wall is a known complication of endograft implants that can be successfully treated,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The Aptus EndoStapling System provides a less invasive option than open surgery to access and repair these leaks.”

The FDA reviewed data for the Aptus EndoStapling System through the de novo reclassification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not comparable to an already legally marketed device.

FDA granted the de novo petition for the EndoStapling System based on review of data from 154 patients who were implanted with 810 EndoStaples. Patients were monitored with routine followup CT scans. After a year, none of the EndoStaples had fractured and no patients experienced endograft movement (migration); one subject needed an additional intervention to address an endoleak.

The Aptus EndoStapling System is for use in patients whose endovascular grafts have moved, exhibit endoleaks, or are at risk for these complications and additional intervention is needed to reattach the graft and seal off the aneurysm.

The Aptus EndoStapling System is manufactured by Aptus Endosystems Inc. of Sunnyvale, Calif.

“Many inconsistent concerns have been voiced about the safety of long-term use of antibiotics,” the authors write as background information in the study. “Because of the high prevalence of acne and the frequent use of antibiotics to control acne, individuals undergoing therapy to treat their acne are an ideal group in which to study the effects of long-term antibiotic use.”

David J. Margolis, M.D., Ph.D., and colleagues with the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, conducted two concurrent studies (a cross-sectional study and a longitudinal study) to examine the association between antibiotics used to treat acne and pharyngitis. The authors also examined the association between oral antibiotics and colonization rates of group A streptococcus (GAS; form bacteria responsible for most cases of streptococcal illness) as previous research has shown a link between oral antibiotics and higher rates of GAS. Participants in both studies included college students, who were asked to fill out a self-administered survey form, were swabbed for culture and had a visual examination for acne.

In the cross-sectional study, the authors found that 10 of 15 students receiving oral antibiotics for acne reported an episode of pharyngitis in the past 30 days, and 47 of 130 students not receiving oral antibiotics, but who had acne, reported an episode of pharyngitis in the previous month. Combining all 251 students not receiving oral antibiotics, 82 (32.7 percent) reported an episode of pharyngitis in the previous 30 days. Three of 145 students with acne (2.1 percent) were found to be colonized with GAS, however none of the three was receiving oral antibiotics.

The longitudinal study included 358 female and 218 male participants; 36 (6.2 percent) received oral antibiotics for acne during the study and 96 (16.6 percent) received topical antibiotics for acne. The authors found that the use of oral antibiotics was strongly associated with a health care evaluation for pharyngitis. Of students receiving oral antibiotic treatment, 11.3 percent reported pharyngitis. Conversely, pharyngitis was reported by 3.3 percent of students not receiving oral antibiotics. Additionally, no association with pharyngitis was noted for those who used a topical antibiotic for acne, and the authors found that less than 1 percent of participants were colonized by GAS, indicating that it is not associated with pharyngitis.

“Our studies show that the odds of developing self-reported pharyngitis is more than three times baseline in patients receiving oral antibiotics for acne vs. the odds for those who are not receiving oral antibiotics,” the authors conclude. “The true clinical importance of these findings needs to be evaluated further by prospective studies.”

“Anecdotally, many researchers have observed that HDL levels may be lower in states of inflammation, such as rheumatoid arthritis, psoriasis and even obesity,” said lead study author Nehal Mehta, MD, MSCE, director of Inflammatory Risk in Preventive Cardiology at Penn. “However, these new findings suggest that in addition to lower levels, chronic inflammation associated with conditions like psoriasis may change the composition and decrease the function of HDL as well.”

In the current studies, researchers enrolled 78 patients with psoriasis and 84 control subjects. In the first study, the authors measured fasting lipid levels and examined the number and size of cholesterol particles using nuclear magnetic resonance (NMR) spectroscopy. This analysis revealed that patients with psoriasis had a higher number of smaller LDL particles, or “bad” cholesterol, which was independent of traditional risk factors and obesity. “It was striking that the NMR profiles from patients with psoriasis resembled those seen in patients with diabetes, and that these patients with psoriasis had otherwise normal traditional lipid panels” Dr. Mehta added.

In the second study, the researchers measured HDL efflux, which is the ability of a patient’s HDL to remove cholesterol from cells involved in atherosclerosis. This process, known as ‘reverse cholesterol transport’, is why HDL may have protective properties. In a previous study, researchers at Penn have demonstrated that measuring HDL efflux capacity may be a more effective barometer of protection from heart disease than measuring HDL levels alone.

In this same group of patients who had normal cholesterol levels compared to controls, patients with psoriasis demonstrated dramatically reduced HDL efflux capacity compared to control patients. This negative association observed between psoriasis and HDL efflux persisted after adjusting for traditional lipid levels and other traditional risk factors, including body mass index (BMI).

“Patients with psoriasis had an approximate 25 percent reduction in the HDL efflux capacity than the controls, despite their relatively normal overall lipid profiles which leads to the question of whether function is more important than concentration in chronic inflammatory states” Dr. Mehta noted.

The new findings may provide a critical clue to the link between psoriasis and heart disease, but the researchers say larger studies are needed to validate their findings. Joel M. Gefland, MD, MSCE, assistant professor of Dermatology and Epidemiology, and a senior author on the studies, said “We’ve been able to show that psoriasis is an important risk factor for vascular disease, and now we may finally be able to identify and ultimately treat the pathways by which psoriasis increases these risks.”

Even relatively common blood disorders fly below the public health system’s radar with no established mechanisms for surveillance, supplement editors Scott D. Grosse, PhD, of the US Centers for Disease Control and Prevention (CDC); Andra H. James, MD, of Duke University; and Michele A. Lloyd-Puryear, MD, PhD, of the US National Institutes of Health, write in an introductory essay with Hani K. Atrash, MD, MPH, also of the CDC.

The authors contend that although most of the blood disorders discussed in the supplement are considered rare in the US and Western Europe—defined as affecting about 1 in 1,500 people—they should be ranked as a public health concern. “A public health framework is needed to address public health services and functions for all rare disorders, including blood disorders, regardless of the incidence or prevalence of a given disorder,” they say.

The most common blood disorder, venous thromboembolism (VTE), consists of deep vein thrombosis and pulmonary embolism. It involves blood clots that occur in veins, usually in the legs, which can break up and move to the lungs and kill. VTE affects at least 1 million people in the US and is a major cause of death in adults, but “little is definitively known about the magnitude of [its] public health burden.”

Hereditary hemochromatosis is a genetic disorder present in about 1 million Americans but “the opportunity to detect iron overload at an early stage and intervene … to prevent the development of clinical disease … remains a challenge,” they add. And while at least 3 million Americans have sickle cell trait or are carriers of the sickle cell gene mutation, “the extent to which the carrier status poses health threats is not well established.”

The supplement, comprised of 13 research papers and five workshop/meeting summaries, is authored by top medical educators and public health professionals. Its publication was supported by the CDC through a cooperative agreement with the Association for Prevention Teaching and Research.

Two papers focus on sickle cell trait screening policy in college athletes and military recruits, while seven address hemophilia and bleeding disorders, the most common of which are hemophilia A and B, and the hemoglobinopathies—sickle cell disease and thalassemia.

Grosse and his colleagues propose a public health framework to address such often-overlooked conditions. The framework is similar to the 10 essential public health services but focuses on rare disorders rather than common exposures or common health problems. The framework calls for public health officials to:

Assess the prevalence/incidence of specific rare disorders;

Monitor the health status and health-related quality of life of people with rare disorders and their families;

Quantify the impacts of rare disorders on disability, mortality, and healthcare system use, particularly hospital-based care;

Conduct research to identify preventable causes of health problems among people with rare disorders, including barriers to the consistent use of effective prophylaxis and treatment;

Establish systems for early and continuous screening where appropriate;

Educate and empower people with rare disorders along with their family members and primary care providers;

Ensure access to cost-effective and affordable screening, diagnostic, primary care, and specialty health services;

Evaluate the effectiveness, accessibility, and quality of health services for people with rare disorders and

Inform program and policy decision makers about cost-effective strategies to improve health outcomes for people with rare outcomes.

“Blood disorders have a vital importance to public health and vice versa,” the authors conclude. “Whether relatively common or relatively rare, people with blood disorders have health challenges specific to their conditions that require knowledgeable healthcare providers, access to screening and diagnostic testing, and information to help them manage their conditions.”

“Overdoses involving prescription painkillers are at epidemic levels and now kill more Americans than heroin and cocaine combined, ” said CDC Director Thomas Frieden, M.D., M.P.H. “States, health insurers, health care providers and individuals have critical roles to play in the national effort to stop this epidemic of overdoses while we protect patients who need prescriptions to control pain. ”

The increased use of prescription painkillers for nonmedical reasons (without a prescription for the high they cause), along with growing sales, has contributed to the large number of overdoses and deaths. In 2010, 1 in every 20 people in the United States age 12 and older—a total of 12 million people—reported using prescription painkillers nonmedically according to the National Survey on Drug Use and Health. Based on the data from the Drug Enforcement Administration, sales of these drugs to pharmacies and health care providers have increased by more than 300 percent since 1999.

“Prescription drug abuse is a silent epidemic that is stealing thousands of lives and tearing apart communities and families across America, ” said Gil Kerlikowske, Director of National Drug Control Policy.  “From day one, we have been laser–focused on this crisis by taking a comprehensive public health and public safety approach.  All of us have a role to play. Health care providers and patients should be educated on the risks of prescription painkillers. And parents and grandparents can take time today to properly dispose of any unneeded or expired medications from the home and to talk to their kids about the misuse and abuse of prescription drugs. ”

In April, the Administration released a comprehensive action plan to address the national prescription drug abuse epidemic to reduce this public health burden.

Titled “Epidemic: Responding to America’s Prescription Drug Abuse Crisis, ” the plan includes support for the expansion of state–based prescription drug monitoring programs, more convenient and environmentally responsible disposal methods to remove unused medications from the home, education for patients and healthcare providers, and support for law enforcement efforts that reduce the prevalence of “pill mills” and doctor shopping.   

Already, 48 states have implemented state–based monitoring programs designed to reduce diversion and doctor shopping while protecting patient privacy and the Department of Justice has conducted a series of takedowns of rogue pain clinics operating as “pill mills. ”  President Obama has also signed into law the Secure and Responsible Drug Disposal Act, which will allow states and local communities to collect and safely dispose of unwanted prescription drugs and support DEA’s ongoing national efforts to collect unneeded or expired prescription drugs  which have collected over 300 tons of medications over the past year.

  “Almost 5,500 people start to misuse prescription painkillers every day, ” said Substance Abuse and Mental Health Services Administration Administrator Pamela S. Hyde.  “Just like other public health epidemics, community–based prevention can be a proven, life–saving and cost–effective key to breaking the trend and restoring health and well–being. ”

The prescription painkiller death rates among non–Hispanic whites and American Indians/Alaska Natives were three times those of blacks and Hispanic whites. In addition, the death rate was highest among persons aged 35–54 years. Overdose resulted in 830,652 years of potential life lost before age 65 years, a number comparable to the years of potential life lost from motor vehicle crashes and much higher than the years of potential life lost due to homicide.

For the analysis, CDC reviewed state data on fatal drug overdoses, nonmedical use of prescription painkillers, and sales of prescription painkillers to pharmacies and health care providers.

The study found:

• State death rates from overdoses (from 2008 data) ranged from a high of 27.0 deaths per 100,000 people in New Mexico to a low of 5.5 deaths per 100,000 people in Nebraska.
• Nonmedical use of prescription painkillers ranged from a high of 1 in 12 people aged 12 and older in Oklahoma to a low of 1 in 30 in Nebraska. States with more nonmedical use tend to have more deaths from drug overdoses.
• Prescription painkiller sales per person were more than three times higher in the highest state, Florida, than in the lowest state, Illinois. States with higher sales per person tend to have higher death rates from drug overdose.

While national strategies are being strengthened, states, as regulators of health care practice and large public insurers, can take the following steps to help prevent overdoses from prescription painkillers and reduce this public health burden:

• Start or improve prescription drug monitoring programs, which are electronic databases that track all prescriptions for painkillers in the state.
• Use prescription drug monitoring programs, public insurance programs, and workers’ compensation data to identify improper prescribing of painkillers.
• Set up programs for public insurance programs, workers’ compensation programs, and state–run health plans that identify and address improper patient use of painkillers.
• Pass, enforce and evaluate pill mill, doctor shopping and other state laws to reduce prescription painkiller abuse.
• Encourage professional state licensing boards to take action against inappropriate prescribing.
• Increase access to substance abuse treatment.

CDC is also releasing “Policy Impact: Prescription Painkiller Overdoses, ”one in a series of issue briefs highlighting key public health issues and important, science–based policy actions that can be taken to address them. Through this new publication, CDC supports state–based efforts to reduce prescription drug abuse while ensuring patients have access to safe, effective pain treatment.

External pacemaker pulse generators are used temporarily to regulate a patient’s heartbeat until a permanent pacemaker can be implanted. They are also used following heart surgery or after a heart attack to control irregular heartbeats.

“The FDA has assessed the benefits and risks of external pacemaker pulse generators,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health (CDRH). “The special controls outlined in this draft guidance, along with general controls, will assure the safety and efficacy of these devices and provide manufacturers with a more predictable path to market.”

General controls include requirements regarding good manufacturing practice, labeling, registering all establishments with the FDA, listing all devices to be marketed and submitting a premarket notification [510(k)] before marketing a device.

However, general controls alone are insufficient to assure safety and effectiveness of Class II devices. In addition to complying with general controls, Class II devices are also subject to special controls, which may include special labeling requirements, mandatory performance standards and postmarket surveillance.

External pacemaker pulse generators are “preamendment” devices, meaning they were on the market prior to the Medical Device Amendments Act of 1976. Approximately 100 preamendment device types were classified as Class III devices, but many continued to be reviewed under the 510(k) program because the FDA did not issue regulations requiring applications for premarket approval (PMAs).

In 2009, CDRH began the process for the review of the remaining Class III preamendment device types subject to 510(k) review to determine whether to reclassify them or require PMAs.

External pacemaker pulse generators are one of the 22 remaining Class III preamendment devices that have been regulated through the 510(k) premarket submission program, rather than the premarket approval program required for other Class III devices.

The proposed rule and draft special controls guidance do not significantly change the FDA’s review of external pacemakers pulse generators, but they do provide manufacturers with clarity and specific guidance on what information is needed in a 510(k) for these products.

“It takes about two weeks after vaccination for the body′s immune response to fully kick in,” says Joe Bresee, M.D., Chief of CDC′s Influenza Epidemiology and Prevention Branch. “It′s best to get vaccinated before activity begins so that you′ll be protected once flu season starts in your community.”

CDC routinely monitors influenza activity in the United States year–round with a system that determines when and where influenza activity is occurring, determines what influenza viruses are circulating and detects changes in influenza viruses. The system also measures the burden of influenza disease in the United States, including tracking influenza related illness, hospitalizations and deaths.

The CDC FluView Report is published each Friday from October through mid–May and appears at http://www.cdc.gov/flu/weekly/fluactivitysurv.htm.

“We know from our first report for this season that influenza activity in the United States is low now, with few people going to the doctor for flu–like symptoms and few respiratory viruses testing positive for flu,” says Bresee. “Though we can′t predict the exact timing, we expect increases in influenza illness, hospitalizations and deaths in the next few weeks,” he said.

More than 110 million doses of vaccine had been delivered in the United States as of the end of September, with manufacturers projecting total production of between 166 and 173 million doses. This is the most flu vaccine ever produced for the U.S. market.

“The good news,” Bresee says, “is that the flu viruses this year′s vaccine will protect against are very well matched to those flu viruses that are circulating now, so it′s looking like we will have a vaccine that provides good protection this season to help keep influenza illness and serious complications down.”

With rare exceptions, CDC recommends that everyone 6 months and older get an annual flu vaccine. This season, people have more options than ever in this regard, both in terms of where they get vaccinated and which vaccine they chose to get.

While doctor′s offices and health departments continue to provide flu vaccinations, vaccine also is available at many pharmacies, work places and other retail and clinic locations.

In addition to the traditional seasonal flu shot that has been available for decades, a nasal spray vaccine was introduced in 2003 for non–pregnant healthy people between 2 and 49 years of age, and a high dose flu shot was introduced last season for people 65 and older. Also, new for this season is an intradermal shot, which uses a needle 90 percent smaller than the regular flu shot and is approved for people 18 to 64 years of age.

Each week, CDC receives reports from international, state and local participants and within 48 hours compiles and analyzes that data to produce a report that provides comprehensive situational awareness regarding influenza activity in the United States. “From our perspective, the time to get vaccinated is now,” Bresee concludes.

The Children’s Asthma Care (CAC) set of process measures evaluates at the hospital level whether patients 2 to 17 years of age admitted with an asthma exacerbation received relievers (CAC-1) and systemic corticosteroids (CAC-2) during the admission and whether they were discharged with a complete home management plan of care (HMPC) (CAC-3), according to background information in the article. “Process measures are designed to evaluate compliance with care that is expected and, when provided, should ‘maximize health benefits to patients’ and lead to improved clinical outcomes. Compliance of health care organizations with many hospital-level process measures has improved over time. However, their association with improved outcomes has been variable.”

Rustin B. Morse, M.D., of the Phoenix Children’s Hospital and University of Arizona College of Medicine, and colleagues evaluated trends in CAC measure compliance at children’s hospitals and the association between CAC measure compliance and improvements in clinical outcomes. The study included administrative and CAC compliance data from 30 U.S. children’s hospitals for a total of 37,267 children admitted with asthma between January 2008 and September 2010, accounting for 45,499 hospital admissions. Follow-up was through December 2010.

The minimum quarterly compliance rates that a hospital reported for CAC-1 and CAC-2 measures were 97.1 percent and 89.5 percent, respectively. Average CAC-3 compliance was 40.6 percent during the initial 3 quarters and improved to 72.9 percent during the final 3 quarters of the study. The researchers found that the average postdischarge emergency department (ED) utilization rates were 1.5 percent at 7 days, 4.3 percent at 30 days, and 11.1 percent at 90 days, while the average quarterly readmission rates were 1.4 percent at 7 days, 3.1 percent at 30 days, and 7.6 percent at 90 days.

The authors write that compliance with CAC-1 and CAC-2 was high, with little variability across hospitals, which precluded examination of their association with the specified outcomes. “… aggregate CAC-3 compliance was initially modest but improved during the study period, with substantial variation in compliance and improvement among the hospitals. We did not find a statistically significant association between aggregate CAC-3 compliance and postdischarge ED utilization or asthma-related readmission rates at 7, 30, or 90 days.”

The researchers add that their findings suggest that within children’s hospitals, CAC measure set compliance alone cannot serve as a means to evaluate and compare the quality of care provided for patients admitted with asthma exacerbations.

“Consideration should be given to refining the CAC-3 measure set to ensure that high-quality HMPCs are being developed using evidence-based resources and that they are conveyed to families in an effective manner. Finally, the CAC-3 measure in its current form may not meet the criteria outlined by the Joint Commission for accountability measures. Until CAC-3 compliance can be linked to improved outcomes, the Joint Commission should reconsider whether the CAC-3 component of the measure set is appropriately classified as an ‘accountability measure’ suitable for public reporting, accreditation, or pay for performance,” the authors conclude.

The study, led Dr Sanjay Basu from the University of California, used a mathematical model to determine the effect of smoking on future tuberculosis rates. The research finds that because smoking increases the risk of contracting TB, there will be 18 million more cases worldwide between 2010 and 2050.

Once smokers develop the disease, they are more likely to die from it, meaning that smoking can single-handedly undermine the Millennium Development Goal to reduce TB mortality by half between 1990 and 2015, say the authors. They add, however, that “aggressive tobacco control could avert millions of deaths from tuberculosis

It is established, say the authors, that smoking tobacco is a TB risk factor. They add that nearly one fifth of the world’s population smokes and that most cigarettes are smoked in countries with high TB prevalence and where the tobacco industry has expanded its market. Given this, the authors wanted to predict how much impact smoking will have on future TB rates.

The research team developed a mathematical model to investigate the issue. Similar models have previously been used for HIV, TB detection systems and drug resistance, but not smoking.

In their analysis, the authors found that smoking may have a substantial impact on future TB rates because a moderate increase in individual risk translates into a large population-level risk because so many people smoke.

The results show that from 2010 to 2050 worldwide smoking could lead to 40 million excess TB deaths (from 61 to 101 million). They also conclude that if current smoking trends continue, the number of excess TB cases could rise from 256 to 274 million – 18 million new cases in total.

Furthermore, the authors found that the number of people with current TB infections may be falsely reduced by smoking. This is because smoking can kill so many people with TB that the number of people living with TB is reduced by smoking, even though smoking also causes a rise in new cases.

According to Basu’s model the African, Eastern Mediterranean and Southeast Asian regions would experience the greatest increase in new TB cases attributable to smoking.

The authors argue that “aggressively lowering the prevalence of tobacco smoking could reduce smoking attributable deaths from tuberculosis by 27 million by 2050″.