NINE REGIONAL EBOLA, SPECIAL PATHOGENS TREATMENT CENTERS SELECTED BY HHS

FROM:  U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
June 12, 2015
HHS selects nine regional Ebola and other special pathogen treatment centers
New network expands US ability to respond to outbreaks of severe, highly infectious diseases

To further strengthen the nation’s infectious disease response capability, the U.S. Department of Health and Human Services has selected nine health departments and associated partner hospitals to become special regional treatment centers for patients with Ebola or other severe, highly infectious diseases.

HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR) has awarded approximately $20 million through its Hospital Preparedness Program (HPP) to enhance the regional treatment centers’ capabilities to care for patients with Ebola or other highly infectious diseases. ASPR will provide an additional $9 million to these recipients in the subsequent four years to sustain their readiness.

“This approach recognizes that being ready to treat severe, highly infectious diseases, including Ebola, is vital to our nation’s health security,” said Dr. Nicole Lurie, HHS assistant secretary for preparedness and response. “This added regional capability increases our domestic preparedness posture to protect the public’s health.”

Each awardee will receive approximately $3.25 million over the full five-year project period. This funding is part of $339.5 million in emergency funding Congress appropriated to enhance state and local public health and health care system preparedness following cases of Ebola in the United States stemming from the 2014 Ebola epidemic in West Africa.

The facilities announced today will be continuously ready and available to care for a patient with Ebola or another severe, highly infectious disease, whether the patient is medically evacuated from overseas or is diagnosed within the United States.

The nine awardees and their partner hospitals are:
Massachusetts Department of Public Health in partnership with Massachusetts General Hospital in Boston, Massachusetts
New York City Department of Health and Mental Hygiene in partnership with New York City Health and Hospitals Corporation/HHC Bellevue Hospital Center in New York City
Maryland Department of Health and Mental Hygiene in partnership with Johns Hopkins Hospital in Baltimore, Maryland
Georgia Department of Public Health in partnership with Emory University Hospital and Children’s Healthcare of Atlanta/Egleston Children’s Hospital in Atlanta, Georgia
Minnesota Department of Health in partnership with the University of Minnesota Medical Center in Minneapolis, Minnesota
Texas Department of State Health Services in partnership with the University of Texas Medical Branch at Galveston in Galveston, Texas
Nebraska Department of Health and Human Services in partnership with Nebraska Medicine - Nebraska Medical Center in Omaha, Nebraska
Colorado Department of Public Health and Environment in partnership with Denver Health Medical Center in Denver, Colorado
Washington State Department of Health in partnership with Providence Sacred Heart Medical Center and Children’s Hospital in Spokane, Washington
The regional facilities are part of a national network of 55 Ebola treatment centers, but will have enhanced capabilities to treat a patient with confirmed Ebola or other highly infectious disease. Even with the establishment of the nine regional facilities, the other 46 Ebola treatment centers and their associated health departments will remain ready and may be called upon to handle one or more simultaneous clusters of patients.
The facilities selected to serve as regional Ebola treatment centers will be required to:
Accept patients within eight hours of being notified,
Have the capacity to treat at least two Ebola patients at the same time,
Have respiratory infectious disease isolation capacity or negative pressure rooms for at least 10 patients,
Conduct quarterly trainings and exercises,
Receive an annual readiness assessment from the soon-to-be-established National Ebola Training and Education Center, composed of experts from health care facilities that have safely and successfully cared for patients with Ebola in the U.S., and funded by ASPR and the Centers for Disease Control and Prevention, to ensure clinical staff is adequately prepared and trained to safely treat patients with Ebola and other infectious diseases,
Be able to treat pediatric patients with Ebola or other infectious diseases or partner with a neighboring facility to do so, and,
Be able to safely handle Ebola-contaminated or other highly contaminated infectious waste.

Proposals from these facilities were reviewed by a panel of experts from professional associations, academia, and federal agencies and were selected based upon extensive criteria published in the funding opportunity announcement released in February.

To be eligible for consideration as an Ebola and other special pathogen treatment center, facilities also had to be assessed by a Rapid Ebola Preparedness team led by the CDC prior to Feb. 20, 2015.

The Department is working with state health officials and hospital executives in HHS Region IX, which includes Arizona, California, Hawaii, Nevada and the Pacific island territories and freely associated states, to identify a partner hospital awardee.

HHS is the principal federal department for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.

VA SAYS STUDY COULD FIND VETERANS WITH HIGH-RISK OF SUICIDE

FROM:  U.S. DEPARTMENT OF VETERANS AFFAIRS
Study may help Department of Veterans Affairs find patients with high-risk of suicide
June 11, 2015, 04:04:00 PM
Study May Help Department of Veterans Affairs Find Patients With High-Risk of Suicide

Clinicians are challenged every day to make difficult decisions regarding patients’ suicide risk. Using Veterans Health Administration (VHA) health system electronic medical record data, Veterans Affairs (VA) and National Institute of Mental Health (NIMH) scientists were able to identify very small groups of individuals within the VHA’s patient population with very high, predicted suicide risk -- most of whom had not been identified for suicide risk by clinicians. Such methods can help the VHA to target suicide prevention efforts for patients at high risk, and may have more wide-ranging benefits.

John McCarthy, Ph.D., M.P.H, director of the Serious Mental Illness Treatment Resource and Evaluation Center in the VA Office of Mental Health Operations, Robert Bossarte, Ph.D., director of epidemiology in the VA Office of Public Health, Ira Katz, M.D., senior consultant for mental health program analysis in the VA Office of Mental Health Operations, and colleagues report their findings today in the online issue of American Journal of Public Health. This paper is the result of a collaboration between the VA and NIMH, which is part of the National Institutes of Health.

Dr. McCarthy and colleagues developed their suicide-risk algorithm by studying the VHA patient population from fiscal years 2009-2011. Data on manner of death came from the National Death Index, and predictors of suicide and other types of death came from VHA clinical records. Dividing randomly the patient population in half, the team used data from one half to develop the predictive model, and then tested the model using data from the other half. Each of the two study samples included 3,180 suicide cases and 1,056,004 control patients. Researchers compared predicted suicide risk to actual mortality to assess the performance of the predictive model.

“As the largest health care provider in the U.S., VA has the responsibility to continuously examine how our extensive suicide prevention efforts are working, and to identify critical opportunities for improvement in service to our nation’s Veterans,” said Dr. Caitlin Thompson, Deputy Director for Suicide Prevention for VA. “This collaborative effort with NIMH provides us with unprecedented information that will allow us to design and implement innovative strategies on how to assess and care for those Veterans who may be at high risk for suicide. This model will advance the care provided to Veterans through VA’s suicide prevention programs to allow us to better tailor our suicide prevention efforts so that we can ensure that ALL Veterans remain safe.”

The VHA care system identifies patients as being at high-risk of suicide based on information assessed during clinical encounters. Researchers found that their predictive model was more sensitive than this clinical flagging, in the sense that, even in groups with the highest predicted suicide risk based on the model, less than one-third of patients had been identified clinically.

“This is valuable, because it gives the VA more extensive information about suicide risk,” said Michael Schoenbaum, Ph.D., senior advisor for mental health service, epidemiology and economics at NIMH and one of the co-authors of the report.  “If the VA can identify small groups of people with a particularly high-risk of suicide, then they can target enhanced prevention and treatment services to these highest-risk individuals,”

“It’s particularly encouraging that these analyses use the types of data available to any large health care system,” said NIMH Director Thomas Insel, M.D. “ These methods could help us prevent civilian as well as veteran suicides.”

In addition to identifying suicide risk, the team looked at deaths among people identified as highest risk for suicide in 2010. The team found that this group had both very high suicide and non-suicide death rates over the next 12 months.

“This finding reinforces the idea that using this process to target suicide risk interventions may have wide benefits across an extended span of time,” concluded Dr. Schoenbaum.

Reference:
McCarthy J.F., et al., Predictive Modeling and Concentration of the Risk of Suicide: Implications for Preventive Interventions in the US Department of Veterans Affairs. American Journal of Public Health (in press)
About the National Institute of Mental Health (NIMH): The mission of the NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.
About the Department of Veterans Affairs: The VA is the second largest Federal department with close to 300,000 employees. The Department's mission is to serve America's veterans and their families with dignity and compassion and to be their principal advocate in ensuring that they receive the care, support and recognition earned in service to this Nation.

CDC SAYS PROGRESS MADE REDUCING SOME FOODBORNE INFECTIONS

FROM:  U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION
CDC data show progress in reducing some foodborne infections in 2014

n 2014, rates of infection from a serious form of E. coli and one of the more common Salmonella serotypes decreased compared with the baseline period of 2006-2008. Meanwhile, some other less common types of Salmonella increased. Campylobacter and Vibrio rose again in 2014, continuing the increase observed during the past few years, according to data published today by the Centers for Disease Control and Prevention. Today’s report summarizes the rates of infection per 100,000 population and tracks illness trends for key foodborne illnesses.

Infection with Shiga-toxin producing E. coli O157, which can sometimes lead to kidney failure, decreased 32 percent when compared with 2006-2008 and 19 percent when compared with the most recent three years. These infections are often linked to consumption of undercooked ground beef and raw leafy vegetables. Salmonella Typhimurium, which has been linked to poultry, beef, and other foods, was 27 percent lower than it was in 2006-2008, continuing a downward trend begun in the mid-1980s. Two other less common types of Salmonella, Javiana and Infantis, more than doubled for reasons that are unclear. Salmonella Javiana is concentrated in the southeastern United States, but has been spreading within the Southeast and to other areas of the country. However, when all Salmonella serotypes are combined, there was no change in 2014. Campylobacter increased 13 percent and Vibrio increased 52 percent compared with 2006-2008. Yersinia has declined enough to meet the Healthy People 2020 goal.

The data are from FoodNet, CDC’s active surveillance system that tracks nine common foodborne pathogens in 10 states and monitors trends in foodborne illness in about 15 percent of the U.S. population. Today’s report compares the 2014 frequency of infection with the frequency in the baseline period 2006-2008 and in the three most recent years. Overall in 2014, FoodNet logged just over 19,000 infections, about 4,400 hospitalizations, and 71 deaths from the nine foodborne germs it tracks. Salmonella and Campylobacter were by far the most common– accounting for about 14,000 of the 19,000 infections reported.

“We’re cautiously optimistic that changes in food safety practice are having an impact in decreasing E.coli and we know that without all the food safety work to fight Salmonella that more people would be getting sick with Salmonella than we are seeing now,,” said Robert Tauxe, M.D., deputy director of CDC’s Division of Foodborne Waterborne and Environmental Diseases. “The increasing use of whole genome sequencing to track foodborne illness cases will also help; however, much more needs to be done to protect people from foodborne illness.”

The recent decline in the incidence of Shiga toxin-producing E. coli (STEC) O157 follows several years of increasing scrutiny for beef products. Since 1994, the Food Safety and Inspection Service of the U.S. Department of Agriculture has taken STEC O157:H7 extremely seriously and made a number of changes in its regulatory oversight of the beef industry to protect public health.

"We are encouraged by the reduction of STEC O157:H7 illnesses, which reflects our science-based approach to beef inspection, and we look forward to seeing further reductions in Salmonella and Campylobacter infections as our improved standards for poultry take effect later this year, " said Al Almanza, Deputy Under Secretary for Food Safety at USDA. "Data sources like FoodNet allow us to be strategic in developing our food safety policies, and we will do everything within our power to keep reducing cases of foodborne illness from all meat and poultry products."

Under the provisions of the FDA Food Safety Modernization Act, the U.S. Food and Drug Administration is planning to publish major new regulations in 2015. The regulations are geared toward ensuring produce safety, implementing preventive controls on processed foods, and improving the safety of imported foods.

“Prevention of illness is the fundamental goal of our new rules under the FDA Food Safety Modernization Act,” said Michael Taylor, deputy commissioner for Foods and Veterinary Medicine at FDA.  “We have worked with a wide range of stakeholders to devise rules that will be effective for food safety and practical for the many diverse elements of our food system. Once the rules are fully implemented, FoodNet will help us evaluate their impact.”

The FoodNet report also includes results of culture-independent diagnostic tests (a new method for diagnosing intestinal illnesses without needing to grow the bacteria) done in the many hospital laboratories in the FoodNet sites. In 2014, the results of more than 1,500 such tests were reported. More than two-thirds of the tests were for Campylobacter. Other tests performed were for STEC, Salmonella, Shigella and Vibrio. Some of the tests had a positive result. However, the infections were not confirmed by culture, and so CDC experts did not include them in the overall FoodNet results for 2014.

For more information on avoiding illnesses from food, please visit www.foodsafety.gov.

About FoodNet

FoodNet collects information to track rates and determine trends in laboratory-confirmed illnesses caused by nine pathogens transmitted commonly by food: Campylobacter, Cryptosporidium, Cyclospora, Listeria, Salmonella, STEC O157 and non-O157, Shigella, Vibrio and Yersinia. CDC compares annual data with data from a baseline period (2006-2008) and a recent period (2010-2012) to measure progress. Since 2010, FoodNet has been tracking the increasing use of culture‐independent diagnostic tests used by clinical laboratories for diagnosis of bacterial enteric infection. Because these tests are replacing culture-based tests, their use is creating challenges to the ability to identify cases, monitor trends, detect outbreaks, and characterize pathogens.

FoodNet is a collaboration among CDC, ten state health departments, the USDA’s Food Safety and Inspection Service, and the FDA. FoodNet covers 48 million people, encompassing about 15 percent of the United States population. The sites are the states of Connecticut, Georgia, Maryland, Minnesota, New Mexico, Oregon, and Tennessee, and selected counties in California, Colorado, and New York.

CDC REPORTS ON DOG-TO-HUMAN PNEUMONIC PLAGUE OUTBREAK IN COLORADO

FROM:   CENTERS FOR DISEASE CONTROL AND PREVENTION
Outbreak of Human Pneumonic Plague with Dog-to-Human and Possible Human-to-Human Transmission — Colorado, June–July 2014

This outbreak highlights 1) the need to consider plague in the differential diagnosis of sick domestic animals from plague endemic areas, including dogs, 2) the limitations of automated diagnostic systems for identifying rare bacteria such as Yersinia pestis, and 3) the potential for milder forms of illness in patients taking antimicrobial agents. Hospital laboratories in plague-endemic areas should be aware of the limitations of current diagnostic methodologies in diagnosing rare diseases such as plague. In July 2014, the Colorado Department of Public Health and Environment Laboratory identified Yersinia pestis in a blood sample collected from a middle-aged man hospitalized with pneumonia. An investigation led by Tri-County Health Department revealed that the man’s dog had been ill and was euthanized. The dog later tested positive for Y. pestis. Three additional persons with contact with the dog and/or patient were ill and tested positive for Y. pestis. One of the cases may have resulted through person-to-person transmission from the index patient, potentially the first such event in North America since 1924. Human illness due to plague remains an ongoing risk in endemic areas. Early recognition of plague, especially the pneumonic form, is critical to clinical management and a timely public health response.

LOOKING TO CURE ANTIBIOTIC RESISTANCE

FROM:  NATIONAL SCIENCE FOUNDATION
Researcher studies how to prevent antibiotic resistance
Solution could be in bacterial protein called UmuD

The widespread and indiscriminate use of antibiotics has prompted many bacteria to mutate, an adaptation that often renders the drugs useless. The increasing threat of resistance worries infectious disease experts who fear that the era of public health successes brought by the introduction of antibiotics in the 1940s is seriously eroding, or soon even may be at an end.

But what if science could improve existing antibiotics in such a way as to not only destroy bacteria, but prevent them from mutating?

At least one research team, in seeking to better understand bacterial mutation, may provide scientific answers that ultimately could lead to thwarting the organisms' ability to mutate, thus blunting the increasing threat of antibiotic resistance.

"The idea would be a one-two punch," says Penny Beuning, an associate professor of chemistry and chemical biology at Northeastern University's college of science. "We need a good therapeutic target that will both kill the bacteria and prevent mutagenesis."

To be sure, the approach almost certainly is years away. Still, the National Science Foundation (NSF)-funded scientist thinks it may be possible. She and her colleagues are studying an important bacterial protein known as UmuD that regulates mutagenesis and may provide important clues about how to stop the process that eventually results in antimicrobial resistance.

Using the bacterium E. coli as a model, she has learned that UmuD interacts with the machinery that replicates DNA, and, when altered, may provide the switch that triggers mutation. UmuD exists in two forms, a full length version when first expressed, and later, if DNA is damaged, a much shorter form. It is this shorter version that allows bacteria to mutate.

Once there is DNA damage, "there is an SOS response, and the levels of some specific proteins go up," she says. "There is a massive stress response, and UmuD responds by cutting its arms off."

In cells where only the full-length version of the protein is present, the bacteria cannot mutate. "But when it forms its shorter self, the cells are mutable," she says.

The fact that UmuD is not present outside bacteria makes it a viable antibiotic target.

"The hope would be to find something that targets UmuD together with an existing antibiotic to prevent bacteria from mutating and developing a resistance to that particular drug," she says. "Among the things we have been looking at: how does UmuD work, and what controls the cleavage of the arms?"

Beuning is conducting her research under an NSF Faculty Early Career Development (CAREER) grant awarded in 2009 under the American Recovery and Reinvestment Act. The award supports junior faculty who exemplify the role of teacher-scholars through outstanding research, excellent education and the integration of education and research within the context of the mission of their organization. NSF is funding her work with $994,655 over five years.

Beuning specifically is looking at the cleavage process of UmuD using gel electrophoresis, which separates proteins according to size.

"UmuD is a small protein--139 amino acids--which loses 24 amino acids from the arm. So it goes from 139 to 115," she says. "We can observe this difference with electrophoresis, allowing us to determine how different conditions or other proteins might affect UmuD cleavage."

The team is studying different UmuD protein interactions in the lab, using biochemistry to see when and how different proteins bind to one another. Essentially "we light up the proteins and measure how they change when other proteins bind, using a method called FRET, which stands for fluorescence resonance energy transfer," she says.

"This measures energy transfer between two proteins using light emission," she adds. "The proteins have to be close to each other for energy transfer to occur, so it's a way of detecting whether two things bind to each other. People often call the technique a molecular ruler, because it can be used to measure precise distances, but we use it simply to measure proximity."

Using FRET, they discovered that UmuD prevents specific protein interactions in the replication process. That is, it stops or slows down replication by keeping two proteins that need to interact for replication from binding to each other. "Protein-protein interactions are generally hard to target with drugs, but the approach has some potential," she says.

They also use another technique that measures how floppy or flexible proteins are by putting them in heavy water and measuring how much heavier the protein gets as it trades its regular hydrogens with heavy hydrogens from the heavy water. "The floppier parts swap out the hydrogens faster than the less floppy parts," she says.

As part of the grant's education component, she has up to ten undergraduates--as well as local high school students and teachers--working in her research lab. Several students have worked in her lab as part of Northeastern's signature co-op program, in which students work full-time for six months in positions related to their career goals.

Also, she teaches an upper level chemical biology class to undergraduates, and created a lab research project for the students that takes place during half of the semester that actually involves them directly in her mutagenesis research.

"A lot of these students had not yet conducted any research, so they were really motivated by the idea of doing something that someone would use as part of a bigger project," she says. "Particularly at Northeastern, where co-op is such a large part of the culture, it is fun to take advantage of the laboratory as the ultimate in experiential education.”

-- Marlene Cimons, National Science Foundation
Investigators
Penny Beuning
Related Institutions/Organizations

NSF ON THE BRAIN AT REST

FROM:  NATIONAL SCIENCE FOUNDATION 

What happens to your brain when your mind is at rest?

Kavli Prize winner recognized as pioneer in research in the development and use of brain imaging techniques

For many years, the focus of brain mapping was to examine changes in the brain that occur when people are attentively engaged in an activity. No one spent much time thinking about what happens to the brain when people are doing very little.

But Marcus Raichle, a professor of radiology, neurology, neurobiology and biomedical engineering at Washington University in St. Louis, has done just that. In the 1990s, he and his colleagues made a pivotal discovery by revealing how a specific area of the brain responds to down time.

"A great deal of meaningful activity is occurring in the brain when a person is sitting back and doing nothing at all," says Raichle, who has been funded by the National Science Foundation (NSF) Division of Behavioral and Cognitive Sciences in the Directorate for Social, Behavioral and Economic Sciences. "It turns out that when your mind is at rest, dispersed brain areas are chattering away to one another."

The results of these discoveries now are integral to studies of brain function in health and disease worldwide. In fact, Raichle and his colleagues have found that these areas of rest in the brain--the ones that ultimately became the focus of their work--often are among the first affected by Alzheimer's disease, a finding that ultimately could help in early detection of this disorder and a much greater understanding of the nature of the disease itself.

For his pioneering research, Raichle this year was among those chosen to receive the prestigious Kavli Prize, awarded by The Norwegian Academy of Science and Letters. It consists of a cash award of $1 million, which he will share with two other Kavli recipients in the field of neuroscience.

His discovery was a near accident, actually what he calls "pure serendipity." Raichle, like others in the field at the time, was involved in brain imaging, looking for increases in brain activity associated with different tasks, for example language response.

In order to conduct such tests, scientists first needed to establish a baseline for comparison purposes which typically complements the task under study by including all aspects of the task, other than just the one of interest.

"For example, a control task for reading words aloud might be simply viewing them passively," he says.

In the Raichle laboratory, they routinely required subjects to look at a blank screen. When comparing this simple baseline to the task state, Raichle noticed something.

"We didn't specify that you clear your mind, we just asked subjects to rest quietly and don't fall asleep," he recalls. "I don't remember the day I bothered to look at what was happening in the brain when subjects moved from this simple resting state to engagement in an attention demanding task that might be more involved than simply increases in brain activity associated with the task.

"When I did so, I observed that while brain activity in some parts of the brain increased as expected, there were other areas that actually decreased their activity as if they had been more active in the 'resting state,"' he adds. "Because these decreases in brain activity were so dramatic and unexpected, I got into the habit of looking for them in all of our experiments. Their consistency both in terms of where they occurred and the frequency of their occurrence--that is, almost always--really got my attention. I wasn't sure what was going on at first but it was just too consistent to not be real."

These observations ultimately produced ground-breaking work that led to the concept of a default mode of brain function, including the discovery of a unique fronto-parietal network in the brain. It has come to be known as the default mode network, whose regions are more active when the brain is not actively engaged in a novel, attention-demanding task.

"Basically we described a core system of the brain never seen before," he says. "This core system within the brain's two great hemispheres increasingly appears to be playing a central role in how the brain organizes its ongoing activities"

The discovery of the brain's default mode caused Raichle and his colleagues to reconsider the idea that the brain uses more energy when engaged in an attention-demanding task. Measurements of brain metabolism with PET (positron emission tomography) and data culled from the literature led them to conclude that the brain is a very expensive organ, accounting for about 20 percent of the body's energy consumption in an adult human, yet accounting for only 2 percent of the body weight.

"The changes in activity associated with the performance of virtually any type of task add little to the overall cost of brain function," he continues. "This has initiated a paradigm shift in brain research that has moved increasingly to studies of the brain's intrinsic activity, that is, its default mode of functioning."

Raichle, whose work on the role of this intrinsic brain activity on facets of consciousness was supported by NSF, is also known for his research in developing and using imaging techniques, such as positron emission tomography, to identify specific areas of the brain involved in seeing, hearing, reading, memory and emotion.

In addition, his team studied chemical receptors in the brain, the physiology of major depression and anxiety, and has evaluated patients at risk for stroke. Currently, he is completing research studying what happens to the brain under anesthesia.

"The brain is capable of so many things, even when you are not conscious," Raichle says. "If you are unconscious, the organization of the brain is maintained, but it is not the same as being awake."

-- Marlene Cimons, National Science Foundation
Investigators
Marcus Raichle
Related Institutions/Organizations
Washington University School of Medicine

NSF VIDEO: ALZHEIMER'S PATIENTS: A SURPRISE FINDING IN EXECUTIVE FUNCTION

SKIN CANCER RATES INCREASING: SURGEON GENERAL ISSUES CALL TO ACTION

FROM:  U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Surgeon General issues call to action to prevent skin cancer

Skin cancer rates rising: most cases are preventable

Skin cancer, the most commonly diagnosed cancer in the United States, is a major public health problem that requires immediate action, according to a new Call to Action released today by the U.S. Surgeon General.

Even though most skin cancers can be prevented, rates of skin cancer, including melanoma, are increasing in the United States. Nearly 5 million people in the U.S. are treated for skin cancer every year, at an average annual cost of $8.1 billion. It is also one of the most common types of cancer among U.S. teens and young adults.

A key message in today’s report is that although people with lighter skin are at higher risk, anyone can get skin cancer—and it can be disfiguring, even deadly. Over the last three decades, the number of Americans who have had skin cancer is estimated to be higher than the number for all other cancers combined.

“While many other cancers, such as lung cancer, are decreasing, rates of melanoma -- the deadliest form of skin cancer -- are increasing,” said Assistant Secretary for Health Howard K. Koh, M.D., M.P.H. “As a skin oncologist who worked in this field for many years, I have cared for both the young and old with skin cancers. Almost all of these cancers were caused by unnecessary ultraviolet radiation exposure, usually from excessive time in the sun or from the use of indoor tanning devices.”

Melanoma is the deadliest form of skin cancer. Each year, more than 63,000 new cases are diagnosed in the U.S. and nearly 9,000 people die from this disease. Rates of melanoma increased more than 200 percent from 1973 to 2011. Melanoma is also one of the most common types of cancer among U.S. teens and young adults.

According to research cited in the Call to Action, more than 400,000 cases of skin cancer, about 6,000 of which are melanomas, are estimated to be related to indoor tanning in the U.S. each year. Currently, as many as 44 states plus the District of Columbia have some type of law or regulation related to indoor tanning, but nearly one out of every three white women aged 16 to 25 years engages in indoor tanning each year.

“Tanned skin is damaged skin, and we need to shatter the myth that tanned skin is a sign of health,” said Acting Surgeon General Boris D. Lushniak, M.D., M.P.H. “When people tan or get sunburned, they increase their risk of getting skin cancer later in life.”

The Surgeon General’s Call to Action helps to educate consumers by providing everyday steps they can take to lead healthy and active lives while being outdoors. These steps include wearing protective gear (such as a hat, sunglasses, and other protective clothing) and seeking shade along with the use of a broad-spectrum sunscreen with a sun protection factor (SPF) of 15 or higher to protect any exposed skin, especially during midday hours.

“We want all Americans to lead healthy, active lives,” Dr. Lushniak said, “We all need to take an active role to prevent skin cancer by protecting our skin while being outdoors and avoiding intentional sun exposure and indoor tanning.”

The report calls on all sectors of Americans society, including the business, health care, education, government and nonprofit sectors, as well as families and individuals, to do more. Examples include communities providing shade in outdoor settings, health care providers counseling patients on the importance of using sun protection, and educational institutions discouraging indoor tanning.

AN EXTENDED-RELEASE OXYCODONE WITH ABUSE-DETERRENT PROPERTIES APPROVED BY FDA

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

FDA approves new extended-release oxycodone with abuse-deterrent properties

July 23, 2014

Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties consistentwith the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.

Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose. Targiniq ER can still be abused, including when taken orally (by mouth), which is currently the most common way oxycodone is abused. It is important to note that taking too much Targiniq ER for purposes of abuse or by accident, can cause an overdose that can result in death.

"The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.,” said Sharon Hertz, M.D., deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain.”

Targiniq ER is not approved, and should not be used, for as-needed pain relief. Given Targiniq ER’s risks for abuse, misuse and addiction, it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management.

The safety and effectiveness of Targiniq ER was evaluated in a clinical trial of 601 people with chronic low back pain. The safety database supporting approval included treatment of more than 3,000 people with Targiniq ER. Data from in vitro (in a laboratory) and in vivo (testing with people) abuse liability studies demonstrated the abuse deterrent features of Targiniq ER as they relate to certain types of abuse (snorting, injecting). The most common side effects of Targiniq ER are nausea and vomiting.

The FDA is requiring postmarketing studies of Targiniq ER, to assess the serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long term use beyond 12 weeks. The FDA is also requiring postmarketing studies to further assess the effects of the abuse-deterrent features on the risk for abuse of Targiniq ER.

In addition, Targiniq ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/LA opioids.

Targiniq ER is manufactured by Stamford-based Purdue Pharma L.P.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

TREATING AIDS WITH SUPERCOMPUTERS

FROM:   NATIONAL SCIENCE FOUNDATION 

Computing a cure for HIV

Nine ways NSF-supported supercomputers help scientists understand and treat the disease

HIV/AIDS has caused an estimated 36 million deaths, according to the World Health Organization, and remains a major menace worldwide. Today, approximately 35 million people are living with the human immunodeficiency virus (HIV), including more than a million individuals in the United States.

The tendency of HIV to mutate and resist drugs has made it particularly difficult to eradicate. Some treatments have shown progress in slowing or even stopping the progress of the virus, but no cure or vaccine has been discovered that can truly stamp out the disease.

In the last decade, scientists have begun using a new weapon in the fight against HIV: supercomputers.

Scientists harness the power of thousands of computer processors simultaneously to better understand how the HIV virus interacts with the cells it infects, to discover or design new drugs that can attack the virus at its weak spots and even to use genetic information about the exact variants of the virus to develop patient-specific treatments.

Among the researchers using supercomputers to study HIV is Klaus Schulten, the keynote speaker at the 2014 International Supercomputing Conference, held earlier this week in Leipzig, Germany. Schulten, a professor of physics at the University of Illinois at Urbana-Champaign, invented the Nanoscale Molecular Dynamics (NAMD) software program, one of the most widely used tools for understanding diseases at a molecular level.

Supported by the National Science Foundation (NSF) and using some of the nation's most powerful supercomputers, teams of researchers are pushing the limits of what we know about HIV, and how we can treat it.

Below are nine examples of how scientists are applying massive computing power and computational know-how to combat the disease.

1) Modeling HIV: from atoms to actions

In order for HIV to infect non-dividing cells, the HIV virus must enter the cell and entice cellular proteins to act as chaperones, ushering the virus towards the cell nucleus and helping it integrate its genes into the cell's genome. This infection process offers opportunities for medical intervention and may suggest new HIV treatments. However the dynamics of the process can only be "observed" through computational modeling and simulation.

The size of the HIV capsid or shell, combined with its irregular shape, had long prevented scientists from simulating the full capsid structure with adequate resolution. But researchers from Klaus Schulten's group at the University of Illinois at Urbana-Champaign, using the NSF-funded Blue Waters supercomputer, observed how the capsid interacts with drugs and host proteins at the atomic level. The model, consisting of about 1,300 proteins and 4 million atoms, is currently the largest entry in the Research Collaboratory for Structural Bioinformatics Protein Data Bank, a repository for the three-dimensional structural data of large biological molecules.

2) Discovery of hidden pocket in HIV protein leads to ideas for new inhibitors

Researchers from the University of California, San Diego; the Salk Institute for Biological Studies and the National Cancer Institute collaborated on an effort to discover new drug candidates to combat HIV.

With the help of the San Diego Supercomputer Center, the scientists ran molecular simulations to capture the movements of a small pocket on the virus's surface that they believed could be targeted by drugs to prevent the replication of the virus. Using the pocket as a target, they virtually screened thousands of compounds and tested 16 for their ability to block HIV infection in human tissue cultures. Ultimately, they discovered two compounds that inhibit HIV replication and block the activity of reverse transcriptase as effectively as a leading FDA-approved drug, nevirapine. The researchers believe these compounds have the potential to develop into future drugs and are exploring them further.

3) Preventing HIV from reaching its mature state

The mature capsid of the HIV virus is comprised of thousands of interlinked proteins that act like a suit of armor around the virus's genetic material. If this armor-like structure does not form, then the virus is unable to infect cells.

Researchers from the University of Chicago used the Kraken supercomputers at the National Institution for Computational Science (NICS) to study how the mature HIV capsid formed. They found that the seemingly complicated behavior of the capsid's self-assembly was relatively simple once they understood the shape and behavior of the proteins that made it up. The work advanced our understanding of the HIV life cycle and is inspiring the development of new drugs to disrupt the virus's growth. Results appeared in the Biophysical Journal in October 2012.

4) Crowdsourcing a cure

After scientists repeatedly failed to piece together the structure of a protein-cutting enzyme that plays an important role in HIV, they called on the players of FoldIt, an online puzzle video game, to find a solution. Using FoldIt, "citizen scientists" were able to determine how the enzyme folded and solved the mystery of its structure. With further help from the game-players, researchers were able to identify target drugs to neutralize the enzyme.

FoldIt is part of an experimental research project supported by NSF and developed by the University of Washington's Center for Game Science in collaboration with the UW Department of Biochemistry. The case of the crowdsourced protein structure serves as a critical example of how games with a purpose can solve real-world problems.

5) Virtual screening of HIV inhibitors

A team of researchers from Pennsylvania used computer modeling and virtual screening, powered by supercomputers, to identify novel inhibitors of HIV and better understand how they react with the HIV virus. They focused on small molecules that block the interaction between the receptors on the surface of human cells and an important protein on the surface of the HIV envelope.

Using the Blacklight system at the Pittsburgh Supercomputing Center, the researchers virtually screened more than 10 million compounds to find small molecules that would be a good molecular fit for the protein that they were targeting. From the 10 million, they identified six, small-molecule, HIV surface protein complexes that display unique modes of binding. Taken together, they constitute what the researchers believe is a potent class of entry inhibitors against HIV.

6) Membrane effects

Some proteins that anchor HIV to cell membranes are thought to promote the development of the virus. Researchers have found that combining experimental methods with computer simulations can reveal much about the cell-binding dynamics.

Hirsh Nanda of the National Institute of Standards and Technology leads a research team that studies the initial stages of the formation of new HIV virus particles in an infected cell. During these first steps, HIV proteins latch onto cell membranes.

Using the Kraken supercomputer at NICS, Nanda's team was able to study the forces that govern protein assemblies on membranes in far greater detail and much faster than if they were using their lab's computers. Kraken also greatly accelerated the analysis of experimental neutron scattering data that they used to compare with simulations.

The simulations revealed that an important HIV surface protein simultaneously binds to the cell membrane and to viral RNA in order to change shape. Also revealed was how another HIV protein transitions between compact and extended structures upon anchoring to the cell membrane. These discoveries are inspiring new treatment approaches that center on membrane interactions.

7) Computing patient-specific treatment methods

Doctors know that there are many different strains of HIV and that drugs for the disease do not have the same effects in all people. Subtle genetic differences between strains and among individuals lead to a range of treatment outcomes. Using the NSF-supported Kraken and Ranger supercomputers, researchers from University College London and Rutgers University determined the shape of a key protein involved in HIV infection in an individual patient, and then ranked the drug molecules most likely to block the activity.

The project demonstrated how researchers might use genetic sequencing techniques and massive computations to design patient-specific treatment protocols in near-real-time. In the future, it is expected that this type of patient-specific drug selection will become routine.

The research was reported at the annual meeting of the American Association for the Advancement of Science and was published in the Journal of Chemical Theory and Computation.

8) Preparing the next generation to continue the fight

At Merrimack College in Massachusetts, students are learning how to conduct virtual screening using the Stampede supercomputer. Virtual screening uses computational methods to identify small molecules that are likely to bind to a known drug target, often a protein. The method has become a valuable tool for many biotechnology and pharmaceutical companies.

The activity exposes students to massive computing resources and shows them a method of conducting science that few previously knew existed. It's one of many ways that educators around the nation are beginning to prepare students for the workforce of the future by incorporating computational techniques into their curriculum.

9) A boy and the BEAST

When Armand Bilge was a 10th-grader at Lexington High School in Massachusetts, he created a map and timeline that identified when HIV arrived in the Americas, and where and when HIV spread across these continents. To do so, Bilge used a combination of molecular sequencing software and NSF-funded high-performance computing resources.

As a member of an after-school computer club, Bilge used a software program called BEAST to create a detailed evolutionary tree, based on similarities and differences in the 3,000 nucleotide subunits of a gene among 400 known HIV strains. The software ran on the CIPRES (CyberInfrastructure for Phylogenetic Research) science gateway, a public resource developed by the San Diego Supercomputer Center and supported by NSF that allows those interested in evolutionary relationships to study virtually every species on Earth.

Bilge's conclusions support previously published results of HIV experts that suggest that "a single introduction of the virus in Haiti in the mid-1900s resulted in its dispersion across the American continent." The project won first place in biology for the 2012 Massachusetts Science and Engineering Fair.

-- Aaron Dubrow, NSF
Investigators
John Towns
Dan Stanzione
Ralph Roskies
Philip Andrews
Gregory Peterson
Patricia Kovatch
Nancy Wilkins-Diehr

WHITE HOUSE REPORT ON HEALTH AND CLIMATE CHANGE

FROM:  THE WHITE HOUSE 

White House Release Report on the Health Impacts of Climate Change on Americans

 June 6, 2014

Today, the White House released a report on the health impacts of climate change on Americans. The report summarizes the ways that climate change will be felt across the Nation.

In the past three decades, the percentage of Americans with asthma has more than doubled, and climate change is putting those Americans at greater risk of landing in the hospital. And extreme weather events are becoming more frequent across the country – from more rain falling in downpours in many regions, to longer and hotter heat waves in others, to more severe droughts and wildfires in some (notably the West and Southwest).

The effects of climate change impact the most vulnerable Americans – putting the elderly, kids, and people already suffering from burdensome allergies, asthma and other illnesses at greater risk.

The President believes we have a moral obligation to leave our children a planet that’s not irrevocably polluted or damaged. While no single step can reverse the effects of climate change, we must take steady, responsible action to cut carbon pollution, protect our children’s health, and begin to slow the effects of climate change so that we leave behind a cleaner, more stable environment. That’s why the President put forward the Climate Action Plan last year and earlier this week, the Environmental Protection Agency released a vital component of that plan – common-sense carbon pollution standards for existing power plants.

Through common-sense measures to cut carbon pollution we can protect the health of our Nation, while stimulating the economy and helping to prevent the worst impacts of climate change.

GENERIC CELEBREX APPROVED BY FDA FOR ARTHRITIS, OSTEOARTHRITIS

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

FDA approves first generic versions of celecoxib

May 30, 2014

Release

The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.

Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.

“It is important for patients to have access to affordable treatment options for chronic conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”

Celecoxib is a Non-Steroidal Anti-Inflammatory Drug (NSAID). All NSAIDs have a Boxed Warning in their prescribing information (label) to alert health care professionals and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for it, such as high blood pressure, or taking NSAIDs for long periods of time. The Boxed Warning also highlights the risk of serious, potential life-threatening gastrointestinal (GI) bleeding that has been associated with use of NSAIDs.

In the clinical trials for Celebrex, the most commonly reported adverse reactions in patients taking the drug for arthritis were abdominal pain, diarrhea, indigestion (dyspepsia), flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, inflammation of the throat (pharyngitis), runny nose (rhinitis), swollen nasal passages, (sinusitis), upper respiratory tract infection, and rash.

Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Information about the availability of generic celecoxib can be obtained from the companies.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA TOUTS ADULT STEM CELL RESEARCH

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

Adult Stem Cell Research Shows Promise

So What Are Stem Cells?

Why Is FDA Studying These Cells?

What's Being Done?

Scientists sporting white coats and safety gloves are working in a bright Food and Drug Administration (FDA) lab on an incredible project.

They are part of FDA’s MSC Consortium, a large team of FDA scientists studying adult mesenchymal stem cells (MSCs)—cells that could eventually be used to repair, replace, restore or regenerate cells in the body, including those needed for heart and bone repair.

The scientists’ investigational work is unprecedented: Seven labs at FDA's Center for Biologics Evaluation and Research formed the consortium to fill in gaps in knowledge about how stem cells function.

“This research aims to facilitate development of this important class of innovative medical products,” explains Carolyn A. Wilson, Ph.D., associate director for research at the center. “It’s the first time we’ve done anything like this, and it’s proven to be a very useful approach. It’s worked so well because this is a huge, complicated project that requires expertise in many different technologies and methods.”

The research could ultimately be key to the advancement of personalized medicine, the practice in which medical treatment is tailored to the needs of an individual patient. “It’s not science fiction,” says Steven R. Bauer, Ph.D., chief of the Cellular and Tissue Therapy Branch in FDA’s Office of Cellular Tissue and Gene Therapies. “For me, regenerative medicine is the most exciting part of what we regulate in our office.”

So What Are Stem Cells?
There are two basic kinds of stem cells that are currently useful in the field of regenerative medicine: multipotent and pluripotent stem cells. Multipotent stem cells are generally taken from adults and can divide and develop into many different cell types. Pluripotent stem cells can develop into any type of cell in the body. Both types could divide to replenish cells damaged by injury, illness or normal wear. When stem cells divide, the new cells can either remain stem cells or develop into a new type of cell with a more specific function.
Two types of pluripotent stem cells exist: human embryonic stem cells and induced pluripotent stem cells, which are created by reprogramming adult cells that had already changed into a mature type of cell.

FDA’s MSC Consortium is not studying stem cells taken from embryos. “We’re looking at a particular kind of multipotent adult stem cell—the MSC—which is being used in a lot of regenerative medicine clinical trials,” adds Bauer.

The group is currently studying eight unique cell lines, each acquired from commercial sources and sourced to one of eight distinct, adult donors. (Males and females age 22 to 47 donated stem cells from bone marrow.)

The cells under study are multipotent: “They can differentiate (mature into) at least three cell types: bone, fat and cartilage, primarily,” Bauer explains. “They can also differentiate into nerve cells, liver cells and a kind of cell called ‘stroma’ that is in the bone marrow and supports blood forming cells. Then, for investigational clinical uses, they’ve been used for repairing hearts, repairing bone and repairing cartilage.”

Why Is FDA Studying These Cells?
In addition to differentiating into a variety of replacement cell types, MSCs can limit a patient’s immune response. So they can potentially be taken from one human donor and placed into a different recipient with less possibility of rejection.

But growing stem cells and making sure they are safe and effective is challenging, which is one reason why stem-cell based clinical trials have not yet resulted in a marketed product.

“The major challenge is that cells are much more complex than traditional products that FDA regulates. And they have the ability to respond to their environment,” Bauer explains. “Taking them out of the body and manufacturing them—that is, growing large numbers of them—or isolating them can change their biology. And it can change the way they behave if they are put back into the patient.”

For instance, if cells are manufactured in large quantities outside their natural environment, they may become ineffective or develop harmful characteristics. For example, they can produce tumors, severe immune reactions or growth of unwanted tissue. So FDA is trying to develop methods that would predict with more certainty how manufactured or isolated adult stem cells will behave in patients.

What's Being Done?
In the labs, cells are suspended in a nutrient liquid solution and grown in sterile containers called tissue culture flasks. Cells then multiply and go through three, five or seven generations of growth.
FDA scientists are using a variety of cutting-edge methods to characterize cells and then determine if any of these characteristics can predict the behavior of the cells in biological assays or in animal models. The next step will be to determine if any characteristics they measure will predict the safety or effectiveness of stem-cell based products in patients.

Specifically, scientists will continue studying whether factors such as different methods of growing the cells, donor age or gender affects the cells’ quality and performance. This research will ultimately provide new tools to the community of academic and private industry scientists who are interested in evaluating and developing stem cells into new clinical treatments.

“The consortium has shown that widely accepted ways to identify and characterize MSCs do not reveal some important biological differences between batches of these cells,” Bauer says. So the consortium seeks to demonstrate ways to better characterize MSCs that will be used in clinical trials. That’s important because, if investigators can improve the tools used to characterize MSCs used for clinical trials, the data generated from their studies could also improve because their MSC products will be more predictable, he adds.

And the improved predictability of their products will, in turn, allow FDA scientists to more easily evaluate the safety and effectiveness of new stem cell technologies—a key part of the regulatory science that is the foundation of FDA decisions.

Agency scientists already have published six papers in scientific journals such as Tissue Engineering and Cytotherapy. “We’re hoping this project will inspire people to do more research in this area,” Bauer says.

Stem cells, like other medical products intended to treat, cure or prevent disease, require FDA approval before they can be marketed. “It is important for FDA to maintain a sound regulatory science research program to promote the development of safe and effective products in emerging areas that hold great promise,” Bauer says.

“My colleagues and I hope our scientific findings will be helpful in the field of regenerative medicine, including the ability to repair or even replace organs and tissues more safely and effectively than traditional means,” he adds. “Although there are many scientific hurdles to overcome before the use of stem cells reaches its full potential, I think this medicine will eventually have the capacity to do that.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

DISEASE SCREENING ACCORDING TO AN INDIVIDUAL'S RISKS

FROM:  NATIONAL SCIENCE FOUNDATION 
Tailoring disease screening programs to individuals

Researcher developed a customized computer algorithm that provides a better decision support tool

Oguzhan Alagoz believes that many existing disease screening programs all too often take a one-size-fits-all approach. To be sure, "it is important to catch a disease early," he says. "But still, most screening programs treat everyone the same."

In breast cancer, for example, "they say any woman who turns 40, or 50, should start screening every year, and they don't differentiate women by individual risks," says Alagoz, an associate professor of industrial and systems engineering at the University of Wisconsin-Madison.

"The common characteristic of all of these guidelines is age," he adds. "They specify age, but don't specify whether women with higher or lower risk should or should not be screened, nor do they take into consideration a woman's personal preferences about mammography. We have to start tailoring screening recommendations to the individual woman."

To try to address this, the National Science Foundation (NSF)-funded scientist has developed a computer algorithm that will allow women to reach a decision customized for them. "You enter your age, your risk factors and how you personally feeling about screening," he says. "Then our model helps you make a decision about mammography."

Although implementation is beyond the scope of his research, he believes the ideal scenario would be to have a woman use the computer model in consultation with her personal physician. "We shouldn't over-trust the model," says Alagoz, who also holds a secondary appointment as an associate professor of population sciences in the university's school of medicine and public health.

"Over-trusting technology in medicine may not be the best thing to do, but it will help you," he adds. "It also will help the physician and the women who might be missing certain things. I see this not as a method to guide the whole decision, but as a decision support tool."

Ultimately, he sees the research as a framework for developing better screening policies for other cancers as well, including prostate and colorectal cancers as well as other conditions, such as diabetic retinopathy.

"Any improvement on cancer screening and diagnosis would directly affect millions of people being screened for cancer, and indirectly affect almost the whole population being screened for other diseases," he says. "Furthermore, the potential life savings and dollar savings of the proposed research are substantial."

Alagoz is conducting his work with an NSF Faculty Early Career Development (CAREER) award, which he received in 2009 as part of the American Recovery and Reinvestment Act. The award supports junior faculty who exemplify the role of teacher-scholars through outstanding research, excellent education, and the integration of education and research within the context of the mission of their organization. NSF is funding his work with about $430,000 over five years.

As part of the grant's educational component, he is training doctoral students to use such operations research techniques to solve complicated decision problems in medicine, and plans to integrate his findings into new courses. "The research will introduce operations research tools to the medical community through a successful application of these tools to a complicated and controversial problem in medicine," he says.

He says there were a number of computational challenges he had to overcome in developing the model, and hopes to soon test it in a local clinic, although widespread clinical practice is likely several years away. "This is really very much still only on paper and in the computer," he says.

His description of the algorithm and how it works appeared in the journal Operations Research.

"Every model is a representation of a real life system," he says. "For this algorithm to work, we have to somehow represent the existence of cancer and probability of getting it over a lifetime."

For this, he used the so-called Markov decision process model, a popular operations research tool used in various areas of applications. His model only considers the present state--for example, the current condition of a patient--to predict the probability of a future state, in this case, the chances of a patient's developing cancer over a certain time period.

"There are already several risk assessment/predictions models that can tell you the probability of getting cancer over the next five or ten years, but this model also will consider your preferences and your risk and tell you at what age you should get a mammogram," Alagoz says. "Then it will tell you, if it is negative, you should get it at such and such an age. It makes a recommendation to you about when you should get your next mammogram and all kinds of other statistics."

The major difference between this model and other existing predictive algorithms "is that it takes into account how the woman feels about the procedure," he says, citing fears over mammography, the risk of false positives that could result in unnecessary biopsies and other tests. "We have to somehow translate your feelings into numbers, that is, how much quality of life is lost due to your feeling toward mammography, a false positive, a biopsy, and the possibility of breast cancer."

Alagoz hopes to include compliance as a factor in the next generation model. "What if she doesn't come back, how should we adjust our model to recommend more or less aggressive screening?" he says. "If compliance is very high, then less aggressive screening recommendations make more sense."

He also is using the model for investigating important screening policy questions such as what age to stop screening, what ages should be screened more aggressively, and the role of compliance in screening recommendations, among other things.

Alagoz is conducting his research with input from the medical community.

"The physicians are helping me build the models," he says. "When you build these models, you have to make some assumptions. I am not a physician, so I meet with physicians/epidemiologists every week who help me build the correct models."

-- Marlene Cimons, National Science Foundation
Investigators
Oguzhan Alagoz
Related Institutions/Organizations
University of Wisconsin-Madison

U.S. TUBERCULOSIS TRENDS

FROM CENTERS FOR DISEASE CONTROL AND PREVENTION

1. Trends in Tuberculosis — United States, 2013

Data indicate that cases and rates of TB disease continue to fall in the U.S.; however, a higher burden in some populations – such as foreign-born individuals and racial/ethnic minorities – keeps TB elimination out of reach. Preliminary data from the CDC National TB Surveillance System show a total of 9,588 cases were reported in the U.S. in 2013, marking a 4.2 percent decline in the 2012 rate (from 3.2 to 3.0 cases per 100,000 population). Despite overall progress, the TB rate for foreign-born individuals is 13 times higher than among individuals born in the U.S., and the proportion of TB cases in the foreign-born group continues to increase. Racial disparities persist. Hispanics, blacks and Asians face higher TB rates—7, 7 and 26 times higher, respectively—than whites. Persons infected with HIV and people who are homeless are also especially vulnerable to TB. Although the proportion of drug-resistant cases remains relatively small, drug resistant TB is a concern because it is difficult and costly to treat and more often fatal. In 2012, multidrug-resistant TB accounted for 1.2 percent of cases (86 cases). Two cases of extensively-drug-resistant TB were reported in 2013. The authors note that eliminating TB in the U.S. requires continuing to address TB in affected populations and improvements in awareness, testing and treatment of TB disease.

2. Implementation of New TB Screening Requirements for U.S.-Bound Immigrants and Refugees — 2007–2014

Updated CDC recommendations for overseas tuberculosis screening of immigrants and refugees has resulted in better diagnosis of TB before individuals arrive in the United States. CDC reports the completion of implementation of new tuberculosis screening and treatment requirements for US-bound immigrants and refugees. Implementation of these requirements has resulted in twice as many cases of tuberculosis being diagnosed and treated before immigrants and refugees arrive in the U.S. compared with the previous screening program. Since the new requirements were implemented, reports of cases of foreign-born tuberculosis have declined. In addition, the increase in persons diagnosed and treated overseas is projected to result in a savings of more than $15 million in US health care costs.

UPDATE: MENINGOCOCCAL DISEASE

FROM:  CENTERS FOR DISEASE CONTROL AND PREVENTION 

Meningococcal Disease Update

On Monday, March 10, a Drexel University student tragically died from serogroup B meningococcal disease. CDC’s laboratory analysis shows that the strain in Princeton University’s serogroup B meningococcal disease outbreak matches the strain in the Drexel University case by “genetic fingerprinting.” This information suggests that the outbreak strain may still be present in the Princeton University community and we need to be vigilant for additional cases.

As with all cases of meningococcal disease, the local health department quickly and thoroughly investigated who has been in close contact with the Drexel University student prior to illness onset. Antibiotic prophylaxis to prevent additional cases of meningococcal disease was recommended and administered to those who had or may have had close contact. To date, no related cases among Drexel University students have been reported.

The public health investigation of the Drexel University student revealed that the student had been in close contact with students from Princeton University about a week before becoming ill. Princeton University has been experiencing a serogroup B meningococcal disease outbreak.

A high percentage of Princeton University undergraduates and eligible graduate students received 2 doses of the investigational serogroup B vaccine as part of a recent vaccination effort at Princeton University. There are currently no serogroup B vaccines licensed (approved) in the United States. Those who have received the investigational vaccine have likely protected themselves from getting sick (there have been no new cases among Princeton University students since the vaccination campaign began on December 9, 2013). Available data show most adolescents that get 2 doses of this vaccine are protected from getting meningococcal disease. However, vaccinated individuals may still be able to carry the bacteria in their throats, which could infect others through close contact.

The local health department and Drexel University are taking all the recommended steps to prevent additional cases. Because Drexel University is not experiencing an outbreak of serogroup B meningococcal disease, members of that community are not considered to be at increased risk.  The investigational serogroup B vaccine is not currently available to the Drexel University community.

We will continue to closely monitor the situation and determine next steps while local health authorities remain vigilant to recognizing and promptly treating any new cases. At this time, CDC does not recommend limiting social interactions or canceling travel plans as a preventive measure for meningococcal disease.

We recognize that when cases of meningococcal disease occur, there is increased concern about the potential spread of disease and desire to take appropriate steps to prevent additional cases. There is no evidence that family members and the community are at increased risk of getting meningococcal disease from casual contact with Princeton University students, faculty, or staff. Although transmission is from person-to-person, this organism is not highly contagious and requires sharing respiratory and oral secretions to spread. Those at highest risk for disease are people who have had close, prolonged, or face-to-face contact with someone who has meningococcal disease.

Students at both Universities should be especially vigilant to the signs and symptoms of meningococcal disease and seek urgent treatment if suspected. Symptoms may include sudden onset of a high fever, headache, stiff neck, nausea, vomiting, rapid breathing, or a rash. Handwashing and covering coughs and sneezes are also good practices to follow.

AGENT ORANGE HEALTH CONCERNS RAISED BY CREWS OF C-123 PROVIDER AIRCRAFT

       Fairchild C-123K Provider  U.S. Air Force

FROM:  DEPARTMENT OF VETERANS AFFAIRS 

Agent Orange Residue on Post-Vietnam War Airplanes

Some Veterans who were crew members on C-123 Provider aircraft, formerly used to spray Agent Orange during the Vietnam War, have raised health concerns about exposure to residual amounts of herbicides on the plane surfaces.
Responding to these concerns, VA asked the Institute of Medicine to study possible health effects. Results are expected in late 2014.
If you have health concerns, talk to your health care provider or local VA Environmental Health Coordinator.

Testing for Agent Orange residue on planes

The U.S. Air Force (USAF) collected and analyzed numerous samples from C-123 aircraft to test for Agent Orange. USAF's risk assessment report (April 27, 2012) (2.3 MB, PDF) found that potential exposures to Agent Orange in C-123 planes used after the Vietnam War were unlikely to have put aircrew or passengers at risk for future health problems. The report’s three conclusions:
There was not enough information and data to conclude how much individual persons would have been exposed to Agent Orange.

It is expected that exposure to Agent Orange in these aircraft after the Vietnam War was lower than exposure during the spraying missions in Vietnam.

Potential Agent Orange exposures were unlikely to have exceeded standards set by regulators or to have put people at risk for future health problems.
How Veterans may have been exposed

During the Vietnam War, the U.S. Air Force used C-123 aircraft to spray Agent Orange to clear jungles that provided enemy cover in Vietnam. At the end of the spraying campaign in 1971, the remaining C-123 planes were reassigned to reserve units in the U.S. for routine cargo and medical evacuation missions spanning the next 10 years.

Crew members aboard one of these post-Vietnam C-123 planes reported smelling strong odors, which raised concerns about Agent Orange exposure – but Agent Orange is odorless. These odors may have come from various chemicals associated with aircraft.

Health effects of Agent Orange residue

The health effects of exposure to Agent Orange residue on airplanes differ from direct contact with liquid Agent Orange. In liquid or spray form, Agent Orange can enter the body through inhalation or ingestion (such as hand-to-mouth contact or getting into food). But in the dry form – for example, adhered to a surface – Agent Orange residue cannot be inhaled or absorbed through the skin, and would be difficult to ingest.

The potential for health effects depends on the amount of Agent Orange present, as well as its ability to enter the body.

After reviewing available scientific reports in 2011 and 2012, VA concluded that the exposure potential in these planes was extremely low and therefore, the risk of long-term health effects is minimal. If crew exposure did occur, it is unlikely that sufficient amounts of dried Agent Orange residue could have entered the body to have caused harm.

We will continue to review new scientific information on this issue as it becomes available.

We’ve also asked the Institute of Medicine of the National Academy of Sciences, an independent non-governmental organization, to study possible health effects from Agent Orange in C-123 post-Vietnam crew members. Results are expected in late 2014.

Research studies on Agent Orange

Research on the health effects of Agent Orange has been extensive and it continues. Diverse populations have been studied, including herbicide sprayers and manufacturers, other Vietnam-era Veterans, and those exposed during industrial accidents. This information helps us to determine what potential health effects may be related to different levels of exposure.

Find out more about research on health effects of Agent Orange.
Health concerns?

If you have health concerns about Agent Orange, talk to your health care provider or local VA Environmental Health Coordinator.
Not enrolled in the VA health care system? Find out if you qualify for VA health care.

Compensation benefits for health problems

The risk of long-term health problems from exposure to Agent Orange residue on post-Vietnam C-123 airplanes is minimal. Veterans may file a claim for disability compensation for health problems they believe are related to exposure to Agent Orange residue on post-Vietnam C-123 airplanes. Veterans must show on a factual basis that they were exposed in order to receive disability compensation for diseases related to Agent Orange exposure.

U.S. AND 26 OTHER NATIONS COMMIT TO GLOBAL HEALTH SECURITY AGENDA GOALS

FROM:  U.S. HEALTH AND HUMAN SERVICES DEPARTMENT 
Nations Commit to Accelerating Progress against Infectious Disease Threats

The United States joins 26 countries, the World Health Organization (WHO), the Food and Agriculture Organization (FAO), and the World Organization for Animal Health (OIE), to accelerate progress toward a world safe and secure from the threat of infectious disease, and committing to the goals of the Global Health Security Agenda.

“Global health security is a shared responsibility; no one country can achieve it alone,” Health and Human Services Secretary Kathleen Sebelius said. “In the coming months, we will welcome other nations to join the United States and the 26 other countries gathered here in Washington and in Geneva, as we work to close the gaps in our ability to prevent, detect, and respond to infectious disease threats.”

Over the next five years the United States plans to work with at least 30 partner countries (containing at least 4 billion people) to prevent, detect and effectively respond to infectious disease threats, whether naturally occurring or caused by accidental or intentional releases of dangerous pathogens.

“While we have made great progress in fighting and treating diseases, biological threats can emerge anywhere, travel quickly, and take lives,” said Lisa Monaco, Assistant to the President for Homeland Security and Counterterrorism.  “The recent outbreaks of H7N9 influenza and Middle East Respiratory Syndrome are reminders of the need to step up our efforts as a global community.  The Global Health Security Agenda is about accelerating progress toward a world safe and secure from infectious disease threats.”

Later this year, the White House will host an event bringing together nations who are committed to protecting the world from infectious disease threats to review progress and chart the way forward on building a global system for preventing, detecting, and responding to such threats.

“The United States and the world can and must do more to prevent, detect, and respond to outbreaks as early and as effectively as possible,” CDC Director Dr. Tom Frieden said.  “CDC conducted two global health security demonstration projects last year in partnership with Vietnam and Uganda to strengthen laboratory systems, develop strong public health emergency operations centers, and create real-time data sharing in health emergencies.  CDC is committed to replicate the successes in these two projects in ten additional countries this year.”

In FY 2014, CDC and the Defense Threat Reduction Agency have jointly committed to accelerate progress on global health security by co-developing a strategy and devoting $40 million toward activities focusing on advancing the U.S. government's GHS objectives in ten nations.

The FY 2015 President’s Budget will include an increase of $45 million within CDC to prevent avoidable catastrophes, detect threats early, and mobilize effective responses to contain outbreaks.  The increase also would allow CDC to partner with up to ten countries in 2015 to begin implementation and accelerate successful CDC efforts including training of field epidemiologists, developing new diagnostic tests, building capacities to detect new pathogens, building public health emergency management capacity, and supporting outbreak responses.

Secretary Sebelius, Ms. Monaco and Dr. Frieden were joined at the launch meeting by representatives in Washington and Geneva from 26 other countries, three international organizations, and by other U.S. government officials, including Deputy Secretary of State Heather Higginbottom, Acting Deputy Secretary of Defense Christine Fox, and Department of Agriculture Chief Veterinary Officer John Clifford, whose agencies will lead efforts to fulfill the U.S. government commitment to global health security.

“Efforts to prevent deadly outbreaks strengthen geopolitical stability and security, Agriculture Secretary Tom Vilsack said. “None of us, not the public health, security or agriculture sectors can accomplish global health security on our own—it is obvious that an interdisciplinary approach is the best way to make progress.”

HHS, DoS, USDA, and DoD will work closely with global partners to build countries’ global health security capacities in areas such as surveillance, detection and response in order to slow the spread of antimicrobial resistance, establish national biosecurity systems, reduce zoonotic disease transmission, increase routine immunization, establish and strengthen national infectious disease surveillance and laboratory systems, and develop public health electronic reporting systems and emergency operations centers.

“The Global Health Security Agenda set forth today establishes a roadmap for progress that ultimately depends on collaboration between the health and security communities,” said Acting Deputy Defense Secretary Fox. “The Department of Defense is committed to continuing our work, together with our national and international partners, to strengthen global health security.”

Countries joining the United States to meet the Global Health Security goals at today’s launch were Argentina, Australia, Canada, Chile, China, Ethiopia, Finland, France, Georgia, Germany, India, Indonesia, Italy, Japan, Kazakhstan, Mexico, Netherlands, Norway, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Turkey, Uganda, United Kingdom, and, Vietnam.

CDC REPORTS ON VIRAL SUPPRESSION OF HIV INFECTION

FROM:  CENTERS FOR DISEASE CONTROL 

Prevalence and Predictors of Viral Suppression Among Persons with Diagnosed HIV Infection Retained in Care — Georgia, 2010

Not all persons with HIV who are receiving and remain in medical care achieve the goal of viral suppression, and fewer persons diagnosed with early stage disease achieve viral suppression compared with persons diagnosed with late stage disease. Health-care providers and community-based organizations should implement the national HIV treatment guidelines by initiating antiretroviral therapy (ART) at any stage of disease and explain to patients the benefits of taking ART earlier and regularly to achieve viral suppression. Early diagnosis of HIV infection and treatment to achieve viral suppression can benefit patients by improving their health status and the community by reducing HIV transmission. This analysis in Georgia, however, found that some persons who receive and remain in care don’t achieve viral suppression. In addition, the analysis found fewer persons diagnosed with early stage disease achieved viral suppression compared with persons diagnosed with late stage disease.

CDC ON TREATING HEAD LICE

FROM:  CENTERS FOR DISEASE CONTROL AND PREVENTION

Head lice. Every parent’s nightmare.
A year-round problem, the number of cases seems to peak when the kids go back to school in the fall and again in January, says Patricia Brown, M.D., a dermatologist at the Food and Drug Administration (FDA).

An estimated 6 to 12 million cases of head lice infestation occur each year in the United States in children 3 to 11 years of age, according to the Centers for Disease Control and Prevention. Head lice are most common among preschool children attending child care, elementary school children, and household members of children who have lice.

Contrary to myth, head lice are not caused by poor hygiene, Brown says. They are spread mainly by direct head-to-head contact with a person who already has head lice. You cannot get head lice from your pets; lice feed only on humans.

Lice don’t fly or jump; they move by crawling. But because children play so closely together and often in large groups, lice can easily travel from child to child, especially when they touch heads during playing or talking.


Blood-Sucking Bugs

Head lice are blood-sucking insects about the size of a sesame seed and tan to grayish-white in color. They attach themselves to the skin on the head and lay eggs (nits) in the hair.

According to Brown, you can check for head lice or nits by parting the hair in several spots. You can use a magnifying glass and a bright light to help spot them. Because head lice can move fast it may be easier to spot the nits. Nits can look like dandruff, but you can identify them by picking up a strand of hair close to the scalp and pulling your fingernail across the area where you suspect a nit. Dandruff will come off easily, but nits will stay firmly attached to the hair, Brown explains.

FDA-approved treatments for head lice include both over-the-counter (OTC) and prescription drugs, such as Nix and Rid, in the form of shampoos, creams and lotions. “Many head lice products are not for use in children under the age of 2, so read the label carefully before using a product to make sure it is safe to use on your child,” Brown says.

Although OTC drugs are available for treatment of head lice, Brown says your health care professional may prescribe drugs recently approved by the FDA, such as Ulesfia (approved in 2009), Natroba (approved in 2011) or Sklice (approved in 2012).


Steps for Safe Use

Follow these steps to use any head lice treatment safely and appropriately:
After rinsing the product from the hair and scalp, use a fine-toothed comb or special “nit comb” to remove dead lice and nits.

Apply the product only to the scalp and the hair attached to the scalp—not to other body hair.

Before treating young children, talk with the child’s doctor or your pharmacist for recommended treatments based on a child’s age and weight.
Use medication exactly as directed on the label and never more often than directed unless advised by your health care professional.
Use treatments on children only under the direct supervision of an adult.

Heading Off Head Lice

Teach children to avoid head-to-head contact during play and other activities at home, school, and elsewhere (sports activities, playgrounds, slumber parties, and camps).

Teach children not to share clothing and supplies, such as hats, scarves, helmets, sports uniforms, towels, combs, brushes, bandanas, hair ties, and headphones.
Disinfest combs and brushes used by a person with head lice by soaking them in hot water (at least 130°F) for 5–10 minutes.

Do not lie on beds, couches, pillows, carpets, or stuffed animals that have recently been in contact with a person with head lice.

Clean items that have been in contact with the head of a person with lice in the 48 hours before treatment. Machine wash and dry clothing, bed linens, and other items using hot water (130°F) and a high heat drying cycle. Clothing and items that are not washable can be dry-cleaned or sealed in a plastic bag and stored for two weeks.

Vacuum the floor and furniture, particularly where the person with lice sat or lay. Head lice survive less than one or two days if they fall off the scalp and cannot feed.

Do not use insecticide sprays or fogs; they are not necessary to control head lice and can be toxic if inhaled or absorbed through the skin.

After finishing treatment with lice medication, check everyone in your family for lice after one week. If live lice are found, contact your health care professional.
Heading Off Head Lice source: Centers for Disease Control and Prevention
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Updated: January 23, 2014