CDC SAYS 3/4 U.S. ADULTS FAVOR 21 AS THE MINIMUM AGE TO BUY TOBACCO PRODUCTS

FROM:  U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION
Three out of 4 American adults favor making 21 the minimum age of sale for tobacco products
Seven in 10 cigarette smokers favor raising age of sale

Three out of 4 American adults—including 7 in 10 cigarette smokers—favor raising the minimum age of sale for all tobacco products to 21, according to an article by CDC published in the American Journal of Preventive Medicine.  While an overwhelming majority of adults favored the policy overall, favorability is slightly higher among adults who never smoked and older adults. In contrast, 11 percent of adults strongly opposed making 21 the legal age of sale, while 14 percent somewhat opposed such measures.

In most states, the minimum age of sale for tobacco is 18; in Alabama, Alaska, New Jersey and Utah the minimum age of sale is 19. One state—Hawaii—currently prohibits sales of tobacco products to youth under the age of 21. Additionally, several cities and counties across the U.S. have adopted laws raising the minimum age to 21, starting with Needham, Massachusetts, in 2005. New York City; Hawaii County, Hawaii; Evanston, Illinois; Englewood, New Jersey; Columbia, Missouri; and several other communities in Massachusetts later followed suit.

“Raising the minimum age of sale to 21 could benefit the health of Americans in several ways,” said Brian King, Ph.D., acting Deputy Director for Research Translation in CDC’s Office on Smoking and Health. “It could delay the age of first experimenting with tobacco, reducing the likelihood of transitioning to regular use and increasing the likelihood that those who do become regular users can quit.”

Data for the study came from Styles, a nationally representative online survey of U.S. adults aged 18 and older. The findings are consistent with those from a national survey conducted in 2013 and polls of voters in Colorado and Utah that found 57 percent and 67 percent, respectively, favor such policies. Favorability for the policies was found to increase with increasing age.

According to the 2014 Surgeon General Report, the tobacco industry aggressively markets and promotes its products and continues to recruit youth and young adults as new consumers. People who begin smoking at a young age are more likely to become addicted, to progress to daily use, to smoke more as they grow into adulthood, and to have trouble quitting.  A previous Surgeon General Report found about 96 percent of adult smokers first try cigarettes by the age of 21.

Age-of-sale restrictions have been shown to contribute to reductions in tobacco use and dependency among youth. In March 2015, an Institute of Medicine (IOM) report found that increasing the legal age of sale for tobacco will likely prevent or delay tobacco use initiation by adolescents and young adults. The IOM found that if all states were to raise the minimum age of sale for all tobacco products to 21, there would be a 12 percent decrease in cigarette smoking prevalence across the nation by 2100. This would translate into nearly 250,000 fewer premature deaths from cigarette smoking among people born between 2000 and 2019.

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.

HHS REPORTS ON QUICK AND EASY TEST FOR EBOLA VIRUS

FROM:  U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
HHS pursues fast, easy test to detect Ebola virus infections
Promising point-of-care test could improve diagnosis and speed response

To assist doctors in diagnosing Ebola virus disease quickly, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) will pursue development of an Ebola virus diagnostic test for use in a doctor’s office, hospital, clinic, or field setting that will provide results within 20 minutes.

“Fast and inexpensive point-of-care diagnostics will improve our ability to control Ebola virus disease outbreaks,” said Robin Robinson, Ph.D., director of ASPR’s Biomedical Advanced Research and Development Authority (BARDA), which will oversee this development program for HHS. “Faster diagnosis of Ebola virus infections allows for more immediate treatment and an earlier response to protect public health worldwide.”

Diagnosing Ebola virus infections quickly in resource-poor areas would enable health care providers to isolate and provide necessary treatment and supportive care to patients suffering from Ebola. Quickly isolating patients helps limit the spread of the disease. Emerging evidence has shown that early initiation of supportive care improves outcomes for patients suffering from Ebola virus disease.

The development of this simple, low-cost, lateral-flow test, called the OraQuick rapid Ebola antigen test, will take place under a $1.8 million contract with OraSure Technologies Inc., headquartered in Bethlehem, Pennsylvania. Lateral flow tests detect the presence of a virus with a drop of the patient’s blood or saliva on a test strip, similar to the tests used in doctors’ offices to diagnose strep throat.

The agreement supports clinical and non-clinical work necessary to apply for approval of the test by the U.S. Food and Drug Administration. The contract could be extended for up to a total of 39 months and $10.4 million.

In addition, OraSure will evaluate whether the test can be used in the post-mortem analysis of oral fluids. During the current epidemic, people died before Ebola virus infections could be confirmed, yet the bodies of people infected with Ebola virus would have remained highly infectious. A simple, rapid test that could determine disease status quickly from the body’s oral fluids would facilitate infection control efforts and support the appropriate handling of remains infected with the Ebola virus.

The OraQuick rapid Ebola antigen test is the first point-of-care Ebola virus testing device to receive BARDA support. To help the United States prepare for and control Ebola virus disease outbreaks, BARDA also is supporting development of vaccines to prevent Ebola virus infections and therapeutic drugs to treat the disease.

BARDA is seeking additional proposals for advanced development of new drugs and products to diagnose and treat Ebola and related illnesses.

The new test is part of BARDA’s comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases.

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. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

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 REPORTS ON HEPATITIS B SCREENING AMONG RESETTLED REFUGEES

FROM:  U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION
Hepatitis B Screening and Prevalence Among Resettled Refugees — United States, 2006‒2011

Refugees are a heterogeneous population and hepatitis B prevalence is associated with country of origin and individual lived experience. Ongoing health surveillance activities focused on refugees are essential to ensuring appropriate assessment and treatment following resettlement. Hepatitis B is a viral disease that can be acute or chronic and is a significant public health concern both globally and in the United States. Refugees frequently emigrate from countries with high prevalence of active hepatitis B infection (≥2 percent), and/or are at higher risk of hepatitis B infection due to their lived experiences as refugees. However, refugees are a heterogeneous group and recent data are not available regarding prevalence of hepatitis B in recently resettled refugee communities. States, local health departments, healthcare providers, resettlement agencies, refugees, and other stakeholders may better target education and screening programs based on the prevalence of hepatitis B among the three refugee groups to have resettled in the greatest numbers over the last several years: Iraqis, Bhutanese, and Burmese.

CDC REPORTS ON CIGARETTE SMOKING AND SMOKELESS TOBACCO USE AMONG ADULTS

FROM:  CENTERS FOR DISEASE CONTROL AND PREVENTION
State-specific Prevalence of Current Cigarette Smoking and Smokeless Tobacco Use Among Adults Aged ≥18 years — United States, 2011–2013

These findings underscore the importance of effective population-based interventions focused on reducing the use of all tobacco products. From 2011 to 2013, there was a decline in current cigarette smoking prevalence in 26 states. During the same period, use of smokeless tobacco significantly increased in Louisiana, Montana, South Carolina, and West Virginia. Additionally, the concurrent use of cigarette smoking and smokeless tobacco significantly increased in Delaware, Idaho, Nevada, New Mexico and West Virginia. The use of more than one tobacco product is concerning because adults who use both cigarettes, and smokeless tobacco have higher levels of nicotine dependence and are less likely to report planning to quit than those who exclusively smoke cigarettes. Evidence-based, statewide tobacco control programs that are comprehensive, sustained, and accountable have been shown to reduce smoking rates, as well as tobacco-related diseases and deaths.

CDC REPORT CENTERS ON SWIMMING RISK OF NOROVIRUS SICKNESS

FROM:  U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION
Study Highlights Risk of Norovirus from Swimming
Simple tips can help swimmers stay safe in various swimming venues.

When most people think of norovirus, they think of people marooned on a cruise ship with raging stomach and intestinal illness, unable to leave their cabins. However, an outbreak at an Oregon lake underscores that swimming can also put the public at risk of catching the ugly bug. Fortunately, following a few easy and effective steps can help maximize the health benefits of swimming while minimizing the risk of getting sick.

In honor of Healthy and Safe Swimming week, experts from the Centers for Disease Control and Prevention and local and state health officials in Oregon report today on a summer 2014 outbreak that spread via swimming in a contaminated lake.

The norovirus outbreak in July 2014 linked to a lake near Portland, Oregon sickened 70 people. Those who swam in the lake were 2.3 times more likely to develop vomiting or diarrhea than those who visited the park but didn’t go in the water. More than half of those who got ill were children between 4–10 years old. Experts believe the outbreak began after a swimmer infected with norovirus had diarrhea or vomited in the water and other swimmers swallowed the contaminated water. To prevent other people from getting sick, park officials closed the lake to swimmers for 10 days.

“Children are prime targets for norovirus and other germs that can live in lakes and swimming pools because they’re so much more likely to get the water in their mouths,” said Michael Beach, Ph.D, CDC’s associate director for healthy water. “Keeping germs out of the water in the first place is key to keeping everyone healthy and helping to keep the places we swim open all summer.”

Swimmers can help protect themselves, their families and friends by following a few easy and effective steps:

Keep the pee, poop, sweat, and dirt out of the water!

Don’t swim if you have diarrhea or have been vomiting
Shower before you get in the water
Don’t pee or poop in the water
Don’t swallow lake or pool water
Every hour—everyone out!

Take kids on bathroom breaks
Check diapers, and change them in a bathroom or diaper-changing area–to keep germs away from the water.

Norovirus was the second-leading cause of outbreaks in untreated recreational water, such as lakes, from 1978-2010. Norovirus can live in water for several months or possibly even years. Swimming venues that are not treated with chlorine can pose a particular risk since there are no chemicals to kill the stomach virus.  

May 18–24, 2015, marks the 11th annual Healthy and Safe Swimming Week (formerly known as Recreational Water Illness and Injury Prevention Week). This observance highlights ways in which swimmers, parents, pool owners and operators, beach managers, and public health can maximize the health benefits of water-based physical activity, while minimizing the risk of recreational water–associated illness and injury.

WHITE HOUSE STATEMENT ON LIBERIA AND NEW EBOLA CASES

FROM:  THE WHITE HOUSE
May 09, 2015
Statement by the Press Secretary on Liberia

Today, the Republic of Liberia reached the important milestone of 42 days without reporting a new Ebola case, and we are pleased the World Health Organization was able to declare the end of the country’s current outbreak.  We congratulate the people of Liberia on reaching this important marker, and once again pledge our commitment to ending the Ebola outbreak in West Africa and helping to rebuild Liberia and other affected nations.  As President Obama said when Liberian President Ellen Johnson Sirleaf visited the White House last month, “We’re proud to partner with you and we intend to see this through until the job is done.” While this milestone is important, the world must not forget that the Ebola outbreak still persists in neighboring Sierra Leone and Guinea.  We must not let down our guard until the entire region reaches and stays at zero Ebola cases. And we must all work together to strengthen capacity around the world to prevent, detect, and rapidly respond to outbreaks before they become epidemics.

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

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.

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.

PRESIDENT OBAMA'S WEEKLY ADDRESS FOR MAY 31, 2014

FROM:  THE WHITE HOUSE 

Weekly Address: Reducing Carbon Pollution in Our Power Plants

WASHINGTON, DC — In this week’s address, President Obama discussed new actions by the Environmental Protection Agency to cut dangerous carbon pollution, a plan that builds on the efforts already taken by many states, cities and companies. These new commonsense guidelines to reduce carbon pollution from power plants were created with feedback from businesses, and state and local governments, and they would build a clean energy economy while reducing carbon pollution. The President discussed this new plan from the Children’s National Medical Center in Washington, D.C., where he visited children whose asthma is aggravated by air pollution.  As a parent, the President said he is dedicated to make sure our planet is cleaner and safer for future generations.

Remarks of President Barack Obama
Weekly Address
Children’s National Medical Center in Washington, D.C.
May 31, 2014

Hi, everybody.  I’m here at Children’s National Medical Center in Washington, D.C., visiting with some kids being treated here all the time for asthma and other breathing problems.  Often, these illnesses are aggravated by air pollution – pollution from the same sources that release carbon and contribute to climate change.  And for the sake of all our kids, we’ve got to do more to reduce it.

Earlier this month, hundreds of scientists declared that climate change is no longer a distant threat – it “has moved firmly into the present.” Its costs can be measured in lost lives and livelihoods, lost homes and businesses; and higher prices for food, insurance, and rebuilding.

That’s why, last year, I put forward America’s first climate action plan.  This plan cuts carbon pollution by building a clean energy economy – using more clean energy, less dirty energy, and wasting less energy throughout our economy. 

One of the best things we can do for our economy, our health, and our environment is to lead the world in producing cleaner, safer energy – and we’re already generating more clean energy than ever before.  Thanks in part to the investments we made in the Recovery Act, the electricity America generates from wind has tripled.  And from the sun, it’s increased more than tenfold. In fact, every four minutes, another American home or business goes solar – and every panel is pounded into place by a worker whose job cannot be shipped overseas.

We’re wasting less energy, too.  We’ve doubled how far our cars and trucks will go on a gallon of gas by the middle of the next decade, saving you money at the pump – and we’re helping families and businesses save billions with more efficient homes, buildings, and appliances.

This strategy has created jobs, grown our economy, and helped make America more energy independent than we’ve been in decades – all while holding our carbon emissions to levels not seen in about 20 years.  It’s a good start.  But for the sake of our children, we have to do more. 

This week, we will.  Today, about 40% of America’s carbon pollution comes from power plants.  But right now, there are no national limits to the amount of carbon pollution that existing plants can pump into the air we breathe. None. We limit the amount of toxic chemicals like mercury, sulfur, and arsenic that power plants put in our air and water.  But they can dump unlimited amounts of carbon pollution into the air.  It’s not smart, it’s not safe, and it doesn’t make sense.

That’s why, a year ago, I directed the Environmental Protection Agency to build on the efforts of many states, cities, and companies, and come up with commonsense guidelines for reducing dangerous carbon pollution from our power plants.  This week, we’re unveiling these proposed guidelines, which will cut down on the carbon pollution, smog, and soot that threaten the health of the most vulnerable Americans, including children and the elderly.  In just the first year that these standards go into effect, up to 100,000 asthma attacks and 2,100 heart attacks will be avoided – and those numbers will go up from there. 

These standards were created in an open and transparent way, with input from the business community.  States and local governments weighed in, too.  In fact, nearly a dozen states are already implementing their own market-based programs to reduce carbon pollution.  And over 1,000 mayors have signed agreements to cut their cities’ carbon pollution. 

So the idea of setting higher standards to cut pollution at our power plants is not new.  It’s just time for Washington to catch up with the rest of the country.

Now, special interests and their allies in Congress will claim that these guidelines will kill jobs and crush the economy.  Let's face it, that’s what they always say. 

But every time America has set clear rules and better standards for our air, our water, and our children’s health – the warnings of the cynics have been wrong.  They warned that doing something about the smog choking our cities, and acid rain poisoning our lakes, would kill business.  It didn’t.  Our air got cleaner, acid rain was cut dramatically, and our economy kept growing.

These excuses for inaction somehow suggest a lack of faith in American businesses and American ingenuity.  The truth is, when we ask our workers and businesses to innovate, they do.  When we raise the bar, they meet it.  When we restricted cancer-causing chemicals in plastics and leaded fuel in our cars, American chemists came up with better substitutes.  When we phased out the gases that depleted the ozone layer, American workers built better refrigerators and air conditioners.  The fuel standards we put in place a few years ago didn’t cripple automakers; the American auto industry retooled, and today, they’re selling the best cars in the world, with more hybrids, plug-in, and fuel-efficient models to choose from than ever before.

In America, we don’t have to choose between the health of our economy and the health of our children.  The old rules may say we can’t protect our environment and promote economic growth at the same time, but in America, we’ve always used new technology to break the old rules.

As President, and as a parent, I refuse to condemn our children to a planet that’s beyond fixing.  The shift to a cleaner energy economy won’t happen overnight, and it will require tough choices along the way.  But a low-carbon, clean energy economy can be an engine of growth for decades to come.  America will build that engine.  America will build the future.  A future that’s cleaner, more prosperous, and full of good jobs – a future where we can look our kids in the eye and tell them we did our part to leave them a safer, more stable world.

Thanks, and have a great weekend.

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.

HHS SAYS U.S. POPULATION GETTING HEALTHIER

FROM:  DEPARTMENT OF HEALTH AND HUMAN SERVICES

HHS announces progress in disease prevention and health promotion

The nation’s health is improving in more than half of the critical measures that are known to have major influence in reducing preventable disease and death, according to a new report from the U.S. Department of Health and Human Services.

Healthy People 2020 represents the nation’s current 10-year goals and objectives for health promotion and disease prevention. Twenty-six specific measures—in categories such as access to care, maternal and child health, tobacco use, nutrition and physical activity—were identified as high-priority health issues. These Leading Health Indicators (LHI), if addressed appropriately, have the potential to significantly reduce major influences or threats on the public’s health that cause illness and death.

“The Leading Health Indicators are intended to motivate action to improve the health of the whole population. Today’s LHI Progress Report shows that we are doing just that,” says Dr. Howard Koh, Assistant Secretary for Health. Koh also notes that with the full implementation of the Affordable Care Act, we can expect to see more improvements across these indicators.

There are 14 health indicators that have either been met or are improving in this first third of the decade, including:

Fewer adults smoking cigarettes;
Fewer children exposed to secondhand smoke;
More adults meeting physical activity targets; and
Fewer adolescents using alcohol or illicit drugs.
While progress has been made across several indicators, the LHI Progress Report highlights areas where further work is needed to improve the health of all Americans. There are 11 Leading Health Indicators that have not shown significant improvement at this point in the decade, and 1 indicator where only baseline data are available.

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.

FDA APPROVES EXPANDED USE OF IMBRUVICA TO TREAT CHRONIC LYMPHOCYTIC LEUKEMIA

FROM:  FOOD AND DRUG ADMINISTRATION 
FDA NEWS RELEASE
For Immediate Release: Feb. 12, 2014
FDA approves Imbruvica to treat chronic lymphocytic leukemia

The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.

CLL is a rare blood and bone marrow disease that usually gets worse slowly over time, causing a gradual increase in white blood cells called B lymphocytes, or B cells. The National Cancer Institute estimates that 15,680 Americans were diagnosed and 4,580 died from the disease in 2013.

Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide. In November 2013, the FDA granted Imbruvica accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer, if those patients received at least one prior therapy.

“Today’s approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA completed its review of Imbruvica’s new indication under the agency’s accelerated approval process, which played a vital role in rapidly making this new therapy available to those who need it most.”

Under the agency’s accelerated approval process, the FDA may approve a drug based on a surrogate or intermediate endpoint that is reasonably likely to predict clinical benefit. Drugs receiving accelerated approval are usually subject to an agreement to conduct confirmatory trials verifying and describing clinical benefit. Imbruvica for CLL also received priority review and orphan-product designation because the drug demonstrated the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition and is intended to treat a rare disease, respectively.

The FDA’s accelerated approval of Imbruvica for CLL is based on a clinical study of 48 previously treated participants. On average, participants were diagnosed with CLL 6.7 years prior to the study and had received four previous therapies. All study participants received a 420 milligram orally administered dose of Imbruvica until the treatment reached unacceptable toxicity or the disease progressed. Results showed nearly 58 percent of participants had their cancer shrink after treatment (overall response rate). At the time of the study, the duration of response ranged from 5.6 to 24.2 months. An improvement in survival or disease-related symptoms has not been established.

The most common side effects observed in the clinical study include low levels of platelets in the blood (thrombocytopenia), diarrhea, bruising, a decrease in infection-fighting white blood cells (neutropenia), low red blood cells (anemia), upper respiratory tract infection, fatigue, pain in the muscles and bones (musculoskeletal pain), rash, fever (pyrexia), constipation, swelling of tissues (peripheral edema), joint pain (arthralgia), nausea, mouth sores (stomatitis), sinus infection (sinusitis) and dizziness.

Imbruvica is manufactured by Sunnyvale, Calif.-based Pharmacyclics.

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

CDC SAYS "OPPORTUNITY FOR CHOICE" EXISTS IF SODIUM LOWERED IN RESTAURANT FOODS

FROM:  CENTERS FOR DISEASE CONTROL AND PREVENTION 
Press Release Reducing sodium in restaurant foods is an opportunity for choice
Communities reduce, replace, reformulate to offer lower-sodium options

Americans eat out at fast food or dine-in restaurants four or five times a week. Just one of those meals might contain more than an entire day’s recommended amount of sodium. CDC has strategies for health departments and restaurants to work together to offer healthier choices for consumers who want to lower their sodium intake. The report, “From Menu to Mouth: Opportunities for Sodium Reduction in Restaurants,” is published in today’s issue of CDC’s journal, Preventing Chronic Disease.

On average, foods from fast food restaurants contain 1,848 mg of sodium per 1,000 calories and foods from dine-in restaurants contain 2,090 mg of sodium per 1,000 calories. The U. S. Dietary Guidelines recommend the general population limit sodium to less than 2,300 mg a day. Too much sodium can cause high blood pressure, one of the leading causes of heart disease and stroke.

“The bottom line is that it’s both possible and life-saving to reduce sodium, and this can be done by reducing, replacing and reformulating,” said CDC Director Tom Frieden, M.D., M.P.H. “When restaurants rethink how they prepare food and the ingredients they choose to use, healthier options become routine for customers.”

EPA WARNING ABOUT CARBON MONOXIDE POISONING

FROM:  U.S. ENVIRONMENTAL PROTECTION AGENCY 
Sources of Carbon Monoxide

Unvented kerosene and gas space heaters; leaking chimneys and furnaces; back-drafting from furnaces, gas water heaters, wood stoves, and fireplaces; gas stoves; generators and other gasoline powered equipment; automobile exhaust from attached garages; and tobacco smoke. Incomplete oxidation during combustion in gas ranges and unvented gas or kerosene heaters may cause high concentrations of CO in indoor air. Worn or poorly adjusted and maintained combustion devices (e.g., boilers, furnaces) can be significant sources, or if the flue is improperly sized, blocked, disconnected, or is leaking. Auto, truck, or bus exhaust from attached garages, nearby roads, or parking areas can also be a source.


Health Effects Associated with Carbon Monoxide

At low concentrations, fatigue in healthy people and chest pain in people with heart disease. At higher concentrations, impaired vision and coordination; headaches; dizziness; confusion; nausea. Can cause flu-like symptoms that clear up after leaving home. Fatal at very high concentrations. Acute effects are due to the formation of carboxyhemoglobin in the blood, which inhibits oxygen intake. At moderate concentrations, angina, impaired vision, and reduced brain function may result. At higher concentrations, CO exposure can be fatal.

Levels in Homes

Average levels in homes without gas stoves vary from 0.5 to 5 parts per million (ppm). Levels near properly adjusted gas stoves are often 5 to 15 ppm and those near poorly adjusted stoves may be 30 ppm or higher.


Steps to Reduce Exposure to Carbon Monoxide

It is most important to be sure combustion equipment is maintained and properly adjusted. Vehicular use should be carefully managed adjacent to buildings and in vocational programs. Additional ventilation can be used as a temporary measure when high levels of CO are expected for short periods of time.

Keep gas appliances properly adjusted.
Consider purchasing a vented space heater when replacing an unvented one.
Use proper fuel in kerosene space heaters.
Install and use an exhaust fan vented to outdoors over gas stoves.
Open flues when fireplaces are in use.
Choose properly sized wood stoves that are certified to meet EPA emission standards. Make certain that doors on all wood stoves fit tightly.
Have a trained professional inspect, clean, and tune-up central heating system (furnaces, flues, and chimneys) annually. Repair any leaks promptly.
Do not idle the car inside garage.
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Measurement Methods

Some relatively high-cost infrared radiation adsorption and electrochemical instruments do exist. Moderately priced real-time measuring devices are also available. A passive monitor is currently under development.