State-by-state analysis shows Montana insurers top list with 45% average rejection rate
HealthPocket looks at which health insurance companies reject applicants most frequently
SUNNYVALE, Calif., Jan. 24, 2013 /PRNewswire-USNewswire/ -- A new analysis from HealthPocket, Inc., shows that the health insurance industry averages an application rejection rate of 22 percent of submitted individual and family applications nationally. States with the highest percentage of area insurer rejections are Montana (45%), Alabama (40%), District of Columbia (37%), Arkansas (35%) and Alaska (34%).
The analysis shows wide variation across the country in how often applicants are rejected by health insurers. Some insurers have declination rates greater than 70 percent; others rarely decline applicants. There is also significant variability within insurance companies across different markets. Kaiser Permanente plans in Georgia have a declination rate of 34 percent, but in Hawaii the same company has a much lower rate of 22 percent. Nationwide, insurers' average rejection rate exceeds one in five applications within the individual and family insurance markets?significantly higher than findings from a 2010 congressional study of the largest for-profit insurers, which found a declination rate of one in seven applications.
"Clearly there is great variability across states and within states in terms of how frequently an insurer rejects a health insurance application, but nationally it seems to be occurring more frequently than industry analysts had assumed," said Kev Coleman, head of research & data at HealthPocket. "What is unclear is whether some insurers have increased their declination rate in order to improve risk pool health and profitability prior to 2014, when insurance companies can no longer reject applications based upon health status or pre-existing medical conditions."
Experts say that health insurance declination rates are a serious issue for consumers, with hundreds of thousands of people being rejected for coverage each year. A health insurance application rejection from one company can negatively affect applications from other companies since insurers typically ask about previous denials when evaluating an application.
The analysis also shows:
Plans with the five highest declination rates include South Dakota's John Alden Life Insurance Company (73%), Utah's Assurant Health (71%), North Dakota's Assurant Health (58%), Kentucky's Time Insurance Company (56%), and Idaho's Assurant Health (56%).
States whose insurers have the highest declination rates include Montana (45%), Alabama (40%), D.C. (37%), Arkansas (35%) and Alaska (34%); Maine, Massachusetts, New Jersey, New York, and Vermont have a zero rating.
Some non-profit insurance companies have higher declination rates than for-profit insurers. Kaiser Permanente in Georgia, for example, has a declination rate of 34 percent while Humana, a large for-profit insurer in Georgia, has a declination rate of 23 percent.
HealthPocket analyzed publicly available insurance records of 9,450 plans for individuals and families under the age of 65 to determine the average declination rate of health insurance applications, and compared this average to the declination rate of individual insurers. HealthPocket.com is a free website that compares and ranks all health plans available to an individual, family, or employer in a given area, all at once. HealthPocket uses only objective data from government, non-profit, and private sources that carry no conditions that might restrict the site from serving as an unbiased resource for consumers. The founders of HealthPocket.com spent decades pioneering online access to health insurance information and launched the company in late 2012.
The HealthPocket InfoStat is one of its ongoing efforts to use health plan data to produce objective, meaningful, and clarifying information and guidance for consumers. To review declination rates for individual plans available in a given geographic area, visit HealthPocket's individual and family health insurance comparison tool, which lists the rate for each plan on its Plan Details page.
About HealthPocket HealthPocket.com is a free website that compares and ranks all health plans available to an individual, family, or employer in a given area, all at once. The Company uses only objective data from government, non-profit, and private sources that carry no conditions that might restrict the site from serving as an unbiased resource for consumers. The founders of HealthPocket.com spent decades pioneering online access to health insurance information and knew they could offer something different that can positively change how people buy and use healthcare in the U.S. Learn more at www.HealthPocket.com.
NEW YORK (AP) ? McDonald's profit rose with the help of its Dollar Menu in the latest quarter. Now the world's biggest hamburger chain is turning to a pipeline of new menu items to boost slumping sales, starting with its "Fish McBites."
The Oak Brook, Ill.-based company is betting that it will be able to fend off intensifying competition and economic pressures with the lineup, which executives said includes new burgers, chicken entrees and breakfast offerings that are performing well in test markets. The Fish McBites, which will come in three sizes and use the same fish used in the Filet-O-Fish, are set to be launched in February.
The rollout of the new menu items will come after McDonald's managed to eke out a higher profit for the October-to-December period with a series of short-term moves, such as touting its Dollar Menu, shifting the release of its McRib from October to December and pushing franchisees to stay open on Christmas.
In November, the company ousted the president of its U.S. business after a key sales figure dropped for the first time in nearly a decade. CEO Don Thompson said Wednesday that the figure is expected to drop again in January.
"By no means do we think 2013 is going to be an easy year," CEO Don Thompson said in a conference call with analysts. He noted that growth in restaurant industry has been relatively flat to declining around the world, with that trend expected to continue.
In addition a more "robust" pipeline of new products, McDonald's executives said they'll also boost sales by continuing with remodeling efforts and extending store hours around the world.
Although McDonald's said it increased its U.S. market share this past year, the chain is facing tougher competition from traditional rivals such as Burger King, Taco Bell and Wendy's, which have been revamping their menus and posing a bigger threat. In addition, people are increasingly heading to chains such as Chipotle and Panera that offer higher-quality food for slightly higher prices.
For the October-to-December period, McDonald's said sales at restaurants open at least a year rose 0.1 percent globally and 0.3 percent in the U.S. But in Europe, McDonald's biggest market, the figure fell 0.6 percent as guest counts declined. It fell 1.7 percent in the region encompassing Asia, the Middle East and Africa.
In China, where the figure fell 0.9 percent, McDonald's downplayed the effect of recent public concerns over its chicken suppliers. Yum Brands Inc., which owns KFC, has said it expects its sales in the region to fall 6 percent, in part because of the issue.
The figure is an important measure of a restaurant chain's performance because it strips out the impact of newly opened and closed locations.
Howard Penney, a restaurant analyst for Hedgeye Risk Management, questioned McDonald's recent emphasis on value and noted that operating profit margins fell globally for the quarter. When sales are up but margins are down, that means "you're giving away food," he said.
Moving forward, however, the company said it didn't plan to add many items to its Dollar Menu unless they are more profitable items, such as the cheddar grilled onion burger that was introduced in December.
McDonald's Corp., based in Oak Brook, Ill., said it earned $1.4 billion, or $1.38 per share, for the quarter. That compares with $1.38 billion, or $1.33 per share, a year ago.
Revenue rose to $6.95 billion, up from $6.82 billion.
The results topped expectations for profit of $1.33 per share on revenue of $6.9 billion.
In the year ahead, the company expects costs for ingredients to rise 1.5 percent to 2.5 percent. Labor costs will also continue pressuring profit margins, executives said.
Thompson, who took over as CEO this summer, said the company continues to target total sales growth of 3 percent to 5 percent over the long term. McDonald's plans to open between 1,500 and 1,600 restaurants this year. It currently has about 34,000.
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Follow Candice Choi at www.twitter.com/candicechoi
FILE - In this Oct. 20, 2012 photo, people line up to enter a newly-opened Apple Store in Wangfujing shopping district in Beijing. Apple's profit surge halted in the latest quarter, as a flood of new products like the iPhone 5 meant high start-up costs for new production lines. Apple posted net income for the October to December quarter that was flat with the year before. It was the first time in years that Apple didn't post a double-digit earnings increase. (AP Photo/Andy Wong, File)
FILE - In this Oct. 20, 2012 photo, people line up to enter a newly-opened Apple Store in Wangfujing shopping district in Beijing. Apple's profit surge halted in the latest quarter, as a flood of new products like the iPhone 5 meant high start-up costs for new production lines. Apple posted net income for the October to December quarter that was flat with the year before. It was the first time in years that Apple didn't post a double-digit earnings increase. (AP Photo/Andy Wong, File)
NEW YORK (AP) ? Apple's blockbuster revenue growth is slowing drastically, as iPhone sales plateau and the company finds itself lacking revolutionary new products.
The company's warning, issued Wednesday as part of its financial results for the holiday quarter, sent Apple Inc.'s stock plunging by more than 10 percent, wiping out a year's worth of gains.
Analysts said the warning suggested Apple can no longer sustain its growth without some completely new products. Its last revolutionary creation, the iPad, was launched in 2010. Co-founder Steve Jobs, who was the engine behind the creation of the iPod, iPhone and iPad, died in 2011.
"It has been an overriding concern with Apple that they would not be able to generate revenue growth just rolling out new versions of old products," said Jeff Sica, president and chief investment officer of SICA Wealth Management. "Now they've proven it in their numbers."
On a conference call with analysts, Apple CEO Tim Cook rebutted that idea, but as usual, gave no details.
"We're working on some incredible stuff. The pipeline is chock full," he said.
Before he died in 2011, Apple co-founder Steve Jobs told biographer Walter Isaacson that he had figured out how to create a groundbreaking, easy-to-use TV set. Since then, company watchers have been waiting for the company to bring out something in that vein to re-energize sales. Cook said the company was still working on it.
"I tend to believe that there's a lot we can contribute in the space, and so we continue to pull the string and see where it leads us," he said.
Apple said it expects sales of between $41 billion and $43 billion in the current quarter, which ends in March. That would usually be little cause for concern, even though analysts were expecting $45.6 billion, because Apple usually lowballs its forecasts. But Chief Financial Officer Peter Oppenheimer said the company is changing its practices and providing a reasonable range rather than a single, easily achievable number.
That means Apple is looking at sales growth of about 7 percent from last year's January to March quarter, a striking number for a company that's posted double-digit increases in every quarter except one since 2008.
Apple's stock fell $55.58 to $458.43 in extended trading, after the release of the results. The shares are down 35 percent from their all-time high, hit Sept. 21, when the iPhone 5 launched.
Fueled by earlier versions of the iPhone, Apple's market capitalization decisively overtook that of Exxon Mobil in early 2012, making it the world's most valuable company. With Wednesday's drop, Apple is worth just 5 percent more than Exxon.
Apple's enviable profit growth also hit a wall in the October to December quarter. It said net income in the fiscal first quarter was $13.1 billion, or $13.81 per share, flat with a year ago. That still beat expectations, as analysts polled by FactSet had forecast earnings of $13.48 per share.
Revenue was $54.5 billion, up 18 percent from a year ago. Analysts were expecting $55 billion. Sales were held back by the fact that the latest quarter had 13 weeks, one less than the corresponding 2011 quarter.
Apple shipped 47.8 million iPhones in the quarter, about 1 million less than analysts were expecting, and 22.9 million iPads, also about 1 million short.
Most surprisingly, Mac sales were also 1 million short, at 4.1 million. That's a 22 percent drop from shipments a year ago. Oppenheimer said this was because Apple couldn't get the new iMac desktops out before December.
Cook said iPhone supplies were short too, and the company could have sold more of both the iPhone 5 and older iPhone 4 if it had been able to make more.
Most technology companies would be ecstatic if they posted 18 percent sales growth and $13 billion in profit for a single quarter, but Apple is held to a high standard, set by the shocking, iPhone-propelled success of the last few years.
"Apple has been growing tremendously and that level of growth can't be sustained by any company," said Sarah Rotman Epps, senior analyst at Forrester Research.
Investors have already been concerned that Apple's strategy of keeping the price of the iPhone high means it's losing out on sales, particularly overseas. Consumers are instead opting to buy cheaper smartphones running Google Inc.'s Android software, which has propelled South Korea's Samsung Electronics to the world's largest maker of smartphones. The average wholesale price of the iPhone is $640, hundreds of dollars more than smartphones with comparable hardware.
There's speculation among company watchers that the company will produce a cheaper iPhone, but that would cut into its profit margin and could tarnish the company's image as a purveyor of premium products.
Apple had warned that the holiday quarter's profits would be lower than Wall Street was initially expecting, because it had so many new products coming out, including the iPhone 5 and iPad Mini. New production lines are more expensive to run and yield more defective products that need to be redone or thrown out rather than sold.
___
AP Technology Writer Barbara Ortutay contributed to this report.
Jan. 23, 2013 ? While autism clearly runs in some families, few inherited genetic causes have been found. A major reason is that these causes are so varied that it's hard to find enough people with a given mutation to establish a clear pattern. Researchers at Boston Children's Hospital have pinpointed several inherited mutations -- among the first to be identified -- through an unusual approach: using whole-exome sequencing to study large Middle Eastern families with autism.
The study, published in the January 23 issue of the journal Neuron, also found evidence for some of the same mutations in U.S. families. It shows that a number of genes implicated in severe genetic syndromes can have milder mutations that primarily cause autism, and could broaden the number of genetic tests available to families.
Researchers Tim Yu, MD, PhD, Maria Chahrour, PhD, and senior investigator Christopher Walsh, MD, PhD, of Boston Children's Hospital, began with three large Middle Eastern families that had two or more children with autism spectrum disorders (ASDs), looking for recessive mutations -- those requiring a "double hit" for the child to have an ASD.
"Families from the U.S. are not ideal for finding inherited genetic mutations, since family sizes are often small," says Walsh, chief of Genetics at Boston Children's and an investigator of the Howard Hughes Medical Institute.
In all three families, the parents were first cousins, a common tradition in the Middle East and one that greatly facilitates the identification of inherited mutations. The researchers first used genetic mapping techniques to narrow their search to specific chromosomal locations, then sequenced the protein-coding genes in those areas (known as whole-exome sequencing).
That turned up recessive mutations in three genes not previously known to be involved in autism, but rather in severe genetic syndromes:
Mutations in AMT, a gene classically associated with a severe metabolic syndrome known as nonketotic hyperglycinemia, marked by severe seizures and death during infancy.
Mutations in PEX7. Typical PEX7 mutations cause rhizomelic chondrodysplasia punctata, a severe syndrome causing metabolic and bone abnormalities, cataracts, severe epilepsy and early death.
Mutations in SYNE1, a gene associated with brain malformation, severe motor and muscle problems, and possibly bipolar psychiatric disease.
The severe syndromes linked to these genes often include autistic behavior or intellectual disability, but not as the primary symptom. Interestingly, the milder mutations discovered in these families seemed to cause disease that is more brain-specific.
"This is the first time these genes have been associated with autism," says Chahrour, who shares first authorship of the study with Yu. "The AMT and PEX7 mutations weren't picked up by standard tests for metabolic disorders, but when you're able to sequence the entire exome, you can find them."
These findings inspired the team to look for other metabolic and other genetic syndromes affecting cognition and behavior with milder forms showing up simply as autism. They screened 163 Middle Eastern families with autism for mutations in 70 genes associated with these syndromes, using a whole-exome approach but analyzing only the 70 genes of interest.
This approach turned up several additional families with ASD mutations, including:
An additional family with a recessive mutation in AMT
Two families with recessive mutations in VPS13B (known to cause Cohen syndrome, which includes intellectual disability, obesity, vision and joint problems, and small head size)
A family with a recessive mutation in POMGNT1 (known to cause muscle-eye-brain disease, marked by brain malformation, intellectual disability, muscle and vision problems)
A family with an X-linked mutation in MECP2 in two boys (MECP2 mutations are known to cause Rett syndrome in girls, but are typically lethal in boys)
"We have textbook descriptions of all these diseases, but in real life, there can be atypical, milder presentations of the same disease," says Yu. "The kids we were studying with autism were alive at age 13. They had double hits for these mutations, but they were much milder mutations. The proteins retained a bit of their function."
The team also examined a cohort of U.S. patients, looking for recessive mutations in six of the genes they identified. They analyzed whole-exome sequence data from 612 families with ASDs, part of a registry known as the Simons Simplex Collection. The analysis suggested that some of the affected children had causative recessive mutations in at least two of the genes identified in the Middle Eastern families, and that larger-scale efforts to examine all 70 genes more fully for recessive mutations may prove fruitful.
"It's not clear yet how many U.S. families have these recessive mutations," says Yu. "Further studies could begin to estimate what fraction of autism cases might fall under this model."
The Boston Children's study complements another study published in the same issue of Neuron, led by Dr. Mark Daly of Massachusetts General Hospital and the Broad Institute. That study looked for recessive mutations across the entire genome in 933 cases and 869 controls -- but specifically sought those that completely abolished a gene's function.
"Together, these two studies firmly establish that recessive mutations contribute importantly to autism, not just in specialized populations but in the population at large," says Yu. "Genome sequencing is going to be a huge advance in identifying more of these mutations, since there are a lot of rare syndromes that are otherwise very difficult to detect."
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TIP! Go on some tours of places you might want to buy. When looking at a property that you are thinking of purchasing, it?s a good idea to have a licensed contractor accompany you.
So, you have made the decision and are now ready to get into commercial real estate? While it may seem that you have too many questions and not enough answers to really get started, take a deep breath and check out these pointers designed to get you on the right track. If you need help figuring out how to get started in the commercial real estate market, read the tips below.
Property Owner
TIP! There are different types of commercial real estate brokers. Full service brokers speak with landlords and the tenants, while others represent tenants solely.
Look into any potential environmental problems before you buy. For example, one of the most important environmental concerns that every property owner must deal with is hazardous waste disposal. Failure to remove waste properly can be a huge problem. As the property owner, the burden of getting these issues resolved rests on your shoulders, even if they initiated during a previous owner?s time.
TIP! Make sure you are dealing with a company that cares about their customers before you make a purchase. If not, you may eventually pay dearly for an easily avoided mistake.
Try to find the proper financing first. Commercial property loans and the establishments that finance them are not the same as the world of residential home finance. In many ways a commercial loan is much better for the investor. Commercial loans typically require larger down payments, but banks are more likely to let you borrow some of this from a partner or friend.
TIP! Keep in mind when considering investing in apartment complexes that very small complexes can sometimes be more of a hassle than larger complexes. For that reason, some experts in the field recommend avoiding properties that have fewer than ten units.
Compared with buying a home, purchasing commercial real estate requires more time, money and paperwork. Yet, you should realize that the extra focus on, and length of, the process is essential in order to gain a better return on the investment.
TIP! Build up a system of prospective financial partners, including local lenders and business contacts; this ensures that you always have access to the cash flow required to make a purchase. Two repayment options for these loans are traditional repayments, in which you repay the loan at a certain interest rate, or a profit-based repayment, in which the lender receives some of the proceeds from the property?s income.
Ensure you have the best real estate agent, ask if they are successful and judge their response. Find out their criteria for deciding whether a result is good or not. This will help you assess their working strategies. You should only employ a real estate agent if you are okay with their business practices.
Commercial Real Estate
TIP! Create an online presence for your company before you start investing. Make a website for yourself and make a LinkedIn profile.
You are now more prepared, than ever, to buy commercial real estate. If you felt prepared before, you surely must feel like a pro by now! Armed with this new information, hopefully you are ready to go out and start a successful journey in the commercial real estate market.
Contact: Nalini Padmanabhan padmanabhannm@niaid.nih.gov 301-402-1663 NIH/National Institute of Allergy and Infectious Diseases
A candidate dengue vaccine developed by scientists at the National Institutes of Health (NIH) has been found to be safe and to stimulate a strong immune response in most vaccine recipients, according to results from an early-stage clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. The trial results were published online on January 17 in the Journal of Infectious Diseases.
Dengue fever, prevalent in many tropical and subtropical regions of the world, is caused by any of four related virusesDENV-1, DENV-2, DENV-3 and DENV-4 that are transmitted to humans by Aedes mosquitoes. The World Health Organization estimates that every year, 50 million to 100 million cases of dengue occur worldwide, resulting in 500,000 hospitalizations of patients with severe disease, many of them in children.
Infection with one dengue virus results in immunity to that specific virus but not to the other three. Research shows that the likelihood of severe disease increases when a person is subsequently infected with a different dengue virus. This observation suggests that the ideal dengue vaccine would be tetravalentthat is, protective against all four dengue viruses.
"The global burden of dengue is enormousand it is growing," said NIAID director Anthony S. Fauci, M.D. "We are cautiously optimistic about these recent clinical trial results with this candidate tetravalent vaccine developed at NIAID; however, much more work still needs to be done."
The Phase I clinical trial, launched in July 2010 and led by principal investigator Anna Durbin, M.D., at Johns Hopkins Bloomberg School of Public Health in Baltimore, tested a single dose of each of four versions of the investigational dengue vaccine TetraVax-DV. The vaccine was developed by scientists in NIAID's Laboratory of Infectious Diseases. It is a live, attenuated vaccine, which means that the viruses it contains are weakened enough such that they do not cause illness but still can induce an immune response. Each of the four vaccines tested included different mixtures of components designed to protect against all four dengue viruses.
The Phase I study was conducted in Baltimore; Burlington, Vt.; and Washington, D.C. The final study analysis included 112 healthy men and women ages 18 to 50 years who had not previously been exposed to dengue or related viruses such as West Nile virus and yellow fever virus.
Participants were randomized into four groups. In each group, 20 volunteers received a single 0.5-milliliter subcutaneous (under the skin) injection of one of the tetravalent candidate vaccine combinations, and eight others received placebo. All were monitored for immediate adverse reactions for at least 30 minutes after vaccination, and subsequently took their body temperatures three times daily for 16 days to check for possible adverse reactions. Participants also received a physical exam every other day up to Study Day 16, and then again on study days 21, 28, 42 and 180, when blood tests were also performed.
The researchers found that all four candidate vaccine combinations induced antibody responses against each of the dengue viruses. However, one vaccine combination, TV003, appeared to induce the most balanced antibody response against the dengue viruses. A single dose of TV003 resulted in an antibody response to all four dengue viruses in 45 percent of participants and against three of the four viruses in an additional 45 percent. Overall, an immune response to at least three viruses was seen in 90 percent of vaccinees given TV003.
"What is promising about TV003 is that it elicited solid antibody responses after just one dose," explained Stephen Whitehead, Ph.D., of NIAID's Laboratory of Infectious Diseases, who led the development of the vaccine candidates. "Other vaccines in development require two or three injections at higher doses to achieve similar results."
All four candidate tetravalent vaccines were found to be safe, and no participants experienced fever or dengue-like illness after vaccination. The most common side effect was a faint rash (in 64 percent of vaccinees and none of the placebo recipients) consisting of small, non-painful bumps on the arms and torso that resolved within five to seven days. The presence of the rash appeared to correlate with being white and having a stronger immune response to vaccination, according to the researchers. Ninety percent of white vaccinees experienced a vaccine-related rash while only 35 percent of African-American vaccinees developed a rash. Further, 97 percent of white vaccine recipients (42 of 43) developed antibodies to at least three of the dengue viruses, compared with 60 percent of African-American vaccine recipients (22 of 37). It is unclear what caused this difference, but previous studies of severe dengue outbreaks in Brazil, Cuba and Haiti suggest that black people may have some inherent protection from dengue infection. Alternatively, unknown factors may have resulted in a weaker antibody response to the vaccine among African-American participants. Additional research to evaluate racial differences in dengue infection and antibody response rates to dengue vaccines is needed, the authors wrote.
"The results of this Phase I dengue vaccine study look very promising, and NIAID scientists and their partners are pursuing further development of TV003," said Kathryn Zoon, Ph.D., director of NIAID's Division of Intramural Research. The researchers are conducting studies to further evaluate the vaccine's safety and ability to stimulate an immune response in healthy volunteers and in people who have been infected previously by dengue or related viruses.
TV003's inexpensive production costless than $1 per doseis critical to its potential use in developing countries, noted Dr. Whitehead. Manufacturers in Brazil, India and Vietnamcountries where dengue is prevalent have licensed the vaccine technology for production and further evaluation. Phase II trials to evaluate the safety of TV003 and its capacity to create an immune response will begin soon in Brazil and Thailand.
###
Additional information about the clinical trials is available at ClinicalTrials.gov using the identifiers NCT01072786, NCT01436422, NCT01506570, and NCT01696422. For more information, visit NIAID's Dengue Portal.
NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website at http://www.niaid.nih.gov.
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. For more information about NIH and its programs, visit www.nih.gov.
NIH...Turning Discovery Into Health
Reference:
Durbin AP et al. A single dose of any of four different live attenuated tetravalent dengue vaccines is safe and immunogenic in flavivirus-nave adults: A randomized, double blind clinical trial. Journal of Infectious Diseases DOI: 10.1093/infdis/jis936.
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Contact: Nalini Padmanabhan padmanabhannm@niaid.nih.gov 301-402-1663 NIH/National Institute of Allergy and Infectious Diseases
A candidate dengue vaccine developed by scientists at the National Institutes of Health (NIH) has been found to be safe and to stimulate a strong immune response in most vaccine recipients, according to results from an early-stage clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. The trial results were published online on January 17 in the Journal of Infectious Diseases.
Dengue fever, prevalent in many tropical and subtropical regions of the world, is caused by any of four related virusesDENV-1, DENV-2, DENV-3 and DENV-4 that are transmitted to humans by Aedes mosquitoes. The World Health Organization estimates that every year, 50 million to 100 million cases of dengue occur worldwide, resulting in 500,000 hospitalizations of patients with severe disease, many of them in children.
Infection with one dengue virus results in immunity to that specific virus but not to the other three. Research shows that the likelihood of severe disease increases when a person is subsequently infected with a different dengue virus. This observation suggests that the ideal dengue vaccine would be tetravalentthat is, protective against all four dengue viruses.
"The global burden of dengue is enormousand it is growing," said NIAID director Anthony S. Fauci, M.D. "We are cautiously optimistic about these recent clinical trial results with this candidate tetravalent vaccine developed at NIAID; however, much more work still needs to be done."
The Phase I clinical trial, launched in July 2010 and led by principal investigator Anna Durbin, M.D., at Johns Hopkins Bloomberg School of Public Health in Baltimore, tested a single dose of each of four versions of the investigational dengue vaccine TetraVax-DV. The vaccine was developed by scientists in NIAID's Laboratory of Infectious Diseases. It is a live, attenuated vaccine, which means that the viruses it contains are weakened enough such that they do not cause illness but still can induce an immune response. Each of the four vaccines tested included different mixtures of components designed to protect against all four dengue viruses.
The Phase I study was conducted in Baltimore; Burlington, Vt.; and Washington, D.C. The final study analysis included 112 healthy men and women ages 18 to 50 years who had not previously been exposed to dengue or related viruses such as West Nile virus and yellow fever virus.
Participants were randomized into four groups. In each group, 20 volunteers received a single 0.5-milliliter subcutaneous (under the skin) injection of one of the tetravalent candidate vaccine combinations, and eight others received placebo. All were monitored for immediate adverse reactions for at least 30 minutes after vaccination, and subsequently took their body temperatures three times daily for 16 days to check for possible adverse reactions. Participants also received a physical exam every other day up to Study Day 16, and then again on study days 21, 28, 42 and 180, when blood tests were also performed.
The researchers found that all four candidate vaccine combinations induced antibody responses against each of the dengue viruses. However, one vaccine combination, TV003, appeared to induce the most balanced antibody response against the dengue viruses. A single dose of TV003 resulted in an antibody response to all four dengue viruses in 45 percent of participants and against three of the four viruses in an additional 45 percent. Overall, an immune response to at least three viruses was seen in 90 percent of vaccinees given TV003.
"What is promising about TV003 is that it elicited solid antibody responses after just one dose," explained Stephen Whitehead, Ph.D., of NIAID's Laboratory of Infectious Diseases, who led the development of the vaccine candidates. "Other vaccines in development require two or three injections at higher doses to achieve similar results."
All four candidate tetravalent vaccines were found to be safe, and no participants experienced fever or dengue-like illness after vaccination. The most common side effect was a faint rash (in 64 percent of vaccinees and none of the placebo recipients) consisting of small, non-painful bumps on the arms and torso that resolved within five to seven days. The presence of the rash appeared to correlate with being white and having a stronger immune response to vaccination, according to the researchers. Ninety percent of white vaccinees experienced a vaccine-related rash while only 35 percent of African-American vaccinees developed a rash. Further, 97 percent of white vaccine recipients (42 of 43) developed antibodies to at least three of the dengue viruses, compared with 60 percent of African-American vaccine recipients (22 of 37). It is unclear what caused this difference, but previous studies of severe dengue outbreaks in Brazil, Cuba and Haiti suggest that black people may have some inherent protection from dengue infection. Alternatively, unknown factors may have resulted in a weaker antibody response to the vaccine among African-American participants. Additional research to evaluate racial differences in dengue infection and antibody response rates to dengue vaccines is needed, the authors wrote.
"The results of this Phase I dengue vaccine study look very promising, and NIAID scientists and their partners are pursuing further development of TV003," said Kathryn Zoon, Ph.D., director of NIAID's Division of Intramural Research. The researchers are conducting studies to further evaluate the vaccine's safety and ability to stimulate an immune response in healthy volunteers and in people who have been infected previously by dengue or related viruses.
TV003's inexpensive production costless than $1 per doseis critical to its potential use in developing countries, noted Dr. Whitehead. Manufacturers in Brazil, India and Vietnamcountries where dengue is prevalent have licensed the vaccine technology for production and further evaluation. Phase II trials to evaluate the safety of TV003 and its capacity to create an immune response will begin soon in Brazil and Thailand.
###
Additional information about the clinical trials is available at ClinicalTrials.gov using the identifiers NCT01072786, NCT01436422, NCT01506570, and NCT01696422. For more information, visit NIAID's Dengue Portal.
NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website at http://www.niaid.nih.gov.
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. For more information about NIH and its programs, visit www.nih.gov.
NIH...Turning Discovery Into Health
Reference:
Durbin AP et al. A single dose of any of four different live attenuated tetravalent dengue vaccines is safe and immunogenic in flavivirus-nave adults: A randomized, double blind clinical trial. Journal of Infectious Diseases DOI: 10.1093/infdis/jis936.
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Dear Lifehacker, Is it actually legal for me to rip all of my DVDs and Blu-Ray discs? Most of the articles I'm reading aren't very clear, so I want to know if there's an actual, definitive answer. Am I going to get sued if I rip all my discs for playback on my computer?
Sincerely, Rip-It Ralph
Dear Ralph, You ask a number of different questions at once, so let's break this down into its most basic parts. The legality of ripping is a very confusing situation where you'll hear a number of different answers. Here's what you need to know.
Ripping copy-protected DVDs is illegal...
To answer the legality question, we called on our legal expert Derek Bambauer, Associate Professor of Law at the University of Arizona who focuses on internet law and intellectual property. While the legality of ripping is very complicated, the legality of ripping copy-protected content?which includes nearly every DVD and Blu-Ray disc you'd buy in the store?is a bit simpler:
The moment you crack DRM (Digital Rights Managemnt) to rip the DVD, you've violated Title I of the Digital Millennium Copyright Act. 17 U.S.C. 1201 prohibits circumvention of DRM . . . Some courts have tried to leaven this rather harsh rule, but most have not. While it's typically hard to detect small-scale circumvention, the question is whether bypassing DRM is legal. The statute sets up some minor exceptions, but our ripper doesn't fall into any of them. So, the moment a studio protects the DVD with DRM, it gains both a technical and a legal advantage?ripping is almost certainly unlawful.
We've talked about this a bit before?in fact, it's one of the ways most of us are breaking the law every day without even knowing it. There are minor exceptions?like for educational purposes?but in general no, ripping a DVD you own is sadly not legal. However, will you get caught? Well...there, you have some wiggle room.
...but you probably won't get caught...
If you don't particularly care about the legality, but are only worried you're going to get sued, then you have a distinct advantage. As long as you don't share the files, it's highly unlikely you'd ever get caught for this, since it all happens locally on your computer, with no internet connection necessary, so no one can "snoop" on what you're doing. Unless you were to have your hard drives seized by the authorities for one reason or another, no one will know.
Does that mean you should go rip your entire collection to your home theater PC? As always, that decision is up to you, whether you want to always stay on the right side of the law or take the (admittedly) minimal risk.
...and hopefully, it won't stay this way forever
This is the law as it stands right now, but as Derek mentioned, some courts have tried to change this section of the DCMA, but we've yet to achieve any real movement. However, ripping music CDs used to be considered illegal as well, until the RIAA decided to officially permit it (though they've waffled on that statement a bit from time to time). The MPAA is notoriously more stubborn, but as ripping becomes more common practice, we're hopeful that we could see this change in the future?or at least see an online store where you could download movies not riddled with DRM. Right now, though, this is just a hope, and as it stands, ripping a DVD you own is still considered illegal?as hard as it may be to enforce.
Sincerely, Lifehacker
Title image remixed from Ilona Baha (Shutterstock) and Vladitto (Shutterstock).
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Public release date: 23-Jan-2013
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Dear Lifehacker,
To answer the legality question, we called on our legal expert Derek Bambauer, Associate Professor of Law at the University of Arizona who focuses on internet law and intellectual property. While the legality of ripping is very complicated, the legality of ripping copy-protected content?which includes nearly every DVD and Blu-Ray disc you'd buy in the store?is a bit simpler:
This is the law as it stands right now, but as Derek mentioned, some courts have tried to change this section of the DCMA, but we've yet to achieve any real movement. However, ripping music CDs used to be considered illegal as well, until the RIAA decided to officially permit it (though they've waffled on that statement a bit from time to time). The MPAA is notoriously more stubborn, but as ripping becomes more common practice, we're hopeful that we could see this change in the future?or at least see an online store where you could download movies not riddled with DRM. Right now, though, this is just a hope, and as it stands, ripping a DVD you own is still considered illegal?as hard as it may be to enforce.