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NCGA Budgets Make Cuts in Biotech Funding


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Cuts in both the House and Senate budgets have members of the biotechnology industry concerned.

By Rose Hoban

Driving through Research Triangle Park at night, it’s not uncommon to see the lights of the experimental greenhouses backlighting the trees.

Sam Taylor, Head of NC BIO said he's worried about what cuts in both House and Senate budgets could do to the biotech industry in N.C.

Sam Taylor, head of NCBIO, said he’s worried about what cuts in both House and Senate budgets could do to the biotech industry in N.C. Photo courtesy NCBIO

Those lights, and those of other biotech companies that have made North Carolina home, have burned brightly over the past few years. However, proposed changes to state budgets at the General Assembly have people in the life sciences and research industries worried those lights may dim some.

At the top of the list of concerns are cuts made by the Senate in their proposed budget, which eliminates more than $12 million in funding for the North Carolina Biotechnology Center, as well as eliminating several tax credits used widely in the biotech industry.

Hits to biotech also come from the House.

“Both the chambers failed to extend the research and development tax credit,” said Sam Taylor, head of NCBIO, the trade association for the biotech industry in the state. “Thirty-eight other states have R&D tax credits. We’ve had one for as long as I can remember.”

Taylor said the research and development tax credit added up to about $44 million last year. He said other cuts to the budget are harder to put numbers to, such as a tax break on maintenance and repair of lab equipment. Formerly, businesses were charged only 1 percent sales tax for equipment, capped at $80 total. Now the fee goes up to the general state sales tax rate of 4.75 percent (with add-ons for county and municipal sales taxes), with a $500 cap on any sales taxes.

“It makes it harder for smaller companies to own and operate expensive research equipment,” Taylor said.

Filling the gap

One of the main purposes of the Biotechnology Center, established in 1989, is to provide grants and loans for biotech start-ups.

The NC Biotechnology Center, opened in 1989, provides support for fledgling life sciences firms in the state. Photo courtesy NC Biotechnology Center.

The N.C. Biotechnology Center, opened in 1989, provides support for fledgling life sciences firms in the state. The proposed Senate budget would eliminate funding for the center. Photo courtesy N.C. Biotechnology Center.

One particularly difficult period for fledgling firms – nicknamed the “valley of death” – is the time after grant funding for discovery runs out but before company leaders are able to take a product to market. Few venture capitalists, or even banks, will make loans at this point in a company’s development.

That’s where the Biotech Center has stepped in. The organization has given 239 business loans to 168 companies at that point in their development.

According to an analysis done in 2014 by the business analytics firm Battelle, 95 of those 168 companies are still operating in North Carolina, generating at least $1.9 billion and as much as $2.9 billion in revenues annually.

The same report calculated those revenues returned at least $45 million in state taxes and another $25 million in county and municipal tax revenues.

“North Carolina is a good example of states that create special initiatives,” said Brad Fenwick, a vice-president for academic publisher Elsevier, which presented on North Carolina’s research environment at the General Assembly in May. Fenwick, a veterinary pathologist, brought several ideas to market during his time in academia.

“I know that the private sector is increasingly risk averse,” Fenwick said. “They’re trying to control the risk, because if they don’t they get penalized by shareholders.”

Fenwick said R&D tax credits and loans made by organizations such as the Biotech Center “essentially help to reduce the risk threshold, and that allows industry to be more able to be engaged in taking a greater level of risk.”

Biotech flagging

Ted Voller, a professor at UNC’s Kenan Flagler School of Business, said the biotech industry is “hitting a real hard patch.”

Elsevier's Brad Fenwick presenting at the NCGA in May about the research environment in North Carolina as Sens. John Alexander (R-Raleigh) and Josh Stein (D-Raleigh) look on.

Elsevier’s Brad Fenwick presenting at the NCGA in May about the research environment in North Carolina as Sens. John Alexander (R-Raleigh) and Josh Stein (D-Raleigh) look on. Photo credit: Rose Hoban

To start, federal funding for basic sciences research is shrinking, making the competition for dollars even fiercer among universities where the basic research gets done.

Then there’s less money for the next step, translating basic science into products. Voller said part of the problem is that most venture capitalists don’t have the patience to invest in biotech.

“Life sciences investments take five to seven years to produce the return [venture capitalists] want,” he said. “Venture capitalists want to see turnarounds in three to five years. So they’ve vacated that market.”

On top of skittish venture capitalists, the pharmaceutical industry is also going through some big changes. Gone are the days of blockbuster drugs producing hundreds of millions in annual profit.

Instead, Voller said, pharmaceutical companies are looking to buy smaller biotech firms along with their intellectual property rather than develop new drugs themselves. He pointed to the recent downsizing at GlaxoSmithKline, where last month the company announced plans to lay off 150 more workers, after 900 were let go last year.

“Right now, we’re dealing with significant market restructuring,” Voller said. “This is when we need to shore up life sciences in the Research Triangle Park, because it’s one of our most competitive sectors.”

Global competition

At the research presentation at the General Assembly in May, Barbara Entwistle, UNC-CH’s vice chancellor for research, told lawmakers the environment in North Carolina is enhanced by having strong ties between academia, industry and government.

Like what you read on NC Health News? Help make it possible. Make a donation today. As little as $5/ month will help keep us going!“It takes a team to do this,” Entwistle said, referring to the research and development that leads to innovation. “It’s really not possible anymore for a single person to go into their office or into their lab and by themselves come up with ideas and commercialize.”

She argued that an essential part of the team is academic institutions that draw the scientific talent to North Carolina, and that they require some level of state support.

“The very best faculty have lots of options,” Entwistle said. “If you are really good at what you do, you get an email once a week, at least, enticing you to come some other place.”

She said the competition for talent and money is no longer just among cities in the U.S., but among other countries trying to develop biotech industries.

“If faculty were to leave, you cannot replace them,” Entwistle said. “It’s more cost efficient to just keep them here and have them not pay attention to all those emails enticing them away.”

She and Fenwick made the point that the state’s investments in research and infrastructure make it the kind of place where it’s easy for top talent to come.

But layering university cuts on top of cuts to state incentives can start to erode that vibrant research environment.

“The universities, as much as they are a powerhouse, they do the initial research; they don’t do the translation and testing to make products ready for market,” Voller said. “You need a bridge.”

He called biotech the “goose that laid the golden egg” for North Carolina, but expressed concern about the “stability and vitality of the Research Triangle early-stage biosciences market.”

“The early-stage fundamentals are not being supported, and we could lose our competitive edge,” he said.

Harmful Or Harmless? New Studies Light Up Debate on E-cigarettes

Even as more people use e-cigarettes, questions arise about their safety and whether they actually do help smokers kick the habit.

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By Whitney L.J. Howell

When e-cigarettes hit the market in 2007, they were embraced as an effective and safe strategy for smokers to break their addiction to traditional cigarettes. Since then, they’ve grown in popularity among all age groups. But research has revealed mixed success in helping to quit.

And now North Carolina researcher are questioning their safety.

Some of the e-cigarette liquids for sale in N.C. today. Flavors from left to right: watermelon, Irish Cream and appletini.

Some of the e-cigarette liquids for sale in N.C. today. Flavors, from left to right: watermelon, Irish cream and appletini. Photo credit: Rose Hoban

A new study from Research Triangle Park-based RTI International points to many e-cigarette characteristics that could pose intrinsic, and yet unidentified, health dangers. The research comes on the heels of reports that e-cigarette use is on the rise.

In North Carolina, according to the North Carolina Youth Tobacco Study, e-cigarette use sky-rocketed 325 percent among high school students from 2011 to 2013. A full 10 percent of students are now considering using e-cigarettes.

Other research, including a March 2014 Journal of the American Medical Association Internal Medicine study, showed e-cigarette use among Americans leaped from 2 percent of U.S. smokers in 2010 to more than 30 percent in 2012.

Whether e-cigarettes are helping smokers quit has been the subject of pretty fierce debate in the research world. A May 2014 study published in Addiction showed the alternative cigarettes helped 60 percent of aspiring quitters reach their goal. Other studies suggest that e-cigarette users quit smoking but keep using the e-cigarette as a way to get nicotine.

Many of those former cigarette smokers argue the newer devices are safer.

But to date, said Jonathan Thornburg, RTI’s director of exposure and aerosol technology and lead study author, there’s been no way to prove e-cigarettes are any safer than traditional cigarettes. And, it turns out, he said, they may be just as dangerous.

“The visible smoke from e-cigarettes dissipates just after exhale, but those particles are still there – there’s still a high potential that the public will breathe them in,” Thornburg said. “Other research has found that second-hand nicotine exposure from e-cigarettes is similar to that of conventional cigarettes.”

N.C. current tobacco users by gender. Data source: N.C. Youth Tobacco Survey, 2013

N.C. tobacco users by gender. Data source: N.C. Youth Tobacco Survey, 2013

Current use

Traditional cigarette use is falling among American high school students, but, based on Centers for Disease Control and Prevention data, e-cigarettes are the popular substitute. An April CDC report, based on the National Youth Tobacco Survey, revealed e-cigarette use has tripled among American teenagers.

From 2011 to 2014, e-cigarette use nationwide among middle-schoolers rose from 1.1 percent to 3.9 percent and from 4.5 percent to 13.4 percent among high-schoolers. Those rates translate to approximately 450,000 middle school students and 2 million high school students.

E-cigarette dangers

Although the Food and Drug Administration has deemed many e-cigarette ingredients safe for consumption, that categorization doesn’t necessarily mean they’re safe to inhale. That’s where the safety of e-cigarettes becomes ambiguous, Thornburg said.

A man smokes an e-cigarette. Often the devices are made to look like traditional cigarettes. Photo by Taylor Dahlin, flickr creative commons

A man “vapes” an e-cigarette. Often the devices are made to look like traditional cigarettes. Photo by Taylor Dahlin, flickr creative commons

E-cigarette vapor particles are small – only slightly larger than a bacteria, at a width of 100 to 800 nanometers. But, even at that size, they pose a threat, he said. Nearly half of all inhaled e-cigarette particles remain in the lungs to grow in the respiratory system, and the remaining exhaled particles can be as dangerous as second-hand smoke.

“People need to know the potential for significant second-hand smoke with e-cigarette vapors,” Thornburg said. “Danger doesn’t just come from inhaling the nicotine, but from the other chemical vapors too.”

Lighting an e-cigarette also presents a risk. E-cigarettes don’t ignite like traditional ones, so there’s no carcinogen from combustion, but starting one produces a slightly altered form of formaldehyde, a disinfectant and embalming fluid. That form has a greater potential for getting stuck in lung tissue.

In addition, little is understood about what happens when other e-cigarette ingredients get into lungs. The glycerin, propylene glycol (a syrupy liquid added to food, cosmetics and some medicines to help them absorb water and stay moist), food preservatives and artificial flavorings could be dangerous to breathe in.

In fact, it’s already well known, Thornburg said, that inhaling artificial butter flavoring, one of the popular flavors in the liquid used in e-cigarettes, is dangerous.

He said that while there could be a level of preservatives and flavors that’s safe to breathe in, “we don’t know what that is yet.”

To answer that question, Thornburg’s team is conducting a study to determine if e-cigarette second-hand exposure to the nicotine and other ingredients is high enough to warrant concern. The goal is to inform public policy on how and when e-cigarettes should be regulated.

But until that data exists, he said, cities and towns can’t create any ordinances addressing e-cigarette use.

Social risks

Determining the actual health risks associated with e-cigarettes goes beyond giving teeth to public health regulations. It’s also critical to combating advertising and marketing efforts that present these products as completely safe alternatives to traditional cigarettes, said Annice Kim, a social scientist in RTI’s public health policy research program.

In this commercial, actress Jenny McCarthy says, "I get to have a blu without the guilt, because there's only vapor, not tobacco smoke."

In this commercial, actress Jenny McCarthy says, “I get to have a blu without the guilt, because there’s only vapor, not tobacco smoke.” Image via youtube screen shot

From 2011 to 2014, money spent on publicizing e-cigarettes ballooned from $6.4 million to more than $100 million, reaching approximately 24 million youths.

“It’s a big public health concern because these ads might make e-cigarettes appealing to young people,” Kim said. “It’s alarming from a social, medicine and public-science perspective that these ads feature celebrities espousing the benefits of e-cigarettes when their safety has not been established.”

Despite heavy advertising and lack of safety data, some states are already implementing measures to curb e-cigarette use. In most states, including North Carolina, e-cigarettes cannot be sold to anyone under age 18. North Carolina also taxes the sale of e-cigarettes.

Other states have implemented e-cigarette bans on school property, and several states, also including North Carolina, specifically prohibit the use of e-cigarettes in 100 percent smoke-free sites.

Additional research

Alongside the RTI study, research is starting to reveal that e-cigarettes carry their own health hazards. A recent study out of UNC-Chapel Hill showed that five of 13 liquid flavors – including hot cinnamon candies, banana pudding and menthol tobacco – are toxic in high doses and can change cell life, cell reproduction and cell communication in the lungs.

Work out of the University of Alabama School of Medicine discovered that the temperature of the e-cigarette coil is directly associated with the production of harmful chemicals, such as acrolein (used in herbicides), acetaldehyde (a toxic irritant) and formaldehyde. And inhaling the vapor suppresses one’s ability to cough.

Albert Einstein University researchers found that after 30 e-cigarette puffs in 15 minutes, users were far less sensitive to capsaicin, a component of chili peppers that can induce coughing. A reduced ability to cough can be dangerous because coughing can prevent choking and it removes infectious agents from the lungs.

New research with mice from Indiana University found that just the nicotine in e-cigarettes is enough to negatively impact lung function. The effects are greater with higher doses, but nicotine inhalation causes acute lung inflammation, decreased lung cell growth and a change in lungs’ ability to act as a barrier to outside insult.

Even substances found in nicotine-free e-cigarettes attacked the molecules that hold together the endothelial cells that line the lungs and protect from infection.

The hope, Kim said, is this current and future research will continue to highlight the yet-unknown dangers of e-cigarettes both to the user and those in the vicinity. Data that reveals the potential negative impacts, she said, could be the best arrow in the quiver to fight against marketing efforts that support e-cigarette use.

“If we don’t make an effort to educate people, we’re only going to be flooded by counter messages that e-cigarettes are perfectly safe,” Kim said. “Perceptions, correct or not, will be spread by word of mouth and on social media.”

Hundreds of Hospitals Struggle to Improve Patient Satisfaction


Kaiser Health News

Lillie Robinson came to Rowan Medical Center for surgery on her left foot. She expected to be in and out in a day, returning weeks later for her surgeon to operate on the other foot.

But that’s not how things turned out.

“When I got here, I found out he was doing both,” she said. “We didn’t realize that until they started medicating me for the procedure.” Robinson signed a consent form and the operation went fine, but she was told she would be in the hospital far longer than she had expected.

“I wasn’t prepared for that,” she said.

Disappointing patients such as Robinson is a persistent problem for Rowan, a hospital with some the lowest levels of patient satisfaction in the country. In surveys sent to patients after they leave, Rowan’s patients are less likely than those at most hospitals to say that they always received help promptly and that their pain was controlled well. Rowan’s patients say they would recommend the hospital far less often than patients do elsewhere.

Feedback from patients such as Robinson matters to Rowan and to hospitals across the country. Since Medicare began requiring hospitals to collect information about patient satisfaction and report it to the government in 2007, these patient surveys have grown in influence.  For the past three years, the federal government has considered survey results when setting pay levels for hospitals. Some private insurers do as well.

In April, the government will begin boiling down the patient feedback into a five-star rating for hospitals. Federal officials say they hope that will make it easier for consumers to digest the information now available on Medicare’s Hospital Compare website. Hospitals say judging them on a one-to-five scale is too simplistic.

Some hospitals improve as others stagnate 

Nationally, the hospital industry has improved in all the areas the surveys track, including how clean and quiet their rooms are and how well doctors and nurses communicate. But hundreds of hospitals have not made headway in boosting their ratings, federal records show.

“For the most part, the organizations that are doing really wonderfully now were doing well five years ago,” said Deirdre Mylod, an executive for Press Ganey, a company that conducts the surveys for many hospitals. “The high performers tend to continue to be the high performers and the low performers tend to be low performers.”

Some hospitals have made great gains. The University of Missouri Health System, for example, created a live simulation center at its medical school in Columbia to help doctors learn to communicate better with patients. The simulations use paid actors. Instead of having to diagnose the patient, doctors must respond to nonmedical issues, such as a feuding teenager and mother or a patient angry that he was not given information about his condition quickly enough.

“My scenario was I was late to the appointment and the patient’s husband was upset,” said Kristin Hahn-Cover, a physician at Missouri’s University Hospital. In 2013, the most recent year that the government has provided data for, 78 percent of patients at University Hospital said doctors always communicated well, a 10 percentage point jump from 2007. Other scores rose even more.

At Virginia Hospital Center in Arlington, executives credit improvements in patient satisfaction to their psychological screening methods in hiring and rigorous job reviews. Potential nurses and other staff must first pass a behavioral screening test and then be interviewed and endorsed by some of the staffers with whom they would be working. In the third element of the program, every six months managers rate employee performance as high, medium or low. Low performers are told to improve or find work elsewhere.

“Those are the three most defining things we did as an organization,” said Adrian Stanton, the hospital’s chief marketing officer. “Without that, I can guarantee you we wouldn’t have had the successes.”

Stubbornly low

Nudging up scores has been a frustrating endeavor elsewhere, like at Novant Health, a nonprofit hospital system that runs Rowan Medical Center and 13 other hospitals in North Carolina, South Carolina and Virginia. While some Novant hospitals have excellent patient reviews, Rowan’s scores have remained stubbornly low since Novant took over the hospital in 2008. The hospital is losing $29,000 this year because of the low scores.

Last fall, Rowan’s president, Dari Caldwell, replaced the physician group that ran the emergency room because the doctors had not reduced wait times. ER waits are down to half an hour, a spokeswoman said. Doctors and nurses also are being coached on their bedside manner, like being advised not to stare at their computer when a patient is talking.

Rowan’s nurses now spend 70 percent of their time with patients, swinging by every hour. Even the president makes rounds once a day. The hospital has made lots of small improvements to provide a warmer environment, such as putting white poster boards in each room where nurses can list a few personal details about their patients.

“I can go in there and say, ‘Oh, you have three dogs,’ or, ‘You have a grandchild; that’s great, great,’” said Jennifer Payne, a nurse manager. “And they can talk for hours about that.”

Payne said she pores over patient comments and surveys, passing around the good ones and tackling complaints. “We’re very driven by what these patients say,” she said. “Everything I do is based around how these patients come back [in comments in the surveys] and say, ‘Hey, is this working,’ or, ‘This isn’t working.’”

Perceptions sometimes hard to change 

Rowan executives fear scores may not be going up because patients still harbor bad memories from previous hospitalizations.

“I was treated like a dog,” Carl Denham, 76, said about a stay two years ago. He said the hospital was doing loud construction work that kept him awake, and it took nurses all day to deliver an oxygen tank his doctor ordered.

Admitted again in Rowan in December, Denham said that visit was different.

“It is fantastic from what it used to be, if you want my opinion,” he said as he lay in his hospital bed a few days after he came back. “I’ve been both ways and the way it is now, it is great. No waiting and the doctors are all pleasant. I never thought I’d see it like this.”

He said he would give the hospital top marks.

His daughter Benicia said that in the last visit she had to nag the nurses to get her dad his medication. This time, it has not been an issue. “It’s like a totally different hospital,” she said. “I had to say, ‘Did I come to Rowan Regional?’”

Despite the unexpected operation on both feet, Robinson also said nurses have been attentive to her pain. “They do the best they can,” she said. “At times, it gets so bad I’m crying because it’s overwhelming to me.”

But “the best they can” is not good enough for Medicare. In determining how much to pay hospitals, the government only gives credit when patients say they “always” got the care they wanted during their stay, such as their pain was “always” well controlled. If a patient says that level of care was “usually” provided, it does not count at all. Likewise, the surveys ask patients to rank their stays on a scale of 0 to 10. Medicare only pays attention to how many patients award the hospital a 9 or 10.

“Sometimes what we see and hear from our patients doesn’t show up on their surveys,” Rowan’s president Caldwell said.

Too Few

Another challenge for hospitals is that Medicare does not take into account the inexact nature of these ratings, which can be based on as few as 100 patients over a year. Medicare recommends a minimum of 300 surveys, but even those have imprecisions that Medicare does not highlight when publishing ratings on Hospital Compare, or take into account when determining financial bonuses or penalties.

In its hospitals with lower ratings, Novant is trying to replicate some of its successes at its Medical Park Hospital in Winston-Salem, a surgical center, which has the best patient-satisfaction scores in the Novant system. Sean Keyser, Novant’s vice president for patient experience, interviewed the staff to figure out how it performed so well.

“The first thing they suggested was the relationship between the physician and the nurses,” he said. “They tend to round more together; they tend to huddle more together. It doesn’t matter how long we study health care organizations, personal relationships that caregivers have with each other translates into better relations with patients.”

Staff members from Medical Park now conduct the pre-surgical discussions for patients at several bigger Novant hospitals. Those preparatory talks, which take place a week or two before planned operations, give nurses the chance to allay fears and make sure that patients have realistic expectations of what will happen.

Scott Berger, a surgeon, said the smallness of the hospital – Medical Park has only 22 beds, while Rowan has 268 – gives Medical Park an advantage over other hospitals in pleasing patients.

“We also think that because we only do surgery here, that we’re really able to have kind of a sharp edge, if you will, of focus on good outcomes and good patient care,” he said. “And that really carries over to the nurses as well. Because all day every day, that’s all they see, is the same kind of surgical patients over and over again.”

Even patients who had not prepared to come to Medical Park are impressed. George Stilphen, who was admitted for emergency colon cancer surgery, said he planned to rate the hospital a 10.

“They said that they’d take great care of us,” he said as he recovered from surgery in the hospital. “They were very soothing, comforting, they weren’t condescending. It was a great experience.”

Michael Tomsic, a reporter for WFAE, contributed to this report.

This story originally appeared in Kaiser Health News, an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.

New Research Points to Feeding Peanuts Early to Avoid Allergy


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New findings about peanut allergies is turning the advice pediatricians give to parents of young children on its head. Scientists from North Carolina are in the thick of this new research.

By Whitney L.J. Howell

As a 15-month-old, Brayden Baylor touched his first peanut butter cracker. Within minutes, his face turned red, he broke out in hives and he began rubbing his eyes until they were swollen shut.

It was a classic peanut-allergy reaction. But, because he hadn’t actually eaten the cracker, or the peanut butter on it, his parents didn’t realize what was happening – until a second reaction erupted within hours.

Peanuts are one of North Carolina's most significant agricultural products, yielding about 8 percent of the U.S. total annual production. Much of the research on peanut allergy has also been done in N.C.

Peanuts are one of North Carolina’s most significant agricultural products, yielding about 8 percent of the U.S. total annual production. Much of the research on peanut allergy has also been done in N.C. Image courtesy USDA

“We had given him a dose of Benadryl, and, at the time, we still didn’t really know what caused the problem. There’s no history of food allergies in either of our families,” said Karrie Baylor, Brayden’s mother and a Charlotte resident. “But when it happened a second time, he was sitting in my lap and suddenly turned red and swollen. That’s when we took him to the emergency room.”

After a blood test, a local allergist diagnosed Brayden with a peanut allergy – a potentially deadly immune response affecting between three million and six million Americans, the majority of whom are children. According to a 2001 Archives of Internal Medicine study on food allergies, peanut allergies rank worst, accounting for more than 50 percent of the 200 annual food allergy-related deaths nationwide.

In fact, the fear of peanut allergy and its potentially fatal outcomes prompted the American Academy of Pediatrics, in 2000, to issue guidelines recommending children consume no peanut protein before age 3. The hope was that delayed exposure would give a child’s immune system time to strengthen and prevent peanut allergies.

But that hasn’t happened. Between 1997 and 2010, peanut-allergy prevalence among American children has skyrocketed 50 percent, according to the Centers for Disease Control and Prevention. And, based on existing data, occurrence within North Carolina mimics the national population.

This meteoric rise has baffled allergy and immunology researchers and sparked many investigations into the body’s response to peanut protein and how it can be calmed. Now there’s a watershed study, funded by the National Institutes of Health, that experts say conclusively proves the existing approach to combating peanut allergies has been wrong.

In short, the AAP guidelines meant to safeguard children like Brayden are actually causing more allergy cases to break out.

“This study is definitive. That’s unusual in this business,” said Herman Mitchell, vice president for Rho, the Chapel Hill-based contract research organization that handled the study’s statistical and data coordination. “We usually see trends, but this is a whopping finding that is very clear. It’s a reason to completely change the recommendations about avoiding peanuts at an early age.”

Problem peanuts?

While peanut-allergy rates are high in the United States and United Kingdom, that’s not the case everywhere. A 2008 Journal of Allergy and Clinical Immunology study revealed British children were 10 times more likely to have a peanut allergy than Israeli children.

Those nation’s health care systems are roughly equivalent, but there’s a significant cultural difference. Israeli families introduce children to peanut products far earlier. A snack called Bamba – a peanut butter-flavored corn puff – is present in 90 percent of Israeli homes and helps transition infants to solid food.

As part of the NIH’s Immune Tolerance Network, Gideon Lack, pediatric allergy professor at King’s College London, launched a study to investigate whether eating peanut-protein products, such as Bamba, early has a protective effect, Mitchell said.

Lack’s five-year study enrolled 600 4-to-11-month-old children who were at risk for developing a peanut allergy.

They either had another existing food allergy, a family history of peanut allergy or eczema. Half of the children were introduced to Bamba, while the other half followed the existing guidelines that prohibit exposure. The children who received Bamba ate it three times a week for five years.

The study ended with a food challenge that escalated the peanut-protein amount participants ate over several hours.

The results, published in a February New England Journal of Medicine issue, showed children who ate Bamba were 81 percent less likely to develop peanut allergy. Among non-consumption participants, 13.7 percent developed a peanut allergy, while only 1.9 percent of the Bamba group did.

According to Wesley Burks, chair of pediatrics at the UNC-Chapel Hill School of Medicine, Lack’s study will change how doctors advise parents about peanuts.

Burks leads a long-standing peanut-allergy study designed to help children with existing peanut allergies, including Brayden, develop a tolerance to peanut protein.

“These studies will change the paradigm with respect to feeding in the first six months of life for kids with allergic diseases. The guidelines for introducing peanut protein will change within the next year,” he said. “That will be the easy part; but medical guidelines take years to be disseminated.”

It will take between five and 10 years, he said, for pediatricians to abandon the current guidelines and begin advising parents based on these new findings.

Testing the idea

While the results of Lack’s study seem to indicate that preventing peanut allergy before it occurs is possible, it’s not yet clear whether that’s the case, Mitchell said. The effect could be desensitization, meaning participants who exhibit no current allergic responses could have reactions to peanut protein later in life.

To answer that question, several Bamba group participants agreed to avoid peanut protein for a year and then complete another food challenge. This new group will also include 40 children who don’t have peanut-allergy risk factors but had a positive allergy skin test. Results of this new study will also help doctors treat children with peanut allergies.

“It would be ideal if we could understand exactly who’s at risk,” he said. “Then pediatricians could measure a child’s risk and could recommend early [peanut-protein] exposure.”

Mitchell advised that parents have their child evaluated by an allergist if any peanut-allergy risk factor exists. An allergist can provide guidance on how to introduce peanut protein into the diet.

Karrie and Brayden Baylor share a Reese's Peanut Butter Cup 3 years after Brayden started treatment for his peanut allergies.

Karrie and 6-year-old Brayden Baylor share a Reese’s Peanut Butter Cup three years after Brayden started treatment for his peanut allergies. Photo courtesy Karrie Baylor.

Slow buildup

These study results and new guidelines will help prevent peanut allergies in infants and newborns, but it can’t help the children who already live with peanut intolerance.

That’s where Burks’ work comes in. For more than 25 years, he has worked toward treatments that help children – most of whom are over age 2 – develop a peanut-protein tolerance that reduces the severity of allergic reaction. The therapy is considered a success if a child can ingest a peanut or peanut protein without being thrown into a debilitating or potentially fatal immune response.

To date, Burks, who is also physician in chief at North Carolina Children’s Hospital, and his team have developed three treatment forms, all of which culminate with a food challenge similar to Lack’s study. In some cases, participants drip peanut protein-infused liquid under their tongue, while others wear patches impregnated with peanut protein. The most effective strategy though has been mixing peanut-protein powder with other well-tolerated foods, such as applesauce or ice cream.

“When the protein powder is introduced regularly – and in increasing quantities – it can make changes to the immune system,” Burks said.

Based on Rho’s data, Burks said he will begin to enroll and treat younger children in a continued effort to reduce peanut-allergy impact.

In the meantime though, he will continue to treat children Brayden’s age and younger, helping them overcome their peanut allergies. Brayden’s therapy has already been declared a success after three years: He passed his final food challenge without exhibiting any signs of allergic reaction.

His celebratory feast? His first-ever Reese’s Peanut Butter Cup.

Fostering Health Care Innovation


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A showcase at UNC-Chapel Hill highlights innovations coming from labs on campus that turn into companies, jobs and new therapies and diagnostics.

By Rose Hoban

In old episodes of Star Trek, medical care in the 24th century looks a lot less invasive and a lot less painful. Bones McCoy waves a wand over his patient to get readings on heart rate. Beverly Crusher uses a light probe to deliver medications or stop internal bleeding.

Just science fiction?

Neuroscientist Mohanish Deshmukh describes his research into a molecule that has potential to arrest degeneration of nerve cells that occurs in Parkinson's and Alzheimer's diseases. Photo credit: Rose Hoban

Neuroscientist Mohanish Deshmukh describes his research into a molecule that has the potential to arrest degeneration of nerve cells that occurs in Parkinson’s and Alzheimer’s diseases. Photo credit: Rose Hoban

Not in the minds of some researchers at UNC-Chapel Hill. Ideas like these were presented at the sixth annual Innovation Showcase at the Kenan School of Business Thursday evening, an event to demonstrate new companies, patents and potential business plans being created by researchers in many departments on the UNC campus.

“What do we need to do?” asked David Lawrence, a professor of pharmacy and chemistry at UNC. “Do we need to wait for the 24th century?

“Well, I’m not a patient man. I have no interest in waiting three centuries to see this.”

Making science fiction reality

Lawrence proposed waiting only three years until physicians have a technology that could use light to release chemicals or drugs at the point where they’ll do the most good in a sick patient.

One of the drugs Lawrence said he wants to target is doxorubicin, a powerful agent that’s effective on cancer cells but causes heart damage as soon as it enters the body. His idea is to use red blood cells to deliver the doxorubicin in minuscule doses directly to the tumor, reducing the toxicity.

“Nothing happens until we flash this system with light and it’s just a tenth-of-a-second light pulse,” Lawrence said. “And with that tenth of a second, the phototherapeutic is released … and enters the cancer cells.”

The PhysioCam would allow physicians to detect a patient's heart rate, along with other biometric measurements, using only a video camera. Photo courtesy Maria Davila

The PhysioCam would allow physicians to detect a patient’s heart rate, along with other biometric measurements, using only a video camera. Photo courtesy Maria Davila

Lawrence has started the process of creating a company that would make this technique of drug delivery commercially viable and bring it to the health sciences marketplace.

Another presenter evoking Star Trek was Greg Lewis from the bioengineering department.

“Imagine a medical world where a doctor can look into your body without hooking you up to a machine,“ Lewis told the audience. “They can just peer inside you and see the workings of your organs.”

Then he described taking consumer-grade digital video cameras and applying a computer algorithm to the images to determine what’s happening to someone’s heart beat.

“The Physiocam is a device that reads your heart rate; it actually sees your heart beating by looking at your face,” Lewis said. “We can measure your heart rate so precisely in real time because we can look at … the timing between subsequent beats.”

He said that gives doctors information about stress and other physiological challenges.

Potentially, the camera could reveal whether a person at airport security is nervous, whether a patient waiting in an emergency room is getting sicker or if someone is developing a fever 24 to 48 hours before the person’s body temperature starts to rise, just by taking a video of a face.

Roadmap to innovation

The innovators and entrepreneurs at Thursday’s event were looking for collaborators, funders and connections with people who might be interested in working together and adding knowledge or funding to their projects.

The event was sponsored by the Office of Innovation and Entrepreneurship, an office created by former UNC Chancellor Holden Thorp that serves as the umbrella for entrepreneurship, commercialization and economic development of ideas that come from within the university.

“Think of yourself on a journey … and there’s a fork in the road and you meet somebody, and they say, ‘You should go here,’ and so you go with them,” said Judith Cone, who leads the office. “We don’t want the process to be so random.”

Hundreds of researchers, venture capitalists, industry representatives and students attended Thursday's event at UNC-Chapel Hill. Photo credit: Rose Hoban

Hundreds of researchers, venture capitalists, industry representatives and students attended Thursday’s event at UNC-Chapel Hill. Photo credit: Rose Hoban

Cone said a large cross-discipline working group was formed to create a road map, called Innovation Carolina, in 2010. That roadmap has served as a guide to making UNC more entrepreneurial.

“We want to help everyone with an idea, regardless of whether its going to be patented or be a social venture. We want to help you on that journey,” Cone said.

Some of the ideas could be spun off into a company, some might stay within the university or some might get picked up and licensed by an existing biotechnology company to create a new product.

The room was full of funding “angel investors,” industry representatives and venture capitalists, including the Hatteras Venture Partners, a Durham-based firm that focuses on new life sciences companies.

“We had a company, G1 Therapeutics…. Hatteras was the lead investor with $6 million,” said Cone, referring to a UNC-generated company that focuses on cancer drugs. “And [Hatteras] brought in some more, and I think the next round of funding was about $30 million.”

Success stories

“I can tell you from my own experience that Carolina does a really, really good job at fostering entrepreneurs inside the university … professors, students, faculty,” said David Levin, CEO of Bivarus, a company that came out of research on patient satisfaction. “They make it very easy to start companies.”

Bivarus uses a sophisticated computer algorithm to send a 10-item questionnaire directly to a patient’s cell phone within a couple of days of the patient’s encounter with a clinic or hospital instead of sending a paper patient-satisfaction survey. Administrators can get a handle on problems in the clinical setting almost in real time, and the service is being used in several UNC Hospitals divisions, including the emergency department.

“It’s been wonderful to be able to go to the Office of Technology and Development, or go to our customers at UNC Health Care, tell them the value proposition and say, ‘How can we help you,’” Levin said.

He said the company wasn’t really looking for money – yet – on Thursday evening, but they were looking to get some publicity. He said Bivarus currently has eight employees and about $250,000 in annual revenue, but projects having $1 million in annual revenue within a year.

“Our growth has been pretty steady over the past year,” he said. “As you get a critical mass of customers, the growth starts to look like a hockey stick.”

John Taylor was another CEO presenting an early-stage company, this time an organization built around a therapeutic discovery that came from a UNC lab.

Taylor’s company, Spyryx Biosciences, got an initial start with money from Carolina KickStart, a fund at the School of Medicine that gives grants to fund the translation of research into actual patient therapies.

Company co-founder Rob Tarran discovered a peptide in his lab that allows for the lungs of people with cystic fibrosis to function better. The mucous in the lungs of someone with cystic fibrosis is thick and sticky, leading to multiple infections and scarring. About 80 percent of patients with cystic fibrosis die from pulmonary complications.

Since launch, Tarran has been able to raise upwards of $50 million to develop the peptide into a drug that will treat people with cystic fibrosis, which is considered an “orphan disease” because it affects fewer than 100,000 annually.

But Taylor said the drug could also be used to treat people with lung diseases, such as emphysema, caused by smoking and air pollution, which is a potentially huge market. Spyryx has licensed the rights to Tarran’s findings from UNC-Chapel Hill, so if the drug becomes a blockbuster some of that money would flow back to the university.

“They translated those ideas into practical benefit,” Cone said. ”They did not just leave them in the lab.”

Exploring the Waves for New Medical Knowledge


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Researchers in eastern North Carolina are culling the waters of the coast to find ingredients for new drugs and treatments for disease.

By Whitney L.J. Howell

Think about the ocean, and visions of whales, shellfish and the occasional starfish might pop to mind, not medical therapeutics and advancements in drug delivery. But with new research, the waves that crash on North Carolina’s coast are bringing innovative strategies and tools for improving health.

Together, researchers from the University of North Carolina-Wilmington and East Carolina University’s Brody School of Medicine are investigating how microorganisms found in ocean waters could improve the performance of existing medications, such as drugs for diabetes, cancer and heart disease.

“There’s a new class of compounds based on marine life that can get inside cells and show the cell’s permeability,” said David Brown, an ECU cardiac physiologist and associate physiology professor involved in the partnership.

Brown said UNCW researchers know the ocean side of the equation, whereas his group has studied compounds that can potentially be used to create designer medicines that get into cells and function better.

“Where UNCW’s expertise stops … is where we pick up,” he said.

The partnership, which still awaits final funding approval, formed in response to a call from the University of North Carolina Board of Governors for game-changing research between UNC system institutions that could spawn new approaches to treating disease.

Sharing work & benefits

Any research successes borne from North Carolina’s 300 miles of coastline and estuaries would likely be further supported by the UNCW-based Marine Biotechnology in North Carolina program and the nonprofit Wilmington-based Marine Bio-Technologies Center of Innovation. The Bio-Technologies Center, bolstered by a $2.5 million grant from the N.C. Biotechnology Center, is charged with helping shepherd discoveries into products and processes.

UNCW Center for Marine Science Director Dan Baden, Ph.D., with some of the more than 750 cloned samples from more than 500 microorganisms collected from the waters off North Carolina's coast.

UNCW Center for Marine Science director Dan Baden with some of the more than 750 cloned samples from more than 500 microorganisms collected from the waters off North Carolina’s coast. Photo courtesy UNC-Wilmington/Jamie Moncrief

The marine life component of this collaboration comes from the lab work of UNCW Center for Marine Science director Dan Baden, who has studied red tide, the algae bloom known for killing large fish populations by paralyzing their central nervous systems.

Baden’s team identified a microorganism capable of crossing a cell’s outer protective layer – the membrane that acts as a gatekeeper, only letting select substances in and out of cells.

His team dubbed these microorganisms “escortins” because they can escort materials through that natural cellular fence, depositing them at a specific target. Escortin™ is already on the market as a cancer-drug delivery tool. Test results showed it delivers cancer medications to cells within minutes, compared to other drug-delivery systems that can take up to a day to be effective.

Work is underway for additional safety and efficacy trials, as well as clinical trials, to test whether Escortin can be used in other ways, Baden said.

Escortin could be given alongside other drugs, said Baden, who is also a UNCW marine sciences professor.

“If we can bind the escortins to a drug of interest at ECU, then we have the potential to develop a pairing where our molecules carry medications across the membrane efficiently,” he explained. He called escortin “a molecular carrier that could potentially have ubiquitous importance well past the end of all our careers.”

Delivering a guarantee

At ECU, Brown’s research has focused on mitochondria, the structures in cells that convert food into energy. He calls mitochondria the key to medication success.

Brown has focused on the mitochondria inside heart cells, how they affect heart disease and irregular heartbeats and how they repair other malfunctioning mitochondria. When cells are diseased, he said, mitochondria don’t work well.

Because of the cell’s outer membrane, there hasn’t yet been a definitive way to get drugs to the mitochondria in order for them to heal and return to normal functioning.

“Many times, there’s no guarantee a medicine will get into the cell that can benefit from it,” Brown said. “There’s no way to be absolutely sure [a medicine] gets to the right place.”

Escortins create that guarantee for mitochondria, Baden said, taking medications through the cell’s outer membrane.

North Carolina waters bring healing

Parts of cells being measured out for testing in the UNCW Center for Marine Science. Investigators use methods that involve physics and biology to learn more about the cells' function and structure at the molecular level. Photo courtesy UNC-Wilmington/Jamie Moncrief

Parts of cells being measured out for testing in the UNCW Center for Marine Science. Investigators use methods that involve physics and biology to learn more about the cells’ function and structure at the molecular level. Photo courtesy UNC-Wilmington/Jamie Moncrief

That targeted drug delivery could have a significant impact on adults living near both institutions.

According to 2010 data from the North Carolina State Center for Health Statistics, nearly 13 percent of adults in eastern North Carolina – the highest rate in the state – live with Type 2 diabetes. Data from the Eat Smart Move More NC initiative also revealed between 63 and 68 percent of adults in the same area are overweight or obese.

“Mitochondria in diabetics aren’t good at burning fuel for many reasons,” ECU’s Brown said. “If we can use the ocean to help design treatments, then there’s huge potential for treating the disproportionately high population of diabetics and people with metabolic illness.”

The escortin-medication relationship could also improve the efficacy of heart medications, Baden said. Being able to deliver heart medications to patients who’ve had a heart attack or stroke in a timely manner can potentially decrease avoidable deaths, an important goal in eastern North Carolina, a region known as the “buckle” of the “stroke belt.”

Economic impact

The state’s 300-mile coastline presents the universities with a wealth of discovery opportunities, said Deb Mosca, the Bio-Technologies Center’s chief executive and a microbial geneticist who studies the genetics of microorganisms.

UNCW researchers are already deeply involved in culling the ocean for plants and animals that could benefit human health. Once they find a new organism with intriguing characteristics, they clone it, eliminating the need to harvest more and potentially disrupt the ocean’s ecosystem.

In doing so, Baden said, investigators are looking for new aspects of genetics and chemistry that haven’t been seen before.

Workers in Jeffrey Wright's lab at UNC Wilmington's Center for Marine Science examine culturable marine organisms as possible sources of new and important compounds for creating new pharmaceuticals. Photo courtesy:  UNC-Wilmington/Jamie Moncrief

Workers in a lab at UNCW’s Center for Marine Science examine marine organisms that can be cultured as possible sources of compounds for creating new pharmaceuticals. Photo courtesy UNC-Wilmington/Jamie Moncrief

“If you combine ECU’s drugs with our molecules, we’ve created new intellectual property that can extend the life of patents and add new value. It’s a scaffold for us to build upon,” UNCW’s Baden said. “Translational science – applying research in a real-world way – earns money from tax dollars and gives back to the American people.”

The process can also work in reverse, he said. If researchers know there’s a need for a certain type of medication that functions in a particular way, they can work toward finding a marine biotechnology solution to the problem. And that could create greater economic stability in the region by bringing new tools, collaborations and science jobs to eastern North Carolina, fueling further economic development.

UNCW is already on that path with its new translational science building, funded by the U.S. Department of Commerce and National Institute of Standards and Technology. The 69,000-square-foot space is the first of its type in the region, and it brings together, under one roof, researchers from a variety of scientific fields, making professional cooperations even easier.

“It’s a resource for North Carolina biotechnology, the UNC system and the state that goes beyond just the faculty and institutions working together – it includes students,” Baden said. “It’s about coming into a multidisciplinary, collaborative environment and developing relationships through big science, business and working with the right people to combine expertise and experiences to do things that weren’t possible before.“

Dense Development Would Harm Air in NC’s Triangle, Study Finds


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New research from UNC-Chapel Hill challenges the new orthodoxy that dense urban development is better for the health of people living there.

By Gabe Rivin

“Smart growth” may not be so smart after all.

According to a recent study, North Carolina’s Triangle, if developed more densely today, would be home to spikes in harmful air pollution that would endanger the region’s residents.

The study, published in December in the peer-reviewed journal Risk Analysis, came to a counterintuitive finding: Denser development would slightly reduce the Triangle’s air pollution on a regional level, but at a more local level it would expose a greater number of citizens to “hotspots” of particulate matter, a harmful pollutant.

The skyline of downtown Raleigh. Urban planners consider the Triangle to be sprawling, but denser development could lead to problems with air pollution. Photo credit: Mark Turner, Wikipedia Creative Commons

The skyline of downtown Raleigh. Urban planners consider the Triangle to be sprawling, but denser development could lead to problems with air pollution. Photo credit: Mark Turner, Wikipedia Creative Commons

Dense development is an overarching goal for many city planners, who see it as a solution to sprawling urban landscapes like Raleigh. Sprawling development, they say, is largely responsible for car dependency, which reduces physical activity and increases air pollution, including the greenhouse gas carbon dioxide.

Yet a cross-disciplinary team from UNC-Chapel Hill and NC State University is challenging this orthodoxy.

“Our suggestion is not necessarily that density is wrong,” said Daniel Rodriguez, a professor at UNC’s department of city and regional planning and a coauthor of the study, “but that in itself, in isolation, it’s probably not going to be beneficial for people.”

According to the study, a denser Triangle in 2010 would have meant more citizens living near car traffic-heavy corridors. And that would have meant more citizens breathing in high levels of particulate matter.

Particulate matter is a complex mixture of small particles and liquid droplets, made up of acids, chemicals and metals, among other matter, according to the U.S. Environmental Protection Agency. Smaller particles develop when cars and other pollution sources emit gases into the air. The EPA says particles whose diameters are 10 micrometers or less – a human hair is about 50 micrometers – can deeply penetrate human lungs, potentially causing heart attacks or lung disease, among other problems.

Some urban planners say that dense development can limit air pollution since it encourages walking and biking. But the UNC researchers reached a different conclusion.

They argue that if the Triangle had been more densely developed in 2010, 65 people would have died from breathing particulate matter. In comparison, a model of pollution in the Triangle found 47 people likely died as a result of breathing particulates in that year.

A very sprawled development, on the other hand, would slightly increase regional levels of particulate matter. But because the pollution would be more dispersed over a wider area, only an estimated 31 people would die from breathing pollutants, compared to the model of the actual Triangle in 2010, the study found.

An illustration of particulate matter, which the EPA says can be harmful to human health. Graphic courtesy U.S. EPA

An illustration of particulate matter, which the EPA says can be harmful to human health. Graphic courtesy U.S. EPA

A novel trio of models

To reach their conclusion, the researchers relied on a system of modeling that they believe is the first of its kind.

First, the researchers modeled three scenarios: the density of the actual Triangle in 2010; a more compact, dense version of that “base” scenario; and a sprawling version of the base scenario.

The researchers then modeled likely traffic patterns for each, which they used to predict air pollution. Finally, the researchers funneled this information into a health model, which estimated the resulting human health effects.

This linking together of public health and urban planning is relatively rare, despite the two fields’ shared history, Rodriguez said.

“Urban planning emerged from urban health issues,” he said. “Back in the late 1800s, an understanding of access to water as a source of potential cholera in London led to the first sort of GIS urban maps and zoning.”

But while the two fields were intertwined, that began to change in the 1930s and ’40s, as public health research focused more on individuals’ health and city planners focused more on landscape architecture and urban design. Only since the 1990s have the two begun to overlap again, Rodriguez said.

Still, planners tend mainly to consider the environmental effects of a development – say, the effect a shopping mall will have on nearby wetlands. They often don’t consider the effects their projects will have on human health using the concept of formal health impact assessments, Rodriguez said.

Yet as the two fields – public health and urban planning – increasingly overlap, that may need to change, according to the researchers.

The need for a ‘menu of policies’

Theodore Mansfield, the study’s lead author and a Ph.D. student at UNC, said there’s an important discussion to be had about the costs and benefits of city living.

Traffic in New York City. New York is densely developed, but parts of it can grow congested with car traffic, producing localized spikes in air pollution. Photo by ILMRT, courtesy Wikipedia

Traffic in New York City. New York is densely developed, but parts of it can grow congested with car traffic, producing localized spikes in air pollution. Photo credit: ILMRT, Wikipedia Creative Commons

“There are a lot of great things that cities do,” he said. “But at the same time, the concentration of all those activities in a small space can have some negative health impacts.”

Density offers many benefits, like an increased ability to provide mass transit, Rodriguez added. But it isn’t necessarily a boon for public health.

“We need to have a menu of policies that are complementary and synergistic,” he said.

Those might include car-free zones in urban centers, a popular feature in Scandinavian cities, and electrified public transit, he said.

The study authors add that urban planning and transportation planning – much of which takes place in government agencies – should rely on formal health impact assessments in order to understand a large-scale project’s effects on the public’s health.

In North Carolina’s state government, that’s still a goal for the future.

Steve Abbott, a spokesman for the state’s Department of Transportation, said that conducting a health assessment for a project “is a consideration” at the department, but that “to say it’s done all the time would not be accurate.”

“However,” he added, “as we move into the future and continue to develop our planning procedures, it will become a more standard consideration and is definitely something we will better integrate into our plans.”

The limits of modeled data

Mansfield admitted that the study’s findings need to be considered with caution.

In addition to the limitations inherent to modeled data, the study’s models produced a broad range of results, he said.

The study’s models may have predicted 65 deaths for a dense Triangle. But those numbers could have varied dramatically, the models also found. In fact, deaths could have been as few as only six or as many as 220, a range large enough to call into question the study’s conclusions.

The authors also admit that their study did not consider some health benefits that accrue from dense development, such as walking.

Those benefits can be big, according to Julian Marshall, a professor of environmental engineering at the University of Minnesota and an expert on the topic.

“When you’re looking at health impacts of the built environment, air pollution and physical activity both matter,” he said. In fact, the benefits of increased exercise could outweigh the drawbacks of increased air pollution, he added.

But that also requires some qualification, he said. A neighborhood may be densely developed, but that doesn’t necessarily mean it’s walkable. The latter characteristic can result from an area that’s safe and has good sidewalks, for example.

“Are there stores to walk to?” he said. “If there’s no grocery store, then you can’t walk to the grocery store by definition.”

Latino Newborns May Be at Risk Due to Immigration Law Fears


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Regulations that give local law-enforcement officers the authority to act on federal immigration laws could have a chilling effect on the use of health care services within Hispanic communities.

By Whitney L.J. Howell

The health of North Carolina’s Hispanic newborns could be at risk from an immigration law.

The federal Immigration and Nationality Act – the same law that led to a racial profiling lawsuit against the Alamance County Sheriff’s Office in 2012 – could also be having a negative impact on the health of unborn babies in North Carolina’s Hispanic communities, according to new research from Wake Forest University.

Are Latina women missing prenatal visits due to fear of deportation? New research from Wake Forest University indicates that could be part of why these women receive fewer prenatal visits.

Are Latina women missing prenatal visits due to fear of deportation? New research from Wake Forest University indicates that could be part of why these women receive fewer prenatal visits. Photo courtesy Dakota Calloway, flickr creative commons

According to researchers from Wake Forest’s School of Medicine, the heightened fear of deportation generated by this and other laws, in addition to Latinos’ lack of understanding of their rights under immigration laws, has played a role in the unwillingness of North Carolina’s pregnant Hispanic women to seek out the medical services they need.

The study reveals these women are less likely than women of other ethnicities to receive timely and sufficient prenatal care.

“Regardless of the status of the mother or father, a child born here is an American citizen under the Constitution, and we would hope that all children born in this country are healthy and can avoid preventable illness,” said Mark Hall, a Wake Forest law professor with expertise in health care law and public policy who participated in the study. “So it’s certainly important that all expectant mothers receive adequate prenatal care.”

Delaying prenatal care

But that’s not what’s happening, Hall said.

Based on a data review and personal interviews conducted in 2012, Hall and his fellow researchers discovered approximately 30 percent of Hispanic women in North Carolina don’t start prenatal care until after the first trimester.

The American Congress of Obstetricians and Gynecologists recommendations suggest the initial visit occur between eight to 10 weeks. In comparison, according to the same study data, only 10 percent of non-Hispanic women delayed receiving care. Additionally, 30 percent of Hispanic women – versus 8 percent of all other women – received less than half of the 14 doctor examinations recommended in ACOG guidelines.

Photo courtesy futureatlas.com

Photo courtesy futureatlas.com

Unfortunately, said Angeline Echevarria, executive director of El Pueblo, a Latino community-advocacy group, North Carolina’s Hispanic residents often forego preventive health care services out of fear associated with their citizenship status.

“We’ve found that when community members feel they’re being singled out or targeted by law enforcement, it puts a damper on their willingness to seek health services that aren’t associated with any type of emergency,” she said. “We see this especially in rural areas where public transportation isn’t really an option. A lack of good mobility options limits their willingness to drive around and take a chance for what they deem as unnecessary care. So they put off preventive services, even though we don’t recommend it.”

Although N.C. Healthy Start reports first-generation Hispanics maintain the state’s lowest infant mortality rate – 3.7 per 1,000 live births – pregnant women in this community still face risks if they don’t receive proper medical services. Inadequate prenatal care has been linked to low birth weight; neural tube defects, such as spina bifida; congenital illnesses, impaired heart and brain development; and increased infant mortality. Newborns who don’t receive proper prenatal care are 40 percent more likely to die within the first month of life, according to the Guttmacher Institute.

It’s also possible, Hall said, that this group’s rate of inadequate prenatal care could create a significant public health issue for North Carolina. Based on 2013 U.S. Census Bureau estimates, there are more than 875,000 Hispanics in North Carolina, nearly 9 percent of the state’s population.

Effects of the law?

Using vital records data from 2012, six focus groups, and 17 in-person interviews, the study analyzed how expectant Hispanic women accessed and used prenatal care services for nine months before and nine to 18 months after the Immigration and Nationality Act went into effect. The researchers reviewed data from seven counties that adopted the law and seven that didn’t.

Under the INA’s section 287(g), U.S. Immigration and Custom Enforcement can effectively deputize state and local agencies, giving them the authority to uphold federal immigration laws during routing law-enforcement activities. The U.S. Department of Justice cited traffic stop data to argue that the Alamance County sheriff’s department was being overly aggressive in targeting Latinos under the aegis of the INA.

Photo courtesy Alamance County Sheriff's Office

Photo courtesy Alamance County Sheriff’s Office

In 2012, federal officials terminated the county’s participation in the program. This past year, Terry Johnson, the Alamance County sheriff, was tried in a federal court on charges of discriminatory policing. A judge has yet to rule in the case.

Researchers can’t say definitively whether immigration regulations caused the drop in access of prenatal care services, Hall said, but the data did indicate fewer women sought care after its enactment than before.

In the interviews, pregnant women frequently reported a lack of insurance contributed to their foregoing prenatal care.

Data from the Henry J. Kaiser Family Foundation reported 43 percent of N.C. Hispanics don’t have health insurance. This amount mirrors the Pew Research Center statistic of 43 percent of Hispanic 18-to-64-year-olds nationally who are without health insurance.

For some women, transportation was an issue, Hall said. Many were concerned they would be pulled over en route to the doctor’s office for a routine traffic violation and have their immigration status discovered. This is what happened in Alamance County, where a review of traffic stops showed deputies from the sheriff’s department were more likely to stop Latinos for minor traffic violations, such as riding without a seat belt.

Another group of women in the study feared the doctor would report them to immigration officials.

Greater clarity

To combat these concerns, North Carolina’s public policy and medical leaders must improve communication around patients’ rights and access to care, Hall said. Greater clarity about whether immigration enforcement can even affect medical care – medical providers are neither required nor expected to check immigration status when providing services – could also be helpful.

In addition, he said, knowing there’s no real risk of being reported by the doctor’s office could encourage more women to find some type of reliable transportation to their appointments.

Ultimately, Hall said, improving prenatal care for Hispanic women could have a positive impact on North Carolina’s health overall.

“As a society, we have concern over everyone’s health, particularly those of children. If reluctance or fear affects the willingness to get immunizations, it could impact communicable diseases,” Hall said. “In general, there’s a larger implication. We need to think beyond just enforcing immigration policy to the labor and economic impacts on families, as well as the public health impacts that aren’t fully recognized.”

Preventing Burnout in Doctors Young and Old


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Many health care practitioners find themselves overwhelmed and depressed, yet there are few outlets for them to get help. A program at UNC-Chapel Hill is targeting doctors who are burnt out.

By Whitney L.J. Howell

Kara McGee knew something was wrong when she felt all the excitement over her job and empathy for her patients draining away.

“I wasn’t missing things, but it was definitely a more ‘here we go again’ attitude,” she said. “I didn’t want it to happen, but I was disconnecting from what I was doing. It felt like it was protective, like it was my way of coping with what I was seeing on a daily basis. I felt very out of control.”

Image courtesy martinak15, Flickr Creative Commons

Image courtesy martinak15, Flickr Creative Commons

At the time, McGee was a physician assistant, working in a pediatric surgery and intensive care unit in Miami. Being surrounded by so many children who were dealing with such intense medical issues made it difficult for her to concentrate on the patients who had good outcomes. Instead, McGee said, she dwelled on those who suffered from long illnesses and died.

So she quit. McGee walked away from patient care for three years. During that time, she went back to school to earn a master’s degree in public health, but eventually returned to working with patients after realizing she missed it. It’s different now though. Today she works in HIV medicine at Duke University Medical Center’s Division of Infectious Diseases.

“Now, I can develop long-term relationships with my patients, and that’s extremely rewarding,” McGee said. “In the ICU or emergency department, there’s either a poor outcome or you don’t know what happens because patients go on their merry ways. It’s the relationship building that’s so gratifying.”

Based on existing research, McGee isn’t alone. Medical professionals are more likely than people in other professions to experience burnout. Studies have looked at burnout prevalence among physician assistants and other health care providers. But until now, there’s one group that’s gone without much examination: medical residents, the physicians-in-training.

According to new work conducted by researchers at the University of North Carolina-Chapel Hill though, as many as 75 percent of medical residents experience at least one time period of burnout, and roughly 50 percent identify themselves as burned out at any given time.

“This is an extremely common problem. The academic medicine centers responsible for training our doctors are under extreme pressure these days,” said Samantha Meltzer-Brody, the lead study investigator. “The entire business of academic medicine and the structure of it are built upon a system that no longer works, and no one is entirely sure what to do about it.

“Residents are on the front lines of providing the care, and I think they feel it acutely.”

Treating the malaise

Physician burnout is a national problem that, in some cases, contributes to an even greater concern: physician suicide. According to Pamela Wible, a family physician and physician-suicide expert, approximately 400 doctors take their own lives annually, and many leave behind letters or evidence of their daily mental stresses.

Image courtesy Kevin Dooley, flickr creative commons

Image courtesy Kevin Dooley, flickr creative commons

Meltzer-Brody’s goal is to identify, treat and diffuse those mental stresses and other mental health concerns before residents reach that level of despair.

Increased patient demands, battles with insurance companies, malpractice concerns and medical school debt are known contributing factors to physician burnout. But, according to Meltzer-Brody, who also directs the Perinatal Psychiatry Program in the UNC Center for Women’s Mood Disorders, residents face additional, more contemporary challenges. To identify the residents’ stress mix, she conducted an online survey with 310 UNC HealthCare residents.

In May and June of 2014, she collected survey results from residents in various specialties, including surgery, internal medicine, pediatrics and psychiatry. The questions queried about interpersonal situations, fatigue, depression and feelings around patients who died. Meltzer-Brody noted residents likely had additional stress during this time because they were training to use the UNC Healthcare system’s new electronic health record system, Epic.

Through this survey and her ongoing mental health program for physicians, “Taking Care of Our Own,” Meltzer-Brody has put North Carolina at the forefront of combating this phenomenon. This UNC-based, first-of-its-kind initiative is specifically designed to treat physician burnout by providing education, confidential support services, advice and mental and physical health referrals.

Within its first year, from 2012 to 2013, the program grew by 200 percent.

What residents are feeling and facing

North Carolina’s medical residents face a challenge that could make resident risk of burnout more severe, Meltzer-Brody said.

Samantha Meltzer-Brody.

Samantha Meltzer-Brody. Image courtesy UNC Healthcare

“We have a growing population that is very diverse. North Carolina is the fifth largest state taking care of Latinos, many of whom are undocumented and use the emergency room as their first point of care,” she said. “The UNC emergency room is exploding as we try to meet the health needs of this influx of people.”

Rural physicians face this same challenge, often having to provide emergency room and hospital coverage in addition to their clinic duties. A significant cadre of physicians and residents in North Carolina fall into this category. According to the N.C. Department of Health and Human Services, 150 to 160 physicians were recruited annually for the past six years to serve the state’s rural populations.

At the same time that there are more patients in waiting rooms, there are fewer residents on call due to a 2003 federal regulation that limited residents to an 80-hour workweek in an effort to create more well-rested residents and increase patient safety.

“The thought was that if residents were more rested, it would decrease medical errors, as well as improve their mental well-being,” Meltzer-Brody said. “Neither has happened. We’re not seeing reduced medical errors, and burnout is at an all-time high.”

Additionally, academic medical centers haven’t increased their resident numbers or hired other personnel, leaving a smaller group of residents responsible for an ever-growing body of work. All these factors contribute to increased daily stress, she said.

Reports from the Physicians’ Foundation revealed that these issues led to 81 percent of doctors finding themselves overextended and half being unlikely to recommend a medical career.

Together, these factors leave little time for team building or mentoring, eroding the sense of community that once existed between residents, attending physicians and other health care personnel, Meltzer-Brody said. Losing that cooperative spirit can fuel a significant burnout feeling.

“What these residents experience isn’t what brought them into being doctors,” she said. “There’s a big disconnect between what’s being emphasized in medical school and what’s happening in actual practice.”

McGee’s advice

Whatever the symptoms, McGee recommended residents or other health care professionals identify someone with whom they can discuss both their physical and mental reactions to work-related stress.

“I think seeking help from employee-assistance groups is an excellent way to cope with the stress you experience as a medical professional,” she said.

In addition, she suggested individuals experiencing burnout take time for self-reflection. If someone’s ability to provide appropriate, compassionate care is compromised, then it’s time to take a break and try something different professionally.

Ultimately, the biggest force behind burnout among medical professionals is the industry’s culture, McGee said, and practitioners need an outlet.

“It’s just like with professional athletes who get injured and play anyway,” she said. “Part of what you do in having to deal with the stress and the patient care is simply putting one foot in front of the other. It’s the culture of medicine that just comes with the territory.”

Mapped Data Offers Insights about Water Quality and Birth Defects

Aggregated data about metals in North Carolina’s well water indicate some disturbing connections between birth defects and well water in some parts of the state.

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By Gabe Rivin

First, pull up a state map. Next, gather six years’ worth of childbirth records from across the state. Top it off with a surplus of data about the state’s drinking-water wells.

Confused what to do next?

If the connection isn’t immediately clear, you might want to ask Rebecca Fry, a professor at UNC-Chapel Hill and an expert in the harms wrought by heavy metals, such as arsenic and cadmium. Fry, along with researchers from UNC and the state’s government, recently combined these disparate data sets while studying the connections between well water and birth defects.

What they found, Fry said, was striking.

Water wells throughout the center of the state are saturated with manganese, they found. And babies in North Carolina were more likely to have heart defects if their mothers drank water from these manganese-rich wells.

In recent years, health researchers have increasingly turned their attention to heavy metals – such as cadmium, mercury, chromium and arsenic – particularly for their effects on unborn children. Fry and others have shown that cadmium can potentially harm newborns’ health and that the heavy metal has accumulated in mothers’ blood.

A map with average concentrations of four heavy metals in well water, listed in parts per billion. Graphic courtesy Rebecca Fry

A map with average concentrations of four heavy metals in well water, listed in parts per billion. Graphic courtesy Rebecca Fry

So it’s not entirely novel that a metal has been implicated in a health problem. But what is new, according to Fry, is that researchers have turned to data-rich maps to make these findings.

“Just being able to map those metals across the state is very new,” said Fry.

Mapping big data

Fry said she and her colleagues had a surfeit of data to work with.

For their study, published in September, the researchers gathered six years’ worth of childbirth data from across the state, captured by the state’s Birth Defects Monitoring Program. That program is part of the N.C. Department of Health and Human Services and keeps records on newborns’ birth defects in all 100 state counties.

The researchers gathered data from about 20,000 babies born with birth defects. As a control, they also considered about 668,000 born without defects.

The babies were born in counties in all regions of the state. And that meant that the babies’ mothers lived in counties across the state where water quality can vary dramatically from well to well.

The researchers wanted to know whether well water had anything to do with newborns’ birth defects. But they were limited, Fry said, since they couldn’t measure the mothers’ actual water consumption.

The Carolina slate belt runs from Virginia to Georgia and through central North Carolina, where it saturates drinking water wells with manganese. Graphic courtesy U.S. Geological survey

The Carolina slate belt runs from Virginia to Georgia and through central North Carolina, where it saturates drinking-water wells with manganese. Graphic courtesy U.S. Geological Survey

“We don’t have active environmental monitoring in everyone’s home,” she said.

So, to estimate the water that the mothers drank, the researchers instead relied on geocoding, a technique that allows different types of data to be plotted on maps.

It’s a technique that’s gaining momentum in public health research, according to Tzy-Mey May Kuo, a research associate at UNC’s Lineberger Comprehensive Cancer Center.

“This is not new, but it’s a technique that’s become popular,” she said, noting that geocoding is used in popular websites like Google Maps, whose maps are enriched with street-level images and information about businesses.

For the study’s authors, geocoding helped explain what was in the water that the mothers drank.

Using state records about well water, the researchers mapped out the different quality of the water across the state. They then combined this water data and another key data set – the locations of mothers’ homes while they were pregnant – in order to predict, on average, what sorts of heavy metals were entering the women’s bodies and potentially the bodies of their unborn children.

This complex method allowed them to answer three simpler questions: Where in the state is well water a problem, where are children being born with defects and is there a connection between the two?

The need for biomonitoring

When the data crunching was done, the picture was clear.

Manganese is highly concentrated in many North Carolina wells, the researchers found, especially in the central counties of the state, which sit above the Carolina slate belt, a cross-state geologic formation with an abundance of manganese. In fact, about 20 percent of private water wells exceeded the EPA’s suggested limit for the metal.

well image image is courtesy of Wikimedia Commons.

2.3 million North Carolinians rely on wells for their drinking water, but some 20 percent of the wells surveyed in the study had manganese levels that exceeded the EPA’s recommended limit. Image courtesy of Wikimedia Commons.

And the manganese appeared to be causing harm. Newborns had a higher chance of being born with heart defects if their mothers drank the manganese-rich water, the study found.

Manganese toxicity follows a basic principle: the dose makes the poison. The body needs a small amount of the metal to function properly. But excessive amounts can be harmful.

Health researchers have known since the 1800s that manganese, which is used to harden steel, can cause neurological disorders in humans who’ve had high enough doses. Its effects, in fact, can emulate those of Parkinson’s disease. Among children, it’s also suspected of causing problems with neurological development.

But while their finding is worrisome, the researchers admit that their study had several significant limitations.

Though their sample size was large, the researchers were hampered by a lack of data about the mothers’ actual water consumption.

The study’s authors say their lack of individual measurements points to the need for biomonitoring, or chemical measurements of study participants’ bodies. But North Carolina currently doesn’t have any biomonitoring programs for pregnant women, they add.

They also note that until 2008 state government did not require residents to test well water – and even then, the tests were only made mandatory for new wells. So while the study relied on data from 1998 to 2010, the pre-2008 data would have come from residents who chose to have their wells tested. And that could have biased the data, the researchers say.

What well users can do

The UNC and government researchers used a sophisticated method to calculate health risks for newborns. But for residents concerned about their water, the solution can be much simpler. County health departments offer tests of private water wells, including tests for a number of heavy metals, including manganese.

In Montgomery County, well tests run between $35 and $85, and can measure pesticides, inorganic chemicals and petroleum. Teresa Davis, an environmental health coordinator with the county, said that most people seek out the county’s services on their own.

“Being such a small community, people know to call the health department,” she said.

Fry said that this is a good idea since federal and state regulations don’t cover the quality of well water. Residents can also install technology to remove heavy metals if they’re having an issue, she added.

But those filters can be more expensive than conventional water filters, like those made by Brita, Fry said. One, manufactured by Apyron, removes about 92 percent of arsenic from water but costs about $500. A reverse-osmosis system made by Certex costs about $300 and removes about 86 percent of arsenic.

The N.C. Department of Health and Human Services also collects water samples from newly drilled wells.

“The wells are sampled and the resident is given a list of contaminants (if any), possible remedies for such contaminants, as well as any health risks associated with consuming the water,” said Alexandra Lefebvre, a press officer with DHHS, in an email interview. “We recommend to all new well owners to sample their well annually after the first samples are collected.”

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