North Carolina Health News
North Carolina Health News. News. Policy. Trends.

Lyme Disease-Bearing Ticks Creeping Their Way Slowly South


Evidence is mounting that ticks carrying Lyme disease are spreading into North Carolina from Virginia.

By Rose Hoban

There are few diseases more controversial than Lyme disease.

The tick-borne virus has been the subject of debate over how many cases occur in the U.S. annually, the correct test and the correct treatment for chronic cases of the disease and whether the chronic form of the disease even exists.

But there are a couple of things that are less subject to debate: that you’re vastly more likely to get Lyme in the Northeast, where the disease was first identified, or in the upper Midwest, where it’s becoming more widespread.

Now there’s increasing evidence that Ixodes scapularis ticks bearing Borrelia burgdorferi, the bacteria that causes the disease, are becoming more common farther south, increasing the risk of contracting the disease in North Carolina.

Video showing the spread and geographical distribution of Lyme disease-bearing ticks since 2000. Maps courtesy CDC

A recent paper published by researchers from the Centers for Disease Control and Prevention mapped the geographic distribution of confirmed Lyme cases and data showing the geographic distribution of where I scapularis (commonly known as blacklegged ticks) were found to be carrying B. burgdorferi to define “high-risk” counties. The research indicated a slow, but steady, spread of increased risk areas extending down the Appalachians.

“Our results show that geographic expansion of high-risk areas is ongoing, emphasizing the need to identify broadly implementable and effective public health interventions to prevent human Lyme disease,” wrote the authors, who published their findings in the August issue of Emerging Infectious Diseases.

Spreading south

“Over the past 15 years, you can see a clear progression of the disease from the DC area along the foothills, almost to the North Carolina border,” said State Public Health Veterinarian Carl Williams. “We see cases reported in North Carolina in areas immediately south of what appears to be an emerging area in southwestern Virginia.”

Williams said he’s specifically concerned about Allegheny and Wilkes counties, and expects to start seeing the numbers of cases climb there.

Ixodes scapularis (black legged tick). Nymphs (l) and mature (r).

Deer ticks (Ixodes scapularis), nymphs and mature, left, compared with American dog ticks (Dermacentor variablis), right, with a 22 50 gauge needle. Photo courtesy Jim Occi, BugPics,

“We’ve been in a position where Lyme disease cases were a much lower incidence rate here, but we’ve seen the incidence rate for Lyme really increase in Virginia,” Williams said.

“The real challenge in North Carolina is that we’re next to an endemic state,” said Duke University infectious disease researcher Paul Lantos.

Lantos said that a look at the epidemiology of Lyme in the Southeast since 2000 indicates that there are about 11,000 confirmed cases, and all but 1,000 of those are in Virginia.

“There’s been a dramatic expansion in Virginia over this time,” he said. “What we found is that northern Virginia has intensified, but there’s also been a rapid expansion down the Appalachians into Blacksburg and Roanoke possibly.”

Lantos also said ticks collected by researchers in Virginia back up the epidemiology.

Jory Brinkerhoff, a researcher at the University of Richmond, saw an increase in the number of Lyme diagnoses, and determined there were probably infected ticks in those areas.

When Brinkerhoff went looking, he found big populations of blacklegged ticks at higher elevations, and many of those were carrying B. burgdorferi.

“When you’re looking at case data, you take it with a grain of salt,” he said. “But corroborated with tick data, you can see there’s a lot of opportunity for infection because there are the ticks crawling around.”

Already here?

But some say Lyme is much more prevalent in North Carolina than this research shows. Included among them is Marcia Herman-Giddens, who advises the Tick-Borne Infections Council of North Carolina.

A Lone Star tick larvae looks to hitch a ride on a host. This behavior is called questing. Lone Star ticks are aggressive biters of humans and are thought to transmit at least a half dozen diseases.

A Lone Star tick larvae looks to hitch a ride on a host. This behavior is called questing. Lone Star ticks are aggressive biters of humans and are thought to transmit at least a half-dozen diseases, including Rocky Mountain Spotted Fever. Photo by Marcée Toliver

Herman-Giddens, who teaches at UNC-CH’s Gillings School of Global Public Health, said part of the story of underdiagnosis has to do with how Lyme is diagnosed, using a two-step series of tests for antibodies that she said is overly strict, ruling out any cases where the reading might be equivocal.

In addition, she said, those borderline cases can be misinterpreted to mean there was no disease.

“There’s not a good test, and there’s not a test of cure,” she said, while allowing that it can be difficult to prove the absence of disease for most diseases. She noted that part of the problem with Lyme is that once someone is exposed to B. burgdorferi their bodies will make antibodies for years, which will then be detected on a subsequent test.

“People do stay positive for some of the [readings] of the test, sometimes for years,” Herman-Giddens said. “So one of the areas is that if people get sick again, and you get another tick bite, then it’s really a mess. They may have antibodies from a previous infection.”

She drew some comfort from an update sent to medical providers around the state by the North Carolina state epidemiologist this April. The memo reminded doctors that testing fewer than two weeks after a rash was not enough time for the antibodies to form.

That memo also noted the presence in North Carolina of another tick-borne disease that’s been dubbed STARI, for Southern tick-associated rash illness. But STARI is caused by the bite of a different species of tick, and researchers are still unsure of what bacteria actually causes it.

“[STARI is] impossible to distinguish from early Lyme disease,” Lantos said. “So I think a lot of cases in North Carolina are diagnosed as Lyme disease because you can’t distinguish between the two.”

Everyone agrees that having around more than one tick-borne bacteria that creates similar symptoms confounds the situation and adds to the controversy over identification, diagnosis and treatment for both diseases.

This year, the Centers for Disease Control and Prevention revised their estimates for annual Lyme disease diagnoses dramatically upwards. For years, the agency counted only cases reported by state health departments, tallying about 30,000 cases per year.

But looking at lab and insurance data yielded many more diagnoses, coming in at anywhere between 288,000 and 329,000 cases per year nationally.

While Herman-Giddens pointed to this revision as evidence of overdiagnosis, Lantos argued there are a lot of false positives in the testing for Lyme, and that people who really had STARI were treated for Lyme using powerful antibiotics, potentially causing harm.

“There probably are more cases,” Lantos conceded. “The range is getting larger and we are diagnosing it more and have more sensitive surveillance to capture more patients.”

Things people can agree on

No matter the controversies over diagnosis, everyone agreed that there’s more of an issue with tick-borne diseases. And all the researchers in North Carolina bemoaned the dismantling of the state’s public health entomology unit in 2011, after it was defunded by the General Assembly. The group had been tracking the presence and spread of insect-borne diseases in the state.

Now that Lyme is poised to really take off in North Carolina, such a group would be a valuable addition to the work of TickNET, a collaboration of academics and state and federal public health entities focused on tracking, researching and preventing tick-borne diseases.

Another point of agreement was that people need to do a better job at preventing tick bites. That includes wearing long pants into the woods and gardens, tucking pants into socks and using insect repellents like DEET.

“People don’t realize you have to rub the DEET into your skin,” Herman-Giddens said. She also has found that permethrin-impregnated clothing is effective at keeping ticks off of her when she leaves her Chatham County house to go into the woods.

She also suggested saving any ticks you pull off of yourself. She tapes the tick to a card and writes the date on it, along with the place on her body where it was biting.

“If you walk into a doctor’s office with a tick on a card, that makes a difference,” she said. “And if someone is knowledgeable, they can identify the tick.”

The guidance from the state epidemiologist noted that five North Carolina counties are now defined as “endemic,” meaning that at least two lab-confirmed cases have been identified in people who did not travel outside their county of residence during the month-long disease-incubation period. Those counties are Allegheny, Guilford, Haywood, Wake and Wilkes.

“A lot more is headed in this direction, and the ticks don’t know from Virginia,” Lantos said.

NC DHHS Tick Poster 11×17 (Text)

UNC Study Finds Rural Medicare Recipients Less Likely to Receive Follow-up Care


Many older patients discharged from rural hospitals end up back in a hospital bed too soon.

By Taylor Sisk

A team of UNC-Chapel Hill researchers has found Medicare patients in rural areas are less likely to receive adequate follow-up care after leaving the hospital than patients in urban areas.

As a result, they may well be at greater risk of winding up back in the hospital or the emergency room soon after discharge.

Matthew Toth, now a research public health analyst at RTI International, was lead author of the study, conducted while he was earning a doctorate in health policy and management at UNC’s Gillings School of Global Public Health and serving as a research assistant with the Cecil G. Sheps Center for Health Services’ N.C. Rural Health Research Program.

The results, published in the September issue of Medical Care, found that Medicare patients living in rural areas were 19 percent less likely to receive follow-up care within 30 days of leaving the hospital than those living in urban areas.

Patients discharged from hospitals in relatively smaller rural areas faced a 42 percent higher risk of being readmitted to the hospital within 30 days than patients discharged from hospitals in urban areas. Patients discharged from hospitals in larger rural areas were 32 percent more likely to be readmitted than their counterparts in urban areas.

Patients living in small rural areas were also 44 percent more likely to be seen in the emergency department within 30 days, while those in large rural areas were 52 percent more likely.

The study comes shortly after the release of the fourth year of federal data showing the 30-day readmission rates for most hospitals in the nation. This year, a majority of hospitals will face Medicare fines for having patients frequently return within a month of discharge.

Barriers to care

The UNC study looked at some 12,000 Medicare-eligible patients with hospital admissions between 2000 and 2010, using data from the Medicare Current Beneficiary Survey.

Toth pointed to workday schedules as a barrier to primary care for people who cannot get to the doctor during regular business hours. He suggested extending weekend clinic hours as a potential solution.

Toth and his colleagues also outline some potential policy initiatives to address the problems they found, including investment in telehealth, care management and transitional care and policies to enhance primary care services.

“Policymakers and researchers ought to continue to monitor the utilizations and outcomes among rural beneficiaries to better understand some of the specific barriers to care that they’re experiencing,” Toth said in an interview.

This could “help shape some of the payment and delivery-system reforms that are taking place in our health care settings,” he said.

Hospital fines

CMS officials will penalize 2,592 hospitals across the country this year, all will receive lower payments for every Medicare patient admitted to that hospital for the coming year.

The penalties will be assessed starting in October. They’re mandated by the Hospital Readmissions Reduction Program, created as part of the Affordable Care Act to encourage hospitals to more closely monitor what happens to patients after discharge.

The hospitals penalized will lose a combined $420 million. The percentage of North Carolina hospitals that will be fined is higher than the national average: 68 percent compared with 54 percent.

Toth placed the results of his team’s study in the context of the Hospital Readmissions Reduction Program.

“Consistent with previous research on safety-net and low-volume hospitals, our study finds that rural hospitals serving elderly Medicare beneficiaries may be disproportionately penalized under this program,” he said in a press release announcing the results. “If so, poor readmission outcomes among these hospitals may be exacerbated.”

A deeper understanding of the reasons for the discrepancies between rural and urban areas could help inform efforts to improve care, he said. “For example, are patients of rural hospitals more likely discharged to under-resourced settings, or are there more likely gaps in post-discharge instructions in the inpatient setting?”

“Especially with new ‘pay-for-performance’ programs tying reimbursement to hospital performance on patient outcomes, [our] results highlight the need for policies to improve follow-up care for patients in rural areas,” he said.

Bad Health Outcomes for Adults Who Don’t Get Help as Teens


By Lisa Gillespie

Kaiser Health News

Young people with health problems left uncared for in adolescence face higher risks of leading unhealthy lives as adults, a new study finds.

A study of 14,800 people found that the odds of adverse adult health conditions were 13 to 52 percent higher among those who reported unmet health needs as adolescents than for those who did not have unmet needs as teens but who were otherwise comparable. The study was conducted first in 1994-95 when many subjects were in their mid-teens, and again in 2008 when many were in their late 20s.

Photo credit: Valentin Ottone, flickr creative commons

Photo credit: Valentin Ottone, flickr creative commons

An article about the study was published Monday in Pediatrics, the journal of the American Academy of Pediatrics.

This isn’t the first study to find a link between health services for adolescents and better adult health, but past research relied on country-level data from sources such as the World Bank. The latest study is the most extensive one using individual data, said lead researcher Dougal Hargreaves, a research fellow at Boston Children’s Hospital.

Teenagers with depression whose needs were unmet then were one and a half times more likely to have depressive symptoms in adulthood than counterparts who received help in adolescence. Similarly, poor general health, functional impairment, missed work or thoughts of suicide in a person’s early years – if not addressed – are a predictor for those issues in later life, researchers said.

The study compared people who had reported unmet health needs in adolescence with subjects with similar adolescent health issues, insurance coverage and socioeconomic backgrounds but no unmet health needs.

There could be two reasons for unresolved teenage problems that carry into adulthood, the study’s authors wrote. One explanation might be that health care not provided in adolescence exacerbates a condition in adulthood – although they said they did not study that specifically. Another possibility is teenagers who don’t take care of their health follow the same habit as adults, the authors speculated.

Adolescence is a time when people begin to form attitudes about health and seeking help when it’s needed that stick with them for life. “Adult behavior may be influenced by experiences in childhood as well as adolescence,” the Pediatrics article said.

Adolescent subjects in the study often didn’t perceive their health needs as important. That was the most common reason those needs were not met. Cost was the least common reason, the authors wrote. Other reasons cited were teens’ fear of negative consequences if they sought help and their lack of confidence that their privacy would be protected.

“Oftentimes, we’re worried about financial access problems. But for adolescents, often the access challenge isn’t related to the ability to pay, but the ability to understand the importance of treating problems now and to find a trusted provider who can offer care in a nonjudgmental way,” said Matthew Davis, a professor of pediatrics at the University of Michigan.

Scott Benson, a child psychiatrist for 35 years in Pensacola, Fla., said the study reported in Pediatrics affirmed the stigma he sees many teen patients come in with. Many have no idea they have depression and wonder why they are sad. While many teens had depression symptoms in the study, he said outcomes could have gotten worse because they were not addressed early.

Hargreaves’ takeaway was that teens need to use services more easily, and get around the stigma of getting help, especially for mental illness. They should be able to talk with health professionals about subjects awkward to them, he said.

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.

What to Do with 264 Billion Pounds of Coal Ash


UNC-Charlotte engineers are developing novel techniques to manage coal ash, but time is running short.

By Gabe Rivin

John Daniels claimed he could make water stand on a block of coal ash.

“Have I ever given you my little show-and-tell trick?” he asked, as he rushed to his cabinet. He returned with a chalky gray cylinder and a bottle of water. “Making stuff water repellent, to me, is just neat.”

Photo shows water beaded on top of a cylinder of ash.

Using organosilanes, John Daniels can make coal ash waterproof, and potentially serve as a cover for ash ponds. Photo credit: Gabe Rivin

Daniels laid two drops of water on the flat face of the cylinder. One droplet began to sink. Soon all that remained was a dark-gray spot.

But on the other side of the cylinder’s face, the water droplet remained globular and inert, repelled by a seal of water-resistant chemicals.

“If it’s water repellent, water’s not getting in,” Daniels said. “Water’s not getting in, water’s not getting out.”

Daniels is one of several engineers at UNC-Charlotte helping to answer a multi-billion-dollar question: What should Duke Energy do with its bounty of coal ash in North Carolina?

The ash, created when coal is burnt to produce electricity, has proven vexing for Duke, environmentalists and state lawmakers, all of whom are jockeying over its fate.

On one hand, the science seems clear. North Carolina’s coal ash is stored in large basins that are dug into the ground. These were constructed without liners, and so toxic metals in the ash, such as arsenic and chromium, can leach out of the basins.

The metals can find their way into subsurface water, or groundwater. This migration has the potential to contaminate drinking water for nearby residents who draw their water from wells drilled into the ground.

After a new round of tests near coal ash ponds, the N.C. Department of Environment and Natural Resources in April raised the possibility that coal ash is contaminating residents’ drinking water.

How to eliminate this threat though has been passionately contested, with some calling on Duke to move its ash to lined landfills and others saying that Duke can safely keep much of the ash where it is, provided that it’s dried out and covered up.

John Daniels, a researcher who chairs UNCC's civil and environmental engineering department, and an expert on coal ash. Shows him standing in front of a blackboard with equations on it.

John Daniels, a researcher who chairs UNCC’s civil and environmental engineering department, and an expert on coal ash. Photo credit Gabe Rivin

For either method, Duke faces an enormous engineering challenge. Duke’s surfeit of ash, a total of some 264 billion pounds, is also spread across 32 basins in the state, some of which are filled with water.

Duke also faces several tight timelines to close its sites.

All of which helps explain the urgency behind UNCC’s research.

Although North Carolina’s legislators prescribed much of Duke’s cleanup plan, there’s still a lot to learn about coal ash, the researchers say. And there are plenty of soon-to-be-proven methods to transform the ash, whether that means turning it into waterproof construction material or using it to build barriers that keep the rest of the ash dry.

In the lab

Milind Khire pointed at what looked like a metal drum, inside of which was a pair of metal arms.

“This is a geo-centrifuge,” he said. “We can actually create a prototype of a dam or a levy system here.”

Khire, another engineering researcher at UNCC, is planning to use the centrifuge with coal ash. By spinning wet ash at high speeds, he’ll be able to measure some of its fundamental physical properties. These include the behavior of water when ash is stacked in 200-foot piles, as may be the case at Duke’s landfills.

Khire said that much of this research is new.

“Very little strength and hydraulic property measurement has been done by anybody for coal ash,” he said.

Milind Khire, an engineering researcher at UNCC who focuses on coal ash. Photo credit: Gabe Rivin

Milind Khire, an engineering researcher at UNCC who focuses on coal ash. Photo credit: Gabe Rivin

And that’s a problem, he said, given some of the rushed deadlines for Duke’s ash basins. For three of its sites, Duke has until 2019 to dig up its coal ash and transport it to landfills.

But Khire said Duke should be given more time as engineers work to better understand ash and develop novel techniques to manage it in place, rather than shipping it to other communities.

Daniels, who has advised Duke on ash management, also criticized a one-size-fits-all approach to coal ash, such as environmentalists’ demand that Duke excavate and landfill all of its ash.

“The notion of excavating every site and putting it on a bunch of trucks – or even rail – and hauling it hundreds of kilometers or miles to some other far-flung site and entombing it is not necessarily the best approach,” he said. “Jumping from, ‘Every site has an impact, therefore excavate,’ to me is understandable, but it’s irresponsible from an engineering perspective.”

Daniels said novel engineering techniques could protect people’s health, at a fraction of the cost.

Those techniques may include deploying organosilanes, a chemical class that can render coal ash waterproof. Since 2007, Daniels has run small-scale tests using the compounds. He’s found organosilanes could efficiently transform large quantities of coal ash, allowing it to serve as a cover for ash ponds.

Khire is experimenting with a similar technique. By mixing coal ash with North Carolina’s soils, it’s possible to create a spongy material that keeps water out of an ash basin, he said. This too could serve as a cover for Duke’s ash.

Elsewhere in his lab, Khire is developing a technique that could improve Duke’s ability to pump water from its ponds. The technique uses charged electrodes to attract water while leaving behind the coal ash.

This technique would help Duke to dry out the ash so it doesn’t leach metals into groundwater. Combined with a waterproof cover, the ash would be protected from rain. Such a combination, the researchers believe, could protect the public’s health while saving enormous costs.

The problem with water tables

“The role of research and development in this entire process is really key,” Erin Culbert, a spokeswoman for Duke, said.

Culbert said researchers have extensively studied ash recycling; coal ash can be used to make concrete and wallboard, among other products. But closing ash basins “in a somewhat urgent timeline is really a place where we feel like there could be a lot of additional assistance and reconnaissance,” she said.

While Khire said Duke’s deadlines are needlessly rushed, environmental groups aren’t so patient.

Wet coal ash left over from last February's spill into the Dan River. Photo courtesy N.C. Department of Environment and Natural Resources. photo shows a large mass of grey, mushy ash

Wet coal ash left over from last February’s spill into the Dan River. Photo courtesy N.C. Department of Environment and Natural Resources

D.J. Gerken, an attorney with the Southern Environmental Law Center, said that Duke and state regulators have known about these problems for years.

“When you start the clock from the time that Duke Energy and the state discovered that these ash pits were failing and contaminating nearby rivers, we are by no means on an aggressive timeline,” he said

He also argued that a system of dewatering and covering the ash, as Khire envisions, would not work. Many of Duke’s ponds were dug below the water table, the highest vertical level of groundwater, he said. And that means groundwater can flow into and out of ash basins, toxic compounds in tow.

Khire admitted this is possible. But he said Duke could still dewater and seal its ponds and continuously pump out any groundwater. He admitted this would be expensive though.

Gerken was skeptical of this plan.

“It is an engineering Band-Aid that must be continuously operated by Duke Energy forever if we’re going to protect groundwater and rivers,” he said.

Regardless of the method, Duke’s priority is to protect groundwater, the company’s spokeswoman Culbert said. When evaluating the options for a site, she said, Duke wouldn’t choose to cap an ash basin if doing so would allow for contamination.

Who will take it?

For now, state regulators have paused their work to determine the fate of Duke’s ash in response to a court fight between Gov. Pat McCrory and the General Assembly.

Nonetheless, Duke has plowed ahead. The company is beginning to excavate – or plans to excavate – 20 ash basins across the state. Duke says it will recycle the ash or transfer it to lined landfills. This meets the strictest requirements under the 2014 coal ash law.

But that hasn’t appeased some environmentalists. Several groups have protested Duke’s proposal to place ash in two abandoned clay mines, even though the ash will be blocked off with liners.

Gerken takes a different view. He said that while there’s no perfect solution for coal ash, “Having it in a modern, properly lined facility anywhere is better than having it in an unlined pit.”

And there’s still 264 billion pounds of waste – the byproduct made from powering refrigerators and air conditioners, North Carolina’s hospitals and homes for several generations – that remains to be disposed of safely.

And it has to go somewhere.

Study: Rural Black Women Suffer Less Depression


Southern African-American women who live in rural areas are far less likely to suffer from depression than those living in urban or suburban areas, a new study finds. For white women, geography appears to play less of a role.

By Emily Goldstein

Daily Yonder

Rural African-American women who live in the South are less likely to suffer from major depression than their urban counterparts, a research report published in JAMA Psychiatry says.

This is true even though black rural women are more likely to live in poverty and have lower rates of education – factors that are associated with the incidence of major depression.

Image courtesy Blue Skyz Studios, flickr creative commons

Image courtesy Blue Skyz Studios, flickr creative commons

While rural black women fared better with depression, rural white women, on the other hand, fared slightly worse, the study found.

The researchers speculate that the lower rate of depression among rural black women may be because these women have better systems of social support than the other groups considered in the study.

Researchers at the University of Michigan sought to understand how factors such as poverty and low rates of education affect mental illness among rural women. Overall, women are 1.5 to 3 times more likely to report being depressed than men.

The study used data gathered from the National Survey of American Life, a large, long-term study designed to explore racial and ethnic differences in mental health disorders.

Respondents were categorized by where they live, their race and whether they suffered from depression. The full sample used in the paper included 3,570 black women and 891 white women.

About 4 percent of rural African-American women in the South experienced depression at some point in their lives, versus about 10 percent for urban black women. (The data has been adjusted so it more accurately reflects the population the researchers sought to study.)

Suburban African-American women in the South had the highest rate of depression for blacks, at about 13 percent, though the margin of error in sampling could account for that difference. (The study had a standard error of 1.0 and 0.9 percent for rural and urban black women and 5.9 percent for suburban black women.)

Among white women in the South, geography appeared to play a less important role in predicting whether a woman had suffered depression at some point in her life. Depression was more prevalent overall among white women (ranging from 21 percent for rural white women to about 19 percent for suburban white women). But there was far less difference in rates of depression among rural, suburban and urban white women.

Overall, white women in the study were twice as likely as African-American women to have suffered from depression.

Although the relationship between depression and race is complex and multifaceted, the authors theorized that varying levels of social support networks between black and white women contributed to the findings.

Factors such as strong familial support and social ties, high levels of spirituality and a sense of solidarity with other rural women of color could contribute to the lower rates of depression, the study said.

The authors noted more research would be needed to better understand the needs of rural communities and to formulate successful intervention strategies.

This story originally appeared here and is shared by NC Health News through a content-sharing agreement with The Daily Yonder, an online publication dedicated to all things rural in the U.S.

NCGA Budgets Make Cuts in Biotech Funding


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.


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


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


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.”

Make Health Primary
Tweets from @NCHealthNews
NC Research Roundup
    Online donation system by ClickandPledge
    • Poultry Workers Will Get Health & Safety Training
    • Feds Send Money to N.C. to Help with Insurance Enrollment
    • Lyme Disease-Bearing Ticks Creeping Their Way Slowly South
    • Charlotte-Based Agency Gets Federal Contract to Provide Recovery-Oriented Care
    • Kids Find Their Own Way to Healthy Living
    • Experts Disagree About Health Benefits of EPA Climate Plan
    • States Looking for More Effective Ways to Encourage Vaccinations
    • UNC Study Finds Rural Medicare Recipients Less Likely to Receive Follow-up Care
    Newsletter Subscribe
    N.C. Press Association
    Local Independent Online News Publishers
    Institute for Non-Profit News