New UNC Study Shows Most Drugs Used for Neonates Unapproved
By Stephanie Soucheray
One of the hardest things for a parent is to watch their child be sick, and that difficulty is only amplified when their little patient is a newborn who’s landed in a neonatal intensive care unit (NICU).
Doctors who treat these infants have applied increasing skill over the past decade to improving outcomes for neonates, but they’re often working with limited information about what really works for very young babies, especially when it comes to the medications used on their patients.
For example, every year half a million babies who spend time in a NICU will receive prophylactic doses of ampicillin and gentamicin. These two powerful antibiotics ward off infections from immature immune systems and are the standard choice for hospitals across America.
There’s only one problem: Neither have been approved for use in neonates, or infants under 28 days old.
“Ninety percent of drugs used in the NICU are used off-label or off-patent,” said Matthew Laughon, a neonatologist at UNC-Chapel Hill.
Because most drugs are never tested in very young infants, neonatologists like Laughton have to make educated guesses based on anecdotal evidence on how to give drugs that have only been approved for use in adults or older children.
Laughton and his colleagues published what he calls an “awareness” article about this topic today in JAMA Pediatrics.
The study looked at federal legislation that encouraged new labeling information for pediatric patients, including neonates. While Laughton estimated there have been 300 to 400 label changes pertaining to older infants and young children, there haven’t been nearly as many labeling changes for neonates.
Laughton looked at two categories of drugs: new medicines used in NICUs that were developed after 1997 and older, established drugs. For each type, drug companies undergo an approval process for adults and then a similar process for children. But drug companies rarely complete trials that establish safety, efficacy and dosing for the smallest infants.
“We found that a little less than half of these drugs have safety or efficacy established for neonates,” said Laughton.
Reviewing the FDA database, he found 28 drug studies including neonates and 24 neonate labeling changes. Only 11 of the 24 labeling changes explicitly state the drug was approved for neonates and was safe and effective. Moreover, 13 of the 28 drugs studied were not commonly used in NICUs.
Without correct dosing information, neonates are at risk of getting too little or too much of a drug. They are also at a greater risk for side effects.
“If you take a drug and look at the adult dose, then try to do some calculation or division based on weight to give to infants, you’ll almost always get it wrong,” said Laughton. “Neonates have special physiologies and characteristics that make them difficult to study and dose correctly.”
According to Laughton, “nearly 100 percent” of babies in the NICU are on some type of medicine during their hospital stay. The federal government is addressing this issue through the Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law in July.
Laughton said the Pediatric Trials Network, which is based at the Duke Clinical Research Institute, will also look at neonatal drug use.
He said the study did not include common over-the-counter drugs given by parents, only hospital-administrated medicines.
Laughton said that parents also have a role in gaining correct safety information about neonatal drug doses.
“If parents volunteer for studies, it’s the only way we can get information,” he said. “It’s the only way we can move the field forward.”
Bartonella is Everywhere, So Why Don’t We Know More About It?
Bartonella is a bacteria transmitted by fleas, ticks, animals, even spiders, but few people know about it. New methods for diagnosing it are showing it’s more common than previously thought.
By Stephanie Soucheray
An N.C. State professor says Bartonella infection is one of the most important untold medical stories.
Ed Breitschwerdt, a professor of veterinary sciences at North Carolina State University, keeps waiting for the tipping point. For the last 30 years, Breitschwerdt has been studying Bartonella, a genus of bacteria found in animals, ticks and humans.
“It’s frustrating,” said Breitschwerdt. “I believed we would hit a tipping point two years ago with this.”
Laura Hopper’s tipping point came in 2006, when she was 15 years old. The Raleigh teen lost her peripheral vision. She next began to suffer bouts of joint and muscle pain and numbness in her hands. Then came the headaches, memory loss and hallucinations.
“As a mother, it’s so hard to watch your child have all these symptoms,” said Maria Hopper. “It was a couple years of going to all kinds of doctors.”
But no neurologist, rheumatologist or psychiatrist could explain all of Laura’s symptoms. And it wasn’t until 2008, when the Hoppers read a news article about Bartonella and Breitschwerdt’s work, that a lightbulb went off in their heads.
Though people have known of cat scratch disease – the most public of the human diseases caused by Bartonella infection – for more than 100 years, Breitschwerdt said he’s convinced that Bartonella is the stealth cause of many neurological, inflammatory and chronic diseases in humans.
And, unlike Lyme disease, another tick-borne illness that can cause an array of distressing symptoms, Bartonella is right in the backyard of most North Carolinians.
“It’s a medically important bacteria in animals and humans in the state. If you took every stray cat along the coast of North Carolina, three quarters of them would have Bartonella,” said Breitschwerdt. “That’s because the bacteria is commonly transmitted to animals by fleas.”
He said that, historically, vets have considered common cat flea a nuisance but have under-appreciated it as a disease vector. For several years, Breitschwerdt has seen all sorts of animals and mites, ticks, fleas and even spiders test positive for Bartonella.
“Animals are the primary reservoir for the Bartonella species,” he said.
Breitschwerdt has worked with the One Health Commission, a collective that looks at the links between environmental, human and animal health. Though his professional and personal life has been guided by his care for animals, his most recent work is geared towards detecting and treating Bartonella infection in humans.
The recovery process
The Hoppers contacted Breitschwerdt at a fortunate time: He was developing new human diagnostic method for Bartonella. Laura tested positive, and after three courses of months-long antibiotic treatments, her symptoms have all but disappeared.
“By the end of the first cycle [of antibiotics], the feeling in her hands came back,” said Maria. “By the end of the second cycle, hallucinations stopped.” Though Laura still suffers some muscle pain, she considers herself 80 to 90 percent healed.
If the bacteria is positively detected, treating Bartonella infection is a daunting task for even otherwise healthy patients
“You cannot float humans or horses in enough Doxycycline to kill this bacteria,” said Breitschwerdt. Treatment, such as Laura’s, requires weeks of multi-antibiotic therapies.
Laura was also lucky in that she tested positive for Bartonella immediately.
A patient infected can have a negative test on a Monday and positive test by Wednesday.
“People are tested several times, but Bartonella can hide in the body,” Breitschwerdt said.
That’s because an animal scratch or bug bite (or a vet’s needle stick) results in Bartonella infection in red blood cells and endothelial cells, which line blood vessels. The bacteria can “hide out” for many infectious cycles, causing symptoms and eventually affecting every organ system in the body.
Most people can clear Bartonella from their bloodstreams effectively. But among the subset of people who can’t eliminate the bacteria, help in mainstream medicine will be difficult to come by.
“I often talk with veterinarians who have these vague complaints – who say they’ve been sick for weeks or months,” said Breitschwerdt.
Many of the vets receive diagnoses of Lyme disease, chronic fatigue, rheumatoid arthritis, or are sent to a psychiatrist and told their symptoms are untreated depression. But Breitschwerdt cautions them to get tested for Bartonella.
Breitschwerdt has ventured into industry with Galaxy Diagnostics, a company he founded to offer Bartonella testing kits to doctors. The company launched into human testing two years ago, and has received orders from 300 doctors across the country.
At this stage, said Amanda Elam, Galaxy’s president, the company’s goal is to educate people about Bartonella.
“We’re dong continuing medical education courses, working with people in public health and doing education with veterinarians,” she said. “I’d really like the medical community to keep an open mind about this.”
While Breitschwerdt waits for the public tipping point for Bartonella, he said he too is focused on disease education.
“It takes 10 years before something added to the medical textbooks gets widely spread in practice,” he said. “We’re working on changing those textbooks.”
Bystander CPR Missing from Rural, Minority Counties
Researchers from Duke University looked at who gets life-saving cardiopulmonary resuscitation during emergencies and found that living in rural areas could put a heart attack sufferer at greater risk of death.
By Stephanie Soucheray
Frantic pumps of the chest and that urgent kiss of life: Thanks to television and the movies, everyone thinks they know what CPR looks like. But in many communities across the United States, less than 3 percent of the population can properly administer the life-saving intervention.
A new study from a team of cardiologists at the Duke Clinical Research Institute shows that in any given county in America, only 5 percent to 16 percent of citizens can perform cardiopulmonary resuscitation (CPR). In rural counties, or counties with predominantly black and Latino populations, that percentage dips even further, to around 1 percent.
And that low number of CPR-trained bystanders in rural and minority-dense counties correlates to geographic differences in cardiac arrest survival, according to the study.
But lack of trained CPR providers is a problem in cities too, said Lance Thigpen, a CPR instructor in Raleigh.
Thigpen works for CPR Consultants, a company that teaches lay people and health care workers CPR. He said most of the people taking CPR classes are doing so not out of a desire to learn how to save a life, but because someone is making them.
“Most of the people who come to us are doing it for compliance,” said Thigpen. “They need to for a job or school.”
CPR Consultants offers a “friends and family” class one or two times per month for $33. The two-hour class teaches lay people CPR, but Thigpen said it’s not popular.
“People have a sense that, ‘Oh, this won’t happen to me,’ or, ‘I won’t need to know this,’” said Duke researcher Monique Anderson, who published her findings in the Nov. 18 edition of JAMA Internal Medicine.
The study is the first to look at CPR training rates among non-medical professionals in the country. Anderson trolled through piles of data to break down CPR rates on the county level.
“This was a huge undertaking because we had to form relationships with CPR organizations and look at 14 million people who have been trained in CPR across the country,” she said.
Anderson said it was reading recent literature about bystander CPR that sparked her interest in breaking down CPR availability by county. In any given year, 350,000 Americans will have a heart attack outside of a hospital, and bystander CPR is often one of the first and best interventions needed to save someone’s life. People who receive CPR double their chance of survival outside of the hospital.
Anderson said people may be reluctant to learn CPR because they may be shy, embarrassed or indifferent. She said she looks to Denmark as a model for America. In Denmark, CPR training is required in order to get a driver’s license, and public schools are required to teach pupils to perform CPR.
In the U.S., Anderson and her fellow researchers looked at the 13.1 million people trained to perform CPR in 2012 by the American Heart Association, the American Red Cross and the Health & Safety Institute, the three major organizations that provide CPR training in the country.
The median percentage of CPR-trained citizens was 2.39 percent. While low overall, the numbers were worse in the South and West than in the Northeast.
Anderson said she was surprised by the lack of training in rural counties, where people are already disadvantaged by being farther away from hospitals and having longer travel times for EMTs. CPR, she said, is the second act in a chain of intervention, and should be performed immediately after bystanders have called 911 for an ambulance.
“The chain of survival is so important for rural patients,” she said. “They need emergency medical services within seven to eight minutes after a cardiac event. We need to be having a national conversation about these disparities.”
Health 2.0 Attempts to Understand the ePatient of the Future
Digital technologies are changing the way doctors work and the way health care gets delivered. But is that always a positive thing?
By Stephanie Soucheray
More than 100 entrepreneurs, health workers and tech industry insiders gathered at RTI International this week for the Health 2.0 NC Triangle meet-up.
Health 2.0, in the same vein as TED talks and South by South West, has chapters around the world that bring together different speakers on a single topic. This week, the Triangle chapter brought together keynote speakers on the future of the ePatient.
“The point of this event is to not have this event,” said Brian Moynihan, an event organizer and project manager at the UNC School of Medicine. “We want people to meet and network so they can work together and build this community.”
Citing rich opportunities for cross-pollination among the numerous health care businesses, research companies, universities and tech start-ups in the region, Moynihan said the Triangle was uniquely primed to become a leader in digital health.
“We’ve got people working at big hospitals, we’ve got pharma, we live in an amazing place,” said Moynihan. “The idea is, if we connect all these things together, we become better.”
He said that he wants the Research Triangle to be one of the top three places where health technology and innovation are created.
“The Triangle is a hub for digital health innovation because of the great universities we have,” said Moynihan. “They not only provide research and a steady stream of students, they also serve as a testing ground for new ideas, particularly through research at university hospitals.
“For instance, UNC is partnering with SAS to personalize diabetes care with better analytics.”
The evening’s first speaker was Cory Annis, a primary care physician in Carrboro. For years, Annis said, she’s been demoralized by how often new technology, including electronic medical records, have invaded the doctor’s office. Instead of helping her perform her job, she said screens remove her from the patient-physician relationship.
Annis made an appeal to the tech entrepreneurs in the room to create technology that keeps the physician and patient together.
“Step back out of the way,” said Annis. “If it takes more than two clicks, it doesn’t work.”
An entrepreneur herself, Annis explained her own medical practice, UnorthoDoc, which is billed as “healthcare for entrepreneurs.” Using video conferencing, texting and email, Annis establishes a personal, eye-to-eye relationship with her patients in a high-tech way. She still sees patients at her brick and mortar office, Carrboro Pediatrics, but has enjoyed using technology to serve a different client base.
Annas said that many of her patients are tech savvy, a population that Fard Johnmar, the second speaker, addressed. The author of the infographic “ePatient 2015: 15 Surprising Trends Changing Healthcare,” Johnmar runs Enspektos, a digital health-innovation and consulting company. He spoke about how patients use – or don’t use – technology to their advantage.
Johnmar urged the crowd to find the “human in the center of data circles,” and addressed concerns specific to the North Carolina Health 2.0 group, including cultural barriers to health innovations and healthy real estate, or planned healthy communities that improve the lives of occupants.
Although he said he’s a believer in digital health, Johnmar said health will always be about human-to-human interactions.
Kate McCarthy, a digital health director from South Carolina, said she was impressed with the evening’s meeting.
“It’s amazing to see what’s in this region,” she said. “ And it was such an interesting mix of people, especially entrepreneurs.”
Nnenna Ibeanusi, an masters student in Health Policy Management at UNC-Chapel Hill, said she’ll be back to future Health 2.0 events.
“There’s a great interest in the health field on how to use information technology,” she said. “Especially, how technology is being used to capture quality measures.”
Connecting students, employers and researchers was all part of Brent Anthony’s goal for the event. Anthony, an organizer of Health 2.0 and a business consultant, said he wanted to “engage the region to develop change.”
“It’s not just about developing the next mobile app,” said Anthony. “It’s about making a real-world change to people’s health.”
Ready-to-Go Labs Expand N.C. Research Campus
For scientific companies trying to get a start, but without a lot of money, having a lab at their disposal can make the difference between failing or flying.
By Stephanie Soucheray
Wenhong Cao has been studying diabetes and insulin resistance for 20 years, but last year the University of North Carolina-Chapel Hill professor decided he wanted to take a broader approach to solving the disease. After years of doing research for industries, Cao decided he wanted to be a business owner and create products that could stop diabetes in its tracks.
Cao started a company, J.C. MED, to create at-home diagnostics for insulin resistance, the metabolic precursor to diabetes. J.C. MED also develops supplements for combating insulin resistance.
“It takes an average of 15 years for someone to go from insulin resistance to diabetes,” said Cao. “And if we can detect the presence of insulin resistance and reverse it, then diabetes is reversible.”
“We’re working at a good pace,” said Cao. “We’re ready to send out our first batch in a couple months.”
And that batch will be created in Cao’s state-of-the-art lab, one of three that opened at the North Carolina Research Campus (NCRC) in Kannapolis this fall. As part of an expansion, the NCRC opened three ready-to-go labs that provide 1,700 square feet of wet lab space for start-ups, like J.C. MED, and big companies like General Mills, who will be conducting nutrition research. Carolinas Healthcare System will be occupying the third lab.
“The ready-to-go labs are something we’ve contemplated for three years,” said Clyde Higgs, vice president for business development at NCRC. “We finally tested the market and wanted to see if something was viable.”
The labs are more than viable: Higgs said he leased all three units before the facilities were open, and there are plans to build three additional ones next year.
A perfect opportunity
Everyone knows scientists work in laboratories. But if you’re not affiliated with a large university or company, laboratories are expensive places to conduct business. Unlike a typical office suite, labs have to come with chemical hoods, sinks, burners and access to million-dollar equipment.
“One piece of equipment can easily be seven figures,” said Higgs. “That’s what makes this such a cool facility. There’s probably not another area [in North Carolina] where companies have access to core lab equipment on site, or are able to access equipment inside the building on an as- needed basis.”
Lynne Safrit, the president and COO of Castle and Cooke, which develops the NCRC, said occupants of the ready-to-go labs can also access a wide spectrum of scientific expertise from the eight universities represented on the NCRC.
On a more practical level, ready-to-go labs are a safer bet for start-up businesses that have no idea how much they will grow (or not) when they rent initial lab space.
“It offers a perfect opportunity for start-up companies to leverage their funding in a very economic way by leasing a small module to test their proof of concept and to solidify their early-stage research,” said Safrit.
Higgs said the lab spaces are the only ones of their kind in Western North Carolina.
“In our region, our labs are the only place to get ready-to-go spec lab space and move into flexible leases,” he said. “A company can grow and contract the lab as needed. They aren’t locked in.”
From N.C. to China
Cao said he’s hoping J.C. MED will grow rapidly after its initial year – which will happen if the company succeeds in its test market: China. He’ll get help from Chinese partner Shanghai I DO Biotechnololgy.
“Diabetes is a huge problem in China,” said Cao. He said that while American rates of the disease have leveled off at 8 percent over the last decade, 11 percent of Chinese people have diabetes.
“And what’s amazing is, 50 percent of Chinese have pre-diabetes,” said Cao.
He said the ready-to-go lab space has been a good place to develop his supplements.
“I’ve worked on the NCRC in nutrition before, so the labs are very convenient,” said Cao. “And the new lab is much better than most labs in universities.”
Higgs said the labs were funded by Castle and Cooke, the development company behind the NCRC, and David Murdock, the founder of the institute. The labs were filled on a first-come, first-served basis.
“As long as a company is willing to use our labs for human health, nutrition or one of our other focuses, they can lease our space,” said Higgs.
Correction: this article originally referred to Dr. Cao’s company as J.C. Medical. It is actually J.C. MED.
Wake Forest Institute Gets Grant for Wounded Warriors
By Stephanie Soucheray
On Friday, Wake Forest University School of Medicine’s Institute for Regenerative Medicine announced it will have $75 million to spend in the next five years to develop novel technologies to help wounded warriors. The institute has been selected to lead the second phase of the Armed Forces Institute of Regenerative Medicine (AFIRM).
The kinds of wounds soldiers suffer in a battlefield are not for the weak of heart: missing limbs, severe burns and nerve damage can result from bomb blasts, gunfire and other forms of combat. Though medicine has helped soldiers with dramatic advancements in prosthesis, new technologies using the body’s own ability to restore tissue can offer even more recovery options for soldiers.
“For us, the most important thing is that we do have an interest in making sure technologies go through the process of development as quickly as possible to help our wounded warriors,” said Anthony Atala, director of the Institute for Regenerative Medicine.
Atala said the grant will fund approximately 14 projects and 60 researchers who are currently working on tissue and functional loss in wounded soldiers.
There are several planned research projects and groups, including the reconstruction of the craniofacial area and the creation of muscles that have been injured. Atala also said he would be working on the creation of blood vessels following an injury.
“We’re working on technologies at a very basic stage,” said Atala. “This is technology at the proof-of-concept stage. Our eventual goal is to get as many technologies as we can into development.”
AFIRM II’s results will also benefit the general public. For instance, new treatments to prevent rejection of “composite” transplants such as face and hand tissue can be used for the civilian population.
Atala oversaw the first phase of AFIRM in 2008. That phase resulted in more than 10 clinical trials for treatments including scar-reduction therapies and fat-grafting techniques.
MRSA Infection Found in Communities Near Pig Farms
Evidence of links between large-scale animal-rearing practices and human health in neighboring communities continues to accumulate.
By Stephanie Soucheray
On Oct. 18 and 19, the North Carolina Environmental Justice Network will hold its 15th annual meeting in Whitakers to discuss unsafe agricultural practices in poor, rural and black communities across the state.
While the NCEJN has been concerned with issues such as dumping, factory farms and clean water, Executive Director Gary Grant said that this year they’ll also be discussing agricultural illness in front of a government listening panel.
There’s good reason for concern.
Last month, UNC researchers published in the online journal PLoS One the results of a study, “Livestock-Associated Methicillin and Multidrug Resistant Staphylococcus aureus Is Present among Industrial, Not Antibiotic-Free Livestock Operation Workers in North Carolina.”
They found that factory-farm workers were much more likely to have colonized MRSA (present in nasal swabs) than workers who worked on antibiotic-free farms.
Now a new study from John Hopkins University further describes the connection between factory farms and MRSA.
The study, “High-density livestock operations, crop field application of manure, and the risk of community-associated methicillin-resistant Staphylococcus aureus infection in Pennsylvania,” published this week in JAMA Internal Medicine, shows that there is an “environmental pathway” that MRSA follows in communities near high-density swine-production facilities.
“We found that in a general population in Pennsylvania, people with a higher exposure to high-density swine production were at an increased risk of community-associated MRSA infection and skin and soft-tissue infection,” said Joan Casey, a lead author of the study. “This risk was about both the livestock operations where the animals live and about the crop fields where manure was spread.”
The John Hopkins study is the first to link factory farming to MRSA infection, not just colonization, and Casey said the UNC and JHU studies both suggest that these types of farming practices are bad for public health.
“While we did not demonstrate every step in the causal chain from farm to infection, we do believe that the association is plausible,” said Casey. “There is certainly an environmental pathway.”
Like the UNC study, the JHU study implicates the overuse of antibiotics in industrial-farmed animals as being a risk factor for MRSA. Animals are given what’s known as “sub-therapeutic” amounts of antibiotics in their feed and water supply to stave off illness, rather than to treat an acute infection. The majority of the antibiotics given to animals in these situations are not absorbed, and instead are passed through to the animal’s manure.
That manure is applied to crop fields, and neighboring residential communities, according to Casey, are at a greater risk for community-associated MRSA, health care-associated MRSA and skin and soft-tissue infections.
Casey’s study looked at 1,539 patients with community-associated MRSA, 1,335 with health care-associated MRSA, 2,895 with skin and soft-tissue infections and 2,914 healthy controls patients in a Pennsylvania health care system between 2005 and 2010.
Higher swine manure exposure meant an increased likelihood of all MRSA infections, and even just living near a high-density swine livestock operation resulted in an increased risk for community-associated MRSA.
Steve Wing, who co-authored UNC’s study, said JHU’s study further illustrated the problem with giving farm animals antibiotics.
“This is an important finding about a problem, the sub-therapeutic use of antibiotics, that’s been recognized a long time,” he said.
Wing said that the findings in the study should be a concern to people in North Carolina who live near high-density farms.
“Eastern North Carolina has the densest livestock production, but it’s also one of the poorest areas in the state,” he said.
Unlike in the JHU study, which benefited from combing a large insurance database for information on MRSA infection, many people in the Eastern part of the state are uninsured, so Wing said it would be difficult to obtain accurate information about MRSA infection rates.
He also said that while research like this is important, it often does little to change policy. The sub-therapeutic use of antibiotics has been banned in Europe for years, but a bill that would do the same in the States has failed to get passed in Congress.
“It takes a lot more involvement by the public to change policy,” said Wing. “The public is who’s affected by this.”
Grant said he’s been concerned about farming practices and community health since the early 1990s.
“In the beginning, many of these communities [where large farms are located] depended on well water, so runoff was a huge concern,” Grant said.
He said that 20 years ago, it was legal for counties to pass individual ordinances on farming practices, but the most recent General Assembly passed legislation that makes it easier for the state to override them.
Though Grant doesn’t have hard data on MRSA in North Carolina, he said sick communities do exist in rural pockets of the state.
“We are aware of it, and still trying to help communities get organized around the issue,” he said.
New UNC Research Shines Light on Schizophrenia
A decade’s worth of research is yielding information about genetic changes that lead to the development of schizophrenia.
By Stephanie Soucheray
Sandy Lovett, 47, is getting her medicine switched this month.
Lovett has schizophrenia, and her symptoms aren’t being fully controlled by her current cocktail of mood stabilizers and atypical antipsychotics.
“I’m still getting some auditory hallucinations,” she said.
When she was 19, Lovett was diagnosed with schizophrenia. Suicidal, she spent six months in a mental hospital, where she said she was overmedicated.
For the next 20 years, Lovett, with the support of her mother, battled not only her mental illness but also drug addiction.
Now data from a decade-long study on the DNA of people with schizophrenia has shown 22 genetic differences between study subjects with the disease and controls. Thirteen of these genetic differences were previously unknown to researchers.
In the multi-stage genome-wide association study, titled “Genome-wide association analysis identifies 13 new risk loci for schizophrenia” and published in the latest edition of Nature Genetics, researchers used the DNA from 21,000 people with schizophrenia and thousands of healthy controls to identify genetic variances.
“These are really 22 clues about what causes schizophrenia,” said Patrick Sullivan, the director of the psychiatric genomics department at UNC. “This is the biggest study of its kind.”
Sullivan has led the research on this project for the last decade. “We’re making progress and are getting able to explain why some people have schizophrenia and other’s don’t,” he said.
About 1 percent of the population has schizophrenia, the symptoms of which include paranoia, auditory and visual hallucinations, delusions and disorganized thinking. Its sufferers describe the disease as a “break” from reality.
Like Lovette, most people with schizophrenia begin to battle the disease in their early 20s, and many are hospitalized throughout their lives. Schizophrenia is treated with typical and atypical antipsychotics. There is no known cure.
“There’s no poster child for schizophrenia,” said Sullivan. “As a consequence, this field and this disease don’t get the attention they deserve.”
Sullivan said people with schizophrenia have a shorter lifespan than the average (usually by 10 to 15 years) because of higher rates of comorbidities such as obesity, substance abuse and suicide. And she said the disease can cost upwards of $1.4 million to treat over a patient’s lifetime.
Sullivan said that when he began collecting DNA samples 10 years ago, he added “a couple of zeroes” to increase his study sample size. Every genome was measured in more than a million different places, and the 22 areas of difference offer some novel understandings of the disease.
He said that the role of calcium, the essential mineral needed for nerve functions in the brain, is one of the areas that show a difference between schizophrenics and controls.
“We have the idea from this study that calcium signaling is important in schizophrenia,” said Sullivan. The paper describes differences between schizophrenics and health controls in the calcium pathway, which includes the genes CACNA1C and CACNB2.
The paper estimates that there are more than 8,000 SNPs (single nucleotide polymorphisms, or DNA sequence variations) that could contribute to a risk for developing schizophrenia in one-third of the patient population.
For years, researchers have been debating whether schizophrenia was caused by a few rare, but strong, genetic mutations or by several hundred smaller mutations that combine to form the disease state. Sullivan said his study points to the later hypothesis, and is a step toward fully understanding schizophrenia.
“Once we fully understand the disease, we have an agenda for moving forward,” he said.
Staying sober, and employed, is hard for Sandy Lovett. But one place that helps is Threshold, a clubhouse in Durham where adults with severe mental illnesses can learn skills, manage club functions and continue their educations. Lovett comes to Threshold a few days a week, one of the 55 adults who gather each day at the clubhouse in East Durham.
Susie Deter is Threshold’s executive director. She said that there are only six or seven such clubhouses (where employees and members decide rules, agendas and perform tasks) in North Carolina. Ten years ago, there were 11 or 12.
Deter said the clubhouse model, even with a shoestring budget and a complicated alphabet-soup system for reimbursements, is one of the only successful models for people with schizophrenia.
“We have the best rehospitalization rate,” said Deter. “Ninety-two to 93 percent of our members stay out, because we offer the whole package of support.”
Meanwhile, researchers continue to look for ways to make places like Threshold a thing of the past.
Bedbugs, While Annoying, Don’t Generate Research Dollars
Bedbugs are annoying, pernicious and frustrating. But they’re not necessarily dangerous to humans. And so, they don’t get a lot of respect in scientific circles.
This classic story first appeared in North Carolina Health News on Oct. 1, 2012.
By Ben McNeeley
Bedbugs don’t get any respect.
Never mind the fact that bedbugs are everywhere now in America. They are infesting high-priced hotels and low-income housing and apartment complexes. They can be found wherever humans are and go.
Bedbugs live in mattresses, mainly, but can be found in carpets, clothing, on the backs of picture frames. They congregate in corners and crevices and only come out at night, feasting on any host that has blood — namely, humans.
They are also a public health threat. The Centers for Disease Control and Prevention, the Environmental Protection Agency and the National Institutes of Health have said so.
Their bites cause skin irritation and, in bad cases, anemia.
Mostly, though, they cause a lot stress for those whose homes are infested. It’s difficult and expensive to get rid of bedbugs.
In other words, it’s becoming harder to sleep tight and not let the bedbugs bite.
But despite the cost, both human and otherwise, there isn’t a lot of research money out there to study why there is a resurgent bedbug problem in America, where they are coming from and how to deal with them.
Ed Vargo, an urban entomologist at NC State University, is trying.
Urban entomology is the branch of bug science that focuses on the genetics of insects found in urban areas — termites, ants, cockroaches and bedbugs — to find out more about their breeding patterns and how to control bug populations.
Vargo is trying to find out how bedbugs are coming to America and from where.
“They are certainly from a foreign source,” he said, “but we haven’t announced from where yet.”
But Vargo said funding to study bedbugs is a problem. They aren’t a vector-carrying species, he said, meaning, they don’t carry disease and aren’t considered dangerous.
They’re just annoying — really annoying.
Much of Vargo’s funding comes from the federal government, but those dollars have been shrinking, and with the country’s budget in deficit, Congress isn’t about to add much more.
Vargo had a three-year grant from the U.S. Department of Agriculture to study bedbugs, but it ran out, and Congress cut funding. He’s applied for a grant from the National Institutes of Health, which didn’t consider projects about bedbugs before, but now will at least entertain the idea.
A bill introduced in a Congressional agriculture subcommittee in March 2011 by Ohio Republican Rep. Jean Schmidt called the Bed Bug Management, Prevention, and Research Act would have allowed federal funding for research into better pesticides to fight bedbugs and to create a bedbug prevention and mitigation pilot program. But there was no money attached to the bill, and it sat in committee.
Resistance is frustrating
During the middle of the last century, exterminators used big weapons, such as DDT, to kill the bugs. But with the banning of DDT and public resistance to using powerful pesticides inside their homes, the arsenal of available bedbug killers has dwindled.
In the meantime, the little critters have become resistant to the pesticides being used now. But there’s no money to study why that resistance has evolved or what new chemicals could possibly kill them.
Such information would help exterminators like Clegg’s Termite & Pest Control in Durham, which just started using trained Labrador retrievers to sniff out bedbugs.
“It’s a matter of speed,” said controller Devone Holmes. “A dog can check an entire room in a few minutes, where it would take humans much longer. You’re looking for something fairly small. They can be seen with the naked eye, but only if you are looking closely.”
The dogs, Smoke and Rambo, are trained to smell the bedbugs and find them quickly. Using dogs to find pests isn’t new, said Holmes, as exterminators have been using beagles to find termites.
Bedbug business has boomed for exterminators, said Holmes, because they’re very mobile and they become resistant to pesticides. “We don’t use those anymore,” he said, “and it can be very nerve wracking for the affected person.”
Bedbug exterminations are very thorough, and don’t always guarantee the pests won’t come back.
But a little research funding could go a long way into finding where bedbugs are coming from, Vargo said, and developing new ways of controlling them.
“The funding would have to come from government funding agencies,” he said. “It would also need a recognition of bedbugs as an important research topic to get some funding.
“I’m not terribly optimistic about it changing,” Vargo said.
Money, Jobs & Research: What the Biotech Industry Really Means to NC
A conversation with Sam Taylor, president of the N.C. Biosciences Organization.
By Stephanie Soucheray
At the end of July, biotechnology industry leaders from across the state gathered at GlaxoSmithKline for a summit called to discuss the biopharmaceutical industry’s economic impact on the state. They mingled and listened to speeches by Sen. Kay Hagen and Speaker of the House Thom Tillis lauding the biotech industry as vital to the state’s economy. They also heard a panel discussion on the biotechnology economic sector moderated by Sam Taylor. Taylor is the president of the North Carolina Biosciences Organization (NCBIO), the trade association for the state’s life-science industry. Unlike the North Carolina Biotechnology Center, NCBIO is not funded by the state; it lobbies and does advocacy work for its members, some of the largest companies in North Carolina.
North Carolina Health News asked Taylor a few questions about doing bioscience research and manufacturing in a post-recession North Carolina. From job creation to the latest legislative session, Taylor answered our questions about the future of life-science research and manufacturing in the Tar Heel State.
NCHN: You’ve been with NCBIO since its inception in 1994. What’s been the biggest change you’ve seen in the last 20 years?
Taylor: The size of the community. Back in 1994, I’m just guessing, but there were probably 20 to 50 biotech life-science companies in North Carolina. Now there are multiple hundreds, probably north of 500 companies. Those companies, depending on what you’re counting, directly employ 55,000 people, and indirectly employ another 220,000 to 230,000 people.
The state’s Biotechnology Center was founded in the 1980s, and had been in business 10 years when the community realized the Biotech Center could be an attractive supporter with grants and loans and research, but could not advocate for the industry or lobby for its members because they were funded by the state. Legislators don’t like to be lobbied by people they pay to do other things.
In 1994, five to 10 people in the industry came to me [Taylor was an associate at a law firm at the time] to set up a trade association. Now we have 150 to 160 members and a half million-dollar budget. Our members are companies like GSK, Merck, United Therapeutics, BASF and Nova Nordisk.
NCHN: What happened to those employment numbers after 2008? Did NCBIO suffer from the recession the way other sectors did?
Taylor: We were one of the few sectors that grew out of the recession, and we were the only sector to add jobs. We have an economic impact of $60 billion annually, and we’re the fourth-largest bioscience cluster in the country. That sort of impact gives people confidence, and that’s why the sector is continuing to grow.
That being said, different segments grow at different times. Clinical-research organizations grow very quickly; pharmaceuticals don’t. But all these companies support a common labor pool and research base. Because of our general growth, we are growing and are expected to continue to grow. What policymakers want to do is create jobs and attract investment, and you can only do that in industries that are growing across the nation and across the world.
NCHN: Job creation has been a huge discussion when it comes to state and national economic recovery. But what sort of jobs does the life-science sector create in the state? Aren’t they mostly specialized jobs for Ph.D.s? Are there any jobs for the Joe Schmoes of North Carolina?
Taylor: Oh, yes; there are absolutely jobs for everyone. When it comes to doing research or running clinical trials, those are usually jobs that have to be held by people with an M.A. or a doctoral degree, but there’s a lot of work that needs to be done to support those folks. And the research centers themselves have to be filled by people with administrative skills, for example. There’s also the supply chains research centers create. There are many more jobs in the manufacturing and service-provision area, and they go to a person with less than a doctoral training.
We are primarily a cluster of manufacturing. We have a large research center here, with GSK and Syngenta. But we have enormous manufacturing here – Merck in Durham, Pfizer in Sanford, Novartis in Holly Springs, Baxter Healthcare in Marion – and all of these are manufacturing operations. We have gone to a lot of trouble and expense to create a workplace training available to people looking for a second career. In 2000, we worked with the Golden LEAF Foundation, NC Central, NC State and community colleges to create training facilities. We spent $20 million for those programs. That’s ongoing. Our system is vertically integrated, so anyone can get training, step out, get more training and move up. In the 2000s, we took a huge step in opening the door for manufacturing professionals. Enrollment has increased dramatically over the years.
We had asked that they restore funding for these programs in this year’s budget. We did not get that funding.
NCHN: In terms of this year’s budget, what’s your opinion on what’s happening in the General Assembly toward your industry?
Taylor: I think that what we’re seeing is a different philosophy of government; we’re not seeing a change of perception of life sciences. They would say their priority is the right sizing of government; they believe we’ve been spending beyond our means in North Caroline for some time. That’s all a matter of degree and perspective, and not my prerogative to make those judgments. We feel like we were treated well, and the value of the industry was recognized in the budget.
Speaker Tillis has been a stalwart supporter of the industry. In their original budget, the Senate had proposed a 50 percent cut of Biotech Center funding and the House budget proposed full funding. In the final budget, [they] compromised and split the difference. Tillis has frequently sought out our opinions. I consider him a person who understands and has given a lot of thought to life sciences.
NCHN: So what’s next for the life sciences in North Carolina?
Taylor: We do have tremendous competition nationally and internationally as we continue to attract bio-manufacturing and life-science facilities, pharmaceutical and industrial companies to our sector. That is going to require continued focus on getting the right information to those companies that are expanding at the right time. We’ve had varying levels of success with that, historically.
The other thing we need to do is grow our small-company sector, using our universities as the economic engines that they can be. We do not have a strong technology transfer system in North Carolina. Most everyone would agree we are not getting the intellectual property and capitol that’s held in our universities out in the private sector. That’s the most important thing that our association will be working on in the next year [to] year and a half. We want to see some new models to try to open the flow of intellectual capital and accelerate the commercialization of university technologies.