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It’s flu season and Paul Walker is leery about getting a flu shot. At 75 and with a history of heart disease, the Kannapolis retiree knows he should participate in the annual roll-up-your-sleeve ritual. But Walker remembers his first flu shot in the 1970s. Three days later, he came down with the flu and missed work for six days.
“I haven’t made up my mind this year,” he says. Walker understands the risks. He knows that flu and flu shots change from year to year. So, if he decides to get the vaccine, does he also know what type of flu he’s protected against?
“No. I don’t,” he says. “I know they are numbered: 6, 1, 12; but I don’t know what that means.”
Walker’s uncertainty has merit. Flu vaccines are a gamble. A few months before flu season, scientists evaluate the data concerning the flu-like (short for influenza) illnesses around the country. They then guess which subtypes will prevail.
Of the two types of flu that frequently affect humans, A and B, the most dangerous is A. For the 2013 flu season, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee recommends protection against two A viruses, H3N2 and H1N1, and one B virus. Some 2013 vaccines will contain a second B virus component.
If guesses prove accurate, the United States will have a mild flu season. If the guesstimates are wrong or incomplete, we could have a replay of 2002 and 2009 when a novel and particularly nasty virus subtype emerged.
During those epidemics, scientists did not have a vaccine ready until the outbreak was well underway. Unlike measles and chicken pox, there is yet no universal flu vaccine. To defend against this massive health and economic disruption, we need accurate and rapid prediction.
The Flu Genome
Dan Janies (pronounced “Janus”) promotes a better way to understand and predict flu outbreaks. At 47, he is the Belk Distinguished Professor of Bioinformatics and Genomics at the University of North Carolina at Charlotte (UNC Charlotte). He neatly unites 21st century biology with big data.
Janies’ university appointment adds validity to the observation made by Michael Levitt when he was recently named a recipient of the Nobel Prize in chemistry. “Biology is very complicated and computers are powerful tools,” said Levitt, a professor of structural biology at Stanford University. “The prize,” he said, “is a belated recognition of the importance of the computer in biology.” More commonly, the combination is referred to as bioinformatics.
Janies believes that the way we describe the flu is outdated. He calls it a “legacy nomenclature based on weak technology.”
That legacy goes back to 1971 when two flu molecules, hemagglutinin and neuraminidase were first used to identify flu subtypes. Hemagglutinin (H) is responsible for attaching the virus to a host’s cell and allowing the virus to enter. The virus then hijacks the cell’s replication machinery to make new copies of itself.
Neuraminidase (N) allows the new viruses to enter and infect more cells and hosts. H and N were the perfect target for the flu vaccine. The H and N proteins are present on the surface of the flu virus and our immune system had no trouble finding them.
Flu vaccines stimulate our immune system to develop antibodies to H and N. If exposed to a live flu virus, these antibodies attack the Hs and Ns on the virus’s surface and, if all function as planned, we escape the flu.
The numbers 1 through 16 for H and 1 through 9 for N refer to the different types of hemagglutinin and neuraminidase. Each influenza virus is defined by only one type of H surface protein and one type of N. Within each subtype, there are also strains that arise from random mutations in the virus.
“I don’t think that way,” says Janies. For him, the entire flu genome, which contains six more genetic segments besides H and N, is the key to understanding and combating the disease.
“The genetic segments contain all the exquisite details—the building blocks of the virus. Knowing our enemy’s bricks and mortar will win the war against influenza,” he maintains.
Each living organism has its own unique genome. Virus, plant, bacteria, microbe, fungus and now human genomes are being studied and sequenced. Such work has led to a paradigm shift in understanding and treatment.
Cancer research is a good example. Some researchers have abandoned their focus on the organs where cancer arises—lung, pancreas, breast, skin—to instead focus on the cancer genome. They have found that different cancers share a number of genetic similarities. These scientists advocate treatment based on what genes are mutated, not the tissue involved.
For Janies, genome sequencing provides a much more accurate way of identifying a virus’s subtype. Once an expensive, tedious, painstaking process, sequencing costs have dropped a hundred-thousand fold.
“The H1N1 virus that our great-grandparents experienced in 1918 is a completely different H1N1 from what emerged in 2009,” says Janies. “The H still reacts to the 1 and the N reacts to the 1 antibody, but all the rest of the genes in the genome—all the internal genes—are completely different. That’s what genomics gives you—a clearer picture of what’s there. It illustrates where the legacy nomenclatures are wanting.”
“In the case of Severe Acute Respiratory Syndrome (SARS) in 2003 it took two months from detection of a novel virus to the public release of the genome,” says Janies. “For H1N1 in 2009, it was two weeks.”
Enter the Supramap
Interestingly, it is this ability to identify a particular virus by genome that made it possible to track a particular virus along with big data. Enter the Supramap.
In 2007, Janies and his colleagues at Ohio State University, the American Museum of Natural History and the Ohio Supercomputer Center developed Supramap to track the spread and evolution of pandemic (H1N1) and avian influenza (H5N1).
At the time, Janies was an expert in computational genomics at the Wexner Medical Center at Ohio State.
“Supramap does more that put points on a map—it is tracking a pathogen’s evolution,” said Janies, as the first author of the research paper on the Web-based tool that combines information about the genetic sequences of pathogens with geographic information on Google Earth, allowing researchers to predict and track where infectious disease will strike and how it may mutate.
Using Supramap, they initially developed maps that illustrated the spread of drug-resistant influenza and host shifts in H1N1 and H5N1 influenza and in coronaviruses, such as SARS.
Describing the transition of the Web service to an open-source, freely available phylogenetic analysis program, able to be used by other researchers, he described, “We package the tools in an easy-to-use Web-based application so that you don’t need a Ph.D. in evolutionary biology and computer science to understand the trajectory and transmission of a disease.
“The tool’s users can obtain a pathogens’ phylogenetic tree by submitting its genetic sequences to the system. Supramap then projects that information onto the globe, showing how diseases can mutate over space and time to infect new populations.”
In July 2012, Janies joined the faculty of the University of North Carolina at Charlotte as Belk Distinguished Professor of Bioinformatics and Genomics.
Janies, it seems, has always been the “inventive” sort. He received B.S. in Biology from the University of Michigan and a Ph.D. in Zoology from the University of Florida. He’s worked as a postdoctoral fellow and a principal investigator at the American Museum of Natural History in New York City where he lead a team that, using off-the-shelf PC components, built one of the world’s largest computing clusters in 2001.
He was attracted to UNC Charlotte by the ability to work with outside businesses and to conduct joint research and innovation.
Tracking the Spread of Infectious Disease
Seeing is believing and when you see the 3D visualization of Google Earth and influenza data that Janies and his colleagues have connected on the Supramap giving influenza height, width, depth, movement and meaning, you realize you are looking at an interactive “weather map of disease.”
“Supra, Latin for over, is a good descriptor of what the map delivers,” Janies says.
For the Supramap for avian flu (H5N1), a flu that moves within bird populations and then jumps from birds to humans, for example, Janies and his colleagues accumulated data on outbreaks among hosts such as ducks, chickens, wild birds and humans in China, Russia, the Middle East, Africa and Europe. Hundreds of thousands of cases were classified by strain, location and host.
Janies and his colleagues then use specialized software and Google Earth to project the latitude and longitude of similar flu strains onto the globe. If the movement of a pathogen is related to bird flyways, for example, and those routes are shifting because of something like climate change, it can predict where the disease might logically emerge next.
The Supramap allows any user to input raw genetic sequences of a pathogen’s strains and build an evolutionary tree based on mutations. The branches are projected onto the globe with pop-up windows to show how strains mutate over space and time and infect new hosts. That is, in essence, what Janies calls the “crystal ball.”
Disease is visualized as a “tree” whose “roots” are the common ancestor of a particular flu strain. When an ancestor gives rise to descendant strains, the tree grows higher. Intermediate ancestors and other descendents are given less altitude. Outbreaks are connected with lines reaching across the globe. Finally, date of outbreak is factored in, giving the tree a temporal dimension.
For H5N1, the “tree” grew and shrunk from 1999 to 2006, as it moved over the landscape infecting new hosts.
“The idea of this evolutionary tree of the virus,” says Janies, “is to help predict where the next outbreak of the virus is likely to occur. The map gives us a whole new way of seeing the virus in action and understanding what it is—and isn’t—doing. In the meantime, we are working on mapping other diseases, such as MERS and H7N9.”
The role birds play in the origin and spread of flu is a fairly recent discovery, going back only to the 1990s, says Janies. “Influenza has many, many strains and most live in birds. Often those strains get into mammals and humans.”
One of the central questions in influenza research was which birds were the chief culprit in the spread of avian flu. The usual suspects were migrating wild birds and chickens and ducks sold and then shipped to distant locations.
With Supramap, Janies has found that domestic fowl were to blame in Indonesia, but in other regions both wild and domestic birds are responsible. In one interesting case, a smuggled eagle carrying the flu virus was caught in customs after being transported thousands of miles from Bangkok to Brussels.
Asia heads the list of places where most flus originate, but Janies is quick to point out that H1N1 began in
“We are not doing a good job of observing flu around the world,” he adds. The World Health Organization operates the influenza surveillance system in partnership with national governments and places its limited number of observers in major cities. Flu in rural areas often goes undetected.
“Until a few years ago,” says Janies, “we just knew about influenza in Johannesburg and Cairo. We didn’t know anything about the rest of the continent of Africa. Without comprehensive influenza surveillance data, and the means to put it in context to inform inoculation programs, influenza prevention will struggle.”
When a pandemic breaks out, disease circles the globe, often leaping from species to species. Supramap doesn’t just track the spread of viruses, it tracks how the viruses are mutating as they jump into new hosts and encounter new medicines. Using Supramap, scientists might be able to stay ahead of the virus mutation curve and figure out when to switch medicines as the microbes adapt and develop resistance.
Usually one would find it challenging to weave the terms health care and man cave into the same conversation, but at Vitality Health Services in Charlotte and Raleigh, that is the conversation.
With over 40 years’ combined experience treating the physical, sexual, endocrinal and hormonal issues that all men face, Drs. Michael Trombley and Douglas Brooks set out to create something new, innovative, and exclusively for patients just like them—“for men, by men.” Yes, even the staff is all men.
In their offices, patients are greeted with a large screen TV showing ESPN SportsCenter along with a collection of blatantly gender-specific reading materials like Sports Illustrated and Men’s Health. Throw in a beer tap and you’d practically have a sports bar.
“Studies show men are less likely to go to the doctor than their female counterparts, and reluctant to take action when they don’t feel physically or mentally well,” says Brooks. “Most men know more stats about their favorite sports team than their own body. Our goal was to create an innovative and affordable practice that could reduce traditional barriers preventing men from making their health care a priority.”
“Statistically, men are three times more likely than women not to see a physician,” notes Trombley, more precisely. “It’s not because men don’t care about their health. It’s because they don’t do well in a traditional medical office setting. We offer an alternative—a place where men can feel comfortable and at ease. We don’t have Sesame Street on the TV and kids running around. We don’t have a young woman at the front desk asking personal questions that most men are never going to feel comfortable answering.”
Vitality Health Services provides men with a safe and discreet environment to discuss and treat the embarrassing stuff—erectile dysfunction (E.D.), sexual performance issues, low testosterone, weight problems, vasectomy and even basic primary care.
Both Trombley and Brooks are board certified in Family Medicine.
Trombley is a native of New York, obtaining his medical degree from the University of Rochester School of Medicine. He completed his residency in 1994 from Carolinas Medical Center Family Medicine where he served as chief resident. He first practiced as a physician at Cabarrus Family Medicine and subsequently at Lakeside Primary Care before joining up with Brooks.
He has also had associate faculty appointments with Duke Medical School and University of North Carolina Medical School, and been a travel speaker for Abbott Laboratories, Astra Zeneca Pharmaceuticals, Ortho-McNeil-Janssen Pharmaceuticals, and Xanodyne Pharmaceuticals.
Brooks is a West Virginia native, obtaining his medical degree from West Virginia University School of Medicine. He completed his family medicine residency at the University of South Carolina’s Palmetto Richland Memorial Hospital in 2000. He first practiced as a family physician with Morton Plant Mease Primary Care, the largest medical corporation in Tampa, Fla., and subsequently practiced as a family physician for Carolinas HealthCare System before striking out on his own.
Brooks is currently an adjunct professor with the University of North Carolina at Chapel Hill, serving locally as a preceptor for medical students during their four years of training.
Trombley and Brooks are 5-star physicians on wellness.com and vitals.com respectively, and both have received the Patient’s Choice Award given to only 5 percent of North Carolina physicians.
Both describe their prior practices as “traditional corporate medicine.”
“The genesis of Vitality Health Services came from our frustration over the direction of the health care industry and an attempt to return to the true patient and physician relationship and direct primary care,” says Brooks.
“We were both suffering from burnout with the current medical system,” explains Trombley. “I was diagnosing patients, but treatment decisions were being taken over by the insurance companies. It felt like a disservice to the patient. Medicine should be based on the relationship between a doctor and the patient.”
In addition to wanting to be his own boss and the freedom to practice medicine on his own terms, Brooks had always had an interest in men’s health issues, and felt there was a need for specialists in the field, just like women have gynecologists and children have pediatricians.
A recruiter helped put Brooks in touch with a small group of like-minded investors and that’s how he met up with Trombley. The two opened up Vitality Health Services in Charlotte, and the business model has worked so well that they added a satellite office in Raleigh.
Setting Themselves Apart
Making the decision to reclaim control of their respective careers, Trombley and Brooks began thinking outside traditional structure and focusing on the particular niche that they both found interesting, men’s health services. Alongside the unique “men’s club” approach to providing care, the two made a conscious decision to have an all-male staff as well, to further set their clients at ease.
Additionally, they made the decision not to bill insurance directly, which means clients pay directly and have the option to seek reimbursement from their own insurance carriers. While some might think this a concierge, boutique approach for a medical practice, it is in reality the opposite.
“By not billing insurance directly, we cut down on practice overhead and staffing, resulting in surprisingly affordable fees,” Trombley points out.
Brooks clarifies, “If we bill $100 through insurance, about $40 immediately goes to the insurance company. Then another $20 goes to pay the salaries of two more employees—a coder and a biller—that we have to hire. So why not have the patient pay us $40 directly, and keep the insurance companies and their medical opinions out of the picture.”
An initial visit to Vitality Health Services runs $300 which includes all necessary blood work and a follow-up visit. Subsequent office visits are only $100. Specific in-office procedures and treatments, such as vasectomy, are individually priced a-la-carte style. The model also works well for patients who have a flex-spending health care plan.
Trombley says, “Our goal is to show that we can provide first-rate quality care, but do so in a cost effective manner.”
In practice, for Brooks and Trombley, it’s all about putting the patient’s needs first and having the luxury of actually spending time with them.
“In my last job we were allowed 15 minutes per patient,” says Trombley. “That’s just not enough time. Here we can spend an hour with each patient. We’re dealing with sensitive and often embarrassing issues. Guys don’t just walk in and blurt out what’s wrong. It takes time for them to relax, feel comfortable and establish a sense of trust.
“By taking our time, we uncover so much more important information; it enables us to formulate a better diagnosis and better treatment plans that address all issues.”
Brooks concurs, saying, “Our patients feel like they actually have a relationship with their doctor. I would love to see a long-term study of my patients 30 years from now, because I truly believe the men I’m treating are going to live longer than those getting a 10 or 15-minute visit.”
Proactive and Progressive
Although the doctors treat more common male-specific issues like the dreaded E.D. (statistics show 40 percent of men are affected by age 40 and 70 percent by age 70), they are increasingly focused on treating more men in the relatively new area of testosterone replacement therapy. Andropause—a decline in testosterone production—is basically the male counterpart to menopause.
Both Trombley and Brooks are firm believers that low testosterone or “Low T” is often the root of many other male-specific problems like E.D., as well as being a contributing factor in more serious issues like hypertension, diabetes and high cholesterol.
Brooks explains, “Testosterone loss happens to every man. It starts in our 30s and continues from there. While women have been on estrogen tablets for 50 years, it is only now that we are starting to look seriously at male hormone replacement therapy.”
Typical symptoms of low testosterone are often reduced energy, moodiness, gain in belly fat and eventually sexual performance issues. However Trombley says the onset is so gradual the symptoms are often incorrectly attributed merely to aging. A low testosterone count is easily diagnosed with a simple blood test and current treatments run from pills to topical creams.
Although still a relatively new frontier in health care, both doctors are resolute in their convictions regarding the benefit of testosterone replacement therapy. Trombley says, “I firmly believe what we’re doing will absolutely become the standard of care. We’re just waiting for everybody else to catch up.”
He attributes the hesitation to insurance companies trying to categorize low testosterone as a disease. As the “normal” range for testosterone count (T-count) has been established as between 300 and 1,200 (all measures in ng/dL or nanograms per deciliter), Trombley says a patient with a 315 T-count will be summarily dismissed by insurance carries and most physicians as being within normal range.
“What we really need is a way to go back in time and learn what your testosterone count was at age 18 and try to restore it to those levels,” he explains. “The way we look at it in a proactive way is that if a patient has a T-count of 315, but is symptomatic, we treat him. There’s no reason to wait until he is at disease state.”
Both Trombley and Brooks can attest to the positive benefits they are seeing in testosterone replacement therapy. Trombley says, “We fix the patient’s testosterone and he suddenly feels 20 years younger, his relationship with his wife is amazing, he’s got more energy and is suddenly motivated to get back in the gym, and now naturally his blood pressure goes down, he’s not a threat for diabetes and his cholesterol is normalizing.”
As further evidence of their proactive and progressive approach to medicine, Dr. Trombley has undergone additional training in stem cell therapy as a promising treatment for erectile dysfunction.
Stem cells are defined by their capacity for both self-renewal and directed differentiation; thus, they represent great promise for regenerative medicine. Historically, stem cells have been categorized as either embryonic stem cells (ESCs) or adult stem cells (ASCs) and it was previously believed that only ESCs hold the ability to differentiate into any cell type.
Recently, however, numerous studies have demonstrated the ability of ASCs to differentiate into cell types beyond their tissue origin. Additionally, there is an abundance of stem cells in body fat which can be harvested via liposuction.
“This means that if a patient is suffering from E.D. due to loss of blood flow to the penis and has not had good results through conventional treatment, application of stem cells harvested through liposuction may be an option to increase blood flow and pressure in the penis,” Trombley explains excitedly.
Vitality Health Services is one of a handful of sites in the United States certified as part of a multicenter study for the application of stem cell research. Although investigational, Trombley is optimistic this may be a viable treatment used in offices in the future.
“Most people’s misconception is that all stem cells used in research are embryonic,” he clarifies. “Our investigational trial studies are non-embryonic and come from the patient himself. It’s a cutting-edge new approach of healing yourself, with your own cells.”
Brooks says, “I’ve never been happier since I began practicing medicine. Michael and I are two peas in a pod and finally doing exactly what we want to be doing—treating the whole male and improving our patients’ lives. It’s extremely rewarding for us and we know that it’s working because our patients keep coming back.”
“It’s such a relief to be free from an insurance company’s standard of care. We’re always looking for better options for treatment for our patients,” says Trombley. “We are ultimately committed to progressive medicine to help our patients enjoy healthier and longer lives.”
Asked about when he started in the family business, M. Kale Hinnant quips, “Birth.” It’s a bit of an exaggeration, but Hinnant is the third generation in a business that spans eight decades. With only 6,000 practitioners nationwide, it’s a unique business started by his grandfather W.T. Hinnant for unique reasons.
In 1930, W.T. Hinnant was struck by a train while pushing his car off the tracks and lost a leg. At the time, no companies in North Carolina manufactured artificial limbs so Hinnant’s grandfather obtained a prosthetic leg from a company based out of Minneapolis.
“Back then,” Hinnant explains the history, “someone would travel to you, take your measurements, go back and make the prosthesis, and then ship it to you. You were left to adjust or repair it. There was no such thing as patient care; my grandfather had to make his own revisions to his prosthetic appliance. Some of his revisions were even later utilized by the Minneapolis Artificial Limb Company on their products.”
It immediately became obvious to Hinnant’s grandfather that he had the ability to help other amputees in the Carolinas, so he apprenticed with the Minneapolis prosthetics maker and, after learning the craft, opened W.T. Hinnant Artificial Limb Company in Charlotte in 1931.
The company keeps the name today but is more commonly known by the signage on their building in Charlotte’s South End—Hinnant Prosthetics.
Specializing in lower and upper limbs and hands and servicing North and South Carolina, the company has fit over 28,000 prosthetics since its founding and is one of the longest established and most recognized prosthetic and orthotic companies in the Southeast.
Started as a one-man operation, W.T. Hinnant’s sons, John and Milton, joined the firm after their graduation from the University of North Carolina at Chapel Hill. Kale Hinnant, Milton’s son and the current owner and manager, now employs three certified technicians who assist with the manufacture of prostheses, two office staff, and two certified prosthetists who instruct the technicians and fit the appliances.
Much has changed since the company’s founding. Educational requirements and certification for practitioners elevated what used to be a craft to a profession.
“In the early days, if you could cut something off a tree and make it work, you were a prosthetist,” Hinnant explains, “Our firm was the first in Charlotte to be certified by the American Board for Certification.
“We believe in education for our employees and we work to further their education and advancement. In order to stay current with the rapid technological advances of this field, our practitioners regularly attend seminars and continuing education classes provided by the American Academy of Orthotists & Prosthetists (AAOP) and various product manufacturers.”
Hinnant sets the example. He holds a B.S. in Accounting, a B.A. in Business, and is one of only six Fellows of the American Academy of Orthotics and Prosthetists (FAAOP) in North Carolina and was among the first 50 recognized for this educational achievement nationwide.
A seasoned veteran in the business, Hinnant emphasizes how keeping up with advances in technology is critical now more than ever.
“New applications of space-age materials, digital technology, and experience with combat injuries from more than a decade of war in Afghanistan and Iraq have spurred a high tech explosion in prosthetic science.
“War is the greatest driver of innovation in prosthetics,” Hinnant says. “Caring for amputee casualties promotes federal funding for developing better technology.”
Hinnant easily ticks off a list of recent technological breakthroughs.
High-tech prosthetics like the C-Leg and the Ossur Rheo Knee use a microprocessor to adjust prosthetic leg swing for a more natural gait, greater freedom of movement and reduced walking fatigue.
Advances in myoelectric-controlled upper extremity prosthetics, which use electronic sensors to translate minute muscle, nerve and EMG activity into prosthetic movement, continue to improve function.
The i-LIMB Hand features five fingers each powered by separate motors which someday may allow the individual use of each finger.
Hinnant Prosthetics utilizies the Omega Tracer CAD. This technology replaces the traditional time-consuming plaster casting process and creates a highly accurate, three-dimensional picture of an amputee’s residual limb producing the best possible socket design for the patient’s needs, physiology and lifestyle.
With better technology comes higher costs, so prosthetic prices vary widely. Lower extremity appliances’ price tags can range from $5,000 to $100,000-plus. Upper extremity prosthetics can cost $3,000 to upwards of $120,000-plus.
“You have to put patients in the right appliance,” says Hinnant. “When you meet with a patient you ask them whether they want to ambulate, what they do, what are their activities. You also ask about their aspirational plans; what they want to be able to do.
“The more technology, the more difficult a prosthetic is to maintain, so it’s not always just the cost of the prosthetic, but also the cost factor over time. But if the patient’s capable and would benefit from a certain appliance, then you just have to educate them so they’re aware.
“This is a very personal, customized product. About 10 to 15 percent of our patients have the higher-end technology, but high-end is a relative term dependent upon their needs and wants. I can put a $30,000 foot on a leg but is it going to benefit that particular patient? That’s the question.”
It’s All About Patient Care
“From the beginning of this company, it’s always been about patient care,” affirms Hinnant. “We don’t only fit patients physically, we fit them mentally. You’re dealing with the emotional issues of losing a limb. It’s the same grief as dealing with death. You have to allow the patient to grieve and get through it.”
One reason Hinnant understands his patients so well is that he’s known many of them for years. Amputees need lifelong care in terms of prosthetic adjustments, maintenance, repairs, and over the course of time, new or upgraded appliances.
Craig Winslow lost his leg to cancer 28 years ago. Hinnant Prosthetics provided him his first appliance and went through the training with him needed to adapt. Since then, they’ve cared for him over his five subsequent prosthetics.
Currently Winslow uses two prosthetics. As a Boy Scout Master and active dad of three boys, he has a waterproof leg for water skiing and family trips to the beach. He also has an everyday leg which, as a Jimmy Buffet fan, he decorated with a sunset beach scene. A past leg sports the logo of Winslow’s alma mater Florida State.
“I just live an ordinary life,” says Winslow. “My prosthetic doesn’t hold me back; it’s allowed me to get on with my life. When I wake up I put it on and I don’t take it off till bed that night. It’s so comfortable there are times I forget that I’m wearing it.
“That all comes down to Kale Hinnant,” Winslow continues. “He watches me walk and makes micro adjustments so that when I walk out of here, I can’t even tell I have it on. Even when I moved to Greenville, S.C., I still came back here for care.
“They spend time with me when I’m here. Kale not only helps me with my prosthesis, he’s become my friend,” says Winslow, holding up a wooden peg leg Hinnant had crafted for him to be a pirate for Halloween a couple of years back.
“A lot of my patients have become my friends,” Hinnant says. “This business continues for two reasons: we have good rapport with our patients and we travel all over North and South Carolina.”
Hinnant Prosthetics’ in-home service is an industry differentiator. Although many patients are treated in their Charlotte office or in their satellite office in Columbia, S.C., understandably some patients have difficulty traveling or can’t afford the expense.
“We will work with them in their home if it helps,” says Hinnant. “By working in their homes, we know the barriers they face and we can better determine the appliance that serves their needs. A lot of other practitioners can’t do that.”
But traveling to patients’ homes can have its challenges. Per Hinnant, “Google Maps can sometimes only get you so far—so you call them up and ask them if they have a ramp in front of the house or what color the car is in the driveway.
“One time I called a patient for directions and they told me to take a right at George’s Store. Well, I drove and drove but I couldn’t find any George’s Store so I called back. Turns out George’s Store had burnt down 10 years before, but that’s how they remember it.”
On-site fabrication is another differentiator for Hinnant Prosthetics. While the industry trend is to outsource manufacture to a central fabrication site, Hinnant Prosthetics continues to fit and make prosthetics in their Charlotte office just a short hallway away from patient care rooms.
“When patients come in, we can take care of them,” Hinnant explains. “We have the knowledge, the supplies, the equipment and the products right here. The prosthetists and the technicians can consult directly with each other and with the patient. It makes for a better patient outcome and that’s what we’re here for.”
Surviving in Changing Times
But Hinnant admits that he may have to change some of the ways he’s currently doing business. The industry is in a period of tremendous flux. A 2011 American Orthotic & Prosthetic Association State of the Industry report notes declines in net billings, profit margins and revenue per employee.
One reason is downward pressure on pricing. While Hinnant Prosthetics works with the U.S. Department of Veterans Affairs, Medicare, Medicaid, vocational rehabilitation and private insurance; Medicaid rather than private insurance now sets the standard on pricing. Medicare increases of only one to two percent can’t keep up with increases in the costs of materials and overall business expenses, which rise an average of five to 10 percent.
Recent changes in Medicare have also impacted the industry. In an attempt to identify improper payments and correct billing and coding errors, the Centers for Medicare & Medicaid Services (CMS) instituted Recovery Audit Contractor (RAC) audits.
Along with the audits, CMS issued a new prosthetic patient referral documentation guide for physicians known in the industry as “Dear Physician” letters. Both CMS actions create a huge compliance burden for the industry, especially for the small mom and pop firms.
Hinnant estimates that his compliance burden has increased from 10 to 40 percent. A recent industry article cites that 17 percent of small orthotic and prosthetic facilities have closed due to audits and that 75 percent have cut staffing.
Another factor affecting the business is a shrinking patient pool. Amputations from diabetic complications are 80 percent of Hinnant Prosthetic’s client base and account for the majority of prosthetic patients nationwide. Improvements in the care and treatment of diabetes and advances in surgical techniques have led to a marked decline in amputations. The Centers for Disease Control and Prevention reports
These challenges leave Hinnant Prosthetics at a crossroads.
“What we need to do is decide what the best approach is going forward,” says Hinnant. “My goal is to structure the company to be an ongoing entity so that it can survive despite outside influences. I’m trying my best to maintain the business because I think it’s important. It’s important to my family’s legacy and to the people that work here to keep it going. But even more than that, I have patients coming to me all the time asking, ‘If you’re not here, what am I going to do?’”
Hinnant has decided to meet these challenges head on. Always active in the industry, Hinnant belongs to five national industry organizations, is past president of the North Carolina Chapter of the American Academy of Orthotists & Prosthetists and is currently on the board of directors for the North Carolina Prosthetic & Orthotic Trade Association. He believes that organizing, educating and being proactive and politically involved is the key to thriving in the future.
Currently he’s meeting with consultants to best craft a new business model. He’s also added administrative defense coverage to his insurance and retained The van Halem Group to assist him with Medicare audits.
“I don’t intend to let these adversities beat me,” Hinnant says. “How can I not fight to keep going when everyday, I see the adversity my patients face and fight and overcome all the time?”
For the last three years, health insurers and health care providers have been preparing for the start of open enrollment for the Federal Health Insurance Exchange or Marketplace created by the Affordable Care Act (ACA). And for the last several months, insurers from coast-to-coast have been announcing their rates for the health plans which will be offered through this new health insurance market beginning on October 1.
As has been the case in most other states where ACA-conforming rates have been announced, the rates to be offered by Blue Cross and Blue Shield of North Carolina (BCBSNC) are lower than many had been expecting. That may be a bit of a surprise given that there will be only two competitors on the North Carolina exchange and only BCBSNC will offer plans in all 100 counties.
“The opportunity to participate on the exchange was open to any company in the country, so we find it curious that many of them chose not to invest in our state,” says Brad Wilson, president and CEO of BCBSNC, “but our obligation is to North Carolina, so we didn’t calibrate our engagement based on how many competitors there would be on the exchange.”
BCBSNC traces its roots back 80 years, when few people even had health insurance. Today, they cover one of every three people in North Carolina. They serve more than 3.75 million members and are the state’s largest health insurer. Their network includes more than 97 percent of medical doctors and 99 percent of hospitals in the state.
BCBSNC executives believe that after the subsidies are taken into account, over two-thirds of the people who are candidates for an ACA-compliant policy will see either a decrease in their cost of insurance or a very minor increase. They also point out that ACA plans will generally offer richer benefits than most of today’s individual market plans. BCBSNC thinks that these cost dynamics will be the primary factor in determining eventual participation rates.
Since many of the people who will buy through the ACA insurance marketplace have never bought health insurance before, education will be key to obtaining good participation rates. BCBSNC is helping educate the public through television commercials as well as their LetsTalkCost.com website, and meeting customers face-to-face through community events and meetings.
“We’re doing some unique things we’ve never done before,” acknowledges BCBSNC Vice President of Sales—Group Markets Steve Crist. “For example, we’re inviting people who don’t historically seek out health insurance to movie premieres where we spend anywhere from 10 to 15 minutes talking generically about the importance of insurance and how easy it is to get. We’re also opening our own storefront retail venues.”
The Political and Economic Costs
Ever since it was passed on March 23, 2010, the Affordable Care Act has been a political lightning rod. Due to their opposition to the Act, many states with Republican-controlled state governments—including North Carolina—have refused to set up their own state-based insurance exchanges, deferring to the federal government to establish and administer the exchange for their state.
Many of these same states—again including North Carolina—have also chosen to opt out the ACA’s expansion of Medicaid to individuals and families with incomes up to 133 percent of the poverty level. However, these individuals will still be eligible for subsidies when purchasing coverage on the federally run exchange.
Those two decisions by the North Carolina General Assembly have had differing impacts on the rollout of the ACA in the state. But, say Wilson and Crist, North Carolina’s decision not to operate a state-based exchange probably had little or no impact on the rates charged.
“I don’t think the lack of a state-based exchange has added to the cost of the insurance,” explains Chist, “it just takes away some of the flexibility and decision-making authority from our state government and puts it in the hands of the feds.
“Frankly, there were some theories that a federally facilitated exchange might be more inviting to national competitors like United Healthcare, Aetna and Cigna because they wouldn’t have to deal with the idiosyncrasies of a state-based exchange. But that did not prove to be the case.”
“Our corporate position from day one has been that a state-based exchange was in the best interest of North Carolina,” adds Wilson. “We believe that the government that is closest to you is typically the best.”
On the other hand, the BCBSNC executives argue North Carolina’s decision to opt out of Medicaid expansion has increased the rates that must be charged on the ACA exchange. They say the rates have to increase to cover the cost of providing care to people without the ability to pay.
“We think between 500,000 and 800,000 North Carolinians would have been covered by the Medicaid expansion,” explains Wilson. “But those people are still accessing care when they need it, so the demands and cost on the system did not go away just because North Carolina chose not to accept additional money from the federal government to pay for that care.
“Doctors and hospitals still are not being paid, which leaves a debt on their balance sheet that has to be made up by the private commercial side of the business.
“As long as people are showing up and getting care that is not paid for, it is going to manifest itself somewhere,” he continues. “The question is: Are we going to do it rationally and appropriately, or are we just going to let this unsustainable economic model continue?”
Another real risk with the insurance exchange is what insurers call “adverse selection,” where only those customers who are in immediate need of insurance actually sign up. Any insurance plan needs a diverse pool across which to spread the risk, so younger, healthier people need to sign up for the plans as well as the old and the sick.
The ACA addresses that situation through what is called the individual mandate—a requirement that every individual not covered by an employer-sponsored plan, Medicaid, or Medicare secure an approved private insurance policy or pay a penalty.
“We are fairly confident that those who need it the most are going to come onto the exchange—as they should,” says Wilson. “But I think one of the weaknesses of the ACA is the participation incentives for young, healthy people are not aggressive enough. There has to be enough incentive so that the cost of not participating outweighs the cost of the insurance.”
BCBSNC also worries that the negative political energy directed toward the ACA will have a negative effect on the participation rate. In fact, some interests that oppose the ACA have launched a campaign to persuade the young and healthy to boycott the exchanges to, in effect, sabotage the ACA by actually encouraging the adverse selection insurers fear most.
“There is so much political energy around it, our fear is this misinformation, coupled with the national ambivalence about the ACA, will keep people from signing up,” admits Crist.
Changing the Health Care Model
In addition to expanding the availability of coverage, the ACA was designed to make health care more affordable by driving innovation and moving providers away from fee-for-service arrangements to more outcome-based reimbursement models that reward higher quality and greater efficiency.
“There’s not a day that goes by that we don’t get a half dozen calls from providers saying they would like to do something collaboratively and differently,” offers Wilson. “Those trends have been initiated and accelerated by the passage of the legislation.”
One significant accomplishment along those lines has been the partnership between BCBSNC and UNC Health Care Systems in forming Carolina Advanced Health. Established in 2011, it resulted from collaboration between Wilson, then new to his role as CEO of BCBSNC, and Dr. Bill Roper, CEO of UNC Health Care and dean of the UNC School of Medicine, as they discussed ways post-health reform could “move the needle” and truly make a difference in health care delivery.
“We came up with the idea based on the patient-centered medical home model,” explains Wilson. “Now that Carolina Advanced Health is up and operational, it’s created a lot of buzz and we believe it will result in higher quality of care at a lower cost.”
The medical home concept was first introduced by the American Academy of Pediatrics (AAP) in 1967 and defined as the center of a child’s medical records in special health care needs situations. Over time, however, it has evolved to signify a home base for any patient, child or adult, family, and primary provider in cooperation with specialists and support from the community.
It has broad support in the medical community as an integral model for health care reform. In a rigorous discussion and analysis entitled The Strategy That Will Fix Health Care (Harvard Business Review, October 2013), authors Michael E. Porter and Thomas H. Lee describe the ultimate strategy for health care reform as maximizing value for patients by achieving the best outcomes at the lowest cost.
They maintain that it will require restructuring how health care delivery is organized, measured, and reimbursed, and they applaud the medical home concept as an important step toward establishing better-coordinated, team-based care that has the ability to improve outcomes and lower costs.
Carolina Advanced Health is certified as a Patient-Centered Medical Home (PCMH), the recognition for the most widely-adopted model for transforming primary care practices into medical homes. Established to help boost quality outcomes, streamline care and reduce medical costs, Roper describes the new practice as representing “the next generation of the PCMH.”
“This is just the beginning of what we hope will be a new era in personalized health care that leads to improved patient health, greater efficiency, and lower health care costs,” he says.
Specifically, doctors, nurses and other health professionals at the practice work together to manage every aspect of patient care to help improve the patient experience. The collaborative approach, aimed at improved health and quality standards and a reduction of complications among patients, will help reduce medical costs in the national transition from production-based to value-based medicine.
Practices that are certified as a PCMH must meet a wide range of standards for technology use, patient access, care plans, care coordination, measurement, and performance improvement. Interestingly, North Carolina is second only to California in PCMH designations, with over 30 percent of statewide primary care practices having received the PCMH certification.
Among the requirements for PCMH certification are electronic medical records, a capability that has proven to be a problem for smaller primary care physician offices that lack the capital to install the necessary systems. However, BCBSNC partnered with health care technology provider Allscripts to offer their electronic solution at cost and provide training and maintenance for a year with BCBSNC paying for 85 percent of the cost for physicians’ offices and 100 percent of the cost for 39 of the state’s free medical clinics.
The Spirit of Collaboration
“Establishing the new clinic didn’t have that many challenges or anything insurmountable,” explains Wilson. “The first step was deciding that these two organizations would come together on this project. If you think about it classically, a health insurer and a major academic medical center typically don’t come together to build things. Once we decided we had the spirit and the will to work together and bring this to pass, the hard work started.
“Along the way, there were bumps in the road on very important issues like governance, how to pay providers working in the clinic, what kind of technology to employ, and how to handle specialty referrals. There were lots of important conversations. The key agreed-upon aspect of the project from the onset was that failure wasn’t an option.
“When we got to a tough place, we stayed together, kept working, and found a solution. Then we moved down the road. All the teams that brought this clinic into being did exactly that. The work got done.”
Carolina Advanced Health is currently available to about 5,000 eligible BCBSNC members, adults 18 to 62 with chronic illnesses. “The parameters were necessary,” says Wilson, “to make sure we had a well-defined population that we could accommodate and not lose our focus trying to determine best practices. As we learn what’s working well, we certainly intend to translate that into other age categories and populations.”
Addressing the future of health care reform, both Wilson and Crist say the ACA is helping to drive more incentive-based wellness programs like the one available to BCBSNC employees. In that plan, each employee can earn up to $750 per year by achieving health goals set in a personalized health risk assessment. An employee’s goal might be weight loss, cholesterol management, blood pressure management, or a combination of goals.
“The fascinating conversation is going to be a year from now when we have a full 12 months under our belt,” admits Wilson. “We’re getting ready to go to school here, and while most of our assumptions are fact-based, there has still been a lot of intuition involved.”
He also suspects that other national competitors will take a look at the data after the first year and may opt to enter select markets where they believe the opportunity for reward is the greatest.
“I’m optimistic about the future,” concludes Wilson. “I believe that we are at the beginning of a revolution, and in 10 years we will have a better system of care delivery and finance in this country.
“I think it is going to look dramatically different than even what we’re talking about today, and I’m not sure exactly what it will look like, but we all have to get beyond the political acrimony that is consuming so much energy.
“We need to focus on making sure that we as Americans become healthier and know how to use the system that will be created over the next 10 years—both for the financial well being of our nation as well as our overall health,” asserts Wilson.
Like trickling rain, binary numbers drop and slide onto the fabric of life, forecasting every possible sequence into infinity. Most participants, mesmerized, will experience the steadfast order; a single reality that can be taken for granted. A rare few will perceive the development of alternate realities—situations arise, problems are clarified; solutions become evident.
Such was the backdrop for the movie, The Matrix. The ability to “see the matrix” allowed for insight and understanding, quick responses, survival itself and a new order.
“I relate to that,” says an enthusiastic Troy Rice, owner and president of See the Matrix Incorporated, a Charlotte-based IT company. “With us IT guys, well, we often live in an alternate universe with the way we think, talk and look.”
Rice also relates this theme to his business. “We see through a different set of lenses. We look into a mess of wires and problems and make sense of it.” And that’s a good thing for his clients whose computer woes often seem otherworldly.
See the Matrix, or STM for short, provides, hosts, maintains, monitors and supports hardware, software, licensing and antivirus protection, allowing its clients to focus on their core business operations and goals.
Work with small to mid-sized businesses in the Charlotte area comprises about 65 percent of the company’s activities, although the growing client directory is scattered over 18 states as well as in satellite offices abroad.
“Entrepreneurial, professional-based businesses such as accounting, legal and medical gravitate towards STM,” says Rice. “Their software works really well with our platform, plus they tend to have multiple offices with a small number of users in each one.” Rice adds that that’s because companies with 50 or more users at one site likely have their own on-site IT person.
STM is currently managing services for approximately 2,200 users. Clients include James McElroy & Diehl, one of Charlotte’s biggest law firms, and Adams Outdoor Advertising. Assisted living communities and small hospitals round out the company’s client base. Rice admits that there are businesses too big for the company.
“We can’t really offer anything to Wells Fargo, but we can go to smaller businesses and offer them the same enterprise-level services that Wells Fargo utilizes,” maintains Rice. “We have the same quality and level of equipment sitting in our data center that Fortune 500 companies, banks and large hospitals have.
“Businesses that have been frustrated with a too-small IT operation lacking in immediate response or face the option of working with a larger firm but at prohibitive costs—these folks are attracted to us. We operate on a flat-priced model; rates are based on the number of users and pieces of equipment.”
One of the company’s largest new clients came on board earlier this year—a small hospital in New Orleans with over 100 users. “That was an amazing project that couldn’t have been done without the right group working on it,” says Rice.
STM’s vendor partners include Cisco, EMC, Dell and SonicWall. Rice likens the process of bridging vendors to customers to building a house. “We buy the best brick, wood, tile, shingles, paint and nails that are available to build a structure; then we sell the house.” See the Matrix earned $2.5 million in revenue last year.
Living in the cloud
“Customers ask, ‘When are we going to the cloud,’” says Rice. “I tell them, ‘You’ve been in it for eight years now.’” See the Matrix was far ahead of the curve, according to Rice. “We’ve been doing it longer than anyone else in Charlotte; before it had a name; before it was cool.”
The cloud is a relatively new delivery paradigm making information and services accessible at any time from any location and from any device such as desktops, laptops and smart phones. Through the cloud, data lives and runs on multiple and highly-redundant servers in locations external to the data owners.
“Why in the world would a company today want to have its data on a server in an office when its whole business life is dependent upon that server and subject to mechanical or electronic failure, theft, damage, accidental deletions or power outages?” ponders Rice.
See the Matrix owns a private data center in the TW Telecom Data Center near Charlotte-Douglas International Airport. All client data is stored there on an EMC SANS appliance and applications are run from an array of redundant servers. STM utilizes TW Telecom’s conditioned power and generator, preventing downtime from loss of power. The company utilizes a triple entry fiber Internet service to insure constant connection.
“Jack Bauer [referring to actor Kiefer Sutherland’s character in the television show 24] couldn’t get into the place. There are nine layers of security before you get to a computer over there,” boasts Rice, describing the facility on which blinds cover, not windows, but more concrete. The unmanned data center is located 3.7 miles from the company’s West Morehead Street offices.
The constant monitoring and probing of the network systems is conducted by the STM staff. Annual upgrades are supported by Varrow, Inc.
“We finished an upgrade about 60 days ago,” says Rice. “It came off without a hitch and no one [customers] knew. That’s the way it’s supposed to be—no lapse for the customers, just seamless backups, faster retrieval and advanced security.”
Downtime is the ultimate nemesis for most businesses, according to Rice. “We work to make sure that computer problems don’t stop your operation in its tracks.”
A bright and capable team
The STM team consists of 12 full-time employees.
“I am blessed with a great staff,” shared Rice. He speaks of Travis Nieves, his director of operations: “Together, we manage the data center. He’s the hardware guy; I’m the money guy,” laughs Rice. “We often act on ideas Travis brings to me because his ideas make sense to further our products and the stability of our program.
“Tim Bailor is senior systems administrator and has worked with the company for over 10 years. He’s kind of my McGyver,” says Rice. “He’s sat at every desk here.”
The company’s on-boarding manager is Mat Schulz. He acknowledges,“It’s a massive undertaking to bring a customer with 25 users on board—two weeks of work for us, then a 24-hour switch-over.”
“I never tell anyone that someone works for me,” says Rice. “They work with me to build this company. We all built this company. Each person is valuable. If somebody doesn’t come in, it’s felt.”
See the Matrix came through the Great Recession with relative ease. “We did notice that our customers weren’t buying new equipment as much, but none of them went out of business. In our house, we weren’t losing money, but we weren’t growing at great strides, so we tried to maintain our war chest in case it was needed. Raises were suspended for a couple of years but we were able to keep all of our staff.”
During that time, the company even picked up some new customers who switched from having an on-site IT person, according to Rice.
See the Matrix started out as a break/fix operation. “We’ve done our share of repairing slow computers, reviving monitors, fixing printers, ramping up memory and, of course, coming to the rescue when servers crash,” says Rice.
The company has a ‘tell it like it is’ approach to repair. “We don’t just fix and leave. We tell them what they need to do so it won’t happen again. Sometimes equipment is just worn out and needs to be replaced. You wouldn’t want your medical doctor to just treat symptoms and not look for the root cause of the problem; you shouldn’t want that in your IT service either.”
Furthering the medical analogy, Rice says that many people think they have to know what’s wrong before calling the IT professional. “You don’t,” he maintains.
Today, fewer customers come on board in direct response to a computer crash. Rather, they have an increased level of awareness regarding operation and security, says Rice.
A native of Charlotte, Rice graduated from West Charlotte High School before attending Appalachian State University. He graduated in 1998 with a degree in graphic arts, part of his somewhat unorthodox business plan.
“I was way too interested in my fraternity and knew that I wouldn’t make it through business school, but I was already very handy with computers,” explains Rice who cleverly traded coursework for the maintenance of department computers.
“I’ve always enjoyed technology,” says Rice who has had no formal IT training. “I was a geek as a kid—an audiophile—always breaking things that had to be fixed before Dad came home. It just made sense to me how these things worked.”
Now, Rice, an avid reader, keeps abreast of new technology by diving into all the publications vendors and researchers offer. He also communicates with his young staff that includes a person dedicated to keeping up with what’s new. Plus, Rice says his customers are a great resource for new information. “It’s a matter of being receptive,” he says.
Staying on track
Rice’s passion also extends to riding motorcycles, from motocross to joy-riding on the track.
“I’m an avid biker,” exclaims Rice. “Four years ago, Santa brought my son a dirt bike for Christmas. I was so enthralled watching his fun—I couldn’t get enough.” Rice’s wife Patty surprised him with a bike for his birthday.
“My first time out, I cracked two vertebrae and fractured my coccyx, a feat that will cause significant back pain for the rest of my life. But, I love it.”
After the terrible accident, Rice engaged a motocross trainer who has taken him from a novice to a skilled rider in competition. Rice competed recently for a spot on the U.S. Team for the BMW Motorrad GS Trophy. Rice grabbed 17th place among 73 riders from around the country. The competition took place at the BMW Performance Center in Greer, South Carolina.
Now the entire family—wife, son 9 and daughter 6 are all involved in riding. “We’re a very active, fit family. Exercise is a very big part of life,” says Rice.
Rice is also active in furthering causes he feels deeply about. Sometimes, these interests overlap. Rice recently participated in a 10-day, 1,056-mile motorcycle ride across Peru as part of the filming of the television show Neale Bayly Rides: Peru on the SPEED Channel. The trip’s goal was to raise awareness in America of a non-profit organization, called Wellspring Outreach International, which helps to support orphaned children in the Peruvian village of Moquegua.
“I lost a dear friend to brain cancer two years ago,” shares Rice. “I like to get involved with efforts to further research and treatment.” Rice also uses his gym workouts to raise funds for Barbells for Boobs. “I have to compete in ungodly awful exercise routines but it’s worth it,” he says with a smile.
Rice hopes to grow the company into a $10 million enterprise during the next five years. “We’re going to continue growing our customer base and advancing our technology,” says Rice. He has been approached by potential buyers but says he has no plans to sell.
“What would I do—perhaps ride motorcycles professionally for a while, but then what? I don’t want to start another business. I’ve already put the work in here.”
“Some people are impressed with what we have and what we do, but I look around in amazement that I could afford a conference table, color laser printer or LCD monitor, much less have the opportunity to buy a building,” says Rice.
He remembers the humble beginnings of the business when he would take a pay check home and say to his wife, “Put it in a drawer or use it as a note paid. We can’t cash it.”
“I know how hard it is to grow a business. It’s been a great ride. We’ve come a long way but we haven’t peaked. We’re still clicking uphill.”
Nestled away off Johnston Road in the Ballantyne area, Chelsea Therapeutics represents the next big evolution of the pharmaceutical industry. A far cry from drug giants like Pfizer and Merck, this small band of entrepreneurial-minded scientists, physicians and business executives are focused on a virtually untapped market.
“We’re going to develop drugs for patients who represent a high unmet medical need and improve their lives,” says CEO Joe Oliveto. He refers to those historically ignored by the pharmaceutical power players because there simply aren’t enough of them.
Chelsea Therapeutics has found its niche in what are called orphan drugs—those developed to treat rare, often little-known medical conditions or orphan diseases. By definition, the population of those suffering from orphan diseases numbers less than 200,000 and can be as little as a few thousand in the case of “ultra-orphans.”
Acknowledging the difficulty and lack of incentive to develop and market these medications, the Food and Drug Administration (FDA) helped pass the Orphan Drug Act of 1983 to encourage the development of rare disease drugs. The act provides sales exclusivity for seven years, possible clinical trial tax incentives, and modifies Phase III clinical trial testing mandates as it literally may be impossible to test the number of patients required under current standard guidelines because they simply may not exist.
Finding Success in a Limited Population
Leaving the humanitarian aspect alone for the moment, servicing such small segments of the population doesn’t mean there isn’t money to be made in this sector. Traditional thinking was that too few patients equaled too little opportunity for return on investment. Oliveto says that there has been a movement toward looking at orphan diseases because of the high unmet medical need and the opportunity to realize a financial return.
Thus, a new generation of smaller companies like Chelsea Therapeutics is emerging and venturing into this underserved market. That is not to say that the big boys are content to sit on the sidelines. There are now large pharmaceutical companies that are also focused on the orphan drug space and even ultra orphan drug space which may serve only tens-of-thousands of patients.
Chelsea Therapeutics has a mere 20 employees—specialists, really—who have come together armed with an entrepreneurial spirit and a deep passion to make an individual difference. As Rachel Couchenour, Chelsea Therapeutics’ director of medical affairs, is fond of saying, “There’s no tall grass here. There’s nowhere to hide.”
Oliveto confirms the sentiment saying, “Here, you’re one-twentieth of the organization! You look around and realize, ‘This is it.’ You quickly find out you’re on your own and there’s not a large safety net like at the larger companies. We attract a particular mindset—risk takers and entrepreneurs.”
Chelsea Therapeutics was founded in Charlotte in 2004 by Simon Pedder, Ph.D., who remains engaged with the organization in the role of consultant. Oliveto jokes that Pedder, who lived in Charlotte at the time, was simply tired of his then weekly commute to New Jersey. More seriously, Pedder saw Charlotte as an excellent location to start and grow a company—a place where one could attract other key players to live and work.
Oliveto notes, “I’ve worked in places where nobody wanted to come, even when the job was a great one. We don’t have that problem here in Charlotte.”
Pedder worked to assemble a group of investors and took the company public almost immediately as part of the initial business model. In the last year Chelsea Therapeutics watched its stock (NASDAQ: CHTP) jump over 200 percent from trading below a dollar to north of $3.00 per share as of late September.
The company has high hopes of celebrating its 10th anniversary in 2014 with FDA approval of Northera (droxidopa), a drug developed for the treatment of neurogenic orthostatic hypotension (nOH), a condition that can affect patients with underlying neurodegenerative disorders such as Parkinson’s disease, multiple system atrophy, and pure autonomic failure. Basically, nOH causes a consistent drop in systolic blood pressure causing a myriad of problems including lightheadedness, dizziness when standing, and generalized weakness.
Bringing Successful Drugs to the U.S. from Abroad
Droxidopa was initially developed by the Japanese company Dainippon Sumitomo Pharma Co., Ltd. Chelsea Therapeutics acquired the global development and commercialization rights to droxidopa (save Japan, Korea, China and Taiwan) in 2006.
Granted orphan drug status by the FDA in January 2007, Chelsea believes Northera has the potential to be the first safe and effective drug that will treat symptomatic nOH without leading to significant supine hypertension, thereby improving the quality of life for patients suffering from the disorder.
One of the challenges for companies in the orphan drug space is the difficulty of accurately assessing how many patients suffer from a given orphan disease due to the extreme lack of data and studies available. Regarding nOH, Oliveto says, “While it’s hard to pinpoint an exact number, we anticipate about 10 percent of Parkinson’s patients are suffering from the disorder and believe the overall number of patients suffering from symptomatic nOH to be around 140,000 to 150,000.”
With such a small potential population of users, the obvious question becomes the price tag. It would seem inevitable that orphan drugs would be more expensive than their mass-produced counterparts.
“Usually that’s the case,” responds Oliveto, “because you have to make your money back at some point and show a return.” But he also points out that Congress understands the need for incentives and through the Orphan Drug Act eliminates user fees normally paid to the FDA to help fund the review of new drug applications.
Often, a foreign company lacks the capacity to navigate the FDA’s roadmap to drug approval and that keeps an orphan drug out of the U.S. market. In the case of Northera, in 2006 Dainippon Sumitomo simply did not have the infrastructure in place to understand FDA regulations and procedures.
Oliveto explains, “This underutilized gem was serving patients well in Japan for years, but no one had the resources to bring it to the U.S. This is the niche that companies like Chelsea Therapeutics have significant opportunities to step in, license the drug, see it through FDA approval, and ultimately get it to market.”
Currently Chelsea Therapeutics is in Phase III (final confirmation of safety and efficacy) of the FDA clinical research process for Northera as a treatment for symptomatic nOH. The FDA Cardiovascular and Renal Drugs Advisory Committee voted to approve Northera in February 2012 and the following March the FDA asked Chelsea Therapeutics to submit data from an additional study.
The company resubmitted a New Drug Application (NDA) in August of this year and in September the FDA officially accepted the NDA resubmission.
None of this is new to Oliveto, who has played a significant role in the success of multiple NDA filings during his tenure with Hoffmann-La Roche. To hear him describe it, the process seems exhaustively complex: “I have seen semi trucks full of boxes and boxes of paper heading to Washington, all to try to get approval for a single drug.”
A Defender of the FDA
Yet, Oliveto remains a fierce defender of the FDA, noting that while it is not uncommon for NDAs to be rejected during their first review, he believes the rigorous procedures and practices are anchored in a genuine desire to protect the public. He also characterizes the Administration as progressive in their efforts to safely expedite the delivery of new drugs to market and sympathizes with their plight, explaining that from his perspective, the FDA is at a disadvantage.
While it may take a drug company a decade to prepare and assemble hundreds of thousands of pages of data regarding a new drug, the FDA has only one year to review it—or in the case of orphan drugs—only six months. Chelsea Therapeutics’ FDA decision date on Northera, known as the PDUFA date (named for the Prescription Drug User Fee Act), is Valentine’s Day 2014—a day Oliveto hopes will be a very special day for those who suffer from nOH.
“When you’re a company as small as we are, and as focused on one disease, you really take the unmet medical need personally,” notes Oliveto. “The patients’ needs are both heartbreaking and the ultimate motivator to achieve success. We never forget for a day what our goal is and who we are fighting for. Their pain and suffering is never lost on a single person here. We are all about the patients and improving their quality of life.”
Unfortunately, for participants, at some point the clinical trials end. When the Northera clinical trials ended, patients contacted Chelsea Therapeutics requesting continued access to the drug. Oliveto explains, “When the drug has worked well for patients, it’s hard to go back to a life without it. These are heartbreaking stories and the patients become very vocal.”
Vocal patients have become an important part of the learning process for the company and potentially the FDA. Oliveto notes, “Unless you really understand the patients and what they’re going through, you don’t have much hope of being successful in developing the drug.”
Fortunately, through the support of the patients’ treating physicians, Chelsea Therapeutics has been able to provide Northera through an expanded access program allowed by the FDA.
Chelsea Therapeutics has also been conducting Phase II trials for the use of Northera to treat fibromyalgia and intradialytic hypotension (IDH), the latter of which can preclude the delivery of adequate doses of dialysis for patients with kidney disease. Another compound, CH-4051, is in Phase II development for use in the treatment of rheumatoid arthritis.
For Chelsea Therapeutics, 2014 stands to be a game-changing year. A development stage company for the last nine years, Oliveto and his team hope to make the successful transformation into a commercial stage company active in production, marketing and sales. If that happens there will be no shortage of larger companies, stressed to fill their commercial pipelines, who will aggressively come knocking.
While not part of their original business model per se, Chelsea Therapeutics has been very open publically and with investors that they are seeking and evaluating opportunities for partnerships with other companies, and even prospects for acquisition.
Oliveto says, “The only thing that’s for certain is that we will not stay the same. We will grow.” He adds, “It is certainly possible today for a small company to come to the orphan market, where they’re not competing with the Pfizers of the world, and actually grow and commercialize a product.
“But for us, everything is on the table and we have to return value to our investors. Ultimately, we are about getting the drug to the patients. Whatever is the best path forward to accomplish that goal is what we will do.”
When Paul Franz of Carolinas HealthCare System (CHS), a vast organization of 30-plus hospitals and 600 care locations, first interviewed Derek Raghavan in late 2010 to potentially head up the multimillion dollar cancer center they were building, he had no idea the precocious doctor would turn the tables on him.
Raghavan was one of a handful of prominent oncology program administrators that CHS had carefully culled as being up for the task. Raghavan was at the time director of the Cleveland Clinic Taussig Cancer Center where, after seven years, he had raised its ranking by U.S. News & World Report from No. 46 to No.9. He wasn’t looking to change jobs.
Yet, by his own admission, he had started thinking more globally about ways to get patients into clinical trials, removing barriers to access to care, eliminating perverse incentives that influence treatments that doctors recommend.
Raghavan came for the meeting anyway. It was during the conversation that he had the audacity to remark to Franz: “I am not really interested in the job you’re offering, because I am not really interested in building a regional cancer center. But,” he continued, “if you want to ramp it up—to let me build you a world-class cancer center, one of the top centers internationally and also that serves the Carolinas—I would be interested in doing that.”
In short, Raghavan was drawn to the opportunity to start with a blank slate and design the foundation and the systems on top of that, as he describes it, “building a rational cancer care system on an empty lot, based on bioinformatics tying together hospitals and outpatient clinics.”
Franz tells it, “Derek’s eyes lit up with the opportunity, and, as you know, he can process things at 300 miles per hour. Immediately, our vision, which we thought was dramatic, Derek made 10 times bigger,” spewing “Here’s what you can do with this…here’s what you can develop here…here’s an opportunity to do this…”
Raghavan continued to think through the implications of the Carolinas challenge, grasping some immediately and others “during shower time.” When CHS determined they wanted him to guide this mega-adventure, he accepted, starting as president of the Levine Cancer Institute in April 2011.
Building It Rationally
Carolinas Healthcare System had been looking for the next big thing. They had successfully embraced cardiovascular services, which Franz describes as typical of most health systems in that they represented the best market share opportunity and were the most profitable service line.
In 2007, they decided oncology made sense. They were already treating a considerable number (10,000) of new patients a year. Competition was weak— there were excellent cancer centers along the system’s boundaries, but not in its core area around Charlotte. And at the time, changes in reimbursement were weakening physician-owned, office-based practices, potentially making doctors more willing to join hospitals.
In 2009, a CHS consultant confirmed that their patient volume was enormous and their timing was good for building a regional cancer center. Estimates for building a regional cancer center in the Charlotte area came up to about $250 million over a decade; however, given the needs of the entire system, CHS executives doubled that number.
Construction began, made possible in part by a generous $20 million donation from philanthropists Sandra and Leon Levine of the Levine Foundation, along with tremendous support from CHS and the community. The center was to be specifically designed as a cancer care center “without walls,” the coordinating center for a series of integrated cancer care centers throughout the system.
Opened in August 2012 and boasting 171,000 square feet of space in a stunning six-story architectural magnum opus, the facility certainly appeases those concerned about the aesthetics of the Charlotte landscape, but more importantly provides nine cancer clinics, infusion therapy, radiation therapy, palliative care and a Phase I clinical trials center, all under one roof.
In addition to containing the most progressive clinical modalities and equipment to treat rare and complex cases, it also serves as the springboard for a clinical trials and research division and community education initiatives.
It is this level of dedication and commitment to improving the patient experience and outcome that makes the Levine Cancer Institute so unique and on the path to becoming an internationally lauded facility. These themes were also considered a top priority in the physical design of this new space.
It includes an Image Boutique on site, complete with wigs, prosthetics and other recommended treatment supplements. The Image Boutique goes a long way to make patients feel and look their best while dealing with some of the physical challenges overcoming cancer can bring.
“Cancer care includes much more than just diagnosis and treatment of the disease itself,” explains Raghavan. “Cancer affects every aspect of a patients’ life and one of the goals of Levine Cancer Institute is to broaden the scope of cancer research, prevention, treatment and survivorship to reflect the full impact of cancer on our patients and community.”
So far, the system has spent $50 million in building the cancer center and another $20 million on renovations and recruitment.
A Man with a Vision
Raghavan is a medical oncologist who came to the U.S. from Australia in 1991, which may be why he sees our health care system with the clarity of an outsider. His reputation is built largely on years of service on the FDA Oncologic Drugs Advisory Committee (ODAC), where he became known as “the sort of guy you don’t want to match wits with.”
In one cancer journal, they say “His precisely aimed, lethal, Australian-accented remarks had, on more than one occasion, trashed cooperative groups, pharmaceutical companies, and the National Cancer Institute (NCI) itself.
They are on point in describing his temperament: “Raghavan’s brand of humor would be better described as aggressive truth-telling. His delivery if perfectly deadpan. Indignation seems to affect his face like a dose of Botox. It’s possible that the guy laughs, but this has not been observed in public. Raghavan claims to be unable to retrain himself when an absurdity materializes within striking distance.”
Indeed, Raghavan unabashedly admits, “I am deficient in self-control,” proud that he “says stuff most people would rather not.”
Even though his tenure on the ODAC committee ended long ago, the agency keeps inviting him to return. “One of the most attractive features about ODAC is it doesn’t have lawyers on it, so we can actually think about patient welfare.”
In selecting Dr. Raghavan CHS graced Charlotte with one of the most brilliant minds in the world of cancer care.
Building a Coalition
One of Raghavan’s first challenges in accepting the position at Levine Cancer Institute, was to reach out and engage the medical community to identify common interests and areas of cooperation and collaboration. That included recruiting key physicians to complement clinical strengths in Charlotte and beyond.
Raghavan reached out to the local community. Physicians like Kathryn Mileham of the Mecklenburg Medical Group graciously accepted because, “They gave us an opportunity to mold our future. Each physician had an opportunity to say, ‘I have an interest in a particular cancer,’ or ‘I prefer to maintain my community focus…without having to subspecialize.’
“We were given the opportunity and support to make those decisions on our own. Without being unwillingly channeled toward a particular focus, it is easy to maintain the energy and the excitement and the drive to succeed in providing all aspects of excellent patient care.”
Raghavan also reached out to academic stars, willing to leave prestigious academic institutions to join the team. With a broad, world-view approach to treating cancer, Raghavan never thinks small.
“When we started, I made a list of 50 of the top cancer physicians and researchers that I wanted working at our center. I was able to recruit 40 of them,” says Raghavan. The feat is a testament to his tenacity for achieving the best for patients; a quality that perfectly complements the Institute’s vision of “changing the course of cancer care.”
Since he joined the staff two years ago, Raghavan has recruited 82 specialists altogether. Mike Tarwater, CEO of CHS, attests to Raghavan as a “skilled recruiter, bringing some of the nation’s most gifted and talented oncologists to our region.”
Raghavan says, “I basically wanted to bring in the very brightest people who weren’t jerks.”
In truth, he wasn’t kidding and simply demonstrating his frank and often unintentionally humorous candor that is such a large part of his charm and unassuming persona. Perhaps most importantly, his belief that “the team trumps the individual” is both genuine and a mandate for his staff.
Raghavan’s Health Care Initiatives
•Access to and Consistency of Quality Care. “We want to make access to cancer care easier for all,” says Raghavan. “Our physicians work with each patient to determine a personalized care plan based on their needs.” Using symmetrical access to care with a system-wide approach, Raghavan and his team utilize a de-centralized model of treatment and support which provides state-of-the-art care distributed evenly.
That’s a hot button for Raghavan who explains, “The quality of care should use an integrated approach and be the same where ever you go in our system. A patient in Greensboro should have the same standard of care available as a patient in Fort Mill, or in Charlotte.” To that end, the Institute has a large and growing network of 12 charter member hospitals to ensure quality cancer care is delivered at each facility across the Carolinas.
•Patient Participation and Navigation. Raghavan also puts a high premium on patient participation in treatment plans and outcome goals and is not satisfied to let them sit idly by as others make decisions for them. “I believe in treating cancer by engaging patients as part of the team so they know they can influence the outcome,” he says.
The Institute offers patient navigators who play a vital role in helping patients find specific cancer services including different types of clinical trials and cancer registries, as well as clinical and support therapies, such as clinical modalities, grief consultation and survivorship, and palliative care. Working in tandem they help guide cancer patients and their families through their journey of healing and transition oncology care to the most appropriate location for the patient.
•Caring for the Underserved. Of great interest to Raghavan and something very influential in his decision to accept the position at CHS was his profound commitment to treating the underserved. Of course that’s a polite term for the poor and those who can’t afford or don’t have access to health care. It is significant to note that in 2012, CHS spent approximately $1 billion in treating these populations.
The breakdown includes $250 million in Medicare contracts, $250 million in Medicaid, and $500 million in caring for the indigent—money they will not recover. It’s one of the things Raghavan is most proud and he admits feeling frustrated over how little attention it gets in the media.
“Doing altruistic work should be celebrated, and I am proud of the fact we look after this population,” he says. “The fact that we are prepared as a system to lose this amount of money from our bottom line is a testament to our commitment to providing care for everyone.”
•Value Not Volume. As the cost of health care continues to be a top concern and albatross for the country, Raghavan was very attracted to what he characterizes as some of the “top, thoughtful” business minds at CHS who understand the need to get health care costs under control. He notes, “We are committed to helping people get better but we should be sensible in how we invest in treating patients and spend our dollars.”
One cost-saving measure has been to consider the best treatment in terms of patient billing. If there are three treatments with equivalent efficiency and side effects, they will choose the least expensive option.
Raghavan is also focused on moving patient care to a model based on outcomes rather than treatment options. “The algorithm has changed. It’s about value, not volume,” he explains. “Don’t choose a particular treatment because you can. Do it because it’s good medicine. We need to set constraints and be thoughtful.”
Regarding the Institute as a microcosm of the nation’s complex health care system, Raghavan believes the underlying problems with health care can be fixed. Overall, he believes that people have some unrealistic expectations for health, government can’t afford the care we want, what consumers ask for is expensive, and that nobody wants to pay for health care. As a result, it creates monumental challenges for the federal and state governments to plan for the future.
“We can’t make changes in health care simply by writing them down,” says Raghavan. “Sometimes we see people making prophetic statements with no skin in the game.”
Continuing to Innovate
CHS now delivers cancer care to over 14,000 new patients a year. In less than three years the Levine Cancer Institute has literally changed the course of cancer and eliminated many of the natural barriers to top-quality care, such as distance to clinical and research sites, cultural barriers and patient access.
From the technological spectrum, the Institute utilizes one of the most advanced wireless systems in the country. Joining forces with Accenture, it developed an app that connects with patients electronically so they don’t have to leave their home. Medical teams can also conference with other hospitals within the Carolinas HealthCare System and physicians have all clinical trials and a system of pathways for cancer care guidelines available for instant download.
The Institute uses a holistic approach to cancer care and cancer survivorship. Part of the approach also includes financial and nutrition counseling sessions, support groups and wellness programs. Doctors and clinical teams also continue work with patients who have been cured and are dealing with the after-effects of their treatments so they can develop algorithms in that group.
The Institute has also launched a Levine Oncology Program for Seniors at
Amazing advancements in research are being made including first-in-human trials and complex cancer. Researchers have implemented unique programs to better track outcomes, drive efficiency, move research from bench to bedside quickly, and establish more accountable cancer care. Currently, there is a 12-bed monitoring unit in Charlotte and they are expanding to other sites.
In addition, Phase II trials are underway, and a bone marrow transplant unit and a palliative medicine unit are being built. “I have had the opportunity to lift the game and increase the interplay between research and trials,” comments Raghavan.
While many in the Charlotte region don’t even realize it, our community is now home to one of the premier cancer treatment centers in the entire world in the Levine Cancer Institute. It houses the largest single institution cancer research databases and is accredited by the American College of Surgeons Commission on Cancer and by the National Accreditation Program of Breast Centers.
Dr. Derek Raghavan and his team are leading us into a new era of innovative, intelligent, and thoughtful cancer treatments and care. He says generously of the Institute, “What I saw here was a well-organized hospital system with the resources and seriousness of purpose to create a world-class institute. Alongside that was their preparedness to bring in national stars and their ability to provide adequate support for clinical trials and patient navigation—I just leveraged the vision they had.”
Reflecting back, he says, “It felt like a perfect fit. And it has been more rewarding than I could have imagined.”
“Service with a smile” has been a core precept of American businesses since the beginning of the last century. Research shows that smiling correlates positively with attractiveness and likability between humans. In fact, smiling correlates with greater trust, increased financial earnings, and enhanced interpersonal cooperation.
A smile conveys respect, patience, empathy, hospitality and compassion. For example, when an employee smiles at a stressed customer, and exhibits excellent listening skills, most of the time, there is a report of total satisfaction.
Research also reports that people receive more help when they smile. Even the smile of a stranger produces more “Good Samaritan” effects on the receiver. Neuroscience research shows that a smile enhances others’ memory retrieval of the person’s name.
“Smiling is how we build trust in business and rapport in relationships. The ability to smile with confidence is foundational to self esteem,” maintains Dr. Christian Yaste, and is ultimately what led he and Dr. Joseph Hufanda to create the Ballantyne Center for Dentistry in 2001.
“Everything starts with a smile,” contributes Hufanda, who says he knew in high school that he wanted to be a dentist. Both his parents were in the medical field, but he had a creative streak. He figured cosmetic dentistry would allow him to be in the medical field and be creative and artistic.
“I have an avid interest in fine arts, music and painting. I firmly believe my art helps me with the artistic side of dentistry,” he says.
Yaste, whose friendship with Hufanda dates back to middle school, had a more abrupt realization. While in dental school at the University of Michigan, Yaste had a bicycle accident on black ice which cracked off his front teeth. The care he received gave him back his smile, but left him disillusioned with “old school” dentistry and its lack of empathy.
“If dentistry meant pain, I wanted out. I did stay the course, but committed to offer patients a totally different experience—one that’s friendly and comfortable. I want them to feel cared for and cared about and I want them to get the smile they have always wanted,” affirms Yaste.
Both Yaste and Hufanda finished their graduate studies at the University of Michigan School of Dentistry, but Hufanda trained at the Upper Peninsula Rural Health Services while Yaste began a two-year residency in Oral Medicine here at Carolinas Medical Center.
It didn’t take long for Yaste to convince Hufanda to join him in Charlotte and the two spent three years working at a general dentistry group practice in town.
“We were seeing a lot of adults—baby boomers—whose needs weren’t being met through general dentistry,” describes Yaste. “We decided we really wanted to focus on that niche market sector.”
So the two set up their own practice in Ballantyne to provide expert care using the latest techniques in cosmetic and restorative dentistry in a spa-like setting with a focus on health, wellness and beauty all under one roof.
“At the Ballantyne Center for Dentistry, we’ve helped thousands of patients achieve the smile of their dreams…affordably, quickly and comfortably,” smiles Hufanda.
Focus on Adult Needs
Ballantyne Center for Dentistry has become a destination for patients with cosmetic or restorative needs. The doctors’ expertise draws patients from both Carolinas and other parts of the country.
“Many baby boomers finally have the time to focus on themselves,” says Yaste. “They want a comfortable, relaxing environment where they can improve their smiles for social or career reasons. We’ve noticed a lot of men coming in saying they’ve got to keep up with the 30-year-olds who look like G.I. Joe in their office.”
With a full array of offerings including veneers, bonding, tooth whitening and the speed of CEREC technology (which can allow the custom crafting and fitting of ceramic restorations in one visit), the Center has options to fit varying needs.
Their Six Month Smile system allows adults with a good bite but crooked or gapped teeth to unobtrusively correct their smile without the time or expense of traditional orthodontics geared toward children.
“I smile a lot more than I used to,” attests patient Colin Pinkney after improving his smile at Ballantyne Center for Dentistry. “It feels good to smile. I think the world of Dr. Yaste and the whole dental family here at Ballantyne Center. Every nurse, every assistant, every person in this office is just incredible and I love coming here…They truly do work miracles.”
Tooth loss is also a major problem for adults. “The denture adhesive market is a billion dollar industry,” explains Hufanda. “Dental implants can replace one tooth, several teeth or provide anchor teeth to help with denture slippage.
“For someone who has had full dentures and who worried that their dentures might come out while they ate or that they might not be able to chew something, implants can be a life changer. Patients can go out and eat again. They can eat salad; they can have a steak.
“And the treatment has improved. In some cases, we can get done in three months what used to take a year. Now we can remove a tooth and put in the implant in the same day in one surgery.”
While some of the tooth loss the doctors treated was due to trauma, they also found an appreciable amount caused merely by a lack of dental care, and “diagnosed” that a fear of going to the dentist was probably an underlying cause.
Nothing to Fear
That revelation led Yaste and Hufanda to focus on dental anxiety and resulted in them expanding their practice to include sedation dentistry. Anxiety was a problem that Yaste understood well.
“I admit I am somewhat of a dental phobic, ever since my bicycle accident,” Yaste confesses. “I can empathize with my patients that are afraid of the dentist. When patients know I feel the same way, it helps them get through it. Sedation dentistry allows people to get the dental care they need or want without the fear and pain they’ve experienced in the past.”
Both Hufanda and Yaste are certified in oral sedation by DOCS (Dental Organization for Conscious Sedation). The protocol they follow involves an oral sedative that puts patients in a calm, relaxed but conscious state where they feel no anxiety or pain. Some patients are so relaxed they drift off to sleep.
A patient will need a ride to and from the office but beside the obvious benefits, sedation dentistry can allow doctors to condense treatment that might take three to four visits into one.
The use of drill-free laser dentistry can also ease patients’ dental anxiety. With this technology, lasers remove decay and prepare teeth for fillings, root canals and gum surgery. All a patient feels is a light flow of water over the teeth and a soft clicking instead of the pressure and fear-triggering sound of drilling.
Treating people with dental anxiety has become such a specialty for Ballantyne Center for Dentistry that other local dentists refer their patients with dental phobia to the practice for treatment.
“We want to help these folks,” Yaste emphasizes. “We have a solution. We even offer a patient their first sedation for free so they can see what it’s like to be able to go to the dentist without fear.”
“When I was a kid, dentistry hurt. It just came with the territory,” says WBT morning radio personality and patient John Hancock. “I spent most of my adult life avoiding the dentist because of my dental phobia. I heard about Dr. Yaste and Dr. Hufanda. I heard that they were miles ahead in both the art and the science and that it didn’t have to hurt.
“I was amazed at the care I got from Dr. Yaste, Dr. Hufanda and their staff. They took my overwhelming dental problems and fixed everything without pain!”
“We’re constantly looking for ways to improve the experience of our patients,” adds Hufanda. “We want to stay in the forefront of technology to find what benefits our patients and at the same time, helps our practice to grow.”
Interestingly, that state-of-the-art compulsion has pushed the doctors into another related area—treating people with chronic headaches and migraines.
Solving Your Headache Pain
Every day, dentists encounter patients who chew, grind, tear, and work their head and neck muscles as strenuously as athletes. The significant forces generated by clenching, grinding, and bruxing put the mouth and masticatory system under constant stress.
Such stress and improper dental forces associated with the muscles, nerves, tendons, and ligaments contribute to a number of symptoms, including chronic headaches and migraines. Other symptoms include temporomandibular joint disorder (TMD), excessive tooth wear and/or breakage, tinnitus, clicking and popping of the jaw (TMJ sounds or vibrations), and discomfort or pain in the head, neck, face, or jaw.
“Symptoms can also often be caused by macro trauma, like biking or automobile accidents, or micro trauma, such as from wisdom tooth removal or orthodontia,” suggests Yaste.
“Sports medicine technologies, such as low-level laser therapy, therapeutic ultrasound, and microcurrent nerve stimulation, have been used successfully for years to improve athletes’ recovery from musculoskeletal and force-related injuries,” explains Yaste, “and now such innovative approaches to treatment are being applied in dentistry.”
Drs. Yaste and Hufanda have embraced a patented pain relief technology called TruDenta to provide relief from headaches and migraines for their patients, branding themselves Charlotte Headache Doctors.
“TruDenta is a state-of-the-art system for the diagnosis, treatment, and management of functional, dynamic force imbalances within the mouth. Utilizing a combination of sports medicine rehabilitation and advanced dentistry technologies cleared by the FDA, it can produce lasting relief and dental foundation rehabilitation for our patients,” describes Hufanda.
“This is a way to successfully and predictably treat migraine, headache, TMJ and other conditions like tinnitus,” enthusiastically explains Yaste. “It revolutionizes how headaches are treated; this system allows us to treat the problem without medications.”
“Several treatment protocols are available,” continues Yaste. “We might use cold laser or orthotics or we might re-map a damaged neural pathway. It depends upon the diagnosis. The correct protocol is determined by the diagnosis and the system uses comprehensive and objective screening tools to get an accurate diagnosis.
“Treatment can take from two to 12 weeks and it has a very high success rate. I started treating patients a year and a half ago and currently we’re treating about four or five headache patients a week. But the whole practice has grown. In 2012, we had our best year ever. We’ve gotten so busy, we’ve had to bring in a new doctor.”
Staffing Up to Meet Needs
Dr. Teresa Mercado has recently joined the Ballantyne Center for Dentistry team after 16 years’ running her own practice in California. Mercado has experience in general, cosmetic and sedation dentistry and she, like Yaste and Hufanda, is trained and certified in the TruDenta system.
“By bringing on Dr. Mercado,” Yaste explains, “we can care for more people. We can handle our growth and still give our patients the same high level of care they’ve come to expect.”
“Dr. Mercado rounds out our team,” Hufanda adds. ”She also brings a woman’s perspective to our practice.”
Ballantyne Center for Dentistry’s growth has also led the doctors to add 1,000 square feet to their second floor office suite in the Ballantyne Commons East Shopping Center and expand business hours for patient convenience.
They’ve also added a significant new technology: a CT (computerized tomography) scanner.
“From a diagnostic standpoint, it’s invaluable,” says Yaste. “It allows us to view a person’s entire head and face in three dimensions. We can find things we never saw on an X-ray. I now have more information available to me before I do a procedure, like where a nerve is or how much bone there is in a particular area.”
The CT scan was especially beneficial in the case of a recent patient. “A gentleman came into the practice for a dental implant and the CT scan we did revealed a golf ball-sized tumor on his upper jaw next to the sinus,” Yaste describes. “He had the tumor removed and luckily it was benign, but it was growing quickly and was potentially disfiguring. He could have lost his front teeth and part of his jaw. This tumor didn’t show up in a traditional x-ray.”
Both Yaste and Hufanda attribute the success and growth of their practice to many factors: keeping their eye on the trends in care and the business of dentistry, their relationships with mentors and influential industry leaders, and their eagerness to learn new techniques and procedures and implement them.
“We are incredibly teachable,” jokes Yaste.
They also list their ability to do most procedures, including root canals and other oral surgeries in-house, as a major differentiator for their practice. “We focus on the whole mouth,” explains Yaste. “We rarely need to refer a patient. We do almost everything here.”
They also work with patients to maximize their insurance benefits and have relationships with several financing companies to assist patients in obtaining needed or wanted dental care.
“Patients’ objections to dental care are fear, time and money,” says Yaste. “We’ve found ways to help patients with all three. There’s a book we keep in the waiting room filled with grateful letters that patients have written to us.”
“Gratitude like that is very rewarding to us,” says Hufanda. “It’s our passion and our nature to help as many people as we can. There are so many people out there hurting. They’re in pain, whether psychologically from an unattractive smile or whether from debilitating headaches. Our goal is to help those people. We truly give service with a smile.”