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PHYSICIAN SPOTLIGHT PAGE 3
Scott W. Fosko, MD
Billion Dollar Pool
SLU selected among nation’s elite to participate in historic contract By LyNNE JETER
ON ROUNDS
Dementia or Delirium? Wash U anesthesiology professor weighs in on controversial studies linking dementia and anesthesia and surgery A noted St. Louis anesthesiologist addresses the controversy on whether elderly patients undergoing anesthesia for surgery are at increased risk for postoperative cognitive dysfunction (POCD), leading to early onset dementia ... 4
Double Impact
Saint Louis University (SLU) Center for Vaccine Development recently landed the largest research contract in the institution’s history. Robert Belshe, MD, longtime center director and the Adorjan Professor of Internal Medicine at SLU, penned the proposal that the National Institutes of Health (NIH) selected as one of nine Vaccine and Treatment Evaluation Units (VTEU) to bid on nearly $1 billion in projects that will study protecting patients from infectious diseases, including emerging threats. The National Institute of Allergy and Infectious Diseases (NIAID), which is part of the NIH, has funded vaccine research at SLU since 1989, when Belshe brought a team from Marshall University to establish the center in St. Louis. “The award is validation that what we do here is important work and we do it very, very well,” said Belshe, principal investigator on the project. “We’ve been a vaccine center at Saint Louis University for 24 years, and before that, 10 years at Marshall. We have a lot of experience working on NIH trails.” SLU received an Indefinite Delivery Indefinite Quantity (IDIQ) contract award that has an estimated value of up to $135 (CONTINUED ON PAGE 8)
Wash U receives $26 million for leukemia research
Integrative Medicine Goes Mainstream
Two years ago, researchers at Siteman Cancer Center at the Washington University School of Medicine were studying potential treatments for adult acute lymphoblastic leukemia (ALL) when Lukas Wartman, MD, a Washington University research fellow, was diagnosed with a relapse of ALL. The survival rate for ALL is roughly 40 percent; for a relapse, it drops to 5 percent
ABIOM finalizes board certification exam for emerging specialty By LyNNE JETER
TAMPA, FLA. – Mimi Guarneri, MD, FACC, and fellow founding members of the American Board of Integrative Medicine (ABIOM) spent the lingering days of summer putting the final touches on a new board certification examination for a specialty that’s garnering national attention. “Creation of integrative medicine as a specialty by the American Board of Physician Specialties (ABPS) guarantees excellence in the field and assures consumers of healthcare the practitioner they’re seeing has reached a high standard of practice,” said Guarneri, board-certified in cardiolDr. Mimi Guarneri
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PhysicianSpotlight
Scott W. Fosko, MD By LUCY SCHULTZE
In an age where every penny of healthcare spending is under scrutiny, specializing in a particularly safe and cost-effective technique is a good niche to claim. “The bottom line is, a day doesn’t go by that you don’t either hear about it or read about it: There’s just not enough money in the system,” said Scott W. Fosko, MD, chair of dermatology at the Saint Louis University School of Medicine and current president of the American College of Mohs Surgery. The latter role connects him to more than 1,200 surgeons across the nation who received advanced fellowship training in this specialized treatment for skin cancers. In addition to the procedure’s effectiveness, it also happens to be practical in terms of cost. “It can be more cost effective than traditional surgery, in that a majority of the procedures are done in an outpatient setting,” Fosko said. “It’s also been proven in many studies that it’s very safely provided in that setting.” Developed in the 1930s by Frederic E. Mohs, MD, the procedure allows the surgeon to remove a skin cancer layer by layer, inspecting each tissue sample for evidence of cancer before removing any more. While the process takes significant time, the result is better preservation of healthy tissues as well as a cure rate of up to 99 percent in certain tumors. “It’s a technique that we most commonly employ in cosmetically sensitive areas and with complex skin cancers,” Fosko said. Fosko began performing the procedure in 1993, when he joined SLU after his fellowship training at the University of Pennsylvania. At the time, there was no program in the SLU School of Medicine for Mohs surgery and cutaneous oncology. “It was very much a ‘Field of Dreams,’” he said. “There was the opportunity to build something from the ground up. Our skin cancer program has really developed to earn a regional and national reputation, and the work of many people has contributed to that.” For Fosko, the specialty of dermatology and the sub-specialty of Mohs surgery have provided an ideal blend for his skills and interests. “I enjoyed pathology in medical school, taking care of patients and doing surgery as well,” he said. “This specialty is a very nice combination of cognitive skills, technical and visual skills, while taking care of patients of all ages. It has a breadth of challenges and many aspects to it.” A native of Maryland, Fosko received an undergraduate degree in microbiology from the University of Notre Dame then returned to the University of Maryland for medical school. He completed a residency in internal medicine at the University of Virginia in Charlottesville. stlouismedicalnews
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His exposure to Mohs surgery during his training gave him a new direction, and he completed a second residency in dermatology at Yale University. After his fellowship, he joined SLU as an assistant professor of dermatology. He has served as chair of the department since 2001. “The university has provided me a wonderful opportunity to focus on patient care and clinical programs,” Fosko said. “Having a strong clinical program has given us the ability to expand our training programs and develop research initiatives.” Today, the department has grown to 10 faculty members and 10 residents, and offers fellowship training experiences
in Mohs surgery, dermatopathology and dermatology research. The department’s research work has also expanded significantly, Fosko said. “All of this has been dependent on my ability to recruit and retain outstanding faculty,” he said. “We have a wonderful group in the department.” Likewise, he said, the department enjoys a healthy collaborative relationship with faculty in related areas. “I have many wonderful colleagues in head and neck oncologic surgery, surgical oncology, plastic surgery, oculoplastic surgery, medical oncology, pathology, radiation oncology and other specialties,” he said. “Many individuals work with these complex-skin-cancer patients – thus we’re able to deliver high-level specialty and subspecialty multidisciplinary care in a very collegial environment. Our patients benefit significantly from this team approach.” Over the course of his career, Fosko has witnessed the rise of skin cancer as a public-health concern. “Forty or 50 years ago, skin cancer tended to be something we thought of as affecting the elderly,” he said. “While that remains the case since people are living longer, we’ve also seen a shift in terms of younger patients having it.” Progress remains to be made when it comes to limiting exposure to sun damage, but Fosko is encouraged by recent advances in treatment techniques. “The number of tools we have in our toolbox to treat skin cancer are increasing,”
he said. “Traditionally, it’s surgery, radiation therapy or other destructive techniques – but we’re starting to develop a range of treatment options, even for advanced tumors.” Fosko’s clinical practice and research focus on both melanoma and non-melanoma skin cancers, the latter comprising a wide range of tumors. Having more treatment choices means the ability to find the right approach for attacking each different type of skin cancer. While Mohs surgery is used most commonly for basal cell and squamous cell carcinomas, Fosko has also been involved in research studies for treating advanced or metastatic cell carcinomas with a pill. On the other end of the spectrum, he also is studying the use of a cream for early-stage skin cancer. “Skin cancer is also part of the targeted therapy era,” he said. “I think we’re going to be able to tailor treatment in a very nice way, and hopefully minimalize destructive or radical surgeries because we can treat skin cancers through different approaches. “Of course, the flip side is still educating the public so that we can drive early detection and treatment.” Outside of his practice, Fosko enjoys spending time with his family and exercising outdoors with his wife. Forest Park is a favorite destination. He and his wife, Patty, have three children: Elyse, 24, Noelle, 23, and Nicholas, 21.
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Dementia or Delirium?
Wash U anesthesiology professor weighs in on controversial studies linking dementia and anesthesia and surgery By LYNNE JETER
A noted St. Louis anesthesiologist addresses the controversy on whether elderly patients undergoing anesthesia for surgery are at increased risk for postoperative cognitive dysfunction (POCD), leading to early onset dementia. Michael Avidan, MD, professor of anesthesiology and surgery at the Washington University School of Medicine, said he’s not swayed by recently released studies pointing to a correlation between dementia and mental changes that occur in some patients Dr. Michael Avidan after anesthesia and surgery. “I’m a bit skeptical about the evidence. It seems quite soft,” said Avidan, pointing out the need “to be careful ... when interpreting these studies.” A recent Duke clinical study published in the Journal of Anesthesiology confirms earlier findings from an important 1998 Lancet publication, showing significant numbers of elderly patients experiencing changes in higher order brain function after anesthesia and surgery. At discharge from the hospital, signs of POCD were present in roughly one in three patients. At the 3-month mark, 12.7 percent of
patients over the age of 50 still showed cognitive impairment. Elderly patients are at risk of POCD, but the study doesn’t specify whether it’s due to anesthesia, surgery, or post-surgery recovery aspects, such as pain, pain medication, other medications, infection, inflammation, sleep disruption. A study by French doctors released earlier this year at a European Society of Anesthesiology congress in Barcelona, Spain, said general anesthesia for the elderly boosts the risks of dementia by more than a third. Researchers led by Francois Sztark at the University of Bordeaux in France analyzed data from a long-term study into cognitive decline covering 9,300 elderly people in three French cities. The volunteers – average age 75 – were interviewed when they were recruited into the study and then two, four, seven and 10 years post-surgery. The data showed a link between the onset of dementia and a general anesthetic that had been administered two or three years earlier. Some experiments suggest that various anesthetics inflame neural tissues, causing protein plaques and tangles to develop that are precursors of Alzheimer’s disease. Another recent study examining the incidence of POCD after major noncardiac, non-carotid, non-neurosurgical procedures shows how certain risk factors have been identified and demonstrated a
number of correlates and risk factors, even though much remains to be clarified about the true incidence, etiology, prevention, and treatment. In the study of 200 patients age 60 and older undergoing hip surgery, postoperative delirium was a strong independent predictor of the development of subsequent cognitive impairment, subjective memory decline, and the need for long-term care. Interestingly, the correlation with the development of POCD isn’t shown whether the patients had regional or general anesthesia. Several theories have been posed to anesthesiologists regarding the possible link between dementia and anesthesia and surgery in patients 85 and older: In the traditional view, anesthetic agents are rapidly metabolized and/or excreted from the body, and therefore are unlikely to cause neurologic injury long term. Also, certain anesthetic agents appear to protect, not injure, the brain. Recent research challenges the belief that a well-done anesthetic and complication-free surgical procedure is totally neurologically benign. Researchers suggest that, in patients who develop POCD, limited brain “reserve” has been somehow “unmasked” by anesthesia and surgery, or that anesthesia and surgery somehow accelerates the aging process in the brain. Inflammation might be the culprit. Previous research has shown signs of inflammation in cerebrospinal fluid
after surgery, but it’s not clear whether this is the cause or the result of POCD. A significant limitation of POCD studies is that they don’t include a standardized preoperative neurological examination, in addition to the neuropsychological testing, making it very difficult to separate the relationship between surgery and anesthesia and subsequent cognitive decline and death from the cognitive decline and death that occur among older adults without surgery. “When you have major insults to the body, such as pneumonia, influenza, or surgery, you’re not going to be at your best cognitively,” explained Avidan. “Typically, people recover from that. If you look at those studies that have followed patients in the long term, say six months, a year, and 2 years (post-surgery), early cognitive decline seems to resolve.” Many patients suffer post-operatively from delirium, a temporary state. “It’s hypothesized that general anesthetic agents could increase the likelihood of dementia, but the evidence is weak,” said Avidan, a researcher in areas related to delirium and cognition in surgery. “It’s plausible that general anesthesia is a minor risk factor for dementia. However, I think that complications after surgery including critical illness are much more potent risk factors for persistent cognitive decline. I’m less convinced that a single exposure to general anesthesia could substantially increase the risk of dementia. That seems unlikely to me.” A common scenario among the elderly, who are otherwise healthy for their age, revolves around their concern about the risk of dementia for elective surgery, such as orthopedic repairs and joint replacements. When discussing the issue with patients, Avidan believes it’s important “to inject some caution into the tone.” “That’s to say, some people believe in a causal link between surgery with general anesthesia and subsequent dementia, but the evidence is far from convincing,” he explained. “There are likely to be many more substantial risks for dementia, and if general anesthesia were a risk, it would be a very minor risk.” The elderly should focus on the benefits of those surgeries, said Avidan. “Substantially enhancing their quality of life is likely to be so much more important than concerns that have been raised,” he said. “It would be a tremendous pity if people chose not to have these procedures because of hypothetical concerns.”
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Diabetes and the Retina By BRADLEY T. SMITH, MD
Mr. Jones (a fictitious name) thought his physician’s recommendation of a “sugar pill” only preventive. His dad suffered many diabetic complications, but Mr. Jones was sure his situation was different. Did he really need to check his sugar levels each day? How could anything be wrong when he felt so well? Mr. Jones was told to see his eye doctor last year. Now he has blurred vision and wishes he had done so. Diabetes affects the nerve tissue, or retina that lines the back wall of the eye. Patients often remain asymptomatic until widespread destruction occurs. Although it can be prevented it is one of the most common causes of vision loss in working Americans. Early detection necessitates frequent eye exams. More vigilance is required during pregnancy when damage to the retina is accelerated. (See chart) Hemorrhage, microvascular abnormalities, microaneurysms, hard exudation and cotton wool spots result from damaged blood vessels and are characteristic of nonproliferative diabetic retinopathy (NPDR). Diabetic macular edema (DME) results from swelling, or accumulation of fluid within the retina and is the most common mechanism by which diabetics lose vision. Obliteration of retinal vessels and subsequent ischemia can occur in advanced cases. This results in the release of cytokines such as vascular endothelial growth fac-
Recommended Eye Examination Schedule for Patients with Diabetes Mellitus Age at Onset of Diabetes
Time of Initial Visit
Recommended Follow-Up
Type 1
3-5 years after onset
Yearly
Type 2
At time of diagnosis
Yearly
Prior to pregnancy (type 1 or type 2)
Prior to conception and early in the first trimester
No retinopathy to mild or moderate NPDR: every 3-12 months; Severe NPDR or worse: every 1-3 months
*Abnormal findings may dictate more frequent follow-up examinations. Source: American Academy of Ophthalmology Retina Panel. Preferred Practice Pattern® Guidelines. Diabetic Retinopathy.
tor (VEGF). VEGF stimulates new vessel growth known as proliferative diabetic retinopathy (PDR). When other organs such as the heart, kidneys, and brain are damaged by ischemia it is desirable to have new vessel growth. However, these new vessels represent another mechanism of vision loss in diabetics if allowed to grow unchecked. They bleed into the vitreous cavity. (see figure) They also grow in the anterior chamber angle and block the outflow of aqueous fluid leading to high intraocular pressures. This causes glaucoma, secondary damage to the optic nerve. Finally, new vessels contract and pull the nerve tissue away from the back wall of the eye to cause retinal de-
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tachment. The result is permanent vision loss if not surgically corrected in a timely fashion. Laser application has been the gold standard in treatment of diabetic retinopathy. It has two main uses. First, it is used to treat macular edema by coagulating leaking icroaneurysms. Second, laser is used to treat proliferative diabetic retinopathy by ablating nonperfused peripheral retina in order to decrease both the demand for oxygen and the ischemic drive that results in the production of VEGF. Regression of new vessel growth is achieved thus reducing the risks of bleeding, glaucoma, and retinal detachment.
The intraocular injection of drugs has emerged as an adjunctive treatment for the retinal complications of diabetes. Various steroids and anti-VEGF inhibitors such as bevacizumab, ranibizumab, and aflibercept have been used with great success. Anti-VEGF inhibitors inhibit angiogenesis and leakage from blood vessels to manage both PDR and diabetic macular edema, respectively. Although they require repetitive administration they are easily performed in the office and have a low risk of complication. Vitreoretinal surgery remains the definitive treatment for the complications of non-clearing vitreous hemorrhage and tractional retinal detachment resulting from diabetic retinal disease. Advancement in sutureless techniques for vitrectomy has resulted in greater patient comfort and faster recovery. This is accomplished in the operating room where modified anesthesia is combined with a retrobulbar injection of anesthetic. Three incisions are made just posterior to the limbus and the eye is kept formed by automated fluid infusion. Microsurgical instruments such as scissors, forceps, picks, lasers, and automated cutters are passed through cannulas in order to perform delicate manipulation of the intraocular tissues. Visualization of surgical maneuvers is achieved by looking through the patient’s pupil with a surgical microscope. Diabetes can cause damage to the ret(CONTINUED ON PAGE 8)
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theEstatePlanner BY STEVEN M. LAIDERMAN
Insurance Company
Providing the Peace of Mind to Practice Medicine THE QUESTIONS YOU SHOULD BE ASKING OF YOUR CURRENT MEDICAL MALPRACTICE INSURANCE CARRIER AND THE ANSWERS YOU DESERVE AS A PROFESSIONAL • What is your current carrier’s dismissal rate and percentage of claims settled? Galen has a 50+ percentage dismissal rate with 95 percent of claims settled. In addition, we have industry low Loss and LAE Ratios.
• Does your current carrier utilize claim adjusters? The answer you are looking for is NO. Galen does not employ a single claims adjuster. Claims are reviewed within 24 hours of being made by an in house Galen Trial Attorney in combination with Galen’s in house Chief Medical Officer. The end result for the insured: a more aggressive and cohesive legal defense resulting in a 50+% rate all of which result in lower premiums offered by Galen.
• What type of requirements does your current carrier meet? Do they meet the Missouri Department of Insurance requirements? Not all medical malpractice insurance companies are required to meet certain Missouri Department of Insurance requirements. Galen is a regulated admitted carrier in MO and IL. Galen meets all regulatory capital requirements.
• Who is your insurance carrier? Galen was founded by physicians in order to protect physicians. We are reinsured with all “A” rated reinsurance carriers, possess over 40 years of experience in underwriting, and more than 26 years in legal and trial practice.
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Double “Step Up In Basis” – A New Focus Why married couples need to re-evaluate their estate plan In March, I wrote about The Portability Factor, where I discussed the American Taxpayer Relief Act of 2012 (ATRA) enacted on Jan 2, and how it fixed the federal estate tax exemption at $5 million, except for increases due to inflation. Under prior law, the federal estate tax exemption of the first spouse to die would be lost if unused. This could happen where the spouse with resources valued below the exemption amount died before the wealthier spouse. Also added by the law is the concept of portability, which allows the surviving spouse to elect to get the unused exemption of the first spouse to die. In 2013, a married couple truly has a combined inflation adjusted federal estate tax exemption of $10.5 million. Given this significant change in the law, the estate plan of nearly every married couple needs to be re-evaluated. Before portability and the larger federal estate tax exemption, the traditional approach to estate planning focused on minimizing federal estate tax. This was accomplished by sheltering assets at the first spouse’s death in what’s commonly referred to as a credit shelter trust. At the first spouse’s death, assets up to the amount of the federal estate tax exemption of the first spouse to die would pass to the credit shelter trust, rather than outright to the surviving spouse. These assets would be held in trust for the benefit of the surviving spouse, and perhaps even the children or other heirs. Regardless of the increase in value, these trust assets would not be subject to federal estate tax at the death of the second spouse to die. With a significantly larger federal estate tax exemption and portability, most estate plans will no longer be influenced by federal estate tax, but by other planning motives. Because of portability, many married couples may opt for leaving all assets outright to their spouse, who can get their unused exemption. That planning will ignore other motives for creating trusts. The use of trusts, rather than outright distribution to a surviving spouse is still preferred to protect assets from creditors of the surviving spouse; protect the inherited assets from a new spouse in a remarriage; protect the assets so that they ultimately pass to the heirs of the first spouse to die; and protect the assets from mismanagement by the surviving spouse. But with portability, the dilemma becomes whether to hold the assets in a marital trust, which is required to be solely for the benefit of the surviving spouse to avoid federal estate tax at the death of
the first spouse to die, or hold them in the credit shelter trust. The new factor in that decision we refer to as “double step up in basis.” The Internal Revenue Code provides that any appreciated assets receive a new basis or cost equal to the fair market value of the property at the date of the decedent’s death. For example, if you bought stock for $10 per share and die when it’s worth $50 per share, the person acquiring the stock will obtain a new basis equal to that $50 date-of-death value. When the stock is subsequently sold, the profit, called capital gain, is taxed. The tax will be determined based on the adjusted $50 per share cost. Likewise, if the stock declines in value, this rule equally applies to set the new basis at the lower value. The tax on capital gains is much more favorable than the tax on ordinary income or estate tax. This “step up in basis” rule applies to assets such as stocks, mutual funds, bonds, businesses, and equipment and real estate that may have grown in value and/or has been depreciated. This rule doesn’t apply to assets such as IRAs, 401(k)s, pensions, tax deferred annuities, certificates of deposit and money market accounts. With the enactment of ATRA, the problem is that the traditional approach found in the estate plans of many married couples of transferring the assets to the credit shelter trust at the death of the first spouse to die ignores “step up in basis.” Under the traditional approach, there’s a “step up in basis” at the death of the first spouse to die, but there’s no “step up in basis” at the surviving spouse’s death. This is because the credit shelter trust was designed to keep the assets outside the estate of the surviving spouse so that any growth in value would pass estate tax free to the children or other heirs. Married couples should now consider whether their combined estate value is such that they’ll never have more than the applicable federal estate tax exemption, currently $10.5 million. If they believe that their combined estate value will be less than their combined federal estate tax exemptions, the assets of the first spouse to die should be left to the surviving spouse either outright or in a marital trust. This way, the assets will be included in the surviving spouse’s estate at death, and there will be another “step up in basis” at the death of the surviving spouse. So, what’s the problem of just leaving the assets in a marital trust for the surviving spouse rather than in the credit shelter trust as was the traditional approach? If (CONTINUED ON PAGE 11)
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Mercy Invests in Nursing
Maryville University’s nursing program gets financial boost – and a new home In the 1970s, Maryville University and Mercy forged a partnership to ensure the healthcare leaders of tomorrow received the best education possible. Today, that dedication to excellence in education was strengthened with the announcement that, thanks to a generous gift from Mercy, Maryville’s nursing program will be named The Catherine McAuley School of Nursing, after the Sisters of Mercy founder. “Naming the school after Catherine is a great honor for all of Mercy,” said Lynn Britton, CEO of Mercy, the nation’s sixth largest healthcare system. “It acknowledges the tremendous influence she and the Sisters have had on healthcare, both by the bedside and through the ‘Careful Nursing’ philosophy that’s still taught to Maryville students today. It also honors those who helped make our partnership with Maryville possible, especially Sister Mary Roch Rocklage, whose leadership helped us transition from two schools into an outstanding unified program that’s still going strong today.” Maryville University President Mark Lombardi thanked Mercy and said, “This partnership will expand Maryville’s healthcare education throughout the entire Mercy network and beyond through on-site and online programs that enable us to reach more students than ever before.”
(L-R): Maryville University Vice President for Institutional Advancement Tom Eschen; Maryville University Dean of the College of Health Professions Charles Gulas; Mercy President and CEO Lynn Britton; Mercy Health Ministry Liaison Sister Mary Roch Rocklage, RSM; Maryville University President Mark Lombardi
Last year, U.S. News & World Report named Maryville the nation’s top Overperforming University. Forbes and Kiplinger’s consistently rank Maryville among the nation’s top private schools. The Catherine McAuley School of Nursing will move into the Myrtle E. and Earl E. Walker Hall when completed in January 2015. This building will be the new home of Maryville’s College of Health Professions, which includes the
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School of Nursing, along with physical, occupational and rehabilitation therapy and counseling, and also music therapy and speech and language pathology. It will house more than 70,000-square-feet of teaching space that uses smart boards and Apple TV. Helping to bring hands-on clinical education into the 21st century are the lifelike adult and child mannequins that can be programmed with symptoms to simulate ill-
ness, giving students classroom training that’s true to life. “Being well prepared for the realities of nursing is key to serving our patients,” said Christine Crain, COO of Mercy Children’s Hospital and Maryville alum. “When I graduated with my nursing degree, I knew I had the best possible foundation for my career, but this partnership will help ensure future graduates are even better trained.” The Catherine McAuley School of Nursing continues a long-standing tradition at Maryville of ensuring a strong education for leaders in healthcare, especially within Mercy. In the last 40 years, since Mercy Junior College merged with Maryville, nearly 300 Mercy co-workers have graduated and gone on to have successful careers in healthcare, many in leadership. Jon Swope, regional president for Mercy’s central communities in Arkansas, (CONTINUED ON PAGE 10)
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Billion Dollar Pool, continued from page 1 million in task orders annually over the course of the 7-year ordering period – or an estimated value of up to $951 million for the contract duration. “The contract could possibly extend as long as 10 years, depending on the budget,” noted Belshe. In the IDIQ contract, only those centers accepted as VTEUs are qualified to bid on specific projects or “task orders,” outlining how they would approach clinical research projects in areas where they have specialized expertise. VTEUs will be paid based on the actual number of task orders for which they are selected. Other VTEUs include the Baylor College of Medicine in Houston; Children’s Hospital Medical Center in Cincinnati; Duke University in Durham, NC; Emory University in Atlanta; Group Health Cooperative in Seattle; University of Iowa in Iowa City; University of Maryland in Baltimore; and Vanderbilt University in Nashville. “NIH has changed the way federal funding is received for vaccine research,” said Belshe. “In the past, there was a fixed dollar amount on the contract, maybe $24 million spread over several years per university. That payment mechanism has changed to IDIQ, which allows the government to set aside funding and issue task orders. Those task orders may be big, like the high-priority one on bird vaccine we just did.” The bird flu vaccine project involved investigating the severe disease seen in China last spring. SLU was among seven VTEUs to test bird flu vaccines for the NIH. “The NIH gives us parameters and we send in a budget for the task order,” he said. “There may be a period of negotiation, but the method should allow for a rapid turnaround. Once we had approval on the bird vaccine project, we completed it in about a month. The flexibility and speed helps with the urgent need for vaccine research. It also helps foster competition, with nine universities competing for
Dr. Robert Belshe
the task order. It ensures that everyone has a competitive price.” Daniel Hoft, MD, PhD, director of Saint Louis University’s division of infectious diseases, allergy and immunology, and Sharon Frey, MD, professor of infectious diseases at SLU, are co-principal investigators of SLU’s VTEU, joined by research pharmacists Richard Nickel and Anna Schmidt, and clinic manager Karla Mosby. “Based on its population and specialty, each (VTEU) has its own strengths,” he said. “We’re very competitive, for example, on influenza studies. For many studies, NIH may have several vaccine centers participating simultaneously, like they did on the bird flu vaccine.” SLU recently established a dedicated research pharmacy within the Center for Vaccine Development, and is partnering with the Aurum Institute for Health Research in Johannesburg, South Africa, to conduct international vaccine research to protect against global health threats including tuberculosis. “The international collaboration was a natural extension of our work,” explained Belshe. The new NIH contract paves the way for SLU to potentially garner funding on
a large range of studies for trials, such as the dengue vaccine. “Dengue isn’t a problem in St. Louis, but it’s clearly a problem in the United States, especially South Florida and for world travelers,” he said. “Some of these trials we need to do in St. Louis to better understand how these vaccines work.” Belshe referred to the new types of influenza vaccines as “moving targets.” “We have to keep up with those, tuberculosis, and hepatitis C,” he said. “We’ve already done vaccine trials on hepatitis C and expect to do more going forward.” Hoft, an internationally known authority on tuberculosis and vaccine research, noted that SLU’s substantial investment in high-tech laboratory and clinical space in the $82 million Doisy Research Center has also greatly facilitated research conducted by SLU’s Center for Vaccine Development. “You can’t work with highly infectious and potentially lethal agents in a traditional lab because of the biosafety risk,” Hoft said. “However, at SLU, biosafety level 3 labs are specially engineered so we can safely work with infectious agents that could be deadly. This capability gives us an expanded realm to do lab studies for
vaccine trials.” SLU’s campus in Madrid, Spain, holds possibilities for research, noted Belshe. “We have strong interactions between campuses,” he said. “It’s something we might take advantage of moving forward.” Fresh funding also provides the center with flexibility to adapt to and apply the best opportunity for new NIH-funded research efforts, said Belshe, who estimated the center has brought up to $150 million in research funding to SLU. The core group that relocated from Marshall with Belshe includes pediatrician Ed Anderson, MD, and SLU School of Medicine infectious diseases professors Geoffrey Gorse, MD, and Frey, a medical graduate of Marshall. “The seven years is very, very important for having a steady budget so we don’t go through cycles – boom or bust,” said Belshe. “We can continue to fund staff that’s trained for these research projects, and are very good at what they do.” Philip Alderson, MD, dean of SLU School of Medicine and vice president for medical affairs, said the new contract affirms SLU’s contributions to vaccine development, which Secretary of Health and Human Services Kathleen Sebelius praised at a university visit during the H1N1 pandemic in 2009. “The continued funding is recognition of SLU’s strength in the study of infectious diseases, which goes beyond the Vaccine and Treatment Evaluation Unit,” Alderson said. “We’re a real hub of translational vaccine science – translating discoveries about human pathogens made in basic science laboratories into clinical practices that have a dramatic impact on the health of people. With new diseases on the horizon every year that threaten global health, our work in protecting public health is critical.”
Diabetes,
continued from page 5
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ina in the absence of symptoms. Frequent dilated eye exams lead to early detection so vision can be preserved or possibly improved. In addition, feedback from the exams may help raise the patient’s awareness their systemic disease state and encourage greater glucose control to prevent other diabetic complications. Mr. Jones was found to have diabetic macular edema causing his blurred vision. He will undergo laser treatments and intravitreal injections to stabilize his vision. He now understands that diabetes is responsible for significant complications even in the absence of symptoms. If only he had his eyes examined sooner. Bradley T. Smith, M.D. is a board certified ophthalmologist who received his medical degree from the University of Alabama School of Medicine, Birmingham, Alabama. He trained at the Wills Eye Institute, Philadelphia, Pennsylvania and subsequently completed a vitreoretinal fellowship at the Barnes Retina Institute/ Washington University, St. Louis, Missouri. He specializes in the treatment of vitreoretinal disorders at The Retina Institute, www.rc-stl.com
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Double Impact
Wash U receives $26 million for leukemia research eral dozen physician scientists and Two years ago, rebasic scientists who searchers at Siteman Cancer will be involved in Center at the Washington a broad portfolio of University School of Medilaboratory and clinicine were studying potential cal research projects treatments for adult acute centering on leukelymphoblastic leukemia mia. The SPORE (ALL) when Lukas Wartgrant also includes a man, MD, a Washington program to develop University research fellow, promising young leuwas diagnosed with a rekemia investigators lapse of ALL. The survival like Wartman. Dr. Lukas Wartman Dr. Daniel Link Dr. John DiPersio rate for ALL is roughly 40 “There’s imporpercent; for a relapse, it tant synergy between drops to 5 percent. the two grants,” said Ley. “The PPG foFor their groundbreaking work in the potential to lead to more personal“The leukemia was very happy in the cuses on basic research to generate ideas, blood cancer research, Washington Uniized treatments for patients based on the bone marrow, where it lives,” said concepts and technologies that can be versity was recently awarded two recordunique genetic and molecular signatures Daniel Link, MD, the Alan A. and evaluated in clinical trials via the SPORE breaking leukemia research grants totaling of their leukemia cells. Edith L. Wolff Distinguished Professor of grant.” $26 million, which includes an $11.3 mil“The PPG grant has been one of Medicine at Washington University. “The As part of the new research, scienlion Specialized Program of Research the most successful grants the NIH has bone marrow provides many growth factists in the Division of Oncology will work Excellence (SPORE) grant that capitalfunded,” said Link. “It was funded with tors that keep the leukemia happy and closely with researchers at Washington izes on research advances at the medical enthusiasm because of its extraordinary resistant to chemotherapy. At the time University’s Genome Institute to explore school to bring new investigational treatsuccess.” Lukas was diagnosed, we were developing the genetic basis of leukemia in even ments into clinical trials, such as the ALL Competition for new or renewed a drug to disrupt that happy environment greater detail. treatment. The National Cancer Institute, grants remains highly competitive, with a in the bone marrow, get rid of supporting “Sequencing the genomes of cancer part of the National Institutes of Health funding rate for grants of roughly 5 to 10 factors, and sensitize leukemia to chemopatients enables us to drill down to the (NIH), funded the grant. percent. therapy. He was the first patient enrolled level of the DNA in cancer cells to under“Ours is one of the first applications “Only one other institution – MD in the protocol.” stand how – and why – cancer develops in of this sort of strategy,” said Link, princiAnderson Cancer Center – has both types That innovative strategy grew from the first place,” said Richard K. Wilson, pal investigator of the SPORE grant. of leukemia grants,” said Link, who joined in-house research suggesting the theory PhD, director of The Genome Institute. The National Cancer Institute also Washington University as a resident in the was correct, and today, Wartman, whose “This type of analysis is critical to developawarded Washington University a $14.3 late 1980s and worked his way through the cancer has been in remission since late ing new, improved treatments.” million Program Project Grant (PPG) in system. “Under the leadership of John Di2011, is a promising young genomics reJohn DiPersio, MD, PhD, chief of the leukemia. Initially funded at Washington Persio, a world-class researcher in his own searcher at Washington University. Division of Oncology and the Virginia E. University in 2003, it has been renewed right, we’ve been fortunate to recruit very and Sam J. Golman Professor of Meditwice. smart people and build a team from within.” cine, said the grants allow researchers to Timothy Ley, MD, the Lewis T. and The funding boosts the reputation better understand the genetic origins of Rosalind B. Apple Chair in Oncology, of the Washington University School of the different types of leukemia. leads the PPG, which aims to identify all Medicine as a premier center for innovacontinued from page 7 “Now, we can begin to ask what genetic changes underlying the developtive leukemia research. The institution is drugs will work best for patients based ment and progression of acute myeloid one of only three nationwide to receive southwest Missouri and Kansas, is one of on the genetic signatures of their cancer leukemia (AML), the most common type SPOREs focused on leukemia. those. He received his degree in managecells,” he said. of acute leukemia in adults. Findings have The two grants bring together sevment from Maryville. “As a non-clinician, getting my education as part of a program where Mercy’s nursing tradition is valued really helped me understand and have a MedEvolve offers the complete solution for the medical practice: greater respect for what our caregivers do Electronic Health Records, Practice Management Software and for patients each day. That’s the human Revenue Cycle Management. See why thousands of side of the healthcare business, something n Fully Integrated EHR/PM/RCM physicians trust MedEvolve as their practice partner. Maryville and Mercy have always valued.” n ICD-10 Ready Charles Gulas, dean of Maryville’s “MedEvolve’s PM software and Revenue n Turnkey Billing and Collections College of Health Professions, said, “Our Cycle Management services have n Improved Bottom Line organizations have always shared a comabsolutely improved our practice’s n Peace of Mind mitment to excellence and compassioncollections. MedEvolve really does stand ate care. By working even closer through out not only in software performance, this new school, we’ll ensure that students Clean Claims Rate but particularly in customer service.” who will shape healthcare in the future are trained with the best possible academic - Barry S. Seibel, MD and clinical resources.” Average Increase Ophthalmic Surgeon Tom Eschen, Maryville’s vice presiin Revenue Beverly Hills, California dent for institutional advancement, said the partnership is especially gratifying Average Reduction long-term. “Maryville and Mercy have in AR days worked together for decades and we’ve only gotten stronger because of it,” he Call to speak to an ICD-10 said. “As quickly as the world is changspecialist today! ing, I’m sure this won’t be our last venture together. We look forward to seeing what 1-800-964-5129 the future brings and evolving to meet the medevolve.com needs of students for years to come.” By LyNNE JETER
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Which Retirement Plan Is Right for Your Business? PROVIDED By CHARLES GRBCICH
If you own a small business, there are many retirement plan alternatives available to help you and your eligible employees with retirement planning. For most closely-held business owners, a Simplified Employee Pension Individual Retirement Account (SEP IRA) was once the most cost-effective choice. Then the Savings Incentive Match Plan for Employees (SIMPLE IRA) became a viable alternative. Today you may find that a defined-benefit or 401(k) plan best suits your needs. To make an informed decision on which plan is right for your business, review the differences carefully before you choose. Simplified Employee Pension Individual Retirement Account (SEP IRA). This plan is flexible, easy to set up, and has low administrative costs. An employer signs a plan adoption agreement, and IRAs are set up for each eligible employee. When choosing this plan, keep in mind that although it does not allow employees to save through payroll deductions, contributions are immediately 100 percent vested. The maximum an employer can contribute each year is 25 percent of an employee’s eligible compensation, up to a maximum of $250,000 for 2012 and $255,000 for 2013. However, the contri-
bution for any individual cannot exceed $49,000 in 2011 and $50,000 in 2012. Employer contributions are typically discretionary and may vary from year to year. With this plan, the same formula must be used to calculate the contribution amount for all eligible employees, including any owners. Eligible employees include those who are age 21 and older and those employed (both part time and full time) for three of the last five years.
December 31, then an additional catch-up contribution of $2,500 is permitted. Each year the employer must decide to do either a matching contribution (the lesser of the employee’s salary deferral or 3 percent of the employee’s compensation) or non-matching contribution of 2 percent of an employee’s compensation (limited to $250,000 for 2012 and $255,000 for 2013). All participants in the plan must be notified of the employer’s decision.
Savings Incentive Match Plan for Employees (SIMPLE). If you want a plan that encourages employees to save for retirement, a SIMPLE IRA might be appropriate for you. In order to select this plan, you must have 100 or fewer eligible employees who earned $5,000 or more in compensation in the preceding year and have no other employer-sponsored retirement plans to which contributions were made or accrued during that calendar year. There are no annual IRS fillings or complex paperwork, and employer contributions are tax deductible for your business. The plan encourages employees to save for retirement through payroll deductions; contributions are immediately 100 percent vested. The maximum salary deferral limit to a SIMPLE IRA plan cannot exceed $11,500 for 2012 and $12,000 for 2013. If an employee is age 50 or older before
Defined-benefit pension plan. This type of plan helps build savings quickly. It generally produces a much larger tax-deductible contribution for your business than a defined-contribution plan; however, annual employer contributions are mandatory since each participant is promised a monthly benefit at retirement age. Since this plan is more complex to administer, the services of an enrolled actuary are required. All plan assets must be held in a pool, and your employees cannot direct their investments. Certain factors affect an employer’s contribution for a plan, such as current value of the plan assets, the ages of employees, date of hire and compensation. A participating employee with a large projected benefit and only a few years until normal retirement age generates a large contribution because there is little time to accumulate the necessary value. The maximum annual benefit at retirement is the lesser of 100 percent of the employee’s compensation or $200,000 per year for 2012 and $205,000 in 2013 (indexed for inflation). 401(k) plans. This plan may be right for your company if you want to
motivate your employees to save towards retirement and give them a way to share in the firm’s profitability. 401(k) plans are best suited for companies seeking flexible contribution methods. When choosing this plan type, keep in mind that the employee and employer have the ability to make contributions. The maximum salary deferral limit for a 401(k) plan for 2012 is $17,000 and $17,500 for 2013. If an employee is age 50 or older before December 31st, then an additional catch-up contribution of $5,500 is permitted. The maximum amount you, as the employer, can contribute is 25 percent of the eligible employee’s total compensation (capped at $250,000 for 2012 and $255,000 for 2013). Individual allocations for each employee cannot exceed the lesser of 100 percent of compensation or $50,000 in 2012 and $51,000 in 2013. The allocation of employer profit-sharing contributions can be skewed to favor older employees, if using age-weighted and new comparability features. Generally, IRS Forms 5500 and 5500-EZ (along with applicable schedules) must be filed each year. Once you have reviewed your business’s goals and objectives, you should check with your financial advisor to evaluate the best retirement plan option for your financial situation. This article was written by Wells Fargo Advisors and provided courtesy of Charles Grbcich, First Vice President – Investment Officer in Chesterfield, MO at charles.grbcich@wfadvisors.com . Wells Fargo Advisors does not provide legal or tax advice. Be sure to consult with your tax and legal advisors before taking any action that could have tax consequences NOT FDIC-INSURED/NOT BANK-GUARANTEED/MAY LOSE VALUE. Wells Fargo Advisors, LLC, Member SIPC, is a registered broker-dealer and a separate non-bank affiliate of Wells Fargo & Company.
The Estate Planner, continued from page 6 the surviving spouse’s estate, which includes the marital trust, later exceeds the applicable federal estate tax exemption of the surviving spouse and the amount that ported over to the survivor from the first spouse to die, estate tax at 40 percent will be due nine months after the death of that survivor. Also, if the assets decline in value after the death of the first spouse, they would have retained the higher basis they obtained at the death of the first spouse to die if they were in the credit shelter trust.
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Also, income from assets in the credit shelter trust can be “sprinkled” among the spouse and other heirs if appropriate, but the income in the marital trust can only be for the survivor. How the assets will be distributed between the marital and credit shelter trust can be determined at the death of the first spouse through various methods not found in trusts drafted under the traditional approach. These methods can give the planner the benefit of knowing the circumstances surrounding the family’s needs and assets, as well as tax laws, at that time. To incorporate these methods and take advantage of the double “step up in basis,” nearly every married couple’s estate plan will need to be revised. Steven M. Laiderman, principal of The Laiderman Law Firm PC, an estate planning, probate, and business law firm based in St. Louis, has extensive experience in estate planning. He also represents clients in the negotiation of real estate leases, sales and acquisitions. A frequent speaker, he also serves as an adjunct professor at the Washington University School of Law, teaching estate planning and family wealth management classes. He may be reached at Steve@ LaidermanLaw.com.
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Wellness Programs’ Impact on the Medical Field By JENNIFER PATEL
With rising healthcare costs companies are searching for ways to not only reduce costs, but also create healthier employees. Stats highlighting a decrease in used sick days and reductions in overall healthcare costs have many employers looking into health and wellness initiatives to encourage employees to live healthier lives. As more companies begin to incorporate wellness programs, the time for healthcare providers to become directly involved is now. While today’s employers are beginning to see the benefits of wellness programs and preventive care, they didn’t always. In the past, employees have been left to worry that taking time off for doctors appointments or tending to other preventative care issues will result in a negative reaction from management. Because of this, employers have to find ways to encourage employee participation in wellness programs. One successful method of encouragement that employers have discovered is to have direct participation from healthcare professionals. The following are ways healthcare professionals can, and are beginning get involved with health and wellness plans.
Encourage Preventive Care
The Centers for Disease Control and Prevention (CDC) estimate that 68 percent of adults and 33 percent of youth are currently overweight or obese. Chronic obesity-related conditions, including heart disease and diabetes, have a big impact on health and wellness. In addition, chronic diseases reduce the overall quality of life with half of all chronic disease-related deaths occurring in people under the age of 70. Healthcare professionals are in an ideal position to offer tools for employees to be healthy. In an effort to combat employees’ reluctance to leave work for such care, employers are beginning to bring in healthcare professionals to offer biometric and preventative screenings in the workplace. This is beneficial for both parties as less time is spent away from work.
Offer Expertise
Generally speaking, most employers are not healthcare experts, which gives physicians extra advantages. When putting together a wellness program, employers look at screenings, physical activity and incentives for positive results. But what constitutes positive results and what is the best way to get there? Not only can the healthcare industry
provide valuable insight when designing these programs, but it can assist in educating employees on what they should be doing, why it’s important, and then monitoring to ensure that no issues arise. Inviting additional healthcare professionals to implement a wellness program will provide extra validation to the importance of a healthy workplace.
Build Relationships
One of the biggest obstacles that employers face when encouraging employees to take part in health and wellness programs is a desire to not be the squeaky wheel. Whether or not it is admitted, employees still feel that taking time off work is seen as something that can affect their growth within the company. The way businesses address this issue is by building positive relationships with their employees and letting them know it’s more beneficial for the entire team if one employee is too sick and needs to stay home and get well. By encouraging preventative care, as well as offering educational opportunities, employees build positive relationships with both their bosses and the healthcare professionals. Through relationships with employers, healthcare professionals are given access to a wealth of potential new clients at no cost to them.
Invest in Your Employees
As the healthcare industry’s role within workplace health and wellness plans increases, it’s important to turn the looking glass upon itself. While providers may have the closest access to the care, it can be difficult to find time to care for themselves. With high rates of smoking, stress levels and long hours, the healthcare industry suffers from many of the same ailments it attempts to rectify. By implementing a health and wellness plan of their own, healthcare professionals are able to practice what they preach. By providing the necessary time to take part in the program, determining what programs are needed, as well as offering incentives, healthcare professionals can not only be a part of others’ programs, but their own. Invest in employee enrichment and see how a wellness program positively impacts a company’s bottom line. Hallmark Business Connections, the business-relationships unit of Hallmark Cards, helps businesses build and strengthen relationships that help them thrive. One valuable service the company provides is corporate wellness program development. For guidance on strategic wellness program implementation, email Jennifer Patel at Jennifer.Patel@ hallmarkbusinessconnections.com or visit www.hallmarkbusinessconnections.com.
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The Evolution of HIPAA Compliance By LINDA RODRIGUE AND LyN SAVOIE
Because the increasing prevalence of technology, mobile devices in the workplace and online health records, as well as the risk of making patient information more public, HIPAA, or the Health Insurance Portability and Accountability Act, recently instituted new safeguards and restrictions. HIPAA was established in 1996 to safeguard protected health information. In 2009, the United States Congress signed the Health Information Technology for Economic and Clinical Health Act into law to promote the proper use of health information technologies. The HITECH Act works to ensure healthcare providers learn the proper methods and are given the resources to transmit Electronic Health Records of patients. The new “Final Rule,” effective on March 26, 2013, through the HITECH Act added several changes to the privacy and security policies in HIPAA. Of the
many additions and regulations enacted by this new rule, three carry the most weight: new Business Associate Agreements; new breach notification rules and enforcement; and new notice of privacy practices requirements. A business associate, as it pertains to the new rule, is any person or entity who creates, receives, maintains or transmits protected health information (PHI) for a covered function or activity, or provides other work that requires them to use or disclose PHI. Under new regulations, this now includes subcontractors, requiring covered entities to make new agreements with their business associates and the business associates to make agreements with their subcontractors. Simply speaking, anyone who touches medical records may need to sign a new agreement. There’s a single exception – if a business associate agreement was made prior to March 26, 2013, the contracts can be used until they expire or on Sept. 23, 2014, whichever comes first.
New, stricter rules addressing breach notification have gone into effect, transferring the burden of proof to covered entities and business associates. Previously, covered entities were not presumed to have breached unless a significant risk was present. Now, all entities have to prove there was no compromise of PHI based on a thorough risk assessment. Three exceptions to breaches have also been maintained – an entity is not held accountable if an in-house use was unintentional; if PHI was disclosed to an unauthorized person under the assumption they won’t retain the information, or if one authorized person inadvertently discloses the information to another authorized person in-house. Finally, healthcare privacy has evolved dramatically since HIPAA was first signed into effect, and updated regulations require entities to address these changes. Staffs should be retrained on PHI, how to use a mobile device in the work environment and protecting shared
data. Regulations also strongly recommend entities preemptively address the use of social media. Health care providers must also give a notice explaining to the patient how they can use and share their health information and how they can exercise their health privacy rights; the notice must explain how they use and disclose PHI, as well as the fact that the entity must get a patient’s permission before using their health records for various uses or disclosures. The task of staying compliant with HIPAA policy changes is evolving as quickly as the medical field itself, and the rise of mobile technology has only served to increase complications. But becoming and staying compliant should be a huge priority for businesses and individuals, to prevent significant public perception and financial losses. Linda Rodrigue is a partner with Kean Miller, LLP in Baton Rouge. Lyn Savoie is an associate at the same location.
Integrative Medicine Goes Mainstream, continued from page 1 ogy, internal medicine, nuclear medicine and holistic medicine. Tampa, Fla.-based ABPS, the first multi-specialty certifying body to offer physician certification in integrative medicine, is the official certifying body of the American Association of Physician Specialists (AAPS) and one of three national certifying organizations of MDs and DOs. The ABPS has led industry response to trends in urgent care, disaster medicine, hospital medicine and family medicine obstetrics. Andrew Weil, MD, said the formation of ABOIM – one of 18 ABPS boards – marks an important milestone in the development in the field of integrative medicine. “Finally, there’s a way for qualified physicians to present themselves as experts in offering competent integrative care to patients,” said Weil, who helped establish integrative medicine as a specialty. Of the other two national certifying
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organizations, the American Board of Medical Specialties (ABMS) represents the largest national organization certifying MDs and DOs. The American Osteopathic Association Bureau of Osteopathic Specialists (AOABOS) certifies DOs only. “Integrative medicine focuses on getting to the underlying cause of disease and implementing personalized programs that help people achieve optimal health,” said Guarneri. “In conventional medicine, we’re taught to make a diagnosis and prescribe a treatment. In integrative medicine, we look for the underlying cause of the problem or health challenge. For example, in conventional medicine, we may diagnose diabetes and prescribe a medication. In integrative medicine, we look at what a person is eating (to determine if) they’re deficient in micronutrients linked to diabetes. If they’re physically fit, are they exposed to toxins? Are they under stress? All of these can cause diabetes. We may prescribe medicine, but we also look
Integrative Medicine Board Certification 4-1-1 ABOIM certification is available to both allopathic and osteopathic physicians in the United States and Canada who are practicing integrative medicine and have completed a residency training program approved by the Accreditation Council of Graduate Medical Education (ACGME), American Osteopathic Association (AOA), Royal College of Physicians and Surgeons of Canada (RCPSC), or College of Family Physicians of Canada (CFPC). Complete eligibility requirements are available online. Qualified physicians interested in becoming board certified in integrative medicine may submit an application by Dec. 1; the initial exam will take place next May. Applications are available online at www.aapsus.org and may be obtained by contacting the ABPS Certification Department at (813) 433-2277.
to correct the underlying cause. We treat the whole person – body, mind and spirit – and we look at an individual’s relationships to family, community and planet.” ABOIM and the Consortium of Academic Health Centers for Integrative Medicine define integrative medicine as “the practice of medicine that reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals, and disciplines to achieve optimal health and healing.” Guarneri, founder of the Scripps Center for Integrative Medicine in La Jolla, Calif., and president of the American Board of Integrative Holistic Medicine (ABIHM), pointed out that as a cardiologist, her goal is to also reverse the patient’s health challenges. “Integrative medicine provides me the tools that weren’t available in my conventional medical training,” she said. “As a cardiologist, I’m well versed in the role of medication, surgery and stenting for treat-
ment of cardiovascular disease. But, it’s my training in integrative medicine that’s taught me the principles of nutrition, the evidenced-based use of natural supplements, and the role of the mind-body connection. Integrative medicine allows me to complete the circle of care.” Eudene Harry, MD, medical director of Oasis Wellness & Rejuvenation Center in Orlando, Fla., was thrilled to learn about the new board certification in integrative medicine. “It’s very good that integrative medicine is being acknowledged as a specialty,” said Harry. “The message is: let’s not be exclusive. Let’s be inclusive. Let’s look at all evidence-based material and treat it equally.” Harry, who specializes in both holistic and emergency medicine, said integrative medicine allows “more focus on information-gathering.” “That’s going to be helpful,” she said. “Medications don’t address the issue that’s driving the patient to the doctor’s office.”
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Managing Addictions Addiction medicine professionals prepare for ‘busy season’ By LYNNE JETER
As another dismal economic year draws to a close, addiction and substance abuse clinics are gearing up for an influx of patients. “We say in our business that the drinking season begins at Thanksgiving and ends on Super Bowl Sunday,” said Percy Menzies, M. Pharm., founder of Assisted Recovery Centers of America (ARCA), Dr. Percy based in St. Louis, Mo. Menzies “We opened in February and just recently had to turn away patients for the first time. It’s that busy. We’re also dealing with a huge iatrogenic epidemic of addiction to prescription pain drugs. For the first time, more people have died of drug overdose than automobile accidents. Heroin has become the cheap ‘generic’ form of opioid pain killers.” Despite the revolving door headlines about celebrities frequenting rehab clinics, addiction medicine remains one of the most underfunded diseases in the United States. According to a 2012 report published by The National Center on Addiction and Substance Abuse at Columbia University (CASA Columbia), “Addiction Medicine: Closing the Gap between Science and Practice,” 15.9 percent (40.3 million) of Americans have the disease of addiction. That’s more than heart conditions (27 million), diabetes (25.8 million) or cancer (19.4 million). Even though one in five deaths is attributable to tobacco, alcohol and other drug use, the U.S. spent $107 billion to treat heart conditions, $86.6 billion to treat cancer, and $43.8 billion to treat diabetes in 2010. But only $28 billion was spent on addiction treatment. Another eye-opening statistic: Of every dollar spent by federal, state and local governments on risky substance use and addiction, 95.6 cents pay for consequences; only 1.9 cents go to prevention and treatment. Genetic predisposition, structural/ functional brain vulnerabilities, psychological and environmental influences are clear risk factors for addiction, as is the age of first use. Ninety-seven percent of addiction cases start with substance abuse before the age of 21, while the brain is still developing. As a result of all risk factors, one-third of the population over the age of 12 is susceptible to substance abuse. “This clearly articulates the monumental challenge ahead of us,” said Menzies, who left an executive role with DuPont Pharmaceuticals to open ARCA’s first integrated outpatient clinic in 2001, and in early 2013, a 25-bed residential substance abuse clinic. He’s on a campaign to move addiction into the mainstream of medicine. “For too long,” he said, “we’ve been on the outside of the margins.”
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Addiction Medicine Challenges
Various factors keep addiction and substance abuse programs in the shadows of medicine: the professional stigma that makes it difficult to recruit healthcare providers, the social stigma that pervades society and the field of addiction medicine, misconceptions among other healthcare providers, and the often unbalanced mix of medications and treatment. “When I give talks to medical school students, and ask who wants to specialize in addiction medicine, not one hand goes up,” said Menzies, noting that of 985,375 active physicians nationwide, only 1,200 are practicing addiction medicine specialists and 355 are practicing addiction psychiatrists. “They don’t see it as a very lucrative business.” The report also noted a significant differential in requirements for addiction counselors by state. Only one state has a minimum requirement of a master’s degree, six states require an undergraduate degree, and 10 states require an associate’s degree. Fourteen states require only a high school degree or GED equivalent, six states have no minimum degree requirements, and 14 states don’t require any licensure or certification. Only 10 states mandate a physician as a medical director or staff member of residential treatment programs. “The majority of people who work in addiction treatment are in recovery and lost everything to their addiction and want to give back to society,” he said. “Part of the challenge is that they come with their own baggage. Being in recovery doesn’t make them an expert. That’s one of the major obstacles we face in this field.” Menzies, who is not in recovery, recalled how his relatives – many are healthcare professionals – questioned his decision to move into addiction medicine. “Others ask me if my practice failed, because they believe no self-respecting healthcare professional would go into this field voluntarily,” he said, with a chuckle. The social stigma of the disease exacerbates misconceptions of addiction. “If you go to your physician and say, ‘doc, I’m drinking too much,’ he’s likely to say ‘stop drinking’ and maybe advise you to go to AA,” he said. “If you go to a psychiatrist and say, ‘I’m drinking too much,’ he’s likely to say, ‘you’re depressed. Let me give you an anti-depressant.’ If you go to your pastor and say, ‘I’m into drugs and alcohol,’ he may say, ‘you should come to church more often.’ My goal is to treat addiction like any other chronic medical condition, such as diabetes or asthma, through the right combination of medications, counseling, behavioral therapies, and psychiatric care.”
Menzies. “Highly dangerous and addicting drugs were touted as ‘cures.’ This has resulted in a very unhealthy segmentation of treatment,” he explained. “Only a small percentage of alcoholics are treated with medications, but addiction to opioids is predominantly treated with addicting and abusable drugs like methadone and buprenorphine, which adds to the stigma and deters many physicians from getting into this field.” Nearly 35 years ago, the federal government developed naltrexone as the first non-addicting medication to prevent detoxed heroin addicts from relapsing, added Menzies. “DuPont introduced this medication in 1984; in 1994, the same medication was approved for the treatment of alcoholism,” he said. “Naltrexone faced opposition from many treatment providers and the practical challenge of medication compliance.” Vivitrol, a monthly injection of naltrexone, was introduced in 2006 but has yet to gain significant use. “It’s an amazing medication to prevent relapse to alcohol or opioid use, but there’s so much opposition to it,” he said. “It gives patients a fighting chance of not relapsing when they return home to the familiar environment of past drug and alcohol use. The
true test of any treatment program is how well patients do when they return home. Vivitrol is a potent tool to keep patients engaged in long-term treatment.”
Improving the Environment
In 1956, the American Medical Association (AMA) referred to alcoholism as an illness that should be treated within the medical profession. In 1989, the AMA adopted a policy naming addiction as a disease. Yet less than 6 percent of referrals to publically-funded addiction treatment emanates from healthcare providers. Addressing the education, training and accountability gap is paramount to moving addiction medicine into the mainstream. Among the report’s next-step recommendations, improved screening and assessment tools need to be developed, national accreditation standards for all addiction treatment facilities and programs that reflect evidence-based care need to be established, addiction medicine workforce needs to be expanded, addiction treatment facilities should be licensed as healthcare providers, and research and data collection to improve and track progress and search for a cure needs a financial shot in the arm. “The stigma of addiction,” said Menzies, “can only be removed with better outcomes.”
HELP PATIENTS QUIT. Refer your patients to the American Lung Association for smoking cessation options. For questions or more information, contact Laura Frick at 314.645.5505 x1014 or lfrick@breathehealthy.org.
Drug Intervention Challenges
Ironically, drug and alcohol treatment has a dark and checkered history, noted NOVEMBER 2013
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GrandRounds Mobius Therapeutics Announces $3M Series B Funding Led by Cultivation Capital Mobius Therapeutics, a leading glaucoma and refractive surgery innovation company headquartered in St. Louis, has announced a $3 million Series B round of financing led by St. Louis-based early stage Venture Capital firm Cultivation Capital. Mobius developed and sells Mitosol, a pre-packaged kit containing mitomycin-c, an agent essential to improved efficacy in glaucoma surgery. Mitosol improves occupational safety for doctors and hospital staff, provides consistent and assured formulation for each patient, improves convenience, and is more cost effective for hospitals and patients. Mitosol is the first and only formulation of mitomycin-c specifically approved for ophthalmic use. Addressing key end-user and patient issues represents a major breakthrough in the field of glaucoma surgery. This latest round of funding brings Mobius’s Series B total to $5 million and enables the company to increase its commercial sales team and reach more doctors and patients nationwide.
Margolis named new head of ophthalmology Todd P. Margolis, MD, PhD, has been named head of the Department of Ophthalmology and Visual Sciences at Washington University School of Medicine in St. Louis. With the new appointment, effective Jan. 1, Margolis also Dr. Todd P. Margolis becomes ophthalmologist-in-chief at Barnes-Jewish Hospital. The appointment was announced by Larry J. Shapiro, MD, executive vice chancellor for medical affairs and dean of the School of Medicine. Margolis comes to Washington University from the University of California, San Francisco, where he is a professor of ophthalmology and the Rose B. Williams Chair for Research in Corneal Diseases. He also directs the Francis I. Proctor Foundation for Research in Ophthalmology, a privately endowed organized research unit dedicated to research and
training in infectious and inflammatory eye diseases, and the application of that research to the prevention of blindness worldwide. Research in Margolis’ laboratory focuses on the cellular and molecular mechanisms that regulate the establishment and maintenance of latent neuronal infection with herpes simplex virus (HSV). His ongoing research is aimed at documenting the role of both neuronal and viral gene expression in the establishment and maintenance of HSV latency. The ultimate goal of this work is to gain enough understanding about the regulation of HSV infection that therapeutic interventions can be devised to eliminate infections or prevent reactivation of the virus.
SSM Medical Group adds adult primary care physician in St. Charles Idelle Fraser, MD, a board eligible internal medicine physician, has joined Drs. Shobha Dixit, Daniel Kramer, Richard Murray and Martin Walsh in practice in St. Charles. Dr. Fraser recently completed the internal medicine residency proDr. Idelle Fraser gram at Southern Illinois University—Springfield, where she served as senior resident and supervised medical students and interns in the intensive care unit and on the general medical floors. Prior to that, Dr. Fraser was in the post baccalaureate program at Southern Illinois University—Carbondale. She has a master’s degree in public health from State University of New York (SUNY) in Albany and worked in San Jose, California, as a public health consultant, researcher and peer health education coordinator for seven years before deciding to become a physician. Dr. Fraser’s experience also includes an internship with the U.S. Centers for Disease Control (CDC) in Atlanta. She has a bachelor’s degree in biology from the University of California—Los Angeles (UCLA). Dr. Fraser’s health care services, for patients ages 18 years old and up, include but are not limited to: preventive care and check-ups, including physicals;
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women’s health, including well-women exams; and identification and management of both acute problems and chronic diseases.
Breast cancer test developed at Washington University gets FDA approval A laboratory testing kit that estimates the risk of breast cancer returning after anti-hormone treatment has received approval from the U.S. Food and Drug Administration (FDA). The technology is a step toward personalized medicine and could help standardize breast cancer diagnosis around the world, according to researchers at Washington University School of Medicine in St. Louis, who led the test’s development. The research team, including collaborators at the University of North Carolina, the University of Utah and the BC Cancer Agency in Canada, designed a test that categorizes breast tumors into one of four main types by looking at the expression of 50 genes. The four types are luminal A, luminal B, HER2-enriched and basal-like. Each subtype has a distinct genetic signature and requires a different treatment approach. These subtype data are then combined with a standard pathology variable to deliver a “risk of recurrence” score that predicts the likelihood of that patient’s disease returning within the next 10 years. In this way, clinicians now may be able to accurately identify those low-risk patients for whom standard hormone therapy is sufficient. The new test removes some of the subjectivity that goes into breast cancer diagnosis, which still involves looking at the cells under a microscope and deciding on likely outcome based on visual cues on how aggressive the tumor is likely to be. Patients with the luminal A subtype have a low risk of recurrence and do well with long-term anti-hormone therapy that reduces or blocks estrogen, which fuels these tumors. But the other tumor types may require more aggressive measures to prevent relapse, including chemotherapy and sometimes investigational drugs. The test, called Prosigna and manufactured by NanoString Technologies, comes with a machine and kit, so patients’ tumor samples do not have to be sent to a specific laboratory for analysis. The test is being distributed to pathology labs around the world and also is approved for use in the European Union. Medical News is pleased to provide space for press releases by providers in our Grand Rounds section. Content and accuracy of the releases is the sole responsibility of the issuer.
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