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. VOLUME 4 • I SSUE 2 • SPRING 2011 X y E e D s r N e I J E w e N I N L f D o E y M n a p W m O o N C e c n E a r T . u S A q s T s L n I I E F U , E ™ i G , . s e N E l q g E u R s a B b t E n a O , K a r T N v e R i . d r N O F A H O . D I W d B T T e M l E A 2011 m e y L i N a b S - n I h F a d o G e D O r E -
M OUTSTANDING MEDICAL L o T s d U n n W o O a E p RESEARCH SCIENTIST AWARD s N s i n
o FOR CLINICAL RESEARCH i t S a E c i E l 1 b 1 R u 0 O
p STEPHEN F. LOWRY, MD, MBA 2 N s i E O h H T H T
E HONORING IMPORTANT M N A I O B C R I CONTRIBUTIONS LEADING F M D E E , R H M TO ADVANCES IN P A C N M I H
, DISEASE THERAPY E T o L C r A u N E P E L H . L S E N t C e O X n E S a J E L L V I I . T J C E D P R S A R E W P D E T N E M T R E A C P e N E n i A D d i R s Y U n E S o S N C R I E J m D o T N W r A E e N n G o i E N s I H s i K T m N M m A o B O C R F F O E T A D P U MDA-126 MDAdvisor Spring 11 PRINTER:Layout 1 4/8/11 10:18 AM Page 2
“When you’re committed to helping achieve excellence in all areas of healthcare, you must begin by recognizing it. ”
Chairman & CE O, MDAdvantage ™
® That’s why MDAdvantage ™ sponsors the Edward J. Ill Excellence in Medicine Awards .
New Jersey is home to some of the finest physicians, medical facilities and treatment and education centers in the world. It takes many dedicated people to keep New Jersey’s healthcare at this world-class level, and we believe that the best of the best should be recognized for their outstanding efforts. The Edward J. Ill Excellence in Medicine Awards pay tribute to New Jersey’s physicians, researchers, healthcare professionals and community leaders who exemplify outstanding competence, leadership and dedication to their profession. At MDAdvantage ™, we are proud to recognize those who give so much, and we honor them by donating all profits to fund medical and healthcare scholarships in New Jersey.
A LEADING PROVIDER OF MEDICAL PROFESSIONAL LIABILITY INSURANCE IN NEW JERSEY Two Princess Road, Suite 2 • Lawrenceville, NJ 08648 • 888-355-5551 • www.MDAdvantageonline.com MDA-126 MDAdvisor Spring 11 PRINTER:Layout 1 4/8/11 10:18 AM Page 1
This issue of MDAdvisor covers a On behalf of MDAdvan - wide variety of subjects that will be, tage ™, I am pleased to O
we think, useful and important for E bring you our latest issue
our readers. We are pleased to pro - C of MDAdvisor . One of my
vide a brief introduction to Mary & very favorite events each O’Dowd, the Acting Commissioner spring is the Edward J. Ill N of the New Jersey Department of Health and Excellence in Medicine Awards ®. This prestigious A R Senior Services. We are also pleased to intro - event highlights New Jersey’s reputation for M O T R
I duce in this issue our first update from New excellence in medicine, research and education I A D Jersey Department of Banking and Insurance and distinguishes us from other states E Commissioner Tom Considine. H through the recognition of our world-class E Also in this issue, two medical historians C healthcare leaders and their many accom - H E
T provide fascinating insights into the collision plishments. This awards program is a wonderful of medicine, pharmaceuticals and culture. H opportunity to highlight the many significant T M Dr. Gerry Grob provides a look at how our aspects of medical care and healthcare O culture of youth, the mass marketing of phar - M throughout our state–which can only benefit all R O F maceuticals and recent advances in medicine of our hospitals and physicians. R R have in many instances led to a pathologizing F Profits from this awards program will be E R
T of old age and the emergence of new diag - dedicated to fund scholarships to improve E T
noses, including osteoporosis. In the article T access to healthcare for New Jersey residents. E T L “Prescribing in an Age of ‘Wonder Drugs,’” In 2010, $30,000 in scholarships was provided E
Dr. David Herzberg investigates the varying L to New Jersey medical students. I am very roles that pharmaceuticals play in medical therapeutics. proud this year that we have been able to And I would be remiss if I failed to mention how expand our scholarship program further to include not proud I am that MDAdvisor has been selected for only medical students but also dental and physician MEDLINE ® indexing. This news is extremely gratifying assistant students in our state. and underscores the hard work and dedication of the Once again, this year’s very accomplished honorees publishing staff and Editorial Board members as well as the were generous in providing their perspectives on the contributions of our many distinguished authors. Inclusion future of healthcare–which once again is a highlight of in this prominent database signals recognition of the our spring issue. The topics cover a wide range, demon - Journal’s scientific merit and contributions to the field of strating the breadth of talented individuals who live and medical publishing. But more importantly, MEDLINE work in our state. I hope you will join me in congratulating indexing will help researchers, healthcare practitioners, the 2011 award recipients, and as you think ahead to educators, administrators and students throughout the next year, consider submitting a nomination for 2012. world locate articles published in MDAdvisor . For more information, visit www.EJIawards.org. As always, we look forward to hearing what our readers think of our latest edition. Please contact us at Sincerely, [email protected] to share your thoughts, feed back and ideas for future issues. Patricia A. Costante Sincerely, Chairman & CEO MDAdvantage ™ Insurance Company of New Jersey
Henry H. Sherk, MD Editor-in-Chief
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MDADVISOR A Journal for the New Jersey Medical Community PUBLISHER MDADVISOR PATRICIA A. COSTANTE, FACHE Chairman & CEO MDAdvantage ™ Insurance Company of New Jersey SEL ECTED PUBLISHING & BUSINESS STAFF
® S CATHERINE E. WILLIAMS T Senior Vice President
FOR MEDLINE N MDAdvantage ™ Insurance Company of New Jersey E JANET S. PURO M Vice President INDEXING E MDAdvantage ™ Insurance Company of New Jersey G THERESA D iGERONIMO D Copy Editor E
The Editorial Board of MDAdvisor: A Journal for the New L MORBELLI RUSSO & PARTNERS
Jersey Medical Community is proud to announce that it has W ADVERTISING INC. been selected by the National Library of Medicine to be O EDITORIAL BOARD ® indexed in MEDLINE . N HENRY H. SHERK, MD, Editor-in-Chief
MEDLINE is the largest component of PubMed ® K PAUL J. HIRSCH, MD, Deputy Editor
(http://pubmed.gov/), the freely accessible online database C STEVE ADUBATO, PhD
A CAROL V. BROWN , PhD of biomedical journal citations and abstracts created by the PETE CAMMARANO U.S. National Library of Medicine. Approximately 5,400 STUART D. COOK, MD journals published in the United States and more than 80 VINCENT A. D eBARI, PhD GERALD N. GROB , PhD other countries have been selected and are currently JEREMY S. HIRSCH, MPAP indexed for MEDLINE. JOHN ZEN JACKSON, Esq. The National Library of Medicine uses an NIH-char - SIMON J. SAMAHA , MD tered committee, the Literature Selection Technical Review PUBLISHED BY MDADVANTAGE ™ Committee (LSTRC), to review all new biomedical and INSURANCE COMPANY OF NEW JERSEY Two Princess Road, Suite Two, health journal titles and recommend those to be indexed Lawrenceville, NJ 08648 for MEDLINE. Overall, only 20 to 25 percent of the titles www.MDAdvantageonline.com reviewed are selected for indexing. Phone: 888-355-5551 • Fax: 609-896-8150 [email protected] Future articles as well as those that have been pub - Material published in MDAdvisor represents only the lished since the first issue in 2008 opinions of the authors and does not reflect those of the will be indexed. Citations editors, MDAdvantage ™ Holdings, Inc., MDAdvantage ™ Insurance Company of New Jersey and any affiliated from the articles indexed, com panies (all as “MDAdvantage ™”), their directors, offi - indexing terms and the cers or employees or the institutions with which the author is affiliated. Furthermore, no express or implied warranty abstracts will be included or any representation of suitability of this published material and searchable using is made by the editors, MDAdvantage ™, their directors, offi - PubMed. By being cers or employees or institutions affiliated with the authors. selected for indexing, The appearance of advertising in MDAdvisor is not a guar - antee or endorsement of the product or service of the MDAdvisor will be available advertiser by MDAdvantage ™. If MDAdvantage ™ ever to health professionals endorses a product or program, that will be expressly noted. for many years. Letters to the editor are subject to editing and abridgment. MDAdvisor (ISSN: 1947-3 61 3 (print); ISSN: 1937-0660 (online)) is published by MDAdvantage ™ Insurance Company of New Jersey (“MDAdvantage ™”). Printed in the USA. Subscription price: $48 per year; $14 single copy. Copyright © 2011 by MDAdvantage ™. POST - MASTER: Send address changes to MDAdvantage ™ Insurance Company of New Jersey, Two Princess Road, Suite Two, Lawrenceville, NJ 08648. For advertising opportunities, please contact MDAdvantage ™ at 888-355-55 51. 2 MD ADVISOR | SPRING 2 011 MDA-126 MDAdvisor Spring 11 PRINTER:Layout 1 4/8/11 10:18 AM Page 3 S T N E T N O C – 1 1 0 ™
1 LETTERS FROM THE EDITOR-IN-CHIEF AND THE MDADVANTAGE CHAIRMAN & CEO 2
4 UPDATE FROM THE NEW JERSEY DEPARTMENT OF BANKING AND INSURANCE G
| By Commissioner Tom Considine N I
6 PERSPECTIVES ON HEALTHCARE FROM THE 2011 R P
EDWARD J. ILL EXCELLENCE IN MEDICINE HONOREES S | Edited by Janet S. Puro, MPH, MBA
12 PROFILE OF MARY O’DOWD, MPH ACTING COMMISSIONER NEW JERSEY DEPARTMENT OF HEALTH AND SENIOR SERVICES
14 PRESCRIBING IN AN AGE OF “WONDER DRUGS” | By David Herzberg, PhD
20 PATHOLOGIZING OLD AGE: THE CASE OF OSTEOPOROSIS | By Gerald N. Grob, PhD
28 NEW LEGISLATION TO REGULATE OUT-OF-NETWORK BENEFITS | By Daniel B. Frier, Esq., and Mohamed H. Nabulsi, Esq.
31 REPAIRING THE COMMUNICATION DISCONNECT | By Steve Adubato, PhD
34 MEDICALLY UNEXPLAINED SYMPTOMS IN THE VETERAN POPULATION: CHALLENGES AND OPPORTUNITIES | By Christina Rumage, MSPH, Major General Maria Falca-Dodson, BSN, MA, Susan Santos, PhD, and Ron Teichman, MD
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N IO T A L U G E R from the New Jersey Department UPDATE of Banking and Insurance
SECURING PROVIDER RESTITUTION By Commissioner Tom Considine In 2010, DOBI recouped more than $9 million for medical providers. This figure represents almost half of the Department’s total restitution of more than $20 million The mission of the Department of Banking and Insurance secured in 2010. Further, the $9 million figure does not (DOBI) is to protect and educate consumers and promote include any fines administered by the Department. growth in the industries it regulates. As the Commissioner Instead, the payments came from various administrative of DOBI, I realize that the regulations crafted by DOBI have actions in response to insurer errors such as processing a direct impact on healthcare providers, including doctors delays, improper handling and denials of claims. The and hospitals. With this in mind, my priority is to create and Department continues to actively investigate allegations enforce rules and regulations that promote access to effective of improper claim denials by insurance companies. healthcare and improve clinical outcomes. I also strive to lessen bureaucratic burdens, and eliminate rules that get in MODIFYING MEDICAL MALPRACTICE RULE the way of a better healthcare system. DOBI is moving forward with a regulatory change This process is most successful when DOBI gains input intended to provide additional protections to providers in from a wide range of interested parties whose businesses the event their medical malpractice liability carriers are directly affected by the rules it promulgates –this group become insolvent. Specifically, the rule change addresses of interested parties certainly includes physicians. This article situations involving minors and medical malpractice liability contains new information and pending changes in health insurance claims. The modified rule is designed to insurance rules and regulations about which all physicians pro tect the assets and livelihoods of medical providers, should be aware. while at the same time protecting consumers by extending
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the time for submitting claims. Finally, the rules allow medical providers to use existing During the liquidation process of insurance carriers, CPT codes to bill for the installment payments so billing claims filed against policyholders of the insolvent carrier practices do not need to be modified. These rules will be are covered by the New Jersey Property Liability Insurance effective six months after they are finalized. Guaranty Association (PLIGA) up to $300,000. Toward the end of the liquidation process (when there are very PREPARING FOR HEALTH INSURANCE EXCHANGES few, if any, claims being filed), in an attempt to wind down As the implementation stages of federal healthcare the estate of the insolvent carrier, a bar date is set after reform progress, it is DOBI’s responsibility to make sure which PLIGA will not cover claims against the insureds. New Jersey is ready. In doing so, the Department is prepar - Unfortunately, providers then face potential personal ing for the establishment of health insurance exchanges, exposure to any such claims filed after the bar date. which will be required starting in 2014. This does not reflect Recognizing this potential exposure, the Department on the Governor or on his administration’s thoughts on the realized the statute of limitations for filing claims Patient Protection and Affordable Care Act. We are merely involving minors could extend beyond the bar date complying with the law of the land: implementing the law and that this issue needed to be addressed. The pro - does not necessarily make us supporters of it. posed rule change would allow PLIGA to consider The creation of health insurance exchanges is another claims from patients who had been minors when the bar instance in which the Department has solicited input and date was set. suggestions from interested stakeholders. The first forum was held on February 21, 2011, and gathered comments ALTERING MATERNITY FEE SCHEDULES from providers. Later forums will be held with insurers, In January 2011, the Department formally proposed con sumers, producers and employers to ensure that regulations that outline payment options for obstetric DOBI receives the broadest possible inclusion of ideas providers. The new rules will offer obstetrical providers in design ing the exchanges. the opportunity to be reimbursed for maternity services as those services are delivered rather than global AN ONGOING DIALOGUE reim bursement in which payment is delayed until after An effective healthcare delivery system requires delivery or until the provider’s services end. These rules ongo ing dialogue among all of the affected constituents. I will have a positive impact on the cash flow of obstetrical want to thank the members of the medical community who providers who opt for the installment payments. While have given so much of their time and expertise to assist the insurance carriers will likely see a short-term adjustment Department of Banking and Insurance in the rulemaking period to reconfigure their processes, in the long run, any process and in its efforts to protect consumers and to initial costs imposed on carriers will be outweighed by promote the growth , financial stability and efficiency of the benefits attained by providers. the insurance industry. Before this proposal, the Department sought input from obstetrical provider groups as well as from health MORE INFORMATION insurance industry representatives to ensure the proposals will be successful for billers and payers. As a result of • For more information about these topics and other insurance - that input, the rules provide obstetrical providers a related issues, please visit: www.state.nj.us/dobi/index.html. choice between continuing with the current global reimbursement system or receiving the installment • Current and pending rules can be found at: payments. Stakeholders involved in the discussions also www.state.nj.us/dobi/legsregs.htm. suggested that carriers permit at least three installment payments of equal value if the providers opt in. In addition, • DOBI can be reached at 609-292-7272. if providers choose the payment plan, the sums must equal what the lump sum total would have been had they Tom Considine is the Commissioner of the New Jersey elected the global option. Department of Banking and Insurance.
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PERSPECTIVES ON HEALTHCARE FROM TH201E 1 EDWARD J. ILL EXCELLENCE IN MEDICINE HONOREES
Edited by Janet S. Puro, MPH, MBA The 20 11 Edward J. Ill Excellence in Medicine honorees were asked to write brief responses to given questions in order to share some insight or to expound on their areas of expertise. The replies give us a peek at the work, the concerns and the hopes of these remarkable leaders in healthcare.
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Mark Jay Zucker, MD, JD made a genuine effort to fairly represent the interests of all Director, Heart Failure Treat - thoracic organ programs and their patients. ment and Transplant Program, As a result of my early training at academic medical Newark Beth Israel Medical centers, I have maintained an interest in research Center and Clinical Professor of Medicine at UMDNJ–New endeavors. Over the past 20+ years, I have had the privilege Jersey Medical School of introducing some of the newest pharmaceutical agents and mechanical cardiac support technologies to the res - idents of New Jersey in order to ensure that no New Jersey EDWARD J. ILL PHYSICIAN’S AWAR D® resident ever needs to leave this state to obtain cardiac care elsewhere.
Comment on your accomplishments as a cardiologist and transplant program coordinator. Deborah M. Spitalnik, PhD I would hope that those who know me well would Professor of Pediatrics and acknowledge that I have committed my entire profession - Executive Director of The Elizabeth M. Boggs Center on al career to the treatment of individuals with end-stage Developmental Disabilities at heart disease. However, the one unstated accomplishment, UMDNJ–Robert Wood Johnson of which I am most proud, is that in more than 23 years as Medical School a transplant cardiologist I have rarely, if ever, denied heart transplantation to an acceptable candidate simply because of an inability to pay. It has been my personal VERICE M. MASON philosophy that all individuals, regardless of insurance COMMUNITY SERVICE LEADER AWARD status, are entitled to treatment and that the resources to care for such patients must be found. To this end, I have Describe the significance of The Boggs Center. been fortunate to work at institutions that share this The Elizabeth M. Boggs Center on Developmental philosophy –Loyola University and Newark Beth Israel Disabilities serves as a source of innovation to improve Medical Center. well-being and quality of life for people with developmental Newark Beth Israel Medical Center’s Heart Failure disabilities. Guided by our federal mandates as New Jer - Treatment and Transplant Program did its first transplant sey’s University Center for Excellence in Developmental in 1986. Over the next 25 years, the program matured Disabilities Education, Research and Service, the Center into one of the 10 busiest in the nation. More than 600 promotes a person-centered approach to the needs and transplants have been performed since my relocation to aspirations of people with disabilities and their families and New Jersey in 1989. In 2010, the program was recognized serves as a resource for the complex systems upon which as one of only two in the nation to have a statistically better - they rely for services. than-expected three-year survival rate, no small feat In an effort to enhance access to quality care and to given the challenges facing any program in an inner city. promote health, The Boggs Center utilizes a range of Fortunately, working with a wonderful medical and modalities to build awareness and skills. For example, administrative team has also allowed me to reach beyond stu dents in the third-year pediatrics rotation at UMDNJ– the arena of healthcare to develop critical political rela - Robert Wood Johnson Medical School learn about family- tion ships, which are crucial to any organization’s advocacy centered care by visiting the homes of children with dis - efforts and essential to program growth. These relationships abilities directly, as well as from faculty. For more than 20 have resulted in leadership positions on multiple state and years, the Center has demonstrated the importance of a national committees. Thus, I have had an opportunity to coordinated medical home for adults with disabilities in collab - work on developing (and, I hope, having a positive impact oration with the Department of Family Medicine, contributing on) not only national transplantation allocation policies but to resident education and health policy development. also state transplantation policies. At all times, I have The Boggs Center has educated students in social work,
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psy chology, special education and other disciplines, devel - oped educational materials to assist Medicaid beneficiaries in accessing managed care and to support the transition to adult healthcare, and has conducted research in healthcare utilization, early hearing loss and traumatic brain injury. The early onset and life-long persistence of develop - mental disabilities, which include intellectual disabilities, cerebral palsy, epilepsy, autism and spina bifida, dictate an interdisciplinary approach across a range of services and systems, levels of government and policy arenas. Consultation, model demonstrations and the education of practitioners and paraprofessionals promote self-determination and community participation. This allows The Boggs Center’s dedicated faculty and staff to enhance efforts to improve community living, family support, elementary and sec - teaching must be a priority. Particularly in biochemistry ondary education and the employment of people with and other basic science subjects, the lectures must be disabilities. The Center also addresses spiritual and con - clinically relevant. The goal of instructors should be to gregational supports, physical and mental health and inspire students so that they will want to understand behavioral disorders. the topic in more detail and perhaps con tribute to this The 218 sessions of the Developmental Disabilities area as a physician, researcher or physician scientist. Lecture Series over the span of 28 years exemplify the Small-group learning for medical students is also com mitment of The Boggs Center to developing disability important since their lives as physicians will involve con - services and policies grounded in national best practices. tinuous self-learning and working in a group for the Providing community education to more than 1,500 people benefit of the patient. In addition, training in bench annually, the series has created common ground for col lab - and/or clinical research, either in the summer during orative problem solving and strengthened the capacity of medical school as part of the MD/PhD program or as part the workforce, agencies and delivery systems –inspiring a of fellowship training, is also important. vision of meaningful community life for our fellow citizens My goal for the medical students and fellows who with developmental disabilities, their families and those train in my lab is to teach them to effectively use the who work on their behalf. process of scientific investigation, to help them become familiar with a particular area of medical science and to encourage them to be independent thinkers. Principal Sylvia Christakos, PhD investigators should have a commitment to be excellent Professor, Biochemistry and mentors not only during the time the students/fellows are Molecular Biology, UMDNJ– in the lab but should also provide help and mentorship New Jersey Medical School throughout the various stages of each trainee’s career. If our future physicians have an excellent and positive expe rience in the lab, that experience will inspire them to continue research and exploration. They will know, as physicians, the important questions to ask, and they OUTSTANDING MEDICAL will have the tools to answer those questions through EDUCATOR AWARD sci entific investigation. We are indeed most fortunate to have such out - Discuss how to best prepare the future physicians of standing, hardworking and talented medical students in New Jersey. New Jersey. It has been a privilege and a joy for me to To better prepare future physicians in New Jersey, work with them as a teacher and mentor.
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on cost management as the driver for efficiency and sees hospitals as a growth industry. In the current model, hospitals and physicians coexist in most instances, engaging in parallel Judith M. Persichilli, RN, BSN, MA play to pursue individual goals. The current fee-for-service President & CEO, system supports the individualism and economic self-interest Catholic Health East of all providers. As we look forward to a reformed system, Accountable Care Organizations and “bundling” of payments for episodes of care will become the norm. This makes it alarmingly clear that stronger relationships between physi - cians and hospitals are needed to support risk-bearing OUTSTANDING MEDICAL care models that focus on quality and comprehensive EXECUTIVE AWARD care man agement across the continuum. As we look at the new business model, one striking Describe the challenges healthcare executives and feature that all clinicians, be they physicians, nurses, leaders face in preparing their health systems for the pharmacists etc., can embrace is the focus on quality. In future, especially considering all of the uncertainties 1999, the Institute of Medicine (IOM) released a landmark associated with health reform. report, “To Err is Human.” Based on studies in New York, There is an old Chinese proverb (curse) that says, Colorado and Utah, the IOM estimated that between “May you live in interesting times.” It is reported that this 44,000 and 98,000 Americans died in hospital settings in curse was the first of three curses of increasing severity. 1997 as a result of preventable medical errors. Rather The other two stated: than ascribing these adverse events to errant individuals, • “May you come to the attention of those in authority.” the IOM argued that the scope of medical errors demanded (Sometimes rendered, “May the government be change from healthcare systems. aware of you.”) In the time since the IOM report was first published, • “May you find what you are looking for.” various initiatives have been implemented to track, report, I think all of us in healthcare agree that we are living investigate and create incentives for improving quality in interesting times, and there is no doubt that the gov - and safety. As of October 2008, Medicare no longer pays ernment is aware of healthcare. The last “proverb” is curi - for some hospital-acquired conditions. The Patient Pro - ous –“May you find what you are looking for.” We all tection and Affordable Care Act passed in 2010 continues hoped for a healthcare system of equal access with this focus on quality. cov erage for all, but the question remains, “Will we find In the book Why Hospitals Should Fly , John Nance what we are looking for?” reminds us, “What we can accomplish as a team of mutually There is still much unknown about what a “reformed” respectful and supportive colleagues, checking one healthcare system will look like. At this time, everyone in anoth er for the common good of keeping our patients safe healthcare is challenged as we struggle to manage in the from unnecessary harm, we could never accomplish “old world” of volume, fee-for-service reimbursement, work ing alone.” misaligned incentives and competition, while we are Therein lies the foundation for our mutual success in building the foundation for the “new world” of value, a reformed healthcare system. Hospitals and physicians can integration, risk-taking and collaboration. It is like no longer do it alone. An effective relationship with driving forward with your eyes in the rearview mirror –a physi cians is critical to the success of any hospital or health - daunting task! care system –a relationship based on trust, mutual respect, The essential and most important provision of reform common goals and the common good. My suggestion is to is rooted in a new business model for the hospital industry. start with a quality agenda –one we can equally embrace as The current model calls for more patients and more a cornerstone in the building of a new and better reformed services to garner more revenue. This model focuses healthcare system.
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Stephen F. Lowry, MD, MBA malignant diseases. Given the many underlying comor - Professor, Chairman of the bidities that can eventuate in this life-threatening condition, Department of Surgery and this arena of clinical research assumes even greater Senior Associate Dean for urgency in the face of an aging population and the Education, UMDNJ–Robert advanced technologies applied in modern medicine. Wood Johnson Medical School We now recognize that such severe inflammatory ill nesses are complex processes and will require applica - tion of systems biology principles. Critical illness and OUTSTANDING MEDICAL injury research will benefit from an influx of concepts that RESEARCH SCIENTIST AWARD challenge our existing clinical paradigms and generate FOR CLINICAL RESEARCH new diagnostic approaches and therapeutic themes. One emerging theme is how the brain fashions any individual’s Discuss a topic related to your area of research and genetically determined adaptive capabilities in the con - explain where you see it headed in the future. text of cumulative life experiences (allostasis). As the late I believe that the future will see a continued effort to Ira Black, MD, our distinguished Robert Wood Johnson develop a unifying model of inflammatory risk. Serious neuroscientist colleague, once wrote in the book The injuries and illnesses activate systemic inflammatory Dying of Enoch Wallace: Life, Death, and the Changing responses that, if not effectively resolved, adversely influence Brain: “Brain growth results from cooperation between the function of organ systems as well as prolong hospital - nature and nurture…creating new biological contexts ization and increase mortality. The consequences of such within which genes and cells operate and develop.” I dysfunctional inflammatory responses are frequently the anticipate that future advances in clinical management of common, terminal phenotype for patients with benign and the seriously ill will incorporate individualized diagnostic
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and treatment strategies from the emerging concepts of impact on basic medical science as well as on clinical brain and systemic allostatic risk. sci ence for treatment of human diseases. To this end, my research team and I have adopted an Twenty-five years after the discovery of antisense RNA, investigative approach that integrates molecular, my research team has now found another groundbreaking metabolomic and proteomic data in an effort to develop mechanism for RNA interference, by proteins rather than by a unifying model of inflammatory risk. A unique adjunct RNA. The protein-based mRNA interference to regulate to this model incorporates continuous efferent neural sig - specific gene expression is carried out by highly RNA naling over the course of severe inflammatory illnesses. In sequence-specific endoribonucleases, now termed mRNA concert with our evolving mathematical models, we antic - interferases . We recently found a Red Sea archaeon mRNA ipate that this multiscale approach will yield future interferase that recognizes a specific seven-base RNA insights that will benefit patients with these devastating sequence. Such a highly sequence-specific mRNA inter - conditions. ferase is unprecedented, opening a new avenue to design and create novel mRNA interferases, which will be highly beneficial for basic as well as applied medical sciences. Masayori Inouye, PhD mRNA interferases can be designed to target and silence Distinguished Professor, the expression of harmful human genes such as oncogenes UMDNJ–Robert Wood and other disease-causing genes and to destroy infectious Johnson Medical School RNA viruses such as HIV and influenza viruses.
OUTSTANDING MEDICAL RESEARCH SCIENTIST AWARD FOR BASIC BIOMEDICAL RESEARCH
Discuss a topic related to your area of research and explain where you see it headed in the future. RNA-based mRNA interference using antisense RNA, miRNA and siRNA has been extensively investigated. The original discovery of antisense RNA in E. coli in 1984 by our group and the following application of the antisense technology to regulate specific gene expression and to create cellular immunity to viral infection proved to be pioneering and led to the discovery of various RNA-based gene regulatory mechanisms and technology. The term mRNA interference was coined by us in 1984 to describe the antisense RNA, which acts as mRNA-interfering com plementary RNA. This paper was cited as the first discovery of antisense RNA in “Advanced Information” for the 2006 Nobel Prize in Physiology or Medicine. RNA-based mRNA interference targeting a specific mRNA can be easily achieved in organisms ranging from bacteria to humans simply by using a short RNA comple - mentary to the mRNA to regulate specific gene expression. RNA-based mRNA interference has made a tremendous
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Profile of Mary O’ Dowd, MPH Acting Commissioner New Jersey Department of Health and Senior Services
On March 25, 2011, Mary O’Dowd was nominated by Governor prescription drug assistance programs for New Jersey Chris Christie to serve as the Commissioner of the Department seniors was not reduced. These senior prescription drug of Health and Senior Services. O’Dowd had been serving as programs offer assistance to nearly 164,000 low-income Deputy Commissioner of the Department since March seniors and disabled New Jerseyans. 2010, and in that capacity, oversaw the areas of healthcare As Deputy Commissioner, O’Dowd worked to improve financing, facilities evaluation and licensing, and senior the ability of seniors to live with greater independence benefits. O’Dowd was recently ranked eighth on the list and dignity in their communities by expanding initiatives compiled by NJ Biz of the 50 most powerful people in New such as the Global Options for Long Term Care program –the Jersey Health Care. Medicaid home- and community-based waiver program During O’Dowd’s time as Deputy Commissioner, she that provides seniors access to a broad array of in-home was instrumental in increasing New Jersey’s financial support long-term services. to hospitals through the Department’s Charity Care program, Before serving as Deputy Commissioner, O’Dowd and she reformed the program to make it more equitable served as Chief of Staff for the Department of Health and and predictable. Specifically, despite the unprecedented Senior Services from January 2008 to March 2010. As fiscal crisis facing the State of New Jersey, O’Dowd led the Chief of Staff, she managed a workforce of more than effort to secure an $85 million increase in Charity Care funding 1,800 employees and a budget of nearly $3 billion. In this for fiscal year 2011, as well as ensuring that funding for role, O’Dowd shaped the Department’s policies in the
"Mary has been a champion of the role of nurses in addressing “Mary’s experience at the New Jersey Hospital Association the fragmentation in the healthcare system. Her appreciation and at one of the region’s premier teaching hospitals for the unique gift that each discipline in the interprofessional makes her uniquely suited to tackle the enormous team brings to comprehensive coordinated care will drive challenges facing teaching facilities in the next few a vision for public policy that is critical in this time of years. I have known and worked with Acting Commis - unprece dented change. Further, her deep sensitivity to the sioner O’Dowd on a number of issues and have found role that nurses must play in the redesign of healthcare across her to be a quick study and, more importantly, an attentive the continuum promises a new day for the enhancement of the listener. Both skills will serve her well during this perfect broader public health," said Mary Ann Christopher, President healthcare storm of rapidly changing policy and shrinking and CEO of the Visiting Nurse Association of Central Jersey revenue,” said Dr. J. Richard Goldstein, President of the and the Chair of the Robert Wood Johnson Foundation's New New Jersey Council of Teaching Hospitals. Jersey Nursing Initiative. —J. Richard Goldstein, MD —Mary Ann Christopher, MSN, RN, FAAN
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“Mary is highly qualified for the job because of her “Every Commissioner regardless of his or her specialized strong background in public health combined with a training needs to be a generalist in public health and healthcare high level of expertise in hospital financing. She has a financing and wise enough to decide how best to deploy limited wonderful ability to work through complex issues with financial resources and staff, especially during emer gencies. relative ease, and most importantly, she is truly a Mary's record is that of a successful health legislative liaison, pleasure to work with. She is going to be a terrific Deputy Commissioner, Chief of Staff, hospital association Commissioner of Health and Senior Services for the executive, public health manager and persuasive communi - people of New Jersey,” said Denise V. Rodgers, MD, cator. She'll bring breadth of experience, intelligence and Executive Vice President for Academic & Clinical Affairs energy to the top job and quickly earn the confidence of the at the University of Medicine and Dentistry of New Jersey. public, and public leaders,” Christine Grant, JD, former Com missioner of Health and Senior Services. —Denise V. Rodgers, MD —Christine Grant, JD
areas of healthcare delivery, senior services, public health a degree in biology at Douglass College, Rutgers University. and emergency preparedness. For example, during the During her time at Rutgers University, she found the public H1N1 outbreak in 2009, O’Dowd helped lead New Jersey’s health field especially appealing because of its broad reach multijurisdictional response to the novel pandemic flu. and impact on the overall population’s health. O’Dowd O’Dowd built and managed coalitions consisting of received her master’s degree in public health from healthcare professionals, education officials and federal, Columbia University Mailman School of Public Health with state and local agency representatives. a focus on health services management. She remains active Before joining the Department in 2008, O’Dowd in the Rutgers University community, serving on the Rutgers spent nearly four years at the New York University (NYU) Institute for Women’s Leadership Board and chairing the Langone Medical Center. O’Dowd began her time at Institute for Women’s Leadership Scholar’s Program Alum - NYU with a one-year fellowship in hospital finance, giving nae Board. her exposure to all aspects of hospital finance operations. Acting Commissioner O’Dowd cites end-of-life care policy After completing the fellowship, O’Dowd spent her as an area of interest, as she has personally experienced the next three years at NYU serving as a financial manager in struggles that families face when a loved one is terminally revenue cycle operations. With specific authority over ill. In recent years, O’Dowd lost two family members under revenue cycle operations for the emergency department, very different circumstances. One family member had clearly O’Dowd developed quality assurance programs to defined healthcare directives and therefore was able to achieve objective goals related to productivity and financial pass away at home comfortably, surrounded by family and metrics. As a member of the Emergency Department under hospice care. Another family member suffered a Leadership Team, O’Dowd collaborated daily with clinical stroke, was unable to communicate and had not prepared leadership on a number of department initiatives, including any healthcare instructions for such an event. Subsequently, emergency management and patient satisfaction. this family member spent the remainder of his life moving O’Dowd is well-known in the New Jersey Statehouse back and forth between an intensive care unit and a through her involvement in the New Jersey Hospital nursing home. The family members suffered great anguish Association (where she served as Assistant Vice President because they had to make decisions without knowing the of Legislation and Policy) and the New Jersey General loved one’s wishes. Because O’Dowd feels that New Jersey can Assembly (where she served as a policy aide on healthcare improve the end-of-life experience by empowering patients issues in the late 1990s). In spring of 2004, while at the and their families, if she is confirmed as Commissioner, this New Jersey Hospital Association, O’Dowd led the charge will be one of her key areas of focus. In fact, O’Dowd’s passion on behalf of the hospital community to secure the passage for end-of-life care is shared with her mother, Maureen of legislation resulting in an increase of more than $200 Marchetta, who coordinates the volunteer program for million in additional charity care funding for hospitals. Princeton Hospice. Growing up in a family of health professionals, including Acting Commissioner Mary O’Dowd was born and surgeons, nurses and primary care physicians, O’Dowd raised in New Jersey and currently resides in the city of developed an interest in healthcare and decided to pursue New Brunswick with her husband.
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PRE SCRIBI NG IN AN AGE OF By David Herzberg, PhD “WONDER D RUGS”
Many Americans are familiar with two broad –and apparently popular lore, this article will focus elsewhere, on the contradictory –stories about the role that pharmaceuticals commercial and cultural dimensions of prescription drugs, play in medical therapeutics. One is a tale of revolutionary, using modern psychiatric medicines as a case study. scientific and medical discoveries in which researchers dis - covered a wealth of miracle drugs that have given physicians MIRACLE MEDICINES AND BLOCKBUSTER DRUGS the power to treat and even cure a wide range of illnesses. Central to any accounting of modern pharmaceuticals The other is a tale of revolutionary commercial advances in is the “blockbuster” drug –one whose apparent therapeutic which pharmaceutical companies devised an astonishing value and commercial hype leads to widespread use and range of creative gimmickry to persuade millions of Americans popular visibility, even celebrity. While blockbusters may to swallow oceans of drugs that they do not actually need. seem to be a recent phenomenon, they actually emerged As it turns out, there are elements of truth to both in the 1950s, at the same time that the modern prescription stories. Antibiotics, the polio vaccine, corticosteroids, the drug system came into being. They are not, in other words, birth control pill, thiazide diuretics, minor tranquilizers, a recent corruption of the system but a fundamental antipsychotics, antidepressants and other drugs, all discov - ele ment of how the system was designed to work. ered in the decades since 1940, represent truly wondrous Prescription medicines were not always supposed to medical breakthroughs. But at the same time, the use of be commercial and popular. In fact, they were originally these drugs was powered by some of the most intense conceived as an alternative to the so-called patent med - marketing blitzes of a postwar era justly famous for icine companies of the late-19th century. Since no advertising hoopla –blitzes that also helped drive the use of laws restricted sale or marketing of any medicine, the many other less revolutionary, ineffective or even harmful pharmaceutical industry was easily dominated by these cousin drugs (think, for example, of combination antibiotics rowdy, hard-sell marketeers, offering secret-ingredient con - and Thalidomide). The two stories do not contradict each coctions of questionable value, at least some other; they build on each other. of which included narcotics or other toxins. Even taking both stories into account, however, cannot Self-styled “ethical” companies voluntarily chose to fully explain the place of pharmaceuticals in modern medical focus on a much smaller market niche: They advertised and practice. For this, we need to add at least one more story: a sold only pure, individual drug ingredients of proven cultural history that tracks how people outside the medical medical value and did so solely to pharmacists and physi - world –journalists, political activists, federal regulators and cians. 1 (Too much should not be made of this patent/ethical others –influenced the way drugs have been understood and divide, since the pharmacopeia included few drugs of used. Prescription drugs are powerful therapeutic tools, gen uine therapeutic worth and many that were as toxic as highly profitable commercial goods and contested cul tural patent medicines.) icons. Their role in medicine (and in society at large) is shaped These circumstances began to change in the 20th cen - by the complex interactions between these worlds. tury, for a variety of reasons. First was a steady drumbeat of To prescribe a drug is thus to play a part in multiple dra - new drug discoveries: barbiturates, aspirin, early anti-infec - mas. A prescription is not only a therapeutic decision but also tive agents such as salvarsan (for syphilis) and the sulfa a commercial and cultural act. Understanding how this came drugs, insulin, amphetamines and, during World War II, true to be, and how it has mattered to doctors and patients, is antibiotics penicillin and streptomycin. The Food and Drug important for fully informed prescribing. Because the story of Administration (FDA), founded in 1906 to rein in “patent” medical breakthroughs and drug discovery is already a familiar medicines, slowly came to address the potential dangers of one, well circulated in medical school classrooms as well as these powerful new agents by requiring a physician’s pre -
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scription to purchase them. 2 The revolutionary drug discov - medical worth. They were particularly useful in America’s eries of the 1950s and 1960s –from antibiotics to the birth Freudian era when physicians were taught to recognize the control pill, as well as antidepressants, minor tranquilizers medical significance of even mild anxiety states. The drugs’ and more –were also largely prescription-only. success was also buoyed by the postwar consumer culture, Despite their seeming rejection of the popular market, which accustomed Americans to the conveniences of new the so-called “ethical” pharmaceutical companies remained technological wonders, even as people suffered from an “age commercial enterprises. These companies may not have of anxiety” marked by sharp cultural changes and the threat advertised specific drugs to the public, but they did market of atomic annihilation. 7 their company name more generally and worked with The medical, commercial and cultural developments that what one historian has called “physician collaborators” turned Miltown into a “blockbuster” also created a self- who helped write and circulate inflated claims about reinforcing cycle that ultimately revolutionized American favored products such as amphetamine. 3 psychiatry. Psychiatry had begun to come under increasing World War II vastly intensified the commercial side of criticism for being “unscientific” even as the rest of medicine prescription drugs, as wartime production of penicillin turned more and more to the methods and data of science. spurred industrial consolidation and expansion. Domestic Psychiatric drugs seemed to provide a much-needed way to sales rose from $150 million in 1939 to more than $2 billion replace the idiosyncrasies of psychoanalysis with replicable in 1963 and returned an astonishing 20 percent on scientific approaches. Disagreements over the definition of invest ment –the highest of any industry. 4 “depression,” for example, could be finessed by defining the Higher profits meant intensified commercial compe - illness as constituting whatever symptoms had been felt by tition, which led to dramatic increases in marketing. Much patients successfully treated with antidepressants. Working advertising still targeted doctors and pharmacists, in keeping backwards this way may have been circular (you were suffering with the “ethical” tradition. Sales reps, known as “detail from depression if the treatment for depression helps you), men,” deluged physicians with glossy ads, direct mailings, but it allowed for simple symptom checklists and statistical gifts, free samples and an endless profusion of creative analyses that satisfied the demand to be scientific, without gimmickry. But as marketing executives noted, “the patient wading into crippling battles over etiology. 8 is our customer,” and under a variety of guises, pharma - This setup was also ideal for pharmaceutical companies. In ceutical companies began to “educate” the public about 1962, new FDA regulations required all medicines to be proven drugs through publicity stunts, ghostwritten popular maga - safe, as well as effective, for a specific illness. What better cir - zine articles, public service announcements and more. 5 cumstances than proving a drug’s value in an illness defined No drug embodied the new pharmaceutical boom by response to a drug? Medical and commercial interests years better than the minor tranquilizer Miltown, perhaps intersected perfectly, helping foster the early stages of “med - one of the earliest blockbusters. Launched with an all- icalization,” or what one historian has described as “prescribing out advertising campaign to physicians and (more by numbers.” It became perfectly ordinary to find and treat ill - discreetly) to the general public, Miltown quickly ness in people whose only “symptom” was a numerical set of became one of the best-selling drugs of the 1950s. Carter data –not any subjective experience of being ill. 9 Products, the manufacturer, saw its profits triple, and Miltown The result was a massive rise in prescription became a minor celebrity. The campaign was so successful drug use. Annual prescriptions more than tripled from 425 that it established a seemingly permanent market for minor million in 1953 to 1.5 billion in 1973. For psychiatric medicines, tranquilizers: By 1960, minor tranquilizers were prescribed the numbers were even more dramatic, quadrupling from 54 nearly 50 million times each year, and by the early 1970s, million to 226 million. By the late 1960s, half of all adults had famed successors of Miltown –Librium and Valium –topped used a psychiatric medicine in their lives, and almost 20 per - 100 million prescriptions annually. 6 cent currently used one “frequently.” 10 Medical attention had Despite the marketing hoopla, Miltown and its shifted from anxiety to depression (rates of diagnosis reached com petitors were not merely commercial creations. Minor a rough parity by the early 1970s), and drug treatment shifted tranquilizers, especially the second generation (benzodi - correspondingly to the antidepressants after the new “block - azepines such as Valium) were new discoveries of genuine buster” Prozac was introduced in the 1980s. By the late 1990s,
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“Valium may have helped tarnish the wonder-drug ideal by 1980, but less than seven years later, drug business grew further. Valium use plummeted, even Prozac emerged and breathed new life though it occupied a privileged (and very lightly restricted) into the blockbuster drug paradigm. ” spot on the Schedule of Controlled Substances. 15
BETTER LIVING THROUGH CHEMISTRY AFTER ALL? antidepressants had taken the place of tranquilizers among For psychiatric drugs, the years in the wilderness were the most widely prescribed medicines in America. 11 They were rel atively few. Valium may have helped tarnish the wonder- prescribed often enough, in fact, that critics charged the drugs drug ideal by 1980, but less than seven years later, Prozac were now used to expunge ordinary human feelings that emerged and breathed new life into the blockbuster drug might in other times have been known simply as “sadness.” paradigm. Once again, this development emerged from a confluence of different medical, commercial and A FUNNY THING HAPPENED ON THE WAY TO PROZAC… cultural forces. The transition from the age of anxiety to the age of Prozac’s popularity, for example, clearly grew out of the depression was not as smooth as one might think, however. In increasing importance of depression in psychiatric theory in fact, after two decades of uninterrupted growth, annual pre - the 1970s and 1980s. But the drug also gained attention in scriptions of all sorts dropped by 7.5 percent (116 million) part because of the way pharmaceutical companies relent - between 1973 and 1980; psychiatric medicines alone account - lessly hyped simple versions of the new brain sciences, ed for more than two-thirds of this drop (76 million). Almost helping set the groundwork for miraculous new psychiatric half the drop (50 million) came solely from minor tranquilizers. medicines even before they were discovered. Starting in These numbers did not indicate any widespread switch to anti - the mid-1960s, scientists had begun to suspect that depres - depressants –antidepressants, too, were prescribed less sion was caused by a chemical imbalance. In 1965, during these years and did not rebound until the 1990s. 12 researcher Joseph Schildkraut of the National Institute of What had happened? No new scientific discoveries or Mental Health identified that the culprit was low levels of paradigm shifts in medical reasoning suddenly made anxiety norepinephrine. However, the serotonin hypothesis, less prevalent, and pharmaceutical companies had by no advanced by Swedish researcher Arvid Carlsson, came means reined in their marketing departments. to be the best known and most influential of the new The explanation lies in an emerging culture of distrust of theories –in part because of the simple version of it made medical professionals and the drug industry, driven by a famous by advertisers for Prozac. Magical before-and-after series of ethical and political scandals in research, therapeutics campaigns instructed physicians and the public that the and pharmaceuticals. 13 Of particular significance were revela - cause of depression was simply an inadequate supply of tions about the addictiveness of many psychiatric medicines serotonin, and that this common chemical imbalance could and prescription narcotics, including Valium, the most be elegantly fixed by Prozac, a high-tech drug that appeared prescribed drug in the world. These revelations produced to have few side effects and thus wide potential use. 16 new laws such as the 1970 Drug Abuse Control Act, which Once again, however, culture mattered, too, in creating imposed unprecedented restrictions on physicians’ freedom a blockbuster. At least part of Prozac’s success came to prescribe a wide range of popular medicines. 14 because its boosters (including best-selling psychiatrist The new laws were not the only important consequence Peter Kramer) were able to define it as a “feminist” drug. 17 of the shifting cultural tides. The story of Valium provides a Prozac, they said, empowered women rather than sedating perfect example. As early as 1963, pioneering feminist Betty them. It made them more assertive and competitive. Friedan had argued that tranquilizers were being used to Prozac-takers were “supermoms” with careers, not Valium- help American housewives accept their unfairly limited lot in addled stay-at-home wives. life. By the 1970s, feminists had sharpened this argument by The troubled path from Valium to Prozac raises an impor - focusing on the addictiveness of Valium, trading on already- tant question: Should prescribers try to isolate the “medical” existing popular fascination with drug abuse to dramatize the developments in order to make decisions uncorrupted by dangers of a sexist medical system. Valium became notorious the influences of commerce and culture? From the per - as “Mother’s Little Helper,” and skepticism of the prescription spective of history, this seems like an impossible goal.
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Medical research and treatment always take place in cir - the transformation of human conditions into treatable cum stances powerfully shaped by economic and social factors. diseases. Baltimore: Johns Hopkins University Press.
To make sense of today’s cacophony of wonder drugs, physi - 10 See, e.g., Parry, H. (1968, October). Use of psychotropic cians must be attentive to the multiple dramas of prescription drugs by U.S. adults. Public Health Reports, 83 (10), 799–810. writing –not just to the latest drug trial results, but to the 11 com mercial and cultural contexts that helped produce them. Diagnosis rates from National Disease and Therapeutic Index, 9 (1962), 13 (1963–64), 17 (1964), 21 (1965) and David Herzberg, PhD, is an assistant professor of history National Disease and Therapeutic Index Review, 1 (1) (1970, at University at Buffalo (SUNY) and author of Happy Pills in March), 2(2) (1971, December), 4(1) (1973, June) and 7(2) America: From Miltown to Prozac , Johns Hopkins University (1976, December): All taken from Herzberg, D. (2009). Press, 2009. Happy pills , 260. Prescription trends from National pre - scription audit. (1974–1973). Ambler, PA: IMS America; U.S. Department of Commerce. (1974 –1988). Drug utilization in the 1 Young, J. H. (1961). The toadstool millionaires: A social history U.S.: Annual reviews by the Department of Health and Hunan of patent medicines in the United States before federal Services. Springfield, VA: National Technical Information Service; regulation. Princeton, NJ: Princeton University Press; and Verispan, LLC’s prescription drug audits, 1991 –2005: Liebenau, J. (1987). Medical science and medical industry: All taken from Herzberg, D. (2009). Happy pills , 207. The formation of the American pharmaceutical industry. Baltimore: Johns Hopkins University Press. 12 Ibid.
2 Temin, P. (1979). Origin of compulsory drug prescriptions. 13 Rothman, D. (1991). Strangers at the bedside: A history of Journal of Law & Economics, 22 (1), 91–105; Marks, H. (1995). how law and bioethics transformed medical decision making. Revisiting “the origins of compulsory drug prescriptions.” New York: Basic Books; Starr, P. (1984). The social transforma - American Journal of Public Health, 85 (1), 109–115. tion of American medicine: The rise of a sovereign profession and the making of a vast industry. New York: Basic Books; 3 Greene, J., & Herzberg, D. (2010, May). Hidden in plain sight: Herzberg, D. (2009). Happy pills; Tone, A. (2008); Watkins, The popular promotion of prescription drugs in the 20th E. S. (2001). On the pill: A social history of oral contraceptives. Century. American Journal of Public Health, 100 (5), 793–803; Baltimore: Johns Hopkins University Press; Watkins, E. S. Rasmussen, N. (2005). The drug industry and clinical research (2007). The estrogen elixir: A history of hormone replacement in interwar America: Three types of physician collaborator. therapy in America. Baltimore: Johns Hopkins University Press. Bulletin of the History of Medicine, 79 (1), 50–80. 14 Herzberg, D. (forthcoming). Busted for blockbusters: “Scrip 4 Herzberg, D. (2009). Happy pills in America: From Miltown to mills,” quaalude, and prescribing power in the 1970s. In J. Prozac. Baltimore: Johns Hopkins University Press. Greene & E. Siegel Watkins (Eds.), The prescription in history. Baltimore: Johns Hopkins University Press. 5 Herzberg, D. (2009). Will wonder drugs never cease!: A prehistory of direct-to-consumer advertising. Pharmacy in History, 51 (2), 47–56. 15 Musto, D., & Korsmeyer, P. (2002). The quest for drug control: Politics and federal policy in a period of increasing 6 Herzberg, D. (2009), Happy pills ; Tone, A. (2008). The age substance abuse, 1963-1981. New Haven, CT: Yale University of anxiety: A history of America’s turbulent affair with Press; Spillane, J. (2004). Debating the Controlled Substances tranquilizers. New York: Basic Books. Act. Drug and Alcohol Dependence, 76, 17–29; Courtwright, D. (2004). The Controlled Substances Act: How a “big tent” 7 Herzberg, D. (2009). Happy pills in America: From Miltown reform became a punitive drug law. Drug and Alcohol to Prozac. Baltimore: Johns Hopkins University Press. Dependence, 76, 9–15; Herzberg, D. (2006, March). The pill you love can turn on you: Feminism, tranquilizers, 8 Hirshbein, L. (2009). American melancholy: Constructions and the Valium panic of the 1970s. American Quarterly, of depression in the 20th century. New Brunswick, NJ: Rutgers 58 (1), 79–103. University Press; Metzl, J. (2003). Prozac on the couch: Prescribing gender in the era of wonder drugs. Durham, NC: 16 Healy, D. (2006). Let them eat Prozac: The unhealthy Duke University Press; Horwitz, A., & Wakefield, J. (2007). relationship between the pharmaceutical industry and The loss of sadness: How psychiatry transformed normal depression. New York: New York University Press; sorrow into depressive disorder. New York: Oxford University Herzberg, D. (2009). Happy pills. Press; Horwitz, A. (2003). Creating mental illness. Chicago: University of Chicago Press. 17 Kramer, P. (1993). Listening to Prozac: A psychiatrist explores antidepressant drugs and the remaking of the 9 Greene, J. (2006). Prescribing by numbers: Drugs and the self. New York: Viking Press. definition of disease. Baltimore: Johns Hopkins University Press; Conrad, P. (2007). The medicalization of society: On
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PATHOLOGIZING OLD AGE: THE CASE OF OST EOPOROSIS *
By Gerald N. Grob, PhD
* This article is adapted from the author's recently published article: Grob, G. N. (2011). “Aging to pathology: The case of osteoporosis.” Journal of the History of Medicine and Allied Sciences, 66 (1), 1–39. doi: 10.1093/jhmas/jrq011.
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It was an obvious fact After World War II, American society underwent a series aging process, bone loss “that osteoporosis meant of profound changes. The decline in infant and child became pathological. too little bone. But mor tality in the early 20th century meant that the propor - New scanning technolo - was the loss of bone tion of the elderly in the population would gradually gies and the develop - mass a normal function increase. Equally significant was the rise in disability that ment of numerical scales related to age or was it was associated with advanced age. At the same time, the hastened the process pathologic? development of antibiotics and other drugs, the rapid of change. In 2008, the ” growth of biomedical knowledge and the introduction lowering of the numerical of new technologies all combined to reshape the the ory threshold for the diag - and practice of medicine. Such developments modified nosis meant that virtually all elderly persons required the traditional view that aging was synonymous with treat ment. The transformation of this diagnosis into a major decline and loss of function. This view was replaced by a health problem provides an illustrative case study of the belief that aging and interrelationships between perceptions of aging, gender, disease, though obvi - the celebration of youth, the role of the medical care ously related, involved sys tem and the pharmaceutical industry, the commercial - ization of healthcare, as well as a variety of social, scientific and technological currents. The term osteoporosis did not appear in medical texts in the 19th and early 20th centuries. The origins of the diagno - sis dates back to the 1920s and 1930s when endocrinologists and physiologists began to illuminate the process of dem ineralization and its relationship to organs such as the parathyroid glands, to calcium and phosphorus metabolism, to the role of other endocrine and metabolic disorders and two distinct processes. to diets deficient in calcium, phosphorous and vitamin D. Although aging was Additionally, demineralization was also tied to the relationship inevitable, many aspects of aging could be addressed in between ovarian function and calcium metabolism. ways that minimized the loss of function and expanded Medical interpretations of menopause, in particular, healthy years. and gender, in general, played a crucial role in shaping Such changes hastened the emergence of new research on bone physiology and osteoporosis. diag noses, some of which were related to advancing age. Menopause was redefined as a condition marked by Many of these diagnoses raised questions about their estrogen deficiency rather than part of the life cycle. The boundaries as well as screening and treatment modal - identification of progesterone and estrogen in the late ities. Moreover, the line between at-risk and disease 1920s introduced a new element; menopause could be became increasingly blurred, leading to an expansion treated with estrogen therapy. In the 1950s and 1960s, a in the use of therapies for those without any evidence new rationale for estrogen therapy emerged. Rather of disease. than simply relieving menopausal symptoms, estrogen therapy was a long-term therapy that could stave off the THE EMERGENCE OF OSTEOPOROSIS effects of aging, a claim that resonated with a culture that Nowhere are these generalizations better illustrated venerated youth and interpreted aging with decline. The than in the emergence of the diagnostic category of result was a blurring of the boundaries between normal osteoporosis. In the 1940s, osteoporosis was a narrow and pathological menopause and aging. From the new diagnosis that referred to postmenopausal women with definition of menopause as a deficiency disease, it would nontraumatic vertebral fractures. During and after the be but a short leap to define osteoporosis as a disease 1980s, the condition was invested with new meanings. related to estrogen deficiency rather than a characteristic Rather than being viewed as an aspect of the normal of the aging process. 1
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During and after the 1980s, osteoporo - logic? 3 Given ambiguous and “sis was transformed into a major public POSTMENOPAUSAL OSTEOPOROSIS conflicting data, it was clear that health problem… A culture that placed a AS A MAJOR PUBLIC HEALTH rigorous and objective criteria premium on youth also sought ways of PROBLEM for diagnosing osteoporosis It was within this context that arresting the aging process, as well as were lacking. Fuller Albright, an American endocri - dealing with the disabilities associated During the 1960s and nologist, introduced the diagnosis of with chronic diseases among the elderly. ” 1970s, however, technology postmenopausal osteoporosis in began to play an increasingly 1941. Albright found that, among 42 important role. Sophisticated patients with idiopathic osteoporosis who were under age methods to quantitate bone tissue mass became available. 65, 40 were postmenopausal women and only two were Clear diagnostic criteria, however, were lacking. 4 Never - men. He, therefore, named this subcategory of osteoporosis theless, these new technologies made it possible to postmenopausal osteoporosis. It was an advanced, painful measure bone mass and density, thereby spurring and deforming condition that generally involved the spine interest in skeletal physiology and pathology. The result and pelvis. The severe disabilities of postmenopausal was not only the creation of a group of clinicians and osteoporosis were not caused by traumatic fractures, nor researchers with a vested interest in bones but also an was this a disease that affected large numbers of people. 2 industry that produced imaging equipment. By the Medical texts and articles published between 1950 and mid-1980s, no fewer than nine companies were producing 1980 agreed that osteoporosis was a serious condition, but bone density testing machines. 5 not a major public health problem. It was an obvious fact During and after the 1980s, osteoporosis was trans - that osteoporosis meant too little bone. But was the loss of formed into a major public health problem. The process bone mass a normal function related to age or was it patho - of change was driven by a combination of factors: a recognition of the prevalence of bone fractures among the elderly, a belief that medical science had the power to alleviate health problems associated with aging, an expansion in the boundaries of osteoporosis, the growing influence of pharmaceutical companies, a tendency to define disease by relying on numbers, an emphasis on risk factors to explain disease etiology and the wide - spread dissemination of imaging technologies. The interaction of these factors helped to reshape the diag nostic boundaries of osteoporosis and elevate it into a major public health problem. A culture that placed a premium on youth also sought ways of arresting the aging process, as well as dealing with the disabilities associated with chronic diseases among the elderly. These developments in turn created significant entre - preneurial opportunities for the pharmaceutical industry. Not only did the industry begin to promote drug therapy for osteoporosis, but the industry also labored to raise pub - lic awareness about a presumably underdiagnosed and undertreated condition and framed exaggerated prevalence estimates. The pharmaceutical industry created disease alliances composed of drug company staff, physicians and consumer groups to expand the market for new phar - maceutical products. The industry was especially effective
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in creating fears about the consequences of disease and dence that a high reading is dangerous, although there is thus drew attention to the latest pharmaceutical treatments. no agreement on the optimum treatment threshold. Direct-to-consumer advertising fueled sales. In many cases, Osteoporosis, by contrast, presented a quite different pharmaceutical companies coopted the medical estab - case, if only because the evidence that low BMD as lishment by using their vast financial resources. 6 expressed by the T-score as a good predictor of fracture During these decades of the ‘80s and beyond, medicinal was at best equivocal. professionals also became preoccupied with risk factors as The development of treatment guidelines was explanatory elements in disease etiology. Under these accompanied by broad epidemiological studies circumstances, osteoporosis was redefined as a disease designed to gather information on the incidence of of major proportions, rather than a physiologic process fractures. A series of international epidemiological studies relating to age that was not necessarily pathologic. In 1984, (including American) emphasized that millions of individuals the Fertility and Maternal Health Drug Advisory Committee had osteoporosis and were at high risk for fractures. 9 of the Food and Drug Administration (FDA) recommended The Surgeon General’s report on osteoporosis in 2004 that estrogen therapy was appropriate for post - reinforced concerns about the condition and was menopausal women with bone loss, as well as for use as designed to increase public and professional awareness a preventive therapy for all postmenopausal women. 7 of the disease as well as to endorse a public health Shortly thereafter, the National Osteoporosis Foundation approach to promote bone health. 10 (NOF) was founded. Its role was to advocate government and public support for research, increase public aware - ENTER THE PHARMACEUTICAL ness, educate physicians and other health professionals INDUSTRY and provide information to patients and their families. Under such circumstances, the phar - In 1993, a conference in Copenhagen sponsored by the maceutical industry wasted little time in World Health Organization (WHO) redefined osteoporosis developing and bringing to market a in terms of bone mineral density (BMD) thresholds. variety of drugs designed to treat and Osteo porosis thus became a disease that affected tens of prevent bone loss and thus reduce frac - millions of people –largely women –throughout the world. tures. By the 1990s, the bisphosphonates entered the The deliberations of WHO led to the development of the therapeutic armamentarium. Although their biological T- score, which was a number that quantified the BMD of a effects in inhibiting resorption had been reported a quarter person relative to the average among white women age 20 of a century earlier, the delay in developing their ther - to 29 (T-score above -1). Since virtually all postmenopausal apeutic potential was probably due to the fact that women lost some bone mass, they had negative T-scores. osteo porosis had not yet been elevated to the status of The WHO threshold for a diagnosis of osteoporosis was a a major health problem. Once this occurred, the industry T-score of greater than -2.5, a number that the study group turned its attention to the potential of the bisphosphonates conceded was “somewhat arbitrary.” Using this definition, as a potential competitor of HRT. Alendronate (marketed 22 percent of all women over age 50 had osteoporosis, and by Merck as Fosamax) was among the earliest of the 52 percent had osteopenia. The NOF quickly emulated the bisphosphonates to be introduced. Merck financed two WHO guidelines when it issued its Physician’s Guide to clinical trials, which reported that the drug increased Pre vention and Treatment of Osteoporosis in 1998. 8 BMD at all sites studied and reduced clinical fractures by The fact that osteoporosis was now diagnosed with a 44 percent (relative risk). Relative risk, of course, is in numerical scale was not unique to this diagnosis. In the last many ways a misleading statistic. The absolute reduction third of the 20th century, numbers and scales became was only 1.7 percent (3.8 percent in the placebo group the definition of disease. Thus, desirable levels of blood developed at least one new fracture compared with 2.1 pressure, cholesterol and glucose, for example, have been percent in the alendronate group). 11 In succeeding years, expressed by numbers. At the same time, shifting numbers a variety of other bisphosphonates came on the market, result in a dramatic expansion of the population requiring all with similar results. The randomized controlled trials treatment. In the case of hypertension, there is clear evi - tended to minimize the adverse effects of these drugs,
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which were by no means minor. It is also important to The NOF provided information to the public about drugs to note that much of the funding for osteoporosis research treat osteoporosis, but failed to mention potential risks, came from the pharmaceutical industry. especially when so little was known about the dangers of At the same time, guidelines prepared by medical long-term use. societies, national organizations and government agencies for the management of postmenopausal osteoporosis DILEMMAS OF MODERN MEDICINE proliferated. Yet a meta-analysis of some 21 guidelines NOF recommendations were based on the assumption concluded that their methodological quality was low and that the burden of osteoporotic fractures would increase as offered no clear guidelines to clinicians. 12 The publicity the population grew older. Yet a series of studies found given to osteoporosis by the NOF as well as other national that the reverse was the case. Between 1985 and 2005, for and international organizations –to say nothing of the example, age-standardized rates of hip fractures declined direct-to-consumer advertising by pharmaceutical in Canada. The decrease began before bone density testing firms –had a dramatic impact. Recommendations for and pharmacotherapy. The decline in the latter period screening proliferated despite weak evidence of efficacy. might have been due to bone density testing and treat - In 2008, the NOF issued stunning recommendations for ment, but the reductions seen in males who were not a practitioners. It recommended that all women and men tar get for screening and treatment militated against such be tested for BMD, the former beginning at age 65 and an explanation. Study authors conceded that there was “no clear answer” that could explain the decline. I5 A systematic review of The NOF provided information to the public about drugs to treat bone density measurement from the o“steoporosis, but failed to mention potential risks, especially when Swedish Council on Technology so little was known about the dangers of long-term use. ” Assessment in Health Care noted that
the latter at age 70. 13 Such guidelines had the effect of expanding in a dramatic manner the number of persons –over - whelmingly women –who would be rec - ommended for pharmacological treatment of osteoporosis. In one study that applied the NOF criteria to 6,096 women participating in the Study of Osteoporotic Fractures, the investigators estimated that at least 72 the technology did not percent of American white women 65 years and older and provide reliable infor - 93 percent age 75 and older would be recommended for mation about whether drug treatment. 14 fracture would occur in the That fact that the pharmaceutical industry welcomed future. Falls, as a matter of fact, were a better the NOF guidelines was no surprise. Indeed, since its predictor of limb fracture than low BMD. Increased risk of founding in 1984, the NOF maintained a close rela - falls could be caused by such factors as poor eyesight, tionship with the industry. The NOF received financial diseases that affected balance, coordination or muscle support from leading pharmaceutical firms, and many strength, use of psychotropic medications, certain endogenous members of the NOF Board of Trustees had ties to factors such as vitamin D deficiency and walking on ice and pharmaceutical firms. (Unfortunately, three queries by snow. 16 Indeed, studies of interventions to prevent falls, this author to the NOF requesting information on contri - including muscle strengthening, balance retraining and walk - butions by pharmaceutical companies went unanswered.) ing proved more effective in reducing fall-related injuries. 17
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By the beginning of the 21st century, the original concern with a “small subgroup of women with a history of non-traumatic fracture and disability had been lost from view. ”
The emergence of osteoporosis as a major health prob - H. M. (2008). Guest authorship and ghostwriting in publi - lem illuminates many of the dilemmas of modern medicine. cations related to rofecoxib: A case study of industry docu ments from rofecoxib litigation. JAMA, 299, 1800– During and after the 1980s, the diagnosis of osteoporosis 1812; DeAngelis, C. D., & Fontanarosa, P. B. (2008). was invested with new meanings. A culture of youth, a Impugning the integrity of medical science: The adverse belief that the effects of aging could be postponed, a faith effects of industry influence. JAMA, 299, 1833–1835; in the redemptive authority of medicine and mass marketing, Angell, M. (2004). The truth about the drug companies: How they deceive us and what to do about it. New York: first of HRT and subsequently of a variety of other drugs by Random House. the pharmaceutical industry, all elevated the significance of osteoporosis and dramatically expanded its boundaries. 7 Osteoporosis. (1984). JAMA, 252, 799–802; Watkins, E. S. By the beginning of the 21st century, the original concern (2007). 164–165.
with a small subgroup of women with a history of non- 8 World Health Organization. (1994). Assessment of fracture traumatic fracture and disability had been lost from view. risk and its application to screening for postmenopausal Osteopenia and osteoporosis now included virtually all osteoporosis (WHO Technical Report Series, No. 843). postmenopausal women, as well as many men in the same Geneva: Author, 5; Kanis, J. A., & WHO Study Group. (1994). Assessment of fracture risk and its application to age category. Whether a broadening of boundaries will screening for postmenopausal osteoporosis: Synopsis of result in better outcomes is a question that only the future a WHO Report. Osteoporosis International, 4, 368–381; will answer. National Osteoporosis Foundation. (1998). Physician’s Gerald N. Grob, PhD, is Henry E. Sigerist Professor guidelines to prevention and treatment of osteoporosis. Washington, DC: Author. of the History of Medicine, Emeritus, Rutgers University and an elected member of the Institute of Medicine of the 9 Lyritis, G. P., & MEDOS Study Group. (1996). Epidemiology National Academy of Sciences. of hip fracture: The MEDOS study. Osteoporosis Interna - tional, 6 (Suppl. 3), S11–S15; Reeve, J. [on Behalf of the 1 EPOS Study Group]. (1996). The European prospective Watkins, E. S. (2007). The estrogen elixir: A history of hormone osteoporosis study. Osteoporosis International, 6(Suppl. replacement in America. Baltimore, MD: Johns Hopkins 3), S16–S19; Hooven, F. H., Adachi, J. D., Adami, S., Boonen, Uni versity Press. S., Compston, J., Cooper, C., et al. (2009). The global 2 longitudinal study of osteoporosis in women (GLOW): Albright, F., Smith, P. H., & Richardson, A. (1941). Post - Rationale and study design. Osteoporosis International, 20, menopausal osteoporosis: Its clinical features. Journal of 1107–1116; Barrett-Connor, E. (2009). Predictors of falls the American Medical Association, 116, 2465–2474. among postmenopausal women: Results from the national 3 osteoporosis risk assessment (NORA). Osteoporosis Interna - Newton-Jones, H. F., & Morgan, D. B. (1968, February 3). tional, 20, 715–722. Osteoporosis: Disease or senescence? Lancet, 232–233.
10 4 U.S. Department of Health and Human Services. (2004). Gam, S. N., Poznanski, A. E., & Nagy, J. M. (1971). Bone Bone health and osteoporosis: A report of the surgeon measurement in the differential diagnosis of osteopenia general. Rockville, MD: Author. and osteoporosis. Diagnostic Radiology, 100, 509–518.
11 5 Cummings, S. R., Black, D. M., Thompson, D. E., Applegate, Watkins, E. S. (2007). 172. W. B., Barrett-Connor, E., Musliner, T. A., et al. (1998). 6 Effect of alendronate on risk of fracture in women with low Moynihan, R., Heath, I., & Henry, D. (2002). Selling sickness: bone density but without vertebral fractures: Results from The pharmaceutical industry and disease mongering. British the fracture intervention trial. JAMA, 280, 2077–2082; Medical Journal, 324, 886–891; Angell, M. (2008). Industry- Liberman, U. A., Weiss, S. R., Broll, J., Minne, H. W., Quan, sponsored clinical research: A broken system. JAMA, 300, H., Bell, N. H., et al. (1995). Effect of oral alendronate on 1069–1071; Ross, J. S., Hill, K. P., Egilman, D. S., & Krumholz,
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bone mineral density and the incidence of fractures in post - than reported falls for future limb fractures in women menopausal osteoporosis. New England Journal of Medi - across Europe: Results from the European prospective osteo - cine, 333, 437–443; Kanis, J. A., Gertz, B. J., Singer, F., & porosis study. Bone, 36, 387–398; Eklund, F., Nordstrom, A., Ortolani, S. (1995). Rationale for the use of alendronate in Neovius, M., Svensson, O., & Nordstrom, P. (2009). Variation osteoporosis. Osteoporosis International, 5, 1–13. in fracture rates by country may not be explained by differ - ences in bone mass. Calcified Tissue International, 85, 10–16. 12 Cranney, A., Waldegger, L., Graham, I. D., Man-Son-Hing, M., Byszewski, A., & Ooi, D. S. (2002). Systematic assessment 17 Gillespie, L. (2004). Preventing falls in elderly people: We of the quality of osteoporosis guidelines. BMC Musculoskeletal need to target interventions at people most likely to benefit Disorders, 3, 20. from them. British Medical Journal, 328, 653–654; Chang, J. T., Morton, S. C., Rubenstein, L. Z., Mojica, W. A., Maglione, 13 National Osteoporosis Foundation. (2008). Clinician’s guide M., Suttorp, M. J., et al. (2004). Interventions for the preven - to prevention and treatment of osteoporosis. Washington, tion of falls in older adults: Systematic review and meta- DC: Author. analy sis of randomised clinical trials. British Medical Journal, 328, 680–683; Gates, S., Fisher, J. D., Cooke, M. W., Carter, Y. H., 14 Donaldson, M. G., Cawthon, P. M., Lui, L. Y., Schousboe, J. & Lamb, S. E. (2008). Multifactorial assessment and targeted T., Ensrud, K. E., Taylor, B. C., et al. (2009). Estimates of intervention for preventing falls and injuries among older the proportion of older white women who would be recom - people in community and emergency care settings: Systematic mended for pharmacologic treatment by the new U.S. review and meta-analysis. British Medical Journal, 336, national osteoporosis guidelines. Journal of Bone and Mineral 130– 133; Järvinen, T. L. Sievänen, H., Kahn, K. M., Heinonen, Research, 24, 675–680; Herndon, M. B., Schwartz, L. M., A., & Kannus, P. (2008). Shifting the focus in fracture preven - Woloshin, W., & Welch, H. G. (2007). Implications of tion from osteoporosis to falls. British Medical Journal, expanding disease definitions: The case of osteoporosis. 336, 124–126. Health Affairs, 26, 1702–1711.
15 Leslie, W. D. (2009). Trends in hip fracture rates in Canada. JAMA, 302, 883–889; Kannus, P., Niemi, S., Parkkari, J., Palvanen, M., Vuori, I., & Jarvinen, M. (2006). Nationwide decline in incidence of hip fractures. Journal of Bone and Mineral Research, 21, 1836–1838; Melton, L. J., III, Atkinson, E. J., & Madbok, R. (1996). Downturn in hip fracture inci - dence. Public Health Reports, 111, 146–150; Gehlbach, S. H., Avrunin, J. S., & Pulco, E. (2007). Trends in hospital care for hip fractures. Osteoporosis International, 18, 585–591; Chevalley, T., Guilley, E., Herrmann, F. R., Hoffmeyer, P., Rapin, C. H., & Rizzoli, R. (2007). Incidence of hip fracture over a 10-year period (1991-2000): Reversal of a secular trend. Bone, 40, 1284–1289.
16 Stone, K. L., Seeley, D. G., Lui, L. Y., Cauley, J. A., Ensrud, K., Browner, W. S., et al. (2003). BMD at multiple sites and risk of fracture of multiple types: Long-term results for the study of osteoporotic fractures research group. Journal of Bone and Mineral Research, 18, 1947–1954; Leipsig, R., Cumming, R. G., & Tinetti, M. E. (1999). Drugs and falls in older people: A systematic review and meta-analysis: I. Psychotropic drugs: II. Cardiac and analgesic drugs. Journal of the American Geriatric Society, 47, 30–50; Nelson, S. P. (2000). The fallacy of the BMD: A critical review of the diagnostic use of dual x-ray absorptiometry. Clinical Rheumatology, 19, 174–183; Currey, J. D. (2001). Bone strength: What are we trying to measure? Calcified Tissue International, 68, 205–210; Swedish Council on Technology Assessment in Health Care. (1997). Bone density measure - ment –a systematic review. Journal of Internal Medicine, 241 (Suppl. 739), 5–9; Heaney, R. P. (2005). BMD: The problem. Osteoporosis International, 16, 1013–1015; Kaptoge, S., Benevolenskaya, L. I., Bhalla, A. K., Cannata, J. B., Boonen, S., Falch, J. A., et al. (2005). Low BMD is less predictive
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NEW LEGISL ATION to Regulate Out-of- Network Benefits
By Daniel B. Frier, Esq., and Mohamed H. Nabulsi, Esq.
New Jersey Assembly Bill A3378, introduced on provision may be subject to state licensure actions by the October 7, 2010, includes various provisions that would further Board of Medical Examiners (BME). Additionally, OON regulate the out-of-network payment system in the State of Providers (specifically, licensed facilities) delivering New Jersey, largely to the detriment of out-of-network healthcare services for any nonemergency or elective providers. A substitute for the bill was successfully reported procedure (e.g., ambulatory surgical centers) must out of the Assembly Committee on December 9, 2010, and pro vide the patient receiving the services (in the patient’s the bill was introduced in the Senate on December 20, 2010. primary language) with a description of the procedure The following is a summary of the bill, followed by a brief and an estimate of the costs for those services. OON background regarding the issues that culminated in the Providers (specifically, physicians) violating this provision introduction of the bill and, finally, a brief discussion of the may be subject to actions by the New Jersey Department potential impact of the bill. of Health and Senior Services (DHSS). 3 — Existing law requiring that insurers comply with SUMMARY a patient’s assignment of benefits (by paying OON 1 — Out-of-network (OON) healthcare providers (i.e., Providers directly or by issuing checks to patients and doctors and facilities) would be required to make good- their OON Providers as joint payees) would be amended faith attempts (and appropriately document such attempts) to exclude OON Providers from the benefit of the pro - to collect deductibles, copayments and coinsurance from posed law for a period of one year, upon a showing, by patients. An OON Provider who has made three good-faith insurers, of a pattern of violations of the obligation to and timely attempts to collect will be deemed to have collect out-of-pocket payments from the patient for a sat isfied this requirement. OON Providers may waive such period of at least six months. The legislation would allow payment obligations if they determine that the patient has OON Providers to appeal such a finding to the Office of a medical or financial hardship, provided that waivers are the Ombudsman. not granted “routinely or excessively” and that providers 4 — An insurer offering managed care plans would notify carriers when waivers are granted. be prohibited from terminating an in-network provider 2 — OON Providers (in this case, the physician’s office based solely on the insurer’s determination that the in- staff who schedule procedures, not surgical centers) must network provider referred a patient to an OON Provider. inform their patients (in the patient’s primary language) at Additionally, an insurer would be prohibited from amending the time of scheduling whether the services they seek are its provider agreement more than once per year and must in-network or out-of-network and must explain to the notify in-network providers with at least 30 days prior patient, among other things, his or her financial responsi - writ ten notice of the implementation of the change. bility. OON Providers (specifically, physicians) violating this
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BACKGROUND by WSC because there was no evidence that WSC know - The stated purpose of the bill is to combat routine ingly submitted false claims by failing to disclose to Health waivers of copayments, deductibles or coinsurance Net the practice of not collecting the Patient Por tions. (Patient Portions) by OON Providers. In the context of As such, the Garcia case has been inter preted to stand Medicare, the routine waiver of Patient Portions has been for the proposition that an OON Provider may routinely previously identified by the Office of Inspector General in waive Patient Portions. However, it should be noted that a Special Fraud Alert as an unlawful practice linked to the Garcia case was unpublished, and, thus, does not Medicare fraud. In a recent New Jersey case (explained serve as legal precedent in New Jersey courts. Therefore, below), a private insurer attempted (unsuccessfully) to medical practitioners should be cautious not to accord link the waiver of Patient Portions to insurance fraud undue authority to this case. under the New Jersey Insurance Fraud Prevention Act With this interpretation of the Garcia case in place and (IFPA). When perceived against this backdrop, the driving the enactment of a law (discussed above) that compels force behind the bill seems to be to combat healthcare third-party payors to reimburse OON Providers either fraud and the rising costs of healthcare in this state that directly or as joint payees with the patient, one could argue may be attributable to the greater access to expensive that the playing field has shifted in favor of OON Providers. OON services, which is afforded by OON Providers who But this may be a temporary state. Having failed to secure engage in the routine waiver of Patient Portions. However, a judicial precedent banning the routine waivers of Patient given the potential financial impact of the bill on OON Portions, insurance companies focused their efforts on lob - Providers, it seems more likely that the real impetus for bying for legislation to prevent waivers of Patient Portions the bill is to make it more difficult for Providers to remain and to dilute the effects of the assignment of benefits law. out-of-network, a goal that directly benefits insurers, which One such legislation was S1743, which would have criminal - have been the primary supporters of the bill. To many ized the waiver of Patient Portions by OON healthcare OON Providers (e.g., surgery centers and physicians), the providers. This legislation appears to have died; however, ability to waive Patient Portions is an essential building the bill that is the subject of this article appears headed for block of their business because it enables them to legislative approval. remove a significant financial burden on a patient’s access to OON services (i.e., patients are not likely to POTENTIAL IMPACT obtain out-of-network services if they are required to pay Compliance with the bill’s Patient Portion collection, Patient Portions). Thus, the bill strikes at the very heart of disclosure and record-keeping requirements may burden the OON business model. OON Providers by requiring that they dedicate staff and Interestingly, the bill comes on the heels of a recent resources to perform the necessary administrative tasks. judicial decision that runs counter to the interests of However, the real impact of the bill will be the likely reduc - insurers. In Garcia v. Health Net of NJ, Inc. , the Wayne tion of out-of-network patient volume. This effect will arise Surgical Center (WSC), an OON Provider, was counter - from two components of the bill that are designed to deter sued by Health Net of New Jersey. The case was based patients from seeking services from OON Providers: on WSC’s practice of routinely waiving Patient Portions, • OON Providers must notify patients of the potential allegedly in violation of the IFPA. Health Net argued that cost of the services the patients have sought and their WSC inflated the charges it submitted to the insurer (and, potential responsibility to pay Patient Portions, and thus, submitted false claims to Health Net) because WSC knew, at the time of submission of such claims, that the • the requirement that OON Providers make good- Provider would have accepted whatever amounts Health faith attempts to collect Patient Portions. Both Net paid (even if lower than its stated charges) as payment components will likely have a chilling effect on in full. Health Net sought to recoup reimbursements patients considering an OON Provider. paid to WSC during the period WSC engaged in this practice. Although WSC routinely waived Patient Por - The second component is particularly problematic tions, the court found that there was no fraud perpetrated because it is not clear how the BME or the DHSS will interpret
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“good-faith attempts.” The current draft of the bill provides in-network providers for referring patients to OON that an OON Provider shall be deemed to have made a Providers, due to evidentiary issues that are beyond the good-faith and timely effort to collect Patient Portions if the scope of this article, it is questionable whether such pro - OON Provider makes three attempts to collect. If such an hibition will cause third-party payors to cease this retaliatory attempt is interpreted to mean that OON Providers must practice. Though the bill does not explicitly provide insurers engage a collection company to collect Patient Portions, with a private cause of action against OON Providers who the impact of this component may be magnified as patients do not comply with the bill, it is conceivable that insurers become aware of the employment of this extraordinary may cite such noncompliance as evidence of an OON measure by OON Providers. Provider’s fraudulent intent in an action under the IFPA. Lack of compliance with the disclosure requirements of Likewise, insurers may wrongfully withhold reimburse - the bill may result in action being taken by the BME (with ments from an OON Provider on the basis of the respect to out-of-network physicians) or the DHSS (with Provider’s violation of the requirements of the bill. respect to out-of-network facilities, e.g., ambulatory surgical Providers who object to this bill may contact their centers). It is not yet clear what actions the BME or the local legislators before the bill is enacted, or, if and when DHSS will take in response to an OON Provider’s failure to the bill is enacted, may submit comments to the BME or comply with the disclosure requirements of the bill. However, the DHSS upon opening of the public comment period. it is known that insurers that determine that an OON Daniel B. Frier, Esq., is a partner of the law firm Provider engages in the routine waiver of Patient Portions Frier Levitt, LLC, in Pine Brook, New Jersey, and Chairman are able to avoid compliance with the assignment of benefits of the firm’s Health Law Department. law –thus, they will be able to engage in the practice of submit - Mohamed H. Nabulsi, Esq., is an associate of the ting payment for OON benefits directly to patients. Although firm. the bill would prohibit third-party payors from terminating
30 MD ADVISOR | SPRING 2 011 MDA-126 MDAdvisor Spring 11 PRINTER:Layout 1 4/8/11 10:19 AM Page 31 T C E Only 48 percent of patients said they
N w“ere always involved in decisions
N about their treatment, and 29 percent of patients didn’t know who was in O charge of their case… C ” S I D N O I T A C I N U M M O C E H T G N I R I A P E R
Much has been said and written about the need to improve doctor-patient communication. However, a recent national poll sheds light on the gap between the By Steve Adubato, PhD perceptions of patients versus those of physicians on this subject. The poll, commissioned by the Schwartz Center for Compassionate Healthcare at Massachusetts General Hospital in Boston, surveyed 800 patients who had been
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hospitalized for at least three days within the previous 18 same skills. To what degree do you monitor how months and 500 physicians who spend at least some of engaged, connected and focused you are on not just their time taking care of hospitalized patients. 1 The results what your patients are saying but what they may be found some alarming trends that must be confronted feeling as they are saying it? This awareness is an directly if doctors and those they service are ever to get on important part of the doctor/patient relationship. the same page. Finally, great listeners and overall communicators Only 48 percent of patients said they were always are constantly paraphrasing what is said to ensure that involved in decisions about their treatment, and 29 per cent of the message received is the message intended. The patients didn’t know who was in charge of their case while Medical Education division of the American Academy they were in the hospital. 2 Beth Lown, Medical Director of Family Physicians advises doctors to offer that kind of the Schwartz Center for Compassionate Healthcare, of concrete feedback: “When you summarize what reacted to these alarming statistics by calling them “terrible.” you’ve heard, frame your responses by saying, ‘Let me see Further, she called many of the surveyed patients if I have this right…’ Seek to identify or clarify the “orphans,” implying that they were being neglected and not patient’s feelings by saying, ‘Tell me how you’re feeling cared for in a compassionate and empathetic fashion. about this’ or ‘I have the sense that…’” 4 Gre gory Makoul, Chairman of the American Academy on While this may be difficult to do, given the time Communication in Healthcare, responded to the results, pres sures and constraints most physicians face, commu - saying, “There’s a disconnect between what people say nication with patients cannot be a low priority. The American they want and what’s happening.” 2 Academy of Family Physicians also advocates that physicians make a more concerted effort to understand IMPROVING COMMUNICATION SKILLS their patients’ lifestyles. It is important to know Physicians and patients may never achieve the desired patients’ situations at work, how stressed they are, what is effective level of communication; still, there are huge going on in their home lives, whether they exercise or opportunities to improve the effort toward that goal. not, how much sleep they get and whether they sleep Con sider the following: through the night or wake up because of anxiety or an Although many physicians are convinced that they inability to relax. 4 are good listeners, according to a recent feature story in To gain this information, the physician must minimize the New York Daily News with television doctor and distractions and interruptions when conversing with a renowned surgeon Mehmet Oz, he and many of his col - patient. The Academy points out that some physicians leagues have a long way to go in this regard. Said Oz, “We keep their beeper on while engaging a patient. Others don’t listen. If you listen, you’ll hear things.” According to keep the door open, allowing corridor noise to get in the Dr. Oz, one of the communication problems he has had way of an effective communication experience. 4 Simple with patients has been his mindset, which he has sought things like putting your beeper on silent or closing the to improve. “I get too intellectual about stuff. Interest - door before you begin a conversation will go a long ingly, the best doctors used to say the first thing to do is way in helping you connect with your patients. look at the patient and connect to them emotionally –and Ultimately, better doctor-patient communication then talk about important things. When I’m doing the also demands that physicians be more direct with their show well, I go back to those roots. When I lose that target, patients, confronting the patient behaviors that can serve I lecture you.” 3 as obstacles. What this means is that tip-toeing If Dr. Oz, whose communication skills have helped him around what a patient needs to hear doesn’t help the become a nationwide media celebrity, acknowledges that patient. Of course, compassion and empathy are essential, his listening skills are falling short, it is worth considering but too many patients walk away from an interaction that other physicians might also need to improve those with a physician believing that their prognosis is X
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while the physician involved knows it is Y. When this 2 Weise, E. (2010, December 5). Survey finds gap in com munication disconnect happens, no one benefits. doctor-patient communication. USAToday.com. www.usatoday.com/yourlife/health/healthcare/studies/2010- The more I study, write and think about doctor- 12-06-1Adoctalks06_ST_N.htm. patient communication, the more I realize how difficult, demanding and complex this equation is. However, its 3 Huff, R. (2011, February 14). Dr. Mehmet Oz learns that importance in terms of clinical outcomes and patient listening makes him a better TV host, surgeon, helps him “stay calm.” NYDailyNews.com. www.nydailynews.com/ care is indisputable, making the effort well worthwhile. entertainment/tv/2011/02/14/2011-02-14_dr_mehmet_ Steve Adubato, PhD, is a four-time Emmy Award- oz_learns_that_listening_makes_him_a_better_tv_host_ winning anchor for Thirteen/WNET (PBS) and is a surgeon_helps_him_.html. media analyst for MSNBC. He is a motivational 4 American Academy of Family Physicians. (n.d.). Tips on building speaker and Star-Ledger columnist who has written doctor/patient relations. Family Medicine Interest Group. extensively on doctor-patient communication. http://fmignet.aafp.org/online/etc/medialib/fmig / documents/medschool/survivingpdfs/relationships.Par.0001. 1 The Schwartz Center for Compassionate Healthcare. File.tmp/tips_relationships.pdf. (2010, November 17). Patients, doctors strongly support compassionate healthcare. Bedside Manner. http://www.theschwartzcenterblog.com/2010/11/ patients-doctors-strongly-support.html.
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Medically Unexplained Symptoms in the Veteran Population: Challenges and Opportunities
By: Christina Rumage, MSPH, Major General Maria Falca-Dodson, BSN, MA, Susan Santos, PhD, and Ron Teichman, MD
Medically Unexplained Symptoms (MUS) are considered a Soldiers endure numerous stressful events and environ - common occurrence in medical settings. MUS are symptoms mental exposures in combat that may increase or exacerbate for which physicians cannot find any corresponding physical the risk of experiencing medically unexplained symptoms. diagnoses or for which a clinical diagnosis does not A recent report by the Institute of Medicine concluded account for a patient’s experience or self-report of the that even 20 years after the end of the first Gulf War, MUS severity of a symptom. 1 The frequency of MUS in the primary are highly prevalent, persistent and apparently disabling care environment is high. 2 Fourteen common physical in the Gulf War Veteran population. 5 Based on the history symptoms are responsible for almost half of all primary care of MUS, Veterans who served in our current conflicts, visits, and 85 to 90 percent of these are unexplained. Patients Operation Enduring Freedom, Operation Iraq Freedom with MUS are frequently frustrating to primary care physicians and Operation New Dawn, are also at risk for developing who do not know what is wrong and tend to overutilize MUS. This recurring medical issue among Veterans health services seeking a cause. 3 Within the Veteran patient involves not just providers at the Department of Veterans population, it is well established that a proportion of service Affairs (VA) and Department of Defense hospitals, but members develop MUS after a deployment. Veterans who also civilian clinicians because nationally only approximately have MUS over a period of time may meet the criteria for 50 percent of these returning men and women seek their the diagnosis of a medically unexplained illness (MUI) such healthcare from the VA. As more and more of these as chronic fatigue syndrome (CFS), fibromyalgia (FM) or Vet erans return from conflict, caring for those with MUS irritable bowel syndrome (IBS). remains an important clinical focus in today’s primary care As far back as the Civil War, poorly understood symptoms environment. have been associated with deployment to a hostile area. 4 Commonly seen unexplained symptoms in Veterans
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“Undoubtedly, include pain, fatigue, headaches, New Jersey physicians difficulties with sleep and intermittent gastrointestinal symptoms and will see more and more headaches, which he was told were cognitive problems, among others. 6,7 Veterans with MUS, tension related. During the ensuing Although the etiology of MUS in especially given two years, Tom experienced increas - that a majority of Veterans Veterans and other populations do not receive ingly debilitating fatigue, daily remains unknown, it is understood medical care from the headaches, diffuse joint and muscle that symptoms that remain unex - VA but instead utilize discomfort, exacerbations of long- plained for long periods of time can private providers.” standing problems with low-back and be confusing and frustrating for knee pain, bouts of exertional shortness patients and providers. of breath and fluctuating diarrhea and The VA has a long history of addressing MUS in Veterans. constipation. He found that he was more forgetful The War Related Illness and Injury Study Center (WRIISC) and was having problems with his concentration. He was initiated in 2001 by federal law to develop a plan for also began having increasing problems with anger establishing national centers for the study of war-related and irritability. illnesses and post-deployment issues, including those Tom had undergone multiple medical evaluations that are medically unexplained or without medical and a myriad of tests –all of which were “normal.” He diagnoses. New Jersey physicians seeking help with described the entire process as unsatisfactory because diagnosing and treating their Veteran patients with MUS “no one has really been able to tell me what’s causing can turn to the WRIISC located at the VA’s New Jersey my problems . . . usually doctors act like there is nothing healthcare facility in East Orange. (There are two other wrong or tell me it is in my head.” He expressed mistrust WRIISC locations: Washington, DC, and Palo Alto, CA.) of the military and the Department of Veterans Affairs. Established as a national program, the WRIISC serves He believed that his symptoms were related to chemical as a resource to VA and non-VA providers for the identifi - weapons exposure. cation and management of MUS and as a second-level At the completion of the evaluation and consulta - opinion for Veterans with ongoing MUS within the Veterans tions at the WRIISC, Tom was informed that he had Health Administration. Veterans with MUS can be referred fibromyalgia and irritable bowel syndrome. The team also to the WRIISC for a second-opinion evaluation conducted determined that he had continued sequelae from a by a team of experts. This evaluation consists of an in-depth significant mild traumatic brain injury, which, when history and physical examination, psychological, neu - combined with his post traumatic stress disorder, ropsychological and social work evaluations and a meeting accounted for his memory and concentration difficulties, with a health education specialist as well as an occupational headaches and irritability problems. His chronic muscle, and environmental medicine physician to discuss exposure bone, back and head pain also significantly contributed concerns. Depending on the complexity of the problems, to his chronic fatigue, which in turn worsened his these evaluations take up to two full days to complete. chronic pain. Each Veteran receives individualized attention from the entire clinical team for the duration of his or her evaluation. Being able to diagnose MUS is important, but provid - A typical patient evaluated at the WRIISC is illustrated in ing assistance to Veterans suffering from MUS is the more the following case presentation: important clinical goal. At the end of the comprehensive Tom is a 35-year-old man who served as an clinical evaluation, Tom got the opportunity to sit down with infantry scout during Operation Iraqi Freedom. During the entire team of specialists to discuss their findings and to his time in Iraq, his bowel movements were loose receive his individualized recommendation plan, or “road- and unpredictable. He was otherwise healthy. Within map.” This document addressed his health concerns and two months of leaving Iraq, Tom began having gave him a path forward to improve the quality of his
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"New Jersey physicians seeking help with diagnosing and treating their Veteran patients with MUS can turn to the WRIISC located at the VA's New Jersey healthcare facility in East Orange."
Christina Rumage, MSPH, CHES, is an Education Specialist at the WRIISC in New Jersey. Major General Maria Falca-Dodson, BSN, MA, is the Assistant Director, Outreach, at the WRIISC in New Jersey day-to-day life. The clinical team also recommended treat - and the current Commander of the New Jersey Air ments for Tom to try with the help of his referring doctor National Guard. that have been proven effective for MUS, such as graded Susan L. Santos PhD, MS, is the Assistant Director exercise for pain/fatigue and medication therapies. A copy for Education and Risk Communication at the WRIISC in of the clinical recommendation summary was sent to Tom’s New Jersey and an assistant professor in the School referring provider to facilitate the patient and doctor’s of Public Health at the University of Medicine and effort to work collaboratively. The team further assisted Den tistry of New Jersey. Tom’s treatment process by being available to speak to his Ron Teichman, MD, MPH, FACP, FACOEM, is the doctor about any of the recommendations that were made Associate Director of the WRIISC in New Jersey. and to answer any questions about the WRIISC areas of 1 specialty. A WRIISC social worker also followed up closely Swanson, L. M., Hamilton, J. C. & Feldman, M. D. (2007). Physician-based estimates of medically unexplained with Tom after his visit to support him along the way, assess symptoms: a comparison of four case definitions. Family any obstacles to implementing the recommendations and Practice, 27 (5), 487–493. to help connect him to additional resources as needed. 2 Veterans, with cases similar to Tom’s, who have been Guthrie, E. (2008). Medically unexplained symptoms in primary care. Advances in Psychiatric Treatment, 14, 432–440. evaluated at the WRIISC have reported a high level of satisfaction, specifically regarding the amount of individualized 3 Katon, W. J. & Walker, E. A. (1998). Medically unexplained attention they receive, the staff’s communication skills and symptoms in primary care. Journal of Clinical Psychiatry, attention to detail, new diagnoses that are made, and also 59 (Suppl 20), 15–21.
the individualized treatment plans that map out the next 4 Hyams, K. C., Wignall, F. S., & Roswell, R. (1996). War syn - steps to take once the Veterans leave the WRIISC. dromes and their evaluation: From the U.S. Civil War to the Undoubtedly, New Jersey physicians will see more Persian Gulf War. Annals of Internal Medicine, 125 (5), 398–405. and more Veterans with MUS, especially given that a majority 5 Institute of Medicine Committee on Gulf War and Health. of Veterans do not receive medical care from the VA but (2010). Gulf War and health: Vol. 8. Update of health instead utilize private providers. Believing that Veterans effects of serving in the Gulf War. Washington, DC: National deserve the best our country has to offer, the New Jersey Academies Press. WRIISC seeks to work collaboratively with all New Jersey 6 Unwin, C., Blatchley, N., Coker, W., Ferry, S., Hotopf, M., physicians to improve the care and quality of life for these Hull, L., et al. (1999). Health of UK servicemen who served men and women with post-deployment health concerns. For in Persian Gulf War. Lancet, 353 ,169–178. more information about the WRIISC clinical services for 7 David, A. S., Farrin, L., Hull, L., Unwin, C., Wessely, S., & Veterans, its educational programs for providers or Wykes, T. (2002). Cognitive functioning and disturbances of Veteran referrals, please visit the WRIISC website at mood in UK Veterans of the Persian Gulf War: A comparative www.warrelatedillness.va.gov. To make a referral, please study. Psychological Medicine, 32 (8), 1357−1370. call 1-800-248-8005.
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