Ineffective pain care costs Americans more than $100 billion annually

• Author: Health Informer
• Filed under: Health News
• Date: Oct 27,2009

Businesses Lose $61 Billion Annually in Lost Productive Time Due to Pain; Population-Based Approach Now Being Fostered

A new Pain Medicine Position Paper published by leaders of the American Academy of Pain Medicine (AAPM), reveals businesses lose $61 billion annually due to ineffective pain care and the lack of optimal pain care delivery. Leaders from the organization are now implementing and teaching a new, “population-based” approach to delivering care with the goal of alleviating pain so patients can get on with their lives.

AAPMedicine’s President Rollin M. Gallagher, MD MPH comments, “Pain affects everyone, and for many millions, pain becomes chronic, a scourge that affects every part of their lives–their work, their hobbies, their friendships, their families, their sex, their fun, their finances, their mood, and even their fundamental sense of identity, who they are. According to the National Institutes of Health, pain is one of our most important national health problems, costing the American public more than $100 billion each year in health care, compensation and litigation. The AAPMedicine’s Position Paper offers solutions that will fundamentally change the way pain is approached in the health care system. The Paper proposes a population-based approach to pain management that will both improve the competency of the health care system to manage pain for the millions of patients suffering needlessly in hospitals with acute pain and on into their lives with chronic pain, and will also reduce the cost of pain to our society. People will be able to work who couldn’t work before. People who work will work longer, better and more productively. People with terminal cancer will die in comfort, preserving their personal dignity and mitigating the emotional suffering of their families. The Proposal is consistent with the medical home approach being fostered as a solution to the problems besetting our health care system, an approach that emphasizes patient responsibility, early effective treatment, and when pain becomes chronic, competent longitudinal treatment, what we call ‘chronic illness management’.”

A population-based approach to pain includes stepped care that is designed to deliver timely access to levels of care that are needed to prevent chronic pain from beginning, or when pain persists, minimizing morbidity through effective care:

Step One: Prevention of disease or injury with the use of evidence-based self-care, such as diet, exercise, ergonomics (alteration of work activities) or cessation of smoking and other drug abuse to reduce the risk of injury or disease.

Step Two: If self-care is not working, patient will then visit their primary care physicians for evaluation and management using evidence-based algorithms.

Step Three: If disabling pain persists, the patient will be referred to a pain medicine specialist who will collaborate with a team of providers, including, nurse case managers, psychologists and physical therapists.

Step Four: If the patient remains in disabling pain, he or she will be referred to a pain medicine specialist within a subspecialty of care.

Currently there is no unified organizational model of pain medicine, which has led to ineffective and fragmented pain care with poor outcomes and higher costs than necessary. This fragmentation threatens patient safety and causes the passing of a patient from doctor to doctor for a diagnosis and pain treatment, even though that doctor may have had minimal or even no specific training in chronic pain management. The Academy believes one of the solutions to this complex problem is the establishment of Pain Medicine as a recognized primary medical specialty. This recognition would allow Pain Medicine’s specialized knowledge, education, training, and multidisciplinary approach to provide standardized training for all physicians and integrated and comprehensive pain care to millions of Americans suffering with acute, cancer and chronic pain.

One segment of society that has carried the burden of an ineffective pain care delivery system is the business community. It is estimated to cost $61.2 billion annually in lost productive time. The majority of this cost (76.6%) is attributed to reduced performance while at work, not work absence. During the course of two weeks, 13 percent of the total workforce experienced a loss in productive time due to a common pain condition. An estimated 3.8 billion hours of work are also lost annually due to pain. For additional statistics on the cost of pain care to businesses visit www.painmed.org.

As the largest purchasers of healthcare, businesses have much to lose from ineffective pain treatment of their employees. Finding a unified approach to pain medicine is critical. Back pain alone cost businesses $19.8 billion in lost productive time, with almost three-quarters of the cost attributed to complications of back pain from the lack of proper care.

“The ineffective treatment of pain results in an escalating cascade of health care issues. Acute pain that is not treated adequately and promptly results in persistent pain that eventually causes irreversible changes in the brain and spinal cord. This is referred to as neuropathic pain, a neurobiological disorder that is difficult to diagnose and manage. Persistent pain of this nature often results in further bio-psycho-social changes, which in turn result in further pain and increasing disability. This vicious cycle transforms a human being into a patient who unwittingly becomes a burden to himself, his family and society at large. The emotional, societal and financial costs are immeasurable,” according to AAPMedicine’s Executive Medical Director, Philipp M. Lippe.

Currently there are not enough pain medicine specialists to treat back pain and other pain conditions, and the system for training physicians in the discipline of pain medicine remains insufficient. The Academy’s solution calls for better residency training programs in pain medicine, which will lead to better and more cost-effective pain care.

Recognizing pain medicine as a primary medical specialty would also increase federal funding into pain research. As the population ages, there will be an increased need for physicians who have both specific expertise in pain medicine and broader training in the needs of an aging population. An increase in federal funding for pain research is critical to keep pace with the growing problem of pain in America.

Taking these steps will also improve health care coverage for pain care. Insurance companies often refuse to cover pain-relieving treatments, and access to pain rehabilitation is non-existent in many parts of the country. The Veteran’s Affairs’ medical system has recognized the need for change in pain care and now requires VA health care institutions to provide organized pain assessment and management. Developing an optimal system of pain care delivery would not only address better healthcare for the millions of Americans in daily pain, but its benefits would filter down to both businesses and society. Safe, effective and affordable pain treatment is possible, and the benefits are immeasurable. Click here to view the Pain Medicine Position Paper.

Source: American Academy of Pain Medicine

New studies demonstrate benefits of Minimally Invasive Hysterectomy and Colectomy when compared to open surgery

• Author: Health Informer
• Filed under: Health News
• Date: Oct 26,2009

Significant Clinical and Economic Benefits Found in Analysis of More than 25,000 Procedures

Ethicon Endo-Surgery announced results from two newly published studies that demonstrate a minimally invasive approach in three common procedures resulted in a reduced rate of complications and lower overall cost of care, including a difference of more than $15,000 on average for minimally invasive colectomies, when compared to open surgery. One study compared two types of minimally invasive hysterectomy procedures to open abdominal hysterectomy(i) and another study analyzed outcomes of minimally invasive approaches for appendectomy and colectomy procedures compared to open surgery(ii).

The study titled “Open Abdominal versus Laparoscopic and Vaginal Hysterectomy: Analysis of a Large United States Payer Measuring Quality and Cost of Care” showed, in line with previous studies, minimally invasive hysterectomy reduced rates of postoperative infection and length of stay in the hospital when compared to open abdominal hysterectomy. Open surgery was also associated with higher costs than those who underwent laparoscopic and vaginal hysterectomy. Given these findings, the study authors concluded a substantial opportunity exists to shift more hysterectomies from an in-patient to an outpatient setting while maintaining or improving the clinical outcome for patients.

“The clinical and economic outcomes of the study demonstrate the need for higher adoption of minimally invasive hysterectomy procedures in patients who are candidates for this approach,” said Lori Warren, M.D.,* lead author of the study and an advanced gynecologic laparoscopic surgeon with Women First of Louisville. “In this age of comparative effectiveness, this study shows that when it comes to hysterectomy, a minimally invasive approach gives physicians the opportunity to increase the quality of care women are receiving while potentially saving the healthcare system millions of dollars. Clinicians who have had concerns that minimally invasive procedures may be riskier for patients should be reassured because this real-world data demonstrates the overall complication rate is actually higher with the open abdominal approach.”

When compared with patients that underwent an open abdominal hysterectomy, the vaginal approach was associated with an average cost-savings of more than $4,000 and laparoscopic hysterectomy an average of $2,000 in cost-savings. Among the three methods of hysterectomy, open abdominal hysterectomy remains the most common approach as 70 percent(iii) of procedures are still performed in this manner, despite the clear benefits of minimally invasive approaches. The retrospective analysis was performed on 15,404 patients using claims data from a large U.S. managed care plan. The results of the study, which was sponsored by Ethicon Endo-Surgery, were published in the September issue of The Journal of Minimally Invasive Gynecology.

In similar findings, another study titled “Comparison of the Clinical and Economic Outcomes Between Open and Minimally Invasive Appendectomy and Colectomy: Evidence from a Large Commercial Payer Database” concluded minimally invasive appendectomy and colectomy were associated with lower infection rates, fewer complications, shorter hospital stays and lower expenditures than open surgery. The results of the retrospective analysis, which was also sponsored by Ethicon Endo-Surgery, has been accepted for publication in the peer-reviewed journal Surgical Endoscopy and is currently available on the journal’s Web site. The data included analysis of 7,532 appendectomy and 2,745 colectomy procedures using a large commercial payer database.

“This data strongly suggests that if someone needs a colectomy, regardless of age, a minimally invasive procedure will result in fewer complications, get them out of the hospital several days sooner and cost the healthcare system $15,000 less than if the patient underwent open surgery,” said Terrence Fullum, M.D*., Associate Professor of Surgery at Howard University College of Medicine and lead author of the study. “Unfortunately, there is a great disparity between the number of colectomy procedures performed with open surgery compared to minimally invasive procedures. This study is the latest in a substantial and growing body of clinical and economic evidence that I believe supports a call to action among the entire healthcare community to increase access to the benefits of minimally invasive colectomy.”

“Open Abdominal versus Laparoscopic and Vaginal Hysterectomy: Analysis of a Large United States Payer Measuring Quality and Cost of Care”

Investigators of the study collected data on intraoperative and postoperative complications, length of stay, rates of readmission, and insurer and patient payment totals for inpatient and outpatient procedures. Of 15,404 patients, MIP was performed in 43 percent of subjects, with 23 percent (3,520) undergoing laparoscopic hysterectomy, and 20 percent (3,130) a vaginal hysterectomy. The study demonstrated that postoperative infection rates were higher for patients undergoing open abdominal hysterectomy: 18 percent as compared with 15 percent of laparoscopic and 14 percent of patients undergoing vaginal hysterectomy (P<.05). With open abdominal hysterectomy, average length of stay was 3.7 days versus 1.6 and 2.2 for patients undergoing MIP laparoscopic and MIP vaginal hysterectomy, respectively.

In addition to the clinical benefits, the data indicated costs associated with MIP were lower than for patients undergoing open abdominal hysterectomy. Healthcare spending, represented as the expenditures for inpatient and outpatient care associated with the procedure, included expenses related to surgical and medical therapy. Adjusted expenditures associated with outpatient MIP were markedly lower than expenditures for inpatient open abdominal hysterectomy, indicating significant savings can be realized when patients can be treated with an MIP procedure in an outpatient setting rather than undergoing an inpatient procedure – MIP or open. When adjusting for the setting, the cost of outpatient laparoscopic hysterectomy averaged $9,426 and vaginal hysterectomy $7,627 compared to $11,739 for inpatient open hysterectomy.

“Comparison of the Clinical and Economic Outcomes Between Open and Minimally Invasive Appendectomy and Colectomy: Evidence from a Large Commercial Payer Database”

Investigators analyzed medical and pharmacy claims data from a large U.S. managed health care insurer and measured post-operative infection rates, procedure-specific complications, length of hospital stay, readmission rates and expenditure rates. The data included 2,745 patients who underwent colectomies; 842 (31 percent) were treated using a minimally invasive approach whereas 1,903 (69 percent) underwent open surgery. Post-operative infection rates for those who underwent an MIP were lower (24 percent) than those who had open surgery (38 percent) as were minor (17 percent vs. 23 percent) and major bleed rates (4 percent vs. 10 percent). When measuring the predicted length of stay (with adjustments for factors such as surgical approach, patient age, and co-morbidities), the data indicated open surgery resulted in a length of stay four days longer when compared to MIP. Overall, the investigators concluded minimally invasive colectomy procedures were associated with a cost of care $15,200 less than open surgery.

When assessing these same outcomes for open and minimally invasive appendectomies the investigators found similar results. The data on 7,532 patients who underwent appendectomies included 5,304 (70 percent) who underwent an MIP and 2,228 (30 percent) treated with open abdominal surgery. Post operative infection rates (16 percent for MIP vs. 20 percent for open) and overall procedure specific complication rates (2.51 percent for MIP vs. 3.82 for open) were lower for minimally invasive procedures when compared with open surgery. Additionally, minimally invasive appendectomy was associated with a lower cost of care ($700) and about a half day shorter hospital stay (3.27 vs. 3.91 days) than open surgery.

Notes:

*Paid consultant for Ethicon Endo-Surgery

(i) Warren L, Ladapo JA, Borah BJ, Gunnarsson CL. Open Abdominal versus Laparoscopic and Vaginal Hysterectomy: Analysis of a Large United States Payer Measuring Quality and Cost of Care. Journal of Minimally Invasive Gynecol. 2009; 581-587.

(ii) Fullum TM, Ladapo JA, Borah BJ, Gunnarsson CL. Comparison of the clinical and economic outcomes between open and minimally invasive appendectomy and colectomy: evidence from a large commercial payer database. Surgical Endoscopy 2009 (published online).

(iii) Babalola E, Bharucha AE, Schleck CD, Gebhart JB, Zinsmeister AR, Melton LJ 3rd. Decreasing utilization of hysterectomy: a population-based study in Olmsted County, Minnesota, 1965-2002. Am J Obstet Gynecol. 2007;196:214-217.

Source: Ethicon Endo-Surgery

One shot of gene therapy and children with congenital blindness can now see

• Author: Health Informer
• Filed under: Health News
• Date: Oct 25,2009

Born with a retinal disease that made him legally blind, and would eventually leave him totally sightless, the nine-year-old boy used to sit in the back of the classroom, relying on the large print on an electronic screen and assisted by teacher aides. Now, after a single injection of genes that produce light-sensitive pigments in the back of his eye, he sits in front with classmates and participates in class without extra help. In the playground, he joins his classmates in playing his first game of softball.

His treatment represents the next step toward medical science’s goal of using gene therapy to cure disease. Extending a preliminary study published last year on three young adults, the full study reports successful, sustained results that showed notable improvement in children with congenital blindness.

The study, conducted by researchers from the Center for Cellular and Molecular Therapeutics at The Children’s Hospital of Philadelphia and from the University of Pennsylvania School of Medicine, used gene therapy to safely improve vision in five children and seven adults with a Leber’s congenital amaurosis (LCA). The greatest improvements occurred in the children, all of whom are now able to navigate a low-light obstacle course–one result that the researchers call “spectacular.”

“This result is an exciting one for the entire field of gene therapy,” said Katherine A. High, M.D., co-first author of the study and the director of the Center for Cellular and Molecular Therapeutics, the facility that sponsored the clinical trial at The Children’s Hospital of Philadelphia. High, an investigator of the Howard Hughes Medical Institute and a past president of the American Society of Gene Therapy, has been a pioneer in translational and clinical studies of gene therapy for genetic disease. “This study reports dramatic results in restoring vision to patients who previously had no options for treatment,” said High. “These findings may expedite development of gene therapy for more common retinal diseases, such as age-related macular degeneration.”

Although the patients did not attain normal eyesight, half of them (six of 12) improved enough that they may no longer be classified as legally blind. “The clinical benefits have persisted for nearly two years since the first subjects were treated with injections of therapeutic genes into their retinas,” said senior author Jean Bennett, M.D., Ph.D., F.M. Kirby professor of Ophthalmology at the University of Pennsylvania School of Medicine. For Bennett, the results build on nearly 20 years of gene studies on hereditary blindness, starting with pioneering work in mice and dogs. “These remarkable results,” she added, “have laid a foundation for applying gene therapy not only to other forms of childhood-onset retinal disease, but also to more common retinal degenerations.”

The study team reported their findings today in an online article in The Lancet.

“Children who were treated with gene therapy are now able to walk and play just like any normally sighted child,” said co-first author Albert M. Maguire, M.D., an associate professor of Ophthalmology at Penn and a physician at Children’s Hospital. “They can also carry out classroom activities without visual aids.”

Maguire and Bennett have been researching inherited retinal degenerations for nearly 20 years. Leber’s congenital amaurosis (LCA), the target of this current study, is a group of inherited blinding diseases that damages light receptors in the retina. It usually begins stealing sight in early childhood and causes total blindness during a patient’s twenties or thirties. Currently, there is no treatment for LCA.

For children and adults in the study, functional improvements in vision followed single injections of genes that produced proteins to make light receptors work in their retinas. Walking along a dimly lit, simulated street route, the children were able to negotiate barriers they bumped into before the surgery. Another child, who since birth, could only see light and shadows, stared into his father’s face and said he could see the color of his eyes. Later they played soccer together.

The 12 subjects ranged in age from 8 to 44 years old at the time of treatment. Four of the children, aged 8 to 11, are the world’s youngest individuals to receive gene therapy for a non-lethal disease (A fifth subject was 17 years old). On the other end of the age scale, the 35-year-old man and 44-year-old woman are the oldest patients to ever receive gene therapy for retinal degeneration.

For the current human trial, the research team used a vector, a genetically engineered adeno-associated virus, to carry a normal version of the gene, called RPE65, that is mutated in one form of LCA, called LCA2, that accounts for 8 to 16 percent of all LCA cases. Jeannette Bennicelli, Ph.D., in Bennett’s laboratory, cloned the gene. The clinical vector production facility at Children’s Hospital’s Center for Cellular and Molecular Therapeutics (CCMT), directed by Fraser Wright, Ph.D., manufactured the vector.

The clinical trial brought together subjects and scientists from two continents. Five patients enrolled in the study were identified at the Department of Ophthalmology at the Second University of Naples, an institution with a long-standing program in researching inherited retinal diseases, under the supervision of Francesca Simonelli, M.D. Two children from Belgium were recruited through the ophthalmic genetics clinics at the Department of Ophthalmology at the Ghent University Hospital, under the supervision of Bart Leroy, M.D., Ph.D. Jennifer Wellman, of the CCMT, directed all local and federal regulatory interactions for the study.

Another co-author, Edwin Stone, M.D., Ph.D., Howard Hughes Medical Institute Investigator and director of the Carver Center, a genetic testing laboratory at the University of Iowa, identified and verified several of the disease-causing mutations in the study subjects.

In April 2008, the current study team published encouraging preliminary results in the New England Journal of Medicine regarding three young adults, the first to receive gene therapy in this current clinical trial. Those subjects showed improvements in their visual function in both objective vision tests and subjective reports by the patients themselves. Patients who could only detect hand movements gained the ability to read lines on an eye chart.

After the first group of three young adults was treated safely, the study team extended gene therapy to five children from the United States, Italy and Belgium, in addition to four other adults. Because animal studies conducted by Bennett and colleagues had shown that visual improvement was age-dependent, the researchers tested the hypothesis that younger human subjects would receive greater benefits from the treatment. “LCA is a progressive disease, so if a treatment was possible, it was plausible to intervene before damage to the retina was severe,” said Bennett.

In all, 12 patients received the gene therapy via a surgical procedure performed by Maguire starting in October 2007 at The Children’s Hospital of Philadelphia. For each subject, Maguire injected the therapeutic genes into the eye with poorer function. There were three patient cohorts, receiving low, middle and high doses. No serious adverse events occurred in any of the test subjects.

Starting two weeks after the injections, all 12 subjects reported improved vision in dimly lit environments in the injected eye. An objective measurement, which measures how the eye’s pupil constricts, showed that all the subjects were able to detect significantly more light after treatment and also showed greater light sensitivity in each patient’s treated eye compared to the untreated eye. In addition, before treatment, nine patients had nystagmus, an involuntary movement of the eyes that is common in LCA. After treatment, seven of them had significant improvements in nystagmus.

Some of the most dramatic results, captured on video by the researchers, are apparent as subjects traverse a standardized obstacle course. Before the treatment, the patients had great difficulty avoiding barriers, especially in dim light. After treatment, the children navigated the course more quickly, with fewer errors than before, even at the lowest light levels. Not all the adults performed better on the mobility course, and for those who did, the improvements were more modest compared to the children’s.

“In follow-up studies, we will continue to monitor these patients to determine whether this treatment stops the progression of this retinal degeneration,” said Maguire. “In the future, we hope to investigate whether other retinal disease will be amenable to this gene therapy approach.”

The clinical trial was sponsored and primarily funded by the Center for Cellular and Molecular Therapeutics at The Children’s Hospital of Philadelphia. Research support was received from the Foundation Fighting Blindness sponsored CHOP-PENN Pediatric Center for Retinal Degenerations, Research to Prevent Blindness, the Macula Vision Foundation, the Paul and Evanina Mackall Foundation Trust at the Scheie Eye Institute, and the F.M. Kirby Foundation. Additional funding was provided by the Italian Telethon Foundation, the Regione Campania Convenzione, the Foundation for Retinal Research, the Associazione Italiana Amaurosi Congenita di Leber, the Fund for Scientific Research and the Fund for Research in Ophthalmology. Drs. High and Stone are Investigators of the Howard Hughes Medical Institute, which also provided support. Other grant support came from the National Center for Research Resources.

Source: The Children’s Hospital of Philadelphia; The University of Pennsylvania School of Medicine

Radiation: Potential risk from medical procedures is small

• Author: Health Informer
• Filed under: Health News
• Date: Oct 24,2009

There’s no reason to forgo a needed radiation-based medical procedure because of concerns about cancer risk, according to the October issue of Mayo Clinic Health Letter. While the volume of radiation-based tests and procedures has increased in the past three decades, scientists haven’t proven that the low doses of radiation used in medical settings actually increase cancer risk.

Everyone is exposed to radiation — from the sun, rocks and minerals. Radiation is naturally present in air, water, food and the human body. On average, annual exposure from natural radiation is estimated to be about 3 millisieverts (mSv).

Until the early 1980s, patients were exposed to minuscule amounts of radiation from basic X-rays, for example, mammograms (0.4 mSv), chest X-rays (two views, 0.1 mSv) and dental X-rays (0.005 mSv).

Since then, it’s estimated that the total amount of radiation from medical exams and procedures in the United States has increased almost six times. Consider that a CT scan of the heart (CT angiogram) is 5 to 15 mSv. Angioplasty, a procedure to open clogged arteries, uses 7 to 57 mSv, depending on the complexity of the procedure. A virtual colonoscopy uses 5 mSv.

Scientists haven’t determined exactly at what level radiation begins to significantly increase cancer risk. Some evidence shows that below about 100 mSv, there’s no increase in risk — or that the increased risk is so small that it’s not possible to accurately estimate risk.

Radiation safety organizations contend that the risk increases whenever radiation dose increases. If that’s true, even the smallest doses of radiation could cause cancer, although the risk would be very low.

Consider that a CT scan of the abdomen or pelvis exposes a patient to an estimated 10 mSv of radiation, increasing the lifetime risk of dying of cancer by 0.05 percent. That increase would be added to the 21 percent lifetime chance of dying from a cancer of natural causes, changing the risk of dying of cancer from 21 percent to 21.05 percent.

To put the 0.05 percent risk increase in perspective, compare it to other lifetime risk statistics: dying from drowning (0.09 percent), from a pedestrian accident (0.16 percent) or from a bicycling accident (0.02 percent). If, in fact, the cancer risk is slightly increased by radiation-based medical tests and procedures, that risk needs to be considered against the benefit resulting from those tests and procedures.

Source: Mayo Clinic