Pain Management News: Ohio attorney general: Last pain management clinic closed down in county hit hard by addiction

2012-12-22 / Pain Management / 0 Comments

Ohio attorney general: Last pain management clinic closed down in county hit hard by addiction

The last pain medication clinic in a southern Ohio county plagued by painkiller addictions and overdose deaths was shut down Tuesday, the Ohio attorney general announced Tuesday.

Greater Medical Advance in Wheelersburg, with just one doctor, doled out 14,000 prescriptions in nine months, Attorney General Mike DeWine said in announcing the closure and four indictments.

“At one point there was over a dozen pill mills in Scioto County,” DeWine said in a phone interview. “As of this morning, there are zero. So we’re very happy about that.”

The Drug Enforcement Administration has said the southern Ohio county is one of the worst places in the country for painkiller abuse.

Tuesday’s announcement came the same day the first defendant in another so-called pill mill case pleaded guilty to illegally shuttling painkiller prescriptions to pharmacists willing to fill them.

James Sadler pleaded guilty on Tuesday to one count of diverting controlled substances at a hearing in federal court in Cincinnati. Sadler is free on his own recognizance. His attorney did not immediately return a phone message Tuesday.

A 2010 indictment against Sadler and other operators of Ohio Medical and Pain Management in Waverly alleged that in some cases, customers traveled more than 200 miles round trip to be treated at the southern Ohio clinic.

In the Wheelersburg case, a county grand jury indicted four people with charges including engaging in corrupt activity, drug trafficking and drug possession, DeWine’s office said.

The clinic’s doctor, Victor Georgescu, and its operator, George Adkins, were each charged with engaging in corrupt activity, conspiracy to engage in corrupt activity, funding drug trafficking and permitting drug abuse, according to DeWine. Georgescu was arrested in Centerville in suburban Dayton on Tuesday.

Georgescu and Adkins were not booked into the county jail by early afternoon and information about their attorneys was not immediately available. A message was left at the clinic for Georgescu; a home listing for Adkins was not functioning.

Stopping the abuse of powerful prescription painkillers has become a top priority for Ohio officials.

In 2007, drug overdoses, led by an increase in prescription painkiller addictions, surpassed car crashes as the leading cause of accidental death in Ohio. It’s a trend also seen in several other states.

In May, Gov. John Kasich signed into law a bill cracking down on pain management clinics, dubbed pill mills by their critics and blamed by health officials for contributing to hundreds of overdose deaths in Ohio each year.

The law requires the State Board of Pharmacy for the first time to license pain clinics as distributors of dangerous drugs.

The law also puts limits on how many pills a doctor could dispense directly at a clinic and tries to reduce the illegal distribution of prescription painkillers by creating a statewide system for collecting unused supplies of the narcotics.

The DEA has recently suspended the prescription-writing powers of physicians in a part of southern Ohio plagued by painkiller abuse.

More than 1,300 people died from accidental drug overdoses in 2009 in Ohio, according to the most recent data from the Ohio Department of Health. The number of fatal overdoses has more than quadrupled from 1999, when the state recorded 327 accidental deaths, according to the department.

The numbers are particularly bad in Scioto County in Appalachia, where high unemployment rates and a profusion of pill mills have led to growing addiction rates.

2011 Consensus Panel Issues New Guidelines for Intrathecal Pain Management

A panel of experts has recommended changes to the guidelines used to determine treatment via intrathecal administration for patients suffering from severe chronic pain. The 2011 Polyanalgesic Consensus Conference (PACC) brought together a group of national leaders in chronic pain management for the purpose of updating their current algorithm to standardize decision-making among providers and improving the technical quality of care in chronic pain.

The 2011 PACC guidelines for management of nociceptive and neuropathic chronic pain by intrathecal drug delivery recommended ziconotide, among other drugs, as a first-line intrathecal treatment. The panel recognized that ziconotide should be titrated in a low and slow manner. Ziconotide was also recommended by the 2011 group as the preferred option for intrathecal administration compared to opioids when there is a concern for recurrent granuloma. [please see important safety information and product indication at the end of this release]

The expert panel recommendation was based on an extensive literature search and an expansive survey with more than 15,000 clinicians worldwide since the last update in 2007. The panel also reviewed changes in the FDA status of medications and their combined clinical expertise to inform their recommendations

“The Consensus Conference was convened to review the importance of drug selection in patient outcomes; to review issues concerning granuloma detection, prevention and treatment; to consider trialing methods and candidates and to consider best practices to reduce morbidity and mortality,” said Tim Deer, MD, president and CEO, The Center for Pain Relief and Clinical Professor of Anesthesiology, West Virginia University School of Medicine, Charleston, WV.

The expert panel of 29 clinicians and the faculty of the North American Neuromodulation Society was convened by Tim Deer, MD, Joshua Prager, MD, MS, Center for the Rehabilitation of Pain Syndromes (CRPS) at UCLA Medical Center, Los Angeles, CA; and Robert Levy, MD, PhD, Northwestern, University, Feinberg School of Medicine, Chicago, IL. The results were presented during the North American Neuromodulation Society Annual Meeting, Dec. 8-11, in Las Vegas, NV.

“The importance of selecting the best drug options for intraspinal drug delivery to treat those in severe pain cannot be understated,” added Deer. “We must continue to keep all our colleagues informed of the best treatment practices in pain management and routinely evaluate treatments and patient data. Best clinical practices, experience, data and overall better patient outcomes will remain at the core of the Polyanalgesic Consensus Conference.”

Neck and Shoulder Massage Device Poses Strangulation Risk, Agency Says

The FDA has issued a new warning to consumers against the use of a massage device called the ShoulderFlex Massager, which was recalled earlier this year after it was blamed for causing at least one death.

According to the FDA, the distributor, King International, has gone out of business since the firm recalled the massagers on Aug. 31, 2011, and many stores that sell the device may not be aware it is dangerous.

Likewise, the FDA says many people who purchased the massager may be unaware that it is dangerous and that King International’s 800 number established for the recall has been out of service.

The ShoulderFlex Massager is a personal massage device sold in retail stores, via catalogs, and over the Internet. It is intended to provide a deep-tissue massage to the neck, shoulders, and back area, while lying down.

But the FDA says hair, clothing, and jewelry can become entangled in the device and cause serious injury or death from strangulation.

There have been reports of one death and one near-death, due to strangulation, associated with the use of the ShoulderFlex Massager.

“The ShoulderFlex Massager poses serious risks,” Steve Silverman of the FDA says in a news release.

Silverman, director of the FDA’s Office of Compliance in its Center for Devices and Radiological Health, says, “consumers should stop using this device, health care providers should not recommend it to their patients, and businesses should stop distributing and selling the device.”

The FDA says it discovered during a recent compliance audit that King International had gone out of business and that it had not followed through with recall procedures.

The FDA warning includes a recommendation to “safely dispose” of the massagers. It says the massage fingers should be removed and disposed of separately from the device, and the power supply disposed of separately, as well.

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Pain Management News: Adolor Corporation Completes Enrollment in Phase 2 OIC Program

2011-06-07 / Pain Management / 0 Comments

Adolor Corporation Completes Enrollment in Phase 2 OIC Program

Adolor Corporation (NasdaqGM: ADLR) today announced that it has completed enrollment in its Phase 2 clinical evaluation of ADL5945 in chronic, non-cancer pain patients with opioid-induced constipation (OIC).

“Enrollment has progressed quite well in these studies”

Adolor is conducting two Phase 2 studies of ADL5945 in OIC patients in parallel. The first study is evaluating two doses of ADL5945 – 0.10 mg and 0.25 mg – given twice daily versus placebo over a 4-week, double-blind treatment period. The second study, of similar design, is evaluating 0.25 mg of ADL5945 given once daily versus placebo. The trials have enrolled 40 or more patients in each arm, for a combined total of over 200 patients.

“Enrollment has progressed quite well in these studies,” said Michael R. Dougherty, President and Chief Executive Officer. “We look forward to reporting results in the third quarter of this year, and to advancing ADL5945 into pivotal testing in the first quarter of 2012. OIC is a frequent and serious consequence of long-term opioid-based pain management and an effective treatment for this condition remains an unmet medical need.”

About ADL5945

ADL5945 is a potent, peripherally-acting mu opioid receptor antagonist intended to block the adverse effects of opioid analgesics on the GI tract without compromising centrally-mediated analgesia. Peripheral mu opioid receptors in the GI tract regulate functions such as motility, secretion and absorption. Stimulation of these GI mu opioid receptors by morphine, or other opioid analgesics, disrupts normal gut motility. Ultimately, this results in constipation, as well as other associated burdensome GI symptoms.

During 2010, Adolor completed single dose and multiple-ascending dose studies of ADL5945 that enrolled both healthy volunteers and chronic non-cancer pain patients on long-term opioid therapy with OIC. At target therapeutic doses, ADL5945 was well tolerated and, in patients with OIC, produced greater increases (over baseline) in weekly average number of spontaneous bowel movements as compared with placebo.

About OIC

According to IMS Health, over 250 million opioid prescriptions are written annually in the United States. For those patients treated with prescription opioids for long term pain management, it is estimated that approximately 50 percent will develop constipation. Currently, there are no FDA-approved therapies to treat opioid induced constipation in patients with chronic non-cancer pain.

About Adolor

Adolor Corporation is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain and pain management products.

Adolor’s first approved product in the United States is ENTEREG® (alvimopan), which is indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have registered in and met all of the requirements for the ENTEREG Access Support and Education (E.A.S.E.) program may use ENTEREG. For more information on ENTEREG, including its full prescribing information, the Boxed Warning regarding short-term hospital use and the E.A.S.E.® Program, visit The Company co-promotes ENTEREG in collaboration with GSK.

The Company’s research and development pipeline includes: ADL5945 and ADL7445, novel mu opioid receptor antagonists undergoing clinical development for chronic OIC; and several earlier-stage compounds under development for the management of pain and CNS disorders.

Bethany Bodyworks Utilizes CranioSacral Therapy Advanced Pain Management Technique

CranioSacral Therapy, a relatively new holistic pain management system, designed to successfully treat headaches, neck and back pain, TMJ, chronic fatigue, motor coordination difficulties, eye problems and many other central nervous system disorders, is available at Bethany Bodyworks in New Haven, Connecticut.

Bethany, CT (PRWEB) June 03, 2011

The CranioSacral Therapy system, created by internationally renowned osteopathic physician John E. Upledger, has been hailed by one of his students, Bethany Bodyworks’ owner Jennifer Kriz, as a very effective method of holistic pain management that she has found to be highly beneficial to the pain management needs of many of her clients.

Ms. Kriz will be hosting an open house to explain and demonstrate CranioSacral Therapy at Bethany Bodyworks, 41 Village Lane, in Bethany, Connecticut on June 9th and again on July 14th, at 7:30 p.m. Bethany Bodyworks is conveniently located just off Route 63, just minutes north of the New Haven line.

Residents living and working in the greater New Haven, CT area, who suffer from debilitating conditions such as migraine headache, back and neck pain, chronic fatigue and many other nervous system disorders, will be happy to hear that Ms. Kriz effectively administers CranioSacral Therapy to her growing list of satisfied clients.

Jennifer Kriz is a member of the International Association of Healthcare Practitioners, an organization dedicated to advancing awareness and recognition of progressive approaches to wellness among the general public and healthcare providers.

Jennifer Kriz, who has been a trained CranioSacral Therapist for several years, is extremely confident in her ability to detect and correct a variety of imbalances often found in a client’s craniosacral system, which consists of the membranes and cerebrospinal fluid that surround and protect the brain and spinal cord. “CranioSacral Therapy (CST) is a gentle, hands-on technique that is used to detect and correct imbalances in the craniosacral system. Any imbalances found there may be the cause of many sensory, motor and neurological dysfunctions,” explains Ms. Kriz.

According to Kriz, CranioSacral Therapy has been successfully used to treat headaches, neck and back pain, TMJ, chronic fatigue, motor coordination difficulties, eye problems and many central nervous system disorders.

In addition to CranioSacral Therapy, Bethany Bodyworks also offers many other services, including Swedish Massage, Deep Tissue Massage, Sports Massage, Hot Stone Treatments, Reiki Energy Massage, and Foot Reflexology Massage.

VUMC Offers Women “Laughing Gas” as Pain Management Option During Childbirth

Vanderbilt University Medical Center is offering nitrous oxide as a pain management tool for women during childbirth – joining only two other hospitals in the country offering this option.

Vanderbilt University Medical Center is offering nitrous oxide as a pain management tool for women during childbirth – joining only two other hospitals in the country offering this option. Nitrous oxide, also called “laughing gas,” can be administered quickly, is widely known to rapidly ease pain, and has been proven safe for both mothers and their babies.

“Childbirth is not a one-size-fits-all process,” said Frank Boehm, M.D., professor of Obstetrics and Gynecology and vice-chair of the department. “Women deserve to have a wide variety of options available to them. Nitrous oxide is an option that takes the edge off of pain, and I think it may become a popular option for some women who give birth at Vanderbilt.”

The odorless, tasteless gas is inhaled through a mask. For labor, 50 percent nitrous oxide and 50 percent oxygen are blended together by a specialized device. The mixture is then self-administered by the mother through a mask or mouthpiece she controls. This mixture of nitrous oxide mixture is safe for both the mother and baby because it is eliminated from the body through the lungs, rather than through the liver. The 50-50 mix does not cause newborns to be groggy.

“Labor pain is subjective and highly individualized depending on the laboring woman,” said Michelle Collins, M.S.N., a certified nurse-midwife and assistant professor at Vanderbilt University School of Nursing. “So this is a wonderful way to provide a non-invasive option that provides pain relief for many women, particularly those who do not want an epidural or intravenous narcotics for pain.”

Nitrous oxide has many advantages including a quick response time. Most women experience its effects in less than one minute, and then it dissipates fully within five minutes after stopping use. It can be started and stopped at any point during labor, depending on the mother’s preference.

“A hallmark of using nitrous oxide in a labor environment is that the mother is able to self-administer via the mask,” said Sarah Starr, M.D., an assistant professor of Clinical Anesthesiology who works with Obstetrics patients. “This increases her sense of control over the dosage, over her pain and over herself during labor.”

“We want to offer women meaningful and different options. There is so much patient interest, we are happy to be able to provide this,” she added.

Nitrous oxide is commonly used for pain relief during childbirth in European countries. It was used in the United States in the 1950s, but was later replaced by other options including epidurals. At Vanderbilt, the provider and the patient will decide together if nitrous oxide is an appropriate option. If so, it will be initiated by an anesthesia provider who will teach the patient how to self-administer.

“Many women want to work through their labor and birth without medication or epidural anesthesia, but may find that they still need some sort of pain management to get them through the rough spots in their labor. Nitrous oxide is ideal in those situations,” Collins said.

Recently, VUMC has experienced a dramatic increase in the number of childbirths performed at Vanderbilt University Hospital, with an estimated 3,800 this year.

12 Great Physicians in Florida

Here are profiles of 12 great physicians in Florida. Physicians are listed in alphabetical order by last name. Note: Physicians do not pay and cannot pay to be on this list. This list is not an endorsement of any individual’s or organization’s clinical abilities.

Lora Brown, MD (Coastal Orthopedics & Pain Management, Bradenton, Fla.). Dr. Brown is a pain management physician at Coastal Orthopedics & Pain Management in Bradenton, Fla., where she has a professional interest in performing spinal injections, facet injections and implantable nerve stimulators. She has also served as the president of the Florida Chapter of the American Society for Interventional Pain Physicians as well as on the organization’s board of directors. During her career, Dr. Brown has also served on the Florida Governor’s Prescription Drug Monitoring Program, Implantation and Oversight Task Force. She is certified in both pain management and anesthesia. Dr. Brown earned her medical degree at the University of Texas in San Antonio and completed a fellowship in pain management at Cleveland Clinic.

Harold Cordner, MD (Florida Pain Management Associates, Sebastian). Dr. Cordner is the founder and sole physician at Florida Pain Management Associates. He treats a variety of conditions, including arthritic back pain, cancer pain, arthritis, failed back surgery and diabetic neuropathy. He is certified in both anesthesiology and pain management. In addition to his clinical practice, Dr. Cordner is a member of several professional organizations, including American Society of Interventional Pain Physicians, Society of Pain Practice Management, International Neuromodulation Society, and the International Spinal Injection Society. He also has experience lecturing nationally and internationally on pain management subjects. Dr. Cordner earned his medical degree at St. George’s University School of Medicine in the West Indies and completed his residency in anesthesiology at Monmouth Medical Center in Long Branch, N.J.

Jonathan Daitch, MD (Advanced Pain Management & Spine Specialists, Fort Myers, Fla.). Dr. Daitch founded Advanced Pain Management & Spine Specialists in Fort Myers, Fla., which is dedicated to treating patients with pain conditions. He is a fellow of the World Institute of Pain and an active member of the American Society of Interventional Pain Physicians. Prior to opening APMSS, Dr. Daitch served as a major in the U.S. Air Force Medical Corps at Wright Patterson Air Force Base. He earned his medical degree at Jefferson Medical College in Philadelphia and completed his residency in anesthesiology at Albert Einstein College of Medicine in Bronx, N.Y. His additional training includes interventional pain management experience at Wright Patterson AFB and board certification in pain management and pain medicine.

Richard A. Hynes, MD (Osler Medical, Melbourne, Fla.). Dr. Hynes is a spine surgeon at Osler Medical. He is a consultant for Medtronic and has participated in numerous FDA approved studies. Along with his clinical work, Dr. Hynes is also a director of TXEDAKA, a charity that helps low-income individuals gain access to the medical care they need. He is a fellow of the American College of Surgeons, the American College of Spine Surgeons and The American Academy of Orthopaedic Surgeons. Dr. Hynes earned his medical degree from Robert Wood Johnson Medical School (then Rutgers Medical School) in New Brunswick, N.J., completed his residency at Tripler Army Medical Center in Honolulu and received fellowship training in spine surgery at Harvard University in Boston.

Carlos J. Lavernia, MD (Orthopaedic Institute at Mercy Hospital, Miami, Fla.). Dr. Lavernia is the medical director of the Orthopaedic Institute and chief of orthopedics at Mercy Hospital in Miami. He also serves as the fist vice president of the American Association of Hip and Knee Surgeons and on the board of directors of the Florida Orthopaedic Society. Throughout his career, Dr. Lavernia has published several professional articles on topics such as the relationship of gender to primary hip arthroplasty outcomes, quality of life after total hip arthroplasty and imaging after hip and knee replacement surgery. He has also lectured across the world on knee and hip surgery and participated in Operation Walk, an organization that brings joint replacement surgery to underdeveloped countries, in places such as Peru, Guatemala and El Salvador. Dr. Lavernia earned his medical degree at the University of Puerto Rico and completed his residency at the University of California in Oakland. His additional training includes a fellowship in lower extremity reconstruction at the Johns Hopkins School of Medicine in Baltimore.

James S. Leavitt, MD (Miami Endoscopy Center, Miami). Dr. Leavitt is an assistant clinical professor at the University of Miami School of Medicine Department of Gastroenterology and a physician at the Miami Endoscopy Center and the Gastroenterology Care Center. He has served as a member of the American College of Gastroenterology’s practice management committee. Dr. Leavitt earned his MD from the State University of New York Downstate Medical School and completed his medical internship and residency and his gastroenterology fellowship at Jackson Memorial Hospital in Miami.

Mary I. O’Connor, MD (Mayo Clinic, Jacksonville, Fla.). Dr. O’Connor is a surgeon at the Mayo Clinic in Jacksonville, Fla., and the president of the American Association of Hip and Knee Surgeons. She also serves as a member of the Advisory Committee on Research on Women’s Health for the National Institute of Health. She has a professional interest in hip and knee replacement, computer-assisted surgery, limb-salvage surgery and pelvic tumors. During her career, Dr. O’Connor has published research on several topics, including osteoporosis screening for patients with hip fractures, hip resurfacing arthroplasty and stem fracture of conserve hemiarthroplasty. Dr. O’Connor earned her medical degree at Medical College of Pennsylvania and completed her residency and fellowship in orthopedics at Mayo.

Bharat Patel, MD (Deuk Spine Institute, Titusville, Fla.). Dr. Patel is the director of interventional pain management at Deuk Spine Institute in Titusville, Fla. He has a professional interest in interventional pain management, physiatry, electrodiagnostic medicine and musculoskeletal ultrasound diagnosis and injections. During his career, Dr. Patel has been chosen as an examiner for the national American Board of Interventional Pain Physicians examinations and served as the chair of the Congress RPC’s practice guideline committee. He is a member of the American Academy of Physical Medicine and Rehabilitation, International Spine Intervention Society and the American Academy of Pain Management. In addition to his clinical practice, Dr. Patel has conducted research on several topics, including ultrasound-guided trigger point injections into the cervicothoracic musculature. He earned his medical degree at Municipal Medical College in Ahmedabad, India, and completed his residency in physical medicine and rehabilitation at New York University School of Medicine in New York City. Dr. Patel’s additional training includes a fellowship in pain management and rehabilitation at The Florida Spine Institute in Clearwater.

Thomas F. Roush, MD (Roush Spine, Lake Worth, Fla.). Dr. Roush is spine surgeon with Roush Spine, which has four Florida offices. He is a member of several professional organizations, including North American Spine Society. Dr. Roush is a co-author of the 2009 book Motion Preservation Surgery of the Spine: Advanced Techniques and Controversies along with several other research publications. He has instructed courses on the anatomy of the spine at Duke University in Durham, N.C. Dr. Roush earned his medical degree from University of Cincinnati College of Medicine, completed his residency in orthopedic surgery at Duke University Medical Center in Durham, N.C., and received fellowship training in spine surgery and spinal arthroplasty at Texas Back Institute in Plano.

Alan Siegel, MD (Interventional Pain Physicians of South Florida, Plantation). Dr. Siegel is board certified in anesthesiology with a special certification in pain management through the American Board of Anesthesiology. He regularly treats chronic pain conditions and has a professional interest in diagnosis and treatment of spinal pain using minimally invasive techniques. He performs disc depression, discography, facet joint injections and epidural steroid injections. In addition to his clinical work, Dr. Siegel serves as a clinical assistant professor at Nova Southeastern College of Osteopathic Medicine in Ft. Lauderdale, Fla. Dr. Siegel is a member of the American Society of Anesthesiologists, International Spine Intervention Society and the American Society of Interventional Pain Physicians. Dr. Siegel earned his medical degree at the University of Florida College of Medicine in Gainesville and completed his residency in general surgery at New England Deaconess Hospital in Boston.

Sanford Silverman, MD (Comprehensive Pain Medicine, Pompano Beach, Fla.). Dr. Silverman is the director of Comprehensive Pain Medicine in Pompano Beach, Fla. He is a diplomate of the American Board of Anesthesiology and the American Board of Pain Medicine. He is also certified in addiction medicine by the American Society of Addiction Medicine. Dr. Silverman’s additional memberships include the International Spine Society and the American Academy of Pain Medicine. He has a professional interest in interventional and medical treatment for chronic pain, opioid adaptation and complex chronic pain with hyperalgesia. During his career, Dr. Silverman has served as the chief of anesthesia and operative service at William Beaumont Army Medical Center in El Paso, Texas, and the director of its pain clinic. He earned his medical degree from New York Medical College and completed his anesthesiology residency at Brooke Army Medical Center in San Antonio.

Andrea Trescot, MD (University of Florida, Gainesville, Fla.). Dr. Trescot is the director of the pain fellowship at the University of Florida in Gainesville and president-elect of the American Society for Interventional Pain Physicians. She is also a founding director and past president of the Florida Academy of Pain Medicine and a member of the World Institute of Pain. During her career, Dr. Trescot has authored textbook chapters and participated in the writing of four national pain guidelines. She has lectured nationally and internationally on topics such as cryoneuroablation, spinal endoscopy, opioids and peripheral nerve entrapments. Dr. Trescot earned her medical degree at the Medical University of South Carolina in Charleston and completed her residency at the National Naval Medical Center in Bethesda. Her additional training includes a pediatric anesthesia fellowship at National Children’s Hospital in Washington, D.C.

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Pain Management News

2011-04-26 / Pain Management / 0 Comments

PAINWeek Prepares for New Education Requirements for Prescribers of Opioid Analgesics

The 2011 PAINWeek National Conference for Frontline Clinicians offers significant educational value as the FDA announces the elements of a Risk Evaluation and Mitigation Strategy (REMS) that will require all manufacturers of long-acting and extended-release opioids to develop information for the use of, and ensure training is provided to, prescribers of these medications.

(PRWEB) April 25, 2011

Recent developments in the legal and regulatory arenas pertaining to management of prescription pain medications offer new evidence of the timeliness and relevance of PAINWeek as essential education for frontline practitioners. On April 19, the White House Office of National Drug Control Policy announced that it would seek legislation setting new education requirements for those who prescribe long-acting narcotics. Concurrently, the FDA announced the elements of a Risk Evaluation and Mitigation Strategy (REMS) that will require all manufacturers of long-acting and extended-release opioids to develop information for the use of, and ensure training is provided to, prescribers of these medications.

While the exact nature and dimensions of these initiatives are still in development, PAINWeek attendees will have the opportunity to enhance their understanding of this emerging issue at multiple points in the conference program. Curriculum tracks in Pharmacology, Pain and Chemical Dependency, and Medical/Legal Aspects of Pain Management will offer the latest perspectives. The National Association of Drug Diversion Investigators (NADDI) will return with a full-day program examining the balance between enforcement and pain management as applied to narcotic medications.

PAINWeek, the National Conference on Pain for Frontline Practitioners, managed by Aventine Co., will convene for its fifth year, September 7-10 in Las Vegas. With over 100 hours of continuing medical education activities available, PAINWeek is the largest and best-attended pain management conference in the country.

Commenting on the curriculum enhancements, Debra Weiner, Director of PAINWeek Program Development, noted, “ We are clearly on the cusp of new and demanding educational requirements for practitioners in all disciplines in the area of prescription medication understanding and practice. PAINWeek has been addressing this issue for some time, and as a result, our attendees will thus be better equipped to deal with the new reality as it emerges. Our curriculum offers a comprehensive approach to chronic pain management that places medication within the broader spectrum of treatment options available to practitioners and patients.”

Over 1,500 healthcare professionals from diverse medical specialties are expected to attend PAINWeek 2011, to be held at the new Cosmopolitan of Las Vegas on the Vegas strip. In addition to the course curriculum and its multidisciplinary faculty, attendees will be able to experience a comprehensive roster of commercially supported programs and special interest sessions, satellite symposia, scientific assemblies, and exhibitors. More information and the PAINWeek 2011 Schedule-at-a-Glance can be found at

About PAINWeek

In 2007, Aventine Co. launched the PAINWeek National Conference on Pain for Frontline Practitioners, the first of its kind designed for frontline clinicians with an interest in pain management. This year, the PAINWeek National Conference is expected to welcome over 1,500 physicians, nurses, pharmacists, and other healthcare professionals seeking to improve their assessment, diagnosis, and treatment of acute and chronic pain. This has made PAINWeek the largest professional pain conference in the U.S. Building on this expertise in pain management education, Aventine is presenting the PAINWeekEnd™ Regional Conference Series in five US metropolitan areas in 2011. In addition to developing and producing the PAINWeek conference series, Aventine is also the management company for the American Society of Pain Educators (ASPE), a 501(c)(3) organization.

FDA looks to crack down on misuse of opioid painkillers

U.S. health officials unveiled Tuesday a new plan to try to curb misuse of extended-release and long-acting opioid pain killers such as OxyContin, morphine and methadone.

The new Risk Evaluation and Mitigation Strategy (REMS) is part of a larger multi-agency initiative announced Tuesday by the White House to reduce overall prescription drug abuse in the United States.

“This new REMS will provide tools to doctors and other prescribers for appropriate pain management to reduce risks and at the same time preserve access for patients and appropriate management of pain for those suffering from moderate to severe pain,” said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, the agency that launched the new program.

For now, the initiative will be limited to extended-release and long-acting products, which, Woodcock said, “have a much greater risk than immediate-release because they contain more medicine.”

She did not rule out the possibility that the approach could be expanded to include immediate-release drugs in the future.

Right now, the action affects 16 companies that make both branded and generic products. The products affected are known under their generic names as hydromorphone, methadone, morphine, oxycodone, oxymorphone, transdermal fentanyl and transdermal buprenorphine.

According to Woodcock, about 23 million prescriptions are dispensed each year for extended-release and long-acting opioids, which represented about 10% of the opioid market in 2009.

But, abuse and misuse is also extensive, with the FDA estimating that 33 million Americans aged 12 and older used such a drug for non-medical purposes in 2007, up from 29 million people in 2002.

Some 50,000 emergency room visits in 2006 were related to opioids, officials said.

“This is a large and growing problem and, despite a number of efforts over the years, it continues to grow,” Woodcock said. “It’s clear we have a huge problem on our hands.”

One of the main components of the new FDA program will be educating doctors and other prescribers on proper ways to prescribe opioids, as well as how to identify appropriate patients for these drugs.

“If a prescriber has a concern that a patient might unintentionally or intentionally misuse the drug, they need to know how to spot these individuals,” Woodcock said.

Doctors will also get materials on how to educate their patients, not only on proper use of opioids but also on proper storage and disposal.

Manufacturers will be required to use one central system to provide these educational materials, Woodcock said. And the FDA will monitor company-generated literature to make sure it isn’t promotional but is effective, she added.

Companies have 120 days to issue a draft REMS and Woodcock hoped matters will be completed by early 2012.

“In the meantime, doctors should be prescribing opioids as they have been doing and we hope they thoroughly discuss risks and benefits with their patients,” Woodcock said. “People taking opioids should continue to take them as directed and, if they have concerns, should consult a health-care professional.”

Florida Pain Clinic Society: PILL MILLS & FALSE STATISTICS

TALLAHASSEE, Fla., April 22, 2011 /PRNewswire/ — The Florida Society of Pain Management Providers urges Government, Law Enforcement and the media to stop using false prescription drug data and statistics. The continued release of false and / or out of context information is solely intended to enflame the public. The misinformation that unfairly portrays Florida as ground zero in this issue has significant consequences for pain management patients and the physicians who provide legitimate care. It is unacceptable to make this a war on pain patients.

Facts have become the greatest casualty in the war on pain medications:

Recently the Kentucky Attorney General made the following false statement in his Sun Sentinel Op-Ed piece which continues to be repeated by leaders and media:

“Law enforcement officials believe that 85 percent of all oxycodone sold in the United States is sold in Florida.”

The Truth is:

Florida sold 16.8% of all oxycodone in the U.S. (DEA 2009 ARCOS 2009 populations)

And what about facts on all the other pain medications:

Source: DEA 2009 ARCOS per 100,000 populations (2009):
Tennessee sold 250% more codeine than Florida
Tennessee sold 250% more hydrocodone than Florida
Arizona sold 100% more morphine than Florida.
Maine sold 100% more methadone than Florida
Pennsylvania sold 75% more fentanyl than Florida
Kentucky was the #3 seller of hydrocodone / Florida was #21


Morphine: 10 times more potent than codeine

Oxycodone: =/ or slightly more potent than morphine

Methadone: 10 times more potent than morphine

Fentanyl: 50 to 100 times more potent than morphine

The United States has a problem with diversion and abuse of pain medications; there must be a balanced approach in finding a solution so as not to affect patient pain care.

That approach:
Most importantly: A substantial increase in affordable drug treatment programs.
State Board of Medicine rules for pain clinic standards of practice, plus inspections.
Pain management licensing that bars felons.
State Prescription Drug Monitoring Programs requiring physician participation and subpoena requirements for law enforcement access.
Physician education regarding the monitoring of patients on long term pain medication.
Patient education in the securing and disposing of their medications.

And lastly be forewarned that heroin is roaring back and soon will surpass Rx med abuse!

Leading Pain Management Experts to Present at the 9th Annual Orthopedic, Spine and Pain Management-Driven ASC Conference (June 9-11; Chicago)

Chicago — Leading pain management experts will present at the upcoming 9th Annual Orthopedic, Spine and Pain Management-Driven Ambulatory Surgery Center Conference: Improving Profitability and Business and Legal Issues on June 9-11, 2011, in Chicago.

This exclusive conference will be held at the Westin Hotel on North Michigan Avenue and is presented by the Ambulatory Surgery Center Association, the national association for surgery centers, and ASC Communications, publisher of Becker’s ASC Review and Becker’s Orthopedic & Spine Review.

Leading pain management experts scheduled to present include:
Scott Glaser, MD, DABIPP, Pain Specialists of Greater Chicago
Nameer R. Haider, MD, Spinal & Skeletal Pain Medicine
Marsha Thiel, RN, MA, CEO, Medical Advanced Pain Specialists
Richard A. Kube, MD, CEO, Founder & Owner, Prairie Spine & Pain Institute
Vishal Lal, CEO, Advanced Pain Management
Amy Mowles, President & CEO, Mowles Medical Practice Management
Marsha Thiel, CEO, MAPS Medical Pain Clinics & MAPS Practice Solutions
And more!

These leaders will discuss key business, financial, clinical and legal issues facing pain management-driven ambulatory surgery centers.

Other highlights of the 9th Annual Orthopedic, Spine and Pain Management-Driven Ambulatory Surgery Center Conference include:
1. 101 sessions and 134 speakers, including 25 CEOs and 30 physician leaders as speakers
2. Last year’s event included 725 attendees and 65 exhibitors
3. Gain practical guidance that can be used immediately
4. Outstanding keynote speakers including legendary NFL player and coach Mike Ditka
5. Terrific pre-conference sessions
6. 15 CME credits available
7. Register before May 1 and save $100
8. Additional discounts when registering two or more attendees, and for ASC Association members and paid Becker’s ASC Review subscribers

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Arthritis Cures Today

2011-04-23 / Pain Management / 0 Comments

Dr. Gott: Readers inquire home remedies, drink recipes, shampoo

DEAR READER: The article to which you are probably referring can be found on my website at

There are many home remedies for nail fungus, some more successful (based on reader input) than others. I believe one of the products you are referring to is Miranel, which is available over-the-counter at Walgreens. It is applied directly to the toenail and surrounding skin daily using the applicator brush provided.

Another product that has been successful is decolorized iodine, also known as white iodine. This product may also improve weak, brittle nails.

As for soaking agents, I have received several letters regarding white vinegar. Some people soak a cotton ball and then apply it to the affected nail several times a day, while others simply dilute the vinegar with warm water and soak the whole foot. This may also help with athlete’s foot.

Others have chosen to use diluted bleach in a similar manner.

Many years ago, I recommended a foot soak using Pau d’Arco tea. The feet have to be soaked several times a day. I have since stopped recommending it because the above remedies appear to be readily available, easier, less expensive and provide better results.

DEAR DR. GOTT: Can you please reprint your colon cocktail and grape arthritis drink recipes? I clipped them out but seem to have misplaced them when I moved. Thank you.

DEAR READER: My colon cocktail is simply equal portions of applesauce, bran and prune juice. Take 1 or 2 tablespoons each morning to prevent and/or remedy constipation. Be sure to store any extra in the refrigerator. It is best to prepare it in small batches because it lasts only up to three or four days once mixed.

The arthritis drink is 8 ounces of purple grape juice mixed with 1 tablespoon of liquid pectin. This can be used up to three times a day until symptoms are under control, and then most users continue with a maintenance dose of one glass per day. Some readers have used apple or light grape juice.

Another popular remedy for arthritis is a castor-oil rub. The oil is massaged onto the affected joint once or twice a day. For those who prefer a warming or cooling effect, Castiva may be preferable because it is made with a castor-oil base and warming capsaicin.

DEAR DR. GOTT: Some time ago, you mentioned a specific shampoo that seemed to have hair-restorative properties. I forgot to write down the name of that shampoo and would like to know if you remember it. Thanks.

DEAR READER: You are likely referring to Tresemme Silk Protein Healthy Volume Shampoo and Tresemme Vitamin E Conditioner. Other readers have also had success with other types of Tresemme shampoos and conditioners that contain biotin and B vitamins.

Other remedies include supplemental biotin, folic acid and/or B complex (which contains all the B vitamins). Over-the-counter Rogaine may also be beneficial but is relatively expensive, and any results achieved will reverse if the product is stopped.

PFIZER : Comments on ORAL Sync Tofacitinib Data in EULAR Abstract LB0005

Pfizer Inc. commented on an abstract concerning the ORAL Sync Phase 3 study of tofacitinib in patients with rheumatoid arthritis (RA) which has been posted for the European League Against Rheumatism (EULAR) conference.

In this study, four deaths were reported in the tofacitinib arms, three of which were determined by the investigators not to be study drug related. The cases reported that were determined not to be study drug related involve one case of brain injury following trauma 22 days after discontinuation of study drug; one case of worsening of RA 42 days after discontinuation of study drug; and one case of acute heart failure. In addition, one case of respiratory failure was reported by the investigator as study drug related.

Because the initial randomization design of the study includes only one-fifth of the patients on placebo (2:2:1 randomization, n = 792), and because the placebo patients are converted to active arms beginning as early as 3 months into the study, the majority of adverse events would be expected to occur in patients on active treatment.

The mortality rate from all causes across the tofacitinib RA development program, including the ORAL Sync study, is within the range of rates reported for biologic therapies for RA.

Full results of ORAL Sync will be presented in a late-breaker oral session at EULAR on May 27, 2011, at 4:20 p.m. GMT in London.

About ORAL Sync

ORAL Sync evaluated the efficacy and safety of tofacitinib doses 5 mg and 10 mg given twice daily compared to placebo in patients with moderately to severely active RA who had a previous inadequate response to a DMARD and who continued to receive background traditional DMARD therapy throughout the study.

Pfizer Inc.: Working together for a healthier world?

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.

DISCLOSURE NOTICE: The information contained in this release is as of April 21, 2011. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about a product in development, tofacitinib, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for tofacitinib as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

Arthritis May Benefit From Homeopathic Treatments

According to a EurekAlert! public release, research from the University of Southampton has shown that arthritis patients can improve from homeopathic treatment along with conventional treatment. The study was published on November 15, 2010 in the journal Rheumatology.
This Article
Improved My Health
Changed My Life
Saved My Life

Researchers speculated that it may not be the remedies themselves that brought improvement so much as the homeopathic consultation process. Homeopathic consultations focus on treating the whole person, unlike conventional treatments that focus on the illness.

The patients’ health improved safely suffering no adverse side effects. Decreases in symptoms were noted, with fewer swollen joints and sores, while pain levels went down and moods lifted.

According to the Mayo Clinic, about 40 percent of adults in the U.S. are exploring and many are embracing alternative and complementary medicines. Alternative therapy refers to any treatment outside of conventional Western medicine practices. Complementary therapy would be an alternative therapy used along with conventional medicine.

Homeopathy on its own is an alternative therapy. When used in conjunction with traditional Western medicine it is a complementary therapy.

The Mayo Clinic website explained that conventional doctors have been and may continue to be cautious in accepting some of these less familiar practices. They traditionally rely on research and test results, and many of these other therapies have not yet been through the batteries of tests, or the results are not yet clearly understood.

Homeopathic medicine’s foundation is that whenever possible, the body can and will heal itself. Symptoms of illness are viewed as the body’s normal responses as it moves towards health.

According to homeopathy, like cures like. A substance that might cause a particular symptom in a healthy person, is considered as a possible cure in very small amounts for an ill person. The idea is to support and enhance the body’s natural abilities to heal and regulate itself.

Remedies may be pills or liquid solutions with a very small amount of an active ingredient. These usually come from a plant or mineral.

According to, homeopathic medicines are considered safe, having been regulated in the U.S. since 1938, and may have helpful effects.
This Article
Improved My Health
Changed My Life
Saved My Life

Critics doubt that any treatment using such small doses can make a difference and assume that any improvement must be due to the placebo effect.

But stated that studies to this end have concluded that while how homeopathic solutions work was not readily apparent, evidence clearly indicated that the effects of homeopathic solutions differed from the effects seen from placebos.

Celabolin Helps Put A Stop To Arthritis Pain… In As Little As Half An Hour

The name ‘arthritis’ actually refers to any acute or chronic abnormality of a joint as a result of inflammation. Degenerative joint disease (DJD) is the most common form of arthritis, in which the main problem is the breakdown of the cartilage that covers the ends of the bones. Celabolin, combines the power of the natural neutriceutical product, Celadrin, with no less than eight other minerals and natural anti-inflammatories. These include zinc, copper and manganese, as well as yucca extract, resveratrol, hops, black pepper and the protein-digesting enzyme bromelain.

With the passing years, many of us experience pain and inflammation in our joints. The name ‘arthritis’ actually refers to any acute or chronic abnormality of a joint as a result of inflammation. Degenerative joint disease (DJD) is the most common form of arthritis, in which the main problem is the breakdown of the cartilage that covers the ends of the bones.

Yet mainstream medicine has little to offer sufferers, as a survey carried out for Bupa in 2009 revealed. It concluded that UK health services are failing to meet the needs of millions of chronic joint pain sufferers, with a staggering 80 per cent still living with daily pain, despite following their recommended treatment.

Now, though, there’s a powerful natural supplement that not only helps relieve pain but also lubricates and restores mobility to your joints. It even encourages the re-growth of new cartilage.

Celabolin, from Life Natural Cures, combines the power of the natural neutriceutical product, Celadrin, with no less than eight other minerals and natural anti-inflammatories. These include zinc, copper and manganese, as well as yucca extract, resveratrol, hops, black pepper and the protein-digesting enzyme bromelain.

What impressed us most, here at HSI, is the sound, scientific research that backs up the formula.

Celadrin ‘switches off’ pain and stiffness in as little as 30 minutes

Celadrin, the key constituent of Celabolin, has taken America by storm, since we first brought it to your attention back in the May 2007 issue of HSI. It is one of the most effective natural anti-inflammatory compounds available, containing a unique blend of fatty acids. These are similar to, but far more effective than, EPA and DHA, the fatty acids found in health-enhancing fish oils.

What makes the naturally-occurring fatty acids in Celadrin so special is their chemical form, as cetylated or esterified fatty acids. Since the body has to convert fatty acids into this form in order to use them, Celadrin delivers their benefits faster and more effectively. This means that it can rapidly ‘switch off’ the processes that lead to joint inflammation, pain and cartilage degeneration. Celadrin also acts as a physical lubricant, allowing muscles and joints to move smoothly and painlessly.

In one clinical trial, when patients with chronic arthritis of the knee took Celadrin capsules or placebo for 10 weeks, the group taking Celadrin experienced significantly less pain than the placebo group as well, as much better joint flexibility and walking ability. Celadrin has also shown outstanding results when used as a topical cream by patients with osteoarthritis of the knee, reducing pain and stiffness in as little as 30 minutes after application.

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Gout Treatment News

2011-01-26 / Pain Management / 0 Comments

Dealing with gout — the malady of kings

OAK RIDGE, Tenn. —

Gout is the most common type of inflammatory arthritis in the United States and the number of cases has doubled in the last two decades. An attack usually involves a single joint in the legs or feet, particularly the big toe, and may cause severe pain for up to a week.

At the heart of gout is a class of molecules called “purines.” Most purines are part of the structure of DNA and because DNA is found in cells, cellular foods like meat have a lot of purines. When purines are broken down into uric acid, it may accumulate in a joint and create symptoms of pain, redness, and swelling.

Impaired uric acid excretion by our kidneys is worsened by many prescription and some over-the-counter drugs. Diuretics and low-dose aspirin are the big offenders. High-fructose sweeteners and alcohol are food sources that also impair uric acid excretion.

Diabetes and a pre-diabetic condition called “metabolic syndrome” are now epidemic in the United States. These conditions contribute to gout by both altering uric acid metabolism and by creating renal insufficiency. Sixty percent of gout sufferers now have metabolic syndrome.

There is often no relationship between blood levels of uric acid and the timing of an acute attack of gout. For diagnosis, the best strategy is to have your doctor perform testing two weeks after the attack.

At that time, if your blood level of uric acid is elevated, you likely have gout. The diagnosis is unlikely if the level is less than 4 mgj dl. In the event of a positive diagnosis, you probably have a problem excreting uric acid instead of overproducing it if your 24-hour urine uric acid is less than 800 mg.

Treatment of an acute gout attack is often best handled with early use of a non-steroidal, anti-inflammatory drug like indomethacin. Colchicine is a drug that has been used for gout in one form or another for centuries but has only recently been approved by the FDA for this purpose. Two pills at onset of symptoms and one more in two hours is all that should be used. Higher doses do not work better and may have toxic effects. Oral or intramuscular steroids may also be helpful.

A drug called probenecid helps promote excretion of uric acid. It may be useful if someone cannot take indomethacin or colchine.

For those that have had three or more gout attacks in a given year, a preventive medicine that limits uric acid production may be helpful. Allopurinol has been widely used for this purpose. Another drug in the same category is now available. There is no good evidence that it works better and it is considerably more expensive. A new drug is in the pipeline that uses a slightly different mechanism to decrease uric acid production. Expect it to be expensive also.

Always discuss strategy with your doctor before considering medicine use, but remember, as with most maladies, the best management of gout is still prevention.

A study of 89,000 older female nurses shows that drinking one to three cups of coffee daily can reduce the risk of developing gout by 22 percent. Four cups or more can reduce the risk by 57 percent. Decaf does not carry the same risk reduction and other caffeinated drinks do not work.

Vitamin C can promote uric acid excretion by limiting its re-absorption in the kidneys. A 20-year study of 47,000 men showed that daily intake of at least 250 mg of Vitamin C was associated with fewer attacks of gout. There was a 17 percent decrease in risk for each 500 mg increase in Vitamin C consumed.

Losing weight and increasing exercise can decrease the risk of gout from diabetes and metabolic syndrome. Limiting alcohol and refined high-fructose foods like soft drinks will also significantly decrease the risk. Decreasing meat consumption, particularly organ and game meats, as well as seafood can decrease the likelihood of gout. Increasing low-fat dairy can also decrease the risk.

Moderate intake of purine-rich vegetables like spinach, beans, peas, mushrooms, oatmeal, and wheat bran have not been found to significantly increase the risk of gout.

Trauma can precipitate an attack of gout, so always protect your feet and knees.

Gout may have once been the malady of kings, but now we have another reason to live longer and healthier lives than Henry the VIII. We know what causes gout and we know how to treat it and prevent it.

Ardea Follows Positive Gout Results with $71.5M Offering

January already had been a pretty good month for Ardea Biosciences Inc. and it got even better on Thursday.

San Diego-based Ardea followed up its announcement earlier this month of positive, preliminary, top-line results from its Phase IIb study of RDEA594 in combination with the current standard of care for the treatment of gout, allopurinol, with an underwritten public offering of 2.75 million shares of common stock priced at $26 a share, about 3 percent below Wednesday’s closing price. The company expects gross proceeds of about $71.5 million.

Ardea stock (NASDAQ:RDEA) was down 56 cents, to close at $26.25 Thursday.

Ardea also earned a $15 million milestone payment earlier this month from partner Bayer HealthCare AG under a 2009 license agreement concerning MEK inhibitor compounds. Bayer’s initiation of a Phase II trial of BAY 86-9766 with sorafenib in hepatocellular carcinoma triggered the payment. The payment brought Ardea’s total under the agreement to $50 million to date, and the company could receive as much as $357 million more in future milestones. (See BioWorld Today, April 29, 2009.)

BofA Merrill Lynch and Jefferies & Co. Inc. are joint book-running managers with JMP Securities, Brean Murray, Carret & Co. and Roth Capital Partners acting as co-managers. The underwriters have a 30-day option to purchase an additional 412,500 shares to cover overallotments, which potentially could raise an additional $10.7 million. The offering is expected to close Jan. 25.

The company said it anticipates using the proceeds for clinical trial expenses – including RDEA594, which is expected to enter Phase III testing this year – research and development expenses and working capital.

John Beck, Ardea’s CFO and senior vice president finance/operations, told BioWorld Today that he expects some of the funds to go toward the Phase III program for RDEA594, but said that it is too soon to pin down specifics.

“Because we have not yet had our end of Phase II meetings with U.S. and EU regulatory authorities, we are unable at this time to provide specifics regarding the scope of our Phase III program for RDEA594,” Beck said. “However, we do believe that the proceeds from this raise, together with our existing resources, provide a strong financial foundation as we plan for Phase III.”

Beck said that the company’s preliminary, unaudited cash balance at the end of 2010 was approximately $80 million. Proceeds from the new financing, net of expenses and conservatively assuming the underwriter’s allotment is not exercised, plus the $15 million milestone payment from Bayer brings Ardea’s post-transaction cash position to approximately $162 million, less cash used in operating activities during the first few weeks of January, he said. The company plans to release its 2010 earnings and file its annual financial report on March 11.

A number of analysts have had good things to say about Ardea since the company reported that the primary and key secondary endpoints of a Phase IIb study of RDEA594 in combination with the allopurinol were achieved, with highly statistically significant reductions in serum uric acid (sUA) and up to 89 percent of patients taking a combination of RDEA594 600 mg and allopurinol reaching target sUA. Allopurinol accounts for more than 90 percent of the unit sales of chronic gout prescription medications, the company said.

Jefferies & Co. analyst Thomas Wei wrote earlier this month that RDEA594. “could become the standard-of-care for second-line gout treatment.”

Wei added that “the next major strategic decision will be whether to partner RDEA594 or retain rights through Phase III trials, a decision which we expect the company to make within the next six to 12 months.”

Leerink Swann Research analyst Joseph Schwartz wrote during the first week of January that “RDEA594 is the front-runner in the race to becoming the next new oral gout drug.”

Jonathan Aschoff, an analyst for Brean Murray, estimated “the U.S. market for RDEA594, which only includes the 60 percent of allopurinol patients that do not adequately respond to allopurinol, as about a $3 billion opportunity.”

Last week Piper Jaffray & Co. analyst M. Ian Somaiya said in a company note that after meeting with Ardea management, “we believe that Ardea will conduct two Phase IIIs to ensure sufficient data, namely safety, for approval. Furthermore, we expect key efficacy endpoints, beyond sUA reductions, to include benefit in flare rate, thus allowing a broader label and potentially encompassing all gout patients.”

Nine months ago Ardea netted proceeds of about $77.1 million in a public offering of about 4 million shares. (See BioWorld Today, April 7, 2010.)

There are limited treatment options currently on the shelves for gout. Allopurinol has been the standard of care with Osaka, Japan-based Takeda Pharmaceutical Co. Ltd.’s xanthine oxidase inhibitor Uloric (febuxostat) gaining approval early in 2009. Savient Pharmaceuticals Inc., of East Brunswick, N.J., gained FDA approval in September 2010 for Krystexxa (pegloticase), a pegylated uric acid-specific enzyme for chronic refractory gout. (See BioWorld Today, Sept. 16, 2010.)

Beyond its gout program and MEK inhibitor partnership with Bayer, Ardea also has a Phase II-stage HIV program testing RDEA806, a non-nucleoside reverse transcriptase inhibitor.

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Pain Management News

2010-12-16 / Pain Management / 1 Comments

Boston Scientific takes pain management unit off the auction block

Boston Scientific Corp.’s neuromodulation business, in which Stryker Corp. was rumored to be interested, is reportedly no longer for sale.

Boston Scientific Corp. (NYSE:BSX) is still stuck with its pain management business.

The Natick, Mass.-based medical device giant was rumored to be looking to offload its neuromodulation unit for about $1.5 billion over the summer, with Stryker Corp. (NYSE:SYK) said to be a leading suitor.

Johnson & Johnson (NYSE:JNJ) also looked into buying the business, but not for much more than $1 billion, according to Bloomberg. Stryker reached “advanced talks” for a transaction in August, according to various news reports, but the companies reportedly couldn’t agree on the value of business.

Boston Scientific spent most of 2010 trying to drum up interest in its neuromodulation and neurovascular businesses. Kalamazoo, Mich.-based Stryker agreed to pay $1.5 billion in cash for the neurovascular unit on Oct. 28, surprising some analysts.

Cochlear developer’s new pain management breakthrough

by Gillian Samuel Monday 13 December 2010 10:55 am

Cochlear former chief technical officer Dr John Parker is leading development of a world-first smartchip to treat chronic pain.

NICTA, Australia’s ICT Research Centre of Excellence, is preparing to run medical trials on the miniature implant device in human patients next year.

The INS2, which stands for Implantable Neuro Sensing and Stimulation, comprises a smartchip embedded in a biocompatible device smaller than a match head, which is sewn into a 1.2mm wide lead made of polymer yarn integrated with electronic wires.

This is implanted in the spine or another suitable location and connected to a central battery-powered intelligent computer processor, around the size of a mobile phone SIM card, which is also implanted in the body. Previous designs involved cumbersome external components and leads.

The INS2 measures nerve impulses and uses electric pulses to block their signals to the brain. “There is real potential for this device to not only be used to treat things like chronic back pain, lower limb pain and pain from nerve damage, but also conditions like migraine headaches and even help ease Parkinson’s disease tremors or epileptic seizures,” Dr Parker said.

NICTA, which is funded by the NSW and Commonwealth governments, plans to manufacture the pain management technology through a commercial spin-out company, Saluda Medical.

Precision Pain & Rehab cuts ribbon

The Rehoboth Beach-Dewey Beach Chamber of Commerce held a ribbon-cutting ceremony for Precision Pain & Rehabilitation Specialists Dec. 2.

Members of the Rehoboth Beach-Dewey Beach Meet & Greet Committee were present to help Precision Pain & Rehabilitation Specialists celebrate its new location in the Rehoboth Beach-Dewey Beach resort area.

Located in the Summit Office Suites at 18958 Coastal Highway in Rehoboth, Precision Pain & Rehabilitation Specialists was opened by Dr. Jeffrey Conly. Conly specializes in pain management, and has special training in the use of x-ray guided injections, EMG/Nerve testing, medication management and rehabilitative techniques.

He is also one of the first physicians in the Rehoboth Beach-Dewey Beach area trained in the use of spinal cord stimulation in the treatment of chronic pain.

Conly is fellowship trained and double-board certified in pain medicine as well as physical medicine and rehabilitation. Most forms of insurance are accepted and the office is currently accepting new patients.

For more information, or for an appointment, call 827-2323.

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Arthritis Treatment Today

2010-12-11 / Pain Management / 0 Comments

Starfish Slime Could Hold Key To New Treatment For Asthma, Arthritis

A non-stick slime made by starfish may lead to new treatments for asthma, arthritis, hay fever and other inflammatory conditions, say marine biologists in Scotland.

The scientists, from the Scottish Association for Marine Science (SAMS) in Oban, Argyll, have been studying the slime produced by the spiny starfish, Marthasterias glacialis, commonly found in the waters around Scotland and other parts of the British Isles, and say it could be vital for treating human infections.

Lead researcher Dr Charlie Bavington, founder and managing director of Glycomar, a marine biotechnology company based at SAMS, has been talking to the media about their work.

In an interview with the BBC aired on Thursday 9 December, he demonstrated how the starfish produced the slime: he took a starfish with a span of about 30 cm or 12 in out of a tank, held it, after a few seconds the slime began visibly to ooze from the creature’s spiny body.

The slime is a defence mechanism and also prevents debris from sticking to the starfish.

Bavington said the compound they were interested in was only part of the starfish’s “goo”; he showed BBC reporter Rebecca Morelle the purified compound, which looks like a white powder, and explained that they are planning to work with chemists to produce a man-made version.

They are hoping that the compound can do for blood vessels what it does for the starfish: stop things sticking to them.

Inflammatory conditions like asthma and arthritis are what happens when the body’s natural immune response to infection overreacts and white blood cells stick to and build up on the inside walls of blood vessels, damaging tissue.

Starfish are continually bathed in micro-organisms, bacteria, larvae, and viruses looking to set up camp on their spiny skin. But the slime that they secrete protects them from this continual onslaught by making their skin too slippery:

“… starfish are better than Teflon: they have a very efficient anti-fouling surface that prevents things from sticking,” said Bavington, according to a report in The Scotsman.

He said they want to see if the compounds they have isolated from the starfish slime could be developed into a drug that coats blood vessels to create the same effect and allow white blood cells to flow through without sticking to the sides.

“In humans cells stick from a flowing medium to a blood vessel wall, so we thought we could learn something from how starfish prevent this so we could find a way to prevent it in humans,” explained Bavington.

Clive Page, professor of pharmacology at King’s College London, is working with Bavington on this. He said discovering this substance in the starfish slime has dramatically shortened the usual timescale for developing a new treatment:

“The starfish have effectively done a lot of the hard work for us,” said Page, explaining that normally scientists have to screen hundreds of compounds before they find such a lead.

The starfish has had “billions of years in evolution to come up with molecules that do specific things,” he added.

The field of research that this kind of discovery belongs to is called glycobiology, a branch of biology that studies the structure, biosynthesis and function of sugar chains or saccharides, for which there is increasing interest because of the important role they play in cells.

Saccharides exist on cell surfaces, they mediate interaction between cells, and also between cells and the extracellular matrix and effector molecules.

Studies in this field are opening up possibilities for the discovery of new drugs made from saccharides or other molecules that target the biosynthesis and function of saccharides.

Managing inflammatory arthritis treatment for adults and children

Dr David Kane provides an update from the Irish Society for Rheumatology Annual Scientific Meeting, where delegates heard about advances in biological therapy and other care developments

The Irish Society for Rheumatology Winter Meeting was held at Killiney Castle on September 23-24 last. The theme of the meeting was ‘The Management of Inflammatory Arthritis in Adults and Children’. The meeting highlighted the major advances that have been made in the care of adults and children with inflammatory arthritis, particularly as a result of novel developments in biological therapy.

Importance of early treatment
Rheumatoid arthritis (RA) is estimated to affect 45,000 people in Ireland, with 2,250 new cases diagnosed each year. Some 75 per cent of these patients are of working age; 30 per cent of patients stop work within one year due to the effects of rheumatoid arthritis, with this increasing to 50 per cent at three years.

Dr Patrick Kiely of St George’s Hospital in London outlined the new paradigm of early, aggressive therapy in RA. Two pivotal studies published by Lard and Nell confirmed that there is an early window of opportunity to treat patients within the first three months of symptoms.

These patients should be commenced at the earliest opportunity on immunomodulatory therapy (disease modifying anti-rheumatic drugs) and/or steroids to obtain control of joint inflammation.

The benefits of early control of joint inflammation in preventing joint damage will persist for many years. However, in patients who have a delay in obtaining treatment for rheumatoid arthritis, there is clear evidence that they will have worse outcomes in terms of function, disability and radiological damage. There are three factors in the delay in obtaining treatment for rheumatoid arthritis.

In the early rheumatoid arthritis network in the United Kingdom, patients waited an average of four months before they sought a GP opinion for their joint pains. There was a second delay from the initial consultation with their GP before a referral to a rheumatologist was made. There was a third delay from referral to achieving the appointment with a rheumatologist.

Clearly, if strategies can be implemented to make patients aware to consult their GPs earlier, and if GPs can access the early arthritis referral pathways present in most Irish hospitals, then the possibility of treating people within the first three months of symptoms could be attainable. Most Irish hospitals now have early inflammatory arthritis referral criteria and designated rapid-access clinics or appointments.

The Fin-RACo study showed the treatment of RA within the first four months of diagnosis led to remission of 40 per cent, but treatment after four months led to remission of just 10 per cent. With remission, the new target of rheumatoid arthritis therapy, the consensus was that more work must be focused not just on earlier rheumatology appointments, but also on patient education.

The choice of treatment is also critical. Immunomodulatory treatment with disease-modifying, anti-rheumatic drugs should be started immediately on making the diagnosis of rheumatoid arthritis.

EULAR guidelines suggest the use of methotrexate, while recent NICE guidelines recommend a combination of methotrexate and sulfasalazine or another DMARDs.
Both EULAR and NICE guidelines recommend initial use of corticosteroids, either oral or intramuscular, to obtain rapid symptom control and to maintain patients at their usual level of social function.

Treat to target: remission
In addition to early treatment with immunomodulatory drugs, there is clear evidence that patients should be seen very frequently at the early stages of the disease and treated according to standardised protocols to obtain remission of joint symptoms. This requires practice change, whereby formal disease activity scores are recorded in patients at each visit, with therapy escalated until the disease activity score is less than 2.6 in early disease and 3.2 in established disease.

The optimal frequency in the TICORA study was one-monthly review of patients until they had obtained remission. Recent data from the RAISE study in Ireland suggest that most patients get an appointment on average of every six months, probably due to issues of capacity within the current system. The consensus was that any service reconfiguration in the future must accommodate frequent visits for patients with new or unstable rheumatoid arthritis until therapeutic target has been obtained.

The gains highlighted were clear, with a change from previous remission rates of approximately 10 per cent to a potential remission rate of 70 per cent using these. Dr Andrew Oster of Addenbrooke’s Hospital, Cambridge, reviewed the data on anti-TNF therapy. There are now five licensed anti-TNF therapies: adalimumab, etanercept, infliximab, golimumab and certolizumab.

All have proven efficacy in not just rheumatoid arthritis but also in psoriatic arthritis, ankylosing spondylitis and other inflammatory conditions. Dr Oster reviewed data from the ATTRACT, PREMIER and ARMADA studies, all of which demonstrate superiority to traditional disease-modifying, anti-rheumatic drugs. The Quinn study also suggests that the earlier these are introduced, the greater the potential to induce remission in patients with rheumatoid arthritis. Further data from the Irish RAISE study demonstrated the beneficial effects of these drugs in Irish patients.

In addition to the anti-TNF therapies, rheumatologists have the option to use anti-IL6 therapy (tocilizumab), anti-B cell therapy (rituximab) and anti-T cell therapy (abatacept).

Dr Oster reviewed the data from the REFLEX, ATTAIN and RADIATE studies demonstrating that all of these agents were effective when used in rheumatoid arthritis, with equivalent efficacies. Selection of optimal therapy for the patient depends on specific features of their disease activity and co-morbidities. There has been a revolutionary change in the management of RA now that eight novel, extremely efficacious biologic agents exist.

Managing co-morbidity and preventing premature mortality
Rheumatoid arthritis causes inflammation and damage of the joints. Most doctors, however, are unaware that most patients with RA will have a reduced life expectancy if the disease is inadequately controlled. It is expected that with the newer therapeutic approaches that the standard of treatment will improve and the frequency of co-morbidities of osteoporosis and coronary disease will diminish. At present, however, established rheumatoid arthritis patients must be viewed as being at significantly increased risk of coronary artery disease and osteoporotic fractures.

Advances in osteoporosis therapy
Prof Eugene McCloskey of the University of Sheffield reviewed the treatment of rheumatoid arthritis-related osteoporosis fractures. It is essential that doctors now recognised that patients with rheumatoid arthritis have an increased risk for osteoporotic fractures. The FRAX score has been developed for clinical diagnosis of osteoporosis within a primary care setting. It is available from By entering clinical data, the 10-year risk of all fractures and the 10-year risk of hip fracture can be calculated, allowing a decision on osteoporosis treatment.

Rheumatoid arthritis is an independent risk in the FRAX model, highlighting the strong association between rheumatoid arthritis and osteoporotic fractures.

Treatment for rheumatoid
arthritis-related osteoporosis
1. Antiresorptive: Oestrogen/SERMS; Bisphosphonate; Calcitonin
2. Calcium/vitamin D/calcitriol
3. RANK ligand targeted therapy
4. Anabolic therapy: Parathyroid hormone
5. Novel action: Strontium ranelate

Prof McCloskey outlined all of the available therapies for osteoporosis, particularly in the setting of rheumatoid arthritis. Currently, bisphosphonates, calcium and vitamin D are the mainstay of therapy. However, he presented data on a novel agent denosumab, which acts by inhibiting osteoclast formation.

Data in the FREEDOM trial demonstrated that three years of denosumab therapy produced a reduced risk of vertebral fracture (68 per cent), non-vertebral fracture (20 per cent) and hip fracture (40 per cent). The therapy is administered by two six-monthly subcutaneous injections, which were felt to improve patients’ compliance.
Added benefits may exist in rheumatoid arthritis where inhibition of osteoclast function has been shown to reduce the development of bone erosion, a key feature of rheumatoid joint damage.

Managing cardiovascular disease
Dr Vincent Maher of the Adelaide and Meath Hospital, Dublin, reviewed the increased risk of coronary heart disease and sudden death that exists in rheumatoid arthritis. Patients with rheumatoid arthritis have had a threefold increase in the incidence of acute myocardial infarction and a twofold increase in the incidence of sudden death. This appears to be related to therapy in the pre-biologic age and there is much hope from initial studies that more effective biological therapy may reduce the risk of coronary artery disease. This remains to be proven.

At present, rheumatoid arthritis patients must be viewed at a high risk for coronary artery disease and should have regular cardiovascular assessment, including lipid profile and blood pressure. Dr Maher pointed out that the patient with rheumatoid arthritis may not present with the usual angina pectoris symptoms due to their reduced capacity for exercise.

Thus, traditional tests such as stress ECG may be limited, while newer modalities – such as CT coronary angiography – are likely to become more widely available, given the combination of high accuracy and the non-invasive nature of the test.

Economic and social impact
Prof Carol Black, the National Director for Health and Work in the UK, presented an overview of work and musculoskeletal diseases. Musculoskeletal disease is the second-leading cause of sickness absence and long-term incapacity in Ireland, with an estimated 14,000,000 working days lost last year due to ill health overall.
It is estimated that the direct cost of musculoskeletal disease due to sickness absence and disability is € 750,000,000 per annum in Ireland.

Rheumatoid arthritis in particular is a serious concern to rheumatologists, as only 22 per cent of rheumatoid arthritis patients in Ireland remain in full-time employment. There is now clear evidence that intervention in the first few months of disease has a major impact on maintaining rheumatoid arthritis patients in the workforce.

While there are obvious economic benefits to this, it is important to realise that work is also a strong social determinant of health. It is imperative that the patients with all musculoskeletal disorders have early intervention to maintain them in the workforce.

Replacing the sick note
In the UK, the ‘sick note’ is being replaced with the ‘fit note’. This has resulted in the Fit for Work Services, which provide early interventions to actively manage the return of patients with musculoskeletal disorders back to work. The fit note was designed to create a management plan for a return to work, rather than an all-or-nothing scenario practised under the old sick note system.

The fit note outlines directions for a graded return to work, in addition to guidance on hours of work, change of duties and adaptations in which the employer needs to engage. The roll-out of this new scheme has been underpinned with planned changes within undergraduate and postgraduate training so that GPs can play a more active role in managing work disabilities.

Prof Black advocated a fit-for-work programme for Ireland that would involve a national plan for musculoskeletal disorders led by a national clinical director. She recommended a change from our current sick-note system to a fit note, with early diagnosis and management of sickness absence due to musculoskeletal disorders.

Arthritis in children
Prof Helen Foster outlined the current state of managing inflammatory arthritis in children. The commonest condition is juvenile inflammatory arthritis which, like many adult diseases, was previously thought to be relatively benign. It is estimated that there are 1,000 juvenile inflammatory arthritis patients in paediatric services in Ireland and 700 adult patients with juvenile inflammatory arthritis.

It is now clear that juvenile inflammatory arthritis is a chronic disorder that is not benign. Joint damage occurs early and it is recognised that early aggressive treatment provides a window of opportunity to obtain tight control and better outcome in terms of overall health and functioning for children with inflammatory arthritis. Methotrexate is the drug of choice in juvenile inflammatory arthritis, but all of the biologic agents used in adults are currently being used in juvenile inflammatory arthritis with good results.

There are many challenges for these children as they grow up, with 1/3 continuing to have active disease and 1/3 having disability problems, despite eventually going into remission of inflammation. Adult patients with JRA are best managed by a transition model run by paediatric and adult rheumatologists. It was highlighted that there is only one paediatric rheumatologist through the whole of Ireland, which makes provision of these services extremely difficult.

The lack of services for children prevents implementation of modern standards of therapy, thus exposing paediatric patients to irreversible loss of joint damage and function, with consequent high risk of permanent disability.

Joint replacement might be best arthritis treatment

December 8, 2010 — Arthritis is a group of conditions involving damage to the joints of the body. There are more than 100 different forms of arthritis.

The most common form, osteoarthritis, is a result of trauma to the joint, infection of the joint – or age. Other arthritis forms are rheumatoid arthritis, psoriatic arthritis, and autoimmune disease.

Arthritis is the most common cause of disability in the United States. More than 20 million people with arthritis have severe limitations that affect their function on a daily basis. Each year, arthritis results in nearly 1,000,000 hospitalizations and close to 45,000,000 outpatient visits to health care centers.

Causes of arthritis include injury metabolic abnormalities, hereditary factors, the direct and indirect effect of infections and a misdirected immune system with autoimmunity. Symptoms of arthritis include pain, limited function of joints, and inflammation of the joints, which is characterized by joint stiffness, swelling, redness, and warmth. (SOURCE: The Arthritis Foundation)

MYTHS: How much do you really know about arthritis? Did you know it’s a two billion dollar a year business?

Many medications promise miracle cures, but doctors say a quick fix with unproven pills, devices, and minimally invasive surgery may be a waste of money if you have an advanced form of arthritis.

The best option: joint replacement surgery.

When joint replacement surgery occurs, the artificial surfaces of the joint replacement are shaped in such a way as to allow joint movement similar to that of a healthy natural joint.


The truth: Some forms of arthritis do mainly affect elderly people, including the most common, osteoarthritis. Yet many types can affect younger people, and joint injuries at any age can lead to osteoarthritis. Currently more than half of the population with arthritis is under 65.


The truth: Many people with arthritis believe that cold and dampness can set off joint symptoms. Indeed, according to the Arthritis Foundation, nearly half of arthritis patients think their flare up happens when they have to take their sweaters out off the closet.


The truth: Regular moderate exercise can help prevent and treat arthritis. Exercise promotes function and mobility, controls weight and strengthens the muscles that support the joints. Though you may want to avoid high-impact exercises if your knees bother you, low-impact exercises such as walking, tai chi or aquatics are all beneficial. Talk to your physician about the best exercise regimen for you. Pool therapy has been shown to cause improvement in mobility in arthritic joints.

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